Notice of Roundtables and Request for Comments Related to Patent Subject Matter Eligibility, 71485-71489 [2016-24888]

Download as PDF Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices jstallworth on DSK7TPTVN1PROD with NOTICES recommended that NMFS issue the Stephens EFP (https://www.pcouncil.org/ wp-content/uploads/2016/09/ 0916decisions.pdf). If the two extensions and the Stephens EFP are approved, they would exempt a limited number of federally permitted commercial fishing vessels from requirements of the HMS FMP pertaining to non-authorized gear types. The EFPs would authorize up to 13 DSBG vessels to fish year-round in areas within the EEZ off the U.S. West Coast. Aside from the exemption described above, vessels fishing under an EFP would be subject to all other regulations implementing the HMS FMP, including measures to protect sea turtles, marine mammals, and seabirds. The three applicants requested EFP issuance for two fishing seasons or the 2017 and 2018 calendar years. The Council suggested NMFS impose requirements on the Stephens EFP consistent with one of the existing EFPs, including, but not limited to: (1) 30 percent observer coverage on each vessel’s fishing trips; (2) fishing only in federal waters; and (3) the operator of the fishing vessel operating under a DSBG EFP must actively tend all gear at all times and maintain the gear within sight (typically within 2–4 nautical miles of the gear) of the EFP participant fishing vessel. NMFS is seeking public comment on the extension of the two existing EFPs, as well as the Stephens EFP application and the Council’s recommended conditions. In accordance with NOAA Administrative Order 216–6, appropriate National Environmental Policy Act documents will be completed prior to the issuance of the EFPs. Additionally, NMFS will consider all applicable laws, including Section 7(a)(2) of the Endangered Species Act (16 U.S.C. 1531 et seq.), to determine if the proposed action is likely to jeopardize the continued existence and recovery of any endangered or threatened species or result in the destruction or adverse modification of critical habitat. Authority: 16 U.S.C. 1801 et seq. Dated: October 11, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2016–24973 Filed 10–14–16; 8:45 am] BILLING CODE 3510–22–P VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No.: PTO–P–2016–0041] Notice of Roundtables and Request for Comments Related to Patent Subject Matter Eligibility United States Patent and Trademark Office, Department of Commerce. ACTION: Notice of public roundtables and request for comments related to patent subject matter eligibility. AGENCY: The United States Patent and Trademark Office (‘‘USPTO’’) seeks public input on patent subject matter eligibility in view of recent decisions by the Supreme Court and Court of Appeals for the Federal Circuit. The USPTO remains interested in feedback from members of the public to improve the USPTO’s existing subject matter eligibility guidance and training examples. The USPTO is also interested in facilitating a discussion among members of the public regarding the legal contours of eligible subject matter in the U.S. patent system. The USPTO will be facilitating these discussions by hosting two roundtable events. The first roundtable will be directed to receiving feedback from members of the public to improve the USPTO’s existing subject matter eligibility guidance and training examples. The second roundtable will be focused on receiving feedback regarding larger questions concerning the legal contours of eligible subject matter in the U.S. patent system. The roundtables will provide a forum for discussion of the topics identified in this notice. DATES: The meeting dates are: 1. November 14, 2016, 1 p.m. to 5 p.m., Alexandria, VA. Written comments will be accepted on an ongoing basis. 2. December 5, 2016, 8 a.m. to 5 p.m., Stanford, CA. Written comments are due by January 18, 2017. ADDRESSES: The meeting locations are: 1. United States Patent and Trademark Office, Madison Building, Madison Auditorium, 600 Dulany Street, Alexandria, Virginia 22314. 2. Paul Brest Hall, 555 Salvatierra Walk, Stanford University, Stanford, California 94305. Submit written comments to: 2014_ interim_guidance@uspto.gov. FOR FURTHER INFORMATION CONTACT: Requests for additional information regarding registration and speaker presentations should be directed to the SUMMARY: PO 00000 Frm 00011 Fmt 4703 Sfmt 4703 71485 attention of Elizabeth Shaw, by telephone at 571–272–9300, or by email at elizabeth.shaw2@uspto.gov. Requests for additional information regarding the topics for written comments and discussion at Roundtable 1 should be directed to Carolyn Kosowski, by telephone at 571–272–7688, or by email at carolyn.kosowski@uspto.gov. Requests for additional information regarding the topics for written comments and discussion at Roundtable 2 should be directed to Amy Nelson, by telephone at 571–272–8978, or by email at amy.nelson@uspto.gov. SUPPLEMENTARY INFORMATION: Roundtable 1: USPTO Subject Matter Eligibility Guidelines Instructions and Information on Roundtable 1: Roundtable 1 will be held on November 14, 2016, at the United States Patent and Trademark Office, Madison Building, Madison Auditorium, 600 Dulany Street, Alexandria, Virginia 22314. The roundtable will begin at 1:00 p.m., Eastern Standard Time (‘‘EST’’) and end at 5:00 p.m., EST. The roundtable will also be available via webcast enabling individuals who cannot attend in person to watch the roundtable via the Internet in real time. The agenda and webcast information will be available before the roundtable on the USPTO’s Roundtable 1 Web page www.uspto.gov/ patent/notice-roundtables-and-requestcomments-related-patent-subjectmatter-eligibility. On-line registration will be available from that Web page, and attendees may register at the door. Attendees are encouraged to register online before the roundtable. Written Comments: The USPTO continues to accept comments on its subject matter eligibility guidance and training examples on an ongoing basis. Those comments, as well as any written comments on the topics for discussion in Roundtable 1, should be sent by electronic mail message via the Internet addressed to 2014_interim_guidance@ uspto.gov. Because comments will be made available for public inspection, information that is not desired to be made public, such as an address or phone number, should not be included in the comments. Roundtable 2: Exploring the Legal Contours of Patent Subject Matter Eligibility Instructions and Information on Roundtable 2: Roundtable 2 will be held on December 5, 2016, at Paul Brest Hall, 555 Salvatierra Walk, Stanford University, Stanford, California 94305. The roundtable will begin at 8:00 a.m., Pacific Standard Time (‘‘PST’’) and end E:\FR\FM\17OCN1.SGM 17OCN1 71486 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices and abstract ideas.6 The Court rejected the view of the U.S. Court of Appeals for the Federal Circuit (‘‘Federal Circuit’’) that the so-called ‘‘machine or transformation test’’ is the exclusive test for assessing patent eligibility of a process.7 Under that test, a process claim is patent eligible provided it is (1) tied to a particular machine or apparatus, or (2) transforms a particular article into a different state or thing.8 The Court explained that although the machine or transformation test ‘‘is a useful and important clue,’’ it is ‘‘not the sole test for deciding whether an invention is a patent-eligible ‘process.’ ’’ 9 The Court held that the claims at issue were invalid because they were directed to the unpatentable abstract idea of hedging risk in the energy market and added only token post-solution components, namely, use of well-known random analysis techniques to establish inputs.10 The Court observed that hedging is a long prevalent fundamental economic practice, and that allowing the patent claims ‘‘would pre-empt use of [risk hedging] in all fields’’ and ‘‘effectively grant a monopoly over an abstract idea.’’ 11 The Court, however, left open 1. Background the possibility that at least some As the world’s most innovative business methods are patent eligible.12 economy, the United States relies Following Bilski, the Supreme Court heavily on intellectual property to in Mayo addressed a method for support economic growth and business optimizing drug dosages for treatment of development. The U.S. patent system is autoimmune diseases in humans.13 The a critical piece of the nation’s robust inventors discovered the relationship system of intellectual property rights. between the concentration of a To obtain patent protection, the metabolite in the blood following requirement of subject matter eligibility administration of the drug and the under 35 U.S.C. 101 must be satisfied. likelihood that the administered dosage Over the past six years, the Supreme would be ineffective or produce harmful Court has issued a series of decisions— side effects.14 The inventors obtained a Bilski,1 Mayo,2 Myriad,3 and Alice 4—that patent claiming a method of have significantly impacted patent determining whether a given dosage eligibility law and continue to generate level is too low or too high based on the substantial public debate. These cases metabolite level.15 are briefly summarized below. The Court held the claims to be patent Bilski, decided in 2010, involved a ineligible.16 In analyzing the claims, the business method for hedging risk.5 In Court introduced a two-step framework analyzing patent eligibility, the for distinguishing patent ineligible Supreme Court recognized that section concepts from patent eligible 101 specifies four independent applications of those concepts.17 The categories of inventions or discoveries first step is to consider whether the that are eligible for patent protection claims are directed to a judicially (processes, machines, manufactures, and compositions of matter), but 6 Id. at 601. 7 Id. at 604. judicial precedent provides three 8 Id. at 602. specific exceptions to patent eligibility 9 Id. at 604. for laws of nature, physical phenomena, jstallworth on DSK7TPTVN1PROD with NOTICES at 5:00 p.m. PST. The roundtable will also be available via webcast enabling individuals who cannot attend in person to watch the roundtable via the Internet in real time. The agenda and webcast information will be available before the roundtable on the USPTO’s Roundtable 2 Web page www.uspto.gov/ patent/laws-and-regulations/commentspublic/notice-roundtables-and-requestcomments-related-patent. On-line registration will be available from that Web page, and attendees may register at the door. Attendees are encouraged to register on-line before the roundtable. Written Comments: For those wishing to submit written comments on the topics to be addressed by Roundtable 2, the deadline for receipt of those comments for consideration by the USPTO is January 18, 2017. Written comments should be sent by electronic mail message via the Internet addressed to 101Roundtable2@uspto.gov. Because comments will be made available for public inspection, information that is not desired to be made public, such as an address or phone number, should not be included in the comments. 10 Id. 1 Bilski v. Kappos, 561 U.S. 593 (2010). 2 Mayo Collaborative Servs. v. Prometheus Labs., Inc., __U.S.__, 132 S. Ct. 1289 (2012). 3 Ass’n for Molecular Pathology v. Myriad Genetics, Inc., __U.S.__, 133 S. Ct. 2107 (2013). 4 Alice Corp. v. CLS Bank Int’l, __U.S.__, 134 S. Ct. 2347 (2014). 5 Bilski v. Kappos, 561 U.S. 593, 599 (2010). VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 at 612. at 611–12. 12 Id. at 606–07. 13 Mayo, 132 S. Ct. at 1294–95. 14 Id. at 1294. 15 Id. 16 Id. at 1305. 17 Id. at 1296–98; see Alice, 134 S. Ct. at 2355 (summarizing two-part test in Mayo). 11 Id. PO 00000 Frm 00012 Fmt 4703 Sfmt 4703 recognized exception to patentability, i.e., abstract ideas, laws of nature, or natural phenomena.18 If so, then the second question is ‘‘whether the claims do significantly more than simply describe these natural relations,’’ i.e., whether additional elements considered separately or as an ordered combination ‘‘transform the nature of the claim’’ into ‘‘a patent-eligible application’’ of the judicial exception.19 Applying the first step of this framework to the claims at issue, the Court found that the claims were directed to a law of nature: The relationship between the concentration of a particular metabolite in the blood and the likelihood that a dosage of a drug will be ineffective or harmful.20 Assessing the second step, the Court determined that the claims did not do ‘‘significantly more’’ than describe this natural relationship, i.e., the additional elements considered separately and as an ordered combination did not ‘‘transform the nature of the claim’’ into ‘‘a patent-eligible application’’ of the judicial exception.21 At issue in Myriad was the patent eligibility of claims to isolated DNA (genes) associated with an increased risk of breast cancer, and synthetic DNA created from RNA known as complementary DNA (cDNA).22 The Supreme Court held that the isolated genes ‘‘fell squarely within the law of nature exception.’’ 23 The Court explained that discovering the location of the genes does not render the genes patent eligible, nor does the act of separating them from their surrounding genetic material.24 While acknowledging that claims to a product ‘‘with markedly different characteristics from any found in nature’’ may be patent eligible,25 the Court explained that Myriad’s claims to isolated genes lacked such characteristics because they do not rely on any chemical changes resulting from isolation, and are not even expressed in terms of chemical composition.26 The Court did, however, rule that the claimed cDNAs were patent eligible because they differed from naturally occurring DNA by the absence of intron regions (i.e., noncoding nucleotide sequences).27 18 Id. at 1296–97, 1293; see Alice 134 S. Ct. at 2355. 19 Id. at 1297–98; see Alice 134 S. Ct. at 2355. 20 Id. at 1296. 21 Id. at 1297–98. 22 Myriad, 133 S. Ct. at 2112–13. 23 Id. at 2117. 24 Id. at 2117–18. 25 Id. at 2117 (quoting Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980)). 26 Id. at 2118. 27 Id. at 2119. E:\FR\FM\17OCN1.SGM 17OCN1 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices Finally, in Alice, the Court reaffirmed the Mayo two-step framework and applied it to claims reciting a computerimplemented process, computer system, and computer readable medium for mitigating settlement risk.28 Under step one of the framework, the Court concluded that the claims were directed to the abstract idea of intermediated settlement.29 In assessing step two, the Court considered whether the claim elements, individually or as an ordered combination, ‘‘‘transform the nature of the claim’ into a patent-eligible application.’’ 30 The Court referred to the second step as ‘‘a search for an inventive concept—i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.’’ 31 Looking at the claims at issue, the Court concluded that mere generic computer implementation does not transform the abstract idea into a patent-eligible invention.32 Thus, the court held the process claims, as well as the claims to the computer system and computer-readable medium, to be patent ineligible.33 These cases continue to have a substantial effect on patent eligibility in the United States. On the one hand, they have overturned decades-old USPTO practice regarding patent eligibility of isolated genes, placing the United States at odds with the practices of major trading partners, including Europe.34 On the other hand, the Mayo two-step test has generally raised the bar for patent eligibility in all fields of technology. In the wake of these cases, the Federal Circuit has issued several decisions applying the Supreme Court test to a broad spectrum of subject matter, from the life sciences 35 to computer-related inventions (including business 134 S. Ct. at 2355, 2352. at 2355–57. 30 Id. at 2355 (quoting Mayo, 132 S. Ct. at 1294). 31 Id. (internal quotation marks omitted). 32 Id. at 2357–60. 33 Id. at 1260. 34 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, 1998 O.J. (L 213) 18 (Art. 5(2) provides ‘‘[a]n element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.’’). 35 See, e.g., In re Roslin Inst.(Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014); Univ. of Utah Research Found. v. Ambry Genetics Corp., 774 F.3d 755 (Fed. Cir. 2014); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015); Genetic Techs., Ltd. v. Merial LLC, 818 F.3d 1369 (Fed. Cir. 2016); Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016). methods).36 Although most of the Federal Circuit decisions have held claims to be patent ineligible, several of the decisions have held claims to be patent eligible.37 In addition, the USPTO has issued and updated guidance documents to aid the public and patent examiners in understanding how these cases apply to the patent examination process. In light of the changing landscape regarding subject matter eligibility in the United States, the USPTO is interested in inviting public discussion on these issues to help refine, if necessary, its guidance and to obtain views on the legal contours of subject matter eligibility. 2. Topics for Public Comment and Discussion At Roundtable 1: USPTO Subject Matter Eligibility Guidelines The USPTO has issued a series of guidance documents and training examples to instruct examiners on how to apply section 101 during examination, which incorporates previously received public input.38 The most recent documents include the May 2016 Life Sciences examples and three memoranda to the Patent Examining Corps: The May 4, 2016 memorandum titled ‘‘Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection’’; the May 19, 2016 memorandum titled ‘‘Recent Subject Matter Eligibility Decisions (Enfish, LLC v. Microsoft Corp. and TLI Communications LLC v. A.V. Automotive, LLC); and the July 14, 2016 memorandum titled ‘‘Recent Subject Matter Eligibility Rulings (Rapid Litigation Management v. CellzDirect and Sequenom v. Ariosa).’’ The USPTO remains interested in feedback from interested stakeholders or members of the public to improve the USPTO’s subject matter eligibility guidance and training examples, and is already 28 Alice, jstallworth on DSK7TPTVN1PROD with NOTICES 29 Id. VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 36 See, e.g., Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir. 2014); DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306 (Fed. Cir. 2015); Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016); Bascom Global Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016); McRO, Inc. dba Planet Blue v. Bandai Namco Games Am. Inc., No. 2015–1080, 2016 WL 4896481 (Fed. Cir. September 13, 2016). 37 DDR Holdings, 773 F.3d 1245; Enfish, 822 F.3d 1327; Bascom, 827 F.3d 1341; Rapid Litigation, 827 F.3d 1042; McRO, 2016 WL 4896481. 38 See, e.g., 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 FR 74,618 (Dec. 16, 2014); July 2015 Update on subject Matter Eligibility, 80 FR 45,429 (July 30, 2015); May 2016 Subject Matter Eligibility Update, 81 FR 27,381 (May 6, 2016); see also additional guidance materials available at https://www.uspto.gov/patent/ laws-and-regulations/examination-policy/2014interim-guidance-subject-matter-eligibility-0. PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 71487 accepting comments on those documents.39 For discussion at Roundtable 1, the Office is particularly seeking views and comments on the following: 1. Suggestions to how to improve the Office’s subject matter eligibility guidance, particularly the three recent memoranda discussed above; 2. Comments on the May 2016 Life Sciences examples and their effect on prosecution of patent applications in the life sciences, and suggestions of additional examples, or technology areas in which examples would be helpful; 3. Suggestions on how best to make examiners aware of newly issued judicial decisions, and how best to incorporate recent decisions holding claims eligible, such as Enfish, Bascom, Rapid Litigation Management, and McRO, into the Office’s subject matter eligibility guidance; and 4. Concerns on how the Office’s subject matter eligibility guidance and training examples, or how court decisions, are being applied by examiners. 3. Topics for Public Comment and Discussion At Roundtable 2: Exploring the Legal Contours of Patent Subject Matter Eligibility The public is invited to submit comments on any topics related to patent subject matter eligibility under 35 U.S.C. 101 that they deem relevant. This roundtable event is not seeking additional input on the examiner guidance and training examples referenced above. Instead, the USPTO is seeking to promote conversation on how the current section 101 jurisprudence is evolving; what the optimum legal contours for patent eligibility should be; and how best to achieve these goals. Specifically, the USPTO would like to facilitate discussion and create a public record with relevant information on the actual or perceived impact of existing law on particular technology areas, and the effects on investment in research and development, and innovation generally. The USPTO would appreciate comments on whether developments in patent-eligibility law should be left primarily to the courts or whether other administrative initiatives are desirable. In addition, the USPTO would appreciate comments on whether legislative changes are desirable and, if so, views on the elements of such changes. 39 May 2016 Subject Matter Eligibility Update, 81 FR 27381 (May 6, 2016); available at https:// www.gpo.gov/fdsys/pkg/FR-2016-05-06/pdf/201610724.pdf. E:\FR\FM\17OCN1.SGM 17OCN1 71488 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices To facilitate the launch of this datagathering exercise, the USPTO is particularly interested in receiving views and comments on questions presented below. However, the tenor of the questions should not be taken as an indication that the USPTO is predisposed to any particular views, positions, or actions. The USPTO also invites the public to share their views and insights on other aspects of patent subject matter eligibility that are not addressed in the questions. Impact of Judicial Interpretation of Section 101 1. How has the Supreme Court’s interpretation of 35 U.S.C. 101 in the past several years affected the enforcement of patents and the development of subject-mattereligibility law? In your response please: a. Identify the scope of the problem, including specific examples; b. identify any legal and/or technical inaccuracies; c. suggest possible changes and/or solutions to any problems with section 101; and d. provide explanations and/or any legal, policy, or economic analyses supporting your comments. jstallworth on DSK7TPTVN1PROD with NOTICES Statutory Categories of Patentable Subject Matter To be eligible for patent protection, an invention must comply with section 101 of the Patent Act, which limits entitlement to a patent to ‘‘whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter.’’ The four categories of invention enumerated in the statute—process, machine, manufacture, and composition of matter—exhaust the possible types of inventions for which a patent may be obtained. 2. Should the patent statute be amended to further define the statutory categories of invention, i.e., process, machine, manufacture, and composition of matter? If so, please identify possible legislative changes, including which sections of title 35 should be amended, e.g., sections 100 or 101. Exceptions to Patentable Subject Matter The Supreme Court has articulated three exceptions to patent eligibility under section 101: Laws of nature, natural phenomena, and abstract ideas. 3. Do you think there should be exceptions to patentable subject matter? a. If no, how should section 101 or other patentability provisions operate to address subject matter currently considered to fall within judicial exceptions? VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 b. If yes, please explain whether the judicial exceptions are sufficient in scope and if not, please identify other exceptions that should be included in the determination of patent eligible subject matter. 4. Should the patent statute be amended to define the judicial exceptions? If so, please suggest possible legislative changes, including which sections of title 35 should be amended, e.g., sections 100 or 101. 5. If you identified other exceptions in your response to 3(b), please suggest possible legislative changes, including which sections of title 35 should be amended, e.g., sections 100 or 101. 6. Other jurisdictions, e.g., Europe and Japan, provide examples of subject matter that does not qualify as an invention or discovery for purposes of patent eligibility. For example, in Europe, scientific theories, methods for performing mental acts, computer programs per se, and presentations of information are not regarded as inventions. a. Do you think that title 35 should be amended to revise the definition for the term ‘‘invention’’ and/or provide a definition for the term ‘‘discovery’’ along with specific examples of subject matter that should not be treated as an invention and/or discovery? b. If so, please suggest possible legislative changes, including which sections of title 35 should be amended, e.g., sections 100 or 101. 7. Does the concept of preemption, either separately or in the context of the Mayo two-step framework, capture useful insight in guarding against the issuance of overly broad patents? If so, please suggest possible legislative changes to capture those insights. Patentable Subject Matter in the Life Sciences 8. What does the term ‘‘discovery’’ in sections 100 and 101 mean, and to what extent should a ‘‘discovery’’ be eligible for a patent? Please provide specific examples. 9. What does the term ‘‘invention’’ in sections 100 and 101 mean, and to what extent should a non-naturally occurring product of human ingenuity qualify as an ‘‘invention’’ to be eligible for a patent? Please provide specific examples. 10. To what extent should products that have been isolated from their natural surroundings as a result of human ingenuity be eligible for a patent? Please provide specific examples as well as scientific explanations and/or legal analyses to support your response. PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 11. To what extent should a ‘‘diagnostic method’’ be eligible for a patent? Please provide specific examples. 12. Are there lines that can or should be drawn scientifically or legislatively between different types of compositions of matter for purposes of obtaining patent protection (e.g., between human genes and genes of other species)? 13. What particular inventions or specific types of technologies that should be patent eligible are not patent eligible, or are likely to be challenged as patent ineligible, under Mayo/Myriad? Please provide specific examples and explain why you believe claim drafting strategies will not be sufficient to avoid patent eligibility problems. Process Patents and the Machine or Transformation Test 14. Should patents be available for methods that do not involve a machine or a transformation? If so, please provide specific examples. 15. If you support some form of ‘‘machine or transformation test,’’ please identify the best expression of such a test. a. Should incorporation of the use of a general purpose computer be enough to satisfy the ‘‘machine’’ part of the test? If not, what more should be required? b. Should a transformation that occurs in the human body as a result of a claimed process be enough to satisfy the ‘‘transformation’’ part of the test? If not, what more should be required? Patentability of Business Methods 16. To what extent should an invention that involves a business method be eligible for a patent? Please provide specific examples. Patentability of Software/ComputerRelated Inventions 17. To what extent should an invention that involves computer software be eligible for a patent? Please provide specific examples. 18. What mechanisms, other than the judicial exceptions, can be used to prevent issuance of overly broad software or computer-related patents that cover wide swaths of economic activity? Do you think that other provisions of title 35 (enablement, written description, definiteness, novelty, non-obviousness) could be used more effectively to achieve this goal? If not, please explain why. Roundtable 1: USPTO Subject Matter Eligibility Guidelines Requests to Speak: Individuals interested in speaking at Roundtable 1 must complete the on-line registration E:\FR\FM\17OCN1.SGM 17OCN1 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices jstallworth on DSK7TPTVN1PROD with NOTICES no later than October 26, 2016, and include their name, contact information (telephone number and email address), the organization(s) the person represents, if any, the topics they wish to address, and the approximate length of the presentation. To ensure a balanced array of views, there is the possibility that not all persons who wish to make a presentation will be able to do so given time constraints; however, the USPTO will do its best to try to accommodate as many persons as possible. Selected speakers will be notified thereafter. However, all members of the public are encouraged to submit written comments by electronic mail message via the Internet addressed to 2014_interim_guidance@uspto.gov. The public is invited to speak at Roundtable 1 by appearing, in person, at the USPTO in Alexandria, Virginia or one of the following USPTO Regional Offices: the Midwest Regional Office, 300 River Place Drive, Suite 2900, Detroit, Michigan 48207; The Rocky Mountain Regional Office, 1961 Stout Street, Denver, Colorado 80294; the West Coast Regional Office, 26 S. Fourth Street, San Jose, California 95113; or the Texas Regional Office, 207 South Houston Street, Suite 159, Dallas, Texas 75202. Individuals requesting to speak at one of the aforementioned Regional Offices will be provided with the opportunity to speak at the roundtable and engage with USPTO representatives in Alexandria, Virginia in real time. If requesting to speak at this roundtable, please check the appropriate location when completing the on-line registration. Public Availability of Transcripts and Public Comments: The transcript of Roundtable 1 and the written comments submitted on the USPTO’s subject matter eligibility guidance and training examples will be made available for public inspection upon request at the Office of the Commissioner for Patents, located at 600 Dulany Street, Madison East Building, Tenth Floor, Alexandria, Virginia and via address: https:// www.uspto.gov. Roundtable 2: Exploring the Legal Contours of Patent Subject Matter Eligibility Requests to Speak: Individuals interested in speaking at Roundtable 2 must complete the on-line registration no later than November 14, 2016, and include their name, contact information (telephone number and email address), the organization(s) the person represents, if any, the topics they wish to address, and the approximate length of the presentation. To ensure a balanced array of views, there is the VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 possibility that not all persons who wish to make a presentation will be able to do so given time constraints; however, the USPTO will do its best to try to accommodate as many persons as possible. Selected speakers will be notified thereafter. However, all members of the public are encouraged to submit written comments by electronic mail message via the Internet addressed to 101Roundtable2@uspto.gov. The public is invited to speak at Roundtable 2 by appearing, in person, at Stanford University, Stanford, California or at one of the following USPTO Regional Offices: The Midwest Regional Office, 300 River Place Drive, Suite 2900, Detroit, Michigan 48207; the Rocky Mountain Regional Office, 1961 Stout Street, Denver, Colorado 80294; or the Texas Regional Office, 207 South Houston Street, Suite 159, Dallas, Texas 75202. Individuals requesting to speak at one of the aforementioned Regional Offices will be provided with the opportunity to speak at the roundtable and engage with USPTO representatives in Stanford, California in real time. If requesting to speak at this roundtable, please check the appropriate location when completing the on-line registration. Public Availability of Transcripts and Public Comments: The transcript of Roundtable 2 and the written comments submitted will be made available for public inspection upon request at the Office of Policy and International Affairs in the Executive Library located at 600 Dulany Street, Madison West Building, Tenth Floor, Alexandria, Virginia, 22314, telephone number 571– 272–9300 and via the Roundtable 2 Web page www.uspto.gov/patent/laws-andregulations/comments-public/noticeroundtables-and-request-commentsrelated-patent. Special Accommodations for Roundtables 1 and 2: The roundtables will be physically accessible to people with disabilities. Individuals requiring accommodation, such as sign language interpretation or other ancillary aids, should communicate their needs to Elizabeth Shaw, by telephone at 571– 272–9300, by email at elizabeth.shaw2@ uspto.gov, or by postal mail addressed to: Mail Stop OPIA, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, Virginia 22313–1450, ATTN: Elizabeth Shaw, at least seven (7) business days prior to the roundtable. PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 71489 Dated: October 11, 2016. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. 2016–24888 Filed 10–14–16; 8:45 am] BILLING CODE 3510–16–P DEPARTMENT OF DEFENSE Department of the Army [Docket ID: USA–2015–0015] Submission for OMB Review; Comment Request ACTION: Notice. The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act. DATES: Consideration will be given to all comments received by November 16, 2016. FOR FURTHER INFORMATION CONTACT: Fred Licari, 571–372–0493. SUPPLEMENTARY INFORMATION: Title, Associated Form and OMB Number: Recreation Area and Visitor Center Visitor Comment Cards; OMB Control Number 0710–XXXX. Type of Request: New. Number of Respondents: 45,000. Responses per Respondent: 1. Annual Responses: 45,000. Average Burden per Response: 5 minutes. Annual Burden Hours: 3,750. Needs and Uses: The information collection requirement is necessary to understand and determine the satisfaction of recreation visitors to US Army Corps of Engineers managed recreation areas. Affected Public: Individuals or households. Frequency: On occasion. Respondent’s Obligation: Voluntary. OMB Desk Officer: Ms. Jasmeet Seehra. Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at Oira_ submission@omb.eop.gov. Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection. You may also submit comments and recommendations, identified by Docket ID number and title, by the following method: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. SUMMARY: E:\FR\FM\17OCN1.SGM 17OCN1

Agencies

[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71485-71489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24888]

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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2016-0041]

Notice of Roundtables and Request for Comments Related to Patent
Subject Matter Eligibility

AGENCY: United States Patent and Trademark Office, Department of
Commerce.

ACTION: Notice of public roundtables and request for comments related
to patent subject matter eligibility.

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SUMMARY: The United States Patent and Trademark Office (``USPTO'')
seeks public input on patent subject matter eligibility in view of
recent decisions by the Supreme Court and Court of Appeals for the
Federal Circuit. The USPTO remains interested in feedback from members
of the public to improve the USPTO's existing subject matter
eligibility guidance and training examples. The USPTO is also
interested in facilitating a discussion among members of the public
regarding the legal contours of eligible subject matter in the U.S.
patent system. The USPTO will be facilitating these discussions by
hosting two roundtable events. The first roundtable will be directed to
receiving feedback from members of the public to improve the USPTO's
existing subject matter eligibility guidance and training examples. The
second roundtable will be focused on receiving feedback regarding
larger questions concerning the legal contours of eligible subject
matter in the U.S. patent system. The roundtables will provide a forum
for discussion of the topics identified in this notice.

DATES: The meeting dates are:
1. November 14, 2016, 1 p.m. to 5 p.m., Alexandria, VA.
Written comments will be accepted on an ongoing basis.
2. December 5, 2016, 8 a.m. to 5 p.m., Stanford, CA.
Written comments are due by January 18, 2017.

ADDRESSES: The meeting locations are:
1. United States Patent and Trademark Office, Madison Building,
Madison Auditorium, 600 Dulany Street, Alexandria, Virginia 22314.
2. Paul Brest Hall, 555 Salvatierra Walk, Stanford University,
Stanford, California 94305.
Submit written comments to: 2014_interim_guidance@uspto.gov.

FOR FURTHER INFORMATION CONTACT: Requests for additional information
regarding registration and speaker presentations should be directed to
the attention of Elizabeth Shaw, by telephone at 571-272-9300, or by
email at elizabeth.shaw2@uspto.gov. Requests for additional information
regarding the topics for written comments and discussion at Roundtable
1 should be directed to Carolyn Kosowski, by telephone at 571-272-7688,
or by email at carolyn.kosowski@uspto.gov. Requests for additional
information regarding the topics for written comments and discussion at
Roundtable 2 should be directed to Amy Nelson, by telephone at 571-272-
8978, or by email at amy.nelson@uspto.gov.

SUPPLEMENTARY INFORMATION:

Roundtable 1: USPTO Subject Matter Eligibility Guidelines

Instructions and Information on Roundtable 1: Roundtable 1 will be
held on November 14, 2016, at the United States Patent and Trademark
Office, Madison Building, Madison Auditorium, 600 Dulany Street,
Alexandria, Virginia 22314. The roundtable will begin at 1:00 p.m.,
Eastern Standard Time (``EST'') and end at 5:00 p.m., EST. The
roundtable will also be available via webcast enabling individuals who
cannot attend in person to watch the roundtable via the Internet in
real time. The agenda and webcast information will be available before
the roundtable on the USPTO's Roundtable 1 Web page www.uspto.gov/patent/notice-roundtables-and-request-comments-related-patent-subject-matter-eligibility. On-line registration will be available from that
Web page, and attendees may register at the door. Attendees are
encouraged to register on-line before the roundtable.
Written Comments: The USPTO continues to accept comments on its
subject matter eligibility guidance and training examples on an ongoing
basis. Those comments, as well as any written comments on the topics
for discussion in Roundtable 1, should be sent by electronic mail
message via the Internet addressed to 2014_interim_guidance@uspto.gov.
Because comments will be made available for public inspection,
information that is not desired to be made public, such as an address
or phone number, should not be included in the comments.

Roundtable 2: Exploring the Legal Contours of Patent Subject Matter
Eligibility

Instructions and Information on Roundtable 2: Roundtable 2 will be
held on December 5, 2016, at Paul Brest Hall, 555 Salvatierra Walk,
Stanford University, Stanford, California 94305. The roundtable will
begin at 8:00 a.m., Pacific Standard Time (``PST'') and end

[[Page 71486]]

at 5:00 p.m. PST. The roundtable will also be available via webcast
enabling individuals who cannot attend in person to watch the
roundtable via the Internet in real time. The agenda and webcast
information will be available before the roundtable on the USPTO's
Roundtable 2 Web page www.uspto.gov/patent/laws-and-regulations/comments-public/notice-roundtables-and-request-comments-related-patent.
On-line registration will be available from that Web page, and
attendees may register at the door. Attendees are encouraged to
register on-line before the roundtable.
Written Comments: For those wishing to submit written comments on
the topics to be addressed by Roundtable 2, the deadline for receipt of
those comments for consideration by the USPTO is January 18, 2017.
Written comments should be sent by electronic mail message via the
Internet addressed to 101Roundtable2@uspto.gov.
Because comments will be made available for public inspection,
information that is not desired to be made public, such as an address
or phone number, should not be included in the comments.

1. Background

As the world's most innovative economy, the United States relies
heavily on intellectual property to support economic growth and
business development. The U.S. patent system is a critical piece of the
nation's robust system of intellectual property rights. To obtain
patent protection, the requirement of subject matter eligibility under
35 U.S.C. 101 must be satisfied. Over the past six years, the Supreme
Court has issued a series of decisions--Bilski,\1\ Mayo,\2\ Myriad,\3\
and Alice \4\--that have significantly impacted patent eligibility law
and continue to generate substantial public debate. These cases are
briefly summarized below.
---------------------------------------------------------------------------

\1\ Bilski v. Kappos, 561 U.S. 593 (2010).
\2\ Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
__U.S.__, 132 S. Ct. 1289 (2012).
\3\ Ass'n for Molecular Pathology v. Myriad Genetics, Inc.,
__U.S.__, 133 S. Ct. 2107 (2013).
\4\ Alice Corp. v. CLS Bank Int'l, __U.S.__, 134 S. Ct. 2347
(2014).
---------------------------------------------------------------------------

Bilski, decided in 2010, involved a business method for hedging
risk.\5\ In analyzing patent eligibility, the Supreme Court recognized
that section 101 specifies four independent categories of inventions or
discoveries that are eligible for patent protection (processes,
machines, manufactures, and compositions of matter), but judicial
precedent provides three specific exceptions to patent eligibility for
laws of nature, physical phenomena, and abstract ideas.\6\ The Court
rejected the view of the U.S. Court of Appeals for the Federal Circuit
(``Federal Circuit'') that the so-called ``machine or transformation
test'' is the exclusive test for assessing patent eligibility of a
process.\7\ Under that test, a process claim is patent eligible
provided it is (1) tied to a particular machine or apparatus, or (2)
transforms a particular article into a different state or thing.\8\ The
Court explained that although the machine or transformation test ``is a
useful and important clue,'' it is ``not the sole test for deciding
whether an invention is a patent-eligible `process.' '' \9\ The Court
held that the claims at issue were invalid because they were directed
to the unpatentable abstract idea of hedging risk in the energy market
and added only token post-solution components, namely, use of well-
known random analysis techniques to establish inputs.\10\ The Court
observed that hedging is a long prevalent fundamental economic
practice, and that allowing the patent claims ``would pre-empt use of
[risk hedging] in all fields'' and ``effectively grant a monopoly over
an abstract idea.'' \11\ The Court, however, left open the possibility
that at least some business methods are patent eligible.\12\
---------------------------------------------------------------------------

\5\ Bilski v. Kappos, 561 U.S. 593, 599 (2010).
\6\ Id. at 601.
\7\ Id. at 604.
\8\ Id. at 602.
\9\ Id. at 604.
\10\ Id. at 612.
\11\ Id. at 611-12.
\12\ Id. at 606-07.
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Following Bilski, the Supreme Court in Mayo addressed a method for
optimizing drug dosages for treatment of autoimmune diseases in
humans.\13\ The inventors discovered the relationship between the
concentration of a metabolite in the blood following administration of
the drug and the likelihood that the administered dosage would be
ineffective or produce harmful side effects.\14\ The inventors obtained
a patent claiming a method of determining whether a given dosage level
is too low or too high based on the metabolite level.\15\
---------------------------------------------------------------------------

\13\ Mayo, 132 S. Ct. at 1294-95.
\14\ Id. at 1294.
\15\ Id.
---------------------------------------------------------------------------

The Court held the claims to be patent ineligible.\16\ In analyzing
the claims, the Court introduced a two-step framework for
distinguishing patent ineligible concepts from patent eligible
applications of those concepts.\17\ The first step is to consider
whether the claims are directed to a judicially recognized exception to
patentability, i.e., abstract ideas, laws of nature, or natural
phenomena.\18\ If so, then the second question is ``whether the claims
do significantly more than simply describe these natural relations,''
i.e., whether additional elements considered separately or as an
ordered combination ``transform the nature of the claim'' into ``a
patent-eligible application'' of the judicial exception.\19\ Applying
the first step of this framework to the claims at issue, the Court
found that the claims were directed to a law of nature: The
relationship between the concentration of a particular metabolite in
the blood and the likelihood that a dosage of a drug will be
ineffective or harmful.\20\ Assessing the second step, the Court
determined that the claims did not do ``significantly more'' than
describe this natural relationship, i.e., the additional elements
considered separately and as an ordered combination did not ``transform
the nature of the claim'' into ``a patent-eligible application'' of the
judicial exception.\21\
---------------------------------------------------------------------------

\16\ Id. at 1305.
\17\ Id. at 1296-98; see Alice, 134 S. Ct. at 2355 (summarizing
two-part test in Mayo).
\18\ Id. at 1296-97, 1293; see Alice 134 S. Ct. at 2355.
\19\ Id. at 1297-98; see Alice 134 S. Ct. at 2355.
\20\ Id. at 1296.
\21\ Id. at 1297-98.
---------------------------------------------------------------------------

At issue in Myriad was the patent eligibility of claims to isolated
DNA (genes) associated with an increased risk of breast cancer, and
synthetic DNA created from RNA known as complementary DNA (cDNA).\22\
The Supreme Court held that the isolated genes ``fell squarely within
the law of nature exception.'' \23\ The Court explained that
discovering the location of the genes does not render the genes patent
eligible, nor does the act of separating them from their surrounding
genetic material.\24\ While acknowledging that claims to a product
``with markedly different characteristics from any found in nature''
may be patent eligible,\25\ the Court explained that Myriad's claims to
isolated genes lacked such characteristics because they do not rely on
any chemical changes resulting from isolation, and are not even
expressed in terms of chemical composition.\26\ The Court did, however,
rule that the claimed cDNAs were patent eligible because they differed
from naturally occurring DNA by the absence of intron regions (i.e.,
non-coding nucleotide sequences).\27\
---------------------------------------------------------------------------

\22\ Myriad, 133 S. Ct. at 2112-13.
\23\ Id. at 2117.
\24\ Id. at 2117-18.
\25\ Id. at 2117 (quoting Diamond v. Chakrabarty, 447 U.S. 303,
310 (1980)).
\26\ Id. at 2118.
\27\ Id. at 2119.

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[[Page 71487]]

Finally, in Alice, the Court reaffirmed the Mayo two-step framework
and applied it to claims reciting a computer-implemented process,
computer system, and computer readable medium for mitigating settlement
risk.\28\ Under step one of the framework, the Court concluded that the
claims were directed to the abstract idea of intermediated
settlement.\29\ In assessing step two, the Court considered whether the
claim elements, individually or as an ordered combination, ```transform
the nature of the claim' into a patent-eligible application.'' \30\ The
Court referred to the second step as ``a search for an inventive
concept--i.e., an element or combination of elements that is sufficient
to ensure that the patent in practice amounts to significantly more
than a patent upon the ineligible concept itself.'' \31\ Looking at the
claims at issue, the Court concluded that mere generic computer
implementation does not transform the abstract idea into a patent-
eligible invention.\32\ Thus, the court held the process claims, as
well as the claims to the computer system and computer-readable medium,
to be patent ineligible.\33\
---------------------------------------------------------------------------

\28\ Alice, 134 S. Ct. at 2355, 2352.
\29\ Id. at 2355-57.
\30\ Id. at 2355 (quoting Mayo, 132 S. Ct. at 1294).
\31\ Id. (internal quotation marks omitted).
\32\ Id. at 2357-60.
\33\ Id. at 1260.
---------------------------------------------------------------------------

These cases continue to have a substantial effect on patent
eligibility in the United States. On the one hand, they have overturned
decades-old USPTO practice regarding patent eligibility of isolated
genes, placing the United States at odds with the practices of major
trading partners, including Europe.\34\ On the other hand, the Mayo
two-step test has generally raised the bar for patent eligibility in
all fields of technology.
---------------------------------------------------------------------------

\34\ Directive 98/44/EC of the European Parliament and of the
Council of 6 July 1998 on the legal protection of biotechnological
inventions, 1998 O.J. (L 213) 18 (Art. 5(2) provides ``[a]n element
isolated from the human body or otherwise produced by means of a
technical process, including the sequence or partial sequence of a
gene, may constitute a patentable invention, even if the structure
of that element is identical to that of a natural element.'').
---------------------------------------------------------------------------

In the wake of these cases, the Federal Circuit has issued several
decisions applying the Supreme Court test to a broad spectrum of
subject matter, from the life sciences \35\ to computer-related
inventions (including business methods).\36\ Although most of the
Federal Circuit decisions have held claims to be patent ineligible,
several of the decisions have held claims to be patent eligible.\37\ In
addition, the USPTO has issued and updated guidance documents to aid
the public and patent examiners in understanding how these cases apply
to the patent examination process. In light of the changing landscape
regarding subject matter eligibility in the United States, the USPTO is
interested in inviting public discussion on these issues to help
refine, if necessary, its guidance and to obtain views on the legal
contours of subject matter eligibility.
---------------------------------------------------------------------------

\35\ See, e.g., In re Roslin Inst.(Edinburgh), 750 F.3d 1333
(Fed. Cir. 2014); Univ. of Utah Research Found. v. Ambry Genetics
Corp., 774 F.3d 755 (Fed. Cir. 2014); Ariosa Diagnostics, Inc. v.
Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015); Genetic Techs., Ltd.
v. Merial LLC, 818 F.3d 1369 (Fed. Cir. 2016); Rapid Litigation
Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016).
\36\ See, e.g., Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709
(Fed. Cir. 2014); DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d
1245 (Fed. Cir. 2014); Versata Dev. Group, Inc. v. SAP Am., Inc.,
793 F.3d 1306 (Fed. Cir. 2015); Enfish, LLC v. Microsoft Corp., 822
F.3d 1327 (Fed. Cir. 2016); Bascom Global Internet Servs., Inc. v.
AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016); McRO, Inc. dba
Planet Blue v. Bandai Namco Games Am. Inc., No. 2015-1080, 2016 WL
4896481 (Fed. Cir. September 13, 2016).
\37\ DDR Holdings, 773 F.3d 1245; Enfish, 822 F.3d 1327; Bascom,
827 F.3d 1341; Rapid Litigation, 827 F.3d 1042; McRO, 2016 WL
4896481.
---------------------------------------------------------------------------

2. Topics for Public Comment and Discussion At Roundtable 1: USPTO
Subject Matter Eligibility Guidelines

The USPTO has issued a series of guidance documents and training
examples to instruct examiners on how to apply section 101 during
examination, which incorporates previously received public input.\38\
The most recent documents include the May 2016 Life Sciences examples
and three memoranda to the Patent Examining Corps: The May 4, 2016
memorandum titled ``Formulating a Subject Matter Eligibility Rejection
and Evaluating the Applicant's Response to a Subject Matter Eligibility
Rejection''; the May 19, 2016 memorandum titled ``Recent Subject Matter
Eligibility Decisions (Enfish, LLC v. Microsoft Corp. and TLI
Communications LLC v. A.V. Automotive, LLC); and the July 14, 2016
memorandum titled ``Recent Subject Matter Eligibility Rulings (Rapid
Litigation Management v. CellzDirect and Sequenom v. Ariosa).'' The
USPTO remains interested in feedback from interested stakeholders or
members of the public to improve the USPTO's subject matter eligibility
guidance and training examples, and is already accepting comments on
those documents.\39\ For discussion at Roundtable 1, the Office is
particularly seeking views and comments on the following:
---------------------------------------------------------------------------

\38\ See, e.g., 2014 Interim Guidance on Patent Subject Matter
Eligibility, 79 FR 74,618 (Dec. 16, 2014); July 2015 Update on
subject Matter Eligibility, 80 FR 45,429 (July 30, 2015); May 2016
Subject Matter Eligibility Update, 81 FR 27,381 (May 6, 2016); see
also additional guidance materials available at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility-0.
\39\ May 2016 Subject Matter Eligibility Update, 81 FR 27381
(May 6, 2016); available at https://www.gpo.gov/fdsys/pkg/FR-2016-05-06/pdf/2016-10724.pdf.
---------------------------------------------------------------------------

1. Suggestions to how to improve the Office's subject matter
eligibility guidance, particularly the three recent memoranda discussed
above;
2. Comments on the May 2016 Life Sciences examples and their effect
on prosecution of patent applications in the life sciences, and
suggestions of additional examples, or technology areas in which
examples would be helpful;
3. Suggestions on how best to make examiners aware of newly issued
judicial decisions, and how best to incorporate recent decisions
holding claims eligible, such as Enfish, Bascom, Rapid Litigation
Management, and McRO, into the Office's subject matter eligibility
guidance; and
4. Concerns on how the Office's subject matter eligibility guidance
and training examples, or how court decisions, are being applied by
examiners.

3. Topics for Public Comment and Discussion At Roundtable 2: Exploring
the Legal Contours of Patent Subject Matter Eligibility

The public is invited to submit comments on any topics related to
patent subject matter eligibility under 35 U.S.C. 101 that they deem
relevant. This roundtable event is not seeking additional input on the
examiner guidance and training examples referenced above. Instead, the
USPTO is seeking to promote conversation on how the current section 101
jurisprudence is evolving; what the optimum legal contours for patent
eligibility should be; and how best to achieve these goals.
Specifically, the USPTO would like to facilitate discussion and create
a public record with relevant information on the actual or perceived
impact of existing law on particular technology areas, and the effects
on investment in research and development, and innovation generally.
The USPTO would appreciate comments on whether developments in patent-
eligibility law should be left primarily to the courts or whether other
administrative initiatives are desirable. In addition, the USPTO would
appreciate comments on whether legislative changes are desirable and,
if so, views on the elements of such changes.

[[Page 71488]]

To facilitate the launch of this data-gathering exercise, the USPTO
is particularly interested in receiving views and comments on questions
presented below. However, the tenor of the questions should not be
taken as an indication that the USPTO is predisposed to any particular
views, positions, or actions. The USPTO also invites the public to
share their views and insights on other aspects of patent subject
matter eligibility that are not addressed in the questions.

Impact of Judicial Interpretation of Section 101

1. How has the Supreme Court's interpretation of 35 U.S.C. 101 in
the past several years affected the enforcement of patents and the
development of subject-matter-eligibility law? In your response please:
a. Identify the scope of the problem, including specific examples;
b. identify any legal and/or technical inaccuracies;
c. suggest possible changes and/or solutions to any problems with
section 101; and
d. provide explanations and/or any legal, policy, or economic
analyses supporting your comments.

Statutory Categories of Patentable Subject Matter

To be eligible for patent protection, an invention must comply with
section 101 of the Patent Act, which limits entitlement to a patent to
``whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter.'' The four categories of
invention enumerated in the statute--process, machine, manufacture, and
composition of matter--exhaust the possible types of inventions for
which a patent may be obtained.
2. Should the patent statute be amended to further define the
statutory categories of invention, i.e., process, machine, manufacture,
and composition of matter? If so, please identify possible legislative
changes, including which sections of title 35 should be amended, e.g.,
sections 100 or 101.

Exceptions to Patentable Subject Matter

The Supreme Court has articulated three exceptions to patent
eligibility under section 101: Laws of nature, natural phenomena, and
abstract ideas.
3. Do you think there should be exceptions to patentable subject
matter?
a. If no, how should section 101 or other patentability provisions
operate to address subject matter currently considered to fall within
judicial exceptions?
b. If yes, please explain whether the judicial exceptions are
sufficient in scope and if not, please identify other exceptions that
should be included in the determination of patent eligible subject
matter.
4. Should the patent statute be amended to define the judicial
exceptions? If so, please suggest possible legislative changes,
including which sections of title 35 should be amended, e.g., sections
100 or 101.
5. If you identified other exceptions in your response to 3(b),
please suggest possible legislative changes, including which sections
of title 35 should be amended, e.g., sections 100 or 101.
6. Other jurisdictions, e.g., Europe and Japan, provide examples of
subject matter that does not qualify as an invention or discovery for
purposes of patent eligibility. For example, in Europe, scientific
theories, methods for performing mental acts, computer programs per se,
and presentations of information are not regarded as inventions.
a. Do you think that title 35 should be amended to revise the
definition for the term ``invention'' and/or provide a definition for
the term ``discovery'' along with specific examples of subject matter
that should not be treated as an invention and/or discovery?
b. If so, please suggest possible legislative changes, including
which sections of title 35 should be amended, e.g., sections 100 or
101.
7. Does the concept of preemption, either separately or in the
context of the Mayo two-step framework, capture useful insight in
guarding against the issuance of overly broad patents? If so, please
suggest possible legislative changes to capture those insights.

Patentable Subject Matter in the Life Sciences

8. What does the term ``discovery'' in sections 100 and 101 mean,
and to what extent should a ``discovery'' be eligible for a patent?
Please provide specific examples.
9. What does the term ``invention'' in sections 100 and 101 mean,
and to what extent should a non-naturally occurring product of human
ingenuity qualify as an ``invention'' to be eligible for a patent?
Please provide specific examples.
10. To what extent should products that have been isolated from
their natural surroundings as a result of human ingenuity be eligible
for a patent? Please provide specific examples as well as scientific
explanations and/or legal analyses to support your response.
11. To what extent should a ``diagnostic method'' be eligible for a
patent? Please provide specific examples.
12. Are there lines that can or should be drawn scientifically or
legislatively between different types of compositions of matter for
purposes of obtaining patent protection (e.g., between human genes and
genes of other species)?
13. What particular inventions or specific types of technologies
that should be patent eligible are not patent eligible, or are likely
to be challenged as patent ineligible, under Mayo/Myriad? Please
provide specific examples and explain why you believe claim drafting
strategies will not be sufficient to avoid patent eligibility problems.

Process Patents and the Machine or Transformation Test

14. Should patents be available for methods that do not involve a
machine or a transformation? If so, please provide specific examples.
15. If you support some form of ``machine or transformation test,''
please identify the best expression of such a test.
a. Should incorporation of the use of a general purpose computer be
enough to satisfy the ``machine'' part of the test? If not, what more
should be required?
b. Should a transformation that occurs in the human body as a
result of a claimed process be enough to satisfy the ``transformation''
part of the test? If not, what more should be required?

Patentability of Business Methods

16. To what extent should an invention that involves a business
method be eligible for a patent? Please provide specific examples.

Patentability of Software/Computer-Related Inventions

17. To what extent should an invention that involves computer
software be eligible for a patent? Please provide specific examples.
18. What mechanisms, other than the judicial exceptions, can be
used to prevent issuance of overly broad software or computer-related
patents that cover wide swaths of economic activity? Do you think that
other provisions of title 35 (enablement, written description,
definiteness, novelty, non-obviousness) could be used more effectively
to achieve this goal? If not, please explain why.

Roundtable 1: USPTO Subject Matter Eligibility Guidelines

Requests to Speak: Individuals interested in speaking at Roundtable
1 must complete the on-line registration

[[Page 71489]]

no later than October 26, 2016, and include their name, contact
information (telephone number and email address), the organization(s)
the person represents, if any, the topics they wish to address, and the
approximate length of the presentation. To ensure a balanced array of
views, there is the possibility that not all persons who wish to make a
presentation will be able to do so given time constraints; however, the
USPTO will do its best to try to accommodate as many persons as
possible. Selected speakers will be notified thereafter. However, all
members of the public are encouraged to submit written comments by
electronic mail message via the Internet addressed to
2014_interim_guidance@uspto.gov.
The public is invited to speak at Roundtable 1 by appearing, in
person, at the USPTO in Alexandria, Virginia or one of the following
USPTO Regional Offices: the Midwest Regional Office, 300 River Place
Drive, Suite 2900, Detroit, Michigan 48207; The Rocky Mountain Regional
Office, 1961 Stout Street, Denver, Colorado 80294; the West Coast
Regional Office, 26 S. Fourth Street, San Jose, California 95113; or
the Texas Regional Office, 207 South Houston Street, Suite 159, Dallas,
Texas 75202. Individuals requesting to speak at one of the
aforementioned Regional Offices will be provided with the opportunity
to speak at the roundtable and engage with USPTO representatives in
Alexandria, Virginia in real time. If requesting to speak at this
roundtable, please check the appropriate location when completing the
on-line registration.
Public Availability of Transcripts and Public Comments: The
transcript of Roundtable 1 and the written comments submitted on the
USPTO's subject matter eligibility guidance and training examples will
be made available for public inspection upon request at the Office of
the Commissioner for Patents, located at 600 Dulany Street, Madison
East Building, Tenth Floor, Alexandria, Virginia and via address:
https://www.uspto.gov.

Roundtable 2: Exploring the Legal Contours of Patent Subject Matter
Eligibility

Requests to Speak: Individuals interested in speaking at Roundtable
2 must complete the on-line registration no later than November 14,
2016, and include their name, contact information (telephone number and
email address), the organization(s) the person represents, if any, the
topics they wish to address, and the approximate length of the
presentation. To ensure a balanced array of views, there is the
possibility that not all persons who wish to make a presentation will
be able to do so given time constraints; however, the USPTO will do its
best to try to accommodate as many persons as possible. Selected
speakers will be notified thereafter. However, all members of the
public are encouraged to submit written comments by electronic mail
message via the Internet addressed to 101Roundtable2@uspto.gov.
The public is invited to speak at Roundtable 2 by appearing, in
person, at Stanford University, Stanford, California or at one of the
following USPTO Regional Offices: The Midwest Regional Office, 300
River Place Drive, Suite 2900, Detroit, Michigan 48207; the Rocky
Mountain Regional Office, 1961 Stout Street, Denver, Colorado 80294; or
the Texas Regional Office, 207 South Houston Street, Suite 159, Dallas,
Texas 75202. Individuals requesting to speak at one of the
aforementioned Regional Offices will be provided with the opportunity
to speak at the roundtable and engage with USPTO representatives in
Stanford, California in real time. If requesting to speak at this
roundtable, please check the appropriate location when completing the
on-line registration.
Public Availability of Transcripts and Public Comments: The
transcript of Roundtable 2 and the written comments submitted will be
made available for public inspection upon request at the Office of
Policy and International Affairs in the Executive Library located at
600 Dulany Street, Madison West Building, Tenth Floor, Alexandria,
Virginia, 22314, telephone number 571-272-9300 and via the Roundtable 2
Web page www.uspto.gov/patent/laws-and-regulations/comments-public/notice-roundtables-and-request-comments-related-patent.
Special Accommodations for Roundtables 1 and 2: The roundtables
will be physically accessible to people with disabilities. Individuals
requiring accommodation, such as sign language interpretation or other
ancillary aids, should communicate their needs to Elizabeth Shaw, by
telephone at 571-272-9300, by email at elizabeth.shaw2@uspto.gov, or by
postal mail addressed to: Mail Stop OPIA, United States Patent and
Trademark Office, P.O. Box 1450, Alexandria, Virginia 22313-1450, ATTN:
Elizabeth Shaw, at least seven (7) business days prior to the
roundtable.

Dated: October 11, 2016.
Michelle K. Lee,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2016-24888 Filed 10-14-16; 8:45 am]
BILLING CODE 3510-16-P

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