2412 The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures to Include a Sequence Listing in XML file format [R-07.2022]
[Editor Note: This section is applicable to all applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]
Patent applications that contain disclosures of nucleotide and/or amino acid sequences, as defined in 37 CFR 1.831(b) must present the associated biological sequence data in a standardized electronic eXtensible Markup Language (XML) format, or a “Sequence Listing XML” as a separate part of the specification. In particular, World Intellectual Property Organization (WIPO) Standard ST.26 permits applicants to submit a single, internationally acceptable sequence listing in a language-neutral format using specified International Nucleotide Sequence Database Collaboration (INSDC) identifiers in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications in the intellectual property offices (IPOs) of WIPO member states. As a result, a single sequence listing in compliance with WIPO Standard ST.26 can be prepared for use in the IPOs of WIPO member states. The regulatory provisions found at 37 CFR 1.831 – 1.835 implement WIPO Standard ST.26 in the USPTO and set forth requirements for presenting sequence data in patent applications filed on or after July 1, 2022, containing disclosures of nucleotide sequences and/or amino acid sequences.
WIPO Standard ST.26 is incorporated by reference into the USPTO regulations by including new regulatory text at 37 CFR 1.839:
37 CFR 1.839 Incorporation by reference.
- (a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the USPTO and at the National Archives and Records Administration (NARA). Contact the USPTO’s Office of Patent Legal Administration at 571–272–7701. For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the source(s) in paragraph (b) of this section.
- (b) World Intellectual Property Organization (WIPO), 34 chemin des Colombettes, 1211 Geneva 20 Switzerland, www.wipo.int.
- (1) WIPO Standard ST.26. WIPO Handbook on Industrial Property Information and Documentation, Standard ST.26: Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) including Annexes I–VII, version 1.5, approved November 5, 2021; IBR approved for §§ 1.831 through 1.834.
- (2) [Reserved]
For ease of access, WIPO Standard ST.26 can be found at: www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf
A link to WIPO Standard ST.26 is also found on the USPTO’s Sequence Listing Resource Center:
www.uspto.gov /patents/apply/sequence-listing-resource-center / learning-and-resources#standard26