USPTO Transitions to New Requirements for Nucleotide and Amino Acid Sequence Listings
Patent applications that include a disclosure of a nucleotide and/or amino acid sequence must be accompanied by a sequence listing presenting the biological sequence data. On July 1, 2022, the United States Patent and Trademark Office transitioned to a new standard for the presentation of nucleotide and amino acid sequence listings, based on the new WIPO Standard 26.
When a patent application includes a disclosure of a nucleotide and/or amino acid sequences, a sequence listing presenting the biological sequence data must accompany the patent application.
On July 1, 2022, the United States Patent and Trademark Office (USPTO) transitioned to a new standard for the presentation of nucleotide and amino acid sequence listings, based on the new WIPO Standard 26 (WIPO Standard ST.26). The USPTO created new rules (87 Fed. Reg. 30806), 37 C.F.R. §§ 1.831-1.835, that incorporate ST.26. The adoption of the new standard simplifies the process for applicants filing in multiple countries, and the USPTO’s transition to the new standard is made along with WIPO and foreign patent offices.
The previous standard for presentation of sequence listing was described in the World Intellectual Property Organization (WIPO) Handbook on Industrial Property Information and Documentation, Standard 25 (ST.25) and under U.S. practice in 37 C.F.R. §§ 1.821-1.825. The major change to the sequence listing rules is a new requirement to submit a “Sequence Listing XML” that is a computer readable sequence listing in eXtensible Markup Language (XML) format, encoded with elements and attributes. Previously a sequence listing must be submitted by ASCII plain text file (TXT) (at least in copy) with numeric identifiers for each item of information. Other changes include the listing of title, priority applications, applicant names and inventor names, as well as updates that cover modern advancements in the biological arts. For example, D-amino acids, linear portions of branched sequences, and nucleotide analogs, which were not required in ST.25, must be disclosed under the new standards.
When determining if the old or the new standard applies for a sequence listing, it is important to look at the application filing date. For applications filed on or before June 30, 2022, sequence listings must comply with ST.25. For applications filed on or after July 1, 2022, sequence listings must comply with ST.26. For sequence listing purposes, a U.S. national phase application filing date is the international filing date, while earlier priority claims or benefits are not considered when determining whether ST.25 or ST.26 applies.
While the USPTO had previously developed software (PatentIn and Checker) to ensure compliance with ST.25, the USPTO is directing applicants and practitioners to use WIPO Sequence to author, validate, and generate ST.26-compliant, XML format sequence listings. WIPO Sequence also facilitates the transformation of an ST.25 sequence listing into an ST.26 XML format sequence listing, which will be particularly helpful for applications filed on or after July 1, 2022, but claiming priority or benefit to an earlier-filed application that would have included an ST.25-compliant sequence listing.
Further information about sequence listings in US applications may be found at the USPTO sequence listing resource center.
