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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/05/2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 12/05/2025. As directed by the amendment: Claims 1, 9, 22, and 64 have been amended, claim 5 have been cancelled, and no claims have been added. Thus, claims 1-4, 6-7, 9-27, 30-37, 39-43, 54, and 64-70 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 14-23, filed 12/05/2025, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Applicants arguments and amendments obviate the rejection of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bhushan et al. (US 20170347894) (IDS 04/22/2021) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), and Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski) and Symons et al. (US 20080272889)(Hereinafter Symons).
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.
Claim 4-5, 23, and 27 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.
Regarding claim 4, it is unclear if the NFC of claim 4 is the same or different than the NFC of claim 1.
Claims 4-5, 23, and 27 contain the trademark/trade name Bluetooth and BLE. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe Bluetooth and BLE and, accordingly, the identification/description is indefinite.
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.
Claim(s) 1-4, 6-7, 15, 17-18, 20-21, 24-26, 30-31, 35-39, 43, 54, 64-65, and 67-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (IDS 04/22/2021) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), and Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Hirsch et al. (US 9866282)(Hereinafter Hirsch).
Regarding claim 1, Bhushan teaches An apparatus for measuring physiological parameters of a mammal subject, ([0076] “the Biostrip device affixed on the sternum, and measuring ECG, SCG, IPG; and another ring-shaped device worn on one of the fingers or toes of the user, measuring PPG on the finger/toe.” The network of sensors includes a PPG and ECG sensor. Additionally, a finger/toe and sternum are human body parts which is a mammal subject.), comprising:
a first sensor system and a second sensor system that are time-synchronized to each other, each of the first sensor system and the second sensor system ([0070] “where the user is wearing two Biostrips, one on the sternum, measuring ECG and SCG, and one on the wrist measuring PPG” [0074] “This is an episodic measurement of Blood Pressure, where the user holds the device in this manner for at least 30 seconds, and PTT is calculated by the delay between the R-peak on the ECG, and the foot/peak/50% mark of the PPG curve measured on the index finger.” PTT calculation requires time synchronization of the R wave with the peak of a PPG signal. [0076] “the Biostrip device affixed on the sternum, and measuring ECG, SCG, IPG; and another ring-shaped device worn on one of the fingers or toes of the user, measuring PPG on the finger/toe.” The ring-shaped device and affixed Biostrip are spatially separated sensor systems.) comprising:
a plurality of electronic components … wherein the plurality of electronic components comprises a sensor member for measuring at least one physiological parameter of the mammal subject ([0010] “to collect medical quality data from a plurality of sensors including, but not limited to Electromyography (“EMG”), Electrocardiography (“ECG” or “EKG”) [physiological parameters], Electroencephalography (“EEG”), EXG, respiration, Photoplethysmograph (“PPG”) temperature sensors, accelerometers and the like, and transmit the data to the required computing device after initial processing.”), a system on a chip (SoC) having a microprocessor coupled to the sensor member for receiving data from the sensor member and processing the received data ([0044] “The Biostrip contains a microprocessor or other processor to collect data from the multiple sensors, which implements a series of algorithms [processing] on the wearable device itself. The Biostrip also contains an integrated circuit [system on a chip] for wireless data communication that enables it to connect and communicate, and send to and receive data from, a smartphone/smartwatch or another gateway device such as a wifi router.”), and a transceiver coupled to the SoC for wireless data transmission and wireless power harvesting ([0009] “transmit the monitored data to a computing device such as a smartphone or a smartwatch or other gateway device trough wireless communication such as Bluetooth (a trademark of Bluetooth SIG, Inc.), ZigBee (a trademark of the Zigbee Alliance) or other Near-Field Communication (“NFC”) protocol” NFC is a type of power harvesting. The Examiner also notes Bhushan discloses a wireless charging coil, i.e. a power harvesting means, as well, see Claim 6), a battery for providing power to said sensor system ([0077] “The ring-shaped device mentioned in the above embodiment … and a battery to run all of the above.” And [0037] “The wearable device (hereon referred to as the “Biostrip” device) includes an electronic module or a component that is reusable and rechargeable (via micro-USB or wirelessly or both)” The biostrip must have a battery if it is rechargeable.);
wherein each of the first sensor system and the second sensor system is adapted to be attached to a respective position on the mammal subject so that the first sensor system and the second sensor system are spatially separated by a distance ([0076] “the Biostrip device affixed on the sternum, and measuring ECG, SCG, IPG; and another ring-shaped device worn on one of the fingers or toes of the user, measuring PPG on the finger/toe.” The ring-shaped device and affixed Biostrip are spatially separated sensor systems. There must be a distance between the ring and the sternum as they are two separate locations on the body.);
wherein the sensor member of the torso sensor system comprises at least two electrodes spatially separated from each other by an electrode distance D for electrocardiogram (ECG) generation ([0074] “the User holds the Biostrip in his hands, with the left index finger covering one electrode on the left, and the right index finger covering the right-most electrode and the central electrode”).
However, Bhushan fails to teach flexible, stretchable interconnects to connect the electronic components, and an elastomeric encapsulation layer with a tissue-facing surface for the skin. Baxi, in the same field of endeavor, teaches a flexible and stretchable patch with an outer substrate by obtaining ECG and PPG signals, and further teaches a plurality of flexible and stretchable interconnects electrically connecting to a plurality of electronic components including the sensor member, the SoC and the transceiver ([0035] “and/or the interconnect between the fabric 306 and the substrate 308.” See Fig. 3 with the zigzag interconnects that connects SoC (1210), transceiver (1218), and sensor member (330). ); and
an elastomeric encapsulation layer surrounding the electronic components and the plurality of flexible and stretchable interconnects to form a tissue-facing surface and an environment-facing surface (See Fig. 9(Substrate 308) and [0091] “the device of at least one of Examples 1-10 can include, wherein the substrate includes an elastomer material.” Fig. 9 shows the elastomer material as a later encapsulating the device as the property of an elastomer is flexible and stretchable. And [0093] “the device of at least one of Examples 1-12 can include an adhesive on the first metallization to help in attaching the device to skin of a user.” Fig. 13 visualizes the environment facing surface.);
a transceiver coupled to the SoC for wireless data transmission and wireless power harvesting, the transceiver including a … antenna tuned to compliance with an NFC protocol([0070] “For example, in an embodiment in which the wireless transmission circuitry 1216 and the antenna 1218 are configured for near field communication” See single link to the wireless (1216) in Fig. 12 to the antenna 1218. NFC is capable of sending and receiving both power and data.);
wherein the electrode distance D is adjustable between a minimal electrode distance Dmin and a maximal electrode distance Dmax wherein the minimal electrode distance Dmin represents a distance between the at least two electrodes when the torso sensor system is in a non-stretched state, and the maximal electrode distance Dmax represents a distance between the at least two electrodes when the torso sensor system is in a maximally stretched state ([0081] “a device includes a stretchable, flexible substrate material mechanically coupled to and on the stretchable, flexible fabric and first metallization mechanically coupled to and on the substrate material, the first metallization including first pads, meandering traces, and at least one of electrocardiogram (ECG) electrodes, a stretch sensor, and at least one stretch limiting patch.” Examiner notes that the flexibility an stretchability would allow the multiple electrodes of each of the patches to ben based on body placement, which are placed on the knees which can bend to alter the distance of the electrodes when the knee is bent versus when the knee is straight. Therefore, when the knee is bent and the patch is maximally stretched, the distance from the first and second electrode around the knee is maximal than when the patch is straight.) to increase the stretchability and/or flexibility of the patch ([0034]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the flexible and stretchable interconnects, elastomeric encapsulation, and tissue-facing surface of Baxi, because such a modification would allow to increase the stretchability and/or flexibility of the patch.
Bhushan does not teach a failure prevention element. Baxi, in the same field of endeavor, teaches a flexible and stretchable patch with an outer substrate by obtaining ECG and PPG signals, and further teaches a failure prevention element that is a short-circuit protection component or a battery circuit to avoid battery malfunction ([0069] “The power conditioning circuitry 1214 can include one or more voltage or current regulators, one or more voltage or current boosters, or other the like, to alter a voltage or current level provided by the battery 1212. For example, the different AFEs may operate at different voltage levels and may require different voltage or current rails for proper digitization of signals, the LED driver 1208 may operate at a different voltage or current level than the SOC 1210 or one or more of the AFEs, or the wireless transmission circuitry 1216 may operate at a different voltage or current level than other circuitry of the sensor node 330 or the sensors 324, 326, or 328.” Although there is no explicit use avoiding battery explosion, the power conditioning circuit [battery circuit] adjusts the voltage and current of the battery when needed and therefore avoids any battery explosion. Examiner notes that the phrase “avoid battery explosion” is the intended use of the battery circuit, which does not contain patentable weight.) to avoid battery explosion. It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the failure prevention element of Baxi, because such a modification would allow to avoid battery explosion. The nature of the problem to be solved may lead inventors to look at references relating to possible solutions to that problem. Id. at 1277, 69 USPQ2d at 1691. See MPEP 2143 (I)(C).
If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40,100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). See MPEP 2114(I). In the instant case, the phrase “avoid battery explosion” is the intended function of the battery circuit. Therefore, if the reference teaches a battery circuit, then the function of avoiding battery explosion would be attributed to the battery circuit.
Bhushan and Baxi do not teach the dynamic baseline control for compensating variability and generating an effective driving current. Lisogurski, in the same field of endeavor, teaches a physiological monitoring system with sensors like PPG ([0022]) and EKG ([0096]) to generate a signal with amplifiers (Abstract), similar to the device of Bhushan, and further teaches wherein at least one of the first sensor system and the second sensor system further comprises a dynamic baseline control module configured to automatically compensate for mammal subject-to- mammal subject variability and generate an effective driving current to ensure sufficient signal-to-noise and avoid saturation ([0017] “amplifier outputs a voltage based on the difference between a sensor current received from a photodetector, and an estimated current received from a digital-to-analog converter (DAC).” [0099] “An amount of gain and an offset applied by an amplifier in generating the difference signal may be adjusted based on the ADC, such that the utilization of the dynamic range of the ADC input is optimized [producing an effective driving current]. In some embodiments, a large gain may be applied so that small current changes in the sensor signal may produce measureable voltage changes at the ADC. In some embodiments, the amount of gain and/or offset may be adjusted based on the utilization of the dynamic range of the ADC is maintained at a particular level.” Examiner notes that the difference between sensor current from photodetector and DAC compensates for mammal-to mammal subject variability. Examiner notes that when the dynamic range is optimized, an optimized voltage and current is applied, which automatically ensures sufficient SNR and avoiding saturation.) to apply a larger gained input and resolution without high power and saturating the signal ([0083]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the dynamic baseline control for compensating variability and generating an effective driving current of Lisogurski, because such a modification would allow to apply a larger gained input and resolution without saturating the signal and requiring high power.
However, Bhushan, Lisogurski, Baxi do not teach the simultaneous transmission and power harvesting. Symons, in the same field of endeavor, teaches the connecting of devices with one another (Abstract and Fig. 6), and further teaches simultaneous wireless data transmission and wireless power harvesting through a single link ([0072] “FIG. 4 may derive power from a second, power providing near field RF communicator or near field RF communications enabled device such as the second NFC communicator 400 shown in FIG. 4, communication of power and data may be simultaneous and utilize the same RF field.”) to maximize the transfer of power while controlling/minimizing power usage ([0072]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the simultaneous transmission and power harvesting of Symons, because such a modification would allow to maximize the transfer of power while controlling/minimizing power usage.
However, neither Bhushan, Baxi teach a magnetic loop antenna. Hirsch, in the same field of endeavor, teaches a wearable device with antennas for transferring data (Abstract), and further teaches a magnetic loop antenna (Col. 4 lines 17-24 “As shown in FIG. 4, where the core of the NFMI antenna 50 [magnetic loop antenna] includes a ferrite sheet magnetic spacer 52, an exterior of the NFMI antenna 50 may be positioned over or wrapped around a battery 54. As shown in FIG. 5, a plurality of coil turns 60 may be wrapped around the battery 54 that is the core of the NFMI antenna 50. The coil turns 60 wrapped around the battery 54 (or other core) form the NFMI antenna 50.”) to reduce electromagnetic interference (Col. 4 lines 17-24). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the magnetic loop antenna of Hirsch, because such a modification would allow to reduce electromagnetic interference.
Regarding claim 2, Bhushan teaches wherein each two adjacent sensor systems are spatially separated by a respective distance that is adjustable between a minimal distance and a maximal distance ([0076] “the Biostrip device affixed on the sternum, and measuring ECG, SCG, IPG; and another ring-shaped device worn on one of the fingers or toes of the user, measuring PPG on the finger/toe.” The Biostrip and ring-shaped device are separated by a distance and can be moved depending on the desired distance.).
Regarding claims 3 and 17, claim 1 is obvious over Bhushan and Baxi. Bhushan fails to teach flexible, stretchable interconnects to connect the electronic components, and an elastomeric encapsulation layer with a tissue-facing surface for the skin. Baxi, in the same field of endeavor, teaches a flexible and stretchable patch with an outer substrate by obtaining ECG and PPG signals, and further teaches wherein the plurality of flexible and stretchable interconnects comprise at least one of serpentine interconnects and zigzag interconnects ([0035] “and/or the interconnect between the fabric 306 and the substrate 308.” See Fig. 3 with the zigzag interconnects that connects SoC (1210), transceiver (1218), and sensor member (330).) to increase the stretchability and/or flexibility of the patch ([0034]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the flexible and stretchable interconnects, elastomeric encapsulation, and tissue-facing surface of Baxi, because such a modification would allow to increase the stretchability and/or flexibility of the patch.
Regarding claim 4, Bhushan teaches wherein the SoC comprises at least one of a near- field communication (NFC) interface and a Bluetooth interface ([0009] “transmit the monitored data to a computing device such as a smartphone or a smartwatch or other gateway device trough wireless communication such as Bluetooth (a trademark of Bluetooth SIG, Inc.), ZigBee (a trademark of the Zigbee Alliance) or other Near-Field Communication (“NFC”) protocol” NFC is a type of power harvesting. The Examiner also notes Bhushan discloses a wireless charging coil, i.e. a power harvesting means, as well, see Claim 6).
Regarding claim 6, Bhushan does not teach isolating the battery from the mammal within the elastomeric encapsulation layer. Baxi, in the same field of endeavor, teaches a flexible and stretchable patch with an outer substrate by obtaining ECG and PPG signals, and further teaches and the elastomeric encapsulation layer is configured to electrically isolate the battery from the mammal subject during use ([0069] “The sensor node 330 as illustrated includes a battery 1212 to provide power to the SOC and/or wireless transmission circuitry 1216.” Which is contained within the elastomeric encapsulation layer as the battery is integrated with the device and therefore isolated from the mammal.) to increase the stretchability and/or flexibility of the patch ([0034]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the flexible and stretchable interconnects, elastomeric encapsulation, and tissue-facing surface of Baxi, because such a modification would allow to increase the stretchability and/or flexibility of the patch.
Regarding claim 7, Bhushan teaches wherein the battery is a rechargeable battery operably recharged with wireless recharging ([0037] “The wearable device (hereon referred to as the “Biostrip” device) includes an electronic module or a component that is reusable and rechargeable (via micro-USB or wirelessly or both)”).
Regarding claim 15, Bhushan teaches the invention of claim 1. Bhushan does not teach a flame retardant material for the elastomeric encapsulation layer. Baxi, in the same field of endeavor, teaches a flexible and stretchable patch with an outer substrate by obtaining ECG and PPG signals, and further teaches wherein the elastomeric encapsulation layer comprises a flame retardant material ([0031] “The substrate material 308 can include a material, such as thermo-plastic polyurethane (TPU), silicone and/or polydimethylsiloxane (PDMS)” PDMS is a flame retardant material.) to avoid flammability of the device. It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with flame retardant material of Baxi, because such a modification would allow to avoid flammability of the device.
Regarding claim 18, Baxi teaches wherein each of the first sensor system and the second sensor system is formed in a multi-layer structure to mechanically isolate mechanically stiff components in a mechanical island configuration to accommodate bending, twisting or stretching without fracture or substantial degradation of an operating parameter (Fig. 7 and [0051] illustrates the multi-layers with flexible and stiff components to allow for a “ stretchable, flexible patch 302.” [0048] ).
Although Baxi teaches a first sensor system with a multi-layer structure, Baxi does not teach a second with a multi-layer structure. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have another multi-layered structure to mechanically isolate stiff components, for the purpose of monitoring a user’s health, since It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 20, Baxi teaches wherein the adhesive-free conformal contact comprises a wrapped geometry, the sensor member of at least one of the first sensor system and the second sensor system further comprises a fastener connected to an external surface of the encapsulation layer to fasten the sensor member in the wrapped geometry to a mammal subject ([0073] “For example, a male connection portion of a button, Velcro, or other attachment mechanism can be adhered to the entity 1302 and the patch system 300, 500, 800, or 1000 can include a mating connection portion that is attached to the attachment mechanism adhered to the user's skin. The attachment mechanism can be situated on the body side of the patch (i.e. the side shown in FIG. 3).” A wrapped geometry can take any shape or form so the patch is its own wrapped geometry.).
Regarding claim 21, Baxi teaches wherein each of the first sensor system and the second sensor system further comprises an adhesive layer operably attached to the tissue-facing surface of the encapsulation layer, wherein the adhesive layer has a pattern of perforations through open regions ([0073] “The fabric 306 of the patch system 300, 500, 800, or 1000 can be attached to the skin using a bio-compatible adhesive film (e.g., a silicon adhesive sheet, spray, or other attachment mechanism.” [0060] “another sensor patch system 1000 in which the sensors contact or be near the skin through one or more holes [perforations] in the stretchable flexible patch.” [0057] “the cover 720 or the metallization/components 710 includes an adhesive layer”).
Regarding claims 24-25, Bhushan teaches further comprising an alarm device for providing at least one of an optical alert and an audio alert (on-board or off-board) when a physiological parameter is out of a pre-defined range ([0073] “the SBP and DBP values are calculated using the values of PTT.sub.foot-foot, PTT.sub.peak-foot, PTT.sub.foot-peak, and PTT.sub.peak-peak, and the difference between the them, where the foot and peak are always of different wrists. Abnormal values of the above mentioned factors may also be used to trigger an alert for the User [or care-giver of [0089]], to indicate possible Ischemia or other cardio-vascular disease in one branch of blood vessels.” Examiner notes that obtaining blood pressure (both SBP and DBP) [critical parameters] require obtaining PTT which comes from both the ECG and PPG signals [which defines multi-modal monitoring]. Claim 12 “continuous monitoring of blood pressure” [0089] “The system further includes a system to automatically alert [alarm on-board] the user, or any authorised third party (friend, family, doctor or other care-giver) when the computed blood pressure [critical parameter] levels cross a certain predefined or adaptive threshold” Crossing the threshold means the critical parameters are outside the range of occurrence.).
Regarding claim 26, Bhushan teaches wherein the second sensor system is a conformable extremity sensor system configured to attach and conform to a limb or appendage region of the mammal subject ([0076] “the Biostrip device affixed on the sternum, and measuring ECG, SCG, IPG; and another ring-shaped device worn on one of the fingers or toes [limb] of the user, measuring PPG on the finger/toe.” The sternum is part of the chest/torso region which encompasses the central region and the finger/toe is the foot/hand region.).
Regarding claim 30, claim 1 is obvious over Bhushan, Baxi, and Lisogurski. Bhushan does not teach electrodes comprising solid electrodes. El, in the same field of endeavor, teaches a flexible patch for measuring biological parameters (Abstract), and further teaches wherein the at least two electrodes comprise at least one of mesh electrodes and solid electrodes ([0053] “The ECG electrodes 500 are dry conductive electrodes, as compared to conventional ECG electrodes with conductive gel (that can dry out within a few hours).”) to avoid the deterioration of the conductive gel ([0053]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the electrodes comprising solid electrodes of El, because such a modification would allow to avoid the deterioration of the conductive gel.
Regarding claim 31, Bhushan teaches wherein the sensor member further comprises one or more of:
an accelerometer for measuring at least one of a position and a movement;
an inertial measurement unit (IMU) for measuring at least one of a movement, a force, an angular rate, and an orientation;
a temperature sensor for measuring temperature ([0041] “The wearable (Biostrip) device includes one or more accelerometers capable of measuring acceleration below a predetermined resolution level.” [0106] “skin temperature and movement”).
Regarding claims 35-36, Baxi teaches wherein the sensor member of the extremity sensor system comprises a photoplethysmogram (PPG) sensor comprising an optical source (LED) and an optical detector located within a sensor footprint ([0025] “wearing ECG/PPG sensors on the hand or other limb.” [0039] “LEDs 324, photodiode 326” which can also be found on the arm.).
Regarding claim 37, Baxi teaches wherein the sensor member of the extremity sensor system further comprises one or more of:
an accelerometer for measuring at least one of a position and a movement;
an inertial measurement unit (IMU) for a motion artifact reduction algorithm; and
a temperature sensor for measuring temperature ([0066] “The circuitry can include an inertial measurement unit (IMU) that can be used to track motion (in one, two, or three directions). Such measurements can be used to help cancel motion artifacts in bio-signals and additionally or alternatively for general motion tracking.” Since motion artifact is for PPG, which is for device 104, motion artifact reduction can be done to the wrist device.).
Regarding claim 39, Baxi teaches wherein the driving current is supplied to an LED to generate an optimized light intensity provided to an underlying mammal subject region ([0069] “the LED driver 1208 may operate at a different voltage or current level than the SOC 1210 or one or more of the AFEs,”).
Although Baxi teaches a change in a specific voltage/current, Baxi does not teach an optimized light intensity. Since the voltage and current can be altered, the lighting intensity can be adjusted. It would have been obvious to one having ordinary skill in the art at the time the invention was made to change in a specific voltage/current, since it has been held that discovering an optimum value for light intensity of a result effective variable (voltage/current) involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 43, Bhushan teaches wherein the physiological parameters comprise one or more of heart activities including a stroke volume and ejection fraction, oxygenation level, temperature, skin temperature differentials, body movement, body position, breathing parameters, blood pressure, crying time, crying frequency, swallow count, swallow frequency, chest wall displacement, heart sounds, core body position, asynchronous limb motion, speaking, and biomechanical perturbation ([0018] “he present invention provides a blood pressure monitoring system has the ability to combine information from multiple sensors—ECG, Respiration (from skin impedance), Implantable Pulse Generator (“IPG”), PPG, Galvanic Skin Response device (“GSR”), Electrodermal activity (“EDA”), movement (from accelerometers), seismocardiography (“SCG”), skin temperature, blood glucose, levels of oxygen and haemoglobin in the blood, and hence calculate a very accurate value of blood pressure for each user, and also show correlations with other parameters.”).
Regarding claim 54, Bhushan teaches wherein the mammal subject is a human subject or a non-human subject ([0108] “FIG. 4 also illustrates that within the system, the user may directly consult the doctor, or the doctor can send alerts or prescriptions to the user.” A human can only consult a physician.).
Regarding claim 64, Bhushan teaches A method of non-invasively measuring physiological parameters of a mammal subject, ([0076] “the Biostrip device affixed on the sternum, and measuring ECG, SCG, IPG; and another ring-shaped device worn on one of the fingers or toes of the user, measuring PPG on the finger/toe.” The network of sensors include a PPG and ECG sensor. Additionally, a finger/toe and sternum are human body parts which is a mammal subject.), comprising:
a first sensor system and a second sensor system that are time-synchronized to each other, each of the first sensor system and the second sensor system ([0070] “where the user is wearing two Biostrips, one on the sternum, measuring ECG and SCG, and one on the wrist measuring PPG” [0074] “This is an episodic measurement of Blood Pressure, where the user holds the device in this manner for at least 30 seconds, and PTT is calculated by the delay between the R-peak on the ECG, and the foot/peak/50% mark of the PPG curve measured on the index finger.” PTT calculation requires time synchronization of the R wave with the peak of a PPG signal. [0076] “the Biostrip device affixed on the sternum, and measuring ECG, SCG, IPG; and another ring-shaped device worn on one of the fingers or toes of the user, measuring PPG on the finger/toe.” The ring-shaped device and affixed Biostrip are spatially separated sensor systems.) comprising:
a plurality of electronic components … wherein the plurality of electronic components comprises a sensor member for measuring at least one physiological parameter of the mammal subject ([0010] “to collect medical quality data from a plurality of sensors including, but not limited to Electromyography (“EMG”), Electrocardiography (“ECG” or “EKG”) [physiological parameters], Electroencephalography (“EEG”), EXG, respiration, Photoplethysmograph (“PPG”) temperature sensors, accelerometers and the like, and transmit the data to the required computing device after initial processing.”), a system on a chip (SoC) having a microprocessor coupled to the sensor member for receiving data from the sensor member and processing the received data ([0044] “The Biostrip contains a microprocessor or other processor to collect data from the multiple sensors, which implements a series of algorithms [processing] on the wearable device itself. The Biostrip also contains an integrated circuit [system on a chip] for wireless data communication that enables it to connect and communicate, and send to and receive data from, a smartphone/smartwatch or another gateway device such as a wifi router.”), and a transceiver coupled to the SoC for wireless data transmission and wireless power harvesting ([0009] “transmit the monitored data to a computing device such as a smartphone or a smartwatch or other gateway device trough wireless communication such as Bluetooth (a trademark of Bluetooth SIG, Inc.), ZigBee (a trademark of the Zigbee Alliance) or other Near-Field Communication (“NFC”) protocol” NFC is a type of power harvesting. The Examiner also notes Bhushan discloses a wireless charging coil, i.e. a power harvesting means, as well, see Claim 6), a battery for providing power to said sensor system ([0077] “The ring-shaped device mentioned in the above embodiment … and a battery to run all of the above.” And [0037] “The wearable device (hereon referred to as the “Biostrip” device) includes an electronic module or a component that is reusable and rechargeable (via micro-USB or wirelessly or both)” The biostrip must have a battery if it is rechargeable.);
wherein each of the first sensor system and the second sensor system is adapted to be attached to a respective position on the mammal subject so that the first sensor system and the second sensor system are spatially separated by a distance ([0076] “the Biostrip device affixed on the sternum, and measuring ECG, SCG, IPG; and another ring-shaped device worn on one of the fingers or toes of the user, measuring PPG on the finger/toe.” The ring-shaped device and affixed Biostrip are spatially separated sensor systems. There must be a distance between the ring and the sternum as they are two separate locations on the body.);
wherein the sensor member of the torso sensor system comprises at least two electrodes spatially separated from each other by an electrode distance, D, for electrocardiogram (ECG) generation ([0074] “the User holds the Biostrip in his hands, with the left index finger covering one electrode on the left, and the right index finger covering the right-most electrode and the central electrode”).
However, Bhushan fails to teach flexible, stretchable interconnects to connect the electronic components, and sensing physiological data to an external reader. Baxi, in the same field of endeavor, teaches a flexible and stretchable patch with an outer substrate by obtaining ECG and PPG signals, and further teaches a plurality of flexible and stretchable interconnects electrically connecting to a plurality of electronic components including the sensor member, the SoC and the transceiver ([0035] “and/or the interconnect between the fabric 306 and the substrate 308.” See Fig. 3 with the zigzag interconnects that connects SoC (1210), transceiver (1218), and sensor member (330). ); and
conformally contacting a first sensor system at a torso region of the mammal subject and a second sensor system at a limb or appendage region of the mammal subject, respectively, wherein the first sensor system and the second sensor system are spatially separated by a distance, and configured to measuring a torso physiological parameter and an extremity physiological parameter, respectively (Fig. 1 (102 [torso device],104 [limb device]) The devices are at a distance, as seen in Fig. 1. Device 102 measures ECG, Device 104 measures PPG. ); and
continuously wirelessly transmitting the time synchronized measured torso physiological parameter and extremity physiological parameter to an external reader, thereby non-invasively measuring the physiological parameters of the mammal subject ([0070] “The combination of the transmission circuitry 1216 and the antenna 1218 can provide signals to the mobile device 106. The signals can be Bluetooth, induction wireless, infrared wireless, ultra-wideband, ZigBee, or other personal area network compliant signals.” [0025] “The patch can transmit (e.g., wired or wirelessly transmit) time-synchronized ECG and PPG data to an aggregator device [external reader] (e.g., a wireless communication device, such as a smartphone) for accurate PTT and BP estimation.” Examiner notes that the claim states the transmitting of the data to an external reader. BP and PTT monitoring is continuous [0018].);
wherein the electrode distance D is adjustable between a minimal electrode distance Dmin and a maximal electrode distance Dmax wherein the minimal electrode distance Dmin represents a distance between the at least two electrodes when the torso sensor system is in a non-stretched state, and the maximal electrode distance Dmax represents a distance between the at least two electrodes when the torso sensor system is in a maximally stretched state ([0081] “a device includes a stretchable, flexible substrate material mechanically coupled to and on the stretchable, flexible fabric and first metallization mechanically coupled to and on the substrate material, the first metallization including first pads, meandering traces, and at least one of electrocardiogram (ECG) electrodes, a stretch sensor, and at least one stretch limiting patch.” Examiner notes that the flexibility an stretchability would allow the multiple electrodes of each of the patches to ben based on body placement, which are placed on the knees which can bend to alter the distance of the electrodes when the knee is bent versus when the knee is straight. Therefore, when the knee is bent and the patch is maximally stretched, the distance from the first and second electrode around the knee is maximal than when the patch is straight.) to increase the stretchability and/or flexibility of the patch ([0034]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the flexible and stretchable interconnects, elastomeric encapsulation, and tissue-facing surface of Baxi, because such a modification would allow to increase the stretchability and/or flexibility of the patch.
Bhushan does not teach a failure prevention element. Baxi, in the same field of endeavor, teaches a flexible and stretchable patch with an outer substrate by obtaining ECG and PPG signals, and further teaches a failure prevention element that is a short-circuit protection component or a battery circuit to avoid battery malfunction ([0069] “The power conditioning circuitry 1214 can include one or more voltage or current regulators, one or more voltage or current boosters, or other the like, to alter a voltage or current level provided by the battery 1212. For example, the different AFEs may operate at different voltage levels and may require different voltage or current rails for proper digitization of signals, the LED driver 1208 may operate at a different voltage or current level than the SOC 1210 or one or more of the AFEs, or the wireless transmission circuitry 1216 may operate at a different voltage or current level than other circuitry of the sensor node 330 or the sensors 324, 326, or 328.” Although there is no explicit use avoiding battery explosion, the power conditioning circuit [battery circuit] adjusts the voltage and current of the battery when needed and therefore avoids any battery explosion. Examiner notes that the phrase “avoid battery explosion” is the intended use of the battery circuit, which does not contain patentable weight.) to avoid battery explosion. It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the failure prevention element of Baxi, because such a modification would allow to avoid battery explosion. The nature of the problem to be solved may lead inventors to look at references relating to possible solutions to that problem. Id. at 1277, 69 USPQ2d at 1691. See MPEP 2143 (I)(C).
If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40,100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). See MPEP 2114(I). In the instant case, the phrase “avoid battery explosion” is the intended function of the battery circuit. Therefore, if the reference teaches a battery circuit, then the function of avoiding battery explosion would be attributed to the battery circuit.
Bhushan and Baxi do not teach the dynamic baseline control for compensating variability and generating an effective driving current. Lisogurski, in the same field of endeavor, teaches a physiological monitoring system with sensors like PPG ([0022]) and EKG ([0096]) to generate a signal with amplifiers (Abstract), similar to the device of Bhushan, and further teaches wherein at least one of the first sensor system and the second sensor system further comprises a dynamic baseline control module configured to automatically compensate for mammal subject-to- mammal subject variability and generate an effective driving current to ensure sufficient signal-to-noise and avoid saturation ([0017] “amplifier outputs a voltage based on the difference between a sensor current received from a photodetector, and an estimated current received from a digital-to-analog converter (DAC).” [0099] “An amount of gain and an offset applied by an amplifier in generating the difference signal may be adjusted based on the ADC, such that the utilization of the dynamic range of the ADC input is optimized [producing an effective driving current]. In some embodiments, a large gain may be applied so that small current changes in the sensor signal may produce measureable voltage changes at the ADC. In some embodiments, the amount of gain and/or offset may be adjusted based on the utilization of the dynamic range of the ADC is maintained at a particular level.” Examiner notes that the difference between sensor current from photodetector and DAC compensates for mammal-to mammal subject variability. Examiner notes that when the dynamic range is optimized, an optimized voltage and current is applied, which automatically ensures sufficient SNR and avoiding saturation.) to apply a larger gained input and resolution without high power and saturating the signal ([0083]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the dynamic baseline control for compensating variability and generating an effective driving current of Lisogurski, because such a modification would allow to apply a larger gained input and resolution without saturating the signal and requiring high power.
However, Bhushan, Lisogurski, Baxi do not teach the simultaneous transmission and power harvesting. Symons, in the same field of endeavor, teaches the connecting of devices with one another (Abstract and Fig. 6), and further teaches simultaneous wireless data transmission and wireless power harvesting through a single link ([0072] “FIG. 4 may derive power from a second, power providing near field RF communicator or near field RF communications enabled device such as the second NFC communicator 400 shown in FIG. 4, communication of power and data may be simultaneous and utilize the same RF field.”) to maximize the transfer of power while controlling/minimizing power usage ([0072]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the simultaneous transmission and power harvesting of Symons, because such a modification would allow to maximize the transfer of power while controlling/minimizing power usage.
However, neither Bhushan, Baxi teach a magnetic loop antenna. Hirsch, in the same field of endeavor, teaches a wearable device with antennas for transferring data (Abstract), and further teaches a magnetic loop antenna (Col. 4 lines 17-24 “As shown in FIG. 4, where the core of the NFMI antenna 50 [magnetic loop antenna] includes a ferrite sheet magnetic spacer 52, an exterior of the NFMI antenna 50 may be positioned over or wrapped around a battery 54. As shown in FIG. 5, a plurality of coil turns 60 may be wrapped around the battery 54 that is the core of the NFMI antenna 50. The coil turns 60 wrapped around the battery 54 (or other core) form the NFMI antenna 50.”) to reduce electromagnetic interference (Col. 4 lines 17-24). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the magnetic loop antenna of Hirsch, because such a modification would allow to reduce electromagnetic interference.
Regarding claim 65, Baxi teaches wherein the distance between the first sensor system and the second sensor system is adjustable between a minimum distance and a maximum distance (Patch electrode 102 device can be placed on the chest at different distances to the PPG device 104.).
Regarding claim 67, Baxi teaches wherein the physiological parameter is obtained from:
electrical sensing by electrodes ([0020] “The ECG is a measure of electrical activity of the heart over a period of time.”); and
oxygen sensing by a plethysmograph ([0020] “The PPG device 104 is a device that mounts to a finger of the patient and measures PPG. The PPG device 104 can be a pulse oximeter.”).
Regarding claim 68, Baxi teaches further comprising measuring at least one additional physiological parameter related to temperature; movement; spatial position; sound; and blood pressure ([0025] “The patch can transmit (e.g., wired or wirelessly transmit) time-synchronized ECG and PPG data to an aggregator device [external reader] (e.g., a wireless communication device, such as a smartphone) for accurate PTT and BP estimation.”).
Regarding claim 69, Baxi teaches further comprising:
determining a mammal subject and region-specific optimized driving voltage provided to an optical light source; and
powering an LED optical light source with the optimized driving voltage, thereby ensuring the LED optical light source intensity provides sufficient signal to an optical detector without saturating the optical detector ([0069] “For example, the different AFEs may operate at different voltage levels and may require different voltage or current rails for proper digitization of signals, the LED driver 1208 may operate at a different voltage or current level than the SOC 1210 or one or more of the AFEs” An LED driver is used for optimizing drive voltage to the LED for not allowing the saturation of an optical detector.).
Regarding claim 70, Baxi teaches A non-transitory tangible computer-readable medium storing instructions which, when executed by one or more processors, cause the method of claim 64 to be performed ([0070] “the memory [non-transitory tangible computer-readable medium] can store data from the AFEs until the mobile device 106 is within about four centimeters or less of the sensor node 330.”).
Claim(s) 9, 27, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Raj et al. (US 10277386) (Hereinafter Raj1).
Regarding claim 9, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. Bhushan does not teach a power management unit electrically coupled to the SoC and transceiver. Raj1, in the same field of endeavor, teaches sensor nodes attached of the surface of different parts of the body (Abstract and Fig. 1), similar to the device of Baxi, and further teaches wherein the plurality of electronic components of each of the first sensor system and the second sensor system further comprise a power management unit electrically coupled between the SoC and the transceiver (Col. 10 lines 16-20 “The electrical power receiver and data transceiver 214 allows the sensor nodes 104 [SoC] to receive electrical power from the master hub 102, and to receive data from and transmit data to the master hub 102, as well as from and to the other sensor nodes 104 within the system 100.”) to wirelessly charge the sensors. It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with power management unit electrically coupled to the SoC and transceiver of Raj1, because such a modification would allow to wirelessly charge the sensors.
Regarding claim 27 and 32, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. Baxi does not teach a BLE. Baxi teaches a ECG and PPG AFE ([0065]) with 2 electrodes and LED and photodetectors. Raj, in the same field of endeavor, teaches sensor nodes attached of the surface of different parts of the body (Abstract and Fig. 1), similar to the device of Baxi, and further teaches wherein the torso and extremity sensor system comprises:
a first electrode and a second electrode as the sensor member (Col. 10 lines 52-54 “In some aspects, the contacts 300 can be four contacts 300 configured as 4-wire measurement electrodes.”);
a photodiode/light emitted diode (LED) and an optical detector as the sensor member (Col. 4 lines 31-42 “Sensor information includes, for example, … optically modulated sensing (e.g., photoplethysmography and pulse-wave velocity).” Which require the LED and photodetector of Baxi.);
a Bluetooth low energy (BLE) SoC as the SoC (Col. 8 lines 23-27 “The communications interface 206 can be any traditional communications interface for communicating with the computer device 108, such as one based on the wireless communication protocols of Wi-Fi, medical telemetry, Bluetooth, Bluetooth Low Energy,”);
an ECG and PPG analog front-end (AFE)/inertial measurement unit (IMU) (Col. 11 lines 10-12 “the contacts 300 can be electrically connected to and in communication with a biasing circuit 302, such as an analog front-end biasing circuit.”); and
a power management integrated circuit (PMIC) and a memory (Col. 10 lines 38-42 “the transceiver 214 includes one or more electrical contacts 300, a biasing circuit 302, an amplifier 304, a demodulator 306, an analog-to-digital converter 308, an alternating current drive circuitry 310, and a power circuitry 312.” Col. 9 lines 35-38 “In some aspects, the processor 210 can include memory for storing one or more algorithms performed by the sensor nodes 104, and for storing information transmitted from the master hub 102.”) for location specific sensing of patient parameters (Col. 8 lines 51-53). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the BLE and a AFE for the PPG sensing node of Raj, because such a modification would allow for location specific sensing of patient parameters.
Claim(s) 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Curto et al. (“Real-time sweat pH monitoring based on a wearable chemical barcode micro-fluidic platform incorporating ionic liquids”, Sensors and Actuators B: Chemical, Volumes 171–172, August–September 2012, Pages 1327-1334) (Hereinafter Curto).
Regarding claims 10-11, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. Bhushan does not teach a microfluidic chamber containing ionic fluid for mechanically isolating the electronic components. Curto, in a similar field of endeavor, teaches a wearable monitoring device including sensors (Abstract). Although Curto is related to pH monitoring using chemical sensors, both Curto and Bhushan allow for real-time monitoring of a user’s health. Curto further teaches wherein each of the first sensor system and the second sensor system further comprises a microfluidic chamber positioned between the tissue-facing surface and the plurality of electronic components configured to mechanically isolate the plurality of electronic components from a skin surface during use, wherein the microfluidic chamber is at least partially filled with at least one of an ionic liquid and a gel (Abstract “This work presents the fabrication, characterisation and the performance of a wearable, robust, flexible and disposable chemical barcode device based on a micro-fluidic platform that incorporates ionic liquid polymer gels (ionogels).”) for monitoring in real-time (Conclusion). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the microfluidic chamber containing ionic fluid for mechanically isolating the electronic components of Curto, because such a modification would allow for monitoring in real-time.
Regarding claim 12, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. Bhushan does not teach a microfluidic chamber containing ionic fluid for mechanically isolating the electronic components. Curto, in a similar field of endeavor, teaches a wearable monitoring device including sensors (Abstract). Although Curto is related to pH monitoring using chemical sensors, both Curto and Bhushan allow for real-time monitoring of a user’s health. Curto further teaches wherein the encapsulation layer comprises channels or conduits configured to facilitate sweat evaporation during use (Pg. 1329 left col. lines 2-5 “The micro-channels connect the four rectangular independent ionogel/dyes reservoirs with a common reservoir (15 mm × 5 mm and 285 μm depth), where an absorbent fibre drives the sweat from the sensing area through the channels by capillary action.”) for monitoring in real-time (Conclusion). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the microfluidic chamber containing ionic fluid for mechanically isolating the electronic components of Curto, because such a modification would allow for monitoring in real-time.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Fan et al. (“Highly Robust, Transparent, and Breathable Epidermal Electrode” ACS Nano 2018, 12, 9, 9326–9332 Publication Date: August 17, 2018)(Hereinafter Fan).
Regarding claim 13, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. However, Bhushan does not teach an optically transparent encapsulation layer. Fan, in the same field of endeavor, teaches a skin electrodes for sophisticated skin electronics (Abstract), similar to the device of Bhushan, and further teaches wherein the encapsulation layer is optically transparent so as to be compatible with visual inspection of underlying tissue (Fig. 1f, Pg. 9327 left col. lines 10-13 “robust, breathable, and transparent electrode that has a strong bonding with the skin for conformal interactions.”) to use in circumstances that require high optical transmission (Pg. 9327 left col. lines 8-10). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the optically transparent encapsulation layer of Marriott, because such a modification would allow to use in circumstances that require high optical transmission.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Toth et al. (US 20210204867)(Hereinafter Toth) (see provisional filed 05/22/2018).
Regarding claim 14, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. However, Bhushan does not teach a isolating the systems from an electroshock. Toth, in the same field of endeavor, teaches at least one sensing device for measuring cardio-pulmonary performance (Abstract) the use of a patch on the skin with interconnects ([0040]), and further teaches wherein the encapsulation layer is configured to electrically isolate each of the first sensor system and the second sensor system from an electroshock applied to the mammal subject ([0071] Data or knowledge from waveforms applied in conducted electrical weapons (CEWs), such as in electroshock devices, may be utilized to avoid painful stimulus. Physical stimulus may also be provided in the form of positive feedback, such as in evoking pleasurable sensations by combining non-painful electrical stimulus with pleasant sounds, music, lighting, smells, etc.” The electroshock is isolated from the sensing devices as it is done by the stimulating device.) to provide feedback to a user ([0071]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the isolating the systems from an electroshock of Toth, because such a modification would allow to provide feedback to a user.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Coggins (US 20130085368)(Hereinafter Coggins).
Regarding claim 16, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. However, Bhushan does not teach a radio-translucent and thermally stable for medical imaging functionality. Coggins, in the same field of endeavor, teaches ECG electrodes on a pad that is attached to a skin of a user, similar to the device of Bhushan, and further teaches wherein each of the first sensor system and the second sensor system is radiotranslucent and thermally stable so that each of the first sensor system and the second sensor system is compatible with medical imaging ([0006] If the device is radio-translucent, it must be compatible with medical imaging and thermally stable.) to visualize the tissue underlying the electrode without loss of image quality ([0016]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the radio-translucent and thermally stable for medical imaging functionality of Coggins, because such a modification would allow to visualize the tissue underlying the electrode without loss of image quality.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Rogers (“Epidermal Electronics” SCIENCE 12 Aug 2011 Vol 333, Issue 6044 pp. 838-843) (IDS 05/11/2021) (Hereinafter Rogers2).
Regarding claim 19, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. However, Bhushan does not teach Van Der Waals interactions for conformally attaching to the skin. Rogers2, in the same field of endeavor, teaches an elastic, thick epidermal device conformally contacting the skin (Abstract), similar to the device of Bhushan, and further teaches wherein each of the first sensor system and the second sensor system is configured to conformally attach to a skin surface in a conformal contact without an adhesive, wherein a contact force is generated by Van der Waals interaction between the tissue facing surface of each of the first sensor system and the second sensor system and a skin surface during use (Fig. 1a description “the PVA leaves the device conformally attached to the skin through van der Waals forces alone, in a format that imposes negligible mass or mechanical loading effects on the skin.”) to mechanically fix the device without adhesives (Page 1 right col. lines 8-11). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the Van Der Waals interactions for conformally attaching to the skin of Rogers2, because such a modification would allow to mechanically fix the device without adhesives.
Claim 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Raj et al. (US 10447347)(Hereinafter Raj2).
Regarding claims 22-23, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. Bhushan and Baxi do not teach simultaneous wireless data transmission and power delivery using BLE and NFC and recording physiological parameters on a computing device. Raj, in the same field of endeavor, teaches a wireless charging system for a wearable sensor device with transceivers and sensors (Abstract), and further teaches further comprising a reader system that comprises an antenna in communication with said transceiver of each of the first sensor system and the second sensor system for simultaneous wireless data transmission and wireless power delivery; wherein the reader system further comprises an NFC reader module for receiving wirelessly transmitted data from each of the first sensor system and the second sensor system, and a Bluetooth low energy (BLE) module for transmitting the received data to an external computing device for at least one of real- time display of the monitored physiological parameters, recording of the monitored physiological parameters, and alarm (Col. 4 lines 34-39 “The wireless charging device 120 can simultaneously charge one or more of the wearable devices 112, 114, 116 and 118 at different charging rates as well as transfer data between one or more of the wearable devices 112, 114, 116 and 118 and a remote computer system (e.g., at different transmission rates).” Col. 5 lines 62-67 and Col 6 lines 1-16 “The wearable device 200 can optionally include one or more wireless transceivers, such as transceiver 207, for communicating with other devices. In this example, one transceiver 207 can be a low energy consuming device that uses a low data transmission rate communication protocol such as Bluetooth Low Energy for transferring commands and status information and another transceiver 208 can be a higher speed communication device using a higher capability transmission protocol such as the Gazelle or Shockwave protocol of Nordic Semiconductors. …In this example, the wearable device 200 can be configured to be recharged by drawing power from a wireless connection or an electromagnetic field (e.g., an induction coil, an NFC reader device, microwaves, and light).” Col. 13 lines 52-54 “This data can then be sent to the cloud server 140, and the wearable device 112 returns to normal operation for monitoring and gathering data”) to initiate and control charging and data transfer (Col. 4 lines 42-45). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the simultaneous wireless data transmission and power delivery using BLE and NFC and recording physiological parameters on a computing device of Raj, because such a modification would allow to initiate and control charging and data transfer.
Claim 33-34 and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Liu et al. (“Lab-on-Skin: A Review of Flexible and Stretchable Electronics for Wearable Health Monitoring” ACS Nano 2017, 11, 10, 9614–9635 Publication Date: September 13, 2017)(Hereinafter Liu).
Regarding claim 33, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. Bhushan teaches
the sensor member is spatially separated from and electronically connected to the main circuit component, and operably extends in a direction different from the wrap direction to attach to a sensor region that is spatially distinct from the wrapped portion during use ([0076] “the Biostrip device affixed on the sternum, and measuring ECG, SCG, IPG” The sternum is a different location than the hand and distinct than the wrapped portion as that is wrapped around the hand versus the biostrip is attached straight on the chest..).
Bhushan and Baxi do not teach the extremity sensor system wrapped around a limb or appendage in a wrap direction. Liu, in the same field of endeavor, teaches an epidermal stretchable electronics device for vital biological signals (Abstract), similar to the device of Bhushan, and further teaches wherein the extremity sensor system is configured such that a main circuit component including at least the SoC and the transceiver is aligned and operably wrapped around a limb or appendage in a wrap direction (Fig. 9 description: “Photograph of a wearable device for sweat analysis mounted on a subject’s wrist for in-place sensing, acquisition, and wireless data transmission. The system consists of circuitry for signal transduction, conditioning, processing [SoC], and wireless transmission [transceiver].” Examiner notes that Fig. 9 shows the device perpendicular to the wrist and wrapped around the wrist) to allow for softness, flexibility, and stretchability on the skin (Pg. 9628 right col. lines 23-24). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the extremity sensor system wrapped around a limb or appendage in a wrap direction of Liu, because such a modification would allow to allow for softness, flexibility, and stretchability on the skin.
Regarding claim 34, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. Bhushan and Baxi do not teach the extremity sensor system wrapped around a limb or appendage in a wrap direction. Liu, in the same field of endeavor, teaches an epidermal stretchable electronics device for vital biological signals (Abstract), similar to the device of Bhushan, and further teaches wherein the sensor member of the extremity sensor system is conformable to a skin surface and configured as a soft wrap for circumferential attaching to the limb or appendage region (Pg. 9628 right col. lines 23-24 soft, flexible and stretchable. Fig. 9 showing device wrapped on the skin in circumference to the wrist as the horizontal portion of the device is perpendicular to the wrist, and therefore in a soft wrap because Examiner interprets a soft wrap to be bendably wrapped around the wrist, which is seen in Fig. 9.) to allow for softness, flexibility, and stretchability on the skin (Pg. 9628 right col. lines 23-24). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the extremity sensor system wrapped around a limb or appendage in a wrap direction of Liu, because such a modification would allow to allow for softness, flexibility, and stretchability on the skin.
Regarding claim 41-42, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. Bhushan does not teach a Young’s modulus and a thickness of the systems. Liu, in the same field of endeavor, teaches an epidermal stretchable electronics device for vital biological signals (Abstract), similar to the device of Bhushan, and further teaches wherein each of the first sensor system and the second sensor system has a thickness less than or equal 3 mm and a Young's modulus less than or equal to 1 GPa (Table 2 Silicone tape with 127 MPa and.33 mm thickness) to allow for skin conformation without delamination (Table 2 description). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the Young’s modulus and a thickness of the systems of Zalar, because such a modification would allow for skin conformation without delamination.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Picard et al. (US 20100268056)(Hereinafter Picard), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Cheong et al. (US 20170011210)(Hereinafter Cheong).
Regarding claim 40, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. However, Bhushan does not teach a waterproof device. Picard, in a similar field of endeavor, teaches a washable wearable sensor with real-time sensed data of a patient of activities (Abstract), and further teaches wherein each of the first sensor system and the second sensor system is encapsulated with a thin film of silicone elastomer so that said sensor system is waterproof ([0078] “one or more of these sensors are coated in plastic or another waterproof or water-resistant material”) to allow for washing of sensors with water ([0078]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the sensors are waterproof of Picard, because such a modification would allow to wash sensors with water.
However, Bhushan, Baxi, and Picard do not teach a thin film of silicone elastomer for waterproofing. Cheong, in the same field of endeavor, teaches obtaining biometric information from a user (Abstract) including ECG data ([0464]), similar to the device of Bhushan, and further teaches a waterproof structure formed by silicone rubber ([0356]) for waterproof protrusions and sealing of the device ([0356]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the thin film of silicone elastomer for waterproofing of Cheong, because such a modification would allow for waterproof protrusions and sealing of the device.
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al. (US 20170347894) (IDS 04/22/2021) (Hereinafter Bhushan) in view of Baxi (US 20190209028)(Hereinafter Baxi), Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski), Symons et al. (US 20080272889)(Hereinafter Symons), and Coggins (US 20130085368)(Hereinafter Coggins).
Regarding claim 66, claim 1 is obvious over Bhushan, Baxi, Symons, and Lisogurski. Bhushan does not teach the application of hydrogels on the first and second sensor systems. Coggins, in the same field of endeavor, teaches ECG electrodes on a pad that is attached to a skin of a user, similar to the device of Bhushan, and further teaches the use of hydrogels for placement against the tissue of a patient for creating an adhesive and conductive surface ([0020]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of Bhushan, with the application of hydrogels on the first and second sensor systems of Coggins, because such a modification would allow to create an adhesive and conductive surface.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-4, 6-7, 9-27, 30-37, 39-43, 54, and 64-70 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 48, 50-51, 66-67, 70, and 77 of copending Application No. 17/287,168 in view of Lisogurski et al. (US 20150031971)(Hereinafter Lisogurski).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, An apparatus for measuring physiological parameters of a mammal subject (Claim 48 “A sensor network for measuring physiological parameters of a mammal subject”), comprising:
a first sensor system and a second sensor system that are time- synchronized to each other, each of the first sensor system and the second sensor system (Claim 48 “each of the plurality of spatially separated sensor systems are time-synchronized by a common time base to each other”) comprising:
a plurality of electronic components, and a plurality of flexible and stretchable interconnects electrically connecting to different electronic components, wherein the plurality of electronic components (Claim 66 “a plurality of flexible and stretchable interconnects electrically connecting to a plurality of electronic components including the sensor member”) further comprise:
a sensor member for measuring at least one physiological parameter of the mammal subject (Claim 48 “wherein the physiological parameters”),
a system on a chip (SoC) having a microprocessor coupled to the sensor member for receiving data from the sensor member and processing the received data (Claim 48 “a microprocessor coupled to the sensor member for receiving data from the sensor member and processing the received data…SoC”),
a transceiver coupled to the SoC for wireless data transmission and wireless power harvesting, the transceiver including a magnetic loop antenna tuned to compliance with an NFC protocol and configured to allow simultaneous wireless data transmission and wireless power harvesting through a single link (Claim 67 “wherein the transceiver comprises a magnetic loop antenna configured to allow simultaneous wireless data transmission and wireless power harvesting through a single link”),
a battery for providing power to said sensor system (Claim 68 “a battery for providing power to said sensor system”), and
a failure prevention element that is a short-circuit protection component or a battery circuit to avoid battery malfunction (Claim 70 “wherein the electronic components of each of the plurality of spatially separated sensor systems further comprises a failure prevention element that is a short-circuit protection component or a battery circuit to avoid battery explosion”); and
an elastomeric encapsulation layer at least partially surrounding the plurality of electronic components and the plurality of flexible and stretchable interconnects to form a tissue-facing surface and an environment-facing surface, wherein each of the first sensor system and the second sensor system is adapted to be attached to a respective position on the mammal subject so that the first sensor system and the second sensor system are spatially separated by a distance (Claim 66 “an elastomeric encapsulation layer surrounding the electronic components and the plurality of flexible and stretchable interconnects to form a tissue-facing surface and an environment-facing surface, wherein the tissue- facing surface is configured to conform to a skin surface of the mammal subject” Claim 77 “deploying the sensor network of claim 48, wherein at least one first sensor system is adapted to be attached to a central region of the mammal subject and at least one second sensor system is adapted to be attached to an extremity region of the mammal subject such that the first sensor system and the second sensor system are spatially separated by a distance”); and
wherein the first sensor system is a conformable torso sensor system configured to attach and conform to a torso region of the mammal subject, the sensor member of the torso sensor system comprises at least two electrodes spatially separated from each other by an electrode distance D for electrocardiogram (ECG) generation (Claim 50 “a first sensor system configured to attach to a central region of the mammal subject and a second sensor system configured to attach to an extremity region of the mammal subject, wherein the central region comprises one or more of a chest region, a neck region including a suprasternal notch area, and a head region including a forehead region or an anterior fontanelle region of the mammal subject, and wherein the extremity region comprises one or more of a limb region, a foot region, a hand region, a toenail region, and a fingernail region of the mammal subject” Claim 51 “wherein the sensor member of the first sensor system comprises at least two electrodes spatially apart from each other for electrocardiogram (ECG) generation”); and
wherein the electrode distance D is adjustable between a minimal electrode distance Dmin and a maximal electrode distance Dmax wherein the minimal electrode distance Dmin represents a distance between the at least two electrodes when the torso sensor system is in a non-stretched state, and the maximal electrode distance Dmax represents a distance between the at least two electrodes when the torso sensor system is in a maximally stretched state (Claim 49 “wherein each two adjacent sensor systems are spatially separated by a respective distance that is adjustable between a minimal distance and a maximal distance”).
‘168 does not teach the dynamic baseline control for compensating variability and generating an effective driving current. Lisogurski, in the same field of endeavor, teaches a physiological monitoring system with sensors like PPG ([0022]) and EKG ([0096]) to generate a signal with amplifiers (Abstract), and further teaches wherein at least one of the first sensor system and the second sensor system further comprises a dynamic baseline control module configured to automatically compensate for mammal subject-to- mammal subject variability and generate an effective driving current to ensure sufficient signal-to-noise and avoid saturation ([0017] “amplifier outputs a voltage based on the difference between a sensor current received from a photodetector, and an estimated current received from a digital-to-analog converter (DAC).” [0099] “An amount of gain and an offset applied by an amplifier in generating the difference signal may be adjusted based on the ADC, such that the utilization of the dynamic range of the ADC input is optimized [producing an effective driving current]. In some embodiments, a large gain may be applied so that small current changes in the sensor signal may produce measureable voltage changes at the ADC. In some embodiments, the amount of gain and/or offset may be adjusted based on the utilization of the dynamic range of the ADC is maintained at a particular level.” Examiner notes that the difference between sensor current from photodetector and DAC compensates for mammal-to mammal subject variability. Examiner notes that when the dynamic range is optimized, an optimized voltage and current is applied, which automatically ensures sufficient SNR and avoiding saturation.) to apply a larger gained input and resolution without high power and saturating the signal ([0083]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the sensor network for measuring physiological parameters of ‘168, with the dynamic baseline control for compensating variability and generating an effective driving current of Lisogurski, because such a modification would allow to apply a larger gained input and resolution without saturating the signal and requiring high power.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Vavelin et al. (US 20210351508) See [0033], [0060], and claim 22 and (US 20190074585). Bohori et al. (US 20120245649) See [0018]. Monson et al. (US 20210393968). Muller et al. (US 20170031441) See Abstract.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796