Reply to Office Action of August 14, 2019
`
`Application No. 14/831,838
`
`- 2 -
`
`GTBBONS er a].
`
`Amendments to the Claims
`
`This listing of claims will replace all prior versions, and listings, of claims in the application.
`
`1-82.
`
`(Canceled)
`
`83.
`
`(Currently Amended) A method for providing quality control, said method comprising:
`
`receiving a cartridge in an instrument, wherein the cartridge comprises a sample,
`
`moving at least a portion of the sample from the cartridge into a sample container,
`
`moving the sample container to an image capture device via a fluid transfer device
`
`comprising a pipette, wherein the instrument comprises the image capture device,
`
`before—perfermi—ng—an—lmayduring a chemical reaction involving the sample,
`
`capturing an image of conditions under which a detection mechanism measures a
`
`characteristic of the sample, w
`
`determining, using a processor, based on the image whether there is an undesirable
`
`condition under which the detection mechanism is operated, and
`
`moving the sample container to a sample processing station for starting the assay.
`
`84.
`
`85.
`
`(Currently Amended) The method of claim 83, wherein the undesirable conditions
`
`include[[s]] a presence of one or more undesirable materials.
`
`(Previously Presented) The method of claim 84, wherein the undesirable materials include
`
`one or more of: bubbles, particles, fibers, debris, and precipitates that interfere with the
`
`measurement of the characteristic of the sample.
`
`Atty. Dkt. No. 4127.0100004
`
`
`
`Application No. 14/831,838
`
`- 2 -
`
`GTBBONS er a].
`
`Amendments to the Claims
`
`This listing of claims will replace all prior versions, and listings, of claims in the application.
`
`1-82.
`
`(Canceled)
`
`83.
`
`(Currently Amended) A method for providing quality control, said method comprising:
`
`receiving a cartridge in an instrument, wherein the cartridge comprises a sample,
`
`moving at least a portion of the sample from the cartridge into a sample container,
`
`moving the sample container to an image capture device via a fluid transfer device
`
`comprising a pipette, wherein the instrument comprises the image capture device,
`
`before—perfermi—ng—an—lmayduring a chemical reaction involving the sample,
`
`capturing an image of conditions under which a detection mechanism measures a
`
`characteristic of the sample, w
`
`determining, using a processor, based on the image whether there is an undesirable
`
`condition under which the detection mechanism is operated, and
`
`moving the sample container to a sample processing station for starting the assay.
`
`84.
`
`85.
`
`(Currently Amended) The method of claim 83, wherein the undesirable conditions
`
`include[[s]] a presence of one or more undesirable materials.
`
`(Previously Presented) The method of claim 84, wherein the undesirable materials include
`
`one or more of: bubbles, particles, fibers, debris, and precipitates that interfere with the
`
`measurement of the characteristic of the sample.
`
`Atty. Dkt. No. 4127.0100004
`
`
`
`Reply to Office Action of August 14, 2019
`
`Application No. 14/831,838
`
`- 3 -
`
`GTBBONS er a].
`
`86.
`
`87.
`
`88.
`
`89.
`
`90.
`
`91.
`
`92.
`
`(Previously Presented) The method of claim 83, wherein the detection mechanism is a
`
`different mechanism from a mechanism used to capture the image.
`
`(Previously Presented) The method of claim 83, wherein the image is captured using a
`
`camera.
`
`(Previously Presented) The method of claim 83, further comprising providing an alert in
`
`response to detecting the undesirable condition.
`
`(Previously Presented) The method of claim 83, further comprising adjusting the sample if
`
`the undesirable condition is detected.
`
`(Previously Presented) The method of claim 83, wherein the image includes an image of the
`
`sample.
`
`(Previously Presented) The method of claim 90, wherein the image includes an image of one
`
`or more of: the sample container or the detection mechanism.
`
`(Currently Amended) A method of performing an analysis on a blood sample, comprising:
`
`receiving a cartridge in an instrument, wherein the cartridge eemprises+includes the
`
`blood sample,
`
`
`
`Atty. Dkt. No. 4127.0100004
`
`
`
`Reply to Office Action of August 14, 2019
`
`Application No. 14/831,838
`
`- 4 -
`
`GTBBONS er a].
`
`moving at least a portion of the blood sample from the cartridge into a sample
`
`container via a fluid transfer device comprising a pipette, wherein the instrument comprises
`
`an image capture device coupled to the sample container,
`
`during a chemical reaction involving the blood samplebefere—perfefini-ng—the—assay,
`
`capturing an image of the blood sample in the sample container with the image capture
`
`device,
`
`determining a quality of the blood sample based on the image,
`
`detecting a presence or absence of an undesirable quality in the blood sample for
`
`performing the assay on the blood sample,
`
`providing an alert in response to detecting the presence of the undesirable quality,
`
`and
`
`moving the sample container to a sample processing station in the instrument for
`
`performing the assay in response to detecting the absence of the undesirable quality.
`
`(Previously Presented) The method of claim 92, wherein the blood sample is a blood sample
`
`obtained by a f1ngerstick.
`
`(Previously Presented) The method of claim 92, wherein the blood sample has a volume of
`
`200 uL or less.
`
`(Previously Presented) The method of claim 92, wherein the undesirable quality is selected
`
`from lipemia, icteria, hemolysis, presence of precipitates, incorrect sample type, incorrect
`
`sample volume, presence of bubbles, and non-uniformity of color.
`
`Atty. Dkt. No. 4127.0100004
`
`93.
`
`94.
`
`95.
`
`
`
`Reply to Office Action of August 14, 2019
`
`Application No. 14/831,838
`
`- 5 -
`
`GTBBONS er a].
`
`96.
`
`97.
`
`98.
`
`99.
`
`100.
`
`101.
`
`102.
`
`(Previously Presented) The method of claim 95, wherein the undesirable quality is
`
`insufficient sample volume.
`
`(Previously Presented) The method of claim 92, wherein the sample container is a sample
`
`tip.
`
`(Currently Amended) The method of claim 92, wherein the instrument includes an assay
`
`unit and [[the]]a reagent unit that are not in fluid communication with each other and are
`
`moveable relative to each other.
`
`(Previously Presented) The method of claim 98, wherein the eafiridgereagent unit comprises
`
`all reagents for performing the assay on the blood sample.
`
`(Previously Presented) The method of claim 92, wherein the instrument further comprises a
`
`centrifuge.
`
`(Previously Presented) The method of claim 100, wherein the blood sample is centrifuged in
`
`the centrifuge to obtain a column of packed red cells in a total sample column.
`
`(Previously Presented) The method of claim 101, further comprising detecting plasma
`
`volume of the blood sample, the detecting of the plasma volume including measuring, based
`
`on the image, (a) length of the total sample column, (b) length of the column of packed red
`
`Atty. Dkt. No. 4127.0100004
`
`
`
`Reply to Office Action of August 14, 2019
`
`Application No. 14/831,838
`
`- 6 -
`
`GTBBONS er a].
`
`cells, and (c) known volume of the sample container,
`
`wherein the undesirable quality is insufficient plasma volume.
`
`103.
`
`(Currently Amended) The method of elaim—92claim 98, wherein the instrument further
`
`comprises a detector configured to detect the assay unit.
`
`104.
`
`(Canceled)
`
`105.
`
`(Currently Amended) The method of claim 92, wherein the fluid transfer device (a) transfers
`
`at least a portion of the blood sample into the one—eHnere—assaJyLunitsassay unit, (b) engages
`
`with the ene—eemere—assayunitsassay unit, and (c) moves tips.
`
`106.
`
`(Previously Presented) The method of claim 92, wherein the cartridge further comprises
`
`control reagents for performing a control assay in parallel with the assay on the blood
`
`sample.
`
`107.
`
`(Previously Presented) The method of claim 92, wherein the cartridge further comprises a
`
`tip, and wherein the fluid transfer device engages in response to a signal received from an
`
`assay, the signal being indicative of the presence of an analyte in the blood sample.
`
`108.
`
`(Currently Amended) A system for performing an analysis on a blood sample, comprising:
`
`'I
`
`..Z
`
`Atty. Dkt. No. 4127.0100004
`
`
`
`Reply to Office Action of August 14, 2019
`
`Application No. 14/831,838
`
`- 7 -
`
`GIBBONS er a].
`
`an assay unit configured to perform a biological assay on the blood sample, the assay
`
`unit containing at least a portion of the blood sample, [[and]]
`
`a reagent unit comprising a reagent to be used in the biological assafimwherein
`
`the assay unit and the reagent unit are not in fluid communication with each other and are
`
`movable relative to each other, and
`
`an instrument comprising:
`
`an image capture device configured to capture an image of the blood sample
`
`
`prier—tewhile performing the biological assay on the blood sample, and during a chemical
`
`reaction involving the blood sample,
`
`a fluid transfer device comprising a pipette configured to move the assay unit
`
`from—theeafiridge to the image capture device, and
`
`a detector configured to detect a signal from the assay unit indicative of the
`
`presence of an analyte in the blood sample,
`
`wherein the fluid transfer device is further configured to move the assay unit to the
`
`detector, and
`
`wherein the assay unit is configured to heldsm the at least the portion of the blood
`
`sample in a non-flowing manner during detection.
`
`109.
`
`(Currently Amended) The system of claim 108, wherein—the_a cartridge comprises all
`
`reagents for performing the biological assay.
`
`Atty. Dkt. No. 4127.0100004
`
`
`
`Reply to Office Action of August 14, 2019
`
`Application No. 14/831,838
`
`- 8 -
`
`GTBBONS er a].
`
`110.
`
`(Currently Amended) The system of claim 108, whereinfl fluid transfer deVice is further
`
`configured to engage with the assay unit and to move the assay unit to the detector.
`
`111.
`
`(Currently Amended) The system of claim 108, wherein—the_a cartridge further comprises
`
`control reagents for performing a control assay in parallel with the biological assay on the
`
`blood sample.
`
`112.
`
`(Previously Presented) The system of claim 108, wherein the instrument further comprises a
`
`centrifuge.
`
`Atty. Dkt. No. 4127.0100004
`
`
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