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 .
Terminal Disclaimer
The terminal disclaimer filed on July 29, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,944,806 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendments
The amendment filed July 29, 2026 has been acknowledged. Claims 1-11 remain pending in the application and are under examination.
In response to the double patenting rejection, the terminal disclaimer has been reviewed and is accepted.
In response to the 35 U.S.C. 103 rejection, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Claude (US 2022/0023615) in view of Pradeep (US 2021/0290155).
In re claim 1, Claude discloses a method for treating a patient for anxiety, depression, and insomnia [0003], the method comprising:
generating a carrier waveform [0018],
the carrier waveform being an alternating current having a duty cycle ratio and a current amplitude ratio [0018],
the duty cycle ratio and the current amplitude ratio being selected such that each respective integration of the current amplitude between successive time instances at which the carrier waveform alternates polarity is substantially equivalent [0018];
generating a stimulation current from the carrier waveform via amplitude modulating the carrier waveform [0018],
the extremes of the stimulation current defining a stimulation current envelope [0018],
the stimulation current envelope defining a first series of pulses occurring at a first frequency [0018]; and
applying the stimulation current to the brain of the patient [0018].
Claude lacks
a method for treating a patient for mild traumatic brain injury (mTBI) and post-concussion symptoms (PCS)
Pradeep teaches a method for applying non-invasive brain stimulation by using transcranial stimulation that delivers current to the brain [0086] to help rehabilitate diseases of the brain including traumatic brain injuries (TBI) or concussions [0135].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the method of Claude with using transcranial stimulation to treat TBIs or concussions as taught by Pradeep, as using non-invasive transcranial stimulation is known to treat and reduce symptoms of various disorders and injuries of the brain.
In re claim 2, the proposed combination (all mapping directed to Claude) discloses wherein the first series of pulses occur at a frequency of about 40 Hz ([0040]: “first series of pulses occurring at a constant 40 Hz”).
In re claim 3, the proposed combination (all mapping directed to Claude) discloses wherein the stimulation current is generated via amplitude modulating the carrier waveform such that the stimulation current envelope current further defines a second series of pulses occurring at a second frequency [0019].
In re claim 4, the proposed combination (all mapping directed to Claude) discloses wherein the second series of pulses occur at a frequency selected from: about 4 Hz, about 40Hz, about 77.5 Hz ([0040]: “a second series of pulses occurring at a variable frequency… being 4 Hz… 40 Hz… 77.5 Hz”).
In re claim 5, the proposed combination (all mapping directed to Claude) discloses
wherein the method comprises applying the stimulation current to the brain of the patient for a treatment duration [0020],
wherein the first series of pulses occurs at a frequency of about 40 Hz for the entire treatment duration ([0040]: “first series of pulses occurring at a constant 40 Hz for the entire duration”), and
wherein the second series of pulses occurs at frequency of about 4 Hz for a first portion of the treatment duration ([0040]: “variable frequency being 4 Hz for a first portion of the treatment”),
a frequency of about 40 Hz for a second portion of the treatment duration ([0040]: “40 Hz for a second portion of the treatment”), and
a frequency of about 77.5 Hz for a third portion of the treatment duration ([0040]: “77.5 Hz for a third portion of the treatment”).
In re claim 6, the proposed combination (all mapping directed to Claude) discloses
wherein the treatment duration is about an hour ([0040]: “duration of an hour”), and
wherein each of the first portion of the treatment duration, the second portion of the treatment duration, and their third portion of the treatment duration are about 20 minutes ([0040]: “each of the first, second, and third portions of treatment may be roughly equal, i.e. be 20 minutes”).
In re claim 7, the proposed combination (all mapping directed to Claude) discloses
wherein the stimulation current is generated via amplitude modulating the carrier waveform such that the stimulation current envelope defines a plurality of series of pulses [0021],
each respective one of the plurality of series of pulses occurring at a respective frequency [0021].
In re claim 8, the proposed combination (all mapping directed to Claude) discloses wherein each of the plurality of series of pulses of the stimulation current envelopes has a frequency selected from one or more of: about 4 Hz, about 40 Hz, about 77.5 Hz ([0040]: “first series of pulses occurring at a constant 40 Hz”; “second series of pulses occurring at a variable frequency… 4 Hz... 40 Hz… 77.5 Hz”).
In re claim 9, the proposed combination (all mapping directed to Claude) discloses wherein the carrier waveform has a frequency of about 100 KHz [0021].
In re claim 10, the proposed combination (all mapping directed to Claude) discloses wherein the carrier waveform is a rectangular wave [0021].
In re claim 11, the proposed combination (all mapping directed to Claude) discloses further comprising
measuring the stimulation current at the patient [0022] and
determining an electrode contact impedance therefrom, and based upon the determined electrode contact impedance [0022],
adjusting one or more parameters of one or more of: the carrier waveform output from the waveform generator, the stimulation current output from the stimulation current generator, or combinations thereof [0022].
Conclusion
THIS ACTION IS MADE FINAL. 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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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