Appeal No. 2006-3012
Application No. 09/808,878
as the most commonly prescribed dosage combination of CEE and MPA.”
(Page 1073, right-hand column.)
Importantly, Utian expresses no surprise at this result: “These
findings are consistent with results of previous studies that examined the
efficacy of lower estrogen dosages for relief of vasomotor symptoms. . . .
The results reported here are especially relevant because they confirm the
effectiveness of lower doses of CEE and MPA . . . in the context of a large
clinical trial.” (Paragraph bridging pages 1073 and 1074, emphases added.)
Thus, Utian provides evidence that a person of ordinary skill in the art
in the field of hormone replacement therapy would have been aware of
“numerous small studies” showing that low doses of estrogen had been
shown to be effective in treating hot flushes. Utian also provides evidence
that a person of ordinary skill in the art would have found the results of the
HOPE study – and the results reported in the instant specification – to be not
unexpected but “consistent with results of previous studies”; in other words,
expected.
Appellant also argues that “the H.O.P.E. study further unexpectedly
showed an additive effect of MPA at low doses.” (Br. 10, citing the First
Lobo Declaration.) In that declaration, Dr. Lobo declares that the “H.O.P.E.
study demonstrated that dosages of CEE and MPA may be better than
equivalent dosages of unopposed CEE for vasomotor symptom relief.” ¶ 15.
This result is said to be unexpected because “[p]revious studies with various
dosages of CEE showed no additive effect of MPA on vasomotor relief.” Id.
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