Appeal No. 1996-3016
Application 08/008,859
least about 0.1 LED per day of said treatment; and and [sic] administering an estrogen
hormone to said subject, at a level of from about 0.2 to about 0.8 LED per day of said
treatment.
16. A unit dosage form composition, for the treatment of osteoporosis, comprising:
(a) at least about 0.1 LED of a bone-active phosphate;
(b) from about 0.2 to about 0.8 LED of an estrogen hormone; and
(c) a pharmaceutically-acceptable carrier.
19. A unit dosage form composition, according to Claim 16, wherein said bone-
active phosphonate is 2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonic acid, or a
pharmaceutically-acceptable salt or ester thereof.
20. A unit dosage form composition according to Claim 19, wherein said estrogen
hormone is estradiol.
The references relied upon by the examiner are:
Francis et al. (Francis), “Chemical, Biochemical, and Medicinal Properties of the
Diphosphonates,” The Role of Phosphonates in Living Systems, Chapter 4, pp. 55-96
(1983)
Chesnut III, “Synthetic salmon calcitonin, diphosphonates, and anabolic steroids in the
treatment of postmenopausal osteoporosis,” Osteoporosis 2, Copenhagen International
Symposium on Osteoporosis, pp. 549-55 (June 3-8,1984)
Lindsay et al. (Lindsay 1984), “The Minimum Effective Dose of Estrogen for Prevention of
Postmenopausal Bone Loss,” Journal of the American College of Obstetricians and
Gynecologists, Vol. 63, No. 6, pp. 759-63 (1984)
Lindsay et al. (Lindsay 1985), “Osteoporosis Current Concepts,” Bulletin of The New York
Academy of Medicine, Vol. 61, No. 4, pp. 307-22 (May 1985)
Wronski et al. (Wronski), “Endocrine and Pharmacological Suppressors of Bone Turnover
Protect against Osteopenia in Ovariectomized Rats,” Endocrinology, Vol. 125, No. 2, pp.
810-16 (1989)
A reference of record discussed by this merits panel is:
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