2415.01 Determining when a Sequence Listing in XML format must be submitted [R-07.2022]

[Editor Note: This section is applicable to all 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).]

An application that has a filing date on or after July 1, 2022, will be required to provide a “Sequence Listing XML” in accordance with 37 CFR 1.831 through 1.835 for disclosures of any nucleotide and/or amino acid sequences that meet the definitions of 37 CFR 1.831(a) and (b). This includes applications having an international filing date on or after July 1, 2022, that claim benefit or priority to applications with filing dates before July 1, 2022. Such applications include, but are not limited to, applications having one or more benefit or priority claims under 35 U.S.C. 119(e) (claiming the benefit of a provisional), 35 U.S.C. 120 (claiming the benefit as a continuation and/or continuation-in-part), 37 CFR 1.121 (claiming the benefit as a divisional), 35 U.S.C. 365(c) (claiming the benefit as a continuing application to a PCT application), or 35 U.S.C. 119(a)–(d) or 35 U.S.C. 365(a) (claiming the priority to a foreign filed application or a prior filed PCT). If a prior application to which benefit or priority is claimed contains a “Sequence Listing” in Standard ST.25 format (in compliance with 37 CFR 1.821 through 1.825), the applicant will be required to transform that “Sequence Listing” to WIPO Standard ST.26 format (a “Sequence Listing XML” in compliance with 37 CFR 1.831 through 1.835) for inclusion in the new application filed on or after July 1, 2022.

As provided in 35 U.S.C. 363, the filing date of an international stage application is also the filing date for the national stage application filed under 35 U.S.C. 371. Accordingly, for applications submitted under 35 U.S.C. 371, WIPO Standard ST.26 will apply to such applications based on the international filing date of the corresponding international application, rather than the date of submission of the national stage application in the USPTO.

Compliance with 37 CFR 1.831 through 1.835 (rules based on WIPO Standard ST.26) is also applicable to any reissue application filed on or after July 1, 2022, where the disclosure or claims contain nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(a) or (b). The filing date of the originally granted patent for which reissue is sought is not relevant in determining the applicability date of 37 CFR 1.831–1.835.

Relying on the actual filing date of an application to determine whether sequence information must conform to 37 CFR 1.821 through 1.825 (rules based on WIPO Standard ST.25) or 37 CFR 1.831 through 1.835 (rules based on WIPO Standard ST.26) simplifies the application of the sequence rules, both for the USPTO and the applicant. Though 37 CFR 1.821 through 1.825 remain applicable for applications with a filing date before July 1, 2022, those provisions will not be applicable to applications filed on or after July 1, 2022.