Appeal No. 2002-1547 Page 2
Application No. 09/259,434
also pending but do not stand rejected. Claims 1 and 11 are representative of
the claims on appeal and read as follows:
1. A composition comprising isolated Apolipoprotein-AI-Milano dimer,
wherein the dimer comprises two monomers and is purified to at
least 90% homogeneity.
11. A method for the treatment of atherosclerosis or cardiovascular
diseases comprising administering the composition of claim 1 in a
pharmaceutically acceptable carrier to a patient in need thereof.
The examiner relies on the following reference:
Sirtori et al. (Sirtori) WO 90/12879 Nov. 1, 1990
Claims 1-5, 8, 9, 11-16, and 18 stand rejected under 35 U.S.C. § 103(a)
as obvious in view of Sirtori.
We reverse.
Background
High-density lipoproteins (HDL) are involved in removal of cholesterol from
peripheral tissues. Specification, page 1. High HDL levels seem to protect
against coronary heart disease (CHD). Id., page 2. The main component of HDL
is apolipoprotein AI (Apo AI); “[h]igh plasma levels of Apo AI are associated with
reduced risk of CHD.” Id.
Apolipoprotein AI-Milano (Apo AI-M) is a mutant form of Apo AI resulting
from substitution of a cysteine residue for the wild-type arginine residue at
position 173. Specification, page 4.
The status of the Apo AI-M carrier individual is characterized by a
remarkable reduction in HDL-cholesterol level. In spite of this, the
affected subjects do not apparently show any increased risk of
arterial disease; indeed, by examination of the genealogic tree it
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