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2411.01 Rejections Based on Deposit Issue - 2400 Biotechnology
2411.01 Rejections Based on Deposit Issue
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, first paragraph - 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.
(B) 35 U.S.C. 112, first paragraph - description requirement. This ground of rejection typically arises in the context that the application as filed does not contain a description to support an amendment to the specification or claims. 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, first paragraph. If an amendment is made to the application, other than the claims, that is not described in the application as filed, this would justify an objection under 35 U.S.C. 112, first paragraph and/or 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, first paragraph - best mode requirement. This ground of rejection 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). The Court of Appeals for the Federal Circuit has at least twice resolved a best mode issue arising in the context of a biotechnology invention in favor of the patentee. See Scripps Clinic and Research Foundation v. Genentech Inc., 927 F.2d 1565, 18 USPQ2d 1001 (Fed. Cir. 1991) with respect to monoclonal antibodies, and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991) with respect to mammalian host cells.
(D) 35 U.S.C. 112, second paragraph - indefiniteness. This ground of rejection, 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, second paragraph - claims do not set forth what applicants regard as their invention. This ground of rejection requires the citation of some evidence, not contained in the application as filed, that the claims do not set forth what applicants regard as their invention. 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, first paragraph. 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. A deposit accepted in any 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.
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