What are the consequences of not making a biological deposit before filing a patent application?

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.

Not making a biological deposit before filing a patent application can have serious consequences:

• The application may be rejected for lack of enablement under 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112.
• If the deposit is made after the filing date, it may not be considered part of the original disclosure, potentially leading to new matter issues.
• Late deposits may require a petition under 37 CFR 1.809(b).

The MPEP 2406 states: “When the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112.”