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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/8/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 9/8/2025 with respect to the rejection of Independent Claim 1 under 35 U.S.C. § 103 as being unpatentable over Goodall et al. (U.S. Pub No. 2018/0021564, hereinafter "Goodall") in view of Evans et al. (U.S. Pub No. 2019/0001127, hereinafter Evans) have been fully considered and are persuasive. The Examiner agrees that the combination of Goodall and Evans does not disclose “the device synchronizes the stimulation to coincide with the exhalation-breathing phase of the user” as recited by amended Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of R. Garcia et al., "Abstract 21014: Respiratory-Gated Auricular Vagal Nerve Stimulation Lowers Blood Pressure in Hypertensive Patients;" Circulation, Volume 136, Number suppl_1, June 9, 2018 (“Garcia”) and US 2008/0091255 A1.
Applicant’s arguments regarding dependent Claims 2-5, 7-17 and 19 are based on Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of R. Garcia et al., "Abstract 21014: Respiratory-Gated Auricular Vagal Nerve Stimulation Lowers Blood Pressure in Hypertensive Patients;" Circulation, Volume 136, Number suppl_1, June 9, 2018 (“Garcia”) and US 2008/0091255 A1.
Applicant’s arguments regarding the rejection of Claim 5 under 35 USC 112(b) has been fully considered, and are persuasive with respect to the rejection based on the now-removed phrase “among others,” but unpersuasive with respect to the rejection based on the term “wherein the electronic circuit is configured to: … and wireless charging of a battery by electromagnetic induction with the charging case.” As a matter of grammar, it is not clear what the recited “electronic circuit” is configured to do with respect to wireless charging (i.e., the term “configured to wireless charging” is grammatically unclear). The rejection based on the now-removed phrase “among others” has been withdrawn. The rejection based on the term “wherein the electronic circuit is configured to: … and wireless charging of a battery by electromagnetic induction with the charging case” is maintained.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 5, and Claims 2-4, 7-17 and 19 by dependency, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, Claim 1 recites “the device automatically stops the stimulation a maximum daily electric charge is reached.” It is grammatically unclear when the device “automatically stops stimulation,” as it appears that a word is missing (e.g., when a maximum daily electric charge is reached, before a maximum daily electric charge is reached, after a maximum daily electric charge is reached, etc.).
For purposes of this Office Action, the limitation “the device automatically stops the stimulation a maximum daily electric charge is reached” is being interpreted to mean when a maximum daily electric charge is reached.
Regarding Claim 5, Claim 5 recites “wherein the electronic circuit is configured to: … and wireless charging of a battery by electromagnetic induction with the charging case.” It is unclear what the recited “electronic circuit is configured” to do regarding “wireless charging of a battery by electromagnetic induction with the charging case.” As a matter of grammar, it is not clear what the recited “electronic circuit” is configured to do with respect to wireless charging (i.e., the term “configured to wireless charging” is grammatically unclear).
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.
Claims 1, 3, 9, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0021564 A1 to Goodall et al. (“Goodall”) in view of R. Garcia et al., "Abstract 21014: Respiratory-Gated Auricular Vagal Nerve Stimulation Lowers Blood Pressure in Hypertensive Patients;" Circulation, Volume 136, Number suppl_1, June 9, 2018 (“Garcia”) and US 2008/0091255 A1 to Caparso et al. (“Caparso”).
Regarding Independent Claim 1, Goodall teaches:
An auricular neurostimulation device wearable by a user and configured to stimulate the Auricular Branch of Vagus Nerve (ABVN) on the user's ear, wherein: (Abstract, “In an embodiment, a nerve stimulation system includes a headset and an earpiece which includes two or more ear-contacting elements, for example an ear canal insert, and a concha insert;” Para. [0163], “…the neural stimulus is delivered with a neural stimulation device and/or neural stimulus configured to activate a cranial nerve, such as the vagus nerve…”);
the device comprises at least two electrodes designed to be located in the cymba and in the cavity of the cavum conchae respectively; (Para. [0043], “A nerve stimulation earpiece includes an ear canal insert, and a concha insert. The ear canal insert is adapted to fit into an ear canal of a human subject. The ear canal insert includes at least one first electrode configured to electrically contact skin within the ear canal of the subject. The concha insert is adapted to fit within a concha of the subject. The concha insert includes a base portion configured to fit within a cavum of the concha of the subject, a wing portion configured to fit within a cymba of the concha of the subject, and at least one second electrode configured to electrically contact at least a portion of the concha of the subject.”); (Para. [0240], “The concha insert 3010 may be adapted to fit within a concha of the subject. The concha insert 3010 may include a base portion 3015 configured to fit within the cavum of the concha of the subject and a wing portion 3020 configured to fit within the cymba of the concha of the subject. … Although the electrode 3035 is shown on the wing portion 3020 in the aspect depicted in FIG. 30A, in other aspects, the electrode 3035 may be … located on both the base portion 3015 and the wing portion 3020.”);
the electrodes electrically stimulate the nerve ramifications of the cymba and the cavum conchae respectively; (Para. [0163], “In an aspect, the neural stimulus is delivered with a neural stimulation device and/or neural stimulus configured to activate a cranial nerve, such as the vagus nerve, facial nerve, trigeminal nerve, or glossopharyngeal nerve. The neural stimulation device can be configured to stimulate a particular nerve by one or both of positioning the neural stimulator on at least a portion of a receptive field of the nerve of interest, and selecting the amplitude and other stimulus parameters (e.g. frequency, waveform, duration) of the stimulus delivered to activate the nerve fibers in the nerve of interest.”);
characterized in that: the device is configured as a wireless earbud (Para. [0246], “In some embodiments, the nerve stimulation earpiece 3000 may include wireless communication circuitry 3120;” Figs. 30A and 30B show “nerve stimulation earpiece 3000” as an earbud);
comprising an earmold and a miniaturized faceplate wherein, the electrodes are arranged on the earmold (Fig. 30A; see Annotated Fig. 30A, below);
PNG
media_image1.png
685
558
media_image1.png
Greyscale
which is customized to the user's ear anatomy (Para. [0242], “In some embodiments, at least a portion of the nerve stimulation earpiece 3000 (e.g., concha insert 3010 and/or ear canal insert 3005) may be formed for a specific subject. For example, at least a portion of the nerve stimulation earpiece 3000 may be custom made for a specific subject.”);
such that the cymba electrode is a large-surface electrode covering almost the whole cymba surface area of the user's ear, (Para. [0243], “In some embodiments, the first electrode 3030 may have an electrical contact area between about 190 mm2 and about 380 mm2. In some embodiments, the second electrode 3035 may have an electrical contact area between about 100 mm2 and about 220 mm2. All or a portion of the electrical contact area of the first electrode 3030 and/or second electrode 3035 may contact the skin of a subject;” Para. [0242], “In some embodiments, at least a portion of the nerve stimulation earpiece 3000 (e.g., concha insert 3010 and/or ear canal insert 3005) may be formed for a specific subject.”);
The Present Specification states at Pg. 24, Ln. 13-18 that “When in this report the term 'large-surface electrode covering almost the whole cymba surface' is used, it refers to an electrode 2 which occupies more15 than 75 of the cymba surface. Therefore, taking into account the human anthropometric standards and the figures indicated in the table above, electrode 2 has a surface between 25 mm2 and 45 mm2, depending on variables such as the age, sex and size, etc. of the user.”
Although the limitation “such that the cymba electrode is a large-surface electrode covering almost the whole cymba surface area of the user's ear” is not being interpreted to require “a surface between 25 mm2 and 45 mm2” (MPEP 2111.01(II), “II. It Is Improper To Import Claim Limitations From The Specification”), the explanation at Pg. 24, Ln. 13-18 confirms that Goodall’s electrodes are such large electrodes as claimed.
a photoplethysmographic or biosensor with a miniaturized configuration is arranged inside the earmold; (Para. [0247], “In some embodiments, the nerve stimulation earpiece 3000 may include a physiological sensor 3125. … The physiological sensor 3125 may include at least one of an electroencephalogram (EEG) sensor, a heart rate sensor, a moisture sensor, a temperature sensor, a bio sensor, a chemical sensor, electrocardiograph (ECG), motion sensor (e.g., accelerometer and/or gyroscope), electromyogram (EMG), pulse oximeter, galvanic response sensor, or a photoplethysmograph probe.”);
and the miniaturized faceplate incorporates inside it all the elements of an electronic circuit built on a Printed Circuit Board (PCB), either in an ITE (In The Ear) configuration or in an BTE (Behind The Ear) configuration. (Para. [0260], “FIG. 40 depicts a block diagram of an ear stimulation device controller 4000 that may be employed to control any of the ear stimulation devices disclosed herein;” Para. [0273], “In some embodiments, the ear stimulation device controller 4000 may include and/or be implemented as PCB 4100. … In some embodiments, the PCB may include a standard FR-4 substrate.”).
Goodall does not disclose:
the device synchronizes the stimulation to coincide with the exhalation-breathing phase of the user;
the device automatically stops the stimulation a maximum daily electrical charge is reached:
Garcia describes “the hypothesis that respiratory gated transcutaneous vagus nerve stimulation (RAVANS tVNS) reduces blood pressure in hypertensive patients” (Abstract). Garcia is analogous art.
Garcia teaches:
the device synchronizes the stimulation to coincide with the exhalation-breathing phase of the user; (Abstract, “Methods” Section, “Electrodes were placed over vagal innervated regions in the ear (cymba concha). RAVANS tVNS was delivered for 15 minutes at 25 Hz (pulse width: 15 ms), and gated in real time to exhalation.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Goodall with the teachings of Garcia (i.e., to modify the device of Goodall such that it synchronizes the stimulation to coincide with the exhalation-breathing phase of the user in the manner of Garcia) because such synchronization “has a significant effect in the acute reduction of blood pressure levels in hypertensive patients” (Garcia at Abstract, “Conclusions” section).
Caparso describes an “Implantable neurostimulator for modulating cardiovascular function” (Title) which is useful in conjunction with stimulating the vagus nerve (Para. [0031]). Caparso is analogous art.
Caparso teaches:
the device automatically stops the stimulation a maximum daily electrical charge is reached (Para. [0045], “Stimulation controller 542 controls the delivery of the neurostimulation by executing a stimulation algorithm for modulating a cardiovascular function. For example, the stimulation algorithm is defined by a plurality of stimulation parameters selected to provide one or more of a cardiac remodeling control therapy, an anti-arrhythmia therapy, and an anti-hypertension therapy. In one embodiment, the stimulation algorithm includes stimulation parameters for control of delivery of the electrical stimulation pulses. Examples of the stimulation parameters for controlling the delivery of electrical stimulation pulses include pulse amplitude, pulse width, stimulation frequency (or inter-pulse interval), periodic dose, and duty cycle. … The periodic dose is a time interval during which a patient is treated with neurostimulation for each predetermined period. In one embodiment, the predetermined period is a day, and the periodic dose is a daily dose.”).
Administration of Caparso’s “periodic dose” in Caparso’s embodiment wherein “the predetermined period is a day, and the periodic dose is a daily dose” results in stopping Caparso’s stimulation at such a maximum daily electrical charge as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Goodall and Garcia with the teachings of Caparso (i.e., to modify the device of combined Goodall and Garcia such that it additionally controls a periodic dose of stimulation in the manner of Caparso, thereby resulting in stopping stimulation at a maximum daily electrical charge) in order to more effectively “modulate the heart rate and contractility” (Caparso at Para. [0002]).
Regarding Claim 3, the combination of Goodall, Garcia and Caparso renders obvious the entirety of Claim 1 as explained above.
Goodall additionally discloses:
wherein the photoplethysmographic or biosensor measures the environment temperature and the user's temperature and to estimate the amount of hemoglobin and oxyhemoglobin circulating through the most superficial capillary vessels of the ear of the patient or user, the measurements made by the photoplethysmographic or biosensor are used to calculate the heart rate, the heart rate variability (HRV) and the oxygen saturation and to detect the breathing phase (exhalation or inhalation) of the user or patient; (Para. [0277], “The physiological sensor 4245 may include at least one of an electroencephalogram (EEG) sensor, a heart rate sensor, a moisture sensor, a temperature sensor, a bio sensor, a chemical sensor, electrocardiograph (ECG), motion sensor (e.g., accelerometer and/or gyroscope), electromyogram (EMG), pulse oximeter, galvanic response sensor, or a photoplethysmograph probe;” Para. [0193], “In an aspect, the override signal originates from a sensor that senses a physiological parameter, such as heart rate.”);
The limitation “are used to calculate… and to detect…” is being interpreted as an intended use of the recited structural components. Goodall discloses each of the structural components, and Goodall’s components are structurally capable of use in the recited manner.
and wherein the measurements made by the photoplethysmographic or biosensor are used to determine which electrical charge is the most suitable for the user at any given time. (Para. [0128], “Control of stimulation may be based on data from one or more sensor 220, including, but not limited to, physiological sensors, neural activity sensors, motion sensors, location sensors, or environmental sensors, for example.”).
Regarding Claim 9, the combination of Goodall, Garcia and Caparso renders obvious the entirety of Claim 1 as explained above.
Goodall additionally discloses:
wherein an electrical charge quantity applied to electrodes is personalized for the user, according to the therapeutic dose needed. (Para. [0128], “Control of stimulation may be based on data from one or more sensor 220, including, but not limited to, physiological sensors, neural activity sensors, motion sensors, location sensors, or environmental sensors, for example.”).
Regarding Claim 10, the combination of Goodall, Garcia and Caparso renders obvious the entirety of Claim 1 as explained above.
Goodall additionally discloses:
wherein an electrical voltage difference applied to electrodes is adjusted in real time to an impedance of a contact of the electrodes with skin, in order to ensure that intensity of stimulation is as established (Para. [0265], “In some embodiments, the current driver 4015 may generate a controlled current output unaffected by load impedance. In some embodiments, the current driver 4015 may be implemented as an XTR300 analog current/voltage output driver. An example of a current driver that may be used to implement the current driver 4015 is Texas Instruments XTR300 Industrial Analog Current/Voltage Output Driver. The current driver 4015 may provide biphasic current stimulation in some embodiments. In some embodiments, the current driver 4015 may provide a current output between −100 mA and 100 mA. In some embodiments, the current driver 4015 may provide a current output between −20 mA and +20 mA. In some embodiments, the current output may be at a maximum voltage of +/−40V. In some embodiments, the current output may be at a maximum voltage of +/−10V.”).
Goodall’s “current/voltage output driver” makes such an adjustment as claimed in order to prevent the impact of impedance.
Regarding Claim 12, the combination of Goodall, Garcia and Caparso renders obvious the entirety of Claim 1 as explained above.
Goodall additionally discloses:
wherein the neurostimulation device is configurable via a smartphone application (Para.[0261], “The wireless microcontroller 4030 may control wireless communication between the ear stimulation device controller 4000 and a personal computing device 4045 to receive one or more stimulation parameters from the personal computing device 4045. Example personal computing devices include, but are not limited to, a smart phone, a mobile phone, a tablet computer, and an mp3 player. The digital stimulus signal generator 4020 may generate a digital stimulus signal based, at least in part, on the one or more stimulation parameters received from the personal computing device 4045.”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0021564 A1 to Goodall et al. (“Goodall”) in view of R. Garcia et al., "Abstract 21014: Respiratory-Gated Auricular Vagal Nerve Stimulation Lowers Blood Pressure in Hypertensive Patients;" Circulation, Volume 136, Number suppl_1, June 9, 2018 (“Garcia”) and US 2008/0091255 A1 to Caparso et al. (“Caparso”) as applied to Claim 1 above, and further in view of US 2002/0041697 A1 to MacDonald et al. (“MacDonald”).
Regarding Claim 2, the combination of Goodall, Garcia and Caparso renders obvious the entirety of Claim 1 as explained above.
Goodall additionally discloses:
wherein the electrodes are made of graphene, biocompatible metals, non- toxic metals, conductive biocompatible inks for 3D printing or flexible conductive biocompatible polymers, (Para. [0243], “All or a portion of the electrical contact area of the first electrode 3030 and/or second electrode 3035 may contact the skin of a subject. In some embodiments, the first electrode 3030 and/or second electrode 3035 may include a silver/silver chloride, platinum, tungsten, stainless steel, and/or gold component, conductive gel, hydrogel, conductive polymer, conductive foam, and/or fabric. In some embodiments, the first electrode 3030 and/or second electrode 3035 may include a layered structure including a hydrogel layer and a conductive polymer layer.”);
The combination of Goodall, Garcia and Caparso does not disclose:
and wherein the earmold is made of a thermoelastic material so that it improves the fit with the user's ear as the earmold acquires body temperature
MacDonald describes “A flexible earhook for positioning an earphone adjacent a wearer's ear…” (Abstract). MacDonald is reasonably pertinent to the problem faced by the inventor, and is analogous art. See MPEP 2141.01(a)(I).
MacDonald discloses:
and wherein the earmold is made of a thermoelastic material so that it improves the fit with the user's ear as the earmold acquires body temperature. (Para. [0037], “The body 129 may, for example, be a soft plastic material such as a thermoelastic material. One example of such a material is a SANTOPRENE material.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Goodall, Garcia and Caparso with the teachings of MacDonald (i.e., to manufacture Goodall’s earmold from a thermoelastic material such as that taught by MacDonald) in order to allow the earpiece to be contoured to the wearer’s ear and thereafter maintain its shape (MacDonald at Para. [0037]).
Claim 4, 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0021564 A1 to Goodall et al. (“Goodall”) in view of R. Garcia et al., "Abstract 21014: Respiratory-Gated Auricular Vagal Nerve Stimulation Lowers Blood Pressure in Hypertensive Patients;" Circulation, Volume 136, Number suppl_1, June 9, 2018 (“Garcia”) and US 2008/0091255 A1 to Caparso et al. (“Caparso”) as applied to Claim 1 above, and further in view of previously cited US 4,431,001 A to Hakansson et al. (“Hakansson”) and previously cited US 2017/0202467 A1 to Zitnik et al. (“Zitnik”).
Regarding Claim 4, the combination of Goodall, Garcia and Caparso renders obvious the entirety of Claim 1 as explained above.
Goodall additionally discloses:
wherein the electronic circuit comprises the following elements: a central circuit that controls all the functioning of the device, (Para. [0175], “Wearable neural stimulation device 1202 includes neural stimulator 706, which is adapted to produce a stimulus …. [and] control circuitry 1206 for controlling operation of neural stimulator 706…”);
a charger circuit… (Para. [0268], “An example of a battery protection integrated circuit that may be used to implement the battery protection integrated circuit 4038 is the Texas Instruments BQ2970 voltage and current protection integrated circuit. Another example of a battery protection integrated circuit that may be used to implement the battery protection integrated circuit 4038 is the Microchip MCP7383X Li-Ion System Power Path Management Reference.”);
and a battery that is rechargeable… (Para. [0268], “In some embodiments, the power source 4035 includes a battery 4036.”);
The combination of Goodall, Garcia and Caparso does not disclose:
a voltage amplifier that raises the voltage supplied by a battery;
a charger circuit that takes advantage of electric current generated in a coil that receives the magnetic field created by a further coil located in a charging case; (i.e., Goodall discloses a charger circuit, but does not disclose a charger circuit “that takes advantage of electric current generated in a coil that receives the magnetic field created by a further coil located in a charging case”);
and a battery that is rechargeable with the current generated in the coil (i.e., Goodall discloses a battery that is rechargeable, but does not disclose a battery that is rechargeable “with the current generated in the coil”).
Hakansson describes “An electrical stimulator system … incorporating rechargeable batteries and a charging circuit” (Abstract). Hakansson is thus analogous art.
Hakansson discloses:
“a voltage amplifier that raises the voltage supplied by a battery;” (Fig. 1, “amplifier 4”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Goodall, Garcia and Caparso with the teachings of Hakansson (i.e., to include such a voltage amplifier as taught by Hakansson in the device of Goodall) in order to reduce the number of batteries needed to power the device, thereby facilitating its portability (Hakansson at Col. 5, Ln. 18-22).
Zitnik describes “Wearable inductive chargers/communication devices for inductively communicating with (including charging) an implanted microstimulator…” (Abstract). Zitnik is thus analogous art.
Zitnick discloses:
a charger circuit that takes advantage of electric current generated in a coil that receives the magnetic field created by a further coil located in a charging case; (i.e., Zitnik discloses a charger circuit “that takes advantage of electric current generated in a coil that receives the magnetic field created by a further coil located in a charging case”); (Para. [0016], “Any of these apparatuses may include a coil for receiving (and in some variations transmitting) information and/or for inductively charging the implanted device.”);
It is noted that “a charging case” is not affirmatively recited, and is thus not a required element of the claim.
and a battery that is rechargeable with the current generated in the coil (i.e., Zitnik discloses a battery that is rechargeable “with the current generated in the coil”) (Para. [0016], “Any of these apparatuses may include a coil for receiving (and in some variations transmitting) information and/or for inductively charging the implanted device.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Goodall, Garcia, Caparso and Hakansson with the teachings of Zitnik (i.e., to employ such an inductive charging mechanism as taught by Zitnik in the device of combined Goodall, Garcia, Caparso and Hakansson) in order to increase reliability of the device by reducing the number of wired components (Zitnik at Paras. [0008] through [0010]).
Regarding Claim 5, the combination of Goodall, Garcia, Caparso, Hakansson and Zitnik renders obvious the entirety of Claim 4 as explained above.
Goodall additionally discloses:
wherein the electronic circuit is configured to: generate stimulation patterns with variable duration, intensity, frequency of bursts and pulses, number of pulses per burst, pulse widths, and pulse delays; (Para. [0228], “…the recommendation relates to at least one parameter of the neural stimulus, for example, an amplitude, frequency, waveform, or duration of delivery of the neural stimulus, or stimulation pattern for delivery of the neural stimulus. The stimulation pattern may be, for example, a preprogrammed pattern, a continuous pattern, an intermittent pattern, a time-varying pattern, and/or a pulsed pattern. In an aspect, the recommendation specifies a selection of one of multiple stimulation patterns;” Para. [0181], “Neural stimulus control signal determination circuitry 1308 includes one or more of amplitude determination circuitry 1326 for determining a neural stimulus amplitude, frequency determination circuitry 1328 for determining a neural stimulus frequency, waveform determination circuitry 1330 for determining a neural stimulus waveform, pattern determination circuitry 1332 for determining a neural stimulus pattern, or duration determination circuitry 1333 for determining a neural stimulus duration.”).
control an electrical charge applied in each stimulation and daily-accumulated charge; (Para. [0163], “The neural stimulation device can be configured to stimulate a particular nerve by one or both of positioning the neural stimulator on at least a portion of a receptive field of the nerve of interest, and selecting the amplitude and other stimulus parameters (e.g. frequency, waveform, duration) of the stimulus delivered to activate the nerve fibers in the nerve of interest.”).
By controlling charge (i.e., amplitude) individual stimulations, daily-accumulated charge is vicariously controlled.
exchange data with external devices through wireless connections, exchange data with the charging case; (Para. [0175], “Both control circuitry 1206 and first communication circuitry 1208 are incorporated into the wearable neural stimulation device 1202;” Para. [0177]);
Zitnik additionally discloses:
and wireless charging of a battery by electromagnetic induction with the charging case. (Para. [0024], “…wherein the electronic assembly comprises power management circuitry configured to receive power from the resonator to charge the battery, and a microcontroller configured to control stimulation of the vagus nerve from the electrodes.”).
Garcia discloses:
generate stimulation patterns synchronized with the exhalation of the user; (Abstract, “Methods” Section, “Electrodes were placed over vagal innervated regions in the ear (cymba concha). RAVANS tVNS was delivered for 15 minutes at 25 Hz (pulse width: 15 ms), and gated in real time to exhalation.”)
Regarding Claim 7, the combination of Goodall, Garcia, Caparso, Hakansson and Zitnik renders obvious the entirety of Claim 5 as explained above.
Goodall additionally discloses:
wherein the electronic circuit implements a plurality of stimulation protocols, where the intensity of electric current, pulse width and repetition frequency of pulses is variable; and wherein the stimulation protocols are based on a waveform of rectangular, biphasic, symmetric and with a delay between a negative and positive pulse. (Para. [0162], “For example, in various aspects the neural stimulus has a frequency in the approximate range of 1 Hz-1000 Hz, 10 Hz-500 Hz, 30 Hz-40 Hz, 10 Hz-50 Hz, 10 Hz-80 Hz, 50 Hz-100 Hz, or 200-300 Hz. In an aspect, the stimulus has a sinusoidal waveform. In other aspects, the stimulus may have a triangular, rectangular, square, trapezoidal, or other waveform, delivered cyclically, with cycle frequencies in the ranges listed above. It will be appreciated that depending on the stimulus waveform or pulse shape, or envelope shape, a given stimulus may include higher or lower frequencies. The neural stimulus may be delivered according to programmed pattern, which may be stored in memory on the neural stimulation device or on a personal computing device or other remote device in communication with the neural stimulation device. In various aspects, the neural stimulus is delivered continuously, intermittently, and/or in a time-varying fashion. The neural stimulus may be a pulsed stimulus;” Para. [0265], “The current driver 4015 may provide biphasic current stimulation in some embodiments.”).
Regarding Claim 8, the combination of Goodall, Garcia, Caparso, Hakansson and Zitnik renders obvious the entirety of Claim 7 as explained above.:
Goodall additionally discloses:
wherein the stimulation protocols include any of the following types: a BEAT type protocol, consisting of continuous application of bursts of pulses, a BFS (Breathing Focused on Stimulation) type protocol combining stimulation moments with standstill moments, so the user breathes in during the standstill moments and breathes out during the stimulation; and an EVANS (Exhalation Vagus Auricular Nerve Stimulation) type protocol stimulating only during exhalation of the user. (Para. [0162], “In various aspects, the neural stimulus is delivered continuously, intermittently, and/or in a time-varying fashion. The neural stimulus may be a pulsed stimulus.”).
Claim 11, 15-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0021564 A1 to Goodall et al. (“Goodall”) in view of R. Garcia et al., "Abstract 21014: Respiratory-Gated Auricular Vagal Nerve Stimulation Lowers Blood Pressure in Hypertensive Patients;" Circulation, Volume 136, Number suppl_1, June 9, 2018 (“Garcia”) and US 2008/0091255 A1 to Caparso et al. (“Caparso”) as applied to Claim 1 above, and further in view of previously cited US 2018/0236217 A1 to Hamner et al. (“Hamner”).
Regarding Claim 11, the combination of Goodall, Garcia and Caparso renders obvious the entirety of Claim 1 as explained above.
The combination of Goodall, Garcia and Caparso does not disclose:
wherein the auricular neurostimulation device is configured to charge a battery wirelessly by electromagnetic induction when stored in a charging case, and where the device is further configured to discharge into the charging case the data captured by the photoplethysmographic or biosensor during stimulation for transmission to a dedicated platform in the cloud
Hamner discloses:
wherein the auricular neurostimulation device is configured to charge a battery wirelessly by electromagnetic induction when stored in a charging case, and where the device is further configured to discharge into the charging case the data captured by the photoplethysmographic or biosensor during stimulation for transmission to a dedicated platform in the cloud (Para. [0091], “In the above embodiments, the ring unit 1000 and/or stimulation unit 1002 can be charged directly with a cable (e.g., micro USB), a contact dock 1006 with direct connection to the power source, inductive charging, direct contact with the stimulation electrodes (i.e., electrodes contact the charging station, which does not require a separate charging connection), and/or a separate carrying case, as shown in FIG. 11, that combines the above concepts on charging and data transfer.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Goodall, Garcia and Caparso with the teachings of Hamner (i.e., to modify the device of Goodall such that it is stored in such a charging case as claimed) in order to reduce the number of dedicated connection means in the device (Hamner at Para. [0091]).
Regarding Claim 15, the combination of Goodall, Garcia, Caparso and Hamner renders obvious the entirety of Claim 11 as explained above.
Goodall additionally discloses:
A method of operation of an auricular neurostimulation device according to claim 1 comprising the following steps: automatic activation of the auricular neurostimulation device when it is removed from the charging case, (Para. [0268], “The power source 4035 may resume operation when an internal timer expires. In some embodiments, the ear stimulation device controller may include an internal timer 4039.”);
automatic check of the correct positioning inside the ear by a proximity detector of the photoplethysmographic or biosensor, (Para. [0152], “In an aspect, neural stimulation system 700 includes position sensor 864 for sensing the position of neural stimulator 706 with respect to the pinna of the subject. Position sensor 864 may detect the position of neural stimulator 706 with respect to the pinna by detecting electrical activity from a nerve, by detecting an image of the ear and determining the position based on landmarks in the image, or by detecting a temperature, pressure, or capacitive signal indicative of adequate contact of the stimulator with the ear, for example.”);
automatic start of stimulation of the auricular neurostimulation device according to defined stimulation conditions, (Para. [0165], “In an aspect, method 900 includes sensing at least one secondary signal with a secondary sensor. In an aspect, delivery of the neural stimulus may be started, stopped, or modulated in response to the secondary signal. The secondary signal may be a secondary neural signal (of the same or different type and sensed from the same or from a different location than the primary neural signal), or it may another type of physiological signal, an environmental signal, a location signal, or a signal from a motion sensor, for example. Such secondary signals may provide additional information relevant for determining whether the neural stimulus should be applied, assessing the subject's response to the neural stimulus, identifying appropriate time of delivery of the neural stimulus, etc.”);
automatic monitoring of the amount of electrical charge entered in the users ear by the auricular neurostimulation device; (Para. [0165], “In an aspect, method 900 includes sensing at least one secondary signal with a secondary sensor. In an aspect, delivery of the neural stimulus may be started, stopped, or modulated in response to the secondary signal. The secondary signal may be a secondary neural signal (of the same or different type and sensed from the same or from a different location than the primary neural signal), or it may another type of physiological signal, an environmental signal, a location signal, or a signal from a motion sensor, for example.”);
automatic stop of the stimulation by the auricular neurostimulation device when a defined stimulation condition indicating an assigned electrical charge value is reached or; (Para. [0165]);
and during stimulation, storage by the photoplethysmographic or biosensor of temperature, hemoglobin and oxyhemoglobin readings of the user. (Para. [0145], “Environmental sensor 750 may include a temperature sensor 788…;” Para. [0148], “Data drawn from one or more neural signals, physiological signals, environmental signals, or other secondary signals (e.g. obtained with secondary sensor 750 in FIG. 7) or secondary inputs (e.g. secondary signal input 800 in FIG. 7), as well as clock or timer information, can be correlated with a mental or emotional state of the subject, reported to a medical care provider or other party, and/or stored in the subject's medical or health records.”).
Regarding Claim 16, the combination of Goodall, Garcia, Caparso and Hamner renders obvious the entirety of Claim 15 as explained above.
Goodall additionally discloses:
wherein the stimulation conditions of the stimulation are used to enhance physical and cognitive performance (Para. [0237], “In the example of FIG. 29, the therapeutic secondary stimulus is provided via digital media, in the form of a therapy application that provides cognitive training and therapy. The therapy application also performs mental health monitoring;” Para. [0026], “In an aspect, a method includes, but is not limited to, receiving a neural activity signal at a personal computing device, the neural activity signal indicative of a physiological status of a subject, determining a neural stimulus control signal based at least in part on the neural activity signal, and outputting the neural stimulus….”).
Regarding Claim 17, the combination of Goodall, Garcia, Caparso and Hamner renders obvious the entirety of Claim 16 as explained above.
Goodall additionally discloses:
wherein the performance enhancement is any of improvement of learning processes, improvement of attention and concentration skills, improvement of divergent thinking, enhancement of response selection processes, enhancement of motor learning, optimization of athlete's adaptation to training loads, enhancement of muscle growth as well as weight control. (Para. [0237], “In an aspect, the therapy application includes an interactive survey 2924 displayed on touchscreen 2926 of mobile phone 2906. The survey asks subject 2904 questions designed, for example, to assess the subject's mental or emotional state (“Rate how you feel today”), identity factors contributing to or relating to the subject's mental or emotional state (“Did you sleep well last night?”), and guide the subject toward positive and/or constructive thought patterns (“What did you enjoy today?”). Subject 2904 provides responses (user input 2930) to the queries via touchscreen 2926, which are received by secondary signal input 2912. In addition, or as an alternative, the therapy application may provide a therapeutic secondary stimulus that includes music or guided meditation, delivered via touchscreen 2926 and/or a speaker in ear canal insert 416.”).
Regarding Claim 19, the combination of Goodall, Garcia, Caparso and Hamner renders obvious the entirety of Claim 15 as explained above.
Goodall additionally discloses:
wherein the stimulation conditions of the stimulation are used to treat at least one of epilepsy, chronic stress, pre-diabetes, obesity, depression, chronic tinnitus, migraine, rehabilitation after ischemic stroke, alleviation of chronic inflammation, muscle regeneration and growth, ventricular arrhythmias, respiratory symptoms associated to COVID-19 as well as to boost associative memory to help patients with Alzheimer's disease and other dementia types. (Para. [0164], “In an aspect, method 900 includes delivering the neural stimulus in response to detection of symptoms of a brain-related disorder (which may be, for example, any mental health disorder (e.g., psychological or psychiatric disorder), depression, post-traumatic stress disorder, seasonal affective disorder, anxiety, headache (e.g., primary headache, cluster headache, or migraine headache), or epilepsy).”).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0021564 A1 to Goodall et al. (“Goodall”) in view of R. Garcia et al., "Abstract 21014: Respiratory-Gated Auricular Vagal Nerve Stimulation Lowers Blood Pressure in Hypertensive Patients;" Circulation, Volume 136, Number suppl_1, June 9, 2018 (“Garcia”) and US 2008/0091255 A1 to Caparso et al. (“Caparso”) as applied to Claim 12 above, and further in view of previously cited US 2019/0122757 A1 to Lin (“Lin”).
Regarding Claim 13, the combination of Goodall, Garcia and Caparso renders obvious the entirety of Claim 12 as explained above.
Goodall additionally discloses:
connection to the auricular neurostimulation device to match a serial number of the auricular neurostimulation device to the user account, so the device is associated to the user (Para. [0220], “In various aspects, identifying information 2506 includes device information 2602 pertaining to the neural stimulation device 2510, or subject information 2610 pertaining to the subject. Device information 2602 includes, for example, device type information 2604, device serial number 2606, or device inventory number 2608. Subject information 2610 includes, for example, a name of the subject 2612, a user name 2614 associated with the subject, an email address 2616 associated with the subject, a subject identification 2618 (e.g., identification number, code or the like), or biometric information 2620 associated with the subject. In various aspects, subject identification 2618 can be input by the subject via a user input, read with a bar-code or RFID reader, received with an RF receiver, etc.”).
The combination of Goodall, Garcia and Caparso does not disclose:
creation, via the smartphone application, by the user of a user account using the application for the smartphone or the web entering a series of personal data;
assignment, via the smartphone application, of an initial electrical charge value to apply in each stimulation session and a maximum daily electrical charge, depending on the user's profile and on the basis of statistical studies;
detection of the user login into the application;
prompting the user to set his/her perception and pain thresholds;
based on both thresholds, establishment of a range in which the stimulation intensity must be placed, so that the stimulation is effective but also comfortable;
detection of a selection of a stimulation protocol by the user;
and configure the auricular neurostimulation device in accordance with the range of stimulation intensity and the stimulation protocol.
Lin describes a “Method and device for software-defined therapy” (Title) in the context of “Electrical Muscle Stimulation (EMS) and Transcutaneous Electrical Nerve Stimulation (TENS)” (Para. [0005]). Lin is analogous art.
Lin discloses:
creation, via the smartphone application, by the user of a user account using the application for the smartphone or the web entering a series of personal data; (Para. [0035], “If the App is connected with the cloud, a query is made to see if the App has login before. If not, a prompt for the login is made.”);
assignment, via the smartphone application, of an initial electrical charge value to apply in each stimulation session and a maximum daily electrical charge, depending on the user's profile and on the basis of statistical studies; (“Para. [0016], “The efficacy and safety of the therapy depends on a complete treatment procedure including a number of important components such as waveforms, intensity, length of treatment time, place on the human body to apply the treatment, how many times a day, how long in terms of days, and the like. Thus, a complete healthcare therapy can be performed in terms of waveforms, initial intensity, time to apply the waveform, how long a waveform should be applied, change of waveform, and the like, can be defined by proprietary script instructions of a program and driven by the program. Intensity can be controlled by user to suit individual personalization.”);
detection of the user login into the application; (Para. [0035], “If the App is connected with the cloud, a query is made to see if the App has login before. If not, a prompt for the login is made. If yes, the App automatically logins in the background, and the App automatically synchronizes with the cloud.”);
prompting the user to set his/her perception and pain thresholds; (Para. [0048], “Thus, the disclosure provides a method based on a pain profile of a user (pain level, pain frequency, pain duration, pain location, and the like). The smartphone App can recommend a list of programs for therapy based on medical expert system built from scientific research and care practice. For example, for joint pain, generic/advanced pain relief programs, nature stimulated endorphin program, generic/advanced muscle strengthen program, thorough relaxation program, and the like can be recommended.”);
based on both thresholds, establishment of a range in which the stimulation intensity must be placed, so that the stimulation is effective but also comfortable; (Para. [0048], “Thus, the disclosure provides a method based on a pain profile of a user (pain level, pain frequency, pain duration, pain location, and the like).”);
detection of a selection of a stimulation protocol by the user; (Para. [0021], “In an embodiment, the App provides a user interface and functions, for example, as a self-made therapy program, a therapy search and selection program, a therapy instruction program, a professional guide program, a therapy operation and control program, and the like, for the user to operate.”);
and configure the auricular neurostimulation device in accordance with the range of stimulation intensity and the stimulation protocol. (Para. [0045], “A set of control commands can be created to define a healthcare therapy program. The commands characterize the waveform used, to control when it is used, characteristic changes, and the time of changes. The waveform can be characterized in terms of type (e.g., sinusoid, square, triangular, sawtooth, width, symmetry, asymmetry), frequency, burst, and the like.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Goodall, Garcia and Caparso with the teachings of Lin (i.e., to modify the device of Goodall such that it is programmable in the manner of Lin) in order to “make healthcare treatment procedures programmable and automatically operable with minimum manual operations involved” (Lin at Para. [0016]).
Regarding Claim 14, the combination of Goodall, Garcia and Caparso renders obvious the entirety of Claim 1 as explained above.
Goodall additionally discloses:
A method of configuration of an auricular neurostimulation device according to claim 1 comprising the following steps after a stimulation session: reception, from the auricular neurostimulation device… session data including readings store