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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 02/09/2026 has been entered.
Response to Amendment
This office action is in response to the communications filed on 02/09/2026, concerning Application No. 18/311,045. The amendments to the claims filed on 02/09/2026 are acknowledged. Presently, claims 1-10, 12-19, and 21 remain pending.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 12/07/2023, 01/04/2024, 02/10/2026, 05/01/2026, and 08/14/2026. The submissions are each in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The information disclosure statement filed 02/10/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Examiner notes that there is no copy provided in the application file for the foreign patent document “DE602017092008T2” (i.e., Cite No. 2204 cited in the IDS filed 02/10/2026). It has been placed in the application file, but the corresponding information referred to therein has not been considered.
Specification
The disclosure is objected to because of the following informalities:
Para. [0233], line 3, “Additionally, while sequences 1401, 1402, 1304, and 1405 ablate the entire target volume” should be changed to “Additionally, while sequences 1401, 1402, 1404, and 1405 ablate the entire target volume”; and
Para. [0234], lines 1-2, “Figs. 14A illustrate the temperature profiles of the sequence strategies of Table 1, and Figs. 14B illustrate the resulting t43 curves produced during treatment” should be changed to “Fig. 14A illustrates the temperature profiles of the sequence strategies of Table 1, and Fig. 14B illustrates the resulting t43 curves produced during treatment”.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 2-10, 13-19, and 21 are objected to because of the following informalities:
Claims 2-10, 13-19, and 21, line 1 of each claim, each limitation “The method of claim” should be changed to “The ultrasound treatment method of claim”;
Claim 6, line 1, the limitation “the target volume” should be changed to “the target tissue volume”;
Claim 7, line 1, the limitation “wherein mechanically moving the focus” should be changed to “wherein the mechanically moving the focus”;
Claim 8, line 1, the limitation “wherein mechanically moving the focus” should be changed to “wherein the mechanically moving the focus”;
Claim 8, line 3, the limitation “the ultrasound therapy system” should be changed to “the ultrasound therapy transducer array”;
Claim 10, lines 1-3, the limitation “wherein rapidly electronically beam-steering the cavitation bubble cloud through the plurality of treatment points within the first of the plurality of treatment volumes comprises” should be changed to “wherein the rapidly electronically beam-steering the cavitation bubble cloud through the plurality of treatment points within the first of the plurality of treatment volumes further comprises”;
Claim 19, line 1, the limitation “claim 12, wherein mechanically positioning the focus” should be changed to “claim 13, wherein the mechanically positioning the focus” (i.e., dependency of claim 19 should change from claim 12 to claim 13, because claims 13 and 19 both recite the limitation “remaining plurality of treatment volumes”, and claim 12 does not recite this limitation); and
Claim 21, lines 1-4, the limitation “wherein rapidly electronically beam-steering the cavitation bubble cloud through the first of the plurality of treatment volumes comprises rapidly electronically beam-steering the cavitation bubble cloud in 3D space through the first plurality of treatment points” should be changed to “wherein the rapidly electronically beam-steering the cavitation bubble cloud through the plurality of treatment points within the first of the plurality of treatment volumes further comprises rapidly electronically beam-steering the cavitation bubble cloud in 3D space through the plurality of treatment points”.
Appropriate correction is required.
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.
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.
Claims 1, 7, 12-13, 17-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al. (US 2011/0054315 A1, of record, hereinafter Roberts) in view of Kim et al. (NPL: “Development of a Wearable Robotic Positioning System for Noninvasive Transcranial Focused Ultrasound Stimulation”; of record, a copy of which was provided by the Examiner on 11/16/2023, hereinafter Kim), and further in view of Gateau et al. (NPL: “Transcranial Ultrasonic Therapy Based on Time Reversal of Acoustically Induced Cavitation Bubble Signature”; of record, a copy of which was provided by the Examiner on 11/16/2023, hereinafter Gateau).
Regarding claim 1 and similarly claim 12, Roberts discloses an ultrasound treatment method (see, e.g., Abstract, “the medical imaging and therapy device is configured controllably apply ultrasound energy into the prostate by maintaining a cavitational bubble cloud generated by an ultrasound therapy system within an image of the prostate generated by an imaging system. The medical imaging and therapy device can be used in therapeutic applications such as Histotripsy, Lithotripsy, and HIFU”), comprising the steps of:
receiving a digital treatment plan that includes a target tissue volume of a subject divided into a plurality of treatment volumes (see, e.g., Para. [0011], “Diagnostic ultrasound can be used during Histotripsy procedures to visualize the surgical anatomy and monitor the process in real time. […] Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”, and Para. [0041], “the surgical planning software or the user can create a surgical plan within the target tissue volume, such as within the prostate, with subsequent treatment volumes separated by 1 mm increments (e.g., total range 0.2 mm-1 cm). Each treatment target can be assigned a different dose of ultrasound therapy. The ultrasound dose can be determined, e.g., by the number of pulses delivered or the treatment duration in each treatment target. In some embodiments, the ultrasound therapy comprises Histotripsy therapy. Histotripsy can be performed within the planned treatment volume”);
mechanically moving a focus of an ultrasound therapy system to a first of the plurality of treatment volumes (see, e.g., Para. [0011], “Diagnostic ultrasound can be used during Histotripsy procedures to visualize the surgical anatomy and monitor the process in real time. The Histotripsy cavitation bubble cloud can appear very clearly on diagnostic ultrasound as a hyperechoic (light) region and ablated homogenized tissue can appear as a hypoechoic (dark) region. Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”, and Para. [0012], “The present invention relates to an imaging and therapy system comprising a micro-manipulator system […] the micro-manipulator system being adapted and configured to maintain a focal point of the ultrasound therapy system within a field of view of the imaging system”, and Para. [0016], “the micro-manipulator system comprises a robotic arm. The robotic arm can move in up to six degrees of freedom, for example. In another embodiment, the micro-manipulator system comprises at least four stepper motors configured to move the micro-manipulator system in up to four degrees of freedom. In one embodiment, one of the at least four stepper motors is configured to rotate the imaging system along a roll axis. In another embodiment, one of the at least four stepper motors is configured to rotate the ultrasound therapy system along a pitch axis”, and Para. [0037], “the initial positioning of focal point 422 can be established mechanically by the micro-manipulator system 402. As shown in FIG. 4A, ultrasound therapy system 406 can be moved by micro-manipulator system 402 to position focal point 422 on target tissues in the prostate P and within the field of view of the imaging system”, and Para. [0046], “FIGS. 1-4 above described and illustrated the micro-manipulator system as a robotic arm”);
forming a cavitation bubble cloud at the focus (see, e.g., Abstract, “the medical imaging and therapy device is configured controllably apply ultrasound energy into the prostate by maintaining a cavitational bubble cloud generated by an ultrasound therapy system within an image of the prostate generated by an imaging system. The medical imaging and therapy device can be used in therapeutic applications such as Histotripsy, Lithotripsy, and HIFU”, and Para. [0011], “The Histotripsy cavitation bubble cloud can appear very clearly on diagnostic ultrasound as a hyperechoic (light) region and ablated homogenized tissue can appear as a hypoechoic (dark) region. Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”, and Para. [0015], “the ultrasound therapy system comprises a histotripsy system. The ultrasound therapy system can comprise an ultrasound therapy transducer configured to generate cavitational micro bubbles in tissue”);
electronically steering the cavitation bubble cloud through a plurality of treatment points within the first of the plurality of treatment volumes to produce an enhanced bubble cloud shape within the first of the plurality of treatment volumes (see, e.g., Para. [0011], “The Histotripsy cavitation bubble cloud can appear very clearly on diagnostic ultrasound as a hyperechoic (light) region and ablated homogenized tissue can appear as a hypoechoic (dark) region. Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”, and Para. [0021], “the controllably applying ultrasound energy step further comprises automatically maintaining the bubble cloud generated by the ultrasound therapy system within the image of the prostate generated by the imaging system with a control system”, and Para. [0041], “the surgical planning software or the user can create a surgical plan within the target tissue volume, such as within the prostate, with subsequent treatment volumes separated by 1 mm increments (e.g., total range 0.2 mm-1 cm). Each treatment target can be assigned a different dose of ultrasound therapy. The ultrasound dose can be determined, e.g., by the number of pulses delivered or the treatment duration in each treatment target. In some embodiments, the ultrasound therapy comprises Histotripsy therapy. Histotripsy can be performed within the planned treatment volume”, and Para. [0043], “the control system can automatically position the micro-manipulator system, imaging system, and the ultrasound therapy system to keep the cavitational bubble cloud in the imaging field. For example, the micro-manipulator system can be rotated and/or advanced in the axial direction automatically by the control system to a degree that is calculated based on the movement of the therapy system and the field of view of the imaging system”, and Disclosed Claim 21, “wherein the controllably applying ultrasound energy step further comprises automatically maintaining the bubble cloud generated by the ultrasound therapy system within the image of the prostate generated by the imaging system with a control system”); and
repeating the mechanically moving, forming, and electronically steering steps for each of a remaining plurality of treatment volumes (see, e.g., Para. [0011], “Diagnostic ultrasound can be used during Histotripsy procedures to visualize the surgical anatomy and monitor the process in real time. The Histotripsy cavitation bubble cloud can appear very clearly on diagnostic ultrasound as a hyperechoic (light) region and ablated homogenized tissue can appear as a hypoechoic (dark) region. Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”, and Para. [0041], “the surgical planning software or the user can create a surgical plan within the target tissue volume, such as within the prostate, with subsequent treatment volumes separated by 1 mm increments (e.g., total range 0.2 mm-1 cm). Each treatment target can be assigned a different dose of ultrasound therapy. The ultrasound dose can be determined, e.g., by the number of pulses delivered or the treatment duration in each treatment target. In some embodiments, the ultrasound therapy comprises Histotripsy therapy. Histotripsy can be performed within the planned treatment volume. […] the focal point of the ultrasound therapy transducer can be automatically moved by the micro-manipulator system through the surgical treatment volume (e.g., of the prostate) to ablate the treatment volume under real time imaging from the imaging system. In some embodiments, the ultrasound therapy system is configured to ablate or mechanically damage the treatment volume. The ultrasound therapy system can be configured to ablate or mechanically damage tissue of the prostate to treat BPH or prostate cancer, for example”, where the step of mechanically moving the focus of the therapeutic transducer and the process of automatically (i.e., electronically) maintaining the bubble cloud within the volume generated by the ultrasound therapy system is repeated for each separated treatment volume).
Roberts does not specifically disclose [1] mechanically moving the focus of an ultrasound therapy transducer array to the first of the plurality of treatment volumes with a robotic positioning system; and [2] rapidly electronically beam-steering the cavitation bubble cloud through the plurality of treatment points within the first of the plurality of treatment volumes with the ultrasound therapy transducer array.
However, in the same field of endeavor of ultrasound treatment/therapy, Kim discloses mechanically moving a focus of an ultrasound therapy transducer array to a first of the plurality of treatment volumes with a robotic positioning system (see, e.g., Abstract, “Transcranial ultrasound neuromodulation has been attracting more and more interest from researchers as a novel modality for brain stimulation. Typical manual positioning for brain stimulation requires the patient to sit still during stimulation for extended periods and readily loses its positioning accuracy if the patient moves. To address these problems of inconvenience and inaccuracy, we proposed a robotic positioning system for targeted ultrasound brain stimulation. The proposed device automatically moves the ultrasound transducer to a desired position and orientation, enabling far more accurate and comfortable automatic positioning of the transducer than when using traditional manual positioning”, and Figs. 8-9, and Page 2292, Col. 2, Section V, “In this study, we proposed a wearable robotic system for automatic transducer positioning”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ultrasound treatment method of Roberts by including [1] mechanically moving the focus of an ultrasound therapy transducer array to the first of the plurality of treatment volumes with a robotic positioning system, as disclosed by Kim. One of ordinary skill in the art would have been motivated to make this modification of Roberts in order to allow a user to position the ultrasound transducers at any arbitrary location of a human body with any arbitrary orientation independently the location of the human body, and thus, maximize the efficiency and accuracy of the positioning of the ultrasound transducers, as recognized by Kim (see, e.g., Abstract).
Roberts modified by Kim still does not specifically disclose [2] rapidly electronically beam-steering the cavitation bubble cloud through the plurality of treatment points within the first of the plurality of treatment volumes with the ultrasound therapy transducer array.
However, in the same field of endeavor of ultrasound treatment/therapy, Gateau discloses rapidly electronically beam-steering the cavitation bubble cloud through a plurality of treatment points within the first of the plurality of treatment volumes with the ultrasound therapy transducer array to produce an enhanced bubble cloud shape within the first of the plurality of treatment volumes (see, e.g., Abstract, “Brain treatment through the skull with high-intensity focused ultrasound can be achieved with multichannel arrays and adaptive focusing techniques such as time reversal. […] In this paper, this simulation-based targeting has been used experimentally as a first step for focusing through an ex vivo human skull at a single location. It has enabled the creation of a cavitation bubble at focus that spontaneously emitted an ultrasonic wave received by the array. […] To target points around the focus with an optimal pressure level, conventional electronic steering from the initial focus has been combined with bubble generation. Thanks to step-by-step bubble generation, the electronic steering capabilities of the array through the skull were improved”, and Figs. 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim by including [2] rapidly electronically beam-steering the cavitation bubble cloud through the plurality of treatment points within the first of the plurality of treatment volumes with the ultrasound therapy transducer array, as disclosed by Gateau. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to obtain a high quality ultrasound image by removing phase aberration using a phase aberration correction method and in order to desirably improve the electronic steering capabilities of the array, as recognized by Gateau (see, e.g., Abstract, and Page 136, Col. 2, Section E).
Regarding claims 7 and 19, Roberts modified by Kim and Gateau discloses the methods of claims 1 and 12, respectively, as set forth above. Roberts further discloses wherein mechanically moving/positioning the focus to each of the remaining plurality of treatment volumes further comprises mechanically moving the focus from the first of the plurality of treatment volumes (see, e.g., Para. [0011], “Diagnostic ultrasound can be used during Histotripsy procedures to visualize the surgical anatomy and monitor the process in real time. The Histotripsy cavitation bubble cloud can appear very clearly on diagnostic ultrasound as a hyperechoic (light) region and ablated homogenized tissue can appear as a hypoechoic (dark) region. Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”).
Roberts does not specifically disclose mechanically moving/positioning the focus from the first of the plurality of treatment volumes outward in a spiraling fashion through the target tissue volume.
However, in the same field of endeavor of ultrasound treatment/therapy, Kim discloses mechanically moving/positioning the focus from the first of the plurality of treatment volumes outward in a spiraling fashion through the target tissue volume (see, e.g., Table 1, and Figs. 6-7, and Page 2291, where it is disclosed that the wearable robotic positioning system is based on an optimized Spherical Parallel Mechanism (SPM)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including mechanically moving/positioning the focus from the first of the plurality of treatment volumes outward in a spiraling fashion through the target tissue volume, as disclosed by Kim. One of ordinary skill in the art would have been motivated to make this modification of Roberts in order to allow a user to position the ultrasound transducers at any arbitrary location of a human body with any arbitrary orientation independently the location of the human body, and thus, maximize the efficiency and accuracy of the positioning of the ultrasound transducers, as recognized by Kim (see, e.g., Abstract).
Regarding claim 13, Roberts modified by Kim and Gateau discloses the method of claim 12, as set forth above. Roberts further discloses the method further comprising repeating the mechanically positioning, forming, and electronically steering steps for each of a remaining plurality of treatment volumes (see, e.g., Para. [0011], “Diagnostic ultrasound can be used during Histotripsy procedures to visualize the surgical anatomy and monitor the process in real time. The Histotripsy cavitation bubble cloud can appear very clearly on diagnostic ultrasound as a hyperechoic (light) region and ablated homogenized tissue can appear as a hypoechoic (dark) region. Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”, and Para. [0041], “the surgical planning software or the user can create a surgical plan within the target tissue volume, such as within the prostate, with subsequent treatment volumes separated by 1 mm increments (e.g., total range 0.2 mm-1 cm). Each treatment target can be assigned a different dose of ultrasound therapy. The ultrasound dose can be determined, e.g., by the number of pulses delivered or the treatment duration in each treatment target. In some embodiments, the ultrasound therapy comprises Histotripsy therapy. Histotripsy can be performed within the planned treatment volume. […] the focal point of the ultrasound therapy transducer can be automatically moved by the micro-manipulator system through the surgical treatment volume (e.g., of the prostate) to ablate the treatment volume under real time imaging from the imaging system. In some embodiments, the ultrasound therapy system is configured to ablate or mechanically damage the treatment volume. The ultrasound therapy system can be configured to ablate or mechanically damage tissue of the prostate to treat BPH or prostate cancer, for example”, where the step of mechanically moving the focus of the therapeutic transducer and the process of automatically (i.e., electronically) maintaining the bubble cloud within the volume generated by the ultrasound therapy system is repeated for each separated treatment volume).
Regarding claim 17, Roberts modified by Kim and Gateau discloses the method of claim 12, as set forth above. Roberts further discloses the method further comprising obtaining images of the first cavitation bubble cloud and the second cavitation bubble cloud with an external imaging system (see, e.g., Para. [0029], “In one Histotripsy system, an imaging system and an ultrasound therapy system are held and positioned by an electromechanical micro-manipulator system. […] A trans-rectal (TR) ultrasound imaging system can be inserted in the patient's rectum to confirm accurate targeting and localization of the bubble cloud formed by the therapy system during treatment, and for imaging of target tissue during the Histotripsy procedure. The imaging system can be attached to the micro-manipulator system and repositioned axially and rotated radially during the procedure to image and track therapy”, and Para. [0044], “the ultrasound therapy system can generate an ultrasonically induced cavitation bubble cloud in a tissue volume using pulsed ultrasound at a frequency of between about 100 kHz and about 5 MHz having high amplitude pressure waves with peak negative pressure above 5 MPa, an ultrasound pulse duration of 1-1000 cycles, a pulse repetition frequency of less than about 5 kHz and a duty cycle less than about 5%”, and Para. [0045], “the focused ultrasound therapy transducer generates an ultrasonically induced cavitation bubble cloud in a tissue volume using an ultrasound frequency between about 250 kHz and about 1.5 MHz, high amplitude pressure waves with intensities exceeding 2000 W/cm.sup.2 and peak positive pressure above 20 MPa (such as, e.g., between 30 MPa and 500 MPa) and peak negative pressure less than 5 MPa (such as, e.g., between 5 MPa and 40 MPa), ultrasound pulse duration of less than 30 cycles (such as, e.g., between 0.2 .mu.s and 30 .mu.s (1 to 20 cycles)), a pulse repetition frequency of less than about 5 kHz and a duty cycle less than about 5%”, where a first cavitation bubble cloud is generated using pulsed ultrasound at a frequency of between 100kHz and 5MHz, and a second cavitation bubble cloud is generated using pulsed ultrasound at a frequency of between 250kHz and 1.5 MHz).
Regarding claim 18, Roberts modified by Kim and Gateau discloses the method of claim 17, as set forth above. Roberts further discloses wherein the images are obtained pre, peri, or post forming the first and/or second cavitation bubble cloud (see, e.g., Para. [0043], “Referring still to FIGS. 4A-B and FIG. 1, the imaging system 408 can be advanced and rotated manually during a Histotripsy procedure to keep the cavitational bubble cloud in the imaging field and to facilitate real time monitoring. Alternatively, the control system can automatically position the micro-manipulator system, imaging system, and the ultrasound therapy system to keep the cavitational bubble cloud in the imaging field”, and Disclosed Claim 18, “wherein the controllably applying ultrasound energy step further comprises maintaining the bubble cloud generated by the ultrasound therapy system within approximately 0.8 cm to 4 cm of the imaging system”).
Regarding claim 21, Roberts modified by Kim and Gateau discloses the method of claim 1, as set forth above. Roberts modified by Kim does not specifically disclose wherein rapidly electronically beam-steering the cavitation bubble cloud through the first of the plurality of treatment volumes comprises rapidly electronically beam-steering the cavitation bubble cloud in 3D space through the first plurality of treatment points.
However, in the same field of endeavor of ultrasound treatment/therapy, Gateau discloses wherein rapidly electronically beam-steering the cavitation bubble cloud through the first of the plurality of treatment volumes comprises rapidly electronically beam-steering the cavitation bubble cloud in 3D space through the first plurality of treatment points (see, e.g., Abstract, “Brain treatment through the skull with high-intensity focused ultrasound can be achieved with multichannel arrays and adaptive focusing techniques such as time reversal. […] In this paper, this simulation-based targeting has been used experimentally as a first step for focusing through an ex vivo human skull at a single location. It has enabled the creation of a cavitation bubble at focus that spontaneously emitted an ultrasonic wave received by the array. […] To target points around the focus with an optimal pressure level, conventional electronic steering from the initial focus has been combined with bubble generation. Thanks to step-by-step bubble generation, the electronic steering capabilities of the array through the skull were improved”, and Figs. 1-2 and 9A, and Page 141, Col. 2, “In order to achieve the acquisition of multiple reference signals noninvasively, cavitation bubbles have been induced at the desired locations. […] a hydrophone-based impulse correction for the geometrical center of the array was first recorded for the 136 emitting transducers. These signals were electronically steered to induce bubbles at the positions taken as reference positions in the previous study. These positions are drawn in the 3-D coordinate system as described in Fig. 9(a). Bubbles at position "zero" were induced using the CT-guided simulation. The other positions were targeted using conventional electronic steering, and bubbles were induced using this first focusing step. We repeated the bubble induction experiment 60 times for each position”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including wherein rapidly electronically beam-steering the cavitation bubble cloud through the first of the plurality of treatment volumes comprises rapidly electronically beam-steering the cavitation bubble cloud in 3D space through the first plurality of treatment points, as disclosed by Gateau. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to obtain a high quality ultrasound image by removing phase aberration using a phase aberration correction method and in order to desirably improve the electronic steering capabilities of the array, as recognized by Gateau (see, e.g., Abstract, and Page 136, Col. 2, Section E).
Claims 2-6, 8-10, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts (US 2011/0054315 A1) in view of Kim (NPL) and Gateau (NPL), as applied to claims 1 and 12 above, and further in view of Darlington et al. (US 2015/0273246 A1, of record, hereinafter Darlington).
Regarding claim 2, Roberts modified by Kim and Gateau discloses the method of claim 1, as set forth above. Roberts discloses the target tissue volume (see, e.g., Abstract, “A medical imaging and therapy device is provided that may include any of a number of features. One feature of the device is that it can image a target tissue volume and apply ultrasound energy to the target tissue volume. In some embodiments, the medical imaging and therapy device is configured controllably apply ultrasound energy into the prostate by maintaining a cavitational bubble cloud generated by an ultrasound therapy system within an image of the prostate generated by an imaging system”).
Roberts modified by Kim and Gateau does not specifically disclose wherein the target tissue volume is generally spherical.
However, in the same field of endeavor of ultrasound treatment/therapy, Darlington discloses wherein the target tissue volume is generally spherical (see, e.g., Fig. 1A, and Para. [0049], “FIG. 1A illustrates a tissue volume, such as a uterine fibroid 20, to be treated. Uterine fibroids may be irregularly shaped but are often generally spherical or oval shaped”, and Para. [0058], “Although the elemental treatment volume 80 shown in FIGS. 3A and 3B is cylindrical in shape, it will be appreciated that other shapes such as spherical or cubic elemental treatment volumes etc. could be created depending on the steering capabilities of the HIFU beam 83”, and Para. [0080], “Although the shape of the ablated shells is shown as being generally spherical in FIGS. 3J-3K, 4A-4B and 4C, it will be appreciated that other shapes, such as conical or double conical, ovoid (e.g., egg shaped), or rectangular could be used. The particular shape of the shell created may depend on the shape of the tissue volume to be treated and the ability of the equipment used to steer the focal zone of the HIFU transducer in a desired pattern”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including wherein the target tissue volume is generally spherical, as disclosed by Darlington. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to treat tissue more efficiently by selecting optimal shape among various shapes based on the shape of the tumor/tissue volume to be treated, as recognized by Darlington (see, e.g., Para. [0058] and [0080]).
Regarding claims 3 and 15, Roberts modified by Kim and Gateau discloses the methods of claims 1 and 12, respectively, as set forth above. Roberts discloses the target tissue volume (see, e.g., Abstract, “A medical imaging and therapy device is provided that may include any of a number of features. One feature of the device is that it can image a target tissue volume and apply ultrasound energy to the target tissue volume. In some embodiments, the medical imaging and therapy device is configured controllably apply ultrasound energy into the prostate by maintaining a cavitational bubble cloud generated by an ultrasound therapy system within an image of the prostate generated by an imaging system”).
Roberts modified by Kim and Gateau does not specifically disclose wherein the target tissue volume is contoured to a tumor.
However, in the same field of endeavor of ultrasound treatment/therapy, Darlington discloses wherein the target tissue volume is contoured to a tumor (see, e.g., Figs. 3I and 5, and Para. [0043], and Para. [0064], “FIG. 3I illustrates a technique for creating another embodiment of an elemental treatment volume with an arc or segment-type geometry. This elemental treatment volume can be used to create rings or other shapes with uniform treatment depths and in one method to form a shell around the desired treatment volume”, and Para. [0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including wherein the target tissue volume is contoured to a tumor, as disclosed by Darlington. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to treat tissue more efficiently by selecting optimal shape among various shapes based on the shape of the tumor/tissue volume to be treated, as recognized by Darlington (see, e.g., Para. [0058] and [0080]).
Regarding claims 4 and 16, Roberts modified by Kim and Gateau discloses the methods of claims 1 and 12, respectively, as set forth above. Roberts discloses the target tissue volume (see, e.g., Abstract, “A medical imaging and therapy device is provided that may include any of a number of features. One feature of the device is that it can image a target tissue volume and apply ultrasound energy to the target tissue volume. In some embodiments, the medical imaging and therapy device is configured controllably apply ultrasound energy into the prostate by maintaining a cavitational bubble cloud generated by an ultrasound therapy system within an image of the prostate generated by an imaging system”).
Roberts modified by Kim and Gateau does not specifically disclose wherein the target tissue volume includes a margin.
However, in the same field of endeavor of ultrasound treatment/therapy, Darlington discloses wherein the target tissue volume includes a margin (see, e.g., Fig. 3I, and Para. [0058], “Although the elemental treatment volume 80 shown in FIGS. 3A and 3B is cylindrical in shape, it will be appreciated that other shapes such as spherical or cubic elemental treatment volumes etc. could be created depending on the steering capabilities of the HIFU beam 83”, and Para. [0064], “FIG. 3I illustrates a technique for creating another embodiment of an elemental treatment volume with an arc or segment-type geometry. This elemental treatment volume can be used to create rings or other shapes with uniform treatment depths and in one method to form a shell around the desired treatment volume. In this embodiment, the focal zone of the HIFU transducer is moved back and forth over a portion (e.g. an arc) of the perimeter. The back-and-forth motion of the HIFU focus results in tissue ablation at uniform depths because it distributes the acoustic energy over a broader region during the treatment, therefore preventing the formation of large focal or pre-focal bubbles that can reflect energy and result in uneven or “ragged” treatment patterns. Multiple treated arcs can therefore be created side by side to complete the treated perimeter of the desired treatment volume”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including wherein the target tissue volume includes a margin, as disclosed by Darlington. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to treat tissue more efficiently by selecting optimal shape among various shapes based on the shape of the tumor/tissue volume to be treated, as recognized by Darlington (see, e.g., Para. [0058] and [0080]).
Regarding claim 5, Roberts modified by Kim and Gateau discloses the method of claim 1, as set forth above. Roberts discloses the target tissue volume (see, e.g., Abstract, “A medical imaging and therapy device is provided that may include any of a number of features. One feature of the device is that it can image a target tissue volume and apply ultrasound energy to the target tissue volume. In some embodiments, the medical imaging and therapy device is configured controllably apply ultrasound energy into the prostate by maintaining a cavitational bubble cloud generated by an ultrasound therapy system within an image of the prostate generated by an imaging system”).
Roberts modified by Kim and Gateau does not specifically disclose wherein the target tissue volume is an ellipsoid.
However, in the same field of endeavor of ultrasound treatment/therapy, Darlington discloses wherein the target tissue volume is an ellipsoid (see, e.g., Para. [0058], “Although the elemental treatment volume 80 shown in FIGS. 3A and 3B is cylindrical in shape, it will be appreciated that other shapes such as spherical or cubic elemental treatment volumes etc. could be created depending on the steering capabilities of the HIFU beam 83”, and Para. [0080], “Although the shape of the ablated shells is shown as being generally spherical in FIGS. 3J-3K, 4A-4B and 4C, it will be appreciated that other shapes, such as conical or double conical, ovoid (e.g., egg shaped), or rectangular could be used. The particular shape of the shell created may depend on the shape of the tissue volume to be treated and the ability of the equipment used to steer the focal zone of the HIFU transducer in a desired pattern”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including wherein the target tissue volume is an ellipsoid, as disclosed by Darlington. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to treat tissue more efficiently by selecting optimal shape among various shapes based on the shape of the tumor/tissue volume to be treated, as recognized by Darlington (see, e.g., Para. [0058] and [0080]).
Regarding claim 6, Roberts modified by Kim and Gateau discloses the method of claim 1, as set forth above. Roberts discloses the target tissue volume (see, e.g., Abstract, “A medical imaging and therapy device is provided that may include any of a number of features. One feature of the device is that it can image a target tissue volume and apply ultrasound energy to the target tissue volume. In some embodiments, the medical imaging and therapy device is configured controllably apply ultrasound energy into the prostate by maintaining a cavitational bubble cloud generated by an ultrasound therapy system within an image of the prostate generated by an imaging system”).
Roberts modified by Kim and Gateau does not specifically disclose wherein the target volume is an arbitrary shape.
However, in the same field of endeavor of ultrasound treatment/therapy, Darlington discloses wherein the target volume is an arbitrary shape (see, e.g., Fig. 1A, and Para. [0049], “FIG. 1A illustrates a tissue volume, such as a uterine fibroid 20, to be treated. Uterine fibroids may be irregularly shaped but are often generally spherical or oval shaped”, and Para. [0064], and Para. [0077], and Para. [0080], “Although the shape of the ablated shells is shown as being generally spherical in FIGS. 3J-3K, 4A-4B and 4C, it will be appreciated that other shapes, such as conical or double conical, ovoid (e.g., egg shaped), or rectangular could be used. The particular shape of the shell created may depend on the shape of the tissue volume to be treated and the ability of the equipment used to steer the focal zone of the HIFU transducer in a desired pattern”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including wherein the target volume is an arbitrary shape, as disclosed by Darlington. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to treat tissue more efficiently by selecting optimal shape among various shapes based on the shape of the tumor/tissue volume to be treated, as recognized by Darlington (see, e.g., Para. [0058] and [0080]).
Regarding claim 8, Roberts modified by Kim and Gateau discloses the method of claim 1, as set forth above. Roberts further discloses wherein mechanically moving the focus through each of the remaining plurality of treatment volumes further comprises traversing the plurality of treatment volumes with the ultrasound therapy system (see, e.g., Para. [0011], “Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”).
Roberts modified by Kim and Gateau does not specifically disclose the plurality of treatment volumes with the ultrasound therapy system beginning with the first of the plurality of treatment volumes positioned at a first axial extreme of the target tissue volume and progressing through the plurality of treatment volumes through a last treatment volume positioned at a second axial extreme of the target tissue volume.
However, in the same field of endeavor of ultrasound treatment/therapy, Darlington discloses the plurality of treatment volumes with the ultrasound therapy system beginning with the first of the plurality of treatment volumes positioned at a first axial extreme of the target tissue volume and progressing through the plurality of treatment volumes through a last treatment volume positioned at a second axial extreme of the target tissue volume (see, e.g., Para. [0077], and Para. [0082], and Para. [0089], “The HIFU transducer and motors within the treatment device 150 are then activated such that a pattern of elemental treatment volumes is ablated to form the shell that surrounds or encapsulates the tissue volume or some other desired pattern of elemental treatment volumes. When creating elemental treatment volumes, the focal zone of the HIFU transducer may be continually moved until a treatment volume is ablated or the focal zone may be moved to discrete positions around the perimeter of the elemental treatment volumes and a HIFU signal applied to create the elemental treatment volumes”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including the plurality of treatment volumes with the ultrasound therapy system beginning with the first of the plurality of treatment volumes positioned at a first axial extreme of the target tissue volume and progressing through the plurality of treatment volumes through a last treatment volume positioned at a second axial extreme of the target tissue volume, as disclosed by Darlington. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to treat tissue more efficiently by selecting optimal shape among various shapes based on the shape of the tumor/tissue volume to be treated, as recognized by Darlington (see, e.g., Para. [0058] and [0080]).
Regarding claim 9, Roberts modified by Kim and Gateau discloses the method of claim 1, as set forth above. Roberts discloses the plurality of treatment volumes (see, e.g., Para. [0011], “Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”).
Roberts modified by Kim and Gateau does not specifically disclose wherein the plurality of treatment volumes are column-shaped.
However, in the same field of endeavor of ultrasound treatment/therapy, Darlington discloses wherein the plurality of treatment volumes are column-shaped (see, e.g., Fig. 1A, and Para. [0049], “FIG. 1A illustrates a tissue volume, such as a uterine fibroid 20, to be treated. Uterine fibroids may be irregularly shaped but are often generally spherical or oval shaped”, and Para. [0064], and Para. [0077], and Para. [0080], “Although the shape of the ablated shells is shown as being generally spherical in FIGS. 3J-3K, 4A-4B and 4C, it will be appreciated that other shapes, such as conical or double conical, ovoid (e.g., egg shaped), or rectangular could be used. The particular shape of the shell created may depend on the shape of the tissue volume to be treated and the ability of the equipment used to steer the focal zone of the HIFU transducer in a desired pattern”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including wherein the plurality of treatment volumes are column-shaped, as disclosed by Darlington. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to treat tissue more efficiently by selecting optimal shape among various shapes based on the shape of the tumor/tissue volume to be treated, as recognized by Darlington (see, e.g., Para. [0058] and [0080]).
Regarding claim 10, Roberts modified by Kim, Gateau, and Darlington discloses the method of claim 9, as set forth above. Roberts discloses electronically steering the cavitation bubble cloud through the plurality of treatment points within the first of the plurality of treatment volumes (see, e.g., Para. [0011], “The Histotripsy cavitation bubble cloud can appear very clearly on diagnostic ultrasound as a hyperechoic (light) region and ablated homogenized tissue can appear as a hypoechoic (dark) region. Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”).
Roberts modified by Kim does not specifically disclose rapidly electronically beam-steering the cavitation bubble cloud in a z-direction through the plurality of treatment points to form a column shaped bubble cloud.
However, in the same field of endeavor of ultrasound treatment/therapy, Gateau discloses rapidly electronically beam-steering the cavitation bubble cloud in a z-direction through the plurality of treatment points to form a column shaped bubble cloud (see, e.g., Abstract, and Figs. 1-2, and Page 142 (last para.) to Page 143 (first para.), “plan to steer the beams with an optimum correction based on bubble signatures, it is important to assess the effect of a small translation along the z-axis of the reference focus point on the location of the steered beam focus. With a first order approximation, the direction of the steered beam has been calculated to maintain the same angle relative to the array axis, but it will focus on the same unknown 2-coordinate as the reference beam. This effect thus appears to be small but might become significant if the steering process from bubble signature-based corrected beams is iterated”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim, Gateau, and Darlington by including rapidly electronically beam-steering the cavitation bubble cloud in a z-direction through the plurality of treatment points to form a column shaped bubble cloud, as disclosed by Gateau. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to obtain a high quality ultrasound image by removing phase aberration using a phase aberration correction method and in order to desirably improve the electronic steering capabilities of the array, as recognized by Gateau (see, e.g., Abstract, and Page 136, Col. 2, Section E).
Regarding claim 14, Roberts modified by Kim and Gateau discloses the method of claim 12, as set forth above. Roberts discloses the target tissue volume (see, e.g., Abstract, “A medical imaging and therapy device is provided that may include any of a number of features. One feature of the device is that it can image a target tissue volume and apply ultrasound energy to the target tissue volume. In some embodiments, the medical imaging and therapy device is configured controllably apply ultrasound energy into the prostate by maintaining a cavitational bubble cloud generated by an ultrasound therapy system within an image of the prostate generated by an imaging system”).
Roberts modified by Kim and Gateau does not specifically disclose wherein the target tissue volume is a shape selected from the group consisting of generally spherical, an ellipsoid, and an arbitrary shape.
However, in the same field of endeavor of ultrasound treatment/therapy, Darlington discloses wherein the target tissue volume is a shape selected from the group consisting of generally spherical, an ellipsoid, and an arbitrary shape (see, e.g., Fig. 1A, and Para. [0049], “FIG. 1A illustrates a tissue volume, such as a uterine fibroid 20, to be treated. Uterine fibroids may be irregularly shaped but are often generally spherical or oval shaped”, and Para. [0058], “Although the elemental treatment volume 80 shown in FIGS. 3A and 3B is cylindrical in shape, it will be appreciated that other shapes such as spherical or cubic elemental treatment volumes etc. could be created depending on the steering capabilities of the HIFU beam 83”, and Para. [0064], and Para. [0077], and Para. [0080], “Although the shape of the ablated shells is shown as being generally spherical in FIGS. 3J-3K, 4A-4B and 4C, it will be appreciated that other shapes, such as conical or double conical, ovoid (e.g., egg shaped), or rectangular could be used. The particular shape of the shell created may depend on the shape of the tissue volume to be treated and the ability of the equipment used to steer the focal zone of the HIFU transducer in a desired pattern”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasound treatment method of Roberts modified by Kim and Gateau by including wherein the target tissue volume is a shape selected from the group consisting of generally spherical, an ellipsoid, and an arbitrary shape, as disclosed by Darlington. One of ordinary skill in the art would have been motivated to make this modification in order to allow a user to treat tissue more efficiently by selecting optimal shape among various shapes based on the shape of the tumor/tissue volume to be treated, as recognized by Darlington (see, e.g., Para. [0058] and [0080]).
Response to Arguments
Applicant's arguments, see Remarks filed 02/09/2026, have been fully considered but they are not persuasive.
Regarding the rejection of independent claims 1 and 12, Applicant argues that claims 1 and 12 recite rapidly electronically beam-steering the cavitation bubble cloud through a plurality of treatment points within the first of the plurality of treatment volumes to produce an enhanced bubble cloud shape, and that this technique is not taught or suggested by the cited art.
Examiner respectfully disagrees and emphasizes that the combination of Roberts (US 2011/0054315 A1) in view of Kim (NPL) and Gateau (NPL) does disclose each and every feature of the independent claims 1 and 12, as set forth above. Specifically, Examiner emphasizes that:
[1] Roberts discloses electronically steering the cavitation bubble cloud through a plurality of treatment points within the first of the plurality of treatment volumes to produce an enhanced bubble cloud shape within the first of the plurality of treatment volumes (see, e.g., Para. [0011], “The Histotripsy cavitation bubble cloud can appear very clearly on diagnostic ultrasound as a hyperechoic (light) region and ablated homogenized tissue can appear as a hypoechoic (dark) region. Large and irregular tissue volumes can be ablated using Histotripsy by electronically changing the focus of a therapeutic array or by mechanically moving the focus of the therapeutic transducer within the surgical target area”, and Para. [0021], “the controllably applying ultrasound energy step further comprises automatically maintaining the bubble cloud generated by the ultrasound therapy system within the image of the prostate generated by the imaging system with a control system”, and Para. [0041], “the surgical planning software or the user can create a surgical plan within the target tissue volume, such as within the prostate, with subsequent treatment volumes separated by 1 mm increments (e.g., total range 0.2 mm-1 cm). Each treatment target can be assigned a different dose of ultrasound therapy. The ultrasound dose can be determined, e.g., by the number of pulses delivered or the treatment duration in each treatment target. In some embodiments, the ultrasound therapy comprises Histotripsy therapy. Histotripsy can be performed within the planned treatment volume”, and Para. [0043], “the control system can automatically position the micro-manipulator system, imaging system, and the ultrasound therapy system to keep the cavitational bubble cloud in the imaging field. For example, the micro-manipulator system can be rotated and/or advanced in the axial direction automatically by the control system to a degree that is calculated based on the movement of the therapy system and the field of view of the imaging system”, and Disclosed Claim 21, “wherein the controllably applying ultrasound energy step further comprises automatically maintaining the bubble cloud generated by the ultrasound therapy system within the image of the prostate generated by the imaging system with a control system”); and
[2] Roberts is then modified by Kim and Gateau, where Gateau discloses rapidly electronically beam-steering the cavitation bubble cloud through a plurality of treatment points within the first of the plurality of treatment volumes with the ultrasound therapy transducer array to produce an enhanced bubble cloud shape within the first of the plurality of treatment volumes (see, e.g., Abstract, “Brain treatment through the skull with high-intensity focused ultrasound can be achieved with multichannel arrays and adaptive focusing techniques such as time reversal. […] In this paper, this simulation-based targeting has been used experimentally as a first step for focusing through an ex vivo human skull at a single location. It has enabled the creation of a cavitation bubble at focus that spontaneously emitted an ultrasonic wave received by the array. […] To target points around the focus with an optimal pressure level, conventional electronic steering from the initial focus has been combined with bubble generation. Thanks to step-by-step bubble generation, the electronic steering capabilities of the array through the skull were improved”, and Figs. 1-2).
Conclusion
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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