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 the Claims
The Amendment filed March 31, 2026 has been entered. Claims 16, 19-22, 25(w), and 28 have been amended; claims 23-27, 29 and 31 have been withdrawn; and claims 1-15 have been cancelled. Claims 16-22, 28 and 30 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed December 31, 2025.
New grounds of rejection under 35 U.S.C. § 112(b) for claim 21 are necessitated by the amendment as outlined below.
All 35 U.S.C. § 103 rejections from the previous office action are essentially maintained and modified only in response to the amendment as outlined below.
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.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Regarding claim 21, claim 21 recites “the switch”, which lacks antecedent basis. Therefore, the scope of claim 21 is indefinite.
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.
Claims 16-20, 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Ohgami et al. (US20140209485A1), and in view of Matsumoto et al. (US20020014409A1).
Regarding claim 16, Ohgami teaches an electrochemical sensor (an electrochemical sensor 90 in Fig.1 [para. 0140]) for measuring a concentration ratio between sodium ions and potassium ions in a liquid to be measured (a concentration ratio between ion species different from each other can be measured [para. 0064]; Fig.21 shows measured concentration ratio between sodium ions and potassium ions in a liquid to be measured [para. 0133, 0284]; thus the disclosed electrochemical sensor is configured to perform the intended use limitation), comprising:
a sensor head (sensor head 30 in Fig.1 [para. 0140]; sensor head 30A-4’ in Fig.18A comprising sodium ion selective electrode 41 and potassium ion selective electrode 42 [para. 0268, 0273]);
a calculation unit (the control part 11 including an arithmetic calculation part 15 in a body 10 in Fig.1 [para. 0140]; personal computer 112 in Fig.18A [para. 0274]) that allows performing a calibration operation (The arithmetic operation part 15 includes: a calibration sample measurement potential recording part 16 [para. 015]; a user can perform calibration by bringing the sensor head in contact with the standard liquid, and the calibration sample measurement potential recording part 16 stores measured electrochemical data with respect to the standard liquid [para. 0162-0163]; [para. 0278-0279] detail measurement with respect to standard liquid) and a measurement operation (the arithmetic operation part 15 includes an arithmetic operation formula calculation part 17; a specimen measurement potential recording part 18; and a concentration conversion processing part 19 [para. 0158]; the sensor head is brought in contact with the liquid to be measured, and the user inputs an instruction for starting measurement with respect to the liquid to be measured by operating the operation part 13 of the body 10 by pushing down the push button switch. The arithmetic operation part 15 functions as a second control part in response to the instruction, and detects a potential difference or an electric current between the first electrode 41 and the second electrode 42 [para. 0163]; [para. 0280-0282] detail measurement with respect to liquid to be measured), the calibration operation calculating a characteristic parameter of the sensor head based on sensing data of the sensor head in a state where the sensor head is brought into contact with a calibration agent (the calibration sample measurement potential recording part 16 stores measured electrochemical data with respect to the standard liquid [para. 0162]; to obtain a concentration ratio between the first ion and the second ion contained in the liquid to be measured, it is necessary to obtain in advance a potential gradient [Nernst constant] S1 and a reference potential
E0—b in the system. These values S1 and E0—b are obtained by calibration [para. 0198]; [para. 0279] details measurement with respect to standard liquid), the measurement operation calculating the concentration ratio based on the characteristic parameter of the sensor head and sensing data of the sensor head in a state where the sensor head is brought into contact with the liquid to be measured (the arithmetic operation part 15 functions as a second control part in response to the instruction, and detects a potential difference or an electric current between the first electrode 41 and the second electrode 42 with respect to the liquid to be measured [para. 0163]; the concentration ratio Ms— b between the first ion and the second ion in the liquid to be measured is obtained by the formula 8 [para. 0199]; [para. 0281-0282] detail the measurement operation calculating the concentration ratio Na [ppm]/K [ppm] based on the characteristic parameter of the sensor head with respect to the standard liquid and a sensing data of the sensor head in a state where the sensor head is brought into contact with the liquid to be measured);
a measurement switch that causes the calculation unit to perform the measurement operation (The operation part 13 is formed of a push button switch, and allows a user to input an instruction for starting measurement of a liquid to be measured [para. 0159]; the user inputs an instruction for starting measurement with respect to the liquid to be measured by operating the operation part 13 of the body 10 by pushing down the push button switch. The arithmetic operation part 15 functions as a second control part in response to the instruction, and detects a potential difference or an electric current between the first electrode 41 and the second electrode 42 [para. 0163]), wherein
the sensor head is brought into contact with the calibration agent (the standard liquid is brought into contact with the first electrode and the second electrode. Thereby, it is possible to obtain measured data with respect to the standard liquid [para. 0085]).
Ohgami is silent to the following limitations: (1) a calibration switch that causes the calculation unit to perform the calibration operation; (2) the sensor head is brought into contact with the calibration agent “by coupling the electrochemical sensor to a calibration member”; and (3) the measurement switch is inoperable when the electrochemical sensor is coupled to the calibration member, and the calibration switch is inoperable when the electrochemical sensor is not coupled to the calibration member.
Matsumoto teaches a measurement apparatus, comprising a biosensor for carrying out measurement of a specified component in a liquid sample, wherein the biosensor is an electrochemical sensor (claims 1 and 3). The apparatus comprises a sensor head (electrode 5 in Figs. 3-4), a main body 1 comprising an electric power switch 3, a calibration switch 4, a data informing part 2, and a calibration liquid temperature setting switch 11 (see Figs. 3-4; [para.0063]), and a calibration liquid container as shown in Fig.2. The calibration liquid container is composed of a container 6 and a cover 8 and an electric power switch 9 and a temperature adjustment switch 10. The container 6 is filled with a calibration liquid 7 [para. 0062]. During the calibration operation, the enzyme electrode 5 is immersed in the calibration liquid and the calibration switch 4 is pushed down to carry out calibration of the liquid component measurement apparatus [para. 0067]. Thus, Matsumoto teaches: (1) a calibration switch (calibration switch 4 in Fig.3) that causes a calculation unit (a data processing part 22 in Fig.4 [para. 0064]) to perform the calibration operation; (2) the sensor head (the electrode 5) is brought into contact with a calibration agent (calibration liquid) by coupling the electrochemical sensor to a calibration member (calibration liquid container in Fig.2).
Ohgami and Matsumoto are considered analogous art to the claimed invention because they are in the same field of electrochemical sensor using electrode(s) for measuring specified component(s) in a liquid sample. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrochemical sensor in Ohgami by providing a calibration switch to the sensor body and a calibration liquid container (corresponding to the claimed calibration member) for holding the calibration agent (calibration liquid or standard liquid), wherein the calibration switch is configured to cause the calculation unit to perform the calibration operation, wherein the sensor head is inserted into the calibration liquid container such that the sensor head is brought into contact with the calibration agent by coupling the electrochemical sensor to the calibration liquid container, as taught by Matsumoto, since it would allow to store a calibration liquid/standard liquid at a constant temperature for calibrating the sensor (abstract in Matsumoto). The claimed calibration switch and calibration member are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results [MPEP 2143(I)(A)]. Furthermore, given the teachings of Ohgami regarding the measurement switch that allows a user to start measurement of a liquid to be measured, and calibration of the electrochemical sensor in a standard liquid, one skilled in the art would add a calibration switch as taught by Matsumoto in the same way as the measurement switch of Ohgami, yielding predictable results of allowing a user to start calibration of the electrochemical sensor.
Modified Ohgami does not explicitly teach: (3) the measurement switch is inoperable when the electrochemical sensor is coupled to the calibration member, and the calibration switch is inoperable when the electrochemical sensor is not coupled to the calibration member.
Ohgami further teaches after measured data is obtained with respect to the standard liquid, the user brings the sensor head into contact with the liquid to be measured. In such a state, the user inputs an instruction for starting measurement with respect to the liquid to be measured by operating the operation part 13 of the body 10 by pushing down the push button switch [para. 0163]. Thus, the measurement switch is pushed down after the calibration operation has been completed and the sensor head is already in contact with the liquid to be measured. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the measurement switch being inoperable when the electrochemical sensor is coupled to the calibration member since the sensor head is still in contact with the calibration agent of the calibration member during the calibration state and the calibration operation is still in progress.
As outlined in the rejection above, Matsumoto teaches next, the enzyme electrode is immersed in the calibration liquid and the calibration switch is pushed down to carry out calibration of the liquid component measurement apparatus [para. 0067]. Thus, in order to calibrate the electrochemical sensor, the electrochemical sensor needs to be coupled to the calibration member such that the electrochemical sensor is in contact with the calibration agent. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the calibration switch being inoperable when the electrochemical sensor is not coupled to the calibration member since the sensor head is not yet in contact with the calibration agent of the calibration member.
Regarding claim 17, modified Ohgami teaches the electrochemical sensor according to claim 16, wherein the calibration operation is allowed to be performed when the electrochemical sensor is coupled to the calibration member, and the measurement operation is allowed to be performed when the electrochemical sensor is not coupled to the calibration member (as outlined in the rejection of claim 16 above, the calibration operation is allowed to be performed when the electrochemical sensor is coupled to the calibration member wherein the sensor head is in contact with the calibration agent stored in the calibration member by pushing down the calibration switch, and the measurement operation is allowed to be performed when the electrochemical sensor is not coupled to the calibration member [After measured data is obtained with respect to the standard liquid, the senso head is in contact with the liquid to be measured. In such a state, the user inputs an instruction for starting measurement with respect to the liquid to be measured by operating the operation part 13 of the body 10 by pushing down the push button switch [para. 0163 in Ohgami]).
Regarding claim 18, modified Ohgami teaches the electrochemical sensor according to claim 16, wherein the calibration switch is operable when the electrochemical sensor is coupled to the calibration member, and the measurement switch is operable when the electrochemical sensor is not coupled to the calibration member (as outlined in the rejection of claim 16 above, the calibration switch is operable when the electrochemical sensor is coupled to the calibration member by pushing down the calibration switch to carry out calibration [para. 0067 in Matsumoto], and the measurement switch is operable when the electrochemical sensor is not coupled to the calibration member for starting measurement with respect to the liquid to be measured by pushing down the measurement switch [para. 0163 in Ohgami]).
Regarding claim 19, modified Ohgami teaches the electrochemical sensor according to claim 16, wherein the calibration member is a calibration holder (as outlined in the rejection of claim 16 above, the calibration member is a calibration liquid container as shown in Fig.2 of Matsumoto) that holds the electrochemical sensor in the state where the sensor head is brought into contact with the calibration agent (as outlined in the rejection of claim 16 above, during the calibration operation, the sensor head of the electrochemical sensor is inserted into the calibration liquid container such that the sensor head is in contact the calibration agent, thus, the calibration liquid container is capable of performing the claimed functions of holding the electrochemical sensor in the state where the sensor head is brought into contact with the calibration agent).
Regarding claim 20, modified Ohgami teaches the electrochemical sensor according to claim 19, wherein the calibration holder includes a housing portion (container 6 in Fig.2 [para. 0062 in Matsumoto]) that houses the calibration agent (the container 6 is filled with a calibration liquid [para. 0062 in Matsumoto]), and
the electrochemical sensor is held in the state where the sensor head is brought into contact with the calibration agent housed in the housing portion (as outlined in the rejection of claim 16 above, the sensor head is inserted into the calibration liquid container such that the sensor head is in contact with the calibration liquid housed in the calibration liquid container).
Regarding claim 28, modified Ohgami teaches the electrochemical sensor according to claim 16, and Ohgami teaches wherein
the sensor head includes a sodium ion selective electrode that selectively reacts with the sodium ions and a potassium ion selective electrode that selectively reacts with the potassium ions (sensor head 30A-4’ in Fig.18A comprising sodium ion selective electrode 41 that selectively reacts with sodium ions and potassium ion selective electrode 42 that selectively reacts with potassium ions [para. 0268, 0273]), and
the sensing data of the sensor head in the state where the sensor head is brought into contact with the liquid to be measured is a potential difference between the sodium ion selective electrode and the potassium ion selective electrode (The arithmetic operation part 15 functions as a second control part in response to the instruction, and detects a potential difference or an electric current between the first electrode 41 and the second electrode 42 [para. 0163]; assuming a concentration ratio between the first ion and the second ion in the liquid to be measured as Ms — b and a potential difference detected with respect to the liquid to be measured as Es — b, the following formula is obtained: log M s — b=(E s — b −E 0 — b)/S 1 [para. 0198 ]; measured data [potential difference Es — b [mV]] was obtained with respect to the liquids to be measured, and the measured data were recorded in the measured potential difference recording part 112a [para. 0281]).
Regarding claim 30, modified Ohgami teaches a measuring device (a measuring device as shown in Figs. 1 and 18A in Ohgami), comprising:
the electrochemical sensor according to claim 16 (modified Ohgami teaches the electrochemical sensor as outlined in the rejection of claim 16 above); and
the calibration member (as outlined in the rejection of claim 16 above, modified Ohgami teaches the calibration member [calibration liquid container as shown in Fig.2 of Matsumoto]).
Allowable Subject Matter
Claim 21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 22 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 21, modified Ohgami teaches the electrochemical sensor according to claim 19, wherein the calibration holder includes a switch (the calibration liquid container includes an electric power switch 9 and a temperature adjustment switch 10 installed in the container 6 [Fig.2 and para. 0062 in Matsumoto]). However, the disclosed power switch and/or temperature adjustment switch is not capable of operating the calibration switch of the held electrochemical sensor from an outside of the calibration holder since the calibration switch is disposed on the upper sensor body. Furthermore, the functions of the disclosed power switch and temperature adjustment switch are different from the function of the claimed switch for operating of the calibration switch of the held electrochemical sensor from an outside of the calibration holder, and one of ordinary skill in the art would not be motivated to use any of the power switch and the temperature adjustment switch for operating the calibration switch of the electrochemical sensor.
Regarding claim 22, modified Ohgami teaches the electrochemical sensor according to claim 19, and Figs.1-3 of Matsumoto show the calibration holder is a cylindrical container, and electrode 5 in the tip part (corresponding to the sensor head in Ohgami) is inserted into the calibration holder such that the electrode is immersed in the calibration liquid during the calibration [para. 0067 in Matsumoto]. Ohgami further teaches the user inputs an instruction for starting measurement with respect to the liquid to be measured by operating the operation part 13 of the body 10 by pushing down the push button switch (corresponding to the measurement switch) [para. 0163]. The prior art of the record does not teach and/or suggest wherein the calibration holder includes a shielding portion that shields the measurement switch of the held electrochemical sensor.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Arguments
Applicant's arguments, see Remarks Pgs. 6-9, filed 3/31/2026, with respect to the 35 U.S.C. § 103 rejections have been fully considered, but are not persuasive.
Applicant’s Argument #1:
Regarding claim 16, Applicant argues at pages 7 to 8 that each of the cited references merely discloses a configuration with a single switch for both calibration and measurement. Even if the cited references are combined, such a combination of the cited references fails to disclose or suggest the claimed configuration (i.e., two separate switches including a calibration switch and a measurement switch that are employed such that the sensor head is brought into contact with the calibration agent by coupling the electrochemical sensor to a calibration member, and the measurement switch is inoperable when the electrochemical sensor is coupled to the calibration member, and the calibration switch is inoperable when the electrochemical sensor is not coupled to the calibration member) as recited in claim 16. Further, the claimed invention is not obvious over the cited references, even in combination, at least based on impermissible hindsight.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. As outlined in the rejection of claim 16 under 103 above, Ohgami teaches the measurement switch, and the electrochemical sensor of Ohgami is further modified by Matsumoto by adding a calibration switch to the sensor body and a calibration liquid container (corresponding to the claimed calibration member) for holding the calibration agent (calibration liquid or standard liquid), wherein the calibration switch is configured to cause the calculation unit to perform the calibration operation, wherein the sensor head is inserted into the calibration liquid container such that the sensor head is brought into contact with the calibration agent by coupling the electrochemical sensor to the calibration liquid container, as taught by Matsumoto, since it would allow to store a calibration liquid/standard liquid at a constant temperature for calibrating the sensor (abstract in Matsumoto).
As outlined in the rejection for claim 16 above, since Ohgami further teaches after measured data is obtained with respect to the standard liquid, the user brings the sensor head into contact with the liquid to be measured. In such a state, the user inputs an instruction for starting measurement with respect to the liquid to be measured by operating the operation part 13 of the body 10 by pushing down the push button switch [para. 0163]. Thus, the measurement switch is pushed down after the calibration operation has been completed and the sensor head is already in contact with the liquid to be measured. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the measurement switch being inoperable when the electrochemical sensor is coupled to the calibration member since the sensor head is still in contact with the calibration agent of the calibration member during the calibration state and the sensor head is NOT yet in contact with the liquid to be measured.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As outlined in the rejection of claim 16 above, the rejection was based on the combined teachings of Ohgami and Matsumoto instead of based on the knowledge gleaned only from the applicant's disclosure.
Examiner suggests applicant to incorporate limitations of either claim 21 or claim 22 into independent claim 16.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Examiner, Art Unit 1795
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