Appeal No. 1997-2751
Application No. 08/159,096
instance, and if the applicant comes forward with reasonable rebuttal, whether
buttressed by experiment, prior art references, or argument, the entire merits of
the matter are to be reweighed.” In re Hedges, 783 F.2d 1038, 1039, 228 USPQ
685, 686 (Fed. Cir. 1986). The fact that the examiner did not rely on these
references in her rejection does not make a response to their citation by
Appellants a new ground of argument. On the contrary, the examiner is required
to reweigh the merits of the entire rejection in view of whatever argument, prior
art, or experimental evidence is presented by an applicant in rebuttal. See id.;
see also In re Rinehart, 531 F.2d 1048, 1052, 189 USPQ 143, 147 (CCPA 1976)
(“When prima facie obviousness is established and evidence is submitted in
rebuttal, the decision-maker must start over.”).
New Ground of Rejection
Under the provisions of 37 CFR § 1.196(b), we make the following new
ground of rejection: The specification is objected to, and claims 1-14 are
rejected, under 35 U.S.C. § 112, first paragraph, because the specification does
not enable a person of skill in the art to make and use the claimed invention. As
evidence supporting our conclusion of non-enablement, we rely on the
references of record by Alpar, Kanis, Reid, Finerman, Henricson, and Lenehan.
Appellants’ specification accurately summarizes the expectation of those
skilled in the art that bisphosphonate compounds would interfere with, not aid,
the fracture healing process. See the Specification at page 1:
As the compounds bind to bone mineral and inhibit bone resorption,
there has been general concern that bisphosphonates could have a
deleterious effect on callus formation and remodelling, which is an
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