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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/02/2025 and 03/30/2025 are being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-21 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5, 7-14, 17, and 19-20 of U.S. Patent No. 12,138,458 B2, and in view of Phillips (US 20130150650 A1), hereinafter Phillips '13, and in view of Phillips (US 20160199656 A1), hereinafter Philipps ’16. The claims of the instant application and the claims of the reference patent are compared in the table below.
Instant Application
US 12,138,458 B2
Claim 2
Claim 1
A device configured for electrical stimulation of a subject's brain, the device comprising: a first electrode adapted to be implanted under a scalp of the subject and under the subject's skull; a second electrode adapted to be implanted under the subject's scalp and outside the subject's skull;
A method of treating a subject having an intrinsic frequency of neuronal firing in a specified EEG band, comprising: positioning a subcranial electrode and a subcutaneous electrode on opposite sides of a skull near a location on the skull of the subject;
insulating material configured to electrically isolate the first electrode from the second electrode; a case; a processor disposed within the case
creating a separate conductive path at a separate location through the skull;
and a generator disposed within the case and in electrical communication with the processor, the generator being adapted to adjust and deliver a current pulse waveform to the first electrode and the second electrode to move a Q-factor of the intrinsic frequency of neuronal firing in the specified EEG band of the subject towards a preselected Q-factor of the intrinsic frequency.
and adjusting the electric current pulses in order to move a Q-factor of the intrinsic frequency of neuronal firing in the specified EEG band of the subject toward a preselected Q-factor of the intrinsic frequency.
Claim 2
Claim 2
the processor being configured to record an EEG between the first electrode and the second electrode, the processor being further configured to determine an intrinsic frequency of neuronal firing in a specified EEG band of the subject with the recorded EEG
The method of claim 1 further comprising: recording an EEG between the subcranial electrode and the subcutaneous electrode; and determining the intrinsic frequency of neuronal firing in the specified EEG band using the recorded EEG.
3. The device of claim 2, wherein a pulse frequency of the waveform is equal to the intrinsic frequency of neuronal firing in the specified EEG band of the subject.
3. The method of claim 1 wherein the pulse frequency is equal to the intrinsic frequency of neuronal firing in the specified EEG band of the subject.
4. The device of claim 2, wherein a pulse shape of the waveform is a sine wave.
4. The method of claim 1 wherein the pulse shape is selected from the group consisting of a sine wave, a square wave, and a triangle wave.
5. The device of claim 2, wherein a pulse shape of the waveform is a square wave.
4. The method of claim 1 wherein the pulse shape is selected from the group consisting of a sine wave, a square wave, and a triangle wave.
6. The device of claim 2, wherein a pulse shape of the waveform is a triangle wave.
4. The method of claim 1 wherein the pulse shape is selected from the group consisting of a sine wave, a square wave, and a triangle wave.
7. The device of claim 2, wherein a pulse amplitude of the waveform is rhythmically varying having a frequency which is equal to the intrinsic frequency of neuronal firing in the specified EEG band of the subject.
5. The method of claim 1 wherein the pulse amplitude is rhythmically varying having a rhythmic frequency which isequal to the intrinsic frequency of neuronal firing in the specified EEG band of the subject.
8. The device of claim 2, wherein the processor is configured to determine the intrinsic frequency by: calculating a fast Fourier transform of the recorded EEG; andfiltering the fast Fourier transform such that a passband is the specified EEG band.
7. The method of claim 2, further comprising: calculating a fast fourier transform of the recorded EEG; andfiltering the fast fourier transform such that a passband is the specified EEG band.
9. The device of claim 8, wherein the processor is further configured to determine the intrinsic frequency by identifying a peak magnitude of the fast Fourier transform.
8. The method of claim 7, wherein determining the intrinsic frequency further comprises identifying a peak magnitude of the fast fourier transform.
10. The device of claim 8, wherein the processor is further configured to determine the intrinsic frequency by applying wavelet transforms to the recorded EEG.
9. The method of claim 7, wherein determining the intrinsic frequency further comprises applying wavelet transforms to the recorded EEG.
11. The device of claim 8, wherein the processor is further configured to determine the intrinsic frequency by applying neural networks to the recorded EEG.
10. The method of claim 7, wherein determining the intrinsic frequency further comprises applying neural networks to the recorded EEG.
12. The device of claim 8, wherein the processor is further configured to determine the intrinsic frequency by applying curve fitting to the recorded EEG.
11. The method of claim 7, wherein determining the intrinsic frequency further comprises applying curve fitting to the recorded EEG.
13. The device of claim 2, wherein the preselected Q factor is defined as a ratio between the intrinsic frequency and a frequency bandwidth for which EEG energy is above one-half of a peak EEG energy.
12. The method of claim 1, wherein the preselected Q factor is defined as a ratio between the intrinsic frequency and a frequency bandwidth for which EEG energy is above one-half of a peak EEG energy.
Claim 14
Claim 13
A device configured for electrical stimulation of a subject's brain, the device comprising: a first electrode adapted to be implanted under a scalp of the subject and under the subject's skull; a second electrode adapted to be implanted under the subject's scalp and outside the subject's skull;
A method of treating a subject having an intrinsic frequency of neuronal firing in a specified EEG band, comprising: positioning a subcranial electrode and a subcutaneous electrode on opposite sides of a skull near a location on the skull of the subject;
insulating material configured to electrically isolate the first electrode from the second electrode; a case; a processor disposed within the case,
creating a separate conductive path at a separate location through the skull;
and a generator disposed within the case and in electrical communication with the processor,
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;
the generator being adapted to adjust and deliver a current pulse waveform to the first electrode and the second electrode to move the intrinsic frequency of neuronal firing in the specified EEG band of the subject towards a preselected intrinsic frequency.
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.
Claim 14
Claim 14
the processor being configured to record an EEG between the first electrode and the second electrode, the processor being further configured to determine an intrinsic frequency of neuronal firing in a specified EEG band of the subject with the recorded EEG;
The method of claim 13 further comprising: recording an EEG between the subcranial electrode and the subcutaneous electrode; and determining the intrinsic frequency of neuronal firing in the specified EEG band using the recorded EEG.
15. The device of claim 14, wherein a pulse amplitude of the waveform is rhythmically varying having a frequency which is higher than the intrinsic frequency of neuronal firing in the specified EEG band of the subject.
17. The method of claim 13 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.
16. The device of claim 14, wherein a pulse amplitude of the waveform is rhythmically varying having a frequency which is lower than the intrinsic frequency of neuronal firing in the specified EEG band of the subject.
17. The method of claim 13 wherein the pulse amplitude is rhythmically varying having a rhythmic frequency whichis equal to the intrinsic frequency of neuronal firing in the specified EEG band of the subject.
17. The device of claim 14, wherein the processor is configured to determine the intrinsic frequency by: calculating a fast Fourier transform of the recorded EEG; andfiltering the fast Fourier transform such that a passband is the specified EEG band.
19. The method of claim 14, further comprising: calculating a fast fourier transform of the recorded EEG; andfiltering the fast fourier transform such that a passband is the specified EEG band.
18. The device of claim 17, wherein the processor is further configured to determine the intrinsic frequency by identifying a peak magnitude of the fast Fourier transform.
20. The method of claim 19, wherein determining the intrinsic frequency further comprises identifying a peak magnitude of the fast fourier transform.
19. The device of claim 17, wherein the processor is further configured to determine the intrinsic frequency by applying wavelet transforms to the recorded EEG.
9. The method of claim 7, wherein determining the intrinsic frequency further comprises applying wavelettransforms to the recorded EEG.
20. The device of claim 17, wherein the processor is further configured to determine the intrinsic frequency by applying neural networks to the recorded EEG.
10. The method of claim 7, wherein determining the intrinsic frequency further comprises applying neural networks to the recorded EEG.
21. The device of claim 17, wherein the processor is further configured to determine the intrinsic frequency by applying curve fitting to the recorded EEG.
11. The method of claim 7, wherein determining the intrinsic frequency further comprises applying curve fittingto the recorded EEG.
Claim 1-2 of the reference patent recites all of the limitations of claim 2 of the instant application except “a device configured for electrical stimulation of a subject's brain, insulating material configured to electrically isolate the first electrode from the second electrode; a case; a processor disposed within the case, and a generator disposed within the case and in electrical communication with the processor”.
However, Phillips ‘13 teaches a device (para. 0011 (a Transcranial Magnetic Stimulation (TMS) device for influencing an intrinsic frequency of a subject within a specified EEG band)) configured for electrical stimulation of a subject's brain, the device comprising:
a processor (para. 0050 (device comprises logic that calculates information from EEG data collected from the subject within a specified EEG band [e.g. intrinsic frequency, Q-factor, EEG phase]), 0047 (logic automatically changes the frequency in response to EEG readings of a subject)).
It would have been obvious to person of ordinary skill in the art before the effective filing data of the invention to have a device configured for electrical stimulation of a subject's brain and a processor, as disclosed in Phillips ‘13, within the method of claim 1 of the reference patent. Such a modification merely applies the method to a device for processing techniques to improve neural stimulation. Additionally, the combination would represent the predictable use of a processor for EEG analysis the enhance the operation of the device.
Phillips ’13 does not teach insulating material configured to electrically isolate the first electrode from the second electrode; a case; a processor disposed within the case, and a generator disposed within the case and in electrical communication with the processor.
However, Phillips ’16 teaches insulating material configured to electrically isolate the first electrode from the second electrode (Fig. 5);
a case (Fig. 5, element 501);
a processor disposed within the case (para. 0073 (current pulses are generated continuously to stimulate an area… the device could… only be activated when the pulse generator control logic detects abnormal electrocorticographic activity)); and
a generator disposed within the case (para. 0073 (pulse generator may also be located in the head of the person, possibly replacing a portion of the skull)) and in electrical communication with the processor (para. 0073 (current pulses are generated continuously to stimulate an area… the device could… only be activated when the pulse generator control logic detects abnormal electrocorticographic activity)).
Phillips ’13 and Phillips ’16 are considered to be analogous to the claimed invention because they are in the same field of applying electrical stimulation with implantable electrodes. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘16 and include insulating material configured to electrically isolate the first electrode from the second electrode. Doing so would prevent short-circuit pathways between the electrodes.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘16 and include a case, and a processor and generator disposed within the case. Doing so would provide a housing that integrates control circuitry, eliminating external components. Such integration reduces electromagnetic interference, thereby improving the device’s overall simplicity and reliability.
Claim 3 of the reference patent recites the same limitations as claim 3 of the instant application.
Claim 4 of the reference patent recites the same limitations as claims 4-6 of the instant application.
Claim 5 of the reference patent recites the same limitations as claim 7 of the instant application.
Claims 7-11 of the reference patent recites the same limitation as claims 8-12 of the instant application except “processor”.
However, Phillips ’13 teaches a processor (para. 0050 (device comprises logic that calculates information from EEG data collected from the subject within a specified EEG band [e.g. intrinsic frequency, Q-factor, EEG phase]), 0047 (logic automatically changes the frequency in response to EEG readings of a subject)).
It would have been obvious to person of ordinary skill in the art before the effective filing data of the invention to have a device configured for electrical stimulation of a subject's brain and a processor, as disclosed in Phillips ‘13, within the method of the reference patent. The combination would represent the predictable use of a processor for EEG analysis the enhance the operation of the device.
Claim 12 of the refence patent recites the same limitations as claim 13 of the instant application.
Claims 13-14 of the reference patent recites the same limitations as claim 12 of the instant application except “a device configured for electrical stimulation of a subject's brain, insulating material configured to electrically isolate the first electrode from the second electrode; a case; a processor disposed within the case, and a generator disposed within the case and in electrical communication with the processor”.
However, Phillips ‘13 teaches a device (para. 0011 (a Transcranial Magnetic Stimulation (TMS) device for influencing an intrinsic frequency of a subject within a specified EEG band)) configured for electrical stimulation of a subject's brain, the device comprising:
a processor (para. 0050 (device comprises logic that calculates information from EEG data collected from the subject within a specified EEG band [e.g. intrinsic frequency, Q-factor, EEG phase]), 0047 (logic automatically changes the frequency in response to EEG readings of a subject)).
It would have been obvious to person of ordinary skill in the art before the effective filing data of the invention to have a device configured for electrical stimulation of a subject's brain and a processor, as disclosed in Phillips ‘13, within the method of claim 1 of the reference patent. Such a modification merely applies the method to a device for processing techniques to improve neural stimulation. Additionally, the combination would represent the predictable use of a processor for EEG analysis the enhance the operation of the device.
Phillips ’13 does not teach insulating material configured to electrically isolate the first electrode from the second electrode; a case; a processor disposed within the case, and a generator disposed within the case and in electrical communication with the processor.
However, Phillips ’16 teaches insulating material configured to electrically isolate the first electrode from the second electrode (Fig. 5);
a case (Fig. 5, element 501);
a processor disposed within the case (para. 0073 (current pulses are generated continuously to stimulate an area… the device could… only be activated when the pulse generator control logic detects abnormal electrocorticographic activity)); and
a generator disposed within the case (para. 0073 (pulse generator may also be located in the head of the person, possibly replacing a portion of the skull)) and in electrical communication with the processor (para. 0073 (current pulses are generated continuously to stimulate an area… the device could… only be activated when the pulse generator control logic detects abnormal electrocorticographic activity)).
Phillips ’13 and Phillips ’16 are considered to be analogous to the claimed invention because they are in the same field of applying electrical stimulation with implantable electrodes. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘16 and include insulating material configured to electrically isolate the first electrode from the second electrode. Doing so would prevent short-circuit pathways between the electrodes.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘16 and include a case, and a processor and generator disposed within the case. Doing so would provide a housing that integrates control circuitry, eliminating external components. Such integration reduces electromagnetic interference, thereby improving the device’s overall simplicity and reliability.
Claim 17 of the reference patent recites the same limitation as claim 15 of the reference patent except “having a frequency which is higher than the intrinsic frequency”.
However, Phillips ’13 teaches (para. 0304 (adjusting the output current comprises setting the output current to a frequency that is higher than the intrinsic frequency of the subject)).
It would have been obvious to person of ordinary skill in the art before the effective filing data of the invention to have a device configured for electrical stimulation of a subject's brain and a processor, as disclosed in Phillips ‘13, within the method of claim 17 of the reference patent to enable the adjustment of an output current of an electric alternating current source for influencing the intrinsic frequency.
Claim 17 of the reference patent recites the same limitation as claim 16 of the reference patent except “having a frequency which is lower than the intrinsic frequency”.
However, Phillips ’13 teaches (para. 304 (adjusting the output current comprises setting the output current to a frequency that is lower than the intrinsic frequency of the subject)).
It would have been obvious to person of ordinary skill in the art before the effective filing data of the invention to have a device configured for electrical stimulation of a subject's brain and a processor, as disclosed in Phillips ‘13, within the method of claim 17 of the reference patent to enable the adjustment of an output current of an electric alternating current source for influencing the intrinsic frequency.
Claims 19-20, and 9-11 of the reference patent recites the same limitations as claims 17-21 of the instant application except “processor”.
However, Phillips ’13 teaches a processor (para. 0050 (device comprises logic that calculates information from EEG data collected from the subject within a specified EEG band [e.g. intrinsic frequency, Q-factor, EEG phase]), 0047 (logic automatically changes the frequency in response to EEG readings of a subject)).
It would have been obvious to person of ordinary skill in the art before the effective filing data of the invention to have a device configured for electrical stimulation of a subject's brain and a processor, as disclosed in Phillips ‘13, within the method of the reference patent. The combination would represent the predictable use of a processor for EEG analysis the enhance the operation of the device.
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 2-3, 7-9, 12-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (US 20130150650 A1), hereinafter Phillips '13, and in view of Phillips (US 20160199656 A1), hereinafter Philipps ’16, and in further view of Govea et al. (US 20170021162 A1), hereinafter Govea.
Regarding claim 2, Phillips ‘13 teaches a device (para. 0011 (a Transcranial Magnetic Stimulation (TMS) device for influencing an intrinsic frequency of a subject within a specified EEG band)) configured for electrical stimulation of a subject's brain, the device comprising:
a first electrode; a second electrode (para. 0300 (applying electrical stimulation across the head via transcutaneous electrodes));
a processor (para. 0050 (device comprises logic that calculates information from EEG data collected from the subject within a specified EEG band [e.g. intrinsic frequency, Q-factor, EEG phase]), 0047 (logic automatically changes the frequency in response to EEG readings of a subject)) being configured to record an EEG between the first electrode and the second electrode, the processor being further configured to determine an intrinsic frequency of neuronal firing in a specified EEG band of the subject with the recorded EEG (para. 301 (adjusting an output of an electric alternating current source for influencing an intrinsic frequency of a EEG band of a subject toward a target frequency of the EEG band… a CES therapy is used to influence the intrinsic frequency of a patient's brain toward a target frequency as measured by EEG); and
adjust and deliver a current pulse waveform to the first electrode and the second electrode to move a Q-factor of the intrinsic frequency of neuronal firing in the specified EEG band of the subject towards a preselected Q-factor of the intrinsic frequency (para. 0305 (frequency of the output current has a waveform), 0304 (adjusting an output current of an electric alternating current source for influencing a Q-factor of an intrinsic frequency of an EEG band of a subject toward a target Q-factor; and applying said output current across a head of the subject)).
Phillips ‘13 does not disclose a first electrode adapted to be implanted under a scalp of the subject and under the subject's skull, a second electrode adapted to be implanted under the subject's scalp and outside the subject's skull, insulating material configured to electrically isolate the first electrode from the second electrode, a case, a processor disposed within the case, a generator disposed within the case, and the generator being adapted to adjust and deliver a current pulse waveform to the first electrode and the second electrode.
Phillips ’16 teaches a device configured for electrical stimulation of a subject's brain (abstract (a method and device is described, which provides electrical stimulation to the brain of a person)), the device comprising:
a first electrode adapted to be implanted under a scalp of the subject and under the subject's skull (para. 0068 (subcranial electrode), Fig. 1, element 103);
a second electrode adapted to be implanted under the subject's scalp and outside the subject's skull (para. 0068 (subcutaneous electrode), Fig. 1, element 104);
insulating material configured to electrically isolate the first electrode from the second electrode (Fig. 5);
a case (Fig. 5, element 501);
a processor disposed within the case (para. 0073 (current pulses are generated continuously to stimulate an area… the device could… only be activated when the pulse generator control logic detects abnormal electrocorticographic activity)); and
a generator disposed within the case (para. 0073 (pulse generator may also be located in the head of the person, possibly replacing a portion of the skull)) and in electrical communication with the processor (para. 0073 (current pulses are generated continuously to stimulate an area… the device could… only be activated when the pulse generator control logic detects abnormal electrocorticographic activity)).
Phillip ’16 does not disclose the generator being adapted to adjust and deliver a current pulse waveform to the first electrode and the second electrode.
Govea teaches a generator being adapted to adjust and deliver a current pulse waveform to electrodes (para. 0098 (processor can be positioned… within a sealed housing of an implantable pulse generator), 0101 (electrical current is emitted by the electrodes… a processor is generally included to control the timing and electrical characteristics of the electrical stimulation system… processor can control the timing, frequency, strength, duration, and waveform of the pulses)).
Phillips ‘13, Phillips ’16 and Govea are considered to be analogous to the claimed invention because they are in the same field of applying electrical stimulation with implantable electrodes. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘16 and include a first electrode under a skull and a second electrode outside the skull, and an insulating material configured to electrically isolate the first electrode from the second electrode. Doing so would provide the device with a more compact electrode arrangement. Additionally, the insulating material would prevent short-circuit pathways between the electrodes.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘16 and include a case, and a processor and generator disposed within the case. Doing so would provide a housing that integrates control circuitry, eliminating external components. Such integration reduces electromagnetic interference, thereby improving the device’s overall simplicity and reliability.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘13 and Govea, and provide a generator being adapted to adjust and deliver a current pulse waveform to the first electrode and the second electrode. Doing so would enable stimulation parameter adjustments for the user for their personal therapeutic treatment.
Regarding claim 3, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 2, as discussed above. Phillips ’13 further discloses wherein a pulse frequency of the waveform is equal to the intrinsic frequency of neuronal firing in the specified EEG band of the subject (para. 0301 (adjusting an output of an electric alternating current source for influencing an intrinsic frequency of a EEG band of a subject toward a target frequency of the EEG band), 0302 (adjusting the output current comprises setting the output current to the target frequency)).
Regarding claim 7, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 2, as discussed above. Phillips ’13 further discloses wherein a pulse amplitude of the waveform is rhythmically varying having a frequency which is equal to the intrinsic frequency of neuronal firing in the specified EEG band of the subject (para. 302 (adjusting the output current comprises setting the output current to the target frequency)).
Regarding claim 8, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 2, as discussed above. Phillips ’13 further discloses wherein the processor is configured to determine the intrinsic frequency by:
calculating a fast Fourier transform of the recorded EEG; and filtering the fast Fourier transform such that a passband is the specified EEG band (para. 0327 (Ten to twenty-four artifact-free epochs in each recording channel are calculated by a fast Fourier transform (FFT) routine to produce a power spectrum… EEG variables used in the analysis include power density, peak frequency, and frequency selectivity)).
Regarding claim 9, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 8, as discussed above. Phillips ’13 further discloses wherein the processor is further configured to determine the intrinsic frequency by identifying a peak magnitude of the fast Fourier transform (para. 0327 (The intrinsic frequency of alpha EEG is defined as the mean peak frequency (Fp) of 3 central leads (C3, C4, and Cz))).
Regarding claim 12, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 8, as discussed above. Phillips ’13 further discloses wherein the processor is further configured to determine the intrinsic frequency by applying curve fitting to the recorded EEG (para. 0263 (Curve smoothing may be applied to the signal (or signals) received from the EEG electrodes)).
Regarding claim 13, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 2, as discussed above. Phillips ’13 further discloses wherein the preselected Q factor is defined as a ratio between the intrinsic frequency and a frequency bandwidth for which EEG energy is above one-half of a peak EEG energy (para. 0137 (frequency bandwith for which the energy is above one-half the peak energy … the Q-factor is defined as the ratio of [intrinsic frequency/frequency bandwidth]), 0108 (target Q-factor is an average Q-factor)).
Regarding claim 14, Phillips ‘13 teaches a device (para. 0011 (a Transcranial Magnetic Stimulation (TMS) device for influencing an intrinsic frequency of a subject within a specified EEG band)) configured for electrical stimulation of a subject's brain, the device comprising:
a first electrode; a second electrode (para. 0300 (applying electrical stimulation across the head via transcutaneous electrodes));
a processor (para. 0050 (device comprises logic that calculates information from EEG data collected from the subject within a specified EEG band [e.g. intrinsic frequency, Q-factor, EEG phase]), 0047 (logic automatically changes the frequency in response to EEG readings of a subject)) being configured to record an EEG between the first electrode and the second electrode, the processor being further configured to determine an intrinsic frequency of neuronal firing in a specified EEG band of the subject with the recorded EEG (para. 301 (adjusting an output of an electric alternating current source for influencing an intrinsic frequency of a EEG band of a subject toward a target frequency of the EEG band… a CES therapy is used to influence the intrinsic frequency of a patient's brain toward a target frequency as measured by EEG); and
adjust and deliver a current pulse waveform to the first electrode and the second electrode to move the intrinsic frequency of neuronal firing in the specified EEG band of the subject towards a preselected intrinsic frequency (para. 0301 (adjusting an output of an electric alternating current source for influencing an intrinsic frequency of a EEG band of a subject toward a target frequency of the EEG band), 0302 (adjusting the output current comprises setting the output current to the target frequency)).
Phillips ‘13 does not disclose a first electrode adapted to be implanted under a scalp of the subject and under the subject's skull, a second electrode adapted to be implanted under the subject's scalp and outside the subject's skull, insulating material configured to electrically isolate the first electrode from the second electrode, a case, a processor disposed within the case, a generator disposed within the case, and the generator being adapted to adjust and deliver a current pulse waveform to the first electrode and the second electrode.
Phillips ’16 teaches a device configured for electrical stimulation of a subject's brain (abstract (a method and device is described, which provides electrical stimulation to the brain of a person)), the device comprising:
a first electrode adapted to be implanted under a scalp of the subject and under the subject's skull (para. 0068 (subcranial electrode), Fig. 1, element 103);
a second electrode adapted to be implanted under the subject's scalp and outside the subject's skull (para. 0068 (subcutaneous electrode), Fig. 1, element 104);
insulating material configured to electrically isolate the first electrode from the second electrode (Fig. 5);
a case (Fig. 5, element 501);
a processor disposed within the case (para. 0073 (current pulses are generated continuously to stimulate an area… the device could… only be activated when the pulse generator control logic detects abnormal electrocorticographic activity)); and
a generator disposed within the case (para. 0073 (pulse generator may also be located in the head of the person, possibly replacing a portion of the skull)) and in electrical communication with the processor (para. 0073 (current pulses are generated continuously to stimulate an area… the device could… only be activated when the pulse generator control logic detects abnormal electrocorticographic activity)).
Phillip ’16 does not disclose the generator being adapted to adjust and deliver a current pulse waveform to the first electrode and the second electrode.
Govea teaches a generator being adapted to adjust and deliver a current pulse waveform to electrodes (para. 0098 (processor can be positioned… within a sealed housing of an implantable pulse generator), 0101 (electrical current is emitted by the electrodes… a processor is generally included to control the timing and electrical characteristics of the electrical stimulation system… processor can control the timing, frequency, strength, duration, and waveform of the pulses)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘16 and include a first electrode under a skull and a second electrode outside the skull, and an insulating material configured to electrically isolate the first electrode from the second electrode. Doing so would provide the device with a more compact electrode arrangement. Additionally, the insulating material would prevent short-circuit pathways between the electrodes.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘16 and include a case, and a processor and generator disposed within the case. Doing so would provide a housing that integrates control circuitry, eliminating external components. Such integration reduces electromagnetic interference, thereby improving the device’s overall simplicity and reliability.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ‘13 and Govea, and provide a generator being adapted to adjust and deliver a current pulse waveform to the first electrode and the second electrode. Doing so would enable stimulation parameter adjustments for the user for their personal therapeutic treatment.
Regarding claim 15, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 14, as discussed above. Phillips ’13 further discloses wherein a pulse amplitude of the waveform is rhythmically varying having a frequency which is higher than the intrinsic frequency of neuronal firing in the specified EEG band of the subject (para. 0304 (adjusting the output current comprises setting the output current to a frequency that is higher than the intrinsic frequency of the subject)).
Regarding claim 16, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 14, as discussed above. Phillips ’13 further discloses wherein a pulse amplitude of the waveform is rhythmically varying having a frequency which is lower than the intrinsic frequency of neuronal firing in the specified EEG band of the subject (para. 304 (adjusting the output current comprises setting the output current to a frequency that is lower than the intrinsic frequency of the subject)).
Regarding claim 17, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 14, as discussed above. Phillips ’13 further discloses wherein the processor is configured to determine the intrinsic frequency by: calculating a fast Fourier transform of the recorded EEG; and filtering the fast Fourier transform such that a passband is the specified EEG band (para. 0327 (Ten to twenty-four artifact-free epochs in each recording channel are calculated by a fast Fourier transform (FFT) routine to produce a power spectrum… EEG variables used in the analysis include power density, peak frequency, and frequency selectivity)).
Regarding claim 18, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 17, as discussed above. Phillips ’13 further discloses wherein the processor is further configured to determine the intrinsic frequency by identifying a peak magnitude of the fast Fourier transform (para. 0327 (The intrinsic frequency of alpha EEG is defined as the mean peak frequency (Fp) of 3 central leads (C3, C4, and Cz))).
Regarding claim 21, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 17, as discussed above. Phillips ’13 further discloses wherein the processor is further configured to determine the intrinsic frequency by applying curve fitting to the recorded EEG (para. 0263 (Curve smoothing may be applied to the signal (or signals) received from the EEG electrodes)).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips '13, and in view of Philipps ’16, and in further view of Govea and Herbst et al. (US 20020143365 A1), hereinafter Herbst.
Regarding claim 4-6, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 2, as discussed above.
Phillips ’13 does not explicitly disclose a pulse shape of the waveform is a sine wave, a square wave, and a triangle wave.
Herbst teaches a pulse shape of the waveform is a sine wave, a square wave, and a triangle wave (Fig. 1, element 10, para. 0030 (generators producing signals of different shape… a sine wave generator… a triangular or sawtooth wave… generator yield a wave of any arbitrary shape)).
Phillips ‘13, Phillips ’16, Govea, and Herbst are all considered to be analogous to the claimed invention because they are in the same field of applying electrical stimulation. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Phillips ’16 generator and modify the pulse shape, as taught by Herbst. Doing so 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)).
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips '13, and in view of Philipps ’16, and in further view of Govea and Lesser et al. (US 7228171 B2), hereinafter Lesser.
Regarding claim 10, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 8, as discussed above.
Phillips ’13 does not explicitly disclose wherein the processor is further configured to determine the intrinsic frequency by applying wavelet transforms to the recorded EEG.
Lesser teaches determine the intrinsic frequency by applying wavelet transforms to the recorded EEG (abstract (methods include wavelet analysis and neighbor cross-correlation count, which is a frequency specific measure of the degree of correlation of a single channel of data with respect to its neighbors), col. 9, lines 45-48 (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 [localizing stimulation] and after LS but before BPS)).
Phillips ‘13, Phillips ’16, Govea, and Lesser are all considered to be analogous to the claimed invention because they are in the same field of applying electrical stimulation. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Lesser and provide wavelet transforms to the recorded EEG. Doing so would provide more accurate identification of intrinsic frequency characteristics thereby producing consistent and predictable therapeutic outcomes.
Regarding claim 19, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 17, as discussed above.
Phillips ’13 does not explicitly disclose wherein the processor is further configured to determine the intrinsic frequency by applying wavelet transforms to the recorded EEG.
Lesser teaches determine the intrinsic frequency by applying wavelet transforms to the recorded EEG (abstract (methods include wavelet analysis and neighbor cross-correlation count, which is a frequency specific measure of the degree of correlation of a single channel of data with respect to its neighbors), col. 9, lines 45-48 (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 [localizing stimulation] and after LS but before BPS)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Lesser and provide wavelet transforms to the recorded EEG. Doing so would provide more accurate identification of intrinsic frequency characteristics thereby producing consistent and predictable therapeutic outcomes.
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips '13, and in view of Philipps ’16, and in further view of Govea and Goetz (US 20070276441 A1).
Regarding claim 11, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 8, as discussed above. Phillips ’13 further discloses wherein the processor is further configured to determine the intrinsic frequency to the recorded EEG (para. 301 (adjusting an output of an electric alternating current source for influencing an intrinsic frequency of a EEG band of a subject toward a target frequency of the EEG band… a CES therapy is used to influence the intrinsic frequency of a patient's brain toward a target frequency as measured by EEG)).
Phillips ’13 does not explicitly disclose applying neural networks to the recorded EEG.
Goetz teaches wherein the processor is further configured to determine the intrinsic frequency to the recorded EEG (para. 0039 (neural network may be employed by programmer to allow a clinician to select electrode configurations, and then program IMD to deliver therapy using the selected electrode configurations)).
Phillips ‘13, Phillips ’16, Govea, and Goetz are all considered to be analogous to the claimed invention because they are in the same field of applying electrical stimulation. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Goetz and apply neural networks to the recorded EEG. Doing so would enable identification of patterns and correlations, resulting in the optimization of the stimulation, thereby improving treatment accuracy.
Regarding claim 20, Phillips ’13 (in view of Phillips ’16 and in further view of Govea) teaches a device comprising the features of claim 17, as discussed above. Phillips ’13 further discloses wherein the processor is further configured to determine the intrinsic frequency to the recorded EEG (para. 301 (adjusting an output of an electric alternating current source for influencing an intrinsic frequency of a EEG band of a subject toward a target frequency of the EEG band… a CES therapy is used to influence the intrinsic frequency of a patient's brain toward a target frequency as measured by EEG)).
Phillips ’13 does not explicitly disclose applying neural networks to the recorded EEG.
Goetz teaches wherein the processor is further configured to determine the intrinsic frequency to the recorded EEG (para. 0039 (neural network may be employed by programmer to allow a clinician to select electrode configurations, and then program IMD to deliver therapy using the selected electrode configurations)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phillips ‘13 to incorporate the teachings of Goetz and apply neural networks to the recorded EEG. Doing so would enable identification of patterns and correlations, resulting in the optimization of the stimulation, thereby improving treatment accuracy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Whitehurst et al. (US 7440806 B1) is another example of a processor adjusting stimulation to an implantable generator.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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