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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
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.
Visit the Federal eRulemaking Portal www.regulations.gov for additional instructions on providing comments via the portal. If electronic submission of comments is not feasible due to a lack of access to a computer and/or the internet, please contact the USPTO
using the contact information below for special instructions on how to submit comments by other means.
Submissions of Business Confidential Information: Any submissions containing business confidential information must be marked confidential treatment requested and submitted through www.regulations.gov.
Submitters should provide an index listing the documents or information they would like the USPTO to withhold.
The index should identify the confidential documents by document numbers and document titles and should identify the confidential information by descriptions and relevant page numbers and/or section numbers within a document. Submitters should also provide a statement explaining their grounds for requesting non-disclosure of the information to the public. The USPTO also requests that submitters of business confidential information include a non-confidential version either redacted or summarized that will be posted on www.regulations.gov and available for public viewing. In the event that the submitter cannot provide a nonconfidential version of their submission, the USPTO requests that the submitter post a notice in the docket stating that they have provided the USPTO with business confidential information.
Should a submitter fail either to docket a non-confidential version of their submission or to post a notice that business confidential information has been provided, the USPTO will note the receipt of the submission on the docket with the submitters organization or name to the degree permitted by law and the date of submission.
Anonymous submissions: The USPTO
will accept anonymous submissions.
Enter N/A in the required fields if you wish to remain anonymous.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Shaw, USPTO, Office of Policy and International Affairs, at Elizabeth.Shaw2@uspto.gov or 571
2729300. Please direct media inquiries to the USPTOs Office of the Chief Communications Officer at 571272
8400.

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In 2016, following the Supreme Courts decisions in Bilski,1 Mayo,2 Myriad,3 and Alice,4 the USPTO held two public roundtables and invited written comments from the public on the state of the law of patent subject matter eligibility and the Courts legal framework for evaluating eligibility. Notice of Roundtables and Request for Comments Related to Patent Subject Matter Eligibility, 81 FR 71485
Oct. 17, 2016. The first roundtable focused on the then-current USPTO
eligibility guidance for patent examiners. Id. at 71487.5 The second roundtable explored the legal contours of patent eligibility, including the impact of the current law, if/how the law should be revised, and whether a legislative solution should be sought. Id.
at 7148671487. In July 2017, the USPTO published a report summarizing patent eligibility law, public views on the impact of the recent Supreme Court patent eligibility jurisprudence, and public recommendations for a path forward. USPTO, Patent Eligible Subject Matter: Report on Views and Recommendations from the Public July 2017, available at www.uspto.gov/sites/
default/files/documents/101-Report_
FINAL.pdf.
Since 2017, the Federal Circuit has issued numerous decisions applying the Supreme Courts legal framework in a variety of contexts, and many petitions for writ of certiorari have been filed. In 2019, the Supreme Court called for the views of the Solicitor General. HP Inc.
v. Berkheimer, No. 18415, 139 S. Ct.
860 Jan. 7, 2019; Hikma Pharms. USA
Inc. v. Vanda Pharms. Inc., No. 18817, 139 S. Ct. 1368 Mar. 18, 2019. In both cases, the Government argued that the Courts recent decisions have strayed from earlier precedent and have fostered uncertainty regarding the patent eligibility standards. Brief for United States, HP Inc. v. Berkheimer, No. 18
415, 2019 WL 6715368, at 1013 Dec.
6, 2019 Berkheimer CVSG Brief; Brief for United States, Hikma Pharms. USA
Inc. v. Vanda Pharms. Inc., No. 18817, 2019 WL 6699397, at 1321 Dec. 6, SUPPLEMENTARY INFORMATION:

v. Kappos, 561 U.S. 593 2010.
Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 2012.
3 Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 2013.
4 Alice Corp. v. CLS Bank Intl, 573 U.S. 208
2014.
5 The USPTO issued revised patent subject matter eligibility guidance for examiners in 2019. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance, 84 FR 50 Jan. 7, 2019; USPTO, October 2019 Patent Eligibility Guidance Update, 84 FR
5594255943 Oct. 18, 2019. That guidance has since been incorporated into the Manual of Patent Examining Procedure, sections 2103 to 2106.07c 9th ed., rev. 10.2019 June 2020. See www.uspto.gov/PatentEligibility.

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2019 Vanda CVSG Brief. While the Government contended that neither of the cases was an optimal vehicle to consider those standards, it urged the Court to grant certiorari in an appropriate case. Berkheimer CVSG
Brief at 10, 14, 19; Vanda CVSG
Brief at 8, 2223. In particular, the Government highlighted the thenpending certiorari petition in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, a case involving medical diagnostic methods in which the Federal Circuit, in denying rehearing en banc, issued multiple separate opinions asking the Supreme Court for further guidance in the area. Berkheimer CVSG
Brief at 13, 19; Vanda CVSG Brief at 2223. Ultimately, the Supreme Court denied writ of certiorari in all three cases. HP Inc. v. Berkheimer, No. 18
415, 140 S. Ct. 911 Jan. 13, 2020;
Hikma Pharms. USA Inc. v. Vanda Pharms. Inc., No. 18817, 140 S. Ct. 911
Jan. 13, 2020; Athena Diagnostics, Inc.
v. Mayo Collaborative Servs., LLC, No.
19430, 140 S. Ct. 855 Jan. 13, 2020.
Last year, after a split panel decision concluding that a method for manufacturing drive shafts was patent ineligible, the Federal Circuit again issued a decision denying rehearing en banc that included multiple separate opinions with differing views on the scope of patent eligible subject matter.
Am. Axle & Mfg., Inc. v. Neapco Holdings LLC, 966 F.3d 1347 Fed. Cir.
2020. Like the dissenting judge on the panel, several of the opinions denying rehearing en banc faulted the panel majority for establishing a new nothing more testif the claimed invention clearly invokes a natural law, and nothing more, to accomplish a desired resultfor patent ineligibility. Id. at 1366 OMalley J., dissenting; id. at 1361 Stoll J., dissenting; id. at 1359
Newman J., dissenting. American Axle petitioned for writ of certiorari on December 28, 2020, and the Supreme Court called for the views of the Solicitor General on May 3, 2021. Am.
Axle & Mfg., Inc. v. Neapco Holdings LLC, No. 20891, 2021 WL 1725166
May 3, 2021. The questions presented in the petition are: 1 What is the appropriate standard for determining whether a claim is directed to a patentineligible concept under step one of the Alice two-step framework?; and 2 Is patent eligibility a question of law for the court or a question of fact for the jury?
On March 5, 2021, Senators Thom Tillis, Mazie Hirono, Tom Cotton, and Christopher Coons sent a letter to Mr.
Drew Hirshfeld, Performing the functions and duties of the Director of the USPTO, asking that the USPTO

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