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 .
Applicant' s arguments, filed 6/2/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 6/2/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-5, 8-13, and 16-20 are the currently pending claims hereby under examination. Claims 6-7 and 14-15 have been canceled; claims 1, 3, 9, 11, 16, and 19 have been amended.
Claim Interpretations
With respect to claims 1 and 9, the Examiner interprets “overlay the respective cross-correlation value computed for each of the plurality of temporal phase variations with a selected one of the plurality of range bins to generate a pulse sensitivity map” as associating each computed cross-correlation value with a corresponding range bin so that the pulse response or pulse sensitivity is represented over range.
Claim Objections
Claim 9 is objected to because of the following informalities:
In claim 9, line 13: “dynamically determine a region of interest of the body part” is inconsistent with the gerund form used in the surrounding method steps, and should be revised to “dynamically determining a region of interest of the body part”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 9 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. Claims 1 and 9 recite “dynamically determine a region of interest of the body part based on a strongest reflection point in the pulse sensitivity map” in lines 16-17 and 13-14 respectively. The originally filed disclosure does not reasonably convey possession of determining a region of interest based on a “strongest reflection point in the pulse sensitivity map,” as presently recited. The specification at ¶[0032] describes determining the region of interest based on a pulse sensitivity map. The specification at ¶[0033] describes that “a strongest reflection point in a range bin can be used to locate the region of interest,” but then explains that the pulse signal quality is not necessarily the best at this single range bin, and that the processing circuit determines the pulse sensitivity map by applying multi-channel signal processing to different phase signals from multiple range bins. Thus, the specification distinguishes locating the region of interest using a strongest reflection point in a range bin from determining the pulse sensitivity map. The specification at ¶¶[0034]-[0035] describes the pulse sensitivity map as being generated by extracting temporal phase variation from range bins, computing cross-correlation values between the extracted temporal phase variations and a reference pulse signal, and overlaying the computed cross-correlation values with range bins. Similarly, Figs. 3A to 3D show temporal phase variations 40 over range and time, filtering of the temporal phase variations, comparison with a pulse reference 42, and a pulse sensitivity map 38 having a peak at a range location. Accordingly, the specification and drawings support a peak or highest pulse sensitivity value in the pulse sensitivity map, but do not reasonably convey possession of a strongest reflection point in the pulse sensitivity map. The originally filed claims 6, 7, 14, and 15 likewise do not provide support for the presently recited feature. Those claims recited determining the region of interest based on a pulse sensitivity map, but did not recite dynamically determining the region of interest based on a strongest reflection point in the pulse sensitivity map. The Examiner notes that this rejection is not based merely on the absence of the exact word “dynamically” from the specification. Rather, the rejection is based on the fact that the originally filed disclosure describes a strongest reflection point in a range bin and separately describes a pulse sensitivity map generated from cross-correlation or pulse sensitivity values, but does not reasonably convey possession of the presently claimed combination of “dynamically determine a region of interest of the body part based on a strongest reflection point in the pulse sensitivity map.”
Claims 2-5 and 8 are rejected by virtue of their dependence from claim 1.
Claims 10-13 and 17-20 are rejected by virtue of their dependence from claim 9.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claims 1 and 9 recite “dynamically determine a region of interest of the body part based on a strongest reflection point in the pulse sensitivity map” in lines 16-17 and 13-14 respectively. The Examiner interprets the recited “pulse sensitivity map” as the map generated by the immediately preceding limitation, namely a map generated by overlaying respective cross-correlation values computed between temporal phase variations and a reference pulse signal with range bins. Under this interpretation, the scope of “a strongest reflection point in the pulse sensitivity map” is not reasonably ascertainable because the pulse sensitivity map is generated from cross-correlation values, not reflection strength values. Thus, it is not reasonably clear whether the claimed “strongest reflection point” refers to the strongest raw RF reflection, the highest cross-correlation value, the highest pulse sensitivity value, or some other point or value in the pulse sensitivity map. The ambiguity is further confirmed by the specification. The specification describes a “strongest reflection point in a range bin” as one way to locate the region of interest, but then describes the pulse sensitivity map as a different processing result generated from temporal phase variations and reference-pulse cross-correlation values. Therefore, the phrase “strongest reflection point in the pulse sensitivity map” conflates reflection strength with pulse sensitivity or correlation values, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed limitation. Accordingly, claims 1 and 9 are indefinite. The Examiner interprets “strongest reflection point in the pulse sensitivity map” as including at least a maximum value point in the pulse sensitivity map used to select a target range or region of interest. To the extent applicant contends that “strongest reflection point” instead requires a strongest raw reflected-power location, the limitation is alternatively interpreted as including a strongest reflected-power range location used to locate or track the observed target region.
Claims 2-5 and 8 are rejected by virtue of their dependence from claim 1.
Claims 10-13 and 17-20 are rejected by virtue of their dependence from claim 9.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 9-13, and 19 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.), hereinafter referred to as Hellbrück, and in view of Choi (Choi, Ho-Ik, et al. “Target Range Selection of FMCW Radar for Accurate Vital Information Extraction,” IEEE Access, Vol. 9, 2021, pp. 1261-1270), hereinafter referred to as Choi, in view of Barak (US-20170065184-A1), hereinafter referred to as Barak, and further in view of Prat (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.), hereinafter referred to as Prat.
Regarding claim 1, Hellbrück teaches that a vascular flow measurement system (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”; p. 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”; p. 2, Sec. 1: “Our major goal in this study was the measurement of the pulse wave and the cross-sectional area of the artery”; Hellbrück expressly describes a system directed to acquiring vascular pulse wave measurements) comprises: a measurement circuit placed at a distance from a body part under measurement, the measurement circuit comprising: (Hellbrück, Fig. 4; p. 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”; p. 2, Sec. 1: “The non-invasive measurement of the arterial pulse wave at arteries close to the surface was also performed contactless”; Hellbrück’s transmitter and receiver pair, multiplexer, pulse generator, detector, and digital signal processor constitute measurement circuitry positioned relative to a human body part so that echoes/reflections are measured between the sensor and the body part); an emitter circuit configured to emit a radio frequency (RF) waveform toward the body part; (Hellbrück, Fig. 4-5; p. 5, Sec. 2.2: “The UWB antennas have a frequency range from 3 to 6 GHz”; p. 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”; p. 9, Sec. 3: “Figure 7 shows the result of measurements for pulse wave radar at the upper arm of a human”; Hellbrück’s transmitter/antenna emitting electromagnetic signals in the gigahertz range corresponds to an emitter circuit configured to emit an RF waveform toward the body part); a receiver circuit configured to receive one or more reflections of the emitted RF waveform reflected by the body part; (Hellbrück, Fig. 4-5; p. 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/detector receives echoes produced by reflections of the emitted RF waveform from the measured body part); and a processing circuit configured to: (Hellbrück, Fig. 4: “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”; Hellbrück’s DSP corresponds to a processing circuit for processing received RF measurements); Hellbrück teaches the processing circuit is configured to measure a micro-vessel motion in the region of interest of the body part based on the one or more reflections of the emitted RF waveform; (Hellbrück, 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”; p. 2, Sec. 1: “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”; p. 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’s determining changes in vessel wall diameter based on measured UWB/reflection signals corresponds to measuring micro-vessel motion based on the one or more reflections of the emitted RF waveform); and characterize vascular flow in the region of interest of the body part based on the measured micro-vessel motion (Hellbrück, p. 2, Sec. 1: “The detection of low blood pressure should be possible as well as the parallel acquisition of the vessel wall extension and the flow velocity profile as seen in Figure 1”; p. 3, Sec. 2: “Suitable UWB and US signals should be analyzed and selected to measure vessel wall expansion and flow velocity profile”; Hellbrück characterizes vascular flow at the target region by acquiring a flow velocity profile in association with vessel wall extension, where vessel wall extension corresponds to the measured micro-vessel motion).
Also regarding claim 1, Hellbrück does not expressly teach that the processing circuit is configured to extract a plurality of temporal phase variations from a plurality of range bins, respectively; compute a respective cross-correlation value between each of the plurality of temporal phase variations and a reference pulse signal; overlay the respective cross-correlation value computed for each of the plurality of temporal phase variations with a selected one of the plurality of range bins to generate a pulse sensitivity map; and dynamically determine a region of interest of the body part based on a strongest reflection point in the pulse sensitivity map. However, Hellbrück does teach related reflected-RF vascular signal processing. In particular, Hellbrück teaches that “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, p. 2, Sec. 1). Hellbrück further teaches that the brachial artery has an inner vessel wall diameter that “expands by up to 0.5 mm due to the pulsatile blood flow” (Hellbrück, p. 2, Sec. 1), and that “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, p. 3, Sec. 2). Hellbrück also teaches analyzing and selecting signals for vascular measurement, because “suitable UWB and US signals should be analyzed and selected to measure vessel wall expansion and flow velocity profile” (Hellbrück, p. 2, Sec. 1). Further, with respect to phase-based radar processing, Hellbrück teaches that “all sensor signals could be analyzed in time domain and frequency domain with flexible sample rate and bandwidth,” and that “for extraction of the vessel diameter in the model environment, we observed the phase shift of the CW radar signal as a function of frequency and medium” (Hellbrück, p. 10, Sec. 3). Thus, Hellbrück teaches using reflected RF radar signals, phase-based radar information, and signal processing to identify vascular motion information, but does not expressly teach the claimed per-range-bin pulse sensitivity map workflow.
Choi teaches an FMCW radar processing architecture in which range and displacement information are extracted using spectral decomposition and range-bin selection. Choi teaches that after spectral decomposition using DFT, “the magnitude and phase are attained at each range (or frequency) bin,” and that the magnitude and phase at each range bin, called the range profile, contain displacement information (Choi, p. 1261, Sec. I). Choi further teaches that to extract vital signs from the range profile, “it is necessary to choose a specific range bin where the vital information exists” (Choi, p. 1261, Sec. I). Choi also teaches that conventional methods select the range bin using magnitude or phase, including selecting “the range bin with the maximum average magnitude, considering the reflected power from the target,” and selecting “the range bin with the maximum phase variation” (Choi, p. 1261, Sec. I).
Choi further teaches that the FMCW intermediate frequency signal x(t,n) is characterized by beat frequency, magnitude M(t,r), and phase P(t,r), where the beat frequency corresponds to range, the magnitude corresponds to reflected power from the range, and phase corresponds to time delay of the radio signal reflected from the range (Choi, p. 1262, Sec. II.A). Choi teaches applying DFT to extract M(t,rk) and P(t,rk) for k = 0, ..., N-1, and teaches that small displacement at a range bin is reflected in both magnitude and phase (Choi, p. 1262, Sec. II.A). Thus, Choi teaches extracting temporal phase information from a plurality of range bins.
Choi further teaches calculating a magnitude-phase coherency (MPC) value for each range bin, where the MPC value quantifies coherency between M(t,r) and P(t,r), and selecting “the range bin with the highest MPC value for the vital target rT(t)” (Choi, p. 1263, Sec. II.B). Choi’s Figs. 3 and 4 show MPC values over a plurality of range bins and show that the highest MPC values correspond to range bins containing accurate respiration or heartbeat information (Choi, Figs. 3-4, pp. 1263-1264). Choi therefore teaches associating a calculated per-bin vital-signal quality value with corresponding range bins to produce a map or profile over range and selecting the maximum-value range bin for the target region.
Choi further teaches dynamic or time-continuous processing, because Choi uses a 15-second interval as an epoch for vital sign analysis and calculates each epoch every 1 second for time continuity (Choi, p. 1265, Sec. III.B). Choi further shows rT(t), namely the selected target range bin as a function of time, when the location of the subject is changed (Choi, p. 1268, Fig. 9). Thus, Choi teaches dynamically selecting a target range or region using repeated range-bin processing.
Barak teaches a vascular/radial artery RF radar context, range-bin separation of tissue reflections, and use of a reference waveform correlation technique for pulse-related measurements. Barak teaches that an ultrawideband microwave signal is radiated into body tissue, preferably at a body location where an artery is close to the skin, such as on the wrist above the radial artery, and that the reflected signal is a summation of multiple reflections representing signals reflected from successively ascending depths into the body tissue caused by dielectric constant changes at different tissue layer boundaries (Barak, ¶[0045]). Barak further teaches that, in the wrist example, the skin layer, radial artery, muscle tissue, and bones correspond to different reflecting tissue structures, and that the time varying amplitude of the signal reflected from the muscle-artery boundary corresponds to the artery-associated reflected signal (Barak, ¶[0045]). Barak teaches that transmit and receive antennas are positioned on the subject wrist above the radial artery and that the radiated signal is transmitted at a repetition rate sufficient to capture changes in artery diameter throughout the heart pulse cycle, where the resulting artery signal may correspond to a sampled representation of the artery diameter and may be referred to as the pressure wave (Barak, ¶[0047]). Barak also teaches that the frequency processor splits the superposition of target information according to relative frequency, and therefore distance, into a multiplicity of bins, where each bin output amplitude represents the radar cross section of the target at a specific distance from the antenna, equivalent to a specific depth inside the limb (Barak, ¶[0084]). Barak further teaches that, in a human wrist example, bin 0 is related to the nearest tissue, the skin, bin 1 is the result of reflection from the farther situated artery, and bin 2 is the result of reflection from the farther situated bone, and that the different FFT bins are referred to as range gates because they represent signals originating from targets in different ranges (Barak, ¶[0085]). Barak further teaches that the FFT bins are connected to a signal processor, which generates a signal that essentially represents only the reflection from the artery, and that the signal in bin 1 represents dilation of the artery and excludes interfering signals from other tissue elements (Barak, ¶[0086]). Barak further teaches that heart-rate can be estimated using a correlation with a set of predefined wave shapes, each having a slightly different repetition rate, and that the candidate predefined wave with the highest correlation maximum is selected as the best estimate (Barak, ¶[0099]). Although Barak describes the predefined-wave-shape correlation technique in an alternative embodiment, Barak is prior art for all that it teaches, including alternative embodiments, and the disclosed correlation technique remains a known pulse/reference waveform processing technique applicable to pulse-related RF radar measurements.
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 modify the system of Hellbrück to use Choi’s FMCW range-bin phase extraction and per-bin range selection, and to further use Barak’s correlation with predefined pulse wave shapes as the per-bin pulse-quality metric. Hellbrück is directed to contactless RF pulse wave measurement of an artery and expressly recognizes the need to analyze and select RF signals to measure vessel wall expansion and flow velocity profile. Choi teaches that accurate vital extraction depends on selecting the range bin that contains the desired physiological motion, and provides a known radar processing framework in which magnitude and phase are extracted at each range bin, a per-bin quality metric is calculated, and the highest-value range bin is selected (Choi, p. 1261, Sec. I; p. 1263, Sec. II.B). Barak confirms the applicability of such range-bin processing to a vascular/radial artery measurement, because Barak teaches FFT bins/range gates corresponding to different tissue depths in the wrist, including a bin representing the artery reflection and artery dilation (Barak, ¶¶[0084]-[0086]). Barak also teaches a known pulse/reference waveform correlation technique in an artery/radial artery RF radar system (Barak, ¶[0099]). Substituting Barak’s known reference-pulse correlation metric for Choi’s known per-bin MPC metric would have amounted to using a known pulse-quality metric in Choi’s known per-range-bin selection framework to obtain the predictable result of per-bin pulse correlation values indexed by range bin, namely a pulse sensitivity map used to select the region containing the best pulse signal.
Further, Prat teaches a radar processing approach in which FFT is performed on the received signal to obtain range resolution, peak detection in a preselected range interval is used to locate the sample corresponding to the patient observed spot, this allows target tracking in the event the patient moves and discards unwanted reflections from objects at other distances, and echo phase is obtained from the target peak complex sample (Prat, p. 3, Sec. II). Prat therefore teaches that it was known in the same FMCW vital-sign radar field to use a strongest detected range-cell peak to locate and dynamically track an observed patient spot while rejecting unwanted reflections.
More specifically, in the modified Hellbrück system, a plurality of temporal phase variations are extracted from a plurality of range bins, respectively, as taught by Choi’s extraction of phase information P(t,rk) at each range bin. A respective cross-correlation value between each temporal phase variation and a reference pulse signal is computed by applying Barak’s reference pulse or predefined wave-shape correlation metric in Choi’s per-range-bin processing framework. The resulting per-bin pulse-correlation values, indexed by corresponding range bins, form the claimed pulse sensitivity map under the Examiner’s interpretation of the claim. The region of interest is then dynamically determined from the maximum point in that map, as suggested by Choi’s selection of the range bin having the highest per-bin metric and repeated epoch calculation every 1 second, and, to the extent “strongest reflection point” is interpreted as a strongest reflected-power location, by Prat’s peak detection in a preselected range interval with target tracking when the patient moves. In the modified Hellbrück system, Hellbrück’s micro-vessel measurement and vascular-flow characterization are performed within the dynamically determined region of interest, rather than being limited to a fixed or manually selected region, so that the vessel wall motion and flow characterization are obtained from the selected region containing the best pulse-related signal.
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 further use Prat’s peak detection and tracking teachings in the modified system of Hellbrück, Barak, and Choi because Choi and Hellbrück both involve physiological motion extracted from radar reflections, and Prat expressly teaches that peak detection in a selected range interval allows target tracking when the patient moves and discards unwanted reflections from objects at other distances (Prat, p. 3, Sec. II). The motivation would have been to improve reliability of the selected region of interest and reduce interference from non-target reflections. The modification would have involved applying a known FMCW radar peak-detection and target-tracking technique to a similar radar vital-sign measurement system, yielding the predictable result of more reliable location and tracking of the target region used for physiological motion measurement.
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 the following: 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 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 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”; p. 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”; p. 2, Sec. 1: “Our major goal in this study was the measurement of the pulse wave and the cross-sectional area of the artery”; Hellbrück expressly describes a method directed to vascular pulse wave measurement); emitting a radio frequency (RF) waveform toward a body part under measurement; (Hellbrück, Fig. 4-5; p. 5, Sec. 2.2: “The UWB antennas have a frequency range from 3 to 6 GHz”; p. 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”; p. 9, Sec. 3: “Figure 7 shows the result of measurements for pulse wave radar at the upper arm of a human”; Hellbrück’s transmitter/antenna emits electromagnetic signals in the gigahertz range toward the body part); receiving one or more reflections of the emitted RF waveform reflected by the body part; (Hellbrück, Fig. 4-5; p. 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/detector receives echoes produced by reflections of the emitted RF waveform from the measured body part); measuring a micro-vessel motion in the region of interest of the body part based on the one or more reflections of the emitted RF waveform; (Hellbrück, 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”; p. 2, Sec. 1: “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”; p. 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’s determining changes in vessel wall diameter based on measured UWB/reflection signals corresponds to measuring micro-vessel motion based on the one or more reflections of the emitted RF waveform); and characterizing vascular flow in the region of interest of the body part based on the measured micro-vessel motion (Hellbrück, p. 2, Sec. 1: “The detection of low blood pressure should be possible as well as the parallel acquisition of the vessel wall extension and the flow velocity profile as seen in Figure 1”; p. 3, Sec. 2: “Suitable UWB and US signals should be analyzed and selected to measure vessel wall expansion and flow velocity profile”; Hellbrück characterizes vascular flow at the target region by acquiring a flow velocity profile in association with vessel wall extension, where vessel wall extension corresponds to the measured micro-vessel motion).
Also regarding claim 9, Hellbrück does not expressly teach extracting a plurality of temporal phase variations from a plurality of range bins, respectively; computing a respective cross-correlation value between each of the plurality of temporal phase variations and a reference pulse signal; overlaying the respective cross-correlation value computed for each of the plurality of temporal phase variations with a selected one of the plurality of range bins to generate a pulse sensitivity map; and dynamically determine a region of interest of the body part based on a strongest reflection point in the pulse sensitivity map. However, Hellbrück does teach related reflected-RF vascular signal processing. In particular, Hellbrück teaches that “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, p. 2, Sec. 1). Hellbrück further teaches that the brachial artery has an inner vessel wall diameter that “expands by up to 0.5 mm due to the pulsatile blood flow” (Hellbrück, p. 2, Sec. 1), and that “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, p. 3, Sec. 2). Hellbrück also teaches analyzing and selecting signals for vascular measurement, because “suitable UWB and US signals should be analyzed and selected to measure vessel wall expansion and flow velocity profile” (Hellbrück, p. 2, Sec. 1). Further, with respect to phase-based radar processing, Hellbrück teaches that “all sensor signals could be analyzed in time domain and frequency domain with flexible sample rate and bandwidth,” and that “for extraction of the vessel diameter in the model environment, we observed the phase shift of the CW radar signal as a function of frequency and medium” (Hellbrück, p. 10, Sec. 3). Thus, Hellbrück teaches using reflected RF radar signals, phase-based radar information, and signal processing to identify vascular motion information, but does not expressly teach the claimed per-range-bin pulse sensitivity map workflow.
Choi teaches an FMCW radar processing architecture in which range and displacement information are extracted using spectral decomposition and range-bin selection. Choi teaches that after spectral decomposition using DFT, “the magnitude and phase are attained at each range (or frequency) bin,” and that the magnitude and phase at each range bin, called the range profile, contain displacement information (Choi, p. 1261, Sec. I). Choi further teaches that to extract vital signs from the range profile, “it is necessary to choose a specific range bin where the vital information exists” (Choi, p. 1261, Sec. I). Choi also teaches that conventional methods select the range bin using magnitude or phase, including selecting “the range bin with the maximum average magnitude, considering the reflected power from the target,” and selecting “the range bin with the maximum phase variation” (Choi, p. 1261, Sec. I).
Choi further teaches that the FMCW intermediate frequency signal x(t,n) is characterized by beat frequency, magnitude M(t,r), and phase P(t,r), where the beat frequency corresponds to range, the magnitude corresponds to reflected power from the range, and phase corresponds to time delay of the radio signal reflected from the range (Choi, p. 1262, Sec. II.A). Choi teaches applying DFT to extract M(t,rk) and P(t,rk) for k = 0, ..., N-1, and teaches that small displacement at a range bin is reflected in both magnitude and phase (Choi, p. 1262, Sec. II.A). Thus, Choi teaches extracting a plurality of temporal phase variations from a plurality of range bins, respectively.
Choi further teaches calculating a magnitude-phase coherency (MPC) value for each range bin, where the MPC value quantifies coherency between M(t,r) and P(t,r), and selecting “the range bin with the highest MPC value for the vital target rT(t)” (Choi, p. 1263, Sec. II.B). Choi’s Figs. 3 and 4 show MPC values over a plurality of range bins and show that the highest MPC values correspond to range bins containing accurate respiration or heartbeat information (Choi, Figs. 3-4, pp. 1263-1264). Thus, Choi teaches associating a calculated per-bin vital-signal quality value with corresponding range bins to produce a map or profile over range and selecting the maximum-value range bin for the target region.
Choi further teaches dynamic or time-continuous processing, because Choi uses a 15-second interval as an epoch for vital sign analysis and calculates each epoch every 1 second for time continuity (Choi, p. 1265, Sec. III.B). Choi further shows rT(t), namely the selected target range bin as a function of time, when the location of the subject is changed (Choi, p. 1268, Fig. 9). Thus, Choi teaches dynamically selecting a target range or region using repeated range-bin processing.
Barak teaches a vascular/radial artery RF radar context, range-bin separation of tissue reflections, and use of a reference waveform correlation technique for pulse-related measurements. Barak teaches that an ultrawideband microwave signal is radiated into body tissue, preferably at a body location where an artery is close to the skin, such as on the wrist above the radial artery, and that the reflected signal is a summation of multiple reflections representing signals reflected from successively ascending depths into the body tissue caused by dielectric constant changes at different tissue layer boundaries (Barak, ¶[0045]). Barak further teaches that, in the wrist example, the skin layer, radial artery, muscle tissue, and bones correspond to different reflecting tissue structures, and that the time varying amplitude of the signal reflected from the muscle-artery boundary corresponds to the artery-associated reflected signal (Barak, ¶[0045]). Barak teaches that transmit and receive antennas are positioned on the subject wrist above the radial artery and that the radiated signal is transmitted at a repetition rate sufficient to capture changes in artery diameter throughout the heart pulse cycle, where the resulting artery signal may correspond to a sampled representation of the artery diameter and may be referred to as the pressure wave (Barak, ¶[0047]). Barak also teaches that the frequency processor splits the superposition of target information according to relative frequency, and therefore distance, into a multiplicity of bins, where each bin output amplitude represents the radar cross section of the target at a specific distance from the antenna, equivalent to a specific depth inside the limb (Barak, ¶[0084]). Barak further teaches that, in a human wrist example, bin 0 is related to the nearest tissue, the skin, bin 1 is the result of reflection from the farther situated artery, and bin 2 is the result of reflection from the farther situated bone, and that the different FFT bins are referred to as range gates because they represent signals originating from targets in different ranges (Barak, ¶[0085]). Barak further teaches that the FFT bins are connected to a signal processor, which generates a signal that essentially represents only the reflection from the artery, and that the signal in bin 1 represents dilation of the artery and excludes interfering signals from other tissue elements (Barak, ¶[0086]). Barak further teaches that heart-rate can be estimated using a correlation with a set of predefined wave shapes, each having a slightly different repetition rate, and that the candidate predefined wave with the highest correlation maximum is selected as the best estimate (Barak, ¶[0099]). Although Barak describes the predefined-wave-shape correlation technique in an alternative embodiment, Barak is prior art for all that it teaches, including alternative embodiments, and the disclosed correlation technique remains a known pulse/reference waveform processing technique applicable to pulse-related RF radar measurements.
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 modify Hellbrück’s vascular flow measurement method to use Choi’s FMCW range-bin phase extraction and per-bin range selection, and to further use Barak’s correlation with predefined pulse wave shapes as the per-bin pulse-quality metric. Hellbrück is directed to contactless RF pulse wave measurement of an artery and expressly recognizes the need to analyze and select RF signals to measure vessel wall expansion and flow velocity profile. Choi teaches that accurate vital extraction depends on selecting the range bin that contains the desired physiological motion, and provides a known radar processing framework in which magnitude and phase are extracted at each range bin, a per-bin quality metric is calculated, and the highest-value range bin is selected (Choi, p. 1261, Sec. I; p. 1263, Sec. II.B). Barak confirms the applicability of such range-bin processing to a vascular/radial artery measurement, because Barak teaches FFT bins/range gates corresponding to different tissue depths in the wrist, including a bin representing the artery reflection and artery dilation (Barak, ¶¶[0084]-[0086]). Barak also teaches a known pulse/reference waveform correlation technique in an artery/radial artery RF radar system (Barak, ¶[0099]). Substituting Barak’s known reference-pulse correlation metric for Choi’s known per-bin MPC metric would have amounted to using a known pulse-quality metric in Choi’s known per-range-bin selection framework to obtain the predictable result of per-bin pulse correlation values indexed by range bin, namely a pulse sensitivity map used to select the region containing the best pulse signal.
Further, Prat teaches a radar processing approach in which FFT is performed on the received signal to obtain range resolution, peak detection in a preselected range interval is used to locate the sample corresponding to the patient observed spot, this allows target tracking in the event the patient moves and discards unwanted reflections from objects at other distances, and echo phase is obtained from the target peak complex sample (Prat, p. 3, Sec. II). Prat therefore teaches that it was known in the same FMCW vital-sign radar field to use a strongest detected range-cell peak to locate and dynamically track an observed patient spot while rejecting unwanted reflections.
More specifically, in the modified Hellbrück method, a plurality of temporal phase variations are extracted from a plurality of range bins, respectively, as taught by Choi’s extraction of phase information P(t,rk) at each range bin. A respective cross-correlation value between each of the plurality of temporal phase variations and a reference pulse signal is computed by applying Barak’s reference pulse or predefined wave-shape correlation metric in Choi’s per-range-bin processing framework. The resulting per-bin pulse-correlation values, indexed by corresponding range bins, overlay the respective cross-correlation value computed for each of the plurality of temporal phase variations with a selected one of the plurality of range bins to generate a pulse sensitivity map under the Examiner’s interpretation of the claim. The region of interest of the body part is then dynamically determined from the maximum point in that map, as suggested by Choi’s selection of the range bin having the highest per-bin metric and repeated epoch calculation every 1 second, and, to the extent “strongest reflection point” is interpreted as a strongest reflected-power location, by Prat’s peak detection in a preselected range interval with target tracking when the patient moves. In the modified Hellbrück method, Hellbrück’s micro-vessel measurement and vascular-flow characterization are performed within the dynamically determined region of interest, rather than being limited to a fixed or manually selected region, so that the vessel wall motion and flow characterization are obtained from the selected region containing the best pulse-related signal.
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 further use Prat’s peak detection and tracking teachings in the modified method of Hellbrück, Barak, and Choi because Choi and Hellbrück both involve physiological motion extracted from radar reflections, and Prat expressly teaches that peak detection in a selected range interval allows target tracking when the patient moves and discards unwanted reflections from objects at other distances (Prat, p. 3, Sec. II). The motivation would have been to improve reliability of the selected region of interest and reduce interference from non-target reflections. The modification would have involved applying a known FMCW radar peak-detection and target-tracking technique to a similar radar vital-sign measurement method, yielding the predictable result of more reliable location and tracking of the target region used for physiological motion measurement.
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 the following: 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 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.
Regarding claim 19, the modified Hellbrück teaches stabilizing the body part during the 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).
Claims 8 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.), hereinafter referred to as Hellbrück, and in view of Choi (Choi, Ho-Ik, et al. “Target Range Selection of FMCW Radar for Accurate Vital Information Extraction,” IEEE Access, Vol. 9, 2021, pp. 1261-1270), hereinafter referred to as Choi, in view of Barak (US-20170065184-A1), hereinafter referred to as Barak, and further in view of Prat (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.), hereinafter referred to as Prat, and further in view of Santra et al. (US 20190240535 A1), hereinafter referred to as Santra.
The modified Hellbrück teaches claim 1 as described above.
The modified Hellbrück teaches claim 9 as described above.
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 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.
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.), hereinafter referred to as Hellbrück, and in view of Choi (Choi, Ho-Ik, et al. “Target Range Selection of FMCW Radar for Accurate Vital Information Extraction,” IEEE Access, Vol. 9, 2021, pp. 1261-1270), hereinafter referred to as Choi, in view of Barak (US-20170065184-A1), hereinafter referred to as Barak, and further in view of Prat (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.), hereinafter referred to as Prat, 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.), hereinafter referred to as Yang.
The modified Hellbrück teaches claim 9 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 9, 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 17 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.), hereinafter referred to as Hellbrück, and in view of Choi (Choi, Ho-Ik, et al. “Target Range Selection of FMCW Radar for Accurate Vital Information Extraction,” IEEE Access, Vol. 9, 2021, pp. 1261-1270), hereinafter referred to as Choi, in view of Barak (US-20170065184-A1), hereinafter referred to as Barak, and further in view of Prat (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.), hereinafter referred to as Prat, and further in view of Messerschmidt et al. (US 20150338338 A1), hereinafter referred to as Messerschmidt, and further in view of Santra et al. (US 20190240535 A1), hereinafter referred to as Santra.
The modified Hellbrück teaches claim 9 as described above.
Regarding claim 17, the modified Hellbrück teaches the method of claim 9, but does not expressly teach that the method further comprises changing the vascular flow in the body part using a pressure pump; and generating the RF waveform using a radar that is one of a millimeter wave and a Terahertz wave radar.
With respect to changing the vascular flow in the body part using a pressure pump, Hellbrück teaches the relevance and desirability of controlled pressure and flow modulation in the same vascular pulse-wave measurement context. Hellbrück teaches a model environment including a tissue phantom and pumps, stating that “[t]he model environment was built up modularly” and that the main components include “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). Hellbrück further teaches that “[w]ith the additional gear pump, a constant flow and pressure in the phantom artery can be adjusted” (Hellbrück, p. 5, Sec. 2.1). Hellbrück also teaches that parameterized measurements with pressure and flow profiles show that vessel wall expansion can be measured reproducibly (Hellbrück, p. 11, Sec. 3). Thus, Hellbrück teaches using a pressure pump to generate or adjust pressure and flow conditions in a vascular measurement environment in order to evaluate vessel wall expansion and flow-related measurement characteristics. Hellbrück does not expressly teach that the pressure pump changes vascular flow in the body part, because Hellbrück’s express pump disclosure is in a phantom artery/model environment. However, Hellbrück’s live measurement context is the upper arm where the brachial artery runs, and Hellbrück recognizes that the brachial artery is the artery typically used for blood pressure measurement with an upper-arm cuff and that cuff measurement serves as a reference measurement and calibration value for indirect blood-pressure determination (Hellbrück, p. 2, Sec. 1).
Messerschmidt teaches applying pump-generated pressure to an actual body part to occlude a blood vessel and thereby change vascular flow, disclosing that a cuff is attached around the subject’s upper arm over the brachial artery and that pressure is pumped up “until the brachial artery is completely occluded,” after which pressure is released so that “blood flow first starts again in the artery” (Messerschmidt, ¶[0006]). Messerschmidt therefore teaches changing vascular flow in the body part using a pressure pump.
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 further modify the modified Hellbrück method to use a pressure pump to change vascular flow in the measured body part, as taught by Messerschmidt, in view of Hellbrück’s own pressure/flow pump teachings and blood-pressure cuff calibration context. Such a modification would have been feasible because Hellbrück already uses pump-generated pressure and flow modulation to evaluate vessel wall expansion and flow profiles in a vascular model, and Hellbrück is directed to measuring pulse wave and vessel wall motion at the upper-arm brachial artery, which Hellbrück expressly identifies as the artery used for upper-arm cuff blood-pressure measurement. Messerschmidt supplies the known live-body implementation of pumping pressure in a cuff around the subject’s upper arm over the brachial artery until the artery is occluded and then releasing pressure so that blood flow starts again. The motivation would have been to intentionally induce, vary, or modulate vascular flow at the live measurement site so that vessel wall motion and vascular-flow characteristics could be measured under known pressure, occlusion, partial-occlusion, or release conditions, thereby improving calibration, repeatability, and diagnostic utility of the radar-based vascular-flow measurement.
With respect to generating the RF waveform using a radar that is one of a millimeter wave and a Terahertz wave radar, 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). Hellbrück does not expressly teach generating the RF waveform using a millimeter wave or Terahertz wave radar.
Santra teaches millimeter-wave radar sensing for physiological monitoring, stating that “one or more millimeter wave based sensors are used to detect the vital signs” (Santra, ¶[0028]). Santra further teaches that the millimeter-wave based radar sensor transmits radar signals and receives reflected radar signals for vital-sign detection (Santra, ¶¶[0028]-[0032]). Because claim 17 recites “one of a millimeter wave and a Terahertz wave radar,” Santra’s millimeter-wave radar teaching satisfies the limitation.
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 further modify the modified Hellbrück method to generate the RF waveform using a millimeter-wave radar, as taught by Santra. Such a modification would have been feasible because Hellbrück, Choi, Barak, Prat, and Santra all involve radar-based physiological sensing using transmitted RF energy and reflected signals. The motivation would have been to improve sensitivity to small physiological displacements and provide higher spatial resolution and compact radar hardware suitable for contactless vascular or vital-sign sensing. Therefore, the modified Hellbrück method, as further modified by Messerschmidt and Santra, teaches or suggests changing the vascular flow in the body part using a pressure pump; and generating the RF waveform using a radar that is one of a millimeter wave and a Terahertz wave radar, as claimed.
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.), hereinafter referred to as Hellbrück, and in view of Choi (Choi, Ho-Ik, et al. “Target Range Selection of FMCW Radar for Accurate Vital Information Extraction,” IEEE Access, Vol. 9, 2021, pp. 1261-1270), hereinafter referred to as Choi, in view of Barak (US-20170065184-A1), hereinafter referred to as Barak, and further in view of Prat (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.), hereinafter referred to as Prat, and further in view of Messerschmidt et al. (US 20150338338 A1), hereinafter referred to as Messerschmidt, and further in view of Santra et al. (US 20190240535 A1), hereinafter referred to 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.), hereinafter referred to as Asif.
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.
Response to Arguments
Objections
Applicant's arguments filed 6/2/2026, page 6, regarding the previous Objections of claims 1, 3, 9, 11, and 19 have been fully considered and are persuasive. The previous Objections have been withdrawn.
35 U.S.C. §102 and 103
Applicant's arguments filed 6/2/2026, pages 6-11, regarding the previous 102 Rejections of claims 1-4, 9-12, and 19 and the previous 103 Rejections of claims 5-8, 13-18 and 20 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Applicant’s Argument: Applicant argues that Hellbrück does not anticipate amended claims 1 and 9 because Hellbrück does not disclose dynamically determining a region of interest based on a pulse sensitivity map, and does not disclose the claimed range-bin, cross-correlation, and pulse sensitivity map processing.
Examiner’s Response: Applicant’s arguments have been considered but are moot with respect to the prior rejection under 35 U.S.C. 102 over Hellbrück because that rejection is not maintained in the same form. Claims 1 and 9 have been amended to include additional limitations, including limitations previously recited in canceled claims 6, 7, 14, and 15. The present Office action rejects claims 1 and 9 under 35 U.S.C. 103 over Hellbrück in view of Choi and Barak, and further in view of Prat. Hellbrück is relied upon for the contactless RF vascular pulse-wave measurement system and method, including emitted RF signals, received reflections, vessel wall motion measurement, and vascular-flow characterization. Choi, Barak, and Prat are relied upon for the added range-bin, reference-correlation, pulse sensitivity map, and dynamic region-of-interest teachings. Accordingly, Applicant’s arguments directed to the prior Hellbrück anticipation rejection do not overcome the present rejection.
Applicant’s Argument: Applicant argues that Hellbrück is restricted to the upper arm region where the brachial artery runs and provides no suggestion that its methodology can be expanded to another region of interest of the body part that is dynamically determined by the processing circuit.
Examiner’s Response: Applicant’s argument has been considered but is not persuasive. The claims do not require that the dynamically determined region of interest be in a body part different from Hellbrück’s upper arm measurement site. Claim 1 broadly recites “a body part under measurement” and “a region of interest of the body part,” and claim 9 similarly recites “a body part under measurement” and “a region of interest of the body part.” Hellbrück’s upper arm is a body part, and Hellbrück’s brachial artery measurement region is a region of interest within that body part. Thus, Hellbrück’s focus on the upper arm does not teach away from the claimed subject matter and does not avoid the rejection.
Further, the present rejection does not rely on Hellbrück alone to teach dynamically determining the region of interest. Hellbrück supplies the contactless RF vascular pulse-wave measurement context at the upper-arm brachial artery. Choi teaches selecting a target range bin containing the desired physiological motion by extracting magnitude and phase at range bins, calculating a per-bin quality metric, selecting the range bin having the highest metric, and repeating the range-bin processing over time. Barak confirms that RF vascular measurements can use range bins or range gates corresponding to different tissue depths, including an artery reflection. Prat teaches peak detection in a selected range interval to locate and track an observed patient spot while rejecting unwanted reflections. Accordingly, in the modified Hellbrück system or method, the dynamically determined region of interest is the selected range-bin or tissue-depth region within the measured body part, such as within Hellbrück’s upper arm measurement site, and the vascular measurement and flow characterization are performed in that dynamically selected region.
Applicant’s Argument: Applicant argues that Santra, Wang, and Barak do not teach the limitations previously recited in claims 7 and 15.
Examiner’s Response: Applicant’s argument has been considered but is moot because claims 7 and 15 have been canceled, and the prior rejection of those claims is not maintained in the same form. The limitations formerly recited in claims 7 and 15 have been incorporated into independent claims 1 and 9, and the present rejection of claims 1 and 9 relies on Choi, Barak, and Prat for the reasons set forth above. The present rejection does not rely on the same Santra, Wang, and Barak formulation previously applied to canceled claims 7 and 15.
Applicant’s Argument: Applicant argues that support for the amendments can be found in originally filed claims 6, 7, 14, and 15 and paragraph [0032] of the application.
Examiner’s Response: Applicant’s argument has been considered but is not persuasive for the reasons set forth in the rejection under 35 U.S.C. 112(a). The originally filed disclosure describes determining a region of interest based on a pulse sensitivity map and separately describes using a strongest reflection point in a range bin to locate the region of interest. However, the originally filed disclosure does not reasonably convey possession of dynamically determining the region of interest based on a strongest reflection point in the pulse sensitivity map, as presently recited.
Applicant’s Argument: Applicant argues that dependent claims 2-5, 8, 10-13, and 16-20 are allowable by virtue of their dependency from claims 1 and 9, and that the additional secondary references do not remedy the alleged deficiencies of the independent-claim rejection.
Examiner’s Response: Applicant’s argument has been considered but is not persuasive because claims 1 and 9 remain rejected. Applicant has not presented separate arguments for the additional limitations of dependent claims 2-5, 8, 10-13, and 16-20. The additional references are relied upon for the additional dependent limitations, including Barak for the wrist limitations of claims 5 and 13, Santra for the beamforming limitations of claims 8 and 20 and the millimeter-wave radar limitation of claim 17, Yang for the fingertip oximeter limitation of claim 16, Messerschmidt for the pressure-pump vascular-flow limitation of claim 17, and Asif and Prat for the palpation and boresight limitations of claim 18. Accordingly, the dependent claims remain unpatentable for the reasons set forth in the rejections.
Applicant’s Argument: Applicant notes that claims 6, 7, 14, and 15 have been canceled.
Examiner’s Response: Applicant’s cancellation of claims 6, 7, 14, and 15 is acknowledged. The prior rejections of those canceled claims are moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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