How can an applicant demonstrate that a biological material deposit is not necessary?

An applicant can demonstrate that a biological material deposit is not necessary by showing that the required biological materials can be obtained or created through routine procedures. The MPEP 2404.02 states:

“No deposit is required, however, where the required biological materials can be obtained from publicly available material with only routine experimentation and a reliable screening test.”

To demonstrate this, an applicant should:

  • Provide detailed methods for obtaining or creating the biological material in the patent application
  • Show that these methods involve only routine experimentation
  • If applicable, cite publicly available sources for the material
  • Describe any necessary screening tests and demonstrate their reliability

By doing so, the applicant can establish that the biological material is readily accessible without the need for a deposit.

To learn more:

Topics: MPEP 2400 - Biotechnology, MPEP 2404.02 - Biological Material That Can Be Made Or Isolated Without Undue Experimentation, Patent Law, Patent Procedure
Tags: Biological Material Deposit, biotechnology patents, Routine Experimentation