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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: “502” and “514”. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference characters in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph 0068, line 2, “operations 402-416” should read “operations 502-514”
In paragraph 0069, line 1, “In operation 402” should read “In operation 502”
In paragraph 0074, line 3, “at operation 412” should read “at operation 514”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the squamous temporal bone" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the posterior aspect" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the zygomatic arch" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the treatment" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the diameter" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the elapsed time" in line 13. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Dar et al. (U.S. PGPub No. 2021/0244942) in view of Kurahashi et al. (U.S. PGPub No. 2020/0206500) 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. 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.
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.
Kurahashi, however, teaches a transcutaneous electric current stimulation device that uses two electrodes (Paragraph 0027, lines 4-6) to deliver an electric signal for a predetermined treatment time (Paragraph 0039, line 5). Although Kurahashi does not disclose that the two electrodes used to deliver an electrical signal are in contact with opposing lateral sides of a patient’s scalp, they do disclose that they may be located on the interior surface of the headset (Paragraph 0028, lines 1-2). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to try moving the two electrode locations to opposing lateral sides of the patient’s scalp.
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 Kurahashi and 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, as recognized by Mishra.
Mishra also 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.
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.
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, 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 Kurahashi et al. (U.S. PGPub No. 2020/0206500) and Mishra (U.S. PGPub No. 2019/0001139) 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, as recognized by Wetmore.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. PGPub No. 2022/0023616, Korean Patent No. 20220081606, U.S. PGPub No. 2019/0030336, U.S. Patent No. 12,383,759, U.S. PGPub No. 2025/0121201, and U.S. PGPub No. 2023/0381510.
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/H.A.H./Patent Examiner , Art Unit 3796
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796