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. 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 , whichpresents 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:
   1. a) In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System( https://www.uspto.gov/PatentLegalFramework ), 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 as required by 37 CFR1.823(b)(1) identifying:
      1. i) the name of the ASCII text file;
      2. ii) the date of creation; and
      3. iii) the size of the ASCII text file in bytes;
   2. b) In accordance with 37 CFR1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR1.52(e)(1)(ii) , labeled according to 37 CFR1.52(e)(5) , with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR1.52(e)(8) and 37 CFR1.823(b)(1) in a separate paragraph of the specification identifying:
      1. i) the name of the ASCII text file;
      2. ii) the date of creation; and
      3. iii) the size of the ASCII text file in bytes;
   3. c) In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file(not recommended); or
   4. d) In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
2. 2) When a "Sequence Listing" has been submitted as a PDF file as in 1.c) above ( 37 CFR 1.821(c)(2) ) or on physical sheets of paper as in 1. d) above ( 37 CFR 1.821(c)(3) , 37 CFR1.821(e)(1) ), requires a computer readable form (CRF) of the "Sequence Listing" in accordance with the requirements of 37 CFR 1.824 .
   1. a) If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF,then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the"Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
   2. b) If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc,then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the"Sequence Listing" content of the paper or read-only optical 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 .