Who bears the initial burden of proof in biological material deposit cases?

Question

Accepted Answer

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. In biological material deposit cases, the initial burden of proof lies with the United States Patent and Trademark Office (USPTO). According to MPEP 2411 : “The burden is initially on the Office to establish that access to a biological material is necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112.” This means that the USPTO must first demonstrate why access to a specific biological material is essential for meeting the patentability requirements, particularly those related to enablement and written description under 35 U.S.C. 112 . Only after the USPTO has successfully established this necessity does the burden shift to the applicant or patent owner. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Deposit Must Be Made for Patent Claims MPEP 2411 Prohibited Office Must Establish Necessity of Deposit for Patentability MPEP 2411 Examiner Procedures for Addressing Deposit Issues MPEP 2411 Deposit of Biological Material Required for Enablement MPEP 2403 Permitted Deposit Requirements for Biological Material MPEP 2402 Required Definition of Biological Materials for Patent Deposits MPEP 2403 Permitted Deposit Requirement Time Period Not Extensible MPEP 2411 Amendments Before Issue Fee Payment Required MPEP 2411 Required Examiner Must Determine If Deposit Is Needed and Acceptable for Patent Purposes MPEP 2411 Required Requirement for Responding to Patent Office Action MPEP 2411 Required Other Related FAQs 5 FAQs Collapse How does 37 CFR 1.809 relate to biological material deposits in patent applications? What are the applicant&#8217;s options when responding to a biological material deposit requirement? What are the exami...