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 .
Response to Amendment
The amendment filed 01/26/2026 has been entered. Claims 1-26 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection of claims 1-26 previously set forth in the Non-Final Office Action mailed 07/24/2025.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Taffler (US 20200055085), hereinafter Taffler, in view of Vortman et al (US20210204915), hereinafter, Vortman.
Regarding claim 1, Taffler teaches a system (200) for ultrasound imaging comprising:
a first transducer array (210) comprising transducer elements and configured to generate an acoustic beam for therapy (“the generated ultrasonic waves from the first transducer array deliver therapeutic energy to a region in the target” claim 12);
a second transducer array (220) comprising transducer elements and configured to receive reflected ultrasound and generate data based on the received reflected ultrasound (“The generated ultrasonic waves from the first transducer array can deliver therapeutic energy to a region in the target, and the second transducer array can detect incident waves reflected or elicited from the region and generate the signal based on the incident waves, the signal carrying data to create a digital image of the target region.” [0050]; “to detect reactive events such as reflected ultrasonic waves” [0078]);
a computing and imaging device (“a processor” [0098]) connected to the first transducer array and the second transducer array and configured to receive the data generated by the second transducer array and generate material property data from the data received from the second transducer array (“The generated ultrasonic waves from the first transducer array can deliver therapeutic energy to a region in the target, and the second transducer array can detect incident waves reflected or elicited from the region and generates the signal based on the incident waves, the signal carrying data to create a digital image of the target region or data that indicates a material property of the target region.” [0038]; “an ultrasonic device 200 having a stacked arrangement according to the disclosed subject matter. The disclosed device 200 includes a first transducer array 210 (“distal array”) to generate ultrasonic waves, a second transducer array 220 (“proximal array”), electrically isolated from the distal array 210, to detect reactive events such as reflected ultrasonic waves, and a driving circuit 230 to supply power. The driving circuit 230 can also include a processor, microprocessor or the like to transmit control signals, execute output timing algorithms,” [0078]. “At operation 460 the generated signal is processed, for example, a processor can apply calculations and algorithms to resolve the signal into readable value or an image for display on a screen, or use an algorithm to determine data from the signal that indicates a material property of a target region.” [0098]; Fig. 2A).
Taffler does not teach that the computing and imaging device is configured to generate a path for the acoustic beam for therapy based on the material property data.
However, in the ultrasound systems field of endeavor, Vortman discloses focused ultrasound system with optimized monitoring of cavitation, which is analogous art. Vortman teaches that the computing and imaging device is configured to generate a path for the acoustic beam for therapy (“to predict acoustic paths of ultrasound beams” [0062]) based on the material property data (“using a physical model” [0063]) (“FIG. 5B is a flow chart illustrating an exemplary approach 530 for determining temporal profile parameters associated with the transducer elements in accordance herewith. In various embodiments, after the tissue characteristic(s) associated with the target region and/or non-target region(s) are determined, a physical model including a thermo-acoustic simulation may be implemented to predict acoustic paths of ultrasound beams transmitted from the transducer elements to the target region based at least in part on the determined tissue characteristic(s) (step 532).” [0062]. “Such functionality may include … determining the anatomical/tissue characteristics (e.g., the tissue type, location, size, thickness, density, structure, shape, vascularization, thermal time constant, etc.) associated with the target/non-target tissue, analyzing the images to identify calcifications in the non-target region(s), using a physical model to predict acoustic paths of ultrasound beams transmitted from the transducer elements to the target region" [0063]).
Therefore, based on Vortman’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler to employ the computing and imaging device that is configured to generate a path for the acoustic beam for therapy based on the material property data, as taught by Vortman, in order to improve ultrasound therapy outcomes.
Regarding claim 2, Taffler modified by Vortman teaches the system of claim 1, wherein Taffler teaches that the material property data comprises one or more of absolute values or changes in longitudinal and shear acoustic velocity, attenuation, thermal expansion coefficient, backscatter (“backscattered waves”), average grain size, tissue nonlinearity, flowrate for fluid, and distortion or shifting of material (“At operation 450 the elements in the receive array generate electrical signals corresponding to the reactive event. For example, when the reactive event is backscattered waves from the generated waves, the elements generate a signal by converting energy from the reflected waves into a voltage signal. This signal may be based on directly-received backscatter waves” [0097]).
Regarding claim 9, Taffler modified by Vortman teaches the system of claim 1, wherein Taffler teaches that the acoustic beam generated by the first transducer array is configured to be directed at a target comprising tissue (“The generated ultrasonic waves from the first transducer array can deliver therapeutic energy to a region in the target.” [0038]; “activation of nerves and other neuronal structures, increasing fluid flow in venous structures through mechanical stress or otherwise, localized warming of deep tissue for physical therapy benefit, cell lysis," [0104]).
Regarding claim 10, Taffler modified by Vortman teaches the system of claim 9, wherein Taffler teaches that the material property data comprises material properties of the tissue (“a material property of the target region.” [0038]; “The reactive event can be, for example, ultrasonic imaging waves hitting an object in the target region and reflecting back, the ultrasonic therapeutic waves hitting an object in the target region and causing an increase in temperature, harmonics generated in the tissues by ultrasonic waves" [0095]).
Claims 3-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Taffler (US 20200055085), hereinafter Taffler, in view of Vortman et al (US20210204915), hereinafter, Vortman, and Rosenzweig et al (US 20200305842), hereinafter, Rosenzweig.
Regarding claim 3, Taffler modified by Vortman teaches the system of claim 2.
Taffler modified by Vortman does not teach that the computing and imaging device is further configured to generate one or more maps based on the material property data.
However, in the acoustic devices field of endeavor, Rosenzweig discloses asymmetry for acoustic radiation force impulse, which is analogous art. Rosenzweig teaches that the computing and imaging device is further configured to generate one or more maps (“color map” [0069]) based on the material property data (“the property (e.g., shear wave velocity) is displayed as a function of location. Displacements for a number of locations are available in response to an ARFI pulse. A one, two, or three-dimensional distribution of those locations provides a corresponding spatial distribution of estimated velocity or property. For a representation of the tissue, the magnitude of the tissue characteristic modulates the color, hue, brightness, and/or other display characteristic for different pixels representing a tissue region. The processor 18 determines a pixel value (e.g., RGB) or a scalar value converted to a pixel value. The image is generated as the scalar or pixel values. The image may be output to a … color map” [0069]).
Therefore, based on Rosenzweig’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler and Vortman to have the computing and imaging device that is further configured to generate one or more maps based on the material property data, as taught by Rosenzweig, in order to provide a spatial distribution of estimated shear wave velocity or other property.
Regarding claim 4, Taffler modified by Vortman and Rosenzweig teaches the system of claim 3.
Taffler teaches that the computing and imaging device is further configured to generate one or more adjustments to one or both of the acoustic beam for therapy generated by the first transducer array and an acoustic beam generated by the second transducer array and to send control signals to one or both of the first transducer array and the second transducer array based on the one or more adjustments (“The driving circuit 230 can also include a processor, microprocessor or the like to transmit control signals, execute output timing algorithms,” [0078]. “At operation 470 the processor or the user determines of the process results are acceptable. For example, the processor can determine whether predetermined threshold values are met or a user can determine whether an image is in focus. If the result is acceptable then no adjustments are necessary and the image can be captured or the settings maintained to continue projecting the ultrasonic beam. If the result is not acceptable (for example the focus is not clear or the position of the detected event is not in the location that was intended to be targeted) then at operation 480 the processor or the user adjusts treatment settings for the elements, e.g., adjust the power level, focus, frequency, etc., and a refined beam is generated with the altered treatment settings at operation 420." [0099]).
Taffler modified by Vortman does not teach that the computing and imaging device is further configured to generate the one or more adjustments based on the one or more maps.
However, in the acoustic devices field of endeavor, Rosenzweig discloses asymmetry for acoustic radiation force impulse, which is analogous art. Rosenzweig teaches the one or more maps (“the property (e.g., shear wave velocity) is displayed as a function of location. Displacements for a number of locations are available in response to an ARFI pulse. A one, two, or three-dimensional distribution of those locations provides a corresponding spatial distribution of estimated velocity or property. For a representation of the tissue, the magnitude of the tissue characteristic modulates the color, hue, brightness, and/or other display characteristic for different pixels representing a tissue region. The processor 18 determines a pixel value (e.g., RGB) or a scalar value converted to a pixel value. The image is generated as the scalar or pixel values. The image may be output to a … color map” [0069]).
Therefore, based on Rosenzweig’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler and Vortman to employ the computing and imaging device that is further configured to generate based on the one or more maps one or more adjustments to one or both of the acoustic beam for therapy generated by the first transducer array and an acoustic beam generated by the second transducer array and to send control signals to one or both of the first transducer array and the second transducer array based on the adjustments, as taught by Rosenzweig, in order to provide improved spatial distributions of material properties.
Regarding claim 8, Taffler modified by Vortman teaches the system of claim 1.
Taffler teaches that the computing and imaging device is further configured to generate one or more adjustments to one or both of the acoustic beam for therapy generated by the first transducer array and an acoustic beam generated by the second transducer array and to send control signals to one or both of the first transducer array and the second transducer array based on the one or more adjustments (“The driving circuit 230 can also include a processor, microprocessor or the like to transmit control signals, execute output timing algorithms,” [0078]. “At operation 470 the processor or the user determines of the process results are acceptable. For example, the processor can determine whether predetermined threshold values are met or a user can determine whether an image is in focus. If the result is acceptable then no adjustments are necessary and the image can be captured or the settings maintained to continue projecting the ultrasonic beam. If the result is not acceptable (for example the focus is not clear or the position of the detected event is not in the location that was intended to be targeted) then at operation 480 the processor or the user adjusts treatment settings for the elements, e.g., adjust the power level, focus, frequency, etc., and a refined beam is generated with the altered treatment settings at operation 420." [0099]).
Taffler modified by Vortman does not teach that the computing and imaging device is further configured to generate the one or more adjustments based on the material property data.
However, in the acoustic devices field of endeavor, Rosenzweig discloses asymmetry for acoustic radiation force impulse, which is analogous art. Rosenzweig teaches the material property data (“the property (e.g., shear wave velocity) is displayed as a function of location. Displacements for a number of locations are available in response to an ARFI pulse. A one, two, or three-dimensional distribution of those locations provides a corresponding spatial distribution of estimated velocity or property. For a representation of the tissue, the magnitude of the tissue characteristic modulates the color, hue, brightness, and/or other display characteristic for different pixels representing a tissue region.” [0069]).
Therefore, based on Rosenzweig’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler and Vortman to employ the computing and imaging device that is further configured to generate based on the material property data one or more adjustments to one or both of the acoustic beam for therapy generated by the first transducer array and an acoustic beam generated by the second transducer array and to send control signals to one or both of the first transducer array and the second transducer array based on the adjustments, as taught by Rosenzweig, in order to provide improved spatial distributions of material properties.
Claims 5-6, 14-15, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Taffler (US 20200055085), hereinafter Taffler, in view of Mahrooghy et al (US 20210035296), hereinafter, Mahrooghy, and Vortman et al (US20210204915), hereinafter, Vortman.
Regarding claim 5, Taffler modified by Vortman teaches the system of claim 1.
Taffler modified by Vortman does not explicitly teach that the computing and imaging device is configured to store the material property data in a data set.
However, in the ultrasound imaging field of endeavor, Mahrooghy discloses a system and method for feature extraction and classification on ultrasound tomography images, which is analogous art. Mahrooghy teaches that the computing and imaging device is configured to store the material property data in a data set (“During the scan, the ring transducer 120 may pass along the tissue, such as in an anterior-posterior direction between the chest wall and the nipple region of the breast to acquire an acoustic data set including measurements such as acoustic reflection, acoustic attenuation, and sound speed. The data set may be acquired at discrete scanning steps, or coronal “slices”.” [0104]. “A set of prognostic parameters can comprise a parameter of a corrected attenuation image or data set. Such a parameter can be of an ROI, of a tumor or of a peri-tumor. Sometimes, a difference in such a value between a tumor and a peri-tumor can be in a set of prognostic parameters. [0153]).
Therefore, based on Mahrooghy’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler and Vortman to have the computing and imaging device that is configured to store the material property data in a data set, as taught by Mahrooghy, in order to facilitate feature classification thereby improving diagnostic capabilities of the system.
Regarding claim 6, Taffler modified by Vortman and Mahrooghy teaches the system of claim 5.
Taffler modified by Vortman does not explicitly teach a trainer configured to train a machine learning model using at least a portion of the data set as training data.
However, in the ultrasound imaging field of endeavor, Mahrooghy discloses a system and method for feature extraction and classification on ultrasound tomography images, which is analogous art. Mahrooghy teaches a trainer (“machine learning algorithms” [0262]) configured to train a machine learning model (“a machine learning classifier model” [0007]) using at least a portion of the data set as training data (“Features can then be extracted from the ROI with the related subsets. Using feature selection technique(s), the most relevant features are then fed to train a machine learning classifier model. The trained classifier can then be fed features from an unknown tissue sample to determine a label or classification for the unknown tissue sample in response to the related feature subsets.” [0007]. “The systems and methods described herein may use machine learning algorithms for training classification models and/or making classifications (e.g., for labeling benign and malignant breast tissue in images from different imaging modalities. Machine learning algorithms herein may learn from and make classification on unknown data. Data may be any input, intermediate output, previous outputs, or training information, or otherwise any information provided to or by the algorithms.” [0262]. “A machine learning algorithm may use a supervised learning approach. In supervised learning, the algorithm can generate a function or model from training data.” [0263]).
Therefore, based on Mahrooghy’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler and Vortman to employ a trainer configured to train a machine learning model using at least a portion of the data set as training data, as taught by Mahrooghy, in order to facilitate feature classification thereby improving diagnostic capabilities of the system.
Regarding claim 14, Taffler teaches a method for ultrasound imaging (“a method of conducting ultrasonic therapy or ultrasonic imaging using an ultrasonic device" [0020]) comprising:
generating, one or more acoustic beams directed at a target with one or more of a first transducer array (210) and a second transducer array (220) of an ultrasound system (200) (“The generated ultrasonic waves from the first transducer array can deliver therapeutic energy to a region in the target, and the second transducer array can detect incident waves reflected or elicited from the region and generates the signal based on the incident waves, the signal carrying data to create a digital image of the target region or data that indicates a material property of the target region.” [0038]; “a driving circuit 230 to supply power. The driving circuit 230 can also include a processor, microprocessor or the like to transmit control signals, execute output timing algorithms,” [0078]; Fig. 2A);
receiving, at the second transducer array, reflected ultrasound that results from reflections of the one or more acoustic beams (“to detect reactive events such as reflected ultrasonic waves” [0078]);
generating, by the second transducer array, data based on the receiving of the reflected ultrasound (“the second transducer array can detect incident waves reflected or elicited from the region and generate the signal based on the incident waves, the signal carrying data to create a digital image of the target region.” [0050]);
generating, by a computing and imaging device of the ultrasound system (“a processor” [0098]), material property data (“At operation 460 the generated signal is processed, for example, a processor can apply calculations and algorithms to resolve the signal into readable value or an image for display on a screen, or use an algorithm to determine data from the signal that indicates a material property of a target region.” [0098]; Fig. 2A) based on the data generated by the second transducer array (“the second transducer array can detect incident waves reflected or elicited from the region and generates the signal based on the incident waves, the signal carrying data to create a digital image of the target region or data that indicates a material property of the target region.” [0038]).
Taffler does not explicitly teach storing, by the computing and imaging device, the material property data in a data set, and generating, by the computing and imaging device, a path for at least one of the one or more acoustic beams directed at the target based on the material property data.
However, in the ultrasound imaging field of endeavor, Mahrooghy discloses a system and method for feature extraction and classification on ultrasound tomography images, which is analogous art. Mahrooghy teaches storing, by the computing and imaging device, the material property data in a data set (“During the scan, the ring transducer 120 may pass along the tissue, such as in an anterior-posterior direction between the chest wall and the nipple region of the breast to acquire an acoustic data set including measurements such as acoustic reflection, acoustic attenuation, and sound speed. The data set may be acquired at discrete scanning steps, or coronal “slices”.” [0104]. “A set of prognostic parameters can comprise a parameter of a corrected attenuation image or data set. Such a parameter can be of an ROI, of a tumor or of a peri-tumor. Sometimes, a difference in such a value between a tumor and a peri-tumor can be in a set of prognostic parameters. [0153]).
Therefore, based on Mahrooghy’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler to employ the step of storing, by the computing and imaging device, the material property data in a data set, as taught by Mahrooghy, in order to facilitate feature classification thereby improving diagnostic capabilities of the system.
Taffler modifed by Mahrooghy does not teach generating, by the computing and imaging device, a path for at least one of the one or more acoustic beams directed at the target based on the material property data.
However, in the ultrasound systems field of endeavor, Vortman discloses focused ultrasound system with optimized monitoring of cavitation, which is analogous art. Vortman teaches generating, by the computing and imaging device, a path for at least one of the one or more acoustic beams directed at the target based on the material property data (“to predict acoustic paths of ultrasound beams” [0062]) (“using a physical model” [0063]) (“FIG. 5B is a flow chart illustrating an exemplary approach 530 for determining temporal profile parameters associated with the transducer elements in accordance herewith. In various embodiments, after the tissue characteristic(s) associated with the target region and/or non-target region(s) are determined, a physical model including a thermo-acoustic simulation may be implemented to predict acoustic paths of ultrasound beams transmitted from the transducer elements to the target region based at least in part on the determined tissue characteristic(s) (step 532).” [0062]. “Such functionality may include … determining the anatomical/tissue characteristics (e.g., the tissue type, location, size, thickness, density, structure, shape, vascularization, thermal time constant, etc.) associated with the target/non-target tissue, analyzing the images to identify calcifications in the non-target region(s), using a physical model to predict acoustic paths of ultrasound beams transmitted from the transducer elements to the target region" [0063]).
Therefore, based on Vortman’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler and Mahrooghy to employ the step of generating, by the computing and imaging device, a path for at least one of the one or more acoustic beams directed at the target based on the material property data, as taught by Vortman, in order to improve ultrasound therapy outcomes.
Regarding claim 15, Taffler modified by Mahrooghy and Vortman teaches the method of claim 14, wherein Taffler teaches that the material property data comprises one or more of absolute values or changes in longitudinal and shear acoustic velocity, attenuation, thermal expansion coefficient, backscatter (“backscattered waves”), average grain size, tissue nonlinearity, flowrate for fluid, and distortion or shifting of material (“At operation 450 the elements in the receive array generate electrical signals corresponding to the reactive event. For example, when the reactive event is backscattered waves from the generated waves, the elements generate a signal by converting energy from the reflected waves into a voltage signal. This signal may be based on directly-received backscatter waves” [0097]).
Regarding claim 18, Taffler modified by Mahrooghy and Vortman teaches the method of claim 14.
Taffler does not teach training a machine learning model using at least a portion of the data set as training data.
However, in the ultrasound imaging field of endeavor, Mahrooghy discloses a system and method for feature extraction and classification on ultrasound tomography images, which is analogous art. Mahrooghy teaches training a machine learning model (“a machine learning classifier model” [0007]) using at least a portion of the data set as training data (“Features can then be extracted from the ROI with the related subsets. Using feature selection technique(s), the most relevant features are then fed to train a machine learning classifier model. The trained classifier can then be fed features from an unknown tissue sample to determine a label or classification for the unknown tissue sample in response to the related feature subsets.” [0007]. “The systems and methods described herein may use machine learning algorithms for training classification models and/or making classifications (e.g., for labeling benign and malignant breast tissue in images from different imaging modalities. Machine learning algorithms herein may learn from and make classification on unknown data. Data may be any input, intermediate output, previous outputs, or training information, or otherwise any information provided to or by the algorithms.” [0262]. “A machine learning algorithm may use a supervised learning approach. In supervised learning, the algorithm can generate a function or model from training data.” [0263]).
Therefore, based on Mahrooghy’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler to employ the step of training a machine learning model using at least a portion of the data set as training data, as taught by Mahrooghy, in order to facilitate feature classification thereby improving diagnostic capabilities of the system.
Regarding claim 19, Taffler modified by Mahrooghy and Vortman teaches the method of claim 14.
Taffler teaches generating, by the computing and imaging device, one or more adjustments to the acoustic beam for therapy generated by the first transducer array and sending control signals to the first transducer array based on the adjustments (“The driving circuit 230 can also include a processor, microprocessor or the like to transmit control signals, execute output timing algorithms,” [0078]. “At operation 470 the processor or the user determines of the process results are acceptable. For example, the processor can determine whether predetermined threshold values are met or a user can determine whether an image is in focus. If the result is acceptable then no adjustments are necessary and the image can be captured or the settings maintained to continue projecting the ultrasonic beam. If the result is not acceptable (for example the focus is not clear or the position of the detected event is not in the location that was intended to be targeted) then at operation 480 the processor or the user adjusts treatment settings for the elements, e.g., adjust the power level, focus, frequency, etc., and a refined beam is generated with the altered treatment settings at operation 420." [0099]).
Regarding claim 21, Taffler modified by Mahrooghy and Vortman teaches the method of claim 14, wherein Taffler teaches that the target comprises tissue of a patient (“The generated ultrasonic waves from the first transducer array can deliver therapeutic energy to a region in the target.” [0038]; “activation of nerves and other neuronal structures, increasing fluid flow in venous structures through mechanical stress or otherwise, localized warming of deep tissue for physical therapy benefit, cell lysis," [0104]).
Regarding claim 22, Taffler modified by Mahrooghy and Vortman teaches the method of claim 18, wherein Taffler teaches that the material property data comprises material properties of the tissue (“a material property of the target region.” [0038]; “The reactive event can be, for example, ultrasonic imaging waves hitting an object in the target region and reflecting back, the ultrasonic therapeutic waves hitting an object in the target region and causing an increase in temperature, harmonics generated in the tissues by ultrasonic waves" [0095]).
Regarding claim 23, Taffler modified by Mahrooghy and Vortman teaches the method of claim 14, wherein Taffler teaches that at least one of the one or more acoustic beams is an acoustic beam for focused ultrasound therapy (“At operation 470 the processor or the user determines of the process results are acceptable. For example, the processor can determine whether predetermined threshold values are met or a user can determine whether an image is in focus … If the result is not acceptable (for example the focus is not clear or the position of the detected event is not in the location that was intended to be targeted) then at operation 480 the processor or the user adjusts treatment settings for the elements, e.g., adjust the power level, focus, frequency, etc., and a refined beam is generated with the altered treatment settings at operation 420.” [0099]. “The disclosed embodiments could be compatible with magnetic resonance imaging (MRI) systems. For MR-guided high intensity focused ultrasound (HIFU) treatments it is important that the array can be used within the magnet bore so that MR imaging can be carried out during operation.” [0101]).
Claims 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Taffler, Mahrooghy, and Vortman as applied to claim 14, and further in view of Rosenzweig et al (US 20200305842), hereinafter, Rosenzweig.
Regarding claim 16, Taffler modified by Mahrooghy and Vortman teaches the method of claim 14.
Taffler modified by Mahrooghy and Vortman does not teach generating one or more maps based on the material property data.
However, in the acoustic devices field of endeavor, Rosenzweig discloses asymmetry for acoustic radiation force impulse, which is analogous art. Rosenzweig teaches generating one or more maps (“color map” [0069]) based on the material property data (“the property (e.g., shear wave velocity) is displayed as a function of location. Displacements for a number of locations are available in response to an ARFI pulse. A one, two, or three-dimensional distribution of those locations provides a corresponding spatial distribution of estimated velocity or property. For a representation of the tissue, the magnitude of the tissue characteristic modulates the color, hue, brightness, and/or other display characteristic for different pixels representing a tissue region. The processor 18 determines a pixel value (e.g., RGB) or a scalar value converted to a pixel value. The image is generated as the scalar or pixel values. The image may be output to a … color map” [0069]).
Therefore, based on Rosenzweig’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler, Mahrooghy, and Vortman to have the step of generating one or more maps based on the material property data, as taught by Rosenzweig, in order to provide a spatial distribution of estimated shear wave velocity or other property.
Regarding claim 17, Taffler modified by Mahrooghy, Vortman, and Rosenzweig teaches the method of claim 16.
Taffler teaches generating, by the computing and imaging device, one or more adjustments to one or both of the acoustic beam for therapy generated by the first transducer array and an acoustic beam generated by the second transducer array and to send control signals to one or both of the first transducer array and the second transducer array based on the one or more adjustments (“The driving circuit 230 can also include a processor, microprocessor or the like to transmit control signals, execute output timing algorithms,” [0078]. “At operation 470 the processor or the user determines of the process results are acceptable. For example, the processor can determine whether predetermined threshold values are met or a user can determine whether an image is in focus. If the result is acceptable then no adjustments are necessary and the image can be captured or the settings maintained to continue projecting the ultrasonic beam. If the result is not acceptable (for example the focus is not clear or the position of the detected event is not in the location that was intended to be targeted) then at operation 480 the processor or the user adjusts treatment settings for the elements, e.g., adjust the power level, focus, frequency, etc., and a refined beam is generated with the altered treatment settings at operation 420." [0099]).
Taffler modified by Mahrooghy does not teach generating, by the computing and imaging device, the one or more adjustments based on the one or more maps.
However, in the acoustic devices field of endeavor, Rosenzweig discloses asymmetry for acoustic radiation force impulse, which is analogous art. Rosenzweig teaches the one or more maps (“the property (e.g., shear wave velocity) is displayed as a function of location. Displacements for a number of locations are available in response to an ARFI pulse. A one, two, or three-dimensional distribution of those locations provides a corresponding spatial distribution of estimated velocity or property. For a representation of the tissue, the magnitude of the tissue characteristic modulates the color, hue, brightness, and/or other display characteristic for different pixels representing a tissue region. The processor 18 determines a pixel value (e.g., RGB) or a scalar value converted to a pixel value. The image is generated as the scalar or pixel values. The image may be output to a … color map” [0069]).
Therefore, based on Rosenzweig’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler, Mahrooghy, and Vortman to employ the step of generating, by the computing and imaging device, based on the one or more maps one or more adjustments to one or both of the acoustic beam for therapy generated by the first transducer array and an acoustic beam generated by the second transducer array and to send control signals to one or both of the first transducer array and the second transducer array based on the one or more adjustments, as taught by Rosenzweig, in order to provide improved spatial distributions of material properties.
Regarding claim 20, Taffler modified by Mahrooghy, Vortman, and Rosenzweig teaches the method of claim 14.
Taffler teaches generating one or more adjustments to the acoustic beam for therapy generated by the first transducer array and to send control signals to the first transducer array based on the one or more adjustments (“The driving circuit 230 can also include a processor, microprocessor or the like to transmit control signals, execute output timing algorithms,” [0078]. “At operation 470 the processor or the user determines of the process results are acceptable. For example, the processor can determine whether predetermined threshold values are met or a user can determine whether an image is in focus. If the result is acceptable then no adjustments are necessary and the image can be captured or the settings maintained to continue projecting the ultrasonic beam. If the result is not acceptable (for example the focus is not clear or the position of the detected event is not in the location that was intended to be targeted) then at operation 480 the processor or the user adjusts treatment settings for the elements, e.g., adjust the power level, focus, frequency, etc., and a refined beam is generated with the altered treatment settings at operation 420." [0099]).
Taffler modified by Mahrooghy and Vortman does not teach generating the one or more adjustments based on the material property data.
However, in the acoustic devices field of endeavor, Rosenzweig discloses asymmetry for acoustic radiation force impulse, which is analogous art. Rosenzweig teaches the material property data (“the property (e.g., shear wave velocity) is displayed as a function of location. Displacements for a number of locations are available in response to an ARFI pulse. A one, two, or three-dimensional distribution of those locations provides a corresponding spatial distribution of estimated velocity or property. For a representation of the tissue, the magnitude of the tissue characteristic modulates the color, hue, brightness, and/or other display characteristic for different pixels representing a tissue region.” [0069]).
Therefore, based on Rosenzweig’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler, Mahrooghy, and Vortman to employ the step of generating based on the material property data one or more adjustments to one or both of the acoustic beam for therapy generated by the first transducer array and an acoustic beam generated by the second transducer array and to send control signals to one or both of the first transducer array and the second transducer array based on the one or more adjustments, as taught by Rosenzweig, in order to provide improved spatial distributions of material properties.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Taffler, Mahrooghy, and Vortman as applied to claim 6, and further in view of Neben et al (US 20230148995), hereinafter, Neben.
Regarding claim 7, Taffler modified by Mahrooghy and Vortman teaches the system of claim 6.
Taffler teaches generating one or more adjustments to the acoustic beam for therapy generated by the first transducer array and to send control signals to the first transducer array based on the one or more adjustments (“The driving circuit 230 can also include a processor, microprocessor or the like to transmit control signals, execute output timing algorithms,” [0078]. “At operation 470 the processor or the user determines of the process results are acceptable. For example, the processor can determine whether predetermined threshold values are met or a user can determine whether an image is in focus. If the result is acceptable then no adjustments are necessary and the image can be captured or the settings maintained to continue projecting the ultrasonic beam. If the result is not acceptable (for example the focus is not clear or the position of the detected event is not in the location that was intended to be targeted) then at operation 480 the processor or the user adjusts treatment settings for the elements, e.g., adjust the power level, focus, frequency, etc., and a refined beam is generated with the altered treatment settings at operation 420." [0099]).
Taffler modified by Mahrooghy and Vortman does not teach generating the one or more adjustments with a machine learning system and the machine learning model.
However, in the ultrasound imaging field of endeavor, Neben discloses a method and system for adjusting scan pattern for ultrasound imaging, which is analogous art. Neben teaches generating the one or more adjustments with a machine learning system (a system to implement “methods of artificial intelligence” [0088]) and the machine learning model (“Devices (150) such as that shown in FIG. 1B may be used in various imaging and/or treatment (e.g., HIFU) applications,” [0044]; “methods of artificial intelligence (AI) are used to infer how to adjust the scan pattern to yield the desired scan pattern. For instance, using AI, the precise adjustment to the steering angle(s) may be identified from information in the current ultrasound image without needing to test alternative steering angles, or as many steering angles. An AI model may be built, for example, by training the AI model on ultrasound image frames each manually labeled with the appropriate change in scan pattern to acquire a better image. Through the training, the model learns to predict the change in scan pattern for any given ultrasound image frame.” [0088]).
Therefore, based on Neben’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler, Mahrooghy, and Vortman to generate the one or more adjustments with a machine learning system and the machine learning model, as taught by Neben, in order to simplify imaging by using AI-powered automation.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Taffler and Vortman as applied to claim 1, and further in view of Al Mayiah et al (US 20160339273), Al Mayiah.
Regarding claim 11, Taffler modified by Vortman teaches the system of claim 1.
Taffler modified by Vortman does not teach that the computing device is further configured to: determine, based on the material property data, a material stiffness of target tissue, and determine, based on the material stiffness of the target tissue, minimum amplitudes to damage the target tissue without damaging other tissue that is not the target tissue.
However, in the ultrasound devices and methods field of endeavor, Al Mayiah discloses therapeutic ultrasound apparatus and method, which is analogous art. Al Mayiah teaches that the computing device is further configured to: determine, based on the material property data, a material stiffness of target tissue and determine, based on the material stiffness of the target tissue, minimum amplitudes to damage the target tissue without damaging other tissue that is not the target tissue (“Current methods using pulsed rate ultrasound require higher intensities than HIFU to generate cavitation. Indeed, the peak negative pressure is twice that used in HIFU thermal ablation. This increases the risk of healthy tissue damage causing pain and the risk of internal organ injury.” [0007]; “carrier wave 300 is amplitude modulated by an arbitrary modulating wave 302 to produce a high frequency amplitude modulated signal 304. The flexibility to shape the modulating signal allows the cavitation therapy to be tailored to the tumour tissue stiffness. Tissue stiffness can very between tumours and between different regions of the same tumour.” [0039]. To have the cavitation therapy tailored as disclosed, the tissue stiffness has to be determined).
Therefore, based on Al Mayiah’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler and Vortman to have the computing device that is further configured to: determine, based on the material property data, a material stiffness of target tissue, and determine, based on the material stiffness of the target tissue, minimum amplitudes to damage the target tissue without damaging other tissue that is not the target tissue as taught by Al Mayiah, in order to reduce the risk of healthy tissue damage and internal organ injury.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Taffler, Mahrooghy, and Vortman as applied to claim 14, and further in view of Al Mayiah et al (US 20160339273), Al Mayiah.
Regarding claim 24, Taffler modified by Mahrooghy and Vortman teaches the method of claim 14.
Taffler modified by Mahrooghy and Vortman does not teach determining, based on the material property data, a material stiffness of target tissue, and determining, based on the material stiffness of the target tissue, minimum amplitudes to damage the target tissue without damaging other tissue that is not the target tissue.
However, in the ultrasound devices and methods field of endeavor, Al Mayiah discloses therapeutic ultrasound apparatus and method, which is analogous art. Al Mayiah teaches determining, based on the material property data, a material stiffness of target tissue and determining, based on the material stiffness of the target tissue, minimum amplitudes to damage the target tissue without damaging other tissue that is not the target tissue (“Current methods using pulsed rate ultrasound require higher intensities than HIFU to generate cavitation. Indeed, the peak negative pressure is twice that used in HIFU thermal ablation. This increases the risk of healthy tissue damage causing pain and the risk of internal organ injury.” [0007]; “carrier wave 300 is amplitude modulated by an arbitrary modulating wave 302 to produce a high frequency amplitude modulated signal 304. The flexibility to shape the modulating signal allows the cavitation therapy to be tailored to the tumour tissue stiffness. Tissue stiffness can very between tumours and between different regions of the same tumour.” [0039]. To have the cavitation therapy tailored as disclosed, the tissue stiffness has to be determined).
Therefore, based on Al Mayiah’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler, Mahrooghy, and Vortman to have the steps of determining, based on the material property data, a material stiffness of target tissue, and determining, based on the material stiffness of the target tissue, minimum amplitudes to damage the target tissue without damaging other tissue that is not the target tissue as taught by Al Mayiah, in order to reduce the risk of healthy tissue damage and internal organ injury.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Taffler and Vortman as applied to claim 1, and further in view of Warnking (US 20160008636), Warnking.
Regarding claim 12, Taffler modified by Vortman teaches the system of claim 1.
Taffler modified by Vortman does not teach that the first transducer array and the second transducer array are implemented as a same transducer array, or that the first transducer array is further configured to receive reflected ultrasound and generate data based on the reflected ultrasound received at the first transducer array.
However, in the ultrasound devices and methods field of endeavor, Warnking discloses therapeutic ultrasound apparatus and method, which is analogous art. Warnking teaches that the first transducer array and the second transducer array are implemented as the same transducer array (64) (112), or wherein the first transducer array is further and configured to receive reflected ultrasound and generate data based on the reflected ultrasound received at the first transducer array (“A dual mode ablation/imaging circular ultrasound array is used to create circular or partial circular lesions. The sites of the individual lesion segments are identified in an ultrasound 2D image.” Abstract; “a split transducer array 64, where one circular or annular section 62 is optimized for imaging with the above described diffraction mechanism (layer 60) and another circular or annular section 68 optimized for therapy.” [0059]. “Transducer array 112 includes a plurality of electrically isolated and independently energizable piezoelectric or PZT transducer elements organized into a therapy transducer section 202 and an imaging transducer section 204 (FIG. 7). [0066]).
Therefore, based on Warnking’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler and Vortman to have the first transducer array and the second transducer array that are implemented as the same transducer array, or the first transducer array that is further configured to receive reflected ultrasound and generate data based on the reflected ultrasound received at the first transducer array, as taught by Warnking, in order to reduce the size of the device.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Taffler as applied to claim 14, and further in view of Warnking (US 20160008636), Warnking.
Regarding claim 25, Taffler modified by Mahrooghy and Vortman teaches the method of claim 14.
Taffler modified by Mahrooghy and Vortman does not teach the first transducer array and the second transducer array that are implemented as the same transducer array, and the method further comprising receiving, with the first transducer array reflected ultrasound and generating data based on the reflected ultrasound received at the first transducer array.
However, in the ultrasound devices and methods field of endeavor, Warnking discloses therapeutic ultrasound apparatus and method, which is analogous art. Warnking teaches that the first transducer array and the second transducer array are implemented as the same transducer array (64) (112), or wherein the first transducer array is further and configured to receive reflected ultrasound and generate data based on the reflected ultrasound received at the first transducer array (“A dual mode ablation/imaging circular ultrasound array is used to create circular or partial circular lesions. The sites of the individual lesion segments are identified in an ultrasound 2D image.” Abstract; “a split transducer array 64, where one circular or annular section 62 is optimized for imaging with the above described diffraction mechanism (layer 60) and another circular or annular section 68 optimized for therapy.” [0059]. “Transducer array 112 includes a plurality of electrically isolated and independently energizable piezoelectric or PZT transducer elements organized into a therapy transducer section 202 and an imaging transducer section 204 (FIG. 7).” [0066]).
Therefore, based on Warnking’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler, Mahrooghy, and Vortman to have the first transducer array and the second transducer array that are implemented as the same transducer array, as taught by Warnking, in order to reduce the size of the device. In the invention of Taffler and Warnking, receiving reflected ultrasound is with the first transducer array and generating data is based on the reflected ultrasound received at the first transducer array.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Taffler and Vortman as applied to claim 1, and further in view of Amadou et al (US 20250000492), Amadou.
Regarding claim 13, Taffler modified by Vortman teaches the system of claim 1.
Taffler modified by Vortman does not teach that the computing and imaging device is further configured to use data from Magnetic Resonance (MR) or Computed Tomography (CT) in addition to the data generated by the second transducer array to generate the material property data.
However, in the medical imaging field of endeavor, Amadou discloses augmenting ultrasound simulations using CT data, which is analogous art. Amadou teaches that the computing and imaging device is further configured to use data from Magnetic Resonance (MR) or Computed Tomography (CT) in addition to the data generated by the second transducer array to generate the material property data (“compute tissue properties” [0010]) (Abstract: “Systems and methods augmenting ultrasound simulations using photon counting computed tomography (CT) data in order to create simulated ultrasound data with fine tissue detail. A virtual volume is generated from acoustic properties derived from the photon counting CT data.”; “a system for generating simulated ultrasound data is provided. The system includes a photon counting CT imaging device and a control unit. The photon counting CT imaging device is configured to acquire photon counting CT data of a region of a patient. The control unit includes at least one processor and a memory and is configured to: generate a three-dimensional volume from the photon counting CT data, the three-dimensional volume comprising a plurality of voxels; compute tissue properties for each of the voxels of the plurality of voxels from the photon counting CT data; determine acoustic properties of each of the voxels from the tissue properties; [0010]).
Therefore, based on Amadou’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler and Vortman to have the computing and imaging device that is further configured to use data from Magnetic Resonance (MR) or Computed Tomography (CT) in addition to the data generated by the second transducer array to generate the material property data, as taught by Amadou, in order to confirm that the generated material property data are sufficiently accurate.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Taffler, Mahrooghy, and Vortman as applied to claim 14, and further in view of Amadou et al (US 20250000492), Amadou.
Regarding claim 26, Taffler modified by Mahrooghy and Vortman teaches the method of claim 14.
Taffler modified by Mahrooghy and Vortman does not teach using, by the computing and imaging device, data from Magnetic Resonance (MR) or Computed Tomography (CT) in addition to the data generated by the second transducer array to generate the material property data.
However, in the medical imaging field of endeavor, Amadou discloses augmenting ultrasound simulations using CT data, which is analogous art. Amadou teaches using, by the computing and imaging device, data from Magnetic Resonance (MR) or Computed Tomography (CT) in addition to the data generated by the second transducer array to generate the material property data (“compute tissue properties” [0010]) (Abstract: “Systems and methods augmenting ultrasound simulations using photon counting computed tomography (CT) data in order to create simulated ultrasound data with fine tissue detail. A virtual volume is generated from acoustic properties derived from the photon counting CT data.”; “a system for generating simulated ultrasound data is provided. The system includes a photon counting CT imaging device and a control unit. The photon counting CT imaging device is configured to acquire photon counting CT data of a region of a patient. The control unit includes at least one processor and a memory and is configured to: generate a three-dimensional volume from the photon counting CT data, the three-dimensional volume comprising a plurality of voxels; compute tissue properties for each of the voxels of the plurality of voxels from the photon counting CT data; determine acoustic properties of each of the voxels from the tissue properties; [0010]).
Therefore, based on Amadou’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Taffler, Mahrooghy, and Vortman to have the step of using, by the computing and imaging device, data from Magnetic Resonance (MR) or Computed Tomography (CT) in addition to the data generated by the second transducer array to generate the material property data, as taught by Amadou, in order to confirm that the generated material property data are sufficiently accurate.
Response to Arguments
Applicant's arguments filed 01/26/2026 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Taffler view of Vortman.
Response to the 35 U.S.C. §102 and §103 rejection arguments on pages 7-10 of the REMARKS.
Claims 1-26
The Applicant argues that “Claim 1 includes the feature of "a computing and imaging device connected to the first transducer array and the second transducer array and configured to receive the data generated by the second transducer array, generate material property data from the data received from the second transducer array, and generate a path for the acoustic beam for therapy based on the material property data." Taffler does not anticipate this feature of claim 1.” (Page 8). The Examiner agrees and therefore the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Taffler view of Vortman. The dependent claims are not allowable because the independent claims are not allowable and because additional secondary references meet additional limitations of the dependent claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
Prosecution Insights