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 .
DETAILED ACTION
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.
Claims 1-8 and 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Zion et al. (WO 2020/198728 (provided in the IDS)) and in view of Konofagou et al. (US 2020/0147415).
Addressing claim 1, Bar-Zion discloses a system for a passive acoustic mapping, comprising (see [0028], [0066] and Fig. 3):
a focused ultrasound (FUS) transducer;
a diagnostic array transducer (see [0028], [0092], [0104] and Fig. 3; linear array);
wherein the diagnostic array transducer is configured to receive a cavitation signal induced from cavitation, the cavitation being induced by introducing microbubbles into a target area (see [0169] and [0172-0175]; gas vesicles (GVs) is the nanobubbles; gas vesicles is better and more advance replacement of microbubbles; GVs is used in the same applicatin as microbubbles, but perform better; cavitation being induced by introducing nanobubbles/GVs into a target area);
a processor configured to generate a cavitation map based on a spatial- temporal cavitation intensity determined using a spatial-temporal parallel programming, wherein the spatial-temporal parallel programming is performed by creating a thread for each pixel of the spatial-temporal map (see [0092-0095], [0099], [0137] and Fig. 3; passive acoustic measurement perform parallel is creating thread for each pixel; parallel processing or programing create thread; cavitation mapping involve parallel processing, including the use of threading, to enhance its speed and efficiency);
calculating the spatial-temporal cavitation intensity at a location and a time point in each thread (see [0136-0137] and [0164]; cavitation map includes the spatial-temporal cavitation intensity at a location and a time point in each thread; cavitation mapping involves calculating spatial-temporal cavitation intensity at specific locations and time points within each thread of a parallel computation, typically using CUDA. This process generates a spatio-temporal map of cavitation intensity);
creating a cavitation map by integrating the spatial-temporal cavitation intensity over temporal pixels (see [0093], [0138] and Fig. 8; imaging transducer measure spatial-temporal cavitation activity/intensity and integrate to form cavitation map; cavitation maps are essentially representations of the spatial distribution of cavitation intensity, and this intensity is often determined by integrating the cavitation signals detected over a defined time period within each pixel or voxel of the map).
Bar-Zion does not explicitly disclose phase array. Konofagou discloses phase array (see [0145]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bar-Zion to use phase array transducer as thought by Konofagou because phase array allows for electronic steering of focus.
Addressing claims 5-7, Bar-Zion discloses:
addressing claim 3, wherein the system further comprises microbubbles, wherein the microbubbles are configured to induce the cavitation (see [0169]; gas vesicles (GSs) is the microbubbles).
addressing claim 5, wherein the FUS transducer has a center frequency of about 0.25 MHz (see [0105], claims 6 and 15; center frequency of designer choice of less than 2.5 Mhz; capable of 0.25 mhz or 2.5 mhz; this only require routine skill in the art; center frequency from 250 khz to 3 mhz).
addressing claim 6, wherein the diagnostic array transducer has a plurality of elements (see [0143]).
addressing claim 7, wherein the diagnostic array transducer has a center frequency of about 2.5 MHz (see [0105], claims 6 and 15).
Addressing claims 2, 4, 8 and 10, Konofagou discloses
addressing claim 2, wherein a length of the FUS burst is less than 10 milliseconds (see [0010], [0193] and [0198]).
addressing claim 4, wherein the FUS transducer is a single-element FUS transducer (see [0145] and [0190]).
addressing claim 8, wherein the diagnostic phase array transducer is inserted into a central opening of the FUS transducer (see Fig. 20A; imaging transducer inserted into a central opening of the FUS therapy transducer).
addressing claim 10, wherein the system further comprises a neuronavigation system configured to position the FUS transducer at a target area (see [0188]; previous system uses neuronavigational system to help target FUS beam; this only require routine skill in the art).
Addressing claims 11, 13 and 15-19, the system performs the method therefore claims 11-15 are being rejected for the same reason as claims 1-2, 4-8 and 10. Also see [0100], blood-brain barrier; Fig. 18A; FUS transducer apply a focused ultrasound to the target. Center frequency modify from 250 khz to 3 mhz.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bar-Zion et al. (WO 2020/198728 (provided in the IDS)), in view of Konofagou et al. (US 2020/0147415) and further in view of Kim et al. (US 2018/0008234).
Addressing claim 9, Bar-Zion does not disclose sampling rate of 10 mhz. Sampling rate is a designer choice that depend on the application on only require routine skill in the art. Kim explicitly disclose sampling rate of 10 Mhz (see [0129]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bar-Zion to use sampling rate of 10 Mhz as taught by Kim because 10 MHz is a frequency where bandpass sampling techniques can be effectively applied, allowing for reduced sampling rates compared to traditional methods. Better for high resolution imaging in certain application.
Response to Arguments
Applicant's arguments filed 11/25/25 have been fully considered but they are not persuasive. Applicant argues Bar-Zion discloses advantages of using GV based cavitation over traditional microbubble, thus, Bar-Zion employs GVs rather than microbubbles. Applicant argues the subject matter of amended claim 1 recites “the cavitation being induced by introducing microbubbles into a target area”, directly opposite to the objectives of Bar-Zion therefore a person skilled in the art would not rely on Bar-Zion, alone or in combination with other references, to arrive at the subject matter of amended claim 1. Applicant’s argument is not persuasive because GVs is a type of bubbles. It is nanobubbles instead of microbubbles. It is a newer, more advance and better bubbles to use. GVs perform the same function as microbubbles such as contrast imaging, create cavitation, open blood-brain-barrier, just perform better. Using a more advance bubble product to create cavitation is not directly opposite of the claim invention. Bar-Zion has the same objective as the claim invention which is using bubbles to create cavitation, the only different is that he is using more advance bubbles. It only requires routine skill in the art to use any type of bubbles to create cavitation.
Applicant argues Fig. 8 of Bar-Zion merely presents an acoustic signature of stable cavitation and two levels of inertial cavitation without any location and time metrics, failing to disclose “spatial-temporal cavitation intensity at a location and a time point in each thread”, as recited in claim 1. Applicant argues applicant’s invention having the cavitation map having featured with coordinates (z pixel, location metrics) and such features are not disclosed, taught, or suggested in Bar-Zion. Applicant’s argument is not persuasive because spatial-temporal refers to things existing or occurring in both space and time. Bar-Zion clearly disclose spatial-temporal map of cavitation activity in [0093]. The monitoring of cavitation activity is in real-time. The map indicates where cavitation occurs (space) at the time. Spatial-temporal map include both space and time of the cavitation activity.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2013/0260416 (see [0146] sample rate of 10 Mhz) and WO 2017/004562((provided in the IDS) use neuronavigation (see page 24)); US 2022/0257503 (see [0003-0006]; GVs is nanobubbles that is an improvement over microbubbles); US 2021/0032128 (see abstract, [0016], [0120] and [0123]; could use microbubble or better bubble version nanobubble/GVs); US 2017/0011508 (see abstract, [0003] and [0007]; spatial-temporal cavitation distribution image) and US 2023/0129687 (see [0153]; spatial and temporal cavitation bubble projection image map).
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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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793