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 action is in response to the remarks filed on 07/07/2025.
The amendments filed on 07/07/2025 have been entered. Accordingly claims 1-20 remain pending. Claims 16 and 20 are presently amended.
The previous rejections of claim 16 under 35 U.S.C 112(b) have been withdrawn in light of applicant's amendments to claim 16.
Response to Arguments
Applicant's arguments filed 07/07/2025 have been fully considered but they are not persuasive. In particular, applicant argues, see page 12 of remarks, that secondary reference Lewis does not teach any other control electronics connected to the transducers of the transducer array via the connection cable and therefore does not disclose the ultrasonic sensor module comprising at least one array of ultrasonic transducers and at least one pre-amplification device coupled to the at least one array of ultrasonic transducers. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Primary reference Shurtliff discloses the limitation that applicant argues are not taught by Lewis. Lewis was merely relied on to teach the connection cable assembly. Applicant’s additional arguments that Lewis teaches away from additional components being part of the ultrasonic sensor module is not persuasive. There is no indication that the ultrasonic sensor module of Lewis cannot have additional components and as per MPEP 716.01(c) ‘[t]he arguments of counsel cannot take the place of evidence in the record’.
Applicant’s arguments with respect to amended claim 20 have been considered but are moot because the new ground of rejection does not rely on secondary reference Lewis applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-5, 9-10, 13-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff et al. (US 2021/0169443) in view of Lewis, Jr. et al. (US 2022/0176163, June 9, 2022).
Regarding claim 1, Shurtliff discloses a wearable system for cardiovascular monitoring (“The present disclosure describes monitoring systems, wearable monitoring devices, and related methods for determining a pulse transit time (PTT) that can optionally be used to estimate blood pressure.” [0004]), the system comprising:
an ultrasonic sensor module comprising at least one array of ultrasonic transducers (transducer array 318 in Fig. 5 and corresponding description) and at least one pre-amplification device coupled to the at least one array of ultrasonic transducers (transmission amplifier 468 in Fig. 6 and corresponding description), the at least one array of ultrasonic transducers comprising a plurality of ultrasonic transducers (“The first and second transducer arrays include a plurality of independent transducer elements for transmitting and receiving ultrasound energy.” [0005]), the ultrasonic sensor module for placement on a human body proximate a blood vessel for performing cardiovascular monitoring (“When a user wears the device, the transducers are positioned near the brachial artery. The device operates to measure the transit time of a cardiac pulse through the brachial artery and across the fixed distance between transducer arrays. The measured pulse transit time may then be used for determining pulse wave velocity and/or blood pressure.” Abstract);
a data storage unit (“external computer system such as a smart phone, tablet, personal computer, and/or computer system associated with a healthcare facility or provider.” [0052]);
a processing unit (microprocessor 350 in Fig. 5 and corresponding description) comprising:
hardware componentry for controlling transmission of ultrasonic signals at the at least one array of ultrasonic transducers and for controlling receipt of reflected ultrasonic signals at the at least one array of ultrasonic transducers (“the ultrasound electronics module 352 may be configured to provide an excitation voltage to the transmitter sections of the transducer array 318 and to receive and digitize the return signals generated by the receiver sections of the transducer array 318” [0050]; also see “The microprocessor 350 is configured to provide logical control over the ultrasound electronics assembly 352” [0051]);
a digital processing module for performing on-board signal processing of the reflected ultrasonic signals received at the at least one array of ultrasonic transducers (“The I and Q components from both the proximal and distal sensors may then be sampled by analog-to-digital converters (ADCs) 482 to digitize the Doppler signal received from the transducer arrays and enable further processing by the microprocessor 450 to determine PTT.” [0062]; also see Fig. 6 and corresponding description); and
a power control system comprising an energy storage device for providing power to the hardware componentry, the digital processing module, and the ultrasonic sensor module (“The electronics assembly 300 also includes a battery 362 and associated power supply 364 for powering the microprocessor 350, ultrasound electronics module 352, communications module 356, motion sensor 358, display module 360, and/or other components that may be included within the electronics assembly 300.” [0054]).
Shurtliff fails to disclose a connection cable assembly for communicatively coupling the ultrasonic sensor module to the processing unit, the connection cable assembly for enabling signal communication and power transmission between the ultrasonic sensor module and the processing unit.
However, Lewis teaches, in the same field of endeavor, a connection cable assembly for communicatively coupling the ultrasonic sensor module to the processing unit, the connection cable assembly for enabling signal communication and power transmission between the ultrasonic sensor module and the processing unit (“ultrasound transducer array 110 is connected to power source 200 with a flexible cable 300” [0091]; also see Fig. 6 and corresponding description, [0074]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with a connection cable assembly for communicatively coupling the ultrasonic sensor module to the processing unit, the connection cable assembly for enabling signal communication and power transmission between the ultrasonic sensor module and the processing unit as taught by Lewis in order to provide a flexible and reliable connection that provides consistent power delivery to the ultrasound sensor module to prevent power fluctuations and data loss.
Regarding claim 2, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above and Shurtliff further discloses wherein the ultrasonic sensor module comprises a first array of ultrasonic transducers and a second array of ultrasonic transducers (“)The wearable monitoring device 100 utilizes two separate ultrasound transducer arrays (one proximal and one distal), each respectively housed in housings 108 and 110.” [0024]; also see e.g., Fig. 1A and corresponding description).
Regarding claim 4, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above and Shurtliff further discloses wherein the ultrasonic sensor module further comprises a motion sensor for performing motion sensing (motion sensor 358 in Fig. 5 and corresponding description), wherein the hardware componentry is also for controlling operation of the motion sensor (“The microprocessor 350 is configured to provide logical control over the ultrasound electronics assembly 352” [0051]; also see Fig. 5 and corresponding description).
Regarding claim 5, Shurtliff modified by Lewis discloses the limitations of claim 4 as stated above and Shurtliff further discloses wherein the digital processing module is also for correlating motion sensing data of the motion sensor with the reflected ultrasonic signals for use in the signal processing of the reflected ultrasonic signals (“Motion/position data detected using the motion sensor 358 may be utilized in conjunction with readings obtained using the transducer arrays 318 to obtain improved and/or calibrated vital sign measurements.” [0055]).
Regarding claim 9, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above, in particular Lewis was relied on to teach the connection cable assembly. Lewis further teaches, in the same field of endeavor, wherein the connection cable assembly comprises a plurality of signal lines corresponding to each transmission signal and each received signal for each receive channel of the at least one array of ultrasonic transducers (“there is illustrated an ultra-flexible screen transducer with embedded transducer elements and flexible cables. The ultra-flexible transducer array is shown with a blunted end. Each transducer element is individually housed and wired with flexible electrical cable. Each element is aligned and secured into a flexible nylon mesh to provide mechanical strength. The wires of each transducer element are knitted into the mesh for durability.” [0130]; also see e.g., Figs. 1-2, 18, 19 and corresponding descriptions).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with wherein the connection cable assembly comprises a plurality of signal lines corresponding to each transmission signal and each received signal for each receive channel of the at least one array of ultrasonic transducers as taught by Lewis in order to provide a flexible and reliable connection that provides consistent power delivery to the ultrasound sensor module to prevent power fluctuations and data loss.
Regarding claim 10, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above and Shurtliff further discloses wherein the digital processing module further comprises a wireless communication module for communicating output of the on-board signal processing to a remote computer system (“The electronics assembly 300 also includes a communications module 356 communicatively coupled to the microprocessor 350. The communications module 356 is shown in this embodiment as a Bluetooth Low Energy (BLE) module, but other communication functionalities and network types may additionally or alternatively be utilized, such as the Internet, cellular RF networks, a local area network (LAN), a wide area network (WAN), and the like. The communications module 356 enables the electronics assembly to communicate data, including measured PTT readings, to an external computer system such as a smart phone, tablet, personal computer, and/or computer system associated with a healthcare facility or provider.” [0052]).
Regarding claim 13, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above and Shurtliff further discloses wherein the ultrasonic sensor module further comprises a light emitting diode for providing visual feedback for aligning the at least one array of ultrasonic transducers with a blood vessel (LEDs 360 in Fig. 5 and corresponding description).
Regarding claim 14, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above and Shurtliff further discloses wherein the digital processing module is also for aligning the at least one array of ultrasonic transducers by selecting an ultrasonic transducer of the at least one array of ultrasonic transducers as an aligned ultrasonic transducer (“The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected.” [0044]; also see [0007]).
Regarding claim 15, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above and Shurtliff further discloses wherein the cardiovascular monitoring comprises at least one of pulse wave velocity, pulse transit time, arterial diameter, arterial wall motion, arterial wall stiffness, heart rate, and blood pressure (“determining a pulse transit time (PTT) that can optionally be used to estimate blood pressure. Pulse transit time (PTT) is the time it takes for a blood pressure pulse from a heartbeat to arrive at two different sites in the arterial tree. The obtained PTT measurements may also be utilized to determine pulse wave velocity (PWV) and/or blood pressure” [0004]).
Regarding claim 19, Shurtliff discloses a wearable system for cardiovascular monitoring (“The present disclosure describes monitoring systems, wearable monitoring devices, and related methods for determining a pulse transit time (PTT) that can optionally be used to estimate blood pressure.” [0004]), the system comprising:
an ultrasonic sensor module comprising a first array of ultrasonic transducers and a second array of ultrasonic transducers (“first and second transducer arrays” Abstract), a first pre-amplification device coupled to the first array of ultrasonic transducers (transmission amplifier 468a in Fig. 6 and corresponding description), a second pre-amplification device coupled to the second array of ultrasonic transducers (transmission amplifier 468b in Fig. 6 and corresponding description), the first array of ultrasonic transducers and the second array of ultrasonic transducers comprising a plurality of ultrasonic transducers (“The first and second transducer arrays include a plurality of independent transducer elements for transmitting and receiving ultrasound energy.” [0005]), the ultrasonic sensor module for placement on a human body proximate a blood vessel for performing cardiovascular monitoring (“When a user wears the device, the transducers are positioned near the brachial artery. The device operates to measure the transit time of a cardiac pulse through the brachial artery and across the fixed distance between transducer arrays. The measured pulse transit time may then be used for determining pulse wave velocity and/or blood pressure.” Abstract);
a data storage unit (“external computer system such as a smart phone, tablet, personal computer, and/or computer system associated with a healthcare facility or provider.” [0052]);
a processing unit (microprocessor 350 in Fig. 5 and corresponding description) comprising:
hardware componentry for controlling transmission of ultrasonic signals at the first array of ultrasonic transducers and the second array of ultrasonic transducers and for controlling receipt of reflected ultrasonic signals at the first array of ultrasonic transducers and the second array of ultrasonic transducers (“the ultrasound electronics module 352 may be configured to provide an excitation voltage to the transmitter sections of the transducer array 318 and to receive and digitize the return signals generated by the receiver sections of the transducer array 318” [0050]; also see “The microprocessor 350 is configured to provide logical control over the ultrasound electronics assembly 352” [0051]);
a digital processing module for performing on-board signal processing of the reflected ultrasonic signals received at the first array of ultrasonic transducers and the second array of ultrasonic transducers (“The I and Q components from both the proximal and distal sensors may then be sampled by analog-to-digital converters (ADCs) 482 to digitize the Doppler signal received from the transducer arrays and enable further processing by the microprocessor 450 to determine PTT.” [0062]; also see Fig. 6 and corresponding description) and for aligning the first array of ultrasonic transducers and the second array of ultrasonic transducers by selecting an ultrasonic transducer of the first array of ultrasonic transducers as an aligned ultrasonic transducer of the first array of ultrasonic transducers and selecting an ultrasonic transducer of the second array of ultrasonic transducers as an aligned ultrasonic transducer of the second array of ultrasonic transducers (“The use of multiple independently functioning transducer elements provides greater versatility and increases the quality of the Doppler shift measurement. This is because for a given reading, the transducer with the strongest signal may be selected.” [0044]; also see [0007]); and
a power control system comprising an energy storage device for providing power to the hardware componentry, the digital processing module, and the ultrasonic sensor module (“The electronics assembly 300 also includes a battery 362 and associated power supply 364 for powering the microprocessor 350, ultrasound electronics module 352, communications module 356, motion sensor 358, display module 360, and/or other components that may be included within the electronics assembly 300.” [0054]).
Shurtliff fails to disclose a connection cable assembly for communicatively coupling the ultrasonic sensor module to the processing unit, the connection cable assembly for enabling signal communication and power transmission between the ultrasonic sensor module and the processing unit.
However, Lewis teaches, in the same field of endeavor, a connection cable assembly for communicatively coupling the ultrasonic sensor module to the processing unit, the connection cable assembly for enabling signal communication and power transmission between the ultrasonic sensor module and the processing unit (“ultrasound transducer array 110 is connected to power source 200 with a flexible cable 300” [0091]; also see Fig. 6 and corresponding description, [0074]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with a connection cable assembly for communicatively coupling the ultrasonic sensor module to the processing unit, the connection cable assembly for enabling signal communication and power transmission between the ultrasonic sensor module and the processing unit as taught by Lewis in order to provide a flexible and reliable connection that provides consistent power delivery to the ultrasound sensor module to prevent power fluctuations and data loss.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff in view of Lewis as applied to claims 1-2 above and further in view of Tsuruno (US 2011/0319767).
Regarding claim 3, Shurtliff modified by Lewis discloses the limitations of claim 2 as stated above but is silent on wherein the first array of ultrasonic transducers and the second array of ultrasonic transducers are one-dimensional arrays of ultrasonic transducers.
However, Tsuruno teaches, in the same field of endeavor, wherein the first array of ultrasonic transducers and the second array of ultrasonic transducers are one-dimensional arrays of ultrasonic transducers (“The ultrasonic array 12 has a one-dimensional array configuration” [0150]; also see e.g., Fig. 3 and corresponding description).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with wherein the first array of ultrasonic transducers and the second array of ultrasonic transducers are one-dimensional arrays of ultrasonic transducers as taught by Tsuruno in order to provide arrays with simpler wiring patterns that results in ultrasound sensors that are small enough to be readily attached to an arm or other body part ([0152] of Tsuruno).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff in view of Lewis as applied to claims 1, 4-5 and further in view of Sundaran et al. (US 2014/0128739).
Regarding claim 6, Shurtliff modified by Lewis discloses the limitations of claim 4 as stated above but fails to disclose wherein the hardware componentry is for controlling transmission of the ultrasonic signals according to motion sensing data of the motion sensor.
However, Sundaran teaches, in the same field of endeavor, wherein the hardware componentry is for controlling transmission of the ultrasonic signals according to motion sensing data of the motion sensor (“data from the motion sensing system 107 may be used to detect a type of scan or to automatically start and stop the acquisition of ultrasound data for a volume. Additionally, the probe 106 may automatically come out of a sleep mode when motion is detected with the motion sensing system. The sleep mode, may, for instance, be a mode where the transducer elements are not energized. As soon as movement is detected, the transducer elements may begin to transmit ultrasound energy” [0055]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with wherein the hardware componentry is for controlling transmission of the ultrasonic signals according to motion sensing data of the motion sensor as taught by Sundaran in order to provide energy saving ([0055] of Sundaran).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff in view of Lewis as applied to claim 1 above and further in view of Mashood et al. (US 2021/0161503).
Regarding claim 7, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above but fails to disclose wherein the ultrasonic sensor module further comprises a force sensor, wherein the hardware componentry is also for controlling operation of the force sensor, wherein the force sensor is for sensing an applied pressure between the ultrasonic sensor module and the human body for ensuring appropriate contact pressure between the ultrasonic sensor module and the human body.
However, Mashood teaches, in the same field of endeavor, wherein the ultrasonic sensor module further comprises a force sensor, wherein the hardware componentry is also for controlling operation of the force sensor, wherein the force sensor is for sensing an applied pressure between the ultrasonic sensor module and the human body for ensuring appropriate contact pressure between the ultrasonic sensor module and the human body (“said probe consists of a unimodal or a bi-modal or a multi-modal arrangement of a pressure sensor or a force sensor or suitable bio-potential transducers along with a single element ultrasound transducer [...] The pressure sensor/force sensor/bio-potential transducers are configured to measure a pressure acting on a skin surface at a measurement site [...] applied/hold-down pressure” [0054]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with wherein the ultrasonic sensor module further comprises a force sensor, wherein the hardware componentry is also for controlling operation of the force sensor, wherein the force sensor is for sensing an applied pressure between the ultrasonic sensor module and the human body for ensuring appropriate contact pressure between the ultrasonic sensor module and the human body as taught by Mashood in order to provide feedback to guide a user ([0015] of Mashood).
Regarding claim 8, Shurtliff modified by Lewis and Mashood discloses the limitations of claim 7 as stated above, in particular Mashood was relied on to teach force sensor that senses an applied pressure. Mashood further teaches, in the same field of endeavor, wherein the digital processing module also utilizes the applied pressure in performing the cardiovascular monitoring (“This can be used for simultaneous or sequential evaluation of arterial diameter and mechanical characteristics (using ultrasound sensor), and estimation of magnitude of blood pressure acting on the skin surface as well as the applied force (hold-down pressure) on the probe (using pressure/force sensor). These estimates would be used for evaluation of blood pulse wave velocity, and blood pressure with/without any subject-specific and/or population-specific calibration.” [0046]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with wherein the digital processing module also utilizes the applied pressure in performing the cardiovascular monitoring as taught by Mashood in order to provide more robust cardiovascular monitoring.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff in view of Lewis as applied to claim 1 above and further in view of Zhao et al. (US 2022/0350022, November 3, 2022).
Regarding claim 11, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above but fails to disclose wherein the hardware componentry, the digital processing module, and the power control system of the processing unit are comprised within a system on a chip (SoC) comprising a processor and a field programmable gate array (FPGA) for performing the on-board signal processing.
However, Zhao teaches, in the same field of endeavor, wherein the hardware componentry, the digital processing module, and the power control system of the processing unit are comprised within a system on a chip (SoC) comprising a processor and a field programmable gate array (FPGA) for performing the on-board signal processing (“Examples of a hardware logic component include but are not limited to a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), an application-specific standard product (ASSP), a system-on-a-chip system (SoC), a complex programmable logic device (CPLD), etc. For instance, a SoC may include an integrated circuit chip that includes one or more of a processor (e.g., a microcontroller, microprocessor, digital signal processor (DSP), etc.), memory, one or more communication interfaces, and/or further circuits and/or embedded firmware to perform its functions.” [0106]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with wherein the hardware componentry, the digital processing module, and the power control system of the processing unit are comprised within a system on a chip (SoC) comprising a processor and a field programmable gate array (FPGA) for performing the on-board signal processing as taught by Zhao in order to improve system efficiency and minimize cost.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff in view of Lewis as applied to claim 1 above and further in view of Shelton, IV et al. (US 2019/0201024).
Regarding claim 12, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above but fails to disclose wherein the ultrasonic sensor module comprises a flex-board sub-unit comprising the at least one array of ultrasonic transducers and a rigid board comprising the at least one pre-amplification device.
However, Shelton teaches, in the same field of endeavor, wherein the ultrasonic sensor module comprises a flex-board sub-unit comprising the at least one array of ultrasonic transducers (“wherein the circuit board comprises a flex circuit mounted to the housing” [0767]; also see [0355]) and a rigid board comprising the at least one pre-amplification device (“a second circuit board in communication with the flex circuit, wherein the second circuit board comprises a laminate circuit board” [0768]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with wherein the ultrasonic sensor module comprises a flex-board sub-unit comprising the at least one array of ultrasonic transducers and a rigid board comprising the at least one pre-amplification device as taught by Shelton in order to provide enhanced structural durability to flexible sensors.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff in view of Lewis as applied to claim 1 above and further in view of Charthad et al. (US 2022/0265157, August 25, 2022).
Regarding claim 16, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above and Shurtliff further discloses a second ultrasonic sensor module for placement on the human body at a different location than the ultrasonic sensor module and proximate a second blood vessel for performing the cardiovascular monitoring (“A wearable monitoring device includes first and second transducer arrays separated by a fixed distance. Each of the transducer arrays includes a plurality of independent transducer elements for transmitting and receiving ultrasound energy. When a user wears the device, the transducers are positioned near the brachial artery.” Abstract; also see “The present disclosure describes monitoring systems, wearable monitoring devices, and related methods for determining a pulse transit time (PTT) that can optionally be used to estimate blood pressure. Pulse transit time (PTT) is the time it takes for a blood pressure pulse from a heartbeat to arrive at two different sites in the arterial tree.” [0004]). Shurtliff is silent on wherein the processing unit is configured to trigger the hardware componentry of the ultrasonic sensor module and the second ultrasonic sensor module for synchronization of the transmission of the ultrasonic signals and the receipt of the reflected ultrasonic signals between the ultrasonic sensor module and the second ultrasonic sensor module.
However, Charthad teaches, in the same field of endeavor, wherein the processing unit is configured to trigger the hardware componentry of the ultrasonic sensor module and the second ultrasonic sensor module for synchronization of the transmission of the ultrasonic signals and the receipt of the reflected ultrasonic signals between the ultrasonic sensor module and the second ultrasonic sensor module (“In order to accurately estimate the signal transit time between the two transducers, it may be important to know both the time at which a signal waveform was transmitted and the time at which it was received, i.e., time synchronization between the two transducers may be important. In some variations, the two transducers may belong to the same wireless monitor and, thus, may be electrically connected to a common processor, allowing the use of typical logic and timing circuits for time synchronization. In some variations, where the two transducers may belong to separate wireless monitors, time synchronization may be performed via an RF or an IR synchronization pulse transmitted by one wireless monitor to the other, or transmitted by the external wireless device to the WMs.” [0171]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with wherein the processing unit is configured to trigger the hardware componentry of the ultrasonic sensor module and the second ultrasonic sensor module for synchronization of the transmission of the ultrasonic signals and the receipt of the reflected ultrasonic signals between the ultrasonic sensor module and the second ultrasonic sensor module as taught by Charthad in order to accurately estimate the signal transmit time between two transducers ([0171] of Charthad).
Regarding claim 17, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above and Shurtliff further discloses a second processing unit coupled to a second ultrasonic sensor module for placement on the human body at a different location than the ultrasonic sensor module and proximate a blood vessel for performing cardiovascular monitoring (“A wearable monitoring device includes first and second transducer arrays separated by a fixed distance. Each of the transducer arrays includes a plurality of independent transducer elements for transmitting and receiving ultrasound energy. When a user wears the device, the transducers are positioned near the brachial artery.” Abstract; also see Fig. 5 and corresponding description). Shurtliff is silent on wherein the processing unit and the second processing unit are configured to coordinate synchronous clocking via a synchronization signal.
However, Charthad teaches, in the same field of endeavor, wherein the processing unit and the second processing unit are configured to coordinate synchronous clocking via a synchronization signal (“In order to accurately estimate the signal transit time between the two transducers, it may be important to know both the time at which a signal waveform was transmitted and the time at which it was received, i.e., time synchronization between the two transducers may be important. In some variations, the two transducers may belong to the same wireless monitor and, thus, may be electrically connected to a common processor, allowing the use of typical logic and timing circuits for time synchronization. In some variations, where the two transducers may belong to separate wireless monitors, time synchronization may be performed via an RF or an IR synchronization pulse transmitted by one wireless monitor to the other, or transmitted by the external wireless device to the WMs.” [0171]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with wherein the processing unit and the second processing unit are configured to coordinate synchronous clocking via a synchronization signal as taught by Charthad in order to accurately estimate the signal transmit time between two transducers ([0171] of Charthad).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff in view of Lewis as applied to claim 1 above and further in view of Mudge et al. (US 2020/0330068).
Regarding claim 18, Shurtliff modified by Lewis discloses the limitations of claim 1 as stated above but fails to disclose an activation timer configured for autonomous activation of the ultrasonic sensor module and the processing unit enabling the transmission of the ultrasonic signals and the receipt of the reflected ultrasonic signals.
However, Mudge teaches, in the same field of endeavor, an activation timer configured for autonomous activation of the ultrasonic sensor module and the processing unit enabling the transmission of the ultrasonic signals and the receipt of the reflected ultrasonic signals (“The timer 218 automatically wakes up the monitoring device 200 from the sleep mode to operate under the active mode at predetermined time intervals. When in the active mode, the first and second transceivers 208, 210 transmit pulses for a predetermined number of cycles to measure and/or monitor the respiration rate of the subject S.” [0029]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with an activation timer configured for autonomous activation of the ultrasonic sensor module and the processing unit enabling the transmission of the ultrasonic signals and the receipt of the reflected ultrasonic signals as taught by Mudge in order to preserve energy by alternating between active and sleep modes ([0029] of Mudge).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shurtliff in view of Xu et al. (US 2020/0261059, August 20, 2020).
Regarding claim 20, Shurtliff discloses a wearable system for cardiovascular monitoring (“The present disclosure describes monitoring systems, wearable monitoring devices, and related methods for determining a pulse transit time (PTT) that can optionally be used to estimate blood pressure.” [0004]), the system comprising:
a first ultrasonic sensor module comprising a first array of ultrasonic transducers (“first transducer array” [0005]; also see transducer array 318 in Fig. 5 and corresponding description) and a first pre-amplification device coupled to the first array of ultrasonic transducers (transmission amplifier 468a in Fig. 6 and corresponding description), the first array of ultrasonic transducers comprising a first plurality of ultrasonic transducers (“The first and second transducer arrays include a plurality of independent transducer elements for transmitting and receiving ultrasound energy.” [0005]), the first ultrasonic sensor module for placement on a human body at a first location proximate a first blood vessel for performing cardiovascular monitoring (“When a user wears the device, the transducers are positioned near the brachial artery. The device operates to measure the transit time of a cardiac pulse through the brachial artery and across the fixed distance between transducer arrays. The measured pulse transit time may then be used for determining pulse wave velocity and/or blood pressure.” Abstract; also see “two different sites in the arterial tree” [0004]);
a second ultrasonic sensor module comprising a second array of ultrasonic transducers (“second transducer array” [0005]; also see transducer array 318 in Fig. 5 and corresponding description) and a second pre-amplification device coupled to the second array of ultrasonic transducers (transmission amplifier 468b in Fig. 6 and corresponding description), the second array of ultrasonic transducers comprising a second plurality of ultrasonic transducers (“The first and second transducer arrays include a plurality of independent transducer elements for transmitting and receiving ultrasound energy.” [0005]), the second ultrasonic sensor module for placement on the human body at a second location proximate a second blood vessel for performing the cardiovascular monitoring (“When a user wears the device, the transducers are positioned near the brachial artery. The device operates to measure the transit time of a cardiac pulse through the brachial artery and across the fixed distance between transducer arrays. The measured pulse transit time may then be used for determining pulse wave velocity and/or blood pressure.” Abstract; also see “two different sites in the arterial tree” [0004]);
a data storage unit (“external computer system such as a smart phone, tablet, personal computer, and/or computer system associated with a healthcare facility or provider.” [0052]);
a processing unit (microprocessor 350 in Fig. 5 and corresponding description) comprising:
hardware componentry for controlling transmission of ultrasonic signals at the first array of ultrasonic transducers and the second array of ultrasonic transducers and for controlling receipt of reflected ultrasonic signals at the first array of ultrasonic transducers and the second array of ultrasonic transducers (“the ultrasound electronics module 352 may be configured to provide an excitation voltage to the transmitter sections of the transducer array 318 and to receive and digitize the return signals generated by the receiver sections of the transducer array 318” [0050]; also see “The microprocessor 350 is configured to provide logical control over the ultrasound electronics assembly 352” [0051]);
a digital processing module for performing on-board signal processing of the reflected ultrasonic signals received at the first array of ultrasonic transducers and the second array of ultrasonic transducers (“The I and Q components from both the proximal and distal sensors may then be sampled by analog-to-digital converters (ADCs) 482 to digitize the Doppler signal received from the transducer arrays and enable further processing by the microprocessor 450 to determine PTT.” [0062]; also see Fig. 6 and corresponding description); and
a power control system comprising an energy storage device for providing power to the hardware componentry, the digital processing module, the first ultrasonic sensor module, and the second ultrasonic sensor module(“The electronics assembly 300 also includes a battery 362 and associated power supply 364 for powering the microprocessor 350, ultrasound electronics module 352, communications module 356, motion sensor 358, display module 360, and/or other components that may be included within the electronics assembly 300.” [0054].
Shurtliff fails to disclose a first connection cable assembly for communicatively coupling the first ultrasonic sensor module to the processing unit, the first connection cable assembly for enabling signal communication and power transmission between the first ultrasonic sensor module and the processing unit; and a second connection cable assembly for communicatively coupling the second ultrasonic sensor module to the processing unit, the second connection cable assembly for enabling signal communication and power transmission between the second ultrasonic sensor module and the processing unit.
However, Xu teaches, in the same field of endeavor, a first connection cable assembly for communicatively coupling the first ultrasonic sensor module to the processing unit, the first connection cable assembly for enabling signal communication and power transmission between the first ultrasonic sensor module and the processing unit; and a second connection cable assembly for communicatively coupling the second ultrasonic sensor module to the processing unit, the second connection cable assembly for enabling signal communication and power transmission between the second ultrasonic sensor module and the processing unit (“Each illustrated connector 18 of the N-channel connector port 14 is configured to connect with a single ultrasound transducer patch 16, for example by way of an electrical cable 20 of the patch 16 that has a distal end with a suitable mating electrical connector that mates with the electrical connector 18 of the N-channel connector port 14.” [0028]; also see Fig. 1, reproduced below, and corresponding description).
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Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Shurtliff with a first connection cable assembly for communicatively coupling the first ultrasonic sensor module to the processing unit, the first connection cable assembly for enabling signal communication and power transmission between the first ultrasonic sensor module and the processing unit; and a second connection cable assembly for communicatively coupling the second ultrasonic sensor module to the processing unit, the second connection cable assembly for enabling signal communication and power transmission between the second ultrasonic sensor module and the processing unit as taught by Xu in order to independently use each ultrasonic sensor module ([0028] of Xu).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797