¶ 24.01    Heading for Sequence Requirements

REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES

Items 1) and 2) provide general guidance related to requirements for sequence disclosures.

  • 1) 37 CFR 1.821(c)  requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a)  must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821  - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
    • a) via EFS-Web (see Section I.1 of the Legal Framework for EFS-Web (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web ), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification identifying:
      • i) the name of the ASCII text file;
      • ii) the date of creation; and
      • iii) the size of the ASCII text file in bytes;
    • b) on compact disc(s) in duplicate according to 37 CFR 1.52(e)(1)(ii)  and (4), labeled according to 37 CFR 1.52(e)(6), together with a statement that the duplicate compact discs are identical and an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(5)  in a separate paragraph of the specification identifying:
      • i) the name of the ASCII text file;
      • ii) the date of creation; and
      • iii) the size of the ASCII text file in bytes;
    • c) via EFS-Web as a PDF (not recommended); or
    • d) on paper.
  • 2) 37 CFR 1.821(e)  requires that a copy of the "Sequence Listing" must also be submitted in computer readable form (CRF) in accordance with the requirements of 37 CFR 1.824.
    • a) If a "Sequence Listing" ASCII text file submitted via EFS-Web on the application filing date complies with the requirements of 37 CFR 1.824(a)(2)  - (6)  and (b), and applicant has not filed a "Sequence Listing" as a PDF, the text file will serve as both the "Sequence Listing" required by 37 CFR 1.821(c)  and the CRF required by 37 CFR 1.821(e), and the statement of identity under the "Legal Framework" is not required.
    • b) If the "Sequence Listing" required by 37 CFR 1.821(c)  is filed via EFS-Web as a PDF, then the "Legal Framework" requires submission of a statement that the "Sequence Listing" content of the PDF copy and the ASCII text file copy submitted via EFS-Web are identical.
    • c) If the "Sequence Listing" required by 37 CFR 1.821(c)  is filed on paper or compact disc, then 37 CFR 1.821(f)  requires submission of a statement that the "Sequence Listing" content of the paper or compact disc copy and the CRF are identical.

Specific deficiencies and the required response to this Office Action are as follows:

Examiner Note:

1. This form paragraph should only be used for sequence listing non-compliance where a compliant sequence listing is not required for examination of the application.

2. This form paragraph must be followed by any of form paragraphs 24.02 - 24.16.