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 .
Response to Amendment
The amendments made to claims 10-13, 15, 16, and 20-22 and the cancellation of claims 24 and 25 in the response filed 4/21/26 are acknowledged.
Claims 10-23 are now pending in the application and are examined below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New references Reykhert, Lee, and Hu have been provided to teach the newly added limitations.
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.
Claim(s) 10, 11, 13, 17, 18, 21, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badinski et al. US 2015/0220109 A1 in view of Reykhert US 10,878,959 B1 further in view of Lee et al. US 2018/0359112 A1 and Hu et al. US 2006/0211936 A1.
Regarding claim 10, von Badinski discloses a wearable sensor arrangement 100 for monitoring sleep health configured to be worn around a body part of a wearer (fig. 1A and [0159]-[0160], [0162], WCD 110 is a fitness, physical activity, and biological data monitoring device with sensor modules 220; [0169], WCD 110 can monitor sleep quality; [0155], the WCD can be in the form of a wrist band), comprising:
a first layer having an inner surface configured to contact the wearer’s skin, the first layer having an opening (fig. 1B and [0160], the WCD 110 has an interior wall with an interior window 130, and the WCD 110 makes constant contact with skin);
a second layer spaced away from the first layer and having an outer surface configured to face away from the wearer’s skin (fig. 1A and [0160], the WCD 110 has an exterior wall, and the exterior surface having window 120 is considered the outer surface that would face away from the skin when worn; fig. 4 and [0187], [0189], WCD 410 (“e.g., WCD 110”, indicating that WCD 110 and 410 are equivalent) receives flexible circuit 415 between its inner and outer walls such that elements of the circuit 415 align with the windows; thus, the inner and outer walls are spaced from each other);
circuitry 415 including a plurality of sensors configured to sense physiological parameters of the wearer (fig. 2 and [0187], circuit 415 may take the form of a printed flexible circuit and may include modules 210-270, which include sensor module 220; [0167], sensor modules 220 can include those related to biological sign monitoring), the plurality of sensors 220 including at least a first sensor 320a-d aligned with and exposed to the opening 130 for direct contact with the wearer’s skin (fig. 3B and [0167], sensors 320a-d are positioned in a way that faces the interior window 130, and they can be seen exposed to the opening 130 in the figure; thus, they would be capable of having direct contact with the wearer’s skin, depending on how tightly the device is worn and how much the skin of the user extends into the window ), wherein the circuitry 415, as seen in cross section, is provided between the first and second layers (fig. 4 and [0189], WCD 410 receives flexible circuit 415 between its inner and outer walls, as the circuit 415 is inserted through the edge), wherein the plurality of sensors 220 includes a movement sensor including an accelerometer and a gyroscope to generate a movement signal indicative of bodily movement of the patient ([0167], the sensors 220 can include accelerometers and gyroscopes, which would be capable of generating the claimed signals), and a temperature sensor 320a configured to generate a temperature signal indicative of the skin temperature of the wearer ([0167], temperature sensor 320a), and the movement sensor being embedded between the first and second layers and not being aligned with or exposed to the opening ([0167], the sensors directly related to biological sign monitoring can be positioned close to the skin facing the interior window 130, and the device can further include sensor modules such as accelerometers and gyroscopes that are not directly related to biological sign monitoring; thus, it is understood that the accelerometers and gyroscopes would not be positioned at the window but rather internally between the first and second layers of the device);
a rechargeable battery to power the plurality of sensors 220 ([0162], battery 280 provides power for the WCD 110, which includes its sensors 220; [0160], the exterior window 120 allows for battery recharge);
a processor 210 configured to monitor the wearer’s sleep ([0172], processor module 210 determines the frequency of operation of the sensors, for example based on the determination that the user is sleeping based on the heart rate, temperature, and movements).
Von Badinski silent on photoplethysmography (PPG) sensors to generate PPG signals indicative of heart rate and blood oxygen saturation level of the wearer, the at least first sensor comprising the PPG sensors.
However, Reykhert teaches an analogous wearable electronic device 100 for biometric sensing (fig. 1 and col. 3, lines 31-36) comprising photoplethysmography (PPG) sensors 618 to generate PPG signals indicative of heart rate and blood oxygen saturation level of the wearer, the at least first sensor comprising the PPG sensors 618 (col. 8, lines 42-59, the electronic device 610 for monitoring the health of the user can include one or more sensors 618 including a PPG sensor, and can generate physiological data including blood oxygen saturation and heartrate; therefore, of the plurality of sensors, a smaller plurality can be considered the “at least first sensor” that comprises the PPG sensors).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the plurality of sensors of von Badinski to comprise photoplethysmography (PPG) sensors to generate PPG signals indicative of heart rate and blood oxygen saturation level of the wearer, the at least first sensor comprising the PPG sensors, as taught by Reykhert, as blood oxygen saturation and heartrate are important metrics to determine the health of an individual.
Von Badinski in view of Reykhert is silent on a processor configured to generate consolidated time series data based on output of the movement sensor, the PPG sensors and the temperature sensor, wherein the processor is configured to provide an indication of the wearer’s sleep stages, including REM sleep, by evaluating output of at least the heart rate indicated by the PPG sensors and the movement sensor, wherein the circuitry includes a transceiver configured to wirelessly transmit a sleep quality signal of the wearer to an external computing device, the sleep quality signal being based in part on the generated time series data relate to the movement signal, the PPG signals and the temperature signal, the transceiver being configured to wirelessly receive data from the external computing device.
However, Lee teaches an analogous health monitoring sensing system 100 (fig. 1 and [0031], [0034]) comprising a processor 154 configured to generate consolidated time series data based on output of the movement sensor, an analogous heart rate sensor, and the temperature sensor, wherein the processor 154 is configured to provide an indication of the wearer’s sleep stages, including REM sleep, by evaluating output of at least the heart rate indicated by the analogous heart rate sensors and the movement sensor ([0135], the processor 154 analyzes a current sleep state of the user based on biometric information (described in [0031] to include biometric information from a temperature sensor, heart rate sensor, and acceleration sensor), and [0137], further generates a sleep pattern based on the information collected; a sleep pattern must inherently extend over a period of time; fig. 14 and [0069], the control device 150, which includes processor 154, analyzes a sleep state of the user including a REM state), wherein the circuitry includes a transceiver 153 configured to wirelessly transmit a sleep quality signal of the wearer to an external computing device ([0131], a transceiver 153 transmits signals generated by the control device 150 to an external server and home device; [0133], the transceiver 153 may transmit sleep quality analyzed by the control device 150 to a user terminal such as a smartphone), the sleep quality signal being based in part on the generated time series data relate to the movement signal, the PPG signals and the temperature signal (the processor utilizing biometric information from the temperature sensor, heart rate sensor, and acceleration sensor, as previously discussed), the transceiver 153 being configured to wirelessly receive data from the external computing device ([0131], the transceiver 153 may exchange data with the outside using wireless networks).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the processor of von Badinski in view of Reykhert to be configured to generate consolidated time series data based on output of the movement sensor, the PPG sensors and the temperature sensor, wherein the processor is configured to provide an indication of the wearer’s sleep stages, including REM sleep, by evaluating output of at least the heart rate indicated by the PPG sensors and the movement sensor, wherein the circuitry includes a transceiver configured to wirelessly transmit a sleep quality signal of the wearer to an external computing device, the sleep quality signal being based in part on the generated time series data relate to the movement signal, the PPG signals and the temperature signal, the transceiver being configured to wirelessly receive data from the external computing device, as taught by Lee, to enable the user to be aware of their sleep health.
Von Badinski in view of Reykhert further in view of Lee is silent on a layer to protect the circuitry from ingress of moisture.
However, Hu teaches a biomonitor 1 (fig. 1 and [0001]) comprising a layer 17 to protect the circuitry from ingress of moisture (fig. 1 and [0025], package 17 covers the circuit layers to protect the biomonitor from moisture).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the circuitry of von Badinski in view of Reykhert further in view of Lee with a layer to protect the circuitry from ingress of moisture, as taught by Hu, to protect the components from moisture and dust pollution.
Regarding claim 11, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
Von Badinski further discloses the first layer, the second layer and the circuitry 415 forming a ring-shaped member configured to be worn by the wearer (fig. 4 shows the ring shaped nature of the layers and circuitry; [0155], the WCD can be in the form of a wrist band).
Regarding claim 13, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
Hu further teaches the electronic components of an analogous biomonitoring device being combined in a single package (figs. 1 and 2 and [0025]); thus, in combination, von Badinski and Hu teach the accelerometer and gyroscope, which are part of the overall device of von Badinski, being combined in a single package), in order to prevent parts from separating.
Regarding claim 17, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
Von Badinski further discloses the circuitry 415 comprising an actuator to provide a sensory stimulus to the wearer ([0183], the WCD can include polymer or piezo actuators to provide haptic or physical feedback, or audible feedback).
Regarding claim 18, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
Von Badinski further discloses the actuator being configured to generate vibration, noise or tactile stimulus to the wearer ([0183], the WCD can include polymer or piezo actuators to provide haptic or physical feedback, or audible feedback).
Regarding claim 21, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
Lee further teaches the external computing device comprising a smartphone ([0133]) configured to receive recommendations for improving the wearer’s sleep quality (a smartphone would be capable of receiving the claimed recommendations, for example, via text), to provide the user with convenient access to health monitoring.
Regarding claim 23, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
Von Badinski further discloses the outer surface including an opening 120 to align with one component 350 of the circuitry 415 (fig. 3A and [0173], antenna/communication module 350 is aligned with exterior window 120), the opening 120 in the outer surface being offset from and not aligned with the opening 130 in the inner surface (since the windows 120 and 130 are on the outer and inner walls, respectively, the can be considered offset from and not aligned with each other, as they are not on the same wall).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badinski et al. US 2015/0220109 A1 in view of Reykhert US 10,878,959 B1 further in view of Lee et al. US 2018/0359112 A1, Hu et al. US 2006/0211936 A1, and Weast et al. US 9,011,292 B2.
Regarding claim 12, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
von Badinski in view of Reykhert further in view of Lee and Hu is silent on the ring-shaped member comprising headgear.
However, Weast teaches a ring-shaped member 10 (figs. 1 and 2 and col. 2, lines 18-21, wearable device for monitoring the wearer) for wearing around the wrist that can also be worn as headgear (col. 7, lines 57-61).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the scale of the ring-shaped member of von Badinski in view of Reykhert further in view of Lee and Hu to allow it to be worn as headgear, as taught by Weast, as some users may find headgear more comfortable the a wristband.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badinski et al. US 2015/0220109 A1 in view of Reykhert US 10,878,959 B1 further in view of Lee et al. US 2018/0359112 A1, Hu et al. US 2006/0211936 A1, and Patel et al. US 11,751,790 B1.
Regarding claim 14, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
von Badinski in view of Reykhert further in view of Lee and Hu is silent on the circuitry including a ground electrode and a reference electrode.
However, Patel teaches an analogous device 150 for measuring physiological signals (fig. 1 and col. 2, lines 57-61), the circuitry 300 including a ground electrode 306 and a reference electrode 304 (col. 5, line 63-col. 6, line 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circuitry of von Badinski in view of Reykhert further in view of Lee and Hu to include a ground electrode and a reference electrode, as taught by Patel, to measure physiological signals (col. 5, lines 63-64).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badinski et al. US 2015/0220109 A1 in view of Reykhert US 10,878,959 B1 further in view of Lee et al. US 2018/0359112 A1, Hu et al. US 2006/0211936 A1, and Lee et al. US 2021/0186420 A1 (“Lee ‘420”).
Regarding claim 15, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
von Badinski in view of Reykhert further in view of Lee and Hu is silent on the processor being configured to provide an indication of when the wearer has experienced an apnea event during sleep by evaluating output of at least the movement sensor combined with the PPG sensor.
However, Lee ‘420 teaches a wearable biometric detecting device ([0002]), wherein the processor 510 is configured to provide an indication of when the wearer has experienced an apnea event during sleep by evaluating output of at least the movement sensor combined with the PPG sensor ([0102], the processor 510 may perform processing to obtain biometric signals, and [0104], the acceleration, PPG, and SpO2 can be measured with the ECG signal to measure sleep apnea).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the processor of von Badinski in view of Reykhert further in view of Lee and Hu is silent to be configured to provide an indication of when the wearer has experienced an apnea event during sleep by evaluating output of at least the movement sensor combined with the PPG sensor, as taught by Lee ‘420, to enable the user to review their apnea history.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badinski et al. US 2015/0220109 A1 in view of Reykhert US 10,878,959 B1 further in view of Lee et al. US 2018/0359112 A1, Hu et al. US 2006/0211936 A1, and Benouali et al. US 2019/0038512 A1.
Regarding claim 16, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
von Badinski in view of Reykhert further in view of Lee and Hu is silent on a bus and a retainer to receive at least one of the plurality of sensors for electrical communication with the bus, the retainer being affixed to the first layer.
However, Benouali teaches a dispensing system (fig. 2 and [0005]) comprising a bus and a retainer to receive at least one of the plurality of sensors for electrical communication with the bus, the retainer being affixed to the first layer ([0066], the sensor network comprises frangible containers (i.e., the sensors) arranged on a retainer sheet (i.e., the retainer) of a dispenser shell (i.e., the first layer), where each path from the frangible container is connected to a power bus and a ground bus).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the first layer of von Badinski in view of Reykhert further in view of Lee and Hu with a bus and a retainer to receive at least one of the plurality of sensors for electrical communication with the bus, the retainer being affixed to the first layer, as taught by Benouali, to provide power to all the sensors and connect them in a sensor network.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badinski et al. US 2015/0220109 A1 in view of Reykhert US 10,878,959 B1 further in view of Lee et al. US 2018/0359112 A1, Hu et al. US 2006/0211936 A1, and Mirov et al. US 2022/0015703 A1.
Regarding claim 19, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
von Badinski in view of Reykhert further in view of Lee and Hu is silent on the actuator being configured to generate white or pink noise, a binaural beat or localized temperature change to the wearer.
However, Mirov teaches an analogous sensing system for the body ([0003], sensing systems for processing physiological signals) comprising an analogous actuator configured to generate white or pink noise ([0062], module 818 may actuate the speaker 836 to provide audible cues including white noise to provide aural feedback to the wearer), a binaural beat or localized temperature change to the wearer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the actuator of von Badinski in view of Reykhert further in view of Lee and Hu to be configured to generate white or pink noise, a binaural beat or localized temperature change to the wearer, as taught by Mirov, as white noise is a well tolerated form of sound that can alert users without discomfort.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badinski et al. US 2015/0220109 A1 in view of Reykhert US 10,878,959 B1 further in view of Lee et al. US 2018/0359112 A1, Hu et al. US 2006/0211936 A1, and Stanfield et al. US 2016/0317383 A1.
Regarding claim 20, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
von Badinski in view of Reykhert further in view of Lee and Hu is silent on the processor configured to receive signals from the plurality of sensors and generate control signals to control the actuator.
However, Stanfield teaches an analogous wearable sensor system ([0030], wearable device to collect sensory related data) comprising a processor configured to receive signals from the plurality of sensors and generate control signals to control the actuator ([0030], the control center has a processor with a transceiver that receives sensory related data, and in response, it sends activating signals to actuate sensor devices to activate sensory events).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the circuitry of von Badinski in view of Reykhert further in view of Lee and Hu with a processor configured to receive signals from the plurality of sensors and generate control signals to control the actuator, as taught by Stanfield, to allow the state of the wearer to determine the necessary stimulation, providing greater accuracy and customization.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badinski et al. US 2015/0220109 A1 in view of Reykhert US 10,878,959 B1 further in view of Lee et al. US 2018/0359112 A1, Hu et al. US 2006/0211936 A1, and Young et al. US 2020/0107734 A1.
Regarding claim 22, von Badinski in view of Reykhert further in view of Lee and Hu discloses the claimed invention as discussed above.
von Badinski in view of Reykhert further in view of Lee and Hu is silent on a portion of the at least one first sensor and the inner surface surrounding the opening forming a flat surface, in cross section, that is configured, in use, to contact with the wearer’s skin.
However, Young teaches an analogous vital monitoring device 102 (figs. 1 and 2 and [0002]) comprising a portion of an analogous at least one first sensor 112-120 and the inner surface surrounding the opening 122 forming a flat surface, in cross section, that is configured, in use, to contact with the wearer’s skin (fig. 2 and [0040], sensor module 102 includes apertures 122 to support sensors 112-120, and the sensors may be flush with the surface 108 to contact the patient’s skin).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the at least one first sensor on the inner surface of von Badinski in view of Reykhert further in view of Lee and Hu such that a portion of the at least one first sensor and the inner surface surrounding the opening form a flat surface, in cross section, that is configured, in use, to contact with the wearer’s skin, as taught by Young, to provide a smooth inner surface so that the device is comfortable to wear on the skin while still allowing for monitoring.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ALIREZA NIA can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786
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