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 submission 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 (MPEP) (9th ed., Rev. 01.2024, November 2024). This
information collection covers the submission of the 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 for applications having a filing date
of on or after July 1, 2022, must be submitted in XML format in
accordance with 37 CFR 1.831-1.835. The submission of a sequence
listing in XML format must be made either electronically via the
USPTO patent electronic filing system (currently Patent Center) 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)(2). 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. Sequence listings
submitted as amendments in accordance with 37 CFR 1.825 must be
submitted as: • An ASCII plain text file via Patent Center or on a
read-only optical disc; • A PDF file via Patent Center; or •
Physical sheets of paper. When an amendment that meets the
requirements of 37 CFR 1.825 is submitted as a PDF or on physical
sheets of paper in an application having a filing date of on or
before June 30, 2022, the applicant may also need to submit 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). Applicants may submit the CRF copy via Patent Center or
on a read-only optical disc as provided in 37 CFR 1.824(b). When a
new or substitute CRF copy is necessary, applicants must submit a
statement indicating that the CRF copy of the sequence listing is
identical to the PDF or paper copy. This information collection
also accounts for these CRF copy and statement
requirements.
US Code:
35 USC
22 Name of Law: Leahy Smith America Invents Act
Change in Responses and Hourly
Burden due to Adjustment in Agency Estimate The total number of
responses has increased by 1,450 due to estimated fluctuations in
the number of submissions in this information collection. This
increase in the number of respondents and responses results in an
increase of 8,700 hours in the annual time burden estimates. Change
in Annual Non-hour Costs due to Adjustment in Agency Estimate For
this renewal, the USPTO estimates that the total annual non-hour
costs will decrease by $924,514 from the previous approval. This
decrease is largely due to the fact that sequence listings for
applications filed on or after July 1, 2022, must be submitted 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.
$714,120
No
Yes
Yes
No
No
No
No
Raul Tamayo 571 272-7728
raul.tamayo@uspto.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
0651-0024 Supporting Statement 2025 Final.docx
Patent Cooperation Treaty.pdf
Sequence Listing in Application