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 .
Drawings
The drawings were received on 29 December 2025. These drawings are acceptable.
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.
Claim(s) 1-7, 16, 17, 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al (2021/0370064) in view of Sinelnikov et al (2016/0374710).
Regarding claim 1, Murphy et al disclose a method of operation of a transcranial ultrasound device comprising:
obtaining a cranial volume imaging scan data of a subject (brain image scans includes scan generated by magnetic resonance imaging (MRI) – [0074]);
estimating acoustic properties of a head of the subject based on the cranial volume imaging scan data (brain substructure mapping software identifies the coordinate space of each transducer elements within the image data and accurately calculates the temporal phase offset of ultrasound-emitting elements based by estimating acoustic temporal path length – [0076]);
acquiring a location of a probe (brain substructure mapping software identifies the coordinate space of each transducer elements within the image data and accurately calculates the temporal phase offset of ultrasound-emitting elements based by estimating acoustic temporal path length – [0076]);
generating a simulated acoustic field within the head based on the acoustic properties, the location of the probe, and a set of transmit voltage phases utilized for the probe (simulation maps patients target brain regions relative to ultrasound-emitting elements – [0060]; voltage waveform pattern delivered to each ultrasound transducer element…can be stored on a stimulation control unit in standard format – [0067]; phase correction instructions for each element are determined by performing acoustic simulations on brain image data – [0069]; brain substructure mapping software identifies the coordinate space of each transducer elements within the image data and accurately calculates the temporal phase offset of ultrasound-emitting elements based by estimating acoustic temporal path length – [0076]); and
displaying the simulated acoustic field in a user interface (offline computing device 250 – [0061]), wherein the simulated acoustic field is overlaid onto anatomical data associated with the cranial volume imaging scan data (Fig.5D showing an acoustic simulation of the ultrasound beam onto the image – [0015];[0060]).
Murphy et al fail to explicitly disclose acquiring a location of a probe based on data from a neuronavigation system.
However, Sinelnikov et al teach in the same medical field of endeavor, acquiring a location of a probe based on data from a neuronavigation system (real time tracking the orientation of the ablation catheter – [0273];[0289]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the acquisition of a location of a probe of Murphy et al with a neuronavigation system of Sinelnikov et al as it would provide the user information regarding the position of the probe with respect to the patient.
Regarding claim 2, Murphy et al disclose wherein the set of transmit voltage phases are adjusted based on a location of a peak of the simulated acoustic field to correspond to at least one desired target within a brain of the subject (voltage waveform pattern…can be stored on a stimulation control unit in a standard format, there can be several files which create specific focal points in brain space – [0067]).
Regarding claim 3, Murphy et al disclose wherein the simulated acoustic field is further based on a spatial distribution of a spatial peak temporal average intensity (a spatial peak pulse average intensity - [0044]).
Regarding claim 4, Murphy et al disclose wherein the simulated acoustic field is updated in response to movement of the subject (acoustic simulations performed on a brain image set of the user wearing neuromodulation device, the simulation maps patients target brain regions relative to ultrasound emitting elements – [0060]; reinforcement learning to adapt in real time to changes in the device position – [0088]).
Regarding claim 5, Murphy et al disclose further displaying, in the user interface, an updated simulated acoustic field based on an updated spatial distribution of spatial peak temporal average intensity (performing acoustic simulations on brain image data to predict optimal focusing parameters…constant input from an EEG electrode results in adjustment – [0069];[0077]; claim 1).
Regarding claim 6, Murphy et al disclose performing neuromodulation of the subject using the probe based on the set of transmit voltage phases (neuromodulation – abstract; voltage waveform pattern delivered to each ultrasound transducer element…can be stored on a stimulation control unit in standard format – [0067]).
Regarding claims 7 and 17, Murphy et al disclose the invention substantially as claimed, but fail to explicitly disclose terminating the neuromodulation in response to an updated simulated acoustic field showing a value outside a clinically acceptable range, wherein the updated simulated acoustic field is generated in response to movement of the subject.
However, Sinelnikov et al teach in the same medical field of endeavor, terminating neuromodulation in response to a value outside a clinically acceptable range, generated in response to movement of the subject (automatic patient movement detection may input to the energy delivery console to cease or adjust energy delivery – [0290]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the updated simulated acoustic field of Murphy et al in response to a value outside a clinically acceptable range based on movement of the subject as it would ensure delivery of neuromodulation only occurs while the transmitting element is located in the correct position with respect to the anatomical region of interest.
Regarding claims 16 and 21, Murphy et al disclose a system comprising:
a cranial volume imaging scan data scanner configured to obtain a cranial volume image scan data of a subject (brain image scans includes scan generated by magnetic resonance imaging (MRI) – [0074]);
at least one ultrasound probe comprising a plurality of ultrasound elements configured to deliver neuromodulation to the subject (one or more ultrasound transducer arrays comprise one or more ultrasound-emitting elements – [0007]; neuromodulating - abstract);
ultrasound probe drive electronics coupled to the ultrasound probe, the ultrasound probe drive electronics configured to adjust a phase of the signals provided to the at least one ultrasound probe (stimulation control computing environment comprising a stimulation control unit – [0008]; ultrasound phase control component – [0060]);
an electroencephalography (EEG) system with one or more EEG electrodes ([0012]; fig.2); and
at least one processor (250) executing an application that, when executed, causes the at least one processor to at least:
estimate acoustic properties of a head of a subject based on the cranial volume image scan data (brain substructure mapping software identifies the coordinate space of each transducer elements within the image data and accurately calculates the temporal phase offset of ultrasound-emitting elements based by estimating acoustic temporal path length – [0076]);
acquire a location of the at least one ultrasound probe based on data (brain substructure mapping software identifies the coordinate space of each transducer elements within the image data and accurately calculates the temporal phase offset of ultrasound-emitting elements based by estimating acoustic temporal path length – [0076]);
generate a simulated acoustic field within the head based on the acoustic properties, the location of the at least one ultrasound probe, and a set of transmit voltage phases utilized for the at least one ultrasound probe (simulation maps patients target brain regions relative to ultrasound-emitting elements – [0060]; voltage waveform pattern delivered to each ultrasound transducer element…can be stored on a stimulation control unit in standard format – [0067]; phase correction instructions for each element are determined by performing acoustic simulations on brain image data – [0069]; brain substructure mapping software identifies the coordinate space of each transducer elements within the image data and accurately calculates the temporal phase offset of ultrasound-emitting elements based by estimating acoustic temporal path length – [0076]); and
display the simulated acoustic field in a user interface (offline computing device 250 – [0061]), wherein the simulated acoustic field is overlaid onto anatomical data associated with the cranial volume image scan data (Fig.5D showing an acoustic simulation of the ultrasound beam onto the image – [0015];[0060]).
Murphy et al fail to explicitly disclose acquiring a location of a probe based on data from a neuronavigation system.
However, Sinelnikov et al teach in the same medical field of endeavor, acquiring a location of a probe based on data from a neuronavigation system (real time tracking the orientation of the ablation catheter – [0273];[0289]).
Regarding claim 19, Murphy et al disclose wherein the application infers quality of acoustic coupling of the at least one ultrasound probe based on impedances of EEG electrodes ([0012]; fig.2).
Claim(s) 8-13 and 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al (2021/0370064) in view of Sinelnikov et al (2016/0374710) as applied to claims 1 and 21 above, and further in view of Moehring et al (2018/0310917).
Regarding claims 8-13 and 22-26, Murphy et al disclose the features of neuromodulation as claimed and discussed above, but fail to explicitly disclose a center frequency between 0.2 and 3.0 MHz, a rise time between 0 and 10 cycles, a fall time of between 0 and 10 cycles, a burst time between 50 µs and 30 s, a number of bursts between 1 and 10,000, and a pulse repetition frequency between 0.2 and 1,000 Hz.
However, Moehring et al teach in an analogous field of endeavor, a center frequency between 0.2 and 3.0 MHz (2MHz – [0024]), a rise time between 0 and 10 cycles, a fall time of between 0 and 10 cycles (8 cycle burst – [0024]), a burst time between 50 µs and 30 s (66.6 µs – [0026]), a number of bursts between 1 and 10,000 (8 cycle burst – [0024]), and a pulse repetition frequency between 0.2 and 1,000 Hz (pulse repetition frequency of 15 KHz or less – [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the neuromodulation parameters of Murphy et al ([0067]) with the specific ranges set forth in Moehring et al as it would provide the selection of ranges from a finite number of parameters known to be applied to the transmission of ultrasound to an object.
Claim(s) 14-15 and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al (2021/0370064) in view of Sinelnikov et al (2016/0374710) as applied to claims 1 and 21 above, and further in view of Hunter et al (2019/0143136).
Regarding claims 14, 15, 27 and 28, Murphy discloses inter-neuromodulation interval and total neuromodulation time ([0067]), but fail to explicitly disclose wherein the inter-neuromodulation interval corresponding to neuromodulation of the subject is between 0.01 and 60s and wherein the total neuromodulation time corresponding to neuromodulation of the subject is between 1 and 1,000 s.
However, Hunter et al teach in the same medical field of endeavor an inter-neuromodulation interval corresponding to neuromodulation of a subject is between 0.01 and 60 seconds (interburst interval of about 200ms – [0035]) and wherein a total neuromodulation time corresponding to neuromodulation of a subject is between 1 and 1,000 s (short period of time, less than 10 minutes of stimulation – [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inter-neuromodulation interval and total neuromodulation time of Murphy et al with the explicit disclosure of 0.01 and 60 seconds and 1 and 1,000 s, respectively as it would provide lasting effects beyond th stimulation session.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al (2021/0370064) in view of Sinelnikov et al (2016/0374710) as applied to claim 16 above, and further in view of Rognin et al (2008/0049994).
Regarding claim 18, Murphy et al as modified by Sinelnikov et al disclose the invention as claimed and discussed above, but fail to explicitly disclose wherein the ultrasound probe drive electronics perform pulse-echo operation to determine whether at least one ultrasound probe remains acoustically coupled to a head of the subject during treatment.
However, Rognin et al teach in an analogous field of endeavor, wherein probe drive electronics perform pulse-echo operation to determine whether the probe remains acoustically coupled to a subject (pulse-echo mode when the probe is in contact with the skin of a patient – [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the probe drive electronics performing acquisition when the transducer elements are coupled to the head of a subject of Murphy et al as modified by Sinelnikov et al with performing a pulse-echo operation to determine whether the probe remains acoustically coupled to a subject as it would provide confirmation that the probe is in contact with the region of interest.
Response to Arguments
Applicant's arguments filed 29 December 2025 have been fully considered but they are not persuasive.
Applicant states that Murphy discloses the use of offline algorithmic mapping and offline using brain image data and offline computing and that Murphy’s teaching relies on using real-time EEG data to start stimulation and an offline unite. Applicant states Murphy’s teachings cannot: 1) determine the location of the transducer element, 2) determine that the transducer element has been correctly placed (such that transducer element’s phase correction matches what was computed by the offline unit), 3) accurately provide a display of the simulated acoustic field in a user interface with the simulated acoustic field is overlaid onto anatomical data associated with the volume image scan of the subject, 4) provide all of the tree above in real time i.e. without the use of an offline unit (so that an operator can make corrections in real time), and 5) allow an operator to determine if the proposed neuromodulation poses a risk, accurately target the correct location, etc.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., 1) “determine the location of the transducer element”. Examiner notes neither the term “transducer” nor “element” are found in the claim set. 2) “determine that the transducer element has been correctly placed”. Examiner notes there are no limitations directed to “correct placement” of a “transducer element”. 4) Providing all limitations in “real time”. Examiner notes the term “real time” is not found in the claim set. Further, the claims do not preclude the use of an “offline unit”.) 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).
Examiner notes the claim does disclose “acquiring a location of a probe based from a neuronavigation system” rather than determining the location of the transducer element; however, Murphy has not been relied upon to disclose this limitation. Examiner also notes the claim does disclose “provide a display of the simulated acoustic field in a user interface with the simulated acoustic field is overlaid onto anatomical data associated with the volume image scan of the subject”; however, Applicant adds the additional term that the displaying is not “accurately” provided by Murphy. Examiner’s position is there are no specific reasons set forth for this rationale and Murphy discloses the limitation as set forth in the claim. Specifically, Murphy discloses displaying the simulated acoustic field in a user interface (offline computing device 250 – [0061]), wherein the simulated acoustic field is overlaid onto anatomical data associated with the cranial volume imaging scan data (Fig.5D showing an acoustic simulation of the ultrasound beam onto the image – [0015];[0060]). As set forth above, the claim does not preclude an “offline computing device” nor does the claim disclose the processing as in “real time”.
Applicant states Murphy teaches that the discloses system can be using non-invasively while Sinelnikov teaches the use of an ablation catheter which is an invasive procedure. One would not use the teaching on an invasive procedure to modify a non-invasive procedure especially for a critical anatomy such as the human brain.
Examiner notes the claim broadly discloses “acquiring a location of a probe based on data from a neuronavigation system”, but does not specify how the data is used to acquire the location of the probe. Further the claim does not define whether the probe is invasive or non-invasive. Examiner does not rely on Sinelnikov et al to disclose the type of probe being used nor does Examiner rely on Sinelnikov et al to provide a specific procedure. The claim broadly discloses “acquiring a location of a probe based on data from a neuronavigation system” which is disclosed by Sinelnikov et al ([0273];[0289]). The type of probe used is independent of this broadly defined limitation.
Applicant states on the other hand, the movement in neuromodulation causes the probe to move away from the skull or cause the wrong structure to be targeted and the present application includes steps to detect this and stop the neuromodulation or warn the operator.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “detect this and stop the neuromodulation or warn the operator”. Examiner notes that while these features may be part of the disclosure of the application, these features are not claimed.) 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).
Examiner suggests amending the claims to explicitly disclose the features set forth in Applicant’s remarks to provide patentable weight in the claims.
Conclusion
THIS ACTION IS MADE FINAL. 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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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797