DETAILED ACTION
This office action is in response to the communication received on May 4, 2026 concerning application No. 16/970,810 filed on August 18, 2020.
Claims 1-6, 8-13, and 15-25 are currently pending.
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 .
Notice of Appeal
In view of the appeal brief filed on May 4, 2026, PROSECUTION IS HEREBY REOPENED. A new grounds of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798
Response to Arguments
Applicant’s arguments filed 05/04/2026 regarding the Garson reference on pgs. 25-27 have been fully considered but are moot because the rejection no longer relies on the Garson reference previously applied.
Applicant's arguments filed 05/04/2026 regarding the Provost reference on pgs. 17-19 have been fully considered but they are not persuasive. In response to applicant’s arguments that the combination of Sharf and Provost is not possible because there is no rationale to combine the ultrafast system of Provost into Sharf’s system, examiner respectfully disagrees. As set forth in the new grounds of rejection below the 2D array ultrasonic probe and beamforming of Provost is integrated into the system of Sharf. Therefore the combined system of Sharf in view of Provost has the capability to perform the ultrafast ultrasound imaging which includes the acquisition duration and ultrafast frame rate consistent with the limitation of claim 1.
In response to applicant’s arguments on pg. 29 that Sharf does not teach the claimed “imaging step” because Sharf is “expressly non-imaging”, examiner respectfully disagrees. As set forth in the previous office action, the generating of the doppler maps of Sharf is considered the imaging step of claim 1, where the doppler maps represent the images. Pg. 1, lines 5-10 of the present applications specification, specifically discloses “doppler imaging”, therefore doppler is considered an imaging process and the generation of doppler maps represents an imaging step.
Lastly, in response to applicant’s arguments on pgs. 29-30 that “the prior art of record fails to render obvious the B-mode anatomical imaging exclusion”, examiner respectfully disagrees. Examiner notes that Garson is no longer being relied upon for the rejection of claim 1. Therefore, the combination of only Sharf in view of Provost needs to be analyzed. As set forth in the previous office action, Sharf discloses generating maps and velocity from doppler data which is not B-mode imaging. Regarding Provost, the abstract discloses the ultrafast ultrasound imaging is specifically being applied to 3D ultrafast doppler imaging. Therefore Provost also teaches the exclusion of B-mode anatomical imaging.
Further, regarding applicant’s argument on pg. 30, “Provost performs 3D B-mode volume imaging and overlays Doppler on those anatomical volumes (Section 1.2 Image Formation) stating “volumes were beamformed using delay-and-sum…and subsequently coherently compounded to form a final high quality volume”. This would be well understood by a skilled artisan to be 3D B-mode imaging”. This appears to be the same process that is being performed within the claims of the present invention. Claim 1 discloses “an imaging step wherein a sequence of 3D images is generated from said raw data by beamforming” and pgs. 14-15 of the present applications specification disclose “after receiving the backscattered echoes, a parallel beamforming may be directly applied by the control system to reconstruct the 3D image from each single ultrasonic wave. Delay and sum beamforming can be used in the time domain…voxels are beamformed using delay-and-sum algorithms for each virtual source and subsequently coherently compounded to form a final, high quality 3D image”. Therefore, using applicant’s own assertions that beamforming volumes using delay-and-sum algorithms results in 3D B-mode imaging, the claims as currently written would also require B-mode imaging at step (b) and therefore contradict themselves.
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.
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, 5, 8-9, 11, 15-16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharf et al. (US 20100049052, hereinafter Sharf) in view of Provost et al. (“3D ultrafast ultrasound imaging in vivo”, hereinafter Provost).
Regarding claim 1, Sharf teaches a method for 4D imaging of a heart of a living being ([0143] discloses data is acquired using ultrasound transducers to map the heart. “the raw data of the received signals are analyzed in real-time in the computing unit to generate a 3 dimensional Doppler (both blood flow and tissue) map of the heart”. [0198] and Fig. 6 further show the steps 606-616 are repeated continuously, meaning the 3D map is generated over time and is therefore considered a 4D image), said method including at least the following steps:
(a) an acquisition step wherein unfocused ultrasonic waves ([0162] “the ultrasonic data is acquired using one or more transducers that are non-focused”) are transmitted in the heart by an array ultrasonic probe and raw data from the backscattered ultrasonic waves are acquired by said ultrasonic probe ([0143] “the system acquired data from a distributed array of ultrasound transducers that are placed over the anterior chest wall in predetermined anatomical sites…the raw data of the received signals are analyzed”. [0154] further discloses the transducer is an array transducer), said acquisition step having a duration of 5s or less ([0340] and fig. 12a discloses that the Doppler signal acquisition is about 1.5s which is less than 5s);
(b) an imaging step wherein a sequence of 3D images is generated from said raw data ([0143] “the raw data of the received signals are analyzed in real-time in the computing unit to generate a 3 dimensional Doppler (both blood flow and tissue) map of the heart” and [0175]-[0176] discloses in acts 606 and 608 velocity maps for both muscle and blood is generated to view the general structure of the heart and [0198] discloses the acts 606-616 are continuously repeating meaning a sequence of 3D velocity maps are generated. [0117]-[0119] disclose the reconstruction of the map of motion is a method of tissue imaging), in an imaged volume including at least part of the heart ([0175] discloses the velocity map is generated to view the structure of the heart);
(c) a velocity computing step wherein Doppler mapping is computed from said sequence of 3D images to obtain a 3D cartography of at least one parameter related to blood velocity in said imaged volume and time ([0176] discloses the 3D velocity map (3D cartography) is generated for blood and [0181] discloses “the diastolic transmittal flow velocity E is derived from blood flow three-dimensional velocity map, by finding the spatial maximal during diastole”, the diastolic transmittal flow velocity is considered the at least one parameter. [0175] discloses acquiring doppler data and [0177] discloses “In an exemplary embodiment of the invention a reconstruction module constructs two separate 3D velocity maps from Doppler data: one map for muscle and one map for blood flow”);
(d) a locating step wherein at least one point of interest having a predetermined property is automatically located in said sequence of 3D images ([0178] discloses at act 610 the maxima and minima measurements are identified in the maps. The location where the maxima and minima are identified are considered the point of interest), wherein said at least one point of interest is automatically located based solely on said 3D cartography and its temporal profile ([0178] discloses the maxima and minimum are identified from the 3D velocity maps and are “temporal maxim/minima”);
(e) a quantification step wherein at least blood velocity is automatically determined at said at least one point of interest and a predetermined quantification parameter is automatically computed, involving said blood velocity ([0176] discloses the maps represent velocity of blood meaning the blood velocity is automatically determined for the identified point of interest. [0181] further discloses the “diastolic transmittal flow velocity E is derived from blood flow three-dimensional velocity map”, the diastolic transmittal flow velocity is considered the predetermined quantification parameter), wherein said blood velocity is automatically determined at said at least one point of interest based solely on said 3D cartography and its temporal profile ([0178] discloses the maxima/minima velocities are identified in the 3D velocity maps and are temporal maxima/minima);
wherein the quantification parameter involves: a peak blood velocity in a certain anatomic area ([0181] discloses the diastolic transmitral flow velocity E is derived by “finding the spatial maximal during diastole”, the anatomic area is the mitral valve) and said locating step (d) includes automatically locating said point of interest as a point of maximum of said peak blood velocity in said anatomic area and in at least part of the sequence of 3D images ([0178] discloses the value being identified in the 3D velocity maps is the maxima measurement and is therefore a point of maximum peak blood velocity in the anatomic area and part of the sequence of 3D images);
and wherein steps (a) to (e) do not use B-mode anatomical imaging ([0143]-[0144] discloses the map and velocity values are generated from doppler data, which is not B-mode anatomical imaging data).
Sharf does not specifically teach the acquisition step is performed using a 2D array ultrasonic probe, the sequence of 3D images is generated by beamforming and said sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step.
However,
Provost in a similar field of endeavor teaches the acquisition step is performed using a 2D array ultrasonic probe (pg. L1, Abstract, discloses using a 32x32 matrix-array probe (2D array ultrasonic probe) to track 3D transient phenomena during 3D ultrafast doppler imaging), the sequence of 3D images is generated by beamforming (pgs. L4-L5, section 1.1-1.2 disclose generating the 3D volumes using beamforming) and a sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step (pg. L1, Abstract, “In this study, we present the first implementation of Ultrafast Ultrasound Imaging in three dimensions based on the use of either diverging or plane waves emanating from a sparse virtual array located behind the probe. It achieves high contrast and resolution while maintaining imaging rates of thousands of volumes per second”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the acquiring of Sharf to have the acquisition step be performed using a 2D array ultrasonic probe, the sequence of 3D images be generated by beamforming and said sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step in order to reduce intra- and inter-observer variability, as recognized by Provost (Abstract).
Regarding claim 8, Sharf teaches an apparatus for 4D imaging of a heart of a living being ([0143] discloses a system that uses ultrasound transducers to map the heart. “the raw data of the received signals are analyzed in real-time in the computing unit to generate a 3 dimensional Doppler (both blood flow and tissue) map of the heart”. [0198] and Fig. 6 further show the steps 606-616 are repeated continuously, meaning the 3D map is generated over time and is therefore considered a 4D image), said apparatus including at least a array ultrasonic probe ([0150] and fig. 3, “ultrasound probe section 310”. [0154] further discloses the transducer is an array transducer) and a control system ([0150]-[0151] and fig. 3 discloses monitor unit 302 that includes a control and processing unit 304) configured to without using B-mode anatomical imaging ([0143]-[0144] discloses the map and velocity values generated below are from doppler data which is not B-mode anatomical imaging):
(a) transmit unfocused ultrasonic waves ([0162] “the ultrasonic data is acquired using one or more transducers that are non-focused”) in the heart through said array ultrasonic probe and acquire raw data from the backscattered ultrasonic waves through said array ultrasonic probe ([0143] “the system acquired data from a distributed array of ultrasound transducers that are placed over the anterior chest wall in predetermined anatomical sites…the raw data of the received signals are analyzed”), said acquisition step having a duration of 5s or less ([0340] and fig. 12a discloses that the Doppler signal acquisition is about 1.5s which is less than 5s);
(b) generate a sequence of 3D images from said raw data ([0143] “the raw data of the received signals are analyzed in real-time in the computing unit to generate a 3 dimensional Doppler (both blood flow and tissue) map of the heart” and [0175]-[0176] discloses in acts 606 and 608 velocity maps for both muscle and blood is generated to view the general structure of the heart and [0198] discloses the acts 606-616 are continuously repeating meaning a sequence of 3D velocity maps are generated. [0117]-[0119] disclose the reconstruction of the map of motion is a method of tissue imaging), in an imaged volume including at least part of the heart ([0175] discloses the velocity map is generated to view the structure of the heart);
(c) automatically compute Doppler mapping from said sequence of 3D images to obtain a 3D cartography of at least one parameter related to blood velocity in said imaged volume ([0176] discloses the 3D velocity map (3D cartography) is generated for blood and [0181] discloses “the diastolic transmittal flow velocity E is derived from blood flow three-dimensional velocity map, by finding the spatial maximal during diastole”, the diastolic transmittal flow velocity is considered the at least one parameter. [0175] discloses acquiring doppler data and [0177] discloses “In an exemplary embodiment of the invention a reconstruction module constructs two separate 3D velocity maps from Doppler data: one map for muscle and one map for blood flow”);
(d) automatically locate at least one point of interest having a predetermined property in said sequence of 3D images ([0178] discloses at act 610 the maxima and minima measurements are identified in the maps. The location where the maxima and minima are identified are considered the point of interest), wherein said control system is configured to automatically locate said at least one point of interest based solely on said 3D cartography and its temporal profile ([0178] discloses the maxima and minimum are identified from the 3D velocity maps and are “temporal maxim/minima”);
(e) automatically determine at least one blood velocity at said at least one point of interest and automatically compute a predetermined quantification parameter involving said blood velocity ([0176] discloses the maps represent velocity of blood meaning the blood velocity is automatically determined for the identified point of interest. [0181] further discloses the “diastolic transmittal flow velocity E is derived from blood flow three-dimensional velocity map”, the diastolic transmittal flow velocity is considered the predetermined quantification parameter), wherein said control system is configured to automatically determine said blood velocity at said at least one point of interest based solely on said 3D cartography and its temporal profile ([0178] discloses the maxima/minima velocities are identified in the 3D velocity maps and are temporal maxima/minima);
wherein the quantification parameter involves: a peak blood velocity in a certain anatomic area ([0181] discloses the diastolic transmitral flow velocity E is derived by “finding the spatial maximal during diastole”, the anatomic area is the mitral valve) and said control system configured to automatically locate said point of interest as a point of maximum of said peak blood velocity in said anatomic area and in at least part of the sequence of 3D images ([0178] discloses the value being identified in the 3D velocity maps is the maxima measurement and is therefore a point of maximum peak blood velocity in the anatomic area and part of the sequence of 3D images).
Sharf does not specifically teach the acquisition step is performed using a 2D array ultrasonic probe, the sequence of 3D images is generated by beamforming and said sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step.
However,
Provost in a similar field of endeavor teaches the acquisition step is performed using a 2D array ultrasonic probe (pg. L1, Abstract, discloses using a 32x32 matrix-array probe (2D array ultrasonic probe) to track 3D transient phenomena during 3D ultrafast doppler imaging), the sequence of 3D images is generated by beamforming (pgs. L4-L5, section 1.1-1.2 disclose generating the 3D volumes using beamforming) and a sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step (pg. L1, Abstract, “In this study, we present the first implementation of Ultrafast Ultrasound Imaging in three dimensions based on the use of either diverging or plane waves emanating from a sparse virtual array located behind the probe. It achieves high contrast and resolution while maintaining imaging rates of thousands of volumes per second”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the acquiring of Sharf to have the acquisition step be performed using a 2D array ultrasonic probe, the sequence of 3D images be generated by beamforming and said sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step in order to reduce intra- and inter-observer variability, as recognized by Provost (Abstract).
Regarding claim 2, Sharf in view of Provost teaches the method of claim 1, as set forth above. Sharf further teaches the quantification parameter involves a temporal variation of the parameter related to the velocity in a certain anatomic area ([0178] discloses the identified maxima in the velocity map is a “temporal maxima”. [0182] discloses the mitral annulus is the location where tissue velocity is measured).
Regarding claim 3, Sharf in view of Provost teaches the method of claim 1, as set forth above. Sharf further teaches the quantification parameter involves a time integral of the parameter related to the velocity in a certain anatomic area ([0180] discloses various cardiac parameters may be extracted including VTI which [0144] discloses is the “velocity time integral (VTI)”).
Regarding claims 5 and 9, Sharf in view of Provost teaches the method of claim 1 and apparatus of claim 8, as set forth above. Sharf further teaches the quantification parameter determined at said quantification step is chosen from E, A, E', A', S, D, Vp, S', E/A, E/E', E/E', E'/A', S, S/D, VTI, Gmean and Gmax ([0180] discloses various cardiac parameters may be extracted from the measured values “for example one or more of E, E′, S′ A, A′, E/E′, E/A, LVOT, VTI, SV, CO and/or HR”).
Regarding claim 11, Sharf in view of Provost teaches the method of claim 8, as set forth above. Sharf further teaches said control system is configured to transmit said unfocused ultrasonic waves as divergent ultrasonic waves ([0162] discloses the transducer beam profile has an angle of +/- 30 degrees meaning the waves are diverging from one another).
Regarding claim 15, Sharf teaches a method for 4D imaging of a heart of a living being ([0143] discloses data is acquired using ultrasound transducers to map the heart. “the raw data of the received signals are analyzed in real-time in the computing unit to generate a 3 dimensional Doppler (both blood flow and tissue) map of the heart”. [0198] and Fig. 6 further show the steps 606-616 are repeated continuously, meaning the 3D map is generated over time and is therefore considered a 4D image), said method including at least the following steps:
(a) an acquisition step wherein unfocused ultrasonic waves ([0162] “the ultrasonic data is acquired using one or more transducers that are non-focused”) are transmitted in the heart by an array ultrasonic probe and raw data from the backscattered ultrasonic waves are acquired by said ultrasonic probe ([0143] “the system acquired data from a distributed array of ultrasound transducers that are placed over the anterior chest wall in predetermined anatomical sites…the raw data of the received signals are analyzed”. [0154] further discloses the transducer is an array transducer), said acquisition step having a duration of 5s or less ([0340] and fig. 12a discloses that the Doppler signal acquisition is about 1.5s which is less than 5s);
(b) an imaging step wherein a sequence of 3D images is generated from said raw data ([0143] “the raw data of the received signals are analyzed in real-time in the computing unit to generate a 3 dimensional Doppler (both blood flow and tissue) map of the heart” and [0175]-[0176] discloses in acts 606 and 608 velocity maps for both muscle and blood is generated to view the general structure of the heart and [0198] discloses the acts 606-616 are continuously repeating meaning a sequence of 3D velocity maps are generated. [0117]-[0119] disclose the reconstruction of the map of motion is a method of tissue imaging), in an imaged volume including at least part of the heart ([0175] discloses the velocity map is generated to view the structure of the heart);
(c) a velocity computing step in which tissue displacement is computed by cross-correlation from said sequence of 3D images to obtain a 3D cartography of at least one parameter related to tissue velocity in said imaged volume and time ([0176] discloses the 3D velocity map is generated for muscle, where the map includes calculating a 2D or 3D vector which represents the tissue displacement. [0182] further discloses “the myocardial wall velocities E’, A’ and S’ are derived from the three-dimensional myocardial velocity map”. [0080]-[0082] discloses the vectors are extracted using correlation);
(d) a locating step wherein at least one point of interest having a predetermined property is automatically located in said sequence of 3D images ([0178] discloses at act 610 the maxima and minima measurements are identified in the maps. The location where the maxima and minima are identified are considered the point of interest), wherein said at least one point of interest is automatically located based solely on said 3D cartography and its temporal profile ([0178] discloses the maxima and minimum are identified from the 3D velocity maps and are “temporal maxim/minima”);
(e) a quantification step wherein at least said tissue velocity is automatically determined at said at least one point of interest and a predetermined quantification parameter is automatically computed, involving said blood velocity ([0176] discloses the maps represent velocity of muscle meaning the tissue velocity is automatically determined for the identified point of interest. [0182] further discloses the “the myocardial wall velocities E’, A’ and S’ are derived from the three-dimensional myocardial velocity map”, the myocardial wall velocities are considered the predetermined quantification parameter), wherein said tissue velocity is automatically determined at said at least one point of interest based solely on said 3D cartography and its temporal profile ([0178] discloses the maxima/minima velocities are identified in the 3D velocity maps and are temporal maxima/minima);
wherein the quantification parameter involves: a peak tissue velocity in a certain anatomic area ([0182] discloses the maximum tissue velocities are determined for the myocardial wall which is the certain anatomic area) and said locating step (d) includes automatically locating said point of interest as a point of maximum of said peak tissue velocity in said anatomic area and in at least part of the sequence of 3D images ([0178] discloses the value being identified in the 3D velocity maps is the maxima measurement and is therefore a point of maximum peak tissue velocity in the anatomic area and part of the sequence of 3D images);
and wherein the steps (a) to (e) do not use B-mode anatomical imaging ([0143]-[0144] discloses the map and velocity values are generated from doppler data which is not B-mode anatomical imaging).
Sharf does not specifically teach the acquisition step is performed using a 2D array ultrasonic probe, the sequence of 3D images is generated by beamforming and said sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step.
However,
Provost in a similar field of endeavor teaches the acquisition step is performed using a 2D array ultrasonic probe (pg. L1, Abstract, discloses using a 32x32 matrix-array probe (2D array ultrasonic probe) to track 3D transient phenomena during 3D ultrafast doppler imaging), the sequence of 3D images is generated by beamforming (pgs. L4-L5, section 1.1-1.2 disclose generating the 3D volumes using beamforming) and a sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step (pg. L1, Abstract, “In this study, we present the first implementation of Ultrafast Ultrasound Imaging in three dimensions based on the use of either diverging or plane waves emanating from a sparse virtual array located behind the probe. It achieves high contrast and resolution while maintaining imaging rates of thousands of volumes per second”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the acquiring of Sharf to have the acquisition step be performed using a 2D array ultrasonic probe, the sequence of 3D images be generated by beamforming and said sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step in order to reduce intra- and inter-observer variability, as recognized by Provost (Abstract).
Regarding claim 16, Sharf teaches an apparatus for 4D imaging of a heart of a living being ([0143] discloses a system that uses ultrasound transducers to map the heart. “the raw data of the received signals are analyzed in real-time in the computing unit to generate a 3 dimensional Doppler (both blood flow and tissue) map of the heart”. [0198] and Fig. 6 further show the steps 606-616 are repeated continuously, meaning the 3D map is generated over time and is therefore considered a 4D image), said apparatus including at least a array ultrasonic probe ([0150] and fig. 3, “ultrasound probe section 310”. [0154] further discloses the transducer is an array transducer) and a control system ([0150]-[0151] and fig. 3 discloses monitor unit 302 that includes a control and processing unit 304) configured to without using B-mode anatomical imaging ([0143]-[0144] discloses the map and velocity values generated below are from doppler data which is not B-mode anatomical imaging):
(a) transmit unfocused ultrasonic waves ([0162] “the ultrasonic data is acquired using one or more transducers that are non-focused” in the heart through said array ultrasonic probe and acquire raw data from the backscattered ultrasonic waves through said array ultrasonic probe ([0143] “the system acquired data from a distributed array of ultrasound transducers that are placed over the anterior chest wall in predetermined anatomical sites…the raw data of the received signals are analyzed”), said acquisition step having a duration of 5s or less ([0340] and fig. 12a discloses that the Doppler signal acquisition is about 1.5s which is less than 5s);
(b) generate a sequence of 3D images from said raw data ([0143] “the raw data of the received signals are analyzed in real-time in the computing unit to generate a 3 dimensional Doppler (both blood flow and tissue) map of the heart” and [0175]-[0176] discloses in acts 606 and 608 velocity maps for both muscle and blood is generated to view the general structure of the heart and [0198] discloses the acts 606-616 are continuously repeating meaning a sequence of 3D velocity maps are generated. [0117]-[0119] disclose the reconstruction of the map of motion is a method of tissue imaging), said sequence of 3D images forming an animation showing movements of an imaged volume including at least part of the heart ([0175] discloses the velocity map is generated to view the structure of the heart and because the acts 606 and 608 are continuously repeated the velocity maps generated over time form an animation showing movement of the heart over time);
(c) automatically compute tissue displacement is computed by cross-correlation from said sequence of 3D images to obtain a 3D cartography of at least one parameter related to tissue velocity in said imaged volume, based on said sequence of 3D images ([0176] discloses the 3D velocity map is generated for muscle, where the map includes calculating a 2D or 3D vector which represents the tissue displacement. [0182] further discloses “the myocardial wall velocities E’, A’ and S’ are derived from the three-dimensional myocardial velocity map”. [0080]-[0082] discloses the vectors are extracted using correlation);
(d) automatically locate at least one point of interest having a predetermined property in said sequence of 3D images ([0178] discloses at act 610 the maxima and minima measurements are identified in the maps. The location where the maxima and minima are identified are considered the point of interest), wherein said control system is configured to automatically locate said at least one point of interest based solely on said 3D cartography and its temporal profile ([0178] discloses the maxima and minimum are identified from the 3D velocity maps and are “temporal maxim/minima”);
(e) automatically determine at least tissue velocity at said at least one point of interest and automatically compute a predetermined quantification parameter involving said tissue velocity ([0176] discloses the maps represent velocity of muscle meaning the tissue velocity is automatically determined for the identified point of interest. [0182] further discloses the “the myocardial wall velocities E’, A’ and S’ are derived from the three-dimensional myocardial velocity map”, the myocardial wall velocities are considered the predetermined quantification parameter), wherein said control system is configured to automatically determine said tissue velocity at said at least one point of interest based solely on said 3D cartography and its temporal profile ([0178] discloses the maxima/minima velocities are identified in the 3D velocity maps and are temporal maxima/minima);
wherein the quantification parameter involves: a peak tissue velocity in a certain anatomic area ([0182] discloses the maximum tissue velocities are determined for the myocardial wall which is the certain anatomic area) and said control system configured to automatically locate said point of interest as a point of maximum of said peak tissue velocity in said anatomic area and in at least part of the sequence of 3D images ([0178] discloses the value being identified in the 3D velocity maps is the maxima measurement and is therefore a point of maximum peak tissue velocity in the anatomic area and part of the sequence of 3D images).
Sharf does not specifically teach the acquisition step is performed using a 2D array ultrasonic probe, the sequence of 3D images is generated by beamforming and said sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step.
However,
Provost in a similar field of endeavor teaches the acquisition step is performed using a 2D array ultrasonic probe (pg. L1, Abstract, discloses using a 32x32 matrix-array probe (2D array ultrasonic probe) to track 3D transient phenomena during 3D ultrafast doppler imaging), the sequence of 3D images is generated by beamforming (pgs. L4-L5, section 1.1-1.2 disclose generating the 3D volumes using beamforming) and a sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step (pg. L1, Abstract, “In this study, we present the first implementation of Ultrafast Ultrasound Imaging in three dimensions based on the use of either diverging or plane waves emanating from a sparse virtual array located behind the probe. It achieves high contrast and resolution while maintaining imaging rates of thousands of volumes per second”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the acquiring of Sharf to have the acquisition step be performed using a 2D array ultrasonic probe, the sequence of 3D images be generated by beamforming and said sequence of 3D images have a frame rate of several thousand 3D images per second over said duration of the acquisition step in order to reduce intra- and inter-observer variability, as recognized by Provost (Abstract).
Regarding claim 19, Sharf in view of Provost teaches the method of claim 16, as set forth above. Sharf further teaches said control system is configured to transmit said unfocused ultrasonic waves as divergent ultrasonic waves ([0162] discloses the transducer beam profile has an angle of +/- 30 degrees meaning the waves are diverging from one another).
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharf in view of Provost as applied to claims 1 above, and further in view of Datta et al. (US 20110208056, as cited in the applicant’s 8/18/2020 IDS, hereinafter Datta).
Regarding claim 4, Sharf in view of Provost teaches the method of claim 1, as set forth above. Sharf in view of Provost does not specifically teach the quantification parameter involves a space integral of the parameter related to the velocity in a certain anatomic area.
However,
Datta in a similar field of endeavor teaches the quantification parameter involves a space integral of the parameter related to the velocity in a certain anatomic area ([0050] discloses the “volume integral of a flow parameter (such as velocity) is computed” and [0062] discloses the “velocity area integral” is determined for the cross section of the anatomy (anatomic area). The volume and area correspond to the space. ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the quantification parameter of Sharf in view of Provost for the space integral quantification parameter of Datta because it amounts to simple substitution of one known element for another to obtain the predictable results of determining a quantification parameter of a region in the heart, thereby increasing the versatility of the system.
Claims 6, 10, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharf in view of Provost as applied to claims 1, 8, 15, and 16 above, and further in view of Wegner (US 20150080725).
Regarding claims 6, 10, 17 and 18, Sharf in view of Provost teaches the method of claims 1 and 15 and the apparatus of claims 8 and 16, as set forth above. Sharf further teaches during said acquisition step (a), the control system (monitor 302 in fig. 3) is configured to transmit said unfocused ultrasonic waves in several series of successive unfocused ultrasonic waves ([0162] discloses the transducers that acquire the ultrasonic data are unfocused and [0198] discloses the acquiring act 606 is repeated meaning a series of successive unfocused ultrasonic waves is transmitted).
Sharf in view of Provost does not specifically teach the successive unfocused ultrasonic waves of each series having respectively different propagation directions and said imaging step (b) includes synthesizing a 3D image by ultrasound synthetic imaging from the respective raw data corresponding to said successive unfocussed ultrasonic waves of each series.
However,
Wegner in a similar field of endeavor teaches the successive unfocused ultrasonic waves of each series have respectively different propagation directions ([0027] and fig. 1B discloses the phase centers are moved in successive positions as shown in fig. 1B. By moving the phase center each of the successive unfocused ultrasonic waves are transmitted in different propagation directions as seen in fig. 1B) and an imaging step that includes synthesizing a 3D image by ultrasound synthetic imaging from the respective raw data corresponding to said successive unfocussed ultrasonic waves of each series ([0027] discloses that a synthetic aperture ultrasound technique is used to produce a three-dimensional image using unfocused transmissions).
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 method and apparatus disclosed by Sharf in view of Provost to have the successive unfocused ultrasonic waves of each series have respectively different propagation directions and the imaging step include synthesizing a 3D image by ultrasound synthetic imaging from the respective raw data corresponding to said successive unfocussed ultrasonic waves of each series in order to improve the quality of the ultrasound images, as recognized by Wegner ([0025]).
Claims 12, 13, and 20-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharf in view of Provost as applied to claims 1, 8, 15, and 16 above, and further in view of Konofagou et al. (US 20150289840, hereinafter Konofagou).
Regarding claims 12, 20, 22, and 24, Sharf in view of Provost teaches the method of claims 1 and 15 and the apparatus of claims 8 and 16, as set forth above. Sharf in view of Provost does not specifically teach said duration is of one cardiac cycle or less.
However,
Konofagou in a similar field of endeavor teaches the acquisition duration is one cardiac cycle or less ([0135] “the acquisition duration was less than the duration of a cardiac cycle”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the duration be one cardiac cycle or less of Konofagou to the methods and apparatus of Sharf in view of Provost to allow for the predictable results of reducing the overall time the machine is used, thereby reducing stress on the machine and increasing its longevity.
Regarding claims 13, 21, 23, and 25, Sharf in view of Provost and Konofagou teaches the method of claims 22 and 24 and apparatus of claims 12 and 20, as set forth above. Konofagou further teaches the duration is a duration of a part of cardiac cycle chosen between diastole and systole ([0074] “in this example, for each acquisition either the whole systolic or the whole diastolic phase was obtained, but not both”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the duration be a duration of a part of cardiac cycle chosen between diastole and systole of Konofagou to the methods and apparatus of Sharf in view of Provost and Konofagou to allow for the predictable results of reducing the overall time the machine is used, thereby reducing stress on the machine and increasing its longevity.
Conclusion
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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