Appeal No. 2006-1083 Page 2
Application No. 09/799,251
Background
According to appellants, “[t]reatment protocols using estrogen [ ] significantly
reduce the risks of cardiovascular disease and osteoporosis . . . [and] [t]he protective
effect of estrogen against heart disease is related to its ability to raise levels of circulating
HDL and lower levels of LDL.” Specification, page 2. Nevertheless, “long-term use of
estrogens is positively correlated with an increased risk for endometrial cancer
development. This risk may be reduced by simultaneous administration of a progestin,
which prevents overgrowth of endometrial cells . . . [but] [t]his form of combination
therapy [ ] apparently diminishes the beneficial effects of estrogen on the plasma lipid
profile.” Id.
Certain carotenoids, on the other hand, have been shown to exhibit various
beneficial effects. For example, “[t]he carotenoid astaxanthin has been demonstrated to
have anti-tumorigenic effects . . . in rodent models” (id., page 4), “phytoene has also
demonstrated anti-cancer activity” (id.), while lycopene “is strongly associated with anti-
oxidant and anti-cancer activities” (id., page 5).
The specification describes compositions, in unit dosage form, “compris[ing] a
physiologically effective amount of at least one hormone and at least one carotenoid in
an [effective] amount” (id., page 10), which “can be used to prevent the adverse effects
associated with the administration of . . . hormones such as, for example, steroidal
estrogens and progestins, without inhibiting the beneficial activity of such hormones.”
Id., page 7.
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