What are the consequences of not making a required biological material deposit for a patent application?
Failing to make a required biological material deposit for a patent application can have serious consequences:
- Rejection of the application for lack of enablement under 35 U.S.C. 112
- Inability to overcome rejections based on prior art
- Potential invalidation of an issued patent
MPEP 2404 emphasizes the importance of deposits: “Where an invention depends on the use of 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.”
If a deposit is required but not made, the applicant may not be able to demonstrate that the invention is fully enabled, potentially leading to a denial of the patent or vulnerability to future challenges.
To learn more:
Topics:
MPEP 2400 - Biotechnology,
MPEP 2404 - Need Or Opportunity To Make A Deposit,
Patent Law,
Patent Procedure