How can I respond to a rejection based on a biological material deposit issue?

According to MPEP 2411.02, there are three ways to respond to a rejection under 35 U.S.C. 112 based on the absence of access to a biological material:

  • Make an acceptable original, replacement, or supplemental deposit in accordance with the regulations.
  • Provide a written assurance that an acceptable deposit will be made on or before the date of payment of the issue fee.
  • Submit an argument explaining why a deposit is not required for the specific application.

The MPEP states: “Once a rejection under 35 U.S.C. 112 has been made by the examiner directed to the absence of access to a biological material, applicant may reply, pursuant to 37 CFR 1.809(b)(1), by either making an acceptable original, replacement, or supplemental deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee, or by submitting an argument of why a deposit is not required under the circumstances of the application being considered.”

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Topics: MPEP 2400 - Biotechnology, MPEP 2411.02 - Replies To Rejections Based On Deposit Issue, Patent Law, Patent Procedure
Tags: 35 u.s.c. 112, 37 Cfr 1.809, Biological Material Deposit, Patent Rejection