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Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules
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The USPTO recommends requiring compliance with Standard ST.26 for an application filed on or after January 1, 2022, because it will reduce the complexity and cost of long-term maintenance of IT systems for accepting sequence listings in multiple formats, provide a clear implementation date, and will facilitate transition to the format requirements of database providers. In addition, a requirement to submit a single sequence listing in XML
format will result in better preservation, accessibility, and sorting of the submitted sequence data for the public.
As noted herein, WIPO has created a tool to assist applicants with translation of existing sequences to the new standard.
e. WIPO Authoring and Validation Tool WIPO Sequence To comply with rules that are based on Standard ST.26, patent applicants will be able to use WIPO Sequence, a freely-available desktop application developed by WIPO and adopted by WIPO member states, to generate a Standard ST.26 compliant sequence listing. WIPO Sequence has two functions: An authoring function and a validation function. Patent applicants will be able to author and validate their sequence listing using WIPO Sequence to comply with the requirements of Standard ST.26. Such a sequence listing will be accepted by all IPOs of WIPO
member states. Thus, the burden of generating a sequence listing which is acceptable across all WIPO member states will be significantly decreased for patent applicants under Standard ST.26.
This tool will be downloadable, free of charge, from the WIPO website.
Currently, a beta version of WIPO
Sequence is accessible at https
www.wipo.int/standards/en/sequence/
index.html. This beta version will allow the public to familiarize themselves with the tool and its dual functionalities.
WIPO Sequence will allow a user to create and save patent application data and biological sequence data in a project, validate the project to ensure all required information is present, and generate a sequence listing in Standard ST.26 XML format. Information can be entered into a project manually, or data can be imported from a source file in one of a number of file types. WIPO
Sequence can import data from other Standard ST.26 projects, Standard ST.26
XML sequence listings, Standard ST.25
sequence listing text files, raw files, multi-sequence format files, and FASTA
FAST-All-a DNA and protein sequence alignment software package files.
Feature keys, qualifiers, and organism
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names are available to select from dropdown lists, simplifying the creation of sequence listings. Applicant and inventor names, as well as custom organism names, can be stored within WIPO Sequence for ease of access. To facilitate review of data entered into a project, WIPO Sequence can generate a human-readable version of the sequence listing in addition to the XML
sequence listing.
WIPO Sequence includes an integrated validation function that will alert users to most errors in a project or sequence listing data. The validation function generates a report that clearly lists every detected error, the location of the error, and the detected value of the error, along with a link to the sequence in question, thereby ensuring users can correct errors before generating a final sequence listing. While the validation function will alert a user to most errors that are contained in a project or sequence listing, there are a small number of errors that can be detected only by human review for example, an inappropriate organism name. In those cases, the integrated validation function will list a warning in the validation report, reminding users of the applicable/relevant rule and urging them to check their input values before generating a final sequence listing.
A sequence listing in Standard ST.25
format cannot automatically be converted into Standard ST.26 format because certain data elements required for a Standard ST.26 compliant sequence listing are not present in Standard ST.25. Therefore, conversion of a sequence listing in Standard ST.25
format to Standard ST.26 format necessarily requires additional input from the applicant. WIPO Sequence supplemented by significant guidance from WIPO and USPTO in Annex VI
and Annex VII of Standard ST.26 will help applicants accomplish this task.
Users can import a Standard ST.25
sequence listing into a project, and WIPO Sequence automatically performs many of the necessary conversions. An Import Report is generated that alerts the user to all data conversions, and lists all sequence entries that require additional input. In response to concerns raised in comment to the USPTOs requests for comments in 2012
and 2016, the USPTO, in conjunction with WIPO, developed Annex VII to provide detailed guidance to help applicants avoid added or deleted subject matter when converting a sequence listing from Standard ST.25
format into Standard ST.26 format.
In order to ensure that IPOs can validate and accept sequence listing projects from applicants generated with
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WIPO Sequence, WIPO is developing a Standard ST.26 sequence listing validation tool, WIPO Sequence Validator. WIPO Sequence Validator will be for use by IPOs. WIPO Sequence Validator will be synchronized with the validation function in the WIPO
Sequence tool. The USPTO is integrating WIPO Sequence Validator into its internal IT systems. The WIPO
Sequence Validator will apply the same validation rules as WIPO Sequence.
Therefore, filers will have a greater level of confidence that a sequence listing authored and validated by WIPO
Sequence will comply with the USPTO
rules for Sequence Listing XMLs 1.831 through 1.835 and accepted since the WIPO Sequence Validator that USPTO will use is based on Standard ST.26, which is incorporated by reference into the USPTO proposed rules of practice.
e. Applicability In accordance with these proposed rules of practice, an application that has a filing date on or after January 1, 2022, would be required to contain a sequence listing in accordance with proposed 1.831 through 1.835, which incorporate by reference Standard ST.26. This includes applications that claim priority to applications with filing dates before January 1, 2022. Such applications include but are not limited to applications having one or more benefit or priority claims under 35
U.S.C. 119e claiming the benefit of a provisional, section 120 claiming the benefit as a continuation and/or continuation-in-part, section 121
claiming the benefit as a divisional, section 365 claiming the benefit as a continuation or continuation in part to a PCT application, or section 119ad claiming the benefit 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, the applicant would be required to convert that sequence listing to Standard ST.26
format for inclusion in the new application filed on or after January 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 filed under 35 U.S.C. 371, compliance with Standard ST.26 is 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. The proposed rules would also be applicable to applications for reissue without
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