DETAILED ACTION
Response to Arguments
Applicant’s arguments, see page 1, filed on 2/17/2026, with respect to the drawing objections have been fully considered and are persuasive. The previous drawing objections have been withdrawn.
Applicant’s arguments, see page 1, filed on 2/17/2026, with respect to the specification objections have been fully considered and are persuasive. The previous specification objections have been withdrawn.
Applicant’s arguments, see page 1, filed on 2/17/2026, with respect to the previous 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The previous 112(b) rejections of claims 10, 12, and 16 have been withdrawn.
Applicant’s arguments, see pages 2-5, filed on 2/17/2026, with respect to the 35 U.S.C. 103 rejections of claims 1-8 and 10-17 under Atkin in view of Wetmore have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection for claim 1 is made in view of Cartledge et al. (U.S. Patent No. 10,130,809) due to a new search that was necessitated by the amendments. Also, upon further consideration, a new ground of rejection for claim 12 is made in view of Gill et al. (WIPO Pub. No. 2022/221644) due to a new search that was necessitated by the amendments.
Applicant’s arguments, see pages 2-5, filed on 2/17/2026, with respect to the 35 U.S.C. 103 rejection of claim 19 over Atkin in view of Wetmore and John have been fully considered and are persuasive. The rejection of claim 19 has been withdrawn.
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 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Atkin et al. (U.S. PGPub No. 2022/0370786) in view of Wetmore et al. (U.S. Patent No. 12,465,718) (cited previously) and Cartledge et al. (U.S. Patent No. 10,130,809).
Regarding claim 1, Atkin teaches a system (Paragraph 0014, lines 1-2) for
transcutaneous auricular branch vagal nerve stimulation (Paragraph 0017, lines 1-3) comprising: a first electrode (Paragraph 0015, line 2) to be attached to a first location in a concha (Paragraph 0040, lines 4-5) of a patient's ear (Paragraph 0022, lines 6-7); and a second electrode (Paragraph 0015, line 3) attached to the patient’s ear.
Atkin does not teach that the second electrode is attached to a second location in the concha of the patient’s ear. Wetmore, however, teaches a non-invasive auricular stimulation apparatus that includes multiple electrodes (Fig. 9, Col. 14, lines 58-59) being attached to multiple locations in a concha of the patient's ear (Fig. 9, Col. 14, lines 51-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Atkin to incorporate the teachings of Wetmore to include that the second electrode attaches to a second location in the concha of the patient’s ear. Doing so would allow for current steering of said system in order to shape the electric field produced by the external ear (Col. 15), as recognized by Wetmore.
Atkin also does not teach a flexible substrate configured to be bent over a helix of the patient's ear to secure the system to the patient's ear. Cartledge, however, teaches a transcutaneous electrostimulator for electric stimulation of the auricular branch of the vagus nerve (Col. 7, lines 10-11). Furthermore, Cartledge teaches that the electrostimulator (Col. 27, line 3) includes a flexible substrate (Fig. 29, Col. 31, lines 32-38) that is configured to be bent over a helix of the patient’s ear (Fig. 29, Col. 31, lines 32-51) to secure the device to the patient’s ear (Fig. 29, Col. 31, lines 42-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Atkin to incorporate the teachings of Cartledge to include that the system has a flexible substrate configured to be bent over a helix of the patient’s ear in order to secure the system to the ear. Doing so would ensure the device conforms to the anatomy of each patient and does not fall off the patient’s ear (Col. 31), as recognized by Cartledge.
Regarding claim 10, Atkin teaches the system (Paragraph 0014, lines 1-2) of claim 1. Atkin does not teach that the system includes a flexible substrate, wherein the flexible substrate is bent over a top of the patient's ear to secure the system to the patient's ear. Cartledge, however, teaches a transcutaneous electrostimulator that includes a flexible substrate (Fig. 29, Col. 31, lines 32-38) that is configured to be bent over a top of the patient’s ear (Fig. 60, Col. 34, lines 53-57) to secure the device to the patient’s ear (Fig. 29, Col. 31, lines 42-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Atkin to incorporate the teachings of Cartledge to include that the flexible substrate is bent over a top of the patient's ear to secure the system to the patient's ear. Doing so would ensure the device conforms to the anatomy of each patient and does not fall off the patient’s ear (Col. 31), as recognized by Cartledge.
Regarding claim 11, Atkin in view of Wetmore and Cartledge discloses the claimed invention of claim 1. Atkin further discloses a system (Paragraph 0014, lines 1-2) of claim 1, wherein the first electrode (Paragraph 0015, line 2) and the second electrode (Paragraph 0015, line 3) further comprise an adhesive (Paragraph 0006, lines 10-11) to attach the first electrode and the second electrode to the patient's ear (Paragraph 0022, lines 6-7).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Atkin et al. (U.S. PGPub No. 2022/0370786) in view of Wetmore et al. (U.S. Patent No. 12,465,718) and Cartledge et al. (U.S. Patent No. 10,130,809) as applied to claim 1 above, and further in view of John et al. (U.S. PGPub No. 2025/0281742).
Regarding claim 9, Atkin teaches the system (Paragraph 0014, lines 1-2) of claim 1 for transcutaneous auricular branch vagal nerve stimulation (Paragraph 0017, lines 1-3). Atkin does not teach that the system is disposable upon conclusion of the stimulation. According to claim 1, the system comprises a first electrode, a second electrode, and a flexible substrate. John teaches a system for nerve stimulation that comprises disposable electrodes (Paragraph 0054, lines 14-16) and a disposable flexible substrate (Paragraph 0186, lines 36-37) that are discarded once stimulation is completed (Paragraph 0216, lines 15-16).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Atkin to incorporate the teachings of John to specify that the system is disposable upon conclusion of the stimulation. Doing so would provide improved sanitary conditions and efficacy for the electrodes and flexible substrate of the system (Paragraph 0239), as recognized by John.
Claims 12-17 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Atkin et al. (U.S. PGPub No. 2022/0370786) in view of Wetmore et al. (U.S. Patent No. 12,465,718) and Gill et al. (WIPO Pub. No. 2022/221644).
Regarding claim 12, Atkin teaches a method (Paragraph 0023, lines 1-3) for
transcutaneous auricular branch vagal nerve stimulation (Paragraph 0017, lines 1-3) to reduce inflammation (Paragraph 0036, lines 1-2) in a central nervous system (Paragraph 0006, lines 13-14) of a patient (Paragraph 0022, line 7), the method comprising: attaching a neuromodulation device (Paragraph 0043, lines 1-2) to an ear (Paragraph 0022, line 6) of the patient, the attaching the neuromodulation device including: attaching a first electrode (Paragraph 0015, line 2) of the neuromodulation device to a first location in a concha (Paragraph 0040, lines 4-5) of a ear; and attaching a second electrode (Paragraph 0015, line 3) of the neuromodulation device to the ear; and stimulating a cutaneous distribution (Paragraph 0037, lines 8-11) of a patient's vagus nerve (Paragraph 0014, line 3) within the patient's ear with a nerve stimulating signal (Paragraph 0043, lines 1-5) via the first electrode and the second electrode.
Atkin does not teach that the method includes attaching the neuromodulation
device to an ear of a patient who has experienced an acute brain injury, where the acute brain injury is associated with a secondary inflammatory brain injury. Furthermore, Atkin does not teach that the neurostimulation signal is used to mitigate neurological deterioration in the patient by modulation inflammatory signaling associated with the secondary inflammatory brain injury following the acute brain injury.
Gill, however, teaches a method for transcutaneously delivering stimulation to an
auricular branch of a vagal nerve (Paragraph 007, lines 3-4) by using a neuromodulation device (Paragraph 008, lines 1-2) that is attached to an ear of a patient (Fig. 7A-7B, Paragraph 00103, lines 4-5). Gill teaches that this device can be used on a patient who has experienced an acute brain injury (Paragraph 007, lines 5-9), where the acute brain injury is associated with a secondary inflammatory brain injury (Paragraph 00212, lines 2-4). Furthermore, Gill teaches that this device provides a neurostimulation signal (Paragraph 008, lines 24-25) that is used to mitigate neurological deterioration in the patient (Paragraph 00212, lines 4-8 and Paragraph 00223, lines 4-6) by modulation inflammatory signaling associated with the secondary inflammatory brain injury following the acute brain injury (Paragraph 0065, lines 2-11).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Atkin to incorporate the teachings of Gill to include that the method includes attaching the neuromodulation device to a patient who has experienced an acute brain injury, where the acute brain injury is associated with a secondary inflammatory brain injury in order to mitigate neurological deterioration in the patient by modulation inflammatory signaling. Doing so would allow clinicians to follow patient progression and change stimulation dosing or treatment paradigms (Paragraph 00223), as recognized by Gill.
Atkin also does not teach that the second electrode is attached to a second location in the concha of the patient’s ear. Wetmore, however, teaches a non-invasive auricular stimulation apparatus that includes multiple electrodes (Fig. 9, Col. 14, lines 58-59) being attached to multiple locations in a concha of the patient's ear (Fig. 9, Col. 14, lines 51-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Atkin to incorporate the teachings of Wetmore to include that the second electrode attaches to a second location in the concha of the patient’s ear. Doing so would allow for current steering of said system in order to shape the electric field produced by the external ear (Col. 15), as recognized by Wetmore.
Regarding claim 13, Atkin teaches the method (Paragraph 0023, lines 1-3) of
claim 12 that includes attaching of the neuromodulation device (Paragraph 0043, lines 1-2) to the ear of the patient (Paragraph 0022, lines 6-7). Atkin does not teach that the method includes attaching the neuromodulation device to a left ear of the patient. Wetmore, however, teaches a non-invasive auricular stimulation method that can be used on a patient's left ear (Col. 2, lines 35-37).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Atkin to incorporate the teachings of
Wetmore to specify that the method is used on a patient's left ear. Doing so would
provide better and safer electrical stimulation of the vagus nerve (Col. 1), as recognized by Wetmore.
Regarding claim 14, Atkin in view of Wetmore and Gill discloses the claimed
invention in claim 12. Atkin further discloses the method (Paragraph 0023, lines 1-3) of claim 12, wherein the nerve stimulating signal (Paragraph 0043, lines 1-5) is electrical stimulation (Paragraph 0014, lines 2-3) of the vagus nerve (Paragraph 0014, line 3).
Regarding claim 15, Atkin teaches the method (Paragraph 0023, lines 1-3) of claim 12, wherein the nerve stimulating signal (Paragraph 0043, lines 1-5) provides stimulation of the vagus nerve (Paragraph 0014, line 3). Atkin does not teach a nerve stimulating signal that is vibrotactile stimulation. Wetmore, however, teaches a non-invasive auricular stimulation method that uses vibrotactile stimulation (Col. 18, lines 41-42) to stimulate the vagus nerve (Col. 32, lines 17-18).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Atkin to incorporate the teachings of
Wetmore to include vibrotactile stimulation as a means for providing stimulation to the
vagus nerve. Doing so would provide a vibration means for electrical stimulation of the
auricular branch of the vagus nerve in order to allow what is best for each patient (Col. 18), as recognized by Wetmore.
Regarding claim 16, Atkin in view of Wetmore and Gill discloses the claimed invention of claim 12. Atkin further discloses the method (Paragraph 0023, lines 1-3) of claim 12, wherein the nerve stimulating signal (Paragraph 0043, lines 1-5) is provided to an auricular branch of the vagus nerve (Paragraph 0017, lines 1-3).
Regarding claim 17, Atkin teaches the method (Paragraph 0023, lines 1-3) of claim 12 that provides the nerve stimulating signal (Paragraph 0043, lines 1-5). Atkin does not teach that the nerve stimulating signal is provided for twenty minutes. Wetmore, however, teaches a non-invasive auricular stimulation method where the stimulation can last any time between 0.2 minutes and 30 minutes (Col. 3, lines 26-29).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Atkin to incorporate the teachings of
Wetmore to specify that the nerve stimulating signal is provided for twenty minutes.
Doing so would ensure that the time the stimulation occurs is a safe and effective value
for the patient (Col. 3), as recognized by Wetmore.
Regarding claim 20, Atkin teaches the method (Paragraph 0023, lines 1-3) of claim 12. Atkin does not teach that the acute brain injury includes at least one of an ischemic stroke, a cerebral hemorrhage, or a traumatic brain injury. Gill, however, teaches a method for transcutaneously delivering stimulation by using a neuromodulation device (Paragraph 008, lines 1-2) on a patient (Fig. 7A-7B, Paragraph 00103, lines 4-5) who has experienced an acute brain injury (Paragraph 007, lines 5-9). Furthermore, Gill teaches that the acute brain injury includes at least one of an ischemic stroke (Paragraph 007, line 6), a cerebral hemorrhage (Paragraph 007, line 7), or a traumatic brain injury (Paragraph 007, line 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Atkin to incorporate the teachings of Gill to specify that the acute brain injury includes at least one of an ischemic stroke, a cerebral hemorrhage, or a traumatic brain injury. Doing so would allow clinicians to follow patient progression and change stimulation dosing or treatment paradigms (Paragraph 00223) for patients with a variety of acute brain injuries, as recognized by Gill.
Regarding claim 21, Atkin teaches the method (Paragraph 0023, lines 1-3) of claim 12. Atkin does not teach that the secondary inflammatory brain injury includes at least one of a cerebral edema or a cerebral ischemia. Gill, however, teaches a method for transcutaneously delivering stimulation by using a neuromodulation device (Paragraph 008, lines 1-2) on a patient (Fig. 7A-7B, Paragraph 00103, lines 4-5) who has experienced an acute brain injury (Paragraph 007, lines 5-9), where the acute brain injury is associated with a secondary inflammatory brain injury (Paragraph 00212, lines 2-4). Furthermore, Gill teaches that the secondary inflammatory brain injury includes at least one of a cerebral edema (Paragraph 00212, line 2) or a cerebral ischemia (Paragraph 00212, line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Atkin to incorporate the teachings of Gill to specify that the secondary inflammatory brain injury includes at least one of a cerebral edema or a cerebral ischemia. Doing so would allow clinicians to follow patient progression and change stimulation dosing or treatment paradigms (Paragraph 00223) for patients with a variety of secondary inflammatory brain injuries, as recognized by Gill.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Atkin et al. (U.S. PGPub No. 2022/0370786) in view of Wetmore et al. (U.S. Patent No. 12,465,718) and Gill et al. (WIPO Pub. No. 2022/221644) as applied to claim 12 above, and further in view of John et al. (U.S. PGPub No. 2025/0281742.
Regarding claim 18, Atkin teaches the method (Paragraph 0023, lines 1-3) of
claim 12 that utilizes the neuromodulation device (Paragraph 0043, lines 1-2). Atkin does not teach that the neuromodulation device is disposable upon conclusion of the nerve stimulating signal. Atkin teaches that the neuromodulation device comprises a first and second electrode. John teaches a stimulation device that comprises disposable electrodes (Paragraph 0054, lines 14-16) that are discarded once stimulation is completed (Paragraph 0216, lines 15-16).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Atkin to incorporate the teachings of John to specify that the neuromodulation device is disposable upon conclusion of the nerve stimulating signal. Doing so would provide improved sanitary conditions and
efficacy for the electrodes (Paragraph 0239), as recognized by John.
Allowable Subject Matter
Claims 3-8 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.
Claim 3 would be allowable for disclosing the system of claim 1, wherein the
flexible substrate includes: a first adhesive patch to secure the system to the patient's ear, the first adhesive patch to be adhered to a first side of the patient's ear; and a second adhesive patch to secure the system to the patient's ear to be adhered to a second side of the patient's ear. Atkin, Wetmore, Cartledge, Gill, and John do not disclose a flexible substrate that includes a first adhesive patch and a second adhesive patch.
Claims 4-8 would be allowable because they depend on claim 3.
Claim 19 is allowed.
Claim 19 is allowable for disclosing a disposable device for transcutaneous
auricular branch vagal nerve stimulation to reduce inflammation in a central nervous system of a patient, the device comprising: an electrical stimulation device including: two electrodes; a battery; and an adhesive configured to attach the device to an ear of the patient, the adhesive configured to be placed behind a helix of the patient's ear, wherein the electrical stimulation device is configured to provide an electrical current to a patient's vagus nerve with an electrical signal for twenty minutes, wherein the electrical signal is configured to stimulate a cutaneous distribution of a vagus nerve of the patient within the ear with a nerve stimulating signal. Atkin, Wetmore, Cartledge, Gill, and John do not disclose an adhesive configured to attach the device to an ear of the patient, where the adhesive is configured to be placed behind a helix of the patient’s ear.
Conclusion
Applicant's amendment necessitated the new grounds 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.
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796