2014 Interim Guidance on Patent Subject Matter Eligibility, 74618-74633 [2014-29414]

Download as PDF 74618 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required. significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations. National Environmental Policy Act This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C) et seq). Small Business Regulatory Enforcement Fairness Act This rule is not a major rule under 5 U.S.C. 804(2), of the Small Business Regulatory Enforcement Fairness Act. This rule: a. Does not have an annual effect on the economy of $100 million. b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule. Paperwork Reduction Act This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Regulatory Flexibility Act The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a Unfunded Mandates This rule will not impose an unfunded Mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the federal regulation did not impose an unfunded mandate. List of Subjects in 30 CFR Part 934 Intergovernmental relations, Surface mining, Underground mining. Dated: July 1, 2014. Ervin Barchenger, Acting Director, Western Region. Editorial note: This document was received for publication by the Office of Federal Register on December 10, 2014. For the reasons set out in the preamble, 30 CFR part 934 is amended as set forth below: PART 934—NORTH DAKOTA 1. The authority citation for part 934 continues to read as follows: ■ Authority: 30 U.S.C. 1201 et seq. 2. Section 934.15 is amended in the table by adding a new entry in chronological order by ‘‘Date of Final Publication’’ to read as follows: ■ § 934.15 Approval of North Dakota regulatory program amendments. * * * * Original amendment submission date Date of final publication * * * November 14, 2012 ............................................................ * * * December 16, 2014 ........................................................... (a)–(cc) [Reserved] 3. Section 934.16 is republished to read as follows: [FR Doc. 2014–29384 Filed 12–15–14; 8:45 am] § 934.16 BILLING CODE 4310–05–P tkelley on DSK3SPTVN1PROD with RULES ■ Required program amendments. 16:25 Dec 15, 2014 Jkt 235001 PO 00000 Citation/description NDAC NDAC NDAC NDAC NDAC NDAC NDAC NDAC NDAC * 69–05.2–05–02 69–05.2–05–08 69–05.2–06–01 69–05.2–06–02 69–05.2–10–01 69–05.2–10–03 69–05.2–10–07 69–05.2–10–08 69–05.2–10–09 DEPARTMENT OF COMMERCE Pursuant to 30 CFR 732.17(f)(1), North Dakota is required to submit to OSM by the specified date the following written, proposed program amendment, or a description of an amendment to be proposed that meets the requirements of SMCRA and 30 CFR Chapter VII and a timetable for enactment that is consistent with North Dakota’s established administrative or legislative procedures. VerDate Sep<11>2014 * United States Patent and Trademark Office 37 CFR Part 1 [Docket No. PTO–P–2014–0058] 2014 Interim Guidance on Patent Subject Matter Eligibility United States Patent and Trademark Office, Commerce. AGENCY: Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\16DER1.SGM 16DER1 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations Examination guidance; request for comments. ACTION: The United States Patent and Trademark Office (USPTO or Office) has prepared interim guidance (2014 Interim Guidance on Patent Subject Matter Eligibility, called ‘‘Interim Eligibility Guidance’’) for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101 in view of recent decisions by the U.S. Supreme Court (Supreme Court). This Interim Eligibility Guidance supplements the June 25, 2014, Preliminary Examination Instructions in view of the Supreme Court decision in Alice Corp. (June 2014 Preliminary Instructions) and supersedes the March 4, 2014, Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products (March 2014 Procedure) issued in view of the Supreme Court decisions in Myriad and Mayo. The USPTO is seeking public comment on this Interim Eligibility Guidance along with additional suggestions on claim examples for explanatory example sets. DATES: Effective Date: This Interim Eligibility Guidance is effective on December 16, 2014. This Interim Eligibility Guidance applies to all applications filed before, on or after December 16, 2014. Comment Deadline Date: To be ensured of consideration, written comments must be received on or before March 16, 2015. ADDRESSES: Comments on this Interim Eligibility Guidance must be sent by electronic mail message over the Internet addressed to: 2014_interim_ guidance@uspto.gov. Electronic comments submitted in plain text are preferred, but also may be submitted in ADOBE® portable document format or MICROSOFT WORD® format. The comments will be available for viewing via the Office’s Internet Web site (https:// www.uspto.gov). Because comments will be made available for public inspection, information that the submitter does not desire to make public, such as an address or phone number, should not be included in the comments. FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, Office of Patent Legal Administration, by telephone at 571–272–7728, or Michael Cygan, Senior Legal Advisor, Office of Patent Legal Administration, by telephone at 571–272–7700. SUPPLEMENTARY INFORMATION: Section 2106 of the Manual of Patent Examining Procedure (MPEP) sets forth guidance tkelley on DSK3SPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 (9th ed. 2014). The USPTO has prepared this Interim Eligibility Guidance for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101 in view of recent decisions by the Supreme Court. The following Interim Eligibility Guidance on patent subject matter eligibility under 35 U.S.C. 101 supplements the June 25, 2014, Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.1 (June 2014 Preliminary Instructions) and supersedes the March 4, 2014, Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products (March 2014 Procedure) 2 issued in view of the Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc.3 and Mayo Collaborative Services v. Prometheus Laboratories Inc.4 Implementation of examination guidance on eligibility will be an iterative process continuing with periodic supplements based on developments in patent subject matter eligibility jurisprudence 5 and public feedback. The USPTO is seeking written comments on this guidance, as well as additional suggestions for claim examples to use for examiner training. Further, the USPTO plans to hold a public forum in mid-January 2015 in 1 Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. __, 134 S. Ct. 2347 (2014). 2 This analysis differs from the March 2014 Procedure in certain respects. Note, for example, the test for determining whether a claim is directed to a ‘‘product of nature’’ exception is separated from the analysis of whether the claim includes significantly more than the exception. Also, the application of the overall analysis is based on claims directed to judicial exceptions (defined as claims reciting the exception, i.e., set forth or described), rather than claims merely ‘‘involving’’ an exception. For instance, process claims that merely use a nature-based product are not necessarily subject to an analysis for markedly different characteristics. Additionally, the markedly different analysis focuses on characteristics that can include a product’s structure, function, and/or other properties as compared to its naturally occurring counterpart in its natural state. 3 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013). 4 Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. __, 132 S. Ct. 1289 (2012). 5 The Court of Appeals for the Federal Circuit has a number of pending appeals that could result in further refinements to the eligibility guidance, including for example, University of Utah Research Foundation v. Ambry Genetics Corp. (In re BRCA1& BRCA2-Based Hereditary Cancer Test Patent Litigation), No. 14–1361 (Fed. Cir. filed Mar. 18, 2014), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 14–1139 (Fed. Cir. filed Dec. 4, 2013). PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 74619 order to discuss the guidance and next steps and to receive additional oral input. When the date and location are finalized, notice of the forum will be provided on the Office’s Internet Web site (https://www.uspto.gov). This Interim Eligibility Guidance does not constitute substantive rulemaking and does not have the force and effect of law. This Interim Eligibility Guidance sets out the Office’s interpretation of the subject matter eligibility requirements of 35 U.S.C. 101 in view of recent decisions by the Supreme Court and the U.S. Court of Appeals for the Federal Circuit (Federal Circuit), and advises the public and Office personnel on how these court decisions impact the provisions of MPEP 2105, 2106 and 2106.01. This Interim Eligibility Guidance has been developed as a matter of internal Office management and is not intended to create any right or benefit, substantive or procedural, enforceable by any party against the Office. Rejections will continue to be based upon the substantive law, and it is these rejections that are appealable. Failure of Office personnel to follow this Interim Eligibility Guidance is not, in itself, a proper basis for either an appeal or a petition. This Interim Eligibility Guidance offers a comprehensive view of subject matter eligibility in line with Alice Corp, Myriad, Mayo, and the related body of case law, and is responsive to the public comments received pertaining to the March 2014 Procedure and the June 2014 Preliminary Instructions (see the Notice of Forum on the Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, and Natural Products, 79 FR 21736 (Apr. 17, 2014) and the Request for Comments and Extension of Comment Period on Examination Instruction and Guidance Pertaining to Patent-Eligible Subject Matter, 79 FR 36786 (June 30, 2014)). In conjunction with this Interim Eligibility Guidance, a set of explanatory examples relating to nature-based products is being released to replace the prior examples issued with the March 2014 Procedure and the related training. The explanatory examples relating to nature-based products address themes raised in the public comments and adopt many suggestions from the comments. Additional explanatory example sets relating to claims that do and do not amount to significantly more than a judicial exception are being developed and will be issued at a future date, taking into account suggestions already received from the public comments, E:\FR\FM\16DER1.SGM 16DER1 74620 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations tkelley on DSK3SPTVN1PROD with RULES future public comments, and any further judicial developments. The June 2014 Preliminary Instructions superseded MPEP sections 2106(II)(A) and 2106(II)(B). MPEP 2105 is also superseded by this Interim Eligibility Guidance to the extent that it suggests that ‘‘mere human intervention’’ necessarily results in eligible subject matter. MPEP 2106.01 is additionally now superseded with this interim guidance. Examiners should continue to follow the MPEP for all other examination instructions. The following sections pertain to examining for patent subject matter eligibility with details on determining what applicant invented and making a rejection under 35 U.S.C. 101 and should be reviewed closely as they are not duplicated in this Interim Eligibility Guidance: • MPEP 2103: Patent Examination Process D 2103(I): Determine What Applicant Has Invented and Is Seeking to Patent D 2103(II): Conduct a Thorough Search of the Prior Art D 2103(III): Determine Whether the Claimed Invention Complies With VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 35 U.S.C. 101 D 2103(IV): Evaluate Application for Compliance With 35 U.S.C. 112 D 2103(V): Determine Whether the Claimed Invention Complies With 35 U.S.C. 102 and 103 D 2103(VI): Clearly Communicate Findings, Conclusions, and Their Bases • MPEP 2104: Patentable Subject Matter • MPEP 2105: Patentable Subject Matter—Living Subject Matter 6 • MPEP 2106: Patent Subject Matter Eligibility D 2106(I): The Four Categories of Statutory Subject Matter D 2106(II): Judicial Exceptions to the Four Categories (not subsections (II)(A) and (II)(B)) D 2106(III): Establish on the Record a Prima Facie Case 6 To the extent that MPEP 2105 suggests that mere ‘‘human intervention’’ necessarily results in eligible subject matter, it is superseded by this Interim Eligibility Guidance. As explained herein, if human intervention has failed to confer markedly different characteristics on a product derived from nature, that product is a judicial exception (a product of nature exception). See generally Myriad; In re Roslin Inst. (Edinburgh), 750 F.3d. 1333 (Fed. Cir. 2014). PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 The current version of the MPEP (9th ed., March 2014) incorporates patent subject matter eligibility guidance issued as of November 2013. This Interim Eligibility Guidance is divided into the following sections: Flowchart: Eligibility Test for Products and Processes; Part I: Two-part Analysis for Judicial Exceptions; Part II: Complete Examination; Part III: Sample Analysis; and Part IV: Summaries of Court Decisions Relating to Laws of Nature, Natural Phenomena, and Abstract Ideas. The following flowchart illustrates the subject matter eligibility analysis for products and processes to be used during examination for evaluating whether a claim is drawn to patenteligible subject matter. It is recognized that under the controlling legal precedent there may be variations in the precise contours of the analysis for subject matter eligibility that will still achieve the same end result. The analysis set forth herein promotes examination efficiency and consistency across all technologies. E:\FR\FM\16DER1.SGM 16DER1 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations 74621 SUBJECT MATTER ELIGIBILITY TEST FOR PRODUCTS AND PROCESSES PRIOR TO EVALUATING A CLAIM FOR PATENTABILITY, ESTABLISH THE BROADEST REASONABLE INTERPRETATION OF THE CLAIM ANALY2E THE CLAIM AS A WHOLE WHEN EVALUATING FOR PATENTABILITY. ( Step 1) IS THE CLAIM TO A PROCESS, MACHINE, MANUFACTURE OR COMPOSITION OF MATTER? NO YES (Step 2A) [PART 1 Mayo test] NO IS THE CLAIM DIRECTED TO A LAW OF NATURE, A NATURAL PHENOMENON, OR AN ABSTRACT IDEA ( JUDICIALLY RECOGNIZED EXCEPTIONS) ? YES (Step 2B) [PART 2 Mayo test] DOES THE CLAIM RECITE ADDITIONAL ELEMENTS THAT AMOUNT TO SIGNIFICANTLY MORE THAN THE JUDICIAL EXCEPTION? YES CLAIM QUALIFIES AS ELIGIBLE SUBJECT MATTER UNDER 35 usc 101 NO CLAIM IS NOT ELIGIBLE SUBJECT MATTER UNDER 35 USC 101 IN ACCORDANCE WITH COMPACT PROSECUTION, ALONG WITH DETERMINING ELIGIBILITY, ALL CLAIMS ARE TO BE FULLY EXAMINED UNDER EACH OF THE OTHER PATENTABILITY REQUIREMENTS: 35 USC §§ 102, 103, 112, and 101 ( UTILITY, INVENTORSHIP, DOUBLE PATENTING) AND NON- STATUTORY DOUBLE PATENTING. 2014 Interim Eligibility Guidance: In accordance with the existing two-step analysis for patent subject matter eligibility under 35 U.S.C. 101 explained in MPEP 2106, the claimed invention (Step 1) ‘‘must be directed to VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 one of the four statutory categories’’ and (Step 2) ‘‘must not be wholly directed to subject matter encompassing a judicially recognized exception.’’ Referring to the attached flowchart titled Subject Matter Eligibility Test for Products and PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 Processes, Step 1 is represented in diamond (1), which is explained in MPEP 2106(I). Step 2 is represented in diamonds (2A) and (2B) and is the subject of this Interim Eligibility Guidance. Step 2 is the two-part E:\FR\FM\16DER1.SGM 16DER1 ER16DE14.031</GPH> tkelley on DSK3SPTVN1PROD with RULES Notable changes from prior guidance: • All daims ( product and process) with a judidal exception ( any type) are subject to the same steps. • Oaims induding a nature- based product are analyzed in Step 2A to identify whether the daim is directed to ( recites) a "product of nature" exception. This analysis compares the nature- based product in the daim to its naturally occurring counterpart to identify markedly different characteristics based on structure, function, and/ or properties. The analysis proceeds to Step 2B only when the daim is directed to an exception (when no markedly different characteristics are shown) . 74622 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations analysis from Alice Corp.7 (also called the Mayo test) for claims directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions). I. Two-Part Analysis for Judicial Exceptions A. Flowchart Step 2A (Part 1 Mayo Test)—Determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea (judicial exceptions). After determining what applicant has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation (MPEP 2103), determine whether the claim as a whole is directed to a judicial exception. A claim to a process, machine, manufacture or composition of matter (Step 1: YES) that is not directed to any judicial exceptions (Step 2A: NO) is eligible and needs no further eligibility analysis. A claim that is directed to at least one exception (Step 2A: YES) requires further analysis to determine whether the claim recites a patent-eligible application of the exception (Step 2B). 1. Determine What the Claim Is ‘‘Directed to’’ A claim is directed to a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim. Such a claim requires closer scrutiny for eligibility because of the risk that it will ‘‘tie up’’ 8 the excepted subject matter and pre-empt others from using the law of nature, natural phenomenon, or abstract idea. Courts tread carefully in scrutinizing such claims because at some level all inventions embody, use, reflect, rest upon, or apply a law of nature, natural phenomenon, or abstract idea.9 To properly interpret the claim, it is important to understand what the 7 Alice Corp., 134 S. Ct. at 2355. 132 S. Ct. at 1301 (‘‘[E]ven though rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, those laws and principles, considered generally, are ‘the basic tools of scientific and technological work.’ And so there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to ‘apply the natural law,’ or otherwise forecloses more future invention than the underlying discovery could reasonably justify’’ (quoting Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). 9 An invention is not rendered ineligible for patent simply because it involves an abstract concept. Applications of such concepts ‘‘to a new and useful end,’’ remain eligible for patent protection. Alice Corp., 134 S.Ct. at 2354 (quoting Benson, 409 U.S. at 67). tkelley on DSK3SPTVN1PROD with RULES 8 Mayo, VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 applicant has invented and is seeking to patent. For claims that may recite a judicial exception, but are directed to inventions that clearly do not seek to tie up the judicial exception, see Section I.B.3. regarding a streamlined eligibility analysis. 2. Identify the Judicial Exception Recited in the Claim MPEP 2106(II) provides a detailed explanation of the judicial exceptions and their legal bases. It should be noted that there are no bright lines between the types of exceptions because many of these concepts can fall under several exceptions. For example, mathematical formulas are considered to be an exception as they express a scientific truth, but have been labelled by the courts as both abstract ideas and laws of nature. Likewise, ‘‘products of nature’’ are considered to be an exception because they tie up the use of naturally occurring things, but have been labelled as both laws of nature and natural phenomena. Thus, it is sufficient for this analysis to identify that the claimed concept aligns with at least one judicial exception. Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/ substances and substances that do not have markedly different characteristics compared to what occurs in nature. See Section I.A.3. for a discussion of the markedly different characteristics analysis used to determine whether a claim that includes a nature-based product limitation recites an exception. The types of concepts courts have found to be laws of nature and natural phenomena are shown by these cases, which are intended to be illustrative and not limiting: • An isolated DNA (Myriad: see Section III, Example 2); • a correlation that is the consequence of how a certain compound is metabolized by the body (Mayo: see Section III, Example 5); • electromagnetism to transmit signals (Morse: 10 see Section IV.A.1.); and • the chemical principle underlying the union between fatty elements and water (Tilghman: 11 see Section IV.A.2.). Abstract ideas have been identified by the courts by way of example, including fundamental economic practices, certain methods of organizing human activities, an idea ‘of itself,’ and mathematical relationships/formulas.12 The types of 10 O’Reilly v. Morse, 56 U.S. 62 (1853). v. Proctor, 102 U.S. 707 (1881). 12 Alice Corp., 134 S. Ct. at 2355–56. 11 Tilghman PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 concepts courts have found to be abstract ideas are shown by these cases, which are intended to be illustrative and not limiting: • Mitigating settlement risk (Alice: see Section III, Example 6); • hedging (Bilski: 13 see Section IV.A.5.); • creating a contractual relationship (buySAFE: 14 see Section IV.C.3.); • using advertising as an exchange or currency (Ultramercial: 15 see Section IV.C.4.); • processing information through a clearinghouse (Dealertrack: 16 see Section IV.B.3.); • comparing new and stored information and using rules to identify options (SmartGene: 17 see Section IV.B.4.); • using categories to organize, store and transmit information (Cyberfone: 18 see Section IV.B.5.); • organizing information through mathematical correlations (Digitech: 19 see Section IV.C.1.); • managing a game of bingo (Planet Bingo: 20 see Section IV.C.2.); • the Arrhenius equation for calculating the cure time of rubber (Diehr: 21 see Section III, Example 3); • a formula for updating alarm limits (Flook: 22 see Section III, Example 4); • a mathematical formula relating to standing wave phenomena (Mackay Radio: 23 see Section IV.A.3.); and • a mathematical procedure for converting one form of numerical representation to another (Benson: 24 see Section IV.A.4.) 3. Nature-Based Products a. Determine Whether the Markedly Different Characteristics Analysis Is Needed To Evaluate a Nature-Based Product Limitation Recited in a Claim Nature-based products, as used herein, include both eligible and 13 Bilski v. Kappos, 561 U.S. 593 (2010). Inc. v. Google, Inc., ___ F.3d ___, 112 USPQ2d 1093 (Fed. Cir. 2014). 15 Ultramercial, LLC v. Hulu, LLC and WildTangent, ___ F.3d ___, 112 USPQ2d 1750 (Fed. Cir. 2014). 16 Dealertrack Inc. v. Huber, 674 F.3d 1315 (Fed. Cir. 2012). 17 SmartGene, Inc. v. Advanced Biological Labs., SA, 555 Fed. Appx. 950 (Fed. Cir. 2014) (nonprecedential). 18 Cyberfone Sys. v. CNN Interactive Grp., 558 Fed. Appx. 988 (Fed. Cir. 2014) (nonprecedential). 19 Digitech Image Tech., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014). 20 Planet Bingo, LLC v. VKGS LLC, ___ Fed. Appx. ___ (Fed. Cir. 2014) (nonprecedential). 21 Diamond v. Diehr, 450 U.S. 175 (1981). 22 Parker v. Flook, 437 U.S. 584 (1978). 23 Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306 U.S. 86 (1939). 24 Benson, 409 U.S. at 63. 14 buySAFE, E:\FR\FM\16DER1.SGM 16DER1 tkelley on DSK3SPTVN1PROD with RULES Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify ‘‘product of nature’’ exceptions. Courts have held that naturally occurring products and some man-made products that are essentially no different from a naturally occurring product are ‘‘products of nature’’ 25 that fall under the laws of nature or natural phenomena exception. To determine whether a claim that includes a nature-based product limitation recites a ‘‘product of nature’’ exception, use the markedly different characteristics analysis to evaluate the nature-based product limitation (discussed in section I.A.3.b). A claim that recites a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state is directed to a ‘‘product of nature’’ exception (Step 2A: YES). Care should be taken not to overly extend the markedly different characteristics analysis to products that when viewed as a whole are not naturebased. For claims that recite a naturebased product limitation (which may or may not be a ‘‘product of nature’’ exception) but are directed to inventions that clearly do not seek to tie up any judicial exception, see Section I.B.3. regarding a streamlined eligibility analysis. In such cases, it would not be necessary to conduct a markedly different characteristics analysis. A nature-based product can be claimed by itself (e.g., ‘‘a Lactobacillus bacterium’’) or as one or more limitations of a claim (e.g., ‘‘a probiotic composition comprising a mixture of Lactobacillus and milk in a container’’). The markedly different characteristics analysis should be applied only to the nature-based product limitations in the claim to determine whether the naturebased products are ‘‘product of nature’’ exceptions. When the nature-based product is produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. In the example above, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately. The container would not be subject to the markedly different characteristics analysis as it is not a nature-based product, but would be evaluated in Step 2B if it is determined that the mixture of Lactobacillus and milk does not have markedly different 25 Myriad, 133 S. Ct. at 2111. VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 characteristics from any naturally occurring counterpart and thus is a ‘‘product of nature’’ exception. For a product-by-process claim, the analysis turns on whether the naturebased product in the claim has markedly different characteristics from its naturally occurring counterpart. (See MPEP 2113 for product-by-process claims.) A process claim is not subject to the markedly different analysis for naturebased products used in the process, except in the limited situation where a process claim is drafted in such a way 26 that there is no difference in substance from a product claim (e.g., ‘‘a method of providing an apple.’’). b. Markedly Different Characteristics Analysis: Structure, Function and/or Other Properties 27 The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. When there is no naturally occurring counterpart to the naturebased product, the comparison should be made to the closest naturally occurring counterpart. In the case of a nature-based combination, the closest counterpart may be the individual nature-based components that form the combination, i.e., the characteristics of the claimed nature-based combination are compared to the characteristics of the components in their natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties,28 and 26 Alice Corp., 134 S. Ct. at 2360. revised analysis represents a change from prior guidance, because now changes in functional characteristics and other non-structural properties can evidence markedly different characteristics, whereas in the March 2014 Procedure only structural changes were sufficient to show a marked difference. 28 To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (‘‘[The inventor did] not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.’’); In re Marden, 47 F.2d 958 (CCPA 1931) (eligibility of a claim to ductile vanadium held ineligible, because the ‘‘ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics’’). Further, a difference in a characteristic that came about or was produced independently of any effort or influence by applicant cannot show a marked difference. Roslin, 750 F.3d at 1338 (Because ‘‘any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee’ ’’ and were ‘‘uninfluenced by Roslin’s efforts’’, they ‘‘do not confer eligibility on their claimed subject matter’’ (quoting Funk Bros.)). 74623 will be evaluated based on what is recited in the claim on a case-by-case basis. As seen by the examples that are being released in conjunction with this Interim Eligibility Guidance, even a small change can result in markedly different characteristics from the product’s naturally occurring counterpart. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product’s naturally occurring counterpart. If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a ‘‘product of nature’’ exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include: • Biological or pharmacological functions or activities; 29 • Chemical and physical properties; 30 • Phenotype, including functional and structural characteristics; 31 and • Structure and form, whether chemical, genetic or physical.32 If the claim includes a nature-based product that has markedly different characteristics, the claim does not recite a ‘‘product of nature’’ exception and is eligible (Step 2A: NO) unless the claim 27 This PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 29 See, e.g., Funk Bros., 333 U.S. at 130–31 (properties and functions of bacteria such as a state of inhibition or non-inhibition and the ability to infect leguminous plants); Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980) (genetically modified bacterium’s ability to degrade hydrocarbons); In re King, 107 F.2d 618 (CCPA 1939) (the ability of vitamin C to prevent and treat scurvy); Myriad, 133 S. Ct. at 2111, 2116–17 (the protein-encoding information of a nucleic acid). 30 See, e.g., Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103–04 (S.D.N.Y. 1911) (the alkalinity of a chemical compound); Marden, 47 F.2d at 958 (the ductility or malleability of metals); Funk Bros., 333 U.S. at 130 (‘‘The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the store-house of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.’’). 31 See, e.g., Roslin, 750 F.3d at 1338 (phenotype, including functional and structural characteristics, e.g., the shape, size, color, and behavior of an organism). 32 See, e.g., Chakrabarty, 447 U.S. at 305 and n.1 (the physical presence of plasmids in a bacterial cell); Parke-Davis, 189 F. at 100, 103 (claimed chemical was a ‘‘nonsalt’’ and a ‘‘crystalline substance’’); Myriad, 133 S. Ct. at 2116, 2119 (nucleotide sequence of DNA); Roslin, 750 F.3d at 1338–39 (the genetic makeup (genotype) of a cell or organism). E:\FR\FM\16DER1.SGM 16DER1 tkelley on DSK3SPTVN1PROD with RULES 74624 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations recites another exception (such as a law of nature or abstract idea, or a different natural phenomenon). If the claim includes a product having no markedly different characteristics from the product’s naturally occurring counterpart in its natural state, the claim is directed to an exception (Step 2A: YES), and the eligibility analysis must proceed to Step 2B to determine if any additional elements in the claim add significantly more to the exception. For claims that are to a single naturebased product, once a markedly different characteristic in that product is shown, no further analysis would be necessary for eligibility because no ‘‘product of nature’’ exception is recited (i.e., Step 2B is not necessary because the answer to Step 2A is NO). This is a change from prior guidance because the inquiry as to whether the claim amounts to significantly more than a ‘‘product of nature’’ exception is not relevant to claims that do not recite an exception. Thus, a claim can be found eligible based solely on a showing that the nature-based product in the claim has markedly different characteristics and thus is not a ‘‘product of nature’’ exception, when no other exception is recited in the claim. If a rejection under 35 U.S.C. 101 is ultimately made, the rejection should identify the exception as it is recited (i.e., set forth or described) in the claim, and explain why it is an exception providing reasons why the product does not have markedly different characteristics from its naturally occurring counterpart in its natural state. B. Flowchart Step 2B (Part 2 Mayo test)—Determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception. A claim directed to a judicial exception must be analyzed to determine whether the elements of the claim, considered both individually and as an ordered combination, are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself—this has been termed a search for an ‘‘inventive concept.’’ 33 To be patent-eligible, a claim that is directed to a judicial exception must include additional features to ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception. It is important to consider the claim as whole. Individual elements 33 Alice Corp., 134 S. Ct. at 2357. VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 viewed on their own may not appear to add significantly more to the claim, but when combined may amount to significantly more than the exception. Every claim must be examined individually, based on the particular elements recited therein, and should not be judged to automatically stand or fall with similar claims in an application. 1. ‘‘Significantly More’’ The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself. The following are examples of these considerations, which are not intended to be exclusive or limiting. Limitations that may be enough to qualify as ‘‘significantly more’’ when recited in a claim with a judicial exception include: • Improvements to another technology or technical field; 34 • Improvements to the functioning of the computer itself; 35 • Applying the judicial exception with, or by use of, a particular machine; 36 • Effecting a transformation or reduction of a particular article to a different state or thing; 37 • Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; 38 or • Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.39 34 Alice Corp., 134 S. Ct. at 2359 (citing Diehr, 450 U.S. at 177–78) (a mathematical formula applied in a specific rubber molding process). 35 Id., at 2359. 36 Bilski, 130 S. Ct. at 3227 (‘‘The Court’s precedents establish that the machine-ortransformation test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101.’’). 37 Diehr, 450 U.S. at 184 (‘‘That respondents’ claims [to a specific rubber molding process] involve the transformation of an article, in this case raw, uncured synthetic rubber, into a different state or thing cannot be disputed.’’). See also Benson, 409 U.S. at 70 (‘‘Transformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines. So it is that a patent in the process of ‘manufacturing fat acids and glycerine from fatty bodies by the action of water at a high temperature and pressure’ was sustained in Tilghman, 102 U.S. at 721’’). 38 Mayo, 132 S. Ct. at 1299, 1302 (claim ineligible because the recited ‘‘instructions add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field,’’ which was ‘‘[u]nlike, say, a typical patent on a new drug or a new way of using an existing drug’’). 39 Alice Corp., 134 S. Ct. at 2360 (noting that none of the hardware recited ‘‘offers a meaningful PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 Limitations that were found not to be enough to qualify as ‘‘significantly more’’ when recited in a claim with a judicial exception include: • Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer; 40 • Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are wellunderstood, routine and conventional activities previously known to the industry; 41 • Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; 42 or • Generally linking the use of the judicial exception to a particular technological environment or field of use.43 Section III provides examples of claims analyzed under this framework. If the claim as a whole does recite significantly more than the exception itself, the claim is eligible (Step 2B: YES), and the eligibility analysis is complete. If there are no meaningful limitations in the claim that transform the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself, the claim is not patent-eligible (Step 2B: NO) and should be rejected under 35 U.S.C. 101. In the rejection, identify the exception by referring to where it is recited (i.e., set forth or described) in the claim and explain why it is considered an exception. Then, if the claim includes additional elements, identify the elements in the rejection and explain why they do not add significantly more to the exception. Also see MPEP limitation beyond generally linking ‘the use of the [method] to a particular technological environment,’ that is, implementation via computers’’ (citing Bilski, 561 U.S. at 610, 611)). 40 Id. at 2358 (simply implementing a mathematical principle on a physical machine, namely a computer (citing Mayo, 132 S. Ct. at 1301)). 41 Id. at 2359 (using a computer to obtain data, adjust account balances, and issue automated instructions); Mayo, 132 S. Ct. at 1300 (telling a doctor to measure metabolite levels in the blood using any known process). 42 Mayo, 132 S. Ct. at 1297–98 (measuring metabolites of a drug administered to a patient); Flook, 437 U.S. at 589–90 (1978) (adjusting an alarm limit variable to a figure computed according to a mathematical formula). 43 Mayo, 132 S. Ct. at 1300–01 (citing Bilski, 130 S. Ct. 3223–24) (limiting hedging to use in commodities and energy markets); Flook, 437 U.S. at 589–90. E:\FR\FM\16DER1.SGM 16DER1 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations 2103(VI) and 2106(III) for instructions on making the rejection. tkelley on DSK3SPTVN1PROD with RULES 2. A Claim Reciting a Plurality of Exceptions For a claim that is directed to a plurality of exceptions, conduct the eligibility analysis for one of the exceptions. If the claim recites an element or combination of elements that amount to significantly more than that exception, consider whether those additional elements also amount to significantly more for the other claimed exception(s), which ensures that the claim does not have a pre-emptive effect with respect to any of the recited exceptions. Additional elements that satisfy Step 2B for one exception will likely satisfy Step 2B for all exceptions in a claim. On the other hand, if the claim fails under Step 2B for one exception, the claim is ineligible, and no further eligibility analysis is needed. 3. Streamlined Eligibility Analysis For purposes of efficiency in examination, a streamlined eligibility analysis can be used for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it. Such claims do not need to proceed through the full analysis herein as their eligibility will be self-evident. However, if there is doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself, the full analysis should be conducted to determine whether the claim recites significantly more than the judicial exception. For instance, a claim directed to a complex manufactured industrial product or process that recites meaningful limitations along with a judicial exception may sufficiently limit its practical application so that a full eligibility analysis is not needed. As an example, a robotic arm assembly having a control system that operates using certain mathematical relationships is clearly not an attempt to tie up use of the mathematical relationships and would not require a full analysis to determine eligibility. Also, a claim that recites a nature-based product, but clearly does not attempt to tie up the nature-based product, does not require a markedly different characteristics analysis to identify a ‘‘product of nature’’ exception. As an example, a claim directed to an artificial hip prosthesis coated with a naturally occurring mineral is not an attempt to tie up the mineral. Similarly, claimed products that merely include ancillary VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 nature-based components, such as a claim that is directed to a cellphone with an electrical contact made of gold or a plastic chair with wood trim, would not require analysis of the nature-based component to identify a ‘‘product of nature’’ exception because such claims do not attempt to improperly tie up the nature-based product. II. Complete Examination Regardless of whether a rejection under 35 U.S.C. 101 is made, a complete examination should be made for every claim under each of the other patentability requirements: 35 U.S.C. 102, 103, 112, and 101 (utility, inventorship and double patenting) and non-statutory double patenting. See MPEP 2103 et seq. and 2106(III). III. Sample Analyses The following examples, based upon Supreme Court decisions, use the Interim Eligibility Guidance and flowchart to analyze claims for subject matter eligibility. Example 1. Diamond v. Chakrabarty 44 (U.S. Patent No. 4,259,444) Background: Stable energy-generating plasmids that provide hydrocarbon degradative pathways exist within certain bacteria in nature. Different plasmids provide the ability to degrade different hydrocarbons, e.g., one plasmid provides the ability to degrade camphor, and a different plasmid provides the ability to degrade octane. Pseudomonas bacteria are naturally occurring bacteria. Naturally occurring Pseudomonas bacteria containing one stable energy-generating plasmid and capable of degrading a single type of hydrocarbon are known. Representative Claim: A bacterium from the genus Pseudomonas containing therein at least two stable energygenerating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway. Analysis: The claim is directed to a statutory category, e.g., a manufacture or composition of matter (Step 1: YES) and recites a nature-based product (a bacterium). To determine whether the claim is directed to a ‘‘product of nature’’ exception, the nature-based product is analyzed using the markedly different characteristics analysis. The claimed bacterium has a different functional characteristic from naturally occurring Pseudomonas bacteria, i.e., it is able to degrade at least two different hydrocarbons as compared to naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon. 44 Chakrabarty, PO 00000 Frm 00041 447 U.S. at 303. Fmt 4700 Sfmt 4700 74625 The claimed bacterium also has a different structural characteristic, i.e., it was genetically modified to include more plasmids than are found in a single naturally occurring Pseudomonas bacterium. The bacterium is new with markedly different characteristics from any found in nature, due to the additional plasmids and resultant capacity for degrading multiple hydrocarbon components of oil. These different functional and structural characteristics rise to the level of a marked difference, and accordingly the claimed bacterium is not a ‘‘product of nature’’ exception. Thus, the claim is not directed to an exception (Step 2A: NO). The claim is eligible. Example 2. Association for Molecular Pathology v. Myriad Genetics, Inc. (U.S. Patent No. 5,747,282) Background: A human gene is a naturally occurring segment of DNA that codes for a protein. In nature, human genes are linked together by covalent bonds to form long chains of DNA called chromosomes. The inventors discovered the location and nucleotide sequence of a naturally occurring human gene called BRCA1. The BRCA1 gene encodes a polypeptide called BRCA1, which helps repair damaged DNA and prevent tumor formation. There are many naturally-occurring mutations in the BRCA1 gene. Some mutations are harmless, but others can dramatically increase a person’s risk of developing breast and ovarian cancer. Knowledge of the location and nucleotide sequence of the BRCA1 gene allows it to be isolated so that it can be studied, manipulated, or used. Isolated genes can be made in two different ways. The first way is to physically remove the gene from its natural location on the human chromosome by breaking two covalent bonds—one on each end of the gene—that connect the gene with the rest of the chromosome in nature. The second way is to synthesize the gene in a laboratory, e.g., by linking together nucleotides to form the naturally occurring sequence of the gene. Both ways result in a gene that is ‘‘isolated’’ from its natural environment, i.e., removed from the chromosome in which it occurs in nature. The BRCA1 gene is about 80,000 nucleotides long, including several introns and several exons. In nature, the BRCA1 polypeptide is produced from the BRCA1 gene through an intermediate product called an mRNA. The natural creation of the BRCA1 mRNA in human cells involves splicing (removal) of the introns, and results in an exons-only molecule. The inventors used the mRNA to create an exons-only E:\FR\FM\16DER1.SGM 16DER1 74626 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations molecule called a complementary DNA (cDNA), which contains the same protein-encoding information as the BRCA1 gene, but omits the non-coding portions (introns) of the gene. The nucleotide sequence of this cDNA was disclosed as SEQ ID NO:1, and the amino acid sequence of the BRCA1 polypeptide as SEQ ID NO:2. Representative Claims: tkelley on DSK3SPTVN1PROD with RULES Claim 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. Claim 2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1. Analysis: The claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES), and recite naturebased products (a DNA). Thus, the markedly different analysis is used to determine if that nature-based product is a ‘‘product of nature’’ exception. Claim 1: The claim encompasses isolated DNA that has the same nucleotide sequence as the naturally occurring BRCA1 gene. The isolation of the claimed DNA results in a different structural characteristic than the natural gene, because the natural gene has covalent bonds on the ends that connect the gene to the chromosome which the claimed DNA lacks. However, the claimed DNA is otherwise structurally identical to the natural gene, e.g., it has the same genetic structure and nucleotide sequence as the BRCA1 gene in nature. The claimed DNA has no different functional characteristics, i.e., it encodes the same protein as the natural gene. Under the holding of Myriad, this isolated but otherwise unchanged DNA is not eligible because it is not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA1 gene. In other words, the claimed DNA is different, but not markedly different, from its naturally occurring counterpart (BRCA 1 gene), and thus is directed to a ‘‘product of nature’’ exception (Step 2A: YES). A claim directed to an exception should be analyzed to determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the exception. Claim 1 does not include any additional features that could add significantly more to the exception (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101. Claim 2: The claim is limited to a DNA having the nucleotide sequence of SEQ ID NO: 1. As disclosed in the specification, SEQ ID NO: 1 is an exons- VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 only sequence of a cDNA created by the inventors. The claimed DNA therefore has different structural characteristics than the naturally occurring BRCA1 gene, e.g., in addition to lacking covalent bonds on its ends, it has a different nucleotide sequence (SEQ ID NO: 1 includes only exons, as compared to the natural sequence containing both exons and introns). The claimed DNA has no different functional characteristics, i.e., it encodes the same protein as the natural gene. Here, the differences in structural characteristics between the claimed DNA and the natural gene are significant, e.g., they are enough to ensure that the claim is not improperly tying up the future use of the BRCA1 gene. Thus, they rise to the level of a marked difference, and the claimed DNA is not a ‘‘product of nature’’ exception. Thus, the claim is not directed to an exception (Step 2A: NO). The claim is eligible. Example 3. Diamond v. Diehr (U.S. Patent No. 4,344,142) Background: The claimed invention is a process for molding raw, uncured synthetic rubber into cured precision products. The process uses a mold for precisely shaping the uncured material under heat and pressure and then curing the synthetic rubber in the mold so that the product will retain its shape and be functionally operative after the molding is completed. Achieving the perfect cure depends upon several factors including the thickness of the article to be molded, the temperature of the molding process, and the amount of time that the article is allowed to remain in the press. It is possible to calculate when to open the press and remove the cured product using well-known time, temperature, and cure relationships by means of the Arrhenius equation. The inventors characterize their invention as the process of constantly measuring the actual temperature inside the mold, and automatically feeding these temperature measurements into a computer that repeatedly recalculates the cure time by use of the Arrhenius equation. When the recalculated time equals the actual time that has elapsed since the press was closed, the computer signals a device to open the press. Representative Claim: Claim 1. A method of operating a rubbermolding press for precision molded compounds with the aid of a digital computer, comprising: providing said computer with a data base for said press including at least, natural logarithm conversion data (ln), the activation energy constant (C) unique to each batch of said compound being molded, and a constant PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 (x) dependent upon the geometry of the particular mold of the press, initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure, constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding, constantly providing the computer with the temperature (Z), repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure, which is ln v = CZ+x, where v is the total required cure time, repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time, and opening the press automatically when a said comparison indicates equivalence. Analysis: The claim is directed to a statutory category, i.e., a process (Step 1: YES). The claim recites the Arrhenius equation, which is the mathematical formula: ln v = CZ+x. The court noted that an algorithm, or mathematical formula, is like a law of nature, which cannot be the subject of a patent. The claimed process when viewed as a whole focuses on the use of the Arrhenius equation to cure synthetic rubber. Thus, the claim is directed to an exception (Step 2A: YES). Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. The specifically disclosed and claimed constant measurement of temperature at a mold cavity of a rubber-molding press and the claimed repetitive computer recalculation of the appropriate cure time using the constantly updated measurements are additional elements that provide ‘‘something more’’ than mere computer implementation of calculation of the Arrhenius equation. Further, the claimed steps act in concert to transform raw, uncured rubber to cured molded rubber. The combination of steps recited in addition to the mathematical formula show that the claim is not to the formula in isolation, but rather that the steps impose meaningful limits that apply the formula to improve an existing technological process. Thus, the claim amounts to significantly more than the judicial exception (Step 2B: YES). The claim is eligible. Note: The Supreme Court has also characterized mathematical formulas as abstract ideas. As noted, all claims that are directed to a judicial exception, regardless of what the exception is called, are subject to the same analysis. E:\FR\FM\16DER1.SGM 16DER1 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations Example 4. Parker v. Flook Background: The invention is a method of updating alarm limits using a mathematical formula. An ‘‘alarm limit’’ is a number. During catalytic conversion processes, operating conditions such as temperature, pressure, and flow rates are constantly monitored. When any of these ‘‘process variables’’ exceeds a predetermined alarm limit, an alarm may signal the presence of an abnormal condition indicating either inefficiency or perhaps danger. The formula for updating alarm limits is used in a catalytic conversion processing system; however, there is no disclosure relating to that system, such as the chemical processes at work, the monitoring of process conditions, the determination of variables in the formula from process conditions, or the means of setting off an alarm or adjusting an alarm system. Representative Claim: tkelley on DSK3SPTVN1PROD with RULES Claim 1. A method for updating the value of at least one alarm limit on at least one process variable involved in a process comprising the catalytic chemical conversion of hydrocarbons wherein said alarm limit has a current value of Bo+K wherein Bo is the current alarm base and K is a predetermined alarm offset which comprises: (1) Determining the present value of said process variable, said present value being defined as PVL; (2) Determining a new alarm base B1, using the following equation: B1=Bo(1.0–F) + PVL(F) where F is a predetermined number greater than zero and less than 1.0; (3) Determining an updated alarm limit which is defined as B1+GK; and thereafter; (4) Adjusting said alarm limit to said updated alarm limit value. Analysis: The claim is directed to a statutory category, i.e., a process (Step 1: YES). The claim recites the mathematical formula ‘‘B1=Bo(1.0–F) + PVL(F)’’. The claimed invention focuses on the calculation of the number representing the alarm limit value using the mathematical formula. Thus, the claim is directed to a mathematical formula, which is like a law of nature that falls within the exceptions to patent-eligible subject matter (Step 2A: YES). A process is not unpatentable simply because it contains a law of nature or mathematical algorithm. The claim as a whole must be analyzed to determine what additional elements are recited in the claim. The claimed formula is limited by the steps of gathering the input variables and carrying out the calculation to update the number describing the alarm limit, and by the field of technology for which it is to be used. The determination of chemical process variables, and the use of a VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 generic computer to calculate values, is routine and conventional in the field of chemical processing. Adjusting the alarm limit based on the solution to the mathematical formula is merely postsolution activity that could be attached to almost any formula. Limiting the claim to petrochemical and oil-refining industries, such that the claim does not seek to wholly preempt the mathematical formula, is a field-of-use limitation that does not impose meaningful limits on the mathematical formula. Moreover, when considered as an ordered combination, the claim is nothing more than a purely conventional computerized implementation of applicant’s formula. Therefore, the claim as a whole does not provide significantly more than a generic computer upon which the claimed formula is calculated. Thus, the claim does not amount to significantly more than the judicial exception itself (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101. Example 5. Mayo v. Prometheus (U.S. Patent No. 6,355,623) Background: The invention is a method of assisting doctors who use thiopurine drugs to treat patients with autoimmune diseases. The method helps doctors determine whether a given dosage level is too low or too high, based on the relationship between the concentration in the blood of a thiopurine metabolite (6-thioguanine) and the likelihood that the drug dosage will be ineffective or induce harmful side-effects. The relationship is a natural consequence of the ways in which thiopurine compounds are metabolized by the body, even though human action is needed to trigger a manifestation of the relationship. Representative Claim: Claim 1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6thioguanine to a subject having said immunemediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. Analysis: The claim is directed to a statutory category, i.e., a process (Step 1: YES). The claim sets forth relationships PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 74627 between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The claim recites that relation and, thus, is directed towards a natural law (Step 2A: YES). Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. The ‘‘administering’’ step simply refers to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs. That audience is a pre-existing audience; doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone asserted these claims. The ‘‘wherein’’ clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that the doctor should take those laws into account when treating the patient. The ‘‘determining’’ step tells the doctor to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishes to use. The claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. Even though the laws of nature at issue are narrow laws that may have limited applications, the claim does not amount to significantly more than the natural law itself (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101. Example 6. Alice Corp. v. CLS Bank (U.S. Patent Nos. 5,970,479 and 7,725,375) Background: The claims at issue relate to a computerized scheme for mitigating ‘‘settlement risk’’; i.e., the risk that only one party to an agreedupon financial exchange will satisfy its obligation. In particular, the claims are designed to facilitate the exchange of financial obligations between two parties by using a computer system as a third-party intermediary. The intermediary creates ‘‘shadow’’ credit and debit records (i.e., account ledgers) that mirror the balances in the parties’ real-world accounts at ‘‘exchange institutions’’ (e.g., banks). The E:\FR\FM\16DER1.SGM 16DER1 74628 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations intermediary updates the shadow records in real time as transactions are entered, allowing only those transactions for which the parties’ updated shadow records indicate sufficient resources to satisfy their mutual obligations. At the end of the day, the intermediary instructs the relevant financial institutions to carry out the ‘‘permitted’’ transactions in accordance with the updated shadow records, thus mitigating the risk that only one party will perform the agreedupon exchange. The invention is claimed in the form of a computerimplemented process, a system enabling that process, and a computer-readable medium enabling that process to be performed by a computer. Representative Method Claim (U.S. Patent No. 5,970,479) tkelley on DSK3SPTVN1PROD with RULES Claim 33. A method of exchanging obligations as between parties, each party holding a credit record and a debit record with an exchange institution, the credit records and debit records for exchange of predetermined obligations, the method comprising the steps of: (a) creating a shadow credit record and a shadow debit record for each stakeholder party to be held independently by a supervisory institution from the exchange institutions; (b) obtaining from each exchange institution a start-of-day balance for each shadow credit record and shadow debit record; (c) for every transaction resulting in an exchange obligation, the supervisory institution adjusting each respective party’s shadow credit record or shadow debit record, allowing only these transactions that do not result in the value of the shadow debit record being less than the value of the shadow credit record at any time, each said adjustment taking place in chronological order; and (d) at the end-of-day, the supervisory institution instructing one of the exchange institutions to exchange credits or debits to the credit record and debit record of the respective parties in accordance with the adjustments of the said permitted transactions, the credits and debits being irrevocable, time invariant obligations placed on the exchange institutions.45 Analysis: The claim is directed to a statutory category, i.e., a process (Step 1: YES). The claim recites the concept of managing settlement risk through an intermediary, i.e., intermediated settlement. The claimed invention describes the procedures an intermediary should take in managing settlement risk between two parties, i.e., specific details of intermediating settlement. Intermediated settlement, 45 In Alice Corp., the parties stipulated that the method was performed by a computer, despite the lack of a computer recitation in the representative method claim. VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 like risk hedging in Bilski, is not a preexisting fundamental truth but rather is a longstanding commercial practice (a method of organizing human activity). The concept of intermediated settlement is a fundamental economic practice long prevalent in our system of commerce, which is in the realm of abstract ideas identified by the Supreme Court. Thus, the claim is directed to the abstract idea of intermediated settlement (Step 2A: YES). Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Although a computer acts as the intermediary in the claimed method, the claims do no more than implement the abstract idea of intermediated settlement on a generic computer. Using a computer to create and maintain ‘‘shadow’’ accounts amounts to electronic recordkeeping, which is one of the most basic functions of a computer. The same is true with respect to the use of a computer to obtain data, adjust account balances, and issue automated instructions. All of these computer functions are ‘‘wellunderstood, routine, conventional activit[ies]’’ previously known to the industry. Each step does no more than require a generic computer to perform generic computer functions. Considered as an ordered combination, the computer components of the method add nothing that is not already present when the steps are considered separately, and thus simply recite the concept of intermediated settlement as performed by a generic computer. The claims do not purport to improve the functioning of the computer itself, or to improve any other technology or technical field. Use of an unspecified, generic computer does not transform an abstract idea into a patent-eligible invention. Thus, the claim does not amount to significantly more than the abstract idea itself (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101. Representative System Claim (U.S. Patent No. 7,725,375) Claim 26. A data processing system to enable the exchange of an obligation between parties, the system comprising: a communications controller, a first party device, coupled to said communications controller, a data storage unit having stored therein (a) information about a first account for a first party, independent from a second account maintained by a first exchange institution, and PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 (b) information about a third account for a second party, independent from a fourth account maintained by a second exchange institution; and a computer, coupled to said data storage unit and said communications controller, that is configured to (a) receive a transaction from said first party device via said communications controller; (b) electronically adjust said first account and said third account in order to effect an exchange obligation arising from said transaction between said first party and said second party after ensuring that said first party and/or said second party have adequate value in said first account and/or said third account, respectively; and (c) generate an instruction to said first exchange institution and/or said second exchange institution to adjust said second account and/or said fourth account in accordance with the adjustment of said first account and/or third account, wherein said instruction being an irrevocable, time invariant obligation placed on said first exchange institution and/or said second exchange institution. Analysis: The claim is directed to a statutory category, i.e., a machine (Step 1: YES). As discussed for the method claim, the claim recites the concept of intermediated settlement and is directed to an abstract idea (Step 2A: YES). Looking again to see what additional features are recited in the claim, the system includes a communications controller, a first party device, a data storage device, and a computer. The claimed hardware is generic hardware that nearly every computer will include. None of the hardware offers a meaningful limitation beyond generally linking the system to a particular technological environment, that is, implementation via computers. Put another way, the system claims are no different from the method claims in substance; the method claims recite the abstract idea implemented on a generic computer, while the system claims recite a handful of generic computer components configured to implement the same idea. The claim does not amount to significantly more than the underlying abstract idea (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101. IV. Summaries of Court Decisions Relating to Laws of Nature, Natural Phenomena, and Abstract Ideas The following brief summaries are taken from decisions from the Supreme Court and the Federal Circuit in which claims were analyzed with respect to judicial exceptions to determine subject matter eligibility. Along with the examples in section III, these decisions demonstrate the various terms used by the courts to describe the exceptions E:\FR\FM\16DER1.SGM 16DER1 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations and are provided simply to illustrate some of the different types of concepts found to fall within the exceptions. It should be noted that the courts’ analyses in these decisions do not necessarily follow the eligibility framework explained in this Interim Eligibility Guidance as most of the cases were decided prior to Alice Corp. Therefore, instead of applying the eligibility analysis set forth in this Interim Eligibility Guidance to the facts of the decisions, a short description of the court’s decision is provided for background purposes only. When considering these decisions, it is important to remember that the mere presence of an exception does not necessarily render a claim ineligible. Part A presents several decisions from the Supreme Court, Part B presents several decisions from the Federal Circuit from 2010—2014 that dealt with abstract ideas, and Part C presents decisions from the Federal Circuit relating to abstract ideas since the Alice Corp. decision. Although the very small set of decisions from the Federal Circuit since Alice Corp. have resulted in findings of ineligibility, it should be recognized that the Supreme Court did not create a per se excluded category of subject matter, such as software or business methods, nor did it impose any special requirements for eligibility of software or business methods. A. Supreme Court Decisions 1. O’Reilly v. Morse (U.S. Reissue Patent No. RE 117) tkelley on DSK3SPTVN1PROD with RULES Claim 6. The claim was interpreted by the Supreme Court as a system of signs (signals) by closing a galvanic circuit rapidly for telegraphing, combined with machinery to record the signs. Claim 8. I do not propose to limit myself to the specific machinery, or parts of machinery, . . . the essence of my invention being the use of the motive power of the electric or galvanic current, which I call electro-magnetism, however developed, for making or printing intelligible characters, signs, or letters, at any distances, being a new application of that power. . . The claims are to the process of using electromagnetism to produce distinguishable signs for telegraphy, and in particular to print intelligible characters at any distance. While the format of the claims is outdated, it can be seen that claim 6 recites the system of signs in combination with the machinery for recording, which was found eligible. In contrast, claim 8 recites the use of electromagnetism without limits on the machinery for recording, which was found ineligible. The discovery of electromagnetism, VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 74629 which is a natural phenomenon, is not patentable by itself. succeeding binary ‘1’ in the second position of said register. 2. Tilghman v. Proctor (U.S. Patent No. 11,766) The claim recites a process for converting binary-coded-decimal (BCD) numerals into pure binary numerals. The procedures set forth in the claim are a generalized formulation for programs to solve mathematical problems of converting one form of numerical representation to another. The mathematical procedures can be carried out in existing computers long in use or can be performed without a computer. The end use is unlimited. The process claim was found to be so abstract and sweeping that it covered both known and unknown uses of the BCD to pure binary conversion. The mathematical formula in the claim has no substantial practical application except in connection with a digital computer, and thus the court found the claim ineligible as it would in effect be a patent on the algorithm itself. The claim was interpreted by the Supreme Court as the process of subjecting to a high degree of heat a mixture continually kept up, of nearly equal quantities of fat and water in a convenient vessel strong enough to resist the effort of the mixture to convert itself into steam. The claim is founded upon the chemical principle or scientific fact that the elements of neutral fat require that they be severally united with an atomic equivalent of water in order to separate from each other and become free. Although the claim recites the chemical union between the fatty elements and water, it is not directed to the mere principle. The claim is directed instead to a particular mode of bringing about the desired chemical union, i.e., by heating the water under such pressure that the water does not become steam, and accordingly was found eligible. 3. Mackay Radio & Telegraph Co. v. Radio Corp. of America (U.S. Patent No. 1,974,387) Claim 15. An antenna comprising a pair of relatively long conductors disposed with respect to each other at an angle substantially equal to twice 50.9(l/l)¥0.513 degrees, l being the length of the wire and l the operating wave length in like units, and means in circuit with said antenna for exciting the conductors in phase opposition whereby standing waves of opposite instantaneous polarity are formed on the conductors throughout their length. The claim is to an antenna system utilizing standing wave phenomena. To obtain the best directional radio propagation by a V type antenna, a mathematical formula is used to arrange the angle of the wires, their length, and the length of the wave propagated. The claim practically applies the mathematical formula to configure a particular antenna and thus was found eligible. 4. Gottschalk v. Benson Claim 8. The method of converting signals from binary coded decimal form into binary which comprises the steps of: (1) storing the binary coded decimal signals in a reentrant shift register, (2) shifting the signals to the right by at least three places, until there is a binary ‘1’ in the second position of said register, (3) masking out said binary ‘1’ in said second position of said register, (4) adding a binary ‘1’ to the first position of said register, (5) shifting the signals to the left by two positions, (6) adding a ‘1’ to said first position, and (7) shifting the signals to the right by at least three positions in preparation for a PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 5. Bilski v. Kappos Claim 1. A method for managing the consumption risk costs of a commodity sold by a commodity provider at a fixed price comprising the steps of: (a) initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical averages, said fixed rate corresponding to a risk position of said consumer; (b) identifying market participants for said commodity having a counter-risk position to said consumers; and (c) initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions. The claim explains the basic concept of hedging, or protecting against risk. The court found that the concept of hedging is an unpatentable abstract idea, just like the algorithms at issue in Benson and Flook. A dependent claim that narrows the concept to a mathematical formula was similarly found to be an abstract idea. The other dependent claims are broad examples of how hedging can be used in commodities and energy markets. Limiting an abstract idea to one field of use or adding token postsolution components does not make the concept patentable. The claims were found ineligible. E:\FR\FM\16DER1.SGM 16DER1 74630 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations B. Abstract Idea Decisions From the Federal Circuit Prior to Alice Corp. (2010–2014) 1. SiRF Technology v. ITC 46 (U.S. Patent No. 6,417,801) Claim 1. A method for calculating an absolute position of a GPS receiver and an absolute time of reception of satellite signals comprising: providing pseudoranges that estimate the range of the GPS receiver to a plurality of GPS satellites; providing an estimate of an absolute time of reception of a plurality of satellite signals; providing an estimate of a position of the GPS receiver; providing satellite ephemeris data; computing absolute position and absolute time using said pseudoranges by updating said estimate of an absolute time and the estimate of position of the GPS receiver. GPS is a satellite navigation system comprising satellites orbiting the Earth that permits a GPS-enabled receiver to detect signals from at least four satellites and use that information to calculate its distance from each satellite and thus its precise position on Earth through trilateration. The claim sets forth the steps of calculating the absolute position, which is a mathematical concept. The court interpreted the claim such that the method could not be performed without a GPS receiver, noting that the preamble expressly states ‘‘calculating an absolute position of a GPS receiver’’ and that a GPS receiver is required to generate pseudoranges and to determine its position. With this interpretation, the presence of the GPS receiver in the claim places a meaningful limit on the scope of the claim. It is essential to the operation of the claimed method and plays a significant part in permitting the claimed method to be performed. As such, although performance of the claim requires calculations, the claim was found eligible. 2. Research Corp. Tech. v. Microsoft Corp.47 (U.S. Patent No. 5,111,310) tkelley on DSK3SPTVN1PROD with RULES Claim 1. A method for the halftoning of gray scale images by utilizing a pixel-by-pixel comparison of the image against a blue noise mask in which the blue noise mask is comprised of a random non-deterministic, non-white noise single valued function which is designed to produce visually pleasing dot profiles when thresholded at any level of said gray scale images. The claim is to digital image halftoning. Halftoning techniques allow computers to present many shades and color tones with a limited number of 46 SiRF Tech. v. ITC, 601 F.3d 1319 (Fed. Cir. 2010). 47 Research Corp. Tech. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010). VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 pixels, which allows computer displays and printers to render an approximation of an image by using fewer colors or shades of gray than the original image. One method of generating a digital halftoned image is called ‘‘thresholding’’ that uses a twodimensional array called a ‘‘mask.’’ The claimed method incorporates algorithms and formulas that control the masks and halftoning, but apply them in a technique that improves the generated digital halftoned image. The invention presents functional and palpable applications in the field of computer technology with specific applications or improvements to technologies in the marketplace. So, although the claimed method uses algorithms and formulas, the claim was found eligible. 3. Dealertrack Inc. v. Huber (U.S. Patent No. 7,181,427) Claim 1. A computer aided method of managing a credit application, the method comprising the steps of: [A] receiving credit application data from a remote application entry and display device; [B] selectively forwarding the credit application data to remote funding source terminal devices; [C] forwarding funding decision data from at least one of the remote funding source terminal devices to the remote application entry and display device; [D] wherein the selectively forwarding the credit application data step further comprises: [D1] sending at least a portion of a credit application to more than one of said remote funding sources substantially at the same time; [D2] sending at least a portion of a credit application to more than one of said remote funding sources sequentially until a finding source returns a positive funding decision; [D3] sending at least a portion of a credit application to a first one of said remote funding sources, and then, after a predetermined time, sending to at least one other remote funding source, until one of the finding sources returns a positive funding decision or until all funding sources have been exhausted; or, [D4] sending the credit application from a first remote funding source to a second remote finding source if the first funding source declines to approve the credit application. The court reduced the claim to its most basic concept which was characterized as receiving data from one source (step A), selectively forwarding the data (step B, performed according to step D), and forwarding reply data to the first source (step C). This basic concept of processing information through a clearinghouse was found to be an abstract idea, similar to Bilski’s basic concept of hedging. The court held that simply adding a ‘‘computer-aided’’ PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 limitation to a claim covering an abstract concept, without more, does not sufficiently limit the claim. The claim was found ineligible. 4. SmartGene, Inc. v. Advanced Biological Laboratories, SA (U.S. Patent No. 6,081,786) Claim 1. A method for guiding the selection of a therapeutic treatment regimen for a patient with a known disease or medical condition, said method comprising: (a) providing patient information to a computing device comprising: a first knowledge base comprising a plurality of different therapeutic treatment regimens for said disease or medical condition; a second knowledge base comprising a plurality of expert rules for evaluating and selecting a therapeutic treatment regimen for said disease or medical condition; a third knowledge base comprising advisory information useful for the treatment of a patient with different constituents of said different therapeutic treatment regimens; and (b) generating in said computing device a ranked listing of available therapeutic treatment regimens for said patient; and (c) generating in said computing device advisory information for one or more therapeutic treatment regimens in said ranked listing based on said patient information and said expert rules. The claims set forth the steps of comparing new and stored information and using rules to identify medical options. Claim 1 does no more than call on a ‘‘computing device’’ with basic functionality for comparing stored and input data and rules, to do what doctors do routinely. The court concluded that these are familiar mental steps performed by or with a computer, and as such the claim was found ineligible. 5. Cyberfone Systems v. CNN Interactive Group (U.S. Patent No. 8,019,060) Claim 1. A method, comprising: obtaining data transaction information entered on a telephone from a single transmission from said telephone; forming a plurality of different exploded data transactions for the single transmission, said plurality of different exploded data transaction indicative of a single data transaction, each of said exploded data transactions having different data that is intended for a different destination that is included as part of the exploded data transactions, and each of said exploded data transactions formed based on said data transaction information from said single transmission, so that different data from the single data transmission is separated and sent to different destinations; and sending said different exploded data transactions over a channel to said different destinations, all based on said data transaction information entered in said single transmission. Using categories to organize, store, and transmit information is well- E:\FR\FM\16DER1.SGM 16DER1 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations established. Here, the well-known concept of categorical data storage, i.e., the idea of collecting information in classified form, then separating and transmitting that information according to its classification, is an abstract idea. The claim was found ineligible. C. Abstract Idea Decisions From the Federal Circuit Since Alice Corp. 1. Digitech Image Tech., LLC v. Electronics for Imaging, Inc. (U.S. Patent No. 6,128,415) Claim 10. A method of generating a device profile that describes properties of a device in a digital image reproduction system for capturing, transforming or rendering an image, said method comprising: generating first data for describing a device dependent transformation of color information content of the image to a device independent color space through use of measured chromatic stimuli and device response characteristic functions; generating second data for describing a device dependent transformation of spatial information content of the image in said device independent color space through use of spatial stimuli and device response characteristic functions; and combining said first and second data into the device profile. The court found the claim to be an abstract idea because it describes a process of organizing information through mathematical correlations and is not tied to a specific structure or machine. The claim recites the process of taking two data sets and combining them into a single data set, the device profile. The two data sets are generated by taking existing information—i.e., measured chromatic stimuli, spatial stimuli, and device response characteristic functions—and organizing this information into a new form. The claim language does not expressly tie the method to an image processor. It generically recites a process of combining two data sets into the device profile; it does not claim the processor’s use of that profile in the capturing, transforming, or rendering of a digital image. Without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible. All of the claims were found ineligible. tkelley on DSK3SPTVN1PROD with RULES 2. Planet Bingo, LLC v. VKGS LLC (U.S. Patent No. 6,398,646) Claim 1. A system for managing a game of Bingo which comprises: (a) a computer with a central processing unit (CPU) and with a memory and with a printer connected to the CPU; (b) an input and output terminal connected to the CPU and memory of the computer; and (c) a program in the computer enabling: VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 (i) input of at least two sets of Bingo numbers which are preselected by a player to be played in at least one selected game of Bingo in a future period of time; (ii) storage of the sets of Bingo numbers which are preselected by the player as a group in the memory of the computer; (iii) assignment by the computer of a player identifier unique to the player for the group having the sets of Bingo numbers which are preselected by the player wherein the player identifier is assigned to the group for multiple sessions of Bingo; (iv) retrieval of the group using the player identifier; (v) selection from the group by the player of at least one of the sets of Bingo numbers preselected by the player and stored in the memory of the computer as the group for play in a selected game of Bingo in a specific session of Bingo wherein a number of sets of Bingo numbers selected for play in the selected game of Bingo is less than a total number of sets of Bingo numbers in the group; (vi) addition by the computer of a control number for each set of Bingo numbers selected for play in the selected game of Bingo; (vii) output of a receipt with the control number, the set of Bingo numbers which is preselected and selected by the player, a price for the set of Bingo numbers which is preselected, a date of the game of Bingo and optionally a computer identification number; and (viii) output for verification of a winning set of Bingo numbers by means of the control number which is input into the computer by a manager of the game of Bingo. The court found the claims to be directed to the abstract idea of solving a tampering problem and also minimizing other security risks during bingo ticket purchases. The claims relate to managing a bingo game while allowing a player to repeatedly play the same sets of numbers in multiple sessions. Managing the game of bingo consists solely of mental steps which can be carried out by a human using pen and paper. The claims do not impose any requirements that would make the invention impossible to carry out manually. Although not drawn to the same subject matter at issue in Bilski and Alice Corp., the court found managing a game of bingo to be similar to the kind of organizing human activity at issue in Alice Corp. The claims recite a generic computer implementation of the abstract idea and a program that is used for the generic functions of storing, retrieving, and verifying a chosen set of bingo numbers against a winning set of bingo numbers. There is no inventive concept sufficient to transform the claimed subject matter into a patenteligible application. The court found no meaningful distinction between the method and system claims. All of the claims were found ineligible. PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 74631 3. buySAFE, Inc. v. Google, Inc. (U.S. Patent No. 7,644,019) Claim 1. A method, comprising: receiving, by at least one computer application program running on a computer of a safe transaction service provider, a request from a first party for obtaining a transaction performance guaranty service with respect to an online commercial transaction following closing of the online commercial transaction; processing, by at least one computer application program running on the safe transaction service provider computer, the request by underwriting the first party in order to provide the transaction performance guaranty service to the first party, wherein the computer of the safe transaction service provider offers, via a computer network, the transaction performance guaranty service that binds a transaction performance guaranty to the online commercial transaction involving the first party to guarantee the performance of the first party following closing of the online commercial transaction. Claim 14. The method according to claim 1, wherein the transaction performance guaranty is provided in one form of: a surety bond; a specialized bank guaranty; a specialized insurance policy; and a safe transaction guaranty provided by the safe transaction service provider. Relying on Bilski in which an abstract idea was found in certain arrangements involving contractual relations, the court found the claims to be squarely about creating a contractual relationship—a ‘‘transaction performance guaranty’’—that is beyond question of ancient lineage. The claims’ invocation of computers adds no inventive concept, with the computer functionality being generic. The transactions being performed online, at best, limits the use of the abstract guaranty idea to a particular technological environment. Although, dependent claim 14 narrows the abstract idea to particular types of relationships, that does not change the analysis because it does not make the idea nonabstract. The claims to the computer readable medium encoded with instructions to carry out the method were treated in the same way. All of the claims were found ineligible. 4. Ultramercial, LLC v. Hulu, LLC and WildTangent (U.S. Patent No. 7,346,545) Claim 1: A method for distribution of products over the Internet via a facilitator, said method comprising the steps of: a first step of receiving, from a content provider, media products that are covered by intellectual-property rights protection and are available for purchase, wherein each said media product being comprised of at least one of text data, music data, and video data; a second step of selecting a sponsor message to be associated with the media product, said sponsor message being selected E:\FR\FM\16DER1.SGM 16DER1 74632 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations tkelley on DSK3SPTVN1PROD with RULES from a plurality of sponsor messages, said second step including accessing an activity log to verify that the total number of times which the sponsor message has been previously presented is less than the number of transaction cycles contracted by the sponsor of the sponsor message; a third step of providing the media product for sale at an Internet Web site; a fourth step of restricting general public access to said media product; a fifth step of offering to a consumer access to the media product without charge to the consumer on the precondition that the consumer views the sponsor message; a sixth step of receiving from the consumer a request to view the sponsor message, wherein the consumer submits said request in response to being offered access to the media product; a seventh step of, in response to receiving the request from the consumer, facilitating the display of a sponsor message to the consumer; an eighth step of, if the sponsor message is not an interactive message, allowing said consumer access to said media product after said step of facilitating the display of said sponsor message; a ninth step of, if the sponsor message is an interactive message, presenting at least one query to the consumer and allowing said consumer access to said media product after receiving a response to said at least one query; a tenth step of recording the transaction event to the activity log, said tenth step including updating the total number of times the sponsor message has been presented; and an eleventh step of receiving payment from the sponsor of the sponsor message displayed. Using the Alice Corp. framework, the court first determined whether the claims at issue are directed to a patentineligible concept. The court found that the ordered combination of the eleven steps recites ‘‘an abstraction—an idea, having no particular concrete or tangible form’’ noting that the majority of limitations describe only the abstract idea of showing an advertisement before delivering content. The court then turned to the next step of the analysis to determine whether the claims do significantly more than simply describe the abstract method. The court explained that consulting and updating an activity log represent insignificant ‘‘data-gathering steps,’’ restricting public access represents only insignificant ‘‘[pre]-solution activity,’’ and narrowing the idea to the Internet is an attempt to limit the use of the abstract idea ‘‘to a particular technological environment.’’ Viewed both individually and as an ordered combination, the claimed steps were found insufficient to supply an inventive concept because the steps are conventional and specified at a high level of generality. The court concluded VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 that the claim limitations do not transform the abstract idea that they recite into patent-eligible subject matter because ‘‘the claims simply instruct the practitioner to implement the abstract idea with routine, conventional activity.’’ All of the claims were found ineligible. Claim 19: A system useful in an outsource provider serving Web pages offering commercial opportunities, the system comprising: (a) a computer store containing data, for each of a plurality of first Web pages, defining a plurality of visually perceptible elements, which visually perceptible elements correspond to the plurality of first Web pages; (i) wherein each of the first Web pages belongs to one of a plurality of Web page owners; (ii) wherein each of the first Web pages displays at least one active link associated with a commerce object associated with a buying opportunity of a selected one of a plurality of merchants; and (iii) wherein the selected merchant, the outsource provider, and the owner of the first Web page displaying the associated link are each third parties with respect to one other; (b) a computer server at the outsource provider, which computer server is coupled to the computer store and programmed to: (i) receive from the web browser of a computer user a signal indicating activation of one of the links displayed by one of the first Web pages; (ii) automatically identify as the source page the one of the first Web pages on which the link has been activated; (iii) in response to identification of the source page, automatically retrieve the stored data corresponding to the source page; and (iv) using the data retrieved, automatically generate and transmit to the web browser a second Web page that displays: (A) Information associated with the commerce object associated with the link that has been activated, and (B) the plurality of visually perceptible elements visually corresponding to the source page. if two Web pages have the same ‘look and feel.’’’ The court did not clearly indicate whether the claim was directed to one or more of these proposed abstract ideas, but stated that ‘‘under any of these characterizations of the abstract idea, the ‘399 patent’s claims satisfy Mayo/Alice step two.’’ The court then explained its analysis of the second Mayo/Alice step, where it determined that the claim amounted to an inventive concept and thus was patent eligible. In particular, the claim addresses the problem of retaining Web site visitors from being diverted from a host’s Web site to an advertiser’s Web site, for which ‘‘the claimed solution is necessarily rooted in computer technology in order to overcome a problem specifically arising in the realm of computer networks.’’ The claim includes additional elements including ‘‘1) stor[ing] ‘visually perceptible elements’ corresponding to numerous host Web sites in a database, with each of the host Web sites displaying at least one link associated with a product or service of a third-party merchant, 2) on activation of this link by a Web site visitor, automatically identif[ying] the host, and 3) instruct[ing] an Internet web server of an ‘outsource provider’ to construct and serve to the visitor a new, hybrid Web page that merges content associated with the products of the third-party merchant with the stored ‘visually perceptible elements’ from the identified host Web site.’’ The court held that, unlike in Ultramercial, the claim does not generically recite ‘‘use the Internet’’ to perform a business practice, but instead recites a specific way to automate the creation of a composite Web page by an outsource provider that incorporates elements from multiple sources in order to solve a problem faced by Web sites on the Internet. Therefore, the court held that the claim is patent eligible. The court found the claim patent eligible under the Alice Corp. framework. First, the court noted that, while in some instances abstract ideas are plainly identifiable and divisible from generic computer limitations recited by the remainder of a claim, in this case, identifying the precise nature of the abstract idea is not as straightforward. The court considered several proposed characterizations of the abstract idea, including ‘‘‘making two Web pages look the same,’ ‘syndicated commerce on the computer using the Internet’ and ‘making two ecommerce Web pages look alike by using licensed trademarks, logos, color schemes and layouts,’’’ and ‘‘that an online merchant’s sales can be increased Guidelines for Written Comments It would be helpful to the USPTO if written comments include information about: (1) The name and affiliation of the individual responding; and (2) an indication of whether comments offered represent views of the respondent’s organization or are the respondent’s personal views. Information provided in response to this request for comments will be made part of a public record and may be available via the Internet. In view of this, parties should not submit information that they do not wish to be publicly disclosed or made electronically accessible. Parties who would like to rely on confidential information to illustrate a point are requested to summarize or otherwise 5. DDR Holdings, LLC v. Hotels.com, L.P. (U.S. Patent No. 7,818,399) PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\FR\FM\16DER1.SGM 16DER1 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations submit the information in a way that will permit its public disclosure. Dated: December 10, 2014. Michelle K. Lee, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office. [FR Doc. 2014–29414 Filed 12–15–14; 8:45 am] BILLING CODE 3510–16–P DEPARTMENT OF COMMERCE United States Patent and Trademark Office 37 CFR Part 2 [Docket No. PTO–T–2014–0011] RIN 0651–AC94 Reduction of Fees for Trademark Applications and Renewals United States Patent and Trademark Office, Commerce. ACTION: Final rule. AGENCY: The United States Patent and Trademark Office (‘‘Office’’ or ‘‘USPTO’’) is amending its regulations to reduce certain trademark fees, as authorized by the Leahy-Smith America Invents Act (‘‘AIA’’). The reductions will reduce total trademark fee collections and promote efficiency for the USPTO and customers. The reductions also will further USPTO strategic objectives to increase the endto-end electronic processing of trademark applications by offering additional electronic application processing. SUMMARY: The changes in this final rule are effective on January 17, 2015. FOR FURTHER INFORMATION CONTACT: Cynthia C. Lynch, Office of the Deputy Commissioner for Trademark Examination Policy, by email at TMPolicy@uspto.gov, or by telephone at (571) 272–8742. SUPPLEMENTARY INFORMATION: Executive Summary: Purpose: Section 10 of the AIA authorizes the Director of the USPTO (‘‘Director’’) to set or adjust by rule any fee established, authorized, or charged under the Trademark Act of 1946 (15 U.S.C. 1051 et seq.) for any services performed by, or materials furnished by, the Office. See Section 10 of the AIA, Pub. L. 112–29, 125 Stat. at 316–17. Section 10(c) of the AIA authorizes the Director to consult with the Trademark Public Advisory Committee (‘‘TPAC’’) on the advisability of reducing trademark fees and, following tkelley on DSK3SPTVN1PROD with RULES DATES: VerDate Sep<11>2014 16:25 Dec 15, 2014 Jkt 235001 the required consultation, to reduce such fees. See Section 10(c) of the AIA, Pub. L. 112–29, 125 Stat. at 317. The Director consulted with the TPAC and thereafter determined that, in order to both improve the alignment of Office costs with revenues and incentivize electronic communications, it was advisable to propose reductions in the filing fees for: (1) Trademark, certification mark, collective membership mark, and collective trademark applications for registration on the Principal or Supplemental Register that are filed using the Trademark Electronic Application System (‘‘TEAS’’), if applicants authorize email communication and file specified documents electronically throughout the application process; (2) TEAS Plus applications for registration; and (3) TEAS applications for renewal of a registration. In addition, the reduction would also apply to TEAS requests for transformation of an extension of protection to the United States into a U.S. application, filed pursuant to 37 CFR 7.31. Thereafter, a proposed rule was published in the Federal Register on May 9, 2014, at 79 FR 26664, and in the Official Gazette on June 3, 2014. The USPTO received comments from three intellectual property organizations and three attorneys and/or law firms. These comments are posted on the USPTO’s Web site at https://www.uspto.gov/ trademarks/notices/TEAS_RF_ comments.jsp and are addressed below. Prior to consulting with the TPAC, the USPTO also published a notice of inquiry to provide the public, including user groups, with an opportunity to comment on possible adjustments to trademark application fees (77 FR 49426 (Aug. 16, 2012)). The public comments overwhelmingly favored a fee reduction, and many expressed a desire for a lower-cost electronic filing option without any restrictions on the nature of the identification of goods and services, as is required under TEAS Plus. The reduced fees will help to: (1) Continue with an appropriate and sustainable funding model; (2) support strategic objectives relating to online filing, electronic file management, and workflow; and (3) improve efficiency for USPTO operations and customers. The reductions will benefit the public by lowering the costs of seeking and renewing federal registration, including advantages to individual and pro se filers, who make greater use of lowercost filing options. In addition, the rule includes an additional filing option for meeting applicants’ needs and preferences. PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 74633 General Comments Comment: All commenters expressed support of the USPTO’s efforts to increase the volume of end-to-end electronic processing of trademark applications and agreed that the proposed fee reductions will make filing for individuals and smaller entities more accessible and promote greater efficiency through electronic filing and communication. Response: The USPTO appreciates the commenters’ support of the general objectives of the rule changes. Comment: One commenter suggested that the USPTO take additional steps to both further the USPTO’s strategic objective and reduce burdens on small businesses. In particular, the commenter recommended that the USPTO collect and track the filing and renewal information related to small businesses and provide reduced filing fees to small entities and applicants that are part of business incubators and other such organizations. In addition, the commenter opined that providing small entities with reduced fees for renewals and maintenance would help incentivize registrants to maintain and renew their marks. Response: The USPTO appreciates the commenter’s suggestions and will consider them in the future, but notes that they are outside the scope of the current rulemaking. Moreover, the USPTO has considered whether and how it is appropriate to reduce any burden on small businesses through increased flexibility. The final rules provide streamlined and simplified procedures for all small entities (and others), given the ease of filing electronically through TEAS and communicating by email. In addition, the fee reductions promote greater efficiency from electronic filing and communication, as the procedures are simpler and not burdensome. Comment: One commenter noted that although the data that becomes the equivalent of an application under Section 66(a) of the Trademark Act is not submitted by applicants directly, the Office’s goals of increasing efficiency through electronic correspondence can be achieved with such applications by requiring that the applicant use TEAS to respond to provisional refusals and for subsequent prosecution. Response: The USPTO notes that the reduced-fee option of filing using TEAS Plus is not currently available for requests for an extension of protection to the United States, i.e., a Section 66(a) application, 15 U.S.C. 1141f(a), nor will the TEAS RF option be available for these applications. The USPTO has not E:\FR\FM\16DER1.SGM 16DER1

Agencies

[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Rules and Regulations]
[Pages 74618-74633]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29414]


=======================================================================
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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2014-0058]


2014 Interim Guidance on Patent Subject Matter Eligibility

AGENCY: United States Patent and Trademark Office, Commerce.

[[Page 74619]]


ACTION: Examination guidance; request for comments.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office (USPTO or 
Office) has prepared interim guidance (2014 Interim Guidance on Patent 
Subject Matter Eligibility, called ``Interim Eligibility Guidance'') 
for use by USPTO personnel in determining subject matter eligibility 
under 35 U.S.C. 101 in view of recent decisions by the U.S. Supreme 
Court (Supreme Court). This Interim Eligibility Guidance supplements 
the June 25, 2014, Preliminary Examination Instructions in view of the 
Supreme Court decision in Alice Corp. (June 2014 Preliminary 
Instructions) and supersedes the March 4, 2014, Procedure For Subject 
Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of 
Nature/Natural Principles, Natural Phenomena, And/Or Natural Products 
(March 2014 Procedure) issued in view of the Supreme Court decisions in 
Myriad and Mayo. The USPTO is seeking public comment on this Interim 
Eligibility Guidance along with additional suggestions on claim 
examples for explanatory example sets.

DATES: Effective Date: This Interim Eligibility Guidance is effective 
on December 16, 2014. This Interim Eligibility Guidance applies to all 
applications filed before, on or after December 16, 2014.
    Comment Deadline Date: To be ensured of consideration, written 
comments must be received on or before March 16, 2015.

ADDRESSES: Comments on this Interim Eligibility Guidance must be sent 
by electronic mail message over the Internet addressed to: 
2014_interim_guidance@uspto.gov. Electronic comments submitted in plain 
text are preferred, but also may be submitted in ADOBE[supreg] portable 
document format or MICROSOFT WORD[supreg] format. The comments will be 
available for viewing via the Office's Internet Web site (https://www.uspto.gov). Because comments will be made available for public 
inspection, information that the submitter does not desire to make 
public, such as an address or phone number, should not be included in 
the comments.

FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, 
Office of Patent Legal Administration, by telephone at 571-272-7728, or 
Michael Cygan, Senior Legal Advisor, Office of Patent Legal 
Administration, by telephone at 571-272-7700.

SUPPLEMENTARY INFORMATION: Section 2106 of the Manual of Patent 
Examining Procedure (MPEP) sets forth guidance for use by USPTO 
personnel in determining subject matter eligibility under 35 U.S.C. 
101. See MPEP 2106 (9th ed. 2014). The USPTO has prepared this Interim 
Eligibility Guidance for use by USPTO personnel in determining subject 
matter eligibility under 35 U.S.C. 101 in view of recent decisions by 
the Supreme Court. The following Interim Eligibility Guidance on patent 
subject matter eligibility under 35 U.S.C. 101 supplements the June 25, 
2014, Preliminary Examination Instructions in view of the Supreme Court 
Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et 
al.\1\ (June 2014 Preliminary Instructions) and supersedes the March 4, 
2014, Procedure For Subject Matter Eligibility Analysis Of Claims 
Reciting Or Involving Laws Of Nature/Natural Principles, Natural 
Phenomena, And/Or Natural Products (March 2014 Procedure) \2\ issued in 
view of the Supreme Court decisions in Association for Molecular 
Pathology v. Myriad Genetics, Inc.\3\ and Mayo Collaborative Services 
v. Prometheus Laboratories Inc.\4\ Implementation of examination 
guidance on eligibility will be an iterative process continuing with 
periodic supplements based on developments in patent subject matter 
eligibility jurisprudence \5\ and public feedback.
---------------------------------------------------------------------------

    \1\ Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _--, 134 
S. Ct. 2347 (2014).
    \2\ This analysis differs from the March 2014 Procedure in 
certain respects. Note, for example, the test for determining 
whether a claim is directed to a ``product of nature'' exception is 
separated from the analysis of whether the claim includes 
significantly more than the exception. Also, the application of the 
overall analysis is based on claims directed to judicial exceptions 
(defined as claims reciting the exception, i.e., set forth or 
described), rather than claims merely ``involving'' an exception. 
For instance, process claims that merely use a nature-based product 
are not necessarily subject to an analysis for markedly different 
characteristics. Additionally, the markedly different analysis 
focuses on characteristics that can include a product's structure, 
function, and/or other properties as compared to its naturally 
occurring counterpart in its natural state.
    \3\ Association for Molecular Pathology v. Myriad Genetics, 
Inc., 569 U.S. _--, 133 S. Ct. 2107 (2013).
    \4\ Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. 
_--, 132 S. Ct. 1289 (2012).
    \5\ The Court of Appeals for the Federal Circuit has a number of 
pending appeals that could result in further refinements to the 
eligibility guidance, including for example, University of Utah 
Research Foundation v. Ambry Genetics Corp. (In re BRCA1- & BRCA2-
Based Hereditary Cancer Test Patent Litigation), No. 14-1361 (Fed. 
Cir. filed Mar. 18, 2014), and Ariosa Diagnostics, Inc. v. Sequenom, 
Inc., No. 14-1139 (Fed. Cir. filed Dec. 4, 2013).
---------------------------------------------------------------------------

    The USPTO is seeking written comments on this guidance, as well as 
additional suggestions for claim examples to use for examiner training. 
Further, the USPTO plans to hold a public forum in mid-January 2015 in 
order to discuss the guidance and next steps and to receive additional 
oral input. When the date and location are finalized, notice of the 
forum will be provided on the Office's Internet Web site (https://www.uspto.gov).
    This Interim Eligibility Guidance does not constitute substantive 
rulemaking and does not have the force and effect of law. This Interim 
Eligibility Guidance sets out the Office's interpretation of the 
subject matter eligibility requirements of 35 U.S.C. 101 in view of 
recent decisions by the Supreme Court and the U.S. Court of Appeals for 
the Federal Circuit (Federal Circuit), and advises the public and 
Office personnel on how these court decisions impact the provisions of 
MPEP 2105, 2106 and 2106.01. This Interim Eligibility Guidance has been 
developed as a matter of internal Office management and is not intended 
to create any right or benefit, substantive or procedural, enforceable 
by any party against the Office. Rejections will continue to be based 
upon the substantive law, and it is these rejections that are 
appealable. Failure of Office personnel to follow this Interim 
Eligibility Guidance is not, in itself, a proper basis for either an 
appeal or a petition.
    This Interim Eligibility Guidance offers a comprehensive view of 
subject matter eligibility in line with Alice Corp, Myriad, Mayo, and 
the related body of case law, and is responsive to the public comments 
received pertaining to the March 2014 Procedure and the June 2014 
Preliminary Instructions (see the Notice of Forum on the Guidance for 
Determining Subject Matter Eligibility of Claims Reciting or Involving 
Laws of Nature, Natural Phenomena, and Natural Products, 79 FR 21736 
(Apr. 17, 2014) and the Request for Comments and Extension of Comment 
Period on Examination Instruction and Guidance Pertaining to Patent-
Eligible Subject Matter, 79 FR 36786 (June 30, 2014)). In conjunction 
with this Interim Eligibility Guidance, a set of explanatory examples 
relating to nature-based products is being released to replace the 
prior examples issued with the March 2014 Procedure and the related 
training. The explanatory examples relating to nature-based products 
address themes raised in the public comments and adopt many suggestions 
from the comments. Additional explanatory example sets relating to 
claims that do and do not amount to significantly more than a judicial 
exception are being developed and will be issued at a future date, 
taking into account suggestions already received from the public 
comments,

[[Page 74620]]

future public comments, and any further judicial developments.
    The June 2014 Preliminary Instructions superseded MPEP sections 
2106(II)(A) and 2106(II)(B). MPEP 2105 is also superseded by this 
Interim Eligibility Guidance to the extent that it suggests that ``mere 
human intervention'' necessarily results in eligible subject matter. 
MPEP 2106.01 is additionally now superseded with this interim guidance. 
Examiners should continue to follow the MPEP for all other examination 
instructions. The following sections pertain to examining for patent 
subject matter eligibility with details on determining what applicant 
invented and making a rejection under 35 U.S.C. 101 and should be 
reviewed closely as they are not duplicated in this Interim Eligibility 
Guidance:

 MPEP 2103: Patent Examination Process
    [ssquf] 2103(I): Determine What Applicant Has Invented and Is 
Seeking to Patent
    [ssquf] 2103(II): Conduct a Thorough Search of the Prior Art
    [ssquf] 2103(III): Determine Whether the Claimed Invention Complies 
With 35 U.S.C. 101
    [ssquf] 2103(IV): Evaluate Application for Compliance With 35 
U.S.C. 112
    [ssquf] 2103(V): Determine Whether the Claimed Invention Complies 
With 35 U.S.C. 102 and 103
    [ssquf] 2103(VI): Clearly Communicate Findings, Conclusions, and 
Their Bases
 MPEP 2104: Patentable Subject Matter
 MPEP 2105: Patentable Subject Matter--Living Subject Matter 
\6\
---------------------------------------------------------------------------

    \6\ To the extent that MPEP 2105 suggests that mere ``human 
intervention'' necessarily results in eligible subject matter, it is 
superseded by this Interim Eligibility Guidance. As explained 
herein, if human intervention has failed to confer markedly 
different characteristics on a product derived from nature, that 
product is a judicial exception (a product of nature exception). See 
generally Myriad; In re Roslin Inst. (Edinburgh), 750 F.3d. 1333 
(Fed. Cir. 2014).
---------------------------------------------------------------------------

 MPEP 2106: Patent Subject Matter Eligibility
    [ssquf] 2106(I): The Four Categories of Statutory Subject Matter
    [ssquf] 2106(II): Judicial Exceptions to the Four Categories (not 
subsections (II)(A) and (II)(B))
    [ssquf] 2106(III): Establish on the Record a Prima Facie Case

    The current version of the MPEP (9th ed., March 2014) incorporates 
patent subject matter eligibility guidance issued as of November 2013.
    This Interim Eligibility Guidance is divided into the following 
sections:
    Flowchart: Eligibility Test for Products and Processes;
    Part I: Two-part Analysis for Judicial Exceptions;
    Part II: Complete Examination;
    Part III: Sample Analysis; and
    Part IV: Summaries of Court Decisions Relating to Laws of Nature, 
Natural Phenomena, and Abstract Ideas.
    The following flowchart illustrates the subject matter eligibility 
analysis for products and processes to be used during examination for 
evaluating whether a claim is drawn to patent-eligible subject matter. 
It is recognized that under the controlling legal precedent there may 
be variations in the precise contours of the analysis for subject 
matter eligibility that will still achieve the same end result. The 
analysis set forth herein promotes examination efficiency and 
consistency across all technologies.

[[Page 74621]]

[GRAPHIC] [TIFF OMITTED] TR16DE14.031

    2014 Interim Eligibility Guidance: In accordance with the existing 
two-step analysis for patent subject matter eligibility under 35 U.S.C. 
101 explained in MPEP 2106, the claimed invention (Step 1) ``must be 
directed to one of the four statutory categories'' and (Step 2) ``must 
not be wholly directed to subject matter encompassing a judicially 
recognized exception.'' Referring to the attached flowchart titled 
Subject Matter Eligibility Test for Products and Processes, Step 1 is 
represented in diamond (1), which is explained in MPEP 2106(I). Step 2 
is represented in diamonds (2A) and (2B) and is the subject of this 
Interim Eligibility Guidance. Step 2 is the two-part

[[Page 74622]]

analysis from Alice Corp.\7\ (also called the Mayo test) for claims 
directed to laws of nature, natural phenomena, and abstract ideas (the 
judicially recognized exceptions).
---------------------------------------------------------------------------

    \7\ Alice Corp., 134 S. Ct. at 2355.
---------------------------------------------------------------------------

I. Two-Part Analysis for Judicial Exceptions

    A. Flowchart Step 2A (Part 1 Mayo Test)--Determine whether the 
claim is directed to a law of nature, a natural phenomenon, or an 
abstract idea (judicial exceptions).
    After determining what applicant has invented by reviewing the 
entire application disclosure and construing the claims in accordance 
with their broadest reasonable interpretation (MPEP 2103), determine 
whether the claim as a whole is directed to a judicial exception. A 
claim to a process, machine, manufacture or composition of matter (Step 
1: YES) that is not directed to any judicial exceptions (Step 2A: NO) 
is eligible and needs no further eligibility analysis. A claim that is 
directed to at least one exception (Step 2A: YES) requires further 
analysis to determine whether the claim recites a patent-eligible 
application of the exception (Step 2B).

1. Determine What the Claim Is ``Directed to''

    A claim is directed to a judicial exception when a law of nature, a 
natural phenomenon, or an abstract idea is recited (i.e., set forth or 
described) in the claim. Such a claim requires closer scrutiny for 
eligibility because of the risk that it will ``tie up'' \8\ the 
excepted subject matter and pre-empt others from using the law of 
nature, natural phenomenon, or abstract idea. Courts tread carefully in 
scrutinizing such claims because at some level all inventions embody, 
use, reflect, rest upon, or apply a law of nature, natural phenomenon, 
or abstract idea.\9\ To properly interpret the claim, it is important 
to understand what the applicant has invented and is seeking to patent.
---------------------------------------------------------------------------

    \8\ Mayo, 132 S. Ct. at 1301 (``[E]ven though rewarding with 
patents those who discover new laws of nature and the like might 
well encourage their discovery, those laws and principles, 
considered generally, are `the basic tools of scientific and 
technological work.' And so there is a danger that the grant of 
patents that tie up their use will inhibit future innovation 
premised upon them, a danger that becomes acute when a patented 
process amounts to no more than an instruction to `apply the natural 
law,' or otherwise forecloses more future invention than the 
underlying discovery could reasonably justify'' (quoting Gottschalk 
v. Benson, 409 U.S. 63, 67 (1972)).
    \9\ An invention is not rendered ineligible for patent simply 
because it involves an abstract concept. Applications of such 
concepts ``to a new and useful end,'' remain eligible for patent 
protection. Alice Corp., 134 S.Ct. at 2354 (quoting Benson, 409 U.S. 
at 67).
---------------------------------------------------------------------------

    For claims that may recite a judicial exception, but are directed 
to inventions that clearly do not seek to tie up the judicial 
exception, see Section I.B.3. regarding a streamlined eligibility 
analysis.

2. Identify the Judicial Exception Recited in the Claim

    MPEP 2106(II) provides a detailed explanation of the judicial 
exceptions and their legal bases. It should be noted that there are no 
bright lines between the types of exceptions because many of these 
concepts can fall under several exceptions. For example, mathematical 
formulas are considered to be an exception as they express a scientific 
truth, but have been labelled by the courts as both abstract ideas and 
laws of nature. Likewise, ``products of nature'' are considered to be 
an exception because they tie up the use of naturally occurring things, 
but have been labelled as both laws of nature and natural phenomena. 
Thus, it is sufficient for this analysis to identify that the claimed 
concept aligns with at least one judicial exception.
    Laws of nature and natural phenomena, as identified by the courts, 
include naturally occurring principles/substances and substances that 
do not have markedly different characteristics compared to what occurs 
in nature. See Section I.A.3. for a discussion of the markedly 
different characteristics analysis used to determine whether a claim 
that includes a nature-based product limitation recites an exception. 
The types of concepts courts have found to be laws of nature and 
natural phenomena are shown by these cases, which are intended to be 
illustrative and not limiting:
     An isolated DNA (Myriad: see Section III, Example 2);
     a correlation that is the consequence of how a certain 
compound is metabolized by the body (Mayo: see Section III, Example 5);
     electromagnetism to transmit signals (Morse: \10\ see 
Section IV.A.1.); and
---------------------------------------------------------------------------

    \10\ O'Reilly v. Morse, 56 U.S. 62 (1853).
---------------------------------------------------------------------------

     the chemical principle underlying the union between fatty 
elements and water (Tilghman: \11\ see Section IV.A.2.).
---------------------------------------------------------------------------

    \11\ Tilghman v. Proctor, 102 U.S. 707 (1881).
---------------------------------------------------------------------------

    Abstract ideas have been identified by the courts by way of 
example, including fundamental economic practices, certain methods of 
organizing human activities, an idea `of itself,' and mathematical 
relationships/formulas.\12\ The types of concepts courts have found to 
be abstract ideas are shown by these cases, which are intended to be 
illustrative and not limiting:
---------------------------------------------------------------------------

    \12\ Alice Corp., 134 S. Ct. at 2355-56.
---------------------------------------------------------------------------

     Mitigating settlement risk (Alice: see Section III, 
Example 6);
     hedging (Bilski: \13\ see Section IV.A.5.);
---------------------------------------------------------------------------

    \13\ Bilski v. Kappos, 561 U.S. 593 (2010).
---------------------------------------------------------------------------

     creating a contractual relationship (buySAFE: \14\ see 
Section IV.C.3.);
---------------------------------------------------------------------------

    \14\ buySAFE, Inc. v. Google, Inc., __-- F.3d __--, 112 USPQ2d 
1093 (Fed. Cir. 2014).
---------------------------------------------------------------------------

     using advertising as an exchange or currency 
(Ultramercial: \15\ see Section IV.C.4.);
---------------------------------------------------------------------------

    \15\ Ultramercial, LLC v. Hulu, LLC and WildTangent, __-- F.3d 
__--, 112 USPQ2d 1750 (Fed. Cir. 2014).
---------------------------------------------------------------------------

     processing information through a clearinghouse 
(Dealertrack: \16\ see Section IV.B.3.);
---------------------------------------------------------------------------

    \16\ Dealertrack Inc. v. Huber, 674 F.3d 1315 (Fed. Cir. 2012).
---------------------------------------------------------------------------

     comparing new and stored information and using rules to 
identify options (SmartGene: \17\ see Section IV.B.4.);
---------------------------------------------------------------------------

    \17\ SmartGene, Inc. v. Advanced Biological Labs., SA, 555 Fed. 
Appx. 950 (Fed. Cir. 2014) (nonprecedential).
---------------------------------------------------------------------------

     using categories to organize, store and transmit 
information (Cyberfone: \18\ see Section IV.B.5.);
---------------------------------------------------------------------------

    \18\ Cyberfone Sys. v. CNN Interactive Grp., 558 Fed. Appx. 988 
(Fed. Cir. 2014) (nonprecedential).
---------------------------------------------------------------------------

     organizing information through mathematical correlations 
(Digitech: \19\ see Section IV.C.1.);
---------------------------------------------------------------------------

    \19\ Digitech Image Tech., LLC v. Electronics for Imaging, Inc., 
758 F.3d 1344 (Fed. Cir. 2014).
---------------------------------------------------------------------------

     managing a game of bingo (Planet Bingo: \20\ see Section 
IV.C.2.);
---------------------------------------------------------------------------

    \20\ Planet Bingo, LLC v. VKGS LLC, __-- Fed. Appx. __-- (Fed. 
Cir. 2014) (nonprecedential).
---------------------------------------------------------------------------

     the Arrhenius equation for calculating the cure time of 
rubber (Diehr: \21\ see Section III, Example 3);
---------------------------------------------------------------------------

    \21\  Diamond v. Diehr, 450 U.S. 175 (1981).
---------------------------------------------------------------------------

     a formula for updating alarm limits (Flook: \22\ see 
Section III, Example 4);
---------------------------------------------------------------------------

    \22\ Parker v. Flook, 437 U.S. 584 (1978).
---------------------------------------------------------------------------

     a mathematical formula relating to standing wave phenomena 
(Mackay Radio: \23\ see Section IV.A.3.); and
---------------------------------------------------------------------------

    \23\ Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306 U.S. 86 
(1939).
---------------------------------------------------------------------------

     a mathematical procedure for converting one form of 
numerical representation to another (Benson: \24\ see Section IV.A.4.)
---------------------------------------------------------------------------

    \24\  Benson, 409 U.S. at 63.
---------------------------------------------------------------------------

3. Nature-Based Products

a. Determine Whether the Markedly Different Characteristics Analysis Is 
Needed To Evaluate a Nature-Based Product Limitation Recited in a Claim
    Nature-based products, as used herein, include both eligible and

[[Page 74623]]

ineligible products and merely refer to the types of products subject 
to the markedly different characteristics analysis used to identify 
``product of nature'' exceptions. Courts have held that naturally 
occurring products and some man-made products that are essentially no 
different from a naturally occurring product are ``products of nature'' 
\25\ that fall under the laws of nature or natural phenomena exception. 
To determine whether a claim that includes a nature-based product 
limitation recites a ``product of nature'' exception, use the markedly 
different characteristics analysis to evaluate the nature-based product 
limitation (discussed in section I.A.3.b). A claim that recites a 
nature-based product limitation that does not exhibit markedly 
different characteristics from its naturally occurring counterpart in 
its natural state is directed to a ``product of nature'' exception 
(Step 2A: YES).
---------------------------------------------------------------------------

    \25\ Myriad, 133 S. Ct. at 2111.
---------------------------------------------------------------------------

    Care should be taken not to overly extend the markedly different 
characteristics analysis to products that when viewed as a whole are 
not nature-based. For claims that recite a nature-based product 
limitation (which may or may not be a ``product of nature'' exception) 
but are directed to inventions that clearly do not seek to tie up any 
judicial exception, see Section I.B.3. regarding a streamlined 
eligibility analysis. In such cases, it would not be necessary to 
conduct a markedly different characteristics analysis.
    A nature-based product can be claimed by itself (e.g., ``a 
Lactobacillus bacterium'') or as one or more limitations of a claim 
(e.g., ``a probiotic composition comprising a mixture of Lactobacillus 
and milk in a container''). The markedly different characteristics 
analysis should be applied only to the nature-based product limitations 
in the claim to determine whether the nature-based products are 
``product of nature'' exceptions. When the nature-based product is 
produced by combining multiple components, the markedly different 
characteristics analysis should be applied to the resultant nature-
based combination, rather than its component parts. In the example 
above, the mixture of Lactobacillus and milk should be analyzed for 
markedly different characteristics, rather than the Lactobacillus 
separately and the milk separately. The container would not be subject 
to the markedly different characteristics analysis as it is not a 
nature-based product, but would be evaluated in Step 2B if it is 
determined that the mixture of Lactobacillus and milk does not have 
markedly different characteristics from any naturally occurring 
counterpart and thus is a ``product of nature'' exception.
    For a product-by-process claim, the analysis turns on whether the 
nature-based product in the claim has markedly different 
characteristics from its naturally occurring counterpart. (See MPEP 
2113 for product-by-process claims.)
    A process claim is not subject to the markedly different analysis 
for nature-based products used in the process, except in the limited 
situation where a process claim is drafted in such a way \26\ that 
there is no difference in substance from a product claim (e.g., ``a 
method of providing an apple.'').
---------------------------------------------------------------------------

    \26\ Alice Corp., 134 S. Ct. at 2360.
---------------------------------------------------------------------------

b. Markedly Different Characteristics Analysis: Structure, Function 
and/or Other Properties \27\
---------------------------------------------------------------------------

    \27\ This revised analysis represents a change from prior 
guidance, because now changes in functional characteristics and 
other non-structural properties can evidence markedly different 
characteristics, whereas in the March 2014 Procedure only structural 
changes were sufficient to show a marked difference.
---------------------------------------------------------------------------

    The markedly different characteristics analysis compares the 
nature-based product limitation to its naturally occurring counterpart 
in its natural state. When there is no naturally occurring counterpart 
to the nature-based product, the comparison should be made to the 
closest naturally occurring counterpart. In the case of a nature-based 
combination, the closest counterpart may be the individual nature-based 
components that form the combination, i.e., the characteristics of the 
claimed nature-based combination are compared to the characteristics of 
the components in their natural state.
    Markedly different characteristics can be expressed as the 
product's structure, function, and/or other properties,\28\ and will be 
evaluated based on what is recited in the claim on a case-by-case 
basis. As seen by the examples that are being released in conjunction 
with this Interim Eligibility Guidance, even a small change can result 
in markedly different characteristics from the product's naturally 
occurring counterpart. In accordance with this analysis, a product that 
is purified or isolated, for example, will be eligible when there is a 
resultant change in characteristics sufficient to show a marked 
difference from the product's naturally occurring counterpart. If the 
claim recites a nature-based product limitation that does not exhibit 
markedly different characteristics, the claim is directed to a 
``product of nature'' exception (a law of nature or naturally occurring 
phenomenon), and the claim will require further analysis to determine 
eligibility based on whether additional elements add significantly more 
to the exception.
---------------------------------------------------------------------------

    \28\ To show a marked difference, a characteristic must be 
changed as compared to nature, and cannot be an inherent or innate 
characteristic of the naturally occurring counterpart. Funk Bros. 
Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (``[The 
inventor did] not create a state of inhibition or of non-inhibition 
in the bacteria. Their qualities are the work of nature. Those 
qualities are of course not patentable.''); In re Marden, 47 F.2d 
958 (CCPA 1931) (eligibility of a claim to ductile vanadium held 
ineligible, because the ``ductility or malleability of vanadium is . 
. . one of its inherent characteristics and not a characteristic 
given to it by virtue of a new combination with other materials or 
which characteristic is brought about by some chemical reaction or 
agency which changes its inherent characteristics''). Further, a 
difference in a characteristic that came about or was produced 
independently of any effort or influence by applicant cannot show a 
marked difference. Roslin, 750 F.3d at 1338 (Because ``any 
phenotypic differences came about or were produced `quite 
independently of any effort of the patentee' '' and were 
``uninfluenced by Roslin's efforts'', they ``do not confer 
eligibility on their claimed subject matter'' (quoting Funk Bros.)).
---------------------------------------------------------------------------

    Non-limiting examples of the types of characteristics considered by 
the courts when determining whether there is a marked difference 
include:
     Biological or pharmacological functions or activities; 
\29\
---------------------------------------------------------------------------

    \29\ See, e.g., Funk Bros., 333 U.S. at 130-31 (properties and 
functions of bacteria such as a state of inhibition or non-
inhibition and the ability to infect leguminous plants); Diamond v. 
Chakrabarty, 447 U.S. 303, 310 (1980) (genetically modified 
bacterium's ability to degrade hydrocarbons); In re King, 107 F.2d 
618 (CCPA 1939) (the ability of vitamin C to prevent and treat 
scurvy); Myriad, 133 S. Ct. at 2111, 2116-17 (the protein-encoding 
information of a nucleic acid).
---------------------------------------------------------------------------

     Chemical and physical properties; \30\
---------------------------------------------------------------------------

    \30\ See, e.g., Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 
95, 103-04 (S.D.N.Y. 1911) (the alkalinity of a chemical compound); 
Marden, 47 F.2d at 958 (the ductility or malleability of metals); 
Funk Bros., 333 U.S. at 130 (``The qualities of these bacteria, like 
the heat of the sun, electricity, or the qualities of metals, are 
part of the store-house of knowledge of all men. They are 
manifestations of laws of nature, free to all men and reserved 
exclusively to none.'').
---------------------------------------------------------------------------

     Phenotype, including functional and structural 
characteristics; \31\ and
---------------------------------------------------------------------------

    \31\ See, e.g., Roslin, 750 F.3d at 1338 (phenotype, including 
functional and structural characteristics, e.g., the shape, size, 
color, and behavior of an organism).
---------------------------------------------------------------------------

     Structure and form, whether chemical, genetic or 
physical.\32\
---------------------------------------------------------------------------

    \32\ See, e.g., Chakrabarty, 447 U.S. at 305 and n.1 (the 
physical presence of plasmids in a bacterial cell); Parke-Davis, 189 
F. at 100, 103 (claimed chemical was a ``nonsalt'' and a 
``crystalline substance''); Myriad, 133 S. Ct. at 2116, 2119 
(nucleotide sequence of DNA); Roslin, 750 F.3d at 1338-39 (the 
genetic makeup (genotype) of a cell or organism).
---------------------------------------------------------------------------

    If the claim includes a nature-based product that has markedly 
different characteristics, the claim does not recite a ``product of 
nature'' exception and is eligible (Step 2A: NO) unless the claim

[[Page 74624]]

recites another exception (such as a law of nature or abstract idea, or 
a different natural phenomenon). If the claim includes a product having 
no markedly different characteristics from the product's naturally 
occurring counterpart in its natural state, the claim is directed to an 
exception (Step 2A: YES), and the eligibility analysis must proceed to 
Step 2B to determine if any additional elements in the claim add 
significantly more to the exception. For claims that are to a single 
nature-based product, once a markedly different characteristic in that 
product is shown, no further analysis would be necessary for 
eligibility because no ``product of nature'' exception is recited 
(i.e., Step 2B is not necessary because the answer to Step 2A is NO). 
This is a change from prior guidance because the inquiry as to whether 
the claim amounts to significantly more than a ``product of nature'' 
exception is not relevant to claims that do not recite an exception. 
Thus, a claim can be found eligible based solely on a showing that the 
nature-based product in the claim has markedly different 
characteristics and thus is not a ``product of nature'' exception, when 
no other exception is recited in the claim.
    If a rejection under 35 U.S.C. 101 is ultimately made, the 
rejection should identify the exception as it is recited (i.e., set 
forth or described) in the claim, and explain why it is an exception 
providing reasons why the product does not have markedly different 
characteristics from its naturally occurring counterpart in its natural 
state.
    B. Flowchart Step 2B (Part 2 Mayo test)--Determine whether any 
element, or combination of elements, in the claim is sufficient to 
ensure that the claim amounts to significantly more than the judicial 
exception.
    A claim directed to a judicial exception must be analyzed to 
determine whether the elements of the claim, considered both 
individually and as an ordered combination, are sufficient to ensure 
that the claim as a whole amounts to significantly more than the 
exception itself--this has been termed a search for an ``inventive 
concept.'' \33\ To be patent-eligible, a claim that is directed to a 
judicial exception must include additional features to ensure that the 
claim describes a process or product that applies the exception in a 
meaningful way, such that it is more than a drafting effort designed to 
monopolize the exception. It is important to consider the claim as 
whole. Individual elements viewed on their own may not appear to add 
significantly more to the claim, but when combined may amount to 
significantly more than the exception. Every claim must be examined 
individually, based on the particular elements recited therein, and 
should not be judged to automatically stand or fall with similar claims 
in an application.
---------------------------------------------------------------------------

    \33\ Alice Corp., 134 S. Ct. at 2357.
---------------------------------------------------------------------------

1. ``Significantly More''

    The Supreme Court has identified a number of considerations for 
determining whether a claim with additional elements amounts to 
significantly more than the judicial exception itself. The following 
are examples of these considerations, which are not intended to be 
exclusive or limiting. Limitations that may be enough to qualify as 
``significantly more'' when recited in a claim with a judicial 
exception include:
     Improvements to another technology or technical field; 
\34\
---------------------------------------------------------------------------

    \34\ Alice Corp., 134 S. Ct. at 2359 (citing Diehr, 450 U.S. at 
177-78) (a mathematical formula applied in a specific rubber molding 
process).
---------------------------------------------------------------------------

     Improvements to the functioning of the computer itself; 
\35\
---------------------------------------------------------------------------

    \35\ Id., at 2359.
---------------------------------------------------------------------------

     Applying the judicial exception with, or by use of, a 
particular machine; \36\
---------------------------------------------------------------------------

    \36\ Bilski, 130 S. Ct. at 3227 (``The Court's precedents 
establish that the machine-or-transformation test is a useful and 
important clue, an investigative tool, for determining whether some 
claimed inventions are processes under Sec.  101.'').
---------------------------------------------------------------------------

     Effecting a transformation or reduction of a particular 
article to a different state or thing; \37\
---------------------------------------------------------------------------

    \37\ Diehr, 450 U.S. at 184 (``That respondents' claims [to a 
specific rubber molding process] involve the transformation of an 
article, in this case raw, uncured synthetic rubber, into a 
different state or thing cannot be disputed.''). See also Benson, 
409 U.S. at 70 (``Transformation and reduction of an article `to a 
different state or thing' is the clue to the patentability of a 
process claim that does not include particular machines. So it is 
that a patent in the process of `manufacturing fat acids and 
glycerine from fatty bodies by the action of water at a high 
temperature and pressure' was sustained in Tilghman, 102 U.S. at 
721'').
---------------------------------------------------------------------------

     Adding a specific limitation other than what is well-
understood, routine and conventional in the field, or adding 
unconventional steps that confine the claim to a particular useful 
application; \38\ or
---------------------------------------------------------------------------

    \38\ Mayo, 132 S. Ct. at 1299, 1302 (claim ineligible because 
the recited ``instructions add nothing specific to the laws of 
nature other than what is well-understood, routine, conventional 
activity, previously engaged in by those in the field,'' which was 
``[u]nlike, say, a typical patent on a new drug or a new way of 
using an existing drug'').
---------------------------------------------------------------------------

     Other meaningful limitations beyond generally linking the 
use of the judicial exception to a particular technological 
environment.\39\
---------------------------------------------------------------------------

    \39\ Alice Corp., 134 S. Ct. at 2360 (noting that none of the 
hardware recited ``offers a meaningful limitation beyond generally 
linking `the use of the [method] to a particular technological 
environment,' that is, implementation via computers'' (citing 
Bilski, 561 U.S. at 610, 611)).
---------------------------------------------------------------------------

    Limitations that were found not to be enough to qualify as 
``significantly more'' when recited in a claim with a judicial 
exception include:
     Adding the words ``apply it'' (or an equivalent) with the 
judicial exception, or mere instructions to implement an abstract idea 
on a computer; \40\
---------------------------------------------------------------------------

    \40\ Id. at 2358 (simply implementing a mathematical principle 
on a physical machine, namely a computer (citing Mayo, 132 S. Ct. at 
1301)).
---------------------------------------------------------------------------

     Simply appending well-understood, routine and conventional 
activities previously known to the industry, specified at a high level 
of generality, to the judicial exception, e.g., a claim to an abstract 
idea requiring no more than a generic computer to perform generic 
computer functions that are well-understood, routine and conventional 
activities previously known to the industry; \41\
---------------------------------------------------------------------------

    \41\ Id. at 2359 (using a computer to obtain data, adjust 
account balances, and issue automated instructions); Mayo, 132 S. 
Ct. at 1300 (telling a doctor to measure metabolite levels in the 
blood using any known process).
---------------------------------------------------------------------------

     Adding insignificant extrasolution activity to the 
judicial exception, e.g., mere data gathering in conjunction with a law 
of nature or abstract idea; \42\ or
---------------------------------------------------------------------------

    \42\ Mayo, 132 S. Ct. at 1297-98 (measuring metabolites of a 
drug administered to a patient); Flook, 437 U.S. at 589-90 (1978) 
(adjusting an alarm limit variable to a figure computed according to 
a mathematical formula).
---------------------------------------------------------------------------

     Generally linking the use of the judicial exception to a 
particular technological environment or field of use.\43\
---------------------------------------------------------------------------

    \43\ Mayo, 132 S. Ct. at 1300-01 (citing Bilski, 130 S. Ct. 
3223-24) (limiting hedging to use in commodities and energy 
markets); Flook, 437 U.S. at 589-90.
---------------------------------------------------------------------------

    Section III provides examples of claims analyzed under this 
framework.
    If the claim as a whole does recite significantly more than the 
exception itself, the claim is eligible (Step 2B: YES), and the 
eligibility analysis is complete. If there are no meaningful 
limitations in the claim that transform the exception into a patent-
eligible application, such that the claim does not amount to 
significantly more than the exception itself, the claim is not patent-
eligible (Step 2B: NO) and should be rejected under 35 U.S.C. 101. In 
the rejection, identify the exception by referring to where it is 
recited (i.e., set forth or described) in the claim and explain why it 
is considered an exception. Then, if the claim includes additional 
elements, identify the elements in the rejection and explain why they 
do not add significantly more to the exception. Also see MPEP

[[Page 74625]]

2103(VI) and 2106(III) for instructions on making the rejection.

2. A Claim Reciting a Plurality of Exceptions

    For a claim that is directed to a plurality of exceptions, conduct 
the eligibility analysis for one of the exceptions. If the claim 
recites an element or combination of elements that amount to 
significantly more than that exception, consider whether those 
additional elements also amount to significantly more for the other 
claimed exception(s), which ensures that the claim does not have a pre-
emptive effect with respect to any of the recited exceptions. 
Additional elements that satisfy Step 2B for one exception will likely 
satisfy Step 2B for all exceptions in a claim. On the other hand, if 
the claim fails under Step 2B for one exception, the claim is 
ineligible, and no further eligibility analysis is needed.

3. Streamlined Eligibility Analysis

    For purposes of efficiency in examination, a streamlined 
eligibility analysis can be used for a claim that may or may not recite 
a judicial exception but, when viewed as a whole, clearly does not seek 
to tie up any judicial exception such that others cannot practice it. 
Such claims do not need to proceed through the full analysis herein as 
their eligibility will be self-evident. However, if there is doubt as 
to whether the applicant is effectively seeking coverage for a judicial 
exception itself, the full analysis should be conducted to determine 
whether the claim recites significantly more than the judicial 
exception.
    For instance, a claim directed to a complex manufactured industrial 
product or process that recites meaningful limitations along with a 
judicial exception may sufficiently limit its practical application so 
that a full eligibility analysis is not needed. As an example, a 
robotic arm assembly having a control system that operates using 
certain mathematical relationships is clearly not an attempt to tie up 
use of the mathematical relationships and would not require a full 
analysis to determine eligibility. Also, a claim that recites a nature-
based product, but clearly does not attempt to tie up the nature-based 
product, does not require a markedly different characteristics analysis 
to identify a ``product of nature'' exception. As an example, a claim 
directed to an artificial hip prosthesis coated with a naturally 
occurring mineral is not an attempt to tie up the mineral. Similarly, 
claimed products that merely include ancillary nature-based components, 
such as a claim that is directed to a cellphone with an electrical 
contact made of gold or a plastic chair with wood trim, would not 
require analysis of the nature-based component to identify a ``product 
of nature'' exception because such claims do not attempt to improperly 
tie up the nature-based product.

II. Complete Examination

    Regardless of whether a rejection under 35 U.S.C. 101 is made, a 
complete examination should be made for every claim under each of the 
other patentability requirements: 35 U.S.C. 102, 103, 112, and 101 
(utility, inventorship and double patenting) and non-statutory double 
patenting. See MPEP 2103 et seq. and 2106(III).

III. Sample Analyses

    The following examples, based upon Supreme Court decisions, use the 
Interim Eligibility Guidance and flowchart to analyze claims for 
subject matter eligibility.

Example 1. Diamond v. Chakrabarty \44\ (U.S. Patent No. 4,259,444)
---------------------------------------------------------------------------

    \44\ Chakrabarty, 447 U.S. at 303.
---------------------------------------------------------------------------

    Background: Stable energy-generating plasmids that provide 
hydrocarbon degradative pathways exist within certain bacteria in 
nature. Different plasmids provide the ability to degrade different 
hydrocarbons, e.g., one plasmid provides the ability to degrade 
camphor, and a different plasmid provides the ability to degrade 
octane. Pseudomonas bacteria are naturally occurring bacteria. 
Naturally occurring Pseudomonas bacteria containing one stable energy-
generating plasmid and capable of degrading a single type of 
hydrocarbon are known.
    Representative Claim:

    A bacterium from the genus Pseudomonas containing therein at 
least two stable energy-generating plasmids, each of said plasmids 
providing a separate hydrocarbon degradative pathway.

    Analysis: The claim is directed to a statutory category, e.g., a 
manufacture or composition of matter (Step 1: YES) and recites a 
nature-based product (a bacterium). To determine whether the claim is 
directed to a ``product of nature'' exception, the nature-based product 
is analyzed using the markedly different characteristics analysis.
    The claimed bacterium has a different functional characteristic 
from naturally occurring Pseudomonas bacteria, i.e., it is able to 
degrade at least two different hydrocarbons as compared to naturally 
occurring Pseudomonas bacteria that can only degrade a single 
hydrocarbon. The claimed bacterium also has a different structural 
characteristic, i.e., it was genetically modified to include more 
plasmids than are found in a single naturally occurring Pseudomonas 
bacterium. The bacterium is new with markedly different characteristics 
from any found in nature, due to the additional plasmids and resultant 
capacity for degrading multiple hydrocarbon components of oil. These 
different functional and structural characteristics rise to the level 
of a marked difference, and accordingly the claimed bacterium is not a 
``product of nature'' exception. Thus, the claim is not directed to an 
exception (Step 2A: NO). The claim is eligible.

Example 2. Association for Molecular Pathology v. Myriad Genetics, Inc. 
(U.S. Patent No. 5,747,282)

    Background: A human gene is a naturally occurring segment of DNA 
that codes for a protein. In nature, human genes are linked together by 
covalent bonds to form long chains of DNA called chromosomes. The 
inventors discovered the location and nucleotide sequence of a 
naturally occurring human gene called BRCA1. The BRCA1 gene encodes a 
polypeptide called BRCA1, which helps repair damaged DNA and prevent 
tumor formation. There are many naturally-occurring mutations in the 
BRCA1 gene. Some mutations are harmless, but others can dramatically 
increase a person's risk of developing breast and ovarian cancer.
    Knowledge of the location and nucleotide sequence of the BRCA1 gene 
allows it to be isolated so that it can be studied, manipulated, or 
used. Isolated genes can be made in two different ways. The first way 
is to physically remove the gene from its natural location on the human 
chromosome by breaking two covalent bonds--one on each end of the 
gene--that connect the gene with the rest of the chromosome in nature. 
The second way is to synthesize the gene in a laboratory, e.g., by 
linking together nucleotides to form the naturally occurring sequence 
of the gene. Both ways result in a gene that is ``isolated'' from its 
natural environment, i.e., removed from the chromosome in which it 
occurs in nature.
    The BRCA1 gene is about 80,000 nucleotides long, including several 
introns and several exons. In nature, the BRCA1 polypeptide is produced 
from the BRCA1 gene through an intermediate product called an mRNA. The 
natural creation of the BRCA1 mRNA in human cells involves splicing 
(removal) of the introns, and results in an exons-only molecule. The 
inventors used the mRNA to create an exons-only

[[Page 74626]]

molecule called a complementary DNA (cDNA), which contains the same 
protein-encoding information as the BRCA1 gene, but omits the non-
coding portions (introns) of the gene. The nucleotide sequence of this 
cDNA was disclosed as SEQ ID NO:1, and the amino acid sequence of the 
BRCA1 polypeptide as SEQ ID NO:2.
    Representative Claims:

    Claim 1. An isolated DNA coding for a BRCA1 polypeptide, said 
polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
    Claim 2. The isolated DNA of claim 1, wherein said DNA has the 
nucleotide sequence set forth in SEQ ID NO:1.

    Analysis: The claims are directed to a statutory category, e.g., a 
composition of matter (Step 1: YES), and recite nature-based products 
(a DNA). Thus, the markedly different analysis is used to determine if 
that nature-based product is a ``product of nature'' exception.
    Claim 1: The claim encompasses isolated DNA that has the same 
nucleotide sequence as the naturally occurring BRCA1 gene. The 
isolation of the claimed DNA results in a different structural 
characteristic than the natural gene, because the natural gene has 
covalent bonds on the ends that connect the gene to the chromosome 
which the claimed DNA lacks. However, the claimed DNA is otherwise 
structurally identical to the natural gene, e.g., it has the same 
genetic structure and nucleotide sequence as the BRCA1 gene in nature. 
The claimed DNA has no different functional characteristics, i.e., it 
encodes the same protein as the natural gene. Under the holding of 
Myriad, this isolated but otherwise unchanged DNA is not eligible 
because it is not different enough from what exists in nature to avoid 
improperly tying up the future use and study of the naturally occurring 
BRCA1 gene. In other words, the claimed DNA is different, but not 
markedly different, from its naturally occurring counterpart (BRCA 1 
gene), and thus is directed to a ``product of nature'' exception (Step 
2A: YES).
    A claim directed to an exception should be analyzed to determine 
whether any element, or combination of elements, in the claim is 
sufficient to ensure that the claim amounts to significantly more than 
the exception. Claim 1 does not include any additional features that 
could add significantly more to the exception (Step 2B: NO). The claim 
is not eligible and should be rejected under 35 U.S.C. 101.
    Claim 2: The claim is limited to a DNA having the nucleotide 
sequence of SEQ ID NO: 1. As disclosed in the specification, SEQ ID NO: 
1 is an exons-only sequence of a cDNA created by the inventors. The 
claimed DNA therefore has different structural characteristics than the 
naturally occurring BRCA1 gene, e.g., in addition to lacking covalent 
bonds on its ends, it has a different nucleotide sequence (SEQ ID NO: 1 
includes only exons, as compared to the natural sequence containing 
both exons and introns). The claimed DNA has no different functional 
characteristics, i.e., it encodes the same protein as the natural gene. 
Here, the differences in structural characteristics between the claimed 
DNA and the natural gene are significant, e.g., they are enough to 
ensure that the claim is not improperly tying up the future use of the 
BRCA1 gene. Thus, they rise to the level of a marked difference, and 
the claimed DNA is not a ``product of nature'' exception. Thus, the 
claim is not directed to an exception (Step 2A: NO). The claim is 
eligible.

Example 3. Diamond v. Diehr (U.S. Patent No. 4,344,142)

    Background: The claimed invention is a process for molding raw, 
uncured synthetic rubber into cured precision products. The process 
uses a mold for precisely shaping the uncured material under heat and 
pressure and then curing the synthetic rubber in the mold so that the 
product will retain its shape and be functionally operative after the 
molding is completed. Achieving the perfect cure depends upon several 
factors including the thickness of the article to be molded, the 
temperature of the molding process, and the amount of time that the 
article is allowed to remain in the press. It is possible to calculate 
when to open the press and remove the cured product using well-known 
time, temperature, and cure relationships by means of the Arrhenius 
equation. The inventors characterize their invention as the process of 
constantly measuring the actual temperature inside the mold, and 
automatically feeding these temperature measurements into a computer 
that repeatedly recalculates the cure time by use of the Arrhenius 
equation. When the recalculated time equals the actual time that has 
elapsed since the press was closed, the computer signals a device to 
open the press.
    Representative Claim:

    Claim 1. A method of operating a rubber-molding press for 
precision molded compounds with the aid of a digital computer, 
comprising:

    providing said computer with a data base for said press 
including at least, natural logarithm conversion data (ln), the 
activation energy constant (C) unique to each batch of said compound 
being molded, and a constant (x) dependent upon the geometry of the 
particular mold of the press,
    initiating an interval timer in said computer upon the closure 
of the press for monitoring the elapsed time of said closure,
    constantly determining the temperature (Z) of the mold at a 
location closely adjacent to the mold cavity in the press during 
molding,
    constantly providing the computer with the temperature (Z),
    repetitively calculating in the computer, at frequent intervals 
during each cure, the Arrhenius equation for reaction time during 
the cure, which is ln v = CZ+x, where v is the total required cure 
time, repetitively comparing in the computer at said frequent 
intervals during the cure each said calculation of the total 
required cure time calculated with the Arrhenius equation and said 
elapsed time, and
    opening the press automatically when a said comparison indicates 
equivalence.

    Analysis: The claim is directed to a statutory category, i.e., a 
process (Step 1: YES). The claim recites the Arrhenius equation, which 
is the mathematical formula: ln v = CZ+x. The court noted that an 
algorithm, or mathematical formula, is like a law of nature, which 
cannot be the subject of a patent. The claimed process when viewed as a 
whole focuses on the use of the Arrhenius equation to cure synthetic 
rubber. Thus, the claim is directed to an exception (Step 2A: YES).
    Next, the claim as a whole is analyzed to determine whether any 
element, or combination of elements, is sufficient to ensure that the 
claim amounts to significantly more than the exception. The 
specifically disclosed and claimed constant measurement of temperature 
at a mold cavity of a rubber-molding press and the claimed repetitive 
computer recalculation of the appropriate cure time using the 
constantly updated measurements are additional elements that provide 
``something more'' than mere computer implementation of calculation of 
the Arrhenius equation. Further, the claimed steps act in concert to 
transform raw, uncured rubber to cured molded rubber. The combination 
of steps recited in addition to the mathematical formula show that the 
claim is not to the formula in isolation, but rather that the steps 
impose meaningful limits that apply the formula to improve an existing 
technological process. Thus, the claim amounts to significantly more 
than the judicial exception (Step 2B: YES). The claim is eligible.

    Note: The Supreme Court has also characterized mathematical 
formulas as abstract ideas. As noted, all claims that are directed 
to a judicial exception, regardless of what the exception is called, 
are subject to the same analysis.


[[Page 74627]]



Example 4. Parker v. Flook

    Background: The invention is a method of updating alarm limits 
using a mathematical formula. An ``alarm limit'' is a number. During 
catalytic conversion processes, operating conditions such as 
temperature, pressure, and flow rates are constantly monitored. When 
any of these ``process variables'' exceeds a predetermined alarm limit, 
an alarm may signal the presence of an abnormal condition indicating 
either inefficiency or perhaps danger. The formula for updating alarm 
limits is used in a catalytic conversion processing system; however, 
there is no disclosure relating to that system, such as the chemical 
processes at work, the monitoring of process conditions, the 
determination of variables in the formula from process conditions, or 
the means of setting off an alarm or adjusting an alarm system.
    Representative Claim:

    Claim 1. A method for updating the value of at least one alarm 
limit on at least one process variable involved in a process 
comprising the catalytic chemical conversion of hydrocarbons wherein 
said alarm limit has a current value of Bo+K wherein 
Bo is the current alarm base and K is a predetermined 
alarm offset which comprises:
    (1) Determining the present value of said process variable, said 
present value being defined as PVL;
    (2) Determining a new alarm base B1, using the 
following equation: B1=Bo(1.0-F) + PVL(F) 
where F is a predetermined number greater than zero and less than 
1.0;
    (3) Determining an updated alarm limit which is defined as 
B1+GK; and thereafter;
    (4) Adjusting said alarm limit to said updated alarm limit 
value.

    Analysis: The claim is directed to a statutory category, i.e., a 
process (Step 1: YES). The claim recites the mathematical formula 
``B1=Bo(1.0-F) + PVL(F)''. The claimed invention 
focuses on the calculation of the number representing the alarm limit 
value using the mathematical formula. Thus, the claim is directed to a 
mathematical formula, which is like a law of nature that falls within 
the exceptions to patent-eligible subject matter (Step 2A: YES).
    A process is not unpatentable simply because it contains a law of 
nature or mathematical algorithm. The claim as a whole must be analyzed 
to determine what additional elements are recited in the claim. The 
claimed formula is limited by the steps of gathering the input 
variables and carrying out the calculation to update the number 
describing the alarm limit, and by the field of technology for which it 
is to be used. The determination of chemical process variables, and the 
use of a generic computer to calculate values, is routine and 
conventional in the field of chemical processing. Adjusting the alarm 
limit based on the solution to the mathematical formula is merely post-
solution activity that could be attached to almost any formula. 
Limiting the claim to petrochemical and oil-refining industries, such 
that the claim does not seek to wholly preempt the mathematical 
formula, is a field-of-use limitation that does not impose meaningful 
limits on the mathematical formula. Moreover, when considered as an 
ordered combination, the claim is nothing more than a purely 
conventional computerized implementation of applicant's formula. 
Therefore, the claim as a whole does not provide significantly more 
than a generic computer upon which the claimed formula is calculated. 
Thus, the claim does not amount to significantly more than the judicial 
exception itself (Step 2B: NO). The claim is not eligible and should be 
rejected under 35 U.S.C. 101.

Example 5. Mayo v. Prometheus (U.S. Patent No. 6,355,623)

    Background: The invention is a method of assisting doctors who use 
thiopurine drugs to treat patients with autoimmune diseases. The method 
helps doctors determine whether a given dosage level is too low or too 
high, based on the relationship between the concentration in the blood 
of a thiopurine metabolite (6-thioguanine) and the likelihood that the 
drug dosage will be ineffective or induce harmful side-effects. The 
relationship is a natural consequence of the ways in which thiopurine 
compounds are metabolized by the body, even though human action is 
needed to trigger a manifestation of the relationship.
    Representative Claim:

    Claim 1. A method of optimizing therapeutic efficacy for 
treatment of an immune-mediated gastrointestinal disorder, 
comprising:
    (a) administering a drug providing 6-thioguanine to a subject 
having said immune-mediated gastrointestinal disorder; and
    (b) determining the level of 6-thioguanine in said subject 
having said immune-mediated gastrointestinal disorder,
    wherein the level of 6-thioguanine less than about 230 pmol per 
8x10\8\ red blood cells indicates a need to increase the amount of 
said drug subsequently administered to said subject and wherein the 
level of 6-thioguanine greater than about 400 pmol per 8x10\8\ red 
blood cells indicates a need to decrease the amount of said drug 
subsequently administered to said subject.

    Analysis: The claim is directed to a statutory category, i.e., a 
process (Step 1: YES). The claim sets forth relationships between 
concentrations of certain metabolites in the blood and the likelihood 
that a dosage of a thiopurine drug will prove ineffective or cause 
harm. While it takes a human action (the administration of a thiopurine 
drug) to trigger a manifestation of this relation in a particular 
person, the relation itself exists in principle apart from any human 
action. The claim recites that relation and, thus, is directed towards 
a natural law (Step 2A: YES).
    Next, the claim as a whole is analyzed to determine whether any 
element, or combination of elements, is sufficient to ensure that the 
claim amounts to significantly more than the exception. The 
``administering'' step simply refers to the relevant audience, namely 
doctors who treat patients with certain diseases with thiopurine drugs. 
That audience is a pre-existing audience; doctors used thiopurine drugs 
to treat patients suffering from autoimmune disorders long before 
anyone asserted these claims. The ``wherein'' clauses simply tell a 
doctor about the relevant natural laws, at most adding a suggestion 
that the doctor should take those laws into account when treating the 
patient. The ``determining'' step tells the doctor to determine the 
level of the relevant metabolites in the blood, through whatever 
process the doctor or the laboratory wishes to use. The claims inform a 
relevant audience about certain laws of nature; any additional steps 
consist of well understood, routine, conventional activity already 
engaged in by the scientific community; and those steps, when viewed as 
a whole, add nothing significant beyond the sum of their parts taken 
separately. Even though the laws of nature at issue are narrow laws 
that may have limited applications, the claim does not amount to 
significantly more than the natural law itself (Step 2B: NO). The claim 
is not eligible and should be rejected under 35 U.S.C. 101.

Example 6. Alice Corp. v. CLS Bank (U.S. Patent Nos. 5,970,479 and 
7,725,375)

    Background: The claims at issue relate to a computerized scheme for 
mitigating ``settlement risk''; i.e., the risk that only one party to 
an agreed-upon financial exchange will satisfy its obligation. In 
particular, the claims are designed to facilitate the exchange of 
financial obligations between two parties by using a computer system as 
a third-party intermediary. The intermediary creates ``shadow'' credit 
and debit records (i.e., account ledgers) that mirror the balances in 
the parties' real-world accounts at ``exchange institutions'' (e.g., 
banks). The

[[Page 74628]]

intermediary updates the shadow records in real time as transactions 
are entered, allowing only those transactions for which the parties' 
updated shadow records indicate sufficient resources to satisfy their 
mutual obligations. At the end of the day, the intermediary instructs 
the relevant financial institutions to carry out the ``permitted'' 
transactions in accordance with the updated shadow records, thus 
mitigating the risk that only one party will perform the agreed-upon 
exchange. The invention is claimed in the form of a computer-
implemented process, a system enabling that process, and a computer-
readable medium enabling that process to be performed by a computer.
Representative Method Claim (U.S. Patent No. 5,970,479)

    Claim 33. A method of exchanging obligations as between parties, 
each party holding a credit record and a debit record with an 
exchange institution, the credit records and debit records for 
exchange of predetermined obligations, the method comprising the 
steps of:
    (a) creating a shadow credit record and a shadow debit record 
for each stakeholder party to be held independently by a supervisory 
institution from the exchange institutions;
    (b) obtaining from each exchange institution a start-of-day 
balance for each shadow credit record and shadow debit record;
    (c) for every transaction resulting in an exchange obligation, 
the supervisory institution adjusting each respective party's shadow 
credit record or shadow debit record, allowing only these 
transactions that do not result in the value of the shadow debit 
record being less than the value of the shadow credit record at any 
time, each said adjustment taking place in chronological order; and
    (d) at the end-of-day, the supervisory institution instructing 
one of the exchange institutions to exchange credits or debits to 
the credit record and debit record of the respective parties in 
accordance with the adjustments of the said permitted transactions, 
the credits and debits being irrevocable, time invariant obligations 
placed on the exchange institutions.\45\
---------------------------------------------------------------------------

    \45\ In Alice Corp., the parties stipulated that the method was 
performed by a computer, despite the lack of a computer recitation 
in the representative method claim.

    Analysis: The claim is directed to a statutory category, i.e., a 
process (Step 1: YES). The claim recites the concept of managing 
settlement risk through an intermediary, i.e., intermediated 
settlement. The claimed invention describes the procedures an 
intermediary should take in managing settlement risk between two 
parties, i.e., specific details of intermediating settlement. 
Intermediated settlement, like risk hedging in Bilski, is not a 
preexisting fundamental truth but rather is a longstanding commercial 
practice (a method of organizing human activity). The concept of 
intermediated settlement is a fundamental economic practice long 
prevalent in our system of commerce, which is in the realm of abstract 
ideas identified by the Supreme Court. Thus, the claim is directed to 
the abstract idea of intermediated settlement (Step 2A: YES).
    Next, the claim as a whole is analyzed to determine whether any 
element, or combination of elements, is sufficient to ensure that the 
claim amounts to significantly more than the exception. Although a 
computer acts as the intermediary in the claimed method, the claims do 
no more than implement the abstract idea of intermediated settlement on 
a generic computer. Using a computer to create and maintain ``shadow'' 
accounts amounts to electronic recordkeeping, which is one of the most 
basic functions of a computer. The same is true with respect to the use 
of a computer to obtain data, adjust account balances, and issue 
automated instructions. All of these computer functions are ``well-
understood, routine, conventional activit[ies]'' previously known to 
the industry. Each step does no more than require a generic computer to 
perform generic computer functions. Considered as an ordered 
combination, the computer components of the method add nothing that is 
not already present when the steps are considered separately, and thus 
simply recite the concept of intermediated settlement as performed by a 
generic computer. The claims do not purport to improve the functioning 
of the computer itself, or to improve any other technology or technical 
field. Use of an unspecified, generic computer does not transform an 
abstract idea into a patent-eligible invention. Thus, the claim does 
not amount to significantly more than the abstract idea itself (Step 
2B: NO). The claim is not eligible and should be rejected under 35 
U.S.C. 101.
Representative System Claim (U.S. Patent No. 7,725,375)

    Claim 26. A data processing system to enable the exchange of an 
obligation between parties, the system comprising:
    a communications controller,
    a first party device, coupled to said communications controller,
    a data storage unit having stored therein
    (a) information about a first account for a first party, 
independent from a second account maintained by a first exchange 
institution, and
    (b) information about a third account for a second party, 
independent from a fourth account maintained by a second exchange 
institution; and
    a computer, coupled to said data storage unit and said 
communications controller, that is configured to
    (a) receive a transaction from said first party device via said 
communications controller;
    (b) electronically adjust said first account and said third 
account in order to effect an exchange obligation arising from said 
transaction between said first party and said second party after 
ensuring that said first party and/or said second party have 
adequate value in said first account and/or said third account, 
respectively; and
    (c) generate an instruction to said first exchange institution 
and/or said second exchange institution to adjust said second 
account and/or said fourth account in accordance with the adjustment 
of said first account and/or third account, wherein said instruction 
being an irrevocable, time invariant obligation placed on said first 
exchange institution and/or said second exchange institution.

    Analysis: The claim is directed to a statutory category, i.e., a 
machine (Step 1: YES). As discussed for the method claim, the claim 
recites the concept of intermediated settlement and is directed to an 
abstract idea (Step 2A: YES).
    Looking again to see what additional features are recited in the 
claim, the system includes a communications controller, a first party 
device, a data storage device, and a computer. The claimed hardware is 
generic hardware that nearly every computer will include. None of the 
hardware offers a meaningful limitation beyond generally linking the 
system to a particular technological environment, that is, 
implementation via computers. Put another way, the system claims are no 
different from the method claims in substance; the method claims recite 
the abstract idea implemented on a generic computer, while the system 
claims recite a handful of generic computer components configured to 
implement the same idea. The claim does not amount to significantly 
more than the underlying abstract idea (Step 2B: NO). The claim is not 
eligible and should be rejected under 35 U.S.C. 101.

IV. Summaries of Court Decisions Relating to Laws of Nature, Natural 
Phenomena, and Abstract Ideas

    The following brief summaries are taken from decisions from the 
Supreme Court and the Federal Circuit in which claims were analyzed 
with respect to judicial exceptions to determine subject matter 
eligibility. Along with the examples in section III, these decisions 
demonstrate the various terms used by the courts to describe the 
exceptions

[[Page 74629]]

and are provided simply to illustrate some of the different types of 
concepts found to fall within the exceptions. It should be noted that 
the courts' analyses in these decisions do not necessarily follow the 
eligibility framework explained in this Interim Eligibility Guidance as 
most of the cases were decided prior to Alice Corp. Therefore, instead 
of applying the eligibility analysis set forth in this Interim 
Eligibility Guidance to the facts of the decisions, a short description 
of the court's decision is provided for background purposes only. When 
considering these decisions, it is important to remember that the mere 
presence of an exception does not necessarily render a claim 
ineligible.
    Part A presents several decisions from the Supreme Court, Part B 
presents several decisions from the Federal Circuit from 2010--2014 
that dealt with abstract ideas, and Part C presents decisions from the 
Federal Circuit relating to abstract ideas since the Alice Corp. 
decision. Although the very small set of decisions from the Federal 
Circuit since Alice Corp. have resulted in findings of ineligibility, 
it should be recognized that the Supreme Court did not create a per se 
excluded category of subject matter, such as software or business 
methods, nor did it impose any special requirements for eligibility of 
software or business methods.

A. Supreme Court Decisions

1. O'Reilly v. Morse (U.S. Reissue Patent No. RE 117)
    Claim 6. The claim was interpreted by the Supreme Court as a 
system of signs (signals) by closing a galvanic circuit rapidly for 
telegraphing, combined with machinery to record the signs.
    Claim 8. I do not propose to limit myself to the specific 
machinery, or parts of machinery, . . . the essence of my invention 
being the use of the motive power of the electric or galvanic 
current, which I call electro-magnetism, however developed, for 
making or printing intelligible characters, signs, or letters, at 
any distances, being a new application of that power. . .

    The claims are to the process of using electromagnetism to produce 
distinguishable signs for telegraphy, and in particular to print 
intelligible characters at any distance. While the format of the claims 
is outdated, it can be seen that claim 6 recites the system of signs in 
combination with the machinery for recording, which was found eligible. 
In contrast, claim 8 recites the use of electromagnetism without limits 
on the machinery for recording, which was found ineligible. The 
discovery of electromagnetism, which is a natural phenomenon, is not 
patentable by itself.
2. Tilghman v. Proctor (U.S. Patent No. 11,766)
    The claim was interpreted by the Supreme Court as the process of 
subjecting to a high degree of heat a mixture continually kept up, 
of nearly equal quantities of fat and water in a convenient vessel 
strong enough to resist the effort of the mixture to convert itself 
into steam.

    The claim is founded upon the chemical principle or scientific fact 
that the elements of neutral fat require that they be severally united 
with an atomic equivalent of water in order to separate from each other 
and become free. Although the claim recites the chemical union between 
the fatty elements and water, it is not directed to the mere principle. 
The claim is directed instead to a particular mode of bringing about 
the desired chemical union, i.e., by heating the water under such 
pressure that the water does not become steam, and accordingly was 
found eligible.
3. Mackay Radio & Telegraph Co. v. Radio Corp. of America (U.S. Patent 
No. 1,974,387)
    Claim 15. An antenna comprising a pair of relatively long 
conductors disposed with respect to each other at an angle 
substantially equal to twice 50.9(l/[lambda])-\0.513\ 
degrees, l being the length of the wire and [lambda] the operating 
wave length in like units, and means in circuit with said antenna 
for exciting the conductors in phase opposition whereby standing 
waves of opposite instantaneous polarity are formed on the 
conductors throughout their length.

    The claim is to an antenna system utilizing standing wave 
phenomena. To obtain the best directional radio propagation by a V type 
antenna, a mathematical formula is used to arrange the angle of the 
wires, their length, and the length of the wave propagated. The claim 
practically applies the mathematical formula to configure a particular 
antenna and thus was found eligible.
4. Gottschalk v. Benson
    Claim 8. The method of converting signals from binary coded 
decimal form into binary which comprises the steps of:
    (1) storing the binary coded decimal signals in a reentrant 
shift register,
    (2) shifting the signals to the right by at least three places, 
until there is a binary `1' in the second position of said register,
    (3) masking out said binary `1' in said second position of said 
register,
    (4) adding a binary `1' to the first position of said register,
    (5) shifting the signals to the left by two positions,
    (6) adding a `1' to said first position, and
    (7) shifting the signals to the right by at least three 
positions in preparation for a succeeding binary `1' in the second 
position of said register.

    The claim recites a process for converting binary-coded-decimal 
(BCD) numerals into pure binary numerals. The procedures set forth in 
the claim are a generalized formulation for programs to solve 
mathematical problems of converting one form of numerical 
representation to another. The mathematical procedures can be carried 
out in existing computers long in use or can be performed without a 
computer. The end use is unlimited. The process claim was found to be 
so abstract and sweeping that it covered both known and unknown uses of 
the BCD to pure binary conversion. The mathematical formula in the 
claim has no substantial practical application except in connection 
with a digital computer, and thus the court found the claim ineligible 
as it would in effect be a patent on the algorithm itself.
5. Bilski v. Kappos
    Claim 1. A method for managing the consumption risk costs of a 
commodity sold by a commodity provider at a fixed price comprising 
the steps of:
    (a) initiating a series of transactions between said commodity 
provider and consumers of said commodity wherein said consumers 
purchase said commodity at a fixed rate based upon historical 
averages, said fixed rate corresponding to a risk position of said 
consumer;
    (b) identifying market participants for said commodity having a 
counter-risk position to said consumers; and
    (c) initiating a series of transactions between said commodity 
provider and said market participants at a second fixed rate such 
that said series of market participant transactions balances the 
risk position of said series of consumer transactions.

    The claim explains the basic concept of hedging, or protecting 
against risk. The court found that the concept of hedging is an 
unpatentable abstract idea, just like the algorithms at issue in Benson 
and Flook. A dependent claim that narrows the concept to a mathematical 
formula was similarly found to be an abstract idea. The other dependent 
claims are broad examples of how hedging can be used in commodities and 
energy markets. Limiting an abstract idea to one field of use or adding 
token postsolution components does not make the concept patentable. The 
claims were found ineligible.

[[Page 74630]]

B. Abstract Idea Decisions From the Federal Circuit Prior to Alice 
Corp. (2010-2014)

1. SiRF Technology v. ITC \46\ (U.S. Patent No. 6,417,801)
---------------------------------------------------------------------------

    \46\ SiRF Tech. v. ITC, 601 F.3d 1319 (Fed. Cir. 2010).

    Claim 1. A method for calculating an absolute position of a GPS 
receiver and an absolute time of reception of satellite signals 
comprising:
    providing pseudoranges that estimate the range of the GPS 
receiver to a plurality of GPS satellites;
    providing an estimate of an absolute time of reception of a 
plurality of satellite signals;
    providing an estimate of a position of the GPS receiver;
    providing satellite ephemeris data;
    computing absolute position and absolute time using said 
pseudoranges by updating said estimate of an absolute time and the 
estimate of position of the GPS receiver.

    GPS is a satellite navigation system comprising satellites orbiting 
the Earth that permits a GPS-enabled receiver to detect signals from at 
least four satellites and use that information to calculate its 
distance from each satellite and thus its precise position on Earth 
through trilateration. The claim sets forth the steps of calculating 
the absolute position, which is a mathematical concept. The court 
interpreted the claim such that the method could not be performed 
without a GPS receiver, noting that the preamble expressly states 
``calculating an absolute position of a GPS receiver'' and that a GPS 
receiver is required to generate pseudoranges and to determine its 
position. With this interpretation, the presence of the GPS receiver in 
the claim places a meaningful limit on the scope of the claim. It is 
essential to the operation of the claimed method and plays a 
significant part in permitting the claimed method to be performed. As 
such, although performance of the claim requires calculations, the 
claim was found eligible.
2. Research Corp. Tech. v. Microsoft Corp.\47\ (U.S. Patent No. 
5,111,310)
---------------------------------------------------------------------------

    \47\ Research Corp. Tech. v. Microsoft Corp., 627 F.3d 859 (Fed. 
Cir. 2010).
---------------------------------------------------------------------------

    Claim 1. A method for the halftoning of gray scale images by 
utilizing a pixel-by-pixel comparison of the image against a blue 
noise mask in which the blue noise mask is comprised of a random 
non-deterministic, non-white noise single valued function which is 
designed to produce visually pleasing dot profiles when thresholded 
at any level of said gray scale images.

    The claim is to digital image halftoning. Halftoning techniques 
allow computers to present many shades and color tones with a limited 
number of pixels, which allows computer displays and printers to render 
an approximation of an image by using fewer colors or shades of gray 
than the original image. One method of generating a digital halftoned 
image is called ``thresholding'' that uses a two-dimensional array 
called a ``mask.'' The claimed method incorporates algorithms and 
formulas that control the masks and halftoning, but apply them in a 
technique that improves the generated digital halftoned image. The 
invention presents functional and palpable applications in the field of 
computer technology with specific applications or improvements to 
technologies in the marketplace. So, although the claimed method uses 
algorithms and formulas, the claim was found eligible.
3. Dealertrack Inc. v. Huber (U.S. Patent No. 7,181,427)
    Claim 1. A computer aided method of managing a credit 
application, the method comprising the steps of:
    [A] receiving credit application data from a remote application 
entry and display device;
    [B] selectively forwarding the credit application data to remote 
funding source terminal devices;
    [C] forwarding funding decision data from at least one of the 
remote funding source terminal devices to the remote application 
entry and display device;
    [D] wherein the selectively forwarding the credit application 
data step further comprises:
    [D1] sending at least a portion of a credit application to more 
than one of said remote funding sources substantially at the same 
time;
    [D2] sending at least a portion of a credit application to more 
than one of said remote funding sources sequentially until a finding 
source returns a positive funding decision;
    [D3] sending at least a portion of a credit application to a 
first one of said remote funding sources, and then, after a 
predetermined time, sending to at least one other remote funding 
source, until one of the finding sources returns a positive funding 
decision or until all funding sources have been exhausted; or,
    [D4] sending the credit application from a first remote funding 
source to a second remote finding source if the first funding source 
declines to approve the credit application.

    The court reduced the claim to its most basic concept which was 
characterized as receiving data from one source (step A), selectively 
forwarding the data (step B, performed according to step D), and 
forwarding reply data to the first source (step C). This basic concept 
of processing information through a clearinghouse was found to be an 
abstract idea, similar to Bilski's basic concept of hedging. The court 
held that simply adding a ``computer-aided'' limitation to a claim 
covering an abstract concept, without more, does not sufficiently limit 
the claim. The claim was found ineligible.
4. SmartGene, Inc. v. Advanced Biological Laboratories, SA (U.S. Patent 
No. 6,081,786)
    Claim 1. A method for guiding the selection of a therapeutic 
treatment regimen for a patient with a known disease or medical 
condition, said method comprising:
    (a) providing patient information to a computing device 
comprising:
    a first knowledge base comprising a plurality of different 
therapeutic treatment regimens for said disease or medical 
condition;
    a second knowledge base comprising a plurality of expert rules 
for evaluating and selecting a therapeutic treatment regimen for 
said disease or medical condition;
    a third knowledge base comprising advisory information useful 
for the treatment of a patient with different constituents of said 
different therapeutic treatment regimens; and
    (b) generating in said computing device a ranked listing of 
available therapeutic treatment regimens for said patient; and
    (c) generating in said computing device advisory information for 
one or more therapeutic treatment regimens in said ranked listing 
based on said patient information and said expert rules.

    The claims set forth the steps of comparing new and stored 
information and using rules to identify medical options. Claim 1 does 
no more than call on a ``computing device'' with basic functionality 
for comparing stored and input data and rules, to do what doctors do 
routinely. The court concluded that these are familiar mental steps 
performed by or with a computer, and as such the claim was found 
ineligible.
5. Cyberfone Systems v. CNN Interactive Group (U.S. Patent No. 
8,019,060)
    Claim 1. A method, comprising:
    obtaining data transaction information entered on a telephone 
from a single transmission from said telephone;
    forming a plurality of different exploded data transactions for 
the single transmission, said plurality of different exploded data 
transaction indicative of a single data transaction, each of said 
exploded data transactions having different data that is intended 
for a different destination that is included as part of the exploded 
data transactions, and each of said exploded data transactions 
formed based on said data transaction information from said single 
transmission, so that different data from the single data 
transmission is separated and sent to different destinations; and
    sending said different exploded data transactions over a channel 
to said different destinations, all based on said data transaction 
information entered in said single transmission.

    Using categories to organize, store, and transmit information is 
well-

[[Page 74631]]

established. Here, the well-known concept of categorical data storage, 
i.e., the idea of collecting information in classified form, then 
separating and transmitting that information according to its 
classification, is an abstract idea. The claim was found ineligible.

C. Abstract Idea Decisions From the Federal Circuit Since Alice Corp.

1. Digitech Image Tech., LLC v. Electronics for Imaging, Inc. (U.S. 
Patent No. 6,128,415)
    Claim 10. A method of generating a device profile that describes 
properties of a device in a digital image reproduction system for 
capturing, transforming or rendering an image, said method 
comprising:
    generating first data for describing a device dependent 
transformation of color information content of the image to a device 
independent color space through use of measured chromatic stimuli 
and device response characteristic functions;
    generating second data for describing a device dependent 
transformation of spatial information content of the image in said 
device independent color space through use of spatial stimuli and 
device response characteristic functions;
    and combining said first and second data into the device 
profile.

    The court found the claim to be an abstract idea because it 
describes a process of organizing information through mathematical 
correlations and is not tied to a specific structure or machine. The 
claim recites the process of taking two data sets and combining them 
into a single data set, the device profile. The two data sets are 
generated by taking existing information--i.e., measured chromatic 
stimuli, spatial stimuli, and device response characteristic 
functions--and organizing this information into a new form. The claim 
language does not expressly tie the method to an image processor. It 
generically recites a process of combining two data sets into the 
device profile; it does not claim the processor's use of that profile 
in the capturing, transforming, or rendering of a digital image. 
Without additional limitations, a process that employs mathematical 
algorithms to manipulate existing information to generate additional 
information is not patent eligible. All of the claims were found 
ineligible.
2. Planet Bingo, LLC v. VKGS LLC (U.S. Patent No. 6,398,646)
    Claim 1. A system for managing a game of Bingo which comprises:
    (a) a computer with a central processing unit (CPU) and with a 
memory and with a printer connected to the CPU;
    (b) an input and output terminal connected to the CPU and memory 
of the computer; and
    (c) a program in the computer enabling:
    (i) input of at least two sets of Bingo numbers which are 
preselected by a player to be played in at least one selected game 
of Bingo in a future period of time;
    (ii) storage of the sets of Bingo numbers which are preselected 
by the player as a group in the memory of the computer;
    (iii) assignment by the computer of a player identifier unique 
to the player for the group having the sets of Bingo numbers which 
are preselected by the player wherein the player identifier is 
assigned to the group for multiple sessions of Bingo;
    (iv) retrieval of the group using the player identifier;
    (v) selection from the group by the player of at least one of 
the sets of Bingo numbers preselected by the player and stored in 
the memory of the computer as the group for play in a selected game 
of Bingo in a specific session of Bingo wherein a number of sets of 
Bingo numbers selected for play in the selected game of Bingo is 
less than a total number of sets of Bingo numbers in the group;
    (vi) addition by the computer of a control number for each set 
of Bingo numbers selected for play in the selected game of Bingo;
    (vii) output of a receipt with the control number, the set of 
Bingo numbers which is preselected and selected by the player, a 
price for the set of Bingo numbers which is preselected, a date of 
the game of Bingo and optionally a computer identification number; 
and
    (viii) output for verification of a winning set of Bingo numbers 
by means of the control number which is input into the computer by a 
manager of the game of Bingo.

    The court found the claims to be directed to the abstract idea of 
solving a tampering problem and also minimizing other security risks 
during bingo ticket purchases. The claims relate to managing a bingo 
game while allowing a player to repeatedly play the same sets of 
numbers in multiple sessions. Managing the game of bingo consists 
solely of mental steps which can be carried out by a human using pen 
and paper. The claims do not impose any requirements that would make 
the invention impossible to carry out manually. Although not drawn to 
the same subject matter at issue in Bilski and Alice Corp., the court 
found managing a game of bingo to be similar to the kind of organizing 
human activity at issue in Alice Corp. The claims recite a generic 
computer implementation of the abstract idea and a program that is used 
for the generic functions of storing, retrieving, and verifying a 
chosen set of bingo numbers against a winning set of bingo numbers. 
There is no inventive concept sufficient to transform the claimed 
subject matter into a patent-eligible application. The court found no 
meaningful distinction between the method and system claims. All of the 
claims were found ineligible.
3. buySAFE, Inc. v. Google, Inc. (U.S. Patent No. 7,644,019)
    Claim 1. A method, comprising:
    receiving, by at least one computer application program running 
on a computer of a safe transaction service provider, a request from 
a first party for obtaining a transaction performance guaranty 
service with respect to an online commercial transaction following 
closing of the online commercial transaction;
    processing, by at least one computer application program running 
on the safe transaction service provider computer, the request by 
underwriting the first party in order to provide the transaction 
performance guaranty service to the first party,
    wherein the computer of the safe transaction service provider 
offers, via a computer network, the transaction performance guaranty 
service that binds a transaction performance guaranty to the online 
commercial transaction involving the first party to guarantee the 
performance of the first party following closing of the online 
commercial transaction.
    Claim 14. The method according to claim 1, wherein the 
transaction performance guaranty is provided in one form of: a 
surety bond; a specialized bank guaranty; a specialized insurance 
policy; and a safe transaction guaranty provided by the safe 
transaction service provider.

    Relying on Bilski in which an abstract idea was found in certain 
arrangements involving contractual relations, the court found the 
claims to be squarely about creating a contractual relationship--a 
``transaction performance guaranty''--that is beyond question of 
ancient lineage. The claims' invocation of computers adds no inventive 
concept, with the computer functionality being generic. The 
transactions being performed online, at best, limits the use of the 
abstract guaranty idea to a particular technological environment. 
Although, dependent claim 14 narrows the abstract idea to particular 
types of relationships, that does not change the analysis because it 
does not make the idea non-abstract. The claims to the computer 
readable medium encoded with instructions to carry out the method were 
treated in the same way. All of the claims were found ineligible.
4. Ultramercial, LLC v. Hulu, LLC and WildTangent (U.S. Patent No. 
7,346,545)
    Claim 1: A method for distribution of products over the Internet 
via a facilitator, said method comprising the steps of:
    a first step of receiving, from a content provider, media 
products that are covered by intellectual-property rights protection 
and are available for purchase, wherein each said media product 
being comprised of at least one of text data, music data, and video 
data;
    a second step of selecting a sponsor message to be associated 
with the media product, said sponsor message being selected

[[Page 74632]]

from a plurality of sponsor messages, said second step including 
accessing an activity log to verify that the total number of times 
which the sponsor message has been previously presented is less than 
the number of transaction cycles contracted by the sponsor of the 
sponsor message;
    a third step of providing the media product for sale at an 
Internet Web site;
    a fourth step of restricting general public access to said media 
product;
    a fifth step of offering to a consumer access to the media 
product without charge to the consumer on the precondition that the 
consumer views the sponsor message;
    a sixth step of receiving from the consumer a request to view 
the sponsor message, wherein the consumer submits said request in 
response to being offered access to the media product;
    a seventh step of, in response to receiving the request from the 
consumer, facilitating the display of a sponsor message to the 
consumer;
    an eighth step of, if the sponsor message is not an interactive 
message, allowing said consumer access to said media product after 
said step of facilitating the display of said sponsor message;
    a ninth step of, if the sponsor message is an interactive 
message, presenting at least one query to the consumer and allowing 
said consumer access to said media product after receiving a 
response to said at least one query;
    a tenth step of recording the transaction event to the activity 
log, said tenth step including updating the total number of times 
the sponsor message has been presented; and
    an eleventh step of receiving payment from the sponsor of the 
sponsor message displayed.

    Using the Alice Corp. framework, the court first determined whether 
the claims at issue are directed to a patent-ineligible concept. The 
court found that the ordered combination of the eleven steps recites 
``an abstraction--an idea, having no particular concrete or tangible 
form'' noting that the majority of limitations describe only the 
abstract idea of showing an advertisement before delivering content. 
The court then turned to the next step of the analysis to determine 
whether the claims do significantly more than simply describe the 
abstract method. The court explained that consulting and updating an 
activity log represent insignificant ``data-gathering steps,'' 
restricting public access represents only insignificant ``[pre]-
solution activity,'' and narrowing the idea to the Internet is an 
attempt to limit the use of the abstract idea ``to a particular 
technological environment.'' Viewed both individually and as an ordered 
combination, the claimed steps were found insufficient to supply an 
inventive concept because the steps are conventional and specified at a 
high level of generality. The court concluded that the claim 
limitations do not transform the abstract idea that they recite into 
patent-eligible subject matter because ``the claims simply instruct the 
practitioner to implement the abstract idea with routine, conventional 
activity.'' All of the claims were found ineligible.
5. DDR Holdings, LLC v. Hotels.com, L.P. (U.S. Patent No. 7,818,399)
    Claim 19: A system useful in an outsource provider serving Web 
pages offering commercial opportunities, the system comprising:
    (a) a computer store containing data, for each of a plurality of 
first Web pages, defining a plurality of visually perceptible 
elements, which visually perceptible elements correspond to the 
plurality of first Web pages;
    (i) wherein each of the first Web pages belongs to one of a 
plurality of Web page owners;
    (ii) wherein each of the first Web pages displays at least one 
active link associated with a commerce object associated with a 
buying opportunity of a selected one of a plurality of merchants; 
and
    (iii) wherein the selected merchant, the outsource provider, and 
the owner of the first Web page displaying the associated link are 
each third parties with respect to one other;
    (b) a computer server at the outsource provider, which computer 
server is coupled to the computer store and programmed to:
    (i) receive from the web browser of a computer user a signal 
indicating activation of one of the links displayed by one of the 
first Web pages;
    (ii) automatically identify as the source page the one of the 
first Web pages on which the link has been activated;
    (iii) in response to identification of the source page, 
automatically retrieve the stored data corresponding to the source 
page; and
    (iv) using the data retrieved, automatically generate and 
transmit to the web browser a second Web page that displays: (A) 
Information associated with the commerce object associated with the 
link that has been activated, and (B) the plurality of visually 
perceptible elements visually corresponding to the source page.

    The court found the claim patent eligible under the Alice Corp. 
framework. First, the court noted that, while in some instances 
abstract ideas are plainly identifiable and divisible from generic 
computer limitations recited by the remainder of a claim, in this case, 
identifying the precise nature of the abstract idea is not as 
straightforward. The court considered several proposed 
characterizations of the abstract idea, including ```making two Web 
pages look the same,' `syndicated commerce on the computer using the 
Internet' and `making two e-commerce Web pages look alike by using 
licensed trademarks, logos, color schemes and layouts,''' and ``that an 
online merchant's sales can be increased if two Web pages have the same 
`look and feel.''' The court did not clearly indicate whether the claim 
was directed to one or more of these proposed abstract ideas, but 
stated that ``under any of these characterizations of the abstract 
idea, the `399 patent's claims satisfy Mayo/Alice step two.''
    The court then explained its analysis of the second Mayo/Alice 
step, where it determined that the claim amounted to an inventive 
concept and thus was patent eligible. In particular, the claim 
addresses the problem of retaining Web site visitors from being 
diverted from a host's Web site to an advertiser's Web site, for which 
``the claimed solution is necessarily rooted in computer technology in 
order to overcome a problem specifically arising in the realm of 
computer networks.'' The claim includes additional elements including 
``1) stor[ing] `visually perceptible elements' corresponding to 
numerous host Web sites in a database, with each of the host Web sites 
displaying at least one link associated with a product or service of a 
third-party merchant, 2) on activation of this link by a Web site 
visitor, automatically identif[ying] the host, and 3) instruct[ing] an 
Internet web server of an `outsource provider' to construct and serve 
to the visitor a new, hybrid Web page that merges content associated 
with the products of the third-party merchant with the stored `visually 
perceptible elements' from the identified host Web site.'' The court 
held that, unlike in Ultramercial, the claim does not generically 
recite ``use the Internet'' to perform a business practice, but instead 
recites a specific way to automate the creation of a composite Web page 
by an outsource provider that incorporates elements from multiple 
sources in order to solve a problem faced by Web sites on the Internet. 
Therefore, the court held that the claim is patent eligible.
Guidelines for Written Comments
    It would be helpful to the USPTO if written comments include 
information about: (1) The name and affiliation of the individual 
responding; and (2) an indication of whether comments offered represent 
views of the respondent's organization or are the respondent's personal 
views. Information provided in response to this request for comments 
will be made part of a public record and may be available via the 
Internet. In view of this, parties should not submit information that 
they do not wish to be publicly disclosed or made electronically 
accessible. Parties who would like to rely on confidential information 
to illustrate a point are requested to summarize or otherwise

[[Page 74633]]

submit the information in a way that will permit its public disclosure.

    Dated: December 10, 2014.
Michelle K. Lee,
Deputy Under Secretary of Commerce for Intellectual Property and Deputy 
Director of the United States Patent and Trademark Office.
[FR Doc. 2014-29414 Filed 12-15-14; 8:45 am]
BILLING CODE 3510-16-P
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