Appeal No. 95-1231
Application No. 07/689,215
An understanding of the invention can be derived from a reading of claims 14 and
15 which are reproduced below:
14. A method of determining the anticomplement activity of an immunoglobulin
biological product intended for infusion, the method comprising the steps of
(A) contacting the product with human serum and then separately contacting the
human serum with immobilized antibody preparations that specifically bind to complement
component C1r and complement activation product C4a in the serum;
(B) separately measuring the amounts of the C1r and C4a that bind to the
respective antibody preparations;
(C) comparing the amounts of the C1r and the C4a bound to the respective
antibody preparations with standards to determine the amounts of C1r and C4a in the
serum; and
(D) using the determinations of step (C) to determine the anticomplement
activity of the product.
15. The method of claim 14 wherein the immunoglobulin product is an antibody
preparation having a pH of about 4.25.
The references relied upon by the examiner are:
Bing, David H., "The Interaction of Immune Serum Globulin and Immune Globulin
Intravenous with Complement." Molecule Immunology, vol. 20, No. 8, pp. 893-900 (1983).
Ziccardi et al. (Ziccardi), "Development of an Immunochemical Test to Assess C1
Inactivator Function in Human Serum and Its Use for the Diagnosis of Hereditary
Angioedema." Clinical Immunology and Immunopathology, vol. 15, pp. 465-471 (1980).
Wagner et al., (Wagner), "Radioimmunoassay for Anaphylatoxins: A Sensitive Method for
Determining Complement Activation Products in Biological Fluids." Analytical
Biochemistry, vol. 136, pp. 75-88, (1984).
Grounds of Rejection
2
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