Appeal No. 2006-3204 Page 12
Application No. 10/057,629
with sitosterolemia. Therefore, I agree that the rejection of claims 16-18, 22-24,
33, 41, 42 should be reversed.
The remaining claims, however, do not require administering a statin.
Statins act in a completely different way than cholestyramine and ezetimibe.
Statins inhibit cholesterol biosynthesis (Rosenblum; column 6, lines 37-39), while
cholestyramine and ezetimibe inhibit sterol absorption. The defect underlying
sitosterolemia was known to involve sterol absorption (Belamarich; page 977,
right-hand column). Therefore, the ineffectiveness of statins would not, in my
opinion, have led those skilled in the art to doubt the effectiveness of treating
sitosterolemia with ezetimibe. For the reasons discussed above, I conclude that
claims 1, 8-11, 13-15, 19-21, 32, 34-40, 43-45 and 53-56 would have been
obvious to those of ordinary skill in the art. I would affirm the rejection of those
claims.
Appellant argues that the references would not have suggested that
ezetimibe would be useful for treating sitosterolemia. Appeal Brief, pages 11-13.
This argument is adequately addressed above. In addition, Appellant argues that
the claimed method solved a long-felt need in the art. Appellant cites Hidaka and
Nguyen as evidence that “those of ordinary skill in the art were working on the
problem of treating sitosterolemia without the deleterious side effects associated
with cholestyramine.” Id., page 14. Appellant cites Steiner as evidence that “this
long-felt need has been successfully satisfied by ZetiaŽ ezetimibe formulation.”
Id., page 16. Appellant concludes that the claimed method “has successfully
met” the “need for a treatment for sitosterolemia with less likelihood of
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