Appeal No. 1996-3016
Application 08/008,859
dose is “the minimum dose of active which is effective, by itself, to cause a significant
inhibition of bone resorption.” The specification indicates at page 20, lines 9-22:
Similarly, the LED of the estrogen hormone is that level of the hormone
which, by itself, is effective to prevent bone loss in subjects having
osteoporosis. That level is generally recognized to be about 0.625 mg per
day of conjugated estrogen or an equivalent dose of other estrogen
hormones (for example, 25 µg per day of ethinyl estradiol; or 2 mg per day of
17-ß-estradiol). See, Barzel, “Estrogens in the Prevention and Treatment of
Post-Menopausal Osteoporosis: a Review”, 85 American Journal of
Medicine 847 (1988); Lindsay, et al., “The Minimum Effective Dose of
Estrogen for Prevention of Post-Menopausal Bone Loss”, 63 Obstetrics and
Gynecology 759 (1984); Ganant et al., “Effect of Estrone Sulfate on
Postmenopausal Bone Loss”, 76 Obstetrics and Gynecology 529 (1990); all
of which are incorporated by reference herein.
In reviewing the examiner’s statement of the rejection on pages 4-5 of the
Answer, we find that the examiner has failed to come to grips with the key claim limitation
that the estrogen is used in an amount of about 0.2 to about 0.8 LED. As seen from page
20 of the specification, the LED of conjugated estrogen is 0.625 mg/day, ethinyl estradiol
is 25 micrograms and 7-ß-estradiol is 2 mg/day. Lindsay 1984 confirms that the minimum
effective dose of estrogen for preventing bone loss is 0.625 mg/day. To account for that
aspect of the claimed invention which requires that estrogen be used in an amount less
than the LED, the examiner points to that disclosure in Lindsay 1984 which discusses a
dose response curve. For example, in the paragraph bridging pages 761-62, Lindsay
indicates that the constructed dose response curve “suggests that 0.45 mg conjugated
5
Page: Previous 1 2 3 4 5 6 7 8 9 Next
Last modified: November 3, 2007