Appeal No. 2001-1654 Page 4
Application No. 08/445,584
This “one-step method” has become possible after successful
elimination of two possible interferences:
In the first place, the effect of antigen-specific IgG antibodies must
be eliminated. . . .
In the second place, the activity of rheumatoid factors (RF), that is
to say antibodies against IgG which belong to various
immunoglobulin classes, has to be suppressed because it can lead
to falsification of the result. This falsification is possible because
RF are bound to the antibody on the solid phase, and bound over
the antigen-specific IgG antigen which is bound by the RF in turn,
and thus a false-positive detection reaction is obtained.
It has been possible to eliminate both possibilities of interference
by, for example, addition of anti-human IgG, gamma chain (“RF
adsorbent” of Behringwerke AG) to the sample (for example
serum).
Specification, pages 4-5.
Thus, the disclosed method involves simultaneous incubation of all the
components of the immunoassay: a solid phase that will bind antibodies of a
particular class (IgA, IgM, IgD, or IgE), a sample, an antigen-specific label,1 and
“a substance which inhibits binding of immunoglobulin G to the solid phase and
inhibits binding of [the] . . . antigen to immunoglobulin G.”
Discussion
The examiner rejected claims 4-7, 13, 14, 16-21, 23, and 24 as obvious in
view of Duermeyer, Unger, David, and Schmitz. The examiner also rejected
claims 8 and 22 over these same references, combined with Molinaro.
1 The antigen-specific label can be supplied in the form of labeled antigen or in the form of
unlabeled antigen combined with a labeled, antigen-specific antibody. The first embodiment is
disclosed in the specification at page 6, lines 14-15, and recited in claim 16; the second
embodiment is disclosed in the specification at page 6, lines 17-19, and recited in claim 17.
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