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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1, 3, 5-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,341,640 to Shintani et al. in view of Japanese Patent No. JP2001249137 to Sawada et al., U.S. Patent No. 7,855,084 to Jakubowicz et al., Japanese Patent Application Publication No. JPH09145719 to Hayashi et al. and U.S. Patent Application Publication No. 2007/0172390 to Ootani et al.
Shintani et al. discloses an analysis device that is provided with multiple measurement units including a third measurement unit 5 (corresponding to applicant’s first measurement unit) that holds a reaction cuvette 25 and performs a blood coagulation time measurement (first measurement) (column 10, lines 52-62) and a first measurement unit 2 (corresponding to applicant’s second measurement unit) that holds a reaction cuvette 25 and performs a biological measurement or immunological measurement (that is different from the first measurement) (column 12, lines 25-26). As shown in Fig. 1 the cuvettes move in a first direction in the first measuring device 5 and in a second direction in the second measuring device 2 that is different from the first direction.
Shintani et al. teaches that a pipette (“sample nozzle”) is used to biosamples are dispensed from a sample supply unit using a pipetter that can move along a guide rail and between upper and lower positions (“third direction”). (column 7, lines 10-20)
A picking-up means (“transporter”) (column 11, lines 15-20) transports a reaction cuvette 25 between a receiving position 55a (attachment/detachment position of the first measurement unit) of the third measurement unit 5 and a cuvette transfer position 25s (attachment/detachment position of the second measurement unit) of the first measurement unit 2.
Shintani et al. teaches dispensing reagents from a reagent supply unit 4 into the reaction cuvettes using a pipetter that can move along a rail. (column 8, lines 31-39).
Shintani et al. does not teach a transport unit that transports the cuvettes along a guide rail or attachment/detachment positions of the first and second measurement units along the guide rail.
Sawada et al. discloses an automated analysis system that includes a reaction container transfer device 11 (transport unit) that grips and lifts reaction containers 9 from a container storage unit 8 and moves the reaction containers the horizontal direction along a linear rail 6 (guide rail). The reaction containers 9 (cuvettes) are gripped by the reaction container transfer device 11 and transferred between the reaction container storage unit 8 (supply unit) and a reaction line 12.
It would have been obvious to one of ordinary skill in the art to modify Shintani et al. to include a transport unit that transports the cuvettes along a guide rail by a transfer device as taught by Sawada et al. as a known means to transfer analysis containers in an automated analyzer to achieve predictable results.
It would have been further obvious to arrange the attachment/detachment positions of the first and second measurement units along the guide rail to make the transferring of the cuvettes by the transfer device conveniently arranged.
Shintani et al. in view of Sawada et al. does not teach that the sample nozzle and the transporter are provided on a common guide rail and have different ranges of movement along the common guide rail.
Jakubowicz et al. teaches a chemical analyzer that includes a common rail 26 along which trucks 30 and 44 are movable along the common rail over different ranges.
It would have been obvious to one of ordinary skill in the art to modify Shintani et al. in view of Sawada et al. to provide a common rail on which to move the sample nozzle and transporter as taught by Jakubowicz et al. in order to lower the costs associated with providing separate rail systems.
In Shintani et al. in view of Sawada et al. and Jakubowicz et al. it would have been obvious to one of ordinary skill in the art to arrange locations of the transport rails, measuring devices, reagent table and sample supply unit, etc. for convenient functioning of the overall system and space considerations.
Shintani et al. as modified by Sawada et al. and Jakubowicz et al. does not teach the first measuring being configured to hold the cuvette into which the biological sample is dispensed, and move a first holding hole which holds the cuvette in a first direction that is substantially perpendicular to a direction of extension of a guide rail; the second measuring device being configured to hold the cuvette, and move a second holding hole which moves the cuvette in a clockwise or counter-clockwise direction and holds the cuvette in a second direction that is different from the direction that the cuvette was held in the first measurement of the content of the cuvette; a transporter that is connected to the guide rail and moves in a horizontal third direction along the guide rail and is different from the first direction and the second direction in which the cuvette was held, along the guide rail, wherein movement of the transporter in a horizontal and perpendicular direction relative to the guide rail is prevented.
Hayashi et al. teaches an automatic analyzer that is configured to “reduce the size of a reactor and to arbitrary change the reaction time and detection time of the reactor by controlling a reaction vessel transferring mechanism which moves reaction vessels arranged along different concentric circumferences to other circumferences, a detector, and the transfer of the vessels.” (Abstract).
As shown in Fig. 1 Hayashi et al. includes a means for moving reaction vessels along lane 7 in a first direction which is perpendicular to lane (rail) 8 and a measuring device in the form of disc 1 that moves reaction vessels in a second direction that is different from the first directed as well as lane (rail) 8 that extends in a direction that is different from the first and second direction and along which reaction vessels are transported. (See SOLUTION section).
It would have been obvious to one of ordinary skill in the art to modify Shintani et al. in view of Sawada et al. and Jakubowicz et al. to provide the third measurement unit 5 (corresponding to applicant’s first measurement unit) in a linear configuration similar to the lane 7 of Hayashi et al. and the a first measurement unit 2 (corresponding to applicant’s second measurement unit) in a circular configuration similar to the disc of Hayashi et al. and provide a transporter in a linear configuration similar to the lane 8 of Hayashi et al. for purposes of reducing the size of a reactor and to arbitrary change the reaction time and detection time as taught by Hayashi et al.
Sawada et al. discloses a reaction container storage unit 8 (supply unit).
Shintani et al. as modified by Sawada et al., Jakubowicz et al. and Hayashi et al. do not teach a supply unit that includes a hopper disposed at an upper portion of the analyzer for accommodating the cuvette and a supply port positioned below the hopper for supplying from the supply port thereof the cuvette.
Ootani et al. teaches an automatic analyzer that includes a cuvette supplying unit 70 that includes a hopper 71 having parallel guide plates 72 that slopes downward and directs cuvettes from the hopper to cut-out portions 73c of a supply port.
It would have been obvious to one of ordinary skill in the art to modify Shintani et al. as modified by Sawada et al., Jakubowicz et al. and Hayashi et al. to include a cuvette supply unit that includes a hopper disposed at an upper portion of the analyzer for accommodating the cuvette and a supply port positioned below the hopper for supplying from the supply port thereof the cuvette, as taught by Ootani et al. for purposes of conveniently loading cuvettes into the hopper and supplying them to the analyzer for use.
As for the limitation added to claim 1 in applicant’s response filed 01/02/2026 that the cuvette supply unit is centrally disposed at an upper portion of the analyzer for accommodating the cuvette and a cuvette supply port positioned below the hopper for supplying the cuvette from the cuvette supply port, first it is noted that the cuvette supply port in Ootani et al. is positioned below the hopper.
Further, in regards to locating the cuvette supply unit being “centrally disposed,” it would have been obvious to one of ordinary skill in the art to arrange the various elements of the analyzer of Shintani et al. as modified by Sawada et al., Jakubowicz et al., Hayashi et al. and Ootani et al. in any convenient manner, taking into consideration of space consideration, speed associated with dispensing, transferring cuvettes, etc.
Note, rearrangement of parts is not patentable if the overall operation of the analyzer of the combination set forth above is not effected by the design choice of arranging the parts. (MPEP 2144.04(VI)(C)). Arranging the parts of an analyzer to accommodate space consideration, speed associated with dispensing, transferring cuvettes, etc. are design choices that one skilled in the art would readily understand and consider.
Shintani et al. as modified by Sawada et al., Jakubowicz et al., Hayashi et al. and Ootani et al. teach a supply port of the supply unit, attachment and detachment positions of the first measuring device, and attachment and detachment positions of the second measuring device arranged on the line along the guide rail, but do not teach that the supply unit is disposed between the first measurement unit or the second measurement unit and the reagent table.
As noted above, rearranging parts is not patentable when the rearranging would not modify operation. (MPEP 2144.04(IV)(B))
It would have been obvious to Shintani et al. as modified by Sawada et al., Jakubowicz et al., Hayashi et al. and Ootani et al. to position the supply unit between the first measurement unit or the second measurement unit and the reagent table in consideration of overall size, processing time, costs, etc.
As noted above, Shintani et al. as modified by Sawada et al., Jakubowicz et al., Hayashi et al. and Ootani et al. teach all the elements of claim 1.
Therefore, Shintani et al. in view of Sawada et al., Jakubowicz et al., Hayashi et al. and Ootani et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 3, as noted above Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 1 obvious from which claim 3 depends.
Claim 3 recites a discarding port for discarding the cuvette, wherein the discarding port, the attachment and detachment position of the first measurement unit, and the attachment and detachment position of the second measurement unit are arranged on the line.
Hayashi et al. teaches a sample disposal unit 9 as shown in Fig. 1.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Shintani et al. in view of Sawada et al, Jakubowicz et al., Hayashi et al., and Ootani et al. to include a sample discarding unit as taught by Hayashi et al. into which used cuvettes can be disposed of.
Therefore, Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 3 obvious.
III.) Regarding applicant’s claim 5, as noted above Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 1 obvious from which claim 5 depends.
Claim 5 recites a reagent nozzle washing tank for washing a reagent nozzle arranged at the reagent nozzle unit, wherein the reagent nozzle washing tank is arranged on the same line, which is substantially in parallel with the guide rail, as the collection position and the dispensing position are arranged.
Sawada et al. teaches a nozzle washing unit 23 that is shown as being a well or tank in Fig. 1.
It would have been obvious to one of ordinary skill in the art to modify Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. to include a washing tank for washing the reagent nozzle as taught by Sawada et al. and locate the washing tank along the guide rail for purposes arranging the nozzle washing unit near the dispenser along the guide rail.
Therefore, Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 5 obvious.
IV.) Regarding applicant’s claim 6, as noted above Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that the guide rail is provided substantially linearly.
Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. all teach linear rails.
It would have been obvious to include a linear guide rail in Shintani et al. as modified by Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. inasmuch as linear rails are taught by each reference.
Therefore, Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 6 obvious.
V.) Regarding applicant’s claim 7, as noted above Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the first measurement unit outputs data indicative of a degree of progress of a prescribed reaction effected in the content of the cuvette, the analyzer further comprising a processor for extending a measuring time and continuing measurement processing when determination is made that, even after an elapse of a preset measuring time, the prescribed reaction has not been completed on the basis of the data outputted from the measurement unit.
As noted above, Shintani et al. teaches measuring blood coagulation time in the first measurement.
It would have been obvious to one of ordinary skill in the art to modify Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. to conduct the first test of coagulation time and, conduct a second measurement of coagulation time later to confirm that coagulation was complete.
Therefore, Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 7 obvious.
VI.) Regarding applicant’s claim 8, as noted above Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 7 obvious from which claim 8 depends.
Claim 8 recites that the prescribed reaction is the coagulation of blood.
As noted above, Shintani et al. teaches measuring blood coagulation time in the first measurement.
Therefore, Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 8 obvious.
VII.) Regarding applicant’s claim 11, as noted above Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 1 obvious from which claim 11 depends.
Claim 11 recites that wherein the supply port is an end of a sloped exit.
As noted above Ootani et al. teaches an automatic analyzer that includes a cuvette supplying unit 70 that includes a hopper 71 having parallel guide plates 72 that slope downward and direct cuvettes from the hopper to cut-out portions 73c of a supply port.
Therefore, Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al. and Ootani et al. render claim 11 obvious.
2. Claim 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2018/008948 to Yabutani et al.
I.) Regarding applicant’s claim 9, as noted above Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. renders claim 1 obvious from which claim 9 depends.
Claim 9 recites a dispensing mechanism for collecting a biological sample from a container accommodating a biological sample, and dispensing the biological sample to a sample cup; and a processor, wherein the first measurement unit holds a cuvette accommodating the sample dispensed from the sample cup, and performs measurement of a coagulation time of the content of the cuvette, the processor causes the dispensing mechanism to prepare a mixed sample obtained by mixing a normal sample and a sample from a patient, which are accommodated in different containers, in an amount capable of measurements of a plurality of specimens and in a prescribed ratio in the sample cup, and causes the first measurement unit to immediately perform measurement of the coagulation time using the prepared mixed sample.
Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. teaches taking a first measurement of a biological sample, but do not teach preparing a mixed sample obtained by mixing a normal sample and a sample from a patient in different containers and taking a measurement of the coagulation time using the mixed sample.
Yabutani et al. discloses an analysis device that performs a blood coagulation test in which a specimen injection probe 101a (injection mechanism) is used to inject a plurality of specimen containers 103d-103i (sample cups) with normal plasma (a normal sample) in specimen container 103a and specimen plasma (a patient sample) in specimen container 103b so as to achieve various set normal plasma ratios (predetermined ratios). Adjusted plasma mixtures are created and are injected into respectively different reaction containers 104 (cuvettes) and coagulation time is measured, thereby performing a cross mixing test.
Yabutani et al. further discloses performing a delay-type measurement in which coagulation time of plasma mixtures is measured after incubation at 37°C for a set time (after heating for a predetermined time).
It would have been obvious to one of ordinary skill in the art to modify Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. to prepare mixed samples obtained by mixing a normal sample and a sample from a patient in different containers art predetermined ratios and take a measurement of the coagulation time using the mixed samples as taught by Yabutani et al. for purposes of performing an automatic cross-mixing test as taught by Yabutani et al.
Therefore, Shintani et al. in view of Sawada et al., Jakubowicz et al., Hayashi et al., Ootani et al. and Yabutani et al. renders claim 9 obvious
II.) Regarding applicant’s claim 10, as noted above Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., Ootani et al. and Yabutani et al. renders claim 1 obvious from which claim 10 depends.
Claim 10 recites an input/output device for inputting/outputting information on the basis of an operation by a user, wherein the processor is configured to cause the first measurement unit to perform measurement of a coagulation time by using the mixed sample after heating for a prescribed time, and receive an input of correspondence between the mixed sample which has undergone the measurement of the coagulation time immediately via the input/output device, and the mixed sample which has undergone the measurement of the coagulation time after heating for a prescribed time, acquire information regarding a coagulation time measured for corresponding mixed samples from the first measurement unit, and cause the input/output device to output the information.
As noted above, Yabutani et al. further discloses performing a delay-type measurement in which coagulation time of plasma mixtures is measured after incubation at 37°C for a set time (after heating for a predetermined time).
It would have been obvious to one of ordinary skill in the art to modify Shintani et al. in view of Sawada et al. Jakubowicz et al., Hayashi et al., and Ootani et al. to prepare mixed samples obtained by mixing a normal sample and a sample from a patient in different containers art predetermined ratios and take a measurement of the coagulation time using the mixed samples and a delay-type measurement in which coagulation time of plasma mixtures is measured after incubation at 37°C for a set time (after heating for a predetermined time) as taught by Yabutani et al. for purposes of performing an automatic cross-mixing test as taught by Yabutani et al.
Therefore, Shintani et al. in view of Sawada et al., Jakubowicz et al., Hayashi et al., Ootani et al. and Yabutani et al. renders claim 10 obvious.
Response to Arguments
Applicant's arguments filed 01/02/2016 have been fully considered but they are not persuasive.
Applicant argues that "a cuvette supply unit including a hopper, wherein the cuvette supply unit is centrally disposed at an upper portion of the analyzer for accommodating the cuvette and a cuvette supply port positioned below the hopper for supplying the cuvette from the cuvette supply port." And that “This feature, which is depicted in Figure 2, provides an unexpected advantage. Since the cuvette supply unit is centrally positioned, cuvettes charged into the hopper can be moved to various parts of the analyzer in a short time. None of the cited references provide any basis for this feature.”
As noted above, arranging the parts of an analyzer to accommodate space consideration, speed associated with dispensing, transferring cuvettes, etc. are design choices that one skilled in the art would readily understand and take into consideration. Arranging the elements of the analyzer of Shintani et al. as modified by Sawada et al., Jakubowicz et al., Hayashi et al. and Ootani et al., including locating the cuvette supply unit in a central location does not provide an unexpected results related to moving cuvettes throughout the system. One skilled in the art would take into consideration space consideration, speed associated with dispensing, transferring cuvettes, etc. as related to where cuvettes are provided by the cuvette supply unit.
Applicant argues that “Figures 1 and 2 of Ootani et al. clearly show cuvette supply unit as being positioned at the back right corner of the analyzer, where it is not centrally disposed.”
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. (MPEP 2145 (IV))
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798