2422.07 Requirements for Compliance and Consequences of Non-Compliance [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.]
37 CFR 1.821(g) requires compliance with the requirements of 37 CFR 1.821(b) through (e), as discussed above, if they are not satisfied at the time of filing under 35 U.S.C. 111(a) or at the time of entering the national stage of an international application under 35 U.S.C. 371, within the period of time set in a notice requiring compliance. When applicant files an amendment to comply with the requirements of 37 CFR 1.821(g) and that amendment adds or replaces a “Sequence Listing” and CRF copy thereof, the amendment must be submitted in accordance with the requirements of 37 CFR 1.825. Failure to provide a proper reply in compliance with 37 CFR 1.825 will result in the abandonment of the application. See MPEP § 2426. Extensions of time in which to reply to a requirement under this paragraph are available pursuant to 37 CFR 1.136. Note, however, that 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 through 1.825 (see 37 CFR 1.704(f)).
Provisional applications filed under 35 U.S.C. 111(b) need not comply with 37 CFR 1.821 through 1.825, however, applicants are encouraged to file a “Sequence Listing” as defined in 37 CFR 1.821(c) for ease of identification of the sequence information contained in the provisional application.
If any of the requirements of 37 CFR 1.821(e)(3) are not satisfied at the time of filing an international application under the Patent Cooperation Treaty (PCT), and the application is to be searched by the United States International Searching Authority or examined by the United States International Preliminary Examining Authority, the applicant may be sent a notice necessitating compliance with the requirements within a prescribed time period. Where a sequence listing under PCT Rule 13ter is provided in reply to a under 37 CFR 1.821(h), the sequence listing must be accompanied by a statement that the information recorded in the ASCII plain text file under 37 CFR 1.821(e)(3)(i) is identical to the sequence listing contained in the international application as filed, or does not go beyond the disclosure in the international application as filed, as applicable. Such a statement may be made by a registered practitioner, the applicant, an inventor, or the person who actually compares the sequence data on behalf of the aforementioned. Also, the ASCII plain text file under 37 CFR 1.821(e)(3)(i) must be accompanied by the late furnishing fee, as set forth in 37 CFR 1.445(a)(5). International applications that fail to comply with any of the requirements of 37 CFR 1.821(e)(3) will be searched and/or examined only to the extent possible without the benefit of the information in computer readable form. See PCT Administrative Instructions Section 513(c).
The requirement to submit a statement that a submission in reply to the requirement under 37 CFR 1.821(h) does not go beyond the disclosure in the application as filed or that the information recorded in the ASCII plain text file under 37 CFR 1.821(e)(3)(i) is identical to the sequence listing contained in the international application as filed is not the first instance in which the applicant has been required to ensure that there is not new matter upon amendment. The requirement is analogous to that found in 37 CFR 1.125 regarding substitute specifications. When a substitute specification is required because the number or nature of amendments would make it difficult to examine the application, the applicant must include a statement that the substitute specification includes no new matter. The necessity of requiring sequence information as an ASCII plain text file is similar to the necessity of requiring a substitute specification and, likewise, the burden is on the applicant to ensure that no new matter is added. Applicants have a duty to comply with the statutory prohibition (35 U.S.C. 132 and 35 U.S.C. 251) against the introduction of new matter.
The correction of errors in sequencing or any other errors that are made in describing an invention are subject to the statutory prohibition (35 U.S.C. 132 and 35 U.S.C. 251) against the introduction of new matter.