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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slayton et al (US 6050943), hereinafter Slayton.
Regarding claim 1, Slayton teaches a system (200, 300, 400), comprising:
an ultrasound transmitter (110) to transmit ultrasound signals through a region of tissue (800) (“The unit is operated so that the acoustic transducer assembly 100 scans the region-of-interest, including the treatment region, in the target tissue 800 with the acoustic waves.” Col. 7, l. 16 – 32; “The therapy subsystem 300 connected to the acoustic transducer assembly 100” Col. 7, l. 35 - 40; “an acoustic pulse wave is first generated by a single transmitting element 110 among the linear array of the acoustic transducer assembly 100.” Col. 8, l. 55-67; Figs. 2-4 and 6) during an ablation procedure (“one of objectives of the therapeutic application is to create a very well-placed thermal gradient in the target tissue to selectively destroy certain regions thereof.” Col. 1, l. 53- col. 2, l. 5);
an ultrasound receiver (120) to receive the ultrasound signals transmitted by the ultrasound transmitter (“The returning acoustic signal is received by the acoustic transducer assembly 100” Col. 7, l. 16-32; “the echoes come back towards the acoustic transducer assembly 100, where they are detected by remaining elements 120 in the linear array” Col. 8, l. 55-Col. 9, l. 35; Fig. 6) after the ultrasound signals pass through the region of tissue (“The above transmitting-and-detecting sequence is repeated for each unique transmitter-receiver combination to form a large data set.” Figs. 2-4); and
a signal processor (200), communicatively coupled to the ultrasound transmitter and the ultrasound receiver (“The unit is operated so that the acoustic transducer assembly 100 scans the region-of-interest, including the treatment region, in the target tissue 800 with the acoustic waves. The returning acoustic signal is received by the acoustic transducer assembly 100, and then sent to the imaging subsystem 200 to generate ultrasonic images of the treatment region.” Col. 7, l. 16-32; Fig. 2), to:
communicate with the ultrasound transmitter and the ultrasound receiver to obtain a set of measurements related to the ultrasound signals transmitted through the region of tissue during the ablation procedure (“Since the speed of sound in the target tissue 800 exhibits temperature dependency, the acoustic wavefronts will be sped up or slowed down in certain regions based on the temperature gradients existing in the target tissue 800. Upon reaching a boundary 850 used for reference, the acoustic wavefronts are reflected thereon so that the reflected wavefronts, i.e., the echoes come back towards the acoustic transducer assembly 100, where they are detected by remaining elements 120 in the linear array. Upon the echoes returned from the target tissue 800 are detected by the acoustic transducer assembly 100, a certain signal is sent to the temperature monitoring subsystem 400 in which the time-of-flight data of the detected echoes (ire., the returned acoustic wavefronts) which is a period of time required from the emission of a certain acoustic pulse to the detection of the corresponding echo (the reflected acoustic wave) is calculated.” Col. 8, l. 55 – Col. 9, l. 10);
determine one or more acoustic characteristics of the ultrasound signals transmitted through the region of tissue based on the set of measurements (“Finally, using propagation path data, the obtained time-of-flight data is numerically converted into speed data of sound in the target tissue, and then further into a matrix of temperature values.” Col. 9, l. 10-27; “the amplitude of the returned echos can also be used to create an image of the acoustic attenuation.” Col. 9, l. 59- 62); and
generate an image representing a thermal map of the region of tissue (“a three-dimensional map of temperature … an accurate spatial map of heating” Col. 10, l. 34-46) during the ablation procedure (“The obtained temperature data is sent to the video display terminal 500 for visualization by the user, and also sent to the therapy subsystem 300 previously described for dynamic control of the heating process for the therapeutic treatment purposes.” Col. 9, l. 63-67. “This architecture non-invasively provides essential functions of real-time imaging and temperature monitoring of the treatment region during the therapeutic treatment process.” Col. 10, l. 52 - 58) based on a mapping between the one or more acoustic characteristics of the ultrasound signals and changes in temperature (“With reference to FIG. 6, a temperature monitoring subsystem 400 which is interfaced to the acoustic transducer assembly 100 and monitor 500 is described below. The temperature monitoring subsystem 400 connected to the acoustic transducer assembly 100 via a cable 410 includes a control unit. The unit is operated so that the temperature mapping process as follows is properly conducted.” Col. 8, l. 48-54; “using propagation path data, the obtained time-of-flight data is numerically converted into speed data of sound in the target tissue, and then further into a matrix of temperature values.” Col. 9, l. 10-27. “In accordance with a particularly preferred aspect, the array can be rotated to allow for a three-dimensional map of temperature to be measured. By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 39 - 46).
Regarding claim 2, Slayton teaches the system of claim 1, wherein the one or more acoustic characteristics include changes in one or more of speeds or intensities at which the ultrasound signals travel through the region of tissue (“the obtained time-of-flight data is numerically converted into speed data of sound in the target tissue” Col. 9, l. 10-27), and
wherein the mapping used to generate the image representing the thermal map of the region of tissue is based on a relationship between changes in temperature and the changes in the speeds or intensities at which the ultrasound signals travel through the region of tissue (“Since the speed of sound in the target tissue 800 exhibits temperature dependency, the acoustic wavefronts will be sped up or slowed down in certain regions based on the temperature gradients existing in the target tissue 800.” Col. 8, l. 59 – 67; “using propagation path data, the obtained time-of-flight data is numerically converted into speed data of sound in the target tissue, and then further into a matrix of temperature values.” Col. 9, l. 10-27).
Regarding claim 3, Slayton teaches the system of claim 2, wherein the mapping used to generate the image representing the thermal map of the region of tissue is further based on temperature-dependent variations in one or more of a time of flight (“t represents the propagation time (i.e., the time of flight)” Col. 9, l. 10-35; “Along a path s the acoustic time-of-flight, .tau. will be the integral of the incremental delays” Col. 10, l. 1-18), an attenuation (“the acoustic attenuation in tissue approximately doubles from 50.degree. C. to 70.degree. C.” Col. 7, l. 55-67), a phase (“in each region computing the temperature from attenuation techniques or phase shifts, a temperature profile can be accurately determined.” Col. 8, l. 40-47), or a nonlinearity for at least one of the ultrasound signals transmitted through the region of tissue (“to compensate for changes in temperature along some line, including, for example, before/after the hot spot. For example, by windowing out regions from the transducer to the region of interest and in each region computing the temperature from attenuation techniques or phase shifts, a temperature profile can be accurately determined.” Col. 8, l. 40-47; “each of these factors can … be included in the analysis.” Col. 10, l. 17-19).
Regarding claim 4, Slayton teaches the system of claim 1, wherein:
the ultrasound receiver includes a transducer array (100) having one or more transducer elements (120) with known locations, and the signal processor is further to:
determine a relative geometry between the ultrasound transmitter (110) and the ultrasound receiver based on the known locations of the one or more transducer elements and time of flight data associated with ultrasound signals transmitted from the ultrasound transmitter to the ultrasound receiver before the ablation procedure (“With reference to FIG. 5, the echo waveform in a windowed region of a waveform A obtained before heating and a waveform B after heating can be examined,” Col. 8, l. 21-25; “an acoustic pulse wave is first generated by a single transmitting element 110 among the linear array of the acoustic transducer assembly 100…Upon reaching a boundary 850 used for reference, the acoustic wavefronts are reflected thereon so that the reflected wavefronts, i.e., the echoes come back towards the acoustic transducer assembly 100, where they are detected by remaining elements 120 in the linear array…The above transmitting-and-detecting sequence is repeated for each unique transmitter-receiver combination to form a large data set.” Col. 8, l. 55-Col. 9, l. 35; Fig. 6. Because the “single transmitting element 110 among the linear array of the acoustic transducer assembly 100” has to be determined before the ablation, “before heating”, a relative geometry is determined in advance as claimed. Col. 8, l. 21-25).
Regarding claim 5, Slayton teaches the system of claim 4, wherein the signal processor is to generate the image representing the thermal map of the region of tissue using one or more tomographic techniques based on the relative geometry between the ultrasound transmitter and the ultrasound receiver (“In any event, by considering the intersecting paths, such as shown in FIG. 7, superimposed over a grid of pixels, where each pixel represents an area (volume) a tomographic configuration shown in FIG. 8 is obtained. By tracing the propagation and reception of the rays a solution to the velocity in each pixel from the matrix can be calculated…Given the dependence of the speed of sound in tissue with temperature, the spatial temperature distribution in each pixel is thus determined…By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 19 - 46).
Regarding claim 6, Slayton teaches the system of claim 1, wherein the signal processor, when generating the thermal map of the region of tissue, is further to:
use a thermal propagation model to segment the region of tissue into groups of voxels that have similar temperatures (“by considering the intersecting paths, such as shown in FIG. 7, superimposed over a grid of pixels, where each pixel represents … volume … a tomographic configuration shown in FIG. 8 is obtained. By tracing the propagation and reception of the rays a solution to the velocity in each pixel from the matrix can be calculated…Given the dependence of the speed of sound in tissue with temperature, the spatial temperature distribution in each pixel is thus determined…By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 19 - 46); and
reduce a region of interest to be represented by the thermal map to an area where the ultrasound signals are causing a change in temperature during the ablation procedure (“the temperature monitoring subsystem can map and monitor the temperature of the treatment region and display the temperature on the display” Abstract. “By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 19 - 46) based on the groups of voxels that have the similar temperatures (“the spatial temperature distribution in each pixel is thus determined” Col. 10, l. 19 – 46. Each group can contain a single voxel).
Regarding claim 16, Slayton teaches a non-transitory computer-readable medium storing instructions (instructions for subsystems 200, 300, and 400), the instructions comprising:
one or more instructions that, when executed by one or more processors, cause the one or more processors to:
determine relative locations (seen in Figs. 6-7) associated with one or more ultrasound transmitters (110) arranged to transmit ultrasound signals through a region of tissue (800) during an ablation procedure (“one of objectives of the therapeutic application is to create a very well-placed thermal gradient in the target tissue to selectively destroy certain regions thereof.” Col. 1, l. 53- col. 2, l. 5) and one or more ultrasound receivers (120) arranged to receive the ultrasound signals transmitted by the one or more ultrasound transmitters after the ultrasound signals pass through the region of tissue (“With reference to FIG. 5, the echo waveform in a windowed region of a waveform A obtained before heating and a waveform B after heating can be examined,” Col. 8, l. 21-25; “an acoustic pulse wave is first generated by a single transmitting element 110 among the linear array of the acoustic transducer assembly 100…Upon reaching a boundary 850 used for reference, the acoustic wavefronts are reflected thereon so that the reflected wavefronts, i.e., the echoes come back towards the acoustic transducer assembly 100, where they are detected by remaining elements 120 in the linear array…The above transmitting-and-detecting sequence is repeated for each unique transmitter-receiver combination to form a large data set.” Col. 8, l. 55-Col. 9, l. 35; Fig. 6. Because the “single transmitting element 110 among the linear array of the acoustic transducer assembly 100” has to be determined before the ablation, “before heating”, relative locations are determined as claimed. Col. 8, l. 21-25);
calculate a set of temperature-dependent measurements (“the time-of-flight data of the detected echoes” Col. 8, l. 55 – Col. 9, l. 10) for the ultrasound signals transmitted through the region of tissue during the ablation procedure (“Since the speed of sound in the target tissue 800 exhibits temperature dependency, the acoustic wavefronts will be sped up or slowed down in certain regions based on the temperature gradients existing in the target tissue 800…Upon the echoes returned from the target tissue 800 are detected by the acoustic transducer assembly 100, a certain signal is sent to the temperature monitoring subsystem 400 in which the time-of-flight data of the detected echoes (ire., the returned acoustic wavefronts) which is a period of time required from the emission of a certain acoustic pulse to the detection of the corresponding echo (the reflected acoustic wave) is calculated.” Col. 8, l. 55 – Col. 9, l. 10);
determine, based on the set of temperature-dependent measurements and the relative locations associated with the one or more ultrasound transmitters and the one or more ultrasound receivers, one or more acoustic characteristics of the ultrasound signals transmitted through the region of tissue (“Finally, using propagation path data, the obtained time-of-flight data is numerically converted into speed data of sound in the target tissue, and then further into a matrix of temperature values.” Col. 9, l. 10-27; “the amplitude of the returned echos can also be used to create an image of the acoustic attenuation.” Col. 9, l. 59- 62; Figs. 5-7);
wherein the one or more acoustic characteristics include one or more of a speed, an intensity, an attenuation, a phase, or a nonlinearity for the ultrasound signals (“speed data of sound” Col. 9, l. 59- 62; Figs. 5-7); and
generate an image representing a thermal map of the region of tissue (“a three-dimensional map of temperature … an accurate spatial map of heating” Col. 10, l. 34-46) during the ablation procedure (“The obtained temperature data is sent to the video display terminal 500 for visualization by the user, and also sent to the therapy subsystem 300 previously described for dynamic control of the heating process for the therapeutic treatment purposes.” Col. 9, l. 63-67. “This architecture non-invasively provides essential functions of real-time imaging and temperature monitoring of the treatment region during the therapeutic treatment process.” Col. 10, l. 52 - 58) based on temperature-dependent variations in the one or more acoustic characteristics of the ultrasound signals (“in each region computing the temperature from attenuation techniques or phase shifts, a temperature profile can be accurately determined.” Col. 8, l. 40-47; “using propagation path data, the obtained time-of-flight data is numerically converted into speed data of sound in the target tissue, and then further into a matrix of temperature values.” Col. 9, l. 10-27; “the array can be rotated to allow for a three-dimensional map of temperature to be measured. By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 39 - 46).
Regarding claim 20, Slayton teaches the non-transitory computer-readable medium of claim 16, wherein the image representing the thermal map of the region of tissue is generated using one or more tomographic techniques (“a tomographic configuration” Col. 10, l. 19 - 46) based on the relative locations associated with the one or more ultrasound transmitters and the one or more ultrasound receivers (“In any event, by considering the intersecting paths, such as shown in FIG. 7, superimposed over a grid of pixels, where each pixel represents an area (volume) a tomographic configuration shown in FIG. 8 is obtained. By tracing the propagation and reception of the rays a solution to the velocity in each pixel from the matrix can be calculated…Given the dependence of the speed of sound in tissue with temperature, the spatial temperature distribution in each pixel is thus determined…By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 19 - 46).
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 7 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Slayton as applied to claims 1 and 16, and further in view of Anand et al (US 20160242838), hereinafter, Anand.
Regarding claim 7, Slayton teaches the system of claim 1, wherein the signal processor is further to:
use one or more tomographic image reconstruction techniques to generate the image representing the thermal map of the region of tissue (“by considering the intersecting paths, such as shown in FIG. 7, superimposed over a grid of pixels, where each pixel represents … volume … a tomographic configuration shown in FIG. 8 is obtained. By tracing the propagation and reception of the rays a solution to the velocity in each pixel from the matrix can be calculated…Given the dependence of the speed of sound in tissue with temperature, the spatial temperature distribution in each pixel is thus determined…By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 19 - 46).
Slayton does not teach that the signal processor is further to obtain patient-specific simulation data including an expected temperature evolution for the region of tissue during the ablation procedure based on a three-dimensional anatomical image of the region of tissue and one or more biophysical parameters; and
use the patient-specific simulation data including the expected temperature evolution for the region of tissue in combination with one or more tomographic image reconstruction techniques to generate the image representing the thermal map of the region of tissue.
However, in the temperature monitoring systems field of endeavor, Anand discloses temperature monitoring apparatus and method for monitoring a temperature within a tissue, which is analogous art. Anand teaches that the signal processor is further to obtain patient-specific simulation data including an expected temperature evolution for the region of tissue during the ablation procedure based on a three-dimensional anatomical image of the region of tissue (“The monitoring apparatus further comprises a temperature estimation unit (46) including a heat transfer model (48) for estimating a temperature in a region of interest (26) within the tissue, wherein the heat transfer model is based on medical images of the tissue.” Abstract; “the medical images are ultrasound images, computer tomography images and/or magnet resonance tomography images. This is a possibility to provide precise medical images in order to improve the temperature estimation on the basis of the heated transfer model.” [0040]. “The measurement data of the ultrasound shear wave detection is continuously provided to the heat transfer model in order to adapt the model and to continuously adapt the specific parameters of the model.” [0049]) and one or more biophysical parameters (“Usually the model utilizes initial values for the tissue parameters derived e.g. from literature values. For example, the electrical conductivity is σ=0.148 S/m, the thermal conductivity is 0.465 W/m° C., the density is 1060 kg/m.sup.3, the heat capacity is 3600 J/C kg, the perfusion rate is 6.4×10.sup.−3/sec.” [0054]) and
use the patient-specific simulation data including the expected temperature evolution for the region of tissue to generate the image representing the thermal map of the region of tissue (““By means of this flexibility of the thermal model, e.g. for local heterogeneities, the temperature map and the ablation zone 16 can be precisely determined so that the boundary of the ablation zone 16 as the region of interest can be precisely measured non-invasively in order to optimize the thermal treatment.” [0055]; Fig. 2).
Therefore, based on Anand’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 Slayton to employ the signal processor that is further to obtain patient-specific simulation data including an expected temperature evolution for the region of tissue during the ablation procedure based on a three-dimensional anatomical image of the region of tissue and one or more biophysical parameters; and use the patient-specific simulation data including the expected temperature evolution for the region of tissue to generate the image representing the thermal map of the region of tissue, as taught by Anand, in order to facilitate ablation in the region of interest. In the combined invention, the signal processor is further to: use the patient-specific simulation data including the expected temperature evolution for the region of tissue in combination with one or more tomographic image reconstruction techniques to generate the image representing the thermal map of the region of tissue, because the one or more tomographic image reconstruction techniques are disclosed by the primary reference.
Regarding claim 18, Slayton teaches the non-transitory computer-readable medium of claim 16, wherein the one or more instructions further cause the one or more processors to:
obtain data including a temperature evolution for the region of tissue during the ablation procedure (“This architecture non-invasively provides essential functions of real-time imaging and temperature monitoring of the treatment region during the therapeutic treatment process.” Col. 10, l. 52 - 58) based on a three-dimensional anatomical image of the region of tissue (“The unit is operated so that the acoustic transducer assembly 100 scans the region-of-interest, including the treatment region, in the target tissue 800 with the acoustic waves. The returning acoustic signal is received by the acoustic transducer assembly 100, and then sent to the imaging subsystem 200 to generate ultrasonic images of the treatment region.” Col. 7, l. 16-32; “both echo time shifts and amplitude changes may be employed. For example, by scanning the windowed region in one, two, or three dimensions, a temperature map or image can be obtained.” Col. 8, l. 35-47),
wherein the image representing the thermal map of the region of tissue is generated based on the temperature evolution for the region of tissue in combination with one or more tomographic image reconstruction techniques (“by considering the intersecting paths, such as shown in FIG. 7, superimposed over a grid of pixels, where each pixel represents … volume … a tomographic configuration shown in FIG. 8 is obtained. By tracing the propagation and reception of the rays a solution to the velocity in each pixel from the matrix can be calculated…Given the dependence of the speed of sound in tissue with temperature, the spatial temperature distribution in each pixel is thus determined…By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 19 - 46).
Slayton does not teach the data being simulation data including an expected temperature evolution for the region of tissue during the ablation procedure based on a three-dimensional anatomical image of the region of tissue and one or more biophysical parameters, wherein the image representing the thermal map of the region of tissue is generated based on the expected temperature evolution for the region of tissue.
However, in the temperature monitoring systems field of endeavor, Anand discloses temperature monitoring apparatus and method for monitoring a temperature within a tissue, which is analogous art. Anand teaches the data being simulation data including an expected temperature evolution for the region of tissue during the ablation procedure based on a three-dimensional anatomical image of the region of tissue (“The monitoring apparatus further comprises a temperature estimation unit (46) including a heat transfer model (48) for estimating a temperature in a region of interest (26) within the tissue, wherein the heat transfer model is based on medical images of the tissue.” Abstract; “the medical images are ultrasound images, computer tomography images and/or magnet resonance tomography images. This is a possibility to provide precise medical images in order to improve the temperature estimation on the basis of the heated transfer model.” [0040]. “The measurement data of the ultrasound shear wave detection is continuously provided to the heat transfer model in order to adapt the model and to continuously adapt the specific parameters of the model.” [0049]) and one or more biophysical parameters (“Usually the model utilizes initial values for the tissue parameters derived e.g. from literature values. For example, the electrical conductivity is σ=0.148 S/m, the thermal conductivity is 0.465 W/m° C., the density is 1060 kg/m.sup.3, the heat capacity is 3600 J/C kg, the perfusion rate is 6.4×10.sup.−3/sec.” [0054]), wherein the image representing the thermal map of the region of tissue is generated based on the expected temperature evolution for the region of tissue (“By means of this flexibility of the thermal model, e.g. for local heterogeneities, the temperature map and the ablation zone 16 can be precisely determined so that the boundary of the ablation zone 16 as the region of interest can be precisely measured non-invasively in order to optimize the thermal treatment.” [0055]; Fig. 2).
Therefore, based on Anand’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 Slayton to employ the simulation data including an expected temperature evolution for the region of tissue during the ablation procedure based on a three-dimensional anatomical image of the region of tissue and one or more biophysical parameters, wherein the image representing the thermal map of the region of tissue is generated based on the expected temperature evolution for the region of tissue, as taught by Anand, in order to facilitate ablation in the region of interest.
Regarding claim 19, Slayton teaches the non-transitory computer-readable medium of claim 16.
Slayton does not teach that the one or more instructions further cause the one or more processors to: obtain simulation data including a simulated thermal map based on expected temperature-dependent measurements for the ultrasound signals to be transmitted through the region of tissue during the ablation procedure; and perform an action based on a comparison of the set of temperature-dependent measurements for the ultrasound signals transmitted through the region of tissue during the ablation procedure and the expected temperature-dependent measurements for the ultrasound signals.
However, in the temperature monitoring systems field of endeavor, Anand discloses temperature monitoring apparatus and method for monitoring a temperature within a tissue, which is analogous art. Anand teaches that the one or more instructions further cause the one or more processors to:
obtain simulation data including a simulated thermal map (“the estimated temperature map is evaluated” [0050]) based on expected temperature-dependent measurements for the ultrasound signals to be transmitted through the region of tissue during the ablation procedure (“the temperature estimated by the thermal model is compared with the temperature obtained by the shear wave thermometry as well as temperature measurements performed by a temperature sensor 30 provided at the tip 14 of the temperature application device 12.” [0055]); and
perform an action (“The so derived temperature distribution may guide the operator of the temperature application unit in order to complete the treatment or adapt the treatment” [0056]; “adjust or terminate the ablation process.” [0064]) based on a comparison of the set of temperature-dependent measurements for the ultrasound signals transmitted through the region of tissue during the ablation procedure and the expected temperature-dependent measurements for the ultrasound signals (“The measurement data of the ultrasound shear wave detection is continuously provided to the heat transfer model in order to adapt the model” [0049]; “the estimated temperature map is evaluated and the heating power provided by the temperature application device 12 into the tissue 10 is controlled or modified in order to optimize the thermal treatment and to control the size of the ablation zone 16.” [0050]. “By means of these measurements and the comparison of the estimated temperature with the measured temperatures, the parameters of the thermal model are constantly and continuously adapted to minimize the difference between the model prediction and the experimental data…By means of this flexibility of the thermal model, e.g. for local heterogeneities, the temperature map and the ablation zone 16 can be precisely determined so that the boundary of the ablation zone 16 as the region of interest can be precisely measured non-invasively in order to optimize the thermal treatment.” [0055] Fig. 1).
Therefore, based on Anand’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 Slayton to employ the one or more instructions that further cause the one or more processors to: obtain simulation data including a simulated thermal map based on expected temperature-dependent measurements for the ultrasound signals to be transmitted through the region of tissue during the ablation procedure; and perform an action based on a comparison of the set of temperature-dependent measurements for the ultrasound signals transmitted through the region of tissue during the ablation procedure and the expected temperature-dependent measurements for the ultrasound signals, as taught by Anand, in order to facilitate the ablation in the region of interest.
Claims 9-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al (US 20160242838), hereinafter Anand, in view of Slayton et al (US 6050943), hereinafter, Slayton.
Regarding claim 9, Anand teaches a method (“The present invention relates to a temperature monitoring apparatus for monitoring a temperature within a tissue, in particular during a thermal ablation process and to a temperature monitoring method for monitoring a temperature within a tissue, in particular during a thermal ablation process.” [0001]), comprising:
obtaining, by a device (46), patient-specific simulation data including expected temperature-dependent measurements for ultrasound signals to be transmitted through a region of tissue (26) during an ablation procedure (“during a thermal ablation process.” [0001]) (“The monitoring apparatus further comprises a temperature estimation unit (46) including a heat transfer model (48) for estimating a temperature in a region of interest (26) within the tissue, wherein the heat transfer model is based on medical images of the tissue.” Abstract; “This is a possibility to provide precise medical images in order to improve the temperature estimation on the basis of the heated transfer model.” [0040]. “The measurement data of the ultrasound shear wave detection is continuously provided to the heat transfer model in order to adapt the model and to continuously adapt the specific parameters of the model.” [0049]);
and
performing, by the device, an action to guide the ablation procedure (“adjust or terminate the ablation process.” [0064]) based on a comparison of the actual temperature-dependent measurements for the ultrasound signals and the expected temperature-dependent measurements for the ultrasound signals (“During the process, the measurement planes 22, 24 are used to generate shear wave imaging based temperature estimation. In parallel, the temperature estimated by the thermal model is compared with the temperature obtained by the shear wave thermometry as well as temperature measurements performed by a temperature sensor 30 provided at the tip 14 of the temperature application device 12. By means of these measurements and the comparison of the estimated temperature with the measured temperatures, the parameters of the thermal model are constantly and continuously adapted to minimize the difference between the model prediction and the experimental data.” [0055] “The temperature estimation unit 46 may be connected to an output device 52 for providing the estimated temperature and in particular the estimated temperature map of the tissue 10 to an operator. The temperature monitoring apparatus 40 may also comprise an operator control (not shown) coupled to the temperature application unit 42 that allows the operator to adjust or terminate the ablation process.” [0064]).
Anand does not teach determining, by the device, a relative geometry between an ultrasound transmitter arranged to transmit the ultrasound signals through the region of tissue during the ablation procedure and an ultrasound receiver arranged to receive the ultrasound signals transmitted by the ultrasound transmitter after the ultrasound signals pass through the region of tissue; calculating, by the device, actual temperature-dependent measurements for the ultrasound signals transmitted through the region of tissue during the ablation procedure based on the relative geometry between the ultrasound transmitter and the ultrasound receiver.
However, in the medical ultrasound systems field of endeavor, Slayton discloses imaging, therapy, and temperature monitoring ultrasonic system, which is analogous art. Slayton teaches determining, by the device, a relative geometry between an ultrasound transmitter (110) arranged to transmit the ultrasound signals through the region of tissue during the ablation procedure and an ultrasound receiver (120) arranged to receive the ultrasound signals transmitted by the ultrasound transmitter after the ultrasound signals pass through the region of tissue (“With reference to FIG. 5, the echo waveform in a windowed region of a waveform A obtained before heating and a waveform B after heating can be examined,” Col. 8, l. 21-25; “an acoustic pulse wave is first generated by a single transmitting element 110 among the linear array of the acoustic transducer assembly 100…Upon reaching a boundary 850 used for reference, the acoustic wavefronts are reflected thereon so that the reflected wavefronts, i.e., the echoes come back towards the acoustic transducer assembly 100, where they are detected by remaining elements 120 in the linear array…The above transmitting-and-detecting sequence is repeated for each unique transmitter-receiver combination to form a large data set.” Col. 8, l. 55-Col. 9, l. 35; Fig. 6. Because the “single transmitting element 110 among the linear array of the acoustic transducer assembly 100” has to be determined before the ablation, “before heating”, a relative geometry is determined in advance as claimed. Col. 8, l. 21-25);
calculating, by the device, actual temperature-dependent measurements for the ultrasound signals transmitted through the region of tissue during the ablation procedure based on the relative geometry between the ultrasound transmitter and the ultrasound receiver (“using propagation path data, the obtained time-of-flight data is numerically converted into speed data of sound in the target tissue, and then further into a matrix of temperature values.” Col. 9, l. 10-27. “In accordance with a particularly preferred aspect, the array can be rotated to allow for a three-dimensional map of temperature to be measured. By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 39 - 46).
Therefore, based on Slayton’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 Anand to employ the steps of determining, by the device, a relative geometry between an ultrasound transmitter arranged to transmit the ultrasound signals through the region of tissue during the ablation procedure and an ultrasound receiver arranged to receive the ultrasound signals transmitted by the ultrasound transmitter after the ultrasound signals pass through the region of tissue; calculating, by the device, actual temperature-dependent measurements for the ultrasound signals transmitted through the region of tissue during the ablation procedure based on the relative geometry between the ultrasound transmitter and the ultrasound receiver, as taught by Slayton, in order to improve ultrasound-based thermal treatment of the tissue.
Regarding claim 10, Anand modified by Slayton teaches method of claim 9, wherein Anand teaches that the patient-specific simulation data further includes a simulated thermal map based on the expected temperature-dependent measurements for the ultrasound signals (“the estimated temperature map” [0050]), and
the action includes displaying the simulated thermal map (implied in [0056], in order to guide the operator) to guide the ablation procedure (“The so derived temperature distribution may guide the operator of the temperature application unit in order to complete the treatment or adapt the treatment” [0056]) based on the comparison indicating a threshold similarity between the actual temperature-dependent measurements and the expected temperature-dependent measurements for the ultrasound signals (“The measurement data of the ultrasound shear wave detection is continuously provided to the heat transfer model in order to adapt the model” [0049]; “the estimated temperature map is evaluated and the heating power provided by the temperature application device 12 into the tissue 10 is controlled or modified in order to optimize the thermal treatment and to control the size of the ablation zone 16.” [0050]. “By means of these measurements and the comparison of the estimated temperature with the measured temperatures, the parameters of the thermal model are constantly and continuously adapted to minimize the difference between the model prediction and the experimental data…By means of this flexibility of the thermal model, e.g. for local heterogeneities, the temperature map and the ablation zone 16 can be precisely determined so that the boundary of the ablation zone 16 as the region of interest can be precisely measured non-invasively in order to optimize the thermal treatment.” [0055] Fig. 1).
Regarding claim 11, Anand modified by Slayton teaches method of claim 9, wherein Anand teaches that the action includes causing the ablation procedure to stop based on the comparison indicating one or more of insufficient ablation in a targeted area of the region of tissue or off-target ablation in the region of tissue (“adjust or terminate the ablation process.” [0064]).
Regarding claim 12, Anand modified by Slayton teaches method of claim 9, wherein Anand teaches that the patient-specific simulation data further includes an expected temperature evolution for the region of tissue during the ablation procedure based on a three-dimensional anatomical image of the region of tissue (“The monitoring apparatus further comprises a temperature estimation unit (46) including a heat transfer model (48) for estimating a temperature in a region of interest (26) within the tissue, wherein the heat transfer model is based on medical images of the tissue.” Abstract; “the medical images are ultrasound images, computer tomography images and/or magnet resonance tomography images. This is a possibility to provide precise medical images in order to improve the temperature estimation on the basis of the heated transfer model.” [0040]. “The measurement data of the ultrasound shear wave detection is continuously provided to the heat transfer model in order to adapt the model and to continuously adapt the specific parameters of the model.” [0049]) and one or more biophysical parameters (“Usually the model utilizes initial values for the tissue parameters derived e.g. from literature values. For example, the electrical conductivity is σ=0.148 S/m, the thermal conductivity is 0.465 W/m° C., the density is 1060 kg/m.sup.3, the heat capacity is 3600 J/C kg, the perfusion rate is 6.4×10.sup.−3/sec.” [0054]), and
the action includes using the expected temperature evolution for the region of tissue to generate an image representing a thermal map of the region of tissue during the ablation procedure (““By means of this flexibility of the thermal model, e.g. for local heterogeneities, the temperature map and the ablation zone 16 can be precisely determined so that the boundary of the ablation zone 16 as the region of interest can be precisely measured non-invasively in order to optimize the thermal treatment.” [0055]; Fig. 2).
Anand does not teach that the action includes using the expected temperature evolution for the region of tissue in combination with one or more tomographic image reconstruction techniques.
However, in the medical ultrasound systems field of endeavor, Slayton discloses imaging, therapy, and temperature monitoring ultrasonic system, which is analogous art. Slayton teaches that the signal processor is further to:
using the temperature evolution for the region of tissue in combination with one or more tomographic image reconstruction techniques to generate an image representing a thermal map of the region of tissue (“by considering the intersecting paths, such as shown in FIG. 7, superimposed over a grid of pixels, where each pixel represents … volume … a tomographic configuration shown in FIG. 8 is obtained. By tracing the propagation and reception of the rays a solution to the velocity in each pixel from the matrix can be calculated…Given the dependence of the speed of sound in tissue with temperature, the spatial temperature distribution in each pixel is thus determined…By measuring the ray paths and then heating the region and rapidly remeasuring an accurate spatial map of heating is obtainable, such map being substantially free of tissue motion artifacts.” Col. 10, l. 19 - 46).
Therefore, based on Slayton’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 Anand to use the temperature evolution for the region of tissue in combination with one or more tomographic image reconstruction techniques, as taught by Slayton, in order to improve ultrasound-based thermal treatment of the tissue. In the combined invention, the temperature evolution is the expected temperature evolution.
Regarding claim 13, Anand modified by Slayton teaches method of claim 12, wherein Anand teaches that the expected temperature evolution for the region of tissue is represented according to one or more of a temporal resolution or a spatial resolution (“It is therefore essential to provide a real-time feedback by means of a temperature map of the ablated zone.” [0004]; “an adaption of the heat transfer model in real-time is possible.” [0034]).
Regarding claim 15, Anand modified by Slayton teaches method of claim 12, wherein Anand teaches that the image is an ultrasound elastography image based on pressure changes along the ultrasound signals transmitted through the region of tissue (“The ultrasound shear wave imaging is applicable up to 65° C” [0047]; “The ultrasound unit 44 provides … shear wave imaging (SWI) in order to determine a temperature at the measurement positions 22, 24.” [0062]; Fig. 2).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Anand and Slayton as applied to claim 12, and further in view of Lee et al (US 20130296743), hereinafter, Lee.
Regarding claim 14, Anand modified by Slayton teaches method of claim 12.
Anand modified by Slayton does not teach that the image is a synthesized thermal image generated using one or more of a deep learning technique or a machine learning technique.
Anand does not teach that in case the third predefined event comprises a command that a current workflow is to be continued with another medical device, the first medical device is retracted from the second extended position to the retracted position, and a second selected medical device is extended from the retracted position to the first extended position upon the third event.
However, in the medical ultrasound systems field of endeavor, Lee discloses ultrasound for therapy control or monitoring, which is analogous art. Lee teaches that the image is a synthesized thermal image generated using one or more of a deep learning technique or a machine learning technique (“The temperature for one or more locations in the treatment region is estimated based on inputs to the model. The computer code implements a machine-learned model and/or a thermal model to estimate the temperature or temperature related information.” [0067] “Any model may be used, such as a neural network ... The model is programmed or designed based on theory or experimentation. In one embodiment, the model is a machine-learned model.” [0112]; “a machine-learned model estimates temperature for uniform tissue. The temperature output is corrected to account for tissue differences in the region, such as reducing the temperature around thermally conductive vessels or fluid regions.” [0116]).
Therefore, based on Lee’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 Anand to employ the image that is a synthesized thermal image generated using one or more of a deep learning technique or a machine learning technique, as taught by Lee, in order to facilitate more complex imaging that accounts for tissue differences in the region of interest.
Allowable Subject Matter
Claims 8 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
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