Appeal No. 1996-3016
Application 08/008,859
equine estrogens per day would exhibit 50% efficacy,” which “suggests significant
retardation of bone loss would occur at this dose level, although it was not tested.”
In considering this aspect of Lindsay 1984, we do not find that it reasonably teaches
the administration of less than the LED of an estrogen hormone for the purpose of treating
osteoporosis. Reading Lindsay 1984 in its entirety, the reference reasonably suggests
that conjugated estrogens would have to be administered in doses of at least 0.625
mg/day in order to be an effective treatment of osteoporosis. As stated in the paragraph
bridging pages 761-62 of Lindsay 1984, “all groups of individuals treated with less than
0.625 mg per day showed evidence of bone loss.” The portion of Lindsay 1984 relied
upon by the examiner refers to a constructed dose response curve and only indicates that
the curve “suggests” that 0.45 mg of conjugated equine estrogens per day would exhibit
50% efficacy. As indicated in Lindsay 1984, such low amounts were not tested so that the
proposition remains a supposition.
We point to Ettinger, of record, in further support that at the time of the present
invention, those of ordinary skill in the art recognized that the LED of conjugated estrogens
thought to be useful in preventing osteoporosis was 0.6 mg/day. See the paragraph
bridging the columns on page 40 of Ettinger. As set forth in the first full paragraph of the
left-hand column of page 44 of Ettinger:
The dose-response relation for the osteotrophic effect of various
estrogens has been evaluated previously, and we have shown that 0.6 mg/d
of conjugated estrogens was required to protect oophorectomized women
against bone loss (1). Our present study confirms the effectiveness of this
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