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
This is an office action in response to Applicant’s arguments and remarks filed on 10 April 2026. Claims 1 and 3-21 are pending in this application. Claim 2 has been canceled. Claim 12 has been withdrawn. Claims 1, 3-11, and 13-21 are being examined herein.
Status of Objections and Rejections
The rejections of claims 1 and 3-4 under 32 U.S.C. § 102(a)(1) anticipated by Onoki, et. al. (US 20210181224 A1) are maintained.
The rejections of claims 13-14 under 32 U.S.C. § 102(a)(1) anticipated by Onoki, et. al. (US 20210181224 A1) are withdrawn in view of Applicant’s amendments.
The rejection of claim 5 under 32 U.S.C. § 103 in view of Onoki, et. al. (US 20210181224 A1) in view of Hawkin (So What Exactly Is A Force Plate?) is maintained.
The rejection of claim 15 under 32 U.S.C. § 103 in view of Onoki, et. al. (US 20210181224 A1) in view of Hawkin (So What Exactly Is A Force Plate?) is withdrawn in view of Applicant’s amendments.
The rejection of claim 6 under 32 U.S.C. § 103 in view of Onoki, et. al. (US 20210181224 A1) in view of Teruaki, et. al. (JP 2011107120 A) is maintained.
The rejection of claim 16 under 32 U.S.C. § 103 in view of Onoki, et. al. (US 20210181224 A1) in view of Teruaki, et. al. (JP 2011107120 A) is withdrawn in view of Applicant’s amendments.
The rejections of claims 7-11 under 32 U.S.C. § 103 in view of Onoki, et. al. (US 20210181224 A1) in view of Yasui, et. al. (US 20160327587 A1) are maintained.
The rejections of claims 17-21 under 32 U.S.C. § 103 in view of Onoki, et. al. (US 20210181224 A1) in view of Yasui, et. al. (US 20160327587 A1) are withdrawn in view of Applicant’s amendments.
Response to Arguments
Applicant's arguments filed 10 April 2026 have been fully considered but they are not persuasive.
As for the first argument, Applicant argues:
"Rather, at most, the '224 application merely discloses a process for detecting that the piercer has penetrated a cover member. However, the '224 application is silent regarding stopping at a penetration position before reaching the sample in response to the detector having detected that the piercer has penetrated through the lid, as recited in amended Claim 1. The '224 application does not disclose that the piercer stops at such a position before reaching the sample, or that the stopping is in response to the detector having detected that the piercer has penetrated through the lid. The '224 application is silent regarding any type of connection between a detector having detected that the piercer has pierced through the lid, and the piercer being stopped at a particular position, as required by Claim 1." (Remarks, pg. 10, par. 02).
Examiner respectfully disagrees that Onoki does not teaches a detection-based stop/penetration position.
Onoki teaches the piezoelectric element 850 on piercer 7 take the applied force and converts is into a voltage that is output as a current to controller 500; this force can be measured and converted by controller 500 to determine when piercer 7 penetrates cover member 22 [Fig. 28-29B] [0186-0195]. Specifically, controller 500 identifies inflection point β (Fig. 29A) to determine that piercer 7 has penetrated through cover member 22 [par. 0195]. Onoki teaches piercer 7 does not extend fully into the sample and stops once penetrating cover member 22; this process is seen in Figures. 4-8, with Figures. 5-7 explicitly depicting the piercer 7 stopped at a penetration position. This stopping is confirmed when controller 500 detects the inflection point β [par. 0195] or else an error is determined and the process is restarted [Fig. 19, 29Bpar. 0186-0195].
Applicant’s arguments, see Remarks, pg. 11, par. 03-04, filed 10 April 2026, with respect to the rejection(s) of claim(s) 13 under U.S.C. 102(a)(1) in view of Onoki, et. al. (US 20210181224 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Onoki, et. al. (US 20210181224 A1) in view of Wada, WO 2011161894 A1 and Yasui, et. al. (US 20160327587 A1).
As for the second argument, Applicant argues:
"Applicant respectfully submits that the "224 application fails to disclose a detector. including a sensor and circuitry, configured to detect the piercer penetrating through the lid, wherein the detector is further configured to detect that the piercer has penetrated through the lid, by measuring force applied to the piercer when the piercer is moving down, and wherein the sensor is arranged such that a top face of the sensor contacts the arm and 8 bottom face of the sensor contacts a top face of the flange, and wherein the force is measured while a pressure is applied to the piercer by an elastic member, as required by amended Claim 13. Rather, the '224 application merely discloses that the piezoelectric element 850 is located "near the tip of the piercer 7," which is above the tapered surface." (Remarks, pg. 11, par. 03-04).
Examiner agrees that Onoki is silent to a flange on the piercer, and the sensor being detected between the flange and the piercer arm. Onoki does however teach other elements of the device such as “a detector. including a sensor and circuitry, configured to detect the piercer penetrating through the lid, wherein the detector is further configured to detect that the piercer has penetrated through the lid, by measuring force applied to the piercer when the piercer is moving down” and other elements of claim 13 not listed in the above argument.
See below for detailed explanation on the new rejection of claim 13 in view of Onoki, et. al. (US 20210181224 A1) in view of Wada, WO 2011161894 A1 and Yasui, et. al. (US 20160327587 A1).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3-4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Onoki, et. al. (US 20210181224 A1).
For claim 1, Onoki teaches biochemical analysis apparatus with a piercer and a nozzle that passes through the piecer [Abstract]. Onoki teaches driving all of the following elements is controller 500 that comprises a CPU and RAM to execute and measure different steps [0061-0063, 0057-0058]. Onoki teaches the analysis apparatus 1 comprises a piercer 7 that moves upward and downward by piercer driving device 71 to pierce a cover member covering the top of sample accommodation container 2 [Fig. 4-5] [0052, 0054] (a piercer configured to pierce a lid which seals an opening of a sample container containing a sample). Onoki teaches an embodiment of the piercer 7 that further includes a piezoelectric element 850 that converts the force applied to the piezoelectric element 850 into a voltage that is supplied to a controller 500 that determines when the piercer 7 moves through the cover member 22 [Fig. 28-29B] [0186-0191] (a detector, including a sensor and circuitry, configured to detect the piercer penetrating through the lid). Once piercer 7 is through cover member 22, nozzle 8 extends through the space of piercer 7 to aspirate the sample [Fig. 6-8] [0053-0058] (a sample dispensing probe configured to pass through an inside of the piercer that has penetrated through the lid, to enter the sample container, and to aspirate the sample) (the sample dispensing probe is configured to pass through the inside of the piercer located at the penetration position so that the sample dispensing probe enters the sample container and aspirates the sample).
Piercer 7 has an uppermost stop position as determined by the length of shaft 712 that moves arm 711 and piercer 7 from the uppermost stop position to penetrating into the sample accommodation container 2 [Fig. 4-6] (wherein the piercer is configured to move down from an upper stop position above the sample container). Onoki teaches the piezoelectric element 850 converts the force applied to the piezoelectric element 850 into a voltage that is supplied to a controller 500 that determines when the piercer 7 moves through the cover member 22 [Fig. 28-29B] [0186-0191] (wherein the piercer is configured to move down from an upper stop position above the sample container, and stop at a penetration position before reaching the sample in response to the detector having detected that the piercer has penetrated through the lid).
For claim 3, Onoki teaches the piezoelectric element 850 on piercer 7 take the applied force and converts is into a voltage that is output as a current to controller 500; this force can be measured and converted by controller 500 to determine when piercer 7 penetrates cover member 22 [Fig. 28-29B] [0186-0195] (wherein the detector is further configured to detect that the piercer has penetrated through the lid, by measuring force applied to the piercer when the piercer is moving down).
For claim 4, Onoki teaches the piezoelectric element 850 on piercer 7 take the applied force and converts is into a voltage that is output as a current to controller 500; this force can be measured and converted by controller 500 to determine when piercer 7 penetrates cover member 22 [Fig. 28-29B] [0186-0195] (wherein the detector is further configured to detect that the piercer has penetrated through the lid, by measuring force applied to the piercer when the piercer is moving down). Onoki teaches the detection of two inflection points α and β from piezoelectric element 850, wherein α indicates when piercer 7 first hits cover member 22 and β specifically indicates when piercer 7 is through cover member 22 and PA indicates the measurement from the uppermost position [Fig. 29A-B] [0190-0195] (wherein the detector is further configured to acquire, when the piercer is moving down and after the force applied to the piercer is increased, a measurement of force that is higher than the force applied to the piercer at the upper stop position and that involves a change within a predetermined extent, so that the detector detects that the piercer has penetrated through the lid).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Onoki, et. al. (US 20210181224 A1) in view of Hawkin (So What Exactly Is A Force Plate?; as cited in OA dated 6 March 2025 and 7 July 2025).
For claim 5, Onoki teaches the force is measured with a piezoelectric sensor that convert the force to a signal to be ready by the controller 500 [Fig. 28-29B] [0186-0195] (configured to convert force applied to the piercer into an electrical signal).
Onoki is silent to wherein the sensor comprises a load cell.
Hawkin teaches force plates are used to measure the force associated with a movement, and these force plates can house different types of sensors, one of which being a load cell [page 2] (sensor comprises a load cell configured to convert force applied to the piercer into an electrical signal). These sensors can operate through a transducer which measure force via a changed electrical current [page 9]. A piezoelectric sensor is a common transducer found in force platforms [page 9].
It would have been obvious to one skilled in the art before the effective filing date of the invention to use a piezoelectric sensor as taught by Onoki that is part of a load cell for a sensor as taught by Hawkin in order to have a sensor to measure the force applied to the piercing nozzle. Because only a finite type of sensors can be used in a force plate, the type of sensor of sensor will not change the overall structural and functional capability of the detector unit and is a finding that one of ordinary skill in the art could have pursued as a known potential solution with reasonable expectation of success. MPEP § 2143 (I)(E).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Onoki, et. al. (US 20210181224 A1) in view of Teruaki, et. al. (JP 2011107120 A) (citations made with respect to attached English translation as provided in earlier office action dated 6 March 2025).
For claim 6, Onoki teaches the limitation according to claim 1 (see above).
Onoki is silent to wherein the detector is further configured to generate image data by imaging the sample container and to detect that the piercer has penetrated through the lid based on the image data.
Teruaki teaches a sample processing unit as part of a larger automatic analyzer [0002]. Teruaki teaches the sample processing unit comprises a transparent sample container with a stopper/lid, a nozzle unit containing a needle/sharp tip for penetrating the stopper [0008], and a detection unit that obtains image information of the sample container [0009]. The detection unit 34 comprises imaging unit 45 that is a CCD camera that can capture the image of the side to the test tube 25/sample container along the transport path and can send the image data to a storage unit 12 [0025]. The imaging data specifically goes into the data processing unit 16 that detects the sample surface and the nozzle needle position; this in turn influenced the control unit 17 to position the nozzle needle 53 within the sample [0040] (wherein the detector is further configured to generate image data by imaging the sample container and to detect that the piercer has penetrated through the lid based on the image data). Teruaki teaches generation of image data allows the device to perform high accuracy sample collection when using capped sample containers [0006].
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify a detector of Onoki to be an image data generating detector unit as taught by Teruaki in order to perform high accuracy sample collection of capped sample container. Because both detection units determine if the piercing nozzle/needle is in contact with the sample in the sample container, a substitution of the detection unit (force plate or capacitance detector) as taught by Onoki, for the image generator detector as taught by Teruaki provide likewise sought functionality that would have reasonable expectation of success. MPEP § 2143(I)(G).
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Onoki, et. al. (US 20210181224 A1) in view of Yasui, et. al. (US 20160327587 A1) (recited in office action dated 6 March 2025).
For claim 7, Onoki teaches the detection of two inflection points α and β from piezoelectric element 850, wherein α specifically indicates when piercer 7 first reaches cover member 22 [Fig. 29A-B] [0190-0195] (the detector is further configured to detect contact between the piercer and the lid).
Onoki teaches controller 500 controls piercing driver 71 that drive piercer 7 downward [0054] (analysis control circuitry configured to cause the piercer to move down) from when piercer tip 7B hits the cover member 22 (corresponding to α) until it detects the piercer tip 7B is through the cover member 22 (corresponding to β) to stops piercer 7 [Fig. 28-29B] [0189-0193] (from a contact position where the piercer and the lid are in contact with each other…and stop at a penetration position where the piercer penetrates through the lid, before reaching the sample). The controller 500 additionally can determine the type of sample container/rack that will influence the subsequent processing steps (like piercer and nozzle movement) [0047, 0050-0051].
Onoki is silent to the stopping of the piercer being determined by a first distance based on information about one or more preset dimensions.
Yasui teaches a sample collection nozzle to be used with an automatic analyzer [Abstract, 0001]. Yasui teaches a piercing nozzle 12a [Fig. 1] that can pierce a cap and enter the sample container and aspirate the sample from the sample container [0033]. Yasui teaches an external force detector 44 [Fig. 2] that can detect when the piercing nozzle 12a is in contact with the lid and when it passes through the lid [0039, 0045-0046] and a controller 21 that causes the descending operation of the piercing nozzle 12a. The controller 21 moves the piercing nozzle 12a down until the external force detector 44 senses the lid; if the detection plate 43 only moves a set predetermined distance that indicates a lid is present, the controller 21 allows the piercing nozzle 12a to continue to descend to a predetermined position to begin the suction operation [0045-0046, 0050] (analysis control circuitry configured to... and stop at a penetration position where the piercer penetrates through the lid). Yasui teaches using a predetermined distance ensures the piercer is within the sample container and prevents damage to nozzle should any inconsistencies in the sample container or sample container cover/lid [par. 0012, 0013-0015].
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify processing steps of the piercer from the controller that is determined by type and force as taught by Onoki to further be determined by a predetermined/preset distance as taught by Yasui in order to ensure the piercer is within the sample container and prevent damage to nozzle should any inconsistencies in the sample container or sample container cover/lid.
For claim 8, modified Onoki teaches piercer 7 has an uppermost stop position as determined by the length of shaft 712 that moves arm 711 and piercer 7 from the uppermost stop position to penetrating into the sample accommodation container 2 [Fig. 4-6] (wherein the piercer is configured to move down from an upper stop position above the sample container). Onoki teaches the piezoelectric element 850 on piercer 7 take the applied force and converts is into a voltage that is output as a current to controller 500; this force can be measured and converted by controller 500 to determine when piercer 7 first makes contact with cover member 22 (corresponding to α) [Fig. 28-29B] [0186-0195] (and the detector is further configured to detect that the piercer has come into contact with the lid, by measuring force applied to the piercer when the piercer is moving down).
For claim 9, modified Onoki teaches piercer 7 has an uppermost stop position as determined by the length of shaft 712 that moves arm 711 and piercer 7 from the uppermost stop position to penetrating into the sample accommodation container 2 [Fig. 4-6]. Onoki teaches the piezoelectric element 850 on piercer 7 take the applied force and converts is into a voltage that is output as a current to controller 500; this force can be measured and converted by controller 500 to determine when piercer 7 first makes contact with cover member 22 (corresponding to α the highest point) [Fig. 28-29B] [0186-0195] (and the detector is further configured to detect that the piercer has come into contact with the lid, by measuring force applied to the piercer when the piercer is moving down, the change being an increase).
For claim 10, modified Onoki in view of Yasui teaches relative movement distance detector which detects a relative movement distance of the sample nozzle 12a with respect to the arm 42 that drives the nozzle [Fig. 4] [0039]. Yasui teaches the preset distance is the distance the piercing nozzle 12a continues to descend after encountering lid and continue to extend past the lid into the sample container [par. 0046]. This includes the vertical dimension of the lid plus the additional distance traveled by the piercing nozzle 12a until the end of the piercing nozzle reaches the predetermined distance into the container (the first distance conforms to a sum of a vertical dimension of a bottom opening of the piercer and a vertical dimension of the lid).
For claim 11, modified Onoki in view of Yasui teaches that in combination with the detector 44, the piercing nozzle 12a can be set to descend vertically a predetermined distance in the sample container to reach the predetermined position to begin the suction operation [0046]. This includes the vertical dimension of the lid plus the additional distance traveled by the piercing nozzle 12a until the end of the piercing nozzle reaches the predetermined distance into the container (the one or more preset dimensions comprises a vertical dimension of the sample container, a vertical dimension of the lid attached to the sample container, and a vertical dimension of a bottom opening of the piercer) (wherein the first distance conforms to a sum of the vertical dimension of the lid attached to the sample container and the vertical dimension of the bottom opening of the piercer).
Yasui teaches one embodiment of the device where height sensors 50a-e can determine the height of the sample container/lid and send the data to the controller 21; in return the controller 21 translates the vertical height data to the piercing nozzle 12a and can predict when more force will need to be applied to overcome piercing the lid [Fig. 9, 0110] (the analysis control circuitry is further configured to calculate the vertical dimension of the sample container based on a second distance traveled by the piercer from an upper stop position above the lid attached to the sample container to the contact position).
Claims 13-14 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Onoki, et. al. (US 20210181224 A1) in view of Wada, WO 2011161894 A1 and Yasui, et. al. (US 20160327587 A1).
For claim 13, Onoki teaches biochemical analysis apparatus with a piercer and a nozzle that passes through the piecer [Abstract]. Onoki teaches driving all of the following elements is controller 500 that comprises a CPU and RAM to execute and measure different steps [0061-0063, 0057-0058]. Onoki teaches the analysis apparatus 1 comprises a piercer 7 that moves upward and downward on piercer arm 711 by piercer driving device 71 to pierce a cover member covering the top of sample accommodation container 2 [Fig. 4-5] [0052, 0054, 0074] (a piercer configured to pierce a lid which seals an opening of a sample container containing a sample) (an arm configured to hold the piercer). Onoki teaches an embodiment of the piercer 7 that further includes a piezoelectric element 850 that converts the force applied to the piezoelectric element 850 into a voltage that is supplied to a controller 500 that determines when the piercer 7 moves through the cover member 22 [Fig. 28-29B] [0186-0195] (a detector, including a sensor and circuitry, configured to detect the piercer penetrating through the lid). Once piercer 7 is through cover member 22, nozzle 8 extends through the space of piercer 7 to aspirate the sample [Fig. 6-8] [0053-0058] (a sample dispensing probe configured to pass through an inside of the piercer that has penetrated through the lid, to enter the sample container, and to aspirate the sample). Onoki teaches the piezoelectric element 850 on piercer 7 take the applied force and converts is into a voltage that is output as a current to controller 500; this force can be measured and converted by controller 500 to determine when piercer 7 penetrates cover member 22 [Fig. 28-29B] [0186-0195] (wherein the detector is further configured to detect that the piercer has penetrated through the lid, by measuring force applied to the piercer when the piercer is moving down).
Onoki is silent to the piercer comprising a flange and wherein the sensor is arranged such that a top face of the sensor contacts the arm and a bottom face of the sensor contacts a top face of the flange, and wherein the force is measured while a pressure is applied to the piercer by an elastic member.
Wada teaches a liquid delivery device [pg. 01, par. 02]. Wada teaches the liquid delivery device 20 comprises a nozzle 22 attached to a moveable platform 34 with a load detection unit 26 attached between the nozzle 22 and platform 34 by a flange-like attachment (see arrow indicating to the flange-like attachment between labels 26 and 24 in provided Fig. 2 below) [Fig. 2; pg. 9, par. 04 - pg. 10, par. 01] (a piercer configured to pierce a lid that seals an opening of a sample container containing a sample, the piercer comprising a flange) (an arm configured to hold the piercer). Wada teaches the liquid delivery device operates by a control unit 53 moving the nozzle 22 by z-axis motor 35 to an opening 16; the nozzle 22 is moved downward to penetrate a sealing film 17 wherein the penetration is monitored by the load detection means 26 [pg. 16, par. 03 - pg. 17, par. 01] (wherein the detector is further configured to detect that the piercer has penetrated through the lid, by measuring force applied to the piercer when the piercer is moving down). As seen in Figure 2, the load detection unit 26 has an upper surface attached to the platform 34 and a lower surface attached to the flange-like attachment of nozzle 22 (wherein the sensor is arranged such that a top face of the sensor contacts the arm and a bottom face of the sensor contacts a top face of the flange). Wada teaches the load detection unit 26 can be a piezoelectric element or an equivalent thereof [pg. 12, par. 01]. Wada teaches the load detection unit when working with the control unit allows for the device to develop a pattern for the correct penetration of the nozzle [pg. 34, par. 03 - [pg. 35, par. 02] reducing error.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the location of the piezoelectric element adjacent to the nozzle tip of Onoki with the piezoelectric element type of load detection unit between the nozzle and arm of Wada because the force detected through repeated penetration allows for a penetration pattern to develop with a reasonable expectation of success. MPEP 2143(I)(G).
Yasui teaches a sample collection nozzle to be used with an automatic analyzer [Abstract, 0001]. Yasui teaches a piercing nozzle 12a [Fig. 2] that can pierce a cap and enter the sample container and aspirate the sample from the sample container [0033]. Yasui teaches piercing nozzle 12a (piercer) is attached to arm 42 (arm) and an obstacle detection plate 43 (flange) and elastic body 45 (elastic body) that work with external force detector 44 [Fig. 2, 4a-c] that can detect when the piercing nozzle 12a is in contact with the lid and when it passes through the lid [0039, 0043-0046] and a controller 21 that causes the descending operation of the piercing nozzle 12a (a piercer configured to pierce a lid that seals an opening of a sample container containing a sample, the piercer comprising a flange) (an arm configured to hold the piercer) (and wherein the force is measured while a pressure is applied to the piercer by an elastic member). The controller 21 moves the piercing nozzle 12a down until the external force detector 44 senses the lid [0043-0046] (wherein the detector is further configured to detect that the piercer has penetrated through the lid, by measuring force applied to the piercer when the piercer is moving down). Yasui teaches the use of an elastic body allows for the reduction of the (force) load in an instance when the nozzle comes into contact with an object other than the rubber portion of the lid [par. 0118] this reduces potential damage in the instance of a collision.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to substitute the drive motor of modified Onoki with the elastic body/spring of Yasui because elastic bodies offer a reduction in force load in the event the nozzle collides with a non-penetrable surface and thus reducing potential nozzle damage. The simple substitution of one known element (drive motor) for another (elastic body/spring) is likely to be obvious when predictable results (applying pressure to a nozzle) are achieved. MPEP 2143(I)(B).
For claim 14, modified Onoki teaches the detection of two inflection points α and β from piezoelectric element 850, wherein α indicates when piercer 7 first hits cover member 22 and β specifically indicates when piercer 7 is through cover member 22 and PA indicates the measurement from the uppermost position [Onoki, Fig. 29A-B; 0190-0195] (wherein the detector is further configured to acquire, when the piercer is moving down and after the force applied to the piercer is increased, a measurement of force that is higher than the force applied to the piercer at the upper stop position and that involves a change within a predetermined extent, so that the detector detects that the piercer has penetrated through the lid).
For claim 17, modified Onoki teaches the detection of two inflection points α and β from piezoelectric element 850, wherein α specifically indicates when piercer 7 first reaches cover member 22 [Onoki, Fig. 29A-B; 0190-0195] (the detector is further configured to detect contact between the piercer and the lid).
Onoki teaches controller 500 controls piercing driver 71 that drive piercer 7 downward [Onoki, 0054] (analysis control circuitry configured to cause the piercer to move down) from when piercer tip 7B hits the cover member 22 (corresponding to α) until it detects the piercer tip 7B is through the cover member 22 (corresponding to β) to stops piercer 7 [Onoki, Fig. 28-29B; 0189-0193] (from a contact position where the piercer and the lid are in contact with each other…and stop at a penetration position where the piercer penetrates through the lid, before reaching the sample). The controller 500 additionally can determine the type of sample container/rack that will influence the subsequent processing steps (like piercer and nozzle movement) [Onoki, 0047, 0050-0051].
Onoki is silent to the stopping of the piercer being determined by a first distance based on information about one or more preset dimensions.
Yasui teaches a sample collection nozzle to be used with an automatic analyzer [Abstract, 0001]. Yasui teaches a piercing nozzle 12a [Fig. 1] that can pierce a cap and enter the sample container and aspirate the sample from the sample container [0033]. Yasui teaches an external force detector 44 [Fig. 2] that can detect when the piercing nozzle 12a is in contact with the lid and when it passes through the lid [0039, 0045-0046] and a controller 21 that causes the descending operation of the piercing nozzle 12a. The controller 21 moves the piercing nozzle 12a down until the external force detector 44 senses the lid; if the detection plate 43 only moves a set predetermined distance that indicates a lid is present, the controller 21 allows the piercing nozzle 12a to continue to descend to a predetermined position to begin the suction operation [0045-0046, 0050] (analysis control circuitry configured to... and stop at a penetration position where the piercer penetrates through the lid). Yasui teaches using a predetermined distance ensures the piercer is within the sample container and prevents damage to nozzle should any inconsistencies in the sample container or sample container cover/lid [par. 0012, 0013-0015]
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify processing steps of the piercer from the controller that is determined by type and force as taught by Onoki to further be determined by a predetermined/preset distance as taught by Yasui in order to ensure the piercer is within the sample container and prevent damage to nozzle should any inconsistencies in the sample container or sample container cover/lid.
For claim 18, modified Onoki teaches piercer 7 has an uppermost stop position as determined by the length of shaft 712 that moves arm 711 and piercer 7 from the uppermost stop position to penetrating into the sample accommodation container 2 [Onoki, Fig. 4-6] (wherein the piercer is configured to move down from an upper stop position above the sample container). Onoki teaches the piezoelectric element 850 on piercer 7 take the applied force and converts is into a voltage that is output as a current to controller 500; this force can be measured and converted by controller 500 to determine when piercer 7 first makes contact with cover member 22 (corresponding to α) [Onoki, Fig. 28-29B] [Onoki, 0186-0195] (and the detector is further configured to detect that the piercer has come into contact with the lid, by measuring force applied to the piercer when the piercer is moving down).
For claim 19, modified Onoki teaches piercer 7 has an uppermost stop position as determined by the length of shaft 712 that moves arm 711 and piercer 7 from the uppermost stop position to penetrating into the sample accommodation container 2 [Onoki, Fig. 4-6]. Onoki teaches the piezoelectric element 850 on piercer 7 take the applied force and converts is into a voltage that is output as a current to controller 500; this force can be measured and converted by controller 500 to determine when piercer 7 first makes contact with cover member 22 (corresponding to α the highest point) [Onoki, Fig. 28-29B, 0186-0195] (and the detector is further configured to detect that the piercer has come into contact with the lid, by measuring force applied to the piercer when the piercer is moving down, the change being an increase).
For claim 20, modified Onoki in view of Yasui teaches relative movement distance detector which detects a relative movement distance of the sample nozzle 12a with respect to the arm 42 that drives the nozzle [Yasui, Fig. 4; 0039]. Yasui teaches the preset distance is the distance the piercing nozzle 12a continues to descend after encountering lid and continue to extend past the lid into the sample container (Yasui, par. 0046). This includes the vertical dimension of the lid plus the additional distance traveled by the piercing nozzle 12a until the end of the piercing nozzle reaches the predetermined distance into the container (the first distance conforms to a sum of a vertical dimension of a bottom opening of the piercer and a vertical dimension of the lid).
For claim 21, modified Onoki in view of Yasui teaches that in combination with the detector 44, the piercing nozzle 12a can be set to descend vertically a predetermined distance in the sample container to reach the predetermined position to begin the suction operation [Yasui, 0046]. This includes the vertical dimension of the lid plus the additional distance traveled by the piercing nozzle 12a until the end of the piercing nozzle reaches the predetermined distance into the container (the one or more preset dimensions comprises a vertical dimension of the sample container, a vertical dimension of the lid attached to the sample container, and a vertical dimension of a bottom opening of the piercer) (wherein the first distance conforms to a sum of the vertical dimension of the lid attached to the sample container and the vertical dimension of the bottom opening of the piercer).
Yasui teaches one embodiment of the device where height sensors 50a-e can determine the height of the sample container/lid and send the data to the controller 21; in return the controller 21 translates the vertical height data to the piercing nozzle 12a and can predict when more force will need to be applied to overcome piercing the lid [Yasui, Fig. 9] [0110] (the analysis control circuitry is further configured to calculate the vertical dimension of the sample container based on a second distance traveled by the piercer from an upper stop position above the lid attached to the sample container to the contact position).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Onoki, et. al. (US 20210181224 A1) in view of Wada, WO 2011161894 A1 and Yasui, et. al. (US 20160327587 A1) as applied to claim 13 in further view of Hawkin (So What Exactly Is A Force Plate?; as cited in OA dated 6 March 2025 and 7 July 2025).
For claim 15, modified Onoki teaches the force is measured with a piezoelectric sensor that convert the force to a signal to be ready by the controller 500 [Onoki, Fig. 28-29B] [Onoki, 0186-0195] (configured to convert force applied to the piercer into an electrical signal).
Modified Onoki is silent to wherein the sensor comprises a load cell.
Hawkin teaches force plates are used to measure the force associated with a movement, and these force plates can house different types of sensors, one of which being a load cell [page 2] (sensor comprises a load cell configured to convert force applied to the piercer into an electrical signal). These sensors can operate through a transducer which measure force via a changed electrical current [page 9]. A piezoelectric sensor is a common transducer found in force platforms [page 9].
It would have been obvious to one skilled in the art before the effective filing date of the invention to use a piezoelectric sensor as taught by Onoki that is part of a load cell for a sensor as taught by Hawkin in order to have a sensor to measure the force applied to the piercing nozzle. Because only a finite type of sensors can be used in a force plate, the type of sensor of sensor will not change the overall structural and functional capability of the detector unit and is a finding that one of ordinary skill in the art could have pursued as a known potential solution with reasonable expectation of success. MPEP § 2143 (I)(E).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Onoki, et. al. (US 20210181224 A1) in view of Wada, WO 2011161894 A1 and Yasui, et. al. (US 20160327587 A1) as applied to claim 13 in further view of Teruaki, et. al. (JP 2011107120 A) (citations made with respect to attached English translation as provided in earlier office action dated 6 March 2025).
For claim 16, modified Onoki teaches the limitation according to claim 13 (see above).
Modified Onoki is silent to wherein the detector is further configured to generate image data by imaging the sample container and to detect that the piercer has penetrated through the lid based on the image data.
Teruaki teaches a sample processing unit as part of a larger automatic analyzer [0002]. Teruaki teaches the sample processing unit comprises a transparent sample container with a stopper/lid, a nozzle unit containing a needle/sharp tip for penetrating the stopper [0008], and a detection unit that obtains image information of the sample container [0009]. The detection unit 34 comprises imaging unit 45 that is a CCD camera that can capture the image of the side to the test tube 25/sample container along the transport path and can send the image data to a storage unit 12 [0025]. The imaging data specifically goes into the data processing unit 16 that detects the sample surface and the nozzle needle position; this in turn influenced the control unit 17 to position the nozzle needle 53 within the sample [0040] (wherein the detector is further configured to generate image data by imaging the sample container and to detect that the piercer has penetrated through the lid based on the image data). Teruaki teaches generation of image data allows the device to perform high accuracy sample collection when using capped sample containers [0006].
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify a detector of Onoki to be an image data generating detector unit as taught by Teruaki in order to perform high accuracy sample collection of capped sample container. Because both detection units determine if the piercing nozzle/needle is in contact with the sample in the sample container, a substitution of the detection unit (force plate or capacitance detector) as taught by Onoki, for the image generator detector as taught by Teruaki provide likewise sought functionality that would have reasonable expectation of success. MPEP § 2143(I)(G).
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.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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