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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “10” has been used to designate both insulating epoxy resin (Fig. 2) and first amplifier (Fig. 1). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Specification cites insulating epoxy resin (10, Fig. 2) and first amplifier (10, Fig. 1) as the same reference character.
Appropriate correction is required.
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.
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.
Claim(s) 1, 5, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishii et al (US Pre Grant Publication 2014/0323838 A1), in view of Jumbe et al (US Pre Grant Publication 2021/0345939 A1).
Regarding claim 1, Nishii teaches an electrocardiographic signal measuring apparatus for measuring an electrocardiographic signal of a subject, the electrocardiographic signal measuring apparatus comprising:
two capacitive coupling type detection electrodes (2A & 2B, Fig. 1, 3) for detecting the electrocardiographic signal of the subject without coming into contact with a skin of a body ([0034-0035]; capacitive coupling electrodes (2A & 2B, Fig. 3) positioned inside of seat (100, Fig. 2) and separated from user 10 by thickness of seat covering material (101, Fig. 3);
a first amplifier (30, Fig. 1) for amplifying a detection signal detected by the two detection electrodes ([0034]; signal from electrodes 2A & 2B connected to differential amplifier circuit 30);
an A/D converter (50, Fig. 1) that converts the detection signal amplified through the first amplifier into a digital signal ([0034]; amplifier 30 passes signal to A/D converter 50);
a communication circuit (control unit 60, Fig. 1) for transmitting the digital signal outputted from the A/D converter ([0034], “A digital signal on which the analog-digital conversion is performed is an electrocardiographic signal of the user (subject person) 10 who is in contact with the seat 100, and is input to a control unit (control device) 60.”; [0066]);
two guard electrodes (4, Fig. 3) placed via an insulator (3, Fig. 3) on a side, of each of the detection electrodes, opposite to a side facing the body of the subject ([0060], Fig. 3); and
two second amplifiers (one of 20D in each sensing circuit 20A & 20B, Fig. 1 & 4) ([0044], Fig. 4; output signal from electrode 2 is amplified by 20D; examiner notes that op-amp polarity indicated in Fig. 4 is switched from specification [0053] and inconsistent with the design of well-known op-amps), wherein each of the detection electrodes is connected to one of differential inputs of each of the second amplifiers ([0053], Fig. 4; sensor circuit 20 connected to sensor electrode 2 at non-inverting (+) input terminal),
outputs of the second amplifiers are connected respectively to differential inputs of the first amplifier (30, Fig. 1) ([0053]; outputs from sensor circuit (20, at least 20D, Fig. 4) connected to each input of differential amplifier 30).
Nishii does not disclose,
a feedback circuit that returns an inverted signal obtained by inverting an in- phase signal from the two detection electrodes to the body of the subject via a feedback electrode,
each of the guard electrodes is connected to the other of the differential inputs of each of the second amplifiers,
as claimed.
However, Jumbe teaches a system and a method for detecting ECG signals using a vibroacoustic sensor module. Jumbe is analogous to the claimed invention as it is reasonably pertinent to the problem of measuring ECG signals without direct electrode contact.
Jumbe further teaches,
a feedback circuit ([0047], Fig. 19 & 22H; DRL feedback circuit Fig. 22E) that returns an inverted signal obtained by inverting an in- phase signal from the two detection electrodes to the body of the subject via a feedback electrode ([0221], [0223-0224], Fig. 22A & 22H; negative feedback DRL signal necessitates signal inversion to remove noise; Fig. 22H shows capacitive coupling electrodes coupled to guard electrodes and EPIC sensors (op-amp without polarity markings) that output an inverted signal to DRL feedback circuit; DRL electrode applies inverted signal to body),
each of the guard electrodes is connected to the other of the differential inputs of each of the second amplifiers (Fig. 19; guard electrode connected to output from voltage follower; output connected to inverting (-) input of voltage follower; capacitive electrode connected to non-inverting (+) input of voltage follower).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Nishii with a feedback circuit that returns an inverted signal obtained by inverting an in-phase signal from the two detection electrodes to the body of the subject via a feedback electrode, and each of the guard electrodes is connected to the other of the differential inputs of each of the second amplifiers, as taught by Jumbe. One of ordinary skill in the art would have been motivated to make these modifications to improve DRL technology by utilizing contactless capacitive electrodes that enable existing techniques to be used through clothing and ambulating patients (Jumbe, [0220]).
Regarding claim 5, Nishii in view of Jumbe teaches the electrocardiographic signal measuring apparatus according to claim 1, but does not disclose further comprising a mounting belt that is mounted on the body of the subject in a wound state in a freely attachable and detachable manner and is configured by arranging the two detection electrodes and the feedback electrode.
However, Jumbe teaches comprising a mounting belt that is mounted on the body of the subject in a wound state in a freely attachable and detachable manner ([0356]; chest strap, belly band) and is configured by arranging the two detection electrodes and the feedback electrode (implicit; various embodiments feature modifications to EPIC sensor and DRL electrode configurations for specific applications).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Nishii and Jumbe, with a mounting belt that is mounted on the body of the subject in a wound state in a freely attachable and detachable manner and configured by arranging the two detection electrodes and the feedback electrode. One of ordinary skill in the art would have been motivated to make these modifications to enable continuous monitoring of multiple physiological conditions by coupling the sensing device to a garment that covers different target locations (Jumbe, [0356]).
Regarding claim 6, Nishii in view of Jumbe teaches the electrocardiographic signal measuring apparatus according to claim 1, but does not disclose further comprising a mounting vest that is wearable by the subject on an upper half of the body and is configured by arranging the two detection electrodes and the feedback electrode.
However, Jumbe teaches comprising a mounting vest that is wearable by the subject on an upper half of the body ([0356]; shirt) and is configured by arranging the two detection electrodes and the feedback electrode (implicit) (examiner notes that a vest is a shirt without sleeves.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Nishii and Jumbe, with a mounting vest that is wearable by the subject on an upper half of the body ([0356]; shirt) and is configured by arranging the two detection electrodes and the feedback electrode. One of ordinary skill in the art would have been motivated to make these modifications to enable continuous monitoring of multiple physiological conditions by coupling the sensing device to a garment that covers different target locations (Jumbe, [0356]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishii et al (US Pre Grant Publication 2014/0323838 A1), in view of Jumbe et al (US Pre Grant Publication 2021/0345939 A1), and in further view of Huang (CN 111417341 A).
Regarding claim 2, Nishii in view of Jumbe, teaches the electrocardiographic signal measuring apparatus according to claim 1, and Nishii further teaches comprising two network resistors (20R, Fig. 4) ([0053], Fig. 1 & 4; 20A & 20B two sensor circuits each with resistor 20R).
Nishii and Jumbe do not disclose, two network resistors, each of which is configured by connecting a plurality of bias resistors in a T-shape and has three ends including a first end, a second end, and a third end, wherein the first end of each of the network resistors is connected to one of the differential inputs of each of the second amplifiers, and
the second end of each of the network resistors is connected to the other of the differential inputs of each of the second amplifiers.
However, Huang teaches a system and a method for measuring ECGs using a feedback circuit. Huang is analogous to the claimed invention because it is reasonably pertinent to the problem of reducing ECG signal noise and interference.
Huang further teaches two network resistors, each of which is configured by connecting a plurality of bias resistors in a T-shape (Fig. 9; resistors 821, 822, and 823 form a t-network) and has three ends including a first end (821, Fig. 9), a second end (822, Fig. 9), and a third end (823, Fig. 9), wherein the first end of each of the network resistors is connected to one of the differential inputs of each of the second amplifiers ([0116], differential amplifier 811 connects to end of 821 at positive input), and
the second end of each of the network resistors is connected to the other of the differential inputs of each of the second amplifiers ([0116], differential amplifier 811 connects to end of 822 at negative input).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Nishii and Jumbe with the two network resistors, each of which is configured by connecting a plurality of bias resistors in a T-shape and has three ends including a first end, a second end, and a third end, wherein the first end of each of the network resistors is connected to one of the differential inputs of each of the second amplifiers, and the second end of each of the network resistors is connected to the other of the differential inputs of each of the second amplifiers, as taught by Huang. One of ordinary skill in the art would have been motivated to make these modifications to remove common-mode signal interference by feeding an interference signal back to the measurement electrodes thereby canceling signal interference (Huang, [0116]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishii et al (US Pre Grant Publication 2014/0323838 A1), in view of Jumbe et al (US Pre Grant Publication 2021/0345939 A1), and in further view of Huang (CN 111417341 A) and Walker (US Pre Grant Publication 2009/0072866).
Regarding claim 3, Nishii in view of Jumbe and in further view of Huang teaches the electrocardiographic signal measuring apparatus according to claim 2, but does not disclose further comprising a specific circuit capable of switching a state of the third end of the network resistor between a high level and a low level.
However, Walker teaches a system and a method for controlling amplified signals in a medical diagnostic device comprising detection of out-of-range signals. Walker is analogous to the claimed invention because it is reasonably pertinent to the problem of accurately detecting physiological signals using switching means.
Walker further teaches comprising a specific circuit (window comparator 20, Fig. 3) capable of switching a state of the third end of the network resistor between a high level and a low level ([0069], [0071], Fig. 3 & 4; input signal to comparator 20 does not exceed trip points, then switch 22 maintained in “on” state or high level; signal outside range of trip points, then switch 22 turned off or low level).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Nishii, Jumbe, and Huang with the specific circuit capable of switching a state of the third end of the network resistor between a high level and a low level, as taught by Walker. One of ordinary skill in the art would have been motivated to make these modifications to preserve signal fidelity by turning off signal output during an out-of-range event (Walker, [0067]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishii et al (US Pre Grant Publication 2014/0323838 A1), in view of Jumbe et al (US Pre Grant Publication 2021/0345939 A1), and in further view of Pekander et al (US Pre Grant Publication 2018/0168458 A1).
Regarding claim 4, Nishii in view of Jumbe teaches the electrocardiographic signal measuring apparatus according to claim 1, but does not disclose wherein the detection electrode is connected to one of the differential inputs of the second amplifier via a center conductor of a coaxial cable, and
the guard electrode is connected to the other of the differential inputs of the second amplifier via an external conductor of the coaxial cable,
as claimed.
However, Pekander teaches a system and a method for monitoring ECG signals with capacitively coupled sensors. Pekander is analogous to the claimed invention because it is reasonably pertinent to the problem of detecting ECG signals with capacitive electrodes.
Pekander further teaches wherein the detection electrode is connected to one of the differential inputs of the second amplifier via a center conductor (21, Fig. 5A) of a coaxial cable ([0046-0047], Fig. 5A; first conductive layer 21 arranged in coaxial configuration with second conductive layer 22 surrounding layer 21), and
the guard electrode is connected to the other of the differential inputs of the second amplifier via an external conductor (22, Fig. 5) of the coaxial cable ([0046-0047], Fig. 5A).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Nishii and Jumbe with a detection electrode connected to one of the differential inputs of the second amplifier via a center conductor of a coaxial cable, and a guard electrode connected to the other of the differential inputs of the second amplifier via an external conductor of the coaxial cable, as taught by Pekander. One of ordinary skill in the art would have been motivated to make these modifications to transmit recorded physiological signals by utilizing the mutual capacitance between adjacent parallel conductive layers from a coaxial cable (Pekander, [0045]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee (US Pre Grant Publication 2019/0274579 A1) discloses a system and a method for bioimpedance measurements using capacitively coupled electrodes ([0109], Fig. 1); bias resistor network 138 [0112]; switching circuit 132 [0091];
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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