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 Status: Claims 1-15 are pending.
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.
Claims 3 and 11-15 are 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.
Re Claim 3, the limitation “the reference electrode is positioned on the sternum of the patient above the reference electrodes” is indefinite, because it is unclear how the reference electrode can be above itself.
For purpose of examination, the limitation has been interpreted as “the reference electrode is positioned on the sternum of the patient above the number of signal electrodes.
Re Claim 11, the limitation “a controller” in line 11 is indefinite, because it is unclear whether it is the same as or different from “a controller” in line 5 of claim 11.
Indefiniteness of claim 11 renders its dependent claims 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 (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.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Hart (US 2013/0310699A1) in view of Tarler (US 7206630 B1).
Re Claims 1 and 4, Hart discloses a wearable sensor for use with a patient monitoring system, the sensor comprising:
a number of EMG signal electrodes (para. [0113], The device 10 receives a signal at the signal input 20 that has been measured from the parasternal electromyogram (EMG)); and
an EMG reference electrode (para. [0071], claim 18, reference electrode);
wherein the sensor is structured to be affixed to a torso of a patient (para. [0071], surface electrodes placed over the parasternal muscles of the second intercostal space along with a reference electrode over the electrically neutral clavicle),
wherein the sensor is structured to automatically and non-invasively sense respiratory muscle activity signals used to calculate a neural respiratory drive index (para. [0112], At the end of recording, the patient is asked to perform repeated maximum sniff manoeuvres in order to allow the signal to be normalised for an individual patient maximum effort (EMGpara%max); para. [0021], [0120]-[0122], The neural respiratory drive is represented by the quantity EMGpara%max. This is derived by expressing the mean(EMGparapeak) as a percentage of the EMGparamax. Equation (1)), and to automatically and non-invasively sense at least one additional physiological signal other than respiratory muscle activity (para. [0067], The signals from these electrodes are processed to obtain and display heart rate), and
wherein the sensor is configured to be in electrical communication with a power supply (Hart inherently discloses a power supply, because the electrical devices cannot function without a power source) and processing means (para. [0165], a processor, fig. 3, a processing unit 30).
Hart is silent regarding a wearable sensor patch, the sensor patch comprising: a number of EMG signal electrodes; an EMG reference electrode; and a controller, the controller comprising the power supply and processing means.
However, Tarler discloses a wireless electrode patch for measuring EMG (page 5, lines 33-50, EMG) and teaches that the wearable sensor patch comprises a number of EMG signal electrodes and an EMG reference electrode (fig. 1, fig. 3, col. 15, lines 18-46, the base 12 comprises at least two electrodes 14 for placing on a subject’s skin and for sensing a physiological signal from the subject. The electrode patch 10 in fig. 1 consists of four electrodes 14 – with one of those electrodes being used as a reference electrode 15). Tarler discloses that the sensor patch is structured to be affixed to a torso of a patient (fig. 9, col. 19, lines 34-41, the subject 40 has an electrode patch 10 placed upon his or her chest 42). Tarler discloses that the sensor patch is configured to be in electrical communication with a power supply and processing means and the sensor patch further comprising: a controller, the controller comprising the power supply and processing means (col. 17, lines 34-62, The electrode patch 10 further comprises one or more electronic components including a battery 32. The electronic components for receiving a physiological signal from the electrodes placed on the subject and for transmitting a signal corresponding to the physiological signal to a receiving unit 44; fig. 10, col. 17, line 63 – col 18, line 8, computer or microprocessor 64).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hart, by adding a wearable sensor patch, the sensor patch comprising: a number of EMG signal electrodes, an EMG reference electrode, and a controller, the controller comprising power supply and processing means, wherein the sensor patch is structured to be affixed to a torso of a patient, wherein the sensor patch is configured to be in electrical communication with the power supply and processing means, as taught by Tarler, for the purpose of making the EMG sensor lightweight, compact and reusable (abstract).
Re Claim 3, Hart as modified by Tarler discloses the claimed invention substantially as set forth in claim 1.
Hart discloses that the sensor is structured such that, when the sensor is affixed to the upper torso of the patient, the number of signal electrodes are positioned on the second intercostal space of the patient and the reference electrode is positioned on the sternum of the patient above the reference electrodes (fig. 1, para. [0071], surface electrodes placed over the parasternal muscles of the second intercostal space along with a reference electrode over the electrically neutral clavicle)
Hart is silent regarding the sensor being a sensor patch.
Tarler disclose the wearable sensor patch comprises a number of EMG signal electrodes and an EMG reference electrode (fig. 1, fig. 3, col. 15, lines 18-46, the base 12 comprises at least two electrodes 14 for placing on a subject’s skin and for sensing a physiological signal from the subject. The electrode patch 10 in fig. 1 consists of four electrodes 14 – with one of those electrodes being used as a reference electrode 15).
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The wearable sensor patch in fig. 1 is structured such that reference electrode 15 is positioned on the sternum of the patient above the signal electrodes 14 when the sensor patch is affixed to the upper torso of the patient.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hart as modified by Tarler, by configuring the structure of the sensor patch such that when the sensor patch is affixed to the upper torso of the patient, the number of signal electrodes are positioned on the second intercostal space of the patient and the reference electrode is positioned on the sternum of the patient above the reference electrodes, as taught by Hart and Tarler, for the purpose of obtaining a measure of the second intercostal space parasternal electromyogram to measure neural respiratory drive (Hart, para. [0019]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hart (US 2013/0310699A1) as modified by Tarler (US 7206630 B1) and further in view of Toth (US 20150335288 A1).
Re Claim 2, Hart as modified by Tarler discloses the claimed invention substantially as set forth in claim 1.
Hart further discloses a number of non-EMG sensors, wherein the number of non-EMG sensors comprises at least one of: an accelerometer, a SpO2 sensor, or a core temperature sensor (para. [0185], oxygen saturations and temperature are measured).
Hart and Tarler are silent regarding the sensor patch further comprising: a number of non-EMG sensors, wherein the number of non-EMG sensors comprises at least one of: an accelerometer, a SpO2 sensor, or a core temperature sensor.
Toth discloses a wearable sensor patch comprising a number of EMG signal electrodes (para. [0063], EMG device; para. [0406], [0517], a macro-electrode useful for providing a reference electrode to the microelectrodes, an electrode for measuring an ECG, EMG, ERG, signal, etc.) and a number of non-EMG sensors, wherein the number of non-EMG sensors comprises at least one of: an accelerometer, a SpO2 sensor, or a core temperature sensor (fig. 6, para. [0042], a temperature sensor, an accelerometer, and an oximeter).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hart as modified by Tarler, by configuring the sensor patch to further comprise a number of non-EMG sensors, wherein the number of non-EMG sensors comprises at least one of: an accelerometer, a SpO2 sensor, or a core temperature sensor, as taught by Toth, for the purpose of making sensor unit portable, lightweight and compact and performing continuous monitoring of the vital signs or activity of the subject (para. [0161]).
Claims 5, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hart (US 2013/0310699A1) in view of Tarler (US 7206630 B1) and Annoni (US20190167176A1).
Re Claim 5, Hart discloses a patient monitoring system for monitoring a health status of a patient, the monitoring system comprising:
a plurality of sensors, the plurality of sensors comprising:
a number of EMG signal electrodes (para. [0113], The device 10 receives a signal at the signal input 20 that has been measured from the parasternal electromyogram (EMG));
an EMG reference electrode (para. [0071], claim 18, reference electrode); and
a controller in electrical communication with the sensors (para. [0165], a processor, fig. 3, a processing unit 30); and
a user interface in electrical communication with the controller (para. [0158], fig. 9 is a screen shot of a possible user interface);
wherein the sensors are structured to be affixed to the torso of the patient, wherein the sensors are structured to non-invasively sense respiratory muscle activity signals (para. [0112], At the end of recording, the patient is asked to perform repeated maximum sniff manoeuvres in order to allow the signal to be normalised for an individual patient maximum effort (EMGpara%max); para. [0021], [0120]-[0122], The neural respiratory drive is represented by the quantity EMGpara%max. This is derived by expressing the mean(EMGparapeak) as a percentage of the EMGparamax. Equation (1)) and to sense at least one additional physiological signal other than respiratory muscle activity (para. [0067], The signals from these electrodes are processed to obtain and display heart rate), and to monitor a plurality of metrics based on the sensed respiratory muscle activity signals and at least one additional physiological signal (para. [0067], display heart rate, respiratory rate, EMGpara signals, para. [0192], table 1, MEWS = medical early warning score, para. [0196], Table 2, HR, para. [0199], Table 3, para. [0203], Table 4, Borg score, NRDI, FEV1),
wherein the controller is configured to determine whether or not the patient is in a resting state based on the plurality of metrics (Hart, para. [0148], para. [0153], The quality of a resting segment is considered ‘GOOD’ if the EMGpara signal is easily distinguishable from noise; para. [0157], Once ‘GOOD’ quality sniff data have been acquired, the operator can proceed with monitoring of resting traces and receive the additional feedback on NRD, NRDI, NRDTP and NRDTI for the last recorded 30 s),
wherein the controller is configured to calculate a neural respiratory drive index based on the sensed respiratory muscle activity signals (para. [0112], At the end of recording, the patient is asked to perform repeated maximum sniff manoeuvres in order to allow the signal to be normalised for an individual patient maximum effort (EMGpara%max); para. [0021], [0120]-[0122], The neural respiratory drive is represented by the quantity EMGpara%max. This is derived by expressing the mean(EMGparapeak) as a percentage of the EMGparamax. Equation (1)), and to automatically and non-invasively sense at least one additional physiological signal other than respiratory muscle activity (para. [0067], The signals from these electrodes are processed to obtain and display heart rate),
wherein the controller is configured to produce a number of health metric scores indicative of a health status of the patient based on the plurality of metrics (para. [0192], table 1, MEWS = medical early warning score, para. [0196], Table 2, para. [0199], Table 3, para. [0203], Table 4, Borg score, NRDI, FEV1),
wherein the user interface is configured to display the number of health metric scores (para. [0066], display the measured/determined neural respiratory drive values in real time; para. [0067], display heart rate, respiratory rate, NRD, NRDI, NRDTP, and NRDTI; para. [0074], Once the system has detected and analysed the maximum manoeuvres the patient undergoes a period of testing that comprises of relaxed breathing at which time continuous measures of HR, RR and NRD, NRDI, and optionally NRDTP and NRDTI are displayed; para. [0093], real time display of important clinical parameters, para. [0094], data log for trend display of changes in parameters).
Hart is silent regarding a wearable sensor patch, the sensor patch comprising: a number of EMG signal electrodes; an EMG reference electrode; and an accelerometer.
However, Tarler discloses a wireless electrode patch for measuring EMG (page 5, lines 33-50, EMG) and teaches that the wearable sensor patch comprises a number of EMG signal electrodes and an EMG reference electrode (fig. 1, fig. 3, col. 15, lines 18-46, the base 12 comprises at least two electrodes 14 for placing on a subject’s skin and for sensing a physiological signal from the subject. The electrode patch 10 in fig. 1 consists of four electrodes 14 – with one of those electrodes being used as a reference electrode 15). Tarler discloses that the sensor patch is structured to be affixed to a torso of a patient (fig. 9, col. 19, lines 34-41, the subject 40 has an electrode patch 10 placed upon his or her chest 42). Tarler discloses that the sensor patch is configured to be in electrical communication with a power supply and processing means and the sensor patch further comprising: a controller, the controller comprising the power supply and processing means (col. 17, lines 34-62, The electrode patch 10 further comprises one or more electronic components including a battery 32. The electronic components for receiving a physiological signal from the electrodes placed on the subject and for transmitting a signal corresponding to the physiological signal to a receiving unit 44; fig. 10, col. 17, line 63 – col 18, line 8, computer or microprocessor 64).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hart, by adding a wearable sensor patch, the sensor patch comprising: a number of EMG signal electrodes, an EMG reference electrode, wherein the sensor patch is structured to be affixed to a torso of a patient, wherein the sensor patch is configured to be in electrical communication with the power supply and processing means, as taught by Tarler, for the purpose of making the EMG sensor lightweight, compact and reusable (abstract).
Hart and Tarler are silent regarding the wearable sensor patch comprising: an accelerometer.
Hart is silent regarding the controller is configured to determine whether or not the patient is asleep based on data sensed by the accelerometer and on the plurality of metrics.
Annoni discloses a wearable sensor patch comprising an accelerometer (para. [0112], a wearable monitor as chest patch; the wearable monitor including respiration rate (e.g., measured with accelerometers, gyroscopes, photoplethysmography (PPG) sensors, and/or impedance sensors, activity levels, and sleep quality.)) and discloses whether or not the patient is in a resting state and whether or not the patient is asleep based on data sensed by the accelerometer and on the plurality of metrics (para. [0017], one or more of an activity sensor configured to sense an activity level of the patient or a sleep sensor configured to sense whether the patient is sleeping; para. [0097], The processing control signal can include a signal indicative of a physical state of the patient, such as a signal indicating an activity level of the patient (e.g., sensed from the patient using an activity sensor) or a signal indicating whether the patient is sleeping (e.g., sensed from the patient using a sleep sensor). For example, the activity or sleep sensor may trigger sampling for heart rate, respiration rate, and lung sounds and processing of these signals only when the patient is sleeping or at rest.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hart as modified by Tarler, by configuring the wearable sensor patch to comprise an accelerometer and configuring the controller to determine whether or not the patient is in a resting state and whether or not the patient is asleep based on data sensed by the accelerometer and on the plurality of metrics, as taught by Annoni, for the purpose of determining the activity level and sleep state of the patient to monitor respiration during sleep or at rest (para. [0097]).
Re Claim 6, Hart as modified by Tarler and Annoni discloses the claimed invention substantially as set forth in claim 5.
Hart discloses that the sensor is structured such that, when the sensor is affixed to the upper torso of the patient, the number of signal electrodes are positioned on the second intercostal space of the patient and the reference electrode is positioned on the sternum of the patient above the reference electrodes (fig. 1, para. [0071], surface electrodes placed over the parasternal muscles of the second intercostal space along with a reference electrode over the electrically neutral clavicle)
Hart is silent regarding the sensor being a sensor patch.
Tarler disclose the wearable sensor patch comprises a number of EMG signal electrodes and an EMG reference electrode (fig. 1, fig. 3, col. 15, lines 18-46, the base 12 comprises at least two electrodes 14 for placing on a subject’s skin and for sensing a physiological signal from the subject. The electrode patch 10 in fig. 1 consists of four electrodes 14 – with one of those electrodes being used as a reference electrode 15).
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The wearable sensor patch in fig. 1 is structured such that reference electrode 15 is positioned on the sternum of the patient above the signal electrodes 14 when the sensor patch is affixed to the upper torso of the patient.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hart as modified by Tarler and Annoni, by configuring the structure of the sensor patch such that when the sensor patch is affixed to the upper torso of the patient, the number of signal electrodes are positioned on the second intercostal space of the patient and the reference electrode is positioned on the sternum of the patient above the reference electrodes, as taught by Hart and Tarler, for the purpose of obtaining a measure of the second intercostal space parasternal electromyogram to measure neural respiratory drive (Hart, para. [0019]).
Re Claim 8, Hart discloses that the controller is configured to calculate the neural respiratory drive index only if the controller has determined that the patient is at rest (para. [0153], The quality of a resting segment is considered ‘GOOD’ if the EMGpara signal is easily distinguishable from noise; para. [0157], Once ‘GOOD’ quality sniff data have been acquired, the operator can proceed with monitoring of resting traces and receive the additional feedback on NRD, NRDI, NRDTP and NRDTI for the last recorded 30 s).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hart (US 2013/0310699A1) as modified by Tarler (US 7206630 B1) and Annoni (US20190167176A1), and further in view of Toth (US 20150335288 A1).
Re Claim 7, Hart as modified by Tarler and Annoni discloses the claimed invention substantially as set forth in claim 5.
Hart further discloses at least one of: a SpO2 sensor or a core temperature sensor (para. [0185], oxygen saturations and temperature are measured).
Hart and Tarler are silent regarding the sensor patch further comprising: at least one of: a SpO2 sensor or a core temperature sensor.
Toth discloses a wearable sensor patch comprising a number of EMG signal electrodes (para. [0063], EMG device; para. [0406], [0517], a macro-electrode useful for providing a reference electrode to the microelectrodes, an electrode for measuring an ECG, EMG, ERG, signal, etc.) and at least one of: a SpO2 sensor or a core temperature sensor (fig. 6, para. [0042], a temperature sensor and an oximeter).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hart as modified by Tarler, by configuring the sensor patch to further comprise at least one of: a SpO2 sensor or a core temperature sensor, as taught by Toth, for the purpose of making sensor unit portable, lightweight and compact and performing continuous monitoring of the vital signs of the subject (para. [0161]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hart (US 2013/0310699A1) in view of Tarler (US 7206630 B1) and Toth (US 20150335288 A1).
Re Claim 11, Hart discloses a method for monitoring a health status of a patient, the method comprising:
positioning a plurality of sensors comprising a number of EMG electrodes on the torso of the patient (para. [0113], The device 10 receives a signal at the signal input 20 that has been measured from the parasternal electromyogram (EMG); para. [0071], claim 18, reference electrode; para. [0071], surface electrodes placed over the parasternal muscles of the second intercostal space along with a reference electrode over the electrically neutral clavicle), the sensors being in electrical communication with a controller (para. [0165], a processor, fig. 3, a processing unit 30);
setting the controller to operate in a selected mode of operation, the selected mode of operation comprising either a trigger mode (para. [0153], The quality of a resting segment is considered ‘GOOD’ if the EMGpara signal is easily distinguishable from noise) or a continuous mode (para. [0154], As signal quality is updated every 5 s, one can expect samples with no respiration activity, therefore flagged as ‘BAD’, during a continuous acquisition.);
sensing respiratory muscle activity signals (para. [0112], At the end of recording, the patient is asked to perform repeated maximum sniff manoeuvres in order to allow the signal to be normalised for an individual patient maximum effort (EMGpara%max); para. [0021], [0120]-[0122], The neural respiratory drive is represented by the quantity EMGpara%max. This is derived by expressing the mean(EMGparapeak) as a percentage of the EMGparamax. Equation (1)) and at least one other physiological signal with the sensors (para. [0067], The signals from these electrodes are processed to obtain and display heart rate);
calculating a neural respiratory drive index based on the sensed respiratory muscle activity signals with a controller (para. [0112], At the end of recording, the patient is asked to perform repeated maximum sniff manoeuvres in order to allow the signal to be normalised for an individual patient maximum effort (EMGpara%max); para. [0021], [0120]-[0122], The neural respiratory drive is represented by the quantity EMGpara%max. This is derived by expressing the mean(EMGparapeak) as a percentage of the EMGparamax. Equation (1));
determining a number of health metric scores based on the neural respiratory drive index and the at least one other physiological signal with the controller (para. [0192], table 1, MEWS = medical early warning score, para. [0196], Table 2, para. [0199], Table 3, para. [0203], Table 4, Borg score, NRDI, FEV1); and
displaying the number of health metric scores on a user interface in electrical communication with the controller (para. [0066], display the measured/determined neural respiratory drive values in real time; para. [0067], display heart rate, respiratory rate, NRD, NRDI, NRDTP, and NRDTI; para. [0074], Once the system has detected and analysed the maximum manoeuvres the patient undergoes a period of testing that comprises of relaxed breathing at which time continuous measures of HR, RR and NRD, NRDI, and optionally NRDTP and NRDTI are displayed; para. [0093], real time display of important clinical parameters, para. [0094], data log for trend display of changes in parameters),
wherein the controller is configured to calculate the neural respiratory drive index as either a relative index based on both sniff and regular breathing activity (para. [0155], Once the operator (for example, nurse, doctor, technician) is satisfied that the data are ‘GOOD’ quality, the patient will be asked to perform a ‘sniff manoeuver’, and 10 s to 20 s of ‘sniff manoeuver’ data should be collected pressing the ‘START SNIFF’ button in the ‘Sniff’ sub-panel (FIG. 2-(d); button not shown in figure)), and calculate a relative index based on respiratory muscle activity signals sensed during the regular breathing and sniff tasks (para. [0157], Once ‘GOOD’ quality sniff data have been acquired, the operator can proceed with monitoring of resting traces and receive the additional feedback on NRD, NRDI, NRDTP and NRDTI for the last recorded 30 s; para. [0119]-[0122], NRDI calculation) or as an absolute index based only on regular breathing activity.
Hart is silent regarding a sensor patch comprising a number of EMG electrodes and a number of non-EMG sensors including an accelerometer
However, Tarler discloses a wireless electrode patch for measuring EMG (page 5, lines 33-50, EMG) and teaches that the wearable sensor patch comprises a number of EMG signal electrodes and an EMG reference electrode (fig. 1, fig. 3, col. 15, lines 18-46, the base 12 comprises at least two electrodes 14 for placing on a subject’s skin and for sensing a physiological signal from the subject. The electrode patch 10 in fig. 1 consists of four electrodes 14 – with one of those electrodes being used as a reference electrode 15). Tarler discloses that the sensor patch is structured to be affixed to a torso of a patient (fig. 9, col. 19, lines 34-41, the subject 40 has an electrode patch 10 placed upon his or her chest 42). Tarler discloses that the sensor patch is configured to be in electrical communication with a power supply and processing means and the sensor patch further comprising: a controller, the controller comprising the power supply and processing means (col. 17, lines 34-62, The electrode patch 10 further comprises one or more electronic components including a battery 32. The electronic components for receiving a physiological signal from the electrodes placed on the subject and for transmitting a signal corresponding to the physiological signal to a receiving unit 44; fig. 10, col. 17, line 63 – col 18, line 8, computer or microprocessor 64).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hart, by adding a wearable sensor patch, the sensor patch comprising: a number of EMG signal electrodes, an EMG reference electrode, wherein the sensor patch is structured to be affixed to a torso of a patient, wherein the sensor patch is configured to be in electrical communication with the power supply and processing means, as taught by Tarler, for the purpose of making the EMG sensor lightweight, compact and reusable (abstract).
Hart and Tarler are silent regarding the wearable sensor patch comprising: a number of non-EMG sensors including an accelerometer.
Toth discloses a wearable sensor patch comprising a number of EMG signal electrodes (para. [0063], EMG device; para. [0406], [0517], a macro-electrode useful for providing a reference electrode to the microelectrodes, an electrode for measuring an ECG, EMG, ERG, signal, etc.) and a number of non-EMG sensors, wherein the number of non-EMG sensors comprises: an accelerometer, a SpO2 sensor, and a core temperature sensor (fig. 6, para. [0042], a temperature sensor, an accelerometer, and an oximeter).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hart as modified by Tarler, by configuring the sensor patch to further comprise a number of non-EMG sensors including an accelerometer, as taught by Toth, for the purpose of making sensor unit portable, lightweight and compact and performing continuous monitoring of the vital signs or activity of the subject (para. [0161]).
Allowable Subject Matter
Claims 9, 10, 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.
Claims 12, 13, 14, and 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
Regarding Claim 9, the closest prior art is Hart (US 2013/0310699A1), which discloses wherein the controller is configured to be selectively operated in a trigger mode, wherein, if the trigger mode has been initiated and any of a number of predetermined trigger conditions are met (para. [0148], para. [0153], The quality of a resting segment is considered ‘GOOD’ if the EMGpara signal is easily distinguishable from noise), the controller is configured to: prompt the patient through the user interface to perform both regular breathing and sniff tasks if the controller has determined that the patient is both resting and awake (para. [0155], Once the operator (for example, nurse, doctor, technician) is satisfied that the data are ‘GOOD’ quality, the patient will be asked to perform a ‘sniff manoeuver’, and 10 s to 20 s of ‘sniff manoeuver’ data should be collected pressing the ‘START SNIFF’ button in the ‘Sniff’ sub-panel (FIG. 2-(d); button not shown in figure)), and calculate a relative index based on respiratory muscle activity signals sensed during the regular breathing and sniff tasks (para. [0157], Once ‘GOOD’ quality sniff data have been acquired, the operator can proceed with monitoring of resting traces and receive the additional feedback on NRD, NRDI, NRDTP and NRDTI for the last recorded 30 s).
Hart is silent regarding wherein the controller is configured such that, if any of the number of predetermined trigger conditions are met and the controller has determined that the patient is asleep, the controller will wait until the patient is determined to be awake and resting and then prompt the patient through the user interface to perform both regular breathing and sniff tasks in order to calculate the relative index, and wherein the controller is configured such that, if any of the number of predetermined trigger conditions are met and the controller has determined that the patient is not resting, the controller will delay calculation of the neural respiratory drive index until the patient is determined to be resting.
Regarding Claim 12, the closest prior art is Hart (US 2013/0310699A1), which discloses initiating the trigger mode if the initial determination is that a patient can perform a sniff task on command (para. [0155], Once the operator (for example, nurse, doctor, technician) is satisfied that the data are ‘GOOD’ quality, the patient will be asked to perform a ‘sniff manoeuver’, and 10 s to 20 s of ‘sniff manoeuver’ data should be collected pressing the ‘START SNIFF’ button in the ‘Sniff’ sub-panel (FIG. 2-(d); button not shown in figure)); calculating the relative index in the trigger mode (para. [0157], Once ‘GOOD’ quality sniff data have been acquired, the operator can proceed with monitoring of resting traces and receive the additional feedback on NRD, NRDI, NRDTP and NRDTI for the last recorded 30 s), provided that a number of predetermined trigger conditions is met, that the patient is resting, and that the patient is awake (para. [0148], para. [0153], The quality of a resting segment is considered ‘GOOD’ if the EMGpara signal is easily distinguishable from noise; para. [0157], Once ‘GOOD’ quality sniff data have been acquired, the operator can proceed with monitoring of resting traces and receive the additional feedback on NRD, NRDI, NRDTP and NRDTI for the last recorded 30 s)
Hart is silent regarding wherein setting the controller to operate in the selected mode of operation comprises: making a determination based on the patient’s overall state about whether or not the patient can perform a sniff task on command; choosing to initiate a continuous mode if the initial determination is that a patient cannot perform a sniff task on command; and calculating the absolute index in the continuous mode at regular predetermined intervals, provided that the patient is resting.
Claim 9 and claims dependent thereon in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with other limitations of the claim, a patient monitoring system comprising wherein the controller is configured such that, if any of the number of predetermined trigger conditions are met and the controller has determined that the patient is asleep, the controller will wait until the patient is determined to be awake and resting and then prompt the patient through the user interface to perform both regular breathing and sniff tasks in order to calculate the relative index, and wherein the controller is configured such that, if any of the number of predetermined trigger conditions are met and the controller has determined that the patient is not resting, the controller will delay calculation of the neural respiratory drive index until the patient is determined to be resting.
Claim 12 and claims dependent thereon in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with other limitations of the claim, a method for monitoring a health status of a patient, the method comprising: wherein setting the controller to operate in the selected mode of operation comprises: making a determination based on the patient’s overall state about whether or not the patient can perform a sniff task on command; choosing to initiate a continuous mode if the initial determination is that a patient cannot perform a sniff task on command; and calculating the absolute index in the continuous mode at regular predetermined intervals, provided that the patient is resting.
Conclusion
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, March 14, 2026Examiner, Art Unit 3792