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 certified translation is received and acknowledged. Applicant’s foreign priority benefit is granted. Applicant’s amendments overcome the interpretation under 35 U.S.C. § 112(f) and the rejections under 35 U.S.C. §§ 112(a) and (b) and 101. Therefore the rejections are withdrawn. Applicant’s amendments further merit new grounds for rejection under 35 U.S.C. § 103 further in view of Popovic et al. (U.S. Patent Application Publication No. 2016/0051817).
Applicant's arguments filed 8/13/2026 have been fully considered but they are not persuasive as they are directed solely to whether the Page reference alone teaches newly amended claim limitations. These amended limitations are taught in combination with the Popovic reference, below.
The Popovic reference teaches a first rectangular signal among the multiple rectangular signals comprise at least one positive spike signal, and a second rectangular signal following the first rectangular signal comprises at least one negative spike signal (Fig. 12, e.g. each positive and negative rectangular pulse further comprise a respective positive or negative spike signal). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the transcutaneous stimulation of Page with the current spikes from Popovic, because Page teaches fast delivery of charge (such as fast pulse slew rate and spike signals) ensures a higher success rate of generating desired action potentials, and allows stimulation with a lower, less painful amplitude overall (Popovic ¶¶[0148-0149]).
Claim Objections
Claims 1 and 11 are objected to because of the following informalities: “the alternating current stimulation signal switched on according to the first frequency is a burst signal that a positive signal having a value exceeding a predetermined standard and a negative signal having a value below a predetermined standard repeat,” appears to be missing a word, “such” for readability. The Examiner suggests “the alternating current stimulation signal switched on according to the first frequency is a burst signal such that a positive signal having a value exceeding a predetermined standard and a negative signal having a value below a predetermined standard repeat.”
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7 and 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Page et al. (U.S. Patent Application Publication No. 2020/0269046) hereinafter referred to as Page; in view of Popovic et al. (U.S. Patent Application Publication No. 2016/0051817) hereinafter referred to as Popovic.
Regarding claim 1, Page teaches a pain relief device (Abstract, treatment of head and face pain) comprising:
an electrical circuit configured to generate an electrical signal recognized as non-painful by a brain (¶[0046]);
an electrode configured to be attached to at least one part of the body (¶¶[0055-0059], e.g., Fig. 7, throughout) to deliver the generated electrical signal (¶[0046]); and
a processor configured to control an operation of the electrical circuit and the electrode (¶[0046]);
wherein, during a process in which a pain signal generated in a first region of the body is transmitted to the brain (this is interpreted as the user experiencing pain), the electrical signal delivered by the electrode is transmitted to the brain along with the pain signal through surface stimulus receptor of the first region, thereby alleviating the pain perceived by the brain in the first region (¶[0018-0019], ¶¶[0150-0151]),
wherein the electrical signal is an alternating current stimulation (ACS) signal (¶[0034]), and
wherein the alternating current stimulation signal repeatedly switches on and off according to a predetermined first frequency (Fig. 10A, duty cycle at one periodicity, ¶[0034], ¶[0036]), and is a first combined stimulation that applies the alternating current stimulation switched on according to the first frequency as stimulus according to a predetermined second frequency (Fig. 10A, duty cycle at one periodicity, and stimulation inside comprising a waveform frequency, ¶[0037] burst stimulation frequency, e.g.);
the alternating current stimulation signal switched on according to the first frequency is a burst signal (¶[0034] bursts delivered at a duty cycle, ¶[0177]) that a positive signal having a value exceeding a predetermined standard and a negative signal having a value below a predetermined standard repeat (the burst oscillations are symmetric around a predetermined baseline of zero, Fig. 10D, 10H and repeat);
the burst signal is a signal comprising multiple rectangular signals having a positive current value and a negative current value (Fig. 10D, 10H exemplary bursts comprising positive and negative current amplitude and rectangular),
Page does not teach, a first rectangular signal among the multiple rectangular signals comprise at least one positive spike signal, and a second rectangular signal following the first rectangular signal comprises at least one negative spike signal.
Attention is drawn to the Popovic reference, which teaches a first rectangular signal among the multiple rectangular signals comprise at least one positive spike signal, and a second rectangular signal following the first rectangular signal comprises at least one negative spike signal (Fig. 12, e.g. each positive and negative rectangular pulse further comprise a respective positive or negative spike signal).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the transcutaneous stimulation of Page with the current spikes from Popovic, because Page teaches fast delivery of charge (such as fast pulse slew rate and spike signals) ensures a higher success rate of generating desired action potentials, and allows stimulation with a lower, less painful amplitude overall (Popovic ¶¶[0148-0149]).
Regarding claim 3, Page as modified teaches the pain relief device of claim 1.
Page further teaches wherein the positive signal and the negative signal consist of multiple positive spike signals and multiple negative spike signals (Fig. 10A-P contemplated signal shapes including both positive and negative and spike signals, ¶[0035] biphasic and charge balanced, ¶[0209]).
Regarding claim 5, Page as modified teaches the pain relief device of claim 1.
Page further teaches wherein the processor, when a degree of pain relief according to the first combined stimulation is below a predetermined range, controls the electrical circuit to generate a second combined stimulation signal that at least one of the first frequency, the second frequency, and an output, a waveform and a period of the stimulation according to the second frequency is modified, and controls the second combined stimulation signal to be delivered to the surface stimulus receptor through the electrode (¶¶[0256-0258] stimulation parameters are altered to ensure adequate pain inhibition, ¶[0298]).
Regarding claim 6, Page as modified teaches the pain relief device of claim 1.
Page further teaches wherein the electrical signal is a similar electrical signal within a certain error range of a biological signal in the body, thus being recognized as non-painful by the brain (¶[0190] modulation of pain signals while maintaining non-painful sensory function, ¶[0191], ¶[0203] avoiding damage).
Regarding claim 7, Page as modified teaches the pain relief device of claim 6.
Page further teaches wherein the electrode is arranged in multiple numbers near the first region (¶[0177] electrodes A-H, 8 electrodes).
Regarding claim 9, Page as modified teaches the pain relief device of claim 8.
Page further teaches wherein the electrical signal has an intensity of 100 µA to 1000 µA (¶[0219] 1mA is equivalent to 1000 µA) and is applied for 10 to 60 minutes (¶[0221] 10-15, 15-20, 20-25, or 25-30 minutes).
Regarding claim 10, Page as modified teaches the pain relief device of claim 1.
Page further teaches wherein the pain occurring in the first region is knee joint pain, frozen shoulder pain, shoulder impingement syndrome pain, carpal tunnel syndrome pain, plantar fasciitis pain, rheumatoid arthritis pain, postherpetic neuralgia pain, back pain, lumbar stenosis pain, or neck pain (¶[0178] shoulder, neck, head, ¶[0014]).
Regarding claims 11 and 14, the claims are directed to substantially the same subject matter as claim 1 and 5 and is rejected under substantially the same sections of Page and Popovic.
Claim(s) 8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Page and Popovic as applied to claims 1 and 11 above, and further in view of Vallejo et al. (U.S. Patent Application Publication No. 2018/0028812) hereinafter referred to as Vallejo.
Regarding claim 8, Page as modified teaches the pain relief device of claim 7.
Page as modified does not teach wherein the multiple electrodes deliver an electrical signal to promote ATP (adenosine triphosphate) generation in the first region, and the promoted ATP generation improves blood flow, thereby improving inflammation related to the first region.
Attention is drawn to the Vallejo reference, which teaches an electrical signal to promote ATP (adenosine triphosphate) generation in the first region, and the promoted ATP generation improves blood flow, thereby improving inflammation related to the first region (¶[0061] electrical field stimulates glial cells to provide a priming response moving synapses to normal state including signaling release of transmitters such as ATP).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Page as modified to include optimization for subthreshold stimulation to modulate the behavior of glial cells and the way they interact with neurons at a synaptic level to control the balance of transmitters for improved pain relief and minimal power usage (Vallejo ¶[0007] and ¶¶[0061-0062]).
Regarding claim 15, Page as modified teaches the control method of the pain relief device of claim 12.
Page further teaches wherein the electrical signal is a similar electrical signal within a certain error range of a biological signal in the body, thus being recognized as non-painful by the brain (¶[0190] modulation of pain signals while maintaining non-painful sensory function, ¶[0191], ¶[0203] avoiding damage; and ¶[0219] 1mA), and the electrode is arranged in multiple numbers near the first region (¶[0221] 10-15, 15-20, 20-25, or 25-30 minutes).
Page as modified does not teach wherein the multiple electrodes deliver an electrical signal to promote ATP (adenosine triphosphate) generation in the first region, and the promoted ATP generation improves blood flow, thereby improving inflammation related to the first region.
Attention is drawn to the Vallejo reference, which teaches an electrical signal to promote ATP (adenosine triphosphate) generation in the first region, and the promoted ATP generation improves blood flow, thereby improving inflammation related to the first region (¶[0061] electrical field stimulates glial cells to provide a priming response moving synapses to normal state including signaling release of transmitters such as ATP).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Page as modified to include optimization for subthreshold stimulation to modulate the behavior of glial cells and the way they interact with neurons at a synaptic level to control the balance of transmitters for improved pain relief and minimal power usage (Vallejo ¶[0007] and ¶¶[0061-0062]).
Conclusion
The prior art made of record and not relied upon remains pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2020/0155847 to Perez teaches low amplitude electrical stimulation for relieving pain.
U.S. Patent Application Publication No. 2023/0148168 to Boggs et al. teaches relieving pain with periodic waveforms by blocking neural transmission, particularly without paresthesia perception.
U.S. Patent Application Publication No. 2021/0008368 to Izvorski et al. teaches a spike signal added to a pain relief neuromodulation device.
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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
