When should a biological material deposit be made for 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.

According to MPEP 2406.01, the timing of a biological material deposit is specified in 37 CFR 1.804(a). The MPEP states:

“37 CFR 1.804(a) specifies not only a permissible time frame for making an original deposit, but also specifies that the biological material deposited must be specifically identified in the application for patent as filed.“

This means that:

• The deposit can be made within a certain timeframe specified by the regulations.
• The biological material must be identified in the original patent application.

However, the Lundak case (In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985)) established that a deposit made after the filing date can be acceptable, provided that:

• The USPTO has access to a sample during the application’s pendency.
• Public access is ensured after the patent is granted.
• The addition of depository information after filing does not violate the prohibition against new matter in 35 U.S.C. 132.