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
Claims 17-21 and 23 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group 2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 2, 2025.
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.
Claims 2-4, 8-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 8,888,672 to Phillips et al. (hereinafter, "Phillips ‘672) in view of USPN 9,872,996 to Phillips et al. (hereinafter Phillips ‘996).
Regarding Claim 2, Phillips ‘672 discloses a method of treating a subject having an intrinsic frequency of neuronal firing in a specified EEG band comprising:
positioning electrodes near a location on the skull of the subject (e.g. placing a first electrode and second electrode; Col. 11; Lns. 40-50; see also Col. 45, Lns. 53-58);
generating electric current pulses with electrodes (e.g. applying AC current across the head of a subject; Col. 41, Lns. 15-20); and
adjusting the electric current pulses in order to move the intrinsic frequency of neuronal firing in the specified EEG band of the subject toward a preselected intrinsic frequency (e.g. adjusting an output current of an electric alternating current source for influencing an intrinsic frequency of an EEG band of a subject toward a target frequency of the EEG band; and applying said output current across a head of the subject; Col. 41, Lns. 30-34).
Phillips ‘672 fails to explicitly disclose positioning a subcranial electrode and a subcutaneous electrode on opposite sides of a skull near a location on the skull of the subject; creating a separate conductive path at a separate location through the skull; and generating electric current pulses with the subcranial electrode and the subcutaneous electrode, the electric current pulses having a pulse frequency, a pulse shape, a pulse amplitude, a pulse width, and a duty cycle, wherein the electric current pulses flow from the subcranial electrode, through a target region of a brain of the subject, through the separate conductive path at the separate location through the skull, to the subcutaneous electrode.
Phillips ‘996 discloses a transcranial current loop stimulation device comprising: positioning a subcranial electrode and a subcutaneous electrode on opposite sides of a skull near a location on the skull of the subject; (e.g. subcutaneous electrode 201 and subcranial electrode 203) creating a separate conductive path at a separate location through the skull (e.g. conductive path that is formed between subcutaneous electrode 201, wire 204, probe 205, and subcranial electrode 206; Examiner notes that the claim does not include any limitations as to what is or is not located in the conductive path) and generating electric current pulses with the subcranial electrode and the subcutaneous electrode, the electric current pulses having a pulse frequency, a pulse shape, a pulse amplitude, a pulse width, and a duty cycle (e.g. as shown in Figure 2).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Phillips ‘672 to include positioning a subcranial electrode and a subcutaneous electrodes as taught by Phillips ‘996. since such a modification would provide the system with a smaller more reliable means of stimulation.
Regarding Claim 3, Phillips ‘672 additionally discloses recording an EEG between electrodes (e.g. EEG data during treatments are recorded and individualized according to the alpha EEG intrinsic frequency (8-13 Hz); Col. 45; Lns 53-58); and determining the intrinsic frequency of neuronal firing in the specified EEG band using the recorded EEG (e.g. determining the intrinsic frequency from the electrical brain activity detected by the first electrode and the reference signal detected by the second electrode; Col. 11; Lns. 40-50).
Regarding Claim 4, Phillips ‘672 additionally discloses wherein the pulse frequency is equal to the intrinsic frequency of neuronal firing in the specified EEG band of the subject (e.g. step of adjusting the output current comprises setting the output current to the target frequency; Col. 41, Lns. 40-42).
Regarding Claim 8, Phillips ‘672 additionally discloses wherein the pulse amplitude is rhythmically varying having a rhythmic frequency which is equal to the intrinsic frequency of neuronal firing in the specified EEG band of the subject (e.g. AC current is a rhythmically varying pulse amplitude across ahead of a subject, and adjusting and/or varying the frequency of the AC current to effect at least one of a characteristic, mental disorder, and an indication presented herein...the step of adjusting the output current comprises setting the output current to the target frequency; Col. 41, Lns. 15-42).
Regarding Claim 9, Philips ‘996 additionally discloses positioning a second subcranial electrode and a second subcutaneous electrode on opposite sides of the skull near a second location on the skull of the subject, further comprising recording a first EEG between the subcranial electrode and the subcutaneous electrode and recording a second EEG between the second subcranial electrode and the second subcutaneous electrode (e.g. devices 1105, 1106, and 1104 as shown in Figure 11).
Regarding Claim 10, Phillips ‘672 additionally discloses calculating a fast fourier transform of the recorded EEG; and filtering the fast fourier transform such that a passband is the specified EEG band (e.g. Fourier Transform and passband as taught in Col. 46, Lns. 36-46).
Regarding Claim 11, Phillips ‘672 additionally discloses wherein determining the intrinsic frequency further comprises identifying a peak magnitude of the fast fourier transform (e.g. intrinsic frequency of alpha EEG is defined as the mean peak frequency (Fp) of 3 central leads (C3, C4, and Cz); Col. 46, Lns. 40-46).
Regarding Claim 14, Phillips ‘672 additionally discloses wherein determining the intrinsic frequency further comprises applying curve fitting to the recorded EEG (e.g. curve smoothing [fitting] may be applied to the signal (or signals) received from the EEG electrodes; Col. 33, Lns. 23-24).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over US 8,888,672 to Phillips et al. (hereinafter, "Phillips ‘672) in view of USPN 9,872,996 to Phillips et al. (hereinafter Phillips ‘996) in further view of US 2002/0143365 to Herbst.
Regarding Claim 5-7, Phillips ‘672 and Phillips ‘996 disclose the claimed invention but do not expressly disclose a pulse shape that is a sine wave, square wave, or a triangle wave. Herbst teaches that it was well known in the art of multi-functional electrical stimulation devices to include pulse shape is a sine wave (e.g. ES signal stage 10 includes signal generators 13 to 17 producing signals of different shape. Generator 14 is a sine wave generator, generator 15 generates a triangular or sawtooth wave, and generator 16 produces a ramp Voltage wave; Fig. 1; Para. [0030]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Phillips ‘672 and Phillips ‘996 to include wherein the pulse shape is a sine wave as taught by Herbst, since such a modification would provide the system with the predictable results of a multi-functional system capable of yielding an electrical stimulation signal that is appropriate for whatever biological or biomedical application is the concern of the user of the system (Herbst; Para. [0010]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over USPN 8,888,672 to Phillips et al. (hereinafter, "Phillips ‘672) in view of USPN 9,872,996 to Phillips et al. (hereinafter Phillips ‘996) in further view of USPN 7,228,171 to Lesser et al.
Regarding Claim 12, Phillips ‘672 and Phillips ‘996 disclose the claimed method except the express mention of the use of applying wavelet transforms to the recorded EEG. Lesser discloses analytical methods and devices for analyzing biological signals,wherein determining a treatment frequency further comprises applying wavelet transforms to the recorded EEG (e.g. wavelet cross-correlation and neighbor correlation count methods similar to those of method 100 and Example 3 were used to evaluate the data for the two consecutive two-second time epochs before LS and after LS but before BPS; Col. 9, Lns. 45-48). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Phillips ‘672 and Phillips ‘996 to include wherein the transforms are wavelet transforms as taught by Lesser, since such a modification would provide the system with the predictable restuls of applying appropriate treatment.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over USPN 8,888,672 to Phillips et al. (hereinafter, "Phillips ‘672) in view of USPN 9,872,996 to Phillips et al. (hereinafter Phillips ‘996) in further view of US 7,853,323 to Goetz.
Regarding Claim 13, Phillips ‘672 and Phillips ‘996 disclose the claimed method except the express mention of applying neural networks to the recorded EEG. Goetz discloses that it was well known to apply to use neural networks to determine an intrinsic frequency (e.g. neural networks may be employed by programmer 20 to allow a clinician to select electrode configurations, and then program IMD 14 to deliver therapy using the selected electrode configurations; Fig. 1; Col. 7, Lns. 47-51). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Phillips ‘672 and Phillips ‘996 to include the neural networks as taught by Goetz since such a modification would provide the system with the predictable results of more reliable treatment.
Conclusion
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792