2421.01 Definition of “Sequence Listing” and Computer Readable Form (CRF) [R-07.2022]

[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 applications filed on or after July 1, 2022.]

The sequence rules (37 CFR 1.821 -1.825) require the use of standard symbols and a standard format for submitting sequence data in most patent applications that disclose nucleic acid or amino acid sequences. For purposes of the sequence rules and the discussion in MPEP Chapter 2400, the phrase “disclose(d) (or disclosure(s) of) nucleic acid or amino acid sequences” is intended to refer to those nucleic acid or amino acid sequences that are described in the patent application by enumeration of their residues and that meet the length thresholds of 37 CFR 1.821(a).

37 CFR 1.821(c) requires that applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) contain, as a separate part, a disclosure of the nucleotide and/or amino acid sequences, and associated information, using the format and symbols that are set forth in 37 CFR 1.822 and 37 CFR 1.823. This separate part of the disclosure is referred to as the “Sequence Listing”. See MPEP § 2422.03 for additional information.

37 CFR 1.821(e) requires a separate computer readable form (CRF) of the “Sequence Listing” under certain circumstances. The CRF is an ASCII plain text file of the sequence information relating to the disclosure of the nucleotide and/or amino acid sequences using the symbols, format, content and file requirements of 37 CFR 1.822. See 37 CFR 1.824. The CRF may be submitted on read-only optical disc or may be submitted as an ASCII plain text file via the Office patent electronic filing system, pursuant to 37 CFR 1.821. The requirements regarding the CRF are discussed in detail in MPEP § 2422.04.

2421.02 Summary of the Requirements of the Sequence Rules [R-07.2022]

[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.]

The sequence rules define a set of symbols and procedures that are both mandatory and the only way that an applicant is permitted to describe information in the “Sequence Listing” about a nucleotide or amino acid sequence that falls within the definitions used in the rules. Thus, 37 CFR 1.821 defines a “sequence” and a “Sequence Listing” for the purpose of the rules, the requirements for specific symbols, and formats for the “Sequence Listing”, the requirement for a computer readable form (CRF) of the “Sequence Listing” and the deadlines for complying with the requirements. 37 CFR 1.822 to 37 CFR 1.824 set forth detailed descriptions of the requirements that are mandatory for the presentation of sequence data, and 37 CFR 1.825 sets forth procedures that are available to an applicant in the event that amendments to add or replace a “Sequence Listing”, including any necessary CRF of the “Sequence Listing” become necessary.

The sequence rules embrace all unbranched nucleotide sequences with ten or more nucleotide bases and all unbranched, non-D amino acid sequences with four or more amino acids, provided that there are at least 10 “specifically defined” nucleotides or 4 “specifically defined” nucleotides or amino acids. The rules apply to all sequences in a given application, whether claimed or not. All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database.

2421.03 Notification of a Failure to Comply [R-07.2022]

[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.]

With respect to the Office’s determination of compliance with the sequence rules and the opportunities afforded applicants to satisfy the requirements of the rules, applicants will be notified of easily detectable deficiencies early in the application process. Applicants whose computer readable forms (which include a “Sequence Listing” submitted as an ASCII plain text file under 37 CFR 1.821(c)(1) and separate CRFs submitted under 37 CFR 1.821(e)) are not readable, or are missing mandatory elements, will be notified shortly after receipt of the application by the Office. See 37 CFR 1.52(e)(9), 1.821(g), and 1.821(h).

The Office of Patent Application Processing (OPAP) will mail a notice to applicant listing the requirements that have not been met and setting a two month time period within which to comply with the sequence rules, 37 CFR 1.821 - 1.825. Failure to comply with these requirements will result in abandonment of the application under 37 CFR 1.821(g). Extensions of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 CFR 1.136. Applications will not be subject to examination on the merits until a compliant “Sequence Listing” has been submitted, as jurisdiction remains with Office of Patent Application Processing until compliance with the Notice to Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures.

Patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013, may be subject to reductions in patent terms adjustment pursuant to 37 CFR 1.704(c)(13) if they are not in condition for examination within eight months from the filing date or date of commencement, respectively. “In condition for examination” includes compliance with 37 CFR 1.821 -1.825 (see 37 CFR 1.704(f)). Deficiencies of a more sophisticated nature will likely only be detected by the examiner to whom the application is assigned. Applicant will be notified of any errors or inconsistencies detected by the examiner in the next Office action.

A notification of a failure to comply with the sequence rules will be accompanied by a report of errors associated with any submitted computer readable form (the 37 CFR 1.821(c)(1), the 1.821(e)(1) or 1.821(e)(2) submission). Any inquiries regarding a specific computer readable form that has been processed by the Office should be directed to the Sequence Systems Service Center (S3C) of the Scientific and Technical Information Center. The S3C manages the Sequence Help Desk, and responds to all questions or concerns, from both inside and outside the USPTO, related to computer readable format sequence listing submissions. The S3C may be contacted at 571-272-2510 or via email at STIC-SSSCHelpdesk@uspto.gov.

2421.04 [Reserved]