What are the grounds for rejection based on deposit issues in biotechnology patent applications?

The Manual of Patent Examining Procedure (MPEP) outlines several grounds for rejection based on deposit issues in biotechnology patent applications. These include:

  • Lack of enablement under 35 U.S.C. 112(a)
  • Lack of written description under 35 U.S.C. 112(a)
  • Lack of best mode under 35 U.S.C. 112(a)
  • Indefiniteness under 35 U.S.C. 112(b)
  • Failure to claim what the inventor regards as the invention under 35 U.S.C. 112(b)

The MPEP states: “Although not exhaustive, the following grounds of rejection may be applicable in appropriate circumstances:” and then lists these specific grounds. Each ground requires the examiner to provide clear reasoning for the rejection based on the specific circumstances of the application.

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Topics: MPEP 2400 - Biotechnology, MPEP 2411.01 - Rejections Based On Deposit Issue, Patent Law, Patent Procedure
Tags: 35 u.s.c. 112, Best Mode, biotechnology patents, deposit requirements, Enablement, indefiniteness, Patent Rejections, Written Description