Appeal No. 95-1618
Application 08/033,456
be intended. In either case the specification is unclear and fails to point out with
particularity the claimed invention to the skilled artisan in such a way that it can [be]
made and used without undue experimentation. The purpose [of the] specification is
to objectively enable the claimed invention. Applicants [sic, Applicants’] specification
appears to only indicate to the skilled artisan the area of subject matter wherein it
would be obvious to try to find the invention. It would require undue experimentation
on the part of the skilled artisan to define the true scope of the claimed invention and
reduce it to practice.
Applicants* disclosure is conspicuously devoid of any specific recitation of
examples that would be considered necessary in the instant case to objectively enable
the invention, i.e. teach one of ordinary skill how to make all the disclosed tautomers
and/or isomer*s [sic, isomers]. There are multiple sets of tautomers and geometric
isomers theoretically possible for Formula I [on page 5 of the specification, which is
the same formula recited in claim 1, supra]. There is no reason to believe that all of
these variations are sufficiently stable, [and] can be made or have the alleged utility
in view [of the] inherent structural differences. Furthermore, the examiner maintains
the position that the originally filed specification fails to adequately specify what is
encompassed by Formula I or clearly specify the true scope of the invention. Even
when considering applicants* amendments which introduce new mater [sic, matter],
the specification remains unclear as to the metes and bounds of the invention intended
to be disclosed.
Each part of the rejection is prefaced on an objection to the specification.
II. Claims 5, 6, 12 and 13 stand rejected under 35 U.S.C. §§ 101 and 112, first paragraph,
on the ground that there is “insufficient data in the specification to show that the claimed
pharmaceutical composition is therapeutically effective in the treatment of the various complications
and diseases disclosed” (Paper No. 26, p. 5).3
Opinion
3This rejection has not been restated or referred to in the Answer by the examiner. Appellants’ identified the
rejection as Issue IV and presented arguments traversing the rejection. The examiner responded to these arguments. It is,
therefore, presumed that the examiner’s failure to restate the rejection was an oversight and that the rejection is viable and
has not been withdrawn.
-4-
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 Next
Last modified: November 3, 2007