MPEP § 2412 — The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures to Include a Sequence Listing in XML file format
Ninth Edition, Revision 01.2024 · last revised R-01.2024
[Editor Note: This section is applicable to all applications with a filing date, or, for national phase applications, an international filing date, on or after July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]
Patent applications that disclose a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in 37 CFR 1.831(b), must present each sequence and associated sequence data in a standardized electronic eXtensible Markup Language (XML) format, (a “Sequence Listing XML”) as a separate part of the specification. This standardized format is set forth in the World Intellectual Property Organization (WIPO) Standard ST.26, and applies to sequence listings in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications filed 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 all 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, that disclose 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 Intellectual 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 1.6, approved November 25, 2022; 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
Contents
- 2412.01 Overview of the Sequence Rules
- 2412.02 Definition of “Sequence Listing XML”
- 2412.03 Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML”
- 2412.04 Use of Sequence Identifiers to Denote Sequences Disclosed in the Description, Drawings or Claims
- 2412.05 Representation and Symbols for Nucleotide and/or Amino Acid Sequences
- 2412.05(a) Use of Sequentially Numbered Sequence Identifiers in the “Sequence Listing XML”
- 2412.05(b) Representation and Symbols of Nucleotide Sequence Data
- 2412.05(c) Representation and Inclusion of Variants
- 2412.05(d) Representation and Symbols of Amino Acid Sequence Data
- 2412.05(e) Presentation of Special Situations
- 2412.06 The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures
- 2412.07 Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences
Cited authority
- 37 CFR 1.831 Requirements for patent applications filed on or after July 1, 2022, having nucleotide and/or amino acid sequence disclosures
- 37 CFR 1.835 Amendment to add or replace a “Sequence Listing XML” in patent applications filed on or after July 1, 2022
- 37 CFR 1.839 Incorporation by reference
- 37 CFR 1.834 Form and format for nucleotide and/ or amino acid sequence submissions as the ‘‘Sequence Listing XML’’ in patent applications filed on or after July 1, 2022
Cited by
- 1410 Content of Reissue Application
- 1823.02 Filing Nucleotide and/or Amino Acid Sequence Listings in International Applications
- 1848 Sequence Listings
- 215.02(b) Timeliness Requirement – Met By Interim Copy of Foreign Application
- 2412.05(e) Presentation of Special Situations
- 2412.07 Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences
- 2420 The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures under World Intellectual Property Office Standard ST.25 (WIPO ST.25) - the Sequence Rules
- 2421.01 Definition of “Sequence Listing” and Computer Readable Form (CRF)
- 2421.02 Summary of the Requirements of the Sequence Rules
- 2421.03 Notification of a Failure to Comply
- 2422 Nucleotide and/or Amino Acid Sequence Disclosures in Patent Applications Subject to WIPO ST.25
- 2422.01 Nucleotide and/or Amino Acids Disclosures Requiring a “Sequence Listing”
- 2422.02 The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures
- 2422.03 Sequence Listing Submission
- 2422.03(a) “Sequence Listing” Submitted as ASCII Plain Text Files
- 2422.04 The Requirement for a Computer Readable Copy of the “Sequence Listing”
- 2422.06 Requirement for Statement Regarding Information Contained in the “Sequence Listing” and Separate Computer Readable Form
- 2422.07 Requirements for Compliance and Consequences of Non-Compliance
- 2422.08 Presumptions Regarding Compliance
- 2423 Symbols and Format To Be Used for Nucleotide and/or Amino Acid Sequence Data for WIPO ST.25
- 2423.01 Format and Symbols To Be Used in a “Sequence Listing”
- 2423.02 Depiction of Coding Regions
- 2423.03 Presentation and Numbering of Sequences
- 2424 Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25.
- 2424.01 Informational Requirements for the “Sequence Listing”
- 2424.02 “Sequence Listing” Numeric Identifiers
- 2424.03 Additional Miscellaneous Requirements
- 2425 Form and Format for a Nucleotide and/or Amino Acid Sequence Submission as an ASCII Plain Text File under WIPO ST.25
- 2426 Amendments to Add or Replace a “Sequence Listing” and CRF Copy Thereof Subject to WIPO ST. 25
- 2427 Form Paragraphs for Applications Subject to WIPO ST.25
- 2428 Sample Statements under WIPO ST.25
- 2429 Helpful Hints for Sequence Rules Compliance under WIPO ST.25
- 2430 PatentIn Information
- 2431 Sample “Sequence Listing” under WIPO ST.25
- 608.05(c) Submissions of Biological Sequence Listings