Appeal No. 2001-1654 Page 6
Application No. 08/445,584
that Duermeyer discloses the claim limitation requiring simultaneous incubation
of all reaction components.
Thus, the method disclosed by Duermeyer differs in two respects from the
method recited in claim 17: first, it includes a washing step between binding of
the sample and addition of a labeled reagent, and second, it does not include an
IgG-binding inhibitor in the incubation. The examiner cited Unger, David, and
Schmitz to make up these deficiencies.
Like Duermeyer, Unger discloses a method for detecting an antigen-
specific antibody of class IgA, IgM, IgD, or IgE. Unger discloses the problem of
false-positives resulting from RF interacting with antigen-specific IgG in the
sample, giving the appearance of an antigen-specific IgM. See column 2, lines
22-33. Unger discloses that this problem can be avoided by pretreating the
sample with anti-IgG, which prevents RF from binding to IgG in the sample. See
column 3, lines 5-11. Thus, Unger’s assay comprises the steps of (1) treating the
sample with anti-IgG, (2) contacting the treated sample with a solid support
having antigen bound to it, (3) washing to remove unbound sample, and (4)
treating the sample bound to the solid support with labeled anti-IgX antibody to
detect bound (antigen-specific) antibody of the IgX class. Column 3, lines 11-26.
Unger does not disclose incubating all the reactants simultaneously. The
examiner cited David as disclosing this limitation. See the Examiner’s Answer,
page 5: “David teaches a simultaneous assay involving a single incubation step
as the antibody bound to the solid support and the labeled antibody are both
added to the sample being tested at the same time.” Finally, apparently in
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