DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/19/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 03/19/2026. As directed by the amendment: Claims 1 and 25 have been amended, claims 4-5, 7, 9, 11-14, 26, 28-29, 31, 33, 38-40, have been cancelled, and claims 45-46 have been added. Claims 16-18, 20-24, and 34-36 were previously withdrawn due to a Restriction Requirement. Thus, claims 1-3, 6, 8, 10, 15, 25, 27, 30, 32, 37, and 42-46 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see page 12, filed 03/19/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 112(b) have been fully considered and are persuasive. The amendments to the claim have obviated the rejection of record. The rejection of the claim has been withdrawn.
Applicant’s arguments, see pages 13-21, filed 03/19/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered. Amendments to the claim obviate the rejection of record. Therefore, the rejection has been withdrawn. Applicant asserts on page 13 that “the same torso-mounted accelerometer that supplies the mechanical signal for the PAT calculation is also configured to extract the mechano-acoustic vocal- cord signal used for the crying-event parameter. This dual use of a single sensor in the integrated system provides further non-obvious synergy: the apparatus simultaneously delivers calibrated blood-pressure monitoring and crying detection without requiring a separate microphone or additional hardware.”
Examiner disagrees because the claim fails to recite that the same accelerometer signal, that is detected from the accelerometer, is used for determining both blood pressure and crying detection and the claim does not recite the simultaneous determination either.
Applicant then argues on pages 14-15 that Wegerich is directed to determining PTT from a torso and head device and not from the limb, as head and limb PPG acquisition introduces different quality issues. Applicant further argues that the motivation of Wegerich constitutes impermissible hindsight because Acquista already teaches real-time processing.
Examiner disagrees because Acquista teaches multiple nodes where each can be placed in a different location including the chest and limb, and Wegerich is brought in to teach that those nodes can also contain PPG sensors. Furthermore, newly cited Cao teaches the PPG at the limb region for PTT. 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). Wegerich discloses the real-time processing of other signals of data for display for a clinician to detect abnormalities in more collected data.
Applicant then argues on page 16 that “For crying, Kethman explicitly teaches detection via "sound or piezoelectric sensors" for voice analysis, not accelerometers (Kethman [[[0035]; see also ||| [0037] for audio feature extraction including "changes in pitch" or "frequency content"). Piezoelectric sensors detect vibrations acoustically, distinct from accelerometers that measure linear acceleration (e.g., for posture or activity in Wegerich 1 [0039]). The clarifying language added to Claims 1 and 25 as noted above emphasizes the obvious technical distinction from Kethman's sound/piezo sensors. Kethman's accelerometer is listed generally for movement detection (Kethman 1 [0030]), but is not linked to crying events. This is a clear technical fallacy: equating sound/piezo-based crying detection with accelerometer-based determination ignores fundamental sensor differences-accelerometers capture mechano-acoustic signals from body vibrations (as claimed and supported in Applicant's specification at TT [0051]-[0052]), while Kethman's sound sensors capture airborne audio.”
Examiner disagrees because the claim fails to claim that the accelerometer signal is configured to be obtained from an accelerometer. Furthermore, an accelerometer can be a piezoelectric accelerometer or a capacitance accelerometer. Applicant is falsely equating sound/audio signals and piezoelectric signals because piezoelectric signals function on the basis of a mechanic squeeze/bend to generate an electrical charge to detect vibrations whereas the audio signal is a sound signal from a microphone. No where in the claim is linear acceleration or posture is being claimed, and the “change in pitch” is audio based, per [0037] of Kethman, but can also be detected from a piezoelectric sensor, as noted in [0035] of Kethman.
Applicant also argues on page 17 that a skin-to-skin event from acceleration signal and temperature signal is not taught by Kethman. Applicant further asserts hindsight for the motivation regarding the recommended action as Wegerich (ambulatory vital signs) and Acquista (patient monitoring) would not prompt to be combined with Kethman’s respiratory symptioms, specifically the sound-based crying.
Although Kenthman does not teach the skin-to-skin event, Examiner disagrees because Kethman visualizes data for a recommendation of an action to take, as Kethman also collects physiological data, similar to Wegerich and Acquista, and is in the same field of endeavor.
However, upon further consideration, a new ground(s) of rejection is made in view of Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of and Wegerich et al. (US 20140275888)(Hereinafter Wegerich), Kethman et al. (US 20160224750)(Hereinafter Kethman), Cao (US 20170202459)(Hereinafter Cao), and Kovacs (US 20170185737).
Claim Objections
Claim 2 is objected to because of the following informalities: the semicolon in “a mechanical signal related to movement, respiration and arterial tonometry; and a the mechano-acoustic signal” should be amended to “a mechanical signal related to movement, respiration and arterial tonometry, and a the mechano-acoustic signal”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6, 8, 10, 15, and 45 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 1, it is unclear how the claim is directed to an apparatus when the limitations recited in the claim are different devices working in a system.
Claim 1 is directed to both product and a process. A single claim that claims both an apparatus and the method steps of using the apparatus is indefinite under 35 USC 112b. See MPEP 2173.05(p). Claim 1 is to an apparatus, i.e. a product, and claim 1 also requires specific method steps of “a microcontroller unit (MCU) to wirelessly receive […], to determine […], and to display[…]”, and “the plurality of sensor systems detect […]”. Examiner suggests amending to recite “configured to” for each of the method steps.
Claim 1 is directed to both product and a process. A single claim that claims both an apparatus and the method steps of using the apparatus is indefinite under 35 USC 112b. See MPEP 2173.05(p). Regarding claim 1, the steps of determining a heart rate parameter, ECG parameter, temperature parameter, and blood pressure parameter are method steps that are not attributed to a component capable of doing the steps. Examiner suggests amending to recite that the MCU is further configured to determine each parameter.
Claim 10 recites the limitation "the power supply" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-3, 6, 8, 10, 15, and 42-45 are rejected due to their dependency on claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3, 6, 27, and 30 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 3 and 27 fail to further limit the “at least one sensor” because claim 1 recites that the first sensor system comprises ECG sensor, accelerometer, and temperature sensor and the second sensor system comprises a PPG sensor and temperature sensor.
Claims 6 and 30 fail to further independent claim 1 because the attachment of the first sensor system on the torso and the second sensor system on the limb region is recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-3, 6, 8, 10, 15, and 45 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the phrase “the first sensor system disposed in a torso region of the mammal subject” is claiming the mammal subject, as the systems are attached to the mammal. Examiner suggests to amend the claim to recite “the first sensor system configured to be disposed in a torso region of the mammal subject”.
Regarding claim 1, the phrase “the second sensor system disposed in a limb region of the mammal subject” is claiming the mammal subject, as the systems are attached to the mammal. Examiner suggests to amend the claim to recite “the second sensor system configured to be disposed in a limb region of the mammal subject”.
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 1-3, 6, 8, 10, 15, 25, 27, 30, 32, 37, and 42-46 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 1 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 25 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1 and 25, the following step is an abstract idea:
“heart rate parameter determined based upon an electrocardiography (ECG) signal and a temperature signal received from the first sensor system, an electrocardiogram parameter determined based upon the electrocardiography signal and the temperature signal received from the first sensor system, a temperature parameter determined based upon the temperature signal from the first sensor system or a temperature signal from the second sensor system, and a blood pressure parameter determined based on the electrocardiography signal from the first sensor system and a photoplethysmography (PPG) signal from the second sensor system… determine a pulse arrival time (PAT) as a time delay At between detection of a first signal by the first sensor system and detection of a second signal by the second sensor system”, 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 evaluate different signals to extract heart rate parameter, ECG parameter, temperature parameter, and blood pressure parameter that judges a time delay between ECG and PPG for a PAT.
“determining a pulse wave velocity (PWV) based on the PAT and distance L between the torso region and the limb region, wherein PWV = L / At; and determining the blood pressure P of the mammal subject from the PWV, wherein P = a PWV2 + 15, and a and p are empirically determined constants depending on artery geometry and artery material properties of the mammal subject” , which is a mathematical concept when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(I), the mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. In this case, the equations of PWV = L / At and P = a PWV2 + b are mathematical concepts.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1 and 25, 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 [first and second] of sensor systems”, 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”, “temperature sensor”, “PPG sensor”, and “accelerometer sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “[first/second set of the](plurality of) physiological signals”, “heart rate parameter”, “electrocardiogram parameter”, “temperature parameter”, “blood pressure parameter”, “electrocardiography (ECG) signal”, “temperature signal”, “photoplethysmography (PPG) signal”, “output signals”, “pulse arrival time (PAT)”, “time delay”, “first/second signal”, “pulse wave velocity (PWV)”, “distance L”, “constants a and b”, “skin-to-skin event parameter”, “crying event parameter”, and “mechano-acoustic signal”, 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)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “plurality [first and second] of sensor systems”, 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”, “temperature sensor”, “PPG sensor”, and “accelerometer sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “[first/second set of the](plurality of) physiological signals”, “heart rate parameter”, “electrocardiogram parameter”, “temperature parameter”, “blood pressure parameter”, “electrocardiography (ECG) signal”, “temperature signal”, “photoplethysmography (PPG) signal”, “output signals”, “pulse arrival time (PAT)”, “time delay”, “first/second signal”, “pulse wave velocity (PWV)”, “distance L”, “constants a and b”, “skin-to-skin event parameter”, “crying event parameter”, and “mechano-acoustic signal”, 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)].
The additional elements of claims 1 and 25, 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 plurality of sensor systems, 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]), and Acquista et al. (US 20170258402) teaches a temperature sensor for measuring a temperature of the skin ([0078]). Sensors and electrodes are regarded as mere data gathering that is well known in the art to establish the inputs of analysis and does not add a meaningful limitation (TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48).
Dependent claims 2-3, 6, 8, 10, 15, 27, 30, 32, 37, and 42-46 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 25. The dependent claim limitations are directed to extra-solution activity (claims 19 and 45-46), generic computer components (claims 3, 6, 10, 15, 27, 30, 37, 42, 43, and 44), and to generic gathering structure (claims 2, 8, and 32), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-3, 6, 8, 10, 15, 25, 27, 30, 32, 37, and 42-46 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Interpretation
Regarding claim 1, the claim fails to distinguish between a product and method. Specifically, the claim fails to recite that the processor is configured to make all the determinations recited in the claim. Therefore, the determinations will be considered intended use because the processor would not need to be capable of performing any of the recited steps.
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 1 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of and Wegerich et al. (US 20140275888)(Hereinafter Wegerich).
Regarding claim 1, Acquista teaches An apparatus for non-invasively measuring physiological parameters of a mammal subject (Abstract “A system for wirelessly obtaining physiological data from a subject includes a sensor patch and a separate electronics package. The sensor patch is disposed on and adheres to the subject, and includes a first part of a releasable electrical connector.” Fig. 3 on mammal/human.), comprising:
a plurality of sensor systems adapted to be attached to the mammal subject, wherein the plurality of sensor systems are wireless communicatively coupled together, wherein the plurality of sensor systems detect physiological signals that are time-synchronized to each other ([0098] “two, three or more ECG sensor packages 300 may be used by a subject. The data collected from these packages can, if properly synchronized or aligned, be used to generate data that is similar to the configuration of traditional 3-lead, 5-lead or 12-lead ECG leads… To facilitate such synchronization or timing alignment, a master clock may be used to synchronize or align sample acquisition within a specified tolerance. In particular, one node in the network, such as the master node or a local device, may be used to generate a master clock signal that is used to synchronize or otherwise align sample acquisition times across all of the nodes.” [0101] “To ensure synchronization (i.e., an understanding of the time alignment of the collected data) of the nodes 120-140, in preferred embodiments network systems, the system establishes a periodic synchronization signal which is sent to the three sensor nodes 120-140 from, for example, the master node 110” [0045] “The master node can also include a portable device having a processor”), and wherein each of the plurality of sensor systems include:
a first sensor system including an electrocardiography (ECG) sensor, an accelerometer sensor and temperature sensor ([0080] “the sensor packages 300, 600 may be deployed together to monitor various aspects of the subject, including the gathering of ECG data via first sensor package 300 and the collection of subject temperature, blood oxygen levels and hydration levels or ionic balance via second sensor package 600” [0078] “a skin temperature sensor” [0041] “an accelerometer” [0050] “An example block diagram of the logical structure of an embodiment ECG sensor 200 is illustrated in FIG. 2.”); and
a second sensor system including a … and a temperature sensor ([0078] “The sensor package 600 includes, for example, three sensors 601-603, which may be any type of sensor, including sensors based upon electrical characteristics, optical characteristics, thermal characteristics, chemical characteristics, or the like. By way of example, the first sensor 601 may be a skin temperature sensor, the second sensor 602 may be a sweat and/or hydration sensor and the third sensor 603 may be a blood oxygen sensor.”); and
a microcontroller unit (MCU) to wirelessly receive the physiological signals from the plurality of sensor systems, to determine a plurality of physiological parameters from the plurality of physiological signals, and to display the plurality of physiological parameters of the mammal subject (Intended use. The processor would not need to be capable of executing the step. [0078] “By way of example, the first sensor 601 may be a skin temperature sensor” [0080] “via first sensor package 300 and the collection of subject temperature, blood oxygen levels and hydration levels or ionic balance via second sensor package 600.” [0140] “as the electronics packages can support wireless communications with a master node, between themselves or both, the use of two or more electronics packages can be supported to generate additional sensor information.” [0045] “the master node of a mesh network can be a PC or workstation computer equipped with a communication component, such as a dongle, for communicating with the wireless sensors. The master node can also include a portable device having a processor, a memory, a display and/or other audiovisual output capabilities to present information to a user, and capabilities of wirelessly communicating with the wireless sensors.” [0047] “these wireless sensors can self-configure into a set or group which wirelessly sends diagnostic quality ECG signals in a synchronous fashion to a master node, which can derive or synthesize ECG spectrum for display or other forms usable by a physician (or other users) based on the transmitted ECG signals.”)
wherein a first set of the plurality of physiological parameters include one or more of: a heart rate parameter determined based upon an electrocardiography (ECG) signal and temperature signal received from the first sensor system, an electrocardiogram parameter determined based upon the electrocardiography signal and the temperature signal received from the first sensor system, a temperature parameter determined based upon the temperature signal from the first sensor system or a temperature signal from the second sensor system, and a blood pressure parameter determined based on the electrocardiography signal from the first sensor system and a photoplethysmography (PPG) signal from the second sensor system (Intended use. The processor would not need to be capable of executing the step.);
wherein the blood pressure parameter is determined by:
receiving output signals of the first sensor system disposed in a torso region of the mammal subject and the second sensor system disposed in a limb region of the mammal subject (Intended use. The processor would not need to be capable of executing the step.);
processing the output signals to determine a pulse arrival time (PAT) as a time delay At between detection of a first signal by the first sensor system and detection of a second signal by the second sensor system (Intended use. The processor would not need to be capable of executing the step.);
determining a pulse wave velocity (PWV) based on the PAT and distance L between the torso region and the limb region, wherein PWV = L / At (Intended use. The processor would not need to be capable of executing the step.); and
determining the blood pressure P of the mammal subject from the PWV, wherein P = a PWV2 + 15, and a and p are empirically determined constants depending on artery geometry and artery material properties of the mammal subject (Intended use. The processor would not need to be capable of executing the step.);
wherein a second set of the plurality of physiological parameters include one or more of: a skin-to-skin event parameter determined based on an accelerometer signal and temperature signal from the first sensor system, and crying event parameter determined based upon a mechano-acoustic signal in the accelerometer signal from the first sensor system (Intended use. The processor would not need to be capable of executing the step.).
However, Acquista does not teach a second sensor system including a photoplethysmography (PPG) sensor and a temperature sensor. Wegerich, in the same field of endeavor, teaches a multi-component multi-sensor wireless wearable biosignal acquisition system, similar to the system of Acquista, and further teaches a second sensor system including a photoplethysmography (PPG) sensor and a temperature sensor ([0044] “Here, peripheral device 305 is held in place on the skin of the forehead by a headband 310. PPG-related light sources and photodetector are directed toward the skin of the forehead.”) to review the processed data in real-time ([O060]). 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 Aquista, with the second sensor system including a photoplethysmography (PPG) sensor and a temperature sensor of Wegerich, because such a modification would allow to review the processed data in real-time.
Regarding claim 19, claim 1 and 25 are obvious over Acquista, Kethman, and Wegerich. However, Acquista does not teach the accelerometer for one sensor system and PPG for another sensor system in two regions of the body. Wegerich, in the same field of endeavor, teaches a multi-component multi-sensor wireless wearable biosignal acquisition system, similar to the system of Acquista, and further teaches wherein the mammal subject is a human subject or a non-human subject (Abstract “Ambulatory monitoring of human health”) to review the processed data in real-time ([0060]). 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 Aquista, with the accelerometer for one sensor system and PPG for another sensor system in two regions of the body of Wegerich, because such a modification would allow to review the processed data in real-time.
Claims 1, 6, 8, 10, 19, 25, 30, 32, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of and Wegerich et al. (US 20140275888)(Hereinafter Wegerich), Kethman et al. (US 20160224750)(Hereinafter Kethman), Cao (US 20170202459)(Hereinafter Cao), and Kovacs (US 20170185737).
Regarding claims 1 and 25, Acquista teaches An apparatus for non-invasively measuring physiological parameters of a mammal subject (Abstract “A system for wirelessly obtaining physiological data from a subject includes a sensor patch and a separate electronics package. The sensor patch is disposed on and adheres to the subject, and includes a first part of a releasable electrical connector.” Fig. 3 on mammal/human.), comprising:
a plurality of sensor systems adapted to be attached to the mammal subject, wherein the plurality of sensor systems are wireless communicatively coupled together, wherein the plurality of sensor systems detect physiological signals that are time-synchronized to each other ([0098] “two, three or more ECG sensor packages 300 may be used by a subject. The data collected from these packages can, if properly synchronized or aligned, be used to generate data that is similar to the configuration of traditional 3-lead, 5-lead or 12-lead ECG leads… To facilitate such synchronization or timing alignment, a master clock may be used to synchronize or align sample acquisition within a specified tolerance. In particular, one node in the network, such as the master node or a local device, may be used to generate a master clock signal that is used to synchronize or otherwise align sample acquisition times across all of the nodes.” [0101] “To ensure synchronization (i.e., an understanding of the time alignment of the collected data) of the nodes 120-140, in preferred embodiments network systems, the system establishes a periodic synchronization signal which is sent to the three sensor nodes 120-140 from, for example, the master node 110” [0045] “The master node can also include a portable device having a processor”), and wherein each of the plurality of sensor systems include:
a first sensor system including an electrocardiography (ECG) sensor, an accelerometer sensor and temperature sensor ([0080] “the sensor packages 300, 600 may be deployed together to monitor various aspects of the subject, including the gathering of ECG data via first sensor package 300 and the collection of subject temperature, blood oxygen levels and hydration levels or ionic balance via second sensor package 600” [0078] “a skin temperature sensor” [0041] “an accelerometer” [0050] “An example block diagram of the logical structure of an embodiment ECG sensor 200 is illustrated in FIG. 2.”); and
a second sensor system including a … and a temperature sensor ([0078] “The sensor package 600 includes, for example, three sensors 601-603, which may be any type of sensor, including sensors based upon electrical characteristics, optical characteristics, thermal characteristics, chemical characteristics, or the like. By way of example, the first sensor 601 may be a skin temperature sensor, the second sensor 602 may be a sweat and/or hydration sensor and the third sensor 603 may be a blood oxygen sensor.”); and
a microcontroller unit (MCU) to wirelessly receive the physiological signals from the plurality of sensor systems, to determine a plurality of physiological parameters from the plurality of physiological signals, and to display the plurality of physiological parameters of the mammal subject ([0078] “By way of example, the first sensor 601 may be a skin temperature sensor” [0080] “via first sensor package 300 and the collection of subject temperature, blood oxygen levels and hydration levels or ionic balance via second sensor package 600.” [0140] “as the electronics packages can support wireless communications with a master node, between themselves or both, the use of two or more electronics packages can be supported to generate additional sensor information.” [0045] “the master node of a mesh network can be a PC or workstation computer equipped with a communication component, such as a dongle, for communicating with the wireless sensors. The master node can also include a portable device having a processor, a memory, a display and/or other audiovisual output capabilities to present information to a user, and capabilities of wirelessly communicating with the wireless sensors.” [0047] “these wireless sensors can self-configure into a set or group which wirelessly sends diagnostic quality ECG signals in a synchronous fashion to a master node, which can derive or synthesize ECG spectrum for display or other forms usable by a physician (or other users) based on the transmitted ECG signals.”)
wherein a first set of the plurality of physiological parameters include one or more of: a heart rate parameter determined based upon an electrocardiography (ECG) signal and temperature signal received from the first sensor system, an electrocardiogram parameter determined based upon the electrocardiography signal and the temperature signal received from the first sensor system, a temperature parameter determined based upon the temperature signal from the first sensor system or a temperature signal from the second sensor system, and a blood pressure parameter determined based on the electrocardiography signal from the first sensor system and a photoplethysmography (PPG) signal from the second sensor system ([0078] “By way of example, the first sensor 601 may be a skin temperature sensor” [0080] “via first sensor package 300 and the collection of subject temperature, blood oxygen levels and hydration levels or ionic balance via second sensor package 600.”).
However, Acquista does not teach a second sensor system including a photoplethysmography (PPG) sensor and a temperature sensor. Wegerich, in the same field of endeavor, teaches a multi-component multi-sensor wireless wearable biosignal acquisition system, similar to the system of Acquista, and further teaches a second sensor system including a photoplethysmography (PPG) sensor and a temperature sensor ([0044] “Here, peripheral device 305 is held in place on the skin of the forehead by a headband 310. PPG-related light sources and photodetector are directed toward the skin of the forehead.”) to review the processed data in real-time ([O060]). 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 Aquista, with the second sensor system including a photoplethysmography (PPG) sensor and a temperature sensor of Wegerich, because such a modification would allow to review the processed data in real-time.
However, Acquista does not teach the crying event parameter determined based upon the accelerometer signal from the first sensor system and displaying the physiological parameters. Kethman, solves the same problem of determining diseases for alerting a healthcare provider to take an action ([0014]). Kethman further wherein a second set of the plurality of physiological parameters include one or more of: a skin-to-skin event parameter determined based on an accelerometer signal and temperature signal from the first sensor system, and crying event parameter determined based upon a mechano-acoustic signal in the accelerometer signal from the first sensor system ([0035] “sound or piezoelectric sensors may be used to measure an individual's cough frequency, breath sound analysis, voice analysis, snoring, sniffle and/or crying. The sensors 50 may be incorporated within the base station 32 or may be external to the base station 32, such as an external sensor placed under and/or attached to the individual or group of individuals”)
to display the plurality of physiological parameters of the mammal subject ([0034] “The sensor data 50 and non-sensor data 52 may be aggregated 56, and the aggregated data 56 may be analyzed, and the data may then be displayed in some way, so that the user/patient can visualize the data 58.”) to visualize processed data for a user recommendation ([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 system of Aquista, with the crying event parameter determined based upon the accelerometer signal from the first sensor system and displaying the physiological parameters of Kethman, because such a modification would allow to visualize processed data for a user recommendation.
Although Acquista teaches the determining of blood pressure using an equation deriving PWV from PTT, Acquista does not teach wherein the blood pressure parameter is determined by:
receiving output signals of the first sensor system disposed in a torso region of the mammal subject and the second sensor system disposed in a limb region of the mammal subject;
processing the output signals to determine a pulse arrival time (PAT) as a time delay At between detection of a first signal by the first sensor system and detection of a second signal by the second sensor system;
determining a pulse wave velocity (PWV) based on the PAT and distance L between the torso region and the limb region, wherein PWV = L / At; and
determining the blood pressure P of the mammal subject from the PWV, wherein P = a PWV2 + 15, and a and p are empirically determined constants depending on artery geometry and artery material properties of the mammal subject. Cao, in the same field of endeavor, teaches a wearable device that detects ECG and PPG used for determining PTT, PAT, and BP (Abstract), and further teaches wherein the blood pressure parameter is determined by:
receiving output signals of the first sensor system disposed in a torso region of the mammal subject and the second sensor system disposed in a limb region of the mammal subject ([0025] “Intravascular BP may be related with the traveling time of blood from the heart to a peripheral organ, which could be measured in the form of pulse transit time (PTT) or pulse arrival time (PAT), for example. FIG. 1 illustrates a time delay 100 in signals 110, 120 detected at two different sites 130, 140 on the body, respectively” See Fig. 1 where position 130 is at the torso, near the heart and position 140 in at the limb.);
processing the output signals to determine a pulse arrival time (PAT) as a time delay At between detection of a first signal by the first sensor system and detection of a second signal by the second sensor system ([0025] “Intravascular BP may be related with the traveling time of blood from the heart to a peripheral organ, which could be measured in the form of pulse transit time (PTT) or pulse arrival time (PAT), for example. FIG. 1 illustrates a time delay 100 in signals 110, 120 detected at two different sites 130, 140 on the body, respectively”);
determining a pulse wave velocity (PWV) based on the PAT and distance L between the torso region and the limb region, wherein PWV = L / At ([0035] “BP may be derived using PTT obtained from ECG and PPG measurements. Using PPT, we can calculate the pulse wave velocity (PWV) as” Equation 6 PWV =d/PTT. [0035] “where d is the distance from heart to the Z-band” [0020] “an armband (referred to as a Z-band)” [0025] “FIG. 1 illustrates a time delay 100 in signals 110, 120 detected at two different sites 130, 140 on the body, respectively” Examiner notes that location 130 is at the chest/torso and location 140 is the limb (z-band), where d is the distance between the heart (where the device is placed on the torso) and the limb.); and
determining the blood pressure P of the mammal subject from the PWV, wherein P = a PWV2 + 15, and a and p are empirically determined constants depending on artery geometry and artery material properties of the mammal subject (Equation 7 BP=a×PWV.sup.2+b) to optimize the calculation of BP for continuously measurement ([0025]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the system of Acquista, with the wherein the blood pressure parameter is determined by: receiving output signals of the first sensor system disposed in a torso region of the mammal subject and the second sensor system disposed in a limb region of the mammal subject; processing the output signals to determine a pulse arrival time (PAT) as a time delay At between detection of a first signal by the first sensor system and detection of a second signal by the second sensor system; determining a pulse wave velocity (PWV) based on the PAT and distance L between the torso region and the limb region, wherein PWV = L / At; and determining the blood pressure P of the mammal subject from the PWV, wherein P = a PWV2 + b, and a and b are empirically determined constants depending on artery geometry and artery material properties of the mammal subject of Cao, because such a modification would allow to optimize the calculation of BP for continuously measurement.
However, Acquista and Cao do not teach the determining of PWV using PAT. Kovacs, in the same field of endeavor, teaches a wearable structure placed on a chest of a user including measuring electrodes (Abstract), and further teaches determining a pulse wave velocity (PWV) based on the PAT ([0019] “From the PAT measurement, pulse wave velocity can be estimated, as well as blood pressure.”) to mitigate the need for leads for remote physical examination ([0020]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the system of Acquista, with the determining of PWV using PAT of Cao, because such a modification would allow to mitigate the need for leads for remote physical examination.
Regarding claim 6, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. However, Acquista does not teach the sensor systems in two different regions of the body. Wegerich, in the same field of endeavor, teaches a multi-component multi-sensor wireless wearable biosignal acquisition system, similar to the system of Acquista, and further teaches wherein the plurality of sensor systems further comprises:
the first sensor system is adapted to be attached to a torso region of the mammal subject ([0012] “a torso device for sensing parameters from the human torso”);
at least one second sensor system adapted to be attached to a limb region of the mammal subject ([0012] “a peripheral device for sensing parameters from the head (or limb) of the human.”) to review the processed data in real-time ([0060]). 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 Aquista, with the sensor systems in two different regions of the body of Wegerich, because such a modification would allow to review the processed data in real-time.
Regarding claim 8, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. However, Acquista does not teach the accelerometer for one sensor system and PPG for another sensor system in two regions of the body. Wegerich, in the same field of endeavor, teaches a multi-component multi-sensor wireless wearable biosignal acquisition system, similar to the system of Acquista, and further teaches wherein the photoplethysmography (PPG) sensor includes an optical source and an optical detector located within a sensor footprint ([0044] “Here, peripheral device 305 is held in place on the skin of the forehead by a headband 310. PPG-related light sources and photodetector are directed toward the skin of the forehead.”) to review the processed data in real-time ([0060]). 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 Aquista, with the accelerometer for one sensor system and PPG for another sensor system in two regions of the body of Wegerich, because such a modification would allow to review the processed data in real-time.
Regarding claims 10 and 37, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. However, Acquista does not teach the embedded power supply. Wegerich, in the same field of endeavor, teaches a multi-component multi-sensor wireless wearable biosignal acquisition system, similar to the system of Acquista, and further teaches wherein the power supply of each of the plurality of sensor systems comprises: one of an embedded rechargeable power supply including a wireless power transfer platform or a detachable replaceable power supply ([0038] “Both the torso device and the peripheral device comprise…a power source” [0049] “an embodiment of the torso device… Power is provided by a 400 mAh lithium polymer rechargeable battery 823 which is separated from the PCB 807 by insulator 812.” Rechargeable batteries can only be embedded or detachable from the devices.) to review the processed data in real-time ([0060]). 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 Aquista, with the embedded power supply of Wegerich, because such a modification would allow to review the processed data in real-time.
Regarding claim 19, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. However, Acquista does not teach the accelerometer for one sensor system and PPG for another sensor system in two regions of the body. Wegerich, in the same field of endeavor, teaches a multi-component multi-sensor wireless wearable biosignal acquisition system, similar to the system of Acquista, and further teaches wherein the mammal subject is a human subject or a non-human subject (Abstract “Ambulatory monitoring of human health”) to review the processed data in real-time ([0060]). 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 Aquista, with the accelerometer for one sensor system and PPG for another sensor system in two regions of the body of Wegerich, because such a modification would allow to review the processed data in real-time.
Regarding claim 30, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. However, Acquista does not teach the accelerometer for one sensor system and PPG for another sensor system in two regions of the body. Wegerich, in the same field of endeavor, teaches a multi-component multi-sensor wireless wearable biosignal acquisition system, similar to the system of Acquista, and further teaches wherein the sensor systems further comprises:
the first sensor system is adapted to be attached to a torso region of the mammal subject ([0012] “a torso device for sensing parameters from the human torso”);
the second sensor system adapted to be attached to a limb region of the mammal subject ([0012] “a peripheral device for sensing parameters from the head (or limb) of the human.”) to review the processed data in real-time ([0060]). 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 Aquista, with the accelerometer for one sensor system and PPG for another sensor system in two regions of the body of Wegerich, because such a modification would allow to review the processed data in real-time.
Regarding claim 32, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. However, Acquista does not teach the accelerometer for one sensor system and PPG for another sensor system in two regions of the body. Wegerich, in the same field of endeavor, teaches a multi-component multi-sensor wireless wearable biosignal acquisition system, similar to the system of Acquista, and further teaches wherein the photoplethysmography (PPG) sensor includes an optical source and an optical detector located within a sensor footprint ([0044] “Here, peripheral device 305 is held in place on the skin of the forehead by a headband 310. PPG-related light sources and photodetector are directed toward the skin of the forehead.”) to review the processed data in real-time ([0060]). 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 Aquista, with the accelerometer for one sensor system and PPG for another sensor system in two regions of the body of Wegerich, because such a modification would allow to review the processed data in real-time.
Claims 3, 27, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of and Wegerich et al. (US 20140275888)(Hereinafter Wegerich), Kethman et al. (US 20160224750)(Hereinafter Kethman), Cao (US 20170202459)(Hereinafter Cao), and Kovacs (US 20170185737), Baxi (US 20190209028)(Hereinafter Baxi)), and Muller et al. (US 20170031441)(Hereinafter Muller).
Regarding claims 3, 27, and 43, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. Aquista teaches at least one sensor configured to detect at least one of the physiological signal (Fig. 3 [0041] “The vital signs to be monitored as contemplated in the disclosed embodiments can include, but are not limited to, ECG (electrocardiogram),” [0098]-[0099] “synchronization is not limited merely to ECG signals, and can be applied to any situation in which the data collected from one node is to be synchronized in time with data collected from another node.” [0054] “multiple surface nodes can be placed on the skin of the subject. As shown in FIG. 3, a first surface node 201 can be placed high on the sternum just below the clavicle. This can be advantageous for detection of atrial rhythm, as it is nearest the heart's atria, affording the best opportunity to monitor atrial fibrillation. There is less muscle in this location to contaminate the ECG with any electromyogram (EMG) artifact, and it can be on a tissue that is less likely to move and contaminate the ECG with motion artifact.” See Fig. 1 where the nodes are communicating bidirectionally. [0140] “as the electronics packages can support wireless communications with a master node, between themselves or both, the use of two or more electronics packages can be supported to generate additional sensor information.” [0127] where PTT is physiological parameters.),
a power supply ([0078] “The sensor package 600 includes a shell 610 within which are disposed the sensors 601-603, as well as electronics 620 (and related PCB) coupled to both the sensors 601-603 and to a battery 630 [power supply].”).
However, Acquista fails to teach flexible, stretchable zigzag interconnects to connect the electronic components, and an elastomeric encapsulation layer with a tissue-facing surface for the skin. Baxi, in the same field of endeavor, teaches a flexible and stretchable patch with an outer substrate by obtaining ECG and PPG signals, and further teaches wherein the at least one sensor, a transceiver and power supply of each sensor systems are coupled together with serpentine or zigzag interconnects ([0035] “and/or the interconnect between the fabric 306 and the substrate 308.” See Fig. 3 with the zigzag interconnects (
PNG
media_image1.png
58
34
media_image1.png
Greyscale
of Fig. 3) that connects SoC (1210), transceiver (1218), and sensor member (330). ) and are distributed on foldable islands of a flexible substrate, wherein the foldable islands of the flexible substrate are arranged as a compressed vertically buckled interface (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. Examiner notes that under compression, it is inherent for the zigzag interconnects to vertically buckle, as they are designed for that reason.)
an elastomeric encapsulation layer surrounding at least one sensor, the transceiver, power supply, serpentine zigzag interconnects and flexible substrate to form a tissue-facing surface and an environment-facing surface, wherein the tissue-facing surface is configured to conform to a skin surface adapted to be 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 system of Acquista, with the flexible and stretchable interconnects, elastomeric encapsulation, and tissue-facing surface of Baxi, because such a modification would allow to increase the stretchability and/or flexibility of the patch.
Although Acquista teaches the power transmitting and data transceiver for transmitting power and data, Acquista does not teach a transceiver comprising a magnetic coil for wireless data transmission and power harvesting through a single link. Muller, in a similar field of endeavor, teaches a wireless medical device with data transmission capabilities, similar to the system of Acquista. Although Muller is directed to an implantable device for electrocorticography, Acquista communicates using a transceiver the data collected for analysis. Muller further teaches a transceiver for wireless communication and wireless power harvesting ([0036] “The implant 110 further includes an antenna 112 that is used to couple wireless power and transmit data wirelessly across the skull”);
wherein the transceiver comprises a magnetic coil configured to perform the wireless data transmission and the wireless power harvesting through a single link ([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.”) to remove the need for cables and plugs ([0035]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the system of Acquista, with the transceiver comprising a magnetic coil for wireless data transmission and power harvesting through a single link of Muller, because such a modification would allow to remove the need for cables and plugs.
Regarding claim 42, Muller teaches wherein each of the sensor systems comprises further comprises a power management unit electrically coupled with the transceiver and configured to manage the wireless power harvesting ([0050] “power management module (PMU) 60 to handle the input voltage variation.” See Fig. 2 (112, 60) showing antenna 112 coupled to PMU 60. ).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of and Wegerich et al. (US 20140275888)(Hereinafter Wegerich), Kethman et al. (US 20160224750)(Hereinafter Kethman), Cao (US 20170202459)(Hereinafter Cao), and Kovacs (US 20170185737), and Picard et al. (US 20100268056)(Hereinafter Picard).
Regarding claim 15, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. However, Acquista does not teach a waterproof device. Picard, in a similar field of endeavor, teaches a washable wearable sensor with real-time sensed data of a patient of activities (Abstract), and further teaches wherein each of the plurality of sensor systems is waterproof ([0078] “one or more of these sensors are coated in plastic or another waterproof”) to allow for washing of sensors with water ([0078]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the system of Acquista, with the sensors are waterproof of Picard, because such a modification would allow to wash sensors with water.
Claims 2 are rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of and Wegerich et al. (US 20140275888)(Hereinafter Wegerich), Kethman et al. (US 20160224750)(Hereinafter Kethman), Cao (US 20170202459)(Hereinafter Cao), and Kovacs (US 20170185737), and Liu et al. (“A physiological sound sensing system using accelerometer based on flip-chip piezoelectric technology and asymmetrically gapped cantilever” 2015 IEEE 65th Electronic Components and Technology Conference (ECTC) 16 July 2015) (Hereinafter Liu).
Regarding claim 2, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. However, Acquista does not teach an accelerometer for detecting heart sounds. Liu, in the same field of endeavor, teaches a physiological detection of body using packaged accelerometer, similar to the system of Acquista, and further teaches wherein the accelerometer sensor is configured to detect one or more of:
a mechanical signal related to movement, respiration and arterial tonometry; and the mechano-acoustic signal,
wherein the mechano-acoustic signal is related to vocal cord vocalization, respiratory sound and heart sound (Fig. 10, page 1877 left col. lines 5-8 “For both accelerometer and stethoscope data, a filter with a bandwidth from 10Hz to 400 Hz is applied to extract the heart sound.”) to improve the sensitivity of the accelerometer while reducing package size (Page 1877 left col. lines 22-25). 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 Aquista, with the accelerometer for detecting heart sounds of Liu, because such a modification would allow to improve the sensitivity of the accelerometer while reducing package size.
Claims 44 are rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of and Wegerich et al. (US 20140275888)(Hereinafter Wegerich), Kethman et al. (US 20160224750)(Hereinafter Kethman), Cao (US 20170202459)(Hereinafter Cao), and Kovacs (US 20170185737), and Nguyen et al. (US 20200029840) (Hereinafter Nguyen).
Regarding claim 44, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. Acquista teaches wherein the wireless communication comprises …providing a common clock for time- synchronizing the detection of the physiological signals by the sensors of the plurality of sensor systems ([0098] “two, three or more ECG sensor packages 300 may be used by a subject. The data collected from these packages can, if properly synchronized or aligned, be used to generate data that is similar to the configuration of traditional 3-lead, 5-lead or 12-lead ECG leads… To facilitate such synchronization or timing alignment, a master clock may be used to synchronize or align sample acquisition within a specified tolerance. In particular, one node in the network, such as the master node or a local device, may be used to generate a master clock signal that is used to synchronize or otherwise align sample acquisition times across all of the nodes.”).
However, Acquista does not teach the use of BLE to communicate clock for time delay and synchronization. Nguyen, in the same field of endeavor, teaches a wearable medical device with a wireless network of nodes for acquiring ECG waveforms, similar to the system of Acquista, and further teaches wherein the wireless communication comprises a Bluetooth Low Energy (BLE) interface providing a common clock for time- synchronizing the detection of the physiological signals by the sensors of the plurality of sensor systems (Fig. 1C and Fig. 3 show 3 separate BLE’s that connect with the base station. [0087] “In example Method C, an example advantage of this specific application is that there is no need for a live data transfer, rather there can be a time delay for data to be received by the base station. For example, data may get to the base station a couple seconds after collection.” [0092] “there is provided a simplified example configuration compared to the configuration provided in FIG. 3. The example configuration includes Bluetooth Low Energy (BLE) wireless MCUs (MicroController Units).”) to consume low energy at a sufficient transfer rate ([0090]) allowing for better correlation and increase accuracy ([0247]). 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 Aquista, with the BLE to communicate clock for time delay and synchronization of Nguyen, because such a modification would allow to consume low energy at a sufficient transfer rate allowing for better correlation and increase accuracy.
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Acquista et al. (US 20170258402) (Hereinafter Acquista) in view of and Wegerich et al. (US 20140275888)(Hereinafter Wegerich), Kethman et al. (US 20160224750)(Hereinafter Kethman), Cao (US 20170202459)(Hereinafter Cao), and Kovacs (US 20170185737).
Regarding claims 45-46, claim 1 and 25 are obvious over Acquista, Kethman, Cao, Kovacs, and Wegerich. Although Cao teaches an adaptable a and b constants, and the calculation of BP ([0035]-[0036]), Cao does not teach a blood pressure range between 5 kPa and 20 kPa, 0.13 kPa x s2/m2< a < 0.23 kPa x s2/m2, and 2.2 kPa <p< 3.2 kPa. Since Cao teaches the constants can be changed based on the individual using a mathematical model, each of the constants, thereby the blood pressure, can be altered to optimize the calculated result. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have blood pressure range between 5 kPa and 20 kPa, 0.13 kPa x s2/m2< a < 0.23 kPa x s2/m2, and 2.2 kPa <p< 3.2 kPa, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights