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 .
Claims 1-20 are the currently pending claims hereby under examination
Claim Objections
Claims 1, 3, 9, 11, and 19 are objected to because of the following informalities:
In claim 1, line 4: “emit a radio frequency, RF, waveform” contains improper punctuation and formatting of abbreviations and should be revised to “emit a radio frequency (RF) waveform”;
In claim 1, line 6: “absorb one or more reflections” should be revised for consistency because a receiver circuit in a measurement system is generally configured to receive and/or detect reflections rather than “absorb” them;
In claim 3, lines 2-4: “emit the RF waveform as one of: a millimeter wave radar waveform, a Terahertz radar waveform, an ultra-wideband, UWB, waveform, and a sawtooth frequency-modulated continuous-wave, FMCW, waveform” should be revised to “selected from the group consisting of” or “one of the following:”;
In claim 3, lines 3-4: “an ultra-wideband, UWB, waveform, and a sawtooth frequency-modulated continuous-wave, FMCW, waveform” contains improper punctuation and formatting of abbreviations and should be revised to "an ultra-wideband (UWB) waveform, and a sawtooth frequency-modulated continuous-wave (FMCW) waveform";
In claim 9, line 2: “emitting radio frequency, RF, waveform” contains improper punctuation and formatting of abbreviations and should be revised to “emit a radio frequency (RF) waveform”;
In claim 9, line 4: “absorbing one or more reflections” should be revised for consistency because a receiver circuit in a measurement system is generally configured to receive and/or detect reflections rather than “absorb” them;
In claim 11, lines 1-4: “emitting the RF waveform as one of: a millimeter wave radar waveform, a Terahertz radar waveform, an ultra-wideband, UWB, waveform, and a sawtooth frequency-modulated continuous-wave, FMCW, waveform” should be revised to “selected from the group consisting of” or “one of the following:”;
In claim 11, lines 3-4: “an ultra-wideband, UWB, waveform, and a sawtooth frequency-modulated continuous-wave, FMCW, waveform” contains improper punctuation and formatting of abbreviations and should be revised to "an ultra-wideband (UWB) waveform, and a sawtooth frequency-modulated continuous-wave (FMCW) waveform"; and
In claim 19, lines 1-2: “stabilizing the body part during the contactless vascular flow measurement” lacks clear antecedent basis for “the contactless vascular flow measurement” because claim 9 does not introduce “a contactless vascular flow measurement” as a term of the method; the limitation should be revised to provide proper antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 9-12, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hellbrück et al. (Hellbrück, Horst et al. “Brachialis Pulse Wave Measurements with Ultra-Wide Band and Continuous Wave Radar, Photoplethysmography and Ultrasonic Doppler Sensors.” Sensors (Basel, Switzerland) 21.1 (2020): 165. Web.), hereto referred as Hellbrück.
Regarding claim 1, Hellbrück teaches that a vascular flow measurement system comprises: (Hellbrück, Abstract: “we investigated the concept, the construction, and the limitations of ultrawideband (UWB) radar and continuous wave (CW) radar, which provide continuous and non-invasive pulse wave measurements”, Hellbrück expressly describes a system directed to acquiring vascular flow measurements) a measurement circuit placed at a distance from a... part under measurement, the measurement circuit comprising: (Hellbrück, FIG. 4-5; p. 1-2, Sec. 1: “A setup of a sensor consisting of a transmitter and receiver pair with electromagnetic signals in the gigahertz range measure path length differences as echoes between the sensor and objects”, Hellbrück’s transmitter and receiver “pair” and multiplexer (as described in figure 4) constitutes measurement circuitry that is positioned separated from the target object such that echoes/reflections are measured between the sensor and the object; p. 1-2, Sec. 1: "The non-invasive measurement of the arterial pulse wave at arteries close to the surface was also performed contactless", showing that the circuit was at a distance from the part being measured); an emitter circuit configured to emit a radio frequency, RF, waveform toward the body part (Hellbrück, FIG. 4-5: depict an emitter circuit; p. 5, Sec. 2.2: “The UWB antennas have a frequency range from 3 to 6 GHz. They have an omnidirectional radiation pattern and geometric dimensions of half a wavelength in the corresponding frequency range”, Hellbrück’s UWB antennas operating in the 3 to 6 GHz range correspond to an emitter circuit configured to emit a radio frequency waveform toward the body part; p. 9, Sec. 3, “Figure 7 shows the result of measurements for pulse wave radar at the upper arm of a human”, Hellbrück expressly reports pulse wave radar measurements at the upper arm of a human, which is a human body part under measurement); a receiver circuit configured to absorb one or more reflections of the emitted RF waveform reflected by the body part (Hellbrück, FIG. 4-5: depict a receiver circuit; p. 1-2, Sec. 1: “A setup of a sensor consisting of a transmitter and receiver pair with electromagnetic signals in the gigahertz range measure path length differences as echoes between the sensor and objects”, Hellbrück’s receiver function is performed by receiving the measured “echoes” that result from reflections of the transmitted electromagnetic signal from the body part; p. 9, Sec. 3, “Figure 7 shows the result of measurements for pulse wave radar at the upper arm of a human”, Hellbrück expressly reports pulse wave radar measurements at the upper arm of a human, which is a human body part under measurement); a processing circuit configured to: measure a micro-vessel motion in a region of interest of the body part based on the one or more reflections of the emitted RF waveform (Hellbrück, FIG. 4: depicts the device with a "The electrical setup consists of four antennas connected to a multiplexer with a pulse generator and detector with digital signal processor (DSP) and a wireless communication interface"; p. 3, Sec. 2: “Algorithms were developed on the basis of the measured UWB signals to determine changes in vessel wall diameter in the model as a feature”, Hellbrück expressly ties processing of the measured UWB signals to determining changes in vessel wall diameter, which corresponds to measuring vessel motion from the reflected RF signals; p. 1-2, Sec. 1: “The aim of the development of the method was to focus on the upper arm region where the brachial artery runs through... The brachial artery… has an average inner vessel wall diameter of about 5 mm, which expands by up to 0.5 mm due to the pulsatile blood flow”, Hellbrück’s artery diameter expansion due to pulsatile blood flow corresponds to micro-vessel motion in a region of interest of the part; 1-2, Sec. 1: “ultrasonic sensor arrays are suitable as they provide a depth-selective contrast image of the tissue composition from reflection signals, from which the cross-sectional area of the vessel can be extracted”, Hellbrück describes obtaining vessel cross-sectional area based on “reflection signals”, which is a measurement of vessel wall motion derived from reflected signals); and characterize vascular flow in the region of interest of the body part based on the measured micro-vessel motion (Hellbrück, p. 1-3, Sec. 1: “parallel acquisition of the vessel wall extension and the flow velocity profile as seen in Figure 1”, Hellbrück characterizes vascular flow at the target region by acquiring flow velocity profile in association with vessel wall extension, where the vessel wall extension is the measured micro-vessel motion; p. 1-3, Sec. 1: “Suitable UWB and US signals should be analyzed and selected to measure vessel wall expansion and flow velocity profile”, Hellbrück teaches characterizing vascular flow using a “flow velocity profile” in association with “vessel wall expansion”).
Regarding claim 2, the modified Hellbrück teaches that a characterized level of the vascular flow is positively related to a measured strength of the micro-vessel motion; (Hellbrück, p. 1-2, Sec. 1: “It has an average inner vessel wall diameter of about 5 mm, which expands by up to 0.5 mm due to the pulsatile blood flow”, Hellbrück expressly states that vessel wall expansion magnitude is caused by pulsatile blood flow, demonstrating that the strength of vessel wall motion increases in response to blood flow; p. 11, Sec. 3: “Parameterized measurements with imprinted pressure and flow profiles show that a vessel wall expansion can be measured reproducibly”, Hellbrück teaches that different pressure and flow profiles produce measurable vessel wall expansion, showing that the characterized vascular flow condition corresponds to and varies with the measured vessel wall motion strength; FIG. 10–14: visually show the proportional relationship between pressure/flow waveform amplitude and measured expansion amplitude).
Regarding claim 3, the modified Hellbrück teaches that the emitter circuit is further configured to emit the RF waveform as one of: a millimeter wave radar waveform, a Terahertz radar waveform, an ultra-wideband, UWB, waveform, and a sawtooth frequency-modulated continuous-wave, FMCW, waveform (Hellbrück, p. 1, Abstract: “In this paper, we investigated the concept, the construction, and the limitations of ultrawideband (UWB) radar and continuous wave (CW) radar, which provide continuous and non-invasive pulse wave measurements”, Hellbrück expressly discloses use of ultrawideband radar for pulse wave measurement; p. 5, Sec. 2.2: “The UWB antennas have a frequency range from 3 to 6 GHz”, Hellbrück teaches transmission of RF signals in the gigahertz range using UWB antennas, which are part of the emitter circuit, corresponding to emitting an ultra-wideband waveform as recited).
Regarding claim 4, the modified Hellbrück teaches that the body part comprises a human peripheral body part (Hellbrück, p. 1-2, Sec. 1: “The aim of the development of the method was to focus on the upper arm region where the brachial artery runs through”, Hellbrück expressly discloses targeting measurement at the upper arm region of a human, which is a peripheral body part).
Regarding claim 9, Hellbrück teaches a method for performing a vascular flow measurement comprising: (Hellbrück, Abstract: “we investigated the concept, the construction, and the limitations of ultrawideband (UWB) radar and continuous wave (CW) radar, which provide continuous and non-invasive pulse wave measurements”, Hellbrück expressly describes a system/method directed to acquiring vascular flow measurements) emitting radio frequency, RF, waveform toward a body part under measurement (Hellbrück, p. 1-2, Sec. 1: “A setup of a sensor consisting of a transmitter and receiver pair with electromagnetic signals in the gigahertz range measure path length differences as echoes between the sensor and objects”, Hellbrück’s “transmitter and receiver pair” with “electromagnetic signals in the gigahertz range” corresponds to emitting an RF waveform toward a body part under measurement; 9, Sec. 3, “Figure 7 shows the result of measurements for pulse wave radar at the upper arm of a human”, Hellbrück expressly reports pulse wave radar measurements at the upper arm of a human, which is a human body part under measurement); absorbing one or more reflections of the emitted RF waveform reflected by the body part (Hellbrück, FIG. 4-5; p. 1-2, Sec. 1: “A setup of a sensor consisting of a transmitter and receiver pair with electromagnetic signals in the gigahertz range measure path length differences as echoes between the sensor and objects”, Hellbrück’s receiver function is performed by receiving the measured “echoes” that result from reflections of the transmitted electromagnetic signal from the body part; p. 9, Sec. 3, “Figure 7 shows the result of measurements for pulse wave radar at the upper arm of a human”, Hellbrück expressly reports pulse wave radar measurements at the upper arm of a human, which is a human body part under measurement); measuring a micro-vessel motion in a region of interest of the body part based on the one or more reflections of the emitted RF waveform (Hellbrück, FIG. 4: depicts the device with a "The electrical setup consists of four antennas connected to a multiplexer with a pulse generator and detector with digital signal processor (DSP) and a wireless communication interface"; p. 3, Sec. 2: “Algorithms were developed on the basis of the measured UWB signals to determine changes in vessel wall diameter in the model as a feature”, Hellbrück expressly ties processing of the measured UWB signals to determining changes in vessel wall diameter, which corresponds to measuring vessel motion from the reflected RF signals; p. 1-2, Sec. 1: “The aim of the development of the method was to focus on the upper arm region where the brachial artery runs through... The brachial artery… has an average inner vessel wall diameter of about 5 mm, which expands by up to 0.5 mm due to the pulsatile blood flow”, Hellbrück’s artery diameter expansion due to pulsatile blood flow corresponds to micro-vessel motion in a region of interest of the body part; 1-2, Sec. 1: “ultrasonic sensor arrays are suitable as they provide a depth-selective contrast image of the tissue composition from reflection signals, from which the cross-sectional area of the vessel can be extracted”, Hellbrück describes obtaining vessel cross-sectional area based on “reflection signals”, which is a measurement of vessel wall motion derived from reflected signals); characterizing vascular flow in the region of interest of the body part based on the measured micro-vessel motion (Hellbrück, p. 1-3, Sec. 1: “parallel acquisition of the vessel wall extension and the flow velocity profile as seen in Figure 1”, Hellbrück characterizes vascular flow at the target region by acquiring flow velocity profile in association with vessel wall extension, where the vessel wall extension is the measured micro-vessel motion; p. 1-3, Sec. 1: “Suitable UWB and US signals should be analyzed and selected to measure vessel wall expansion and flow velocity profile”, Hellbrück teaches characterizing vascular flow using a “flow velocity profile” in association with “vessel wall expansion”).
Regarding claim 10, the modified Hellbrück teaches that a characterized level of the vascular flow is positively related to a measured strength of the micro-vessel motion; (Hellbrück, p. 1-2, Sec. 1: “It has an average inner vessel wall diameter of about 5 mm, which expands by up to 0.5 mm due to the pulsatile blood flow”, Hellbrück expressly states that vessel wall expansion magnitude is caused by pulsatile blood flow, demonstrating that the strength of vessel wall motion increases in response to blood flow; p. 11, Sec. 3: “Parameterized measurements with imprinted pressure and flow profiles show that a vessel wall expansion can be measured reproducibly”, Hellbrück teaches that different pressure and flow profiles produce measurable vessel wall expansion, showing that the characterized vascular flow condition corresponds to and varies with the measured vessel wall motion strength; FIG. 10–14: visually show the proportional relationship between pressure/flow waveform amplitude and measured expansion amplitude).
Regarding claim 11, the modified Hellbrück teaches that the emitter circuit is further configured to emit the RF waveform as one of: a millimeter wave radar waveform, a Terahertz radar waveform, an ultra-wideband, UWB, waveform, and a sawtooth frequency-modulated continuous-wave, FMCW, waveform (Hellbrück, p. 1, Abstract: “In this paper, we investigated the concept, the construction, and the limitations of ultrawideband (UWB) radar and continuous wave (CW) radar, which provide continuous and non-invasive pulse wave measurements”, Hellbrück expressly discloses use of ultrawideband radar for pulse wave measurement; p. 5, Sec. 2.2: “The UWB antennas have a frequency range from 3 to 6 GHz”, Hellbrück teaches transmission of RF signals in the gigahertz range using UWB antennas, which are part of the emitter circuit, corresponding to emitting an ultra-wideband waveform as recited).
Regarding claim 12, the modified Hellbrück teaches that emitting the RF waveform toward the body part comprises emitting the RF waveform toward a human peripheral body part (Hellbrück, p. 1-2, Sec. 1: “The aim of the development of the method was to focus on the upper arm region where the brachial artery runs through”, Hellbrück expressly discloses targeting measurement at the upper arm region of a human, which is a peripheral body part).
Regarding claim 19, the modified Hellbrück teaches stabilizing the body part during the contactless vascular flow measurement (Hellbrück, p. 9, Sec. 4: “Measurements in this setup were performed with individual humans sitting on an office chair and breathing normally without moving too much”, Hellbrück teaches performing the contactless measurement while the subject avoids movement, which stabilizes the body part during the measurement; p. 14-15, Sec. 5: “even the smallest movement of the arm or the antennas had unpredictable effects”, Hellbrück teaches that arm movement adversely affects the measurement, supporting the need for stabilizing the body part during contactless measurement).
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 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hellbrück et al. (Hellbrück, Horst et al. “Brachialis Pulse Wave Measurements with Ultra-Wide Band and Continuous Wave Radar, Photoplethysmography and Ultrasonic Doppler Sensors.” Sensors (Basel, Switzerland) 21.1 (2020): 165. Web.), hereto referred as Hellbrück, and further in view of Barak (US 20170065184 A1), hereto referred as Barak.
The modified Hellbrück teaches claim 1 as described above.
The modified Hellbrück teaches claim 9 as described above.
Regarding claim 5, the modified Hellbrück does not teach that the human peripheral body part comprises a human wrist. Rather, the modified Hellbrück teaches contactless pulse wave measurement using radio frequency sensing directed to a human peripheral body part, but does not teach that the measured human peripheral body part comprises a human wrist (Hellbrück, p. 1-2, Sec. 1).
Barak teaches applying contactless RF sensing at the wrist by transmitting a modulated microwave signal near the wrist of a person (Barak, ¶[0010]: “the invention provides transmitting a modulated microwave signal near the wrist of a person”). Barak further teaches non-contact spacing for wrist measurement, explaining that a transmitter and sensor can be positioned away from the skin (Barak, ¶[0011]: “includes a transmitter and sensor that can be positioned up to one centimeter away from the skin”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Barak to perform the modified Hellbrück’s contactless RF-based vascular measurement at a human wrist. Such a modification would have been feasible because both references use RF energy transmitted toward tissue and analyzed based on reflected signals, and Barak expressly teaches implementing the RF sensing approach at the wrist with a transmitter and sensor positioned away from the skin. The benefit of the combination would have been enabling the modified Hellbrück’s contactless RF vascular measurement to be implemented at the wrist, a location where arteries are superficial and readily accessible, thereby facilitating integration into wearable devices and enabling convenient, repeatable, and continuous vascular monitoring in everyday use.
Regarding claim 13, the modified Hellbrück does not teach that emitting the RF waveform toward the human peripheral body part comprises emitting the RF waveform toward a human wrist. Rather, the modified Hellbrück teaches contactless pulse wave measurement using radio frequency sensing directed to a human peripheral body part, but does not teach that the measured human peripheral body part comprises a human wrist (Hellbrück, p. 1-2, Sec. 1).
Barak teaches applying contactless RF sensing at the wrist by transmitting a modulated microwave signal near the wrist of a person (Barak, ¶[0010]: “the invention provides transmitting a modulated microwave signal near the wrist of a person”). Barak further teaches non-contact spacing for wrist measurement, explaining that a transmitter and sensor can be positioned away from the skin (Barak, ¶[0011]: “includes a transmitter and sensor that can be positioned up to one centimeter away from the skin”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Barak to perform the modified Hellbrück’s contactless RF-based vascular measurement at a human wrist. Such a modification would have been feasible because both references use RF energy transmitted toward tissue and analyzed based on reflected signals, and Barak expressly teaches implementing the RF sensing approach at the wrist with a transmitter and sensor positioned away from the skin. The benefit of the combination would have been enabling the modified Hellbrück’s contactless RF vascular measurement to be implemented at the wrist, a location where arteries are superficial and readily accessible, thereby facilitating integration into wearable devices and enabling convenient, repeatable, and continuous vascular monitoring in everyday use.
Claims 6, 8, 14, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hellbrück et al. (Hellbrück, Horst et al. “Brachialis Pulse Wave Measurements with Ultra-Wide Band and Continuous Wave Radar, Photoplethysmography and Ultrasonic Doppler Sensors.” Sensors (Basel, Switzerland) 21.1 (2020): 165. Web.), hereto referred as Hellbrück, and further in view of Santra et al. (US 20190240535 A1), hereto referred as Santra.
The modified Hellbrück teaches claim 1 as described above.
The modified Hellbrück teaches claim 9 as described above.
Regarding claim 6, the modified Hellbrück teaches determining a target location based on RF processing, but does not explicitly teach that the processing circuit is further configured to determine the region of interest of the body part based on a pulse sensitivity map.
Santra teaches generating a range map and a range-time intensity map that identify reflected signal strength across range bins and are processed to identify range bins corresponding to physiological motion (Santra, ¶[0028]-¶[0030]). Santra further teaches determining the relevant vital signal by identifying “high response ‘range gate’ measurements” derived from FFT of FMCW radar measurements and using those high-response range gates as the basis for vital signal measurement (Santra, ¶[0032]: “the relevant vital signal is determined by using high response "range gate” measurements that may be determined, for example, by taking a fast Fourier transform ( FFT ) of down converted frequency modulated continuous wave ( FMCW ) measurements from the millimeter-wave based radar sensor”) and further teaches compensating for motion “by tracking shifts in the high response range gates and stitching together measurements from multiple range gates to form the basis for the vital signal measurement” (Santra, ¶[0032]). These disclosures expressly describe forming a map across range bins and selecting the range bins corresponding to physiological motion based on signal strength, which corresponds to determining a region of interest of the body part based on a pulse sensitivity map.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Santra to determine the region of interest of the body part based on a pulse sensitivity map. Such a modification would have been feasible because the modified Hellbrück already processes radar reflections to determine a target location, and Santra’s FFT-derived high-response range-gate selection and tracking could be applied to Hellbrück’s reflected-signal processing to identify and select the range gate(s) corresponding to the strongest pulse-related motion as the region of interest. The benefit of the combination would have been improved robustness and reliability of selecting the pulse-related region of interest for downstream vascular-flow characterization by focusing processing on the highest-response range gate(s) and accommodating shifts in the selected range gate(s) during measurement.
Regarding claim 8, the modified Hellbrück teaches a radar sensor having multiple transmit and receive antennas in a sensor array, but does not explicitly teach that the emitter circuit comprises a plurality of antennas configured to emit the RF waveform via RF beamforming.
Santra teaches that a radar sensor may be configured to perform beamforming, stating “In some embodiments, radar sensor 130 may be configured to perform MIMO operations to separate multiple spatially-separated targets, perform beamforming, and derive a target angle (e.g., azimuth angle and elevation angle)” (Santra, ¶[0038]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Santra to configure the emitter circuit plurality of antennas to emit the RF waveform via RF beamforming. Such a modification is feasible because the modified Hellbrück already uses a radar “sensor array” with multiple transmit antennas, and Santra teaches that a radar sensor can use MIMO operations to “perform beamforming” and derive target angle, which is implemented by using the antenna plurality with appropriate transmission phasing and signal processing to form a directed RF beam. The benefit of the combination is improved spatial selectivity and robustness of the contactless vascular measurement by directing and shaping the emitted RF energy toward the desired measurement region while reducing interference from other reflectors.
Regarding claim 14, the modified Hellbrück teaches determining a target location based on RF processing, but does not explicitly teach that it further comprises determining the region of interest of the body part based on a pulse sensitivity map.
Santra teaches generating a range map and a range-time intensity map that identify reflected signal strength across range bins and are processed to identify range bins corresponding to physiological motion (Santra, ¶[0028]-¶[0030]). Santra further teaches determining the relevant vital signal by identifying “high response ‘range gate’ measurements” derived from FFT of FMCW radar measurements and using those high-response range gates as the basis for vital signal measurement (Santra, ¶[0032]: “the relevant vital signal is determined by using high response "range gate” measurements that may be determined, for example, by taking a fast Fourier transform ( FFT ) of down converted frequency modulated continuous wave ( FMCW ) measurements from the millimeter-wave based radar sensor”) and further teaches compensating for motion “by tracking shifts in the high response range gates and stitching together measurements from multiple range gates to form the basis for the vital signal measurement” (Santra, ¶[0032]). These disclosures expressly describe forming a map across range bins and selecting the range bins corresponding to physiological motion based on signal strength, which corresponds to determining a region of interest of the body part based on a pulse sensitivity map.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Santra to determine the region of interest of the body part based on a pulse sensitivity map. Such a modification would have been feasible because the modified Hellbrück already processes radar reflections to determine a target location, and Santra’s FFT-derived high-response range-gate selection and tracking could be applied to Hellbrück’s reflected-signal processing to identify and select the range gate(s) corresponding to the strongest pulse-related motion as the region of interest. The benefit of the combination would have been improved robustness and reliability of selecting the pulse-related region of interest for downstream vascular-flow characterization by focusing processing on the highest-response range gate(s) and accommodating shifts in the selected range gate(s) during measurement.
Regarding claim 17, the modified Hellbrück teaches
changing the vascular flow in the body part using a pressure pump
(Hellbrück, p. 5, Sec. 2.1: “The model environment was built up modularly. The main components are a tissue phantom, a pump to generate a pulsatile flow or pressure, and a pump to generate a constant flow or pressure”, Hellbrück teaches using a pressure pump to generate and adjust pulsatile or constant flow or pressure, which is conceptually equivalent to changing vascular flow using a pressure pump; p. 5, Sec. 2.1: “With the additional gear pump, a constant flow and pressure in the phantom artery can be adjusted”, Hellbrück further teaches adjusting flow and pressure using a pump, which corresponds to changing vascular flow using a pressure pump).
Also regarding claim 17, the modified Hellbrück does not expressly teach generating the RF waveform using a radar that is one of a millimeter wave and a Terahertz wave radar. Rather, the modified Hellbrück teaches using RF radar for pulse wave measurement, including “ultrawideband (UWB) radar and continuous wave (CW) radar” for “continuous and non-invasive pulse wave measurements” (Hellbrück, Abstract), but does not expressly teach generating the RF waveform using a radar that is one of a millimeter wave and a Terahertz wave radar.
Santra teaches millimeter wave radar sensing, stating “one or more millimeter wave based sensors are used to detect the vital signs” (Santra, ¶[0028]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hellbrück in view of Santra to generate the RF waveform using a radar that is one of a millimeter wave and a Terahertz wave radar by implementing Hellbrück’s pulse wave measurement using Santra’s millimeter wave radar sensor. Such a modification would have been possible because both references perform radar based transmission toward a target and processing of reflected radar signals to detect physiological characteristics, and substituting a millimeter wave radar front end for Hellbrück’s radar front end is a predictable implementation choice for the same reflected signal measurement objective. The benefit of the combination would have been improving sensitivity to small vessel wall displacements and enabling higher spatial resolution physiological monitoring due to the shorter wavelength of millimeter wave radar, while also allowing more compact antenna structures suitable for contactless vital sign sensing applications.
Regarding claim 20 the modified Hellbrück teaches a radar sensor having multiple transmit and receive antennas in a sensor array, but does not explicitly teach that emitting the RF waveform comprises emitting the RF waveform via RF beamforming.
Santra teaches that a radar sensor may be configured to perform beamforming, stating “In some embodiments, radar sensor 130 may be configured to perform MIMO operations to separate multiple spatially-separated targets, perform beamforming, and derive a target angle (e.g., azimuth angle and elevation angle)” (Santra, ¶[0038]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Santra to configure the emitter circuit plurality of antennas to emit the RF waveform via RF beamforming. Such a modification is feasible because the modified Hellbrück already uses a radar “sensor array” with multiple transmit antennas, and Santra teaches that a radar sensor can use MIMO operations to “perform beamforming” and derive target angle, which is implemented by using the antenna plurality with appropriate transmission phasing and signal processing to form a directed RF beam. The benefit of the combination is improved spatial selectivity and robustness of the contactless vascular measurement by directing and shaping the emitted RF energy toward the desired measurement region while reducing interference from other reflectors.
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hellbrück et al. (Hellbrück, Horst et al. “Brachialis Pulse Wave Measurements with Ultra-Wide Band and Continuous Wave Radar, Photoplethysmography and Ultrasonic Doppler Sensors.” Sensors (Basel, Switzerland) 21.1 (2020): 165. Web.), hereto referred as Hellbrück, and further in view of Santra et al. (US 20190240535 A1), hereto referred as Santra, and further in view of Wang et al. (Wang, Yong et al. “Remote Monitoring of Human Vital Signs Based on 77-GHz Mm-Wave FMCW Radar.” Sensors (Basel, Switzerland) 20.10 (2020): 2999. Web.), hereto referred as Wang, and further in view of Barak (US 20170065184 A1), hereto referred as Barak.
The modified Hellbrück teaches claim 1 as described above.
The modified Hellbrück teaches claim 9 as described above.
Regarding claim 7, the modified Hellbrück teaches radar-based pulse-wave measurement and reflected-signal processing, but does not explicitly teach that the processing circuit is further configured to: extract a respective one of a plurality of temporal phase variations from a respective one of a plurality of range bins; compute a cross-correlation value between each of the plurality of temporal phase variations and a reference pulse signal; and overlay the cross-correlation value computed for each of the plurality of temporal phase variations with one of the plurality of range bins to generate the pulse sensitivity map.
Specifically, the modified Hellbrück teaches radar-based pulse-wave measurement using reflected RF signals and teaches correlation and Doppler-based processing for identifying target location and frequency shift (Hellbrück, p. 7, Sec. 3: “This was revealed with the correlation of transmit pulse and receive pulse in the time domain, as well as with a Doppler evaluation, which returns target location and frequency shift”). However, the modified Hellbrück does not teach extracting a respective temporal phase variation from each of a plurality of range bins, computing a cross-correlation value between each of those temporal phase variations and a reference pulse signal, or overlaying the resulting correlation values with corresponding range bins to generate a pulse sensitivity map.
Santra teaches performing a Range FFT and determining high response range gates (Santra, FIG. 2D: “Range FFT” and “Determine high response range gates”), and further teaches that “the relevant vital signal is determined by using high response "range gate" measurements that may be determined, for example, by taking a fast Fourier transform (FFT) of down converted frequency modulated continuous wave (FMCW) measurements from the millimeter-wave based radar sensor” (Santra, ¶[0032]). Santra therefore teaches organizing reflected radar data into range gates or bins and selecting those bins based on signal response, which corresponds to identifying candidate range-bin regions associated with physiological motion.
Wang teaches constructing a range-time map organized by distance distribution, stating that “the range time map (RTM) is constructed according to the range distribution” (Wang, p. 5-6, Sec. 3.1), and further teaches that “the phase information is extracted at the distance interval where the target position is located” (Wang, p. 7, Sec. 3.3). Wang therefore teaches extracting phase information associated with a selected distance interval, which corresponds to extracting a temporal phase variation from a range bin. Wang’s construction of a “range time map (RTM)” “according to the range distribution” expressly provides a plurality of range bins across distance, and Santra expressly evaluates those multiple bins by “determining high response range gates,” such that a respective temporal phase variation is extracted from a respective one of the plurality of range bins for comparison (Wang, p. 5-6, Sec. 3.1; Wang, p. 7, Sec. 3.3; Santra, FIG. 2D).
Barak teaches computing correlation between a measured physiological signal and predefined reference wave shapes, stating that “the heart-rate can be estimated using a correlation with a set of predefined wave shapes” (Barak, ¶[0099]). Barak therefore teaches computing a correlation value between a measured physiological temporal signal and a reference waveform used as a reference pulse signal, where the “set of predefined wave shapes” provides candidate reference pulse signals against which correlation values are computed and compared (Barak, ¶[0099]). The claimed “reference pulse signal” is satisfied by Barak’s predefined reference wave shapes because those wave shapes are used as the reference signals in the correlation operation to identify the pulse periodicity, and the claim does not require that the reference be generated by any particular external instrument.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Santra, Wang, and Barak to extract a respective one of a plurality of temporal phase variations from a respective one of a plurality of range bins, compute a cross-correlation value between each of the plurality of temporal phase variations and a reference pulse signal, and overlay the cross-correlation value computed for each of the plurality of temporal phase variations with one of the plurality of range bins to generate the pulse sensitivity map. Such a modification is feasible because the modified Hellbrück already performs correlation and Doppler processing on reflected radar signals, Santra and Wang teach organizing reflected radar data into range bins and extracting phase information from selected distance intervals, and Barak teaches correlating physiological temporal signals with reference pulse waveforms, including selecting from ‘a set of predefined wave shapes,’ which serves as one or more reference pulse signals for the cross-correlation operation (Barak, ¶[0099]). Applying Barak’s correlation technique to the per-range-bin temporal phase signals organized according to Santra’s and Wang’s range-bin structures yields per-range-bin correlation values that are associated with and indexed by their corresponding range bins, and presenting those indexed correlation values across the plurality of range bins in a map representation constitutes overlaying the computed correlation values onto the range-bin structure to generate the pulse sensitivity map. The benefit of the combination is improved reliability and robustness in identifying the pulse-related region of interest by quantitatively determining, across multiple range bins, which range-bin temporal variation most closely matches a reference pulse signal for downstream vascular-flow characterization, and visually presenting those correlation values across range bins to facilitate selection of the region of interest.
Regarding claim 15, the modified Hellbrück teaches radar-based pulse-wave measurement and reflected-signal processing, but does not explicitly teach extracting a respective one of a plurality of temporal phase variations from a respective one of a plurality of range bins; computing a cross-correlation value between each of the plurality of temporal phase variations and a reference pulse signal; and overlaying the cross-correlation value computed for each of the plurality of temporal phase variations with one of the plurality of range bins to generate the pulse sensitivity map.
Specifically, the modified Hellbrück teaches radar-based pulse-wave measurement using reflected RF signals and teaches correlation and Doppler-based processing for identifying target location and frequency shift (Hellbrück, p. 7, Sec. 3: “This was revealed with the correlation of transmit pulse and receive pulse in the time domain, as well as with a Doppler evaluation, which returns target location and frequency shift”). However, the modified Hellbrück does not teach extracting a respective temporal phase variation from each of a plurality of range bins, computing a cross-correlation value between each of those temporal phase variations and a reference pulse signal, or overlaying the resulting correlation values with corresponding range bins to generate a pulse sensitivity map.
Santra teaches performing a Range FFT and determining high response range gates (Santra, FIG. 2D: “Range FFT” and “Determine high response range gates”), and further teaches that “the relevant vital signal is determined by using high response "range gate" measurements that may be determined, for example, by taking a fast Fourier transform (FFT) of down converted frequency modulated continuous wave (FMCW) measurements from the millimeter-wave based radar sensor” (Santra, ¶[0032]). Santra therefore teaches organizing reflected radar data into range gates or bins and selecting those bins based on signal response, which corresponds to identifying candidate range-bin regions associated with physiological motion.
Wang teaches constructing a range-time map organized by distance distribution, stating that “the range time map (RTM) is constructed according to the range distribution” (Wang, p. 5-6, Sec. 3.1), and further teaches that “the phase information is extracted at the distance interval where the target position is located” (Wang, p. 7, Sec. 3.3). Wang therefore teaches extracting phase information associated with a selected distance interval, which corresponds to extracting a temporal phase variation from a range bin. Wang’s construction of a “range time map (RTM)” “according to the range distribution” expressly provides a plurality of range bins across distance, and Santra expressly evaluates those multiple bins by “determining high response range gates,” such that a respective temporal phase variation is extracted from a respective one of the plurality of range bins for comparison (Wang, p. 5-6, Sec. 3.1; Wang, p. 7, Sec. 3.3; Santra, FIG. 2D).
Barak teaches computing correlation between a measured physiological signal and predefined reference wave shapes, stating that “the heart-rate can be estimated using a correlation with a set of predefined wave shapes” (Barak, ¶[0099]). Barak therefore teaches computing a correlation value between a measured physiological temporal signal and a reference waveform used as a reference pulse signal, where the “set of predefined wave shapes” provides candidate reference pulse signals against which correlation values are computed and compared (Barak, ¶[0099]). The claimed “reference pulse signal” is satisfied by Barak’s predefined reference wave shapes because those wave shapes are used as the reference signals in the correlation operation to identify the pulse periodicity, and the claim does not require that the reference be generated by any particular external instrument.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Santra, Wang, and Barak to extract a respective one of a plurality of temporal phase variations from a respective one of a plurality of range bins, compute a cross-correlation value between each of the plurality of temporal phase variations and a reference pulse signal, and overlay the cross-correlation value computed for each of the plurality of temporal phase variations with one of the plurality of range bins to generate the pulse sensitivity map. Such a modification is feasible because the modified Hellbrück already performs correlation and Doppler processing on reflected radar signals, Santra and Wang teach organizing reflected radar data into range bins and extracting phase information from selected distance intervals, and Barak teaches correlating physiological temporal signals with reference pulse waveforms, including selecting from ‘a set of predefined wave shapes,’ which serves as one or more reference pulse signals for the cross-correlation operation (Barak, ¶[0099]). Applying Barak’s correlation technique to the per-range-bin temporal phase signals organized according to Santra’s and Wang’s range-bin structures yields per-range-bin correlation values that are associated with and indexed by their corresponding range bins, and presenting those indexed correlation values across the plurality of range bins in a map representation constitutes overlaying the computed correlation values onto the range-bin structure to generate the pulse sensitivity map. The benefit of the combination is improved reliability and robustness in identifying the pulse-related region of interest by quantitatively determining, across multiple range bins, which range-bin temporal variation most closely matches a reference pulse signal for downstream vascular-flow characterization, and visually presenting those correlation values across range bins to facilitate selection of the region of interest.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hellbrück et al. (Hellbrück, Horst et al. “Brachialis Pulse Wave Measurements with Ultra-Wide Band and Continuous Wave Radar, Photoplethysmography and Ultrasonic Doppler Sensors.” Sensors (Basel, Switzerland) 21.1 (2020): 165. Web.), hereto referred as Hellbrück, and further in view of Santra et al. (US 20190240535 A1), hereto referred as Santra, and further in view of Yang et al. (Yang, Zi-Kai et al. “Vital Sign Detection during Large-Scale and Fast Body Movements Based on an Adaptive Noise Cancellation Algorithm Using a Single Doppler Radar Sensor.” Sensors (Basel, Switzerland) 20.15 (2020): 4183. Web.), hereto referred as Yang.
The modified Hellbrück teaches claim 9 as described above.
The modified Hellbrück teaches claim 14-15 as described above.
Regarding claim 16, the modified Hellbrück does not teach that the method further comprises generating the reference pulse signal using a fingertip oximeter. Rather, the modified Hellbrück, as applied in the rejection of claim 15, teaches radar based reflected signal processing to obtain a physiological signal (pulse wave), but does not expressly teach generating the reference pulse signal using a fingertip oximeter.
Yang teaches using a fingertip oximeter as a reference source for a heartbeat signal, stating (Yang, p. 7, Sec 3: “For the heartbeat, a finger pulse oximeter YX303 (Yuwell, Suzhou, China) measurement served as the HR reference”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Yang to comprise generating the reference pulse signal using a fingertip oximeter. Such a modification would have been possible because the fingertip oximeter provides a readily obtainable, time synchronized reference heartbeat signal that can be used alongside the radar derived signal processing of Hellbrück for reference based processing steps, and incorporating an external reference sensor does not require changing the radar hardware of the modified Hellbrück beyond adding a measurement input. The benefit of the combination would have been improved reliability and validation of radar based pulse measurements by using an independent fingertip oximeter reference signal for reference based processing.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hellbrück et al. (Hellbrück, Horst et al. “Brachialis Pulse Wave Measurements with Ultra-Wide Band and Continuous Wave Radar, Photoplethysmography and Ultrasonic Doppler Sensors.” Sensors (Basel, Switzerland) 21.1 (2020): 165. Web.), hereto referred as Hellbrück, and further in view of Santra et al. (US 20190240535 A1), hereto referred as Santra, and further in view of Asif et al. (Asif, Mohammed, and Pradip K Sarkar. “Three-Digit Allen’s Test.” The Annals of thoracic surgery 84.2 (2007): 686–687. Web.), hereto referred as Asif, and further in view of Prat et al. (Prat, Arnau et al. “Collimated Beam FMCW Radar for Vital Sign Patient Monitoring.” IEEE transactions on antennas and propagation 67.8 (2019): 5073–5080. Web.), hereto referred as Prat.
The modified Hellbrück teaches claim 9 as described above.
The modified Hellbrück teaches claim 17 as described above.
Regarding claim 18, the modified Hellbrück does not expressly teach determining a measurement site on the body part via wrist palpation; and aligning boresight of the radar with the measurement site on the body part. Rather, the modified Hellbrück teaches radar-based pulse wave measurements in which “measurements can be carried out with variable positioning of the antennas” (Hellbrück, p. 11, Fig. 9) and further teaches that the human measurement setup is highly sensitive to positioning such that “even the smallest movement of the arm or the antennas had unpredictable effects” (Hellbrück, p. 15, Sec. 5). Additionally as shown above in claim 17, it shows using a pressure pump in its measurement configuration, stating “The main components are a tissue phantom, a pump to generate a pulsatile flow or pressure, and a pump to generate a constant flow or pressure” (Hellbrück, p. 5, Sec. 2.1) and further that “With the additional gear pump, a constant flow and pressure in the phantom artery can be adjusted” (Hellbrück, p. 5, Sec. 2.1). These disclosures show that Hellbrück’s system is concerned with generating and controlling vascular flow conditions at a selected arterial site in order to observe vessel wall motion and flow characteristics, which implies identification and targeting of a specific measurement site, although Hellbrück does not expressly teach determining that measurement site via wrist palpation or aligning a boresight of the radar with the measurement site on the body part.
Asif teaches palpation-based site determination by stating “The radial artery is located by palpation at the proximal skin crease of the wrist and then compressed with three digits” (Asif, p. 686, 'Technique'). This expressly teaches determining a wrist arterial location via palpation by identifying the radial artery at the wrist skin crease, establishing palpation as a known technique for selecting a wrist measurement site.
Prat provides explicit boresight context in a patient-monitoring radar by stating “It is observed that the maximum of the field is not in the boresight direction and the diameter of the illuminated area is approximately 10 cm” (Prat, p. 5, Sec. III). This disclosure explains that radar field distribution is referenced relative to a defined boresight direction, demonstrating that radar measurements are understood in terms of alignment between the antenna boresight and an illuminated body region. Prat further teaches “Peak detection in a preselected range interval to locate the sample corresponding to the patient observed spot” (Prat, p. 3, Sec. II), showing that a specific observed spot on the patient is intentionally selected for radar measurement. Together these disclosures provide technical context for aligning a radar boresight toward a selected measurement site on the body.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Hellbrück in view of Asif and Prat to determine a measurement site on the body part via wrist palpation and align a boresight of the radar with the measurement site on the body part. Such a modification would have been feasible because Hellbrück already contemplates varying antenna positioning for the measurement and recognizes sensitivity to antenna placement, Asif teaches locating the radial artery at the wrist by palpation prior to intervention, and Prat teaches directing and overlapping antenna beams along a principal direction toward a selected observed spot. The benefit of the combination is improved repeatability and reliability of the radar-based vascular measurement by standardizing wrist site selection via palpation and directing the radar sensing axis toward the selected arterial location.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791