[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36257-36260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14628]


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

DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2021-0032]


Patent Eligibility Jurisprudence Study

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

ACTION: Request for information.

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

SUMMARY: At the request of Senators Tillis, Hirono, Cotton, and Coons, 
the United States Patent and Trademark Office (USPTO) is undertaking a 
study on the current state of patent eligibility jurisprudence in the 
United States, and how the current jurisprudence has impacted 
investment and innovation, particularly in critical technologies like 
quantum computing, artificial intelligence, precision medicine, 
diagnostic methods, and pharmaceutical treatments. The USPTO seeks 
public input on these matters to assist in preparing the study.

DATES: Comments must be received by September 7, 2021.

ADDRESSES: For reasons of government efficiency, comments must be 
submitted through the Federal eRulemaking Portal at 
www.regulations.gov. To submit comments via the portal, enter docket 
number PTO-P-2021-0032 on the homepage and click ``Search.'' The site 
will provide a search results page listing all documents associated 
with this docket. Find a reference to this request for information and 
click on the ``Comment Now!'' icon, complete the required fields, and 
enter or attach your comments. Attachments to electronic comments will 
be accepted in ADOBE[supreg] portable document format or MICROSOFT 
WORD[supreg] format. Because

[[Page 36258]]

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 
document(s) or information they would like the USPTO to withhold. The 
index should identify the confidential document(s) by document 
number(s) and document title(s) and should identify the confidential 
information by description(s) 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 non-confidential 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 submitter's 
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 [email protected] or 571-
272-9300. Please direct media inquiries to the USPTO's Office of the 
Chief Communications Officer at 571-272-8400.

SUPPLEMENTARY INFORMATION: In 2016, following the Supreme Court's 
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 Court's 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 71486-71487. 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.
---------------------------------------------------------------------------

    \1\ Bilski v. Kappos, 561 U.S. 593 (2010).
    \2\ Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 
U.S. 66 (2012).
    \3\ Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 
U.S. 576 (2013).
    \4\ Alice Corp. v. CLS Bank Int'l, 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 55942-55943 (Oct. 18, 
2019). That guidance has since been incorporated into the Manual of 
Patent Examining Procedure, sections 2103 to 2106.07(c) (9th ed., 
rev. 10.2019) (June 2020). See www.uspto.gov/PatentEligibility.
---------------------------------------------------------------------------

    Since 2017, the Federal Circuit has issued numerous decisions 
applying the Supreme Court's 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. 18-415, 139 S. Ct. 860 (Jan. 7, 2019); Hikma Pharms. 
USA Inc. v. Vanda Pharms. Inc., No. 18-817, 139 S. Ct. 1368 (Mar. 18, 
2019). In both cases, the Government argued that the Court's 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 
*10-13 (Dec. 6, 2019) (Berkheimer CVSG Brief); Brief for United States, 
Hikma Pharms. USA Inc. v. Vanda Pharms. Inc., No. 18-817, 2019 WL 
6699397, at *13-21 (Dec. 6, 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, *22-23. In particular, the Government highlighted the 
then-pending 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 *22-23. 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. 18-817, 140 S. Ct. 911 (Jan. 13, 2020); Athena Diagnostics, 
Inc. v. Mayo Collaborative Servs., LLC, No. 19-430, 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'' test--if the claimed 
invention ``clearly invokes a natural law, and nothing more, to 
accomplish a desired result''--for patent ineligibility. Id. at 1366 
(O'Malley 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. 20-891, 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 patent-
ineligible 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

[[Page 36259]]

publish a request for information on the current state of patent 
eligibility jurisprudence in the United States (since the Supreme 
Court's decisions in Mayo and Alice), evaluate the responses, and 
provide a detailed summary of its findings by March 5, 2022. The 
Senators indicated a particular interest in learning how the current 
jurisprudence has adversely impacted investment and innovation in 
critical technologies like quantum computing, artificial 
intelligence,\6\ precision medicine, diagnostic methods, and 
pharmaceutical treatments.
---------------------------------------------------------------------------

    \6\ On October 6, 2020, the USPTO released a report titled 
``Public Views on Artificial Intelligence and Intellectual Property 
Policy.'' The report takes a comprehensive look at a wide variety of 
stakeholder views on the impact of artificial intelligence across 
the intellectual property landscape. See generally ``Public Views on 
Artificial Intelligence and Intellectual Property Policy,'' 
available at www.uspto.gov/sites/default/files/documents/USPTO_AI-Report_2020-10-07.pdf.
---------------------------------------------------------------------------

    Request for Information: To aid in the study that Senators Tillis, 
Hirono, Cotton, and Coons requested, the USPTO invites stakeholders to 
submit written comments on the questions below. In the questions, the 
phrase ``the current state of patent eligibility jurisprudence in the 
United States'' should be understood as referring to the body of patent 
subject matter eligibility decisions issued by the U.S. Federal 
Judiciary.
    When responding to the questions, please identify yourself and your 
interest in the U.S. patent system. If applicable, please indicate 
whether you fall within one or more of the following categories: (1) 
Inventors, patent owners, or investors (e.g., venture capital, 
investment bank, fund, etc.); (2) licensees or users of patented 
technology; (3) entities that represent inventors or patent owners 
(e.g., law firms); (4) recipients of demand letters concerning alleged 
patent infringement or accused infringers in a patent lawsuit; (5) 
entities that represent accused infringers; (6) government agencies or 
officials; (7) academic or research institutions; (8) intellectual 
property organizations or associations; and (9) nonprofit organizations 
or advocacy groups. Additionally, if you are a patent owner or 
inventor, please include the number of U.S. and foreign patent 
applications you have filed; the number of U.S. and foreign patents you 
hold; the number of patents you have licensed or sold; and the number 
of patent cases you have been involved in since the Supreme Court's 
decision in Bilski in 2010.
    Commenters need not respond to every question and may provide 
relevant information even if not responsive to a particular question.

Topics for Public Comment

Section I--Observations and Experiences

    1. Please explain how the current state of patent eligibility 
jurisprudence affects the conduct of business in your technology 
area(s). Please identify the technology area(s) in your response.
    2. Please explain what impacts, if any, you have experienced as a 
result of the current state of patent eligibility jurisprudence in the 
United States. Please include impacts on as many of the following areas 
as you can, identifying concrete examples and supporting facts when 
possible:
    a. Patent prosecution strategy and portfolio management;
    b. patent enforcement and litigation;
    c. patent counseling and opinions;
    d. research and development;
    e. employment;
    f. procurement;
    g. marketing;
    h. ability to obtain financing from investors or financial 
institutions;
    i. investment strategy;
    j. licensing of patents and patent applications;
    k. product development;
    l. sales, including downstream and upstream sales;
    m. innovation; and
    n. competition.
    3. Please explain how the current state of patent eligibility 
jurisprudence in the United States impacts particular technological 
fields, including investment and innovation in any of the following 
technological areas:
    a. Quantum computing;
    b. artificial intelligence;
    c. precision medicine;
    d. diagnostic methods;
    e. pharmaceutical treatments; and
    f. other computer-related inventions (e.g., software, business 
methods, computer security, databases and data structures, computer 
networking, and graphical user interfaces).
    4. Please explain how your experiences with the application of 
subject matter eligibility requirements in other jurisdictions, 
including China, Japan, Korea, and Europe, differ from your experiences 
in the United States.
    5. Please identify instances where you have been denied patent 
protection for an invention in the United States solely on the basis of 
patent subject matter ineligibility, but obtained protection for the 
same invention in a foreign jurisdiction, or vice versa. Please provide 
specific examples, such as the technology(ies) and jurisdiction(s) 
involved, and the reason the invention was held ineligible in the 
United States or other jurisdiction.
    6. Please explain whether the state of patent eligibility 
jurisprudence in the United States has caused you to modify or shift 
investment, research and development activities, or jobs from the 
United States to other jurisdictions, or to the United States from 
other jurisdictions. If so, please identify the relevant modifications 
and their associated impacts.
    7. Please explain whether the state of patent eligibility 
jurisprudence in the United States has caused you to change business 
strategies for protecting your intellectual property (e.g., shifting 
from patents to trade secrets, or vice versa). If so, please identify 
the changes and their associated impacts.
    8. Please explain whether you have changed your behavior with 
regard to filing, purchasing, licensing, selling, or maintaining patent 
applications and patents in the United States as a result of the 
current state of patent eligibility jurisprudence in the United States. 
If so, please describe how you changed your behavior.
    9. Please explain how, in your experience, the status of patent 
eligibility jurisprudence in the United States has affected any 
litigation for patent infringement in the United States in which you 
been involved as a party, as legal counsel, or as another participant 
(e.g., an expert witness). For example, please explain whether this 
jurisprudence has affected the cost or duration of such litigation, the 
ability to defend against claims of patent infringement, the certainty/
uncertainty of litigation outcomes, or the likelihood of settlement.

Section II--Impact of Subject Matter Eligibility on the General 
Marketplace

    10. Please identify how the current state of patent eligibility 
jurisprudence in the United States impacts the global strength of U.S. 
intellectual property.
    11. Please identify how the current state of patent eligibility 
jurisprudence in the United States impacts the U.S. economy as a whole.
    12. Please identify how the current state of subject matter 
eligibility jurisprudence in the United States impacts the global 
strength of U.S. intellectual property and the U.S. economy in any of 
the following areas:
    a. Quantum computing;
    b. artificial intelligence;
    c. precision medicine;
    d. diagnostic methods;
    e. pharmaceutical treatments; and
    f. other computer-related inventions (e.g., software, business 
methods,

[[Page 36260]]

computer security, databases and data structures, computer networking, 
and graphical user interfaces).
    In responding to this question, please provide concrete examples 
and supporting facts when possible.
    13. Please identify how the current state of patent eligibility 
jurisprudence in the United States affects the public. For example, 
does the jurisprudence affect, either positively or negatively, the 
availability, effectiveness, or cost of personalized medicine, 
diagnostics, pharmaceutical treatments, software, or computer-
implemented inventions?

Andrew Hirshfeld,
Commissioner for Patents, Performing the Functions and Duties of the 
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2021-14628 Filed 7-8-21; 8:45 am]
BILLING CODE 3510-16-P