What regulation governs the requirements for patent applications with nucleotide and/or amino acid sequence disclosures?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

The requirements for patent applications with nucleotide and/or amino acid sequence disclosures are governed by 37 CFR 1.831. This is referenced in MPEP 2412.03(c):

37 CFR 1.831 Requirements for patent applications filed on or after July 1, 2022, having nucleotide and/or amino acid sequence disclosures.

This regulation sets forth the specific requirements that patent applicants must follow when their applications include nucleotide and/or amino acid sequences, including modified amino acids. It’s important for applicants to be familiar with these requirements to ensure their applications are compliant.