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 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.
Claims 1, 3-4, 7, 8, 10, 16-19, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Towe et al. (US 2015/0148710; hereinafter Towe), in view of Goetz et al. (US 2018/0214716; hereinafter Goetz), and in view of Hettrick et al. (US 2018/0236235; hereinafter Hettrick).
Regarding claims 1, 7 and 8, Towe discloses an ultrasound modulation of the brain for treatment of stroke, brain injury or other neurological disorders. Towe shows a method for improving cognitive function in an individual who does not have a neurodegenerative disease characterized by presence of a pathological protein (see abstract), the method comprising: determining a plurality of discrete application sites for applications of acoustic energy (see “frontal regions of the brain” in par. [0040] and par. [0048]) and determining a scanning path along which acoustic energy is to be applied to saturate or substantially saturate a region with acoustic energy to saturate or substantially saturate the region of the individual’s brain (see par. [0038], [0040], [0048]; fig. 1 and 4), wherein the region comprises a region of the brain associated with a cognitive impairment (see abstract; par. [0040]; fig. 1 and 4); applying acoustic energy to plurality of discrete application sites within along the determined scanning path (See fig. 1-3; par. [0038]), wherein the region comprises at least one hemisphere of the individual’s brain (see fig. 1-3; par. [0038]), wherein the ultrasound is applied at an ultrasound pressure at some range (see fig. 1-3; par. [0038], the examiner notes that the ultrasound energy will have provide some pressure) with a pulse length of about 1 to about 100 milliseconds (see par. [0050]) and burst mode repetition frequencies of 0.1 to 10 Hz (see par. [0051]), thereby saturating or substantially saturating the region with ultrasound energy such that their corresponding treatment volumes from treatment volume that corresponds substantially with the region (see par. [0038], [0050], [0051]), therefore improving cognitive functions in the individual (see par. [0040], [0045], [0046]), and wherein the improved cognitive function is learning or memory (see par. [0040], [0045], [0046]).
But, Towe fails to explicitly state that the individual of at least 45 years old and that the ultrasound pressure range is of 0.1 MPa to 2 MPa.
Goetz discloses using ultrasound to treat brain disease. Goetz teaches ultrasound pressure range is of 0.1 MPa to 2 MPa (see par. [0137]) and performing ultrasound therapy to the forebrain at least one hemisphere (see par. [0031]), and treatment volumes from a contiguous treatment volume that corresponds substantially with the region (see par. [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of ultrasound pressure range is of 0.1 MPa to 2 MPa, and treatment volumes from a contiguous treatment volume that corresponds substantially with the region in the invention of Towe, as taught by Goetz, to be able to provide adequate pressure for ultrasound brain therapy without causing tissue damage and to be able to improve specific cognitive functions. As stated above, prior art Towe already discloses using ultrasound energy with a pulse length of 1-100 milliseconds and burst mode repetition frequencies of 0.1 to 10 Hz to improve cognitive function of a patient with stroke or brain injury, therefore, it would have obvious to try and use of known technique of using ultrasound pressure range of 0.1 MPa to 2 MPa as taught by Goetz because it provides predictable solutions, with reasonable expectation of success and improve cognitive method.
But, Towe and Goetz fail to explicitly state that the individual of at least 45 years old.
Hettrick discloses a system and device for treating patient to reduce a risk of developing cognitive impairment. Hettrick teaches the importance and method of reducing severity of neurological symptoms of patient in middle age such as at least 45 years old (see par. [0016], [0069]) or older patient (see par. [0069]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the individual of at least 45 years old in the invention of Towe and Goetz, to be able to reducing severity of neurological symptoms of patient in middle age patients or older patients.
Regarding claim 3, Towe, Goetz and Hettrick disclose the invention substantially as described in the 103 rejection above, furthermore, Towe teaches that the improved cognitive function comprises memory ((see par. [0040], [0045], [0046]), and Goetz teaches improving short-term memory (see par. [0119]).
Regarding claim 4, Towe, Goetz and Hettrick disclose the invention substantially as described in the 103 rejection above, furthermore, Towe teaches that the improved cognitive function comprises memory ((see par. [0040], [0045], [0046]), and Goetz teaches improving short-term memory (see par. [0120]).
Regarding claim 10, With regards to the indefiniteness claim limitation of “...the improvement is by at least 50%”, the examiner notes that as best understood of the indefiniteness claim limitation, upon modification of prior art Towe to incorporate the teaching of Goetz and Hettrick will provide that the memory is improved by at least 50%. The examiner notes that prior art Towe teaches that the ultrasound therapy to the brain will improve cognitive function in the individual after the therapy ((see par. [0040], [0045], [0046]) using the required claimed specific ultrasound pulse length of about 1 to about 100 milliseconds (see par. [0050]) and burst mode repetition frequencies of 0.1 to 10 Hz (see par. [0051]), and Goetz teaches improving memory function can be done using ultrasound therapy using ultrasound pressure range of 0.1 MPa to 2 MPa (see par. [0137]). Also, the examiner notes that method claim 1 which claims 10 depends from merely states applying ultrasound energy at the specific ultrasound pressure, pulse length and repetition frequency thereby saturating the region with ultrasound energy and then states a conclusionary statement reciting “thereby improving cognitive function in individual, wherein the improved cognitive function is one or both of learning and memory, and wherein one or both of learning and memory is improved by at least 10% relative to (i) an age-matched control who has not undergone the treatment or (ii) the subject prior to the treatment. Therefore, as sated above, that combined invention of Towe and Goetz teaches the applying ultrasound energy at the specific ultrasound pressure, pulse length and repetition frequency thereby saturating the region with ultrasound energy to improve cognitive function such as memory, therefore, would also improve at memory at least 50%.
Regarding claim 16, Towe, Goetz and Hettrick disclose the invention substantially as described in the 103 rejection above, furthermore, Towe focused ultrasound (see par. [0040]), and Goetz also teaches focused ultrasound energy (see par. [0040]).
Regarding claim 17, Towe, Goetz and Hettrick disclose the invention substantially as described in the 103 rejection above, Towe furthermore shows unfocused ultrasound (see “ultrasound to the brain globally” in par. [0040]) and Goetz also teaches that the ultrasound can be focused or unfocused (see par. [0037]).
Regarding claim 18-19, Towe, Goetz and Hettrick disclose the invention substantially as described in the 103 rejection above, furthermore, Towe shows wherein the method does not comprise a step of administering microbubbles and does not comprise a step of administering an agent to promote an increase in permeability of blood brain barrier ((see fig. 1-3, par. [0038], [0045], [0046], [0050], [0051])).
Regarding claim 26 Towe, Goetz and Hettrick disclose the invention substantially as described in the 103 rejection above, furthermore, Towe shows wherein the region of the brain comprises at least one hemisphere of the brain (see fig. 1-3; par. [0038]).
Regarding claim 28, Towe, Goetz and Hettrick disclose the invention substantially as described in the 103 rejection above, furthermore, Goetz teaches administering microbubbles to the individual (see par. [0035]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of administering microbubbles to the individual in the invention of Towe, as taught by Goetz, to be able to increase in the permeability of the blood brain barrier.
Response to Arguments
The previous objection to claim 1 has been withdrawn in view of Applicant’s amendments to the claim 1.
The previous rejection under 35 USC 112 (a) to claims 1-3, 7-8, 10, 16-19 and 28 has been withdrawn in view of Applicant’s amendment to claim 1.
The previous rejection under 35 USC 112 (b) to claims 1-3, 7-8, 10, 16-19 and 28 has been withdrawn in view of Applicant’s amendment to claim 1.
The examiner notes that upon further consideration and in view of Applicant’s amendments to claim 1, a prior art rejection has been to claim 1, and the dependent claims there off in view of prior arts Towe, Goetz and Hettrick.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aharonovitch et al. (US 2020/0139112) disclose closed loop neuro feedback simulating device and methods.
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 SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797