37 CFR 1.823 sets forth the informational requirements for the content of a “Sequence Listing” part of the specification that must be submitted in accordance with 37 CFR 1.821(c) as part of the application. See MPEP § 2422.03 for a discussion of 37 CFR 1.821(c).

37 CFR 1.823(a) sets forth the content requirements for a “Sequence Listing”. Such requirements include, but are not limited to, sequence identifiers, the order and presentation of items of information, mandatory and optional information, the format as to line spacing, and the use of numeric identifiers.

37 CFR 1.823(b)(2) specifically exempts international applications during the international stage from the incorporation by reference requirement in 37 CFR 1.823(b)(1).

37 CFR 1.823(b)(3) sets forth the format and content for a “Sequence Listing” that is submitted either as a PDF image file via the USPTO patent electronic filing system or on physical sheets of paper, in accordance with 37 CFR 1.823(b)(1)(i) – (vi).

[Editor Note: This section is not applicable to 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). See MPEP §§ 2412 – 2419 for guidance on WIPO ST.26 requirements for applications filed on or after July 1, 2022.]

37 CFR 1.823(b)(1) sets forth a requirement for applications, other than an international application in the international stage, to contain, in the specification of the patent application, an express incorporation by reference of the material submitted as an ASCII plain text file via the USPTO patent electronic filing system or on a read-only optical disc(s) identifying the name of the file, the date of creation, and the size of the file in bytes.