When should a biological material deposit be made for a patent application?

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.

To learn more:

• biological material deposit
• patent application
• timing
• Lundak case
• 37 CFR 1.804(a)