Appeal No. 2006-3012
Application No. 09/808,878
In summary, after considering all of the evidence of record, we find
that the weight of the evidence does not support Dr. Lobo’s assertion that
0.625 mg/day of CEE was considered the minimum daily dosage required to
control hot flushes at the time the claimed method was made.
Dr. Lobo also states that the “dosage of 2.5 mg of MPA has been
recognized as the minimum amount needed to oppose 0.625 mg CEE and
protect the endometrium.” ¶ 2. No evidence is cited to support this
assertion but regardless of its accuracy, Dr. Lobo’s declaration does not
address what dosages of MPA would have been expected to be necessary to
oppose CEE at the lower dosages suggested by Plunkett – 0.3 to 0.6 mg/day.
Appellant also asserts that he has provided evidence of unexpected
results to rebut any prima facie case of obviousness. (Br. 9-12; Reply Br.
5-8.) Appellant points to Dr. Lobo’s discussion of the “Women’s Health,
Osteoporosis, Progestin, Estrogen (H.O.P.E.)” study and the results of that
study that are reproduced in the instant specification. In his first declaration,
Dr. Lobo states:
I and others expected that the study would show that there
would be a dose response such that the lower combination
doses of CEE and MPA would have some effect in reducing the
number and severity of hot flushes compared with the placebo,
but far less of an effect than the standard dose of CEE 0.625
[mg] plus 2.5 mg MPA. In fact, I and others were interested in
seeing the results of the various lower doses, but doubted the
study was worth the economic effort.
(First Lobo Declaration, ¶ 12.) Dr. Lobo states that “[i]t was very surprising
and unexpected” that a daily dosage of 1.5 mg MPA combined with 0.3 or
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