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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-7) in the reply filed on 06/11/2026 is acknowledged. In addition to cancelling claims 8-33, Applicant has added new claims 34-49. However, claims 34-49 comprise the claim material of the restricted Inventions II-V. The restriction indicated that the inventions were related as subcombinations; even though the inventions have been amended to all depend from claim 1, they still remain subcombinations. Dependent claims 34, 40, 45, & 49 all contain claim material not present in the others, as well as dependent claims 2-7. Therefore, claim groups 1-7, 34-39, 40-44, 45-48, & 49 remain distinct inventions and a search burden still exists. As such, the restriction still applies. Claims 1-7—the claims of elected Invention I—will be examined, and claims 34-49 will be withdrawn.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5 & 7 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Tyler (US 2012/0289869).
Regarding claim 1, Tyler teaches a transcranial-focused ultrasound system (tFUS) delivery and tracking system comprising:
a transducer array assembly (transducers, [0031]) configured to deliver a tFUS waveform to a subject ([0071]);
a direct neural activity measurement system (EEG sensors/MEG sensors/sensors that provide information about the scattered photons, [0096]) measuring neural activity in response to the tFUS waveform ([0063] & [0096]);
a physiological measurement system (components for measuring or detecting physiological status indicators, [0063]) measuring a physiological response to the tFUS waveform ([0063] & [0096]);
an electromyography (EMG) system ([0028]); and
a user interface device (remote command center, [0063]) displaying data from at least one of the direct neural activity measurement system or the physiological measurement system ([0063]).
Regarding claim 2, Tyler teaches the tFUS delivery and tracking system of claim 1, wherein the physiological measurement system measures at least one of respiration ([0116]), blood pressure ([0063]), blood flow ([0096]), blood oxygen saturation ([0063]), heart rate ([0063]), or temperature ([0135]).
Regarding claim 3, Tyler teaches the tFUS delivery and tracking system of claim 1, further comprising an anatomical targeting system for targeting a position on a skull or brain of the subject ([0047]).
Regarding claim 4, Tyler teaches the tFUS delivery and tracking system of claim 1, wherein the transducer array assembly delivers a tFUS waveform comprising at least one of an excitatory ([0057]), an inhibitory ([0057]), or a modulatory ([0030]) waveform that modulates the magnitude of induced activity in the brain region in response to stimuli (environmental cues, [0089] & stressful event, [0092]).
Regarding claim 5, Tyler teaches the tFUS delivery and tracking system of claim 1, further comprising a stress and sympathetic measurement to measure stress and sympathetic responses to the tFUS waveform ([0116]).
Regarding claim 7, Tyler teaches the tFUS delivery and tracking system of claim 1, wherein the direct neural activity measurement system comprises at least one of EEG, MEG, or fNIRS ([0063] & [0096]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tyler, as applied to claim 1, above, in view of Tyler (US 2014/0211593, hereinafter Tyler ‘593).
Regarding claim 6, Tyler teaches the tFUS delivery and tracking system of claim 1.
However, Tyler fails to disclose that the transducer array assembly indirectly targets the target region in response to the tFUS waveform yielding no measurable or quantifiable effect on the target region.
Tyler ‘593 teaches that the transducer array assembly indirectly targets the target region in response to the tFUS waveform yielding no measurable or quantifiable effect on the target region ([0094]).
Paragraph [0094] of Tyler ‘593 teaches modifying the targeting of the brain region to achieve the intended effect. The tFUS waveform yielding “no measurable or quantifiable effect” constitutes the intended effect not being achieved.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Tyler such that the transducer array assembly indirectly targets the target region in response to the tFUS waveform yielding no measurable or quantifiable effect on the target region, as taught by Tyler ‘593. If the desired effect of the neuromodulation is not achieved, then an adjustment of the ultrasound parameters (including focus area) can help achieve the goal of the procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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