Appeal No. 2006-3204 Page 3
Application No. 10/057,629
. . . employing . . . ezetimibe with simvastatin, a HMG-CoA reductase inhibitor
and/or cholestyramine, . . . to treat sitosterolemia.” Id. at 4.
Belamarich is cited for teaching that “hypercholesterolemia is one of the
manifestation[s, sic] of sitosterolemia,” and that a low-sterol diet, as well as
cholestyramine, are effective in lowering sterol and cholesterol levels in
sitosterolemic patients. Id.
The examiner concludes:
It would have been obvious to one of ordinary skill in the art
at the time the invention was made to employ ezetimibe with
simvastatin and/or cholestyramine, . . . to treat sitosterolemia.
One of ordinary skill in the art would have been motivated to
employ ezetimibe with simvastatin and/or cholestyramine, . . . to
treat sitosterolemia. [Rosenblum] teaches the combination of
simvastatin and ezetimibe as useful in reducing cholesterol level.
Employing the combination of simvastatin and ezetimibe in a
method to reduce cholesterol level and thereby treating
sitosterolemia, a condition known to have elevated cholesterol
level, would have been reasonably expected to be effective, absent
evidence to the contrary. Moreover, cholestyramine is known to be
effective in lowering cholesterol in sitosterolemic patient.
Therefore, administering all three compounds concomitantly for the
very same purpose would have been obvious to one of ordinary
skill in the art (See In re Kerkhoven, 205 USPQ 1069).
Id. at 4-5.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness. Only if that burden is
met, does the burden of coming forward with evidence or argument shift to the
applicant.” In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir.
1993) (citations omitted). The test of obviousness is “whether the teachings of
the prior art, taken as a whole, would have made obvious the claimed invention.”
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