Appeal No. 2006-1036
Application No. 10/191,760
Thus, the claims are not enabled for their full breadth. In light
of the optimal nature of delivery targeting the liver for
expression of FVIII, and the lack of guidance or working
examples in the specification and prior art of record on other
suitable target tissues, including effective routes of delivery to
those other target tissues, undue experimentation would be
required to develop the vectors and mode of administration for
non-hepatic expression of therapeutic levels of FVIII.
Id. at 7-8.
The examiner bears the initial burden of showing that a claimed
invention is nonenabled. “[A] specification disclosure which contains a
teaching of the manner and process of making and using the invention in
terms which correspond in scope to those used in describing and defining the
subject matter sought to be patented must be taken as in compliance with the
enabling requirement of the first paragraph of § 112 unless there is reason to
doubt the objective truth of the statements contained therein which must be
relied on for enabling support.” In re Marzocchi, 439 F.2d 220, 223,
169 USPQ 367, 369 (CCPA 1971). “When rejecting a claim under the
enablement requirement of section 112, 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.”
In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir.
1993). “[E]nablement requires that the specification teach those in the art to
make and use the invention without ‘undue experimentation.’ . . . . That
some experimentation may be required is not fatal; the issue is whether the
5
Page: Previous 1 2 3 4 5 6 7 8 9 10 Next
Last modified: September 9, 2013