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 .
Amendment Entered
In response to the amendment filed on 11/03/2025 , amended claims 1, 3-9, and 11-17 are entered, and claims 2 and 10 are cancelled. Claims 1, 3-9, and 11-17 remain pending in the application.
Response to Amendment
Applicant’s remarks and amendments with respect to the specification, drawings, and claims have been fully considered and overcome each and every objection and rejection under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 07/01/2025. The objections and rejections are withdrawn in view of amendments to the claims, and further in view of applicant’s arguments regarding interpretation of interpretation under 35 U.S.C. 112(f) (see page 10-11 of remarks).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-9, and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0081912 A1 to McKenna et al. (“McKenna”, cited by applicant in 09/30/2022 IDS) in view of US 2019/0370518 A1 to Maor et al. (“Maor”), and further in view of US 2019/0125191 A1 to Siedenburg.
Regarding independent claim 1, McKenna discloses a device for estimation of a blood pressure of a user (see [0010], “…sensors, or sensor assemblies, and monitoring systems are provided herein that may employ optical-acoustic measurements to more accurately determine physiological parameters…”. See also [0012], “…determination of other hemodynamic parameters…parameters may include blood pressure values…”.), the device being configured to be worn by the user (see Fig. 2 and [0019], “…the sensor assembly 10 may be applied to a patient's tissue…”) the device comprising:
a support configured to be applied against the skin of the user (see Fig. 2 and [0019], “…sensor assembly 10…may be coupled together in a single sensor unit, such as a disposed on a single sensor body…the sensor assembly 10 may be applied to a patient's tissue…”, sensor body of sensor assembly 10 (i.e., support) applied to the tissue of a patient (i.e., skin of a user));
a plurality of light sources disposed on the support and configured to emit light toward a blood vessel below the skin of the user (see Fig. 2 and [0023], “…the emitter 16 may be one or more laser diodes adapted to transmit one or more wavelengths of light…”. see also [0022], “…emitter 16 may be configured to transmit electromagnetic radiation, such as light, into the tissue of a patient”. see also [0024], “…emitter 16 and the detector 18 may be disposed on a sensor housing…”, see also [0019], “…sensor assembly 10 may be applied to a patient's tissue so that light from the emitter may penetrate into a vessel 60…”, emitter 16 has one or more laser diodes (i.e., plurality of light sources), emits light into tissue of a patient to penetrate a blood vessel 60 (i.e., emits light toward a blood vessel below the skin of a patient), and is located on a sensor housing (i.e., sensor housing of the support));
a plurality of photodetectors disposed on the support at a distance from each light source, each photodetector of the plurality of photodetectors being configured to detect light emanating from the skin of the user following activation of a light source of the plurality of light sources (see Fig. 2 and [0023], “…the detector 18 may one or more photodetectors selected to receive light in the range or ranges emitted from the emitter 16”. see also [0024], “…emitter 16 and the detector 18 may be disposed on a sensor housing…”. see also [0020], “…the spacing between the emitter 16 and detector 18 may be determined based upon the region of skin or compartment of the body that is to be tested…”, detector 18 (i.e., plurality of photodetectors) located on the sensor housing (i.e., sensor housing of the support), is positioned at a distance from emitter 16 and receives light emitted from emitter 16 (i.e., detects light from an activated light source of a plurality of light sources)),
a plurality of acoustic transducers (see [0028], “…includes one or more ultrasonic transducers 12 (such as one or more piezoelectric transducers) for transmitting and/or receiving the one or more ultrasound waves”, transducers 12), including:
emit an acoustic wave through the skin (see [0021], “…ultrasound transducer 12…converting high-frequency electrical signals into ultrasound waves a beam, which may be transmitted into a patient's tissue”, transducer 12 emits acoustic waves through patient tissue); and
detect the acoustic wave reflected in the body of the user and propagating through the skin (see [0021], “…ultrasound transducer 12…converting high-frequency electrical signals into ultrasound waves a beam, which may be transmitted into a patient's tissue…receive the reflected and/or scattered ultrasound waves”, transducer 12 receives acoustic waves transmitted through patient tissue); and
processing circuitry (see Fig. 1 and [0013], “…sensor assembly 10 is capable of providing an optical signal and an ultrasound signal…a microprocessor 22 that is, in turn, capable of using the optical signal and the ultrasound signal in calculating various hemodynamic parameters…related to the signal…” microprocessor 22 (i.e., processing circuitry)) configured to:
in accordance with an acoustic selection criterion, select an acoustic transducer, as a function of a respective acoustic signal detected by each acoustic detector following emission of an acoustic wave by at least one acoustic emitter (see [0016], “…ultrasound drive unit 39 may control the timing of ultrasound components, such as an ultrasonic transducer 12, in the sensor assembly 10… the operation of the analog-to-digital converter 36 may be gated by the ultrasound drive 39 by means of a gate signal”, see also [0021], “…ultrasound transducer 12…for converting high-frequency electrical signals into ultrasound waves...receive the reflected and/or scattered ultrasound waves and convert these into received electrical signals”, ultrasound drive unit 39 of microprocessor 22 (i.e., processing circuitry) controls the operation of transducer 12 (i.e., accounts for an acoustic selection criterion) and transducer 12 detects an electrical signal representative of ultrasound waves transmitted to patient tissue (i.e., detects acoustic signals based on emitted acoustic waves));
estimate the blood pressure from both the acoustic signal detected by the selected acoustic detector and the signals detected by photodetectors (see Fig. 1 and [0013], “…a microprocessor 22 that is, in turn, capable of using the optical signal and the ultrasound signal in calculating various hemodynamic parameters, such as hematocrit, related to the signal…”. See also [0012], “…determination of other hemodynamic parameters…parameters may include blood pressure values…”, microprocessor 22 (i.e., a central unit) uses ultrasound signals (i.e., from acoustic transducer) and optical signals (i.e., from detector(s) 18) to calculate hemodynamic parameters (i.e., estimate a blood pressure),
wherein the processing circuitry (i.e., microprocessor 22 of McKenna) is further configured to
estimate an arterial diameter from the acoustic signal detected by an acoustic detector (see [0011], “…ultrasound beam that is reflected back to the transducer may also generate a signal that may be processed to determine arterial size”, see also [0029], “…one or more reflected and/or scattered ultrasound waves are converted into received electrical signals…used to determine one or more characteristics of the vessel…such as a mean cross-sectional diameter D”, detected acoustic signal used to estimate arterial diameter); :
estimate a velocity from the signals detected by a photodetector (see [0031], “…the detector 18 may be a photomultiplier, capable of detecting both Doppler-shifted and non Doppler-shifted light…detector 18 generates a signal at block 92 that may be analyzed at block 94 to provide information about the red blood cell velocity”, detector 18 detects Doppler shifted and non-Doppler-shifted light to determine a velocity); and
estimate the blood pressure as a function of the estimated arterial diameter and the estimated velocity (see [0011], “…combining information about the size of the vessel with information generated by the detector about the velocity…determination of hemodynamic parameters may be established…”. see also [0012], “…determination of other hemodynamic parameters…parameters may include blood pressure values…”, microprocessor 22 (i.e., processing circuitry) determines hemodynamic parameters (i.e., estimates a blood pressure) using vessel size (i.e., arterial diameter) and velocity determined with detector 18).
However, McKenna does not explicitly disclose an acoustic emitter configured to emit an acoustic wave through the skin, and an acoustic detector configured to detect the acoustic wave reflected in the body of the user and propagating through the skin.
McKenna discloses an ultrasonic transducer emitting ultrasound waves into tissue of a patient, and receiving the reflected ultrasound waves from the patient’s tissue (see Fig. 1 and [0021]). The ultrasonic transducer disclosed by McKenna performs both the function of emitting ultrasound waves, and receiving the transmitted waves. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the transducer of McKenna to contain both an acoustic emitting element and an acoustic receiving element, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlicnrnan, 168 USPQ 177, 179.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to emit an acoustic wave into the skin (with an acoustic emitter) and detect reflected acoustic waves from the skin (with an acoustic detector) for the purpose of focusing ultrasound waves in order to determine vascular characteristics, as evidence by McKenna (see [0011]).
Although McKenna fails to explicitly disclose a plurality of acoustic transducers, in an alternate embodiment, McKenna teaches an ultrasound system using one or more transducers (see [0021]) and further teaches integrating additional emitter-detector and acoustic transducer pairs for taking additional measurements (see McKenna [0033]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to further modify the device of McKenna (to include a plurality of acoustic transducers), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Furthermore, one of ordinary skill in the art would have had predictable success modifying the device of McKenna to include multiple acoustic transducers, for the purpose of isolating components indicating vascular properties, as evidence by McKenna (see [0033]).
Additionally, McKenna fails to disclose “processing circuitry configured to…in accordance with an acoustic selection criterion, select a particular acoustic emitter and a particular acoustic detector from among the acoustic transducers, as a function of a respective acoustic signal detected by each acoustic detector following emission of an acoustic wave by at least one acoustic emitter of the plurality of acoustic transducers”.
McKenna further discloses one or more ultrasonic transducers that transmit and receive ultrasound waves (see [0028], “…ultrasound waves may be generated using a continuous wave, Doppler, pulsed-wave, or pulsed-chirp ultrasound system that includes one or more ultrasonic transducers 12 (such as one or more piezoelectric transducers) for transmitting and/or receiving the one or more ultrasound waves”), where the transducers are capable of generating electrical signals in response to emission of an acoustic wave (see [0029], “…the ultrasound transducer 12 may be capable of generating pulsed waves for a period of time in order to generate electrical signals…”). McKenna further discloses selecting a focus area of the ultrasound transducer based on emitted light (see [0019], “…ultrasound focus area 52 may be selected so that the emitted light may encounter the ultrasound beam 54 and undergo a Doppler shift of a detectable frequency…”).
Maor teaches an ultrasonic sensor system used to identify biologic parameters (see abstract) including an ultrasonic transmitter and an array of ultrasonic receivers (see Fig. 9A-9B and [0073], “…include an ultrasonic transmitter 20 and an ultrasonic receiver 30… ultrasonic transmitter 20 may be a piezoelectric transmitter that can generate ultrasonic waves 21…ultrasonic receiver 30 may include a piezoelectric material and a two dimensional array of pixel circuits…”). Maor further teaches controlling the ultrasonic sensor (see Fig. 9B and [0085], “…control electronics 50…to control various aspects of sensor system 90, e.g., ultrasonic transmitter 20's timing and excitation waveforms…and so forth”) and selectively gating the ultrasonic transmitter and ultrasonic receivers based on transmission of an acoustic signal (see Fig. 9A-9B and [0086], “…send a transmitter (Tx) excitation signal to a Tx driver at regular intervals to cause the Tx driver 57 to excite the ultrasonic transmitter 20… send level select input signals…and allow gating of acoustic signal detection by the pixel circuits…turn on and off gate drivers 56 that cause a particular row or column of pixel circuits…to provide sensor output signals”, an ultrasonic signal is transmitted (i.e., emission of an acoustic wave) and an ultrasonic receiver (i.e., acoustic detector) is selected based on the ultrasonic signal detected by the array of ultrasonic receivers).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the acoustic selection unit of McKenna to select a particular acoustic emitter and a particular acoustic detector from among the acoustic transducers as a function of an acoustic signal detected by each acoustic detector, for the purpose of measuring acoustic energy with both a spatial and temporal component, as evidence by Maor (see [0048]).
Furthermore, one of ordinary skill in the art would have had predictable success combining McKenna and Maor, since both teachings relate to the same narrow field of endeavor, i.e., utilizing ultrasonic measurements for non-invasive bio-information measurements.
Additionally, the McKenna/Maor combination fails to disclose “processing circuitry configured to…in accordance with an optical selection criterion, to select a first light source—photodetector pair that includes a first light source and a first photodetector chosen from among possible combinations of one of the plurality of light sources and one of the plurality of photodetectors, and a second light source—photodetector pair that includes a second light source and a second photodetector chosen from among the possible combinations of one of the plurality of light sources and one of the plurality of photodetectors, the selection being based on signals output by the first photodetector and the second photodetector following respective activation of the first light source and of the second light source…”.
McKenna further discloses a plurality of light sources and optical detectors (see [0023], “…emitter 16 may be one or more laser diodes adapted to transmit one or more wavelengths of light in the red to infrared range, and the detector 18 may one or more photodetectors selected to receive light in the range or ranges emitted from the emitter 16…”, a plurality of light sources and detectors) which together form an optical sensor (see [0019], “…an optical sensor 50 that includes an emitter 16 and a detector 18”, pairs formed by a plurality of light sources and detectors (i.e., source-photodetector pairs) indicative of a first light source and a first photodetector forming a first light-source photodetector pair, and a second light source and a second photodetector forming a second light-source photodetector pair). McKenna further discloses controlling emitter activation timing based on an optical selection criterion (see Fig. 1 and [0016], “…light drive unit 38 in the monitor 20 controls the timing of the optical components, such as emitters 16, in the sensor assembly 10”, light drive unit 38 controls the timing of emitters 16 (i.e., accounts for an optical selection criterion)).
Siedenburg teaches a non-invasive blood pressure system (see abstract) with a sensor measuring non-invasive blood pressure using ultrasound (see Fig. 1 and [0019], “…a sensor for measuring NIBP using ultrasound…”) including multiple light sources and detectors forming a plurality of light source – detector pairs (see [0074], “the light emitter 220/320 can contain multiple light sources that are arranged to emit light into the tissues 251, 260 and the light detector 230/330 can contain multiple detectors, such as photodiodes, arranged to receive the reflected light. Each of the light sources of the light emitter 220/320 can be arranged to form a pair with a detector of the light detector 230/330, separated by a spacing 212”). Siedenburg further teaches a plurality of detectors receiving emitted light from light sources, generating a signal based on the received light, and selecting a light source- detector pair based on received signals (see [0075], “…NIBP sensor can include a manual and/or automatic search algorithm that…can activate one or more light sources of the light emitter… light source-detector pair…can then be selected for use in determining and/or measuring various physiological parameters and/or features…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the optical selection unit of the McKenna/Maor combination, to select a first and second light source – detector pair as a function of signals detected by a first and second photodetector receiving light emitted from a first and second light source, for the purpose of increasing the acquisition rate and temporal resolution of monitored parameters, as evidence by Siedenburg (see [0076]). Furthermore, one of ordinary skill in the art would have had predictable success combining McKenna, Maor and Siedenburg, since their teachings relate to the same narrow field of endeavor, i.e., utilizing optical and acoustic measurements for non-invasive monitoring of bio-information.
Additionally, the McKenna/Maor/Siedenburg combination fails to disclose “…wherein the processing circuitry is further configured to: estimate an arterial diameter of the acoustic signal detected by the selected acoustic detector (of the McKenna/Maor/Siedenburg combination)… estimate a pulse wave velocity from the signals detected by the first photodetector and the second photodetector (of the McKenna/Maor/Siedenburg combination)… ”.
Although the McKenna/Maor/Siedenburg combination discloses estimating a velocity from the signals detected by the first photodetector and the second photodetector, the estimated velocity is a red blood cell velocity rather than a pulse wave velocity.
Siedenburg further teaches determining a pulse wave velocity using light emitters and detectors (see Siedenburg Fig. 6 and [0086], “…pulse wave velocity can be determined, such as from data…can be used to determine PWV data using the light emitter and light detector of the NIBP system”). Additionally, Siedenburg teaches calculating the blood pressure of a patient using pulse wave velocity data and blood velocity data (see Siedenburg [0087], “…blood pressure of the patient can be calculated and/or determined using the pulse wave velocity data from 650, 652 and the instantaneous blood velocity and/or vessel dynamics data…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the processing circuitry of the McKenna/Maor/Siedenburg combination, to estimate a pulse wave velocity from signals detected by the first and second photodetector (of the McKenna/Maor/Siedenburg combination), for the purpose of determining blood pressure without a calibration step, as evidence by Siedenburg (see [0086]).
Additionally, the McKenna/Maor/Siedenburg combination fails to disclose “…wherein the processing circuitry is further configured to:… and estimate the blood pressure as a function of the estimated arterial diameter and the estimated pulse wave velocity”.
The McKenna/Maor/Siedenburg combination discloses determining a blood pressure of a patient using the estimated arterial diameter and an estimated blood cell velocity (see McKenna [0011]). Siedenburg further teaches calculating the blood pressure of a patient using pulse wave velocity data and blood velocity data (see Siedenburg [0087], “…blood pressure of the patient can be calculated and/or determined using the pulse wave velocity data from 650, 652 and the instantaneous blood velocity and/or vessel dynamics data…”), and obtaining pulse wave velocity data simultaneously with blood cell velocity data (see Siedenburg [0085], “…pulse wave velocity data is determined/received at near, or substantially, simultaneously as the determination of the blood velocity…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the processing circuitry of the McKenna/Maor/Siedenburg combination, to estimate a blood pressure as a function of arterial diameter and estimated pulse wave velocity (of the McKenna/Maor/Siedenburg combination), for the purpose of assessing cardiac performance parameters, as evidence by Siedenburg (see [0088]).
Regarding claim 3, the McKenna/Maor/Siedenburg combination discloses the device as claimed in claim 1 above. The McKenna/Maor/Siedenburg combination further discloses wherein each light source of the plurality of light source (of the McKenna/Maor/Siedenburg combination, discussed above) emits light in a spectral band (see McKenna [0023], “…the emitter 16 emits light at a wavelength in the range of about 400 nm to about 800 nm”).
Although the McKenna/Maor/Siedenburg combination fails to disclose “…wherein each light source of the plurality of light sources emits light in a spectral band between 500 nm and 1200 nm inclusive”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the light sources of the McKenna/Maor/Siedenburg combination (to emit light in the inclusive wavelength range of 500 nm – 1200 nm) since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 4, the McKenna/Maor/Siedenburg combination discloses the device as claimed in claim 1 above. The McKenna/Maor/Siedenburg combination further discloses wherein the plurality of light sources and the plurality of photodetectors (of the McKenna/Maor/Siedenburg combination, discussed above) are grouped into
a first group of light sources and of photodetectors (see McKenna [0019], “…optical sensor 50 that includes an emitter 16 and a detector 18…”, optical sensor (of the McKenna/Maor/Siedenburg combination) (i.e., first group of light sources and photodetectors));
a second group of light sources and of photodetectors at a distance from the first group of light sources and of photodetectors (see McKenna [0033], “…optical properties of the blood and/or vessel may be more specifically isolated by comparing the selected component to an optical intensity reference including a similarly selected component of an ultrasound-modulated optical signal from a second optical path having similar dimensions…may be derived by…integrating a second emitter, detector, and/or transducer into the sensor so as to form a second reference path away from the vessel”, integration of a second emitter/detector into the optical sensor (of the McKenna/Maor/Siedenburg combination) (i.e., a second group of light sources and of photodetectors) forming a reference path away from vasculature being measured (i.e., located at a distance from the first group)),
However, the McKenna/Maor/Siedenburg combination fails to disclose “the processing circuitry is further configured: to select the first light source and the first photodetector from among the light sources and the photodetectors of the first group; and to select the second light source and the second photodetector from among the light sources and the photodetectors of the second group”.
McKenna further discloses formation of a first and a second group of light sources and detectors (see McKenna [0033], “…optical properties of the blood and/or vessel may be more specifically isolated by comparing the selected component to an optical intensity reference including a similarly selected component …sensor 50 may be constructed so as to define a first emitter-transducer-detector path along the direction of a vessel and a second reference path at a right angle to the vessel”, formation of first emitter-transducer-detector path (i.e., first light source and the first photodetector from the first group) and second emitter-transducer-detector reference path (i.e., second light source and the second photodetector from the second reference group)). Additionally, the processing circuitry (of the McKenna/Maor/Siedenburg combination) selects a light source- detector pair based on received signals (see Siedenburg [0075], “…NIBP sensor can include a manual and/or automatic search algorithm that…can activate one or more light sources of the light emitter… light source-detector pair…can then be selected for use in determining and/or measuring various physiological parameters and/or features…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the processing circuitry of the McKenna/Maor/Siedenburg combination, to select a first light source and detector from a first group and a second light source and detector from a second group, for the purpose of altering the sensing depth without physically altering distances between light sources and receivers, as evidence by Siedenburg (see [0074]).
Regarding claim 5, the McKenna/Maor/Siedenburg combination discloses the device as claimed in claim 1 above.
However, the McKenna/Maor/Siedenburg combination fails to disclose “…wherein, the acoustic selection criterion is a signal-to-noise ratio, the processing circuitry is further configured to: estimate a signal-to-noise ratio of each acoustic signal detected by an acoustic detector; and select the acoustic detector for which the estimated signal-to-noise ratio is highest”.
Maor further teaches estimating a signal-to-noise ratio (see Maor [0057], “calculate an estimated signal-to-noise ratio and a quality factor, to determine the presence of a peak (and hence a signal oscillating at a rate in the predetermined range…”) and selecting a frequency criteria for which a signal-to noise ratio is high (see Maor [0039], “…as the frequency increases the SNR decreases (the signal is attenuated) and the acoustic energy cannot travel deeper…controller 104 is configured…to specify…frequency that is sufficiently low for the reflections of acoustic energy from the one or more subdermal structures to have intensities at the ultrasound receiver sufficiently high to be distinguishable from noise”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the processing circuitry and acoustic selection criteria of the McKenna/Maor/Siedenburg combination to estimate a signal-to-noise ratio and select an acoustic detector for which an estimated signal-to-noise ratio is highest, for the purpose of distinguishing detected acoustic signals from noise, as evidence by Maor (see [0039]).
Regarding claim 6, the McKenna/Maor/Siedenburg combination discloses the device as claimed in claim 1 above. The McKenna/Maor/Siedenburg combination further discloses wherein, the optical selection criterion is a correlation criterion, (see McKenna Fig. 1 and [0016], “…controls the timing of the optical components, such as emitters 16… timing of the emitters may be synchronized to correspond with the generation of the ultrasonic wave”, control of the timing of emitters 16 corresponding to acoustic wave generation (i.e., a temporal correlation), processing circuitry (of the McKenna/Maor/Siedenburg combination) is configured to:
estimate a temporal correlation between the signals detected at different times by the photodetectors of each light source—photodetector pair (see McKenna Fig. 1 and [0016], “…controls the timing of the optical components, such as emitters 16… timing of the emitters may be synchronized to correspond with the generation of the ultrasonic wave…means of a gate signal, the optical signal may be recorded only for the short period of the ultrasound pulse traversing the focus”, control of the timing of emitters 16 and gating optical signal detection (i.e., by optical detectors) based on timing of acoustic wave generation (i.e., accounts for a temporal correlation between detected optical signals emitted at different times)).
However, the McKenna/Maor/Siedenburg combination fails to disclose “…the processing circuitry is configured to: … select the first light source and the first photodetector as well as the second light source and the second photodetector as a function of the estimated temporal correlation”.
McKenna further discloses a time processing unit providing timing control signals and controlling the gating of signals from the optical emitter and detector (see McKenna [0016], “…time processing unit (TPU) 28 may provide timing control signals. TPU 28 may also control the gating-in of signals from detector 18 through an amplifier 30 and a switching circuit 31”) and a time varying parameter over the length of a blood vessel (see McKenna [0032], “…N is a parameter that varies along the vessel length L at any given time, and also varies in time, at any given point along the vessel length L…”).
Additionally, the optical selection unit (of the McKenna/Maor/Siedenburg combination) selects a light source- detector pair based on received signals (see Siedenburg [0075], “…NIBP sensor can include a manual and/or automatic search algorithm that…can activate one or more light sources of the light emitter… light source-detector pair…can then be selected for use in determining and/or measuring various physiological parameters and/or features…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the processing circuitry of the McKenna/Maor/Siedenburg combination, to select a first light source and detector and a second light source and detector as a function of a temporal correlation between signals detected at different times by photodetectors of each light source-photodetector pair, for the purpose of detecting a Doppler shift, as evidence by Siedenburg (see [0031]).
Regarding claim 7, the McKenna/Maor/Siedenburg combination discloses the device as claimed in claim 1 above.
However, the McKenna/Maor/Siedenburg combination fails to disclose “…wherein the optical selection criterion is an amplitude criterion, and the processing circuitry is configure to: estimate an amplitude of respective signals detected at various times by the photodetectors of each light source—photodetector pair; and to select the first light source and the first photodetector as well as the second light source and the second photodetector as a function of the estimated amplitude”.
Siedenburg further teaches detecting an amplitude response of optical detectors (see Siedenburg [0065], “…response signal generated by the reception/photodetection of light by the light detector 230 exhibits an amplitude variation at various depths…”) and using the amplitude response to predict vasculature features by varying the spacing between an optical emitter and detector and observing the magnitude of the amplitude response (see Siedenburg [0065], “…amplitude response variation phenomenon can be used to determine…various features of the blood vessel 260…spacing 212 between the light emitter 220 and light detector 230 can be varied to determine the spacing 212 at which the signal response exhibits an increased amplitude…”).
Additionally, the optical selection unit (of the McKenna/Maor/Siedenburg combination) selects a light source- detector pair based on received signals (see Siedenburg [0075], “…NIBP sensor can include a manual and/or automatic search algorithm that…can activate one or more light sources of the light emitter… light source-detector pair…can then be selected for use in determining and/or measuring various physiological parameters and/or features…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the processing circuitry of the McKenna/Maor/Siedenburg combination, to select a first light source and detector and a second light source and detector as a function of an estimated amplitude between signals detected at different times by photodetectors of each light source-photodetector pair, for the purpose of determining features of a blood vessel, as evidence by Siedenburg (see [0065]).
Regarding claim 8, the McKenna/Maor/Siedenburg combination discloses the device as claimed in claim 1 above.
However, the McKenna/Maor/Siedenburg combination fails to disclose “…wherein the optical selection criterion is a form criterion, and the processing circuitry is further configured to: determine a temporal evolution of the signals detected at different times by the photodetectors of each light source—photodetector pair; and select the first light source and the first photodetector as well as the second light source and the second photodetector as a function of a correlation between the temporal evolution of the signals detected and a predetermined temporal form”.
Siedenburg further teaches generating a signal based on a response of optical detectors to received emitted light (see Siedenburg [0063], “…received by the light detector 230, and cause a signal to be generated in response to and based on the detected light…”), mapping a distribution of Doppler energy based on vasculature geometry for comparison to a measured blood velocity profile (see Siedenburg [0064], “…distribution of Doppler energy is then mapped, either analytically, based upon the geometry of the vasculature with respect to the source and receiver and the assumed and/or measured blood velocity profile…”, mapping of Doppler energy distribution over time (i.e., temporal evolution of a form criterion ) and comparison to a known blood velocity profile (i.e., correlation to a predetermined form)). Additionally, the optical selection unit (of the McKenna/Maor/Siedenburg combination) selects a light source- detector pair based on received signals (see Siedenburg [0075], “…NIBP sensor can include a manual and/or automatic search algorithm that…can activate one or more light sources of the light emitter… light source-detector pair…can then be selected for use in determining and/or measuring various physiological parameters and/or features…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the processing circuitry of the McKenna/Maor/Siedenburg combination, to select a first light source and detector and a second light source and detector as a function a correlation of a temporal evolution between signals detected at different times by photodetectors of each light source-photodetector pair with a predetermined form, for the purpose of assessing cardiac performance parameters over time, as evidence by Siedenburg (see [0088]).
Regarding claim 9, McKenna discloses a method of estimating a blood pressure of a user (see [0027], “…method…for determining hemodynamic parameters…”), using a device configured to be worn by the user (see Fig. 2 and [0019], “…the sensor assembly 10 may be applied to a patient's tissue…”), the device including a support configured to be applied against skin of the user (see Fig. 2 and [0019], “…sensor assembly 10…may be coupled together in a single sensor unit, such as a disposed on a single sensor body…the sensor assembly 10 may be applied to a patient's tissue…”, sensor body of sensor assembly 10 (i.e., support) applied to the tissue of a patient (i.e., skin of a user));
a plurality of light sources disposed on the support and configured to emit light toward a blood vessel below the skin of the user (see Fig. 2 and [0023], “…the emitter 16 may be one or more laser diodes adapted to transmit one or more wavelengths of light…”. see also [0022], “…emitter 16 may be configured to transmit electromagnetic radiation, such as light, into the tissue of a patient”. see also [0024], “…emitter 16 and the detector 18 may be disposed on a sensor housing…”, see also [0019], “…sensor assembly 10 may be applied to a patient's tissue so that light from the emitter may penetrate into a vessel 60…”, emitter 16 has one or more laser diodes (i.e., plurality of light sources), emits light into tissue of a patient to penetrate a blood vessel 60 (i.e., emits light toward a blood vessel below the skin of a patient), and is located on a sensor housing (i.e., sensor housing of the support)); and
a plurality of photodetectors disposed on the support at a distance from each light source, each photodetector of the plurality of photodetectors being configured to detect light emanating front the skin of the user following activation of a light source of the plurality of light sources (see Fig. 2 and [0023], “…the detector 18 may one or more photodetectors selected to receive light in the range or ranges emitted from the emitter 16”. see also [0024], “…emitter 16 and the detector 18 may be disposed on a sensor housing…”. see also [0020], “…the spacing between the emitter 16 and detector 18 may be determined based upon the region of skin or compartment of the body that is to be tested…”, detector 18 (i.e., plurality of photodetectors) located on the sensor housing (i.e., sensor housing of the support), is positioned at a distance from emitter 16 and receives light emitted from emitter 16 (i.e., detects light from an activated light source of a plurality of light sources)):
the method comprising:
a) disposing the support on the skin of the user, facing an artery (see [0019], “…sensor assembly 10 may be applied to a patient's tissue so that light from the emitter may penetrate into a vessel 60…”);
b) emitting at least one incident acoustic wave with an acoustic emitter (see [0021], “…ultrasound transducer 12…converting high-frequency electrical signals into ultrasound waves a beam, which may be transmitted into a patient's tissue”, see also [0017], “…provide information to a monitor 20 related to…the incident angle of the wave or the location of the ultrasound transducer 12…”, transducer 12 emits acoustic waves through patient tissue, the emitted wave being an incident wave)
and acquiring acoustic signals with an acoustic detector (see [0021], “…ultrasound transducer 12…converting high-frequency electrical signals into ultrasound waves…which may be transmitted into a patient's tissue…receive the reflected and/or scattered ultrasound waves”, transducer 12 receives acoustic waves transmitted through patient tissue),
each acoustic signal detected including echoes representative of reflections of the at least one incident acoustic wave by the artery (see [0029], “…one or more reflected and/or scattered ultrasound waves are converted into received electrical signals… used to determine one or more characteristics of the vessel…electrical signals that include information corresponding to Doppler frequencies….provides a measurement of an acoustic power that is proportional to a volume of scatterers in the sample volume that moved through the one or more beams at a corresponding velocity”, reflected acoustic waves are converted to acoustic signals, acoustic power representative of scatterers (i.e., echoes) reflected by vasculature),
the emitting step being performed for different acoustic emitters and different acoustic detectors (see [0028], “…one or more ultrasonic transducers 12 (such as one or more piezoelectric transducers) for transmitting and/or receiving the one or more ultrasound waves”, see also [0021], “…ultrasound transducer 12…for converting high-frequency electrical signals into ultrasound waves...receive the reflected and/or scattered ultrasound waves and convert these into received electrical signals”, plurality of transducers 12 detects an electrical signal representative of ultrasound waves transmitted to patient tissue (i.e., detects acoustic signal based on emitted acoustic wave) for each of the plurality of acoustic transducers))…
c) select an acoustic transducer, as a function of a respective acoustic signal detected by each acoustic detector following emission of an acoustic wave by at least one acoustic emitter and an acoustic selection criterion (see [0016], “…ultrasound drive unit 39 may control the timing of ultrasound components, such as an ultrasonic transducer 12, in the sensor assembly 10… the operation of the analog-to-digital converter 36 may be gated by the ultrasound drive 39 by means of a gate signal”, see also [0021], “…ultrasound transducer 12…for converting high-frequency electrical signals into ultrasound waves...receive the reflected and/or scattered ultrasound waves and convert these into received electrical signals”, ultrasound drive unit 39 of microprocessor 22 (i.e., processing circuitry) controls the operation of transducer 12 (i.e., accounts for an acoustic selection criterion) and transducer 12 detects an electrical signal representative of ultrasound waves transmitted to patient tissue (i.e., detects acoustic signals based on emitted acoustic waves));
d) for each light source of the plurality of light sources, emitting incident light toward the skin of the user and detecting back-scattered radiation with at least one photodetector of the plurality of photodetectors, each photodetector of the plurality of photodetectors generating an optical signal representative of an intensity of the back-scattered radiation (see [0022], “…emitter 16 may be configured to transmit electromagnetic radiation, such as light, into the tissue of a patient. The electromagnetic radiation is scattered and absorbed by the various constituents of the patient's tissues…photoelectric detector 18 in the sensor 50 is configured to detect the scattered and reflected light and to generate a corresponding electrical signal”, See also [0011], “…strength of light scattered back to the detector may be related to the number of red blood cells in the artery…” detector 18 (i.e., at least one photodetector) detects backscattered light transmitted to patient tissue and generates a signal (i.e., generates optical signal based on detected light) for each light source(i.e., of emitter 16) emitted, where a strength of back scattered light (i.e., intensity) is related to vascular parameters)).
f) emitting a particular incident acoustic wave from the acoustic transducer and forming a particular acoustic signal representative of echoes following reflection of the particular incident acoustic wave by the artery (see [0029], “…one or more reflected and/or scattered ultrasound waves are converted into received electrical signals… used to determine one or more characteristics of the vessel…electrical signals that include information corresponding to Doppler frequencies….provides a measurement of an acoustic power that is proportional to a volume of scatterers in the sample volume that moved through the one or more beams at a corresponding velocity”, see also [0017], “…the ultrasound wave generated at the transducer 12 or the incident angle of the wave…”, emitting an acoustic wave by an acoustic transducer, the reflected acoustic waves are converted to acoustic signals, including an acoustic power (i.e., a particular acoustic signal), where acoustic power is representative of scatterers (i.e., echoes) reflected by vasculature, and the acoustic wave has an incident angle (i.e., an incident acoustic wave));
g) activating, at different times, light sources of each light source—photodetector pair each photodetector of each pair forming an optical signal representative of the intensity of the radiation back-scattered by the artery (see [0016], “…light drive unit 38…controls the timing of the optical components, such as emitters 16…”, see also [0022], “…emitter 16 may be configured to transmit electromagnetic radiation, such as light, into the tissue of a patient…scattered and absorbed by the various constituents of the patient's tissues… detector 18 in the sensor 50 is configured to detect the scattered and reflected light and to generate a corresponding electrical signal…”, see also [0033], “…comparing the selected component to an optical intensity…”, light drive unit 38 of microprocessor 22 controls activation timing of emitters 16 (i.e., activating light sources at different times) and detector 18 generates a signal representative of backscattered light by patient tissue (i.e., artery), where an optical signal component is representative of optical intensity)); and
h) estimating the blood pressure of the user as a function of the particular acoustic signal and the optical signals (see Fig. 1 and [0013], “…using the optical signal and the ultrasound signal in calculating various hemodynamic parameters, such as hematocrit, related to the signal…”. See also [0012], “…determination of other hemodynamic parameters…parameters may include blood pressure values…”, using ultrasound signals (i.e., signals from acoustic transducer) and optical signals (i.e., from detector(s) 18) to calculate hemodynamic parameters (i.e., estimate a blood pressure)).
wherein the estimating step further comprises estimating a diameter of the artery as a function of the formed acoustic signal (see [0011], “…ultrasound beam that is reflected back to the transducer may also generate a signal that may be processed to determine arterial size”, see also [0029], “…one or more reflected and/or scattered ultrasound waves are converted into received electrical signals…used to determine one or more characteristics of the vessel…such as a mean cross-sectional diameter D”, detected acoustic signal used to estimate arterial diameter),
estimating a velocity as a function of the optical signals formed at the different times (see [0031]-[0032], “…the detector 18 may be a photomultiplier, capable of detecting both Doppler-shifted and non Doppler-shifted light…detector 18 generates a signal at block 92 that may be analyzed at block 94 to provide information about the red blood cell velocity… information from blocks 88, 94, and 96 may be used to calculate a physiological parameter… where N is a parameter that varies along the vessel length L at any given time, and also varies in time, at any given point along the vessel length…”, detector 18 detects Doppler shifted and non-Doppler-shifted light to determine a velocity at varying times), and
estimating the blood pressure of the user from the estimated diameter of the artery and from the estimated velocity (see [0011], “…combining information about the size of the vessel with information generated by the detector about the velocity…determination of hemodynamic parameters may be established…” see also [0012], “…determination of other hemodynamic parameters…parameters may include blood pressure values…”, microprocessor 22 (i.e., processing circuitry) determines hemodynamic parameters of a user (i.e., estimates a blood pressure) using vessel size (i.e., arterial diameter) and velocity determined with detector 18).
However, McKenna fails to explicitly disclose “…the emitting step being performed for different acoustic emitters and different acoustic detectors so that each acoustic signal detected is associated with a particular acoustic emitter and a particular acoustic detector…”.
Maor teaches an ultrasonic sensor system used to identify biologic parameters (see abstract) including an ultrasonic transmitter and an array of ultrasonic receivers (see Fig. 9A-9B and [0073], “…include an ultrasonic transmitter 20 and an ultrasonic receiver 30… ultrasonic transmitter 20 may be a piezoelectric transmitter that can generate ultrasonic waves 21…ultrasonic receiver 30 may include a piezoelectric material and a two dimensional array of pixel circuits…”). Maor further teaches association of particular input acoustic signals with respective acoustic detectors (see Fig. 9A and [0083], “…an ultrasonic sensor pixel circuit array 31 included in an ultrasonic receiver 30…circuit 31J (FIG. 9A) may, for example, be associated with…a pixel input electrode…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the emitting step of McKenna (to perform the emitting step for different acoustic emitters and different acoustic detectors) for the purpose of associating a particular emitted acoustic signal with a respective detected acoustic signal, as evidence by Maor (see [0076]). Furthermore, one of ordinary skill in the art would have had predictable success combining McKenna and Maor, since both teachings relate to the same narrow field of endeavor, i.e., utilizing ultrasonic measurements for non-invasive bio-information measurements.
Additionally, the McKenna/Maor combination fails to explicitly disclose “…c) selecting a particular acoustic emitter and a particular acoustic detector as a function of each acoustic signal detected during the emitting step and an acoustic selection criterion…”.
McKenna further discloses one or more ultrasonic transducers that transmit and receive ultrasound waves (see [0028], “…ultrasound waves may be generated using a continuous wave, Doppler, pulsed-wave, or pulsed-chirp ultrasound system that includes one or more ultrasonic transducers 12 (such as one or more piezoelectric transducers) for transmitting and/or receiving the one or more ultrasound waves”), where the transducers are capable of generating electrical signals in response to emission of an acoustic wave (see [0029], “…the ultrasound transducer 12 may be capable of generating pulsed waves for a period of time in order to generate electrical signals…”). McKenna further discloses selecting a focus area of the ultrasound transducer based on emitted light (see [0019], “…ultrasound focus area 52 may be selected so that the emitted light may encounter the ultrasound beam 54 and undergo a Doppler shift of a detectable frequency…”).
Maor further teaches controlling ultrasonic sensors (see Fig. 9B and [0085], “…control electronics 50…to control various aspects of sensor system 90, e.g., ultrasonic transmitter 20's timing and excitation waveforms…and so forth”) and selectively gating ultrasonic transmitters and ultrasonic receivers based on transmission of an acoustic signal (see Fig. 9A-9B and [0086], “…send a transmitter (Tx) excitation signal to a Tx driver at regular intervals to cause the Tx driver 57 to excite the ultrasonic transmitter 20… send level select input signals…and allow gating of acoustic signal detection by the pixel circuits…turn on and off gate drivers 56 that cause a particular row or column of pixel circuits…to provide sensor output signals”, an ultrasonic signal is transmitted (i.e., emission of an acoustic wave) and an ultrasonic receiver (i.e., acoustic detector) is selected based on the ultrasonic signal detected by the array of ultrasonic receivers).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify McKenna to select a particular acoustic emitter and a particular acoustic detector from among the acoustic transducers as a function of an acoustic signal detected by each acoustic detector, for the purpose of measuring acoustic energy with both a spatial and temporal component, as evidence by Maor (see [0048]).
Additionally, the McKenna/Maor combination fails to disclose “…e) selecting two light source—photodetector pairs from among possible combinations of one of the plurality of light sources and one of the plurality of photodetectors, based on each optical signal from each photodetector of the plurality of photodetectors and an optical selection criterion…”.
McKenna further discloses a plurality of light sources and optical detectors (see [0023], “…emitter 16 may be one or more laser diodes adapted to transmit one or more wavelengths of light in the red to infrared range, and the detector 18 may one or more photodetectors selected to receive light in the range or ranges emitted from the emitter 16…”, a plurality of light sources and detectors) which together form an optical sensor (see [0019], “…an optical sensor 50 that includes an emitter 16 and a detector 18”, i.e., source-photodetector pairs formed by a plurality of light sources and detectors, indicative of a first light source and a first photodetector forming a first light-source photodetector pair, and a second light source and a second photodetector forming a second light-source photodetector pair). McKenna further discloses controlling emitter activation timing based on an optical selection criterion (see Fig. 1 and [0016], “…light drive unit 38 in the monitor 20 controls the timing of the optical components, such as emitters 16, in the sensor assembly 10”, light drive unit 38 controls the timing of emitters 16 (i.e., accounts for an optical selection criterion)).
Siedenburg teaches a non-invasive blood pressure system (see abstract) with a sensor measuring non-invasive blood pressure using ultrasound (see Fig. 1 and [0019], “…a sensor for measuring NIBP using ultrasound…”) including multiple light sources and detectors forming a plurality of light source – detector pairs (see [0074], “the light emitter 220/320 can contain multiple light sources that are arranged to emit light into the tissues 251, 260 and the light detector 230/330 can contain multiple detectors, such as photodiodes, arranged to receive the reflected light. Each of the light sources of the light emitter 220/320 can be arranged to form a pair with a detector of the light detector 230/330, separated by a spacing 212”). Siedenburg further teaches a plurality of detectors receiving emitted light from light sources, generating a signal based on the received light, and selecting a light source- detector pair based on received signals (see [0075], “…NIBP sensor can include a manual and/or automatic search algorithm that…can activate one or more light sources of the light emitter… light source-detector pair…can then be selected for use in determining and/or measuring various physiological parameters and/or features…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the optical selection unit of the McKenna/Maor combination, to select a first and second light source – detector pair as a function of signals detected by a first and second photodetector receiving light emitted from a first and second light source, for the purpose of increasing the acquisition rate and temporal resolution of monitored parameters, as evidence by Siedenburg (see [0076]). Furthermore, one of ordinary skill in the art would have had predictable success combining McKenna, Maor and Siedenburg, since their teachings relate to the same narrow field of endeavor, i.e., utilizing optical and acoustic measurements for non-invasive monitoring of bio-information.
Additionally, McKenna fails to explicitly disclose “…f) emitting a particular incident acoustic wave from the selected acoustic transducer…”.
Although McKenna fails to explicitly disclose emitting an incident acoustic wave from the selected acoustic transducer, Maor teaches selectively gating acoustic transmitters and receivers based on transmission of an acoustic signal (see Maor Fig. 9A-9B and [0086]). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the McKenna/Maor/Siedenburg combination to emit an incident acoustic wave from a selected acoustic transducer for the purpose of measuring acoustic energy with both a spatial and temporal component, as evidence by Maor (see [0048]).
Additionally, the McKenna/Maor/Siedenburg combination fails to explicitly disclose “…g) activating, at different times, light sources of each selected light source—photodetector pair each photodetector of each pair forming an optical signal representative of the intensity of the radiation back-scattered by the artery…”.
McKenna further discloses a time processing unit providing timing control signals and controlling the gating of signals from the optical emitter and detector (see McKenna [0016], “…time processing unit (TPU) 28 may provide timing control signals. TPU 28 may also control the gating-in of signals from detector 18 through an amplifier 30 and a switching circuit 31”).
Although McKenna fails to explicitly disclose activating light sources of each selected light source photo-detector pair at different times, Siedenburg teaches selecting a light source- detector pair based on received signals (see [0075]). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the McKenna/Maor/Siedenburg combination to activate at different times, light sources of each selected light source—photodetector pair at different times, for the purpose of increasing the acquisition rate and temporal resolution of monitored parameters, as evidence by Siedenburg (see [0076]).
Additionally, the McKenna/Maor/Siedenburg combination fails to explicitly disclose “…h) estimating the blood pressure of the user as a function of the particular acoustic signal and the optical signals formed by each photodetector of each of the pairs at different times…”.
McKenna further discloses using acoustic and optical signals to determine hemodynamic parameters (see [0013], “…using the optical signal and the ultrasound signal in calculating various hemodynamic parameters…”) including blood pressure (see [0010], “…related to hemodynamic parameters, such as hematocrit or blood pressure…”). However, McKenna is silent regarding estimating blood pressure of a user at different times.
Siedenburg further teaches obtaining patient parameter measurements at different times (see [0085], “…averaged or taken a time separate from the determination of the blood velocity, such as an average of the patient's historical PWV over time…the patient's historical data can also be used…”) and determining parameters over time (see [0088], “…data derived and/or generated from the NIBP system can be used to assess various cardiac performance parameters. Using the blood vessel velocity profile and the blood velocity measurement and the vessel diameter and/or area from the NIBP system, the blood volume per unit time can be calculated/determined, including net flow by integrating over time…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the McKenna/Maor/Siedenburg combination to estimate a user’s blood pressure at different times for the purpose of monitoring blood pressure throughout the cardiac cycle, as evidence by Siedenburg (see [0017]).
Additionally, the McKenna/Maor/Siedenburg combination fails to disclose “…wherein the estimating step further comprises… estimating a pulse wave velocity as a function of the optical signals formed at the different times (of the McKenna/Maor/Siedenburg combination) …”.
Although the McKenna/Maor/Siedenburg combination discloses estimating a velocity from the signals detected by the first photodetector and the second photodetector, the estimated velocity is a red blood cell velocity rather than a pulse wave velocity.
Siedenburg further teaches determining a pulse wave velocity using light emitters and detectors (see Siedenburg Fig. 6 and [0086], “…pulse wave velocity can be determined, such as from data…can be used to determine PWV data using the light emitter and light detector of the NIBP system”). Additionally, Siedenburg teaches calculating the blood pressure of a patient using pulse wave velocity data and blood velocity data (see Siedenburg [0087], “…blood pressure of the patient can be calculated and/or determined using the pulse wave velocity data from 650, 652 and the instantaneous blood velocity and/or vessel dynamics data…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the McKenna/Maor/Siedenburg combination, to estimate a pulse wave velocity as a function of the optical signals formed at different times (of the McKenna/Maor/Siedenburg combination), for the purpose of determining blood pressure without a calibration step, as evidence by Siedenburg (see [0086]).
Additionally, the McKenna/Maor/Siedenburg combination fails to disclose “…wherein the estimating step further comprises… estimating the blood pressure of the user from the estimated diameter of the artery and from the estimated pulse wave velocity (of the McKenna/Maor/Siedenburg combination) …”.
The McKenna/Maor/Siedenburg combination discloses determining a blood pressure of a patient using the estimated arterial diameter and an estimated blood cell velocity (see McKenna [0011]). Siedenburg further teaches calculating the blood pressure of a patient using pulse wave velocity data and blood velocity data (see Siedenburg [0087], “…blood pressure of the patient can be calculated and/or determined using the pulse wave velocity data from 650, 652 and the instantaneous blood velocity and/or vessel dynamics data…”), and obtaining pulse wave velocity data simultaneously with blood cell velocity data (see Siedenburg [0085], “…pulse wave velocity data is determined/received at near, or substantially, simultaneously as the determination of the blood velocity…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the McKenna/Maor/Siedenburg combination, to estimate a blood pressure as a function of an estimated arterial diameter and estimated pulse wave velocity (of the McKenna/Maor/Siedenburg combination), for the purpose of assessing cardiac performance parameters, as evidence by Siedenburg (see [0088]).
Regarding claim 11, the McKenna/Maor/Siedenburg combination discloses the device and method as claimed in claim 9 above. The McKenna/Maor/Siedenburg combination further discloses wherein the step of estimating pulse wave velocity (of the McKenna/Maor/Siedenburg combination as described above)includes estimating a temporal offset between the optical signals respectively formed by the first photodetector and the second photodetector (see McKenna Fig. 1 and [0016], “…controls the timing of the optical components, such as emitters 16… timing of the emitters may be synchronized… also control the gating-in of signals from detector 18…”, control of the timing of emitters 16 sending optical signals, and timing of optical signals received by detectors (i.e., a temporal offset of received signals) of selected light source-detector pair (of the McKenna/Maor/Siedenburg combination)).
Regarding claim 12, the McKenna/Maor/Siedenburg combination discloses the device and method as claimed in claim 9 above. The McKenna/Maor/Siedenburg combination further discloses wherein the steps a) to e) constitute a phase of calibration of the device (see McKenna [0017], “…the sensor assembly 10 may include components…used to calibrate the monitor 20…”, calibration (of the device of claim 1, of the McKenna/Maor/Siedenburg combination).
Although the McKenna/Maor/Siedenburg combination is silent regarding the steps f) to h) being reiterated between two successive calibrations, this would have been obvious to one of ordinary skill in the art when the invention was filed for several reasons. McKenna further discloses providing various acoustic and optical transducer property information to decrease variance in sensor performance (see McKenna [0017]). Additionally, Siedenburg further teaches an initial calibration step (see Siedenburg [0014]) and a distinct calibration step (see Siedenburg [0015]).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the method of McKenna/Maor/Siedenburg combination to include two calibrations, for the purpose of reducing variance in sensor measurements, as evidence by McKenna (see [0017]). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to perform two successive calibration iterations, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Regarding claim 13, the McKenna/Maor/Siedenburg combination discloses the device and method as claimed in claim 9 above. The McKenna/Maor/Siedenburg combination further discloses wherein the plurality of light sources and the plurality of photodetectors (of the McKenna/Maor/Siedenburg combination, discussed above) are grouped into
a first group of light sources and photodetectors (see McKenna [0019], “…optical sensor 50 that includes an emitter 16 and a detector 18…”, optical sensor (of the McKenna/Maor/Siedenburg combination) (i.e., first group of light sources and photodetectors)),
and a second group of light sources and photodetectors located away from the first group of light sources and photodetectors (see McKenna [0033], “…optical properties of the blood and/or vessel may be more specifically isolated by comparing the selected component to an optical intensity reference including a similarly selected component of an ultrasound-modulated optical signal from a second optical path having similar dimensions…may be derived by…integrating a second emitter, detector, and/or transducer into the sensor so as to form a second reference path away from the vessel”, integration of a second emitter/detector into the optical sensor (of the McKenna/Maor/Siedenburg combination) (i.e., a second group of light sources and of photodetectors) forming a reference path away from vasculature being measured (i.e., located at a distance from the first group)), and the method further comprises:
selecting a first light source—photodetector pair in the first group; selecting a second light source—photodetector pair in the second group (see Siedenburg [0075], “…NIBP sensor can include a manual and/or automatic search algorithm that…can activate one or more light sources of the light emitter… light source-detector pair…can then be selected for use in determining and/or measuring various physiological parameters and/or features…”, selecting a first and second light source – detector pair in the first and second groups (of the McKenna/Maor/Siedenburg combination) respectively).
Regarding claim 14, the McKenna/Maor/Siedenburg combination discloses the device and method as claimed in claim 12/9 above.
However, the McKenna/Maor/Siedenburg combination fails to disclose “…if the estimated blood pressure is outside a range of validity, repeating the calibration phase”.
Maor further teaches a determining oscillation of a measured signal within a range of measurement parameters (see Maor [0044], “…determine whether any signal oscillating at a rate in a predetermined range…”) and identifying and tracking the oscillation of the signal around the predetermined range (see Maor [0044], “…predetermined ranges for a human organ as described herein may use lower limits and upper limits that approximate the just-described values… using the signal's oscillation rate in several ways… identify and track…the signal's oscillation rate”). Additionally, Maor teaches repeating a signal range validity detection a predetermined number of times (see Maor [0045], “…just-described loop, between blocks 208, 204, 205 and 206 may be repeated a predetermined number of times…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the method of McKenna/Maor/Siedenburg combination to include repeating a calibration phase if a detected blood pressure is outside a range of validity, for the purpose of determining oscillations in detected signals, as evidence by Maor (see [0050]).
Regarding claim 15, the McKenna/Maor/Siedenburg combination discloses the device and method as claimed in claim 9 above.
The McKenna/Maor/Siedenburg combination fails to disclose “…wherein the acoustic selection criterion is a maximum signal-to-noise ratio, and the selecting of the acoustic emitter and of the acoustic detector further comprises selecting the acoustic emitter and the acoustic detector as a function of the acoustic signal associated with a particular acoustic emitter—acoustic detector pair for which the signal-to-noise ratio is maximum”.
Maor further teaches estimating a signal-to-noise ratio (see Maor [0057], “calculate an estimated signal-to-noise ratio and a quality factor, to determine the presence of a peak (and hence a signal oscillating at a rate in the predetermined range…”) and selecting a frequency criteria for which a signal-to noise ratio is high (see Maor [0039], “…as the frequency increases the SNR decreases (the signal is attenuated) and the acoustic energy cannot travel deeper…controller 104 is configured…to specify…frequency that is sufficiently low for the reflections of acoustic energy from the one or more subdermal structures to have intensities at the ultrasound receiver sufficiently high to be distinguishable from noise”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the acoustic selection unit and acoustic selection criteria of the McKenna/Maor/Siedenburg combination to estimate a signal-to-noise ratio and select an acoustic detector for which a signal-to-noise ratio is maximum, for the purpose of distinguishing detected acoustic signals from noise, as evidence by Maor (see [0039]).
Regarding claim 16, the McKenna/Maor/Siedenburg combination discloses the device and method as claimed in claim 9 above. The McKenna/Maor/Siedenburg combination further discloses wherein the optical selection criterion (of the McKenna/Maor/Siedenburg combination) includes a temporal correlation criterion ignoring a temporal offset (see McKenna Fig. 1 and [0016], “…controls the timing of the optical components, such as emitters 16… timing of the emitters may be synchronized to correspond with the generation of the ultrasonic wave”, control of the timing of emitters 16 (i.e., a temporal correlation) corresponding to acoustic wave generation (i.e., synchronized with ultrasonic wave generation indicating ignoring temporal offset between acoustic wave emission and light emission) , and the selecting of each source—photodetector pair (of the McKenna/Maor/Siedenburg combination) comprises:
estimating a temporal correlation between the signals detected at different times by the photodetectors of each light source—photodetector pair (see McKenna Fig. 1 and [0016], “…controls the timing of the optical components, such as emitters 16… timing of the emitters may be synchronized to correspond with the generation of the ultrasonic wave…means of a gate signal, the optical signal may be recorded only for the short period of the ultrasound pulse traversing the focus”, control of the timing of emitters 16 and gating optical signal detection (i.e., by optical detectors) based on timing of acoustic wave generation (i.e., accounts for a temporal correlation between detected optical signals emitted at different times));
Although the McKenna/Maor/Siedenburg combination is silent regarding determining the light source—photodetector pairs for which the resulting signal from the photodetector has a highest temporal correlation, such a modification would have been obvious to one of ordinary skill in the art at the time the invention was filed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 17, the McKenna/Maor/Siedenburg combination discloses the device and method as claimed in claim 13/9 above. The McKenna/Maor/Siedenburg combination further discloses
the first light source—photodetector pair defines a first measurement point; the second light source—photodetector pair defines a second measurement point; the first measurement point and the second measurement point are at a distance from one another (see McKenna [0033], “…optical properties of the blood and/or vessel may be more specifically isolated by comparing the selected component to an optical intensity reference including a similarly selected component of an ultrasound-modulated optical signal from a second optical path having similar dimensions…may be derived by…integrating a second emitter, detector, and/or transducer into the sensor so as to form a second reference path away from the vessel”, a first emitter/detector (i.e., located at a measurement point), integration of a second emitter/detector into the optical sensor (of the McKenna/Maor/Siedenburg combination) (i.e., a second emitter/detector) forming a reference path away from vasculature being measured (i.e., located at a distance from the first group, i.e., at a different point than the first emitter/detector)).
Response to Arguments
Applicant's arguments filed 11/03/2025 with respect to the rejection of claims 1, 3-9, and 11-17 under 35 U.S.C. § 103 have been fully considered but they are not persuasive in view of the current combination of references that were necessitated by amendment.
Applicant argues, on pages 13-16 of the remarks, that McKenna, Maor and Siedenburg, taken individually or in combination, fail to teach or suggest features as recited in amended claims 1 and 9. In the instant case, this line of argument is considered not persuasive in view of the treatment of claims 1 and 9 above.
Applicant further argues, on pages 15-16 of the remarks, that Siedenburg fails to teach or suggest the use of an optical selection criteria to select first and second source and detected pairs based on all possible combinations of one of the plurality of light sources and one of the plurality of photodetectors as recited in amended claim 1.
MPEP § 2145(IV) states that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Examiner respectfully disagrees that the cited prior art of record does not teach or suggest using an optical selection criterion to select light source-detector pairs based on all possible combinations of light sources and detectors for several reasons. First, Examiner relies on the teachings of McKenna and to teach an optical selection criterion (see [0016], light drive unit 38 controls the timing of emitters 16 (i.e., accounts for an optical selection criterion)), and relies on the teachings of Siedenburg to teach selecting a light source – photodetector pair from possible combinations of light source -photodetector pairs (see [0075], controlled activation of light sources, and the selection of light source – detector pairs to determine physiological parameters). Second, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., selecting light source-detector pairs based on all possible combinations of light sources and detectors) are not recited in the rejected claims. In particular, claim 1 recites, in lines 24-32, that the light source-detector pairs are chosen from among possible combinations of one light source and one photodetector of the plurality of light sources and photodetectors. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, this line of argument is considered not persuasive in view of the treatment of claims 1 and 9 above.
Applicant further argues, on pages 16-17 of the remarks, that Siedenburg is silent regarding the estimation of pulse wave velocity using two photodetectors, as recited in amended claim 1. In particular, Applicant argues that Siedenburg determines an instantaneous velocity, which is different than a pulse wave velocity of the claimed invention.
In response to applicant’s argument that the cited prior art of record is silent regarding estimating a pulse wave velocity using two photodetectors, Examiner respectfully disagrees for several reasons. First, Examiner relies on the teachings of McKenna to teach estimating an instantaneous velocity from the signals detected by the first and second photodetector (see [0031], detector 18 detects Doppler shifted and non-Doppler-shifted light to determine an instantaneous velocity). Second, Examiner relies on the teachings of Siedenburg to teach determining a pulse wave velocity using light emitters and detectors (see Fig. 6 and [0086], pulse wave velocity determined using light emitter and detector). Therefore, this line of argument is considered not persuasive in view of the treatment of claims 1 and 9 above.
Applicant further argues, on page 17 of the remarks, that McKenna, Maor and Siedenburg, taken individually or in combination, fail to teach or suggest features as recited in amended claim 3.
Applicant’s arguments regarding the features of claim 3 have been fully considered but they are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant further argues, on page 17 of the remarks, that Siedenburg does not teach or suggest “a plurality of light sources disposed on the support and configured to emit light toward a blood vessel below the skin”, as recited in amended claim 1. In particular, applicant argues that Siedenburg teaches away from using two groups of light sources and photodetectors, where the light sources of both groups emit toward a blood vessel and the second group of light sources and photodetectors located away from the first group, because the second optical pathway taught by Siedenburg is arranged away from the vessel (see pg. 17 of remarks). Applicant further cites portions of McKenna regarding a second optical path.
However, a reference does not teach away from a claimed invention merely by expression a preference or an alternative feature. See In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004), "the prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed....". See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023), "a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed".
Examiner relies on the teachings of McKenna to teach a plurality of light sources and a plurality of photodetectors disposed on a support (see [0019]-[0024], emitter 16 has one or more laser diodes (i.e., plurality of light sources), emits light into tissue of a patient to penetrate a blood vessel 60 (i.e., emits light toward a blood vessel below the skin of a patient), and is located on a sensor housing (i.e., sensor housing of the support)) and detectors 18 (i.e., plurality of photodetectors) located on the sensor housing (i.e., sensor housing of the support), positioned at a distance from emitters 16 and receives light emitted from emitters 16 (i.e., detects light from an activated light source of a plurality of light sources)).Therefore, this argument is considered not persuasive in view of the treatment of claims 1 and 9 above.
Claims 1, 3-9 and 11-17 remain rejected under 35 U.S.C. §103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA P NOVAK whose telephone number is (703)756-1947. The examiner can normally be reached M-F: 8-5.
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/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/
Primary Examiner, Art Unit 3791