Appeal No. 2001-0982 Page 2
Application No. 08/310,950
16. A pharmaceutical composition comprising an admixture of (a)
prostacyclin or prostacyclin analog and at least one of (c) an
estrogen and (d) a progestin, wherein the amounts of (a) and (c)
and/or (d) are synergistincally effective and are individually
ineffective or marginally effective.
According to appellants’ dependent claims the prostacyclin or prostacyclin
analog may be iloprost (see e.g., claim 7), the progestin may be progesterone
(see e.g., claim 10), and the estrogen may be an estradiol (see e.g., claim 12).
As set forth in appellants’ specification (pages 9-10) the method aspect of the
invention involves administering a prostacyclin or a prostacyclin analog in a
amount bioequivalent to 0.1-10 ng/kg/min of prostacyclin intravenously, and one
or both of a progestin and an estrogen in an amount of estrogen bioequivalent to
approximately 2 mg per day of estradiol and an amount of progestin
bioequivalent to 50-300 mg of injected progesterone. Furthermore, the
specification states (page 10), “[a] synergistic effect is achieved when a
progestational and/or estrogenic agent is administered concurrently with the
prostacyclin or prostacyclin analog.”
The references relied upon by the examiner are:
Adams et al. (Adams), “Effects of Estrogens and Progestins on Atherosclerosis
in Primates,” in Sex steroids and the cardiovascular system, Schering
Foundation Workshop 5, pp. 161-175 (P. Ramwell et al., eds., Springer Verlag)
(1992)
Braun et al. (Braun), “Antiatherosclerotic Properties of Oral Cicaprost in
Hypercholesterolemic Rabbits,” Prostaglandins in the Cardiovascular System,
pp 282-288 (1992)
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