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The United States Patent and Trademark Office (USPTO) is adding to the rules of practice for submitting biotechnology data associated with disclosures of amino acids and nucleotides in patent applications to comply with the new international standard adopted by the World Intellectual Property Organization.  Patent applications that contain disclosures of nucleotides and/or amino acids must present the associated biological sequence data in a standardized electronic format (a Sequence Listing) as a separate part of the disclosure. Under the new rules, a single internationally acceptable Sequence Listing will be presented in a language neutral format using specified International Nucleotide Sequence Database Collaboration (INSDC) identifiers rather than the numeric identifiers previously used. These new rules will ensure that a Sequence Listing submitted in an original application filed on or after January 1, 2022, complies with the international standard. Unlike the previous standard, no separate paper Sequence Listing or portable document file (PDF) submission of a Sequence Listing will be permitted. Any Sequence Listing that exceeds the USPTO patent electronic filing system limits may be submitted on physical media.

Overall Description of Deadline: The standardized electronic format for applications filed in the United States and internationally on or after January 1, 2022, must conform to the WIPO standard for sequence listings, Standard ST.26, which requires sequence listings to be submitted in XML format.