DETAILED ACTION
This office action is in response to the communication received on June 8, 2026 concerning application No. 19/046,805 filed on February 6, 2025.
Claims 1-18 are currently pending.
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 filed 06/08/2026 regarding the 35 USC 112 rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112 rejection of claims 14 and 15 previously set forth.
Applicant's arguments filed 06/08/2026 regarding the prior art rejection have been fully considered but they are not persuasive. In response to the applicant’s arguments that the prior art fails to teach “a non-transitory computer-accessible medium having stored thereon computer-executable instructions which, when executed by a processor, performs the following step: directs an ultrasound transducer to deliver an ultrasound signal to a target site of a patient’s brain to improve tinnitus, the ultrasound signal comprising a mechanical index between about 1.0 and about 5.0 and/or an acoustic pressure of between about 0.55 MPa and about 2.5 MPa.”, examiner respectfully disagrees. As set forth in the previous office action Vasan is relied upon to teach the argued limitation. [0044] of Vasan specifically teaches “a non-transitory computer readable medium storing instructions. The instructions may cause operations may executed by at least one data processor. The operations may include:…administering, to the patient, the ultrasound stimulation treatment”. Therefore, the non-transitory computer-readable medium storing instructions is directly related to delivering an ultrasound signal to a target site of a patient. [0070] and [0096] of Vasan further teach the ultrasound stimulation is used for targeting brain regions and that neurostimulation is used to treat patients with tinnitus. Applicant further argues that “Vasan only describes tinnitus by way of background”. [0070] provides tinnitus as an example disorder that can be treated using neurostimulation and [0072] and [0096] further disclose ultrasound as a way of performing neurostimulation. Therefore, the ultrasound system of Vasan is configured to deliver ultrasound signals to improve tinnitus. Lastly, [0079] and [0141] of Vasan disclose the acoustic pressure of the stimulation being applied by the ultrasound apparatus is between 1MPa and 2MPa. Where the determined acoustic pressure parameter is determined in order to properly treat the patient. For at least these reasons Vasan teaches the argued limitations recited above.
For similar reasons as above, the rejection of claims 1, 3-4, and 6-12 stand.
In response to applicant’s arguments on pg. 8 that the Mishelevich reference “does not link the medial geniculate nucleus, the nucleus accumbens the caudate nucleus, the pulvinar nucleus, the insula, the subcallosal anterior cingulate area, the cingulate cortex, the auditory cortex with tinnitus”, examiner respectfully disagrees. As set forth in the previous office action [0035] of Mishelevich discloses the target brain region includes nucleus accumbens, the insula, and the cingulate cortex. [0036] further discloses that for any of the listed parts above the selected disorder to be treated includes tinnitus. Therefore, any of the listed brain regions can be used for treating tinnitus. [00694] further teaches the auditory cortex is used as a target region for treating tinnitus. [0727] further discloses the caudate nucleus and subcallosal anterior cingulate area as potential target areas. For at least these reasons Mishelevich teaches the argued limitation recited above.
In response to applicant’s arguments on pg. 8, regarding claim 10, that the prior art does not specifically teach “exposing the patient to a cue associated with the tinnitus prior to or during delivering the ultrasound signal to the target site”, examiner respectfully disagrees. [00169]-[0173] of Mishelevich disclose providing ancillary stimulation (cue) such as visual or auditory stimulation as an augment to the ultrasound neuromodulation. The ancillary stimulation is used to up-regulate or down-regulate the disorder of the patient. [0036] of Mishelevich discloses the disorders being treated include tinnitus, therefore the ancillary stimulation is associated with tinnitus.
For similar reasons as above, the rejection of claim 2 stands.
In response to applicant’s arguments on pg. 9, regarding claim 5, that the prior art of record does not disclose targeting the pulvinar nucleus to treat tinnitus, examiner respectfully disagrees. As set forth in the previous office action [0017] of Ridder discloses using neuromodulation to treat tinnitus and [0130]-[0133] disclose providing neuromodulation directly to the pulvinar to provide treatment, therefore Ridder teaches targeting the pulvinar nucleus to treat tinnitus.
In response to applicant’s arguments on pg. 9, regarding claim 13, that the prior art of record does not disclose exposing the patient to sensory deprivation before or during delivery of the ultrasound signal to the target, examiner respectfully disagrees. As set forth the previous office action [0364] and [0369] of Santarnecchi disclose using sensory deprivation protocols during stimulation. Therefore, the combination of Vasan in view of Mishelevich and Santarnecchi results in a method that exposes the patient to sensory deprivation during delivery of the ultrasound signal to the target tissue in order to treat tinnitus.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Objections
Claims 16-18 are objected to because of the following informalities:
Claims 16-18, lines 1-2 “a mechanical index” should read “the mechanical index”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 102(a)(2) as being unpatentable by Vasan et al. (US 20240238619, hereinafter Vasan).
Regarding claim 14, Vasan teaches a non-transitory computer-accessible medium having stored thereon computer-executable instructions which, when executed by a processor ([0044] discloses a non-transitory computer readable medium storing instructions that are executed by a processor), performs the following steps:
directs an ultrasound transducer to deliver an ultrasound signal to a target site of a patient's brain to improve tinnitus ([0141] discloses in step 1406 ultrasound stimulation treatment is delivered to the patient. [0096] discloses the ultrasound stimulation is used for targeting brain regions. [0070] discloses the neurostimulation is used to treat patients with tinnitus), the ultrasound signal comprising a Mechanical Index of between about 1.0 and about 5.0 and/or an acoustic pressure of between about 0.55 MPa and about 2.5 MPa ([0079] and [0141] discloses the acoustic pressure of the stimulation is at least 1 MPa and up to 2MPa).
Regarding claim 15, Vasan teaches a system to improve tinnitus comprising:
an ultrasound transducer ([0046] discloses the apparatus includes a transducer element. [0077] transducer 204 in fig. 2A);
a processor (the electronic circuitry of the system 100 in fig. 1); and
a non-transitory computer-accessible medium having stored thereon computer-executable instructions which, when executed by a processor ([0044] discloses a non-transitory computer readable medium storing instructions that are executed by a processor), performs the following step:
directs an ultrasound transducer to deliver an ultrasound signal to a target site of a patient's brain to improve tinnitus ([0141] discloses in step 1406 ultrasound stimulation treatment is delivered to the patient. [0096] discloses the ultrasound stimulation is used for targeting brain regions. [0070] discloses the neurostimulation is used to treat patients with tinnitus), the ultrasound signal comprising a Mechanical Index of between about 1.0 and about 5.0 and/or an acoustic pressure of between about 0.55 MPa and about 2.5 MPa([0079] and [0141] discloses the acoustic pressure of the stimulation is at least 1 MPa and up to 2MPa).
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.
Claim(s) 1, 3-4, and 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vasan et al. (US 20240238619, hereinafter Vasan) in view of Mishelevich et al. (US 20160001096, hereinafter Mishelevich).
Regarding claim 1, Vasan teaches a method of improving tinnitus in a patient in need thereof (Abstract discloses a system for ultrasound based stimulation that delivers acoustic pressure. [0070] discloses the neurostimulation is used to treat patients with tinnitus) comprising: delivering an ultrasound signal to a target site of the patient's brain ([0141] discloses in step 1406 ultrasound stimulation treatment is delivered to the patient. [0096] discloses the ultrasound stimulation is used for targeting brain regions) without delivering microbubbles to open the blood brain barrier ([0106] discloses no microbubbles were used in the procedure), the ultrasound signal comprising a Mechanical Index of between about 1.0 and about 5.0 and/or an acoustic pressure of between about 0.55 MPa and about 2.5 MPa ([0079] and [0141] discloses the acoustic pressure of the stimulation is at least 1 MPa and up to 2MPa); and
improving the patient's tinnitus ([0070] by treating the tinnitus the neurostimulation is improving the patient’s tinnitus).
Vasan does not specifically teach the target site comprises a medial geniculate nucleus, a nucleus accumbens, a caudate nucleus, a pulvinar nucleus, an insula, a subcallosal anterior cingulate area, a cingulate cortex, an auditory cortex or combinations thereof.
However,
Mishelevich in a similar field of neuromodulation discloses treating tinnitus by stimulating a brain region target comprising a medial geniculate nucleus, a nucleus accumbens, a caudate nucleus, a pulvinar nucleus, an insula, a subcallosal anterior cingulate area, a cingulate cortex, an auditory cortex or combinations thereof ([0035] discloses the target includes the cingulate cortex, insula, and nucleus accumbens. [0727] discloses the subcallosal anterior cingulate area and caudate nucleus).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the targeted brain region of Vasan for the brain regions of Mishelevich because it amounts to simple substitution of one known element for another to obtain the predictable results of improving tinnitus.
Regarding claim 3, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Mishelevich further teaches the target site is the nucleus accumbens ([0035] discloses the target site is the nucleus accumbens).
Regarding claim 4, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Mishelevich further teaches the target site is the caudate nucleus ([0727] discloses the target is the caudate nucleus).
Regarding claim 6, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Mishelevich further teaches the target site is the insula ([0035] discloses the target site is the insula).
Regarding claim 7, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Mishelevich further teaches the target site is the subcallosal anterior cingulate area ([0727] discloses the target is the subcallosal anterior cingulate area).
Regarding claim 8, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Mishelevich further teaches the target site is the cingulate cortex ([0035] discloses the target site is the cingulate cortex).
Regarding claim 9, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Mishelevich further teaches the target site is the auditory cortex ([0694] discloses the target site is the auditory cortex).
Regarding claim 10, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Mishelevich further teaches exposing the patient to a cue associated with the tinnitus prior to or during delivering the ultrasound signal to the target site ([0169]-[0173] discloses providing an ancillary stimulation to the patient that includes visual or auditory stimulation as an augment to the ultrasound neuromodulation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to expose the patient to a cue associated with the tinnitus prior to or during delivering the ultrasound signal to the target site in order make the ultrasound neuromodulation more effective, as recognized by Mishelevich ([0170]).
Regarding claim 11, Vasan in view of Mishelevich teaches the method of claim 10, as set forth above. Mishelevich further teaches the cue is an auditory cue or a visual cue ([0169] discloses the additional stimulus is an auditory or visual stimulus).
Regarding claim 12, Vasan in view of Mishelevich teaches the method of claim 10, as set forth above. Mishelevich further teaches the cue associated with tinnitus is a cue that elicits anxiety in the patient ([0171] discloses providing a stimulus that up-regulates the patient. [0209] further discloses providing stimulus that promotes anxiousness).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vasan in view of Mishelevich as applied to claim 1 above, and further in view of Lim et al. (US 20150126802, hereinafter Lim).
Regarding claim 2, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Vasan in view of Mishelevich does not specifically teach the target site is the medial geniculate nucleus.
However,
Lim in a similar field of neuromodulation discloses treating tinnitus by targeting the medial geniculate nucleus (Abstract discloses the method is for treating tinnitus. [0032]-[0033] and [0095] disclose the target location is the medial geniculate nucleus).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the targeted brain region of Vasan in view of Mishelevich for the medial geniculate nucleus region of Lim because it amounts to simple substitution of one known element for another to obtain the predictable results of improving tinnitus.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vasan in view of Mishelevich as applied to claim 1 above, and further in view of Ridder (US 20060095088).
Regarding claim 5, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Vasan in view of Mishelevich does not specifically teach the target site is the pulvinar nucleus.
However,
Ridder in a similar field of neuromodulation discloses treating tinnitus by targeting the pulvinar nucleus ([0017] discloses using the neuromodulation method to treat tinnitus. [0130]-[0133] discloses providing neuromodulation directly to a target neuronal tissue which includes the pulvinar).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the targeted brain region of Vasan in view of Mishelevich for the pulvinar nucleus region of Ridder because it amounts to simple substitution of one known element for another to obtain the predictable results of improving tinnitus.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vasan in view of Mishelevich as applied to claim 1 above, and further in view of Santarnecchi (WO2023239647A2).
Regarding claim 13, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Vasan in view of Mishelevich does not specifically teach exposing the patient to sensory deprivation before or during delivering of the ultrasound signal to the target site.
However,
Santarnecchi in a similar field of neuromodulation teaches exposing the patient to sensory deprivation before or during delivering of the ultrasound signal to the target site ([0364], [0369] discloses using sensory deprivation protocols during stimulation).
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 Vasan in view of Mishelevich to include exposing the patient to sensory deprivation before or during delivering of the ultrasound signal to the target site in order to increase brain plasticity, thereby increasing the chances of a successful stimulation, as recognized by Santarnecchi ([0369]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vasan in view of Mishelevich as applied to claim 1 above, and further in view of Szablowski et al. (US 20230047753, hereinafter Szablowski).
Regarding claim 16, Vasan in view of Mishelevich teaches the method of claim 1, as set forth above. Vasan in view of Mishelevich does not specifically teach the ultrasound signal comprises a Mechanical Index of between about 1.0 and about 5.0.
However,
Szablowski in a similar field of endeavor teaches providing an ultrasound signal comprising a Mechanical Index of between about 1.0 and about 5.0 ([0247] discloses operating the ultrasound transducer with a mechanical index below 1.9. [0300] discloses the disorder being treated is tinnitus).
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 Vasan in view of Mishelevich to have the ultrasound signal comprises a Mechanical Index of between about 1.0 and about 5.0 in order to ensure the transducer focus is sufficient to open the blood brain barrier, as recognized by Szablowski ([0247]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vasan in view of Szablowski et al. (US 20230047753, hereinafter Szablowski).
Regarding claims 17 and 18, Vasan teaches the non-transitory computer-accessible medium of claim 14 and the system of claim 15, as set forth above. Vasan does not specifically teach the ultrasound signal comprises a Mechanical Index of between about 1.0 and about 5.0.
However,
Szablowski in a similar field of endeavor teaches providing an ultrasound signal comprising a Mechanical Index of between about 1.0 and about 5.0 ([0247] discloses operating the ultrasound transducer with a mechanical index below 1.9. [0300] discloses the disorder being treated is tinnitus).
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 non-transitory computer-accessible medium and system of Vasan to have the ultrasound signal comprises a Mechanical Index of between about 1.0 and about 5.0 in order to ensure the transducer focus is sufficient to open the blood brain barrier, as recognized by Szablowski ([0247]).
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 ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 5712701790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW W BEGEMAN/Primary Examiner, Art Unit 3798
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