Appeal 2007-0181
Application 10/057,323
99 (Fed. Cir. 1988). In order to determine whether a prima facie case of
obviousness has been established, we considered the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1996); (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present. We find that the Examiner has set
forth a prima facie case of obviousness, and the rejection is affirmed.
Appellants argue that neither Rosenblum nor Medical Letter provides
motivation for substituting a PPAR such as fenofibrate for the statin used in
combination with the ezetimibe as taught by Rosenblum, as Medical Letter
teaches at page 68 that fenofibrate is not as effective as the statins in
lowering LDL cholesterol, a major risk factor in atherogenesis (Br. 9-10).
Moreover, according to Appellants, “[t]here is no guidance provided by
Rosenblum [ ] nor Medical Letter to pick and choose among numerous
cholesterol treatments to select the particularly claimed combination of
sterol adsorption inhibitor . . . (e.g., ezetimibe)[ ] and PPAR activator (such
as fenofibrate).” (Id. at 10).
Rosenblum teaches that the disclosed compounds, such as ezetimibe,
lower serum lipid levels, and in particular, serum cholesterol levels
(Rosenblum, col. 20, ll. 39-40). The compounds “inhibit the intestinal
absorption of cholesterol and . . . significantly reduce the formation of liver
cholesteryl esters,” and are thus hypocholesterolemic agents, useful in the
treatment and prevention of atherosclerosis (id. at ll. 42-48). In addition,
Rosenblum teaches that the compounds of the invention, such as ezetimibe,
may be administered in combination with a cholesterol biosynthesis inhibitor
(id. at col. 21, ll. 26-28).
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