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 .
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the
specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-3, 6-8, 11-16, 18, and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0179053 A1 to Gemignani et al. (hereinafter “Gemignani”) in view of US 2021/0204824 A1 to Wang et al. (hereinafter “Wang”).
Regarding claims 1 and 12, Gemignani teaches:
A multi-sensor device/apparatus (see abstract-first sentence, fig. 1, reference numbers 1-2 and 100/100’) and method for measuring the physiological parameter (blood pressure/pressure wave) of a user (abstract), the device comprising:
a first acoustic/vibration sensor and a second acoustic/vibration sensor disposed at a first distance from each other (see abstract, first sentence: “An apparatus for measuring the propagation velocity of a pressure wave comprises a first sensor of cutaneous vibration to measure a vibration generated in a first application point, creating a corresponding first signal, and a second sensor of cutaneous vibrations to measure a local cutaneous vibration generated in second point of an arterial vessel, creating a corresponding second signal caused by the deformation of the vessel responsive to the progression of the pressure wave in the vessel. ”, fig. 1, 1-2, para 0034 —predetermined distance, para 0046, para 0058, and claim 5),
the first and second acoustic (vibration or sound) sensors each configured to obtain respective first and second acoustic/vibration or sound signals associated with a blood vessel/arterial vessel of a user (see abstract-first sentence above, para 0058, and claim 4),
the first distance corresponding to a first characteristic of the blood vessel (such as pulse wave velocity/propagation wave velocity— see abstract, para 0001, para 0004, para 0026-0032, para 0070, and claim 1 ), and wherein the sensors of the system are securable to the user (see fig. 1 – reference numbers 1-2) and comprising the first acoustic (vibration or sound) sensor and the second acoustic (vibration or sound) sensor (para 0064, lines 1-14), and wherein the first and second sound sensor/acoustic sensor signals and the first distance are used to determine the physiological parameter (pressure wave/blood pressure) of a user (see para 0029-0032), but does not explicitly disclose a multi-sensor user device also comprising:
a first motion sensor and a second motion sensor disposed at a second distance from each other,
the first and second motion sensors each configured to obtain respective first and second motion signals associated with the blood vessel,
the second distance corresponding to a second characteristic of the blood vessel;
a photoacoustic sensor configured to obtain a photoacoustic signal generated from light incident on the blood vessel, the photoacoustic signal corresponding to one or more physiological characteristics of the blood vessel, wherein a combination of the one or more physiological characteristics of the blood vessel, the first characteristic of the blood vessel, and the second characteristic of the blood vessel correlate to a physiological parameter of the user; and a wearable structure securable to the user and comprising the first acoustic sensor, the second acoustic sensor, the first motion sensor, the second motion sensor, and the photoacoustic sensor.
However, Wang teaches a multi-sensor user device/wearable device for determining a physiological parameter (blood pressure) of a user (para 0005), and a method for measuring blood pressure (see abstract, line 1, fig. 2- 100 and 110, and para 0005-0006). The device (fig. 2) teaches:
a first motion sensor and a second motion sensor/ accelerometers disposed at a second distance from each other (see fig. 2 -110, para 0019, para 0033, para 0076: “In at least one embodiment of the present disclosure, the wearable device 100 may include various types of sensors including, for example, nanosecond pulse near-field sensing (NPNS) based sensor, near-infrared spectroscopy (NIRS) based sensor, piezoelectric sensor, accelerometer, gyroscope, barometer, temperature sensor, Doppler sensor, ultrasound transducer, laser diode sensor, photodiode sensor, GPS or the like. In at least one embodiment of the present disclosure, the physiological signal monitoring system may include one or more wearable devices 100. The wearable devices 100 may include, but are not limited to, watch, sleevelet, belt, bracelet, ankle bracelet, tourniquet, scarf, collar, necklace, shoe or the like.”),
the first and second motion sensors/piezoelectric sensors each configured to obtain respective first and second motion signals associated with the blood vessel (such as using the piezoelectric sensors to find a variety of different physiological parameters, such as pulse beat – see para 0076),
the second distance corresponding to a second characteristic of the blood vessel ( such as the pulse transit time-- see figs. 12-13, para 0016, para 0030, para 0044, para 0076-
para 0077, and para 0095);
a photoacoustic sensor/optical sensor (such as laser diode sensor) configured to obtain a photoacoustic signal generated from light incident on the blood vessel, the photoacoustic signal corresponding to one or more physiological characteristics of the blood vessel (such as obtaining PPG signals—see para 0076-0077),
wherein a combination of the one or more physiological characteristics of the blood vessel, the first characteristic of the blood vessel (Pulse Wave Velocity (PWV)), and the second characteristic of the blood vessel (Pulse Transit Time (PTT)) correlate to a physiological parameter of the user (such as blood pressure—see abstract, para 0030, and para 0076-0077);
and a wearable structure securable to the user and comprising the first motion/piezoelectric sensor, the second motion/ piezoelectric sensor, and the photoacoustic sensor/ a laser diode sensor (see figs. 1-2, 100 and para 0076 – the wearable device/ one or more wearable devices of the present invention can contain a plurality of sensors, such as the aforementioned sensors stated above that are in direct contact with the patient/patient’s skin).
And wherein the first and second motion signal and the second distance are used to determine the physiological parameter (blood pressure) of a user ( see abstract, figs. 12-13, para 0005, para 0016, para 0030, para 0044, para 0076-para 0077, and para 0095).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gemignani with the teachings of Wang to arrive at the claimed invention. Such combination would improve the system by providing a portable, non-invasive monitoring device enabled to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claims 2 and 13, Gemignani as modified teaches:
The user device of claims 1 and 12, wherein the first acoustic sensor and the second acoustic sensor are contactable with the skin of the user (see fig. 1, reference numbers 1-2 and para 0046), but does not explicitly disclose wherein the system and method comprises a first motion sensor, a second motion sensor, and the photoacoustic sensor are contactable with a skin of the user.
However, Wang teaches wherein a first motion sensor/piezoelectric sensor, a second motion sensor/piezoelectric sensor, and the photoacoustic/laser diode sensor are contactable with a skin of the user (see figs. 1-2 and para 0076 – the wearable device/ one or more wearable devices of the present invention can contain a plurality of sensors, such as the aforementioned sensors stated above that are in direct contact with the patient/patient’s skin).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gemignani with the teachings of Wang to arrive at the claimed invention. Such combination would improve the system by providing a portable, non-invasive monitoring device enabled to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claim 3, Gemignani as modified teaches:
The user device of claims 1, wherein:
the first distance (distance D shown of fig. 1 below) corresponds to a first temporal difference (difference in measurement time of the first acoustic signal and a measurement time of the second acoustic signal) between the respective first and second acoustic (sound or vibration) signals (abstract, para 0026-0032, para 0034, para 0035-0036, para 0066, and para 0068-0070),
the first characteristic comprising a pulse wave velocity/propagation velocity determined based on the first temporal difference and the first distance (see abstract, para 0034, para 0036, and claim 3), and wherein the device (fig. 1) can select sensors from a group consisting of not only acoustic/sound sensors, but also motion/accelerometers (see para 0046 and claim 5), but does not explicitly disclose where the system (in addition to the acoustic sensors) comprises
wherein the second distance corresponds to a second temporal difference between the respective first and second motion signals, the second characteristic comprising a pulse wave velocity determined based on the second temporal difference and the second distance.
However, Wang teaches wherein the second distance corresponds to a second temporal difference between the respective first and second motion/piezoelectric signals, the second characteristic comprising a pulse wave velocity determined based on the second temporal difference and the second distance (para 0016, para 0030, para 0076, para 0095-0096, and para 0115).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the acoustic sensor system of Gemignani with the motion sensors and system of Wang to arrive at the claimed invention. Such combination would improve the system by providing various input characteristics to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claim 6, Gemignani as modified teaches:
The user device of claim 1, wherein the one or more physiological characteristics of the blood vessel (carotid artery) comprise a diameter of the blood vessel (diameter of a carotid artery), a distension of the blood vessel, volumetric blood flow, or a combination thereof (see para 0060).
Regarding claim 7, Gemignani as modified teaches:
The user device of claim 1, further comprising a control system/control unit, wherein the control system/control unit is configured to determine a physiological parameter (blood pressure/pressure wave) of the user based at least on the combination of the one or more physiological characteristics of the blood vessel, the first characteristic of the blood vessel /pulse wave velocity or propagation velocity, and the second characteristic of the blood vessel (control unit and propagation velocity—see abstract and para 0070).
Regarding claim 11, Gemignani teaches:
The user device of claim 1, further comprising a data interface/display (see fig. 1, 45) configured to communicate with a control system/control unit (see fig. 1, 45 and 50, and para 0070), the control system/control unit configured to determine the physiological parameter (blood pressure/pressure wave) of the user based on the combination of the one or more physiological characteristics of the blood vessel, the first characteristic of the blood vessel, and the second characteristic of the blood vessel (control unit and propagation velocity—see abstract and para 0070).
Regarding claim 14, Gemignani as modified teaches:
The method of claim 12, further comprising determining a physiological characteristic of the blood vessel based on:
the first distance (distance D shown of fig. 1 below) corresponds to a first temporal difference (difference in measurement time of the first acoustic signal and a measurement time of the second acoustic signal) between the respective first and second acoustic (sound or vibration) signals (abstract, para 0026-0032, para 0034, para 0035-0036, para 0066, and para 0068-0070),
the first characteristic comprising a pulse wave velocity/propagation velocity determined based on the first temporal difference and the first distance (see abstract, para 0034, para 0036, and claim 3), and wherein the device (fig. 1) can select sensors from a group consisting of not only acoustic/sound sensors, but also motion/accelerometers (see para 0046 and claim 5), but does not explicitly disclose where the method (in addition to the acoustic sensors) comprises
determining the second distance and the second temporal difference, the second temporal distance comprising a difference in measurement time of the first motion measurement time of the first motion signal and the measurement time of the second motion signal.
However, Wang teaches wherein the second distance corresponds to a second temporal difference between the respective first and second motion/piezoelectric signals, the second temporal difference comprising a difference in measurement time of the first motion measurement time of the first motion signal and the measurement time of the second motion signal (para 0016, para 0030, para 0076, para 0095-0096, and para 0115).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified system of Gemignani with the motion sensors and system of Wang to arrive at the claimed invention. Such combination would improve the system by providing various input characteristics to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claim 15, Gemignani as modified teaches:
The method of claim 14, wherein the physiological characteristic of the blood vessel comprises a pulse wave velocity of the blood vessel (see abstract, last two sentences and para 0004).
Regarding claim 16, Gemignani as modified teaches:
The method of claim 15, wherein:
the determining of the physiological parameter of the user comprises determining a blood pressure/pressure wave of the user (see title and abstract);
and the determining of the blood pressure/pressure wave of the user is based on the pulse wave velocity/propagation velocity of the blood vessel/atrial vessel (see abstract, para 0001, and para 0004).
Regarding claim 18, Gemignani as modified teaches:
The method of claim 12, wherein the physiologic characteristics of the blood vessel is based on a diameter of the blood vessel (diameter of a carotid artery), a distension of the blood vessel, volumetric blood flow, or a combination thereof (see para 0060), but does not disclose wherein the method comprises determining one or more physiological characteristics of the blood vessel based on the photoacoustic signal.
However, Wang teaches wherein the method comprises determining one or more physiological characteristics of the blood vessel based on the photoacoustic signal/signal obtained from an optical sensor or laser diode sensor (obtaining PPG signals—see para 0076-0077).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified teachings of Gemignani with the teachings of Wang to arrive at the claimed invention. Such combination would improve the system by providing a portable, non-invasive monitoring device enabled to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claim 21, Gemignani teaches:
An apparatus (see abstract-first sentence, fig. 1, reference numbers 1-2 and 100/100’) comprising:
first acoustic sensing means (acoustic/vibration sensors according to para 0004 of the specification) and second acoustic sensing means (acoustic/vibration sensors according to para 0004 of the specification) disposed at a first distance from each other (see abstract, first sentence: “An apparatus for measuring the propagation velocity of a pressure wave comprises a first sensor of cutaneous vibration to measure a vibration generated in a first application point, creating a corresponding first signal, and a second sensor of cutaneous vibrations to measure a local cutaneous vibration generated in second point of an arterial vessel, creating a corresponding second signal caused by the deformation of the vessel responsive to the progression of the pressure wave in the vessel. ”, fig. 1, 1-2, para 0034 —predetermined distance, para 0046, para 0058, and claim 5),
the first and second acoustic (vibration or sound) sensing means (acoustic or sound sensors according to para 0004 of the specification) each being for obtaining respective first and second acoustic/vibration signals associated with a blood vessel of a user (see abstract-first sentence above, para 0058, and claim 4),
the first distance corresponding to a first characteristic of the blood vessel (such as pulse wave velocity/propagation wave velocity— see abstract, para 0001, para 0004, para 0026-0032, para 0070, and claim 1 ), and wearable means (wearable structure according to para 00004 of the specification) for securing the apparatus to the user (see fig. 1 – reference numbers 1-2 and 100/100’) and comprising the first acoustic sensing means (first acoustic sensors as stated above) the second acoustic sensing means (second acoustic sensors as stated above—first and second vibration or sound sensor as stated in para 0064, lines 1-14), but does not disclose
first motion sensing means (first motion sensor according to para 0004 of the specification) and second motion sensing means (second motion sensor according to para 0004 of the specification) disposed at a second distance from each other,
the first and second motion sensing means each being for obtaining respective first and second motion signals associated with the blood vessel, the second distance corresponding to a second characteristic of the blood vessel;
photoacoustic sensing means (photoacoustic sensor according to para 0004 of the specification) for obtaining a photoacoustic signal generated from light incident on the blood vessel, the photoacoustic signal corresponding to one or more physiological characteristics of the blood vessel, wherein a combination of the one or more physiological characteristics of the blood vessel, the first characteristic of the blood vessel, and the second characteristic of the blood vessel correlate to a physiological parameter of the user, and wearable means (wearable structure according to para 0004 of the specification) comprising first motion sensing means, the second motion sensing means, and the photoacoustic sensing means.
However, Wang teaches a multi-sensor user device/wearable device for determining a physiological parameter (blood pressure) of a user (para 0005), and a method for measuring blood pressure (see abstract, line 1, fig. 2- 100 and 110, and para 0005-0006). The device (fig. 2) teaches:
a first motion sensor and a second motion sensor/ accelerometers disposed at a second distance from each other (see fig. 2 -110, para 0019, para 0033, para 0076: “In at least one embodiment of the present disclosure, the wearable device 100 may include various types of sensors including, for example, nanosecond pulse near-field sensing (NPNS) based sensor, near-infrared spectroscopy (NIRS) based sensor, piezoelectric sensor, accelerometer, gyroscope, barometer, temperature sensor, Doppler sensor, ultrasound transducer, laser diode sensor, photodiode sensor, GPS or the like. In at least one embodiment of the present disclosure, the physiological signal monitoring system may include one or more wearable devices 100. The wearable devices 100 may include, but are not limited to, watch, sleevelet, belt, bracelet, ankle bracelet, tourniquet, scarf, collar, necklace, shoe or the like.”),
the first and second motion sensors/piezoelectric sensors each configured to obtain respective first and second motion signals associated with the blood vessel (such as using the piezoelectric sensors to find a variety of different physiological parameters, such as pulse beat – see para 0076),
the second distance corresponding to a second characteristic of the blood vessel ( such as the pulse transit time-- see figs. 12-13, para 0016, para 0030, para 0044, para 0076-
para 0077, and para 0095);
a photoacoustic sensor/optical sensor (such as laser diode sensor) configured to obtain a photoacoustic signal generated from light incident on the blood vessel, the photoacoustic signal corresponding to one or more physiological characteristics of the blood vessel (such as obtaining PPG signals—see para 0076-0077),
wherein a combination of the one or more physiological characteristics of the blood vessel, the first characteristic of the blood vessel (Pulse Wave Velocity (PWV)), and the second characteristic of the blood vessel (Pulse Transit Time (PTT)) correlate to a physiological parameter of the user (such as blood pressure—see abstract, para 0030, and para 0076-0077);
and a wearable structure securable to the user and comprising the first motion/piezoelectric sensor, the second motion/ piezoelectric sensor, and the photoacoustic sensor/ a laser diode sensor (see figs. 1-2, 100 and para 0076 – the wearable device/ one or more wearable devices of the present invention can contain a plurality of sensors, such as the aforementioned sensors stated above that are in direct contact with the patient/patient’s skin).
And wherein the first and second motion signal and the second distance are used to determine the physiological parameter (blood pressure) of a user ( see abstract, figs. 12-13, para 0005, para 0016, para 0030, para 0044, para 0076-para 0077, and para 0095).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gemignani with the teachings of Wang to arrive at the claimed invention. Such combination would improve the system by providing a portable, non-invasive monitoring device enabled to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claim 22, Gemignani as modified teaches:
The apparatus of claim 21, wherein the first acoustic sensing means (first acoustic sensor as stated above) and the second acoustic sensing means( second acoustic sensor as stated above) are contactable with the skin of the user (see fig. 1, reference numbers 1-2 and para 0046), but does not explicitly disclose wherein the first motion sensing means/first motion sensors, the second motion sensing means/second motion sensors, and the photoacoustic sensing means/photoacoustic sensors are contactable with a skin of the user.
However, Wang teaches wherein a first motion sensor/piezoelectric sensor, a second motion sensor/piezoelectric sensor, and the photoacoustic/laser diode sensor are contactable with a skin of the user (see figs. 1-2 and para 0076 – the wearable device/ one or more wearable devices of the present invention can contain a plurality of sensors, such as the aforementioned sensors stated above that are in direct contact with the patient/patient’s skin).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gemignani with the teachings of Wang to arrive at the claimed invention. Such combination would improve the system by providing a portable, non-invasive monitoring device enabled to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claim 23, Gemignani as modified teaches:
The apparatus of claim 21, wherein:
the first distance (distance D shown of fig. 1 below) corresponds to a first temporal difference (difference in measurement time of the first acoustic signal and a measurement time of the second acoustic signal) between the respective first and second acoustic (sound or vibration) signals (abstract, para 0026-0032, para 0034, para 0035-0036, para 0066, and para 0068-0070),
the first characteristic comprising a pulse wave velocity/propagation velocity determined based on the first temporal difference and the first distance (see abstract, para 0034, para 0036, and claim 3), and wherein the device (fig. 1) can select sensors from a group consisting of not only acoustic/sound sensors, but also motion/accelerometers (see para 0046 and claim 5), but does not explicitly disclose where the system (in addition to the acoustic sensors) comprises
wherein the second distance corresponds to a second temporal difference between the respective first and second motion signals, the second characteristic comprising a pulse wave velocity determined based on the second temporal difference and the second distance.
However, Wang teaches wherein the second distance corresponds to a second temporal difference between the respective first and second motion/piezoelectric signals, the second characteristic comprising a pulse wave velocity determined based on the second temporal difference and the second distance (para 0016, para 0030, para 0076, para 0095-0096, and para 0115).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the acoustic sensor system of Gemignani with the motion sensors and system of Wang to arrive at the claimed invention. Such combination would improve the system by providing various input characteristics to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claim 24, Gemignani as modified teaches:
The apparatus of claim 21, wherein the one or more physiological characteristics of the blood vessel (carotid artery) comprise a diameter of the blood vessel (diameter of a carotid artery), a distension of the blood vessel, volumetric blood flow, or a combination thereof (see para 0060).
Regarding claim 25, Gemignani as modified teaches:
The apparatus of claim 21, further comprising means for (such as a control system as supported by para 0197 of the specification) determining the physiological parameter (blood pressure/pressure wave) of the user based at least on the combination of the one or more physiological characteristics of the blood vessel, the first characteristic/pulse wave velocity or propagation velocity, and the second characteristic (control unit and propagation velocity—see abstract and para 0070).
Regarding claims 8 and 26, Gemignani as modified teaches:
The device and apparatus of claims 7 and 25, wherein the physiological parameter of the user comprises a blood pressure of the user (see para 0004 and 0070—pulse wave velocity/propagation velocity).
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gemignani and Wang, and further in view of US 2016/0287172 A1 to Morris et al. (hereinafter “Morris”).
Regarding claims 4 and 17, Gemignani as modified teaches:
The user device and method of claims 1 and 12, wherein the first and second acoustic sensors each comprise a microphone (para 0046 and claim 5), and wherein the first and second sensor can be selected from a group of sensors, including accelerometers (see para 0046 and claim 5), but does not disclose wherein separate first and second motion sensors each comprise an accelerometer.
However, Morris teaches a wrist-worn heart-monitoring/blood pressure device (see abstract, line 1, fig. 3, and para 0052). The device (fig. 3) can collect many raw or pre-processed signals from one or more microphones, cameras, accelerometers, gyroscopes, etc. (see para 0091).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified acoustic sensor system of Gemignani with the motion sensors and system of Morris to arrive at the claimed invention. Such combination would lead to a reasonable expectation for success, since the prior art of Morris already discloses using both microphones and accelerometers to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gemignani in view of Wang and Morris, and further in view of US 2024/0090785 A1 to Lezzoum et al. (hereinafter “Lezzoum”).
Regarding claim 5, Gemignani as modified teaches the user device of claim 4, but does not disclose wherein the first motion sensor, the second motion sensor, or a combination thereof comprises a voice accelerometer configured to obtain motion signals.
However, Wang teaches wherein the system containing first and second motion sensors can contain an accelerometer and gyroscope to adjust pulse transit time and/or the pulse wave velocity (PWV) of the device (para 0019, para 0107, and para 0111), but does not explicitly disclose wherein the first motion sensor, the second motion sensor, or a combination thereof comprises a voice accelerometer configured to obtain motion signals.
However, Lezzoum teaches a device for determining the heart activity of a user (see abstract). The device (fig. 1) teaches using a voice accelerometer/ voice accelerometer signal in order to obtain motion signals/signals indicative of the user’s heart beat (see para 0058).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Gemignani with the sensors of motion sensor system of Wang and the voice accelerometer of Lezzoum to arrive at the invention. Such combination would improve the system, by allowing continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gemignani in view of Wang, and further in view of US 2023/0082362 A1 to Varadan et al. (hereinafter “Varadan”).
Regarding claims 9 and 19, Gemignani as modified teaches:
The user device and method of claims 1 and 12, further comprising a control system/control unit (see para 0068-0069), but does not disclose wherein the control system is configured to use a trained artificial intelligence model configured to:
receive the photoacoustic signal, the first and second acoustic signals, the first and second motion signals, or a combination thereof;
and output a prediction the physiological parameter of the user.
However, Varadan teaches systems and methods for predicting blood pressure (see abstract, lines 1-2). The system (figs. 1 and 7A-7B) teach wherein a control system/control module (see para 0076, lines 1-16) is configured to use a trained artificial intelligence model (para 0027, 0036, 0072, and para 0074) configured to:
receive the photoacoustic signal, the first and second acoustic/sound signals, the first and second motion signals, or a combination thereof,
and output a prediction the physiological parameter of the user (see abstract, para 0021, para 0026, para 0037, and claim 34).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified system of Gemignani machine learning system of Varadan to arrive at the claimed invention. Such combination would improve the system by providing highly accurate blood pressure prediction when monitoring each patient, ultimately allowing for faster diagnostic and medical intervention.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gemignani in view of Wang, and further in view of US 2018/0008228 A1 to An et al. (hereinafter “An”).
Regarding claims 10 and 20, Gemignani as modified teaches:
The user device and method of claims 1 and 12, further comprising a control system/control unit (para 0070), but does not disclose wherein the control system is configured to wake up the first motion sensor, the second motion sensor, or the photoacoustic sensor from a low-power state responsive to the first acoustic sensor or the second acoustic sensor detecting an acoustic signal having a signal quality above a threshold.
However, An teaches an apparatus, systems, and methods to collect heart sound data (see abstract, lines 1-2). The implantable and/or wearable device and system (figs. 1-2 and para 0005 and para 0016, last sentence: “The systems, devices, and methods disclosed herein can enable more efficient patient monitoring of heart sound information for any type of medical device, including implantable, subcutaneous, wearable, or external devices.”) teach wherein the control system/machine (computer system—see para 0046-0047) contains a processor (para 0047-0048) that is configured perform functions of the system, such as waking up one or more motion sensors/ accelerometers from a low-power state responsive to one or more acoustic/sound sensors detecting an acoustic/sound signal having a signal quality above a threshold (see para 0023-0024).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Gemignani with the teachings of An to arrive at the claimed invention. Such combination would improve the system by providing highly accurate blood pressure prediction when monitoring each patient, ultimately allowing for faster diagnostic and medical intervention.
Claims 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Gemignani in view of Morris and Wang.
Regarding claim 27, Gemignani teaches:
A non-transitory computer-readable apparatus comprising a storage medium (ROM—see fig. 1, 41), and an apparatus comprising a first acoustic/vibration sensor and a second acoustic/vibration sensor disposed at a first distance from each other (see abstract, first sentence: “An apparatus for measuring the propagation velocity of a pressure wave comprises a first sensor of cutaneous vibration to measure a vibration generated in a first application point, creating a corresponding first signal, and a second sensor of cutaneous vibrations to measure a local cutaneous vibration generated in second point of an arterial vessel, creating a corresponding second signal caused by the deformation of the vessel responsive to the progression of the pressure wave in the vessel. ”, fig. 1, 1-2, para 0034 —predetermined distance, para 0046, para 0058, and claim 5),
the first and second acoustic (vibration or sound) sensors each configured to obtain respective first and second acoustic/vibration or sound signals associated with a blood vessel/arterial vessel of a user (see abstract-first sentence above, para 0058, and claim 4),
the first distance corresponding to a first characteristic of the blood vessel (such as pulse wave velocity/propagation wave velocity— see abstract, para 0001, para 0004, para 0026-0032, para 0070, and claim 1 ), and wherein the sensors of the system are securable to the user (see fig. 1 – reference numbers 1-2) and comprising the first acoustic (vibration or sound) sensor and the second acoustic (vibration or sound) sensor (para 0064, lines 1-14), and wherein the first and second sound sensor/acoustic sensor signals and the first distance are used to determine the physiological parameter (pressure wave/blood pressure) of a user (see para 0029-0032), but does not explicitly disclose wherein the storage medium comprises a plurality of instructions configured to, when executed by one or more processors, cause an apparatus to:
use a first motion sensor and a second motion sensor disposed at a second distance from each other,
the first and second motion sensors each configured to obtain respective first and second motion signals associated with the blood vessel,
the second distance corresponding to a second characteristic of the blood vessel;
a photoacoustic sensor configured to obtain a photoacoustic signal generated from light incident on the blood vessel, the photoacoustic signal corresponding to one or more physiological characteristics of the blood vessel, wherein a combination of the one or more physiological characteristics of the blood vessel, the first characteristic of the blood vessel, and the second characteristic of the blood vessel correlate to a physiological parameter of the user; and a wearable structure securable to the user and comprising the first acoustic sensor, the second acoustic sensor, the first motion sensor, the second motion sensor, and the photoacoustic sensor.
However, Morris teaches a wrist-worn heart monitoring device (see abstract, line 1 and figs. 1 and 3). The device (figs. 1 and 3) contain a plurality of sensors, and contain a data-storage machine to hold data and instructions for the control of the device (see para 0025), but does not explicitly teach all of the following:
obtain a first acoustic signal associated with a blood vessel of a user measured by a first acoustic sensor of a wearable device, and a second acoustic signal associated with the blood vessel measured by a second acoustic sensor of the wearable device which is disposed at a first distance from the first acoustic sensor;
obtain a first motion signal associated with the blood vessel measured by a first motion sensor of the wearable device, and a second motion signal associated with the blood vessel measured by a second motion sensor of the wearable device which is disposed at a second distance from the first motion sensor;
obtain a photoacoustic signal generated from light incident on the blood vessel measured by a photoacoustic sensor;
and determine a physiological parameter of the user based on the first acoustic signal, the second acoustic signal, the first distance, the first motion signal, the second motion signal, the second distance, and the photoacoustic signal.
However, Wang teaches a multi-sensor user device/wearable device for determining a physiological parameter (blood pressure) of a user (para 0005), and a method for measuring blood pressure (see abstract, line 1, fig. 2- 100 and 110, and para 0005-0006). The device (fig. 2) teaches:
a first motion sensor and a second motion sensor/ accelerometers disposed at a second distance from each other (see fig. 2 -110, para 0019, para 0033, para 0076: “In at least one embodiment of the present disclosure, the wearable device 100 may include various types of sensors including, for example, nanosecond pulse near-field sensing (NPNS) based sensor, near-infrared spectroscopy (NIRS) based sensor, piezoelectric sensor, accelerometer, gyroscope, barometer, temperature sensor, Doppler sensor, ultrasound transducer, laser diode sensor, photodiode sensor, GPS or the like. In at least one embodiment of the present disclosure, the physiological signal monitoring system may include one or more wearable devices 100. The wearable devices 100 may include, but are not limited to, watch, sleevelet, belt, bracelet, ankle bracelet, tourniquet, scarf, collar, necklace, shoe or the like.”),
the first and second motion sensors/piezoelectric sensors each configured to obtain respective first and second motion signals associated with the blood vessel (such as using the piezoelectric sensors to find a variety of different physiological parameters, such as pulse beat – see para 0076),
the second distance corresponding to a second characteristic of the blood vessel ( such as the pulse transit time-- see figs. 12-13, para 0016, para 0030, para 0044, para 0076-
para 0077, and para 0095);
a photoacoustic sensor/optical sensor (such as laser diode sensor) configured to obtain a photoacoustic signal generated from light incident on the blood vessel, the photoacoustic signal corresponding to one or more physiological characteristics of the blood vessel (such as obtaining PPG signals—see para 0076-0077),
wherein a combination of the one or more physiological characteristics of the blood vessel, the first characteristic of the blood vessel (Pulse Wave Velocity (PWV)), and the second characteristic of the blood vessel (Pulse Transit Time (PTT)) correlate to a physiological parameter of the user (such as blood pressure—see abstract, para 0030, and para 0076-0077);
and a wearable structure securable to the user and comprising the first motion/piezoelectric sensor, the second motion/ piezoelectric sensor, and the photoacoustic sensor/ a laser diode sensor (see figs. 1-2, 100 and para 0076 – the wearable device/ one or more wearable devices of the present invention can contain a plurality of sensors, such as the aforementioned sensors stated above that are in direct contact with the patient/patient’s skin).
And wherein the first and second motion signal and the second distance are used to determine the physiological parameter (blood pressure) of a user ( see abstract, figs. 12-13, para 0005, para 0016, para 0030, para 0044, para 0076-para 0077, and para 0095).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gemignani with the teachings of Morris and Wang to arrive at the claimed invention. Such combination would improve the system by providing a portable, non-invasive monitoring device enabled to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claim 28, Gemignani as modified teaches:
The non-transitory computer-readable apparatus of claim 27, wherein the plurality of instructions are further configured to, when executed by the one or more processors, cause the apparatus to determine a physiological characteristic of the blood vessel based on:
the first distance (distance D shown of fig. 1 below) corresponds to a first temporal difference (difference in measurement time of the first acoustic signal and a measurement time of the second acoustic signal) between the respective first and second acoustic (sound or vibration) signals (abstract, para 0026-0032, para 0034, para 0035-0036, para 0066, and para 0068-0070),
the first characteristic comprising a pulse wave velocity/propagation velocity determined based on the first temporal difference and the first distance (see abstract, para 0034, para 0036, and claim 3), and wherein the device (fig. 1) can select sensors from a group consisting of not only acoustic/sound sensors, but also motion/accelerometers (see para 0046 and claim 5), but does not explicitly disclose where the system (in addition to the acoustic sensors) comprises
determining the second distance and the second temporal difference, the second temporal distance comprising a difference in measurement time of the first motion measurement time of the first motion signal and the measurement time of the second motion signal.
However, Wang teaches wherein the second distance corresponds to a second temporal difference between the respective first and second motion/piezoelectric signals, the second temporal difference comprising a difference in measurement time of the first motion measurement time of the first motion signal and the measurement time of the second motion signal (para 0016, para 0030, para 0076, para 0095-0096, and para 0115).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified system of Gemignani with the motion sensors and system of Wang to arrive at the claimed invention. Such combination would improve the system by providing various input characteristics to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Regarding claim 29, Gemignani as modified teaches:
The non-transitory computer-readable apparatus of claim 28, wherein the determination of the physiological parameter of the user comprises determination of a blood pressure of the user based on the physiological characteristic (pulse wave velocity) of the blood vessel (See abstract, line 1, para 0004, and para 0070).
Regarding claim 30, Gemignani as modified teaches:
The non-transitory computer-readable apparatus of claim 27, wherein the plurality of instructions are further configured to, when executed by the one or more processors, cause the apparatus to determine one or more physiologic characteristics of the blood vessel is based on a diameter of the blood vessel (diameter of a carotid artery), a distension of the blood vessel, volumetric blood flow, or a combination thereof (see para 0060), but does not disclose wherein the method comprises determining one or more physiological characteristics of the blood vessel based on the photoacoustic signal.
However, Wang teaches wherein the method comprises determining one or more physiological characteristics of the blood vessel based on the photoacoustic signal/signal obtained from an optical sensor or laser diode sensor (obtaining PPG signals—see para 0076-0077).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified teachings of Gemignani with the teachings of Wang to arrive at the claimed invention. Such combination would improve the system by providing a portable, non-invasive monitoring device enabled to provide continuous and highly accurate blood pressure monitoring for each patient, ultimately allowing for faster diagnostic and medical intervention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Niehaus et al. (US 2017/0245769 A1) teaches devices and methods for estimating blood pressure using intelligent (AI or neural network) oscillometric blood pressure measurement techniques (see abstract and para 0114).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792