`Office Action Mailed September 5, 2008
`Office Action Reply Filed on December 5, 2008
`
`Amendments To The Claims
`
`1.
`
`(Currently Amended) An apparatus for detecting an analyte in a biological fluid of a subject,
`
`comprising:
`
`a) a sample collection unit for introducing a biological fluid in fluid communication with a
`
`plurality of reaction sites through which optical signals are detected;
`
`b) a plurality of reactant chambers carrying a plurality of reactants in fluid communication
`
`with said reaction sites,
`
`wherein said plurality of reaction sites comprise a plurality of reactants bound thereto for
`
`detecting said analyte; and
`
`c) a system of fluidic channels to allow said biological fluid and said plurality of reactants to
`
`flow in said apparatus, wherein at least one channel leeated—betweenconnecting said plurality
`
`of reaction sites comprises an optical barrier effective in reducing the amount of optical
`
`cross—talk between said plurality of said reaction sites during detection of said analyte.
`
`2.
`
`(Previously Presented) The apparatus of claim 1, further comprising a plurality of waste
`
`chambers in fluid communication with at least one of said reaction sites, positioned to receive fluid
`
`that has passed through said reaction sites.
`
`3.
`
`(Original) The apparatus of claim 1 wherein each channel located between said plurality of
`
`reaction sites comprises an optical barrier.
`
`4.
`
`(Original) The apparatus of claim 1 wherein the biological fluid is less than about 500
`
`microliters.
`
`5.
`
`(Original) The apparatus of claim 1 wherein said optical barrier comprises a nonlinear
`
`fluidic channel.
`
`6.
`
`(Previously Presented) The apparatus of claim 1 wherein the sample collection unit is
`
`configured to provide to the plurality of reaction sites a volume of fluid that is less than about 50
`
`microliters.
`
`7.
`
`(Original) The apparatus of claim 1, wherein the reactants comprise immunoassay reagents.
`
`350825 8_1.DOC
`
`Atty. Docket No. 30696-71220]
`
`_2_.
`
`
`
`Appln. No.: 11/388,723
`Office Action Mailed September 5, 2008
`Office Action Reply Filed on December 5, 2008
`
`8.
`
`(Previously Presented) The apparatus of claim 7, wherein said apparatus is configured to
`
`identify a plurality of analytes, wherein the analytes are identified by distinct signals detectable over
`
`a range of 3 orders of magnitude.
`
`9.
`
`(Original) The apparatus of claim 7, wherein the immunoassay reagents detect a polypeptide
`
`glycoprotein, polysaccharide, lipid, nucleic acid, and a combination thereof.
`
`10.
`
`(Original) The apparatus of claim 7, wherein the immunoassay reagents detect a member
`
`selected from the group consisting of drug, drug metabolite, biomarker indicative of a disease, tissue
`
`specific marker, and biomarker specific for a cell or cell type.
`
`11.
`
`(Original) The apparatus of claim 1, wherein the detectable signal is a luminescent signal.
`
`12.
`
`(Withdrawn) An apparatus for detecting an analyte in a biological fluid of a subject,
`
`comprising
`
`a) a sample collection unit for introducing a biological fluid in fluid communication with a
`
`plurality of reaction sites, wherein said plurality of reaction sites comprise a plurality of
`
`bound reactants for detecting said analyte;
`
`b) a plurality of reactant chambers carrying a plurality of reactants in fluid communication
`
`with said reaction sites; and
`
`c) a system of fluidic channels to allow said biological fluid and said plurality of reactants to
`
`flow in said apparatus,
`
`wherein said bound reactants in at least one reaction site are unevenly distributed.
`
`13.
`
`(Withdrawn) The apparatus of claim 12, wherein said bound reactants in the at least one
`
`reaction site are localized around the center of said reaction site.
`
`14.
`
`(Withdrawn) The apparatus of claim 13, wherein an outer edge of the at least one reaction
`
`site is at a distance sufficiently far from said bound reactants to reduce signals unrelated to the
`
`presence of said analyte.
`
`15.
`
`(Withdrawn) The apparatus of claim 12, further comprising a waste chamber in fluid
`
`communication with said reaction sites.
`
`3508258_1.DOC
`
`Atty. Docket No. 30696—712201
`
`
`
`' Appln. No: 11/388,723
`Office Action Mailed September 5, 2008
`Office Action Reply Filed on December 5, 2008
`
`16.
`
`(Withdrawn) The apparatus of claim 14 wherein said unbound reactant is coupled to said
`
`edge of said reaction site.
`
`17.
`
`(Withdrawn) A method of manufacturing a fluidic device for detecting an analyte in a
`
`biological fluid of a subject, comprising:
`
`a) providing a plurality of layers of a fluidic device;
`
`b) ultrasonically welding said layers together such that a fluidic network exists between a
`
`sample collection unit, at least one reactant chamber, at least one reaction site, and at least
`
`one waste chamber.
`
`18.
`
`(Withdrawn) The method of claim 17 wherein said at least one reaction chamber is vacuum
`
`sealed.
`
`19.
`
`(Withdrawn) The method of claim 17, wherein said fluidic device comprises a system of
`
`fluidic channels to allow contact of said biological fluid With reactants in said at least one reaction
`
`site.
`
`20.
`
`(Withdrawn) The method of claim 17, wherein said reaction site comprises an optical barrier
`
`to reduce the amount of optical cross—talk between another reaction site on the fluidic device.
`
`21.
`
`(Previously Presented) The apparatus of claim 1, wherein the optical barrier is coated with
`
`an optically opaque material.
`
`22.
`
`(New) The apparatus of claim 1, wherein said reactants bound to an individual reaction site
`
`of said plurality are located around a center of said individual reaction site.
`
`23.
`
`(New) The apparatus of claim 22, wherein an outer edge of said reaction site surrounding
`
`said center is at a distance sufficiently far from said bound reactants to reduce the amount of optical
`
`cross-talk between said reaction site and another reaction site.
`
`350825 8_1.DOC
`
`Atty. Docket No. 30696-712201
`
`

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