The United States Patent and Trademark Office (USPTO) has issued a notice of proposed rulemaking (NPRM) to revise the rules of practice for submitting biological sequence data associated with disclosures of nucleotide and amino acid sequences in patent applications by incorporating by reference the provisions of Standard ST.26 into the USPTO rules. Other conforming changes based on the new standard are also included.
Under the proposed rules, an applicant will be able to submit a single, internationally acceptable, sequence listing in a language-neutral format using specified identifiers. If adopted, the proposed rules would apply to international applications filed under the Patent Cooperation Treaty and in national and regional applications filed in Intellectual Property Offices of World Intellectual Property Organization (WIPO) member states, for filing dates on or after January 1, 2022. In addition to simplifying the process for applicants filing in multiple countries, a requirement to submit a single sequence listing in eXtensible Mark-up Language (XML) format will result in better preservation, accessibility, and sorting of the submitted sequence data for the public.
The full text of the notice is available at the Federal Register, and can also be found on the Patent Related Notices webpage. Comments on the NPRM must be submitted by September, 7, 2021, through the Federal eRulemaking Portal at www.regulations.gov to ensure consideration.