Appeal No. 1996-2538
Application 08/097,869
The specification describes the hybrid cytokines as being useful in treating
“indications for which their native counterparts are often employed.” See lines 18-20 on
page 17 of the specification. The native counterparts used to make the hybrid cytokines
as well as certain of their activities and uses are described on pages 1 through 4 of the
specification.
In initiating and maintaining the rejection of the claims under 35 U.S.C. § 112, first
paragraph (enablement), it does not appear that the examiner has considered the relevant
legal standards which govern the issue of enablement. As a consequence, the requisite
factual analysis has not been undertaken by the examiner. For example, the examiner has
not presented a reasoned analysis of the state of the prior art in regard to the known
activity uses of the native cytokines which are used to make the hybrid cytokines of the
invention. Such an analysis is needed since the specification need not disclose what is
well known in the art. Genentech, Inc. v. Novo Nordisk, 108 F.3d 1361, 1366, 42
USPQ2d 1001, 1005 (Fed. Cir. 1997); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802
F.2d 1367, 1385, 231 USPQ 81, 94 (Fed. Cir. 1986). As indicated the specification
describes the hybrid cytokines are useful for treating the indications for which their native
counterparts are employed, and describes several of the known, prior art uses for the
native cytokines. The examiner has not explained why the claimed hybrid cytokines would
not be useful in the same manner.
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