Appeal No. 2006-3204 Page 13
Application No. 10/057,629
deleterious side effects such as those associated with treatment with
cholestyramine.” Id., page 18.
The majority reverses for lack of a prima facie case and thus has no need
to address this argument. I would reach it, but I find it unpersuasive for the
following reasons. First, although Hidaka states that cholestyramine can have
side effects,9 it does not disclose a specific problem and provide evidence that
those in the art were attempting to solve that problem. “[L]ong-felt need is
analyzed as of the date of an articulated identified problem and evidence of
efforts to solve that problem.” Texas Instruments, Inc. v. International Trade
Comm., 988 F.2d 1165, 1178, 26 USPQ2d 1018, 1029 (Fed. Cir. 1993). Neither
Hidaka nor any other reference identified by Appellant articulates a specific,
identified problem with existing sitosterolemia treatments and provides evidence
of efforts to solve that problem.
Second, Appellant defines the need allegedly met by ezetimibe as a “need
for a treatment for sitosterolemia with less likelihood of deleterious side effects
such as those associated with treatment with cholestyramine.” Appeal Brief,
page 18. This definition of the “long-felt need”, in addition to lacking support in
the evidence, sets the bar too low to be useful in an obviousness analysis.
Under Appellant’s standard, any incremental improvement in a method of
treatment would satisfy a “long-felt need” if it is more effective, or effective in
more patients, than pre-existing treatments. Thus, for example, substituting
9 “The patient had been treated with cholestyramine, but unfortunately could not tolerate the
treatment because of her associated hemorrhoids.” Page 61, right-hand column.
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