Appeal 2007-1152
Application 10/660,924
specification of the application; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the scope of
enablement. . . . Marzocchi, 439 F.2d at 223-24, 169 USPQ at 369-70.” In
re Wright, 999 F.2d at 1561-62, 27 USPQ2d at 1513 (Fed. Cir. 1993).
Enablement is determined as of the application filing date. See In re
Brana, 51 F.3d 1560, 1567 n.19, 34 USPQ2d 1436, 1441 n.19 (Fed. Cir.
1995). Thus, the issue in this rejection is whether the Examiner has set forth
a reasonable explanation as to why the scope of protection provided by the
claims is not adequately enabled by the Specification as of the application
filing date.
The Examiner contends that the Specification does not adequately
teach how to effectively prevent the onset of Type I diabetes in any mammal
predisposed to it (Answer 4). The Examiner asserts that the Specification
“only discloses the effects of the implanting of insulin-producing cells on the
level of blood glucose using streptozotocin-induced [diabetes] in murine
experimental model, using NOD mouse. (See Examples 1-2 in particular)”
(Answer 4). However, the Examiner contends that the examples are
insufficient to enable the scope of the claims because “the state of the art is
that it is unpredictable [from] the in vivo murine data using NOD model
disclosed in the specification as [to] whether the instant invention can be
used for the in vivo preventing onset of type I diabetes in mammals
including human” (Answer 7). To support the position that the murine
model is not adequate to predict the efficacy of the method as it is broadly
claimed, the Examiner cites six literature references: Atkinson (Nature,
1999, vol. 5, pages 601-604), Knip (Acta Paediatr. Suppl., 1998, vol. 452,
pages 54-62), Metas (J. of Immunology, 2004, vol. 172, pages 2731-2738),
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