Appeal No. 2006-3012
Application No. 09/808,878
suggested to those skilled in the art that the use of 1.5 mg MPA in
combination with about 0.3 to about 0.45 mg CEE would have been
reasonably successful in providing relief of vasomotor symptoms of
menopause.” (Br. 8.)
The evidence of record does not support Appellant’s position that
those skilled in the art would have expected the lower dosages of MPA and
CEE disclosed by Plunkett to be unsuccessful in controlling hot flushes. The
Second Lobo Declaration does not support the weight Appellant puts on it.
In that declaration, Dr. Lobo declares that “[f]or the past 20 years, the
dosage of 0.625 mg CEE has been accepted as the minimum dosage of
estrogen necessary to relieve the symptoms of menopause, including hot
flushes and bone loss.” ¶ 2. As support for this statement, Dr. Lobo cites
Sobel2 and Kronenberg.3 These references, however, do not state that 0.625
mg/day of CEE was accepted as the minimum effective dosage.
Sobel states that the standard dose of conjugated estrogens was 0.625
mg (page 313). Kronenberg states that the “most commonly used regimen
for treating hot flashes in the United States is 0.625 to 1.25 mg of oral
conjugated equine estrogens (Premarin)” (page 109, emphasis added). A
dose that is “standard” or a regimen that is “most commonly used,”
however, is not necessarily the same as a dosage or regimen that is
considered the minimum effective dose. Rather, a standard or most
2 Sobel, “Progestins in preventative hormone therapy,” Obstetrics and
Gynecology Clinics of North America, Vol. 21, No. 2, pp. 299-319 (1994).
3 Kronenberg, “Chap. 9 Hot Flashes,” in Treatment of the Postmenopausal
Woman: Basic and Clinical Aspects, R.A. Lobo (ed.), Raven Press, NY, pp.
97-117 (1994).
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