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 .
Claim Status: Claims 1-3, 5, 6, 10-17, and 21-27 are pending.
Response to Arguments
Applicant's arguments filed on February 2, 2026 have been fully considered but they are not persuasive.
1) Applicant argued that Honeycutt does not disclose a single wearable housing comprising each of a light source for directing a light output towards the outer ear of the user, a biometric sensor for obtaining biometric data, and at least one processor for controlling emission of the light output based on the biometric data.
This argument has been considered but is not persuasive.
In the previous rejection, Examiner relied on Jovanov to teach that stimulation device and a biometric sensor can be disposed within a single housing (fig. 3, fig. 5A-5C).
2) Applicant argued that Honeycutt fails to disclose a light source configured to direct the light output substantially perpendicular to a region of the outer ear that is innervated by a branch of a vagus nerve of the user. Applicant stated that no portion of Honeycutt mentions the angle at which the energy stimulation contacts each target area, let alone that a light output is directed substantially perpendicular to the intended region.
This argument has been considered but is not persuasive.
Honeycutt discloses in fig. 2B and fig. 2C Vagus nerve targets and discloses in fig. 3A, 3B, and 4A the locations of optical emitters 102, 103 in the wearable that target the Vagus nerve targets (fig. 2C, ref# 93 Dorsolateral Auricular Branch Vagus Nerve Target V4; fig. 3A, 3B; para. [0124], FIG. 3B illustrates an embodiment incorporating an ear loop 101 integrating one or more electrical energy coupling emitters 102 and 103 designed to contact the dorsal side nerve targets 90 through 93 as depicted in FIG. 2C; para. [0124], said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment of said ear loop with said slip ring swivel assembly supporting three said support arms with different shaped energy coupling emitters. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88).
3) Applicant argued that Honeycutt does not disclose “auto-shut-off” feature but only optimizing the effectiveness of the energy stimulation by lowering the energy levels if the biofeedback demonstrates over stimulation. Applicant argued that Honeycutt does not describe fully stopping the light emission upon receiving biometric data that indicates an abnormal response to the light output.
This argument has been considered but is not persuasive.
Para. [0024] discloses “This law describes an empirical relationship between arousal (in the present case, electrical stimulation) and performance (the bodily response to or effects of stimulation) that dictates that performance (stimulation effects) increases with physiological or mental arousal (electrical stimulation), but only up to a point, beyond which more arousal (or stimulation) causes lower performance (stimulation effects). The empirical relationship described by Yerkes-Dodson law is often illustrated graphically as a bell-shaped performance curve which increases and then decreases with higher levels of arousal, in this case stimulation. High stimulation current levels may over-arouse both target nerves and the nervous system itself thereby defeating the purpose of stimulation therapy.”
Para. [0016] discloses “an intelligent, stimulus-response based energy stimulation therapy system that delivers energy stimulation to the nerve targets of a user, collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user ‘Iometrics’ or user generated data.”
para. [0030] discloses “methods to collect, track and measure user responses to stimulation through rapid symptom sampling scales and biofeedback measures; methods to access a common, internet cloud server database for storage and aggregation of user stimulation parameters, user symptom scale responses and user responses as biofeedback; methods to automate the electronic communication of user stimulation parameters and user response data to remote healthcare providers; methods enabling health care professionals to alter user stimulation setting remotely and to obtain informed consent; and algorithmic methods for adjusting and updating user stimulation parameters in accordance with emerging research findings and local user-coupler factors such as nerve field receptivity, electrode contact site conductivity, electrode position optimization, and electrode combination optimization.”
para. [0023] discloses that “in the present disclosure, both electric and electromagnetic or light energy emitters are referred to as “electrodes,” “energy emitters,” “emitters” and the like.”
Para. [0024] states that stimulation results in arousal which increases performance up to a point and then additional stimulation results in over-arousal which causes lower performance. The paragraph states that over-arousal rather decreases the performance, which means an optimal period of stimulation is up to the point where the performance reaches its peak. Any stimulation after that would be ineffective and defeats the purpose of stimulation therapy.
Based on the automated process described in para. [0016], [0030], the adjustment of stimulation protocols for maximal effectiveness is to stop the stimulation such that there is no over-arousal that drops the performance.
Therefore, the disclosure reads on the limitation “responsive to the abnormal user response, transmit a second control signal to the light source to stop emission of the light output”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16, 17, and 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Honeycutt et al. (US 2020/0338348).
Re Claim 16, Honeycutt discloses a method performed by at least one processor in communication with a light source and a biometric sensor, the method comprising:
transmitting, to the light source, a first control signal configured to initiate emission of a light output that is directed substantially perpendicular to a region at or near an outer ear of a user, the region innervated by a branch of a vagus nerve of the user (para. [0016], an intelligent, stimulus-response based energy stimulation therapy system that delivers energy stimulation to the nerve targets of a user; para. [0123], FIG. 3A illustrates an electrical energy type with at least one emitter 104 supported by an ear loop 100 assembly fitted over and within the fold of the ear and skull, termed herein as crotch; fig. 2C, ref# 93 Dorsolateral Auricular Branch Vagus Nerve Target V4; fig. 3A, 3B, para. [0124], FIG. 3B illustrates an embodiment incorporating an ear loop 101 integrating one or more electrical energy coupling emitters 102 and 103 designed to contact the dorsal side nerve targets 90 through 93 as depicted in FIG. 2C. Said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment of said ear loop with said slip ring swivel assembly supporting three said support arms with different shaped energy coupling emitters. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88);
receiving, from the biometric sensor, biometric data of the user while the light output is directed towards the region (para. [0016], collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data; para. [0134], biofeedback sensors; para. [0030], methods to collect, track and measure user responses to stimulation through rapid symptom sampling scales and biofeedback measures; methods to access a common, internet cloud server database for storage and aggregation of user stimulation parameters, user symptom scale responses and user responses as biofeedback; methods to automate the electronic communication of user stimulation parameters and user response data to remote healthcare providers; methods enabling health care professionals to alter user stimulation setting remotely and to obtain informed consent; and algorithmic methods for adjusting and updating user stimulation parameters in accordance with emerging research findings and local user-coupler factors such as nerve field receptivity, electrode contact site conductivity, electrode position optimization, and electrode combination optimization; claim 19, a group of biofeedback sensors that includes a heart rate sensor, a Heart Rate Variability (HRV) sensor, a blood pressure sensor, an oxygen saturation sensor, a breathing sensor, a sensor for detecting peripheral vasodilation and vasoconstriction, sensors for detecting autonomic nervous system activity, sensors for detecting brainwaves and the like);
determining an abnormal user response based on the received biometric data (para. [0024], This law describes an empirical relationship between arousal (in the present case, electrical stimulation) and performance (the bodily response to or effects of stimulation) that dictates that performance (stimulation effects) increases with physiological or mental arousal (electrical stimulation), but only up to a point, beyond which more arousal (or stimulation) causes lower performance (stimulation effects). The empirical relationship described by Yerkes-Dodson law is often illustrated graphically as a bell-shaped performance curve which increases and then decreases with higher levels of arousal, in this case stimulation. High stimulation current levels may over-arouse both target nerves and the nervous system itself thereby defeating the purpose of stimulation therapy – over-arousal reads on abnormal user response); and
responsive to the abnormal user response, transmitting, to the light source, a second control signal configured to stop emission of the light output (para. [0016], collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data; para. [0024], This law describes an empirical relationship between arousal (in the present case, electrical stimulation) and performance (the bodily response to or effects of stimulation) that dictates that performance (stimulation effects) increases with physiological or mental arousal (electrical stimulation), but only up to a point, beyond which more arousal (or stimulation) causes lower performance (stimulation effects). The empirical relationship described by Yerkes-Dodson law is often illustrated graphically as a bell-shaped performance curve which increases and then decreases with higher levels of arousal, in this case stimulation. High stimulation current levels may over-arouse both target nerves and the nervous system itself thereby defeating the purpose of stimulation therapy; para. [0030], methods to collect, track and measure user responses to stimulation through rapid symptom sampling scales and biofeedback measures; methods to access a common, internet cloud server database for storage and aggregation of user stimulation parameters, user symptom scale responses and user responses as biofeedback; methods to automate the electronic communication of user stimulation parameters and user response data to remote healthcare providers; methods enabling health care professionals to alter user stimulation setting remotely and to obtain informed consent; and algorithmic methods for adjusting and updating user stimulation parameters in accordance with emerging research findings and local user-coupler factors such as nerve field receptivity, electrode contact site conductivity, electrode position optimization, and electrode combination optimization).
Re Claim 17, Honeycutt discloses that the biometric data includes information associated with an electrical activity of a heart of the user (claim 19, a heart rate sensor, a heart rate variability (HRV) sensor).
Re Claim 25, Honeycutt discloses that the region includes a concha area of the outer ear (fig. 3A, 3B; para. [0124], said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment of said ear loop with said slip ring swivel assembly supporting three said support arms with different shaped energy coupling emitters. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88).
Re Claim 26, Honeycutt discloses that the region includes a scalp area near a back of the outer ear (fig. 2C, ref# 93 Dorsolateral Auricular Branch Vagus Nerve Target V4; para. [0124], FIG. 3B illustrates an embodiment incorporating an ear loop 101 integrating one or more electrical energy coupling emitters 102 and 103 designed to contact the dorsal side nerve targets 90 through 93 as depicted in FIG. 2C).
Re Claim 27, Honeycutt discloses that the light source is configured to emit light at a wavelength selected from a range of about 420 nanometers to about 470 nanometers, or from a range of about 500 nanometers to about 565 nanometers (para. [0016], [0117], research also has found electromagnetic energy provides optimal parasympathetic nervous system response in the range of wavelengths from 400 to 1600 nanometers with a fluence power density from 0.5 to 35 joules per square centimeter.).
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.
Claims 1-3, 5, 6, 10-15, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al. (US 2020/0338348) in view of Jovanov (US 10688274).
Re Claim 1, Honeycutt discloses a wearable device, comprising:
a housing configured for coupling to an outer ear of a user (para. [0123], FIG. 3A illustrates an electrical energy type with at least one emitter 104 supported by an ear loop 100 assembly fitted over and within the fold of the ear and skull, termed herein as crotch; fig. 2C, ref# 93 Dorsolateral Auricular Branch Vagus Nerve Target V4; fig. 3A, 3B, para. [0124], said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment of said ear loop with said slip ring swivel assembly supporting three said support arms with different shaped energy coupling emitters. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88);
a light source disposed in the housing and configured to direct a light output substantially perpendicular to a region of the outer ear that is innervated by a branch of a vagus nerve of the user (fig. 2C, ref# 93 Dorsolateral Auricular Branch Vagus Nerve Target V4; fig. 3A, 3B; para. [0124], FIG. 3B illustrates an embodiment incorporating an ear loop 101 integrating one or more electrical energy coupling emitters 102 and 103 designed to contact the dorsal side nerve targets 90 through 93 as depicted in FIG. 2C. Said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment of said ear loop with said slip ring swivel assembly supporting three said support arms with different shaped energy coupling emitters. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88.; abstract, electromagnetic emitter modules configured with light emitting diodes deliver electromagnetic stimulation; para. [0023], two kinds of energy stimulation modules: the first having electrodes configured for traditional transcutaneous electrostimulation and the second having optical emitters configured for electromagnetic stimulation, a modality which takes advantage of the fact that light can be passed through the skin and its electromagnetic energy deposited in tissues including nerve fibers. In the present disclosure, both electric and electromagnetic or light energy emitters are referred to as “electrodes,” “energy emitters,” “emitters” and the like; para. [0032], Electromagnetic or photo-stimulation offers unique and clinically significant advantages over electrical stimulation. Light energy passes easily through human skin and may be absorbed by targeted tissues. Light energy in the infrared band can easily penetrate up to five millimeters of skin tissue to stimulate targeted nerves in the auricular nerve field with virtually no risk of the skin burns associated with electrical electrodes.); and
at least one processor disposed in the housing and communicatively coupled to the light source, the at least one processor configured to transmit, to the light source, a control signal for controlling emission of the light output by the light source (para. [0114], [0115], said stimulation unit 200 includes electronic circuitry and battery powered, microprocessor controlled. Stimulation signals including waveforms, frequency and amplitude are generated by said microprocessor and converted to analog output energy by means of amplifier electronics, fig. 1), and
a biometric sensor communicatively coupled to the at least one processor, wherein the biometric sensor is configured to: obtain biometric data of the user, and transmit the biometric data to the at least one processor (para. [0016], an intelligent, stimulus-response based energy stimulation therapy system that delivers energy stimulation to the nerve targets of a user, collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data.; para. [0134], FIG. 7 depicts a stimulator package assembly 140 to be worn by the user fastened to a lanyard 141. Said stimulator package assembly includes said stimulator unit which may be connected by a cable 109), wherein the at least one processor is further configured to:
transmit a first control signal to the light source to initiate emission of the light output towards the user (para. [0016], an intelligent, stimulus-response based energy stimulation therapy system that delivers energy stimulation to the nerve targets of a user);
receives biometric data from the biometric sensor during emission of the light output (para. [0016], collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data; para. [0134], biofeedback sensors; para. [0030], methods to collect, track and measure user responses to stimulation through rapid symptom sampling scales and biofeedback measures; methods to access a common, internet cloud server database for storage and aggregation of user stimulation parameters, user symptom scale responses and user responses as biofeedback; methods to automate the electronic communication of user stimulation parameters and user response data to remote healthcare providers; methods enabling health care professionals to alter user stimulation setting remotely and to obtain informed consent; and algorithmic methods for adjusting and updating user stimulation parameters in accordance with emerging research findings and local user-coupler factors such as nerve field receptivity, electrode contact site conductivity, electrode position optimization, and electrode combination optimization; claim 19, a group of biofeedback sensors that includes a heart rate sensor, a Heart Rate Variability (HRV) sensor, a blood pressure sensor, an oxygen saturation sensor, a breathing sensor, a sensor for detecting peripheral vasodilation and vasoconstriction, sensors for detecting autonomic nervous system activity, sensors for detecting brainwaves and the like); and
determine an abnormal user response based on the received biometric data (para. [0024], This law describes an empirical relationship between arousal (in the present case, electrical stimulation) and performance (the bodily response to or effects of stimulation) that dictates that performance (stimulation effects) increases with physiological or mental arousal (electrical stimulation), but only up to a point, beyond which more arousal (or stimulation) causes lower performance (stimulation effects). The empirical relationship described by Yerkes-Dodson law is often illustrated graphically as a bell-shaped performance curve which increases and then decreases with higher levels of arousal, in this case stimulation. High stimulation current levels may over-arouse both target nerves and the nervous system itself thereby defeating the purpose of stimulation therapy – over-arousal reads on abnormal user response), and
responsive to the abnormal user response, transmit a second control signal to the light source to stop emission of the light output (para. [0016], collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data; para. [0024], recent clinical research has shown that is nerve stimulation is more clinically efficacious at lower energy levels, which is consistent with Yerkes-Dodson law. This law describes an empirical relationship between arousal (in the present case, electrical stimulation) and performance (the bodily response to or effects of stimulation) that dictates that performance (stimulation effects) increases with physiological or mental arousal (electrical stimulation), but only up to a point, beyond which more arousal (or stimulation) causes lower performance (stimulation effects). The empirical relationship described by Yerkes-Dodson law is often illustrated graphically as a bell-shaped performance curve which increases and then decreases with higher levels of arousal, in this case stimulation. High stimulation current levels may over-arouse both target nerves and the nervous system itself thereby defeating the purpose of stimulation therapy; para. [0030], methods to collect, track and measure user responses to stimulation through rapid symptom sampling scales and biofeedback measures; methods to access a common, internet cloud server database for storage and aggregation of user stimulation parameters, user symptom scale responses and user responses as biofeedback; methods to automate the electronic communication of user stimulation parameters and user response data to remote healthcare providers; methods enabling health care professionals to alter user stimulation setting remotely and to obtain informed consent; and algorithmic methods for adjusting and updating user stimulation parameters in accordance with emerging research findings and local user-coupler factors such as nerve field receptivity, electrode contact site conductivity, electrode position optimization, and electrode combination optimization).
Honeycutt is silent regarding a biometric sensor disposed within the housing.
However, Jovanov discloses systems and methods for multi-modal and non-invasive stimulation of the nervous system (abstract) and discloses non-invasive stimulation of branches of the vagus nerve (col. 2). Jovanov teaches that a biometric sensor disposed within a housing configured for coupling to an outer ear of a user (abstract, Multiple sensor and stimulation devices and modalities can be combined into a single, compact unit that minimizes the need for additional sensors or stimulation devices. The system features several subunits, referred to as sensory and stimulation devices (SSD), that are integrated into a headphone setup. The system is controlled by a centralized controller that communicates with all of the SSDs and with an external computer system that delivers learning material synchronized with the delivery of stimulations and the collection of user responses based on physiological signals.; fig. 1, an embodiment of a multi-modal sensor and stimulation system, fig. 3, an embodiment of the user wearable device of the multi-modal sensor and stimulation system of FIG. 1; col. 5 – col. 6, As shown in FIGS. 5A-5C, the auricular SSD 116 can include a photoplethysmogram (PPG) sensor 132 (e.g., a pulse oximeter) to measure the PPG of the user. The PPG represents blood volume pulse and can be used to measure or assess: a) heart rate (HR); b) heart rate variability (HRV); c) breathing rate (BR); and d) vascular tone using blood volume pulse or pulse travel time (PIT) as a latency of the PPG peak from the R peak in an electrocardiogram (ECG). The PPG sensor 132 can be implemented on the front of the auricular SSD 116 to allow good contact with the lobule 131 (see FIG. 2) of the ear, which is a location that can be used for PPG sensing. The auricular SSD 116 can also include one or more electrical contacts (or electrodes) 134 for the monitoring of heart activity (e.g., an ECG), brain electrical activity (e.g., an electroencephalogram (EEG)), or galvanic skin response (GSR). The electrodes 134 can be located on one or both sides of the auricular SSD 116 to contact either a portion of the user's ear or a portion of the user's head (e.g., the temporal bone or the mastoid bone). An electrical contact (or electrode) 136 for the EEG reference can be located at the bottom of the auricular SSD 116 in contact with the mastoid bone or the lobule 131. A vibrator or speaker 138 can be used to apply stimulation using bone conduction. An accelerometer 140 can be used for detection of a balistocardiograph (BCG) representing motion caused by the mechanical movement of the heart. In one embodiment, the delay between the BCG and the PPG is a function of vascular tone/blood pressure and can be used to assess the arousal of the user.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Honeycutt, by configuring the biometric sensor to be disposed within the housing, as taught by Jovanov, for the purpose of providing a single, compact unit that minimizes the need for additional sensors or stimulation devices (abstract).
Re Claim 14, Honeycutt discloses a system, comprising:
a first housing configured for coupling to a first outer ear of a user (claim 6, at least one ear-worn loop coupler may be composed with anatomically differentiating structural features corresponding to the left ear of said at least one user), the first housing comprising a first light source configured to direct a first light output substantially perpendicular to a first region at or near the first outer ear, the first region innervated by a first branch of a vagus nerve of the user (fig. 2C, ref# 93 Dorsolateral Auricular Branch Vagus Nerve Target V4; fig. 3A, 3B; para. [0124], said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment incorporating an ear loop 101 integrating one or more electrical energy coupling emitters 102 and 103 designed to contact the dorsal side nerve targets 90 through 93 as depicted in FIG. 2C. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88.; abstract, electromagnetic emitter modules configured with light emitting diodes deliver electromagnetic stimulation; para. [0023], two kinds of energy stimulation modules: the first having electrodes configured for traditional transcutaneous electrostimulation and the second having optical emitters configured for electromagnetic stimulation, a modality which takes advantage of the fact that light can be passed through the skin and its electromagnetic energy deposited in tissues including nerve fibers. In the present disclosure, both electric and electromagnetic or light energy emitters are referred to as “electrodes,” “energy emitters,” “emitters” and the like; para. [0032], Electromagnetic or photo-stimulation offers unique and clinically significant advantages over electrical stimulation. Light energy passes easily through human skin and may be absorbed by targeted tissues. Light energy in the infrared band can easily penetrate up to five millimeters of skin tissue to stimulate targeted nerves in the auricular nerve field with virtually no risk of the skin burns associated with electrical electrodes.), and
a first biometric sensor configured to obtain first biometric data of the user (para. [0016], an intelligent, stimulus-response based energy stimulation therapy system that delivers energy stimulation to the nerve targets of a user, collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data.; para. [0134], FIG. 7 depicts a stimulator package assembly 140 to be worn by the user fastened to a lanyard 141. Said stimulator package assembly includes said stimulator unit which may be connected by a cable 109);
a second housing configured for coupling to a second outer ear of the user (claim 6, at least one ear-worn loop coupler may be composed with anatomically differentiating structural features corresponding to the right ear of said at least one user), the second housing comprising a second light source configured to direct a second light output substantially perpendicular to a second region at or near the second outer ear, the second region innervated by a second branch of the vagus nerve (fig. 2C, ref# 93 Dorsolateral Auricular Branch Vagus Nerve Target V4; fig. 3A, 3B; para. [0124], said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment incorporating an ear loop 101 integrating one or more electrical energy coupling emitters 102 and 103 designed to contact the dorsal side nerve targets 90 through 93 as depicted in FIG. 2C. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88.; abstract, electromagnetic emitter modules configured with light emitting diodes deliver electromagnetic stimulation; para. [0023], two kinds of energy stimulation modules: the first having electrodes configured for traditional transcutaneous electrostimulation and the second having optical emitters configured for electromagnetic stimulation, a modality which takes advantage of the fact that light can be passed through the skin and its electromagnetic energy deposited in tissues including nerve fibers. In the present disclosure, both electric and electromagnetic or light energy emitters are referred to as “electrodes,” “energy emitters,” “emitters” and the like; para. [0032], Electromagnetic or photo-stimulation offers unique and clinically significant advantages over electrical stimulation. Light energy passes easily through human skin and may be absorbed by targeted tissues. Light energy in the infrared band can easily penetrate up to five millimeters of skin tissue to stimulate targeted nerves in the auricular nerve field with virtually no risk of the skin burns associated with electrical electrodes.), and
a second biometric sensor configured to obtain second biometric data of the user (para. [0016], an intelligent, stimulus-response based energy stimulation therapy system that delivers energy stimulation to the nerve targets of a user, collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data.; para. [0134], FIG. 7 depicts a stimulator package assembly 140 to be worn by the user fastened to a lanyard 141. Said stimulator package assembly includes said stimulator unit which may be connected by a cable 109); and
one or more processor communicatively coupled to each of the first and second light sources and configured to control emission of the first and second light outputs from the first and second light sources, respectively (para. [0114], [0115], said stimulation unit 200 includes electronic circuitry and battery powered, microprocessor controlled. Stimulation signals including waveforms, frequency and amplitude are generated by said microprocessor and converted to analog output energy by means of amplifier electronics, fig. 1), and receive the first and second biometric data from the first and second biometric sensors, respectively (para. [0016], an intelligent, stimulus-response based energy stimulation therapy system that delivers energy stimulation to the nerve targets of a user, collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data.; para. [0134], FIG. 7 depicts a stimulator package assembly 140 to be worn by the user fastened to a lanyard 141. Said stimulator package assembly includes said stimulator unit which may be connected by a cable 109),
wherein the one or more processors are further configured to:
transmit a first control signal to each of the first and second light sources to initiate emission of the first and second light output towards the user (para. [0016], an intelligent, stimulus-response based energy stimulation therapy system that delivers energy stimulation to the nerve targets of a user);
receives the first and second biometric data from the first and second biometric sensor, respectively, during emission of the first and second light outputs (para. [0016], collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data; para. [0134], biofeedback sensors; para. [0030], methods to collect, track and measure user responses to stimulation through rapid symptom sampling scales and biofeedback measures; methods to access a common, internet cloud server database for storage and aggregation of user stimulation parameters, user symptom scale responses and user responses as biofeedback; methods to automate the electronic communication of user stimulation parameters and user response data to remote healthcare providers; methods enabling health care professionals to alter user stimulation setting remotely and to obtain informed consent; and algorithmic methods for adjusting and updating user stimulation parameters in accordance with emerging research findings and local user-coupler factors such as nerve field receptivity, electrode contact site conductivity, electrode position optimization, and electrode combination optimization; claim 19, a group of biofeedback sensors that includes a heart rate sensor, a Heart Rate Variability (HRV) sensor, a blood pressure sensor, an oxygen saturation sensor, a breathing sensor, a sensor for detecting peripheral vasodilation and vasoconstriction, sensors for detecting autonomic nervous system activity, sensors for detecting brainwaves and the like); and
determine an abnormal user response based on the biometric data received during emission of the first and second light outputs (para. [0024], This law describes an empirical relationship between arousal (in the present case, electrical stimulation) and performance (the bodily response to or effects of stimulation) that dictates that performance (stimulation effects) increases with physiological or mental arousal (electrical stimulation), but only up to a point, beyond which more arousal (or stimulation) causes lower performance (stimulation effects). The empirical relationship described by Yerkes-Dodson law is often illustrated graphically as a bell-shaped performance curve which increases and then decreases with higher levels of arousal, in this case stimulation. High stimulation current levels may over-arouse both target nerves and the nervous system itself thereby defeating the purpose of stimulation therapy – over-arousal reads on abnormal user response), and
responsive to the abnormal user response, transmit a second control signal to each of the first and second light sources to stop emission of the first and second light outputs, respctively (para. [0016], collects user response feedback as subjective self-assessment responses to empirically developed symptom-sampling scales and as biofeedback obtained from user-worn sensors, wherein energy stimulation parameters and protocols may be adjusted and calibrated for maximal effectiveness by a remote therapist or an algorithm according to said user “Iometrics” or user generated data; para. [0024], recent clinical research has shown that is nerve stimulation is more clinically efficacious at lower energy levels, which is consistent with Yerkes-Dodson law. This law describes an empirical relationship between arousal (in the present case, electrical stimulation) and performance (the bodily response to or effects of stimulation) that dictates that performance (stimulation effects) increases with physiological or mental arousal (electrical stimulation), but only up to a point, beyond which more arousal (or stimulation) causes lower performance (stimulation effects). The empirical relationship described by Yerkes-Dodson law is often illustrated graphically as a bell-shaped performance curve which increases and then decreases with higher levels of arousal, in this case stimulation. High stimulation current levels may over-arouse both target nerves and the nervous system itself thereby defeating the purpose of stimulation therapy; para. [0030], methods to collect, track and measure user responses to stimulation through rapid symptom sampling scales and biofeedback measures; methods to access a common, internet cloud server database for storage and aggregation of user stimulation parameters, user symptom scale responses and user responses as biofeedback; methods to automate the electronic communication of user stimulation parameters and user response data to remote healthcare providers; methods enabling health care professionals to alter user stimulation setting remotely and to obtain informed consent; and algorithmic methods for adjusting and updating user stimulation parameters in accordance with emerging research findings and local user-coupler factors such as nerve field receptivity, electrode contact site conductivity, electrode position optimization, and electrode combination optimization).
Honeycutt is silent regarding a first biometric sensor disposed within the first housing and a second biometric sensor disposed within the second housing.
However, Jovanov discloses systems and methods for multi-modal and non-invasive stimulation of the nervous system (abstract) and discloses non-invasive stimulation of branches of the vagus nerve (col. 2). Jovanov teaches that a biometric sensor disposed within a housing configured for coupling to an outer ear of a user (abstract, Multiple sensor and stimulation devices and modalities can be combined into a single, compact unit that minimizes the need for additional sensors or stimulation devices. The system features several subunits, referred to as sensory and stimulation devices (SSD), that are integrated into a headphone setup. The system is controlled by a centralized controller that communicates with all of the SSDs and with an external computer system that delivers learning material synchronized with the delivery of stimulations and the collection of user responses based on physiological signals.; fig. 1, an embodiment of a multi-modal sensor and stimulation system, fig. 3, an embodiment of the user wearable device of the multi-modal sensor and stimulation system of FIG. 1; col. 5 – col. 6, As shown in FIGS. 5A-5C, the auricular SSD 116 can include a photoplethysmogram (PPG) sensor 132 (e.g., a pulse oximeter) to measure the PPG of the user. The PPG represents blood volume pulse and can be used to measure or assess: a) heart rate (HR); b) heart rate variability (HRV); c) breathing rate (BR); and d) vascular tone using blood volume pulse or pulse travel time (PIT) as a latency of the PPG peak from the R peak in an electrocardiogram (ECG). The PPG sensor 132 can be implemented on the front of the auricular SSD 116 to allow good contact with the lobule 131 (see FIG. 2) of the ear, which is a location that can be used for PPG sensing. The auricular SSD 116 can also include one or more electrical contacts (or electrodes) 134 for the monitoring of heart activity (e.g., an ECG), brain electrical activity (e.g., an electroencephalogram (EEG)), or galvanic skin response (GSR). The electrodes 134 can be located on one or both sides of the auricular SSD 116 to contact either a portion of the user's ear or a portion of the user's head (e.g., the temporal bone or the mastoid bone). An electrical contact (or electrode) 136 for the EEG reference can be located at the bottom of the auricular SSD 116 in contact with the mastoid bone or the lobule 131. A vibrator or speaker 138 can be used to apply stimulation using bone conduction. An accelerometer 140 can be used for detection of a balistocardiograph (BCG) representing motion caused by the mechanical movement of the heart. In one embodiment, the delay between the BCG and the PPG is a function of vascular tone/blood pressure and can be used to assess the arousal of the user.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Honeycutt, by configuring a first biometric sensor to be disposed within the first housing and a second biometric sensor to be disposed within the second housing, as taught by Jovanov, for the purpose of providing a single, compact unit that minimizes the need for additional sensors or stimulation devices (abstract).
Re Claim 2, Honeycutt discloses that the light source is configured to emit light at a wavelength selected from a range of about 420 nanometers to about 470 nanometers (para. [0016], [0117], research also has found electromagnetic energy provides optimal parasympathetic nervous system response in the range of wavelengths from 400 to 1600 nanometers with a fluence power density from 0.5 to 35 joules per square centimeter.).
Re Claim 3, Honeycutt discloses that the light source is configured to emit light at a wavelength selected from a range of about 500 nanometers to about 565 nanometers (para. [0016], [0117], research also has found electromagnetic energy provides optimal parasympathetic nervous system response in the range of wavelengths from 400 to 1600 nanometers with a fluence power density from 0.5 to 35 joules per square centimeter.).
Re Claim 5, Honeycutt discloses that the region includes a concha area of the outer ear (fig. 3A, 3B; para. [0124], said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment of said ear loop with said slip ring swivel assembly supporting three said support arms with different shaped energy coupling emitters. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88).
Re Claim 6, Honeycutt discloses that the region includes a scalp area near a back of the outer ear (fig. 2C, ref# 93 Dorsolateral Auricular Branch Vagus Nerve Target V4; para. [0124], FIG. 3B illustrates an embodiment incorporating an ear loop 101 integrating one or more electrical energy coupling emitters 102 and 103 designed to contact the dorsal side nerve targets 90 through 93 as depicted in FIG. 2C).
Re Claim 10, Honeycutt discloses that the biometric data includes information associated with an electrical activity of a heart of the user (claim 19, a heart rate sensor, a heart rate variability (HRV) sensor).
Re Claim 11, Honeycutt discloses the claimed invention substantially as set forth in claim 1.
Honeycutt is silent regarding the housing is an ear cup configured to be worn on or over the outer ear of the user.
However, Jovanov discloses systems and methods for multi-modal and non-invasive stimulation of the nervous system (abstract) and discloses non-invasive stimulation of branches of the vagus nerve (col. 2). Jovanov teaches that the housing is an ear cup configured to be worn on or over the outer ear of the user (col. 3, lines 29 – 50, the headgear can include ear pads that are placed over the ears of the user. The ear pads can include both an ear bud placed in the ear and an SSD that is placed behind the ear. .
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Honeycutt, by configuring the housing to be an ear cup configured to be worn on or over the outer ear of the user, as taught by Jovanov, for the purpose of hearing protection, enhanced sound quality, and physical comfort.
Re Claim 12, Honeycutt discloses that the housing is an earpiece configured to be worn at least partially within the outer ear of the user (fig. 3A, 3B).
Re Claim 13, Honeycutt discloses that the light source comprises at least one light emitting diode ("LED") (para. [0032], LEDs).
Re Claim 15, Honeycutt discloses a band connected to the first housing and the second housing, the band configured to be worn on or adjacent to a head of the user (fig. 7, 109 Ear stimulator connection cable, 141 Stimulator lanyard).
Re Claim 21, Honeycutt discloses that each of the first region and the second region includes a concha area of the corresponding outer ear (fig. 3A, 3B; para. [0124], said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment of said ear loop with said slip ring swivel assembly supporting three said support arms with different shaped energy coupling emitters. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88).
Re Claim 22, Honeycutt discloses that each of the first region and the second region includes a scalp area near a back of the corresponding outer ear (fig. 2C, ref# 93 Dorsolateral Auricular Branch Vagus Nerve Target V4; para. [0124], FIG. 3B illustrates an embodiment incorporating an ear loop 101 integrating one or more electrical energy coupling emitters 102 and 103 designed to contact the dorsal side nerve targets 90 through 93 as depicted in FIG. 2C).
Re Claim 23, Honeycutt discloses that each of the first light source and the second light source is configured to emit light at a wavelength selected from a range of about 420 nanometers to about 470 nanometers, or from a range of about 500 nanometers to about 565 nanometers (para. [0016], [0117], research also has found electromagnetic energy provides optimal parasympathetic nervous system response in the range of wavelengths from 400 to 1600 nanometers with a fluence power density from 0.5 to 35 joules per square centimeter.).
Re Claim 24, Honeycutt discloses that each of the first biometric data and the second biometric data includes information associated with an electrical activity of a heart of the user (claim 19, a heart rate sensor, a heart rate variability (HRV) sensor).
Conclusion
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 VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, June 17, 2026Examiner, Art Unit 3792
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