Appeal No. 2004-1823 Page 7
Application No. 09/148,012
of cholesterol or cholesteryl ester to a method to enhance or restore fertility or treat a
reproductive disorder in a female mammal by administering a compound that alters
lipoprotein, LDL, HDL or cholesterol levels without regard to SR-BI. The original
disclosure of this application only describes a single mode of affecting fertility in a
female mammal, i.e., SR-BI knockout female mice are infertile. There is no disclosure
that fertility may be enhanced or restored as now claimed by simply altering lipoprotein,
LDL, HDL or cholesterol levels in the female mammal.
Further evidence that claim 1 is directed to an entirely new concept not described
in the original disclosure is seen by the continued presence of claim 8 in the case which
requires the compound be administered in an amount effective to prevent normal
reproductive function. This claim is entirely at odds with claim 1 as now amended
where the compound is to be administered inter alia to enhance or restore fertility.
In addition, we find no written description of a method to treat a reproductive
disorder in a female mammal by merely administering a compound altering lipoprotein,
LDL, HDL or cholesterol levels. This concept is not found in the original disclosure of
this application.
Our finding of lack of written description extends to all of the claims pending in
this appeal. Claims such as claims 2 and 3 which limit the compound used in the
claimed methods to one that alters SR-BI expression or binding of SR-BI to high density
lipoprotein are not described in the original disclosure. Again, the only disclosed mode
of action of SR-BI that affects fertility in a female mammal is that SR-BI knockout female
mice are infertile. There is no disclosure in the original application that the observed
infertility can be ameliorated or corrected in any manner by any compound effective to
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