Can an applicant replace a biological deposit with a different material in a pending 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.

Yes, in a pending application, an applicant can replace a biological deposit with a different material, provided it meets certain conditions. According to MPEP 2407.01:

“It should be noted that in a pending application, an applicant need not replace the identical material previously deposited, but may make an original deposit of a biological material which is specifically identified and described in the application as filed.”

However, the new deposit must satisfy the following criteria:

• It must meet all the requirements for making an original deposit.
• It must be specifically identified and described in the application as filed.
• The examiner must determine if it meets the requirements of 35 U.S.C. 112 with respect to the claimed subject matter.
• The conditions in 37 CFR 1.802(b) and 37 CFR 1.804(b) must be satisfied.