Appeal No. 1997-2518
Application 08/359,642
The examiner notes that claim 1 encompasses “a considerable number of
possible substitutions or permutations” at positions other than seven, not exemplified in
the specification. As “[t]he high unpredictability of the peptide art, particularly the Bk
art, has been notoriously known,” and “no guidance or reasonable assurance is
provided in the specification that would aid one . . . as to the specific combinations of
residues that would produce the desired result,” “one skilled in the art would have to
experiment unduly to achieve such result.” Examiner’s Answer, pages 3 through 5.
Having carefully considered the examiner’s commentary on pages 3 through 5
and 8 through 12 of the Examiner’s Answer and the arguments on pages 14 through 19
of appellants’ Brief, we hold that the examiner has not set forth a reasonable basis for
questioning the enablement of the claims on appeal. In our view, there are two
principal flaws in the examiner’s reasoning: equating a considerable quantity of
experimentation with undue experimentation, and failing to acknowledge what was
known in the art at the time of appellant’s invention.
The specification contains working examples demonstrating the synthesis and
activity of several bradykinin antagonists within the scope of claim 1, specifically defines
an additional hundred or so, and outlines methods for making, identifying and using
others encompassed by the claim (pages 12 through 20, and Example 41). The crux of
the invention, and a feature common to all of the antagonists, is the substitution of the
L-pro at position seven of bradykinin with various D-hydroxyproline ethers or thioether
derivatives.
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