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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 11/07/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maghsoudnia et al. (U.S. Pub. No. 20180228462) hereinafter Maghsoudnia.
Regarding claim 1, Maghsoudnia teaches:
A method for monitoring a medical condition of a patient (abstract; [0042]-[0043]), the method comprising:
receiving an indication that a transducer array is placed at a position in proximity to a body part of the patient to be scanned, the transducer array including a plurality of transducer array elements, the transducer array being a part of a wearable device ([0028]-[0029], wearable ultrasonic device; [0036], ultrasound transducers; [0037]-[0039], wearable transducer array of elements; [0040], wearable transducer array of elements; [0042]-[0043]; [0052], ultrasonic transducers; [0053]-[0060]; [0092], “In a positioning mode, the processing electronics may determine the device is positioned in a suitable location and transmit feedback to a user via alarm actuators, the remote device, and/or the personal computer” and forms an indication that the transducer is placed at a position in proximity to a body part to be scanned; figure 2);
producing transducer data by scanning the body part ([0028]-[0032], ultrasound scanning of regions of interest; [0035]-[0036], transducer scanning of body regions of interest; [0040], generating signals of ultrasound region of interest; [0042]-[0043]; [0046]; [0052]-[0060]; [0072]-[0075]; see also [0081]-[0092]); and
conducting a type of test using the transducer data ([0030]-[0033], determination of diagnostic testing on the region of interest based upon the transducer data; [0040]-[0042], generating diagnostic information about the region of interest based upon ultrasound data forms a type of test; [0043], analyze features such as volume of fluid; [0046]; [0072]-[0075]; see also [0080]-[0092]),
wherein the transducer array is configured to monitor the patient without operator supervision ([0028], without requiring inputs from a trained operator; [0030]; [0040]-[0043], a patient has the device placed in a wearable configuration for monitoring without operator supervision; [0072]-[0075], monitoring of fluid volume continuously; see also [0080]-[0092]).
Regarding claim 7, Maghsoudnia teaches all of the limitations of claim 1. Maghsoudnia further teaches:
wherein the wearable device comprises automatic calibration ([0008]; [0125], calibration phase forms automatic calibration; [0126]).
Regarding claim 8, Maghsoudnia teaches all of the limitations of claim 1. Maghsoudnia further teaches:
wherein the wearable device comprises wireless communications electronics ([0033], wireless radio; [0064]; figure 5A; [0070]; [0084]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia as applied to claim 1 above, and further in view of Waechter-Stehle et al. (U.S. Pub. No. 20200060660) hereinafter Waechter-Stehle.
Regarding claim 2, primary reference Maghsoudnia teaches all of the limitations of claim 1. Primary reference Maghsoudnia further fails to teach:
wherein producing transducer data by scanning the body part comprises:
automatically directing the transducer array to sweep an ultrasound beam across the body part when the indication is received;
capturing images as the ultrasound beam is sweeping;
locating an image of interest from the captured images, a position of the ultrasound beam where the image of interest was collected, and a collecting transducer array element from the plurality of transducer array elements that collected the image of interest, the image of interest being based on the type of test, the collecting transducer array element centering a tissue of interest; and
moving the ultrasound beam to the position where the image of interest was collected,
wherein the position is associated with a beam steering angle
However, the analogous art of Waechter-Stehle of an ultrasound imaging system for imaging a region of interest (abstract) teaches:
wherein producing transducer data by scanning the body part comprises:
automatically directing the transducer array to sweep an ultrasound beam across the body part when the indication is received ([0041], beam steering; [0062]; [0075]; [0078]-[0079]; [0081], volume sweeping of the ultrasound array via electronic steering of beams across the region of interest);
capturing images as the ultrasound beam is sweeping ([0081], volume sweeping through electronic steering of the beams with the array forming a capturing of images during the sweeping);
locating an image of interest from the captured images, a position of the ultrasound beam where the image of interest was collected, and a collecting transducer array element from the plurality of transducer array elements that collected the image of interest, the image of interest being based on the type of test, the collecting transducer array element centering a tissue of interest ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.” Vessel imaging forms the type of diagnostic test for imaging); and
moving the ultrasound beam to the position where the image of interest was collected ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.”),
wherein the position is associated with a beam steering angle ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.” This is associated with the beam steering angles of the volume sweeping and electronic beam steering of the ultrasound transducer towards the target region of interest).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia to incorporate the volume sweeping and steering of beams to a target region of interest as taught by Waechter-Stehle because it provides higher quality “zoomed-in” ultrasound signal and image data at the region of interest (Waechter-Stehle, [0081]). This leads to higher quality images and improved clinical diagnostics.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Waechter-Stehle as applied to claim 2 above, and further in view of Peterson et al. (U.S. Pub. No. 20040181154) hereinafter Peterson.
Regarding claim 3, the combined references of Maghsoudnia and Waechter-Stehle teach all of the limitations of claim 2. Primary reference Maghsoudnia further fails to teach:
further comprising: saving the beam steering angle for future grayscale imaging of the patient
However, the analogous art of Peterson of an ultrasonic diagnostic imaging device (abstract) teaches:
further comprising: saving the beam steering angle for future grayscale imaging of the patient ([0034], saving of steering and focusing of beams in colorflow Doppler mode to use in an overlaid subsequent grayscale imaging mode).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia and Waechter-Stehle to incorporate the saving of steering and focusing of beams in colorflow Doppler mode to use in an overlaid subsequent grayscale imaging mode as taught by Peterson because it provides for a multi-mode imaging of color overlay of a grayscale image (Peterson, [0034]). This enables viewing of both moving flow as well as physical structures within an overall image.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Waechter-Stehle as applied to claim 2 above, and further in view of Loupas et al. (U.S. Pub. No. 20140221838) hereinafter Loupas.
Regarding claim 4, the combined references of Maghsoudnia and Waechter-Stehle teach all of the limitations of claim 2. Primary reference Maghsoudnia further fails to teach:
enabling collecting Doppler images in proximity to the position using a Doppler angle that is different from but related to the beam steering angle
However, the analogous art of Loupas of an ultrasound system for colorflow Doppler imaging (abstract) teaches:
enabling collecting Doppler images in proximity to the position using a Doppler angle that is different from but related to the beam steering angle ([0017]-[0022], the setting of the steering angle to a desired Doppler angle for the particular region of blood flow from the B mode data forms a using of a Doppler angle different from the beam steering angle set for a particular blood vessel region of interest in the overall imaged space).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia and Waechter-Stehle to incorporate the using of a unique Doppler angle different from beam steering as taught by Loupas because a fixed Doppler angle with respect to the region of blood flow provides higher quality sensitivity and output data quality (Loupas, [0017]-[0021]). This leads to improved diagnostic data and better clinical determinations.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia as applied to claim 1 above, and further in view of Nazer et al. (U.S. Pub. No. 20230093814) hereinafter Nazer.
Regarding claim 5, primary reference Maghsoudnia teaches all of the limitations of claim 1. Primary reference Maghsoudnia further fails to teach:
wherein the proximity position is a popliteal fossa
However, the analogous art of Nazer of a wearable ultrasound device for detecting disease states (abstract) teaches:
wherein the proximity position is a popliteal fossa ([0088], “Positioning over landmarks such as the calf borders or the popliteal fossa could ensure consistent muscle and artery coverage”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia to incorporate the positioning at a popliteal fossa as taught by Nazer because it ensures consistent muscle and artery coverage, leading to improved signal acquisition quality at the target region of interest (Nazer, [0088]).
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia as applied to claim 1 above, and further in view of Kruger et al. (U.S. Pub. No. 20200163650) hereinafter Kruger.
Regarding claim 6, primary reference Maghsoudnia teaches all of the limitations of claim 1. Primary reference Maghsoudnia further fails to teach:
wherein the wearable device comprises a backing layer
However, the analogous art of Kruger of a fully automated ultrasound apparatus (abstract) teaches:
wherein the wearable device comprises a backing layer ([0039], backing material on the sensor 100 forms a backing layer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia to incorporate the backing layer as taught by Kruger because it mitigates unwanted artifacts leading to higher signal quality (Kruger, [0039]). These provides improved diagnostic imaging and better clinical outcomes.
Regarding claim 9, primary reference Maghsoudnia teaches all of the limitations of claim 1. Primary reference Maghsoudnia further fails to teach:
wherein the wearable device comprises a sensor
However, the analogous art of Kruger of a fully automated ultrasound apparatus (abstract) teaches:
wherein the wearable device comprises a sensor ([0050], sensors; [0088], secondary sensors such as temperature sensors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia to incorporate the additional secondary sensor as taught by Kruger because it provides additional diagnostic and physiological signal data to the device, leading to greater insights into the overall health of the patient during diagnostic testing (Kruger, [0088]) and better patient outcomes.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia as applied to claim 1 above, and further in view of Bappoo et al. (U.S. Pub. No. 20240180523) hereinafter Bappoo.
Regarding claim 10, primary reference Maghsoudnia teaches all of the limitations of claim 1. Primary reference Maghsoudnia further fails to teach:
wherein the wearable device comprises a tourniquet
However, the analogous art of Bappoo of a portable ultrasound device for sensing target structures of interest (abstract) teaches:
wherein the wearable device comprises a tourniquet ([0140], “The fastening force can be likened to that produced of a commonly used tourniquet, required to increase intra vascular pressure and hence engorge the vessel and improve visibility and reduce blood velocity to a range pre-programmed to be extracted by digital processing algorithms 208.” Therefore fastening means 107 forms a tourniquet).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia to incorporate the tourniquet fastener as taught by Bappoo because it increases the intravascular pressure and improves visibility while reducing blood velocity (Bappoo, [0140]). This improves signal quality leading to enhanced diagnostics.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Waechter-Stehle as applied to claim 2 above, and further in view of Wilson et al. (EP4098205) hereinafter Wilson (see attached FOR publication for citations).
Regarding claim 11, the combined references of Maghsoudnia and Waechter-Stehle teach all of the limitations of claim 2. Primary reference Maghsoudnia further fails to teach:
providing the image to an inference engine; and
receiving information from the inference engine, the information enabling identification of the image(s) of interest
However, the analogous art of Wilson of adapting parameters for an ultrasound system (abstract) teaches:
providing the image to an inference engine ([0024]-[0025], inference engine; [0079]-[0080]; [0092]-[0093]; see also [0094]-[0098]); and
receiving information from the inference engine, the information enabling identification of the image(s) of interest ([0024]-[0025], inference engine; [0079]-[0080]; [0092]-[0093]; see also [0094]-[0098]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia and Waechter-Stehle to incorporate the interference engine image identification feature as taught by Wilson because it provides efficient, automatic, and precise determination of features of interest within an acquired ultrasound image (Wilson, [0024]-[0025]). This enables real-time adjustment of imaging parameters to achieve higher quality and reduced overheating of imaging hardware (Wilson, [0020]-[0023]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Waechter-Stehle as applied to claim 2 above, and further in view of Arnaout (U.S. Pub. No. 20220012875) hereinafter Arnaout.
Regarding claim 12, the combined references of Maghsoudnia and Waechter-Stehle teach all of the limitations of claim 2. Primary reference Maghsoudnia further fails to teach:
further comprising:
providing the image of interest to a predictive model; and
receiving a diagnosis and a probability that the diagnosis is correct from the predictive model
However, the analogous art of Arnaout of a system and method for image diagnoses in medical image data (abstract) teaches:
further comprising:
providing the image of interest to a predictive model ([0054]-[0055], classification or deep learning model for diagnosis of normal or abnormal tissue including a confidence probability estimation); and
receiving a diagnosis and a probability that the diagnosis is correct from the predictive model ([0054]-[0055], classification or deep learning model for diagnosis of normal or abnormal tissue including a confidence probability estimation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia and Waechter-Stehle to incorporate the predictive model with probability estimation as taught by Arnaout because automated image analysis can improve the speed, accuracy, and scale of medical image diagnostics over human practitioners (Arnaout, [0006]-[0007]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Waechter-Stehle, in further view of Arnaout as applied to claim 12 above, and further in view of Erikson et al. (U.S. Pat. No. 5301674) hereinafter Erikson.
Regarding claim 13, the combined references of Maghsoudnia, Waechter-Stehle, and Arnaout teach all of the limitations of claim 12. Primary reference Maghsoudnia further fails to teach:
further comprising:
using the diagnosis to activate/deactivate selective of the plurality of transducer array elements
However, the analogous art of Erikson of an ultrasound imaging system with dynamic focusing (abstract) teaches:
further comprising:
using the diagnosis to activate/deactivate selective of the plurality of transducer array elements (col 5, lines 41-49, select switching of transducer elements based upon the presence of a detected tumor object forms a selective activation/deactivation based upon a diagnosis of a tumor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia, Waechter-Stehle, and Arnaout to incorporate the selective activation and deactivation based upon the presence of a tumor as taught by Erikson because it provides advanced, dynamic focusing of an object of interest, leading to improved image quality (Erikson, col 5, lines 41-49).
Claims 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Kruger.
Regarding claim 14, primary reference Maghsoudnia teaches:
A wearable ultrasound device for monitoring of tissue (abstract; [0042]-[0043]) comprising:
a transducer array including a plurality of transducer array elements and a plurality of subdice elements ([0028]-[0029], wearable ultrasonic device; [0036], ultrasound transducers; [0037]-[0039], wearable transducer array of elements; [0040], wearable transducer array of elements; [0042]-[0043]; [0052], ultrasonic transducers; [0053]-[0060]; figure 2);
the wearable ultrasound device having a pre-selected thickness and spacing between elements ([0028]-[0029], wearable ultrasonic device; [0036], ultrasound transducers; [0037]-[0039], wearable transducer array of elements; [0040], wearable transducer array of elements; [0042]-[0043]; [0052], ultrasonic transducers; [0053], predetermined distance 311 as in figures 3A-3B, between PMUTs within the overall device; [0054]-[0060];); and
communications electronics receiving control information to control the plurality of transducer array elements ([0028]-[0032], ultrasound scanning of regions of interest using processing electronics which forms control information to control the elements; [0033], wireless radio coupled to processing electronics; [0035]-[0036], transducer scanning of body regions of interest; [0040]; [0046], processing electronics; [0052]-[0060]; [0064]; figure 5A; [0070]; [0072]-[0075]; see also [0081]-[0092]),
wherein the control information enables monitoring of the plurality of transducer array elements ([0028]-[0032], ultrasound scanning of regions of interest using processing electronics which forms control information to control the elements; [0033], wireless radio coupled to processing electronics; [0035]-[0036], transducer scanning of body regions of interest; [0040]; [0046], processing electronics; [0052]-[0060]; [0064]; figure 5A; [0070]; [0072]-[0075]; see also [0081]-[0092]), and
wherein the communications electronics transmits data from the plurality of transducer array elements to a processor ([0028]-[0032], ultrasound scanning of regions of interest using processing electronics which forms control information to control the elements; [0033], wireless radio coupled to processing electronics; [0035]-[0036], transducer scanning of body regions of interest; [0040]; [0046], processing electronics; [0052]-[0060]; [0064]; figure 5A; [0070]; [0072]-[0075]; see also [0081]-[0092]).
Primary reference Maghsoudnia further fails to teach:
a thermal sensor configured to monitor a temperature of the wearable ultrasound device; and
wherein the communications electronics transmits data from the thermal sensor and the plurality of transducer array elements to a processor
However, the analogous art of Kruger of a fully automated ultrasound apparatus (abstract) teaches:
a thermal sensor configured to monitor a temperature of the wearable ultrasound device ([0050], sensors; [0088], secondary sensors such as temperature sensors); and
wherein the communications electronics transmits data from the thermal sensor and the plurality of transducer array elements to a processor ([0050], sensors; [0088], secondary sensors such as temperature sensors; see also [0051]-[0056], ultrasound data from transducers and element arrays)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia to incorporate the additional secondary temperature sensor as taught by Kruger because it provides additional diagnostic and physiological signal data to the device, leading to greater insights into the overall health of the patient during diagnostic testing (Kruger, [0088]) and better patient outcomes.
Regarding claim 19, the combined references of Maghsoudnia and Kruger teach all of the limitations of claim 14. Primary reference Maghsoudnia further teaches:
wherein the communications electronics comprise wireless electronics ([0033], wireless radio; [0064]; figure 5A; [0070]; [0084]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Kruger as applied to claim 14 above, and further in view of Rothberg et al. (U.S. Pub. No. 20190069842) hereinafter Rothberg.
Regarding claim 15, the combined references of Maghsoudnia and Kruger teach all of the limitations of claim 14. Primary reference Maghsoudnia further fails to teach:
comprising: an acoustic lens
However, the analogous art of Rothberg of an ultrasound wearable device (abstract) teaches:
comprising: an acoustic lens ([0058]-[0059], acoustic lens 146; [0073], acoustic lens 146).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia and Kruger to incorporate the acoustic lens as taught by Rothberg because it provides a structure in which acoustic waves can propagate through the device and to the surface of the patient (Rothberg, [0058]). This provides for higher quality transmission and reception of signals, leading to better diagnostic data.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Kruger as applied to claim 14 above, and further in view of Waechter-Stehle, in further view of Peterson.
Regarding claim 16, the combined references of Maghsoudnia and Kruger teach all of the limitations of claim 14. Primary reference Maghsoudnia further teaches:
when the wearable ultrasound device is affixed to a surface ([0028]-[0029], wearable ultrasonic device; [0036], ultrasound transducers; [0037]-[0039], wearable transducer array of elements; [0040], wearable transducer array of elements; [0042]-[0043]; [0052], ultrasonic transducers; [0053]-[0060]; [0092]; figure 2)
Primary reference Maghsoudnia further fails to teach:
wherein the control information comprises beam steering information including instructions to:
automatically direct the transducer array to sweep an ultrasound beam across the tissue; and
However, the analogous art of Waechter-Stehle of an ultrasound imaging system for imaging a region of interest (abstract) teaches:
wherein the control information comprises beam steering information including instructions to:
automatically direct the transducer array to sweep an ultrasound beam across the tissue ([0041], beam steering; [0062]; [0075]; [0078]-[0079]; [0081], volume sweeping of the ultrasound array via electronic steering of beams across the region of interest); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia and Kruger to incorporate the volume sweeping and steering of beams to a target region of interest as taught by Waechter-Stehle because it provides higher quality “zoomed-in” ultrasound signal and image data at the region of interest (Waechter-Stehle, [0081]). This leads to higher quality images and improved clinical diagnostics.
Primary reference Maghsoudnia further fails to teach:
save a beam steering angle for grayscale imaging of a patient
However, the analogous art of Peterson of an ultrasonic diagnostic imaging device (abstract) teaches:
save a beam steering angle for grayscale imaging of a patient ([0034], saving of steering and focusing of beams in colorflow Doppler mode to use in an overlaid subsequent grayscale imaging mode).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia, Kruger, and Waechter-Stehle to incorporate the saving of steering and focusing of beams in colorflow Doppler mode to use in an overlaid subsequent grayscale imaging mode as taught by Peterson because it provides for a multi-mode imaging of color overlay of a grayscale image (Peterson, [0034]). This enables viewing of both moving flow as well as physical structures within an overall image.
Regarding claim 17, the combined references of Maghsoudnia, Kruger, Waechter-Stehle, and Peterson teach all of the limitations of claim 16. Primary reference Maghsoudnia further fails to teach:
wherein the beam steering information comprises instructions to:
capture images as the ultrasound beam is sweeping;
locate an image of interest from the captured images, a position of the ultrasound beam where the image of interest was collected;
identify transducer array elements from the plurality of transducer array elements that collected the image of interest,wherein the image of interest is based on a type of test,wherein the identified transducer array elements center an area of interest; andmove the ultrasound beam to the position where the image of interest was collected,wherein the position is associated with a beam steering angle
However, the analogous art of Waechter-Stehle of an ultrasound imaging system for imaging a region of interest (abstract) teaches:
wherein the beam steering information comprises instructions to:
capture images as the ultrasound beam is sweeping ([0081], volume sweeping through electronic steering of the beams with the array forming a capturing of images during the sweeping);
locate an image of interest from the captured images, a position of the ultrasound beam where the image of interest was collected ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.” Vessel imaging forms the type of diagnostic test for imaging);
identify transducer array elements from the plurality of transducer array elements that collected the image of interest, wherein the image of interest is based on a type of test, wherein the identified transducer array elements center an area of interest ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.” Vessel imaging forms the type of diagnostic test for imaging); and
move the ultrasound beam to the position where the image of interest was collected ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.”),
wherein the position is associated with a beam steering angle ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.” This is associated with the beam steering angles of the volume sweeping and electronic beam steering of the ultrasound transducer towards the target region of interest).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia, Kruger, Waechter-Stehle, and Peterson to incorporate the volume sweeping and steering of beams to a target region of interest as taught by Waechter-Stehle because it provides higher quality “zoomed-in” ultrasound signal and image data at the region of interest (Waechter-Stehle, [0081]). This leads to higher quality images and improved clinical diagnostics.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Kruger, in view of Waechter-Stehle, in further view of Peterson as applied to claim 17 above, and further in view of Loupas.
Regarding claim 18, the combined references of Maghsoudnia, Kruger, Waechter-Stehle, and Peterson teach all of the limitations of claim 17. Primary reference Maghsoudnia further fails to teach:
wherein the control information enables collecting Doppler images in proximity to the position using a Doppler angle that is different from but related to the beam steering angle
However, the analogous art of Loupas of an ultrasound system for colorflow Doppler imaging (abstract) teaches:
wherein the control information enables collecting Doppler images in proximity to the position using a Doppler angle that is different from but related to the beam steering angle ([0017]-[0022], the setting of the steering angle to a desired Doppler angle for the particular region of blood flow from the B mode data forms a using of a Doppler angle different from the beam steering angle set for a particular blood vessel region of interest in the overall imaged space).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia, Kruger, Waechter-Stehle, and Peterson to incorporate the using of a unique Doppler angle different from beam steering as taught by Loupas because a fixed Doppler angle with respect to the region of blood flow provides higher quality sensitivity and output data quality (Loupas, [0017]-[0021]). This leads to improved diagnostic data and better clinical determinations.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Kruger as applied to claim 14 above, and further in view of Siedenburg et al. (U.S. Pub. No. 20180368804) hereinafter Siedenburg.
Regarding claim 20, the combined references of Maghsoudnia and Kruger teach all of the limitations of claim 14. Primary reference Maghsoudnia further teaches:
wherein the control information comprises: duty cycle information for the transducer array elements, the duty cycle information based on data from the thermal sensor
However, the analogous art of Siedenburg of a non-invasive blood pressure sensor including ultrasound measurements (abstract) teaches:
wherein the control information comprises: duty cycle information for the transducer array elements, the duty cycle information based on data from the thermal sensor ([0045], “In an example, the temperature sensor 260 can cause a performance parameter of the NIBP patch/device 200, such as a duty-cycle or sampling rate, of the wearable NIBP patch/device 200 to be decreased when a sensed temperature exceeds a threshold value which can prevent thermal damage to the patient's skin and/or patient discomfort while wearing the NIBP patch/device 200”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia and Kruger to incorporate the temperature sensor-based duty cycle information as taught by Siedenburg because it provides adjustment to sensor energy output, which can reduce damage or discomfort to a user (Siedenburg, [0045]).
Claim 21-23 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Kruger, in view of Waechter-Stehle, in view of Peterson, in further view of Loupas.
Regarding claim 21, primary reference Maghsoudnia teaches:
A system for ultrasonic monitoring (abstract; [0042]-[0043]) comprising:
a wearable device configured to collect ultrasound data from a user wearing the wearable device ([0028]-[0029], wearable ultrasonic device; [0036], ultrasound transducers; [0037]-[0039], wearable transducer array of elements; [0040], wearable transducer array of elements; [0042]-[0043]; [0052], ultrasonic transducers; [0053]-[0060]; [0092]; figure 2), the wearable device including:
a transducer array including a plurality of transducer array elements ([0028]-[0029], wearable ultrasonic device; [0036], ultrasound transducers; [0037]-[0039], wearable transducer array of elements; [0040], wearable transducer array of elements; [0042]-[0043]; [0052], ultrasonic transducers; [0053]-[0060]; [0092]; figure 2);
communications electronics receiving control information for the transducer array elements, the control information enabling the ultrasonic monitoring ([0028]-[0032], ultrasound scanning of regions of interest using processing electronics which forms control information to control the elements; [0033], wireless radio coupled to processing electronics; [0035]-[0036], transducer scanning of body regions of interest; [0040]; [0046], processing electronics; [0052]-[0060]; [0064]; figure 5A; [0070]; [0072]-[0075]; see also [0081]-[0092]),
the communications electronics transmitting data from the transducer array elements to a processor, the processor configured to control the wearable device ([0028]-[0032], ultrasound scanning of regions of interest using processing electronics which forms control information to control the elements; [0033], wireless radio coupled to processing electronics; [0035]-[0036], transducer scanning of body regions of interest; [0040]; [0046], processing electronics; [0052]-[0060]; [0064]; figure 5A; [0070]; [0072]-[0075]; see also [0081]-[0092]), the processor including instructions to:
when the wearable device is affixed to a surface ([0028]-[0029], wearable ultrasonic device; [0036], ultrasound transducers; [0037]-[0039], wearable transducer array of elements; [0040], wearable transducer array of elements; [0042]-[0043]; [0052], ultrasonic transducers; [0053]-[0060]; [0092]; figure 2)
Primary reference Maghsoudnia further fails to teach:
a thermal sensor configured to monitor a temperature of the wearable device; and
the communications electronics transmitting data from the thermal sensor and the transducer array elements to a processor,
However, the analogous art of Kruger of a fully automated ultrasound apparatus (abstract) teaches:
a thermal sensor configured to monitor a temperature of the wearable device ([0050], sensors; [0088], secondary sensors such as temperature sensors); and
the communications electronics transmitting data from the thermal sensor and the transducer array elements to a processor ([0050], sensors; [0088], secondary sensors such as temperature sensors; see also [0051]-[0056], ultrasound data from transducers and element arrays)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia to incorporate the additional secondary temperature sensor as taught by Kruger because it provides additional diagnostic and physiological signal data to the device, leading to greater insights into the overall health of the patient during diagnostic testing (Kruger, [0088]) and better patient outcomes.
Primary reference Maghsoudnia further fails to teach:
automatically direct the transducer array to sweep an ultrasound beam across tissue;
capture images as the ultrasound beam is sweeping;
locate an image of interest from the captured images, a position of the ultrasound beam where the image of interest was collected;
locate the transducer array element that collected the image of interest, wherein the image of interest is based on a type of test, wherein the transducer array element centers an area of interest;
move the ultrasound beam to a position where the image of interest was collected,
wherein the position is associated with a beam steering angle;
However, the analogous art of Waechter-Stehle of an ultrasound imaging system for imaging a region of interest (abstract) teaches:
automatically direct the transducer array to sweep an ultrasound beam across tissue ([0041], beam steering; [0062]; [0075]; [0078]-[0079]; [0081], volume sweeping of the ultrasound array via electronic steering of beams across the region of interest);
capture images as the ultrasound beam is sweeping ([0081], volume sweeping through electronic steering of the beams with the array forming a capturing of images during the sweeping);
locate an image of interest from the captured images, a position of the ultrasound beam where the image of interest was collected ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.” Vessel imaging forms the type of diagnostic test for imaging);
locate the transducer array element that collected the image of interest, wherein the image of interest is based on a type of test, wherein the transducer array element centers an area of interest ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.” Vessel imaging forms the type of diagnostic test for imaging);
move the ultrasound beam to a position where the image of interest was collected ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.”),
wherein the position is associated with a beam steering angle ([0041]; [0062], “the ROI identified of the described system would take the optimal range of angles between ultrasound beams and vessel flow into account in order to generate the identification data indicating the region of interest.”; [0075], “the ultrasound wave controlling unit 64′ can adapted to vary a steering angle of the ultrasound beams within the identified ROI”; [0078], “In case the CMUT array 14 is a linear array the transducer frequency controller 62 can address (drive) the individual transducer cells 103 with different frequencies so that the ROI is imaged at high frequency and that the other elements are maintained at low frequencies.” Control over individual transducer cells such that the ROI is imaged at a high frequency forms a collecting transducer array element centering a tissue region of interest; [0079]; [0081], “For example, in case of a CMUT array 14, if the distance between the transducer array 14 (or practically the probe 10) and the ROI is beyond the penetration depth of the beams with the selected high frequency, the drive mechanism 21 would be communicated to move closer towards the ROI within the volumetric field of view 131′ (FIG. 7b), such that a “zoom-in” image of the ROI can be acquired, or to move the probe 10 closer to a target location relative to the ROI as specified in the selected use case.” This is associated with the beam steering angles of the volume sweeping and electronic beam steering of the ultrasound transducer towards the target region of interest);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia and Kruger to incorporate the volume sweeping and steering of beams to a target region of interest as taught by Waechter-Stehle because it provides higher quality “zoomed-in” ultrasound signal and image data at the region of interest (Waechter-Stehle, [0081]). This leads to higher quality images and improved clinical diagnostics.
Primary reference Maghsoudnia further fails to teach:
save the beam steering angle for grayscale imaging of a patient; and
However, the analogous art of Peterson of an ultrasonic diagnostic imaging device (abstract) teaches:
save the beam steering angle for grayscale imaging of a patient ([0034], saving of steering and focusing of beams in colorflow Doppler mode to use in an overlaid subsequent grayscale imaging mode).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia, Kruger, and Waechter-Stehle to incorporate the saving of steering and focusing of beams in colorflow Doppler mode to use in an overlaid subsequent grayscale imaging mode as taught by Peterson because it provides for a multi-mode imaging of color overlay of a grayscale image (Peterson, [0034]). This enables viewing of both moving flow as well as physical structures within an overall image.
Primary reference Maghsoudnia further fails to teach:
enable collecting Doppler images in proximity to the position using a Doppler angle that is different from but related to the beam steering angle
However, the analogous art of Loupas of an ultrasound system for colorflow Doppler imaging (abstract) teaches:
enable collecting Doppler images in proximity to the position using a Doppler angle that is different from but related to the beam steering angle ([0017]-[0022], the setting of the steering angle to a desired Doppler angle for the particular region of blood flow from the B mode data forms a using of a Doppler angle different from the beam steering angle set for a particular blood vessel region of interest in the overall imaged space).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia, Kruger, Waechter-Stehle, and Peterson to incorporate the using of a unique Doppler angle different from beam steering as taught by Loupas because a fixed Doppler angle with respect to the region of blood flow provides higher quality sensitivity and output data quality (Loupas, [0017]-[0021]). This leads to improved diagnostic data and better clinical determinations.
Regarding claim 22, the combined references of Maghsoudnia, Kruger, Waechter-Stehle, Peterson, and Loupas teach all of the limitations of claim 21. Primary reference Maghsoudnia further teaches:
comprising: an adhesive affixed to one side of the wearable device, the adhesive configured to removably attach the one side to a surface ([0035], adhesive hydrogel; [0043]; [0048]-[0049]).
Regarding claim 23, the combined references of Maghsoudnia, Kruger, Waechter-Stehle, Peterson, and Loupas teach all of the limitations of claim 21. Primary reference Maghsoudnia further teaches:
wherein the transducer array elements are individually controlled ([0053]-[0059], each transducer array element are individually controlled for signal generation and reception; [0097]-[0098]).
Regarding claim 25, the combined references of Maghsoudnia, Kruger, Waechter-Stehle, Peterson, and Loupas teach all of the limitations of claim 21. Primary reference Maghsoudnia further teaches:
wherein the wearable device comprises wireless communications electronics ([0033], wireless radio; [0064]; figure 5A; [0070]; [0084]).
Regarding claim 26, the combined references of Maghsoudnia, Kruger, Waechter-Stehle, Peterson, and Loupas teach all of the limitations of claim 21. Primary reference Maghsoudnia further fails to teach:
wherein the wearable device comprises a sensor
However, the analogous art of Kruger of a fully automated ultrasound apparatus (abstract) teaches:
wherein the wearable device comprises a sensor ([0050], sensors; [0088], secondary sensors such as temperature sensors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia, Kruger, Waechter-Stehle, Peterson, and Loupas to incorporate the additional secondary sensor as taught by Kruger because it provides additional diagnostic and physiological signal data to the device, leading to greater insights into the overall health of the patient during diagnostic testing (Kruger, [0088]) and better patient outcomes.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Maghsoudnia, in view of Kruger, in view of Waechter-Stehle, in view of Peterson, in further view of Loupas as applied to claim 21 above, and further in view of Bappoo.
Regarding claim 24, the combined references of Maghsoudnia, Kruger, Waechter-Stehle, Peterson, and Loupas teach all of the limitations of claim 21. Primary reference Maghsoudnia further fails to teach:
wherein the wearable device comprises a tourniquet
However, the analogous art of Bappoo of a portable ultrasound device for sensing target structures of interest (abstract) teaches:
wherein the wearable device comprises a tourniquet ([0140], “The fastening force can be likened to that produced of a commonly used tourniquet, required to increase intra vascular pressure and hence engorge the vessel and improve visibility and reduce blood velocity to a range pre-programmed to be extracted by digital processing algorithms 208.” Therefore fastening means 107 forms a tourniquet).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable ultrasound sensing and monitoring device of Maghsoudnia, Kruger, Waechter-Stehle, Peterson, and Loupas to incorporate the tourniquet fastener as taught by Bappoo because it increases the intravascular pressure and improves visibility while reducing blood velocity (Bappoo, [0140]). This improves signal quality leading to enhanced diagnostics.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Richter et al. (U.S. Pat. No. 8483488) teaches to a method and system for generating stabilized intravascular images which includes a predictive model determination of objects of interest within the image.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798