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DOC/PTO RIN: 0651-AD53 Publication ID: Fall 2021 
Title: Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) in Patent Applications to Implement WIPO Standard ST.26; Incorporation by Reference 

The United States Patent and Trademark Office (USPTO) is adding to the rules of practice for submitting biotechnology data associated with disclosures of amino acids and nucleotides in patent applications to comply with the new international standard adopted by the World Intellectual Property Organization.  Patent applications that contain disclosures of nucleotides and/or amino acids must present the associated biological sequence data in a standardized electronic format (a Sequence Listing) as a separate part of the disclosure. Under the new rules, a single internationally acceptable Sequence Listing will be presented in a language neutral format using specified International Nucleotide Sequence Database Collaboration (INSDC) identifiers rather than the numeric identifiers previously used. These new rules will ensure that a Sequence Listing submitted in an original application filed on or after January 1, 2022, complies with the international standard. Unlike the previous standard, no separate paper Sequence Listing or portable document file (PDF) submission of a Sequence Listing will be permitted. Any Sequence Listing that exceeds the USPTO patent electronic filing system limits may be submitted on physical media.

Agency: Department of Commerce(DOC)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 37 CFR 1   
Legal Authority: 35 U.S.C. 2(b)(2)   
Legal Deadline:
Action Source Description Date
Final  Statutory    01/01/2022 

Overall Description of Deadline: The standardized electronic format for applications filed in the United States and internationally on or after January 1, 2022, must conform to the WIPO standard for sequence listings, Standard ST.26, which requires sequence listings to be submitted in XML format.

Action Date FR Cite
NPRM  07/06/2021  86 FR 35429   
NPRM Comment Period End  09/07/2021 
Final Action  11/00/2021 
Final Action Effective  12/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Raul Tamayo
Senior Legal Advisor
Department of Commerce
Patent and Trademark Office
P. O. Box 1450,
Alexandria, VA 22313-1450
Phone:571 272-7728
Fax:571 273-7728