2417 Helpful Hints for Sequence Rules Compliance under WIPO Standard ST.26 [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).]
The Office has the following non-exhaustive tips regarding sequence rules in compliance with WIPO Standard ST.26, as incorporated by reference in 37 CFR 1.839 and implemented by 37 CFR 1.831-1.835.
—Compliance is not required for establishing a filing date.
─ A sequence listing submitted with a new application in compliance with 37 CFR 1.831-1.834 is considered part of the specification and thus contributes to disclosure of the invention for the purpose of 35 U.S.C. 112.
—Compliance is not per se a new matter issue. See MPEP § 2414.02 for adding initial sequence listings under 37 CFR 1.835(a)(2)-(4) and MPEP § 2414.03 for amendments adding to, deleting from, or replacing sequence information under 37 CFR 1.835(b)(2)-(4).
─ Amino acid sequences required to be included in a “Sequence Listing XML” include those comprising D-amino acids, modified amino acids and linear portions of branched sequences.
─ Nucleotide sequences required to be included in a “Sequence Listing XML” include those comprising modified nucleotides, nucleotide analogs and linear portions of branched sequences.
─Sequences of <10 nucleotides and <4 amino acids are prohibited in a “Sequence Listing XML.”
─ Uracil is represented by “t” in RNA and DNA, and is considered to be a modified nucleotide that requires additional annotation when present in a DNA sequence.
─ Thymine is represented by “t” in RNA and DNA, and is considered to be a modified nucleotide that requires additional annotation when present in an RNA sequence.
─ Amino acid representations are each one letter.
─ Each sequence disclosed in the “Sequence Listing XML” must have its sequence identification number (identifier) associated with “SEQ ID NO:” or the like designator next to each occurrence within the disclosure, i.e. SEQ ID NO: X.
─ Variations of “SEQ ID NO:” format (e.g. “Seq Id No.”) are permitted. Parentheses are NOT required; the sequence identifier, however, must be clearly separated from the sequence shown in the specification.
─ Sequences in figures can have “SEQ ID NO:” or the like with the sequence identifier in the figure itself OR in the Brief Description of the Drawings, but it does not have to be in both places.
─ Each “Sequence Listing XML” filed in a 111(a) application must be accompanied by an incorporation by reference statement that includes the name of the file, the date of creation, and the size of the file in bytes.
─ A “Sequence Listing XML” filed along with a new application need not be accompanied by any statement about new matter.
─ An added “Sequence Listing XML” filed after the filing date of the application must be accompanied by a statement: • indicating that no new matter has been introduced; AND • identifying the support for each new sequence and sequence-associated data within the application as filed.
─ An amended “Sequence Listing XML,” including one submitted to address a defective sequence listing (validated as CRFD), must be accompanied by a statement: • indicating that no new matter has been introduced; • identifying the locations of additions, deletions or replacements of sequence information relative to the replaced listing; AND • identifying the support for the additions, deletions or replacements of sequence information within the application as filed.
─ The international filing date (PCT filing date) is controlling for submission of a sequence listing in compliance with WIPO Standard ST.26 in 35 U.S.C. 371 (national stage) applications.
─ A sequence listing as an XML file in compliance with WIPO Standard ST.26 that is part of the description of an international (PCT) application and transmitted by the International Bureau of WIPO to the USPTO upon entry into the national phase does not require amendment of the specification of the application to add a statement about incorporation by reference, and no statement about new matter is needed.
─ A sequence listing as an XML file in compliance with WIPO Standard ST.26 that is part of the description of an international (PCT) application and transmitted by the International Bureau of WIPO to the USPTO upon entry into the national phase does not need to be amended to update bibliographic data, such as the 371 application number.
─ In cases where no sequence is present in a “Sequence Listing XML” for a sequence identification number, i.e. an intentionally skipped sequence, “000” is entered as the sequence.
─ Sequences that are prohibited from inclusion in a “Sequence Listing XML” may be presented within the description, but should not be associated with a sequence identification number.
