How are polynucleotide molecules defined by their nucleic acid sequence treated in patent applications?

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.

Polynucleotide molecules defined by their nucleic acid sequence, also known as nucleotide sequences, are treated as structurally distinct chemical compounds in patent applications. According to MPEP 803.04:

“Polynucleotide molecules defined by their nucleic acid sequence (hereinafter “nucleotide sequences”) that encode different proteins are structurally distinct chemical compounds. These sequences are thus deemed to normally constitute independent and distinct inventions within the meaning of 35 U.S.C. 121.”

This means that each nucleotide sequence is presumed to represent an independent and distinct invention, which may be subject to restriction requirements. The treatment of these sequences follows the standards set forth in MPEP Chapter 800 for independence, relatedness, distinction, and burden.