[Federal Register Volume 90, Number 121 (Thursday, June 26, 2025)]
[Notices]
[Pages 27284-27287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11798]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Comment
Request; Requirements for Patent Applications Containing Nucleotide
Sequence and/or Amino Acid Sequence Disclosures
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice of information collection; request for comments.
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SUMMARY: The United States Patent and Trademark Office (USPTO), as
required by the Paperwork Reduction Act of 1995, invites comments on
the extension and revision of an existing information collection: 0651-
0024 (Requirements for Patent Applications Containing Nucleotide
Sequence and/or Amino Acid Sequence Disclosures). The purpose of this
notice is to allow 60 days for public comments preceding submission of
the information collection to the Office of Management and Budget
(OMB).
DATES: To ensure consideration, you must submit comments regarding this
information collection on or before August 25, 2025.
ADDRESSES: Interested persons are invited to submit written comments by
any of the following methods. Do not submit Confidential Business
Information or otherwise sensitive or protected information.
Email: [email protected]. Include ``0651-
0024 comment'' in the subject line of the message.
Federal eRulemaking Portal: http://www.regulations.gov.
Mail: Justin Isaac, Office of the Chief Administrative
Officer, United States Patent and Trademark Office, P.O. Box 1450,
Alexandria, VA 22313-1450.
FOR FURTHER INFORMATION CONTACT: Request for additional information
should be directed to Raul Tamayo, Senior Legal Advisor, at: United
States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA
22313-1450; 571-272-7728; or [email protected] with ``0651-0024
comment'' in the subject line. Additional information about this
information collection is also available at http://www.reginfo.gov
under ``Information Collection Review.''
SUPPLEMENTARY INFORMATION:
I. Abstract
Patent applications that contain nucleotide and/or amino acid
sequence disclosures falling within the definitions of 37 CFR 1.831
(for applications filed on or after July 1, 2022) or 37 CFR 1.821(a)
(for applications filed on or before June 30, 2022) must include, as a
separate part of the application disclosure, a copy of the sequence
listing in accordance with the requirements in 37 CFR 1.831-1.835 or 37
CFR 1.821-1.825, respectively. Applicants may submit sequence listings
for both U.S. and international patent applications. For more
information concerning the submissions of sequence listings in
international applications, see the Patent Cooperation Treaty (PCT)
Rules 5.2 and 13ter, Annex C of the PCT Administrative Instructions,
and section 1848 of the Manual of Patent Examining Procedure
[[Page 27285]]
(MPEP) (9th ed., Rev. 01.2024, November 2024).
The USPTO uses the sequence listings during the examination process
to determine the patentability of the invention claimed in the
application. The USPTO also uses the sequence listings for pre-grant
publication of applications and issued patents. Applicants use sequence
listings when preparing both national and international patent
applications that disclose nucleotide and/or amino acid sequences to
provide a written description of the invention and to distinguish the
claimed subject matter from the prior art.
This information collection only covers the submission of sequence
listing information. Information pertaining to the initial filing of a
U.S. patent application is collected under OMB Control Number 0651-0032
(Initial Patent Applications), and information pertaining to the
initial filing of international applications is collected under OMB
Control Number 0651-0021 (Patent Cooperation Treaty).
For sequence listings filed as 37 CFR 1.825 amendments in
applications having a filing date of on or before June 30, 2022, this
information collection also accounts for the submission of a new or
substitute computer readable form (CRF) copy of the sequence listing
under 37 CFR 1.821(e) and 1.824, with the amendment incorporated
therein, if necessary, under 37 CFR 1.825(a)(5)(ii) or (b)(6)(ii).
II. Method of Collection
Sequence listings for applications having a filing date of on or
after July 1, 2022, must be submitted as XML files, either by
electronically transmitting the XML file through the USPTO patent
electronic filing system (Patent Center), where the file does not
exceed 100MB without compression, or on read-only optical discs.
Sequence listings filed as 37 CFR 1.825 amendments in applications
having a filing date of on or before June 30, 2022, are preferably
submitted as an ASCII plain text file via Patent Center or on a read-
only optical disc. They may also be submitted electronically through
Patent Center as a PDF or on paper with a submission that is mailed or
hand delivered.
III. Data
OMB Control Number: 0651-0024.
Forms: None.
Type of Review: Extension and revision of a currently approved
information collection.
Affected Public: Private sector.
Respondent's Obligation: Required to obtain or retain benefits.
Frequency: On occasion.
Estimated Number of Annual Respondents: 30,000 respondents.
Estimated Number of Annual Responses: 30,000 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 items to the
USPTO.
Estimated Total Annual Respondent Burden Hours: 180,000 hours.
Estimated Total Annual Respondent Hourly Cost Burden: $80,460,000.
Table 1--Total Burden Hours and Hourly Costs to Private Sector Respondents
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Estimated Estimated time Estimated annual
Item No. Item annual Responses per Estimated annual for response Estimated burden Rate \1\ ($/ respondent cost
respondents respondent responses (hours) (hour/year) hour) burden
(a) (b) (a) x (b) = (c) (d) (c) x (d) = (e) (f) (e) x (f) = (g)
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1.......... Sequence Listing 30,000 1 30,000 6 180,000 $447 $80,460,000
in Application.
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Totals......... 30,000 .............. 30,000 .............. 180,000 .............. 80,460,000
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\1\ 2023 Report of the Economic Survey, published by the Committee on Economics of Legal Practice of the American Intellectual Property Law Association;
pg. F-41. The USPTO uses the average billing rate for intellectual property work in all firms which is $447 per hour (https://www.aipla.org/home/news-publications/economic-survey).
Estimated Total Annual Respondent Non-hourly Cost Burden: $336,973.
There are no capital start-up costs, maintenance costs, or
recordkeeping costs associated with this information collection.
However, the USPTO estimates that the total annual non-hour cost burden
for this information collection, in the form of filing fees and paid
postage, is $336,973.
Filing Fees
Sequence Listings for Applications Filed on or After July 1, 2022
Applicants must submit sequence listings as XML files, either by
electronically transmitting the XML file through Patent Center, where
the file does not exceed 100MB without compression, or on read-only
optical discs. Accordingly, the size fees for excess pages under 35
U.S.C. 41(a)(1)(G) and 37 CFR 1.16(s), 1.52(f), and 1.492(j), from
which XML file submissions via Patent Center or read-only optical discs
are excluded, do not apply to sequence listings filed in applications
having a filing date of on or after July 1, 2022.
Sequence Listings for Applications Filed on or Before June 30, 2022
Sequence listings may still be filed in applications having a
filing date of on or before June 30, 2022, as amendments that meet the
requirements of 37 CFR 1.825. The USPTO prefers that such an amendment
be submitted as an ASCII plain text file via Patent Center or a read-
only optical disc. If so, the size fees for excess pages under 35
U.S.C. 41(a)(1)(G) and 37 CFR 1.16(s) and 1.52(f), from which ASCII
plain text file submissions via Patent Center or read-only optical
discs are excluded, do not apply.
However, the USPTO permits the amendment to be submitted
electronically through Patent Center as a PDF or on paper. When doing
so, the submission may incur a size fee for excess pages under 35
U.S.C. 41(a)(1)(G) and 37 CFR 1.16(s) and 1.52(f).
Specifically, under 37 CFR 1.16(s), if a patent application
inclusive of a sequence listing amendment filed as a PDF or on paper
exceeds 100 pages, the application size fee is $450 ($180 for small
entities, $90 for micro entities) for each additional 50 pages or
fraction thereof. For the purposes of this calculation, the USPTO
assumes that the average length of a sequence listing filed as a PDF or
on paper is 150 pages, which would result in a total size fee of three
times the $450 application size fee under 37 CFR 1.16(s), i.e., $1,350
($540 for small entities, $270 for micro entities) for applications
that are at least 100 pages long prior to the sequence listing
amendment. The USPTO estimates that 67 respondents annually will file
sequence listing amendments as a PDF or on paper that will require the
payment, on average, of $1,350 for the
[[Page 27286]]
undiscounted utility application size fee under 37 CFR 1.16(s). The
USPTO presents this estimate in Table 2 below as 201 responses annually
for the undiscounted utility application size fee under 37 CFR 1.16(s)
of $450 (67 respondents paying the fee three times). Table 2 also
reflects similar adjustments for the small and micro entity discounted
utility application size fee under 37 CFR 1.16(s).
Mega-Sequence Listings
Regardless of application filing date, the USPTO's receipt in
electronic form of a very lengthy sequence listing (mega-sequence
listing) in an application under 35 U.S.C. 111 or 371 is subject to the
fee under 37 CFR 1.21(o). In particular, the first receipt by the USPTO
of a sequence listing in electronic form ranging in size from 300MB to
800MB (without file compression) incurs the fee under 37 CFR
1.21(o)(1). The first receipt by the USPTO of a sequence listing in
electronic form exceeding 800MB (without file compression) incurs the
fee under 37 CFR 1.21(o)(2).
Late Furnishing Fee in PCT Applications
Where a PCT applicant has not provided a sequence listing, and the
USPTO acts as the International Searching Authority (ISA) or
International Preliminary Examining Authority (IPEA), the USPTO may
invite the applicant to furnish a sequence listing, with a late
furnishing fee under 37 CFR 1.445(a)(5) and 1.482(c), under PCT Rule
13ter. See section 1848(I) of the MPEP for more information.
Table 2--Filing Fees
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Estimated Estimated
Fee annual Number of annual number Non-hourly cost
Item No. code Item respondents responses per of fees being Filing fee ($) burden
paying a fee respondent paid
(a) (b) (c) (d) (c) x (d) = (e)
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1......................... 1081 Utility application size fee 67 3 201 $450 $90,450
under 37 CFR 1.16(s)
(undiscounted entity).
1......................... 2081 Utility application size fee 82 3 246 180 44,280
under 37 CFR 1.16(s) (small
entity).
1......................... 3081 Utility application size fee 1 3 3 90 270
under 37 CFR 1.16(s) (micro
entity).
1......................... 1091 Submission of sequence listings 10 1 10 1,140 11,400
of 300MB to 800MB (undiscounted
entity).
1......................... 2091 Submission of sequence listings 1 1 1 456 456
of 300MB to 800MB (small
entity).
1......................... 3091 Submission of sequence listings 1 1 1 228 228
of 300MB to 800MB (micro
entity).
1......................... 1092 Submission of sequence listings 1 1 1 11,290 11,290
of more than 800MB
(undiscounted entity).
1......................... 2092 Submission of sequence listings 1 1 1 4,516 4,516
of more than 800MB (small
entity).
1......................... 3092 Submission of sequence listings 1 1 1 2,258 2,258
of more than 800MB (micro
entity).
1......................... 1627 Late Furnishing Fee for 230 1 230 345 79,350
Providing a Sequence Listing in
Response to an Invitation Under
PCT Rule 13ter (undiscounted
entity).
1......................... 2627 Late Furnishing Fee for 645 1 645 138 89,010
Providing a Sequence Listing in
Response to an Invitation Under
PCT Rule 13ter (small entity).
1......................... 3627 Late Furnishing Fee for 5 1 5 69 345
Providing a Sequence Listing in
Response to an Invitation Under
PCT Rule 13ter (micro entity).
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Totals....................... 1,045 .............. 1,345 .............. 333,853
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Postage Costs
Sequence listings filed as 37 CFR 1.825 amendments in applications
having a filing date of on or before June 30, 2022, may be submitted by
mail through the United States Postal Service. The USPTO estimates that
at most 1% of the 30,000 items will be submitted in the mail resulting
in 300 mailed items. The USPTO estimates that the average postage cost
for a mailed submission, using a Priority Mail legal flat rate
envelope, will be $10.40. Therefore, the USPTO estimates the total
mailing costs for this information collection at $3,120.
IV. Request for Comments
The USPTO is soliciting public comments to:
(a) Evaluate whether the collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
(b) Evaluate the accuracy of the agency's estimate of the burden of
the collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected; and
(d) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
All comments submitted in response to this notice are a matter of
public record. The USPTO will include or summarize each comment in the
request to OMB to approve this information collection. Before including
an address, phone number, email address, or other personally
identifiable information (PII) in a comment, be aware that the entire
comment--including PII--may be made publicly available at any time.
While one may ask in a comment to withhold
[[Page 27287]]
PII from public view, the USPTO cannot guarantee that it will be able
to do so.
Justin Isaac,
Information Collections Officer, Office of the Chief Administrative
Officer, United States Patent and Trademark Office.
[FR Doc. 2025-11798 Filed 6-25-25; 8:45 am]
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