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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/15/2024 has been considered by the examiner.
Election/Restrictions
Applicant's election of Species A, claims 16-22, 28 and 30, with traverse in the reply filed on 10/20/2025 is acknowledged.
The traversal is on the ground(s) that “there would be no undue burden on the Examiner to examine all the species”. This is not found persuasive because for purposes of the initial requirement, a serious burden on the Examiner may be prima facie shown if the Examiner shows by appropriate explanation of separate classification, or separate status in the art, or a different field of search (as defined in MPEP § 808.02). The restriction requirement clearly meets this requirement. While that prima facie showing may be rebutted by appropriate showings or evidence by the Applicant, an unsupported statement by Applicant that no serious burden would exist in the examination of all pending claims does not qualify as an “appropriate showing” or “evidence”. See MPEP § 803. As stated in the prior Office Action, the claims of the present application contain distinct inventions. A search of these inventions may overlap, but the search of one invention does not include all the areas required for the others. A serious burden does exist, as different searches are required for each invention. Therefore, in order to ensure the quality of the search and examination, these inventions should be searched separately to account for their differences.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objection
Claims 16, 19-20 and 28 are objected to because of the following informalities:
Claim 16: please amend “the sensing data of the sensor head in a state where the sensor head is brought into contact with the liquid to be measured” to – [[the]] a sensing data of the sensor head in a state where the sensor head is brought into contact with the liquid to be measured— since this sensing data is different from the sensing data of the sensor head in a state where the sensor head is brought into contact with a calibration agent.
Claim 19: please amend “in a state where the sensor head is brought into contact with the calibration agent” to -- in [[a]] the state where the sensor head is brought into contact with the calibration agent--.
Claim 20: please amend “in a state where the sensor head is brought into contact with the calibration agent” to -- in [[a]] the state where the sensor head is brought into contact with the calibration agent--.
Claim 28: please amend “any one of claims 16” to -- athe sodium ions--; “potassium ions” to – the potassium ions--.
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.
Claim 28 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 28, claim 28 recites “the sensing data of the sensor head”, which is unclear if it refers to the sensing data of the sensor head in a state where the sensor head is brought into contact with a calibration agent and/or the sensing data of the sensor head in a state where the sensor head is brought into contact with the liquid to be measured since the sensing data in the two different states are different. Therefore, the scope of claim 28 is indefinite.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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). Ohgami and Matsumoto are provided in IDS filed on 2/15/2024.
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 a 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 a 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 a 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 a 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 sodium ions and a potassium ion selective electrode that selectively reacts with 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 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
Claims 21-22 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 calibration switch of the electrochemical sensor, 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).
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Kasai et al. (JP2016080425A) teaches electrochemical sensor comprising various operation switches for instructing measurement condition setting operations and start / stop of measurement processing, and outputs operation signals according to these operations to the control unit 14. Abeytathne et al. (US20200116664A1) teaches ion selective sensor for measuring sodium and potassium ions (Figs. 15-16). Cox et al. (US20140200840A1) teaches an electrochemical sensor 100 comprising a sensor head 101 and a button for calibration. Iwamoto (US20130168265A1) teaches an electrochemical sensor for measuring a ratio between a sodium ion concentration and a potassium ion concentration in urine. Ishige et al. (US20110276278A1) teaches an electrochemical sensor comprising a button to manually start the measurement [para. 0054]. Allmendinger (US20070261475A1) teaches a hand-held diagnostic device comprising a calibrate button 908 connected to the computing device 218 provides a user interface for initiating the calibration procedure [para. 0141]. Tomita (US5234568A) teaches an apparatus for the simultaneous measurement of a plurality of ionic concentrations. Liston et al. (US4946651A) teaches a modular multi-channel automated medical analyzer device using an ion selective electrode and/or enzymatic electrode which permits rapid analysis of various substances of interest contained within undiluted body fluids and the device comprises a calibration toggle switch 28.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHIZHI QIAN/Examiner, Art Unit 1795