Appeal No. 1997-4132
Application No. 08/263,500
THE INVENTION
According to appellant,
[t]he invention is directed to an article comprising a unit-of-use
reagent composition for a single specific binding assay. The claimed article
contains a porous material. A carrier matrix made up of gelatin
encapsulates an assay reagent which is a specific binding member. The
resultant mixture coats the porous material (page 12, lines 3-5 and 24-28).
The carrier matrix is lyophilizable, and may be rehydrated upon
contact with a solvent to expose or release the assay reagent from the
porous material for a specific binding reaction (page 12, lines 5-6 and page
13, lines 30-33). [Brief, p. 2, § 5.]
OPINION
According to the examiner,
Ito ... teach[es] the use of multilayer assay devices in several
configurations. Ito ... teach[es] that the specific binding pair member, gelatin,
and trehalose (column 12, lines 16-20; column 16, line 50 to column 17, line
20) are cast or molded in a porous reaction layer (Fig. 2, layer 1; column 15,
lines 11-15). Ito ... teach[es] that in order to maintain the activities of the
material capable of specifically combing [sic, combining] with the
immobilized specific component, signal modulation material and labeled
material, preservation materials such as gelatin and non-reducing sugars
may be incorporated in the element (column 16, line50 [sic, line 50] - column
17, line 3). This reference fails to specifically exemplify a device in which the
assay reagent, i.e., the specific binding memver [sic, member], is
"encapsulated" in the carrier matrix, i.e., the gelatin, however, it would have
been obvious to one of ordinary skill in the art at the time the invention was
made to add gelatin to the assay reagent layer because Ito ... specifically
teach[es] that in order to maintain the activities of the material capable of
specifically combing [sic, combining] with the immobilized specific
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