2412.04 Use of Sequence Identifiers to Denote Sequences Disclosed in the Description or Claims [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).]

37 CFR 1.831(c) requires that each nucleotide and/or amino acid sequence set forth in a “Sequence Listing XML” in accordance with 37 CFR § 1.831(a) must be referenced by a sequence identifier, preceded by the notation “SEQ ID NO:” or the like, when in the text of the description or claims. Additionally, where a sequence is presented in a drawing, reference must be made using the sequence identifier from the “Sequence Listing XML” associated with the particular sequence either in the drawing or in the Brief Description of the Drawings. The sequence identifiers in the disclosure must correspond to sequence identifiers set forth in the “Sequence Listing XML” as defined in 37 CFR 1.832(a).

37 CFR 1.831(c) requires that where the description or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing XML,” a reference to the sequence using the sequence identifier of that sequence is required at all occurrences, even if the text of the description or claims include the sequence by enumeration of its residues. This requirement is also intended to permit references elsewhere in the application (e.g., specification, claims, or drawings) to sequences set forth in the “Sequence Listing XML” by the use of assigned sequence identifiers without repeating the sequence. Sequence identifiers can also be used to discuss and/or claim parts or fragments of a properly presented sequence. For example, language such as “residues 14 to 243 of SEQ ID NO:23” is permissible and the fragment need not be separately presented in the “Sequence Listing XML.” Where a nucleotide and/or amino acid sequence that meets the length thresholds of 37 CFR 1.831(b) is disclosed by enumeration of its residues anywhere in an application, it must be presented in a “Sequence Listing XML” in a manner that complies with the requirements 37 CFR §§ 1.831 – 1.834.

The rules do not alter, in any way, the requirements of 35 U.S.C. 112. The implementation of the rules has had no effect on disclosure and/or claiming requirements. The rules, in general, or the use of sequence identifiers throughout the specification and claims, specifically, should not raise any issues under 35 U.S.C. 112(a) or 35 U.S.C. 112(b). The use of sequence identifiers (“SEQ ID NO: or the like”) only provides a shorthand way for applicants to discuss and claim their inventions. These identifiers do not in any way restrict the manner in which an invention can be claimed.