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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/12/2026 has been entered.
Response to Arguments
Applicant’s arguments, see page 13, filed 02/12/2026, with respect to 35 U.S.C. 112(b) have been fully considered and are persuasive. Amendments to the claim obviate the rejection of record. The rejection of the claims has been withdrawn.
Applicant's arguments, see pages 14-21, filed 02/12/2026, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. In response to Examiners reply that a human processes measured data and identify conditions, due to Applicant assertion that ECG and PPG signals cannot be performed in the mind, Applicant argues on page 17 that “The human mind has to be able to first sense and/or measure the physiological parameters and the ECG/PPG signals before it can even begin to process the sensed and/or measured parameter and signal data… Neither the physicality of the sensing, nor the technical complexity of the measuring of these parameters and signals can be performed by a human mind… A human cannot mentally amplify or filter ionic signals… Humans cannot mentally detect infrared light absorption in deep tissue. Humans cannot mentally sense chest wall movement to derive heart and respiratory rate”
Examiner disagrees because this is not a requirement under the step 2A prong 1 analysis under 35 U.S.C. 101. Looking at claim 1 of Example 48 of the Guidance Update on Patent Subject Matter Eligibility released in 2024, the receiving of mixed speech signals, which also cannot be done in the human mind, has no effect on the analysis under step 2A prong 1 because a mathematical concept (abstract idea) is recited as a limitation in the claim. Similarly, the instant claims recite the mental process of identifying conditions of normal, aberrant alarming condition, and calculating PTT or PAT from a time difference.
Applicant then argues on page 18 that “The measuring described in the detailed description is not simple arithmetic (which if so could be construed a mental process), but rather complex signal processing… A human mind cannot do this measurement or even calculate PAT/PTT as a mental process… A human mind cannot synchronize disparate data streams with millisecond precision to calculate PTT… A human cannot do this processing in the mind (or with pen and paper)”.
Examiner disagrees because calculating a PTT or PAT is just measuring the time difference between peaks that a human can analyze and determine. Determining the time difference in time points is a simple task that can be done by observation and evaluation.
Applicant then asserts on page 18 that the electrodes, LEDS, machine, and cuff-less pressure do not fall under the mental process.
Examiner disagrees because the mental process is still recited, that being identifying conditions of normal, aberrant alarming condition, and calculating PTT or PAT from a time difference.
Applicant then asserts on pages 19-20 that Example 38 is equivalent to the instant claims and argues “the analysis under Step 2A Prong 2 and Step 2B is not applicable (N/A) because the claimed steps of simulating an analog audio mixer are not practically performed in the human mind… The human mind cannot: (a) sense one or more physiological parameters time-
synchronized to the common time base, or sense an ECG or PPG signal. Neither can the
human mind (b) receive these sensed ECG and PPG signals to process the received
sensed signals. Further, in no way can the human mind (c) calculate a PAT or PTT value
based on a time difference between a pulse sensed by an ECG sensor system and a pulse
sensed by a PPG sensor system.”
Examiner disagrees. Example 38 does not recite the mathematical concept or mental process in the claim. The instant claims actively recite the determining of peaks, the calculation of PAT or PTT, and the identification of a normal or aberrant signal.
In regards to Desjardins, Applicant lastly argues on page 21 that “The 2025 Memo cautions against assuming recitation when claims "merely involve" an idea (p. 3). Claim 48's hardware-integrated network enables non-invasive monitoring (e.g., cuffless BP) via means that cannot be replicated mentally.”
Examiner disagrees because Desjardins is directed to the improvement of storage, and also not pertinent to the fact patterns of the instant case. Therefore, the rejection of the claims is maintained.
Applicant’s arguments, see pages 21-26, filed 02/12/2025, with respect to the rejection(s) of claim(s) 48-89 under 35 U.S.C. 103 have been fully considered. Applicant argues improper hindsight and that Acquista and Bhushan does not teach sensor-level time synchronization with local clocks or integrating PAT/PTT calculation for condition identification.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Examiner further notes that Acquista does teach sensor-level time synchronization with local clocks or integrating PAT/PTT calculation for condition identification in [0124]-[0126].
Applicant argues on page 23-24 that the sensor-level synchronization and PAT/PTT based identification yields unexpected results in neonatal monitoring.
Examiner disagrees because Applicant has failed to provide evidence of the unexpected results, through the disclosure of data.
Applicant lastly argues on pages 23-24 that Acquista and Bhushan suffer from technical incompatibility, specifically “Both prioritize receiver-side processing; implementing sensor-level synchronization would render systems inoperable without redesign. To achieve the claimed PAT/PTT use for conditions, one must integrate local clocks-a configuration neither suggests.”
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, both references are directed to a wearable device for obtaining physiological parameters and transferring of data across devices, and the combination is obvious because it enables a user’s to take the necessary precautions based on the calculations done.
Nevertheless, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of Bhushan et al. (US 20170347894)(Hereinafter Bhushan) and Muller et al. (US 20170031441)(Hereinafter Muller).
Claim Objections
Claim 48 is objected to because of the following informalities: the phrase “at least one of a sensed ECG signal ” should be amended to recite “at least one of a sensed ECG signal or a sensed PPG signal”. Appropriate correction is required.
Claim 93 is objected to because of the following informalities: the phrase “wherein each of the plurality of time- synchronized sensor systems are encapsulated”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 48-89 and 91-93 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.
Claim 48 recites the limitation "the other sensor system" in page 4 lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 83 recites the limitation "the physiological parameters" in page 4 lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 84 recites the limitation " at least one of the physiological parameters " in page 4 lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claims 49-89 and 91-93 are rejected due to their dependency on claim 48.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 48-89 and 91-93 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claims 48 recites a step process the received parameter data to generate processed parameter data representing at least one vital sign… calculate a pulse arrival time (PAT) or pulse transit time (PTT) based on a time difference between a pulse sensed by an ECG sensor system and a pulse sensed by a PPG sensor system; and identify an alarming vital sign reading condition or a sensor aberrant signal output condition based on the calculated PAT or PTT, the sensor aberrant output condition including a lead off state where a tissue facing surface of a sensor system is not in intimate contact with an underlying patient surface, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. a storage device, a processing circuitry, implantable medical device), determining values, and identifying different conditions and neurophysiological parameters do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and identifying conditions, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 48 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 48, the following step is an abstract idea:
“process the received parameter data to generate processed parameter data representing at least one vital sign… calculate a pulse arrival time (PAT) or pulse transit time (PTT) based on a time difference between a pulse sensed by an ECG sensor system and a pulse sensed by a PPG sensor system; and identify an alarming vital sign reading condition or a sensor aberrant signal output condition based on the calculated PAT or PTT, the sensor aberrant output condition including a lead off state where a tissue facing surface of a sensor system is not in intimate contact with an underlying patient surface”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could process measured data by looking at peaks of physiological signals, calculating PAT or PTT by observing and evaluating a time difference, and identify conditions such as a normal, aberrant alarming conditions from the processed physiological parameters.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 48, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “plurality of time-synchronized sensor systems”, “ECG sensor system”, “PPG sensor system”, “microprocessor”, “clock or oscillator”, “SoC”, “transceiver”, and “an MCU” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “ECG sensor”, “blood pressure sensor”, “acoustic sensor”, “pulse oximetry sensor”, “temperature sensor”, “accelerometer sensor”, “sensor member”, and “PPG sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “time-synchronized”, “PTT or PAT”, “ECG data”, “PPG signal”, “time difference”, “lead off state”, “vital sign signals”, “parameter data”, “raw signal data”, “alarming vital sign reading condition”, “vital sign parameters”, “(time-synchronized) physiological parameters”, “heart activities, a heart rate, a heart rate variability, a respiratory rate, a respiratory effort, a peripheral oxygen saturation (Sp02), an oxygenation level, a temperature, skin temperature differentials, a body movement, a body position, breathing parameters, a blood pressure, a crying time, a crying frequency, a swallow count, a swallow frequency, a chest wall displacement, heart sounds, a core body position, an asynchronous limb motion, speaking, and a biomechanical perturbation”, “physiological parameter”, “stroke volume, and an ejection fraction”, “heart activities”, “common time base”, and “normal vital sign reading condition, an aberrant sensor output condition, and an alarming vital sign reading condition” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “wireless power harvesting” and “time synchronization” are generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “plurality of time-synchronized sensor systems”, “ECG sensor system”, “PPG sensor system”, “microprocessor”, “clock or oscillator”, “SoC”, “transceiver”, and “an MCU” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “ECG sensor”, “blood pressure sensor”, “acoustic sensor”, “pulse oximetry sensor”, “temperature sensor”, “accelerometer sensor”, “sensor member”, and “PPG sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “time-synchronized”, “PTT or PAT”, “ECG data”, “PPG signal”, “time difference”, “lead off state”, “vital sign signals”, “parameter data”, “raw signal data”, “alarming vital sign reading condition”, “vital sign parameters”, “(time-synchronized) physiological parameters”, “heart activities, a heart rate, a heart rate variability, a respiratory rate, a respiratory effort, a peripheral oxygen saturation (Sp02), an oxygenation level, a temperature, skin temperature differentials, a body movement, a body position, breathing parameters, a blood pressure, a crying time, a crying frequency, a swallow count, a swallow frequency, a chest wall displacement, heart sounds, a core body position, an asynchronous limb motion, speaking, and a biomechanical perturbation”, “physiological parameter”, “stroke volume, and an ejection fraction”, “heart activities”, “common time base”, and “normal vital sign reading condition, an aberrant sensor output condition, and an alarming vital sign reading condition” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “wireless power harvesting” and “time synchronization” are generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
The additional elements of claims 48, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the implantable medical device, processing circuitry, and storage devices, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The ECG sensor, EKG sensor, pulse oximeter sensor, temperature sensor, blood pressure sensor, accelerometer or an acoustic sensor” are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Zhao et al (US 20170258356) teaches the use of ECG/EKG sensors to collect ECG signals ([0006]), Boppart (US 20090306489) teaches the use of a pulse oximetry sensor to measure oxygen saturation ([0011]), Shin et al (US 20060253041) teaches a blood pressure sensor for measuring blood pressure ([0011]-[0012]), Roovers et al (US 20170007166) teaches an accelerometer for detecting motion signals ([0008]), and Gopinathan et al (US 20210338190) teaches a heart sound sensor for detecting heart sounds ([0196]-[0198]).
Dependent claims 49-89 and 91-93 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 48. The dependent claim limitations are directed to the type of data (claims 54-58, 60-62, 77, 81-85, and 92), and generic structure (claim 49-53, 59, 63-76, 78-80, 86-89, 91, and 93).
In summary, claims 48-89 and 91-93 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
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.
Claims 48-54, 56, 59-60, 62-65, 68-78, 80-82, 84, 88-89, and 91-92 rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of Bhushan et al. (US 20170347894)(Hereinafter Bhushan) and Muller et al. (US 20170031441)(Hereinafter Muller).
Regarding claim 48, Acquista teaches A sensor network for measuring physiological parameters of a mammal subject ([0021] “FIG. 1 illustrates a network formed by a plurality of sensors according to an embodiment of the invention;”), comprising:
a plurality of spatially separated sensor systems, wherein: each of the plurality of spatially separated sensor systems are time-synchronized by a common time base to each other as a plurality of time- synchronized sensor systems ([0098] “two, three or more ECG sensor packages 300 may be used by a subject. The data collected from these packages can, if properly synchronized or aligned, be used to generate data that is similar to the configuration of traditional 3-lead, 5-lead or 12-lead ECG leads… To facilitate such synchronization or timing alignment, a master clock may be used to synchronize or align sample acquisition within a specified tolerance. In particular, one node in the network, such as the master node or a local device, may be used to generate a master clock signal that is used to synchronize or otherwise align sample acquisition times across all of the nodes.”),
each of the plurality of time-synchronized sensor systems are adapted to be attached to a respective location of the mammal subject (Fig. 3);
each of the plurality of time-synchronized sensor systems includes a sensor member, a system on a chip (SoC) and a transceiver ([0063] “the flexible circuit boards 550 [SoC] may be molded into the substrate 510, and during this molding process a tool of the mold may form a respective depression in each of the flexible circuit boards 550 which forms the U-shaped depression or bulge around which the substrate 510 is molded.” [0067] “in preferred embodiments, the wireless transceiver is disposed within one compartment 501 at the end of one leg of the L-shaped structure”),
the sensor member of each time-synchronized sensor system is adapted to sense one or more physiological parameters time-synchronized to the common time base, and at least on sensor member in the plurality of time-synchronized sensor systems is adapted to sense an electrocardiogram (ECG) signal or to sense a photoplethysmogram (PPG) signal ([0124] “continuous blood pressure measurements can be developed using a single ECG sensor 300 in combination with the second embodiment sensor package 600, and more specifically, with the data developed by a plethysmographic sensor 603” [0080] “the gathering of ECG data via first sensor package 300…each sensor package 300, 600 may directly communicate and synchronize with the local monitoring device to send sensor data directly to the local monitoring device.”),
the system on a chip (SoC) having a microprocessor coupled to the sensor member and configured to: (a) receive raw signal data from the sensor member, the raw signal data comprising at least one of a sensed ECG signal and a sensed PPG signal, and process the raw signal data to generate processed signal data; and (b) receive one or more sensed physiological parameters from the sensor member and process the received parameter data to generate processed parameter data representing at least one vital sign: ([0067] “The central compartment 502 at the juncture of the legs of the L-shaped structure could contain, for example, the digital processing equipment, including a microprocessing unit, memory (volatile, non-volatile or both) and the program code stored in the memory and executable by the microprocessing unit to control operations of the sensor package 300. Suitable traces are provided on the flexible circuit boards 550 to deliver ECG and ground signals from the respective electrodes 402-408 to the analog front end 299 in compartment 503” [0050] “The digitized ECG signals from the analog front end 299 are passed through to a micro-processing unit (MPU) 260 for processing.” Fig. 2A.” [0125] “The arrival of the pulse wave can be determined, for example, by the peak value of the differentiated plethysmographic signal”), and
the transceiver of each sensor system is coupled to the SoC for wireless data transmission of the processed signal data and processed parameter data… ([0016] “a wireless transceiver to wirelessly transmit the corresponding physiological data.” [0080] “each device 300, 600 supports wireless communications for data transfer, thus eliminating the need for wires and other physical connections. The devices 300, 600 also support wireless synchronization between themselves and/or another device to ensure data integrity when collecting sensor information across multiple nodes, especially for measurements that require high fidelity, such as ECG measurements” [0101] “To ensure synchronization (i.e., an understanding of the time alignment of the collected data) of the nodes 120-140 , in preferred embodiments network systems, the system establishes a periodic synchronization signal which is sent to the three sensor nodes 120-140 from, for example, the master node 110.” Examiner also notes that data transmission and wireless power harvesting is intended use.)
a microcontroller unit (MCU) adapted to be in wireless communication with the plurality of time-synchronized sensor systems for the wireless data transmission of the processed signal data and processed parameter data to and from the plurality of time-synchronized sensor systems ([0101] “To ensure synchronization (i.e., an understanding of the time alignment of the collected data) of the nodes 120-140, in preferred embodiments network systems, the system establishes a periodic synchronization signal which is sent to the three sensor nodes 120-140 from, for example, the master node [MCU] 110” [0045] “The master node can also include a portable device having a processor” [0044] “A control or master node can include a communication component configured to wirelessly receive signals from each of the plurality of wireless sensors, and send data and/or commands to each of the plurality of wireless sensors.”),
wherein the MCU is further configured to:
receive the sensed one or more time-synchronized physiological parameters from the plurality of time-synchronized sensor systems (Fig. 16 and [0125] “Pulse transit time (“PTT”) is first calculated, which can be defined as the time delay between the R-wave of the ECG signal obtained from the ECG sensor 300 and the arrival of the pulse wave in the periphery, as measured by the oxygen sensor 603 in the secondary sensor 600.”);
calculate a pulse arrival time (PAT) or pulse transit time (PTT) based on a time difference between a pulse sensed by an ECG sensor system and a pulse sensed by a PPG sensor system ([0122] “With data synchronization between the various nodes, the master node 110, or a computing device to which the master node 110 [MCU] is connected and providing the sample values 1006 and related sample times t.sub.s, can generate medically useful information that might not otherwise be possible if the data packets 1010 were not synchronized in time with each other in a known way. The following provides two non-limiting examples.” [0124] “By way of another example, continuous blood pressure measurements can be developed using a single ECG sensor 300 in combination with the second embodiment sensor package 600, and more specifically, with the data developed by a plethysmographic sensor 603” [0125] “Pulse transit time (“PTT”) is first calculated, which can be defined as the time delay between the R-wave of the ECG signal obtained from the ECG sensor 300 and the arrival of the pulse wave in the periphery, as measured by the oxygen sensor 603 in the secondary sensor 600.”); and
identify an …vital sign reading condition … based on the calculated PAT or PTT, the sensor aberrant output condition including a lead off state where a tissue facing surface of a sensor system is not in intimate contact with an underlying patient surface ([0126] “The blood pressure BP.sub.cal is measured at a known calibration time “cal” using a conventional sphygmomanometer. A blood pressure BP.sub.PTT,CAL at this calibration time “cal” is then calculated as a function of PWV at the calibration time (i.e., using PTT as measured at the this calibration time “cal”), and can be given (when the secondary sensor 603 is placed on the fingertip) as” Examiner notes that blood pressure is calculated from PTT.);
wherein each of the plurality of time-synchronized sensor systems further comprises a local clock or oscillator that is synchronized to the common time base such that the sensed one or more time-synchronized physiological parameters of any given sensor system in the plurality of time- synchronized sensor systems are aligned in time with the sensed one or more time-synchronized physiological parameters of the other sensor systems within the plurality of time-synchronized sensor systems prior to wireless transmission ([0112] “Upon receipt of a first synchronization packet 1001, the sensor node 120-140 obtains the time of receipt t.sub.RS1 of this first synchronization packet 1001 as measured by its base clock 1004. Upon receipt of an immediately subsequent second synchronization packet 1001, the sensor node 120-140 obtains the time of receipt t.sub.RS2 of this second synchronization packet 1001.” [0099] “By way of example, and with reference back to FIG. 1 (and considering the case in which each cluster 120, 130, 140 has only a single node), in one embodiment it may be desirable to wirelessly capture ECG signals from three sensor nodes 120-140, such as from three ECG sensor packages 300, on a subject and provide a composite waveform which is a combination of the signals from the three nodes 120-140. To do so, the signals from the nodes 120-140 are preferably aligned in time in a known manner to within +/−1 to 2 msec or even better, depending upon the processing that is subsequently performed on the collected data.” Examiner notes that Fig. 19 shows the master node sends the synchronization to the sensor nodes which synchronize the physiological signal at the sensor node, and then wirelessly transmit them to the master node, which is clarified in [0101] “To ensure synchronization (i.e., an understanding of the time alignment of the collected data) of the nodes 120-140”. This inherently required the transmitting of synchronized ECG to the sensor node.),
wherein the one or more time-synchronized physiological parameters adapted to be sensed by a sensor member of each time-synchronized sensor system comprise one or more of heart activities, a heart rate, a heart rate variability, a respiratory rate, a respiratory effort, a peripheral oxygen saturation (SpO2), an oxygenation level, a temperature, a skin temperature differentials, a body movement, a body position, a breathing parameters, a blood pressure, a crying time, a crying frequency, a swallow count, a swallow frequency, a chest wall displacement, a heart sounds, a core body position, an asynchronous limb motion, a speaking, and a biomechanical perturbation, wherein the heart activities include a stroke volume, and an ejection fraction ([0078] “the first sensor 601 may be a skin temperature sensor, the second sensor 602 may be a sweat and/or hydration sensor and the third sensor 603 may be a blood oxygen sensor.”).
However, Acquista does not teach a transceiver for wireless power harvesting and identifying an alarming vital sign reading condition, based on the processed data of the physiological parameters. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further teaches and the transceiver of each sensor system is coupled to the SoC for wireless data transmission of the processed time-synchronized physiological parameters and for 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. Examiner also notes that data transmission and wireless power harvesting is intended use.)
identify an alarming vital sign reading condition or a sensor aberrant signal output condition based on the calculated PAT or PTT, the sensor aberrant output condition including a lead off state where a tissue facing surface of a sensor system is not in intimate contact with an underlying patient surface ([0013] "Yet another object of the present invention is to transmit alerts to the user and to one or more authorized contacts when there is a variation of the blood pressure beyond a pre-determined threshold." Blood pressure is the vital sign that is recorded, and Acquista determines BP from PTT. The alert/alarm occurs during a variation in blood pressure. Examiner notes that the claim recites the term “or” which means only one limitation is required.) to enable a user to take proper precautions ([0089]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the system of Acquista, with the transceiver for wireless power harvesting and identifying an alarming vital sign reading condition, based on the processed data of the physiological parameters of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Acquista does not teach a transceiver comprising a magnetic coil for wireless data transmission and power harvesting through a single link. Muller, in a similar field of endeavor, teaches a wireless medical device with data transmission capabilities, similar to the system of Bhushan. Although Muller is directed to an implantable device for electrocorticography, both Bhushan communicate using a transceiver the data collected for analysis. Muller further teaches the transceiver of each sensor system is coupled to the SoC for wireless data transmission of the processed time-synchronized physiological parameters and for wireless power harvesting ([0036] “In a preferred embodiment, a single-loop antenna 112 (e.g. 6.5 mm diameter) [magnetic single coil link] is monolithically integrated together with the array 120 neural electrodes 106, and is used for both power and data telemetry.” Examiner notes that the simultaneous data transmission and power harvesting through a single link is intended use.) to remove the need for cables and plugs ([0035]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the system of Acquista, with the transceiver comprising a magnetic coil for wireless data transmission and power harvesting through a single link of Muller, because such a modification would allow to remove the need for cables and plugs.
Regarding claim 49, 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 claim 50, Bhushan teaches wherein the plurality of time-synchronized sensor systems comprises 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 ([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 sternum is part of the chest region which encompasses the central region and the finger/toe is the foot/hand region.).
Regarding claim 51, Bhushan teaches wherein the sensor member of the first sensor system comprises at least two electrodes spatially apart from each other 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”).
Regarding claim 52, Bhushan teaches wherein the sensor member of the second sensor system comprises a photoplethysmogram (PPG) sensor comprising an optical source and an optical detector located within a sensor footprint (Claim 14 a reflective PPG (photoplethysmograph) sensor on the underside of the device, the reflective PPG sensor comprising of at least two or more LEDs, including one red and one infra-red LED, and one or more photodiodes”).
Regarding claim 53, 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 claim 54, Bhushan teaches wherein the accelerometer or the IMU is used to measure at least one of seismocardiography (SCG) and a respiratory rate ([0041] “The accelerometer(s) records Seismocardiography (SCG) when affixed to particular parts of the chest.” And claim 4 “respiration cycles”).
Regarding claim 56, Bhushan teaches wherein critical parameters of the one or more time-synchronized physiological parameters include one or more of the heart parameters, brain activities, temperature, body movements, respiratory parameters, oxygenation, vocalization parameters, swallow parameters, and blood pressure and blood flow ([0018] “the 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… hence calculate a very accurate value of blood pressure for each user, and also show correlations with other parameters.”).
Regarding claim 59, Bhushan teaches wherein the MCU is configured to perform at least one function of:
transmitting at least one of the processed parameter data and processed signal data of the physiological parameters to at least one of a patient database, a cloud server, and a mobile device (Fig. 4 and Fig. 5 where processed data regarding the blood pressure goes to the smartphone and cloud server.);
continuously multi-modal monitoring one or more critical parameters associating at least one vital sign; and notifying a practitioner or caregiver when a sensor aberrant signal output condition occurs ([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”); and
generating an alarm when an alarming vital sign reading condition in which the one or more of the critical parameters are out of pre-defined ranges occurs, and notifying a practitioner or caregiver of the alarm ([0089] “The system further includes a system to automatically alert [alarm] 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 60, Bhushan teaches wherein the MCU is configured to further perform at least one function of:
localizing anatomical pathology based on the one or more time-synchronized physiological parameters sensed by the plurality of time-synchronized sensor systems placed in differential locations ([0019] “The present invention provides the blood pressure monitoring system described herein allowing the wearable device (biostrip) to send automatic alerts to user, and authorized third party contacts, when abnormal blood pressure levels are detected” [0087] “diagnose and inform the user if he is in a state of hypertension, and also describe the probable cause of the hypertension.” [0088] “The blood pressure monitoring system has the ability to combine all the parameters mentioned above, from multiple locations on the body, with each user wearing one or more wearable devices (bio-strip), and thus obtaining derived parameters that combine information from various locations.”); and
detecting an apneic event when sudden decreases or cessation of the respiratory rate followed by compensatory increases in the heart rate and decreases in the SpOz, and notifying a practitioner or caregiver when the apneic event occurs, and vibrating the sensor systems itself to trigger the mammal subject to change its position or awake from sleep ().
Regarding claim 62, Bhushan teaches wherein the MCU comprises a mobile device for at least one of real-time display of the one or more time- synchronized physiological parameters, recording of the one or more time- synchronized physiological parameters, and alarm ([0096] “The system used information collected from other sensors on the smartphone or tablet or other device, about the user's environment, in order to present the parent or care-giver with a periodic report of the blood pressure levels recorded during different activities, at different times of the day.” The smartphone records the physiological parameters such as blood pressure. Or [0101] “The wearable (Biostrip) device also contains status diodes 109 which indicate different states of the device, and a vibration motor 108, which can alert [alarm] the user when configured to do so, either by the MCU or upon receiving an instruction from the smartphone.”).
Regarding claim 63, Bhushan teaches wherein the mobile device in bi-directionally wireless communication with the plurality of time- synchronized sensor systems ([0044] “The Biostrip also contains an integrated circuit for wireless data communication that enables it to connect and communicate, and send to and receive data [bi-directional] from, a smartphone/smartwatch” The biostrip contains the plurality of spatially separated sensor systems.).
Regarding claim 64, Bhushan teaches wherein the mobile device is in wireless communication with the patient database ([0110] “FIG. 5 illustrates that this above mentioned data is stored in a centralized, secure database that is HIPAA compliant.” HIPPA compliant databases means that it is storing patient information. See Fig. 5.).
Regarding claim 65, Bhushan teaches wherein the mobile device is a hand-held device or a portable device having a graphical user interface to display the one or more time-synchronized physiological parameters ([0044] “The Biostrip also contains an integrated circuit for wireless data communication that enables it to connect and communicate, and send to and receive data from, a smartphone/smartwatch” The smartphone must have a GUI (hence the name “smart” phone) and is a hand-held device. Even if it doesn’t, [0083] “the device also contains an electronic display, which allows the User to observe different parameters in the device itself. The display may further have the capability to detect the touch of the User, and accept commands using a touchscreen.” The smartphone must have a GUI (hence the name “smart” phone) and is a hand-held device.).
Regarding claim 68, Bhushan teaches wherein the electronic components of each of the plurality of time-synchronized sensor systems further comprises 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.).
Acquista 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 Acquista, 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 69, 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 70, claim 48 is obvious over Bhushan, Acquista, and Muller. Acquista 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 wherein the electronic components of each of the plurality of time-synchronized sensor systems further comprises a failure prevention element that is a short-circuit protection component or a battery circuit to avoid battery explosion ([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.) 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 Acquista, with flame retardant material of Baxi, because such a modification would allow to avoid battery explosion.
Regarding claim 71, claim 48 is obvious over Bhushan, Acquista, and Muller. Acquista 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 Acquista, with flame retardant material of Baxi, because such a modification would allow to avoid flammability of the device.
Regarding claims 72-73, Bhushan teaches wherein at least one of the plurality of time-synchronized sensor systems further comprises an actuator/electromechanical motor configured to generate a force for providing a stimulus to the mammal subject when a pre-defined trigger signal is detected ([0042] “the Biostrip contains a vibration motor [actuator/electromechanical motor] to alert the user under certain predefined circumstances [trigger signal]. Alerts are sent when some abnormality is detected from the bio-signals being recorded.” The vibration motor generate a force as the vibration [stimulus] is felt by the user.).
Regarding claim 74, Bhushan teaches further comprising a power unit for wirelessly powering the sensor systems ([0082] “the Biostrip device also contains a photoelectric and/or thermoelectric module [power unit] for harvesting energy from the light or heat in the environment, or the heat emanating from the body, or energy generated from motion. This energy is used to charge the battery, or to run the components of the device itself.” Wireless powering of the sensor systems is intended use.).
Regarding claim 75, Bhushan teaches being capable of operating wirelessly for a period of at least 24 hours without a source of external power ([0037] “The wearable device (hereon referred to as the “Biostrip” device) includes an electronic module or a component that is reusable and rechargeable”). Bhushan discloses the claimed invention except for wirelessly operating for at least 24 hours without an external power source. It would have been obvious to one having ordinary skill in the art at the time the invention was made to operate for at least 24 hours without an external power, for the purpose of the device being completely wireless and self-contained ([0037]), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 76, 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 77, Bhushan teaches deploying the sensor network of claim 1, wherein at least one first sensor system is attached to a central region of the mammal subject and at least one second sensor system is 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 ([0048] "the blood pressure is calculated from a combination of measurements from two wearable (bio-strip) devices: one affixed on the sternum, and measuring ECG, SCG, IPG, and another one affixed on the wrist or forehead or other part of the exposed skin, measuring PPG.");
synchronizing the at least one first sensor system and at least one second sensor system to a common time base to realize time-synchronized at least one first and second sensor systems ([0047] " the pulse transit time (PTT), calculated as the delay between the R-peak of the ECG, and the beginning, or the half-way point, or the peak of the PPG pulse" This allows for a common base time to occur because delaying the R wave to a peak PPG allows to connect the signals together based on a common time.);
measuring data of the one or more time-synchronized physiological parameters from the time-synchronized at least one first and second sensor systems to realize measured parameter data ([0047] ", the blood pressure is calculated from a combination of: (a) the pulse transit time (PTT), calculated as the delay between the R-peak of the ECG, and the beginning, or the half-way point, or the peak of the PPG pulse;"); and
wirelessly transmitting the measured parameter data ([0044] "The Biostrip also contains an integrated circuit for wireless data communication that enables it to connect and communicate, and send to and receive data from, a smartphone/smartwatch").
However, Bhushan does not teach the time-synchronization of sensor systems to a common time base to sense time-synchronized physiological parameters. Acquista, in the same field of endeavor, teaches, and further teaches a plurality of spatially separated sensor systems that are time-synchronized to a common time base to sense time-synchronized physiological parameters ([0098] “two, three or more ECG sensor packages 300 may be used by a subject. The data collected from these packages can, if properly synchronized or aligned, be used to generate data that is similar to the configuration of traditional 3-lead, 5-lead or 12-lead ECG leads… To facilitate such synchronization or timing alignment, a master clock may be used to synchronize or align sample acquisition within a specified tolerance. In particular, one node in the network, such as the master node or a local device, may be used to generate a master clock signal that is used to synchronize or otherwise align sample acquisition times across all of the nodes.”) a microcontroller unit (MCU) adapted in wireless communication with the plurality of spatially separated sensor systems for the wireless data transmission of the time-synchronized physiological parameters ([0101] “To ensure synchronization (i.e., an understanding of the time alignment of the collected data) of the nodes 120-140, in preferred embodiments network systems, the system establishes a periodic synchronization signal which is sent to the three sensor nodes 120-140 from, for example, the master node 110” [0045] “The master node can also include a portable device having a processor”) to correct for differences in the clock and align the samples in each data packet ([0101]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the system of Bhushan, with the time-synchronization of sensor systems to a common time base to sense time-synchronized physiological parameters of Acquista, because such a modification would allow to correct for differences in the clock and align the samples in each data packet.
Regarding claim 78, Bhushan teaches wherein said wirelessly transmitting the measured parameter data is performed with the MCU in wireless communication with the time-synchronized at least one first and second sensor systems ([0044] "The Biostrip also contains an integrated circuit for wireless data communication that enables it to connect and communicate, and send to and receive data from, a smartphone/smartwatch").
Regarding claim 79, Bhushan teaches wherein said wirelessly transmitting the measured parameter data comprises:
transmitting the measured parameter data to at least one of a patient database, a cloud server, and a mobile device ([0044] "The Biostrip also contains an integrated circuit for wireless data communication that enables it to connect and communicate, and send to and receive data from, a smartphone/smartwatch" See Fig. 5.).
Regarding claim 81, Bhushan teaches further comprising continuously multi-modal monitoring one or more critical parameters associated with the alarming vital sign reading condition ([0047] “the pulse transit time (PTT) [critical parameter], calculated as the delay between the R-peak of the ECG [vital sign], and the beginning, or the half-way point, or the peak of the PPG pulse [vital sign];”);
and notifying a practitioner or caregiver when the sensor aberrant signal output condition occurs ([0089] “The system further includes a system to automatically alert the user, or any authorised third party (friend, family, doctor or other care-giver) when the computed blood pressure levels cross a certain predefined or adaptive threshold”). Baxi does teach the cancellation of motion artifacts ([0066]), however Bhushan and Baxi do not teach notifying a practitioner when a motion artifact in a signal [sensor aberrant output] occurs. Notifying for when a motion artifact occurs in a signal would allow to warn that a signal has an issue, in order to find a way to cancel the noise from the signal (Baxi [0066]) It would have been obvious to one having ordinary skill in the art at the time the invention was made to notify a practitioner of motion artifact occurrence in a signal, for the purpose of cancelling the noise from the signal, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 82, Bhushan teaches further comprising generating an alarm when an alarming vital sign reading condition occurs in which the one or more of the critical parameters are out of pre-defined ranges, and notifying a practitioner or caregiver of the alarm ([0089] “The system further includes a system to automatically alert [alarm] 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 84, Bhushan teaches further comprising displaying at least one of the physiological parameters, notifications, and the alarm in a display having a graphical user interface ( [0083] “the device also contains an electronic display, which allows the User to observe different parameters in the device itself. The display may further have the capability to detect the touch of the User, and accept commands using a touchscreen.”).
Regarding claim 88, Bhushan teaches further comprising actuating an actuator to generate a force for providing a stimulus to the mammal subject when a pre-defined trigger signal is detected, wherein the stimulus comprises gentle vibrations for soothing the mammal subject ([0042] “the Biostrip contains a vibration motor [actuator] to alert the user under certain predefined circumstances [trigger signal]. Alerts are sent when some abnormality is detected from the bio-signals being recorded.” Examiner notes that the user will feel a vibration, as taught in [0019], and that the terms “gentle” and “soothing” do not add to the claim as the vibration is still felt by the user. Additionally, the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The vibration motor generate a force as the vibration [stimulus] is felt by the user.).
Regarding claim 89, Bhushan teaches A non-transitory tangible computer-readable medium storing instructions which, when executed by one or more processors, cause the method of claim 31 to be performed ([0021] "The present invention facilitates automatic storage of all the blood pressure data in a secure location on the cloud, and allows doctors and care-givers to view this data easily through a web client, at their own convenience.").
Regarding claim 91, Bhushan teaches wherein the plurality of time-synchronized sensor systems further comprise:
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 each sensor member of the first and second sensor systems comprises one or more of an ECG sensor, an EKG sensor, a pulse oximeter sensor, a temperature sensor, a blood pressure sensor, an accelerometer, and an acoustic sensor ([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 sternum is part of the chest region which encompasses the central region and the finger/toe is the foot/hand region.”).
Regarding claim 92, Acquista teaches wherein the lead off state is detected by monitoring impedance or signal quality from the sensor member (Examiner notes that claim 48 requires either alarming vital sign reading condition or sensor aberrant signal output. Since Examiner selected alarming vital sign reading condition, the lead off state is not required.).
Claims 55, 57-58, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of Bhushan et al. (US 20170347894)(Hereinafter Bhushan), Muller et al. (US 20170031441)(Hereinafter Muller), and Baxi (US 20190209028)(Hereinafter Baxi).
Regarding claim 55, claim 48 is obvious over Bhushan, Acquista, and Muller. However, Acquista fails to teach corrected motion artifacts. 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 accelerometer or the IMU is used with a motion artifact module to identify a vital sign as subject to motion artifact and to correct of motion artifact ([0041] “The signals from one or more of the motion, noise, and stretch sensor [motion artifact module] can be used for adaptive noise cancellation and can help reduce motion related noise from bio-signals.” Which can affect the [0027] “PPG signal quality as there is less signal degradation due to motion of the torso in ambulatory conditions as compared to the signal degradation due to motion of fingers or hand.” PPG signal is used to obtain the blood pressure [vital sign].) to reduce the motion related noise from the bio-signal ([0041]). 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 Acquista, with the motion artifact module to correct motion artifacts of Baxi, because such a modification would allow to reduce the motion related noise from the bio-signal.
Regarding claim 57, claim 48 is obvious over Bhushan, Acquista, and Muller. However, Acquista fails to teach motion artifacts. 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 sensor aberrant signal output condition further includes a patient motion artifact, and/or an output discrepancy relative to at least two different sensor systems ([0041] “The signals from one or more of the motion, noise, and stretch sensor [motion artifact module] can be used for adaptive noise cancellation and can help reduce motion related noise from bio-signals.” Which can affect the [0027] “PPG signal quality as there is less signal degradation due to motion of the torso in ambulatory conditions as compared to the signal degradation due to motion of fingers or hand.” PPG signal is used to obtain the blood pressure [vital sign].) to reduce the motion related noise from the bio-signal ([0041]). 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 Acquista, with the motion artifact module to correct motion artifacts of Baxi, because such a modification would allow to reduce the motion related noise from the bio-signal.
Regarding claim 58, claim 48 is obvious over Bhushan, Acquista, and Muller. However, Acquista fails to teach motion artifacts. 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 sensor aberrant signal output condition is identified when at least one vital sign detected from the first sensor system differs from that detected from the second sensor by 25% or greater ([0027] “Also, the signal quality of the PPG device 104 can degrade under ambulatory conditions. Motion artifacts can corrupt the PPG signal (e.g., by moving the PPG device 104) making it difficult to sufficiently locate a corresponding fiducial point of the PPG data for PTT measurement.” Since ECG and PPG [vital signs] are both used to determine PTT for time-synchronized PPG and ECG data, and the fiducial points of the PPG signal cannot be located due to motion artifacts, the ECG and PPG signals must differ by more than 25% since the PPG signal cannot be used.) to reduce the motion related noise from the bio-signal ([0041]). 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 Acquista, with the motion artifact module to correct motion artifacts of Baxi, because such a modification would allow to reduce the motion related noise from the bio-signal.
Regarding claim 66, claim 48 is obvious over Bhushan, Acquista, and Muller. However, Acquista 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 each of the plurality of time-synchronized sensor systems further comprises:
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, wherein the tissue-facing surface is configured to conform to a skin surface of the mammal subject (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.) 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 Acquista, 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.
Claims 61 and 83 are rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of Bhushan et al. (US 20170347894)(Hereinafter Bhushan), Muller et al. (US 20170031441)(Hereinafter Muller), Picard et al. (US 20100268056)(Hereinafter Picard), and DeBusschere et al. (US 20160338599)(Hereinafter DeBusschere).
Regarding claims 61 and 83, Bhushan teaches wherein the MCU is configured to further perform at least one function of:
assessing body pain of the mammal subject, based on the physiological parameters including a heart rate, …, respiratory rate, respiratory effort…, and notifying a practitioner or caregiver where the pain is assessed (Claim 9 “Heart Rate, Respiration Rate, Pulse Wave Velocity, Blood Pressure, Respiratory Sinus Arrhythmia, and Cardiac Time Intervals” [0025] “respiration cycles [respiratory effort]” [0089] “a system to automatically alert the user, or any authorised third party (friend, family, doctor or other care-giver) when the computed blood pressure levels cross a certain predefined or adaptive threshold” An example of a different blood prerssure: [0091] “the application running on the computing device also trigger other kinds of responses/alerts for the user, upon detecting different levels of blood pressure that are indicative of hypertension”).
However, Acquista does not teach a crying time. Picard, in the same field of endeavor, teaches a washable and wearable biosensor that gathers PPG, ECG and motion data and analyzes real-time lifestyle activities (Abstract), and further teaches a crying behavior (this must occur during a time period) to monitor physiological arousal for infants ([0107]). 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 Acquista, with the crying time of Picard, because such a modification would allow to monitor physiological arousal for infants.
However, Acquista do not teach a heart rate variability used to assess body pain. DeBusschere, in a similar field of endeavor, teaches synchronizing cardiovascular sensor to sense hemodynamics (Abstract), and further teaches monitoring heart rate variability to assess a patient’s cardiovascular health ([0005]). 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 Acquista, with the heart rate variability of DeBusschere, because such a modification would allow to assess a patient’s cardiovascular health.
Claims 67 is rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of Bhushan et al. (US 20170347894)(Hereinafter Bhushan), and Muller et al. (US 20170031441)(Hereinafter Muller), Symons et al. (US 20080272889)(Hereinafter Symons), and Hirsch et al. (US 9866282)(Hereinafter Hirsch).
Regarding claim 67, claim 48 is obvious over Bhushan, Acquista, and Muller. Acquista does not teach a transceiver comprising a magnetic coil for wireless data transmission and power harvesting through a single link. 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, Acquista, Muller, and Symans 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.
Claims 80 and 85-87 are rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of Bhushan et al. (US 20170347894)(Hereinafter Bhushan), Muller et al. (US 20170031441)(Hereinafter Muller), and Shay et al. (US 20170119318)(Hereinafter Shay).
Regarding claim 80, claim 48 is obvious over Bhushan, Acquista, and Muller. However, Acquista does not teach a unique patient identifier which identifies physiological parameters with a subject in a database. Shay, in a similar field of endeavor, teaches monitoring the cardiovascular health of a user and generating a cardiovascular parameter based on pulse data from a wearable device (Abstract and Fig. 1), and further teaches further comprising:
associating the wirelessly transmitted measured parameter data with a unique patient identifier, thereby identifying the measured parameter data with the mammal subject in at least one of the patient database, the cloud server, and the mobile device ([0076] “Data received by the processing subsystem 152 can be stored in memory 153 of the processing subsystem 152, stored in remote databases (e.g., in response to transmission by the communications module 154), displayed at an output module 185, stored and/or displayed at a distinct user device, encrypted, and/or otherwise processed. Data received and/or generated by a processing subsystem 152 can be stored and/or presented in association with a user identifier (e.g., name, digital identifier, username and password, biometric identifier, e-mail, etc.) and/or a user account.” And [0078] “parameter determination mode for determining one or more parameters (e.g., identifying initial parameters, updating parameters, optimizing parameters, etc.) according to which components of the RF system 105”) to store data received relating to a user under the identity of the user ([0076]). 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 Acquista, with the unique patient identifier of Shay, because such a modification would allow to store data received relating to a user under the identity of the user.
Regarding claim 85, claim 48 is obvious over Bhushan, Acquista, and Muller. However, Acquista does not teach a secure login to access physiological parameters. Shay, in a similar field of endeavor, teaches monitoring the cardiovascular health of a user and generating a cardiovascular parameter based on pulse data from a wearable device (Abstract and Fig. 1), and further teaches further comprising securing the display of the one or more time-synchronized physiological parameters by requiring a secure login before a user can access the one or more time-synchronized physiological parameters ([0076] “Data received by the processing subsystem 152 can be stored in memory 153 of the processing subsystem 152, stored in remote databases (e.g., in response to transmission by the communications module 154), displayed at an output module 185, stored and/or displayed at a distinct user device, encrypted, and/or otherwise processed. Data received and/or generated by a processing subsystem 152 can be stored and/or presented in association with a user identifier (e.g., name, digital identifier, username and password, biometric identifier [secure], e-mail, etc.) and/or a user account.” Examiner notes that the user needs to login to their account to access their physiological parameters. ) to store data received relating to a user under the identity of the user ([0076]). 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 Acquista, with the unique patient identifier of Shay, because such a modification would allow to store data received relating to a user under the identity of the user.
Regarding claim 86, Bhushan teaches wherein the user is a practitioner or caregiver, the mammal subject or family member, further comprising wirelessly communicating between the practitioner or caregiver and the mammal subject or family member based on the one or more time-synchronized physiological parameters ([0022] “Further, the system allows the user to consult doctors/psychologists or care-givers online, or book appointments with doctors through online, and pay consultation fee through payment gateway, thus completing the loop between diagnosis and treatment.” Consulting with a care-giver or doctor online is a form of communicating wirelessly between the caregiver and the subject.).
Regarding claim 87, Bhushan teaches further comprising securely sending a command from a remote practitioner or caregiver to a practitioner or caregiver in proximity to the mammal subject based on the one or more time-synchronized physiological parameters ([0022] “Further, the system allows the user to consult doctors/psychologists or care-givers online, or book appointments with doctors through online, and pay consultation fee through payment gateway, thus completing the loop between diagnosis and treatment.” And [0098] “The application on the phone further gives recommendations to the user or care-giver or the concerned doctor for different ways of controlling blood pressure levels more effectively at different times of the day.”). However, neither Acquista and Shay teach a command sent from a practitioner or caregiver to a different practitioner or caregiver. Although Bhushan discloses the claimed command from a phone to a care-giver, the physiological parameter regarding blood pressure will need to be regulated ([0098]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to sending a command from a practitioner or caregiver to a different practitioner or caregiver, for the purpose of regulating blood pressure, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 93 is rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of Bhushan et al. (US 20170347894)(Hereinafter Bhushan), Muller et al. (US 20170031441)(Hereinafter Muller), and Wang et al. (US 20170325724)(IDS)(Hereinafter Wang).
Regarding claim 93, claim 48 is obvious over Bhushan, Acquista, and Muller. However, Acquista, Bhushan, and Muller do not teach each of the plurality of time- synchronized sensor systems are encapsulated in a soft biocompatible polymer. Wang, in the same field of endeavor, teaches (Abstract), and further teaches wherein each of the plurality of time- synchronized sensor systems is encapsulated in a soft biocompatible polymer (see paragraph [0108] and claim 1: sensor electrodes disposed on a stretchable substrate are covered with a biocompatible hydrogel layer) to protect the inner layers of the device ([0108]). 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 Acquista, with the each of the plurality of time- synchronized sensor systems are encapsulated in a soft biocompatible polymer of Wang, because such a modification would allow to protect the inner layers of the device.
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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