What happens if a deposit is not made according to the requirements?

Source: FAQ (MPEP-Based)BlueIron Update: 2024-09-29

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.

If a deposit is not made according to the requirements, the examiner should reject the affected claims under pre-AIA 35 U.S.C. 112, first paragraph, as not enabled. According to MPEP 2411.01:

“Where a deposit is required to satisfy 35 U.S.C. 112, a rejection under pre-AIA 35 U.S.C. 112, first paragraph, for lack of enablement should be made where the deposit has not been made or has been made and accepted but fails to comply with any of the requirements in 37 CFR 1.801-1.809.”

This means that if the deposit does not meet the necessary criteria, the examiner will reject the claims due to lack of enablement, as the invention cannot be properly understood or replicated without the required biological material.

Topics: MPEP 2400 - Biotechnology MPEP 2411.01 - Rejections Based On Deposit Issue Patent Law Patent Procedure
Tags: Access Records, Budapest Compliance, Specification