Appeal No. 2006-3012
Application No. 09/808,878
(citing Greendale6). Thus, Dr. Lobo declares that the “H.O.P.E. study
surprisingly demonstrated that at these low doses [1.5 mg MPA plus 0.3 or
0.45 mg CEE] MPA may contribute to ameliorating the vasomotor
symptoms.” Id.
We do not find the additive effect of MPA on vasomotor symptoms,
in combination with low doses of estrogen, to overcome the prima facie case
of obviousness. It is true that Greendale reports that MPA does not
contribute to reducing vasomotor symptoms when administered in
combination with 0.625 mg of CEE. See, e.g., page 986, last paragraph. It
is also true that Utian reports that the results of the HOPE study “suggest
that lower doses of CEE combined with MPA may be better than equivalent
lower doses of unopposed CEE for vasomotor symptom relief.” Page 1074,
left-hand column. Thus, this result of the HOPE study might well have been
unexpected in comparison to the earlier PEPI study reported by Greendale.
Unexpected results, however, must be established in comparison to
the closest prior art. See In re Baxter-Travenol Labs., 952 F.2d 388, 392, 21
USPQ2d 1281, 1285 (Fed. Cir. 1991).
Here, Greendale is not the closest prior art. The embodiment in the
prior art that is closest to the claimed method is that of Plunkett’s claim 42:
2.5 mg of MPA combined with 0.3 mg of CEE. Thus, the relevant question
is not whether the combination of claim 7 (1.5 mg MPA and 0.3 - 0.45 mg
CEE) is unexpectedly superior to 0.3 - 0.45 mg CEE alone. The relevant
6 Greendale et al., “Symptom relief and side effects of postmenopausal
hormones: Results from the Postmenopausal Estrogen/Progestin
Interventions Trial,” Obstetrics & Gynecology, Vol. 92, pp. 982-988 (1998).
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