Appeal No. 1999-0161
Application 08/441,567
the phosphatidylethanolamine is coated on a substrate bead, wherein the bead is
composed of an inert material and wherein the bead has a diameter of from about
1 nm to 50 nm.
The prior art references relied upon by the examiner are:
Janoff et al. (Janoff) 4,698,299 Oct. 6, 1987
Huang 4,839,111 June 13, 1989
Madden et al. (Madden), AStabilization of Bilayer Structure for Unsaturated
Phosphatidylethanolamines by Detergents,@ Biochemica et Biophysica Acta., Vol. 684, pp.
149-153 (1982)
BACKGROUND
The claimed invention relates to diagnostic assays, particularly for lupus
anticoagulants, which employ phospholipid as assay reagents. Specification, page 1.
The blood of patients with systemic lupus erythematosus (SLE) contains Alupus
anticoagulants,@ Acoagulation inhibitors,@ or Alupus inhibitors@ which are believed to be
antibodies against phospholipid which are produced by the immune system of patients
suffering from SLE. Specification, page 2. Patients with diseases where anti-
phospholipid antibodies are present are also likely to give false positive test results when
subjected to lipid dependent diagnostic assays. Id.
The invention provides for a stable aqueous suspension of phospholipid particles
for use in an assay for lupus anticoagulants. The phospholipid has a hexagonal
organization when dispersed in an aqueous medium without detergent. Specification,
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