Appeal No. 2006-3204 Page 7
Application No. 10/057,629
cholesterol. Id. Therefore, the only similarity that ezetimibe and cholestyramine
is that both have been shown to lower cholesterol in hypocholestermic patients.
But, by the dissent’s reasoning, all classes of cholesterol lowering drugs would
have “similar mechanisms of action.”
As indicated by the evidence submitted by appellants, not all cholesterol
lowering agents are effective in treating sitosterolemia. The physiological defect
in sitosterolemia is the increase in intestinal absorption of dietary plant sterols,
not the metabolism of cholesterol. The assumption that all cholesterol lowering
agents would be effective in the treatment of sitosterolemia was demonstrated to
be incorrect as statins were shown to be ineffective in treating sitosterolemia.
Thus, once the assumption was proven wrong, there would have been no
expectation of using other cholesterol lowering agents in the treatment of
sitosterolemia.
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