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 .
Election/Restrictions
Claims 1-11 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 May 2026.
Applicant’s election without traverse of Group II: Claims 12-20 in the reply filed on 19 May 2026 is acknowledged.
Response to Amendment
This Office Action is responsive to the amendment filed 19 May 2026. As per the amendment: claims 1-11 have been withdrawn and no claims have been added, cancelled, or amended. Thus, claims 12-20 are presently pending and under examination.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 12-13, 15-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al. (US 2022/0062622 A1), hereinafter Errico in view of Mattila et al. (US 2022/0117534 A1), hereinafter-r Mattila .
Regarding claim 12, Errico teaches a system for stimulating a nerve within a user ([0003] “The field of the present invention generally relates to the delivery of electrical impulses (and/or fields) to bodily tissues for therapeutic purposes, and more specifically to vagal nerve stimulation devices and methods”), the system comprising: a patch (patch 106) comprising an adhesive layer configured for adhering the patch to an outer skin surface of the user ([0266] “The patch 106 may include a suitable adhesive strip or pad on one surface for adhering the patch 106 and stimulator to the outer skin surface of the patient.”), an electrode disposed within the patch ([0043] “The electrodes are housed within the patch.”); and an energy source coupled to the electrode, wherein the energy source is configured to generate at least one electrical impulse and to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the user to a selected nerve in the user adjacent to, or near, a target location ([0043] “The patch may further comprise a signal generator and an energy source for applying the electrical impulses through the electrodes to the vagus nerve”, [0045] “contacting one or more electrodes to an outer skin surface of a neck of the patient and generating an electrical impulse with an energy source. The electrical impulse is transmitted transcutaneously and non-invasively from the electrodes through the outer skin surface of the patient to a vagus nerve in the patient”).
Errico fails to explicitly disclose wherein the adhesive layer has at least one opening and an electrode is disposed within the opening of the adhesive layer.
However, Mattila teaches a system with a patch assembly and a frame wherein the adhesive layer has at least one opening and an electrode is disposed within the opening of the adhesive layer ([0047] “The first lower housing 492 defines an opening 492A such that an electrode 481 disposed on a bottom side of the portion 486 is accessible through the opening 492A. The first adhesive portion can also define an opening (e.g., similar in size and shape to the opening 492A) such that the electrode 481 disposed on a bottom side of the portion 486 is accessible through the opening 492A. The first assembly 410 also includes a hydrogel portion 472., [0048] “The second adhesive portion can also define an opening (e.g., similar in size and shape to the opening 494A) such that the electrode 483 disposed on a bottom side of the portion 484 is accessible through the opening 492A”)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Errico’s adhesive layer to incorporate the teachings of Mattila to have the adhesive layer has at least one opening and an electrode is disposed within the opening of the adhesive layer, as these prior art references are directed to patch assemblies attached to a user. One would be motivated to do this to allow for better contact of the electrode with the skin.
Regarding claim 13, Errico in view of Mattila teaches the system of claim 12 (as shown above). Errico further discloses the system further comprising an electrically conductive fluid on the electrode ([0269] “The stimulator may also include a conductive fluid, such as a gel pad, disposed between the electrode(s) and the patient's outer skin surface to enhance conductivity of the electrical impulses through the outer skin surface to the nerve”).
Regarding claim 15, Errico in view of Mattila teaches the system of claim 12 (as shown above). Errico further teaches the system further comprising a stimulator housing, wherein the energy source is disposed within the stimulator housing ([0266]-[0267] “Stimulator may be housed in an outer covering or patch 106 to protect stimulator from the environment…The stimulator in this embodiment includes one or more electrodes. The stimulator may also include a power source such as a battery, and a signal generator for applying the electrical impulses to the electrodes.”).
Regarding claim 16, Errico in view of Mattila teaches the system of claim 12 (as shown above). Errico further discloses wherein the energy source is disposed within the patch ([0043] “The patch may further comprise a signal generator and an energy source for applying the electrical impulses through the electrodes to the vagus nerve.”).
Regarding claim 20, Errico in view of Mattila teaches the system of claim 12 (as shown above). Errico further discloses wherein the selected nerve is a vagus nerve (Abstract, [0033] “The patch may further comprise a signal generator and an energy source for applying the electrical impulses through the electrodes to the vagus nerve.”).
Claim(s) 14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Errico in view of Mattila as applied to a claim 12 and 16 above, and further in view of Wong et al. (US 2019/0134393 A1), hereinafter Wong.
Regarding claim 14, Errico in view of Mattila teaches the system of claim 12 (as shown above). Errico fails to disclose wherein the electrode is a dry electrode.
However, Wong teaches a system for peripheral nerve stimulation (Abstract) wherein the electrode is a dry electrode ([0089] “the integrated electrodes 902, 904 can be dry electrodes”, [0090]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrodes of Errico with the dry electrodes of Wong, as these prior art references and the instant application are directed to wearable electrodes for stimulation of vagus nerve. One would be motivated to do this as dry electrodes are more suitable for long term use and do not require any adhesive to achieve skin contact sufficient for comfortable delivery of electrical stimulation, as recognized by Wong ([0089]-[0090]).
Regarding claim 17, Errico in view of Mattila teaches the system of claim 16 (as shown above). Errico fails to explicitly disclose the system further comprising flexible circuitry disposed within the patch, wherein the flexible circuitry is configured to generate the electrical impulse.
However, Wong teaches a system for electrically stimulating peripheral nerves to treat various disorders ([0002]) wherein the system further comprises flexible circuitry disposed within the patch, wherein the flexible circuitry is configured to generate the electrical impulse ([0042] “The band includes a strap configured to be worn around a body part, at least two dry electrodes disposed on the strap, a flexible circuit disposed within the strap, and an electrical connect feature… The flexible circuit is in electrical communication with the at least two dry electrodes.”, [0115] “The base layer of the dry electrodes 702 may be directly integrated into the flex circuit 712. The electrical connection tab 714 can be an extension of the flex circuit that can be connected to an electrical nerve stimulation device.”, [0043] “The electrical nerve stimulation device can be programmed to deliver electrical stimulation through the dry electrodes to treat tremor”, view Figure 15A-D and 8).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Errico to incorporate the teachings of Wong to have the system further comprise of a flexible circuitry disposed within the patch, wherein the flexible circuitry is configured to generate the electrical impulse, as these prior art references are directed to wearable electrodes for stimulation of vagus nerve. One would be motivated to do this to allow the device and its components to adhere/conform to the patient’s body for better contact.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Errico in view of Mattila as applied to claim 16 above, and further in view of Salisbury (US 2024/0009057 A1), hereinafter Salisbury.
Regarding claim 18, Errico in view of Mattila teaches the system of claim 16 (as shown above), wherein the energy source comprises a capacitor configured for electrical coupling to the outer skin surface.
However, Salisbury teaches a wearable stimulation system wherein “The garment further includes a power source operable to supply electrical current to the stimulation device 10 when it is desired to deliver muscle stimulation. In the examples shown in FIGS. 6 to 11, the power source includes one or more energy harvesting yarns 58 and at least one capacitor 60, such as supercapacitor, operable to store electrical energy harvested by the one or more energy harvesting yarns. The energy harvesting yarns 58 may comprise a piezoelectric material, such that the energy harvesting yarn is operable to generate electricity when the wearer of the garment moves.” ([0132],[0151]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Errico in view of Mattila to incorporate the teachings of Salisbury to have the energy source comprises a capacitor configured for electrical coupling to the outer skin surface, as these prior art references are directed to wearable stimulation devices. One would be motivated to do this to reduce reliance on batteries and allow for long-term use without maintenance.
Regarding claim 19, Errico in view of Mattila in view of Salisbury teaches the system of claim 18 (as shown above). Errico and Mattila, alone or in combination, fail to teach wherein the capacitor is configured to store energy from the user’s body and to transmit the energy to the electrode.
However, Salisbury teaches a wearable stimulation system wherein “The garment further includes a power source operable to supply electrical current to the stimulation device 10 when it is desired to deliver muscle stimulation. In the examples shown in FIGS. 6 to 11, the power source includes one or more energy harvesting yarns 58 and at least one capacitor 60, such as supercapacitor, operable to store electrical energy harvested by the one or more energy harvesting yarns. The energy harvesting yarns 58 may comprise a piezoelectric material, such that the energy harvesting yarn is operable to generate electricity when the wearer of the garment moves.” ([0132],[0151]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Errico and Mattila to incorporate the teachings of Salisbury to have the capacitor configured to store energy from the user’s body and to transmit the energy to the electrode, as these prior art references are directed to wearable stimulation devices. One would be motivated to do this to reduce reliance on batteries and allow for long-term use without maintenance.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Aleksov et al. (US Patent 9,735,893 B1) teaches a patch system for providing therapy to a user with capacitor energy storage and energy harvesting electronics (Column 6, lines 4-6)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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