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.