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 .
Claim Status
Claims 1-11 are pending with claims 1-5 under examination and claims 6-11 withdrawn from consideration.
Response to Amendment
The amended claims, received 01/06/2026, have overcome the claim objection(s) set forth in the Non-Final Action mailed on 11/03/2025. Therefore, the claim objections have been withdrawn. However, new claim objections have been set forth.
Applicant’s amendments to the claims have overcome the 112(b) rejection(s) previously set forth in the Non-Final Office Action. Accordingly, the 112(b) rejection(s) have been withdrawn. However, based on the claim amendments, new 112(b) rejections have been set forth.
Based on the amended claims and remarks, received 01/06/2026, the previous prior art rejection over Tatsuya has been withdrawn and a new are rejection set forth (see below).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 9 recites “washing fluid detecting unit”. The examiner requests applicant include article “a” prior to recitation of “washing fluid detecting unit”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 4 recites “a flow channel”. Claim 1 line 8 has been amended to recite “a flow channel”. It is unclear if applicant if referring to the flow channel in claim 1 or if applicant is intending to define an additional flow channel. Perhaps applicant is intending to recite “the flow channel”?
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Mishima et al. (US 2011/0171069; already of record – hereinafter “Mishima”), and further in view of Tatsuya et al. (Machine Translation of JP-2018194301A; already of record – hereinafter “Tatsuya”).
Regarding claim 1, Mishima teach an automatic analyzer (Mishima; [0027]) comprising:
a dispensing mechanism including a dispensing probe dispensing a sample or reagent into a reaction container (Mishima; figs. 1, 3 & 6-7, #1, [0027-0032]);
a discharge port discharging washing fluid onto an external surface of the dispensing probe (Mishima; figs. 1, 3 & 6-7, #2, [0032]);
liquid amount changing unit changing an amount of the washing fluid to be supplied to the dispensing probe (Mishima disclose controlling an automatic flow selector valve 4 to change an amount of washing fluid 3 supplied to the dispensing probe 1 after specimen aspiration from the dashed line to the solid line before the dispensing nozzle 1 moves to the cleaning tank; fig. 6, #4, [0043-0045]. When the automatic analyzer is powered the probe 1 performs an initialization operation determine the cross-sectional shape of the washing fluid flow path; figs. 7(a)-(d), #11, #12, #14, #15, [0047-0049]). Upon the start of the initialization operation following the completion of apparatus power-on, the dispensing nozzle 1 moves to the position 14 during the dispensing nozzle position control operation shown in fig. 7. If the liquid level is not detectible, the dispensing nozzle 1 remains in a stopped condition and the automatic flow selector valve 4 on the cleaning liquid pipeline shown in fig. 6 is opened to increase the flow rate and keep the path of the cleaning liquid flow 3 constant until the nozzle has detected the liquid level; [0053]), the liquid amount changing unit being a valve provided in a flow channel to the discharge port (Mishima; fig. 6, #4, [0043, 0053]);
washing fluid detecting unit provided at the dispensing mechanism (Mishima disclose the nozzle 1 includes a liquid level detection function that detects contact with a liquid; [0048]); and
a control section controlling the dispensing probe, the liquid amount changing unit, and the washing fluid detecting unit (Mishima disclose a nozzle driving unit for controlling the position of the nozzle, a liquid level detection to detect contact with a liquid, and the automatic flow selector valve 4 for controlling the flow rate of the cleaning liquid 3. The nozzle, valve, and detection unit are controlled to perform the initialization operation to determine the cross-sectional shape and position of the cleaning liquid; fig. 7, [0011, 0045, 0048-0050, 0053]),
wherein at a time of washing the dispensing probe, the control section moves the dispensing probe so that a height of a tip end of the dispensing probe is at a predetermined first position and to cause washing fluid of a reference liquid amount to be discharged from the discharge port so the washing fluid contacts a predetermined washing range of an external surface of the dispensing probe, the predetermined washing range being between the first position and a second position above the first position along a vertical direction (Mishima disclose during washing the flow selector 4 has its degree of opening narrowed for a smaller flow rate (0.2 m/s) before the probe 1 moves to the cleaning tank so that a range of about 5 mm of the dispensing nozzle comes into contact with the cleaning liquid; fig. 6, solid lines, [0043-0045]), and
wherein, at a time of adjusting a washing fluid amount, the control section closes the liquid amount changing unit, moves the dispensing probe so that the height of the tip end of the dispensing probe is higher than the second position and gradually opens the liquid amount changing unit until the washing fluid detecting unit detects the washing fluid, and stores a degree of opening of the liquid amount changing unit upon the detection of the washing fluid as a post-adjusted liquid amount to renew the reference liquid amount (Mishima disclose upon the start of initialization operation following completion of apparatus power-on, the dispensing nozzle 1 moves to position 14 and the automatic flow selector valve 4 is opened to increase the flow rate (1.5 m/s) and keep the path of the cleaning flow constant until the nozzle has detected the liquid level. The examiner notes that upon initialization, the liquid amount changing unit 4 would be closed, and the dispensing probe moved to position 14 to perform the initialization operation. Further, position 14 depicted by dashed line in figs 6, 7(d), and 7(e) is at a height above the 5 mm range of the cleaning flow state represented by the solid lines in fig. 6. Lastly, the degree of opening of the liquid amount changing unit is stored as flow velocities as either 1.5 m/s and 0.2 m/s; figs. 7-6, [0043-0044, 0048, 0053]).
Mishima does not teach the liquid amount changing unit being an electromagnetic valve provided in a flow channel from a pump to the discharge port.
However, Tatsuya teach the analogous art of an automatic analyzer (Tatsuya; fig. 1, #1, [0011]), comprising a dispensing mechanism including a dispensing probe dispensing a sample or reagent into a reaction container (Tatsuya; figs. 2-4, arm 204 and probe 205, [0033-0034]), a discharge port discharging washing fluid onto an external surface of the dispensing probe (Tatsuya; fig. 4, #2081, #2082, [0043-0044]), a liquid amount changing unit changing an amount of the washing fluid to be supplied to the dispensing probe (Tatsuya; fig. 4, solenoid valve 288, [0045-0046, 0048, 0069]), wherein the liquid amount changing unit is an electromagnetic valve provided in a course of a flow channel from a pump to the discharge port (Tatsuya; fig.4, valve 288 is connected to pump 287, [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the liquid amount changing unit being a valve provided in a flow channel to the discharge port of Mishima with the liquid amount changing unit being an electromagnetic valve provided in a course of a flow channel from a pump to the discharge port, as taught by Tatsuya, because Tatsuya teach the electromagnetic valve and pump connected in a course of a flow channel to the discharge port allows the flow rate of the cleaning liquid to be adjusted in a stepless manner; [0046]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Mishima and Tatsuya both teach controlling the amount of washing liquid for cleaning a nozzle in a cleaning tank.
Regarding claim 2, modified Mishima teach the automatic analyzer according to claim 1 above, wherein at the time of washing the dispensing probe, the control section controls the electromagnetic valve into a reference opening degree to discharge the washing fluid from the discharge port (Mishima disclose during washing the flow selector 4 has its degree of opening narrowed for a smaller flow rate (0.2 m/s) before the probe 1 moves to the cleaning tank so that a range of about 5 mm of the dispensing nozzle comes into contact with the cleaning liquid; fig. 6, solid lines, [0043-0045]. Further, the modification of the liquid amount changing unit being a valve provided in a flow channel to the discharge port of Mishima with the liquid amount changing unit being an electromagnetic valve provided in a course of a flow channel from a pump to the discharge port, as taught by Tatsuya, has previously been discussed in claim 1 above).
Regarding claim 3, modified Mishima teach the automatic analyzer according to claim 1 above, wherein the washing fluid detecting unit is a liquid level detection device (Mishima; [0032, 0048, 0053]).
Modified Mishima does not teach the liquid level detection device detecting capacitance of the dispensing probe to detect a liquid level.
However, Tatsuya teach the analogous art of an automatic analyzer (Tatsuya; fig. 1, #1, [0011]), comprising a dispensing mechanism including a dispensing probe dispensing a sample or reagent into a reaction container (Tatsuya; figs. 2-4, arm 204 and probe 205, [0033-0034]), and a washing fluid detecting unit provided at the dispensing mechanism (Tatsuya; fig. 2, capacitance sensor 207, [0033, 0036, 0066-0067, 0074, 0077, 0083]), wherein the washing fluid detecting unit a liquid level detection device detecting capacitance of the dispensing probe to detect a liquid level (Tatsuya; fig. 2, #207, [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the liquid level detection device of modified Mishima with the liquid level detection device detecting capacitance of the dispensing probe to detect a liquid level, as taught by Tatsuya, because Tatsuya teach the liquid level detection device detecting capacitance of the dispensing probe to detect a liquid level obtains a detection signal upon contact of the liquid with the probe (Tatsuya; [0036]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Mishima and Tatsuya both teach probes for aspirating sample that comprise a liquid level detection device.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mishima, in view of Tatsuya, and further in view of Ogusu (US 2009/0169434; already of record – hereinafter “Ogusu”).
Regarding claim 4, modified Mishima teach the automatic analyzer according to claim 1 above, comprising the automatic analyzer, the dispensing probe, and the washing fluid detecting.
Modified Mishima does not teach wherein the automatic analyzer comprises a syringe performing aspiration and discharge of the specimen or reagent, and a pressure sensor provided in a flow channel connecting the syringe and the dispensing probe, and the washing fluid detecting unit is the pressure sensor.
However, Ogusu teach the analogous art of an automatic analyzer (Ogusu; fig. 5, #100, [0041]) comprising a dispensing mechanism comprising a dispensing probe dispensing a sample into a reaction container (Ogusu; figs. 1 & 5, #2, #37 [0016, 0043]), a syringe performing aspiration and discharge of the specimen (Ogusu; fig. 1, #4, [0006, 0016]) and a pressure sensor provided in a flow channel connecting the syringe and the dispensing probe, and the washing fluid detecting unit is the pressure sensor (Ogusu teach a pressure sensor 61 and signal processing circuit 62 as a pressure unit 6 where the pressure sensor is provided in a flow channel connecting the syringe and the probe; fig. 1, [0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the dispensing probe of modified Mishima to comprise a pressure sensor in a flow channel connecting the syringe and probe, and to modify the washing fluid detecting unit with the pressure sensor, as taught by Ogusu, because Ogusu teach the pressure sensor allows the control to set a correction coefficient as a result of the measuring by the pressure measuring unit (Ogusu; [0008]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Mishima and Ogusu both teach a liquid transfer probes that aspirates and dispenses fluids via automatic control.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mishima, in view of Tatsuya, and further in view of Hirotoshi et al. (Machine Translation of JP 2012053064A; already of record – hereinafter “Hirotoshi”).
Regarding claim 5, modified Mishima teach the automatic analyzer according to claim 1 above, wherein, at the time of adjusting the washing fluid amount (Mishima disclose upon the start of initialization operation following completion of apparatus power-on, the dispensing nozzle 1 moves to position 14 and the automatic flow selector valve 4 is opened to increase the flow rate (1.5 m/s) and keep the path of the cleaning flow constant until the nozzle has detected the liquid level. The examiner notes that upon initialization, the liquid amount changing unit 4 would be closed, and the dispensing probe moved to position 14 to perform the initialization operation. Further, position 14 depicted by dashed line in figs 6, 7(d), and 7(e) is at a height above the 5 mm range of the cleaning flow state represented by the solid lines in fig. 6. Lastly, the degree of opening of the liquid amount changing unit is stored as flow velocities as either 1.5 m/s and 0.2 m/s; figs. 7-6, [0043-0044, 0048, 0053]).
Modified Mishima does not teach the control section gives an alarm in a case where the washing fluid detecting unit does not detect the washing fluid even if the washing fluid amount reaches a prescribed upper limit value or in a case where the washing fluid detecting unit detects the washing fluid before the washing fluid amount reaches a prescribed lower limit value.
However, Hirotoshi teach the analogous art of an automatic analyzer (Hirotoshi; fig. 1, #300, [0019]) comprising a dispensing mechanism and a washing fluid detecting unit provided at the dispensing mechanism (Hirotoshi; fig. 2, #20, #18a, [0041]), a discharge port discharging washing fluid onto an external surface of the dispensing mechanism (Hirotoshi; fig. 5, #80, [0062]) and a control section (Hitoshi; fig. 5, #30a, [0042]), wherein the control section gives an alarm in a case where the washing fluid detecting unit is outside of an allowable supply amount (Hirotoshi; figs. 11, & 13, step S7, “Yes” and step S10, “No”, [0110-0112, 0138, 0141]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the automatic analyzer and control section of modified Mishima to give an alarm in a case where the washing fluid detecting unit detects the washing fluid is outside of an allowable supply amount, as taught by Hirotoshi, because Hirotoshi teaches the alarm is triggered to indicate an error has occurred and alerts an operator to clean the system (Hirotoshi; [0138, 0141]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Mishima and Hirotoshi both teach detection and calibration of washing fluid amounts in a cleaning tank.
Response to Arguments
Applicant’s arguments, filed 01/06/2026, have been considered but are moot because the arguments are towards the amended claims and do not apply to the current grounds of rejection. However, because the examiner is using the same prior art in the rejection, then the examiner will address applicant’s remarks in order to promote compact prosecution.
Applicant argues, see pages 9-14 of their remarks, that Tatsuya does not disclose the amended limitation “wherein, at a time of adjusting a washing fluid amount, the control section closes the liquid amount changing unit, moves the dispensing probe so that the height of the tip end of the dispensing probe is higher than the second position and gradually opens the liquid amount changing unit until the washing fluid detects the washing fluid, and stores a degree of opening of the liquid amount changing unit upon the detection of the washing fluid as a post-adjusted liquid amount to renew the reference liquid amount”. The examiner agrees and notes that the arguments are toward the amended limitations and do not apply to the current grounds of rejection. Accordingly, the examiner has withdrawn the previous prior art rejection. In addition, the examiner disagrees with applicant’s argument on page 14 of their remarks that Mishima does not cure the deficiencies in Tatsuya. Regarding the claim amendments, Mishima disclose upon the start of initialization operation following completion of apparatus power-on, the dispensing nozzle 1 moves to position 14 and the automatic flow selector valve 4 is opened to increase the flow rate (1.5 m/s) and keep the path of the cleaning flow constant until the nozzle has detected the liquid level. The examiner notes that upon initialization, the liquid amount changing unit 4 would be closed, and the dispensing probe moved to position 14 to perform the initialization operation. Further, position 14 depicted by dashed line in figs 6, 7(d), and 7(e) is at a height above the 5 mm range of the cleaning flow state represented by the solid lines in fig. 6. Lastly, the degree of opening of the liquid amount changing unit is stored as flow velocities as either 1.5 m/s and 0.2 m/s; figs. 7-6, [0043-0044, 0048, 0053]. Accordingly, the examiner has withdrawn the previous prior art rejection and set forth a new prior art rejection over Mishima in view of Tatsuya which teach the amended limitations of claim 1.
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
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CURTIS A THOMPSON whose telephone number is (571)272-0648. The examiner can normally be reached on M-F: 7:00 a.m. - 5:00 p.m..
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Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798