DETAILED ACTION
This action is pursuant to the claims filed on 10/11/2024. Claims 1-7 and 9-21 are pending. A first action on the merits of claims 1-7 and 9-21 is as follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/04/2025, 12/30/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 9-10, 14, 16, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sunderland (U.S. PGPub No. 2014/0088394).
Regarding claim 1, Sunderland teaches A signal measurement circuit, comprising: a plurality of electrodes configured to be attached to a human body and collect physiological signals of the human body (Fig 1 electrodes 112); a contact impedance detection circuit electrically connected with the plurality of electrodes, the contact impedance detection circuit being configured to measure a contact impedance between each of the plurality of electrodes and the human body (Fig 1 circuitry 120); and a switching circuit configured to control a conduction state between the plurality of electrodes and the contact impedance detection circuit ([0091] discloses analog multiplexers (i.e., switching circuitry) used to cycle through electrode selection to measure impedance for each electrode), such that only a portion of the plurality of electrodes is in the conduction state with the contact impedance detection circuit simultaneously (Fig 12 and [0148] further discloses selection of a portion of the electrodes to be in conduction state with the impedance detection circuitry), wherein the portion of the plurality of electrodes includes at least two electrodes (see Fig 1).
Regarding claim 2, Sunderland teaches wherein the plurality of electrodes include two electrodes attached to the same muscle (Fig 1 electrodes are arranged as ECG electrodes and are attached to indirectly to the heart (i.e., a muscle); alternatively two electrodes can also be interpreted to be attached to a pec muscle), and the two electrodes attached to the same muscle are synchronously in the conduction state with the contact impedance detection circuit (Fig 12 and [0148] discusses how the two electrodes can be synchronously in the conduction state).
Regarding claim 3, Sunderland teaches wherein the plurality of electrodes include two electrodes attached to the same muscle (Fig 1 electrodes are arranged as ECG electrodes and are attached to indirectly to the heart (i.e., a muscle); alternatively two electrodes can also be interpreted to be attached to a pec muscle), and the two electrodes attached to the same muscle are in the conduction state with the contact impedance detection circuit at different times (Fig 12 and [0148] discusses how the circuitry cycles through all electrodes to measure contact impedance, such that two electrodes attached to the same muscle would be in the conduction state at different times).
Regarding claim 9, Sunderland teaches a gain circuit configured for processing the physiological signals (Fig 9 ECG acquisition circuitry with amplifiers having gains of G1), wherein the gain circuit and the contact impedance detection circuit are in the conduction state with the plurality of electrodes at different times, respectively ([0082-0083] circuitry inhibits device from proceeding with instrument operations (ECG acquisition) until electrode contact quality is determined to meet the threshold).
Regarding claim 10, Sunderland teaches wherein the gain circuit provides a gain for the physiological signals (ECG acquisition electronics 306 define gain circuit for physiological signals).
Regarding claim 14, Sunderland teaches a processing circuit configured to determine parameter information reflecting an attachment state of each of the plurality of electrodes to the human body according to the contact impedance of each of the plurality of electrodes ([0103] “processing device 328 operates to perform processing operations of the electrode contact quality evaluation circuitry 120 as part of the determination of the quality of electrical connections between the electrodes 112 and the patient P”).
Regarding claim 16, Sunderland teaches A method for signal measurement, comprising: controlling a conduction state between a plurality of electrodes and a contact impedance detection circuit through a switching circuit (Fig 1, 9, 12, [0091] discloses analog multiplexers (i.e., switching circuitry) used to cycle through electrode selection to measure impedance for each electrode), such that only a portion of the plurality of electrodes are in the conduction state with the contact impedance detection circuit simultaneously (Fig 12 and [0148] further discloses selection of a portion of the electrodes to be in conduction state with the impedance detection circuitry), wherein the plurality of electrodes are configured to be attached to a human body and collect physiological signals of the human body (see Fig 1), and the contact impedance detection circuit is configured to measure a contact impedance between each of the plurality of electrodes and the human body (Fig 1 circuitry 120), wherein the portion of the plurality of electrodes includes at least two electrodes (see Fig 1 electrodes 112); and determining parameter information reflecting an attachment state of each of the plurality of electrodes to the human body according to the contact impedance of each of the plurality of electrodes ([0103] “processing device 328 operates to perform processing operations of the electrode contact quality evaluation circuitry 120 as part of the determination of the quality of electrical connections between the electrodes 112 and the patient P”).
Regarding claim 18, Sunderland teaches the method of claim 17 and further teaches for each of the plurality of electrodes, obtaining a detection signal reflecting the contact impedance between the electrode and the human body (detection value is the contact impedance value calculated for each electrode); and determining an indicator parameter value reflecting a quality of the physiological signal of the human body collected by the electrode by processing the detection signal (Fig 15 indicator parameter defined as the key with icons 520, 522, 524).
Claim Rejections - 35 USC § 103
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.
Claim(s) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sunderland in view of Shui (U.S. PGPub No. 2020/0077955).
Regarding claim 4, Sunderland teaches wherein the contact impedance detection circuit includes: an excitation source configured to provide an excitation signal to the two electrodes attached to the same muscle to generate detection signals each of which corresponds to one of the two electrodes attached to the same muscle (Fig 8 test current source 332), each detection signal reflecting the contact impedance between the corresponding electrode and the human body ([0006] disclosing one or more sense leads and measuring differences between signals corresponding to each sense lead); two impedances, each of the two impedances being coupled between the excitation source and one of the two electrodes attached to the same muscle to form the corresponding detection signal (Fig 12, step 450; Fig 9 showing voltage drops VIS and VSR used to calculate two impedances coupled to injection source 332); and an analog-to-digital converters configured to perform an analog-to-digital conversion on the detection signals, respectively (Fig 9 ADC 336)
Sunderland fails to teach the two impedances as two voltage-dividing impedances by performing a voltage division on the excitation source; and two analog-to-digital converters configured to perform an analog-to-digital conversion on the detection signals, respectively.
In related prior art, Shui teaches a similar measurement circuit wherein two voltage-dividing impedances by performing a voltage division on the excitation source (Fig 6 impedance network 635 defines a voltage divider); and two analog-to-digital converters configured to perform an analog-to-digital conversion on the detection signals, respectively (Fig 6 ADCs 628/638). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the excitation source circuitry of Sunderland in view of Shui to incorporate a voltage divider such that the resultant two impedances are two voltage-dividing impedances with corresponding ADCs for each respective detected signal to arrive at claim 4. Providing the voltage dividing circuitry would advantageously allow for the scaling of the voltage for analog-to-digital conversion as is known in the art as a predictable result for the use of voltage dividers. Furthermore, providing a second ADC for the corresponding second voltage dividing impedance would be obvious to one of ordinary skill in the art as a simple engineering design choice as it has been held that “mere duplication of parts has no patentable significance unless a new and unexpected result is produced”. In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). In the instant case, utilizing two distinct ADCs to convert two signals yields the same result as utilizing one ADC to convert two distinct signals.
Regarding claim 5, Sunderland teaches wherein the contact impedance detection circuit includes: an excitation source configured to provide an excitation signal to each of the plurality of electrodes to generate a detection signal reflecting the contact impedance between each of the plurality of electrodes and the human body (Fig 8 test current source 332); an impedance coupled between the excitation source and each of the plurality of electrodes to form the detection signal by performing a voltage division on the excitation source (Fig 12 step 450); and an analog-to-digital converter configured to perform an analog-to-digital conversion on the detection signal (Fig 9 ADC 336).
Sunderland fails to teach wherein the impedance is a voltage dividing impedance between the excitation source and each of the plurality of electrodes to form the detection signal by performing a voltage division on the excitation source.
In related prior art, Shui teaches a similar measurement circuit comprising a voltage-dividing impedance by performing a voltage division on the excitation source (Fig 6 impedance network 635 defines a voltage divider). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the excitation source circuitry of Sunderland in view of Shui to incorporate a voltage divider such that the resultant impedance is a voltage-dividing impedances to arrive at claim 5. Providing the voltage dividing circuitry would advantageously allow for the scaling of the voltage for analog-to-digital conversion as is known in the art as a predictable result for the use of voltage dividers.
Regarding claim 6, in view of the combination of claim 4 above, Sunderland further teaches wherein the excitation source is a DC excitation source or an AC excitation source with a frequency not less than 0.1 Hz ([0097]).
Regarding claim 7, in view of the combination of claim 4 above, Shui further teaches wherein the voltage-dividing impedance includes a resistor or a capacitor (Fig 6 impedance network 635 has both resistor and capacitor), and a follower is coupled between the analog-to-digital converter and the voltage-dividing impedance (Fig 6 buffer 624 is a voltage follower circuit).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sunderland in view of Lee (U.S. PGPub No. 2017/0188878).
Regarding claim 11, Sunderland teaches the device of claim 10.
Sunderland fails to teach wherein a ratio of a gain of the gain circuit at 100 Hz to a gain of the gain circuit at 10 Hz is a first signal-to-noise ratio, the first signal-to-noise ratio being not less than 4.
In related prior art, Lee teaches a similar device wherein a gain has a linear characteristic from 1 to 100 in 0 to 50 Hz bands ([0084], a gain at 10 Hz would be 20, again at 50 Hz would be 100, a gain at 100 Hz would necessarily be greater than 100). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sunderland in view of Lee to incorporate a linear characteristic of gain from 0 to 100 Hz such that a ratio of a gain circuit at 100 Hz to a gain circuit at 10 Hz to be not less than 4 to arrive at claim 11. Doing so would be obvious to one of ordinary skill in the art as the use of a linear gain characteristic is well-known in the art to yield predictable results therein.
Regarding claim 12, Sunderland teaches the device of claim 10.
Sunderland fails to teach wherein a ratio of a gain of the gain circuit at 100 Hz to a gain of the gain circuit at 50 Hz is a second signal-to-noise ratio, the second signal-to-noise ratio being not less than 2.
In related prior art, Lee teaches a similar device wherein a gain has a linear characteristic from 1 to 100 in 0 to 50 Hz bands ([0084], a gain at 50 Hz would be 100, with a linear characteristic a gain at 100 Hz would be 200; 200/100 is not less than 2). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sunderland in view of Lee to incorporate a linear characteristic of gain from 0 to 100 Hz such that a ratio of a gain circuit at 100 Hz to a gain circuit at 50 Hz to be not less than 2 to arrive at claim 12. Doing so would be obvious to one of ordinary skill in the art as the use of a linear gain characteristic is well-known in the art to yield predictable results therein.
Regarding claim 13, Sunderland teaches the device of claim 10. Sunderland further teaches a first frequency being a frequency corresponding to ½ of a sampling rate of an ADC ([0097] sampling frequency of ADC is 1000 Hz, ½ would be 500 Hz).
Sunderland fails to teach wherein a ratio of a gain of the gain circuit at 100 Hz to a gain of the gain circuit at a first frequency is a third signal-to-noise ratio, the first frequency being a frequency corresponding to 1/2 of a sampling rate of an analog-to-digital converter, and the third signal-to-noise ratio being not less than 10.
In related prior art, Lee teaches a similar device wherein a gain has a linear characteristic from 1 to 100 in 0 to 50 Hz bands ([0084]).
Sunderland/Lee discloses substantially all the limitations of the claim(s) except a ratio of a gain of the gain circuit at 100 Hz to a gain of the gain circuit at a first frequency corresponding to 1/2 of a sampling rate of an analog-to-digital converter is not less than 10. It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide a ratio of a gain of the gain circuit at 100 Hz to a gain to a gain of the gain circuit at a first frequency corresponding to 1/2 of a sampling rate of an analog-to-digital converter is not less than 10, since applicant has not disclosed that this third signal-to-noise ratio solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well as it is known in the art that a higher signal-to-noise ratio is ideal for maximizing signal quality..
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sunderland in view of Martikka (U.S. PGPub No. 2016/0143592).
Regarding claim 15, Sunderland teaches the device of claim 1 as stated above.
Sunderland fails to teach wherein the signal measurement circuit is disposed in a wearable device.
In related prior art, Martikka teaches wherein the signal measurement circuit is disposed in a wearable device (see Fig 2A). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sunderland in view of Martikka to incorporate the signal measurement device disposed in a wearable device to arrive at claim 15. Doing so would advantageously enable the system of Sunderland to be used on the move to monitor physiological signals during exercise for real-time monitoring ([0008]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sunderland in view of Hwang (KR 20160144620).
Regarding claim 17, Sunderland teaches the method of claim 16.
Sunderland fails to teach determining a warm-up state of a user based on a difference or a ratio of the contact impedances of two of the plurality of electrodes attached to the same muscle.
In related prior art, Hwang teaches a similar device wherein impedance differences of two electrodes attached to the same muscle vary instantaneously due to movement of the body (Pg 2 of translation; Pg 8 and Fig 4 disclose same impedance variation for electrodes 1 and 2 of Fig 4 on the same muscle group). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sunderland in view of Hwang to incorporate the determination of a warm up state based on a difference of the contact impedances of two electrodes on the same muscle to arrive at claim 17. It is known in the art that an instantaneous variation of impedance between electrodes is indicative of the beginning of exercise (i.e., a warm up state), such that associating said impedance variation a determined warm up stated based on said impedance variation would yield predictable results therein using knowledge and techniques known in the art.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sunderland.
Regarding claim 19, Sunderland teaches the method of claim 18 and further teaches in response to determining that the indicator parameter value is within a first amplitude range (Table 1 at [0158] disclosing amplitude ranges of impedances to define indicator parameter values), outputting first indication information (see Fig 15, [0077] disclosing how increased impedance can be caused by physical movement of the electrodes).
Sunderland fails to explicitly teach wherein the outputting of first indication information indicates a movement of the user.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outputting of the first indication information to indicate a movement of the user to arrive at claim 19. Doing so would be obvious to one of ordinary skill in the art as Sunderland establishes that poor contact impedance can be caused by physical movement of the electrodes ([0077]), such that a poor impedance indication information can be indicative of movement of the user.
Regarding claim 20, Sunderland teaches the method of claim 18 and further teaches in response to determining that the indicator parameter value is within a second amplitude range (Table 1 at [0158] disclosing amplitude ranges of impedances to define indicator parameter values, second amplitude range being poor or fair), outputting second indication information (Fig 15)
Sunderland fails to explicitly teach the outputting second indication information being to remind the user to adjust the attachment state of each of the plurality of electrodes.
However, Sunderland teaches wherein “feedback can then be provided to the user to identify the quality of each electrical connection so that the user can fix poor connections” ([0078]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sunderland to incorporate the outputting second indication information to remind the user to adjust the attachment state of each of the plurality of electrodes to arrive at claim 20. Doing so would be obvious to one of ordinary skill in the art to advantageously provide the user with the contact quality information to remind them to fix poor contact quality electrodes ([0078]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sunderland in view of Bibian (U.S. PGPub No. 2011/0295096).
Regarding claim 21, Sunderland teaches wherein the plurality of electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode (See Fig 1, also [0083] disclosing EMG and EEG instruments), the first electrode and the second electrode are attached to a first muscle and synchronously in the conduction state with the contact impedance detection circuit at a first time (Fig 12 and [0148] discusses how the two electrodes can be synchronously in the conduction state).
Sunderland fails to teach the third electrode and the fourth electrode are attached to a second muscle and synchronously in the conduction state with the contact impedance detection circuit at a second time.
In related prior art, Bibian teaches a similar system for monitoring contact impedance of electrodes ([0012]) wherein ECG, EOG, EMG and/or EIT signals can be acquired with the system ([0024]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sunderland in view of Bibian to incorporate the EMG and/or EEG electrodes in addition to the ECG electrodes such that a third and fourth electrode are attached to a second muscle and synchronously in the conduction state with the contact impedance detection circuit at a second time to arrive at claim 21. Doing so would advantageously provide a system capable of measuring both ECG, EMG, and EEG signals for additional physiological monitoring as needed of different muscle groups.
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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