Appeal No. 2001-1409 Page 2
Application No. 09/044,214
A filter to remove particulate matter from a saliva sample suspected of
containing primary antibodies specific to said antigens;
Secondary antibodies specific to said primary antibodies available for use;
and
A label or indicator capable of attaching directly to the primary antibodies
or indirectly to said secondary antibodies producing a detectable signal.
8. An immunodiagnostic assay method for detecting antibodies in saliva
specific to a disease comprising:
Contacting and immobilizing antigens specific to a disease with a solid
flow-through substrate to form a spot or as nonspecific contact;
Blocking said solid substrate to reduce nonspecific binding;
Gathering a saliva sample suspected of containing primary antibodies to
the antigens specific to a disease;
Separating particulate matter from said sample with a separating device
selected from the group consisting of filters and centrifuges to form a salivary
sample filtrate or supernatant;
Spotting the saliva filtrate or supernatant on to the immobilized antigen on
the solid substrate;
Contacting the immobilized antigen and sample on the solid substrate with
a label capable of directly attaching to the primary antibodies or indirectly
attaching to secondary antibodies specific to the primary antibodies; and
Detecting and reading the intensity of the label in less than 5 minutes
whereby the presence and concentration of primary antibodies in the sample are
determined.
The examiner relies on the following references:
Todd et al. (Todd) 4,962,023 Oct. 9, 1990
Maes 4,965,192 Oct. 23, 1990
Brown et al. (Brown)
(PCT Application) WO 95/28642 Oct. 26, 1995
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