[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). Formatting representations of XML (eXtensible Markup Language) elements in this section appear different than shown in Standard ST.26, which may be accessed at: www.wipo.int /export/sites/www/ standards/en/pdf/03-26-01.pdf.]

37 C.F.R. 1.831 Requirements for patent applications filed on or after July 1, 2022, having nucleotide and/or amino acid sequence disclosures.

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2. (c) Where the description or claims of a patent application discuss a sequence that is set forth in the "Sequence Listing XML" in accordance with paragraph (a) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:" or the like in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application. Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier (§ 1.832(a) ), either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers (§ 1.832(a) ) in the Brief Description is clear.

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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 as defined in 37 CFR 1.832(a) (see MPEP § 2412.05(a)), preceded by the notation "SEQ ID NO:" or the like, when the sequence appears in the description or claims. Additionally, where a sequence set forth in a "Sequence Listing XML" is presented in a drawing, reference must be made using the sequence identifier preceded by the notation "SEQ ID NO:" or the like, 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) is also intended to permit references 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 enumerating 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."

37 CFR 1.831(c) does not alter, in any way, the requirements of 35 U.S.C. 112. The implementation of this rule has had no effect on disclosure and/or claiming requirements. 37 CFR 1.831 - 1.835, 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) because the of sequence identifiers (preceded by "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.