DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 22 July 2025 has been considered by the Examiner.
Claim Objections
3. Claims 1 and 13-14 are objected to because of the following informalities.
Claims 1 and 13 contain minor typographical errors.
Claim 1, line 18: The Examiner suggests changing “when a pulse of the low frequency signal is inactive” to “when the pulse of the low frequency signal is inactive”.
Claim 13, line 14: The Examiner suggests changing “when a pulse of the low frequency signal is inactive” to “when the pulse of the low frequency signal is inactive”.
Claim 14, lines 2-3: The Examiner suggests changing “a portion of a body of a subject who has fibromyalgia” to “the portion of the body of the subject who has fibromyalgia”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
4. 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.
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.
5. Claims 1-2, 10-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ironi et al. (US 2020/0038656 A1).
Regarding claims 1 and 13, Ironi teaches an apparatus and method ([abstract, 0019]) and comprising:
a set of two or more electrodes configured to be placed in electrical contact with a portion of a body of a subject ([abstract, 0019-0020]); and
at least one computer processor configured to drive the electrodes to apply an amplitude shift keying signal into the portion of the subject's body ([0021]), the amplitude shift keying signal containing:
a high frequency component that acts as a carrier wave ([0022]), the high frequency component having a frequency of between 80 Hz and 120 Hz ([0022]), and a low frequency component that acts as a modulating component that modulates the carrier wave, the low frequency component having a frequency of between 1 Hz and 8 Hz ([0023]), the computer processor configured to drive the electrodes to apply the amplitude shift keying signal into the portion of the subject's body by applying the low frequency signal ([0025]) such that:
when a pulse of the low frequency signal is active, a current of the amplitude shift keying signal alternates between a nominal maximum and a nominal minimum of the amplitude shift keying signal ([0026, 0087]), and when the pulse of the low frequency signal is inactive, the current of the amplitude shift keying signal alternates between the nominal maximum minus a modulation factor and the nominal minimum plus the modulation factor ([0026, 0087]), the modulation factor being between 0.3 and 0.8 of the nominal maximum ([0026, 0087-0088]).
Ironi does not explicitly teach wherein the modulation factor being between 0.05 and 0.15 of the nominal maximum. However, Ironi teaches that the modulation factor may be adjusted to values that are close to 0 ([0087-0088]). Therefore, a person having ordinary skill in the art would have found it obvious to modify the modulation factor to be between 0.05 and 0.15 of the nominal maximum. The advantage of such modification will provide a modulation wave that has a lower impact ([0087-088]). The Examiner respectfully submits that the skilled artisan could arrive at the claimed modulation factor via routine experimentation (MPEP 2144.05).
Regarding claim 2 and 17, Ironi suggests the apparatus according to claim 1 and the method according to claim 13. Ironi teaches wherein the computer processor is configured to set the high frequency component to be between 80 Hz and 120 Hz ([abstract, 0016, 0022])
Ironi does not explicitly teach wherein the computer processor is configured to set the high frequency component to be between 100 Hz and 120 Hz.
However, Applicant’s claimed range of 100 Hz and 120 Hz lies entirely within Ironi’s range of 80 Hz and 120 Hz ([0016, 0022]). Therefore, a prima facie case of obviousness exists. Based on the overlapping range, a person having ordinary skill in the art would have found it obvious to modify Iron’s high frequency component to be between 100 Hz and 120 Hz (MPEP 2144.05). The advantage of such modification will enhance the frequency of the electrical stimulation pulses which may improve the treatment of pain (see paragraphs [0015-0016] by Ironi).
Regarding claim 9, Ironi teaches a patch ([0024, 0066]), wherein the electrodes are disposed upon the patch and the electrodes are configured to be placed in electrical contact with the portion of the subject's body by placing the patch upon the portion of the subject's body (the electrodes 22 are disposed upon a patch 20 that may be arranged on the patient’s body (e.g., neck, arm legs, hands, or feet) [0024, 0066]).
Regarding claim 10, Ironi teaches a mount that is selected from a group consisting of a cuff ([0066]), and wherein the electrodes are disposed upon the selected mount and are configured to be placed in electrical contact with the portion of the subject's body by placing the selected mount upon the portion of the subject's body ([0066]).
Regarding claims 11 and 15, Ironi teaches wherein the computer processor is configured to drive the electrodes to apply the amplitude shift keying signal into the portion of the subject's body ([0027]) by:
applying the high frequency component, the high frequency component including a biphasic pulse ([0028]), and applying the low frequency component, the low frequency component including a monophasic pulse ([0029]).
Regarding claims 12 and 16, Ironi teaches wherein the computer processor is configured to drive the electrodes to apply the amplitude shift keying signal into the portion of the subject's body by applying the high frequency component, the high frequency component having a base frequency, and the frequency of the high frequency component drifting from the base frequency up to 20 percent above the base frequency, and down to 20 percent below the base frequency ([0030]).
6. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ironi et al. in view of Jashek et al. (US 2021/0052884 A1)
Regarding claim 14, Ironi suggests the method according to claim 13. Ironi does not explicitly teach wherein applying the electrical amplitude shift keying signal comprises applying the electrical amplitude shift keying signal to the portion of the body of a subject who has fibromyalgia.
The prior art by Jashek is analogous to Ironi, as they both teach electrodes that are configured to apply an amplitude shift keying signal ([0179, 0181]).
Jashek teaches wherein applying the electrical amplitude shift keying signal comprises applying the electrical amplitude shift keying signal to the portion of the body of the subject who has fibromyalgia (the electrodes are configured to apply the amplitude shift keying signal to a patient that has fibromyalgia [0179, 0181]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Ironi’s electrical amplitude shift keying signal to be applied to a subject who has fibromyalgia, as taught by Jashek. The advantage of such modification will allow for treating fibromyalgia (see paragraphs [0179, 0181] by Jashek).
Allowable Subject Matter
7. Claims 3-8 and 18-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
8. The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided an explanation below that describes how the prior art of record fails to suggest the corresponding claims.
Regarding claim 3, Ironi suggests the apparatus according to claim 1. Ironi does not explicitly teach an accelerometer configured to generate an accelerometry signal indicative of motion of the portion of the body of the subject, wherein the computer processor is configured to modify a parameter of the amplitude shift keying signal in response to the accelerometry signal.
The prior art by Paz (US 2021/0138232 A1) is analogous to Ironi, as they both electrodes that are attached to the patient’s body to provide electrical stimulation ([abstract, 0268]).
Paz teaches an accelerometer configured to generate an accelerometry signal indicative of motion of the portion of the body of the subject ([0124, 0307, 0359]).
However, Paz does not explicitly teach wherein the computer processor is configured to modify a parameter of the amplitude shift keying signal in response to the accelerometry signal.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 4-6 are considered to contain allowable subject matter, as claims 4-6 depend upon claim 3.
Regarding claim 7, Ironi suggests the apparatus according to claim 1. Ironi does not explicitly teach an accelerometer configured to generate an accelerometry signal indicative of motion of the portion of the body of the subject, wherein the computer processor is configured to direct the subject to move the set of two or more electrodes in response to a low level of the accelerometry signal.
However, Paz teaches an accelerometer configured to generate an accelerometry signal indicative of motion of the portion of the body of the subject ([0124, 0307, 0359]).
Paz does not explicitly teach wherein the computer processor is configured to direct the subject to move the set of two or more electrodes in response to a low level of the accelerometry signal.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 8, Ironi suggests the apparatus according to claim 1, wherein the set of two or more electrodes is a first set of two or more electrodes (the set of two or more stimulation electrodes [abstract, 0148]), wherein the apparatus further comprises a second set of two or more electrodes (the set of two or more sensing electrodes [0149]).
Ironi does not explicitly teach an accelerometer configured to generate an accelerometry signal indicative of motion of the portion of the body of the subject, and wherein the computer processor is configured to drive the electrodes of the second set, rather than the electrodes of the first set, to apply the amplitude shift keying signal in response to a low level of the accelerometry signal.
However, Paz teaches an accelerometer configured to generate an accelerometry signal indicative of motion of the portion of the body of the subject ([0124, 0307, 0359]).
Paz does not explicitly teach wherein the computer processor is configured to drive the electrodes of the second set, rather than the electrodes of the first set, to apply the amplitude shift keying signal in response to a low level of the accelerometry signal.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 18, Ironi suggests the method according to claim 13. Ironi does not explicitly teach wherein applying the electrical amplitude shift keying signal further comprises modifying a parameter of the amplitude shift keying signal in response to an accelerometry signal generated by an accelerometer and indicative of motion of the portion of the body of the subject.
The prior art by Paz is analogous to Ironi, as they both electrodes that are attached to the patient’s body to provide electrical stimulation ([abstract, 0268]).
Paz teaches an accelerometer configured to generate an accelerometry signal indicative of motion of the portion of the body of the subject ([0124, 0307, 0359]).
However, Paz does not explicitly teach wherein applying the electrical amplitude shift keying signal further comprises modifying a parameter of the amplitude shift keying signal in response to an accelerometry signal generated by the accelerometer.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 19-21 are considered to contain allowable subject matter, as claims 19-21 depend upon claim 18.
Regarding claim 22, Ironi suggests the method according to claim 13. Ironi does not explicitly teach directing the subject to move the electrodes in response to a low level of an accelerometry signal generated by an accelerometer and indicative of motion of the portion of the body of the subject.
However, Paz teaches an accelerometer configured to generate an accelerometry signal indicative of motion of the portion of the body of the subject ([0124, 0307, 0359]).
Paz does not explicitly teach directing the subject to move the electrodes in response to a low level of an accelerometry signal generated by an accelerometer and indicative of motion of the portion of the body of the subject.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 23, Ironi suggests the method according to claim 13, wherein the electrodes are first electrodes ([abstract, 0148]).
Ironi does not explicitly teach wherein applying the electrical amplitude shift keying signal comprises applying the amplitude shift keying signal via second electrodes, rather than the first electrodes, in response to a low level of an accelerometry signal generated by an accelerometer and indicative of motion of the portion of the body of the subject.
However, Paz teaches an accelerometer configured to generate an accelerometry signal indicative of motion of the portion of the body of the subject ([0124, 0307, 0359]).
Paz does not explicitly teach wherein applying the electrical amplitude shift keying signal comprises applying the amplitude shift keying signal via second electrodes, rather than the first electrodes, in response to a low level of an accelerometry signal generated by the accelerometer.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Conclusion
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Examiner respectfully submits that the prior art by Kern (US 2021/0308452 A1) is pertinent to Applicant’s disclosure, as Kern teaches an amplitude shift keying signal containing a carrier wave ([0073]).
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached 7:30am -4:30pm.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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