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, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/30/2026 has been entered.
Response to Amendment
This action is in response to Applicant’s remarks, filed on 1/30/2026. Claim(s) 7-10 and 12-15 have been previously withdrawn pursuant to the Election/Restriction requirement filed 2/6/2025. Accordingly, claim(s) 1-6 and 11 remain pending for examination on the merits.
Response to Arguments
Applicant’s arguments, see p. 2-10, with respect to claim(s) 1-6 and 11 have been fully considered. Regarding the rejection(s) under 35 U.S.C. § 102 and 35 U.S.C. § 103, Examiner respectfully disagrees with the remarks and does not find Applicant’s arguments persuasive. New grounds of rejection are made in view of the following: new amendments provided by Applicant and attached remarks; updated search and review of pertinent, eligible prior art; and/or different interpretation of the previously applied references. Independent claim 1 is newly rejected under 35 U.S.C. § 102 over Ebbini et al. (US20130144165A1, 2013-06-06; hereinafter “Ebbini”). Applicant previously argued against Ebbini in response filed 7/7/2025. Examiner respectfully disagrees with the Applicants interpretation of Ebbini, as well as Hynynen, in view of the claim language as drafted.
Regarding the amended claim 1, Applicant provided the following arguments against Ebbini:
The Office Action cites Ebbini particularly paragraphs [0045-0098, 0134-0171] and Figures 1-3, 5-7F, 8A-8F as teaching the technical features of Claim 1 of the present application, and thus alleges that the application is clearly anticipated by Ebbini.
However, the amended Claim 1 introduces a new technical feature:
"Step (A): using a position-tracking system to obtain positioning data of the dual- mode ultrasonic phased array and a patient, and guiding a focal point of the dual-mode ultrasonic phased array to the intracranial target point of the patient." Applicant respectfully submits that Ebbini does not teach the above technical feature.
Upon review, while several paragraphs of Ebbini mention motion tracking, none of them teach the above feature. Specifically, paragraph [0035] describes that processing programs or routines 16 may include various algorithms such as computational and matrix mathematics, signal processing, image construction, and motion tracking, among others, to implement different system functions like multi-mode imaging, therapy, and data fusion.
Paragraph [0105] describes that multi-modal coded excitation imaging algorithms may be used to improve frame rate and allow for 2D (or 3D) motion tracking capabilities. Although motion tracking is referenced, it more accurately pertains to improving frame rate to enhance image guidance. Clearly, this paragraph does not teach the above technical feature either. Paragraph [0153] describes capturing pulse-echo data at a frame rate that allows motion tracking of both the vessel wall and the blood flow simultaneously. Evidently, this paragraph does not disclose the above feature. Paragraph [0177] discusses STF (spatio- temporal focusing) imaging that allows acquisition rates sufficient for real-time tracking.
Examiner respectfully disagrees with the Applicant’s assertion that Ebbini fails to teach “a position tracking system”, and particularly the step of "Step (A): using a position-tracking system to obtain positioning data of the dual- mode ultrasonic phased array and a patient, and guiding a focal point of the dual-mode ultrasonic phased array to the intracranial target point of the patient." Indeed, Ebbini teaches this feature – particularly the combination of ultrasound imaging data and real-time motion tracking constitutes the acquisition of ‘positioning data’ [see claim 1 rejection]. Ebbini discloses multiple imaging modes compatible with the therapy method: “Multiple real-time imaging modes (e.g., SA imaging or B-mode imaging, SFT imaging, M2D-mode strain imaging, QB-mode imaging, etc.) can be used to: 1) guide the therapeutic beam, 2) assess, for example, thermal and mechanical tissue response to estimate the initial dose, 3) monitor and characterize tissue response during therapy, and 4) assess the state of the treated tissue at the completion of each exposure (e.g., for use in defining subsequent therapy exposures).” [0078]. Ebbini teaches that the initiation of the therapy process begins with imaging the patient. This establishes the position of the transducer array relative to the target regions to calibrate and deliver subsequent therapy pulses. Ebbini discloses:
Yet further, control image data as shown in FIG. 2, may also be generated based on one or more test patterns (represented generally by line 37 in FIG. 2) representative of calculated therapy signals generated for delivery of a subsequent burst. In other words, prior to delivery of a subsequent therapy burst (block 34) of the plurality of sequential therapy bursts based on therapy signals generated using control image data generated during and/or following delivery of a previous therapy burst, the method 30 may include testing the subsequent therapy burst at sub-therapeutic levels. Control image data generated based on such test patterns may be used to modifying the therapy signals generated to deliver the subsequent therapy burst.
[0155] (emphasis added)
For example, SA imaging or any other real-time DMUA imaging (e.g. coded excitation) may be used to provide display images of the treatment region and/or target region for use in identifying the control points. SA imaging is known in the art and will not be described in further detail herein. For example, such imaging is generally described in Ebbini, et al., “Dual-mode ultrasound phased arrays for image-guided surgery,” Ultrason. Imag., vol. 28, pp. 201-220, 2006.
[0158] (emphasis added)
With the control points, such as target points, identified (block 252), imaging (e.g., STF imaging) using one or more focused beams may be performed to measure target point directivities (e.g., as set forth in FIG. 8B, lines 13-20) and/or be performed to measure critical point directivities (e.g., as set forth in FIG. 8B, lines 21-28) (e.g., generate control image data including such directivities). A utility function for generating an “X” matrix for use in performing such routines is shown, for example, in FIG. 8B, lines 29-34.
[0159] (emphasis added)
Ebbini teaches the use of test patterns at sub-therapeutic levels prior to actual HIFU therapy bursts to refocus and obtain directivity data, which indicates the position of the ultrasound transducer array relative to the target tissues within the patient [see Ebbini fig. 2, 8A reproduced below]. The combination of convention ultrasound (e.g., synthetic aperture) imaging with sub-therapeutic test therapy pulses to generate control images for refocusing provides the required positioning information to guide ultrasound therapy of the target regions. Subsequent control images obtained from actual HIFU therapy bursts may be used to generate treatment region image data indicating the pressure fields and response of the target tissue to cavitation (Ebbini [0134-0171]).
PNG
media_image1.png
939
810
media_image1.png
Greyscale
PNG
media_image2.png
950
680
media_image2.png
Greyscale
Flowcharts of ultrasound therapy method describing identification of target regions and localization of ultrasound transducer array relative to the target region prior to transmission of HIFU therapy pulses (Ebbini [fig. 2, 8A])
Ebbini therefore does teach the tracking and guidance limitations as claimed. Applicant has previously agreed that Ebbini teaches spatial registration in arguments addressing the integration of DMUA and MRI, providing excerpts from Ebbini and concluding that “Based on these excerpts, it is evident that Ebbini merely mentions MRI to highlight the challenges of existing imaging modalities in the context of HIFU treatment, and then introduces its own innovation i.e., the use of a single transducer array to achieve inherent spatial registration for more precise and real-time guidance and treatment control.” (Remarks 7/7/2025, p.13). The spatial registration (i.e., position) of the transducer array relative to the target region is inherent based on the imaging data, and supplemented through the use of directivity data, to guide therapy. In response to applicant's prior arguments that the reference fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “reacquisition of absolute spatial location”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, Ebbini indeed teaches the capability to re-acquire spatial location of the transducer and target, teaching the use of motion tracking in real time [see claim 1 rejection]. Accordingly, Examiner respectfully disagrees with the Applicant, and provides that Ebbini does teach the limitations of amended claim 1.
The rejections of claim(s) 1-6 and 11 under 35 U.S.C. § 102 and 35 U.S.C. § 103 are maintained.
Drawings
The drawings are objected to for minor informalities. The “tracking system 2” is misidentified in the instant figure 1 as a ‘tacking system’. The box indicating the tracking system must be corrected to remain consistent with the disclosure of the instant specification [see objection to specification].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of informalities. The “tracking system 2” is misspelled in the instant specification (‘tacking system 2’ [p.10, ln.23]); the specification should be amended to correct the typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5 and 11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ebbini et al. (US20130144165A1, 2013-06-06; hereinafter “Ebbini”).
Regarding claim 1, Ebbini teaches a method of reconstructing a transcranial acoustic distribution image using a dual-mode ultrasonic phased array, wherein the acoustic distribution image represents a degree of acoustic pressure distribution at an intracranial target point, the method being applicable to a processing device in signal communication with a plurality of channels forming an array on the dual-mode ultrasonic phased array (“A dual mode ultrasound transducer therapy method comprising: providing an array of ultrasound transducer elements,” [clm 31]; “The methods described […] may be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors,” [0065]; “Other therapy that may be provided by the exemplary therapy system 10 (e.g., using delivery of a plurality of sequential therapy bursts) may include use for cancer treatment (including prostate, hepatic cellular carcinoma, kidney, breast, brain, etc.),” [0080]; “Additional insight on the workings of the refocusing algorithm was provided by direct measurement of the acoustic field profiles in the rib and target planes for different HIFU excitation vectors in the presence of the ribs.” [0216]; The dual mode ultrasound transducer therapy method may be implemented by one or more processors and used to perform ultrasound imaging – including measurement of pressures at focal point(s) – and ultrasonic therapy directed towards the brain [0045-0098, 0134-0171, 0200-0224], [fig. 1-3, 5, 7A-7F, 8A-8F]),
the method comprising the steps of:
Step (A): using a position-tracking system to obtain positioning data of the dual-mode ultrasonic phased array and a patient, and guiding a focal point of the dual- mode ultrasonic phased array to the intracranial target point of the patient (“transmit/receive imaging ultrasonic energy to/from the target region; generating treatment region image data and identifying at least one or more target points within a target region thereof based on pulse echo data received by one or more of the plurality of ultrasound transducer elements;” [clm 31]; “processing programs or routines 16 may include programs or routines for performing computational mathematics, […] generate a graphical user interface to allow a user to input commands, carry out motion tracking or speckle tracking,” [0053]; “This permits: 1) motion tracking to maintain the therapeutic application at the target point; 2) in situ estimation of the dose based on target tissue response to sub-therapeutic HIFU beams; 3) monitoring tissue response to HIFU beams with sub-millisecond resolution and adjust the exposure parameters” [0082]; “a start procedure may provide for implementation of one or more imaging processes (e.g., one or more imaging modes) as shown by pre-therapy imaging pulses 42. For example, an array of ultrasound transducer elements (e.g., array 22 configured to deliver a plurality of sequential therapy bursts of ultrasonic energy to at least a portion of a target region and to transmit/receive imaging ultrasonic energy to/from the target region) may deliver image pulses 42 to obtain pulse echo data representative of a treatment region in which a target for therapy is located.” [0136]; “With the control points, such as target points, identified (block 252), imaging (e.g., STF imaging) using one or more focused beams may be performed to measure target point directivities” [0159]; One or more target points (i.e., focal points) are identified based on ultrasound imaging of the treatment region, wherein motion tracking/directivity data of the ultrasound transmissions of the transducer array relative to the patient tissues is provided to guide therapy, prior to generating HIFU ultrasound therapy signals [0045-0098, 0134-0171, 0200-0224], [fig. 1-3, 5, 7A-7F, 8A-8F; see fig. 2, 8A reproduced below]);
PNG
media_image2.png
950
680
media_image2.png
Greyscale
Test patterns may be used to generate control image data from pulses delivered at sub-therapeutic levels, in order to acquire directivity data for refocusing the HIFU therapy beam (Ebbini [fig. 8A])
Step (B): using the processing device to control the transmission of the plurality of channels of the dual-mode ultrasonic phased array to emit acoustic energy, thereby forming a focused ultrasound beam directed to the intracranial target point according to the positioning data (“generating treatment region image data […] generating therapy signals to drive one or more of the plurality of ultrasound transducer elements to deliver a plurality of sequential therapy bursts of ultrasonic energy to at least one of the one or more target points in the target region” [clm 31]; “the therapy method 30 includes generating therapy signals to drive one or more of the plurality of ultrasound transducer elements to deliver a therapy burst […] of ultrasonic energy (e.g., forming a focused beam) to at least one of the one or more target points in the target region)” [0138]; The sequential therapy bursts are generated to produce a response at identified target points within the target region based on the treatment region image data [0045-0098, 0134-0171, 0200-0224], [fig. 1-3 5-7F, 8A-8F; see fig. 2 reproduced below]);
Step (C): receiving, via the dual-mode ultrasonic phased array, backscattered acoustic energy reflected from the intracranial target point by the focused ultrasound beam, and converting the backscattered acoustic energy into backscattered radiofrequency (RF) signals (“generating control image data based on pulse echo data received by one or more of the plurality of ultrasound transducer elements during and/or following delivery of each therapy burst of a plurality of sequential therapy bursts,” [clm 31]; “Data 18 may include, for example, sampled pulse-echo information (e.g., sampled or collected using the one or more transducers elements 22, control image data (e.g., directivity data, imaging data, thermal response data, mechanical response data including displacement/strain data associated with the target region, such as measurements or vascular characteristics),” [0054]; “control image data may include displacement/strain data (or any other mechanical response data associated with the target region, such as temperature change data, cavitation activity data, etc.). Such displacement/strain data may be used to control the focused beam in any number of ways.” [0150]; “M2D mode may produce 2D beamformed RF echo data from a selected region of the field of view (FoV) of a given probe.” [0151]; The dual-mode ultrasound array receives ultrasonic reflections and may generate control image data (i.e., 2D RF data) from real-time M2D-mode strain/temperature change data of the target region [0045-0098, 0134-0171, 0200-0224], [fig. 1-3 5-7F, 8A-8F]); and
Step (D): reconstructing an acoustic distribution image in real-time by the processing device based on the backscattered RF signals (“generating control image data comprises generating control image data comprising at least one of ultrasound transducer element directivity data, displacement and/or strain data, thermal response data, and data indicative of cavitation,” [clm 40]; “Further, various peripheral devices, such as a computer display, […] are contemplated to be used in combination with the control apparatus 12, such as for visualization of imaging results (e.g., display of multimodal images, display of therapy delivery in real time such as with use of high intensity focused ultrasound, etc.)” [0058]; “Multiple real-time imaging modes (e.g., SA imaging or B-mode imaging, SFT imaging, M2D-mode strain imaging, QB-mode imaging, etc.) can be used to: 1) guide the therapeutic beam, 2) assess, for example, thermal and mechanical tissue response to estimate the initial dose, 3) monitor and characterize tissue response during therapy, and 4) assess the state of the treated tissue at the completion of each exposure” [0078]; “different modes of imaging may be fused 139 to provide the user with desirable imaging of the therapy being carried out. For example, SA image data may be fused with STF image data and be displayed. Further, for example, more detail information (e.g., using M2D imaging) regarding structures (e.g., vasculature, including plaque structures) may be provided to be fused with other data” [0117]; Real-time images for viewing the treatment region (i.e., acoustic distribution image) are derived from 2D beamformed RF echo data (e.g., displacement/ strain data, temperature change data, cavitation activity data, etc.) and presented for display [0045-0098, 0134-0171, 0200-0224], [fig. 1-3 5-7F, 8A-8F]).
PNG
media_image1.png
939
810
media_image1.png
Greyscale
The treatment region is imaged to identify targets for therapy, and control images are acquired subsequent to therapy pulses to display results of treatment to the user (Ebbini [fig. 2])
Regarding claim 5, Ebbini teaches the method according to claim 1,
Ebbini further teaching wherein after the step of reconstructing the acoustic distribution image, the method further comprises a step: adjusting energy output by the dual-mode ultrasonic phased array according to the acoustic distribution image (“generating control image data based on pulse echo data received by one or more of the plurality of ultrasound transducer elements during and/or following delivery of each therapy burst of a plurality of sequential therapy bursts, wherein the control image data generated during and/or following delivery of a therapy burst is used to generate therapy signals to drive one or more of the plurality of ultrasound transducer elements to deliver a subsequent therapy burst of the plurality of sequential therapy bursts.” [clm 31]; “the amplitude, duration, and spectral content of therapy bursts can be adjusted in real-time based on imaging feedback between bursts, i.e. therapy bursts are dynamically changed during treatment” [0051]; “Real-time intensity modulation (or generally beam resynthesis; including adjustment of phase/delay, amplitude, and/or spectral content of the therapeutic beam) can be performed based on imaging feedback with millisecond time resolution.” [0079]; Feedback from real-time control imaging data is used to modulate intensity, including amplitude (i.e., energy output) [0045-0098, 0134-0171], [fig. 1-3, 5, 7A-7F, 8A-8F], [see claim 2 rejection]).
Regarding claim 11, Ebbini teaches the method according to claim 1,
Ebbini further teaching wherein the plurality of channels is configured to perform the step of emitting energy to the intracranial target point and the step of receiving the backscattered energy respectively at different time points (“generating the control image data comprises generating the control image data substantially in real-time relative to the therapy signals.” [clm 48]; “the imaging pulses 46 (e.g., which may include one pulse or more than one pulse between each therapy burst 40) are used to provide image control data for use in redefining the therapy beam over time (e.g., guide the beam). In other words, the focused beam is imaged and guided based on the imaging performed in real-time with the delivery of the therapy” [0048]; Imaging is performed in real-time (i.e., at different time points) to guide therapy and to monitor the thermal and mechanical tissue response to therapy delivery [0045-0098, 0134-0171], [fig. 1-3, 5, 7A-7F, 8A-8F], [see claim 1 rejection]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 2-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebbini as applied to claims 1 and 5 above, in view of Hynynen et al. (US20200205773A1, 2020-07-02; hereinafter “Hynynen”).
Regarding claim 2, Ebbini teaches the method according to claim 1,
Ebbini further teaching wherein before the step of reconstructing the acoustic distribution image, the method further comprises steps:
acquiring spatial positional data of the dual-mode ultrasonic phased array and the patient's head by the position-tracking system, the spatial positional data being capable of determining coordinates of the dual-mode ultrasonic phased array and the patient's head (“During the ultrasound imaging of a target (e.g., a tumor, a vessel, etc.), the transducer array 122 may be positioned relative to the target so as to be capable of delivering energy to the target resulting in reflected energy (also known as the resultant pulse-echo or echo energy) and also sampling the echo energy.” [0086]; “where c is the speed of sound, Ai and Bj are, respectively, the transmit and receive apodization weights, Rip and Rjp are, respectively, the distances from the transmitting and receiving elements to the image pixel P, and sij(t) is the echo received by element j when transmitting with element i.” [0189]; The transducer is positioned relative to the target, wherein the distances between the transducer elements and the image pixel (i.e., spatial positional data) are determined for each ultrasound transmission[0045-0098, 0134-0171, 0200-0224], [fig. 1-3, 5, 7A-7F, 8A-8F]); and
calculating phases of the plurality of channels for emitting the acoustic energy to the intracranial target point based on the spatial positional data and the difference between the emitted acoustic energy and the backscattered acoustic energy of the dual-mode ultrasonic phased array (“generating control image data based on pulse echo data received by one or more of the plurality of ultrasound transducer elements during and/or following delivery of each therapy burst of a plurality of sequential therapy bursts,” [clm 31]; “Real-time intensity modulation (or generally beam resynthesis; including adjustment of phase/delay, amplitude, and/or spectral content of the therapeutic beam) can be performed based on imaging feedback with millisecond time resolution.” [0079]; “examination of the typical magnitude and phase distributions of the DMUA excitation vector resulting from the application of adaptive refocusing according to Equation was also performed.” [0219]; “Phase and amplitude control is achieved through a 200-MHz FPGA-based digital control circuit […] The phase and amplitude distributions are obtained using the optimal pattern synthesis method” [0235]; The phase distribution of the transmission is calculated and used for correction [0045-0098, 0134-0171, 0200-0224], [fig. 1-3, 5, 7A-7F, 8A-8F]).
Although Ebbini teaches all the limitations of claim 2 as shown above, if in an interpretation, one argues (or interprets differently) that Ebbini does not teach acquiring spatial positional data of the patient's head by the position-tracking system, below is an alternative rejection in addition to the above.
In the same field of endeavor, Hynynen teaches a method of reconstructing a transcranial acoustic distribution image using a dual-mode ultrasonic phased array (“An ultrasound imaging method comprising: transmitting longitudinal ultrasound waves via an ultrasound probe toward a target at a plurality of incident angles, […] producing received radio frequency (RF) signals via the ultrasound probe based on the received reflected longitudinal ultrasound waves;” [clm 26]; “the dual wave ultrasound imaging system 50 includes a host controller 52, an ultrasound driving system (also known as an ultrasound transceiver) 56, a fast ultrasound system switch 60 (shown in FIG. 2) or 61 (shown in FIG. 7), and an ultrasound transducer probe 68.” [0081]; The ultrasound imaging method utilizes a dual wave ultrasound imaging system to transmit longitudinal waves through the skull into the soft tissue as either shear or longitudinal waves depending on incident angle, and are reflected back from features to be imaged as longitudinal waves which propagate back through bone either as shear waves or as longitudinal waves [0074-0101], [fig. 2-5, 7-11, 13]);
Hynynen further teaching wherein before the step of reconstructing the acoustic distribution image, the method further comprises steps:
acquiring spatial positional data of the dual-mode ultrasonic phased array and the patient's head by the position-tracking system, the spatial positional data being capable of determining coordinates of the dual-mode ultrasonic phased array and the patient's head (“wherein co-registering the pixels or voxels utilizes one or more of optical tracking, magnetic tracking, kinetic tracking, or software-based feature tracking.” [clm 52]; “The host controller 52 is a computer that is programmed to control the ultrasound driving system 56 or 90 and, when present, the optical tracking system 84” [0083]; “The software may take tracking data 238 to co-register the ultrasound pixels (or voxels) to a global coordinate system, resulting in a larger imaging field of view than what can be produced from one location of the transducer.” [0084]; “the position of the ultrasound probe on the patient's head is monitored (e.g., tracked optically, acoustically, magnetically, etc.), where the positional information is used to co-register ultrasound pixels (or voxels), or otherwise correlate with imaging data from the ultrasound probe 68” [0121]; “exemplary embodiments can provide 2D imaging, 3D imaging and tomography, and 4D time lapse imaging and tomography (i.e., 3D tomography in real-time) of whole or partial brain images through the skull 10,” [0152]; An optical tracking system (i.e., position tracking system) acquires tracking data of the ultrasound transducer array and the patient’s head to co-register ultrasound voxels from imaging to a global coordinate system [0074-0123], [fig. 2-5, 7-13; see fig. 13 reproduced below]); and
calculating phases of the plurality of channels for emitting the acoustic energy to the intracranial target point based on the spatial positional data and the difference between the emitted acoustic energy and the backscattered acoustic energy of the dual-mode ultrasonic phased array (“correcting the digitized received RF signals from the ultrasound waves for phase shift.” [clm 33]; “received RF signals received from the non-distorted converted shear waves (produced by shear angle transmit/receive pad C1, FIGS. 3A and 3B) and/or received RF signals received from the longitudinal waves are used to correct the phase distortions of the received longitudinal waves.” [0085]; Phase and amplitude corrections to the received longitudinal waves (including converted shear waves) are used in receive beamforming to correct for bone aberrations [0074-0123], [fig. 2-5, 7-13; see fig. 13 reproduced below]).
PNG
media_image3.png
640
629
media_image3.png
Greyscale
The optical tracking system co-registers the ultrasound data acquired by the probe in global coordinate space (Hynynen [fig. 13])
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 method of reconstructing an image using a dual-mode ultrasonic phased array as taught by Ebbini by acquiring spatial positional data of the patient's head by the position-tracking system as taught by Hynynen. High-intensity focused ultrasound (HIFU) continues to receive increased attention as a therapeutic tool in the treatment of cancer and other tissue abnormalities; however, current technology for imaging based on ultrasonic signals and for providing therapy using ultrasonic energy is inadequate (Ebbini [0004]). Signals from echoes within the brain structure are weak compared to reflections from bone-tissue interfaces, which also confounds effective imaging. The skull bone is also highly attenuating, further reducing the signals returning from structures below the skull bone. Distortion of the transmitted ultrasound as it passes through the skull results in artifacts and beamforming challenges (Hynynen [0006]). By utilizing the various combinations of converted shear waves as well as unconverted longitudinal waves that have been corrected for aberration during receive beamforming, the image quality can be improved for clinical efficacy (Hynynen [0078]).
Regarding claim 3, Ebbini and Hynynen teach the method according to claim 2,
Hynynen further teaching wherein before the step of calculating the phases of the plurality of channels emitting energy to the intracranial target point, the method further comprises a step:
calculating a density distribution of intracranial tissue based on Hounsfield Unit (HU) values of a computed tomography (CT) image corresponding to the patient, so as to derive the difference between the emitted acoustic energy and the backscattered acoustic energy of the dual-mode ultrasonic phased array (“The ultrasound system switch 60 provides rapid switching between channels to occur immediately following the transmit event, to allow transmit and receive on separate transducer elements of the ultrasound transducer probe 68.” [0103]; “The performance of candidate transducer element array designs were tested using simulations of imaging through skull bone (FIG. 18A), where the simulation medium was taken from CT scans of skull caps. The density of the skull bone is determined from a simple relation between the CT pixel intensity in bone (in Hounsfield units, HU), air and water,” [0125]; [0074-0101, 0121-0144], [fig. 2-5, 7-11, 13]).
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 method of reconstructing an image using a dual-mode ultrasonic phased array as taught by Ebbini by calculating density of intracranial tissue based on computer tomography as taught by Hynynen. High-intensity focused ultrasound (HIFU) continues to receive increased attention as a therapeutic tool in the treatment of cancer and other tissue abnormalities; however, current technology for imaging based on ultrasonic signals and for providing therapy using ultrasonic energy is inadequate (Ebbini [0004]). Signals from echoes within the brain structure are weak compared to reflections from bone-tissue interfaces, which also confounds effective imaging. The skull bone is also highly attenuating, further reducing the signals returning from structures below the skull bone. Distortion of the transmitted ultrasound as it passes through the skull results in artifacts and beamforming challenges (Hynynen [0006]). By utilizing the various combinations of converted shear waves as well as unconverted longitudinal waves that have been corrected for aberration during receive beamforming, the image quality can be improved for clinical efficacy (Hynynen [0078]).
Regarding claim 4, Ebbini and Hynynen teach the method according to claim 3,
Hynynen further teaching wherein after the step of calculating the phases of the plurality of channels emitting energy to the intracranial target point, the method further comprises a step:
performing phase calibration on the plurality of channels emitting the acoustic energy according to the coordinates of the dual-mode ultrasonic phased array and the patient's head and the“correcting the digitized received RF signals from the ultrasound waves for phase shift” [clm 33]; “The software may apply skull aberration correction 222 based on phase information from the digitized received RF signals;” [0084]; “longitudinal waves are immediately reflected back off the bone surface, or trabecular bone, or the interior surface in order to characterize the bone morphology and calculate the phase shift introduced by the bone layer to the propagating longitudinal waves. […] the received RF signals collected from the reflected longitudinal waves 30 may be corrected for attenuation and phase shift due to the skull bone 10 for image reconstruction purposes.” [0086]; “The software may selectively apply phase and amplitude correction to digitized receive RF signals, depending on the transmit and/or receive incident angle in order to correct for the distortion of longitudinal waves passing through the skull layer. […] An estimate of the phase shift and amplitude correction to apply to each receive element of the transducer can then be either calculated from the digitized received RF signals or calculated through simulation of transmission through the skull to account for variation in skull morphology over the region of interest. This element-wise phase shift correction can be included in reconstruction beamforming selectively to account for distortion of the bone” [0135]; Software may selectively apply phase and amplitude correction to digitized receive RF signals, depending on the transmit and/or receive incident angle, to address bone artifacts [0074-0101, 0121-0144], [fig. 2-5, 7-11, 13]).
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 method of reconstructing an image using a dual-mode ultrasonic phased array as taught by Ebbini by performing phase calibration as taught by Hynynen. Signals from echoes within the brain structure are weak compared to reflections from bone-tissue interfaces, which also confounds effective imaging. The skull bone is also highly attenuating, further reducing the signals returning from structures below the skull bone. Distortion of the transmitted ultrasound as it passes through the skull results in artifacts and beamforming challenges (Hynynen [0006]). Furthermore, positional information may be used to co-register ultrasound pixels (or voxels), or otherwise correlate with imaging data from the ultrasound probe to enhance imaging and image processing capabilities of the dual wave ultrasound imaging system (Hynynen [0121]).
Regarding claim 6, Ebbini teaches the method according to claim 5,
Ebbini further teaching a compensation parameter according to reflected energy so as to adjust the energy output in real-time (“the amplitude, duration, and spectral content of therapy bursts can be adjusted in real-time based on imaging feedback between bursts, i.e. therapy bursts are dynamically changed during treatment” [0051]; [0045-0098, 0134-0171], [fig. 1-3, 5, 7A-7F, 8A-8F], [see claim 1, 5 rejections]);
but Ebbini may fail to explicity teach the transcranial decay rate.
However, in the same field of endeavor, Hynynen further teaches wherein the processing device calculates a transcranial decay rate and a compensation parameter according to reflected energy so as to adjust the energy output in real-time (“A digital map of the individual characteristics (internal and external surfaces) of each skull is created and used to estimate and correct for the delay introduced by the bone layer, in order to correct for aberration artifacts. Phase and amplitude corrections to the received longitudinal waves (including converted shear waves) are used in receive beamforming to correct for bone aberrations.” [0012]; “The software may apply skull aberration correction 222 based on phase information from the digitized received RF signals;” [0084]; “the received RF signals collected from the reflected longitudinal waves 30 may be corrected for attenuation and phase shift due to the skull bone 10 for image reconstruction purposes.” [0086]; “The beamforming delay may be adjusted to account for the bone layer.” [0135]; The bone layer attenuates transmitted ultrasound signals (i.e., transcranial delay) and may be compensated by adjusting beamforming delay and phase/amplitude correction [0074-0101, 0121-0144], [fig. 2-5, 7-11, 13]).
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 method of reconstructing an image using a dual-mode ultrasonic phased array which adjusts the energy output in real-time as taught by Ebbini by calculating a transcranial decay rate as taught by Hynynen. Signals from echoes within the brain structure are weak compared to reflections from bone-tissue interfaces, which also confounds effective imaging. The skull bone is also highly attenuating, further reducing the signals returning from structures below the skull bone. Distortion of the transmitted ultrasound as it passes through the skull results in artifacts and beamforming challenges (Hynynen [0006]). Furthermore, positional information may be used to co-register ultrasound pixels (or voxels), or otherwise correlate with imaging data from the ultrasound probe to enhance imaging and image processing capabilities of the dual wave ultrasound imaging system (Hynynen [0121]).
Hynynen et al. (US2020/0205773A1, 2020-07-02; hereinafter “Hynynen”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Brien et al. ("Image-guided Application and Monitoring of Transcranial Focused Ultrasound in Realistic Human Head Phantom," 2019 IEEE International Ultrasonics Symposium (IUS), Glasgow, UK, 2019, pp. 1898-1901, 2019-12-08) demonstrates the feasibility of DMUA guidance and control of tFUS application in a realistic human head phantom. A DMUA was used to image through the temporal bone of the phantom in SA and STF modes [abst].
Liu et al. ("Three-dimensional image guidance for transcranial focused ultrasound therapy," 2017 IEEE 14th International Symposium on Biomedical Imaging (ISBI 2017), Melbourne, VIC, Australia, 2017, pp. 916-919, 2017-06-19) teaches a dual-mode ultrasound array (DMUA) imaging system for monitoring and delivery of transcranial focused ultrasound (tFUS) therapy, wherein real-time ultrasound thermography was shown to be feasible using beamformed DMUA imaging data [abst].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at 5712727230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
Prosecution Insights