Appeal No. 2006-1304 Page 4
Application No. 10/214,058
F.3d 1365, 1370, 55 USPQ2d 1313, 1316 (Fed. Cir. 2000). A finding of motivation to
combine must be supported by a preponderance of the evidence. See In re Kahn, 441
F.3d 977, 989, 78 USPQ2d 1329, 1337 (Fed. Cir. 2006).
In this case, the claims require the combination, in a single pharmaceutical
composition, of amlodipine and atorvastatin. Appellant does not dispute that Roth
discloses atorvastatin or that Lazar discloses amlodipine. See the Appeal Brief, page 5
(“Appellant recognizes that the two specified agents were known per se.”).
The central issue in this appeal is whether those skilled in the art, without the
benefit of the present disclosure, would have been led to combine the known
compounds in the manner claimed. We conclude that Jukema’s teachings, as read by
those of ordinary skill in the art, would have led the skilled artisan to make the claimed
composition. See In re Hedges, 783 F.2d 1038, 1041, 228 USPQ 685, 687 (Fed. Cir.
1986) (When determining obviousness, “the prior art as a whole must be considered.
The teachings are to be viewed as they would have been viewed by one of ordinary
skill.”).
Jukema provides a retrospective analysis of a study that had been “designed to
determine the effect of lipid-lowering therapy with pravastatin.” Abstract. Jukema
analyzes the results found in patients who had been given pravastatin as part of the
previous study and who also had been taking any of several calcium channel blockers
(CCBs) at the same time. See the abstract (“To assess whether the two therapies may
have an additive or synergistic beneficial effect on human atherosclerosis, we reviewed
in this regard the data of the angiographic Regression Growth Evaluation Statin Study
(REGRESS) trial.”).
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