Sequence listing basics

What is a sequence listing?

A sequence listing provides a standardized means of presenting the entirety of biological sequence data that is disclosed in a patent application in a single document. More specifically, it includes a list of the nucleotide (DNA or RNA) and/or amino acid protein sequences that are described in a patent application by enumeration of their residues and that meet sequence length thresholds.

Sequence listings enable biological sequence data in patent applications to be collected and transmitted to search databases that are used by the United States Patent and Trademark Office (USPTO) and by the public. It is therefore important that all of the biological sequences that meet the criteria set forth in the relevant standard (see below), regardless of whether they are naturally occurring, artificially synthesized, or randomly generated for exemplary purposes be included in the sequence listing. Biological sequences serve as prior art and as references for future research and innovation. The presentation of the biological sequence data in the standardized format of a sequence listing facilitates both publication and inclusion in searchable databases.

Currently, the international standard for this sequence listing is World Intellectual Property Organization (WIPO) Standard ST.25. The current USPTO regulations regarding sequence listings (see 37 CFR 1.821 – 1.825) are based on ST.25. However, a new international standard, WIPO Standard ST.26, is being implemented internationally.  The USPTO has adopted this standard and revised its regulations accordingly (see 37 CFR 1.831-1.835).