Appeal No. 2005-0545
Application No. 09/989,019
since lipolytic agents such as caffeine and theophylline were
reported to cause adverse effects (Sekiya, col. 1, l. 11-26).
Persons having ordinary skill in the art would have known that PDE
inhibition and lipolytic activity are agent/dose dependent.
However, not all strong PDE inhibitors are strong lipolytic agents
and vice versa. See Kuppusamy, p. 1309, Table 2. Accordingly, it
prima facie would have been obvious in view of either the implicit
and explicit teachings of the applied prior art to combine two or
more of the agents described by the applied prior art to promote fat
degradation and/or lean body mass, control digestion and absorption
of lipids, increase lipolysis, inhibit phosphodiesterase activity,
cause slimming, treat obesity and regenerate tissue by the same or
different mechanisms in amounts effective to promote that desired
activity without undesirable side effects.
Having determined that a prima face case of obviousness has
been established in view of the combined prior art teachings, we
consider Pugliese’s evidence of nonobviousness. Pugliese’s primary
evidence of nonobviousness is the Declaration of P.T. Pugliese under
37 C.F.R. §1.68 and 1.132, dated April 30, 2001, including attached
Exhibits A, B and C (Paper No. 5). According to Dr. Pugliese,
Formulas #1, #2 and #3 (Spec., pp. 10-12), each comprising the
isoflavone genistein, were evaluated for efficacy in treating the
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