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 .
Status of Claims
Claim 16-35 are pending and under examination.
Claims 1-15 have been canceled.
Response to Amendment
Based on the amended claims and remarks received on 11/24/2025, the previous prior art rejection over Hansen has been maintained (see below).
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 16, 26, and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (US 2008/0072664 – hereinafter “Hansen”) in view of Girvin et al. (US 2007/0047385 – hereinafter “Girvin”), and further in view of Maeshima (US 2014/0087370 – hereinafter “Maeshima”).
Regarding claim 16, Hansen disclose a fluid analysis arrangement (Hansen; figs. 1 & 3, #1, [0027, 0029, 0042], comprising:
a particle quantifying device (Hansen disclose the fluid analysis arrangement 1 comprise a controller 300 configured for quantifying a concentration of particles in a fluid, and determining an amount of diluent to be added to a sample container 10 and/or an amount of preliminary sample to be removed from the sample container in order to prepare a sample having a selected concentration of particles; fig. 1, [0049]. The controller receives a measured concentration form a sensor device 200 and determines an overall dilution scheme to prepare a sample having a selected concentration of particles; fig. 8, #805-806, [0070]. Accordingly, the fluid analysis arrangement 1 and controller 300 comprises a particle quantifying device) having a sensor unit (Hansen disclose a fluidics system 100 in communication with controller 300 and robotic system 400 to measure the concentration of particles in a sample 10 and determine a dilution scheme to prepare a sample having a selected concentration of particles; figs. 4 & 8, #805-806, [0043-0047, 0070]), with a sensing stick (Hansen disclose a sensor device 200 arranged on the sensor unit 100 for measuring a concentration of particles in a sample and sending the measured value to the particle quantifying device 300; figs. 4 & 8, #200, #805, #806, [0046, 0049, 0070, 0074]), and an evaluation unit (Hansen disclose the sensing stick 200 transmits measurement concentration information to the particle quantifying device 300 to determine subsequent operations until a desired concentration of particles in the sample is achieved; fig. 8, [0046, 0049, 0072-0080]);
a holder having a plurality of seats each configured to receive a container in which a sample fluid is arranged (Hansen disclose a holder 50 having seats 51 configured to receive container 10 containing a sample fluid; fig. 2, #10, #50, #51, [0053-0054]);
a robot (Hansen; figs. 1, 3-4, & 5, #400, [0014, 0016-0019, 0045-0046]);
a washing station (Hansen; fig. 3, #600, [0019, 0023, 0068]); and
a control unit connected to the particle quantifying device and the robot (Hansen; fig. 1, #300, [0027]), wherein
the sensor unit is mounted to the robot (Hansen disclose sensor unit 100 is mounted to robot 430; fig. 4, [0046]), and
the control unit (Hansen; fig. 1, #300, [0027]) is configured to
control the robot to arrange the sensing stick in one of the sample seats of the holder after another (Hansen; figs. 4 & 8, Step 815, [0047, 0053, 0056, 0061, 0066, 0080]),
activate the particle quantifying device to sense for particles in the sample fluids (Hansen; fig. 8, Steps 805-806, [0074]), and
control the robot to arrange the sensing stick in the washing station after each sensing for particles in one of the sample fluids and before arranging the sensing stick in a next one of the sample seats (Hansen; fig. 4, [0019, 0066, 0068]).
Hansen does not teach the sensing stick is to be arranged in a fluid to sense for particles in the fluid.
However, Girvin teach the analogous art of a particle quantifying device having a sensor unit with a sensing stick to be arranged in a fluid to sense for particles in the fluid, and an evaluation unit (Girvin; fig. 1, [0004-0005]). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the particle quantifying device having a sensor unit with a sensing stick of Hansen with the particle quantifying device having a sensor unit and sensing stick to be arranged in a fluid to sense for particles in the fluid, as taught by Girvin, because Girvin teach the particle quantifying device having a sensor unit and sensing stick to be arranged in a fluid to sense for particles in the fluid complies with pharmaceutical industry requirements for measuring particle size distribution for pharmaceutical production (Girvin; [0003]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Hansen and Girvin both teach particle quantification of samples using sensors and sensing sticks.
Modified Hansen does not explicitly teach the control unit is configured to arrange the sensing stick in the sample fluid of each container received in the seats.
However, Maeshima teach the analogous art of a holder having a plurality of seats each configured to receive a container in which a sample fluid is arranged (Maeshima; fig. 1, #102, [0097]) a stick to be arranged in a fluid (Maeshima; fig. 1, 105, [0100]) and a control unit configured to arrange the stick in one of the fluid samples of each container received in the seats of the holder (Maeshima; fig. 1, #109, [0095, 0097, 0100, 0109, 0140]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the control of modified Hansen to be configured to arrange the stick in one of the fluid samples of each container received in the seats of the holder, as taught by Maeshima, because Maeshima teach the control configured to arrange the stick in one of the fluid samples of each container received in the seats of the holder allows automated processing of the fluid sample according to a specified processing method (Maeshima; [0109]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hansen and Maeshima both teach a control unit for controlling a robot comprising a stick.
Regarding claim 26, Hansen disclose the fluid analysis arrangement of claim 16 above, wherein the robot is a linear robot embodied to move the sensor unit along a horizontal x axis and a vertical z-axis (Hansen; figs. 3 & 5, [0014, 0061, 0065]).
Regarding claim 28, Hansen disclose the fluid analysis arrangement of claim 16 above, wherein the fluid analysis arrangement comprises a sample fluid drawer in fluid connection with the sensing stick of the sensor unit (The modification of the particle quantifying device having a sensor unit with a sensing stick of Hansen with the particle quantifying device having a sensor unit and sensing stick to be arranged in a fluid to sense for particles in the fluid, as taught by Girvin, and the modification of the control of modified Hansen to be configured to arrange the stick in one of the fluid samples of each container received in the seats of the holder, as taught by Maeshima, have previously been discussed in claim 16 above. Girvin teach the sensing stick withdraws sample fluid; [0005], and Maeshima teach a pump connected to the stick to suction and discharge fluid; [0099]), or
the fluid analysis arrangement comprises the sample fluid drawer in fluid connection with the sensing stick of the sensor unit wherein a fluid connection structure between the sample fluid drawer and the sensing stick of the sensor unit is at least partially filled with a transmission medium.
Regarding claim 29, Hansen disclose a method of analyzing a fluid (Hansen; fig. 8, [0072-0080]), comprising the steps of:
i) obtaining a plurality of containers each filled with a sample fluid to be analyzed (Hansen disclose a holder 50 having seats 51 configured to receive container 10 containing a sample fluid; figs. 2 & 8, #10, #50, #51, #801-802, [0053-0054, 0072]);
ii) a robot (Hansen; figs. 1, 3-4, & 5, #400, [0014, 0016-0019, 0045-0046]) automatically arranging a sensing stick (Hansen disclose a sensor device 200 arranged on the sensor unit 100 for measuring a concentration of particles in a sample and sending the measured value to the particle quantifying device 300; figs. 4 & 8, #200, #805, #806, [0046, 0049, 0070, 0074]) of a sensor unit (Hansen disclose a fluidics system 100 in communication with controller 300 to measure the concentration of particles in a sample and determine a dilution scheme to prepare a sample having a selected concentration of particles; figs. 4 & 8, #805-806, [0043-0047, 0070]) of a particle quantifying device (Hansen disclose the fluid analysis arrangement 1 comprise a controller 300 configured for quantifying a concentration of particles in a fluid, and determining an amount of diluent to be added to a sample container 10 and/or an amount of preliminary sample to be removed from the sample container in order to prepare a sample having a selected concentration of particles; fig. 1, [0049]. The controller receives a measured concentration form a sensor device 200 and determines an overall dilution scheme to prepare a sample having a selected concentration of particles; fig. 8, #805-806, [0070]. Accordingly, the fluid analysis arrangement 1 and controller 300 comprises a particle quantifying device);
iii) the sensor unit of the particle quantifying device automatically sensing for particles in the one of the sample fluids (Hansen disclose the sensor device 200 is configured for measuring a concentration of particles suspended in the preliminary sample in the sample container 10; figs. 4 & 8, #805, [0046, 0070]);
iv) the robot automatically arranging the sensing stick of the sensor unit of the particle quantifying device in a washing station (Hansen; fig. 3, #600, [0019, 0023, 0068]);
v) cleaning the sensing stick of the sensor unit of the particle quantifying device arranged in the washing station (Hansen; fig. 3, #600, [0019, 0023, 0068]); and
vi) repeating steps ii) to v) for each of the other ones of the samples of the plurality of containers one after the other (Hansen; fig. 8, 815, [0080]).
Hansen does not teach arranging the sensing stick in one of the sample fluids of the plurality of containers.
However, Girvin teach the analogous art of a particle quantifying device having a sensor unit with a sensing stick to be arranged in a fluid to sense for particles in the fluid (Girvin; fig. 1, [0004-0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the particle quantifying device having a sensor unit with a sensing stick of Hansen with the particle quantifying device having a sensor unit and sensing stick to be arranged in a fluid to sense for particles in the fluid, as taught by Girvin, because Girvin teach the particle quantifying device having a sensor unit and sensing stick to be arranged in a fluid to sense for particles in the fluid complies with pharmaceutical industry requirements for measuring particle size distribution for pharmaceutical production (Girvin; [0003]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Hansen and Girvin both teach particle quantification of samples using sensors and sensing sticks.
Modified Hansen does not explicitly teach the robot automatically arranges the sensing stick in the sample fluid of each container received in the seats.
However, Maeshima teach the analogous art of obtaining a plurality of containers each filled with a sample fluid to be analyzed (Maeshima; fig. 1, #102, [0097]) and a robot that automatically arranges a stick to be in one of the sample fluids of the plurality of containers (Maeshima; fig. 1, #105, #109, [0095, 0097, 0100, 0109, 0140]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the robot of modified Hansen to automatically arrange the stick in one of the fluid samples of each container, as taught by Maeshima, because Maeshima teach the robot that automatically arranges the stick in one of the fluid samples of each containers allows automated processing of the fluid sample according to a specified processing method (Maeshima; [0109]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hansen and Maeshima both teach a control unit for controlling a robot comprising a stick.
Claims 17-20 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Girvin, in view of Maeshima, and further in view of Kuroda (US 2011/0017238 – hereinafter “Kuroda”).
Regarding claim 17, modified Hansen disclose the fluid analysis arrangement of claim 16 above, wherein the washing station configured to activate the cleaning after the particle quantifying device sensing for particles in the sample fluid of one of the containers received in the seats of the holder and before the particle quantifying device sensing for particles in the sample fluid of another one of the containers received in the seats of the holder (The modification of the particle quantifying device having a sensor unit with a sensing stick of Hansen with the particle quantifying device having a sensor unit and sensing stick to be arranged in a fluid to sense for particles in the fluid, as taught by Girvin, and the modification of the control of modified Hansen to be configured to arrange the stick in one of the fluid samples of each container received in the seats of the holder, as taught by Maeshima, have previously been discussed in claim 16 above. Hansen disclose washing the sensing unit during and/or between dispensing, aspirating, and/or measuring cycles; [0019, 0068]).
Modified Hansen does not teach the washing station comprises a cleaning medium reservoir housing a cleaning medium and a cleaning medium forwarder connected to the cleaning medium reservoir, wherein the control unit is connected to the washing station and configured to activate the cleaning medium forwarder to flush the sensor unit with the cleaning medium.
However, Kuroda teach the analogous art of a wash station (Kuroda; fig. 3, #6, [0102]) wherein the wash station comprises a cleaning medium reservoir housing a cleaning medium (Kuroda; fig. 3, #61c, L2, [0103]) and a cleaning medium forwarder connected to the cleaning medium reservoir (Kuroda; fig. 3, #61e, [0103]), wherein the control unit is connected to the wash station and configured to activate the cleaning medium forwarder to flush the unit with the cleaning medium (Kuroda; figs. 4-6, [0112-0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the washing station of modified Hansen to comprise a cleaning medium reservoir housing a cleaning medium and a cleaning medium forwarder connected to the cleaning medium reservoir, wherein the control unit is connected to the washing station and configured to activate the cleaning medium forwarder to flush the sensor unit with the cleaning medium, as taught by Kuroda, because Kuroda teach the reservoir, station, and medium configured to operate under control of the control device provides the benefit of reducing the cleaning time and reduces carry-over (Kuroda; [0128]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hansen and Kuroda both teach units for handling sample fluids and washing stations for washing the units after each operation.
Regarding claim 18, modified Hansen teach the fluid analysis arrangement of claim 17 above, wherein the washing station has a washing seat in which the sensing stick is arranged when the sensor unit is flushed with the cleaning medium (The modification of the washing station of modified Hansen to comprise a cleaning medium reservoir housing a cleaning medium and a cleaning medium forwarder connected to the cleaning medium reservoir, wherein the control unit is connected to the washing station and configured to activate the cleaning medium forwarder to flush the sensor unit with the cleaning medium, as taught by Kuroda, has previously been discussed in claim 17 above. Hansen disclose a wash seat for the sensing stick; fig. 3, #600, [0019, 0068]. Furthermore, Kuroda disclose a washing seat where the unit is arranged when flushed with the cleaning medium; fig. 3, #62, [0103]).
Regarding claim 19, modified Hansen teach the fluid analysis arrangement of claim 18 above, the washing station comprises a cleaning medium cavity arranged to receive the cleaning medium after flushing the sensor unit (The modification of the washing station of modified Hansen to comprise a cleaning medium reservoir housing a cleaning medium and a cleaning medium forwarder connected to the cleaning medium reservoir, wherein the control unit is connected to the washing station and configured to activate the cleaning medium forwarder to flush the sensor unit with the cleaning medium, as taught by Kuroda, has previously been discussed in claim 17 above. Kuroda further disclose the wash station comprise a cleaning medium cavity arranged to receive the cleaning medium after flushing the unit; fig. 3, 64, [0104]).
Regarding claim 20, modified Hansen teach the fluid analysis arrangement of claim 19 above, wherein the washing seat and the cleaning medium cavity are in fluid communication such that after flushing the sensor unit the cleaning medium is provided into the washing seat and transferred from the washing seat into the cleaning medium cavity (The modification of the washing station of modified Hansen to comprise a cleaning medium reservoir housing a cleaning medium and a cleaning medium forwarder connected to the cleaning medium reservoir, wherein the control unit is connected to the washing station and configured to activate the cleaning medium forwarder to flush the sensor unit with the cleaning medium, as taught by Kuroda, has previously been discussed in claim 17 above. Kuroda further disclose the wash station comprise a cleaning medium cavity arranged to receive the cleaning medium after flushing the unit; fig. 3, 64, [0104]).
Regarding claim 30, modified Hansen teach the method of claim 29 above, wherein step v) comprises flushing the sensor unit with a cleaning medium, or step v) comprises flushing the sensor unit with a cleaning medium, and the washing station has a washing seat in which the sensing stick is arranged when the sensor unit is flushed with the cleaning medium (Hansen; fig. 6, #600, [0019, 0068]).
Modified Hansen does not teach step v) comprises a cleaning medium forwarder.
However, Kuroda teach the analogous art of a wash station (Kuroda; fig. 3, #6, [0102]) comprising a cleaning medium forwarder (Kuroda; fig. 3, #61c, L2, [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method and washing station of modified Hansen to comprise a cleaning medium forwarder, wherein the control unit is connected to the washing station and configured to activate the cleaning medium forwarder to flush the sensor unit with the cleaning medium, as taught by Kuroda, because Kuroda teach the reservoir, station, and medium configured to operate under control of the control device provides the benefit of reducing the cleaning time and reduces carry-over (Kuroda; [0128]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hansen and Kuroda both teach units for handling sample fluids and washing stations for washing the units after each operation.
Claims 21-22, 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen, in view of Girvin, in view of Maeshima, in view of Kuroda, and further in view of Bauer (US 2019/0151904 – hereinafter “Bauer”).
Regarding claim 21, modified Kuroda disclose the fluid analysis arrangement of claim 19 above, wherein the control unit is configured to control the robot to arrange the sensing stick in the cleaning medium cavity (Hansen; [0019, 0068]).
Modified Hansen does not teach to sense for particles in the cleaning medium after flushing the sensor unit.
However, Bauer teaches the analogous art of a washing station (Bauer; fig. 2, #42, [0034]) configured to clean a part in cleaning medium (Bauer; fig. 2, #48, #46, [0034]), and a sensor configured to sense for particles in the cleaning medium after flushing the part (Bauer teach cleaning medium 46 is dispensed into the station 42 to clean part 48, sensor 76 measures the concentration of particles 78 until a threshold value 102 is reached; figs. 2 & 3, [0025, 0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the control unit to be configured to sense for particles in the cleaning medium after flushing the unit, as taught by Bauer, because Bauer teach sensing for particles after flushing allows the concentration of particles in the washing station to be reduced to a threshold value, thereby ensuring the washing station itself is sufficiently clean for the next washing operation; [0034]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hansen and Bauer both teach washing stations that perform continuous washing operations and flushing the tank with a cleaning medium.
Regarding claim 22, modified Hansen teach the fluid analysis arrangement of claim 21 above, wherein the control unit is configured to control the robot to arrange the sensing stick in the sample fluid of the other one of the containers received in the seats of the holder when the amount of particles sensed in the cleaning medium after flushing the sensor unit is below a predefined threshold, and/or the control unit is configured to re-activate the cleaning medium forwarder to flush the sensor unit with the cleaning medium when the amount of particles sensed in the cleaning medium after flushing the sensor unit is above the predefined threshold (The modification of the control unit to be configured to sense for particles in the cleaning medium after flushing the unit, as taught by Bauer, has previously been discussed in claim 21 above. Bauer teach the cleaning medium is flushed through the wash station until the sensor detects a threshold concentration of particles; fig. 3, #102, [0034]).
Regarding claim 31, modified Hansen teach the method of claim 30 above, wherein the cleaning medium is gathered after flushing the sensor unit (The modification of the washing station of Hansen to comprise a cleaning medium forwarder, wherein the control unit is connected to the washing station and configured to activate the cleaning medium forwarder to flush the sensor unit with the cleaning medium, as taught by Kuroda, has previously been discussed in claim 30 above. Kuroda further teach the cleaning medium is gathered in tank 62 after flushing the unit; fig. 3, #62, [0103-0104]).
Modified Hansen does not teach the sensor unit of the particle quantifying device automatically senses for particles in the gathered cleaning medium.
However, Bauer teach the analogous art of a washing station (Bauer; fig. 2, #42, [0034]) configured to clean a part in cleaning medium (Bauer; fig. 2, #48, #46, [0034]), and a sensor configured to sense for particles in the cleaning medium after flushing the part (Bauer teach cleaning medium 46 is dispensed into the station 42 to clean part 48, sensor 76 measures the concentration of particles 78 until a threshold value 102 is reached; figs. 2 & 3, [0025, 0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method and sensor unit of modified Hansen to be configured to sense for particles gathered in the cleaning medium, as taught by Bauer, because Bauer teach sensing for particles allows the concentration of particles in the washing station to be reduced to a threshold value, thereby ensuring the washing station itself is sufficiently clean for the next washing operation; [0034]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hansen and Bauer both teach washing stations that perform continuous washing operations and flushing the tank with a cleaning medium.
Regarding claim 32, modified Hansen teach the method of claim 31 above, wherein step vi) is performed when the amount of particles sensed in the gathered cleaning medium is below a predefined threshold (The modification of the method and sensor unit of modified Hansen to be configured to sense for particles gathered in the cleaning medium, as taught by Bauer, has previously been discussed in claim 31 above. Bauer teach the cleaning medium is flushed through the wash station until the sensor detects a threshold concentration of particles; fig. 3, #102, [0034]).
Regarding claim 33, modified Hansen teach the method of claim 31 above, wherein step v) is re-performed when the amount of particles sensed in the gathered cleaning medium is above a predefined threshold (The modification of the method and sensor unit of modified Hansen to be configured to sense for particles gathered in the cleaning medium, as taught by Bauer, has previously been discussed in claim 31 above. Bauer teach the cleaning medium is flushed through the wash station until the sensor detects a threshold concentration of particles; fig. 3, #102, [0034]).
Claims 23-24, 34 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Girvin, in view of Maeshima, and further in view of Ikushima (US 2013/0108521 – hereinafter “Ikushima”).
Regarding claim 23, modified Hansen disclose the fluid analysis arrangement of claim 16 above, wherein the control unit is configured to control the robot to arrange the sensing stick in the sample fluid of the other one of the containers received in the seats of the holder (Hansen; fig. 8, #815, [0080]).
Modified Hansen does not teach the washing station comprises a drying coupler and the control unit is configured to control the robot to arrange the sensing stick in the drying coupler before arranging the sensing stick in the sample fluid of the other one of the containers.
However, Ikushima teach the analogous art of a washing station (Ikushima; fig. 2, #14, [0066]) comprising a drying coupler (Ikushima; fig. 2, #17, [0066]), a robot (Ikushima; fig. 1, #34, [0046]), a unit mounted to the robot (Ikushima; fig. 1, #12, [0048]) and a control unit (Ikushima; fig. 1, #13, [0047]) wherein the control unit is configured to control the robot to arrange the unit mounted on the robot in the drying coupler before arranging the unit mounted on the robot in the sample fluid of another container (Ikushima; [0075-0076, 0081-0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the washing station and control of modified Hansen to comprise a drying coupler wherein the control unit is configured to control the robot to arrange the unit mounted to the robot in the drying coupler before arranging the unit mounted on the robot in the sample fluid of the other one of the containers, as taught by Ikushima, because Ikushima teaches drying the unit on mounted on the robot before arranging the unit mounted on the robot in the sample fluid of the other one of the containers prevents mixing of the cleaning liquid from interacting with the content of the next container; [0083]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hansen and Ikushima both teach units mounted on a robot that interact with the contents of containers, and washing stations for cleaning the units mounted on the robot.
Regarding claim 24, modified Hansen teach the fluid analysis arrangement of claim 23 above, wherein the washing station comprises a vacuum creator connected to the control unit, the control unit being configured to activate the vacuum creator to dry the sensor unit when the sensing stick is arranged in the drying coupler (The modification of the washing station and control of Hansen to comprise a drying coupler wherein the control unit is configured to control the robot to arrange the unit mounted to the robot in the drying coupler before arranging the unit mounted on the robot in the sample fluid of the other one of the containers, as taught by Ikushima, has previously been discussed in claim 23 above. Ikushima teach a vacuum creator 44 is activated to dry the unit mounted to the robot; fig. 12, [0068]).
Regarding claim 34, modified Hansen teach the method of claim 29 above, comprising step v).
Modified Hansen does not teach wherein step v) comprises drying the sensor unit, or step v) comprises drying the sensor unit, and drying the sensor unit comprises a vacuum creator of the washing station applying a vacuum to the sensor unit.
However, Ikushima teach the analogous art of a washing station (Ikushima; fig. 2, #14, [0066]) comprising a drying coupler (Ikushima; fig. 2, #17, [0066]), a robot (Ikushima; fig. 1, #34, [0046]), a unit mounted to the robot (Ikushima; fig. 1, #12, [0048]) and a control unit (Ikushima; fig. 1, #13, [0047]) wherein the control unit is configured to control the robot to arrange the unit mounted on the robot in the drying coupler, and a vacuum creator of the washing station applies a vacuum to the unit mounted to the robot (Ikushima; fig. 12, [0068, 0075-0076, 0081-0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method, washing station, and control of modified Hansen to comprise a drying coupler wherein the control unit is configured to control the robot to arrange the unit mounted to the robot in the drying coupler and a applying a vacuum to the unit mounted to the robot, as taught by Ikushima, because Ikushima teaches drying the unit on mounted on the robot with a vacuum creator before arranging the unit mounted on the robot in the next sample fluid prevents mixing of the cleaning liquid from interacting with the content of the next container; [0083]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hansen and Ikushima both teach units mounted on a robot that interact with the contents of containers, and washing stations for cleaning the units mounted on the robot.
Claims 25 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen, in view of Girvin, in view of Maeshima, and further in view of Le Comte (US 2009/0142844 – hereinafter “Le Comte”).
Regarding claim 25, modified Hansen disclose the fluid analysis arrangement of claim 16 above.
Modified Hansen does not teach the fluid analysis arrangement comprising a shaker, wherein the holder is arranged on the shaker to be moved by the shaker, and the control unit is connected to the shaker and configured to activate the shaker when the sensing stick is not arranged in the sample fluid of any container received in the seats of the holder.
However, Le Comte teach the analogous art of a fluid analysis arrangement (Le Comte; fig. 1, #1, [0085]) comprising a robot (Le Comte; fig. 1, #24/25/26/27, [0113]), and a shaker (Le Comte; fig. 1, #14, [0103]), wherein a holder is arranged on the shaker to be moved by the shaker (Le Comte teach shaker comprises three holders to be agitated; fig. 1, #14, [0103]), and the control unit is connected to the shaker and configured to activate the shaker when the robot is not arranged in the sample fluid of any container received in the seats of the holder (Le Comte teach the robot 27 arranges tubes in the holder to be shaken to a suitable stage of agitation and engages the holder once agitation is completed; [0085, 0126-0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fluid analysis arrangement of Hansen to comprise a shaker, wherein a holder is arranged on the shaker to be moved by the shaker, and the control unit connected to the shaker and configured to activate the shaker when the robot is not arranged in the sample fluid of any container received in the seats of the holder, as taught by Le Comte, because Le Comte teaches the shaker agitates the samples prior to analysis according to compliance with recommendations of the National Committee on Clinical Laboratory Standards (NCCLS) (Le Comte; [0126]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Hansen and Le Comte teach fluid analysis arrangements with robots for interacting with containers.
Regarding claim 35, modified Hansen teach the method of claim 29, comprising steps iii), iv), and v).
Hansen does not teach shaking the plurality of containers in step iii), in step iv) and in step v).
However, Le Comte teach the analogous art of a method of analyzing a fluid (Le Comte; fig. 1, #1, [0023-0028, 0085]) comprising a robot (Le Comte; fig. 1, #24/25/26/27, [0113]), and a shaker (Le Comte; fig. 1, #14, [0103]), wherein the shaker shakes a plurality of containers (Le Comte teach shaker 14 agitates a plurality of containers; fig. 1, #14, [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify steps iii), iv), and v) of the method of analyzing a fluid Hansen to comprise shaking the plurality of containers, as taught by Le Comte, because Le Comte teaches the shaker agitates the samples prior to analysis according to compliance with recommendations of the National Committee on Clinical Laboratory Standards (NCCLS) (Le Comte; [0126]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Hansen and Le Comte teach fluid analysis arrangements with robots for interacting with containers.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Girvin, in view of Maeshima, and further in view of Hanafusa et al. (US 2019/0154553 – hereinafter “Hanafusa”).
Regarding claim 27, modified Hansen disclose the fluid analysis arrangement of claim 16 above, comprising a sample, the sensor unit, the particle quantifying device, and evaluation unit.
Modified Hansen does not teach the fluid analysis arrangement comprising a sample loop positioned between the sensor unit of the particle quantifying device and the evaluation unit of the particle quantifying device.
However, Hanafusa teach the analogous art of a fluid analysis arrangement (Hanafusa; fig. 15, #200, [0138]) comprising a unit mounted to a robot (Hanafusa teach a needle 222 mounted on a sample injection apparatus 202; fig. 15, [0142]) and a particle quantifying device (Hanafusa; fig. 15, #208. [0139]) where the fluid analysis arrangement comprises a sample loop positioned between the unit mounted on the robot and the particle quantifying device (Hanafusa; fig. 15, #216, [0141]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fluid analysis arrangement of modified Hansen to comprise a sample loop positioned between the unit mounted on the robot and the particle quantifying device, as taught by Hanafusa, because Hanafusa teach the sample loop temporarily retains the fluid while the flow path is switched from the unit mounted on the robot to the particle quantifying device (Hanafusa; [0143]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hansen and Hanafusa both teach fluid analysis arrangements with robots that interact with a fluid and devices to quantify particles in the fluid.
Response to Arguments
Applicant’s arguments filed on 11/24/2025 have been considered but were not found persuasive.
Applicant argues on pages 7-9 of their remarks that the HIAC device of Girvin and the optical instrument of Hansen are not equivalent structure for measuring the particle concentration and further substitution of the optical instrument for the HAIC device would concomitantly negate the advantageous property of contactless measurement of the sensor device of Hansen, and that that substitution of the optical instrument of Hansen for the HIAC device of Girvin would change the principle of operation of Hansen with respect to how the sensor device of Hansen measure the particle concentration in a fluid in a contactless manner.
The examiner respectfully disagrees. Hansen and Girvin both teach a particle quantifying device having a sensor unit with a sensing stick to sense for particles in the fluid, and an evaluation unit. Although the device of Hansen is contactless, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the particle quantifying device having a sensor unit with a sensing stick of Hansen with the particle quantifying device having a sensor unit and sensing stick to be arranged in a fluid to sense for particles in the fluid, as taught by Girvin, because Girvin teach the particle quantifying device having a sensor unit and sensing stick to be arranged in a fluid to sense for particles in the fluid complies with pharmaceutical industry requirements for measuring particle size distribution for pharmaceutical production (Girvin; [0003]). That is, depending on the regulatory environment in which the device is used, one of ordinary skill in the art would be motivated to modify the sensor device of Hansen with the sensor device of Girvin in order to comply with pharmaceutical industry requirements.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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