How can an applicant show that a biological material is known and readily available?

An applicant can demonstrate that a biological material is known and readily available through various means. According to MPEP 2404.01, some factors that may serve as evidence include:

• Commercial availability
• References to the biological material in printed publications
• Declarations of accessibility by those working in the field
• Evidence of predictable isolation techniques
• An existing deposit made in accordance with USPTO rules

The MPEP states:

“Each factor alone may or may not be sufficient to demonstrate that the biological material is known and readily available. Those applicants that rely on evidence of accessibility other than a deposit take the risk that the patent may no longer be enforceable if the biological material necessary to satisfy the requirements of 35 U.S.C. 112 ceases to be accessible.”

It’s important to note that the Office will accept commercial availability as evidence only when it’s clear and convincing that the public has access to the material.

To learn more:

• biological material
• patent application
• public accessibility
• commercial availability
• deposit