DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This action is in response to Applicant’s remarks, filed on 7/8/2026. The amendments to claim(s) 1-5 and 11 have been entered. No new claim(s) have been entered, no claims have been cancelled. Claims 7-10 and 12-15 were previously withdrawn. Accordingly, claim(s) 1-6 and 11 remain pending for examination.
Response to Arguments
Applicant’s arguments, see p. 12-19, with respect to claim(s) 1-6 and 11 have been fully considered. Regarding the objections, Examiner respectfully agrees with Applicant and the prior objections to the drawings and specification are withdrawn.
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. Applicant’s arguments with respect to claim(s) 1-6 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. 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.
Examiner respectfully notes that Applicant’s arguments only address independent claim(s), and no remarks regarding the subject matter of the dependent claim(s) have been presented. Accordingly, the rejections to dependent claims are modified to address Applicant’s amendments and the new rejection to independent claim(s) and are sustained. The rejections of claim(s) 1-6 and 11 under 35 U.S.C. § 103 are maintained.
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) 1-2, 5-6 and 11 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Liu et al. (“Design and Implementation of a Dual-Transmit/ Receive-Mode Therapeutic Ultrasound Phased Array System for Brain Therapy," 2018 IEEE International Ultrasonics Symposium (IUS), Kobe, Japan, 2018, pp. 1-4, 2018-12-20; hereinafter “Liu”) as provided by Applicant
Regarding claim 1, Liu 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 (“This study proposes a dual-mode ultrasound phased array system design to support transmit/receive operations for concurrent ultrasound exposure and
backscattered focal beam reconstruction through a spherically focused ultrasound array. […] and may facilitate the design of a dual-mode ultrasound phased array for brain therapeutic applications.” [abst]; “a 256-channel phased array driving system to transcranially induce BBB-opening[14], […] and to implement the dual-mode function on the spherically focused ultrasound array, a multiple-channel receiving module was designed and implemented in the system” [p.2, col.2]; [fig. 1-3]), the method comprising the steps of:
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 (“a 256-channel phased array driving system […] which is used to drive multiple-channel transmission” [p.2, col.2]; “evaluate PSF reconstruction under the experimental setup using a point reflector or microbubble-perfused PE tube as a strong reflector to penetrate through human skull. The human cranial bone was positioned between the reflector and the spherically focused phased array.” [p.3, col.2]; [fig. 1-4]);
receiving, via the dual-mode ultrasonic phased array, backscattered acoustic energy reflected from the intracranial target point by the focused ultrasound beam (“a multiple-channel receiving module” [p.2, col.2]; “Receiving circuits with channel numbers ranging from 4–64 received the RF signals.” [p.3, col.1]; [fig. 1-4]);
converting the backscattered acoustic energy into backscattered radiofrequency (RF) signals (“Receiving circuits with channel numbers ranging from 4–64 received the RF signals.” [p.3, col.1]; “The transmission cycle was set to 2, and the backscattered emissions were transcranially collected via 32 receiving channels. […] Phase aberration correction successfully corrected the phase aberration, and the PSF can be successfully restored (Fig. 4(c)). Phase aberration correction can successfully restore the PSF for microbubble concentrations of at least 0.1%” [p.3, col.2]; [fig. 1-4]); and
reconstructing an acoustic distribution image in real-time by the processing device based on the backscattered RF signals (“One potential approach to realizing real-time intraoperative beam mapping is to integrate diagnostic ultrasound to passively receive backscattered emissions resulting from the therapeutic transducer and to perform reconstruction (or socalled “passive imaging”) […] demonstrate the feasibility of passive beam-formation imaging to visualize the focal beam pattern” [p.1, col.2]; The backscattered ultrasound from therapeutic pulses are passively collected in real-time during the ultrasound procedure and used to reconstruct the PSF image [fig. 1-4]);
but Liu fails to explicitly teach the position-tracking system to obtain positioning data indicating spatial coordinates for respective spatial positions of each of the dual-mode ultrasonic phased array and of a head of a patient in a shared three-dimensional space.
However, in the same field of endeavor, Vitek 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 method for calibrating a magnetic-resonance-guided focused-ultrasound system,” [clm 1]; “MRI may be used to visualize, for example, a brain tumor, and determine its location relative to the patient's skull. An ultrasound transducer system, […] may then be placed on the patient's head, and the transducers driven so as to focus ultrasound onto the tumor.” [0003]; [0019-0033], [fig. 1-4]), the method comprising
using a position-tracking system to obtain positioning data indicating spatial coordinates for respective spatial positions of each of the dual-mode ultrasonic phased array and of a head of a patient in a shared three-dimensional space, the position- tracking system being external to the dual-mode ultrasonic phased array (“(b) establishing MR coordinates of the MR trackers; (c) for each of a plurality of sonication schemes, (i) creating an ultrasound focus, and (ii) establishing parameters indicative of MR coordinates of the ultrasound focus;” [clm 1]; [0019-0033], [fig. 1-4]);
guiding a focal point of the dual-mode ultrasonic phased array to the intracranial target point of the patient according to the positioning data (“(i) creating an ultrasound focus, and (ii) establishing parameters indicative of MR coordinates of the ultrasound focus; and, (d) based at least in part on the parameters, determining a geometric relationship between the ultrasound transducers and the MR trackers.” [clm 1]; “facilitates determination of the relative positions between ultrasound transducers 102 and MR trackers 110 or, in other words, the relationship between ultrasound and MR coordinates” [0027]; The positions of the ultrasound transducers are determined in MR coordinates and used to target the focus for ultrasound into intracranial regions [0019-0033], [fig. 1-4]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of reconstructing a transcranial acoustic distribution image using a dual-mode ultrasonic phased array taught by Liu with the position-tracking system taught by Vitek. Focused ultrasound phased array systems have attracted increased attention for brain therapy applications; however, such systems currently lack a direct and real-time method to intraoperatively monitor ultrasound pressure distribution for securing treatment (Liu [abst]). It is known that focused ultrasound may be used to ablate diseased (e.g., cancerous) tissue without causing significant damage to surrounding healthy tissue. The noninvasive nature of ultrasound surgery is particularly appealing for the treatment of, for example, brain tumors (Vitek [0002]). The combined system may have potential for real-time guidance of ultrasound brain intervention and may facilitate the design of a dual-mode ultrasound phased array for brain therapeutic applications (Liu [abst]).
Regarding claim 2, Liu and Vitek teach the method according to claim 1,
Liu further teaching wherein before reconstructing the acoustic distribution image, the method further comprises 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 (“Ani is the weighting factor for each receiving element sn(rni,ti) represents the received backscattered RF data on the n-th receiving element on the spherically focused array, ti is the total delay contributed by the delay including the wave transmission phase and the receiving phase” [p.2, col.1]; “Phase aberration correction successfully corrected the phase aberration, and the PSF can be successfully restored” [p.3, col.2]; [fig. 1-4], [see claim 1 rejection]).
Regarding claim 5, Liu and Vitek teach the method according to claim 1,
Liu further teaching wherein after reconstructing the acoustic distribution image, the method further comprises adjusting energy output by the dual-mode ultrasonic phased array according to the acoustic distribution image (“We first tested the capability of PSF reconstruction via a strong-scattering point reflector. Figures 3(a) compares the reconstructed PSF with varying receiving channels (with element numbers ranging from 4 to 64) to characterize beamformation performance and its dependence on the number of receiving channels.” [p.3, col.1]; Calibration is performed to adjust the ultrasound focus and frequency based on phantom imaging [fig. 1-4]).
Regarding claim 6, Liu and Vitek teach the method according to claim 5, Liu further teaching 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 (“current diagnostic ultrasound with the frequency ranging 2–10 MHz results in severe transcranial energy loss and aberration, and is ineffective for beam pattern reconstruction for CNS application” [p.1, col.1]; Attenuation occurs due to transmission of ultrasound due to skull and is corrected [fig. 1-4], [see claim 1 rejection]).
Regarding claim 11, Liu and Vitek teach the method according to claim 1,
Liu further teaching wherein the plurality of channels is configured to emit energy to the intracranial target point and to receive the backscattered energy respectively at different time points (“The proposed approach considers all backscattered emissions and then coherently sums the contribution of each acoustic emission received by the array, with a time delay tn.” [p.2, col.1]; [fig. 1-4], [see claim 1 rejection]).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu and Vitek as applied to claim 2 above, and further in view of Hynynen et al. (US20200205773A1, 2020-07-02; hereinafter “Hynynen”).
Regarding claim 3, Liu and Vitek teach the method according to claim 2,
but the combination of references above fails to explicitly teach calculating a density distribution of intracranial tissue based on Hounsfield Unit (HU) values of a computed tomography (CT) image.
However, 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 calculating the phases of the plurality of channels emitting energy to the intracranial target point, the method further comprises 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 acquire 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 Liu and Vitek by calculating density of intracranial tissue based on computer tomography 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]). 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, Liu, Vitek and Hynynen teach the method according to claim 3,
Liu further teaching wherein after calculating the phases of the plurality of channels emitting energy to the intracranial target point, the method further comprises “Phase aberration correction successfully corrected the phase aberration, and the PSF can be successfully restored” [p.3, col.2]; [fig. 1-4], [see claim 1 rejection]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
