USPTO Issues Final Rule Amending Rules of Practice For Biological Sequence ListingsMay 25, 2022

On May 20th, the United States Patent and Trademark Office published a Final Rule amending the rules of practice associated with disclosures of nucleotide and amino acid sequences in patent applications. The new standards, applicable to all patent applications filed on or after July 1, 2022, will bring the USPTO rules of practice into conformity with World Intellectual Property Standard ST.26 (“WIPO Standard ST.26”). WIPO Standard ST.26 permits applicants to submit a single, internationally acceptable sequence listing (“Sequence Listing XML”) in a language-neutral format. This is expected to streamline the procedural requirements for sequence listings between the USPTO and patent offices of WIPO member states, ultimately reducing the burden on both applicants and patent offices.

Highlights of the changes include:

• Creation of new rules (37 C.F.R. §§ 1.831-39) that incorporate by reference WIPO Standard ST.26
• Use of new International Nucleotide Sequence Database Collaboration (“INSDC”) identifiers to replace the numeric identifiers used in the previous Standard ST.25
• Elimination of the ability to file a paper or PDF copy of nucleotide or amino acid sequences; under the new standard all sequence listings must be filed in an “XML” file format
• Elimination of the option to include sequences with fewer than 4 amino acids or 10 nucleotides with a Sequence Listing XML
• Implementation of “WIPO Sequence”, a free desktop application used to generate and validate sequence listings

Applicability

The new standards will apply to all patent applications containing biological sequence listings filed on or after July 1, 2022. This includes applications claiming benefit/priority to applications with filing dates before July 1, 2022. In cases where the prior application to which benefit or priority is claimed contains a sequence listing in the old Standard ST.25 format, the applicant will be required to convert the sequence listing to WIPO Standard ST.26 “Sequence Listing XML” format for inclusion in the new application.

For national stage applications, Standard ST.26 will apply to applications based on the international filing date of the corresponding international application rather than the date of submission of the national stage application to the USPTO.

Compliance with Standard ST.26 is also applicable to any reissue application filed on or after July 1, 2022, regardless of the filing date of the originally granted patent for which reissue is sought.

WIPO Sequence

Applicants are able to generate a fully compliant sequence listing using “WIPO Sequence” a free desktop program developed by WIPO and adopted by all WIPO member states. WIPO Sequence also includes a validation function that generates a report listing every detected error, the location of the error, the detected value of the error, along with a link to the sequence in question. This allows an applicant to correct errors before generating a final sequence listing.

Sequence listings in Standard ST.25 format cannot be automatically converted into WIPO Standard ST.26. However, WIPO Sequence allows applicants to import Standard ST.25 sequence listings and will automatically perform many of the necessary conversions. An Import Report will then be generated directing the applicant to entries that need additional input.

The current version of WIPO Sequence is already available for download here.

The USPTO expects the new sequence listing rules will simplify the process for applicants filing in multiple countries. Furthermore, it is expected that the new XML file format will result in better preservation, accessibility, and searching of submitted sequence data for both patent offices and the public. The full text of the final rule can be found in the Federal Register here.

Melissa Mitchell is an intellectual property attorney in the MVS Biotechnology and Chemical Practice Group. To learn more, visit our MVS website, or contact Melissa directly via email.