What is the requirement for referencing sequences 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.
According to 37 CFR 1.831(c), each nucleotide and/or amino acid sequence set forth in a “Sequence Listing XML” must be referenced by a sequence identifier in the text of the description or claims. The MPEP states:
“reference must be made to the sequence by use of the sequence identifier, preceded by ‘SEQ ID NO:’ or the like in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.”
This requirement applies to all occurrences of the sequence in the application, ensuring consistent and clear referencing throughout the document.