When should a biological deposit be made during the patent application process?

When should a biological deposit be made during the patent application process?

The timing of a biological deposit during the patent application process is flexible, but there are important considerations. According to MPEP 2404:

“Where an invention depends on the use of a biological material that must be deposited to satisfy the enablement requirement, the biological material need not be deposited during the pendency of the application, if the biological material is known and readily available to the public or can be made or isolated without undue experimentation.”

However, it’s generally recommended to make the deposit:

  • Before filing: This ensures compliance with enablement requirements from the start.
  • During prosecution: If an examiner raises enablement issues, a deposit can be made to address these concerns.
  • Before allowance: The deposit must be made and the accession number provided before the application is allowed.

It’s crucial to ensure that the deposit is made and all necessary information is provided before the patent is granted. Failure to do so could result in the patent being unenforceable. Consult with a patent attorney to determine the best timing for your specific situation.

To learn more:

Topics: MPEP 2400 - Biotechnology, MPEP 2404 - Need Or Opportunity To Make A Deposit, Patent Law, Patent Procedure
Tags: Accession Number, Biological Deposit, enablement requirement, Patent Application Process