When must amino acid sequences be set forth separately in a patent application?

According to the MPEP, amino acid sequences must be set forth separately under certain conditions. Specifically:

“When the coding parts of a nucleotide sequence and their corresponding amino acids have been enumerated by their residues, those amino acids must also be set forth as a separate sequence if the amino acid sequence meets the length thresholds in 37 CFR 1.821(a).”

This means that if the amino acid sequence derived from the coding regions meets the minimum length requirements specified in 37 CFR 1.821(a), it must be presented as a separate sequence in the patent application, in addition to being depicted below the corresponding codons.

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Topics: MPEP 2400 - Biotechnology, MPEP 2423.02 - Depiction Of Coding Regions, Patent Law, Patent Procedure
Tags: amino acid sequences, biotechnology patents, nucleotide sequences, patent applications, Sequence Listings