Appeal No. 95-1231
Application No. 07/689,215
Claims 14-15 stand rejected under 35 U.S.C. § 112, first paragraph, as being
based on a non-enabling disclosure.
Claims 14-15 stand rejected under 35 U.S.C. § 103. As evidence of
obviousness, the examiner relies on Bing, Wagner et al., and Ziccardi et al.
We reverse.
BACKGROUND
At page 4 of the specification, the applicants describe the invention as a method of
determining the safety of a therapeutic immunoglobulin preparation comprising measuring
its anticomplementary activity when mixed with human serum. The preferred embodiment
is described as an assay wherein the immunoglobulin preparation is contacted with human
serum and the human serum is then assayed for decreases in the specific complement
component known as C1r and increases in the complement activation product known as
C4a. Decreasing levels of C1r, combined with an increasing level of C4a are said to be
indicative of the relative anticomplement activity and thus the safety of the immunoglobulin
product being tested.
Discussion
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