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).

─Sequences of <10 nucleotides and <4 amino acids are prohibited in a “Sequence Listing XML.”

─ 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.

─ 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.

─ 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.

─ 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.

[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).]

─ 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.

─ 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.

─ 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.