Appeal No. 2001-2646 Page 4
Application No. 08/463,951
“pharmaceutically acceptable salt[s] or hydrate[s]” of the claimed compounds.
See, e.g., claim 58. Other claims are directed to pharmaceutical compositions
comprising the compounds and methods of treating numerous disorders using
the compounds. The examiner rejected all of the claims except claim 21 for
nonenablement and rejected most of the claims for obviousness-type double
patenting.
1. Enablement
The examiner rejected all of the claims except claim 21 as nonenabled.
With regard to all of the rejected claims, the examiner’s position, as we
understand it, was that the working examples provided in the specification
showed only an acetyl or t-butoxycarbonyl group at this position, while the claim
encompassed “a variety of unrelated functional groups such as phenoxy,
morpholino, piperazino, piperadino, indolinyl, isoquinolinyl, benzothienyl, etc. as
well as substituted derivatives thereof directly or indirectly attached to the C(O)
group in the main formulae.” Examiner’s Answer, page 5. The examiner cited
Appellants’ own data as “show[ing] much structure sensitivity at this location,”
and argued that certain nonelected compounds with a piperazino or piperadino
moiety at R7 had IC50 values “a thousandfold higher than the nanomolar ranges
(10-9) reported for instant alkanoyl derivatives.” Examiner’s Answer, pages 5-6.
The examiner concluded that the disclosure was not representative of the scope
of the claims and rejected the claims for lack of enablement. Id., page 6.
“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
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