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 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 7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the second micro-signal measuring circuit" in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether or not the second micro-signal measuring circuit is the same second micro-signal measuring circuit recited in claim 6. The examiner has interpreted claim 7 to depend on claim 6 rather than claim 3.
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-10, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 4,655,880 issued to Liu (“Liu”) in view of U.S. Patent 7,964,146 issued to Harding et al. (“Harding”).
As for claim 1, Liu discloses circuitry (Fig. 6) for an electrochemical sensor, comprising:
an electrochemical sensor comprising a working electrode (52, W2), a counter electrode (54, C1), a reference electrode (53, R1), and an auxiliary electrode (22, W1);
a potentiostatic circuit (40, 41) operatively connected to the reference electrode (23, R1) and the counter electrode (24, C1), and configured to apply a bias voltage to the working electrode relative to the reference electrode (col. 6, lines 43-48); and
a first micro-signal measuring circuit (16, 18, 44a) operatively coupled to the working electrode (52, W2) and configured to measure a current signal generated at the working electrode.
Liu does not disclose an on-off element as recited.
However, Harding discloses an on-off element (46 in Fig. 7b) connected in series between a counter electrode (36) and a potentiostatic circuit (35);
wherein the on-off element (46) is configured to be in a closed state to connect the counter electrode to the potentiostatic circuit before and after a detection period (i.e. switch 46 in the form of a mechanical relay is capable of being closed before and after a detection period), and is configured to be switched to an open state during the detection period to disconnect the counter electrode from the potentiostatic circuit while the current signal is being measured by a first micro-signal measuring circuit (i.e. the switch 46 in the form of a mechanical relay is capable of being opened during a detection period; see also col. 5, lines 18-22 which suggests that the switch is opened when a current in the working electrode is measured).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to modify the circuitry of Liu to include the on-off switch as disclosed by Harding in order to allow the ability to switch at will between amperometric measurements and potentiometric measurements (Harding: Abstract).
As for claim 2, Liu as modified by Harding discloses that the first micro-signal measuring circuit (Liu: 44a, 16, 18) comprises an I/V conversion amplifier circuit (Liu: 44a).
As for claim 3, Liu as modified by Harding discloses a reference voltage generating circuit (Liu: 31-35) configured to provide a reference voltage to the potentiostatic circuit (Liu: 40, 41).
As for claim 4, Liu as modified by Harding discloses that the potentiostatic circuit (Liu: 40, 41) is further configured to apply a bias voltage to the auxiliary electrode relative to the reference electrode (Liu: see Fig. 6 and col. 6, lines 43-48).
As for claim 5, Liu as modified by Harding discloses that the electrochemical sensor is a gas sensor (Lu: col. 2, lines 13-20).
As for claim 6, Liu as modified by Harding discloses a second micro-signal measuring circuit (Liu: 44, 15, 17) operatively coupled to the auxiliary electrode (Liu: 22, W1).
As for claim 7, Liu as modified by Harding discloses that the second micro-signal measuring circuit (Liu: 44, 15, 17) comprises an I/V conversion amplifier circuit (Liu: 44).
As for claim 8, Liu as modified by Harding discloses a differential circuit (Liu: 81), configured to receive the current signal form the working electrode (Liu: 52, W2) and a current signal form the auxiliary electrode (Liu: 22, W1) and to output a differential signal (Liu: col. 9. lines 2-6).
As for claim 9, Liu as modified by Harding discloses that the on-off element (Harding: 46) is selected from an on-off switch, a relay (Harding: col. 2, lines 29-30), a field effect transistor, an analog switch, or a triode.
As for claim 10, Liu as modified by Harding discloses a test device for the detection of an analyte in a sample, the test device comprising the circuitry according to claim 1 (see the rejection of claim 1 above).
Liu as presently modified by Harding does not disclose a chamber configured to house the electrochemical sensor and to receive the sample.
However, Harding discloses a chamber (Fig. 11) configured to house the electrochemical sensor and to receive the sample.
It would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to modify the test device of Liu and Harding to include the chamber as disclosed by Harding in order to provide a convenient apparatus with which to measure samples.
As for claim 17, Liu as modified by Harding discloses a detection method for detecting an analyte in a sample, wherein a test device is provided, and the test device comprises the circuitry according to claim 1 (see the rejection of claim 1 above), and the detection comprises the steps of:
before detection, connecting the counter electrode with the circuit (Harding: the counter electrode is connected so that electrochemical reaction can be driven by the counter electrode; col. 1, lines 26-42);
during the detection, disconnecting the counter electrode from the circuit (Harding: col. 2, lines 25-28), and detecting the analyte in the sample by the test device (col. 2, lines 25-59); and
after the detection is completed, connecting the counter electrode with the circuit (col. 5, lines 61-63).
As for claim 18, Liu as modified by Harding discloses the steps of: before detection, applying a bias voltage to the electrochemical sensor (Harding: col. 5, lines 37-40 and col. 6, lines 28-40), and making the counter electrode and the circuit remain to be in a connected state (Harding: col. 18-22).
Claims 11, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 4,655,880 issued to Liu (“Liu”) in view of U.S. Patent 7,964,146 issued to Harding et al. (“Harding”) as applied to claims 1 and 17, further in view of U.S. Patent Application Publication 2017/0184564 by Liu et al. (“Liu ‘564”).
As for claims 11 and 19, Liu as modified by Harding discloses the test device according to claim 10 and the method according to claim 17 (see the rejections of claims 10 and 17 above).
Liu as modified by Harding does not disclose that the analyte is selected from nitric oxide in a gas sample.
However, Liu ‘564 discloses a test device that detects an analyte selected from nitric oxide in a gas sample (Abstract).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to modify the test device of Harding to detect nitric oxide as disclosed by Liu ‘564 in order to indicate the existence or a disease (Liu ‘564: paragraph [0005]).
Liu as modified by Harding and Liu ’564 discloses that the electrochemical sensor is a nitric oxide gas sensor (Liu ‘564: paragraph [0005]).
As for claim 20, Liu as modified by Harding and Liu ‘564 discloses that during the detection, a gas sample is introduced into the test device, the introduced gas is contacted with the electrochemical sensor, and the test device detects the content of nitric oxide in the gas sample (Liu ‘564: paragraph [0060]).
Allowable Subject Matter
Claims 13-16 and 21 are 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 13, the prior art of record and the examiner’s knowledge does not disclose or suggest the steps of switching an on-off element to an open state during a detection period to electrically isolate a counter electrode from a potentiostatic circuit while measuring a current signal from a working electrode via a first micro-signal measuring circuit.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive.
On pages 9-11 of the Remarks, Applicant argues that the prior art does not disclose an on-off switch as recited in claim 1. The examiner respectfully disagrees. Harding discloses an on-off switch that is capable of performing the claimed functions of claim 1, although the examiner acknowledges that Harding does not explicitly disclose the steps described by claim 1.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN N OLAMIT whose telephone number is (571)270-1969. The examiner can normally be reached M-F, 8 am - 5 pm (Pacific).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephen Meier can be reached at (571) 272-2149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN N OLAMIT/Primary Examiner, Art Unit 2853