Appeal No. 1997-3542
Application No. 08/192,507
the examiner states that the specification fails to provide an adequate written description
of the invention and fails to provide an enabling disclosure without complete evidence
either that the claimed biological materials are known and readily available to the public or
complete evidence of the deposit of the biological materials. Paper No. 5, page 2. The
examiner acknowledges that appellants have made reference to a deposit of 2G10
hybridoma ATCC HB10436 on page 19 of the specification, but indicates that appellants
have failed to provide sufficient assurances that the required deposit has been made and
that all the conditions of 37 CFR § 1.801-1.809 have been met. In addition, the examiner
indicates that appellants have failed to address the requirement for deposit of 1C2
hybridoma reference in claim 14.
In order to sustain a rejection under 35 U.S.C. § 112, first paragraph, for lack of
enablement, the examiner has the initial burden to establish a reasonable basis to
question the enablement provided for the claimed invention. See In re Wright, 999 F.2d
1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). The examiner must provide a
reasonable explanation as to why the scope of protection provided by a claim is not
adequately enabled by the disclosure. See In re Marzocchi, 439 F.2d 220, 223, 169
USPQ 367, 369 (CCPA 1971). In the present case, we believe that the examiner has met
this burden.
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