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 .
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.
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Claim 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,944,806 in view of Pradeep (US 2021/0290155). The claims of the instant application and the claims of the reference patent are compared in the table below.
Instant Application 18/890,458
US Patent 11,944,806
Claim 1: A method for treating a patient for mild traumatic brain injury (mTBI) and post-concussion symptoms (PCS), the method comprising:
generating a carrier waveform, the carrier waveform being an alternating current having a duty cycle ratio and a current amplitude ratio,
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;
generating a stimulation current from the carrier waveform via amplitude modulating the carrier waveform,
the extremes of the stimulation current defining a stimulation current envelope,
the stimulation current envelope defining a first series of pulses occurring at a first frequency; and
applying the stimulation current to the brain of the patient.
Claim 3: The method of claim 1,
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.
Claim 4: The method of claim 3,
wherein the second series of pulses occur at a frequency selected from: about 4 Hz, about 40 Hz, about 77.5 Hz.
Claim 5: The method of claim 3,
wherein the method comprises applying the stimulation current to the brain of the patient for a treatment duration,
wherein the first series of pulses occurs at a frequency of about 40 Hz for the entire treatment duration, and
wherein the second series of pulses occurs at frequency of about 4 Hz for a first portion of the treatment duration, a frequency of about 40 Hz for a second portion of the treatment duration, and a frequency of about 77.5 Hz for a third portion of the treatment duration.
Claim 1: A method for treating a patient for anxiety, depression, and insomnia, the method comprising:
(a) generating a stimulation current conveyed to the patient for a treatment duration via the steps of:
generating a carrier waveform, the carrier waveform being an alternating current having a duty cycle ratio and a current amplitude ratio,
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; and
generating a stimulation current from the carrier waveform via amplitude modulating the carrier waveform,
the extremes of the stimulation current defining a stimulation current envelope,
the stimulation current envelope defining a first series of pulses occurring at a first frequency and a second series of pulses occurring at a second frequency,
the first series of pulses occurring at a first frequency that does not substantially vary for the entire treatment duration,
the second series of pulses occurring at a second frequency that varies during the treatment duration,
the second series of pulses occur at a frequency between 4 Hz and 100 Hz; and
(b) conveying the stimulation current to the frontal cortex region of the brain of the patient.
Claim 2: The method of claim 1,
wherein the first series of pulses occur at a frequency of about 40 Hz.
Claim 2: The method of claim 1,
wherein the first series of pulses occur at a frequency between 4 Hz and 100 Hz.
Claim 6: The method of claim 5,
wherein the treatment duration is about 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.
Claim 3: The electrostimulation system of claim 1,
wherein the treatment duration is about an hour, and wherein the second frequency varies during the treatment duration to predefined frequencies corresponding to a first portion having a duration of about 20 minutes, a second portion having a duration of about 20 minutes, and a third portion having a duration of about 20 minutes.
Claim 7: The method of claim 1,
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, each respective one of the plurality of series of pulses occurring at a respective frequency.
Claim 4: The method of claim 1,
wherein in step (a), the stimulation current is generated via amplitude modulating the carrier waveform such that the stimulation current envelope defines a plurality of series of pulses, each respective one of the plurality of series of pulses occurring at a respective frequency.
Claim 8: The method of claim 7,
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.
Claim 5: The method of claim 4,
wherein each of the plurality of stimulation current envelopes has a frequency between 4 Hz and 100 Hz.
Claim 9: The method of claim 1,
wherein the carrier waveform has a frequency of about 100 KHz.
Claim 6: The method of claim 1,
wherein the carrier waveform has a frequency of about 100 KHz.
Claim 10: The method of claim 1,
wherein the carrier waveform is a rectangular wave.
Claim 7: The method of claim 1,
wherein the carrier waveform is a rectangular wave.
Claim 11: The method of claim 1, further comprising
measuring the stimulation current at the patient and determining an electrode contact impedance therefrom, and
based upon the determined electrode contact impedance, 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.
Claim 8: The method of claim 1, further comprising
the steps of measuring the stimulation current at the patient and determining an electrode contact impedance therefrom, and
based upon the determined electrode contact impedance, 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.
Claim 1
Claim 1 of the reference patent recites all limitations of claim 1 of the instant application except for treating a patient for “mild traumatic brain injury (mTBI) and post-concussion symptoms (PCS)”. However, 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 have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use non-invasive brain stimulation to treat mild TBIs and concussions, as disclosed by Pradeep, within the method of claim 1 of the reference patent, to allow a medical practitioner to use the same type of stimulation for different disorders including concussions and TBIs. This would allow a method for treating a patient that has a TBI or concussion with non-invasive brain stimulation which could reduce the severity of symptoms they are experiencing and reverse some of the brain damage they received (Pradeep, [0139]).
Claims 3, 4, and 5
Claim 1 of the reference patent anticipates the same limitations as claims 3, 4, and 5 of the instant application.
Claim 2
Claim 2 of the reference patent anticipates the same limitations as claim 2 of the instant application.
Claim 6
Claim 3 of the reference patent anticipates the same limitations as claim 6 of the instant application.
Claim 7
Claim 4 of the reference patent anticipates the same limitations as claim 7 of the instant application.
Claim 8
Claim 5 of the reference patent anticipate the same limitations as claim 8 of the instant application.
Claim 9
Claim 6 of the reference patent anticipates the same limitations as claim 9 of the instant application.
Claim 10
Claim 7 of the reference patent anticipates the same limitations as claim 10 of the instant application.
Claim 11
Claim 8 of the reference patent anticipates the same limitations as claim 11 of the instant application.
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jeffery et al. (US 2016/0346530) teaches a transcranial neuromodulation device that can be used to modulate the user’s cognitive state [0011]. The device can use alternating current stimulation [0201] and has an analog waveform signal that is modulated by a second signal to form the final electrical stimulation waveform [0116].
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
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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