How can an applicant demonstrate that a biological material deposit is not necessary?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-29 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. An applicant can demonstrate that a biological material deposit is not necessary by showing that the required biological materials can be obtained or created through routine procedures. The MPEP 2404.02 states: “No deposit is required, however, where the required biological materials can be obtained from publicly available material with only routine experimentation and a reliable screening test.” To demonstrate this, an applicant should: Provide detailed methods for obtaining or creating the biological material in the patent application Show that these methods involve only routine experimentation If applicable, cite publicly available sources for the material Describe any necessary screening tests and demonstrate their reliability By doing so, the applicant can establish that the biological material is readily accessible without the need for a deposit. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Publicly Available Biological Material Not Requiring Deposit MPEP 2404 Permitted Patent Application May Reference Biological Material Deposit MPEP 2404 Permitted Deposited Biological Material Is Considered Readily Available Regardless of Access Conditions MPEP 2404 No Deposit When Routinely Obtainable MPEP 2404.02 Required Requirement for Established Known Biological Material MPEP 2404.01 Biological Material Must Be Known and Readily Available MPEP 2404.01 Required Deposit Required for Undue Experimentation MPEP 2404.02 Required Factors May Not Alone Prove Biological Material Known and Readily Available MPEP 2404.01 Prohibited Deposit of Biological Material Permitted for Invention Relying on Such Material MPEP 2404 Description of Biological Material Must Be Adequate ...