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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the acts" in line 9 page 3. There is insufficient antecedent basis for this limitation in the claim, since “act” was not previously recited in claim 11.
Claims 12-15 are rejected as they inherit rejection of claim 11 due to their dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 10-11, 15-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over “Levy et al.,” US 2015/0359603 (hereinafter Levy) and “Ishi et al.,” US 2018/0368800 (hereinafter Ishi), and “Berlinger et al.,” US 2019/0201109 (hereinafter Berlinger).
Regarding to claim 1, Levy teaches a neuromodulation system, comprising:
an ultrasound energy application device configured to deliver a neuromodulating energy dose to a target region in a subject (ultrasound-based treatment, neuromodulation [0011]; neuromodulation [0028]); and,
a controller (central processing unit [0046]) configured to:
receive real-time ultrasound image data of an internal tissue of the subject (a visual representation of the patient’s anatomy within a region of interest in a series of images acquired with ultrasound [0023]),
wherein the ultrasound image data depicts anatomical structures when reconstructed (region of interest, target [0023]);
analyze the ultrasound image data to determine and update a visibility of the target region within the ultrasound image data over time (identifies target in the image [0023]; select the region of which treatment to be planned [0024]-[0025]);
compare, in real-time (real-time information about treatment effect [0007]), the visibility of the target region to a threshold target region (detect deformation and positional changes of target region, adjustment to the treatment plan; movements or changes to occur within certain limits [0043]; clinical constraints such as image of the region and surrounding areas and efficacy and safety thresholds [0039]); based on the comparison:
when the visibility of the target region meets or exceeds the threshold target region visibility, apply the neuromodulating energy dose to the target region in the subject via a therapy ultrasound beam emitted by the ultrasound energy application device (clinical constraints evaluated, including image of the region and surrounding areas and indications including efficacy and safety thresholds are met, physician can modify the plan, adjusting the energy and proceed to subsequent treatment to execute the plan [0039]; feedback includes positional changes of relevant target in the image [0043])
when the visibility of the target region is below the threshold target region visibility, cause or prompt a remediating act to be performed ([0017]; detect deformation and positional changes of target region, adjustment to the treatment plan [0043]);
Levy does not explicitly disclose determine/update a percent visibility of the target region over time and comparing the percent visibility and based on the comparison, applying the treatment or a remediating act to be followed.
However, in the analogous field of endeavor in image guided treatment planning and monitoring system, Ishi teaches calculating a real-time ([0133]), a suitability level including an index of visibility of treatment target site ([0125]), in a level of 0 to 10 ([0108]), and visibility index is quantified based on the target site and content of the procedure [0061]) and visibility is calculated during treatment ([0138]).
Moreover, Ishi explicitly discloses indexes are determined when index is equal to more than a threshold value, thus, comparing the value to a threshold ([0093]) and subsequent action to be followed when the value is below threshold ([0138]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the motion tracking of target in the image as taught by Levy to incorporate teaching of Ishi, since real-time suitability level of the procedure based on the visibility index was well known in the art as taught by Ishi. One of ordinary skill in the art could have combined the elements as claimed by Levy with no change in their respective functions, determining visibility index of the target region in the image, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to select appropriate direction for X-ray irradiating direction for treatment site ([0065]), and there was reasonable expectation of success.
Ishi discloses a visibility index, ranging from 0 to 10, but one can rescale and manipulate the index to be presented as a percent by multiplying the index by 10.
The examiner further submits that one can present visibility in percentage format and Berlinger supports the percent visibility.
In the analogous field of endeavor in medical imaging system, Berlinger teaches that visibility is defined by a threshold describing a percentage of images in which the anatomical structures are visible, a degree of how much of the anatomical body part is visible in the image ([0054]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute visibility index as taught by Ishi to replace with percent visibility, since percent visibility was well known in the art as taught by Berlinger. One of ordinary skill in the art could have combined the elements as claimed by Levy and Ishi with no change in their respective functions, replacing its index to be percent visibility, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to determine a degree of how much of the anatomical body part is visible in the image ([0054]), and there was reasonable expectation of success.
Regarding to claims 2-4 and 10, Levy, Ishi, and Berlinger together teach all limitations of claim 1 as set forth above.
Levy further teaches following limitations:
Of claim 2, wherein the controller is further configured to prior to applying the neuromodulating energy dose to the target region, perform a further determination that the neuromodulating energy dose can be applied to the target region based on an effectiveness threshold (a treatment efficacy threshold for each tissue type [0027]-[0028])
Of claim 3, wherein the controller is further configured to: prior to applying the neuromodulating energy dose to the target region, perform a further determination that the neuromodulating energy dose can be applied to the target region based on a safety criterion (safety threshold and constraints for each tissue type [0027]-[0028])
Of claim 4, wherein the controller is further configured to: prior to applying the neuromodulating energy dose to the target region, perform a further determination that the neuromodulating energy dose can be applied to the target region based on a therapy dose criterion (thermal dose required to achieve the desired therapeutic effect [0027])
Of claim 10, wherein the remediating act comprises performing an electronic adaptation of the ultrasound energy application device (electronic control signals in a beam former [0045])
Regarding to claim 11, Levy teaches a neuromodulation method, comprising the acts of:
operating an ultrasound energy application device to generate real-time ultrasound image data of an internal tissue of a subject, wherein the ultrasound image data depicts anatomical structures when reconstructed (a visual representation of the patient’s anatomy within a region of interest in a series of images acquired with ultrasound, a region of interest [0023]);
analyzing the ultrasound image data to determine and update visibility of a target region within the ultrasound image data over time (Select the region of which treatment to be planned [0024]-[0025]);
comparing, in real-time (Real time information [0007]), the visibility of the target region to a threshold target region visibility specific to a treatment protocol being administered to the subject (detect deformation and positional changes of target region, adjustment to the treatment plan; movements or changes to occur within certain limits [0043] clinical constraints such as image of the region and surrounding areas and efficacy and safety thresholds [0039]; visibility calculating function calculate a quantitative value, suitability level corresponding to area of treatment target sites [0108]);
based on the comparison: when the visibility of the target region meets or exceeds the threshold target region visibility, applying a neuromodulating energy dose to the target region in the subject via a therapy ultrasound beam emitted by the ultrasound energy application device (clinical constraints evaluated, including image of the region and surrounding areas and indications including efficacy and safety thresholds are met, physician can modify the plan, adjusting the energy and proceed to subsequent treatment to execute the plan [0039]; feedback includes positional changes of relevant target in the image [0043]);
when the percent visibility of the target region is below the threshold target region visibility, causing or prompting a remediating act to be performed ([0017]; detect deformation and positional changes of target region, adjustment to the treatment plan [0043]);
Levy does not explicitly disclose determine/update a percent visibility of the target region and comparing the percent visibility and based on the comparison, applying the treatment or a remediating act to be followed.
However, in the analogous field of endeavor in image guided treatment planning and monitoring system, Ishi teaches calculating a real-time ([0133]), a suitability level including an index of visibility of treatment target site ([0125]), in a level of 0 to 10 ([0108]), and visibility index is quantified based on the target site and content of the procedure [0061]) and visibility is calculated during treatment ([0138]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the motion tracking of target in the image as taught by Levy to incorporate teaching of Ishi, since real-time suitability level of the procedure based on the visibility index was well known in the art as taught by Ishi. One of ordinary skill in the art could have combined the elements as claimed by Levy with no change in their respective functions, determining visibility index of the target region in the image, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to select appropriate direction for X-ray irradiating direction for treatment site ([0065]), and there was reasonable expectation of success.
Ishi discloses a visibility index, ranging from 0 to 10, but one can rescale and manipulate the index to be presented as a percent by multiplying the index by 10.
The examiner further submits that one can present visibility index in percentage format and Berlinger supports the percent visibility.
In the analogous field of endeavor in medical imaging system, Berlinger teaches that visibility is defined by a threshold describing a percentage of images in which the anatomical structures are visible, a degree of how much of the anatomical body part is visible in the image ([0054]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute visibility index as taught by Ishi to replace with percent visibility, since percent visibility was well known in the art as taught by Berlinger. One of ordinary skill in the art could have combined the elements as claimed by Levy and Ishi with no change in their respective functions, replacing its index to be percent visibility, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to determine a degree of how much of the anatomical body part is visible in the image ([0054]), and there was reasonable expectation of success.
Regarding to claim 15, Levy, Ishi, and Berlinger together teach all limitations of claim 11 as set forth above.
Levy further discloses wherein the remediating act comprises performing an electronic adaptation of the ultrasound energy application device (electronic control signals in a beam former [0045]).
Regarding to claim 16, Levy teaches one or more tangible, machine-readable media storing processor-executable routines, wherein the processor-executable routines, when executed by a processor ([0017]), cause acts to be performed comprising:
generating real-time ultrasound image data of an internal tissue of a subject, wherein the ultrasound image data depicts anatomical structures when reconstructed (a visual representation of the patient’s anatomy within a region of interest in a series of images acquired with ultrasound, a region of interest [0023]);
analyzing the ultrasound image data to determine and update visibility of a target region within the ultrasound image data over time (Select the region of which treatment to be planned [0024]-[0025]);
comparing, in real-time (real time information [0007]), the visibility of the target region to a threshold target region visibility specific to a treatment protocol being administered to the subject (detect deformation and positional changes of target region, adjustment to the treatment plan; movements or changes to occur within certain limits [0043] clinical constraints such as image of the region and surrounding areas and efficacy and safety thresholds [0039]);
based on the comparison: when the visibility of the target region meets or exceeds the threshold target region visibility, applying a neuromodulating energy dose to the target region in the subject via a therapy ultrasound beam emitted by the ultrasound energy application device (clinical constraints evaluated, including image of the region and surrounding areas and indications including efficacy and safety thresholds are met, physician can modify the plan, adjusting the energy and proceed to subsequent treatment to execute the plan [0039]; feedback includes positional changes of relevant target in the image [0043]);
when the percent visibility of the target region is below the threshold target region visibility, causing or prompting a remediating act to be performed ([0017]; detect deformation and positional changes of target region, adjustment to the treatment plan [0043]);
Levy does not explicitly disclose determine/update a percent visibility of the target region and comparing the percent visibility and based on the comparison, applying the treatment or a remediating act to be followed.
However, in the analogous field of endeavor in image guided treatment planning and monitoring system, Ishi teaches calculating a real-time ([0133]), a suitability level including an index of visibility of treatment target site ([0125]), in a level of 0 to 10 ([0108]), and visibility index is quantified based on the target site and content of the procedure [0061]) and visibility is calculated during treatment ([0138]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the motion tracking of target in the image as taught by Levy to incorporate teaching of Ishi, since real-time suitability level of the procedure based on the visibility index was well known in the art as taught by Ishi. One of ordinary skill in the art could have combined the elements as claimed by Levy with no change in their respective functions, determining visibility index of the target region in the image, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to select appropriate direction for X-ray irradiating direction for treatment site ([0065]), and there was reasonable expectation of success.
Ishi discloses a visibility index, ranging from 0 to 10, but one can rescale and manipulate the index to be presented as a percent by multiplying the index by 10.
The examiner further submits that one can present visibility in percentage format and Berlinger supports the percent visibility.
In the analogous field of endeavor in medical imaging system, Berlinger teaches that visibility is defined by a threshold describing a percentage of images in which the anatomical structures are visible, a degree of how much of the anatomical body part is visible in the image ([0054]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute visibility index as taught by Ishi to replace with percent visibility, since percent visibility was well known in the art as taught by Berlinger. One of ordinary skill in the art could have combined the elements as claimed by Levy and Ishi with no change in their respective functions, replacing its index to be percent visibility, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to determine a degree of how much of the anatomical body part is visible in the image ([0054]), and there was reasonable expectation of success.
Regarding to claim 20, Levy, Ishi, and Berlinger together teach all limitations of claim 16 as set forth above.
Levy further discloses wherein the remediating act comprises performing an electronic adaptation of the ultrasound energy application device (electronic control signals in a beam former [0045]).
Claims 5-8, 12-13 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Levy, Ishi, and Berlinger as applied to claims 1, 11, and 16 above, and further in view of “Puleo et al.,” WO 2019/173525 (hereinafter Puleo).
Regarding to claims 5-6, 12-13, and 17-18, Levy, Ishi, and Berlinger together teach all limitations of claims 1, 11, and 16 as set forth above.
Levy, Ishi, and Berlinger do not further teach wherein the controller is configured to:
prior to applying the neuromodulating energy dose to the target region, performing a further determination that the neuromodulating energy dose can be applied to the target region based on one or more specific features of the target region specified by the treatment protocol being visible in the ultrasound image data.
wherein the one or more specific features of the target region comprise a porta hepatis.
However, in the analogous field of endeavor in monitoring neuromodulation of a tissue, Puleo teaches applying energy to a liver, selectively focusing on a target porta hepatis site (Figure 18A [00161]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify target in the image as taught by Levy to incorporate teaching of Puleo, since targeting porta hepatis was well known in the art as taught by Puleo. One of ordinary skill in the art could have combined the elements as claimed by Levy with no change in their respective functions, determining and/or identifying porta hepatis as a target, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide local targeted ultrasound neuromodulation ([00161]) and there was reasonable expectation of success.
Regarding to claims 7-8, Levy, Ishi, and Berlinger together teach all limitations of claim 1 as set forth above.
Levy, Ishi, and Berlinger do not explicitly disclose image transducers and therapy transducers, and transducers configured to both emit an imaging beam and therapy ultrasound beam.
However, in the analogous field of endeavor in ultrasound neuromodulation system, Puleo teaches following limitations:
Of claim 7, wherein the one or more specific image transducers configured to acquire the ultrasound image data; and therapy transducers configured to the therapy ultrasound beam (HIFU transducer 74A and imaging ultrasound transducer 74B arranged in a single energy application device [00124])
Of claim 8, wherein the ultrasound energy application device comprises: transducers configured to both emit both an imaging beam to acquire the ultrasound image data and the therapy ultrasound beam (The ultrasound transducer capable of applying energy to a target tissue and may also be configured to acquire image data [00112]).
Claims 9, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Levy, Ishi, and Berlinger as applied to claims 1, 11 and 16 above, and further in view of “Puleo et al.,” WO 2018/081826 (hereinafter Puleo 826).
Regarding to claims 9, 14, and 19, Levy, Ishi, and Berlinger together teach all limitations of claims 1, 11 and 16 as set forth above.
Levy does disclose treatment profile having position and orientation of the transducer and plan can be modified (treatment profile includes position and orientation of transducer [0010]; transducer position and physician can modify the plan [0039]), but does not teach the remediating act comprises one or both of repositioning or reorienting the ultrasound energy application device.
However, in the analogous field of endeavor in neuromodulation system, Puleo 826 discloses repositioning the energy application device based on the feedback (claims 71 and 78-79).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment profile of transducer position and orientation as taught by Levy to incorporate teaching of Puleo 826, since repositioning the energy application device was well known in the art as taught by Puleo 826. One of ordinary skill in the art could have combined the elements as claimed by Levy with no change in their respective functions, repositioning the transducer, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide selective activation of target by repositioning the energy application device to specific target area to provide desired effect ([00164] and claim 71, 78), and there was reasonable expectation of success.
Conclusion
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798