Appeal No. 95-1231
Application No. 07/689,215
The rejection under 35 U.S.C. § 112, first paragraph is reversed.
The rejection under 35 U.S.C. § 103
Claims 14 and 15 stand rejected under 35 U.S.C. § 103 as unpatentable over the
combination of Bing, Wagner, and Ziccardi.
The claims before us are directed to a method of determining the anticomplement
activity of an immunoglobulin product intended for infusion comprising contacting the
immunoglobulin product with human serum and then contacting the human serum
separately with immobilized antibody preparations to determine the amounts of
complement component C1r and the complement activation product C4a in the serum.
These determinations are then compared with standards to determine the anticomplement
activity of the product.
The examiner's primary reference, Bing, is also concerned with determining the
anticomplementary activity of immunoglobulin products through the determination of a
complement component and a complement activation product following contacting the
immunoglobulin product with a serum containing complement. However the reference
differs from the claimed method in several ways. The examiner acknowledges at page
5 of the Answer that:
1) Bing measures for complement component C1q rather than C1r;
2) Bing measures for complement activation product C3a rather than C4a;
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