Appeal No. 2006-1993 Page 4
Application No. 10/147,651
cardiac fibrosis, myocardial infarction, defects in electrical
conductance, atherosclerosis, unstable plaque, and stroke. In
contrast to other known models for atherosclerosis, these animals
do not have to be fed extreme diets for long periods before
developing atherosclerosis and heart dysfunction. No other known
model for heart attacks and stroke with these characteristics is
known.
Id. at 8.
The specification teaches further that
a number of compounds are useful in altering lipid levels and
cholesterol metabolism. A preferred class of compounds are
PROBUCOL . . . and monoesters of PROBUCOL . . . .
PROBUCOL has two known effects: (1)hypercholesteromic agent
(reduces plasma cholesterol, HDL and LDL in humans – side
effects, causes long QT syndrome, which their esters avoid, as well
as decrease in HDL) and (2) antioxidant, may also play a role in
fertility.
* * *
Based on the PROBUCOL data, other compounds that will
be effective include other hypocholestemic and antioxidant
compounds, including vitamin E and vitamin C, as fertility
enhancing agents as well as for treatment and/or prevention of
cardiovascular disease or atherosclerosis. The preferred
compounds would have both activities.
Id. at 10.
DISCUSSION
Claims 1-8 and 10-12 stand rejected under 35 U.S.C. § 112, first
paragraph, on the grounds that
the specification, while being enabling for a method for identifying
compounds for treating or preventing atherosclerosis or
cardiovascular disease comprising administering compounds that
may have an effect on disorders selected from the group consisting
of cardiac fibrosis, myocardial infarction, defects in electrical
conductance, atherosclerosis, unstable plaque and stroke to a
transgenic mouse whose genome comprises homozygous
disruptions in the SR-BI and ApoE genes that inhibit expression of
active SR-BI and Apo-E, wherein the mouse develops
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