DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the amendment filed on 09/03/2025. As directed by the amendment: Claims 48, 51-53, 60-61, 77-80, 83-84, and 93 have been amended, claims 1-47 and 90 have been cancelled, and claims 94-96 have been added. Thus, claims 48-89 and 91-96 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see page 14, filed 06/30/2026, with respect to 35 U.S.C. 112(b) and objections have been fully considered and are persuasive. Amendments to the claim obviate the rejection of record. The rejection and objection of the claims have been withdrawn.
Applicant's arguments, see pages 15-20, filed 06/30/2026, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues on page 15 that “The above characterization omits the actual claim structure, which requires spatially separated sensor systems attached to different body locations, each including a sensor member, SoC, transceiver, and synchronized local clock or oscillator, with timestamping of the sensed or measured physiological parameters (at each of the time- synchronized sensor systems) prior to wireless transmission, and subsequent PAT/PTT calculation from ECG and PPG pulses sensed by different sensor systems.”
Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity. 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 asserted additional elements are not a mental process. The sensor member, SoC, transceiver, and synchronized local clock or oscillator are all generic computing components that are additional elements that do not integrate the judicial exception into practical application.
Applicant then argues on page 16 that “Those operations are not practically performable in the human mind. The prior response already framed this point through the physical and technical realities of ECG and PPG sensing, synchronized acquisition, and timing-based computation, and the Examiner's latest rationale still abstracts away the required hardware interactions and distributed synchronization architecture”. Applicant also argues on page 16 that the amendments “are all concrete engineering constraints and functions of a wearable sensor network, not a human mental review of information… the Examiner's comparison of Claim 48 to Example 48 in the 2024 guidance update is misplaced because the rejection here still rests on stripping the claim down to a generalized notion of "calculate a timing difference and identify a condition," while ignoring the expressly recited distributed hardware, synchronized clocks, and pre-transmission timestamping that make the claimed operation technologically specific.”
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. The sensor member, SoC, transceiver, and synchronized local clock or oscillator are all generic computing components that are additional elements that do not integrate the judicial exception into practical application.
Applicant then asserts on page 17 the following are technological improvements:
“(1) local clocks or oscillators synchronized to a common time base,
(2) timestamping the sensed one or more time-synchronized physiological
parameters by the common/local clock of each sensor system prior to transmission of the
timestamped parameter data thereby,
(3) ECG sensing by one sensor system and PPG sensing by another sensor
system, and
(4) PAT/PTT calculation using the timestamped parameter data timestamped on
the sensor side and processed at the SoC, and also using the processed signal data.”
Applicant then argues on page 17 that “Those features are not mere field-of-use limitations or generic data gathering; these features are specific to the hardware organization, and are not mere "data gathering structures for the insignificant extra-solution activity of data gathering"; see [MPEP 2106.05(b)]. In fact, features (1) to (4) above define how the distributed hardware I organized and how the system improves the accuracy and technical reliability of physiologic timing analysis in a multi-sensor network.”
Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application.
Applicant then cites on pages 17-18 that Ex parte Martineau (PTAB, May 2026) where Examiner improperly “asked at Step 2A, Prong Two whether additional elements were well-understood, routine,
and conventional, which is the wrong question for that step. The proper inquiry is whether
the claims integrate any alleged exception into a practical application, including by
improving the relevant technology, and that inquiry requires attention to the specification
and to whether one of ordinary skill would recognize the claimed arrangement as an
improvement.” Applicant then argues that “that same procedural defect is present here. The Office Action repeatedly dismisses the recited sensors, transceivers, clocks, SoCs, and synchronization features
as generic computer components, data gathering, or field-of-use limitations, but does not
perform the required inquiry into whether the claim as a whole reflects a specific
improvement to the relevant monitoring technology… The Examiner treats the hardware as generic and therefore effectively irrelevant, while never meaningfully engaging the disclosed technological improvement in the specification or the way the amended claim now expressly reflects that improvement. Under the Office's own guidance, additional elements may integrate a judicial exception
into a practical application even if some individual components are themselves known,
because the question is whether the claimed arrangement improves technology, not
whether every component is novel in isolation”. Applicant further argues on page 21 that “This case is exactly the kind of case in which those reminders matter because the rejection continues to ignore the technological architecture actually recited and instead reduces the claim to an
overgeneralized result… the Appeals Review Panel criticized reasoning that evaluated claims at too
high a level of generality and warned against collapsing specific technical
implementations into abstract labels without adequate explanation. That concern applies
with equal force here, where the Examiner reduces a synchronized multi-node
physiological sensing network to a supposed mental step of looking at signal peaks and
identifying conditions.”
Examiner disagrees because the improvement Applicant asserts is an improvement to the abstract idea itself. MPEP 2106.05(a) says:
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
The claims are using generic computing components to integrate the abstract idea, which is not enough to show practical application.
Applicant argues on pages 19-20 that “the Office Action cites several references for the proposition that certain sensors were known, the rejection does not support the actual claimed combination as amended: synchronization and timestamping of measured data via local clocks -- all pre- transmission -, cross-location ECG/PPG timing analysis, and differentiation between alarming physiologic conditions and sensor aberrant conditions within the claimed distributed architecture… the Office Action mainly uses conventionality rhetoric to dismiss individual pieces of the claim, but it does not establish that the ordered combination now recited in amended claim 48 (and new claims 94-96) was routine or conventional… Applicant's prior response already emphasized that the claimed architecture differs from receiver-side synchronization approaches and instead requires synchronization and timestamping of the one or more time-synchronized physiological parameters sensed by its corresponding sensor system prior to wireless transmission, which is presented as a technical distinction and improvement over the cited art combinations. [Previous RCE reply, pp. 22]. The new claims are designed to make those distinctions even harder to ignore by forcing the record to confront concrete technical hooks that are directed to improved networked physiological sensing, not abstract data review.”
Examiner disagrees because as noted by Applicant, the additional elements are WURC, but the combination of what Applicant is arguing is simply the implementation of the abstract idea onto a generic computing device, which does not add significantly more. MPEP 2106.05 (I)(A) states that “Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).” Examiner notes that the claims are implemented on a generic computer and are therefore, WURC. Further, the time synchronization of a local clock between sensor systems is generically linking the use of the judicial exception to a particular technological environment or field of use. 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.
Nevertheless, amendments to the claim 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 Holsti et al. (US 20210202061) (Hereinafter Holsti) in view of Shay et al. (US 20170119318)(Hereinafter Shay) and Muller et al. (US 20170031441)(Hereinafter Muller).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 48-89 and 91-96 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 48 has been amended to include the limitation, " the local clock or oscillator of each time-synchronized sensor system further configured to timestamp the one or more time-synchronized physiological parameters sensed by its corresponding sensor system prior to wireless transmission therefrom as timestamped parameter data ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for the private star network that is bound to base station allowing individualized body-sensor synchronization without a central hub so that the timestamped sensor data can be downloaded and used later ([0129] of the PG pub). However, the specification does not provide support for the specific step of timestamping physiological parameter data prior to the wireless transmission, as the cited section does not speak to the wireless transmission of data required after the timestamping of physiological parameter data has occurred. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " the local clock or oscillator of each time-synchronized sensor system further configured to timestamp the one or more time-synchronized physiological parameters sensed by its corresponding sensor system prior to wireless transmission therefrom as timestamped parameter data”. Therefore, the new claim limitations introduce new matter.
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 95 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 95, it is unclear if the “lead off state” of claim 95 the same or different than the “lead off state” of 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 91-96 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
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 timestamped parameter data to generate processed timestamped 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 using the processed signal data and processed timestamped parameter data; 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”, “local clock or oscillator”, “SoC”, “transceiver”, “mobile device”, 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”, “physiological parameter”, “timestamp”, “timestamped parameter data”, “stroke volume, and an ejection fraction”, “heart activities”, “common time base”, “alert or notification”, 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”, “local clock or oscillator”, “SoC”, “transceiver”, “mobile device”, 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”, “physiological parameter”, “timestamp”, “timestamped parameter data”, “stroke volume, and an ejection fraction”, “heart activities”, “common time base”, “alert or notification”, 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 91-96 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, 92, and 94-95), and generic structure (claim 49-53, 59, 63-76, 78-80, 86-89, 91, 93, and 96). Claims 94-95 recites a mental process which is implemented on a generic computer which is well-understood, routine, and conventional.
In summary, claims 48-89 and 91-96 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 48-50, 52, 76-82, 84-85, 89, and 91-92, and 94-95 rejected under 35 U.S.C. 103 as being unpatentable over Holsti et al. (US 20210202061) (Hereinafter Holsti) in view of Shay et al. (US 20170119318)(Hereinafter Shay) and Muller et al. (US 20170031441)(Hereinafter Muller).
Regarding claim 48, Holsti teaches A sensor network for measuring physiological parameters of a mammal subject (Abstract “receiving a data packet from each of a plurality of peripheral devices configured to perform measurements with respect to one or more users and to transmit physiological measurement data on the one or more users to the collector device”), 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 (Fig. 1 peripheral devices 104A-C and 102. Abstract “synchronizing data streams from the plurality of peripheral devices with each other based on the indicated clock values”),
each of the plurality of time-synchronized sensor systems are adapted to be attached to a respective location of the mammal subject (Fig. 1 and 4 [0034] “the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),”);
each of the plurality of time-synchronized sensor systems includes a sensor member, a system on a chip (SoC) and a transceiver, and a local clock or oscillator synchronized to the common time base ([0034] “the data packets may be transmitted and received according to Bluetooth (e.g. BLE) [transceiver] standards. Peripheral device(s) described with respect to FIGS. 2 and 3 may refer to, for example, sensor devices which are discussed above…the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),” [0040] “For example, the peripheral device 410, 420 may start/initiate its clock [local clock] in response and/or upon starting/initiating measurement.” [0099] “Referring to FIGS. 9 and 10, apparatuses 900, 1000 comprise a control circuitry (CTRL) 910, 1010 [system on chip], such as at least one processor, and at least one memory 930, 1030 including a computer program code (software) 932, 1032, wherein the at least one memory and the computer program code (software) 932, 1032, are configured, with the at least one processor, to cause the respective apparatus 900, 1000 to carry out any one of the embodiments described above, such as with reference to FIGS. 1 to 8B, or operations thereof.”),
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 and at least one other sensor member in the plurality of time-synchronized sensor systems is adapted to sense a photoplethysmogram (PPG) signal ([0034] “the data packets may be transmitted and received according to Bluetooth (e.g. BLE) [transceiver] standards. Peripheral device(s) described with respect to FIGS. 2 and 3 may refer to, for example, sensor devices which are discussed above…the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),” [0040] “For example, the peripheral device 410, 420 may start/initiate its clock [local clock] in response and/or upon starting/initiating measurement.” [0030] “broadcasting (block 202) a timing signal on a predetermined radio channel [common time base]…synchronizing (block 206) data streams from the plurality of peripheral devices with each other based on the indicated clock values.”),
the local clock or oscillator of each time-synchronized sensor system further configured to timestamp the one or more time-synchronized physiological parameters sensed by its corresponding sensor system prior to wireless transmission therefrom as timestamped parameter data ([0031] “The time stamp may have been measured with a clock of the respective peripheral device, and the same clock may be used to provide the time stamp and the clock value in the data packet. In other words, as the physiological measurement data is generated in the peripheral device, the time stamp at the time of the generation may be recorded and added to the data packet carrying the physiological measurement data.” See Fig. 4 where each peripheral collects measurement data along with the time stamp prior to wirelessly transmitting the measurement to the collective device for time synchronization.);
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 the timestamped parameter data and process the received timestamped parameter data to generate processed timestamped parameter data representing at least one vital sign: (Fig. 10 (1010 controller/microprocessor connected to sensor 1050) [0034] “Peripheral device(s) described with respect to FIGS. 2 and 3 may refer to, for example, sensor devices which are discussed above…the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),” [0040] “For example, the peripheral device 410, 420 may start/initiate its clock [local clock] in response and/or upon starting/initiating measurement.” [0068] “ECG data and PPG data may be measured by different peripheral devices. The collector device may use the time stamps indicating the (measurement) timing of the measurement data to combine the ECG data with PPG data that both relate to detection of the same blood pulse, thus enabling computation of the PTT and/or PWV.”), and
the transceiver of each sensor system is coupled to the SoC for wireless data transmission of the processed signal data and processed timestamped parameter data… (Fig. 10 (1020) [0101] “The apparatus 900, 1000 may further comprise communication circuitry 920, 1020 (e.g. wireless communication circuitry) comprising hardware and/or software for realizing communication connectivity according to one or more communication protocols, such as Bluetooth or BLE.” Examiner also notes that data transmission and wireless power harvesting is intended use.)
a microcontroller unit (MCU) in wireless communication with the plurality of time-synchronized sensor systems and configured to receive the processed signal data and processed time-stamped parameter data to and from the plurality of time-synchronized sensor systems ([0103] “the apparatus 900 may be or be comprised in a collector device [MCU], such as the collector device 400.”),
wherein the MCU is further configured to:
(c) 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 using the processed signal data and the processed timestamped parameter data (Fig. 4 (450) [0042] “may synchronize the data streams based on the indicated clock values which are obtained from the data packets. It is noted that the data packets may further comprise the timing signal value which is detected by the peripheral device 410, 420 and added to the data packet. Hence, the syncing may be performed based on clock values that are indicated in response to the same broadcasted timing signal (e.g. block 432). It is further noted that the collector device 400 may take this into account when performing the syncing, i.e. that the clock values are indicated in response to the same or possibly different timing signals.” [0074] “the collector device 400 may determine a pulse transit time based on the synchronized first and second cardiac activity data streams (block 718).” [0075] “PTT can be measured from two different cardiac activity data streams. As shown, PTT may denote delay or time between R peak value, obtained from ECG sensor (e.g. ear-ECG, or chest ECG) and PPG foot value, obtained from PPG sensor (e.g. ear-PPG, wrist unit optical sensor, or arm sensor).”).
However, Holsti does not teach a identify an alarming vital sign reading condition or a sensor aberrant signal output condition based on the calculated PAT or PTT and generate an alert or notification for a practitioner, caregiver, or mobile device based on the identified alarming vital sign reading condition or sensor aberrant signal output condition, 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. Shay, in the same field of endeavor, teaches a system for evaluating cardiovascular-related heath for PTT (Abstract), and further teaches (d) identify an alarming vital sign reading condition or a sensor aberrant signal output condition based on the calculated PAT or PTT ([0201] “if a measured result indicates abnormal or critical condition, the user can be alerted and reminded to repeat the measurement after a predetermined time. The predetermined time depends on the biometric being measured. Depending on the condition, if multiple successive measurement results indicate abnormal or critical conditions, the user can be alerted to contact appropriate medical personnel. In an example, medical personnel, and/or a preselected list of people or entities is alerted automatically.”);
(e) generate an alert or notification for a practitioner, caregiver, or mobile device based on the identified alarming vital sign reading condition or sensor aberrant signal output condition;
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 ([0201] “if a measured result indicates abnormal or critical condition, the user can be alerted and reminded to repeat the measurement after a predetermined time. The predetermined time depends on the biometric being measured. Depending on the condition, if multiple successive measurement results indicate abnormal or critical conditions, the user can be alerted to contact appropriate medical personnel. In an example, medical personnel, and/or a preselected list of people or entities is alerted automatically.”) to alert for an aberrant condition of a user ([0201]). 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 Holsti, with the identify an alarming vital sign reading condition or a sensor aberrant signal output condition based on the calculated PAT or PTT and generate an alert or notification for a practitioner, caregiver, or mobile device based on the identified alarming vital sign reading condition or sensor aberrant signal output condition, 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 of Shay, because such a modification would allow to alert for an aberrant condition of a user.
Holsti 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 device of Holsti. 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 Holsti, 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, Holsti 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 ([0034] “Peripheral device(s) described with respect to FIGS. 2 and 3 may refer to, for example, sensor devices which are discussed above…the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),”).
Regarding claim 50, Holsti 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 ([0034] “Peripheral device(s) described with respect to FIGS. 2 and 3 may refer to, for example, sensor devices which are discussed above…the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),”).
Regarding claim 52, Holsti 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 ([0034] “Peripheral device(s) described with respect to FIGS. 2 and 3 may refer to, for example, sensor devices which are discussed above…the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),”).
Regarding claim 76, Holsti teaches wherein the mammal subject is a human subject or a non-human subject (Fig. 1 is a human.).
Regarding claim 77, Holsti teaches deploying the sensor network of claim 48, 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 ([[0034] “Peripheral device(s) described with respect to FIGS. 2 and 3 may refer to, for example, sensor devices which are discussed above…the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),”);
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 ([0068] " Combining ECG and PPG data for obtaining pulse transit time (PTT) and/or pulse wave velocity (PWV). ECG data and PPG data may be measured by different peripheral devices. The collector device may use the time stamps indicating the (measurement) timing of the measurement data to combine the ECG data with PPG data that both relate to detection of the same blood pulse, thus enabling computation of the PTT and/or PWV.”);
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 ([0068] " Combining ECG and PPG data for obtaining pulse transit time (PTT) and/or pulse wave velocity (PWV). ECG data and PPG data may be measured by different peripheral devices. The collector device may use the time stamps indicating the (measurement) timing of the measurement data to combine the ECG data with PPG data that both relate to detection of the same blood pulse, thus enabling computation of the PTT and/or PWV. ");
timestamping, using the local clock or oscillator in each time-synchronized at least one first and second sensor systems, the one or more time- synchronized physiological parameters measured thereby as timestamped measured parameter data ([0031] “The time stamp may have been measured with a clock of the respective peripheral device, and the same clock may be used to provide the time stamp and the clock value in the data packet. In other words, as the physiological measurement data is generated in the peripheral device, the time stamp at the time of the generation may be recorded and added to the data packet carrying the physiological measurement data.” See Fig. 4 where each peripheral collects measurement data along with the time stamp prior to wirelessly transmitting the measurement to the collective device for time synchronization.); and
wirelessly transmitting the timestamped measured parameter data (Fig. 4 transmitting of the time-stamped data.).
Regarding claim 78, Holsti 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 (Fig. 4).
Regarding claim 79, Holsti 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 ([0017] " Thus, for example, the wrist device 102 may be connected (i.e. wirelessly connected) to the portable electronic device 106, such as a mobile phone, smart phone, tablet and/or computer to name a few.").
Regarding claim 80, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do 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 Holsti in view of Muller, 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 81, Shay teaches further comprising continuously multi-modal monitoring one or more critical parameters associated with the alarming vital sign reading condition ([0031] “The RF system (e.g., based on RF detection and ranging) can be compact, non-invasive, and enable continuous monitoring of cardiovascular parameters, overcoming issues of inconvenience, discomfort, lack of adherence, and other issues associated with, for example, a blood pressure cuff.”);
and notifying a practitioner or caregiver when the sensor aberrant signal output condition occurs (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.).
Regarding claim 82, Shay 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 ([0203] “Notifications can trigger when specific conditions are met, including any one or more of: a measurement has not been taken within a specific time period, a scheduled measurement has not occurred, a measured value is outside a range of historical values, a measured value falls within or outside a predefined range, and/or any other suitable conditions.” [0201] “if a measured result indicates abnormal or critical condition, the user can be alerted and reminded to repeat the measurement after a predetermined time. The predetermined time depends on the biometric being measured. Depending on the condition, if multiple successive measurement results indicate abnormal or critical conditions, the user can be alerted to contact appropriate medical personnel. In an example, medical personnel, and/or a preselected list of people or entities is alerted automatically.”).
Regarding claim 84, Holsti teaches further comprising displaying at least one of the physiological parameters, notifications, and the alarm in a display having a graphical user interface ( [0066] “outputting of block 710 may comprise transmitting the physiological parameter to an external device, storing the parameter, displaying the parameter on a display, and/or providing a haptic and/or visual output based on the parameter, to name a few examples.”).
Regarding claim 85, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do 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 Holsti in view of Muller, 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 89, Holsti 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 (Fig. 10 (1030 memory)).
Regarding claim 91, Holsti 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 ([0034] “Peripheral device(s) described with respect to FIGS. 2 and 3 may refer to, for example, sensor devices which are discussed above…the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),” [0040] “For example, the peripheral device 410, 420 may start/initiate its clock [local clock] in response and/or upon starting/initiating measurement.”).
Regarding claim 92, Holsti 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.).
Regarding claim 94, Holsti teaches wherein the ECG sensor system is attached to a central region of the mammal subject and the PPG sensor system is attached to an extremity region of the mammal subject, and wherein the PAT or PTT is calculated from pulses sensed at the different body regions to characterize vascular propagation between the different body regions ([0034] “Peripheral device(s) described with respect to FIGS. 2 and 3 may refer to, for example, sensor devices which are discussed above…the sensor(s) may be comprised in a chest strap (e.g. ECG sensor, such as electrode based measurement), arm or armband that measures PPG, foot pod (e.g. speed sensor, such as a stride sensor),” [0040] “For example, the peripheral device 410, 420 may start/initiate its clock [local clock] in response and/or upon starting/initiating measurement.” [0075] “PTT can be measured from two different cardiac activity data streams. As shown, PTT may denote delay or time between R peak value, obtained from ECG sensor (e.g. ear-ECG, or chest ECG) and PPG foot value, obtained from PPG sensor (e.g. ear-PPG, wrist unit optical sensor, or arm sensor).”).
Regarding claim 95, Holsti teaches wherein the MCU is configured to distinguish the sensor aberrant signal output condition from the alarming vital sign reading condition by determining whether an abnormal PAT or PTT value corresponds to a lead off state or motion-related signal corruption at one of the plurality of time-synchronized sensor systems (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 51, 53-54, 56, 59-60, 62-65, 72-75, and 86-88 rejected under 35 U.S.C. 103 as being unpatentable over Holsti et al. (US 20210202061) (Hereinafter Holsti) in view of Shay et al. (US 20170119318)(Hereinafter Shay), Muller et al. (US 20170031441)(Hereinafter Muller), and Bhushan et al. (US 20170347894)(Hereinafter Bhushan).
Regarding claim 51, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the sensor member of the first sensor system comprises at least two electrodes spatially apart from each other for electrocardiogram (ECG) generation. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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”) 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 Holst in view of Shay and Muller, with the sensor member of the first sensor system comprises at least two electrodes spatially apart from each other for electrocardiogram (ECG) generation of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 53, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the sensor member further comprises one or more of: an accelerometer for measuring at least one of a position and a movement. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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”) 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 Holst in view of Shay and Muller, with the sensor member further comprises one or more of: an accelerometer for measuring at least one of a position and a movement of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 54, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the accelerometer or the IMU is used to measure at least one of seismocardiography (SCG) and a respiratory rate. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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”) 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 Holst in view of Shay and Muller, with the accelerometer or the IMU is used to measure at least one of seismocardiography (SCG) and a respiratory rate of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 56, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.”) 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 Holst in view of Shay and Muller, with the 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 of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 59, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach 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, 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, 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.) 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 Holst in view of Shay and Muller, with 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, 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, 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 of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 60, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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 () 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 Holst in view of Shay and Muller, with the 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 of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 62, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.”) 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 Holst in view of Shay and Muller, with 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 of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 63, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the mobile device in bi-directionally wireless communication with the plurality of time- synchronized sensor systems. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.) 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 Holst in view of Shay and Muller, with the mobile device in bi-directionally wireless communication with the plurality of time- synchronized sensor systems of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 64, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the mobile device is in wireless communication with the patient database. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.) 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 Holst in view of Shay and Muller, with the mobile device is in wireless communication with the patient database of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 65, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.) 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 Holst in view of Shay and Muller, with 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 of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claims 72-73, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.) 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 Holst in view of Shay and Muller, with the 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 of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 74, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the power unit for wirelessly powering the sensor systems. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.) 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 Holsti in view of Shay and Muller, with the power unit for wirelessly powering the sensor systems of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 75, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the operating wirelessly for a period of at least 24 hours without a source of external power. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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 86, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.) 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 Holst in view of Shay and Muller, with the 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 of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 87, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.
Regarding claim 88, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.) 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 Holst in view of Shay and Muller, with the 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 of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Claims 68-71 rejected under 35 U.S.C. 103 as being unpatentable over Holsti et al. (US 20210202061) (Hereinafter Holsti) in view of Shay et al. (US 20170119318)(Hereinafter Shay), Muller et al. (US 20170031441)(Hereinafter Muller), Bhushan et al. (US 20170347894)(Hereinafter Bhushan), and Baxi (US 20190209028)(Hereinafter Baxi).
Regarding claim 68, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the electronic components of each of the plurality of time-synchronized sensor systems further comprises a battery for providing power to said sensor system. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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.) 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 Holst in view of Shay and Muller, with the electronic components of each of the plurality of time-synchronized sensor systems further comprises a battery for providing power to said sensor system of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Holsti, Shay, Muller, and Symans do 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 Holsti in view of Shay, Muller, and 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 69, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the battery is a rechargeable battery operably recharged with wireless recharging. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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)”) 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 Holsti in view of Shay and Muller, with the battery is a rechargeable battery operably recharged with wireless recharging of Bhushan, because such a modification would allow to enable a user to take proper precautions.
Regarding claim 70, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do 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 Holsti in view of Shay and Muller, with flame retardant material of Baxi, because such a modification would allow to avoid battery explosion.
Regarding claim 71, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do 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 Holsti in view of Shay and Muller, with flame retardant material of Baxi, because such a modification would allow to avoid flammability of the device.
Claims 55, 57-58, 66, and 96 are rejected under 35 U.S.C. 103 as being unpatentable over Holsti et al. (US 20210202061) (Hereinafter Holsti) in view of Shay et al. (US 20170119318)(Hereinafter Shay), Muller et al. (US 20170031441)(Hereinafter Muller), and Baxi (US 20190209028)(Hereinafter Baxi).
Regarding claim 55, cl claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not 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 Holsti in view of Shay and Muller, 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 Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not 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 Holsti in view of Shay and Muller, 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 Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not 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 Holsti in view of Shay and Muller, 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 and 96, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not 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 Holsti in view of Shay and Muller, 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 Holsti et al. (US 20210202061) (Hereinafter Holsti) in view of Shay et al. (US 20170119318)(Hereinafter Shay), Muller et al. (US 20170031441)(Hereinafter Muller), Bhushan et al. (US 20170347894)(Hereinafter Bhushan), Picard et al. (US 20100268056)(Hereinafter Picard), and DeBusschere et al. (US 20160338599)(Hereinafter DeBusschere).
Regarding claims 61 and 83, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do not teach the 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. Bhushan, in the same field of endeavor, teaches a network of sensors with data transfer capabilities onto a computing device (Abstract), and further 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”) 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 Holsti in view of Shay and Muller, with the 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 of Bhushan, because such a modification would allow to enable a user to take proper precautions.
However, Holsti, Shay, Muller, and Symans do 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 Holsti in view of Shay and Muller, with the crying time of Picard, because such a modification would allow to monitor physiological arousal for infants.
However, Holsti, Shay, Muller, and Symans 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 Holsti in view of Shay and Muller, 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 Holsti et al. (US 20210202061) (Hereinafter Holsti) in view of Shay et al. (US 20170119318)(Hereinafter Shay), 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 Holsti, Shay, and Muller. However, Holsti in view of Shay and Muller do 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 Holsti in view of Shay and Muller, 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 Holsti, Shay, 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 Holsti in view of Shay and Muller, with the magnetic loop antenna of Hirsch, because such a modification would allow to reduce electromagnetic interference.
Claims 93 is rejected under 35 U.S.C. 103 as being unpatentable over Holsti et al. (US 20210202061) (Hereinafter Holsti) in view of Shay et al. (US 20170119318)(Hereinafter Shay), Muller et al. (US 20170031441)(Hereinafter Muller), and Wang et al. (US 20170325724)(IDS)(Hereinafter Wang).
Regarding claim 93, claim 48 is obvious over Holsti, Shay, and Muller. However, Holsti in view of Shay 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 Holsti in view of Shay and Muller, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
/REX R HOLMES/Primary Examiner, Art Unit 3796
