What are the consequences of not making a biological deposit before filing a patent application?

Not making a biological deposit before filing a patent application can have serious consequences:

• The application may be rejected for lack of enablement under 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112.
• If the deposit is made after the filing date, it may not be considered part of the original disclosure, potentially leading to new matter issues.
• Late deposits may require a petition under 37 CFR 1.809(b).

The MPEP 2406 states: “When the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112.”

To learn more:

• biological deposit
• patent application
• enablement
• 35 U.S.C. 112
• new matter