Appeal No. 1996-3016
Application 08/008,859
dosage in women having had spontaneous menopause who have low initial
spinal mineral content. Lindsay and associates (4) found 0.6 mg was
effective, and Horseman and coworkers (3) showed that ethinyl estradiol,
0.02 mg, a dose equivalent to 0.6 mg of conjugated estrogens, was also the
minimum protective dosage. Christensen and associates (2) found that 1
mg of estradiol-17ß, combined with 800 mg of calcium supplementation,
was sufficient to maintain bone mineral.
The reference cited in Ettinger as “Lindsay and associates (4)” is Lindsay 1984 relied
upon by the examiner in maintaining the rejection under 35 U.S.C. § 103. Ettinger was
published in 1987, three years after Lindsay 1984. Thus, to the extent Lindsay 1984
speculated about the effectiveness of a lower dose of conjugated estrogens in treating
osteoporosis, workers in the art three years later still considered 0.6 mg/day to be the
LED of conjugated estrogens.
We have considered the remaining references relied upon by the examiner but do
not find that they teach or suggest the use of from about 0.2 to about 0.8 LED of an
estrogen hormone in treating osteoporosis.
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