Appeal No. 1997-2741
Application 08/213,873
practice the full scope of the claimed invention without undue experimentation.2
The examiner has conceded that the specification enables inhibition of ß-amyloid
peptide production in the brain (Examiner’s Answer, page 3). However, he notes
that the specification contains “no discussion or guidelines at all of any other
organ system which is associated with ß-amyloid. Nor is there any evidence that
aspartyl protease (cathepsin D) is present in any system other than the brain.”
Id. The examiner argues that the specification is not enabling for the full scope of
the claims because its guidance “is limited to the brain system.” Examiner’s
Answer, page 4.
Appellants state that “there are conditions in organs other than the brain
which are associated with ß-amyloid peptide,” although they fail to identify any
such disorders. Appella nts argue that the full scope of the claims is enabled by
the specification. In particular, Appellants point out that the level of ordinary skill
in the art (of clinical medicine, presumably) is very high and that skilled artisans
would be familiar with dosing schedules and regimens for the disclosed
compounds. Appellants also argue that assays to test the cathepsin D-inhibiting
activity of the subject compounds are disclosed, and that the scope of the claims
2 The basis of the examiner’s rejection is not as clear as it could be because of a pronounced
change in emphasis between the final rejection and the Examiner’s Answer. In the final rejection,
the Examiner rejected the claims “under 35 U.S.C. § 112, first and second paragraphs.” The
explanation given was that “[t]he specification teaches the use of the compounds in the brain.
However, there are other conditions ‘associated with ß-amyloid peptide’ in other organ systems A
[sic] which specification does not teach.” The final rejection did not state with any clarity that it
was on the basis of non-enablement. The Examiner’s Answer explains, for the first time, that the
rejection is based on non-enablement.
3
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