How does the USPTO determine if a biological material is “known and readily available”?

How does the USPTO determine if a biological material is “known and readily available”?

The USPTO considers several factors to determine if a biological material is “known and readily available,” which may negate the need for a deposit. According to MPEP 2404:

“The Office will accept commercial availability as evidence that a biological material is known and readily available only when the evidence is clear and convincing that the public has access to the material.”

The USPTO considers the following factors:

  • Commercial availability: Is the material available from a commercial source?
  • Reproducibility: Can the material be made or isolated without undue experimentation?
  • Public access: Is there unrestricted access to the material?
  • Patent or publication disclosure: Has the material been adequately described in prior patents or publications?

Applicants should provide clear evidence of availability when relying on this exception to avoid making a deposit. The burden is on the applicant to demonstrate that the biological material is known and readily available.

To learn more:

Topics: MPEP 2400 - Biotechnology, MPEP 2404 - Need Or Opportunity To Make A Deposit, Patent Law, Patent Procedure
Tags: biological material, Commercial Availability, Known And Readily Available, public access, uspto determination