Appeal No. 2001-2410 Page 4
Application No. 08/914,700
The specification discloses an alternative immunoassay method in which a
liquid biological specimen is mixed with
(a) a binding substance of a ligand, antiligand or receptor capable
of binding the analyte and (b) a detector substance of a colloidal
metal labeled ligand or antiligand. . . . The test sample is then
applied onto a defined zone of an insoluble porous support film
having a pore size impassable to a complex formed between the
analyte, if present, with the binding substance and the detector
substance, but passable to the binding substance and detector
substance while remaining uncomplexed in the absence of the
desired analyte.
Id., pages 3-4 (emphasis added). Thus, “[if] the analyte is present in the test
specimen, the analyte binds with both the detector substance and the binding
substance to form a visually discernable precipitable complex on the surface of
the porous support film.” Id., page 4.
Discussion
The claims are directed to a method and kit for carrying out the disclosed
immunoassay method. Thus, for example, claim 1 is directed to a method
comprising forming a test sample by mixing a biological specimen with “a binding
substrate [sic, substance] . . . which specifically binds the analyte” and a colloidal
metal-labeled detector substance; the binding substance and the detector
substance both bind to the analyte. The test sample is then applied “to a defined
zone on a porous support, the support having a maximum effective pore size
smaller than a complex formed between the analyte, the binding substance and
the detector substance and having a minimal effective pore size larger than each
of the analyte, the binding substance and the detector substance if a precipitable
complex with an analyte is not formed, so that the analyte, the binding substance
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