Appeal No. 1997-2518
Application 08/359,642
been implicated in the pathogenesis of several shock syndromes . . .
Bradykinin is also a potent bronchoconstrictor . . .
Thus, a bradykinin inhibitor or bradykinin receptor antagonist is expected
to possess a number of desirable biological effects in the treatment, for
example, of inflammation, septic shock, asthma, burn pain, rhinitis and
allergy.
According to appellants, the present invention is directed to bradykinin receptor
antagonists “that act as specific and competitive inhibitors of the biological activities of
bradykinin,” wherein the L-Pro at position seven of the native bradykinin is replaced by
a D-hydroxyproline ether or a thioether derivative. In addition, the antagonists may
include “modifications at other positions . . . which confer increased antagonist potency,
resistance to enzymatic degradation, and/or tissue specificity.” Specification, page 1.
DISCUSSION
Enablement
Claims 1, 2, 4 and 5 stand rejected under the first paragraph of 35 U.S.C. § 112
as “[t]he specification is not enabling for the scope of e.g., claim 1.” Examiner’s Answer,
page 3. The examiner’s conclusion is based on an analysis in keeping with that
described in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988):
Factors to be considered in determining whether a disclosure would
require undue experimentation have been summarized by the board in Ex
parte Forman [230 USPQ 546, 547 (BdPatAppInt 1986)]. They include
(1) the quantity of experimentation necessary, (2) the amount of direction
or guidance presented, (3) the presence or absence of working examples,
(4) the nature of the invention, (5) the state of the prior art, (6) the relative
skill of those in the art, (7) the predictability or unpredictability of the art,
and (8) the breadth of the claims (footnote omitted).
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