How does 37 CFR 1.809 relate to biological material deposits in patent applications?

37 CFR 1.809 is a crucial regulation that outlines the examination procedures for biological material deposits in patent applications. As mentioned in MPEP 2411:

“37 CFR 1.809 sets forth procedures that will be used by the examiner to address a deposit issue.”

This regulation establishes the framework for how patent examiners should handle issues related to biological material deposits. It covers several key aspects:

  • The initial burden on the USPTO to establish the necessity of access to biological materials
  • The shift of burden to the applicant or patent owner once the USPTO has met its initial burden
  • The options available to applicants in responding to deposit requirements
  • The process for ensuring compliance with deposit regulations

Understanding 37 CFR 1.809 is essential for both patent examiners and applicants dealing with biological inventions that may require deposits to satisfy the enablement and written description requirements of 35 U.S.C. 112.

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Topics: MPEP 2400 - Biotechnology, MPEP 2411 - Examination Procedures, Patent Law, Patent Procedure
Tags: 35 u.s.c. 112, 37 Cfr 1.809, Biological Material Deposits, patent examination, USPTO procedures