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 Arguments
Applicant's arguments below filed 1/23/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
The Applicant asserts on page 11 of the Remarks:
“The Examiner rejected claims 2, 8, 9, 14, 15, and 17-19 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 regards as the invention.
[…]
Claims 17-19 have also been amended herein, rendering the rejections moot. Accordingly, Applicant requests that the rejections be withdrawn.”
In response the examiner respectfully asserts that claims 17-19 were not amended to fix the issue recited in the 35 USC § 112(b) rejection. Therefore claims 17-19 remain rejected under 35 USC § 112(b).
The Applicant asserts on pages 12-13 of the Remarks:
“The office action recognizes that Taylor does teach "one or more neuro- navigational aids" and points to Konofagou. Konofagou in Fig. 1 and paragraph [0038] disclose the use of a camera. It is unclear from Konofagou's teaching how the camera is used for positioning as Konofagou in paragraph [0038] states
“Any suitable technique can be used for neuronavigation. For purpose of
illustration and not limitation, and as embodied herein, the neuronavigation
system 120 can include one or more imaging devices (e.g., cameras) 125 for
mapping the brain tissue. The imaging devices can use a variety of techniques,
such as CT scanning, MRI, or positron emission tomography (PET). As
embodied herein, functional MRI (fMRI) can be used in combination with an
electroencephalogram (EEG) to map at least a portion of the brain tissue. In this
manner, the neuronavigation system can collect and record electrical activity in
the target region, as localized by fMRI. One or more EEG electrodes can be
positioned on the subject in order to detect electrical activity. (Emphasis added)
Konofagou's teaching is for mapping of brain tissue by using other techniques such as CT scanning, MRI or PET in combination with an EEG to map at least a portion of the brain tissue. Konofagou's teachings don't include using LIDAR, one or more reflective beads, reflective strips, LEDs, display devices or speakers, etc. as disclosed by this application. It is unclear how one would incorporate Konofagou's teaching for moving holder unit using neuro-navigation aids to appropriate locations before the stimulation as Konofagou's teaching further include "causing a cavitation, detecting cavitation signal magnitude."”
In response the examiner respectfully asserts that the camera was not cited as the one or more neuro- navigational aids. The trackers were cited as the neuronavigational aids as they provide tracking for the subject, the FUS transducer, and tools. One with ordinary skill in the art would find it obvious based Fig. 1 that the camera could be used to track the trackers. Additionally the independent claims do not require moving holder unit using neuro-navigation aids to appropriate locations before the stimulation.
The remainder of applicants arguments are moot because Konofagou and Taylor were not relied upon to teach generation of pulse waveforms for a diagnostic mode or the one or more buttons.
Claim Objections
Claim 2 is objected to because of the following informalities: claim 2 recites “the tFUS and EEG system” however this should be read as “the tFUS system and the EEG system”. 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 1-15 and 21-22 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.
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.
Claims 1-15, 17-19, and 21-22 are 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 claim 1, lines 22 and 23 of claim 1 recite “based on the comparison and the determined coupling quality, activating the one or more neuro-navigational aids”. However a comparison has not been defined in claim 1 therefore it is unclear what the comparison is referring to and therefore it is unclear what causes the one or more neuro-navigational aids to be activated. The specification discloses in paragraph [0035] “applying a predetermined ultrasound signal to a predetermined area, using the EEG to detect EEG biomarkers in association with a predetermined stimulus, performing a comparison of the detected EEG biomarkers to predetermined expected EEG biomarkers for the predetermined stimulus, and activating neuro-navigational indicators to indicate a direction to move the system to improve efficacy”. Therefore the claim will be interpreted as “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”. Dependent claims are also rejected due to their dependency.
Claims 17-19 recite “the method of claim 11”. However claim 11 is a system claim that is dependent on the system of claim 1 and claim 16 is a method claim. Therefore it is unclear if the claims are system claims dependent on claim 11 or method claims dependent on the method of claim 16. For examination purposes the claims will be interpreted as “the method of claim 16”.
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 Konofagou (US 20180140871), and Lin (CN108652670A) machine translation.
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 neuro-navigational aids;
one or more buttons; and
a computing device configured to control the tFUS system to generate ultrasound waveforms for aligning the at least one transducer of the tFUS system in response to an input from the one or more buttons.
However Konofagou discloses one or more neuro-navigational aids ([0036] – “the system 100 can further include a neuronavigation system 120”, [0035] – “the ultrasound assembly 110 can include one or more trackers 114”, the tracker is interpreted as a navigational aid).
Konofagou is an analogous art considering it is in the field of transcranial ultrasound with EEG sensing.
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 neuro-navigational aids of Konofagou to achieve the same results. One would have motivation to combine because “the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112” (Konofagou [0037]), therefore the treatment may be performed more accurately.
As cited above Tyler teaches the tFUS system and a computing device to control the tFUS system conversely Tyler and Konofagou do not teach one or more buttons; and
[…] control the […focused ultrasound] system to generate ultrasound waveforms for aligning the at least one transducer of the […focused ultrasound] 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 generate 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.
Regarding claim 17, Tyler, Konofagou, and Lin 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), Konofagou (US 20180140871), and Lin (CN108652670A) machine translation as applied to claim 16 above, and further in view of Segre (US 20240008847).
Regarding claim 19, Tyler, Konofagou, and Lin 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
In light of the examiners interpretations made in the 35 U.S.C. 112(b) rejections claims 1-15, 18 and 21-22 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
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.
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.
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, 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
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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