Appeal No. 1997-3122
Application No. 08/082,848
under the enablement requirement of section 112,” it is well settled that “the PTO bears an
initial burden of setting forth a reasonable explanation as to why it believes that the scope
of protection provided by that claim is not adequately enabled by the description of the
invention provided in the specification of the application; this includes, of course, providing
sufficient reasons for doubting any assertions in the specification as to the scope of
enablement.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir.
1993).
Thus, the dispositive issue here is not whether appellants have established that
their disclosure is broadly enabling for the scope of the claims, or whether it is predictive or
representative of in vivo results, rather, the issue is whether the PTO has met the “initial
burden of setting forth a reasonable explanation as to why” it is not. Keeping this in mind,
we consider the specific reasons provided by the examiner in support of her position.
First, the examiner acknowledges that the claims require administration of a drug
“which upon binding to an immunophilin inhibits calcineurin,” but finds that “the
specification does not provide guidance in selecting those drugs other than FK-506 that
would meet the functional limitations of the claims,” thus, it would “constitute undue
experimentation to identify all drugs which bind to an immunophilin where the binding
results in inhibiting calcineurin.” Examiner’s Answer, page 8. However, the specification
5(...continued)
7
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 Next
Last modified: November 3, 2007