Appeal No. 2006-3204 Page 11
Application No. 10/057,629
I agree with the examiner that these teachings would have made it
obvious to administer the ezetimibe taught by Rosenblum to a patient having
sitosterolemia. Motivation to do so is provided by the cited references:
Belamarich teaches that cholestyramine, a bile-acid binding resin, is an effective
treatment for sitosterolemia. Those skilled in the art recognized that bile acid
binding resins act by inhibiting absorption of sterol-containing bile acids. See
Salen. Rosenblum teaches that ezetimibe inhibits intestinal absorption of
cholesterol. Based on the similar mechanisms of action of cholestyramine and
ezetimibe, and the known effectiveness of cholestyramine in treating
sitosterolemia, those of skill in the art would have been led to administer
ezetimibe with a reasonable expectation that it would be an effective treatment of
sitosterolemia.
The majority focuses on the reasoning that the examiner provided for
combining the references: that it would have been obvious to use a combination
of simvastatin, ezetimibe, and cholestyramine to treat patients having
sitosterolemia because those patients also suffer from high serum cholesterol
(hypercholesterolemia) and Rosenblum teaches that the combination of
simvastatin and ezetimibe is effective in lowering serum cholesterol. The
majority finds this reasoning flawed because the evidence of record shows that
HMG-CoA reductase inhibitors (i.e., statins such as simvastatin) are ineffective in
lowering cholesterol levels in sitosterolemic patients.
I agree with my colleagues that the prior art of record would not have led
those skilled in the art to expect a statin to lower cholesterol levels in a patient
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