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.
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