Request for Comments on Determining Whether a Claim Element Is Well-Understood, Routine, Conventional for Purposes of Subject Matter Eligibility, 17536-17538 [2018-08428]

Download as PDF 17536 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices Kim Iverson, Public Information Officer, SAFMC; phone: (843) 571–4366 or toll free: (866) SAFMC–10; fax: (843) 769– 4520; email: kim.iverson@safmc.net. SUPPLEMENTARY INFORMATION: Agenda items for the Spiny Lobster Advisory Panel include the following: A review of Spiny Lobster Amendment 13 (gear requirements and cooperative management procedures), development of a Fishery Performance Report for spiny lobster, and a discussion of regulatory reform. Advisory panel members will provide recommendations as appropriate. FOR FURTHER INFORMATION CONTACT: Special Accommodations The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES) 3 days prior to the public meeting. Note: The times and sequence specified in this agenda are subject to change. Authority: 16 U.S.C. 1801 et seq. Dated: April 17, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2018–08340 Filed 4–19–18; 8:45 am] BILLING CODE 3510–22–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No.: PTO–P–2018–0033] Request for Comments on Determining Whether a Claim Element Is WellUnderstood, Routine, Conventional for Purposes of Subject Matter Eligibility United States Patent and Trademark Office, Commerce. ACTION: Request for comments. AGENCY: The U.S. Court of Appeals for the Federal Circuit (Federal Circuit) recently issued a decision regarding the inquiry of whether a claim limitation represents well-understood, routine, conventional activities (or elements) to a skilled artisan in the relevant field. Specifically, the Federal Circuit found that whether a claim element, or combination of elements, represents well-understood, routine, conventional activities to a skilled artisan in the relevant field is a question of fact. The United States Patent and Trademark Office (USPTO) has implemented this decision in a memorandum recently issued to the Patent Examining Corps (the Berkheimer memorandum). The Berkheimer memorandum is available to the public on the USPTO’s internet sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:44 Apr 19, 2018 Jkt 244001 website. Examiners had been previously instructed to conclude that an element (or combination of elements) is wellunderstood, routine, conventional activity only when the examiner can readily conclude that the element(s) is widely prevalent or in common use in the relevant industry. The Berkheimer memorandum now clarifies that such a conclusion must be based upon a factual determination that is supported as discussed in the memorandum. Aditionally the Berkheimer memorandum now also specifies that the analysis for determining whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification. The USPTO is now seeking public comment on its subject matter eligibility guidance, and particularly its guidance in the Berkheimer memorandum to the Patent Examining Corps. DATES: Comment Deadline Date: Written comments must be received on or before August 20, 2018. ADDRESSES: Comments must be sent by electronic mail message over the internet addressed to: Eligibility2018@ uspto.gov. Electronic comments submitted in plain text are preferred, but also may be submitted in ADOBE® portable document format or MICROSOFT WORD® format. Comments not submitted electronically should be submitted on paper in a format that facilitates convenient digital scanning into ADOBE® portable document format. The comments will be available for viewing via the USPTO’s internet website (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: Carolyn Kosowski, Senior Legal Advisor, at 571–272–7688 or Matthew Sked, Senior Legal Advisor, at 571–272– 7627, both with the Office of Patent Legal Administration. SUPPLEMENTARY INFORMATION: I. Federal Circuit Decision in Berkheimer: The Federal Circuit recently issued a precedential decision holding that the question of whether certain claim limitations are wellunderstood, routine, conventional elements raised a disputed factual issue, which precluded summary judgment that all of the claims at issue were not PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 patent eligible. See Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018). Shortly thereafter, the Federal Circuit reaffirmed the Berkheimer standard in the context of a judgment on the pleadings and judgment as a matter of law.1 While summary judgment, judgment on the pleadings, and judgment as a matter of law standards in civil litigation are generally inapplicable during the patent examination process, these decisions inform the inquiry into whether an additional element (or combination of additional elements) represents wellunderstood, routine, conventional activity. The USPTO has implemented this decision in the Berkheimer memorandum, which was recently issued to the Patent Examining Corps and is available to the public on the USPTO’s internet website. The USPTO recognizes that unless careful consideration is given to the particular contours of subject matter eligibility (35 U.S.C. 101), it could ‘‘swallow all of patent law.’’ Alice Corp. v. CLS Bank International, 573 U.S. __ _, ___, 134 S. Ct. 2347, 2352 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71 (2012)). The Berkheimer memorandum provides additional USPTO guidance that will further clarify how the USPTO is determining subject matter eligibility in accordance with prevailing jurisprudence. Specifically, the Berkheimer memorandum addresses the limited question of whether an additional element (or combination of additional elements) represents wellunderstood, routine, conventional activity. The USPTO is determined to continue its mission to provide clear and predictable patent rights in accordance with this rapidly evolving area of the law and, to that end, may issue further guidance in the future. II. Well-Understood, Routine, Conventional Activity: The USPTO’s current understanding of the judicial framework distinguishing patents and applications that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible 1 See Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121 (Fed. Cir. 2018) (reversing a judgment on the pleadings of ineligibility, finding that whether the claims in the challenged patent perform well-understood, routine, conventional activities is an issue of fact); Exergen Corp. v. Kaz USA, Inc., Nos. 2016–2315, 2016–2341, 2018 WL 1193529, at *1 (Fed. Cir. Mar. 8, 2018) (non-precedential) (affirming a district court’s denial of a motion for judgment as a matter of law of patent ineligibility, thus upholding the district court’s conclusion that the claims were drawn to a patent eligible invention, concluding that the district court’s fact finding that the claimed combination was not proven to be well-understood, routine, conventional was not clearly erroneous). E:\FR\FM\20APN1.SGM 20APN1 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices sradovich on DSK3GMQ082PROD with NOTICES applications of those concepts—the Mayo-Alice framework—is set forth in section 2106 of the Manual of Patent Examining Procedure (MPEP). While the Berkheimer decision does not change the basic subject matter eligibility framework as set forth in MPEP § 2106, it does provide clarification as to the inquiry into whether an additional element (or combination of additional elements) represents well-understood, routine, conventional activity. Specifically, the Federal Circuit held that ‘‘[w]hether something is wellunderstood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination.’’ Berkheimer, 881 F.3d at 1369. As set forth in MPEP § 2106.05(d)(I), an examiner should conclude that an element (or combination of elements) represents well-understood, routine, conventional activity only when the examiner can readily conclude that the element(s) is widely prevalent or in common use in the relevant industry. The Berkheimer memorandum clarifies that such a conclusion must be based upon a factual determination that is supported as discussed in section III below. The Berkheimer memorandum further clarifies that the analysis as to whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification.2 The question of whether additional elements represent well-understood, routine, conventional activity is distinct from patentability over the prior art under 35 U.S.C. 102 and 103. This is because a showing that additional elements are obvious under 35 U.S.C. 103, or even that they lack novelty under 35 U.S.C. 102, is not by itself 2 See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377 (Fed. Cir. 2016) (supporting the position that amplification was well-understood, routine, conventional for purposes of subject matter eligibility by observing that the patentee expressly argued during prosecution of the application that amplification was a technique readily practiced by those skilled in the art to overcome the rejection of the claim under 35 U.S.C. 112, first paragraph); see also Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1463 (Fed. Cir. 1984) (‘‘[T]he specification need not disclose what is well known in the art.’’); In re Myers, 410 F.2d 420, 424 (CCPA 1969) (‘‘A specification is directed to those skilled in the art and need not teach or point out in detail that which is well-known in the art.’’); Exergen Corp., 2018 WL 1193529, at *4 (holding that ‘‘[l]ike indefiniteness, enablement, or obviousness, whether a claim is directed to patent eligible subject matter is a question of law based on underlying facts,’’ and noting that the Supreme Court has recognized that ‘‘the inquiry ‘might sometimes overlap’ with other fact-intensive inquiries like novelty under 35 U.S.C. 102’’). VerDate Sep<11>2014 17:44 Apr 19, 2018 Jkt 244001 sufficient to establish that the additional elements are well-understood, routine, conventional activities or elements to those in the relevant field. See MPEP § 2106.05. As the Federal Circuit explained: ‘‘[w]hether a particular technology is well-understood, routine, and conventional goes beyond what was simply known in the prior art. The mere fact that something is disclosed in a piece of prior art, for example, does not mean it was well-understood, routine, and conventional.’’ Berkheimer, 881 F.3d at 1369. III. Impact on Examination Procedure: The Berkheimer memorandum revises the procedures set forth in MPEP § 2106.07(a) (Formulating a Rejection For Lack of Subject Matter Eligibility) and MPEP § 2106.07(b) (Evaluating Applicant’s Response). A. Formulating Rejections: In a step 2B analysis, an additional element (or combination of elements) is not wellunderstood, routine or conventional unless the examiner finds, and expressly supports a rejection in writing with, one or more of the following: 1. A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the wellunderstood, routine, conventional nature of the additional element(s). A specification demonstrates the wellunderstood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a). A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with respect to describing such element. 2. A citation to one or more of the court decisions discussed in MPEP § 2106.05(d)(II) as noting the wellunderstood, routine, conventional nature of the additional element(s). 3. A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s). An appropriate publication could include a book, manual, review article, or other source that describes the state of the art and discusses what is well-known and in common use in the relevant industry. It does not include all items that might otherwise qualify as a ‘‘printed PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 17537 publication’’ as used in 35 U.S.C. 102.3 Whether something is disclosed in a document that is considered a ‘‘printed publication’’ under 35 U.S.C. 102 is a distinct inquiry from whether something is well-known, routine, conventional activity. A document may be a printed publication but still fail to establish that something it describes is well-understood, routine, conventional activity. See Exergen Corp., 2018 WL 1193529, at *4 (the single copy of a thesis written in German and located in a German university library considered to be a ‘‘printed publication’’ in Hall ‘‘would not suffice to establish that something is ‘well-understood, routine, and conventional activity previously engaged in by scientists who work in the field’ ’’). The nature of the publication and the description of the additional elements in the publication would need to demonstrate that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so wellknown that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. 112(a). For example, while U.S. patents and published applications are publications, merely finding the additional element in a single patent or published application would not be sufficient to demonstrate that the additional element is wellunderstood, routine, conventional, unless the patent or published application demonstrates that the additional element are widely prevalent or in common use in the relevant field. 4. A statement that the examiner is taking official notice of the wellunderstood, routine, conventional nature of the additional element(s). This option should be used only when the examiner is certain, based upon his or her personal knowledge, that the additional element(s) represents wellunderstood, routine, conventional activity engaged in by those in the relevant art, in that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. 112(a). Procedures for taking official notice and addressing an 3 See, e.g., In re Klopfenstein, 380 F.3d 1345 (Fed. Cir. 2004) (publicly displayed slide presentation); In re Hall, 781 F.2d 897 (Fed. Cir. 1986) (doctoral thesis shelved in a library); Mass. Inst. of Tech. v. AB Fortia, 774 F.2d 1104, 1108–09 (Fed. Cir. 1985) (paper orally presented at a scientific meeting and distributed upon request); In re Wyer, 655 F.2d 221 (CCPA 1981) (patent application laid open to public inspection). E:\FR\FM\20APN1.SGM 20APN1 17538 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices applicant’s challenge to official notice are discussed in MPEP § 2144.03. B. Evaluating Applicant’s Response: If an applicant challenges the examiner’s position that the additional element(s) is well-understood, routine, conventional activity, the examiner should reevaluate whether it is readily apparent that the additional elements are in actuality well-understood, routine, conventional activities to those who work in the relevant field. If the examiner has taken official notice per paragraph (4) of section (III)(A) above that an element(s) is well-understood, routine, conventional activity, and the applicant challenges the examiner’s position, specifically stating that such element(s) is not well-understood, routine, conventional activity, the examiner must then provide one of the items discussed in paragraphs (1) through (3) of section (III)(A) above, or an affidavit or declaration under 37 CFR 1.104(d)(2) setting forth specific factual statements and explanation to support his or her position. As discussed previously, to represent well-understood, routine, conventional activity, the additional elements must be widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. 112(a). The MPEP will be updated in due course to incorporate the changes put into effect the Berkheimer memorandum. As discussed previously, the Berkheimer memorandum is available to the public on the USPTO’s internet website. The USPTO is seeking public comment on its subject matter eligibility guidance, and particularly its guidance in the Berkheimer memorandum. Dated: April 18, 2018. Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. 2018–08428 Filed 4–19–18; 8:45 am] BILLING CODE 3510–16–P The Committee is proposing to add a product and services to the Procurement List that will be furnished by the nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services previously furnished by such agencies. SUMMARY: Comments must be received on or before: May 20, 2018. DATES: Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202–4149. ADDRESSES: For further information or to submit comments contact: Amy B. Jensen, Telephone: (703) 603–7740, Fax: (703) 603–0655, or email CMTEFedReg@ AbilityOne.gov. FOR FURTHER INFORMATION CONTACT: This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51–2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions. SUPPLEMENTARY INFORMATION: Additions If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the product and services listed below from the nonprofit agencies employing persons who are blind or have other severe disabilities. The following product and services are proposed for addition to the Procurement List for production by the nonprofit agencies listed: Product NSN—Product Name: 6220–01–266–1651— Spotlight, .52 AMPS 28V BA15S bulb, yellow/white output, HMMWV Mandatory Source of Supply: Cincinnati Association for the Blind and Visually Impaired, Cincinnati, OH Mandatory for: 100% of the requirement of the Department of Defense Contracting Activity: Defense Commissary Agency Distribution: C-List Services sradovich on DSK3GMQ082PROD with NOTICES COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions and Deletions Committee for Purchase From People Who Are Blind or Severely Disabled. ACTION: Proposed additions to and deletions from the Procurement List. AGENCY: VerDate Sep<11>2014 17:44 Apr 19, 2018 Jkt 244001 Service Types: Furniture Design, Configuration and Installation Service Sourcing, Warehousing, Assembly and Kitting Service Tool & MRO Sourcing and Fulfillment Service Mandatory for: USPFO Connecticut, National Guard Bureau, National Guard Armory, 360 Broad Street, Hartford, CT Mandatory Source of Supply: Industries for the Blind, Inc., West Allis, WI Contracting Activity: United States Property and Fiscal Office (USPFO), Connecticut National Guard, ANGB, CT PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 Deletions The following products and services are proposed for deletion from the Procurement List: Products NSN(s)—Product Name(s): 8410–01–466–4892—Slacks, Dress, Coast Guard, Women’s, Blue, 16JS 8410–01–466–4905—Slacks, Dress, Coast Guard, Women’s, Blue, 12MS 8410–01–466–4906—Slacks, Dress, Coast Guard, Women’s, Blue, 14MS 8410–01–466–4912—Slacks, Dress, Coast Guard, Women’s, Blue, 18MR 8410–01–466–4914—Slacks, Dress, Coast Guard, Women’s, Blue, 8ML 8410–01–466–4915—Slacks, Dress, Coast Guard, Women’s, Blue, 12ML 8410–01–466–4926—Slacks, Dress, Coast Guard, Women’s, Blue, 14WS 8410–01–466–4930—Slacks, Dress, Coast Guard, Women’s, Blue, 12WR 8410–01–466–4935—Slacks, Dress, Coast Guard, Women’s, Blue, 12WL 8410–01–466–6326—Slacks, Dress, Coast Guard, Women’s, Blue, 4JR 8410–01–466–6332—Slacks, Dress, Coast Guard, Women’s, Blue, 6JS 8410–01–466–6485—Slacks, Dress, Coast Guard, Women’s, Blue, 8JL 8410–01–466–6486—Slacks, Dress, Coast Guard, Women’s, Blue, 4MS 8410–01–466–8155—Slacks, Dress, Coast Guard, Women’s, Blue, 10JS 8410–01–466–8157—Slacks, Dress, Coast Guard, Women’s, Blue, 12JS 8410–01–466–8161—Slacks, Dress, Coast Guard, Women’s, Blue, 18JS 8410–01–466–8172—Slacks, Dress, Coast Guard, Women’s, Blue, 18JL 8410–01–466–8176—Slacks, Dress, Coast Guard, Women’s, Blue, 16MS 8410–01–466–8195—Slacks, Dress, Coast Guard, Women’s, Blue, 18ML 8410–01–466–8197—Slacks, Dress, Coast Guard, Women’s, Blue, 20ML 8410–01–466–8199—Slacks, Dress, Coast Guard, Women’s, Blue, 16WS 8410–01–466–8203—Slacks, Dress, Coast Guard, Women’s, Blue, 18WL 8410–01–466–8207—Slacks, Dress, Coast Guard, Women’s, Blue, 20WL 8410–01–466–8211—Slacks, Dress, Coast Guard, Women’s, Blue, 22WL Mandatory Source of Supply: VGS, Inc., Cleveland, OH Contracting Activity: Defense Logistics Agency Troop Support Services Service Type: Food Service and Food Service Attendant Mandatory for: Fort Hood: Postwide, Fort Hood, TX Mandatory Source of Supply: Unknown Contracting Activity: Dept of the Army, W40M NORTHEREGION Contract Ofc Service Type: Janitorial/Custodial Service Mandatory for: Naval & Marine Corps Readiness Reserve Center, Providence, RI Mandatory Source of Supply: The Fogarty Center, North Providence, RI Contracting Activity: Dept of the Navy, Navy Crane Center E:\FR\FM\20APN1.SGM 20APN1

Agencies

[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Notices]
[Pages 17536-17538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08428]


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DEPARTMENT OF COMMERCE

 Patent and Trademark Office

[Docket No.: PTO-P-2018-0033]


Request for Comments on Determining Whether a Claim Element Is 
Well-Understood, Routine, Conventional for Purposes of Subject Matter 
Eligibility

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Request for comments.

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

SUMMARY: The U.S. Court of Appeals for the Federal Circuit (Federal 
Circuit) recently issued a decision regarding the inquiry of whether a 
claim limitation represents well-understood, routine, conventional 
activities (or elements) to a skilled artisan in the relevant field. 
Specifically, the Federal Circuit found that whether a claim element, 
or combination of elements, represents well-understood, routine, 
conventional activities to a skilled artisan in the relevant field is a 
question of fact. The United States Patent and Trademark Office (USPTO) 
has implemented this decision in a memorandum recently issued to the 
Patent Examining Corps (the Berkheimer memorandum). The Berkheimer 
memorandum is available to the public on the USPTO's internet website. 
Examiners had been previously instructed to conclude that an element 
(or combination of elements) is well-understood, routine, conventional 
activity only when the examiner can readily conclude that the 
element(s) is widely prevalent or in common use in the relevant 
industry. The Berkheimer memorandum now clarifies that such a 
conclusion must be based upon a factual determination that is supported 
as discussed in the memorandum. Aditionally the Berkheimer memorandum 
now also specifies that the analysis for determining whether an element 
(or combination of elements) is widely prevalent or in common use is 
the same as the analysis under 35 U.S.C. 112(a) as to whether an 
element is so well-known that it need not be described in detail in the 
patent specification. The USPTO is now seeking public comment on its 
subject matter eligibility guidance, and particularly its guidance in 
the Berkheimer memorandum to the Patent Examining Corps.

DATES: Comment Deadline Date: Written comments must be received on or 
before August 20, 2018.

ADDRESSES: Comments must be sent by electronic mail message over the 
internet addressed to: [email protected].
    Electronic comments submitted in plain text are preferred, but also 
may be submitted in ADOBE[supreg] portable document format or MICROSOFT 
WORD[supreg] format. Comments not submitted electronically should be 
submitted on paper in a format that facilitates convenient digital 
scanning into ADOBE[supreg] portable document format. The comments will 
be available for viewing via the USPTO's internet website (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: Carolyn Kosowski, Senior Legal 
Advisor, at 571-272-7688 or Matthew Sked, Senior Legal Advisor, at 571-
272-7627, both with the Office of Patent Legal Administration.

SUPPLEMENTARY INFORMATION: 
    I. Federal Circuit Decision in Berkheimer: The Federal Circuit 
recently issued a precedential decision holding that the question of 
whether certain claim limitations are well-understood, routine, 
conventional elements raised a disputed factual issue, which precluded 
summary judgment that all of the claims at issue were not patent 
eligible. See Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018). 
Shortly thereafter, the Federal Circuit reaffirmed the Berkheimer 
standard in the context of a judgment on the pleadings and judgment as 
a matter of law.\1\ While summary judgment, judgment on the pleadings, 
and judgment as a matter of law standards in civil litigation are 
generally inapplicable during the patent examination process, these 
decisions inform the inquiry into whether an additional element (or 
combination of additional elements) represents well-understood, 
routine, conventional activity. The USPTO has implemented this decision 
in the Berkheimer memorandum, which was recently issued to the Patent 
Examining Corps and is available to the public on the USPTO's internet 
website.
---------------------------------------------------------------------------

    \1\ See Aatrix Software, Inc. v. Green Shades Software, Inc., 
882 F.3d 1121 (Fed. Cir. 2018) (reversing a judgment on the 
pleadings of ineligibility, finding that whether the claims in the 
challenged patent perform well-understood, routine, conventional 
activities is an issue of fact); Exergen Corp. v. Kaz USA, Inc., 
Nos. 2016-2315, 2016-2341, 2018 WL 1193529, at *1 (Fed. Cir. Mar. 8, 
2018) (non-precedential) (affirming a district court's denial of a 
motion for judgment as a matter of law of patent ineligibility, thus 
upholding the district court's conclusion that the claims were drawn 
to a patent eligible invention, concluding that the district court's 
fact finding that the claimed combination was not proven to be well-
understood, routine, conventional was not clearly erroneous).
---------------------------------------------------------------------------

    The USPTO recognizes that unless careful consideration is given to 
the particular contours of subject matter eligibility (35 U.S.C. 101), 
it could ``swallow all of patent law.'' Alice Corp. v. CLS Bank 
International, 573 U.S. ___, ___, 134 S. Ct. 2347, 2352 (2014) (citing 
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71 
(2012)). The Berkheimer memorandum provides additional USPTO guidance 
that will further clarify how the USPTO is determining subject matter 
eligibility in accordance with prevailing jurisprudence. Specifically, 
the Berkheimer memorandum addresses the limited question of whether an 
additional element (or combination of additional elements) represents 
well-understood, routine, conventional activity. The USPTO is 
determined to continue its mission to provide clear and predictable 
patent rights in accordance with this rapidly evolving area of the law 
and, to that end, may issue further guidance in the future.
    II. Well-Understood, Routine, Conventional Activity: The USPTO's 
current understanding of the judicial framework distinguishing patents 
and applications that claim laws of nature, natural phenomena, and 
abstract ideas from those that claim patent-eligible

[[Page 17537]]

applications of those concepts--the Mayo-Alice framework--is set forth 
in section 2106 of the Manual of Patent Examining Procedure (MPEP). 
While the Berkheimer decision does not change the basic subject matter 
eligibility framework as set forth in MPEP Sec.  2106, it does provide 
clarification as to the inquiry into whether an additional element (or 
combination of additional elements) represents well-understood, 
routine, conventional activity. Specifically, the Federal Circuit held 
that ``[w]hether something is well-understood, routine, and 
conventional to a skilled artisan at the time of the patent is a 
factual determination.'' Berkheimer, 881 F.3d at 1369.
    As set forth in MPEP Sec.  2106.05(d)(I), an examiner should 
conclude that an element (or combination of elements) represents well-
understood, routine, conventional activity only when the examiner can 
readily conclude that the element(s) is widely prevalent or in common 
use in the relevant industry. The Berkheimer memorandum clarifies that 
such a conclusion must be based upon a factual determination that is 
supported as discussed in section III below. The Berkheimer memorandum 
further clarifies that the analysis as to whether an element (or 
combination of elements) is widely prevalent or in common use is the 
same as the analysis under 35 U.S.C. 112(a) as to whether an element is 
so well-known that it need not be described in detail in the patent 
specification.\2\
---------------------------------------------------------------------------

    \2\ See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377 
(Fed. Cir. 2016) (supporting the position that amplification was 
well-understood, routine, conventional for purposes of subject 
matter eligibility by observing that the patentee expressly argued 
during prosecution of the application that amplification was a 
technique readily practiced by those skilled in the art to overcome 
the rejection of the claim under 35 U.S.C. 112, first paragraph); 
see also Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 
730 F.2d 1452, 1463 (Fed. Cir. 1984) (``[T]he specification need not 
disclose what is well known in the art.''); In re Myers, 410 F.2d 
420, 424 (CCPA 1969) (``A specification is directed to those skilled 
in the art and need not teach or point out in detail that which is 
well-known in the art.''); Exergen Corp., 2018 WL 1193529, at *4 
(holding that ``[l]ike indefiniteness, enablement, or obviousness, 
whether a claim is directed to patent eligible subject matter is a 
question of law based on underlying facts,'' and noting that the 
Supreme Court has recognized that ``the inquiry `might sometimes 
overlap' with other fact-intensive inquiries like novelty under 35 
U.S.C. 102'').
---------------------------------------------------------------------------

    The question of whether additional elements represent well-
understood, routine, conventional activity is distinct from 
patentability over the prior art under 35 U.S.C. 102 and 103. This is 
because a showing that additional elements are obvious under 35 U.S.C. 
103, or even that they lack novelty under 35 U.S.C. 102, is not by 
itself sufficient to establish that the additional elements are well-
understood, routine, conventional activities or elements to those in 
the relevant field. See MPEP Sec.  2106.05. As the Federal Circuit 
explained: ``[w]hether a particular technology is well-understood, 
routine, and conventional goes beyond what was simply known in the 
prior art. The mere fact that something is disclosed in a piece of 
prior art, for example, does not mean it was well-understood, routine, 
and conventional.'' Berkheimer, 881 F.3d at 1369.
    III. Impact on Examination Procedure: The Berkheimer memorandum 
revises the procedures set forth in MPEP Sec.  2106.07(a) (Formulating 
a Rejection For Lack of Subject Matter Eligibility) and MPEP Sec.  
2106.07(b) (Evaluating Applicant's Response).
    A. Formulating Rejections: In a step 2B analysis, an additional 
element (or combination of elements) is not well-understood, routine or 
conventional unless the examiner finds, and expressly supports a 
rejection in writing with, one or more of the following:
    1. A citation to an express statement in the specification or to a 
statement made by an applicant during prosecution that demonstrates the 
well-understood, routine, conventional nature of the additional 
element(s). A specification demonstrates the well-understood, routine, 
conventional nature of additional elements when it describes the 
additional elements as well-understood or routine or conventional (or 
an equivalent term), as a commercially available product, or in a 
manner that indicates that the additional elements are sufficiently 
well-known that the specification does not need to describe the 
particulars of such additional elements to satisfy 35 U.S.C. 112(a). A 
finding that an element is well-understood, routine, or conventional 
cannot be based only on the fact that the specification is silent with 
respect to describing such element.
    2. A citation to one or more of the court decisions discussed in 
MPEP Sec.  2106.05(d)(II) as noting the well-understood, routine, 
conventional nature of the additional element(s).
    3. A citation to a publication that demonstrates the well-
understood, routine, conventional nature of the additional element(s). 
An appropriate publication could include a book, manual, review 
article, or other source that describes the state of the art and 
discusses what is well-known and in common use in the relevant 
industry. It does not include all items that might otherwise qualify as 
a ``printed publication'' as used in 35 U.S.C. 102.\3\ Whether 
something is disclosed in a document that is considered a ``printed 
publication'' under 35 U.S.C. 102 is a distinct inquiry from whether 
something is well-known, routine, conventional activity. A document may 
be a printed publication but still fail to establish that something it 
describes is well-understood, routine, conventional activity. See 
Exergen Corp., 2018 WL 1193529, at *4 (the single copy of a thesis 
written in German and located in a German university library considered 
to be a ``printed publication'' in Hall ``would not suffice to 
establish that something is `well-understood, routine, and conventional 
activity previously engaged in by scientists who work in the field' 
''). The nature of the publication and the description of the 
additional elements in the publication would need to demonstrate that 
the additional elements are widely prevalent or in common use in the 
relevant field, comparable to the types of activity or elements that 
are so well-known that they do not need to be described in detail in a 
patent application to satisfy 35 U.S.C. 112(a). For example, while U.S. 
patents and published applications are publications, merely finding the 
additional element in a single patent or published application would 
not be sufficient to demonstrate that the additional element is well-
understood, routine, conventional, unless the patent or published 
application demonstrates that the additional element are widely 
prevalent or in common use in the relevant field.
---------------------------------------------------------------------------

    \3\ See, e.g., In re Klopfenstein, 380 F.3d 1345 (Fed. Cir. 
2004) (publicly displayed slide presentation); In re Hall, 781 F.2d 
897 (Fed. Cir. 1986) (doctoral thesis shelved in a library); Mass. 
Inst. of Tech. v. AB Fortia, 774 F.2d 1104, 1108-09 (Fed. Cir. 1985) 
(paper orally presented at a scientific meeting and distributed upon 
request); In re Wyer, 655 F.2d 221 (CCPA 1981) (patent application 
laid open to public inspection).
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    4. A statement that the examiner is taking official notice of the 
well-understood, routine, conventional nature of the additional 
element(s). This option should be used only when the examiner is 
certain, based upon his or her personal knowledge, that the additional 
element(s) represents well-understood, routine, conventional activity 
engaged in by those in the relevant art, in that the additional 
elements are widely prevalent or in common use in the relevant field, 
comparable to the types of activity or elements that are so well-known 
that they do not need to be described in detail in a patent application 
to satisfy 35 U.S.C. 112(a). Procedures for taking official notice and 
addressing an

[[Page 17538]]

applicant's challenge to official notice are discussed in MPEP Sec.  
2144.03.
    B. Evaluating Applicant's Response: If an applicant challenges the 
examiner's position that the additional element(s) is well-understood, 
routine, conventional activity, the examiner should reevaluate whether 
it is readily apparent that the additional elements are in actuality 
well-understood, routine, conventional activities to those who work in 
the relevant field. If the examiner has taken official notice per 
paragraph (4) of section (III)(A) above that an element(s) is well-
understood, routine, conventional activity, and the applicant 
challenges the examiner's position, specifically stating that such 
element(s) is not well-understood, routine, conventional activity, the 
examiner must then provide one of the items discussed in paragraphs (1) 
through (3) of section (III)(A) above, or an affidavit or declaration 
under 37 CFR 1.104(d)(2) setting forth specific factual statements and 
explanation to support his or her position. As discussed previously, to 
represent well-understood, routine, conventional activity, the 
additional elements must be widely prevalent or in common use in the 
relevant field, comparable to the types of activity or elements that 
are so well-known that they do not need to be described in detail in a 
patent application to satisfy 35 U.S.C. 112(a).
    The MPEP will be updated in due course to incorporate the changes 
put into effect the Berkheimer memorandum.
    As discussed previously, the Berkheimer memorandum is available to 
the public on the USPTO's internet website. The USPTO is seeking public 
comment on its subject matter eligibility guidance, and particularly 
its guidance in the Berkheimer memorandum.

    Dated: April 18, 2018.
Andrei Iancu,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2018-08428 Filed 4-19-18; 8:45 am]
 BILLING CODE 3510-16-P