What are the requirements for viability of deposited biological materials?

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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 viability of deposited biological materials is a crucial aspect of the deposit process. According to MPEP 2410.01 , the following requirements apply: The deposit must be viable at the time it is made. The deposit must be tested for viability. The deposit must be replaced if it becomes non-viable. As stated in the MPEP: “The deposit must be viable at the time of deposit.” This ensures that the deposited material can be used to recreate the invention as described in the patent application. If the deposit becomes non-viable, the patent owner is responsible for replacing it to maintain the validity of the patent. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Deposit Must Be Available During Pendency and Post-Grant MPEP 2410 Required Certification of Deposit Availability Upon Patent Grant MPEP 2410 Deposit of Biological Material Must Be Accessible and Unrestricted Upon Patent Grant MPEP 2410.01 Conditions for Sample Requests During Patent Term MPEP 2410.01 Required Budapest Treaty Deposit Compliance MPEP 2410.01 Permitted Deposit Restrictions Must Be Removed on Grant MPEP 2410.01 Required Deposit Restrictions Must Be Removed Upon Patent Grant MPEP 2410 Requirement for Sample Request During Patent Term MPEP 2410 Required Notification Required for Sample Filing During Patent Term MPEP 2410 Request for Sample Must Notify Depositor MPEP 2410.01 Other Related FAQs 5 FAQs Collapse Who can access deposited biological material during the pendency of a patent application? What are the specific conditions for biological material deposits under 37 CFR 1.801-1.809? What are the specific viability requirements for biological material deposits? How does the Budapest Treaty r...