Interference No. 102,572
reduction to practice. Cabilly et al. have chosen to rely upon a difference between an
assay value of an alleged reformed product and an antigen and the background values of
the heavy and light chain individually. Cabilly et al. conclude that such data shows
recombination and utility. Cabilly et al. urge that binding activity to the antigen which binds
the known hybridoma antibody is sufficient to prove the utility of the recombinantly
produced antibodies.
We disagree with Cabilly et al. that such testing establishes practical utility.
This record does not identify the antigen used in the binding assay and its
relationship to the original source of immunoglobulin cDNA.
Cabilly et al. have provided no testimony which explains how a comparison of an
assay value of an allegedly reformed antibody of CEA.66-E3 bound to an unidentified
antigen and the background values of the individual unfolded chains is indicative of
practical utility. Practical utility is a shorthand way of attributing “real world” value to the
claimed subject matter. In other words, one skilled in the art can use a claimed discovery
in a manner which provides some immediate benefit to the public. Nelson v. Bowler, 626
F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980). We acknowledge that assays, in
general, are useful for immunological diagnostic testing to detect or quantitate antigens or
antibodies in solution. Antibodies and antigens bind; how they bind, that is, how
complementary the antibody and antigen are to one another and the strength of the bond
between the antibody and antigen is determinative of the specificity of the antibody-antigen
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