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
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 in the reply filed on 12/01/25 is acknowledged.
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.
Claim 3 is 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 3 recites the limitation "the plurality of skull aberration correction parameters" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 3 should depend on claim 2 and not claim 1.
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 and wherein the at least one
ultrasonic transducer array transmits the inhibitory waveform (see Fig. 1, [0003], [0009], [0013-0014], [0034], [0051], [0053], [0077], [0093-0094], [0109] and [0112]; the protocol that stimulate brain to inhibit nerves come from database/library contains the appropriate parameters such as frequency, intensity, tone burst, etc.).
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).
Conclusion
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793