Can a patent applicant rely on the reproduction of biological materials from a written description?

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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. Yes, a patent applicant can potentially rely on the reproduction of biological materials from a written description, but there are important considerations. MPEP 2404 states: “The invention may rely on biological material which is known and readily available to the public or reproducible from the written description.” However, the applicant must ensure that: The written description is sufficiently detailed to allow reproduction without undue experimentation The reproduction process is reliable and consistent The resulting material is identical to the original in all relevant aspects If these conditions are not met, or if there’s any doubt about the reproducibility, a biological material deposit may still be required to satisfy the enablement requirement under 35 U.S.C. 112 . Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Biological Material Must Be Known and Readily Available MPEP 2404.01 Required Biological Material Must Be Known and Readily Available MPEP 2404.01 Requirement for Known and Readily Available Biological Material MPEP 2404.01 Required Indicia for Known and Readily Available Biological Materials MPEP 2404.01 Permitted Commercial Availability as Known and Readily Available Evidence MPEP 2404.01 Material Known and Readily Available Must Be Described Adequately MPEP 2404.01 Availability of Biological Material Must Be Known and Accessible MPEP 2404.01 Permitted Patent Application May Reference Biological Material Deposit MPEP 2404 Permitted Publicly Available Biological Material Not Requiring Deposit MPEP 2404 Permitted Deposited Biological Material Is Considered Readily Available Regardless of Access Conditions MPEP 2404 Other Related FAQs 5 FAQs Col...