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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/28/2026 has been entered.
Response to Arguments
Applicant's arguments below filed 7/28/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
The Applicant asserts on page 10 of the Remarks:
“In the Advisory Action dated July 2, 2026, the Examiner indicated that the amendments to the claims provided in the After-Final Response did not mirror the Examiner's interpretation of the 35 U.S.C. § 112(b) rejection, thus necessitating further search and consideration.
In the Final Office Action, the Examiner rejected Claim 1 under 35 U.S.C. §
112(b) because the term "comparison" lacked a proper antecedent basis.
To resolve this, the Examiner explicitly provided an allowable interpretation
based on the specification: "detecting, based on the EEG electrodes, EEG
biomarkers in association with a predetermined ultrasound stimulus; performing a
comparison of the EEG biomarkers and expected EEG biomarkers for the
predetermined stimulus; and based on the comparison and the determined
coupling quality, activating the one or more neuro-navigational aids".
Applicant has amended independent Claim 1 herein to recite detecting the EEG biomarkers, performing the comparison of the biomarkers, and activating the neuro- navigational aids based on that specific comparison.
Furthermore, the Examiner rejected Claims 17-19 under 35 U.S.C. § 112(b) because they incorrectly depended from system claim 11. Applicant has amended Claims 17-19 to properly depend from method Claim 16.
Applicant submits that these amendments fully address and resolve all antecedent basis and dependency issues raised by the Examiner. Accordingly, Applicant respectfully requests that the 35 U.S.C. § 112(a) and § 112(b) rejections be withdrawn and that the claims be allowed.”
In response the examiner respectfully asserts that claim 1 was not amended to fix the issue recited in the 35 USC § 112(a) rejection. Therefore claims 1-15 and 20-21 remain rejected under 35 USC § 112(a). In light of the amendments the 35 USC § 112(b) rejection has been withdrawn.
Applicant’s arguments with respect to the 35 USC § 103 rejections of claims 16, 17, 19, and 20 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.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “detecting, based on the EEG electrodes”, however this should be read as “detecting, based on the at least one EEG electrode”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: claim 10 recites “the one or more ultrasound transducers or the one or more EEG electrodes”, however this should be read as “the at least one ultrasound transducer or the at least one EEG electrode”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 recites in lines 19-21 “detecting reflections of the diagnostic pulse waveforms to determine coupling quality between the at least one ultrasound transducer of the tFUS system and the subject's head”. However the specification does not disclose diagnostic pulse waveforms used to determine coupling quality between the at least one ultrasound transducer of the tFUS system and the subject's head. Paragraph [0040] of the current application recites “Commands can be used to turn on or off ultrasound transmission of pulse waveforms. Pulse waveforms are used for alignment and differ from waveforms used for tFUS. For example, a pulse can refer to a diagnostic signal emitted by the tFUS and EEG system 300, having a relatively short duration relative to tFUS waveforms. The tFUS and EEG system 300 can capture a reflection of the pulse to perform diagnostics”. Therefore the specification discloses that the pulse waveforms are used for alignment however it does not disclose that the alignment is determined by determining the coupling quality. Claims 2-15 and 21-22 are also rejected due to their dependency.
Regarding claims 16 and 20, lines 14-15 of claim 16 and lines 13-14 of claim 20 recite “aligning the at least one transducer of the tFUS system automatically based on detected reflections”. However this is not disclosed in the current application. Paragraph [0040] discloses pulse waveforms used for alignment by reciting “Pulse waveforms are used for alignment and differ from waveforms used for tFUS”. It is not disclosed that the alignment is done automatically. Additionally paragraph [0030] discloses “two parts of the tFUS and EEG system include 1) navigational aids that help register the location of the tFUS and EEG systems relative to the subject's brain and 2) visual aids that help indicate to the subject or another person how to adjust the location of the systems according to the navigational info” and paragraph [0041] discloses “neuro-navigational markers 315, LEDs 318, etc., aid the adjustment and improve tFUS and/or EEG targeting and coupling quality”. Therefore the specification discloses that the alignment (adjustment) is performed by the subject or another person based on visual aids. Therefore the limitation is considered to be new matter. Claims 17-19 are also rejected due to their dependency.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 and 11 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 6 and 11, claims 6 and 11 each recite “the at least one transducer”. However the at least one transducer has not been previously defined therefore its unclear if it is referring to the at least one ultrasound transducer of claim 1 or a different transducer. For examination purposes claims 6 and 11 will be interpreted as “the at least one ultrasound transducer”.
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.
Claims 16, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tyler (US 20120289869) and further in view of Jödicke NPL 2004 (“Real-time integration of ultrasound into neuronavigation: technical accuracy using a light-emitting-diode-based navigation system”, of record), Lin (CN108652670A) machine translation, and Mingxi (CN108175439A).
Regarding claims 16, and 20, Tyler discloses a method ([0040] – “The present invention comprises devices, methods using such devices, and systems”) comprising: [claim 16]
an apparatus ([0040] – “The present invention comprises devices, methods using such devices, and systems”) comprising: [claim 20]
providing a holder unit configured to be placed on the head of a subject ([0061] – “FIG. 1C shows a chassis-type embodiment which may be removably mounted within head gear”), comprising:
a transcranial focused ultrasound (tFUS) system with at least one transducer ([0046] – “Single element focused transducers may be used”, [0081] – “providing transcranial ultrasound to one or more brain regions”),
an electroencephalogram (EEG) system with at least one EEG electrode ([0096] – “a device may comprise laser diodes and MEG/EEG sensors, in addition to ultrasound transducers”),
a computing device configured to control the tFUS system to generate ultrasound waveforms (Abstract – “The devices are used to provide ultrasound waves”, [0063] – “Information and commands may be transmitted to and from a remote command center, such as a centralized computing cluster, wherein the remote command center can control one or more of the other components comprised by the device”, as seen in Fig. 4 the US transducers are indirectly in communication with the remote command center)
Conversely Tyler does not teach one or more neuronavigation aids that provide positioning information and comprise at least one of one or more reflective beads, one or more reflective strips, or one or more light emitting diodes;
one or more buttons; and
a computing device configured to control the tFUS system to operate in a diagnostic mode by generating ultrasound pulse waveforms that have a duration parameter shorter than a duration of stimulation waveforms for aligning the at least one transducer of the tFUS system automatically based on detected reflections in response to an input from the one or more buttons.
However Jodicke discloses one or more neuronavigation aids that provide positioning information and comprise at least one of one or more reflective beads, one or more reflective strips, or one or more light emitting diodes (Title – “Real-time integration of ultrasound into neuronavigation”, Pg. 1212 left col. - "An optical emitter rod (6 LED's; Carl Zeiss Inc., Oberkochen, Germany) was rigidly attached to each ultrasound probe allowing the surgeon to hold the probe like a pencil. This tracking device defined the localization and orientation of the ultrasound probe").
generating ultrasound pulse waveforms […] for aligning the at least one transducer of the tFUS system automatically based on detected reflections (pgs. 1211-1212 bridging paragraph – “We used a LED-based neuronavigation device (SMN, Carl Zeiss Inc., Oberkochen, Germany; STP4.x software, Leibinger Inc., Freiburg Germany) for navigational planning and intraoperative guidance”, pg. 1213 left col. – “The ultrasound image was transferred via a S-VHS video port/frame grabber to the navigational workstation”).
Jödicke is an analogous art considering it is in the field of emitting ultrasound to brain tissue.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Tyler to incorporate the LED nuero-navigational aid of Jödicke to achieve the same results. One would have motivation to combine because "Using a LED-based navigation system, we achieved a better accuracy" (Jödicke - pg. 1216 right col.).
As cited above Tyler teaches the tFUS system and a computing device to control the tFUS system conversely Tyler and Jödicke do not teach one or more buttons; and
[…] control the […focused ultrasound] system to operate in a diagnostic mode by generating ultrasound pulse waveforms that have a duration parameter shorter than a duration of stimulation waveforms for aligning the at least one transducer of the […focused ultrasound] system […] based on detected reflections in response to an input from the one or more buttons.
However Lin discloses one or more buttons ([0075] – “use the mode switch button to switch the working mode of the ultrasound probe, turning it into imaging mode”); and
[…] control the […focused ultrasound] system to operate in a diagnostic mode by generating ultrasound […] waveforms for aligning the at least one transducer of the […focused ultrasound] in response to an input from the one or more buttons (paragraphs [0075] – [0081] disclose the steps of using a mode switch button to switch to an imaging mode to image the tissue and then use the echo signal to locate an abnormal area for treatment and therefore allows one to align the probe for the treatment mode).
Lin is an analogous art considering it is in the field of focused ultrasound treatment.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and apparatus of Tyler to incorporate the button to switch between an imaging mode and a treatment mode of Lin to achieve the same results. One would have motivation to combine because it would allow one to more easily determine the correct position for the ultrasound transducer.
As cited above Tyler teaches the tFUS system and a computing device to control the tFUS system conversely Tyler, Jödicke, and Lin do not explicitly teach control the […ultrasound] system to operate in a diagnostic mode by generating ultrasound pulse waveforms that have a duration parameter shorter than a duration of stimulation waveforms.
However Tyler, Lin, and Mingxi can be combined to teach control the […ultrasound] system to operate in a diagnostic mode by generating ultrasound pulse waveforms that have a duration parameter shorter than a duration of stimulation waveforms (Tyler teaches in paragraph [0141] “Single US pulses contained between 80 and 225 acoustic cycles per pulse (c/p) for pulse durations (PD) lasting 0.16-0.57 ms” and paragraphs [0075] – [0081] of Lin teaches a dual mode ultrasound probe including an imaging mode and a therapy mode. Mingxi discloses in paragraph [0013] – “Preferably, the pulse width of the ultrasonic transducer is less than or equal to 10 μs” and paragraph [0014] “The above-mentioned low-frequency transcranial ultrasound transducer is used in transcranial B-mode ultrasound imaging, transcranial Doppler imaging, or transcranial pulse reversal imaging”. The pulse width for transcranial ultrasound imaging as taught by Mingxi is less than the pulse duration for stimulation taught by Tyler therefore it would be obvious to generate ultrasound pulse waveforms that have a duration parameter shorter than a duration of stimulation waveforms).
Mingxi is an analogous art considering it is in the field of emitting ultrasound to brain tissue.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and apparatus of Tyler to incorporate the short pulse duration for imaging of Mingxi to achieve the same results. One would have motivation to combine because “the low-frequency ultrasound transducer involved in this invention has better penetration and stronger sound pressure after passing through the skull than existing high-frequency ultrasound transducers, thus resulting in better imaging effect and improved imaging resolution” (Mingxi [0017])
Regarding claim 17, Tyler, Jödicke, Lin, and Mingxi disclose all the elements of the claimed invention as cited in claim 16.
Tyler further discloses further comprising: applying a predetermined ultrasound stimulation waveform using the tFUS system to a predetermined brain region ([0046] – “deliver transcranial pulsed ultrasound into the brain”, [0036] – “providing ultrasound waves to a target site to modulate brain activity comprises providing an ultrasound stimulus waveform to a subject”),
detecting using the EEG system, EEG signals responsive to the predetermined ultrasound stimulation waveform ([0095] – “Methods comprise use of an ultrasound device of the present invention in combination with EEG and/or MEG sensors to monitor brainwave activity”),
determining based on the detected EEG signals whether the stimulation waveform is effectively targeting the predetermined brain region, and adjusting the parameters of the tFUS system in response to the determination ([0096] – “EEG sensors may be used in a device of the present invention to detect electrical brain activity, or to detect changes in brain electrical activity. The data regarding brain activity acquired from these sensors can be relayed to a remote or local microprocessor…The relayed data may be used by the microprocessor to return instructions to components in the device, such as ultrasound transducers, such as to modulate the ultrasound waveform, adjust the frequency, intensity or waveform characteristics to fine tune the ultrasound being delivered to the subject”, it is interpreted that a determination is made whether the ultrasound stimulation waveform effectively targeting the target site to provide instructions on when/how to fine tune the ultrasound stimulation).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tyler (US 20120289869), Jödicke NPL 2004 (“Real-time integration of ultrasound into neuronavigation: technical accuracy using a light-emitting-diode-based navigation system”, of record), Lin (CN108652670A) machine translation, and Mingxi (CN108175439A) machine translation as applied to claim 16 above, and further in view of Segre (US 20240008847).
Regarding claim 19, Tyler, Jödicke, Lin, and Mingxi disclose all the elements of the claimed invention as cited in claim 16.
Conversely Tyler does not teach further comprising: generating one or more ultrasound pulse waveforms by the tFUS system,
detecting using the tFUS system response waveforms associated with the one or more ultrasound pulse waveforms,
determining the tissue characteristics using the detected ultrasound waveforms, and
generating correction parameters to be applied for the ultrasound stimulus based on the tissue characteristics.
However Segre discloses further comprising: generating one or more ultrasound pulse waveforms by the tFUS system (Abstract – “a first subset of the plurality of transducer elements are configured to emit ultrasound pulses through the subject's skull”),
detecting using the tFUS system response waveforms associated with the one or more ultrasound pulse waveforms (Abstract – “a second subset of the plurality of transducer elements are configured to receive ultrasound signals from the subject's skull and brain in response to the ultrasound pulses being emitted”),
determining the tissue characteristics using the detected ultrasound waveforms ([0099] – “determine at least one characteristic of the subject's skull based on, at least in part, the at least one image (408)”), and
generating correction parameters to be applied for the ultrasound stimulus based on the tissue characteristics ([0099] – “The process 400 may then adjust at least one parameter for emitting the ultrasound pulses from the transducer elements of the neuro-modulation sub-system 116 to adapt to the at least one characteristic of the subject's skull (410)”).
Segre is an analogous art considering it is in the field of transcranial ultrasound stimulation of the brain.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Tyler to incorporate the correction of parameters based on tissue characteristics of Segre to achieve the same results. One would have motivation to combine because it would allow for the neuromodulation parameters to be adjusted specific to the subject and therefore provide neuromodulation that is customized to the subject.
Allowable Subject Matter
Claims 1-15 and 20-21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action.
The prior art does no teach or suggest detecting, EEG biomarkers in association with a predetermined ultrasound stimulus, performing a comparison of the EEG biomarkers and expected EEG biomarkers for the predetermined stimulus, and based on the comparison and a determined coupling quality, activating the one or more neuro-navigational aids to provide positioning guidance to move a holder unit comprising at least one ultrasound transducer, at least one EEG electrode, and one or more neuro-navigational aids.
Claim 18 would be allowable if rewritten to overcome the rejection of claim 16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The prior art does no teach or suggest determining based on detected EEG signals whether a stimulation waveform is effectively targeting the predetermined brain region, and activating one or more navigational aids to guide the repositioning of a holder unit comprising at least one ultrasound transducer, at least one EEG electrode, and one or more neuro-navigational aids in response to the determination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at 571-272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.C.L./Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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