USPTO Demands Neat DNA Patents: Sequence Up!
Published Date: 10/24/2025
Notice
Summary
The USPTO is asking for feedback on how it collects info from patent applications that include DNA or protein sequences. This review aims to keep the process smooth and reduce paperwork for inventors and companies. If you’re involved in biotech patents, now’s the time to share your thoughts before November 24, 2025!
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
Sequence Listings Required in Patent Filings
If your patent application discloses DNA (nucleotide) or protein (amino acid) sequences, you must include a separate sequence listing part with the application under the rules set out in 37 CFR 1.831 (for applications filed on or after July 1, 2022) or 37 CFR 1.821(a) (for applications filed on or before June 30, 2022). The USPTO uses these sequence listings during patent examination and for pre-grant publication, and applicants may submit them for both U.S. and international applications.
Paperwork Time and Cost Estimate
The USPTO estimates this information collection will have about 30,000 annual respondents and 30,000 annual responses, with each response taking about 6 hours to complete. The notice estimates a total annual respondent burden of 180,000 hours and an estimated total annual non-hourly cost burden of $336,973.
CRF Submission for Older Application Amendments
For sequence listings filed as 37 CFR 1.825 amendments in applications with a filing date on or before June 30, 2022, the submission may also require a new or substitute computer readable form (CRF) copy of the sequence listing under 37 CFR 1.821(e) and 1.824, incorporated as part of the amendment under 37 CFR 1.825(a)(5)(ii) or (b)(6)(ii).
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