Appeal No. 2006-3204 Page 5
Application No. 10/057,629
Appellant cites Hidaka,4 Nguyen5 and Salen,6 all of which teach that HMG-CoA
reductase inhibitors such as lovastatin and pravastatin are ineffective in the
treatment of sitosterolemia.
Thus, Hidaka teaches that “[p]ravastatin had little effect in a sitosterolemic
patient on plasma levels of sterols, where cholestyramine decreased the plasma
levels of both cholesterol and cholestanol.” Hidaka, abstract. Salen teaches that
“[l]ovastatin, a competitive inhibitor of cholesterol biosynthesis that is widely used
in the treatment of hypercholesterolemia has been tried but has not been an
effective treatment in sitosterolemia.” Salen, page 952, paragraph bridging the
two columns. Nguyen also teaches that lovastatin is “ineffective” in the treatment
in sitosterolemia. Nguyen, page 1942, first column. Moreover, Nguyen suggests
that differences in responses may be used diagnostically. Specifically, Nguyen
teaches that “[t]he therapies with cholestyramine and lovastatin not only support
our contention of the fundamental abnormality in the regulation of cholesterol
biosynthesis that underlies sitosterolemia, but the response to these therapies
can also be used to detect sitosterolemia. . . . Therefore, the failure to respond
to lovastatin and a substantial response to cholestyramine may suggest
sitosterolemia . . . .” Id. at page 1946, second column.
4 Hidaka et al. (Hidaka), “Effects of an HMG-CoA Reductase Inhibitor, Prevastatin, and Bile
Sequestering Resin, Cholestyramine, on Plasma Plant Sterol Levels in Hypercholesterolemic
Subjects,” Journal of Atherosclerosis and Thrombosis, Vol. 2, No. 1, pp. 60-65 (1995).
5 Nguyen et al. (Nguyen), “Regulation of cholesterol biosynthesis in sitosterolemia: effects of
lovastatin, cholestyramine, and dietary sterol restriction,” Journal of Lipid Research, Vol. 32,
pp. 1941-48 (1991).
6 Salen et al. (Salen), “Sitosterolemia,” Journal of Lipid Research, Vol. 33, pp. 945-55 (1992).
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