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:

• biological material deposit
• patent application
• routine experimentation
• biotechnology patents