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 .
Response to Arguments
Applicant’s arguments, see page 5, filed on 4/09/2026, with respect to the drawing objections have been fully considered and are persuasive. The previous drawing objections have been withdrawn.
Applicant’s arguments, see page 5, filed on 4/09/2026, with respect to the specification objections have been fully considered and are persuasive. The previous specification objections have been withdrawn.
Applicant’s arguments, see page 6, filed on 4/09/2026, with respect to the previous 35 U.S.C. 112(b) have been fully considered and are persuasive. The 112(b) rejections of claims 2-3 have been withdrawn.
Applicant’s arguments, see pages 10-11, filed on 4/09/2026, with respect to the rejections of claims 1-3 under Dar in view of Kurahashi and Mishra have been fully considered and are persuasive. The examiner agrees with the Applicant’s argument that Kurahashi does not teach or suggest “two electrodes in contact with opposing lateral sides of a patient’s scalp to deliver a therapeutic dose of tACS”, as recited in claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Claude.
Applicant's arguments filed on 4/09/2026 regarding the recited electrical current parameters of claim 1 have been fully considered but they are not persuasive. Both the Dar and Mishra references disclose claimed ranges for current amplitude (mA), carrier waveform frequency (kHz), first and second modulating waveform frequencies (Hz), and pulse duration (µs) that encompass the claimed electrical current parameters of claim 1. As acknowledged in the Applicant’s remarks (see page 13), a prima facie case of obviousness exists when claimed ranges overlap or lie inside ranges disclosed by a cited reference (see MPEP §§ 2144.05 and In re Wertheim, 191 USPQ 90). Furthermore, arguments presented by the Applicant cannot take the place of evidence in the record (See MPEP 716.01(c)).
Applicant's arguments filed on 4/09/2026 regarding the combination of Dar and Kurahashi with Mishra have been fully considered but they are not persuasive. The Applicant argues that the Mishra reference cannot be used in combination with the Dar and Kurahashi references, as Mishra teaches a device that delivers and/or provides energy to one or more tissue locations, and is implanted beneath the skin of a patient. However, it would be well understood that such stimulation parameters and bursts/sub-bursts could be equally applied in both internal and external stimulation applications, as they would implement the same effect of minimizing power consumption while delivering effective therapy.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Dar et al. (U.S. PGPub No. 2021/0244942) in view of Claude (U.S. PGPub No. 2022/0023629) and Mishra (U.S. PGPub No. 2019/0001139).
Regarding claim 1, Dar teaches a method of transcranial alternating current (tACS) stimulation (Paragraph 0160, lines 3-6), comprising: generating and transmitting (Paragraph 0378, lines 3-6), by a controller (Paragraph 0363, lines 3-4) including a processor (Paragraph 0378, line 7), an electrical current (Paragraph 0162, line 4) for receipt by two electrodes (Paragraph 0162, line 7) in contact with a patient's scalp (Paragraph 0197, line 9) to deliver a therapeutic dose of tACS (Paragraph 0160, lines 3- 4); wherein the generated electrical current has a constant, an average amplitude of about 2.2 mA (Paragraph 0157, lines 1-4) and a bidirectional (Paragraph 0156, lines 1-3) square waveform; wherein the current switches polarity after each burst duration (Paragraph 0156, lines 1-3); wherein each pulse (Paragraph 0158, line 3) of the plurality of pulses extends for about 33.33 µs (Paragraph 0158, lines 4-5) followed by a pause of about 33.33 µs (Paragraph 0158, lines 4-5).
Dar does not teach a method of tACS that includes using two electrodes in contact
with opposing lateral sides of a patient's scalp to deliver a therapeutic does of tACS for a
predetermined treatment time. Claude, however, teaches a system and method of tACS stimulation (Fig. 6, Paragraph 0041, lines 2-3) that uses two electrodes (Fig. 6, Paragraph 0044, lines 3-4) in contact with opposing lateral sides of a patient’s head (Paragraph 0044, lines 11-12) to deliver a therapeutic dose of tACS (Paragraph 0044, lines 2-5) for a predetermined treatment time (Paragraph 0053, lines 12-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dar to incorporate the teachings of Claude to specify that the method of tACS includes using two electrodes in contact with opposing lateral sides of a patient's scalp to deliver a therapeutic does of tACS for a
predetermined treatment time. Doing so would optimize frontal cortical stimulation (Paragraph 0044), as recognized by Claude.
Dar also does not teach a generated electrical current that has a bidirectional square waveform utilizing a carrier waveform having a frequency of about 15 kHz, a first modulating waveform having a frequency of about 15 Hz, and a second modulating waveform having a frequency of about 500 Hz.
Mishra, however, teaches a medical apparatus with a generated electrical current
(Paragraph 0021, lines 3-4) that has a bidirectional square waveform (0250, lines 8-9) utilizing a carrier waveform (Paragraph 0412, lines 4-5), a first modulating waveform
(Paragraph 0412, line 5), and a second modulating waveform (Paragraph 0412, line 6).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Dar to incorporate the teachings of Mishra to include a generated electrical current that has a bidirectional square waveform that utilizes a carrier waveform, a first modulating waveform, and a second modulation waveform. Doing so would improve signal transmission efficiency (Paragraph 0365), as recognized by Mishra.
Furthermore, Dar does not teach a method of tACS wherein the generated current
includes a plurality of sub-bursts within a burst duration, and wherein each sub-burst
includes a plurality of pulses within a sub-burst duration. Dar does not specify that a
burst duration includes a burst on duration of about 50 ms including the plurality of sub-
bursts followed by a burst off duration of about 16.7 ms without the plurality of sub-
bursts. Dar also does not specify that the sub-burst duration includes a sub-burst on
duration of 1 ms including the plurality of pulses followed by a sub-burst off duration of
about 1 ms without the plurality of pulses.
Mishra discloses having a burst waveform having a plurality of positive pulses followed by a plurality of negative pulses ("in some embodiments, a train comprises two or more sequential pulses in one phase followed by one or more pulses in the opposite phase", paragraph 0393, lines 19-21), wherein the waveforms have an overall carrier frequency that defines the pulse burst and then has sub-bursts defined by different frequency modulations to the carrier frequency (Paragraph 0412, lines 4-7). Mishra further discloses varying the sub-bursts as defined by TOFF1 and TOFF2 (Paragraph 0397, lines 12-13). Mishra teaches that the various train periods T.sub.ON can be similar or different (Paragraph 0397, lines 9-11), and the inter-train period between trains can be similar or different (Paragraph 0397, lines 11-13). Mishra also discloses that each burst-off period B.sub.OFF can comprise a time period between 1 µsec and 10 seconds (Paragraph 0397, lines 13-14) to have different values for the purpose of minimizing power consumption while delivering effective therapy (Paragraph 0434, lines 5-6). Therefore, it would have been obvious to modify Dar with the burst/sub-burst modulation scheme of Mishra, for the purpose of minimizing power consumption while delivering effective therapy (Paragraph 0434).
Dar and Mishra do not disclose the exact values of "an average amplitude of about
2.2 mA, carrier and modulating waveform frequencies of 15 kHz, 15 Hz, and 500 Hz, or
a pulse width of 33.33 µsec", but Dar discloses using current amplitude values in the
range of 0 - 15 mA, frequency values in the range of 1 - 20,000 Hz, and pulse widths in
the range of 10 - 1,000 µsec (Paragraphs 0157-0159). Likewise, Mishra discloses using
current amplitude values in the range of 1 Hz - 100 kHz, frequency values in the range of
0.01 Hz - 1500 Hz, and pulse widths in the range of 10 - 300 µsec (Paragraph 0029 and
0412). It would have been obvious to one having ordinary skill in the art before the
effective filing date of the claimed invention to utilize the parameter values claimed,
since it has been held that where the claimed ranges overlap or lie inside ranged disclosed
by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Dar et al. (U.S. PGPub No. 2021/0244942) in view of Claude (U.S. PGPub No. 2022/0023629) and Mishra (U.S. PGPub No. 2019/0001139) as applied to claim 1 above, and further in view of Kurahashi et al. (U.S. PGPub No. 2020/0206500).
Regarding claim 2, Dar teaches a method (Paragraph 0160, lines 3-6) of claim 1,
wherein each of the two electrodes (Paragraph 0162, line 7) is positioned on the
squamous temporal bone, above the posterior aspect of the zygomatic arch (Paragraph
0069, lines 3-7 and paragraph 0279, lines 1-5) and maintained in place during delivery of
the therapeutic dose of tACS (Paragraph 0027, lines 1-5) for the treatment of Major
Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD); wherein the
diameter of each of the electrodes is about 36 mm (Paragraph 0082, lines 1-3).
Although Dar does not explicitly state that the two electrodes are positioned on the
squamous temporal bone and above the posterior aspect of the zygomatic arch, Dar describes that the at least one electrode can be above the zygomaticotemporal nerve on
the side of the head (Paragraph 0069), which is in the same location as the squamous
temporal bone and above the posterior aspect of the zygomatic arch.
Dar does not teach a processor that retrieves the predetermined treatment time
from a memory in communication with the processor, wherein the predetermined
treatment time is about 20 minutes. Dar also does not teach a method that measures a
treatment time, and then compares the treatment time to the predetermined treatment
time. Furthermore, Dar does not teach a method that ceases transmission of the generated
electrical current when the elapsed time is equal to the predetermined treatment time.
Kurahashi, however, teaches an electric current stimulation device that includes a
processor (Paragraph 0035, line 2) that retrieves (Paragraph 0035, lines 5-6) the
predetermined treatment time (Paragraph 0039, line 5) from a memory (Paragraph 0035,
line 3) in communication with the processor (Paragraph 0035, lines 1-3), wherein the
predetermined treatment time is about 20 minutes (Paragraph 0039, line 6). Kurahashi
also teaches a device that measures a treatment time (Paragraph 0039, line 5), and then
compares the treatment time to the predetermined treatment time (Paragraph 0039, lines
9-11). Furthermore, Kurahashi teaches a device that ceases transmission of the generated
electrical current (Paragraph 0039, lines 12-15) when the elapsed time is equal to the
predetermined treatment time (Paragraph 0039, lines 9-11).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Dar to incorporate the teachings of
Kurahashi to include a processor that retrieves the predetermined treatment time, which is about 20 minutes, from a memory, and then measures treatment time and compares is to
the predetermined treatment time. Doing so would ensure that the device only provides
electrical stimulation for the desired amount of treatment time, and then transmission of
electrical current is turned off (Paragraph 0039), as recognized by Kurahashi.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Dar et al. (U.S. PGPub No. 2021/0244942) in view of Claude (U.S. PGPub No. 2022/0023629), Mishra (U.S. PGPub No. 2019/0001139), and Kurahashi et al. (U.S. PGPub No. 2020/0206500) as applied to claim 2 above, and further in view of Wetmore et al. (U.S. Patent No. 12,465,718).
Regarding claim 3, Dar teaches a method (Paragraph 0160, lines 3-6) of claim 2, further comprising administering the therapeutic dose of tACS (Paragraph 0160, lines 3-4) to the patient (Paragraph 0197, line 9).
Dar does not teach that the patient receives the therapeutic dose of tACS twice
daily for the predetermined treatment time, wherein one administration occurs within two hours or less after waking from sleep, and another occurs within two hours or less prior to sleeping. Wetmore, however, discloses a method for modulation of integrated neural networks that applies treatment one or more times per day (Col. 8, lines 29-30), and can be separated by 12 hours or less, 8 hours or less, or 6 hours or less at morning and at night (Col. 8, lines 30-34). These treatment time frames cover the range of time of a person sleeping, as well as receiving treatment 2 hours or more before and 2 hours or more after sleeping.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Dar to incorporate the teachings of
Wetmore to include a desired treatment regimen of a patient receiving the therapeutic dose of tACS twice a day, and where they occur within two hours or less after waking from sleep and two hours or less prior to sleeping. Doing so would ensure that the patient receives the proper amount of treatments at the most optimal times of day in order to maximize the efficacy of said tACS treatment (Col. 8), as recognized by Wetmore.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Claude (U.S. PGPub No. 2022/0023616) discloses an alternating current dynamic frequency stimulation system and method that stimulates regions of the brain (Abstract) using two electrodes disposed on opposing lateral sides of a patient’s head (Fig. 6).
Lee (KR 20220081606) discloses a wearable nerve stimulation device that can provide transcutaneous nerve stimulation to the forehead of a patient using pulse bursts (Specification).
Kwan (U.S. PGPub No. 2019/0030336) discloses a portable composite waveform transcranial electrical stimulation system that varies stimulation parameters and works to treat brain disorders (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Heidi Hilsmier whose telephone number is (571)272-2984. The examiner can normally be reached Monday - Fridays from 7:30 AM - 3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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