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 § 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) 1-3, 6-10, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov(US 20170049352 A1) in view of Zhou(20210321893).
Regarding claim 1, Mirov discloses a measurement device configured to perform physiological measurements of a user body using a direct excitation source, referred to as a DC measurement, or using an alternative excitation source, referred to as an AC measurement, the measurement device comprising: a pair of electrodes comprising a left electrode and a right electrode configured to be respectively in contact with the left foot and the right foot of the user(For example, ECG waveforms can be extracted from pairs of skin locations on a person, such as between the left and right arms, between the right arm and left leg, and between the left arm and left leg[0046]); a DC measurement circuit comprising a direct excitation source configured to apply a direct voltage or current to the left electrode of the right electrode; an AC measurement circuit comprising an alternative excitation source configured to apply an alternative voltage or current to the left electrode and/or the right electrode; a discharging circuit, configured to be connected to at least one of the left electrode and right electrode; wherein the measurement device is configured to: discharge at least one of the left electrode and the right electrode using the discharging circuit connected to the at least one of the left electrode and the right electrode; perform the AC measurement using the AC measurement circuit connected to at least one electrode of the pair of electrodes; and perform the DC measurement using the DC measurement circuit connected to the pair of electrodes(The capacitor could be charged (e.g., charged to a specified voltage) during a first period of time and subsequently discharged through the two electrical contacts (e.g., through skin to which the electrical contacts are mounted). A voltage across and/or a current through the capacitor could be measured during the discharge to determine an impedance (e.g., a DC impedance, a phase and magnitude of an AC impedance at one or more frequencies, an impedance spectrum, a resistive, capacitive, inductive, and/or reactive component of the impedance) between the two electrical contacts[0077][Fig. 4]). Mirov fails to specifically disclose an excitation source corresponding to electrodes and the DC and AC measurements.
However, Zhou teaches “In this embodiment, the first electrode 6 and the first electrode 7 are used to generate an excitation signal as well as collect a signal, which reduces the number of electrodes for skin conductance monitoring to two. In addition, because the electrocardiographic monitoring analog front end 3 is connected to the first electrode 6 and the second electrode 7 by direct current coupling, and the skin conductance monitoring module 4 is connected to the first electrode 6 and the second electrode 7 by alternating current coupling, the electrocardiographic signal and the skin impedance signal collected by the first electrode 6 and the second electrode 7 will not interfere with each other. It should be noted that the electrocardiographic monitoring analog front end 3 may be connected to the first electrode 6 and the second electrode 7 by alternating current coupling, while the skin conductance monitoring module 4 may be connected to the first electrode 6 and the second electrode 7 by direct current coupling[0035]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical contact voltage detection device of Mirov with the excitation source of the electrode multiplexing physiological monitor of Zhou. Doing so would specify an excitation source for each kind of measurement in the circuit to ensure proper ECG measurements are taken.
Regarding claim 2, Mirov in view of Zhou discloses the measurement device according to claim 1, wherein the discharging circuit comprises a ground(Mirov - Further, at least the reference voltage source 441, voltage sensor 447, capacitance sensor 460, and electronic switch 435 are electrically connected to the common electrical ground 420 that is electrically connected to the second electrical contact 415[0079][FIG. 4]).
Regarding claim 3, Mirov in view of Zhou teaches the measurement device according to claim 2, wherein the DC measurement circuit further comprises a measurement resistor connected to the ground and configured to determine a current value flowing through the user body, wherein an electrical resistance value of the measurement resistor is variable amongst a zero value and predetermined range, wherein the discharging circuit comprises the measurement resistor set to the zero value(In the example of FIG. 4, the voltage source 441 is electrically connected to the first electrical contact 410 through the voltage source switch 443 and the resistor 435. Additionally, the voltage sensor 447 has an input electrically connected to the first electrical contact 410 through the resistor 445. Further, at least the reference voltage source 441, voltage sensor 447, capacitance sensor 460, and electronic switch 435 are electrically connected to the common electrical ground 420 that is electrically connected to the second electrical contact 415[0079]. The impedance between the electrical contact and the skin is substantially all reactive (that is, such that the impedance has a real or resistive component that is substantially zero). An electrical contact could include a surface texture configured to increase the effective surface area of the electrical contact[0037]).
Regarding claim 6, Mirov in view of Zhou discloses the measurement device according to claim 1, which is configured to perform the discharge, then the AC measurement and then the DC measurement and then optionally another discharge(That is, the capacitance sensor could include components configured to repeatedly charge and discharge an equivalent capacitance between the first and second electrical contacts 410, 415 (e.g., a capacitance of skin, air, or other substances between the first and second electrical contacts 410, 415) in a specified manner (e.g., by applying a specified charge/discharge current, by apply a specified charge/discharge voltage to the first and second electrical contacts 410, 415 via a resistor having a specified resistance) such that a frequency, a duty cycle, or some other property of the operation of the relaxation oscillator is related to the capacitance between the first and second electrical contacts 410, 415[0090]).
Regarding claim 7, Mirov in view of Zhou discloses the measurement device according to claim 1, further configured to discharge before performing the AC measurement(A voltage across and/or a current through the capacitor could be measured during the discharge to determine an impedance (e.g., a DC impedance, a phase and magnitude of an AC impedance at one or more frequencies, an impedance spectrum, a resistive, capacitive, inductive, and/or reactive component of the impedance) between the two electrical contacts[0029]).
Regarding claim 8, Mirov in view of Zhou discloses the measurement device according to claim 1, further configured to discharge after performing the DC measurement(The wearable device of claim 1, further comprising a capacitor electrically connected between the first and second electrical contacts, and wherein detecting an impedance between the first and second electrical contacts comprises: charging the capacitor during a first period of time; discharging the capacitor via the first and second electrical contacts during a second period of time; and determining a capacitor voltage across the capacitor at one or more points in time during the second period of time[claim 9]).
Regarding claim 9, Mirov in view of Zhou discloses the measurement device according to claim 1, further configured to perform the AC measurement before the DC measurement(The capacitor could be charged (e.g., charged to a specified voltage) during a first period of time and subsequently discharged through the two electrical contacts (e.g., through skin to which the electrical contacts are mounted). A voltage across and/or a current through the capacitor could be measured during the discharge to determine an impedance (e.g., a DC impedance, a phase and magnitude of an AC impedance at one or more frequencies, an impedance spectrum, a resistive, capacitive, inductive, and/or reactive component of the impedance) between the two electrical contacts[0077]). There is no specified order in obtaining the AC and DC measurements in the system of Mirov, however there is nothing stating one can not be obtained before the other, so it is reasonable to assume the AC measurement can be obtained before the DC measurement.
Regarding claim 10, Mirov in view of Zhou discloses The measurement device according to claim 1, further comprising a commutator configured to selectively connect at least one of the left electrode and the right electrode to: the discharging circuit in a set of discharging positions; and the DC measurement circuit in a set of DC positions, the measurement device being configured to set the commutator in the discharging position to discharge and in the DC position to carry out the DC measurement(An impedance between two electrical contacts can be detected in a variety of ways. In some examples, a specified voltage and/or current could be applied between/through the electrical contacts and amplitude, time dependence, or other properties of a current/voltage responsively developed through/between the electrical contacts could be detected and used to determine the impedance. The applied specified voltage and/or current could have a specified waveform or other property of variation over time, e.g., a specified frequency, pulse width, pulse repetition frequency, pulse rise time, or other properties. In a particular example, a capacitor could be electrically connected between the two electrical contacts. The capacitor could be charged (e.g., charged to a specified voltage) during a first period of time and subsequently discharged through the two electrical contacts (e.g., through skin to which the electrical contacts are mounted). A voltage across and/or a current through the capacitor could be measured during the discharge to determine an impedance (e.g., a DC impedance, a phase and magnitude of an AC impedance at one or more frequencies, an impedance spectrum, a resistive, capacitive, inductive, and/or reactive component of the impedance) between the two electrical contacts[0029]. Communication interface(s) 840 may also be operated by instructions within the controller module 882, such as instructions for sending and/or receiving information via a wireless antenna, which may be disposed on or in the device 800[0136]. This could include closing the voltage source switch 443 during the first period of time such that the voltage source 441 charges the capacitor 430 via the resistor 445 at a rate (i.e., with a current) related to at least the capacitance of the capacitor 430, the resistance of the resistor 445, and a difference between the voltage provided by the voltage source 441 and the voltage across the capacitor 430. The impedance detector 440 could then be operated to detect a voltage across the capacitor 430 at one or more points in time as the capacitor discharges through the skin at an external body surface via the first and second electrical contacts 410, 415 during a second period of time when the electronic switch 435 is closed[0081]).
Regarding claim 13, Mirov discloses a method to perform a physiological measurement of a user body using a direct excitation source, referred to as a DC measurement, wherein the method is carried out using the measurement device according to claim 1, wherein the method comprises: discharging at least one of the left electrode and the right electrode using the discharging circuit connected to the at least one of the left electrode and the right electrode; performing the AC measurement using the AC measurement circuit connected to the pair of electrodes; and performing the DC measurement using the DC measurement circuit connected to the pair of electrodes(For example, ECG waveforms can be extracted from pairs of skin locations on a person, such as between the left and right arms, between the right arm and left leg, and between the left arm and left leg[0046]. The capacitor could be charged (e.g., charged to a specified voltage) during a first period of time and subsequently discharged through the two electrical contacts (e.g., through skin to which the electrical contacts are mounted). A voltage across and/or a current through the capacitor could be measured during the discharge to determine an impedance (e.g., a DC impedance, a phase and magnitude of an AC impedance at one or more frequencies, an impedance spectrum, a resistive, capacitive, inductive, and/or reactive component of the impedance) between the two electrical contacts[0077]).
Mirov fails to specifically disclose an excitation source corresponding to electrodes and the DC and AC measurements.
However, Zhou teaches “In this embodiment, the first electrode 6 and the first electrode 7 are used to generate an excitation signal as well as collect a signal, which reduces the number of electrodes for skin conductance monitoring to two. In addition, because the electrocardiographic monitoring analog front end 3 is connected to the first electrode 6 and the second electrode 7 by direct current coupling, and the skin conductance monitoring module 4 is connected to the first electrode 6 and the second electrode 7 by alternating current coupling, the electrocardiographic signal and the skin impedance signal collected by the first electrode 6 and the second electrode 7 will not interfere with each other. It should be noted that the electrocardiographic monitoring analog front end 3 may be connected to the first electrode 6 and the second electrode 7 by alternating current coupling, while the skin conductance monitoring module 4 may be connected to the first electrode 6 and the second electrode 7 by direct current coupling[0035]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical contact voltage detection device of Mirov with the excitation source of the electrode multiplexing physiological monitor of Zhou. Doing so would specify an excitation source for each kind of measurement in the circuit to ensure proper ECG measurements are taken.
Regarding claim 14, Mirov discloses the method according to claim 13, wherein the discharging is performed before performing the AC measurement(The capacitor could be charged (e.g., charged to a specified voltage) during a first period of time and subsequently discharged through the two electrical contacts (e.g., through skin to which the electrical contacts are mounted). A voltage across and/or a current through the capacitor could be measured during the discharge to determine an impedance (e.g., a DC impedance, a phase and magnitude of an AC impedance at one or more frequencies, an impedance spectrum, a resistive, capacitive, inductive, and/or reactive component of the impedance) between the two electrical contacts[0077]).
Regarding claim 15, Mirov discloses a non-transitory machine readable medium comprising instructions configured to carry out the method of claim 13(The computer readable medium 870 may include or take the form of one or more non-transitory, computer-readable storage media that can be read or accessed by at least one processor 860[0124]).
Regarding claim 16, Mirov discloses a measurement device configured to perform physiological measurements of a user body using a direct excitation source, referred to as a DC measurement, or to perform an electrocardiogram, ECG, measurement, the measurement device comprising: a pair of electrodes comprising a left electrode and a right electrode configured each to be respectively in contact with the left foot and the right foot of the user; a DC measurement circuit comprising a direct excitation source configured to apply a direct voltage or current to the left electrode or the right electrode; an ECG measurement circuit configured to obtain an electrocardiogram of the user using at least one electrode of the pair of electrode; a discharging circuit. configured to be connected to at least one of the left electrode and right electrode; wherein the measurement device is configured to: discharge at least one of the left electrode and the right electrode using the discharging circuit connected to the at least one of the left electrode and the right electrode; perform the ECG measurement using the ECG measurement circuit connected to at least one electrode of the pair of electrodes; and perform the DC measurement using the DC measurement circuit connected to the pair of electrodes((For example, ECG waveforms can be extracted from pairs of skin locations on a person, such as between the left and right arms, between the right arm and left leg, and between the left arm and left leg[0046]. The capacitor could be charged (e.g., charged to a specified voltage) during a first period of time and subsequently discharged through the two electrical contacts (e.g., through skin to which the electrical contacts are mounted). A voltage across and/or a current through the capacitor could be measured during the discharge to determine an impedance (e.g., a DC impedance, a phase and magnitude of an AC impedance at one or more frequencies, an impedance spectrum, a resistive, capacitive, inductive, and/or reactive component of the impedance) between the two electrical contacts[0077]).
Mirov fails to specifically disclose an excitation source corresponding to electrodes and the DC and AC measurements.
However, Zhou teaches “In this embodiment, the first electrode 6 and the first electrode 7 are used to generate an excitation signal as well as collect a signal, which reduces the number of electrodes for skin conductance monitoring to two. In addition, because the electrocardiographic monitoring analog front end 3 is connected to the first electrode 6 and the second electrode 7 by direct current coupling, and the skin conductance monitoring module 4 is connected to the first electrode 6 and the second electrode 7 by alternating current coupling, the electrocardiographic signal and the skin impedance signal collected by the first electrode 6 and the second electrode 7 will not interfere with each other. It should be noted that the electrocardiographic monitoring analog front end 3 may be connected to the first electrode 6 and the second electrode 7 by alternating current coupling, while the skin conductance monitoring module 4 may be connected to the first electrode 6 and the second electrode 7 by direct current coupling[0035]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical contact voltage detection device of Mirov with the excitation source of the electrode multiplexing physiological monitor of Zhou. Doing so would specify an excitation source for each kind of measurement in the circuit to ensure proper ECG measurements are taken.
Regarding claim 17, Mirov in view of Zhou teaches the measurement device according to claim 16, further configured to discharge before performing the ECG measurement(For example, the electronics could be configured to generate an electronic signal (e.g., to generate an extracted ECG waveform) that is related to a band-passed version of the voltage fluctuations between two or more electrical contacts. This could include applying the voltage fluctuations to a band-pass filter having a pass-band between approximately 0.05 Hertz and approximately 150 Hertz. Additionally or alternatively, an electronic signal could be digitally sampled and some digital filtering could be performed (e.g., by a processor of the wearable device 110) to generate an extracted ECG waveform. The electronics could include fast recovery circuitry configured to determine that one or more elements (e.g., amplifiers, filters) of the electronics are saturated and to responsively control one or more properties of the electronics (e.g., operate an electronic switch to discharge a capacitor, change a corner frequency or other parameter of a filter) to reduce the electronic saturation of the one or more elements of the electronics[0065]).
Regarding claim 18, Mirov discloses a method to perform a physiological measurement of a user body using a direct excitation source, referred to as a DC measurement, wherein the method is carried out using a measurement device of claim 16, wherein the method comprises: discharging at least one of the left electrode and the right electrode using the discharging circuit connected to the at least one of the left electrode and the right electrode; performing an ECG measurment using the ECG measurement circuit connected to at least one electrode of the pair of electrodes; and performing a DC measurment using the DC measurment circuit connected to the pair of electrodes(For example, ECG waveforms can be extracted from pairs of skin locations on a person, such as between the left and right arms, between the right arm and left leg, and between the left arm and left leg[0046]. The capacitor could be charged (e.g., charged to a specified voltage) during a first period of time and subsequently discharged through the two electrical contacts (e.g., through skin to which the electrical contacts are mounted). A voltage across and/or a current through the capacitor could be measured during the discharge to determine an impedance (e.g., a DC impedance, a phase and magnitude of an AC impedance at one or more frequencies, an impedance spectrum, a resistive, capacitive, inductive, and/or reactive component of the impedance) between the two electrical contacts[0077]).
Mirov fails to specifically disclose an excitation source corresponding to electrodes and the DC and AC measurements.
However, Zhou teaches “In this embodiment, the first electrode 6 and the first electrode 7 are used to generate an excitation signal as well as collect a signal, which reduces the number of electrodes for skin conductance monitoring to two. In addition, because the electrocardiographic monitoring analog front end 3 is connected to the first electrode 6 and the second electrode 7 by direct current coupling, and the skin conductance monitoring module 4 is connected to the first electrode 6 and the second electrode 7 by alternating current coupling, the electrocardiographic signal and the skin impedance signal collected by the first electrode 6 and the second electrode 7 will not interfere with each other. It should be noted that the electrocardiographic monitoring analog front end 3 may be connected to the first electrode 6 and the second electrode 7 by alternating current coupling, while the skin conductance monitoring module 4 may be connected to the first electrode 6 and the second electrode 7 by direct current coupling[0035]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical contact voltage detection device of Mirov with the excitation source of the electrode multiplexing physiological monitor of Zhou. Doing so would specify an excitation source for each kind of measurement in the circuit to ensure proper ECG measurements are taken.
Regarding claim 19, Mirov in view of Zhou teaches the method according to claim 18, wherein the discharging is performed before performing the ECG measurement(For example, the electronics could be configured to generate an electronic signal (e.g., to generate an extracted ECG waveform) that is related to a band-passed version of the voltage fluctuations between two or more electrical contacts. This could include applying the voltage fluctuations to a band-pass filter having a pass-band between approximately 0.05 Hertz and approximately 150 Hertz. Additionally or alternatively, an electronic signal could be digitally sampled and some digital filtering could be performed (e.g., by a processor of the wearable device 110) to generate an extracted ECG waveform. The electronics could include fast recovery circuitry configured to determine that one or more elements (e.g., amplifiers, filters) of the electronics are saturated and to responsively control one or more properties of the electronics (e.g., operate an electronic switch to discharge a capacitor, change a corner frequency or other parameter of a filter) to reduce the electronic saturation of the one or more elements of the electronics[0065]).
Regarding claim 20, Mirov in view of Zhou teaches a non-transitory machine readable medium comprising instructions configured to carry out the method of claim 18(The computer readable medium 870 may include or take the form of one or more non-transitory, computer-readable storage media that can be read or accessed by at least one processor 860[0124]. Controller 850 may be provided as a computing device that includes one or more processors 860. The one or more processors 860 can be configured to execute computer-readable program instructions 880 that are stored in the computer readable data storage 870 and that are executable to provide the functionality of a device 800 described herein[0123]).
Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov in view of Zhou and further in view of Eletr(US 20180177459 A1).
Regarding claim 4, Mirov in view of Zhou teaches the measurement device according to claim 1, but fails to disclose wherein the discharging circuit comprises an excitation source set to a zero voltage.
However, Eletr teaches “If this filtering effect is not desired, the voltage on C2 may be discharged to zero before the signal is measured each cycle, so that the signal held on C2 is simply: (C2*s)/(C1+C2)[0081]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical contact voltage detection device of Mirov with the zeroed voltage of the health monitoring system of Eletr. Doing so would specify the voltage is discharged to zero from the ground to reset the system.
Regarding claim 5, Mirov in view of Zhou and further in view of Eletr teaches the measurement device according to claim 4, wherein the discharging circuit is a direct excitation source of the DC measurement circuit(The electronics can further include elements (capacitors, current sources, voltage sources, electronic switches) configured to inject a current though and/or apply a voltage across two or more of the electrical contacts (e.g., the first and second electrical contacts) to allow an impedance between such electrical contacts to be detected[0064]. The capacitor could be charged (e.g., charged to a specified voltage) during a first period of time and subsequently discharged through the two electrical contacts (e.g., through skin to which the electrical contacts are mounted). A voltage across and/or a current through the capacitor could be measured during the discharge to determine an impedance (e.g., a DC impedance, a phase and magnitude of an AC impedance at one or more frequencies, an impedance spectrum, a resistive, capacitive, inductive, and/or reactive component of the impedance) between the two electrical contacts[0077]).
Claim(s) 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov in view of Zhou and further in view of Banet(US 20170188955 A1).
Regarding claim 11, Mirov in view of Zhou teaches the measurement device according to claim 1, but fails to disclose further comprising a weight sensor and further configured to acquire weight data using the weight sensor, wherein the measurement device is configured to discharge at least partially during acquisition of the weight data.
However, Banet teaches “As shown in FIG. 1, the invention provides a stand-on sensor (“floormat”) 100 that measures a number of physiological parameters, e.g. vital signs (e.g. HR, RR, SpO2, SYS, DIA), hemodynamic parameters (CO, SV, TFI), and biometric parameters (weight, percent body fat, muscle mass) of a patient 105[0105]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical contact voltage detection device of Mirov with the weight sensor of the floormat sensing device of Banet. Doing so would allow the body sensors and electrodes of the system to be placed on or under the feet when in contact with the user to obtain different physiologic metrics.
Regarding claim 12, Mirov in view of Zhou teaches the measurement device according to claim 1, but fails to disclose further configured to associate a user profile of the measurement device to a user standing on the measurement device, where the measurement device is configured to discharge at least partially during identifying the user.
However, Banet teaches “In this way, a comprehensive set of physiological data can be measured easily and on a daily basis while the patient 105 simply stands on the floormat 100, in a manner that is similar to how the patient would use a standard bathroom scale to weigh himself or herself[0105]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical contact voltage detection device of Mirov with the weight sensor of the floormat sensing device of Banet. Doing so would allow the body sensors and electrodes of the system to be placed on or under the feet when in contact with the user to obtain different physiologic metrics.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796