Appeal No. 2004-1823 Page 3
Application No. 09/148,012
drugs that decrease steroids, such as endometriosis, and breast and
prostate cancer.
Id., page 7, second paragraph.
Appellant also states that “SR-BI has now been confirmed as the principal
mediator of cholesteryl ester transport from peripheral tissues to the liver and other
steroidogenic tissues, including the adrenal gland, testes and ovaries.” id., page 10,
and “[i]nhibition of SR-BI can . . . be used to limit steroid production in steroidogenic
tissues, and serve either as a means of contraception or a means of treating disorders
associated with overproduction of steroids.” Id., page 11.
Of particular interest in this appeal are the data set forth in Example 6 which
show that deletion of SR-BI can be effective as a contraceptive. Example 6 describes
the generation of mice containing a targeted null mutation in the gene encoding SR-BI.
Specification, page 45. The mutants generated in Example 6 are stated to have “looked
normal (weight, general appearance and behavior) and the males were fertile. No
offspring from female homozygous mutants have been obtained following multiple
attempts to do so, indicating a substantial, and possibly complete, decrease in fertility in
these females.” Id., page 49. Example 7 refers to several studies conducted to
determine why the female homozygous knockout mice were infertile.
A reading of the entire specification indicates that SR-BI plays a role in
transporting cholesterol to steroidogenic tissues and the liver. One effect from inhibiting
SR-BI activity is to lower fertility in females. Thus, inhibition of SR-BI in females is
stated to be useful as a contraceptive and indeed in Example 6 homozygous female
mice having no SR-BI activity were found to be infertile. Notably missing from the
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