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 .
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15, line 6, “an ultrasound transducer” should read “the ultrasound transducer”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 14-15 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.
Claim 14 recites the limitation "the patient’s brain" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. The claim does not previously recite a patient’s brain.
Claim 15 recites the limitation "the patient’s brain" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. The claim does not previously recite a patient’s brain.
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 the 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 1.5 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 the 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 1.5 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 1.5 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]).
Conclusion
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798