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