DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1, 8, and 13 are amended and claim 14 is cancelled. Claims 1-13 are pending.
Response to Arguments
Applicant's arguments filed 6/4/2026 have been fully considered.
Regarding the rejections of independent claims 1-2 and 13 under 103, and as noted by Applicant on pages 24-29, the amendments overcome the rejections, which are withdrawn. However, based on further search and analysis new grounds for rejecting claims 1-2 and 13 and all claims depending therefrom are set forth herein.
Claim Objections
Claim 13 objected to because of the following informalities:
In claim 13 line 9, “the rack” should read “the integrated rack” in accordance with apparent antecedent relation to “an integrated rack” in line 8.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tatsutani (US 2011/0290040 A1) in view of Sano (US 2017/0328925 A1), and in further view of Applicant’s Admitted Prior Art (AAPA) and Thorne (US 4,678,752).
As to claim 1, Tatsutani teaches “[a]n automatic analysis apparatus (FIG. 1 sample processing apparatus 1) comprising:
a rack buffer (FIG. 1 combination of insertion unit 22 and recovery unit 21 configured as temporary rack storages) constructed to” “hold a plurality of” “racks ([0033]-[0034] insertion unit 22 and recovery unit 21 configured to place a plurality of racks (requires holding the plurality of racks)) and configured to provide the plurality of” “racks one-at-a-time to a dispensing line (FIG. 1 depicting insertion unit 22 as coupled to a dispensing line including output unit 23 in which barcode reader 232 is disposed (barcode reader function infers one-at-a-time transfer of racks with respect to reader as per [0039]); [0040]-[0041] describing transport of multiple racks individually by transport units 31-34; FIG. 3 depicting insertion unit 22 providing racks serially to output unit 23)”
“a conveyor line configured to move the plurality of” “racks one-at-a-time to and from the rack buffer (FIG. 1 depicting conveyor lines starting with output unit 23 implemented by transport units 31-34 for sequentially moving the racks to recovery unit 21 and from insertion unit 22)”
“an identification device (FIG. 1 barcode reading section 232) configured to identify the” “rack ([0039] barcode reading section 232 configured to read the rack ID of a rack L) attached with identification information (FIG. 2B barcode label BL2 attached to rack L; [0037] and [0039] rack includes a barcode label) as the” “rack moves along the conveyor line (FIG. 1 barcode reader 232 configured to read rack ID within conveyor line (output unit 23), [0039]); and
a control unit configured to control an operation of dispensing a liquid contained in a container housed in the” “rack (FIG. 1 transport controller 6 and transport units 31-34 configured to position racks/containers along a supply line running between measurement units 41 and smear preparation apparatus 5; [0083]-[0084] as part of decided transport destination, fluid is dispensed from a designated container) based on information on the” “rack identified by the identification device (FIG. 8 transport unit 34 including and/or receiving input from barcode reader 343 and in which output is provided to driving section 344; [0098]-[0099] destination determined based on rack ID),” and
[the] “rack is constructed to hold a plurality of containers each mounted at a corresponding one of a plurality of positions in the” “rack (FIG. 2B rack L holding multiple containers that are each mounted at a corresponding one or multiple rack locations).
Tatsutani further teaches a cleaning supply step of aspirating the cleaning solution when recognizing a rack mounted with a cleaning solution container containing a cleaning solution ([0039] and [0049] rack ID read to determine transport control (i.e., location where container processed); FIG. 9 code positions “S” and “R” indicate for cleaning; [0098]-[0099] rack ID indicates transport and cleaning operation; FIG. 17 blocks S205 and S206; [0044], [0061], [0080] application of container contents at a processing location performed by suction) and, in a similar rack ID based transport procedure, aspirating a quality control substance when recognizing a rack mounted with a quality control container ([0039] and [0049] rack ID read to determine transport control (i.e., location where container processed); FIG. 9 code position “Q” indicates for accuracy control; [0098]-[0099] rack ID indicates transport and cleaning operation; [0115] transport destination for quality control; FIG. 17 blocks S205 and S206; [0044], [0061], [0080], [0084] application of container contents at a processing location performed by suction).
Tatsutani does not expressly teach that the quality control substance comprises a calibrator, and furthermore the special processing of cleaning racks/containers and quality control racks/containers disclosed by Tatsutani entails recognizing an individual rack as a whole as either a cleaning rack or a quality control rack and Tatsutani does not teach that the rack is an “integrated” rack that holds cleaning and quality control containers. Therefore, Tatsutani does not teach that the control unit is configured to perform a cleaning supply step and perform a calibrator supply step “after a cleaning solution supply step” “when recognizing an integrated rack mounted with a cleaning solution container containing a cleaning solution and a calibrator container containing a calibrator,” and that the control unit is configured to “recognize a plurality of container types of the plurality of containers based on the container type of two containers being mounted at two predetermined positions of the plurality of positions in the integrated rack, and to perform the calibrator supply step based on the recognized container type of the two containers mounted at the two predetermined positions of the plurality of positions in the integrated rack.”
Sano discloses an automatic analysis apparatus (FIG. 1) that includes an integrated rack containing cleaning and calibrator containers (FIG. 1 specimen rack 102; FIGS. 3A and 8 depicting registration patterns for rack positions including positions for cleaning solution, calibrator, and quality control sample) and in which position information within a rack is correlated to the type of container (e.g., cleaning, calibrator, quality control) (FIG. 2 and [0046]-[0047] containers stored at position encoded locations in rack; FIG. 3A and [0075] depicting and describing displayed registration pattern in which rack positions are associated with containers in terms of container content; [0051] registration pattern relates position in a rack to container type in terms of container content) and is encoded for the system in transporting and executing the corresponding operation including dispensing container contents ([0033] execution incudes aspiration of container contents; [0042]-[0043] control unit 120 controls transfer and dispensing; [0050]-[0051] registration pattern information encodes the relative position information of containers and registration pattern used to control operation flow via the control unit (necessarily entails position-specific container recognition)) in a continuous manner (FIG. 12 blocks S1203, S1209, and S1210 depicting continuous processing of containers subject to registration pattern).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Sano’s teaching of using an integrated rack that includes multiple different containers containing calibration as well as other substances in addition to cleaning fluids and in which the different types of containers are processed respectively based on coded information that correlates the rack itself (relative container positions within the rack) with the various different types of containers for respective execution of aspiration of the containers during execution (necessarily entails position-specific container recognition among the multiple containers) to the apparatus taught by Tatsutani, such that the combined apparatus includes an integrated rack that includes a cleaning solution container and a calibrator container and in which the rack information attached such as by barcode to a rack as disclosed by Tatsutani (the means of recognition of the rack) further includes information correlating the container types (cleaning solution and calibrator) with positions within the rack in a form of registration pattern and in which the registration pattern is processed continuously in a manner in which the control unit recognizes the container types being mounted in predetermined positions in the integrated rack and performs the calibrator supply step based on the recognized container types.
The motivation would have been to automatically process various containers that may include different types of substances (e.g., cleaning and calibration) in a more streamlined and efficient manner by using the registration of particular container types at particular rack positions as disclosed by Sano.
Neither Tatsutani nor Sano expressly teaches that the calibration operation including aspirating a calibrator is performed “after a cleaning solution supply step of aspirating the cleaning solution.” However, it was well-known in the art prior to the effective filing date to perform cleaning between (after/before) sampling operations (e.g., between patient samples and between calibrator/QC analysis) as evidenced by AAPA ([0008] and [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have performed the calibration operation (i.e., aspirating the calibrator) after a cleaning operation as taught by AAPA using the apparatus taught by Tatsutani as modified by Sano.
The motivation would have been to adapt current calibration to the current condition of the analyzer mechanism following cleaning to ensure accurate calibration as suggested by AAPA.
Regarding buffering and transporting the integrated racks, neither Tatsutani nor Sano teaches that the rack buffer is constructed to “radially” hold a plurality of integrated racks, and is configured to provide the plurality of integrated racks one-at-a-time to a dispensing line “via a corresponding plurality of slots arranged about an outer circumference of the rack buffer.” Tatsutani and Sano further do not disclose that the conveyor line is configured to move the plurality of integrated racks one-at-a-time to and from the rack buffer “via the plurality of slots” and that the conveyor line is further configured “to move the plurality of integrated racks one-at-a-time to a rack storage tray and to receive the plurality of integrated racks one-at-a-time from a rack supply tray.”
Thorne discloses a sample analysis apparatus (Abstract disclosing analytic apparatus; FIG. 1 random access analyzer) that implements a rack buffer that is constructed to “radially” hold a plurality of racks (FIG. 1 carousel 18 in which packages 24 are disposed; FIG. 2 depicting package 24 as fixedly holding multiple receptacles 36, 38, 39, etc. within radial slots; col. 5 lines 32-36 describing each of the packages as unitary (therefore package 24 entails a rack or sub-rack with respect to rack 22 in FIG. 1)) and is configured to provide the plurality of racks “via a corresponding plurality of slots arranged about an outer circumference of the rack buffer (FIG. 1 carousel 18 includes radial slots extended to the outer circumference of carousel for holding packages 24 which can be transferred between (to and from) carousel 18 and rack 22; col. 2 lines 56-62; col. 6 lines 54-56 describing conveyance provided by shuttle system as providing bi-directional transfer of packages between the carousel and rack 22; col. 10 lines 20-47),” and further teaches a conveyor line configured to move the plurality of racks one-at-a-time to and from a rack buffer “via the plurality of slots” (col. 2 lines 56-62; col. 6 lines 54-56 describing conveyance provided by shuttle system as providing bi-directional transfer of packages between the carousel and rack 22; col. 10 lines 20-47) and that the conveyor line is further configured “to move the plurality of integrated racks one-at-a-time to a rack storage tray (FIG. 1 depicting shuttle system 15 configured move packages 24 to rack 22; col. 6 lines 51-56) and to receive the plurality of integrated racks one-at-a-time from a rack supply tray (FIG. 1 depicting shuttle system 15 configured move packages 24 from rack 22; col. 6 lines 51-56).”
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Thorne’s teaching of using a rack buffer in the form of a circular component having radially disposed slots for loading and unloading racks that contain receptacles for dispensing, and further including a distinct supply/storage tray for providing and collecting racks to the apparatus taught by Tatsutani as modified by Sano and AAPA, which includes a multi-state dispensing/conveyance line such that in combination the apparatus includes a rack buffer that is constructed to “radially” hold a plurality of integrated racks, and is configured to provide the plurality of integrated racks one-at-a-time to a dispensing line (e.g., supply line depicted in Tatsutani FIG. 1) “via a corresponding plurality of slots arranged about an outer circumference of the rack buffer” with the conveyance line configured to move the plurality of integrated racks one-at-a-time to and from the rack buffer “via the plurality of slots”
The motivation would have been to provide additional flexibility and efficiency afforded to the substance analysis processes by the multidirectional and radial disposition of the racks as suggested by Thorne.
It would further have been obvious to one of ordinary skill in the art before the filing date, in view of the obvious need to supply the racks for dispensing to remove/store used racks following dispensing to have applied Thorne’s teaching of using some form of tray to supply and store racks (e.g., rack 22 in FIG. 1) to the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne, such that the conveyor line is further configured “to move the plurality of integrated racks one-at-a-time to a rack storage tray and to receive the plurality of integrated racks one-at-a-time from a rack supply tray.”
The motivation would have been to provide an orderly means for supplying integrated racks to the rack buffer and removing used racks from the analytic processing circuit.
As to claim 2, Tatsutani teaches “[a]n automatic analysis apparatus (FIG. 1 sample processing apparatus 1) comprising:
a rack buffer (FIG. 1 combination of insertion unit 22 and recovery unit 21 configured as temporary rack storages) constructed to” “hold a plurality of” “racks ([0033]-[0034] insertion unit 22 and recovery unit 21 configured to place a plurality of racks (requires holding the plurality of racks)) and configured to provide the plurality of” “racks one-at-a-time to a dispensing line (FIG. 1 depicting insertion unit 22 as coupled to a dispensing line including output unit 23 in which barcode reader 232 is disposed (barcode reader function infers one-at-a-time transfer of racks with respect to reader as per [0039]); [0040]-[0041] describing transport of multiple racks individually by transport units 31-34; FIG. 3 depicting insertion unit 22 providing racks serially to output unit 23)”
“a conveyor line configured to move the plurality of” “racks one-at-a-time to and from the rack buffer (FIG. 1 depicting conveyor lines starting with output unit 23 implemented by transport units 31-34 for sequentially moving the racks to recovery unit 21 and from insertion unit 22)”
“an identification device (FIG. 1 barcode reading section 232) configured to identify the” “rack ([0039] barcode reading section 232 configured to read the rack ID of a rack L) configured to identify a rack ([0039] barcode reading section 232 configured to read the rack ID of a rack L) attached with identification information (FIG. 2B barcode label BL2 attached to rack L; [0037] and [0039] rack includes a barcode label) as the” “rack moves along the conveyor line (FIG. 1 barcode reader 232 configured to read rack ID within conveyor line (output unit 23), [0039]); and
a control unit configured to control an operation of dispensing a liquid contained in a container housed in the” “rack (FIG. 1 transport controller 6 and transport units 31-34 configured to position racks/containers along a supply line running between measurement units 41 and smear preparation apparatus 5; [0083]-[0084] as part of decided transport destination, fluid is dispensed from a designated container) based on information on the” “rack identified by the identification device (FIG. 8 transport unit 34 including and/or receiving input from barcode reader 343 and in which output is provided to driving section 344; [0098]-[0099] destination determined based on rack ID),”
[the] “rack is constructed to hold a plurality of containers each mounted at a corresponding one of a plurality of positions in the” “rack (FIG. 2B rack L holding multiple containers that are each mounted at a corresponding one or multiple rack locations).
Tatsutani further teaches a cleaning supply step of aspirating the cleaning solution when recognizing a rack mounted with a cleaning solution container containing a cleaning solution ([0039] and [0049] rack ID read to determine transport control (i.e., location where container processed); FIG. 9 code positions “S” and “R” indicate for cleaning; [0098]-[0099] rack ID indicates transport and cleaning operation; FIG. 17 blocks S205 and S206; [0044], [0061], [0080] application of container contents at a processing location performed by suction) and, in a similar rack ID based transport procedure, applying a quality control substance when recognizing a rack mounted with a quality control container ([0039] and [0049] rack ID read to determine transport control (i.e., location where container processed); FIG. 9 code position “Q” indicates for accuracy control; [0098]-[0099] rack ID indicates transport and cleaning operation; [0115] transport destination for quality control; FIG. 17 blocks S205 and S206; [0044], [0061], [0080] application of container contents at a processing location performed by suction).
The special processing of cleaning racks/containers and quality control racks/containers disclosed by Tatsutani entails recognizing an individual rack as a whole as either a cleaning rack or a quality control rack and Tatsutani does not teach an integrated rack that holds cleaning and quality control containers. Therefore, Tatsutani does not teach performing a cleaning supply step and a measurement step of aspirating the QC specimen from the QC container “when recognizing an integrated rack mounted with a cleaning solution container containing a cleaning solution and a quality control (QC) specimen container containing a QC specimen,” and that the control unit is configured to “recognize a plurality of container types of the plurality of containers based on the container type of two containers being mounted at two predetermined positions of the plurality of positions in the integrated rack, and to perform the cleaning solution supply step based on the recognized container type of the two containers mounted at the two predetermined positions of the plurality of positions in the integrated rack.”
Sano discloses an automatic analysis apparatus (FIG. 1) that includes an integrated rack containing cleaning and QC specimen containers (FIG. 1 specimen rack 102; FIGS. 3A and 8 depicting registration patterns for rack positions including positions for cleaning solution, calibrator, and quality control sample) and in which position information within a rack is correlated to the type of container (e.g., cleaning, calibrator, quality control) (FIG. 2 and [0046]-[0047] containers stored at position encoded location in rack; FIG. 3A and [0075] depicting and describing displayed registration pattern in which rack positions are associated with containers in terms of container content; [0051] registration pattern relates position in a rack to container type in terms of container content) and is encoded for the system in transporting and executing the corresponding operation including dispensing container contents ([0033] execution incudes aspiration of container contents; [0042]-[0043] control unit 120 controls transfer and dispensing; [0050]-[0051] registration pattern information encodes the relative position information of containers and registration pattern used to control operation flow via the control unit (necessarily entails position-specific container recognition)) in a continuous manner (FIG. 12 blocks S1203, S1209, and S1210 depicting continuous processing of containers subject to registration pattern).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Sano’s teaching of using an integrated rack that includes multiple different containers containing QC specimen as well as other substances in addition to cleaning fluids and in which the different types of containers are processed respectively based on coded information that correlates the rack itself (relative container positions within the rack) with the various different types of containers for respective execution of aspiration of the containers during execution (necessarily entails position-specific container recognition among the multiple containers) to the apparatus taught by Tatsutani, such that the combined apparatus includes an integrated rack that includes a cleaning solution container and a QC specimen container and in which the rack information attached such as by barcode to a rack as disclosed by Tatsutani further includes information correlating the container types (cleaning solution and QC specimen) with positions within the rack in a form of registration pattern and in which the registration pattern is processed continuously in a manner in which the control unit recognizes the container types being mounted in predetermined positions in the integrated rack and performs the cleaning solution supply step based on the recognized container types.
The motivation would have been to automatically process various containers that may include different types of substances (e.g., cleaning and QC specimen) in a more streamlined and efficient manner by using the registration of particular container types at particular rack positions as disclosed by Sano.
Neither Tatsutani nor Sano expressly teaches that the QC specimen operation including aspirating a QC specimen is performed “after a cleaning solution supply step of aspirating the cleaning solution.” However, it was well-known in the art prior to the effective filing date to perform cleaning between (after/before) sampling operations (e.g., between patient samples and between calibrator/QC analysis) as evidenced by AAPA ([0008] and [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have performed the QC specimen analysis operation including aspirating the QC specimen after a cleaning operation as taught by AAPA using the apparatus taught by Tatsutani as modified by Sano.
The motivation would have been to adapt current accuracy measurement to the current condition of the analyzer mechanism following cleaning to ensure accurate accuracy measurement as suggested by AAPA.
Regarding buffering and transporting the integrated racks, neither Tatsutani nor Sano teaches that the rack buffer is constructed to “radially” hold a plurality of integrated racks, and is configured to provide the plurality of integrated racks one-at-a-time to a dispensing line “via a corresponding plurality of slots arranged about an outer circumference of the rack buffer.” Tatsutani and Sano further do not disclose that the conveyor line is configured to move the plurality of integrated racks one-at-a-time to and from the rack buffer “via the plurality of slots” and that the conveyor line is further configured “to move the plurality of integrated racks one-at-a-time to a rack storage tray and to receive the plurality of integrated racks one-at-a-time from a rack supply tray.”
Thorne discloses a sample analysis apparatus (Abstract disclosing analytic apparatus; FIG. 1 random access analyzer) that implements a rack buffer that is constructed to “radially” hold a plurality of racks (FIG. 1 carousel 18 in which packages 24 are disposed; FIG. 2 depicting package 24 as fixedly holding multiple receptacles 36, 38, 39, etc. within radial slots; col. 5 lines 32-36 describing each of the packages as unitary (therefore package 24 entails a rack or sub-rack with respect to rack 22 in FIG. 1)) and is configured to provide the plurality of racks “via a corresponding plurality of slots arranged about an outer circumference of the rack buffer (FIG. 1 carousel 18 includes radial slots extended to the outer circumference of carousel for holding packages 24 which can be transferred between (to and from) carousel 18 and rack 22; col. 2 lines 56-62; col. 6 lines 54-56 describing conveyance provided by shuttle system as providing bi-directional transfer of packages between the carousel and rack 22; col. 10 lines 20-47),” and further teaches a conveyor line configured to move the plurality of racks one-at-a-time to and from a rack buffer “via the plurality of slots” (col. 2 lines 56-62; col. 6 lines 54-56 describing conveyance provided by shuttle system as providing bi-directional transfer of packages between the carousel and rack 22; col. 10 lines 20-47) and that the conveyor line is further configured “to move the plurality of integrated racks one-at-a-time to a rack storage tray (FIG. 1 depicting shuttle system 15 configured move packages 24 to rack 22; col. 6 lines 51-56) and to receive the plurality of integrated racks one-at-a-time from a rack supply tray (FIG. 1 depicting shuttle system 15 configured move packages 24 from rack 22; col. 6 lines 51-56).”
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Thorne’s teaching of using a rack buffer in the form of a circular component having radially disposed slots for loading and unloading racks that contain receptacles for dispensing, and further including a distinct supply/storage tray for providing and collecting racks to the apparatus taught by Tatsutani as modified by Sano and AAPA, which includes a multi-state dispensing/conveyance line such that in combination the apparatus includes a rack buffer that is constructed to “radially” hold a plurality of integrated racks, and is configured to provide the plurality of integrated racks one-at-a-time to a dispensing line (e.g., supply line depicted in Tatsutani FIG. 1) “via a corresponding plurality of slots arranged about an outer circumference of the rack buffer” with the conveyance line configured to move the plurality of integrated racks one-at-a-time to and from the rack buffer “via the plurality of slots”
The motivation would have been to provide additional flexibility and efficiency afforded to the substance analysis processes by the multidirectional and radial disposition of the racks as suggested by Thorne.
It would further have been obvious to one of ordinary skill in the art before the filing date, in view of the obvious need to supply the racks for dispensing to remove/store used racks following dispensing to have applied Thorne’s teaching of using some form of tray to supply and store racks (e.g., rack 22 in FIG. 1) to the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne, such that the conveyor line is further configured “to move the plurality of integrated racks one-at-a-time to a rack storage tray and to receive the plurality of integrated racks one-at-a-time from a rack supply tray.”
The motivation would have been to provide an orderly means for supplying integrated racks to the rack buffer and removing used racks from the analytic processing circuit.
As to claim 3, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 1,” and as set forth in the grounds for rejecting claim 1, AAPA teaches applying calibrations following/between cleanings ([0012]), which in a system designed for reuse constitutes re-calibrations. Examiner notes that a new calibration for a particular cleaning cycle effectively replaces/invalidates any previous calibration performed on the target device of the auto analyzer.
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied AAPA’s teaching of calibrating/re-calibrating of auto analyzer devices following (substantially contemporaneous with) cleaning to have configured the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne to invalidate a measurement result acquired by previously-performed calibration when performing the cleaning solution supply step.
The motivation would have been to obtain updated/corrected calibration results as suggested by AAPA.
As to claim 4, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 1,” and as set forth in the grounds for rejecting claim 2, AAPA teaches applying quality control measurement following/between cleanings ([0012]), which in a system designed for reuse constitutes a next quality control measurement. Examiner notes that a new quality control measurement for a particular cleaning cycle effectively replaces/invalidates any previous quality control measurement performed on the target device of the auto analyzer.
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied AAPA’s teaching of performing/re-performing quality control measurements of auto analyzer devices following (substantially contemporaneous with) cleaning to have configured the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne to invalidate a measurement result acquired by previously-performed quality control measurement when performing the cleaning solution supply step.
The motivation would have been to obtain updated/corrected quality control measurement results as suggested by AAPA.
As to claim 5, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 1,” which in the foregoing combination as set forth in the rejection of claim 1 includes an “integrated rack” that may or may not include a cleaning container and/or a calibration container and/or a QC container. Furthermore, Tatsutani teaches discharging a rack which per [0038] may be a cleaning rack holding cleaning containers or QC containers following processing (e.g., cleaning/QC processing) (FIG. 1 depicting a processing circuit for the racks beginning with insertion unit 22 and output unit 23 inputting the racks (e.g., cleaning and/or QC) for processing and ending with recovery unit 21 into which racks are routed following processing; [0039], [0041], [0060]-[0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Tatsutani’s teaching of discharging racks following cleaning and when the racks do not include a QC container to the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne to implement such a step in a case in which the integrated racks taught by Sano are utilized, such that in combination the apparatus is configured to implement “wherein when the calibrator container or the QC specimen container is not mounted on the integrated rack, the control unit discharges the integrated rack out of the apparatus after the cleaning solution supply step.”
The motivation would have been to implement an operational input/output procedure for inputting racks to be processed and discharging such racks following processing of the containers held by the rack as disclosed by Tatsutani.
As to claim 6, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 1,” including as combined in the rejection of claim 1 “wherein the integrated rack is configured to mount the cleaning solution container, the calibrator container, and a quality control (QC) specimen container containing a QC specimen containing a sample having a known concentration (Sano: FIG. 8 depicting registration pattern in which “Cleaning Solution,” “Calibrator,” and “Quality Control Sample” included in a mount on a rack 102 (Examiner notes that a quality control sample is understood in the art to be a sample having a known concentration)).”
As to claim 7, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 2,” and AAPA further teaches calibration and/or QC sample processing is performed following cleaning in a non-incidental manner (i.e., cleaning performed for the purpose of enhancing calibration/QC sample process) ([0008], [0010], and [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied AAPA’s teaching performing calibration and/or quality control (either of which may constitute a “control measurement”) in a purposeful manner following cleaning to the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne such that the apparatus is configured to implement performing a control measurement with respect to a particular cleaning operation (i.e., a particular calibration and/or quality control measurement is performed only with respect to the particular analysis unit part that has been cleaned).
The motivation would have been to optimize calibration and/or quality control measurements by implementing the calibration and/QC measurement with respect to a specific cleaning operation such that accuracy of the calibration/QC measurement is optimized.
As to claim 8, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 1, wherein when recognizing the integrated rack (Tatsutani as combined with Sano for claim 1 recognizes the integrated rack in terms of Sano’s disclosed registration pattern having mixed constituency (e.g., Sano: FIG. 8 pattern including cleaning, calibration, and quality control) for Tatsutani’s implementation in which individual box-type racks are used and may vary between box-type racks), the control unit creates a dispensing plan (Tatsutani: FIGS 10B and 12 depicting processing algorithms (plans) for transporting/dispensing (plan is created by controller (e.g., transport controller 6 in FIG. 1) in terms of receiving and interpreting corresponding instructions in part based on input from rack information from barcode reader). Sano: FIG. 12 blocks S1203, S1206, S1207, S1208, S1209, and S1210), while regarding another integrated rack to be loaded next as a control rack mounted with a quality control (QC) specimen container containing a QC specimen containing a sample having a known concentration (Tatsutani: FIG. 1 depicting loading/processing/unloading circuit for racks, any one of which may per FIG. 9 be a rack containing a quality control specimen (i.e., specimen containing a sample having a known concentration)).”
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tatsutani in view of Sano, AAPA, and Thorne as applied to claim 1 above, and further in view of Ueda (US 2013/0078617 A1).
As to claim 9, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 1, wherein when two or more calibrator containers are mounted on the integrated rack (as combined for claim 1 Tatsutani’s disclosed rack may be an integrated rack as disclosed by Sano (e.g., FIG. 3A depicting registration pattern 1 in which calibrators are held at positions 21 through 80)).
Neither Tatsutani nor Sano expressly teaches two-point calibration and therefore neither teaches “in the calibrator supply step, one having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed, and then the one having the higher concentration among the calibrators is dispensed again.”
Multi-point (e.g., two-point) calibration using different calibrator concentrations such as for generating a calibration curve was well-known prior to the effective filing date. For example, Ueda discloses an automatic analysis apparatus (Abstract; FIG. 1) that is configured to, in a calibration step, a container having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed (FIG. 10 depicting calibration curve rack setting screen 500 in which calibrators (samples C0 – C5 are sequenced within positions 1-6 of Rack-56; FIG. 11 depicting calibration curve screen 600 showing calibrator concentrations increasing in the calibrator sample sequence from C0 to C5; FIG. 12 blocks S119, S120; [0115]-[0116]), and then the one having the higher concentration among the calibrators is dispensed again (FIG. 10 depicting that sample C1 is dispensed two times following dispensing of sample C0 and that sample C4 is dispensed two times following dispensing of sample C3).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Ueda’s teaching of using a multi-point calibration sequence in which higher concentration calibrators are dispensed following lower concentration calibrators and one or more higher concentration dispensing is repeated to the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne such that in combination the apparatus is configured to “in the calibrator supply step, one having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed, and then the one having the higher concentration among the calibrators is dispensed again.”
Such a combination would amount to implementing a known calibration technique for automatic analyzers to achieve predictable results and a particular motivation would have been to obtain a calibration curve over multiple calibrator concentrations to obtain calibration range information as suggested by Ueda.
As to claim 10, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 1, wherein when two or more calibrator containers are mounted on the integrated rack (as combined for claim 1 Tatsutani’s disclosed rack may be an integrated rack as disclosed by Sano (e.g., FIG. 3A depicting registration pattern 1 in which calibrators are held at positions 21 through 80)),” and as set forth in the grounds for rejecting claim 1 the combination of Tatsutani, Sano, AAPA, and Thorne also teaches dispensing a cleaning solution for conditioning the cleaning container following calibration (i.e., teaches “and then a cleaning solution for conditioning of the cleaning container is dispensed”) (AAPA: [0012]).
Neither Tatsutani nor Sano expressly teaches multi-point calibration and therefore neither teaches “in the calibrator supply step, one having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed.”
Multi-point (e.g., two-point) calibration using different calibrator concentrations such as for generating a calibration curve was well-known prior to the effective filing date. For example, Ueda discloses an automatic analysis apparatus (Abstract; FIG. 1) that is configured to, in a calibration step, a container having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed (FIG. 10 depicting calibration curve rack setting screen 500 in which calibrators (samples C0 – C5 are sequenced within positions 1-6 of Rack-56; FIG. 11 depicting calibration curve screen 600 showing calibrator concentrations increasing in the calibrator sample sequence from C0 to C5; FIG. 12 blocks S119, S120; [0115]-[0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Ueda’s teaching of using a multi-point calibration sequence in which higher concentration calibrators are dispensed following lower concentration calibrators to the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne such that in combination the apparatus is configured to “in the calibrator supply step, one having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed.”
Such a combination would amount to implementing a known calibration technique for automatic analyzers to achieve predictable results and a particular motivation would have been to obtain a calibration curve over multiple calibrator concentrations to obtain calibration range information as suggested by Ueda.
As to claim 11, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 1, wherein when two or more calibrator containers are mounted on the integrated rack (as combined for claim 1 Tatsutani’s disclosed rack may be an integrated rack as disclosed by Sano (e.g., FIG. 3A depicting registration pattern 1 in which calibrators are held at positions 21 through 80; [0038] and [0081])).”
Neither Tatsutani nor Sano expressly teaches multi-point calibration and therefore neither teaches “in the calibrator supply step, one having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed.”
Multi-point (e.g., two-point) calibration using different calibrator concentrations such as for generating a calibration curve was well-known prior to the effective filing date. For example, Ueda discloses an automatic analysis apparatus (Abstract; FIG. 1) that is configured to, in a calibration step, a container having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed (FIG. 10 depicting calibration curve rack setting screen 500 in which calibrators (samples C0 – C5 are sequenced within positions 1-6 of Rack-56; FIG. 11 depicting calibration curve screen 600 showing calibrator concentrations increasing in the calibrator sample sequence from C0 to C5; FIG. 12 blocks S119, S120; [0115]-[0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Ueda’s teaching of using a multi-point calibration sequence in which higher concentration calibrators are dispensed following lower concentration calibrators to the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne such that in combination the apparatus is configured to “in the calibrator supply step, one having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed.”
Such a combination would amount to implementing a known calibration technique for automatic analyzers to achieve predictable results and a particular motivation would have been to obtain a calibration curve over multiple calibrator concentrations to obtain calibration range information as suggested by Ueda.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Tatsutani as modified by Sano, AAPA, and Thorne as applied to claim 2 above, and further in view of Menhardt (US 2022/0050121 A1) and Ueda.
As to claim 12, the combination of Tatsutani, Sano, AAPA, and Thorne teaches “[t]he automatic analysis apparatus according to claim 2, wherein when two or more QC specimen containers are mounted on the integrated rack (as combined for claim 1 Tatsutani’s disclosed rack may be an integrated rack as disclosed by Sano (e.g., FIG. 3A depicting registration pattern 1 in which quality control samples are held at positions 1 through 20; [0038] and [0081])).”
Neither Tatsutani nor Sano expressly teaches multi-point quality control and therefore neither teaches “in the control measurement step, one having a higher concentration among the QC specimens is dispensed after one having a lower concentration among the QC specimens is dispensed.”
Multi-point quality control sampling using different QC concentrations was well-known prior to the effective filing date. For example, Menhardt discloses a method for performing quality control testing for diagnostic analyzer (Abstract) that includes, in the control measurement step, dispensing a QC specimen having a higher concentration among the QC specimens in association with dispensing a QC specimen having a lower concentration among the QC specimens (FIG. 12 blocks 1501, 1502, and 1503; [0071]-[0075] including table 1; claims 9 and 18. Examiner notes that dispensing a QC sample is inherently entailed within obtaining QC sample results).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Menhardt’s teaching of obtaining QC sample results (inherently includes dispensing) for QC samples having a higher concentration in association with QC samples having a lower concentration to the apparatus taught by Tatsutani as modified by Sano, AAPA, and Thorne such that the combined apparatus includes dispensing QC samples having a higher concentration in association with QC samples having a lower concentration.
Such a combination would amount to implementing a known QC sampling/analysis technique for diagnostic analyzers to achieve predictable results and a particular motivation would have been to obtain a quality control sampling data over multiple quality control concentrations to obtain usefully comparative quality control information as disclosed by Menhardt.
Menhardt appears to be silent regarding the sequential ordering of dispensing the higher concentration QC sample and the lower concentration QC sample, and therefore does not appear to express teach that the higher concentration QC sample is dispensed after the lower concentration QC sample is dispensed.
The Examiner notes that the actual sequencing of QC dispensing/sampling is limited to either low and then high or high and then low, such that the ordering may be dependent on contextual factors and selecting low and then high would have been a readily available and therefore obvious design option. Furthermore, Ueda discloses an automatic analysis apparatus (Abstract; FIG. 1) that is configured to, in a calibration step, a container having a higher concentration among the calibrators is dispensed after one having a lower concentration among the calibrators is dispensed (FIG. 10 depicting calibration curve rack setting screen 500 in which calibrators (samples C0 – C5 are sequenced within positions 1-6 of Rack-56; FIG. 11 depicting calibration curve screen 600 showing calibrator concentrations increasing in the calibrator sample sequence from C0 to C5; FIG. 12 blocks S119, S120; [0115]-[0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Ueda’s teaching of applying a high-to-low concentration sequencing in which higher concentration calibrators are dispensed following lower concentration calibrators to the apparatus taught by Tatsutani as modified by Sano, AAPA, Thorne and Menhardt such that in combination the apparatus is configured to “in the control measurement step, one having a higher concentration among the QC specimens is dispensed after one having a lower concentration among the QC specimens is dispensed.”
Such a combination would amount to implementing a known design option for dispensing an analytic solution (quality control like calibration sample is an analytic solution), to achieve predictable results and furthermore a particular motivation would have been to systematically determine analytic results in an orderly manner (e.g., low-to-high or high-to-low testing) as suggested by Ueda.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tatsutani (US 2011/0290040 A1) in view of Sano (US 2017/0328925 A1) and in further view of Thorne (US 4,678,752).
As to claim 13, Tatsutani teaches “[a] maintenance method (method implemented by FIG. 1 sample processing apparatus 1; [0038] processing includes quality control samples, which is a form of maintenance) in an automatic analysis apparatus (FIG. 1 sample processing apparatus 1) including a rack buffer (FIG. 1 combination of insertion unit 22 and recovery unit 21 configured as temporary rack storages) constructed to” “hold a plurality of” “racks ([0033]-[0034] insertion unit 22 and recovery unit 21 configured to place a plurality of racks (requires holding the plurality of racks)) and configured to provide the plurality of” “racks one-at-a-time to a dispensing line (FIG. 1 depicting insertion unit 22 as coupled to a dispensing line including output unit 23 in which barcode reader 232 is disposed (barcode reader function infers one-at-a-time transfer of racks with respect to reader as per [0039]); [0040]-[0041] describing transport of multiple racks individually by transport units 31-34; FIG. 3 depicting insertion unit 22 providing racks serially to output unit 23)” “a conveyor line configured to move the plurality of” “racks one-at-a-time to and from the rack buffer (FIG. 1 depicting conveyor lines starting with output unit 23 implemented by transport units 31-34 for sequentially moving the racks to recovery unit 21 and from insertion unit 22)” “an identification device (FIG. 1 barcode reading section 232) configured to identify an” “rack ([0039] barcode reading section 232 configured to read the rack ID of a rack L) attached with identification information (FIG. 2B barcode label BL2 attached to rack L; [0037] and [0039] rack includes a barcode label) as the rack moves along the conveyor line (FIG. 1 barcode reader 232 configured to read rack ID within conveyor line (output unit 23), [0039]), and a control unit configured to control an operation of dispensing a liquid contained in a container housed in the” “rack (FIG. 1 transport controller 6 and transport units 31-34 configured to position racks/containers along a supply line running between measurement units 41 and smear preparation apparatus 5; [0083]-[0084] as part of decided transport destination, fluid is dispensed from a designated container) based on information on a rack identified by the identification device (FIG. 8 transport unit 34 including and/or receiving input from barcode reader 343 and in which output is provided to driving section 344; [0098]-[0099] destination determined based on rack ID),”
[the] “rack is constructed to hold a plurality of containers each mounted at a corresponding one of a plurality of positions in the” “rack (FIG. 2B rack L holding multiple containers that are each mounted at a corresponding one or multiple rack locations).
Tatsutani further teaches a cleaning supply step of aspirating the cleaning solution when recognizing a rack mounted with a cleaning solution container containing a cleaning solution ([0039] and [0049] rack ID read to determine transport control (i.e., location where container processed); FIG. 9 code positions “S” and “R” indicate for cleaning; [0098]-[0099] rack ID indicates transport and special operation (applicable for cleaning); FIG. 17 blocks S205 and S206; [0044], [0061], [0080] application of container contents at a processing location performed by suction) and, in a similar rack ID based transport procedure, aspirating a quality control substance when recognizing a rack mounted with a quality control container ([0039] and [0049] rack ID read to determine transport control (i.e., location where container processed); FIG. 9 code position “Q” indicates for accuracy control (Examiner notes that a quality/accuracy control sample is understood in the art to be a sample having a known concentration); [0098]-[0099] rack ID indicates transport and special operation (applicable for accuracy control); [0115] transport destination for quality control; FIG. 17 blocks S205 and S206; [0044], [0061], [0080], [0084] application of container contents at a processing location performed by suction), and therefore teaches “a recognition step of recognizing an” “rack mounted with a cleaning solution container containing a cleaning solution” and recognizing a rack mounted with a “container containing a calibrator or a QC specimen container containing a QC specimen containing a sample having a known concentration,” “a cleaning solution supply step of aspirating the cleaning solution” and “a supply step of aspirating the calibrator or the QC specimen.”
The special processing of cleaning racks/containers and quality control racks/containers disclosed by Tatsutani entails recognizing an individual rack as a whole as either a cleaning rack or a quality control rack and Tatsutani does not teach an integrated rack that holds cleaning and quality control containers. Therefore, Tatsutani does not teach continuously performing a cleaning supply step and a calibrator or quality control supply step in association with “recognizing an integrated rack mounted with a cleaning solution container containing a cleaning solution, and a calibrator container containing a calibrator or a QC container containing a QC specimen containing a sample having a known concentration,” and that the control unit is configured to “recognize a plurality of container types of the plurality of containers based on the container type of two containers being mounted at two predetermined positions of the plurality of positions in the integrated rack, and to perform one of the cleaning solution supply step and the supply step based on the recognized container type of the two containers mounted at the two predetermined positions of the plurality of positions in the integrated rack.”
Sano discloses an automatic analysis apparatus (FIG. 1) that includes an integrated rack containing cleaning and calibrator containers (FIG. 1 specimen rack 102; FIGS. 3A and 8 depicting registration patterns for rack positions including positions for cleaning solution, calibrator, and quality control sample) and in which position information within a rack is correlated to the type of container (e.g., cleaning, calibrator, quality control) (FIG. 2 and [0046]-[0047] containers stored at position encoded locations in rack; FIG. 3A and [0075] depicting and describing displayed registration pattern in which rack positions are associated with containers in terms of container content; [0051] registration pattern relates position in rack to container type in terms of container content) and is encoded for the system in transporting and executing the corresponding operation including dispensing container contents ([0033] execution incudes aspiration of container contents; [0042]-[0043] control unit 120 controls transfer and dispensing; [0050]-[0051] registration pattern information encodes the relative position information of containers and registration pattern used to control operation flow via the control unit necessarily entails position-specific container recognition)) in a continuous manner (FIG. 12 blocks S1203, S1209, and S1210 depicting continuous processing of containers subject to registration pattern).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Sano’s teaching of using an integrated rack that includes multiple different containers containing calibration as well as other substances in addition to cleaning fluids and in which the different types of containers are processed respectively based on coded information that correlates the rack itself (relative container positions within the rack) with the various different types of containers for respective execution of aspiration of the containers during execution (necessarily entails position-specific container recognition among the multiple containers) to the method taught by Tatsutani, such that the combined method includes an integrated rack that includes a cleaning solution container and a quality control and/or calibrator container and in which the rack information attached such as by barcode to a rack as disclosed by Tatsutani (the means of recognition of the rack) further includes information correlating the container types (cleaning solution, calibrator, quality control) with positions within the rack in a form of registration pattern and in which the registration pattern is processed continuously in a manner in which the control unit recognizes the container types being mounted in predetermined positions in the integrated rack and preforms the cleaning solution supply step and the supply step based on the recognized container types.
The motivation would have been to automatically process various containers that may include different types of substances (e.g., cleaning and quality control and/or calibration) in a more streamlined and efficient manner by using the registration of particular container types at particular rack positions as disclosed by Sano.
Sano further teaches “the cleaning solution container and either one of the calibrator container or the QC specimen container are housed in predetermined positions determined in advance of the integrated rack (FIG. 2 depicting encoded positions “1”, “2”, and “3’’ for containers within specimen rack 102; FIG. 8 depicting a registration pattern (pre-determined positioning) in designating respective positions of cleaning solution, calibrator, and quality control sample containers within specimen rack 102).”
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Sano’s teaching of using a registration pattern (pre-determined positioning) to determining container positioning of cleaning, calibrator, and quality control samples within a rack to the method of Tatsutani as modified by Sano such that Tatsutani’s racks adopt a similar registration pattern.
The motivation would have been to enable the positioning of respectively different types of containers to be efficiently processed by a control/processing system to ensure accurately routed and processed containers for the respective cleaning and quality control/calibration operations as suggested by Sano.
Regarding buffering and transporting the integrated racks, neither Tatsutani nor Sano teaches that the rack buffer is constructed to “radially” hold a plurality of integrated racks, and is configured to provide the plurality of integrated racks one-at-a-time to a dispensing line “via a corresponding plurality of slots arranged about an outer circumference of the rack buffer.” Tatsutani and Sano further do not disclose that the conveyor line is configured to move the plurality of integrated racks one-at-a-time to and from the rack buffer “via the plurality of slots” and that the conveyor line is further configured “to move the plurality of integrated racks one-at-a-time to a rack storage tray and to receive the plurality of integrated racks one-at-a-time from a rack supply tray.”
Thorne discloses a sample analysis apparatus (Abstract disclosing analytic apparatus; FIG. 1 random access analyzer) that implements a rack buffer that is constructed to “radially” hold a plurality of racks (FIG. 1 carousel 18 in which packages 24 are disposed; FIG. 2 depicting package 24 as fixedly holding multiple receptacles 36, 38, 39, etc. within radial slots; col. 5 lines 32-36 describing each of the packages as unitary (therefore package 24 entails a rack or sub-rack with respect to rack 22 in FIG. 1)) and is configured to provide the plurality of racks “via a corresponding plurality of slots arranged about an outer circumference of the rack buffer (FIG. 1 carousel 18 includes radial slots extended to the outer circumference of carousel for holding packages 24 which can be transferred between (to and from) carousel 18 and rack 22; col. 2 lines 56-62; col. 6 lines 54-56 describing conveyance provided by shuttle system as providing bi-directional transfer of packages between the carousel and rack 22; col. 10 lines 20-47),” and further teaches a conveyor line configured to move the plurality of racks one-at-a-time to and from a rack buffer “via the plurality of slots” (col. 2 lines 56-62; col. 6 lines 54-56 describing conveyance provided by shuttle system as providing bi-directional transfer of packages between the carousel and rack 22; col. 10 lines 20-47) and that the conveyor line is further configured “to move the plurality of integrated racks one-at-a-time to a rack storage tray (FIG. 1 depicting shuttle system 15 configured move packages 24 to rack 22; col. 6 lines 51-56) and to receive the plurality of integrated racks one-at-a-time from a rack supply tray (FIG. 1 depicting shuttle system 15 configured move packages 24 from rack 22; col. 6 lines 51-56).”
It would have been obvious to one of ordinary skill in the art before the effective filing date, to have applied Thorne’s teaching of using a rack buffer in the form of a circular component having radially disposed slots for loading and unloading racks that contain receptacles for dispensing, and further including a distinct supply/storage tray for providing and collecting racks to the apparatus taught by Tatsutani as modified by Sano, which includes a multi-state dispensing/conveyance line such that in combination the apparatus includes a rack buffer that is constructed to “radially” hold a plurality of integrated racks, and is configured to provide the plurality of integrated racks one-at-a-time to a dispensing line (e.g., supply line depicted in Tatsutani FIG. 1) “via a corresponding plurality of slots arranged about an outer circumference of the rack buffer” with the conveyance line configured to move the plurality of integrated racks one-at-a-time to and from the rack buffer “via the plurality of slots”
The motivation would have been to provide additional flexibility and efficiency afforded to the substance analysis processes by the multidirectional and radial disposition of the racks as suggested by Thorne.
It would further have been obvious to one of ordinary skill in the art before the filing date, in view of the obvious need to supply the racks for dispensing to remove/store used racks following dispensing to have applied Thorne’s teaching of using some form of tray to supply and store racks (e.g., rack 22 in FIG. 1) to the apparatus taught by Tatsutani as modified by Sano and Thorne, such that the conveyor line is further configured “to move the plurality of integrated racks one-at-a-time to a rack storage tray and to receive the plurality of integrated racks one-at-a-time from a rack supply tray.”
The motivation would have been to provide an orderly means for supplying integrated racks to the rack buffer and removing used racks from the analytic processing circuit.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW W BACA whose telephone number is (571)272-2507. The examiner can normally be reached Monday - Friday 8:00 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Schechter can be reached at (571) 272-2302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW W. BACA/Examiner, Art Unit 2857
/ALEXANDER SATANOVSKY/Primary Examiner, Art Unit 2857
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