MPEP 2411.01
Rejections Based on Deposit Issue

Ninth Edition of the MPEP, Revision 07.2022, Last Revised in February 2023

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2411.01    Rejections Based on Deposit Issue [R-07.2015]

Under 37 CFR 1.809(a), once the examiner has determined that access to a biological material is necessary, and there is no information that would support the conclusion that access is currently available in accordance with these regulations, the examiner should make an appropriate rejection under 35 U.S.C. 112 until such time as a deposit in accordance with these regulations is actually made or a written assurance is received in the patent application that such a deposit will be made upon an indication of allowability of the application. The examiner should clearly indicate the statutory basis for the rejection and the reasons that are relied upon by the examiner to conclude that the application does not comply with some requirement of 35 U.S.C. 112. Although not exhaustive, the following grounds of rejection may be applicable in appropriate circumstances:

  • (A) 35 U.S.C. 112(a), enablement requirement. Rejection for lack of an enabling disclosure without access to a specific biological material. This ground of rejection should be accompanied by evidence of scientific reasoning to support the conclusion that a person skilled in the art could not make or use the invention defined in and commensurate with the claims without access to the specific biological material. See MPEP § 2164.06(a).
  • (B) 35 U.S.C. 112(a), written description requirement. A rejection for lack of written description typically arises in the context that the application as filed does not contain a description to support an amendment to the specification or claims, although it can arise in the context of original claims. See MPEP § 2163 et seq. An amendment to the claims that is not described in the application as filed would justify a rejection of the affected claims under 35 U.S.C. 112(a). If an amendment is made to the application, other than the claims, that is not described in the application as filed, this would justify a rejection under 35 U.S.C. 112(a) and/or an objection under 35 U.S.C. 132 (prohibition against the introduction of new matter) and a requirement that the amendment be canceled.
  • (C) 35 U.S.C. 112(a), best mode requirement. A rejection for lack of a best mode will be rare in the ex parte examination process because it requires (1) a finding by the examiner that, at the time the application was filed, the inventor(s) knew of a specific material that was considered by the inventor(s) to be better than any other, and (2) if a best mode was contemplated at that time, that the inventor(s) concealed the best mode (accidentally or intentionally) by failing to adequately describe that best mode. See Chemcast Corp. v. Arco Industries Corp., 913 F.2d 923, 16 USPQ2d 1033 (Fed. Cir. 1990). See also MPEP § 2165 et seq.
  • (D) 35 U.S.C. 112(b), requirement to particularly point out and distinctly claim invention. A rejection for indefiniteness, as applied to a deposit issue, requires the examiner to provide reasons why the terms in the claims and/or scope of the invention are unclear because of an incomplete or inaccurate description or the absence of a reference to a biological material.
  • (E) 35 U.S.C. 112(b), requirement to claim what the inventor or a joint inventor regards as the invention. A rejection on the basis that the claims do not set forth the subject matter that the inventor or a joint inventor regards as the invention requires the citation of some evidence, not contained in the application as filed, to support the rejection. In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969). Any disagreement between the content of the application disclosure and the scope of the claims should be addressed under 35 U.S.C. 112(a). See In re Ehrreich, 590 F.2d 902, 200 USPQ 504 (CCPA 1979).

Where a deposit is required to satisfy 35 U.S.C. 112, a deposit must be made in accordance with these regulations. See 37 CFR 1.802. A deposit accepted in any International Depositary Authority (IDA) under the Budapest Treaty shall be accepted for patent purposes if made under conditions which comply with 37 CFR 1.806 and 37 CFR 1.808(a) concerning term of deposit and permissible conditions on access once the patent is granted.