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

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-30 10 Rules 5 Related FAQs This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice. 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. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Commercial Availability as Known and Readily Available Evidence MPEP 2404.01 Biological Material Must Be Known and Readily Available MPEP 2404.01 Required Commercial Availability as Evidence of Readiness MPEP 2404.01 Biological Material Must Be Known and Readily Available MPEP 2404.01 Indicia for Known and Readily Available Biological Materials MPEP 2404.01 Permitted Publicly Available Biological Material Not Requiring Deposit MPEP 2404 Permitted Requirement for Known and Readily Available Biological Material MPEP 2404.01 Required Material Known and Readily Available Must Be Described Adequately MPEP 2404.01 Availability of Biological Material Must Be...