Appeal No. 1999-2330
Application No. 08/219,200
An analysis of whether the claims under appeal are supported by an enabling
disclosure requires a determination of whether that disclosure contained sufficient
information regarding the subject matter of the appealed claims as to enable one skilled
in the pertinent art to make and use the claimed invention.
In order to establish a prima facie case of lack of enablement, the examiner has
the initial burden to establish a reasonable basis to question the enablement provided
for the claimed invention. See In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d
1510, 1513 (Fed. Cir. 1993) (examiner must provide a reasonable explanation as to
why the scope of protection provided by a claim is not adequately enabled by the
disclosure). See also In re Morehouse, 545 F2d 162, 192 USPQ 29 (CCPA 1976).
The threshold step in resolving this issue is to determine whether the examiner has met
his burden of proof by advancing acceptable reasoning inconsistent with enablement.
In support of the rejection for lack of enablement, the examiner argues (Answer,
pages 2-3):
In vitro and animal model studies have not correlated well with in
vivo clinical trials in patients. Since the therapeutic indices of
immunosuppressive drugs such as adhesion-based biopharmaceutical
drugs can be species- and model-dependent, it is not clear that reliance
on the experimental observations of inhibiting cognate T:B interaction s
[sic] with anti-CD28 antibodies and anti-B7 antibodies provides the basis
for employing CD28Ig and B7 Ig fusion proteins (CD28 immunoglobulin
fusion protein and B7 immunoglobulin fusion protein)... It is noted that
B7Ig inhibited CD28-mediated adhesion in vitro to a lesser degree than
the CD28-specific antibody 9.3 and that CD28Ig did not inhibit said in vitro
adhesion (see page 64 of the instant specification). In addition, B7Ig in
solution showed a modest enhancement of proliferation of T cells in vitro
even though anti-CD28 antibody 9.3 was effective (page 65 of the instant
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