Appeal No. 2006-3204 Page 6
Application No. 10/057,629
Therefore, the references as combined do not teach or suggest that
known cholesterol lowering agents may be used in the treatment of
sitosterolemia, but in fact teach that patients with sitosterolemia respond
differently to known cholesterol-lowering agents than hypercholesterolemic
patients, and we find that the examiner has not set forth a prima facie case of
obviousness. Moreover, even if we were to assume for the sake of argument
that the combination suggests the use of ezetimibe in the treatment of
sitosterolemia, at most, it merely would have obvious to try its use, “[b]ut,
‘obvious to try’ is not the standard,” and the rejection of the claims must be
reversed. Ecolochem, Inc. v. Southern California Edison Co., 227 F.3d 1361,
1374, 56 USPQ2d 1065, 1075 (Fed. Cir. 2000).
The dissent bases its conclusion that it would have been obvious to use
ezetimibe to treat sitosterolemia “[b]ased on the similar mechanisms of action of
cholestyramine and ezetimibe.”
Rosenblum, however, discloses that ezetimibe exerts its therapeutic effect
“by virtue of [its] ability to inhibit absorption and/or esterification of cholesterol.”
Rosenblum, col. 20, lines 44-46. In contrast, cholestyramine is a bile-
sequestering resin. See Hikada, abstract. That is, cholestyramine is a
quaternary ammonium exchange resin with a polystyrene polymer skeleton, and,
as the chloride salt, it binds to bile acids. See Casdorph,7 page 293, column 1.
With the increased loss of bile acids in stool, there is also a reduction in serum
7 Casdorph, “Hypercholesteremia: Treatment with Cholestyramine, a Bile Sequestering Resin,”
California Medicine, Vol. 106, pp. 293-95 (1967).
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