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 .
DETAILED ACTION
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.
Claims 1, 4-7 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tyler et al. (US 2014/0211593).
Addressing claim 1, Tyler discloses a system comprising:
at least one ultrasonic transducer array (see [0085]);
at least one processor coupled to the at least one ultrasonic transducer array,
wherein the at least one processor generates an inhibitory waveform
based upon an acoustic frequency (AF), acoustic intensity (AI), or tone
burst duration (TBD) specified by a library of inhibitory waveforms
accessible to the at least one processor to suppress dysregulated neural activity, wherein the at least one processor receives physiological feedback indicating the dysregulated neural activity and adjusts the inhibitory waveform based upon the physiological feedback, and wherein the at least one ultrasonic transducer array transmits the adjusted inhibitory waveform (see Figs. 1, 7, 9-10, [0003], [0009], [0013-0014], [0034], [0051], [0053], [0077], [0093-0094], [0109], [0112] and [0114-0117]; the protocol that stimulate brain to inhibit nerves come from database/library contains the appropriate parameters such as frequency, intensity, tone burst, etc.; in [0114-0117], Figs. 7 and 9-10, 1002, 1004, 1006 performs physiological measurements, 916 explicitly shows feedback, 915, 903, 904, 906, 910, 1010, 1011 determine appropriate stimulation protocol to maintain the same protocol or make adjustment to stimulation protocol, 911, 1013 transducer deliver stimulation protocol to patient; Figs. 7 and 9-10 shows close loop system using feedback to select/adjust stimulation protocol to provide better treatment; Tyler discloses inhibit nerves; Tyler’s system is capable of inhibiting nerves to suppress production of certain molecules or nerve activities; overly active nerve could be suppress; overly active nerve activity is dysregulated nerve activity; Tyler’s system inhibit nerve activities therefore Tyler’s system is capable of inhibiting nerves to suppress production of certain molecules or inhibit overly active nerve activity).
Addressing claim 4-7 and 10-11, Tyler discloses:
addressing claim 4, a pulser coupled to the processor, the pulser configured to transmit electrical signals corresponding to the inhibitory waveform to the at least one ultrasonic transducer array, wherein the at least one ultrasonic transducer array converts the electrical signals to ultrasonic signals (see [0041] and [0087]; generator operate like a pulser to generate pulse ultrasound).
addressing claim 5, at least one electroencephalogram (EEG) electrode configured to detect electrical activity in response to the inhibitory waveform and transmit the electrical activity to the at least one processor (see Figs. 1, 9, [0064] and [0124], EEG is used to monitor brain activity (physiological recording) to help adjust neuromodulation).
addressing claim 6, a Functional Near-Infrared Spectroscopy (fNIRS) probe configured to detect brain dynamics in response to the inhibitory waveform and transmit the brain dynamics to the at least one processor (see Figs. 1, 9, [0064] and [0124]; fNIRS is used to monitor brain activity (physiological recording) to help adjust neuromodulation).
addressing claim 7, a cooling system (see [0089]).
addressing claim 10, wherein the at least one processor adjusts the
inhibitory waveform in response to feedback obtained in response to the inhibitory waveform (see Fig. 9, [0048], [0075], [0084], [0112], [0115], [0125] and [0139]; feedback to adjust stimulation protocol).
addressing claim 11, wherein the at least one processor adjusts
the inhibitory waveform by modifying at least one of the acoustic frequency (AF), acoustic intensity (AI), or tone burst duration (TBD) (see Fig. 9, [0048], [0075], [0084], [0112], [0115], [0125] and [0139]; modify stimulation protocol; stimulation protocol include frequency, intensity, etc.).
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Tyler et al. (US 2014/0211593) and in view of Maev et al. (US 10,330,782).
Addressing claims 2-3, Tyler does not disclose wherein the inhibitory waveform is modified based upon a plurality of skull aberration correction parameters; wherein the plurality of skull aberration correction parameters are calculated by the at least one processor based upon ultrasound reflections received by the at least one ultrasonic transducer array. Maev discloses wherein the ultrasound waveform is modified based upon a plurality of skull aberration correction parameters; wherein the plurality of skull aberration correction parameters are calculated by the at least one processor based upon ultrasound reflections received by the at least one ultrasonic transducer array (see Fig. 2, col. 2, lines 22-50 and col. 4, lines 21-30; beamforming algorithm modify/adapted the waveform to correct for the phase aberration and refraction effect due to the properties and geometry of the skull; the phase aberration, refraction effect cause by geometry and acoustical properties of the barrier are determined by ultrasound reflection from ultrasound array reflection-mode; Tyler discloses inhibitory waveform). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tyler to have wherein the ultrasound waveform is modified based upon a plurality of skull aberration correction parameters; wherein the plurality of skull aberration correction parameters are calculated by the at least one processor based upon ultrasound reflections received by the at least one ultrasonic transducer array as taught by Maev because this improve the treatment or imaging procedure (see col. 4, lines 41-45; better image; better ultrasound wave effect at the target).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tyler et al. (US 2014/0211593) and in view of Agarwal et al. (US 2022/0257984).
Addressing claims 8-9, Tyler does not disclose specific type of cooling system. However, using any type of cooling system only require routine skill in the art. Tyler also does not disclose intravenous drug delivery. Argarwal explicitly discloses cooling channel in transducer patch and intravenous drug delivery (see abstract, [0105] and [0137]; cooling channels and cooling layers in a patch is a cooling patch). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tyler to have cooling patch and intravenous drug delivery as taught by Argawal because this allow the system to be used for other applications (see abstract; use for application of treating tumor; see Tyler’s paragraph [0009]; ultrasound transmission to the brain could be used in many applications).
Response to Arguments
Applicant's arguments filed 04/17/26 have been fully considered but they are not persuasive. Applicant argues Tyler further discloses utilizing physiological feedback to determine whether an intended message was successfully communicated to a recipient and to update a relational translation database rather than receiving physiological feedback indicating dysregulated neural activity and adjusting an inhibitory waveform to specifically suppress the dysregulated neural activity, as explicitly required by the limitations of claim 1. Applicant’s argument is not persuasive because as see in applicant’s specification abstract, [0007] and Fig. 3 applicant monitor treatment and adjust stimulation to make sure the treatment is effective and Tyler is doing the same. As see in Fig. 10, 1002 and 1014 perform physiological measurement, 1003 compare to see if the measurement within desired value (treatment is effective; measure of brain function such as attention, a person having attention problem would have overly active nerve activity or dysregulated nerve; a person having attention problem would not have measurement within desired value), 1011 determine appropriate stimulation protocol for inducing physiological signal toward desired value. The desired value would be a normal nerve activity and not an overly active nerve (dysregulated nerve). The feedback help choose the appropriate stimulation protocol that inhibit overly active nerve (suppress dysregulated nerve) therefore Tyler’s system does receive physiological feedback indicating dysregulated neural activity and adjusting an inhibitory waveform to specifically suppress the dysregulated neural activity.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2015/0251008 (see [0071] and [0073]; inhibit or modulate or suppress dysregulated ANS nerve in a feedback close loop system) and US 2012/0282241 (see [0010]; modulate or suppress dysregulated nerve).
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.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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