How are biological sequences defined in patent applications?

Source: FAQ (MPEP-Based)BlueIron Update: 2024-09-09

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 definition of biological sequences in patent applications depends on the filing date of the application:

  • For applications filed before July 1, 2022: Biological sequences are defined in 37 CFR 1.821(a).
  • For applications filed on or after July 1, 2022: Biological sequences are defined in 37 CFR 1.831(b).

MPEP 608.05(c) states: “Applications disclosing nucleotide and/or amino acid sequences, as defined in 37 CFR 1.821(a) for applications filed before July 1, 2022 or as defined in 37 CFR 1.831(b) for applications filed on or after July 1, 2022, are required to provide the biological sequence information in a sequence listing.”

These definitions typically include specific criteria for nucleotide and amino acid sequences that must be disclosed in the sequence listing.

Topics: Patent Law Patent Procedure
Tags: Biological Sequences, patent applications, Sequence Definitions, Uspto Regulations