What are the applicant’s options when responding to a biological material deposit requirement?

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.

When an applicant is faced with a biological material deposit requirement during patent examination, they have several options to respond. According to MPEP 2411, once the USPTO has established the necessity for access to a biological material, the applicant can:

1. Demonstrate that access to the biological material is not necessary for satisfying the statutory requirements for patentability.
2. Show that access to the biological material is already available to the public.
3. Agree to make a deposit of the biological material in accordance with the regulations.

The MPEP states: “Once the Office has met this burden, the burden shifts to the applicant or patent owner to demonstrate that access to such biological material either is not necessary, or is already available, or that a deposit of such material will be made in accordance with these regulations.”

Each of these options allows the applicant to address the examiner’s concerns regarding the biological material and potentially overcome the deposit requirement.