Appeal 2007-3261
Application 09/854,802
8 USPQ2d at 1404. Not all the factors need not be reviewed when
determining whether a disclosure is enabling. See Amgen, Inc. v. Chugai
Pharm. Co., Ltd., 927 F.2d 1200, 1213, 18 USPQ2d 1016, 1027 (Fed. Cir.
1991) (noting that the Wands factors “are illustrative, not mandatory. What
is relevant depends on the facts.”); Enzo Biochem, Inc. v. Calgene, Inc., 188
F.3d 1362, 1371, 52 USPQ2d 1129, 1135 (Fed. Cir. 1999).
In order to make a rejection, the examiner has the initial burden to
establish a reasonable basis to question the enablement provided for the
claimed invention. Wright, 999 F.2d at 1562, 27 USPQ2d at 1513. The
Examiner made the following key findings with respect to the factors set out
in Wands:
The state of the prior art and the predictability or lack thereof in the
art. “[T]he prior art indicates that HPMC [hydroxypropyl methylcellulose]
is a known retardant and dose of drug and amount and type of excipients all
have an effect on release rates (See Bromet et al. (US Pat. 5,879,710),
Column 5, lines 1-5; Lee et al. (1999), pages 74-77). The Appellant argues
that the prior art does not exhibit the release profile of the claimed invention
as represented by Figure 1, yet the claimed invention also contains HPMC, a
known retardant. As such, it appears that predictability in the art is low”
(Answer 4-5).
The amount of direction or guidance present and the presence or
absence of working examples. “The Specification appears to provide only
one formulation that exhibits the release profile that the Appellant argues is
the exhibited by the claimed invention” (Answer 5).
The breadth of the claims and the quantity of experimentation needed.
“The claims are broad in that the only mentioned components are HPMC,
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