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
Regarding the 35 USC § 112 rejections
The claim rejections with respect to the word “about” found in claims 29-31, 33-35 and 37-38 have not been addressed and are repeated below.
Regarding the 35 USC § 102 rejections
Applicant’s arguments, see Applicant’s Response, filed 1/26/2026, with respect to the rejections of claims 26-28, 32, 34-36, 38-40 and 42 under Katsnelson US 2015/0238759 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Goldwasser et al. US 2017/0224990.
Regarding the Katsnelson disclosure; applicant argues that Katsnelson closed loop control is not configured to dynamically adjust parameters of the stimulation current and that Katsnelson adjust voltage and not stimulation current. Katsnelson is clearly applying current to the electrodes for the transcranial device. This is seen in figures 2, 3A and 3B where the y-axis is designated as the current and the x-axis is time.
Katsnelson describes a system which uses resistance measurements from the current sense module to create symmetry between the current amplitudes of the electrical signals (paragraph 0045). This could be a form of voltage-current correction. In a voltage-current correction system the voltage variation of the electrodes placed on the scalp is used in a feedback manner to correct current. This is performed in order to maintain the current, based on the voltage from an impedance signal, at a level which can reach the desired tissue. However, paragraph 0044, states that voltages are adjusted to maintain a desired current output. It is noted that this is the only time in the Katsnelson disclosure that voltage is mentioned. Therefore based on this ambiguity in the Katsnelson disclosure the secondary reference of Goldwasser will be used.
Goldwasser teaches of neuromodulation (abstract and title) which includes transcranial electric stimulation (TES) through scalp electrodes (paragraph 0017). In paragraph 0106 of Goldwasser it is stated; “Any of the variations described herein may be configured so that the controller regulates the applied energy (e.g., current) by adjusting the applied current based on a detected resistance/impedance between the electrodes. For example, the controller may be configured to adjust current across the first and second electrodes based on a detected impedance.” This language alone reads on the claims as amended and will be demonstrated in the below rejections.
Claim Rejections - 35 USC § 112
Claims 29-31, 33-35, and 37-38 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.
The term “about” in claims is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not explicitly disclose how much the frequency is allowed to deviate from 4 Hz, 40 Hz, and 77.5 Hz. The specification also does not provide how much time is allowed to deviate from “an hour” and “20 minutes.”
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 26-28, 32, 34-36, 38-40 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Katsnelson US 2015/0238759 previously cited in view of Goldwasser et al. US 2017/0224990.
Regarding claims 26 and 42: Katsnelson disclose:
a transcranial electrostimulation system for treating a patient, the transcranial electrostimulation system (paragraph 0020) comprising:
a carrier waveform generator configured according to software control provided by a central processing unit (CPU) (microcontroller 500, figure 1) to output an alternating current carrier waveform that is charge-balanced despite a difference in magnitude between portions of the carrier waveform defining opposite polarities (paragraphs 0020-21, 0048, 0050 and fig. 2; the microcontroller is capable of adjusting the amplitude, polarity, and timing of the waveform to create a charge-balanced waveform (paragraph 0021) and the positive area looks substantially equal to the negative area in the inset graph of fig. 2, which is further confirmed by paragraph 0050 disclosing the negative pulse mirrors the positive pulse.
a stimulation current generator (drive circuit 130, figure 1) configured to generate a stimulation current from the carrier waveform output by the waveform generator (see fig. 1 and paragraphs 0044, 0050);
one or more reference electrodes (outputs 137, figure 1), the stimulation current being measurable at the patient by the one or more reference electrodes (paragraph 0047); and
a controller (control 104, figure 1) in communication with the one or more reference electrodes (paragraph 0047), the controller configured to dynamically adjust one or more parameters of the carrier waveform output by the waveform generator in real time with the generation of the stimulation current according to the receipt by the controller of feedback signals based upon an electrode contact impedance (paragraph 0044).
However, it is unclear if Katsnelson is adjusting stimulation current in real time in a feedback manner based on electrode contact impedance. Goldwasser however, teaches of a similar device for transcranial stimulation (Goldwasser paragraph 0102) which regulates the applied current by adjusting the current based on detected resistance/impedance detected at an impedance meter (Goldwasser paragraph 0648) across electrodes in a feedback manner (Goldwasser paragraphs 0106 and 0606). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Katsnelson to include monitoring impedance across electrodes to utilize the impedance as a feedback variable to adjust stimulation, as taught by Goldwasser, in order to “adjust, pause, or otherwise modulate stimulation due to capacitive interference as is known to occur for dry electrodes during movement such as raising a hand near the head” Goldwasser paragraph 0648.
Regarding claim 27: Katsnelson discloses wherein the stimulation current generator is configured to generate the stimulation current via amplitude modulation of the carrier waveform (paragraph 0049), the extremes of the stimulation current defining a stimulation current envelope (see low amplitude and high amplitude; paragraph 0048, figures 1, 3A-3B).
Regarding claim 28: Katsnelson discloses wherein the stimulation current generator is configured to generate the stimulation current via amplitude modulating the carrier waveform such that the stimulation current envelope defines a first series of pulses occurring at a first frequency (high frequency”; paragraph 0039).
Regarding claim 32: Katsnelson discloses wherein the stimulation current envelope further defines a second series of pulses occurring at a second frequency (“low frequency”; paragraph 0038).
Regarding claim 34: Katsnelson disclose a random carrier frequency generator (paragraph 0040), but does not explicitly disclose the order of frequencies wherein the first series of pulses occurs at a frequency about 40 Hz for the entire treatment duration, and wherein the second series of pulses occur at a frequency of about 4 Hz for a first portion of the treatment duration, about 40 Hz for a second portion of the treatment duration, and about 77.5 Hz for a third portion of the treatment duration. However, Katsnelson does disclose the user can adjust frequencies ranging from 1 to 10 kHz (paragraph 0040) and repeat of the stimulation as desired (paragraph 0055). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 35: Katsnelson discloses wherein each of the first portion of the treatment duration, the second portion of the treatment duration, and the third portion of the treatment duration are about 20 minutes (paragraph 0053).
Regarding claim 36: Katsnelson wherein the stimulation current generator is configured to generate the stimulation current 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 (paragraph 0043).
Regarding claim 38: Katsnelson discloses wherein the carrier waveform has a frequency of about 100 KHz (83 Hz; paragraph 0048).
Regarding claim 39: Katsnelson discloses wherein the carrier waveform is a rectangular wave (figures 2-3).
Regarding claim 40: Katsnelson discloses wherein the stimulation current generator is configured to generate the stimulation current so as to produce an uninterrupted non-zero resultant rectified charge (see abolishment of hyperpolarization; paragraph 0041).
Claims 29-31, 33, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Katsnelson US 2015/0238759 previously cited in view of Goldwasser et al. US 2017/0224990.
Regarding claims 29-30: Katsnelson/Goldwasser discloses the claimed invention. Katsnelson further discloses wherein the first series of pulses occur at a frequency of about 40 Hz and 77.5 Hz (paragraphs 0039 and 0053). The examiner considers 65 Hz is relatively close to 40 Hz [emphasis added]. It would have been obvious to one of ordinary skill in the art at the time of the invention to make the first series of pulses occur at a frequency of about 40 Hz and 77.5 Hz since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233).
Regarding claim 31: Katsnelson/Goldwasser discloses the claimed invention. Katsnelson further discloses wherein the first series of pulses occur at a frequency of about 4 Hz (see par. 39). Again, on a scale of 1 Hz to 10 kHz, 65 Hz is relatively close to 4 Hz [emphasis added]. It would have been obvious to one of ordinary skill in the art at the time of the invention to make the first series of pulses occur at a frequency of about 4 Hz since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233). Further, MPEP 2144.05(I) states that “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”
Regarding claims 33 and 37: Katsnelson/Goldwasser discloses the claimed invention. Katsnelson further discloses wherein the second series of pulses occur at a frequency selected from: about 4 Hz, about 40Hz, about 77.5 Hz. Examiner considers 0.2Hz is about 4 Hz [emphasis added]. It would have been obvious to one of ordinary skill in the art at the time of the invention to make the second series of pulses occur at a frequency of about 4 Hz, 40 Hz or 77.5 Hz since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233). Further, MPEP 2144.05(I) states that “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Katsnelson US 2015/0238759 previously cited in view of in view of Goldwasser et al. US 2017/0224990 and further in view of Demers et al. US 2015/0328467 previously cited .
Regarding claim 41: Katsnelson/Goldwasser discloses the claimed invention however, Katsnelson/Goldwasser does not explicitly disclose a patient cable. Demers discloses a similar transcranial stimulator (Demers paragraph 0112) including a patient cable for conveying to the patient the stimulation current generated by the stimulation current generator (Demers paragraph 0152). It would have been obvious to one of ordinary skill in the art at the time of the invention to include a cable because this is a common and well-known way of connecting the electrodes to the stimulator (see par. 152).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kwan US 2019/0030336 discloses a TES system (title) which varies stimulation parameters based on impedance tracking (paragraphs 0002 and 0044), this is known as voltage-current correction.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H 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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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
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