Appeal No. 2006-3012
Application No. 09/808,878
commonly used dosage represents a commercially marketed product that is
designed to be administered to many patients. A dosage intended for
administration to many patients would necessarily contain a dosage that is
large enough to be effective in a large majority of patients but not so much
as to cause side effects or complications in a significant number. As taught
by Plunkett, the minimum effective dosage is determined patient-by-patient
and depends on factors including the body weight of an individual patient.
In addition, the method of claim 7 only requires administration of
CEE and MPA to control hot flushes (“vaosmotor symptoms”). Dr. Lobo’s
declaration, by contrast, addresses the amount of hormones allegedly
thought necessary “to relieve the symptoms of menopause, including hot
flushes and bone loss.” ¶ 2. The amount of hormones required to alleviate
hot flushes is not necessarily the same as the amount required to alleviate all
of the symptoms of menopause, including bone loss.
Finally, the evidence of record includes Utian.4 Utian states that
“[n]umerous small studies of short duration have found lower doses of
various estrogens to be effective in reducing the number and severity of hot
flushes, the effect being almost as great as that seen with the most
commonly prescribed HRT doses.” (Page 1066, left-hand column.) Utian
was published after the effective filing date asserted for the present
application but cites at least three prior art references in support of the
quoted statement.
4 Utian et al., “Relief of vasomotor symptoms and vaginal atrophy with
lower doses of conjugated equine estrogens and medroxyprogesterone
acetate,” Fertility and Sterility, Vol. 75, p. 1065-1079 (2001). The
co-authors of Utian include inventor James H. Pickar.
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