How does the USPTO determine if a biological material is known and readily available?
The USPTO determines if a biological material is known and readily available based on several factors:
- Public availability of the material
- Ability to reproduce the material from the written description
- Accessibility without undue experimentation
MPEP 2404 states: “The USPTO 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 burden is on the applicant to demonstrate that the material meets these criteria.
To learn more:
Topics:
MPEP 2400 - Biotechnology,
MPEP 2404 - Need Or Opportunity To Make A Deposit,
Patent Law,
Patent Procedure