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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/26/2026 has been entered.
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, 4-7, 10-11 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Tyler et al. (US 2014/0211593) and in view of Tyler et al. (US 2012/0289869).
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, wherein the library of inhibitory waveforms comprises waveforms predetermined 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).
Tyler (US 2014/0211593) discloses provide ultrasound treatment (bioTU) to mother suffering from post-partum depression. However, he does not explicitly disclose the inhibitory waveforms comprises waveforms predetermine to suppress depression associated with a stroke or neurotrauma events. Tyler (US 2012/0289869) discloses the inhibitory waveforms comprises waveforms predetermine to suppress depression (see Figs. 3-5, [0004], [0043], [0057], [0078], [0080], [0083] and [0115]; provide waveform of predetermine frequency and intensity to treat long term depression cause by a stroke/neurotrauma (especially [0078] and [0115])). 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 (US 2014/0211593) to have the inhibitory waveforms comprises waveforms predetermine to suppress depression as taught by Tyler (US 2012/0289869) because this allows the system to treat patient with specific disorder of long-term depression or clinical depression or drug-resistant depression due to stroke/neurotrauma (see [0100] and [0115]).
Addressing claim 4-7 and 10-11, Tyler (US 2014/0211593) 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.).
Addressing claims 22-23, Tyler (US 2012/0289869) discloses:
addressing claim 22, wherein the library of inhibitory waveforms comprises waveforms predetermined to affect at least one of: depolarizations by inactivation of sodium channels, opening of K+ and CI- channels, activation of inhibitory cells to release inhibitory neurotransmitters, or inhibition of a brain region that feeds into a location of the acute stroke (see [0043], [0057] and [0078]; inhibit one more regions of the brain therefore those regions would not feed into a location of the stroke).
addressing claim 23, wherein the at least one processor is further configured to target the adjusted inhibitory waveform to at least one of: a location of the acute stroke, a local neuronal network at or near the location of the acute stroke, or an area connected to the location of the acute stroke to proactively suppress excitotoxicity (see [0057], [0074], [0080] and [0162]; target one or more brain regions such as hippocampal formation, hippocampus proper, amygdala, thalamus, cerebellum, striatum, entorhinal cortex, perirhinal cortex, and cerebral cortex (including prefrontal cortex, auditory cortex, visual cortex, somatosensory cortex, and/or motor cortex) is targeting a local neuronal network at or near the location of the stroke, or an area connected to the location of the stroke to proactively suppress excitotoxicity).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Tyler et al. (US 2014/0211593), in view of Tyler et al. (US 2012/0289869) and further in view of Maev et al. (US 10,330,782).
Addressing claims 2-3, Tyler (US 2014/0211593) 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 (US 2014/0211593) 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), in view of Tyler et al. (US 2012/0289869) and further in view of Agarwal et al. (US 2022/0257984).
Addressing claims 8-9, Tyler (US 2014/0211593) 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 (US 2014/0211593) 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 with respect to claim(s) 1-11 and 22-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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), US 2012/0282241 (see [0010]; modulate or suppress dysregulated nerve), US 2012/0220812 (see claim 1; ultrasound target stroke location); US 2017/0220812 (see [0105]; ultrasound target a local neuronal network at or near the location of the stroke, or an area connected to the location of the acute stroke) and US 2024/0050660 (see [0195] opening K+ and Cl- channels).
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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