Appeal No. 2004-1823 Page 2
Application No. 09/148,012
8. The method of claim 1 wherein the mammal is a female and the compound is
administered in an amount effective to prevent normal reproductive function.
The examiner does not rely upon prior art in any of the pending rejections.
Claims 1-10, 12, 15, 16, and 20-22 stand rejected under 35 U.S.C. § 112, first
paragraph (written description). Claims 1-10, 15, 16, and 20-22 stand rejected under 35
U.S.C. § 112, first paragraph (enablement). Claims 1-10, 12, 15, 16, and 20-22 stand
rejected under 35 U.S.C. § 112, second paragraph. We vacate the examiner’s written
description and enablement rejections and reverse the indefiniteness rejection. In
addition, we make a new ground of rejection under the provisions of 37 CFR §41.50(b).
Background
SR-BI receptor is expressed principally in steroidogenic tissues and liver.
Specification, page 6. The SR-BI is stated to mediate HDL-transfer and uptake of
cholesterol. Id. Appellant states that “SR-BI might play a major role in transfer of
cholesterol from peripheral tissues, via HDL, into the liver and steroidogenic tissues,
and that increased or decreased expression in the liver or other tissues may be useful in
regulating uptake of cholesterol by cells expressing SR-BI . . . .” Id. The present
invention is summarized as follows:
SR-BI is present at relatively high levels on the membranes of
hepatocytes and steroidogenic tissues, including the adrenal gland, testes,
and ovaries, where it mediates the uptake and transport of cholesteryl
ester from high density lipoproteins. It has been demonstrated that
transgenic animals which do not produce SR-BI are healthy, with the
exception that the females are infertile. This provides evidence that
inhibition of uptake, binding or transport of cholesteryl ester to SR-BI can
be used to inhibit pregnancy. The same pathway can also be used to
decrease production of steroids, and therefore be used as a therapy for
disorders involving steroidal overproduction and disorders treated with
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