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 18-21, 23-24, 27-29, 31, 33, 35, 37-39, 42-44, and 46-55 are the currently pending claims hereby under examination.
Claim Objections
Claims 18, 23, 27, and 50 are objected to because of the following informalities:
In claim 18, line 2: "a regions" is grammatically incorrect and should be revised to "regions" for clarity;
In claim 23, line 2: "isolating one or more changes in pressure" should be revised to "isolating the one or more changes in pressure" to maintain consistency with prior claim language and grammatical clarity;
In claim 27, line 3: "determining one or more physiological parameters" should be revised to "determining the one or more physiological parameters" for grammatical consistency and to maintain proper antecedent basis; and
In claim 50, line 4: "parameters the blood pressure" is missing a preposition and should be revised to "parameters of the blood pressure" for grammatical correctness.
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 18-21, 24, 27-29, 31, 33, 35, 37-38, 42-44, 46-52, and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kinoshita et al. (US 20190046045 A1), hereto referred as Kinoshita.
Regarding claim 18, Kinoshita teaches that a method of measuring one or more physiological parameters comprises: measuring one or more changes in pressure on one or more a regions of a skin surface of a wearer (Kinoshita, ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown, on a living body portion... in which an artery to be measured for vital information... is present"; Kinoshita, ¶[0036]: "The air bag 2 functions... as a pressing section for pressing a pressing surface 6b of the sensor section 6 against the body surface of a living body portion"; Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin, namely, a pulse wave", explaining that Kinoshita measures changes in pressure on the skin surface via contact-based sensing elements); generating a dynamic pressure map of the skin surface of the wearer based on the measured one or more changes in pressure of the skin surface (Kinoshita, ¶[0039]: "The sensor section 6 includes an element row 60 including a plurality of pressure detecting elements 6a arranged in a direction B... and an element row 70 including a plurality of pressure detecting elements 7a arranged in the direction B...", explaining that the sensor array forms a 2D grid across the skin surface; ¶[0138]: "In this manner, when the DC level of the pressure signal detected by each pressure detecting element of the element row is observed, a distribution of the pressure from a hard tissue such as a bone or a tendon can be grasped", showing spatial distribution of pressure across the skin surface; ¶[0141]: "Each curve illustrated in FIG. 11 is formed by using DC levels of pressure signals detected by all the pressure detecting elements included in the selected element row", confirming spatially-resolved pressure data; ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state", showing that the system dynamically processes these signals to extract time-varying physiological data, consistent with generating a dynamic pressure map).
Regarding claim 19, Kinoshita teaches that the measuring one or more changes in pressure on the skin surface of the wearer further comprises measuring physiological reaction forces on the skin surface of the wearer (Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin, namely, a pulse wave", explaining that the sensor detects physiological forces such as pulse waves transferred to the skin surface; ¶[0003]: "...measuring vital information such as the pulse, the heart rate or the blood pressure using information detected by a pressure sensor set in contact with a surface of a living body portion", supporting that the sensor measures physiological forces interacting with the skin).
Regarding claim 20, Kinoshita teaches that the physiological reaction forces are oscillometric pressure waves generated by a blood vessel proximal to the skin surface of the wearer (Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin, namely, a pulse wave", explaining that the physiological force being measured is a pressure wave—such as those used in oscillometric blood pressure measurement—originating from a blood vessel near the skin surface, which is implicitly or inherently oscillometric).
Regarding claim 21, Kinoshita teaches that the method further comprises determining a location of a blood vessel proximal to the skin surface of the wearer (Kinoshita, Figs. 1, 10A–C; ¶[0141]: "Each curve illustrated in FIG. 11 is formed by using DC levels of pressure signals detected by all the pressure detecting elements included in the selected element row", showing that location-specific signal profiles are used to detect features such as arteries; ¶[0138]: "...a distribution of the pressure from a hard tissue such as a bone or a tendon can be grasped", indicating that spatial analysis of sensor data is used to infer anatomical structure location including blood vessels; ¶[0087]: "a target element (hereinafter referred to as the first target element) corresponding to one pressure detecting element positioned above the radial artery T out of all the pressure detecting elements 6 a...", showing that specific sensor elements, designated as target elements, are selected based on physiological signal characteristics, thereby identifying locations associated with blood vessels).
Regarding claim 24, Kinoshita teaches that the method further comprises: occluding the blood vessel; and calibrating the one or more measured pressure changes of the skin surface (Kinoshita, ¶[0034]: "The air pump 10 is an example of a pressurizing section that supplies air to the air bag 2 to cause the air bag 2 to expand, whereby the pressing surface 6b is pressed against the skin surface...", showing that the air bag is used to apply pressure to the skin; ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmax) of the air bag 2 applied at the time when the AC level... has reached the occlusion completion determination threshold value", explicitly stating that the pressing force corresponds to occlusion completion and is used to calibrate the pressure response; ¶[0054]: "Further, based on the MBP, a maximum value of a rising slope and a maximum value of a falling slope of the pulse wave are calculated. A systolic blood pressure and a diastolic blood pressure are estimated based on the MBP and the maximum values...", confirming that the pressure waveforms obtained during occlusion are used to calibrate and estimate physiological pressures).
Regarding claim 27, Kinoshita teaches that the method further comprises determining one or more physiological parameters of the wearer based on the measured one or more changes in pressure of the skin surface, wherein the one or more physiological parameters comprise a systolic blood pressure, a diastolic blood pressure, a mean blood pressure, a heart rate, a blood vessel viscoelasticity, an arterial stiffness, or a combination thereof (Kinoshita, ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15, and stores the calculated vital information in the memory 15", teaching that physiological parameters are computed from pressure signals; ¶[0071]: "The vital information may be any information as long as it can be calculated based on a pulse wave. The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", expressly disclosing the determination of systolic blood pressure, diastolic blood pressure, and heart rate from pulse waveforms).
Regarding claim 28, Kinoshita teaches that a wearable physiological measurement device, comprising: a support configured to engage a portion of a limb of a wearer (Kinoshita, Fig. 1; ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown, on a living body portion... in which an artery to be measured for vital information... is present", showing that the device includes a support structure intended to be worn on a limb to measure arterial information; ¶[0038]: “In the worn state illustrated in FIG. 1, the pressing surface 6b of the sensor section 6 included in the pulse wave detection unit 100 is in contact with the skin of the wrist of the user”, showing that the device is worn on a limb of the user); a sensor array coupled to the support and configured to sense one or more pressure changes on a skin surface of the wearer (Kinoshita, Fig. 1; ¶[0039]: “the sensor section 6 includes an element row 60 including a plurality of pressure detecting elements 6a… and an element row 70 including a plurality of pressure detecting elements 7a…”, and ¶[0042]: “Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin”, showing that the sensor array is part of the wearable structure and receives pressure signals while supported against the skin); and a data processing module configured to generate a dynamic pressure map of the skin surface based on the one or more sensed pressure changes on the skin surface (Kinoshita, ¶[0070]: “The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state”, showing that physiological parameters are calculated from the pressure signals detected by the sensor array¶[0138]: "In this manner, when the DC level of the pressure signal detected by each pressure detecting element of the element row is observed, a distribution of the pressure from a hard tissue such as a bone or a tendon can be grasped", demonstrating analysis of pressure distributions across the array; ¶[0141]: "Each curve illustrated in FIG. 11 is formed by using DC levels of pressure signals detected by all the pressure detecting elements included in the selected element row", confirming the system uses spatial data across the array to form pressure profiles, consistent with dynamic pressure mapping), wherein one or more physiological parameters of the wearer are derived from the dynamic pressure map (Kinoshita, ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15, and stores the calculated vital information in the memory 15", teaching that physiological parameters are computed from pressure signals; ¶[0071]: "The vital information may be any information as long as it can be calculated based on a pulse wave. The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", demonstrating that parameters such as systolic/diastolic pressure and heart rate are calculated using waveform information obtained from the
Regarding claim 29, Kinoshita teaches that the device of claim 28, wherein the data processing module is configured to transmit the dynamic pressure map to a biometric display unit (Kinoshita, Fig. ¶[0072]: “In this case, the pressure signals stored in the memory 15 of the vital information measuring device are transmitted to the electronic equipment, and vital information is calculated and stored in the electronic equipment”, showing that pressure signal data from which a dynamic pressure map is generated is transmitted for processing and display; ¶[0076]: “The vital information measuring device of the present embodiment has a continuous blood pressure measurement mode in which the SBP and the DBP are calculated every heart rate to be displayed in the display section 13”, ¶[0060]: "The display section 13 is used for displaying various information including vital information, and includes, for example, a liquid crystal display", confirming that the device transmits derived pressure-based data to an onboard display unit).
Regarding claim 31, Kinoshita teaches that at least one of the one or more sensed pressure changes is associated with one or more physiological parameters of a blood vessel proximal to the skin surface of the wearer (Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin, namely, a pulse wave, when pressed against the radial artery T in such a manner that the arrangement direction crosses the radial artery T (at substantially right angles)", showing that the pressure signals sensed by the device correspond to a blood vessel beneath the skin; ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15, and stores the calculated vital information in the memory 15", teaching that physiological parameters are computed from pressure signals; ¶[0071]: "The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", showing that the sensed pressure signals are used to determine physiological parameters of the underlying vessel).
Regarding claim 33, Kinoshita teaches that the support is configurable in a configuration of either: a non-occlusion configuration; or an occlusion configuration for occluding the blood vessel (Kinoshita, ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmor) of the air bag 2 applied at the time when the AC level of the target element... has reached the occlusion completion determination threshold value", showing that the device enters an occlusion configuration by applying a specific pressing force sufficient to complete occlusion; ¶[0188]: "the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T", demonstrating a controlled transition into an occlusion configuration via pressure adjustment from a non-occluded state; ¶[0206]: "The state where the radial artery T is appropriately pressed refers to a state where the radial artery T is not occluded... namely, what is called a tonometry state", showing that in continuous measurement mode the support remains in a non-occlusion configuration).
Regarding claim 35, Kinoshita teaches that a mechanism to change the configuration of the support comprises an actuator mechanism, a mechanical actuation mechanism, a fluid actuation mechanism, or a combination thereof (Kinoshita, ¶[0059]: "The air bag drive section 11 includes a pump or the like, and controls the amount of air injected into the air bag 2 (the internal pressure of the air bag 2) in accordance with an instruction issued by the control unit 12", showing that a fluid actuation mechanism (air pump) changes the support's configuration for pressure application; ¶[0058]: "The rotation drive section 10 is an actuator for driving the biaxial rotation mechanism 5a of the pulse wave detection unit 100", showing that a mechanical actuation mechanism is also used to reposition the support structure).
Regarding claim 37, Kinoshita teaches that the device is operable in a calibration mode, and wherein operation in the calibration mode configures the support in the occlusion configuration for calibrating baseline parameters for the one or more physiological parameters (Kinoshita, ¶[0188]–[0197]: “the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T”, “the control unit 12 generates pulse wave envelope data based on the pressure signals detected by the pressure detecting elements”, and “the control unit 12 holds the pressing force at the optimal pressing force... [and] calculates the SBP and the DBP based on the thus generated pulse wave envelope data, and generates the correction data”, showing that the device enters an occlusion configuration during calibration mode and uses pressure signals collected under that condition to calibrate baseline parameters including systolic and diastolic blood pressure; Figs. 7–8: Figure 7 shows the procedure for selecting the element row and setting first and second pressing values, demonstrating how calibration mode defines specific force thresholds associated with occlusion; Figure 8 illustrates the change in pressing force and corresponding AC signal during measurement, visually showing how the system reaches and holds an occlusion-level force to generate calibration data for vital sign determination).
Regarding claim 38, Kinoshita teaches that the device is operable in a calibration mode, and wherein operation in the calibration mode configures the support in the occlusion configuration for monitoring the one or more physiological parameters (Kinoshita, ¶[0076]: "The vital information measuring device of the present embodiment has a continuous blood pressure measurement mode in which the SBP and the DBP are calculated every heart rate to be displayed in the display section 13", showing that the device calculates systolic and diastolic blood pressure values repeatedly during operation, confirming that physiological parameters are monitored during the same occlusion-based calibration mode described in ¶[0188]–[0197] and Figs. 7-8, as shown in claim 37 above).
Regarding claim 42, Kinoshita teaches that the one or more physiological parameters comprise a systolic blood pressure, a diastolic blood pressure, a mean blood pressure, a heart rate, a blood vessel viscoelasticity, an arterial stiffness, or a combination thereof (Kinoshita, ¶[0071]: "The vital information may be any information as long as it can be calculated based on a pulse wave. The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", showing that Kinoshita discloses systolic pressure, diastolic pressure, and heart rate).
Regarding claim 43, Kinoshita teaches that a wearable blood pressure measurement device, comprising: a sleeve configured to engage a portion of a limb of a wearer (Kinoshita, Fig. 1; ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown, on a living body portion... in which an artery to be measured for vital information... is present", showing that the device includes a sleeve structure intended to be worn on a limb to measure arterial information; ¶[0003]: “measuring vital information such as the pulse, the heart rate or the blood pressure ”, showing that the device is used to measure blood pressure); a sensor array coupled to the sleeve and configured to sense one or more changes in pressure on a skin surface associated with a blood vessel (Kinoshita, Fig. 1; ¶[0038]: “In the worn state illustrated in FIG. 1, the pressing surface 6b of the sensor section 6 included in the pulse wave detection unit 100 is in contact with the skin of the wrist of the user”, the sensor section is an array, the device is in contact with the skin and the figure depicts it over an artery (¶[0042])); and a data processing module configured to generate a dynamic pressure map of the blood vessel based on the one or more sensed pressure changes (Kinoshita, ¶[0070]: “The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state”, showing that physiological parameters are calculated from the pressure signals detected by the sensor array¶[0138]: "In this manner, when the DC level of the pressure signal detected by each pressure detecting element of the element row is observed, a distribution of the pressure from a hard tissue such as a bone or a tendon can be grasped", demonstrating analysis of pressure distributions across the array; ¶[0141]: "Each curve illustrated in FIG. 11 is formed by using DC levels of pressure signals detected by all the pressure detecting elements included in the selected element row", confirming the system uses spatial data across the array to form pressure profiles, consistent with dynamic pressure mapping), wherein a blood pressure of the wearer is determined from the dynamic pressure map (Kinoshita, ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15, and stores the calculated vital information in the memory 15", teaching that physiological parameters are computed from pressure signals; ¶[0071]: "The vital information may be any information as long as it can be calculated based on a pulse wave. The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", demonstrating that parameters such as systolic/diastolic pressure and heart rate are calculated using waveform information obtained from the pressure distribution map).
Regarding claim 44, Kinoshita teaches that the data processing module is configured to transmit the dynamic pressure map to a biometric display unit, wherein the biometric display unit is physically coupled to the sleeve (Kinoshita, ¶[0072]: “In this case, the pressure signals stored in the memory 15 of the vital information measuring device are transmitted to the electronic equipment, and vital information is calculated and stored in the electronic equipment”, showing that pressure signal data from which a dynamic pressure map is generated is transmitted for processing and display; ¶[0076]: “The vital information measuring device of the present embodiment has a continuous blood pressure measurement mode in which the SBP and the DBP are calculated every heart rate to be displayed in the display section 13”, showing that the calculated blood pressure information is displayed continuously by the device; ¶[0060]: “The display section 13 is used for displaying various information including vital information, and includes, for example, a liquid crystal display”, confirming that the display unit receives and shows data derived from the pressure signal and is integrated with the wearable device structure; ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown" where the band is equivalent to the sleeve and the display is coupled to the measuring device (¶[0056], Fig. 5])).
Regarding claim 46, Kinoshita teaches that the sleeve engages the portion of the limb of the wearer at an effective diameter (Kinoshita, ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown", establishing the wearable nature of the device with a sleeve-like band engaging the limb; ¶[0059]: "The air bag drive section 11 includes a pump or the like, and controls the amount of air injected into the air bag 2 (the internal pressure of the air bag 2) in accordance with an instruction issued by the control unit 12", showing that a fluid actuation mechanism (air pump) changes the support's configuration for pressure application; ¶[0079]: "a state where the rotation drive section 10... rotates the sensor section 6 so that, with the pulse wave detection unit 100 worn on the wrist, the pressing surface 6b can be placed in uniform contact with the skin", confirming the support structure adapts for a proper fit around the limb, including variable pressing force states consistent with effective diameter control), the sleeve configurable in either: a non-occlusion configuration (Kinoshita, ¶[0206]: "The state where the radial artery T is appropriately pressed refers to a state where the radial artery T is not occluded... namely, what is called a tonometry state", showing that the device is operable in a non-occlusion configuration during normal pressure sensing; Fig. 8: depicts a zero pressure state at t0); or an occlusion configuration for occluding the blood vessel (Kinoshita, ¶[0188]: "the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T", showing that the device enters an occlusion configuration when needed; ¶[0218]: "The state where the pressing force is held at the first pressing value in step S4 is a state where the radial artery T is occluded by the selected element row", confirming the device can actively configure into an occlusion state).
Regarding claim 47, Kinoshita teaches that the sleeve further comprises a partial occlusion configuration for partially occluding the blood vessel (Kinoshita, ¶[0206]: "The state where the radial artery T is appropriately pressed refers to a state where the radial artery T is not occluded... namely, what is called a tonometry state", showing a non-occlusion configuration; ¶[0210]: "the second pressing value is preferably set to an arbitrary numerical value corresponding to a range of the pressing force with which the AC level of the target element determined at each time in the selected element row is as high as 0.9 times or more of the maximum value... ", showing the device is operable in a state of partial occlusion, where the blood vessel is neither fully open nor fully closed; ¶[0211]: "The state where the pressing force is held at HDP ACmor is regarded to be the closest to the tonometry state", confirming that this intermediate pressing force correlates to a partial occlusion configuration).
Regarding claim 48, Kinoshita expressly or inherently teaches that the effective diameter of the sleeve is reduced to occlude the blood vessel (Kinoshita, ¶[0188]: "the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T", showing that the device actively changes its pressing configuration to achieve occlusion; ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmor) of the air bag 2 applied at the time when the AC level... has reached the occlusion completion determination threshold value", confirming that the pressing surface of the device increases applied pressure until vessel occlusion is achieved through compression, effectively reducing the diameter of the encircling sleeve-like structure. The air bag expands within the band, pressing inward against the skin and thereby reducing the effective diameter of the wearable around the limb).
Regarding claim 49, Kinoshita teaches that a mechanism to reduce the effective diameter of the sleeve comprises an actuator mechanism, a fluid actuation mechanism, or a combination thereof (Kinoshita, ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmor) of the air bag 2 applied at the time when the AC level... has reached the occlusion completion determination threshold value", showing that the system uses an air bag to apply force against the body for occlusion; ¶[0083]: "the control unit 12 controls the air bag drive section 11 to start injecting air into the air bag 2, so as to increase the pressing force applied by the sensor section 6 to the body surface", showing that the pressing mechanism is a fluid actuation mechanism; ¶[0079]: "the rotation drive section 10... rotates the sensor section 6 so that... the pressing surface 6b can be placed in uniform contact with the skin", showing an actuator mechanism used in conjunction with the fluid-driven bag to conform and press the device structure against the limb, thereby reducing the effective diameter of the wearable system).
Regarding claim 50, Kinoshita teaches that the device is operable in a calibration mode, wherein operation in the calibration mode configures the sleeve in the occlusion configuration for calibrating baseline parameters the blood pressure of the wearer (Kinoshita, Fig. 6: shows the calibration sequence including occlusion and data generation for correction, verifying operation in calibration mode for baseline blood pressure determination; ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmor) of the air bag 2 applied at the time when the AC level... has reached the occlusion completion determination threshold value", showing the calibration mode actively presses to achieve full occlusion of the radial artery; ¶[0188]: "the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T", confirming this pressing force corresponds to an occlusion state used in calibration; ¶[0195]: "the control unit 12 calculates the SBP and the DBP based on the thus generated pulse wave envelope data, and generates the correction data for correcting the SBP and the DBP based on the result of the comparison", showing that the system calibrates baseline blood pressure parameters during this occlusion configuration).
Regarding claim 51, Kinoshita teaches that the device is operable in a continuous monitoring mode (Kinoshita, ¶[0076]: "The vital information measuring device of the present embodiment has a continuous blood pressure measurement mode in which the SBP and the DBP are calculated every heart rate to be displayed in the display section 13", showing that the system performs ongoing measurements in a continuous mode), wherein operation in the calibration mode configures the sleeve in the partial occlusion configuration for monitoring the blood pressure of the wearer (Kinoshita, Fig. 6; ¶[0210]: "the second pressing value is preferably set to an arbitrary numerical value corresponding to a range of the pressing force with which the AC level of the target element determined at each time in the selected element row is as high as 0.9 times or more of the maximum value", demonstrating that in the calibration process, the system identifies a pressing force below full occlusion, which is then used in continuous monitoring, consistent with a partial occlusion configuration; ¶[0211]: "The state where the pressing force is held at HDP ACmor is regarded to be the closest to the tonometry state", confirming that this partial occlusion force is used during ongoing pressure monitoring operations).
Regarding claim 52, Kinoshita teaches that the device comprises a sensor array comprised of a plurality of sensing elements (Kinoshita, ¶[0039]: "the sensor section 6 includes an element row 60 including a plurality of pressure detecting elements 6a arranged in a direction B... and an element row 70 including a plurality of pressure detecting elements 7a arranged in the direction B", showing that the sensor array is composed of multiple pressure detecting elements; ¶[0040]: "Every pressure detecting element 6a forms a pair with a pressure detecting element 7a disposed in the same position in the direction B, and a plurality of such pairs are arranged in the direction B in the sensor section 6", confirming the sensor section comprises a grid-like array of pressure sensing elements that collectively function as a sensor array).
Regarding claim 55, Kinoshita teaches that the blood pressure comprises a systolic blood pressure, a diastolic blood pressure, a mean blood pressure, a heart rate, a blood vessel viscoelasticity, an arterial stiffness, or a combination thereof (Kinoshita, ¶[0071]: "The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", showing the derivation of systolic and diastolic pressures and heart rate from the pressure signal).
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.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over by Kinoshita et al. (US 20190046045 A1), hereto referred as Kinoshita, and further in view of Handler et al. (US 20190183362 A1), hereto referred as Handler, and further in view of Elgendi et al. (Elgendi, Mohamed et al. “The Use of Photoplethysmography for Assessing Hypertension.” NPJ digital medicine 2.1 (2019): 1--60. Web.), hereto referred as Elgendi.
Kinoshita teaches claim 18 and 21 and as described above.
Regarding claim 23, Kinoshita does not teach that the method further comprises isolating one or more changes in pressure of the skin surface at the location of the blood vessel, wherein isolating the one or more changes in pressure of the skin surface at the location of the blood vessel comprises carrying out a time, frequency, and space domain clustering analysis of a comparison of the changes in pressure at the location of the blood vessel relative to one or more changes in pressure on the skin surface of the wearer at a location away from the blood vessel. Rather, Kinoshita teaches identifying a target sensor element positioned above a blood vessel and analyzing both temporal and spatial aspects of pressure signals to locate that vessel (Kinoshita, ¶[0087], ¶[0130], ¶[0141]). However, it does not teach performing a clustering analysis in time, frequency, and space domains comparing signals from the vessel site to signals away from it. Handler fills the gap with respect to clustering analysis in the time and frequency domains using circulatory waveforms. Handler teaches that pressure signals can be segmented in the time domain using slope detection (Handler, ¶[0017]) and transformed into the frequency domain using fast Fourier transform (FFT) techniques (Handler, ¶[0065]). Handler further shows that different frequency-domain distributions can be compared to identify meaningful peaks related to physiological events (Handler, Fig. 7). These teachings demonstrate that Handler provides a basis for clustering analysis of pressure signals in the time and frequency domains. Elgendi fills the gap with respect to spatial domain analysis of pulse waveforms using photoplethysmographic signals. Elgendi teaches the use of multiple signal acquisition sites, such as the finger, earlobe, and toe, to monitor physiological signals (Elgendi, p. 1, 'PHOTOPLETHYSMOGRAPHY', R-col.). It also describes comparing photoplethysmographic waveforms from two different arterial sites to determine physiological parameters (Elgendi, p. 1, 'ELECTROCARDIOGRAPHY AND PHOTOPLETHYSMOGRAPHY' R-col.), thus supporting comparative spatial analysis of signals for identifying vascular features. 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 Kinoshita in view of Handler and Elgendi to perform a time, frequency, and space domain clustering analysis of pressure signals at and away from a blood vessel location. The combination would have been possible because each reference addresses compatible aspects of physiological waveform signal acquisition and analysis. Handler’s time and frequency domain clustering techniques could be directly applied to the pressure waveforms captured by Kinoshita’s sensor array, and Elgendi’s spatial analysis across multiple body sites could be incorporated to compare signals from vessel and non-vessel locations. Together, the domain-specific analyses taught by Handler and Elgendi would have guided a skilled artisan to group and distinguish waveform features across time, frequency, and space domains for isolating physiologic signal sources. The benefit of the combination would be improved differentiation and isolation of physiological pressure signals, enhancing the reliability of identifying blood vessel-specific signals and increasing the accuracy of derived physiological parameters.
Claims 39 and 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over by Kinoshita et al. (US 20190046045 A1), hereto referred as Kinoshita, and further in view of Tal et al. (US 20180184923 A1), hereto referred as Tal.
Kinoshita teaches claim 28, 43, and 52 as described above.
Regarding claim 39, Kinoshita teaches that the sensor array is comprised of a plurality of sensing elements, but does not teach that the sensing elements comprise polymeric thin-film transducers. Rather, Kinoshita teaches a wearable physiological measurement device comprising a plurality of pressure sensing elements (¶[0040]), but does not disclose that those sensing elements are polymeric thin-film transducers. Tal also uses pressure sensors to measure blood pressure and teaches an array of pressure sensors made using polymeric foil materials such as Velostat or Linqstat, which change resistance under pressure and serve as individual sensor elements (¶[0081]–[0082]). 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 Kinoshita in view of Tal to form the plurality of sensing elements using polymeric thin-film transducers. The combination would have been possible because both references disclose flexible pressure sensing arrays designed for wearable use. It would have been obvious to substitute the generic sensors in Kinoshita with the polymeric film-based sensors of Tal to improve flexibility, skin conformity, and manufacturing cost. The benefit of the combination would be a more comfortable, flexible, and cost-effective sensor array suitable for prolonged wearable use.
Regarding claim 53, Kinoshita does not teach that the plurality of sensing elements comprises pressure detecting elements comprise thin-film transducers. Rather, Kinoshita teaches a plurality of pressure detecting elements arranged in rows on a flat surface for physiological monitoring (¶[0040], ¶[0041]), but does not specify that these elements are thin-film transducers. Tal also uses pressure sensors to measure blood pressure and teaches a pressure sensor array made from polymeric piezoresistive thin-film materials such as Velostat and Linqstat, which serve as low-cost, flexible pressure transducers (¶[0081]–[0083]). 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 Kinoshita in view of Tal to implement the plurality of sensing elements using thin-film piezoresistive transducers. The combination would have been possible because both references describe pressure sensor arrays for wearable physiological monitoring. It would have been obvious to substitute the generic sensing elements in Kinoshita with the thin-film polymeric sensors of Tal to improve comfort, flexibility, and manufacturability. The benefit of the combination would be a more flexible, biocompatible, and cost-effective sensor array suitable for continuous physiological monitoring in wearable applications.
Regarding claim 54, the Kinoshita does not teach that the thin-film transducers are polymeric thin-film transducers. Rather, Kinoshita teaches the use of pressure detecting elements such as piezoresistive and capacitive types (¶[0040]) but does not disclose that they are formed from polymeric materials. Tal teaches that pressure sensor elements are implemented using piezoresistive electrically conductive film sheets, specifically Velostat and Linqstat, which are made from a polymeric foil (¶[0081]-[0083]). These polymeric materials serve as thin-film pressure transducers in Tal’s wearable pressure sensor array. 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 the combined Kinoshita and Tal in view of Tal to form the thin-film transducers using polymeric materials. The combination would have been possible because both references address wearable pressure sensors. It would have been obvious to use polymeric thin-film materials like those in Tal to enhance flexibility, biocompatibility, and manufacturability of the sensing array in Kinoshita. The benefit of the combination would be a more compliant and skin-conforming sensor system that improves comfort and performance in wearable medical monitoring devices.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791