Appeal No. 2006-1304 Page 3
Application No. 10/214,058
b. an amount of atorvastatin or a pharmaceutically acceptable salt thereof;
and
c. a pharmaceutically acceptable carrier or diluent.
Thus, claim 1 is directed to composition comprising amlodipine (or a salt thereof),
atorvastatin (or a salt thereof), and a pharmaceutically acceptable carrier.
2. Obviousness in view of Roth, Lazar, and Jukema
The examiner rejected claims 1, 3, 118-120, 124, 125, and 128-141 under 35
U.S.C. § 103 on the basis that the claimed subject matter would have been obvious in
view of Roth,1 Lazar,2 and Jukema.3 The examiner relies on Roth and Lazar for their
respective teachings of atorvastatin and amlodipine. See the Examiner’s Answer,
pages 4-5. The examiner relies on Jukema as evidence that a person of ordinary skill in
the art would have been led to combine the known compounds and thereby create the
composition defined by claim 1. See id., pages 6-8.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden
of presenting a prima facie case of obviousness.” In re Rijckaert, 9 F.3d 1531, 1532, 28
USPQ2d 1955, 1956 (Fed. Cir. 1993). “[I]dentification in the prior art of each individual
part claimed is insufficient to defeat patentability of the whole claimed invention.
Rather, to establish obviousness based on a combination of the elements disclosed in
the prior art, there must be some motivation, suggestion or teaching of the desirability of
making the specific combination that was made by the applicant.” In re Kotzab, 217
1 Roth, U.S. Patent 5,273,995, issued December 28, 1993.
2 Lazar et al., U.S. Patent 5,155,120, issued October 13, 1992.
3 Jukema et al., “Evidence for a synergistic effect of calcium channel blockers with lipid-lowering therapy
in retarding progression of coronary atherosclerosis in symptomatic patients with normal to moderately
raised cholesterol levels,” Arteriosclerosis, Thrombosis, and Vascular Biology, Vol. 16, pp. 425-430
(1996).
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