[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 56933-56934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20131]


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

DEPARTMENT OF COMMERCE

Patent and Trademark Office


Agency Information Collection Activities; Submission to the 
Office of Management and Budget (OMB) for Review and Approval; Comment 
Request; Requirements for Patent Applications Containing Nucleotide 
Sequence and/or Amino Acid Sequence Disclosures

    The United States Patent and Trademark Office (USPTO) will submit 
the following information collection request to the Office of 
Management and Budget (OMB) for review and clearance in accordance with 
the Paperwork Reduction Act of 1995, on or after the date of 
publication of this notice. The USPTO invites comment on this 
information collection renewal, which helps the USPTO assess the impact 
of its information collection requirements and minimize the public's 
reporting burden. Public comments were previously requested via the 
Federal Register on June 7, 2022 during a 60-day comment period. This 
notice allows for an additional 30 days for public comments.
    Agency: United States Patent and Trademark Office, Department of 
Commerce.
    Title: Requirements for Patent Applications Containing Nucleotide 
Sequence and/or Amino Acid Sequence Disclosures.
    OMB Control Number: 0651-0024.
    Needs and Uses: Patent applications that contain nucleotide and/or 
amino acid sequence disclosures falling within the definitions of 37 
CFR 1.821(a) (for applications filed on or before June 30, 2022) or 37 
CFR 1.831 (for applications filed on or after July 1, 2022) must 
include, as a separate part of the disclosure, a copy of the sequence 
listing in accordance with the requirements in 37 CFR 1.821-1.825 or 37 
CFR 1.831-1.835, respectively. Applicants may submit sequence listings 
for both U.S. and international biotechnology patent applications. 
Submissions of sequence listings in international applications are 
governed by Patent Cooperation Treaty (PCT) Rules 5.2 and 13ter, as 
well as the PCT Administrative Instructions, Annex C. The USPTO uses 
applicants' sequence listings during the examination process to 
determine the patentability of the claimed invention. The USPTO also 
uses sequence listings for pre-grant publication of patent applications 
and publication of issued patents. Sequence listings are publicly 
searchable after publication of the pre-grant application or issued 
patent.
    This information collection covers the submission of sequence 
listing information itself. Information pertaining to the initial 
filing of U.S. patent applications is collected under OMB Control 
Number 0651-0032 and information pertaining to the initial filing of 
international applications is collected under OMB Control Number 0651-
0021.
    Sequence listings in applications filed on or before June 30, 2022 
may be submitted via the USPTO patent electronic filing system as an 
ASCII text file or as a Portable Document Format (PDF) file. For U.S. 
applications filed on or before June 30, 2022, 37 CFR 1.821(c) permits 
all modes of submission: paper, read-only optical disc, or electronic 
filing via the USPTO patent electronic filing system. Sequence listings 
for international applications may only be submitted on paper or 
through the USPTO patent electronic filing system. Sequence listings 
that are too large to be filed electronically through the USPTO patent 
electronic filing system may be submitted on read-only optical disc.
    This information collection also accounts for the requirement under 
37 CFR 1.821(e)(1) or 1.821(e)(2) that a copy of the sequence listing 
submitted pursuant to 37 CFR 1.821(c)(2) or (c)(3) must also be 
submitted in computer readable form (CRF) in accordance with 37 CFR 
1.824. Under 37 CFR 1.821(e)(1) or 1.821(e)(2), applicants who submit 
their sequence listings on paper or as a PDF via the USPTO patent 
electronic filing system must submit a copy of the sequence listing in 
CRF with a statement indicating that the CRF copy of the sequence 
listing is identical to the paper or PDF copy provided under 37 CFR 
1.821(c)(3) or 1.821(c)(2), respectively. Applicants may submit the CRF 
copy of the sequence listing to the USPTO via the USPTO patent 
electronic filing system, or on read-only optical disc or other 
acceptable media as provided in 37 CFR 1.824. If a new application is 
filed via the USPTO patent electronic filing system with an ASCII text 
file sequence listing that complies with the requirements of 37 CFR 
1.824(a)(1)-(5) and (b), and the applicant has not filed a sequence 
listing on paper or as a PDF file, no separate text file is required. 
Therefore, no associated statement regarding both copies being 
identical would be required. Similarly, if a new application is filed 
with an ASCII text file sequence listing on read-only optical disc that 
complies with the requirements of 37 CFR 1.824(a)(1)-(5) and 37 CFR 
1.52(e), the single read-only optical disc is the CRF, and no 
additional submission is required.
    Sequence listings in applications filed on or after July 1, 2022 
must be submitted in XML format per 37 CFR 1.831, which was recently 
implemented to achieve alignment with World Intellectual Property 
Office Standard ST.26 (WIPO Standard ST.26) (Standard for Presentation 
of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup 
Language (XML) in Patent Applications To Implement WIPO Standard ST.26; 
Incorporation by Reference, 87 FR 30806, 5/20/22, effective July 1, 
2022). These submissions may be made electronically via the USPTO 
patent electronic filing system as an XML file not exceeding 100MB 
without file compression, or as an XML file on a read-only optical disc 
in accordance with 37 CFR 1.834(b)-(c).
    One item, Request for Transfer of a Computer Readable Form under 37 
CFR 1.821(e), has been removed from this information collection. This 
item is no longer part of this information collection's process per a 
recent rulemaking (Electronic Submission of a Sequence Listing, a Large 
Table, or a Computer Program Listing Appendix in Patent Applications; 
86 FR 57035, 10/14/2021, effective November 15, 2021).
    Form Number(s): None.
    Type of Review: Extension and revision of a currently approved 
information collection.
    Affected Public: Private sector; individuals or households.
    Respondent's Obligation: Required to obtain or retain benefits.
    Frequency: On occasion.

[[Page 56934]]

    Estimated Number of Annual Respondents: 9,550 respondents.
    Estimated Number of Annual Responses: 28,550 responses.
    Estimated Time per Response: The USPTO estimates that the responses 
in this information collection will take the public approximately 6 
hours to complete. This includes the time to gather the necessary 
information, create the document, and submit the completed request to 
the USPTO.
    Estimated Total Annual Respondent Burden Hours: 171,300 hours.
    Estimated Total Annual Respondent Non-Hourly Cost Burden: 
$1,483,936.
    This information collection request may be viewed at 
www.reginfo.gov. Follow the instructions to view Department of 
Commerce, USPTO information collections currently under review by OMB.
    Written comments and recommendations for this information 
collection should be submitted within 30 days of the publication of 
this notice on the following website www.reginfo.gov/public/do/PRAMain. 
Find this particular information collection by selecting ``Currently 
under 30-day Review--Open for Public Comments'' or by using the search 
function and entering either the title of the information collection or 
the OMB Control Number 0651-0024.
    Further information can be obtained by:
     Email: [email protected]. Include ``0651-
0024 information request'' in the subject line of the message.
     Mail: Justin Isaac, Office of the Chief Administrative 
Officer, United States Patent and Trademark Office, P.O. Box 1450, 
Alexandria, VA 22313-1450.

Justin Isaac,
Acting Information Collections Officer, Office of the Chief 
Administrative Officer, United States Patent and Trademark Office.
[FR Doc. 2022-20131 Filed 9-15-22; 8:45 am]
BILLING CODE 3510-16-P