DETAILED ACTION
This Office Action is in response to Applicant’s Amendment filed on 09/02/2026.
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 .
Claim Objection
Following claims are objected to because of the following informalities:
Each of claims 1 and Claim 11 line 1 “A sensing and stimulation device arranged on an ear of a subject for autonomic nervous system balance” needs to be corrected. A suggested correction is – A sensing and stimulation device arranged on an ear of a subject for achieving autonomic nervous system balance –.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 in lines 6-11 recites “wherein the control module is configured to drive the coil structure for an eddy current induction measurement to an ear measurement area… at least one measurement result of the eddy current induction measurement” which renders this claim unclear. More specifically, it is unclear as to how just driving the coil structure to an ear measurement area for an eddy current induction measurement by itself can generate the required signal representing at least one measurement result of the eddy current induction measurement . Additionally, claim 1 would also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: that the control module includes: a signal generation unit coupled to the coil structure for generating and providing to the coil structure an alternating current signal to generate a first electromagnetic signal which elicits a second corresponding second electromagnetic signal from the conductive portions that mutually influences the first electromagnetic signal based on which the coil structure generates the sensing signal as evidenced in [0048] which explicitly states (“generate an eddy current induced by the first electromagnetic signal MS1, and generate a corresponding second electromagnetic signal MS2. The coil structure 11 would generate a sensing signal SS due to the mutual influence of the first electromagnetic signal MS1 and the second electromagnetic signal MS2”). Examiner suggests including the necessary implementation features and subject-matter of instant application specification as-filed [0048] (“generate an eddy current induced by the first electromagnetic signal MS1, and generate a corresponding second electromagnetic signal MS2. The coil structure 11 would generate a sensing signal SS due to the mutual influence of the first electromagnetic signal MS1 and the second electromagnetic signal MS2”) and claim 9 to cure the notes issues. A suggested amendment is --wherein the control module includes: a signal generation unit coupled to the coil structure for generating and providing to the coil structure an alternating current signal to generate a first electromagnetic signal which elicits a second corresponding second electromagnetic signal from the conductive portions that mutually influences the first electromagnetic signal based on which the coil structure generates the sensing signal --.
Claim 1 in lines 10-12 recites “wherein the control module controls at least one parameter of the electromagnetic stimulation based on at least one measurement result of the eddy current induction measurement, the at least one measurement result including a heart rate signal of the subject” which renders this claim unclear. More specifically, it is unclear as how, in what manner or what parameters are used to derive a heart rate signal of the subject from the at least one measurement result. Dependent claims 2-5, 7-10 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-5, 7-10 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims. Examiner suggests amending claim 1 to include claim 6 limitations.
Claim 11 in lines 5-18 recites “wherein the sensing controller is configured to drive the sensing coil for an eddy current induction measurement to an ear measurement area… at least one measurement result of the eddy current induction measurement” which renders this claim unclear. More specifically, it is unclear as to how just driving the sensing coil to an ear measurement area for an eddy current induction measurement by itself can generate the required signal representing at least one measurement result of the eddy current induction measurement. Additionally, claim 1 would also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: that the control module includes: the sensing controller includes: a signal generation unit coupled to the sensing coil for generating and providing to the sensing coil an alternating current signal to generate a first electromagnetic signal which elicits a second corresponding second electromagnetic signal from the conductive portions that mutually influences the first electromagnetic signal based on which the sensing coil generates a sensing signal as evidenced in [0048] which explicitly states (“generate an eddy current induced by the first electromagnetic signal MS1, and generate a corresponding second electromagnetic signal MS2. The coil structure 11 would generate a sensing signal SS due to the mutual influence of the first electromagnetic signal MS1 and the second electromagnetic signal MS2”). Examiner suggests including the necessary implementation features and subject-matter of instant application specification as-filed [0048] (“generate an eddy current induced by the first electromagnetic signal MS1, and generate a corresponding second electromagnetic signal MS2. The coil structure 11 would generate a sensing signal SS due to the mutual influence of the first electromagnetic signal MS1 and the second electromagnetic signal MS2”) and claim 18 to cure the notes issues. A suggested amendment is --a signal generation unit coupled to the sensing coil for generating and providing to the sensing coil an alternating current signal to generate a first electromagnetic signal which elicits a second corresponding second electromagnetic signal from the conductive portions that mutually influences the first electromagnetic signal based on which the sensing coil generates a sensing signal--.
Claim 11 in lines 17-19 recites “wherein the stimulation controller controls at least one parameter of the electromagnetic stimulation based on at least one measurement result of the eddy current induction measurement, the at least one measurement result including a heart rate signal of the subject” which renders this claim unclear. More specifically, it is unclear as how, in what manner or what parameters are used to derive a heart rate signal of the subject from the at least one measurement result. Dependent claims 12-14, 16-19 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 12-14, 16-19 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims. Examiner suggests amending claim 11 to include claim 15 limitations.
Dependent claims 2-10 and 12-19 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-10 and 12-19 and 14-16 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Contingently Allowable Subject-Matter
As per independent claims 1 and 11, independent claims 1 and 11 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 2-10 and 12-19, dependent claims 2-10 and 12-19 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and by further including all of the limitations of the base claims and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 2-10 and 12-19, dependent claims 2-10 and 12-19 each is being 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 in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per independent Claim 1, the prior art of record fails to disclose or render obvious eat worn sensing and stimulation device arranged on an ear of a subject, comprising… setting structure combined with the coil structure… configured to position the coil structure on the ear; and a control module coupled to the coil structure…wherein the control module controls at least one parameter of the electromagnetic stimulation based on at least one measurement result of the eddy current induction measurement including all the other features, structures, specific arrangement and combination of features and structures in independent Claim 1.
As per independent Claim 11, the prior art of record fails to disclose or render obvious a sensing and stimulation device arranged on an ear of a subject, comprising: a sensing module including… a sensing controller coupled to the sensing coil, wherein the sensing controller is configured to drive the sensing coil for an eddy current induction measurement … a stimulation module including…and a stimulation controller coupled to the stimulation coil, wherein the stimulation controller is configured to drive the stimulation coil for an electromagnetic stimulation to an ear stimulation area… wherein the stimulation controller controls at least one parameter of the electromagnetic stimulation based on at least one measurement result of the eddy current induction measurement including all the other features, structures, specific arrangement and combination of features and structures in independent Claim 11.
Prior art US 20210379374 A1 to Hamner et al. discloses systems and methods of treating migraine, cephalgia, headache, and other headache conditions through noninvasive peripheral nerve stimulation. More specifically, Hamner discloses a system for treating migraine in a patient that include, or consist essentially of a peripheral nerve stimulator including a pulse generator and at least two electrodes configured to deliver electrical neuromodulation, e.g., stimulation to a nerve, acupressure point, or meridian in the patient's limb or ear. In some embodiments, the stimulation is not delivered to the patient's head, but rather on the patient's ear, lower extremity, or upper extremity. The upper extremity neuromodulation, e.g., stimulation could be in some embodiments on the upper arm, spanning the upper arm and lower arm, or only below the elbow (e.g., only on one or more of the forearm, wrist, and/or finger(s)), and the stimulation devices can be configured accordingly. The neuromodulation, e.g., stimulation can be sufficient in some embodiments to reduce one or more of throbbing cranial pain, sensory sensitivity to light, sound, and smell, nausea, and dysfunction of autonomic, cognitive, emotional, and motor systems. In some embodiments, the neuromodulation, e.g., stimulation could be therapeutic (e.g., after the start of symptoms), and/or prophylactic/preventative (e.g., when the patient is not currently experiencing any symptoms). The system can also include one, two, or more sensors. The stimulator and/or the sensor could be implantable within a patient, or wearable without any implantable components. The stimulator and/or the sensor(s) could be percutaneous or transcutaneous in some embodiments.
Prior art WO 2011011748 A1 to Burnett et al. discloses system with a conductive coil within or along housing to generate magnetic field focused on target nerve near to the coil. A sensor attachable to skin surface near to target nerve or muscle for detecting electrical conduction on nerve or muscle stimulation, where sensor is one of titanium, silver, silicon, biocompatible polymers or suture material. A controller couples with the coil and sensor facilitating coil to generate magnetic field focused on target nerve while sensor attached to skin surface to sense it.
Prior art US 20190009087 A1 to Cakmak et al. discloses stimulation device where the supplementary motor area, premotor area, cerebellum and/or subthalamic nucleus are stimulated. More specifically, stimulation system that includes an electro-stimulation device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated extra-cranially. The stimulation device includes at least one electrode, said at least one electrode being provided with a stimulation end configured to be directly attached to intrinsic auricular muscles of a human so as to establish a direct contact relation therewith, said stimulation end being operatively coupled with a sensor.
Non-patent literature prior art Magnetic nerve stimulation by Harry A. C. Eaton discloses non-invasive magnetic nerve stimulation based on magnetic stimulators ability to generate eddy currents in tissue by producing a high-amplitude, short-duration magnetic pulse from a small coil located near the tissue.
However, patentable subject-matter as now explicitly, positively and specifically recited by the Applicants in independent device claims 1 and 11 has neither been disclosed nor is rendered obvious by the prior art of record.
Additionally, as per dependent claims 2-10 and 12-19, dependent claims 2-10 and 12-19 would be contingently allowable based on their direct/indirect dependency on contingently allowable respective base claims.
Response to Amendment
According to the Amendment, filed 09/02/2026, the status of the claims is as follows:
Claims 1, 6-7, 11, 15-16 are currently amended; and
Claims 2-5, 8-10, 12-14, 17-19 are as originally filed;
The Specification/Drawings has been amended in view of the Amendment, filed 09/02/2026. No new matter was introduced.
By the current amendment, as a result, claims 1-19 are now pending in this application and are being examined on the merits.
Response to Arguments
Issues Raised and Arguments/Remarks to Rejections/Objections Not Based On Prior Art presented on Page 9-14 of Applicant’s Amendment dated 09/02/2026
[A]: The Examiner agrees with the Applicant, and in light of the amendments/arguments, withdraws the following non prior art related objections/rejections raised in Office Action dated 07/01/2026: [A1] The objection to Specification/Drawings is withdrawn in view of the amendment and arguments, filed 09/02/2026; [A2] The objection to claims is withdrawn in view of the amendment and arguments, filed 09/02/2026; [A3] The 35 U.S.C. 112(a), rejections to claims as raised in Office Action dated 07/01/2026; [A4] The 35 U.S.C. 112(b), rejections to claims as raised in Office Action dated 07/01/2026 paras. [11-12], [15-16] are withdrawn in view of the amendment, filed 09/07/2018.
[B]: The Examiner disagrees with the Applicant, and in light of the amendments/arguments, maintains the following non prior art related objections/rejections raised in Office Action dated 07/01/2026: [B1] The 35 U.S.C. 112(b), rejections to claims as raised in Office Action dated 07/01/2026 paras. [13-14] are withdrawn in view of the amendment, filed 09/07/2018. Please see detailed rejections enumerating the issue above.
Issues Raised and Arguments/Remarks to Rejections/Objections Not Based On Prior Art presented on Page 13 of Applicant’s Amendment dated 09/02/2026
[A] The Examiner has indicated that claims 1-19 would be allowable if rewritten to overcome the rejections under 35 U.S.C. §§ 112(a) and 112 (b). Applicant greatly appreciates the indication of allowable subject matter by the Examiner.
[B]As mentioned, since it is believed that the rejections under 35 U.S.C. §§ 112(a) and 112 (b) have been overcome, it is believed that claims 1-19 are now in condition for allowance.
Applicant’s arguments [A-B] above with respect amended independent claim 1 and claim 11 have been considered but as now explicitly, positively and specifically amended by the Applicants, amended claim 1 and claim 11 each raise additionally issues which are detailed above.
As per independent claims 1-19, independent claims 1-19 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action in addition to overcoming any other rejections/objections enumerated above. Additionally, as per dependent claims 2-10 and 12-19, dependent claims 2-10 and 12-19 each is being 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 in addition to overcoming any other rejections/objections enumerated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20200398068 A1 to Agnihotri et al. discloses providing stimulation by generating a stimulatory electromagnetic field to selectively activate neurons similar to that disclosed. More specifically, Agnihotri discloses apparatus including a controller that receives the input signals from the input, performs analysis of the input signals and, uses results of the analysis to cause the signal generator to generate stimulation signals, the stimulation signals being applied to the coil system to thereby generate a stimulatory electromagnetic field in a target region of the subject, the stimulatory electromagnetic field being configured to selectively activate neurons to thereby stimulate the subject in accordance with the stimulatory input.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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