Appeal No. 2006-3012
Application No. 09/808,878
specific dosages claimed herein in a method of treating hot
flashes because they (dosages herein) fall within the therapeutic
ranges of the conjugated equine estrogen/medroxyprogesterone
taught by the prior art. Optimization of amounts is within the
purview of the Skilled Artisan, and is therefore obvious absent
evidence to the contrary.
(Id. at 4.)
We agree with the Examiner that Plunkett’s teachings would have
made the method of claim 7 prima facie obvious. Plunkett does not
specifically disclose a method of controlling hot flushes by administering 1.5
mg/day of MPA in combination with 0.3 to 0.45 mg/day of CEE. However,
Plunkett teaches a method of controlling hot flushes (col. 3, ll. 51-53) by
“continuously and uninterruptedly administering a progestogen and an
estrogen” (col. 3, ll. 8-9). One “especially preferred combination[ ]” is
conjugated equine estrogen and medroxyprogesterone acetate (col. 6, l. 53;
col. 7, ll. 10-11), the same compounds recited in claim 7.
Plunkett discloses dosages of conjugated equine estrogens ranging
from a minimum of 0.300 mg/day to a maximum of 2.5 mg/day; 0.600
mg/day is disclosed as preferred (col. 4, l. 65). Plunkett discloses dosages of
MPA ranging from a minimum of 1 mg/day to a maximum of 15 mg/day;
2.5 mg/day is disclosed as preferred (col. 5, l. 50). Plunkett claims methods
involving administering less than the “preferred dosage” of MPA or
conjugated equine estrogens. See claim 32 (about 1 to about 2.5 mg/day
MPA); claim 35 (about 0.300 to about 0.600 mg/day CEE); and claim 42
(about 2.5 mg/day MPA and about 0.300 mg/day CEE). Thus, Plunkett
discloses dosage ranges for those compounds that encompass the dosages
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