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 .
Response to Arguments
Applicant’s arguments filed 12/10/2025 with respect to the rejections of Claims 113-115, 117-120, 122-128, and 133-137 under 35 U.S.C. 102(a)(1) as allegedly being anticipated by WO 2018039458 All to Hamner et al. ("Hamner"), Claims 113-115, 117-128 under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2017/0087364 Al to Cartledge et al. ("Cartledge") in view of Hamner and Claim 121 under 35 U.S.C. 103 as being unpatentable over Hamner in view of Cartledge have been fully considered and are persuasive. Independent Claims 113, 123 and 133 have been amended to include recitations regarding the timing of stimulation relative to inhalation and exhalation. Neither Hamner nor Cartledge teach such timing. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20050076909 A1 to Stahmann et al., Garcia RG, Lin RL, Lee J, Kim J, Barbieri R, Sclocco R, Wasan AD, Edwards RR, Rosen BR, Hadjikhani N, Napadow V. Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation in migraine patients. Pain. 2017 Aug;158(8):1461-1472, and Hu, H., Li, S. & Li, S. Pain modulation effect of breathing-controlled electrical stimulation (BreEStim) is not likely to be mediated by deep and fast voluntary breathing. Sci Rep 5, 14228 (2015).
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 113, 115, 117-119, 122, 133-137, and 139 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited WO 2018039458 A1 to Hamner et al. (“Hamner”) in view of US 20050076909 A1 to Stahmann et al. (“Stahmann”) and Garcia RG, Lin RL, Lee J, Kim J, Barbieri R, Sclocco R, Wasan AD, Edwards RR, Rosen BR, Hadjikhani N, Napadow V. Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation in migraine patients. Pain. 2017 Aug;158(8):1461-1472 (“Garcia”).
Regarding Independent Claim 113, Hamner teaches:
A method of transcutaneously stimulating one or more peripheral nerves of a patient or other user with a wearable neurostimulation device regulated by a measured rhythmic biological signal the method comprising: (Title, “Systems and methods for treating cardiac dysfunction through peripheral nerve stimulation;” Para. [0022], “The system can include, for example, a wearable device that includes a controller; a first peripheral nerve effector configured to be positioned on a patient's skin on an extremity of the patient; and at least one biomedical sensor or data input source configured to provide feedback information.”);
positioning a first peripheral nerve effector proximate a skin surface on an ear of the patient or other user to stimulate a first peripheral nerve of the patient or other user; (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
positioning a second peripheral nerve effector proximate a second location of the patient or other user to stimulate a second peripheral nerve of the patient or other user; (Para. [0110], “In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
measuring a rhythmic biological signal of the patient or other user … and determining one or more features of the measured rhythmic biological signal of the patient or other user in real-time, (Para. [0161], “In one embodiment, the therapy unit with the inflatable wrist band or arm cuff has a pressure sensor, such as a piezo-resistive transducer, to measure heart rate, blood pressure, or other cardiac parameters, in addition to the stimulation electronics and electrodes.”);
Hamner teaches use of a microphone for determining blood pressure (see Hamner at Para. [0161]), but does not teach use of a microphone in the context of respiratory cycles. This deficiency is addressed below.
wherein the rhythmic biological signal is a respiratory cycle, (Para. [0096], “The housing can use a plurality of sensors to collect, store, and analyze biological measures about the wearer including, but not limited to … respiratory rate…”);
delivering a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate the first peripheral nerve …(Para. [0014], “ The controller can be configured to generate a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate a first peripheral nerve sufficient to modify at least one brain or spinal cord autonomic feedback loop relating to the cardiac arrhythmia or hypertension;” Para. [0099], “ In some embodiments, a system can sense an increase or decrease in HRV of about or more than about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 75%, 100%, or more over a baseline value (or target desired HRV value) and institute a change in one, two, or more stimulation modality parameters accordingly.”);
and delivering a second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate the second peripheral nerve …; (Para. [0014], “The controller can be configured to generate a second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate a second peripheral nerve sufficient to modify at least one brain or spinal cord autonomic feedback loop relating to the cardiac arrhythmia or hypertension.”)
wherein the first peripheral nerve is a vagus nerve, (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
and the second peripheral nerve is a nerve other than the vagus nerve, (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
wherein the second electrical nerve stimulation signal is offset at a preselected time interval from the first electrical nerve stimulation signal, (Para. [0015], “Delivering the second electrical nerve stimulation signal can be offset temporally from delivering the first electrical nerve stimulation signal, such as between about 1.0 millisecond to about 2.1 milliseconds in some cases.”);
and wherein the first peripheral nerve effector and the second peripheral nerve effector are not placed within an inner ear or an ear canal of the ear. (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
Hamner does not disclose:
using a microphone
and wherein the one or more features of the measured rhythmic biological signal comprise an onset of an inhalation phase of the respiratory cycle and the onset of an exhalation phase of the respiratory cycle;
delivering a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate the first peripheral nerve during only the exhalation phase of the respiratory cycle
and delivering a second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate the second peripheral nerve during only the exhalation phase or only the inhalation phase of the respiratory cycle;
Stahmann describes “Methods and systems for detecting medical disorders through synergistic use of one or more medical devices…” (Abstract). Stahmann is reasonably pertinent to the problem faced by the inventor and is thus analogous art.
Stahmann teaches:
using a microphone (Para. [0111], “For example, respiration sounds may be detectable using the accelerometer of a CRM or a patient-external microphone.”)
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 method of Hamner with the teachings of Stahmann (i.e., to use a microphone to monitor respiration in the manner of Stahmann) in order to prevent interference from patient movement from degrading respiration sound detection (Stahmann at Para. [0111]).
Garcia describes “Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) in migraine patients” (Title). Garcia is analogous art.
Garcia teaches:
and wherein the one or more features of the measured rhythmic biological signal comprise an onset of an inhalation phase of the respiratory cycle and the onset of an exhalation phase of the respiratory cycle; (Pg. 5, Second Paragraph, “Stimulation was gated, with 0.5-second delay, after peak inhalation (i.e. during exhalation, for eRAVANS) or after peak exhalation (i.e. during inhalation, for iRAVANS).”);
delivering a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate the first peripheral nerve during only the exhalation phase of the respiratory cycle (Pg. 5, Second Paragraph, “Stimulation was gated, with 0.5-second delay, after peak inhalation (i.e. during exhalation, for eRAVANS) or after peak exhalation (i.e. during inhalation, for iRAVANS).”)
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 method of combined Hamner and Stahmann with the teachings of Garcia (i.e., to use onset of inhalation and exhalation as features of the measured rhythmic biological signal, and to stimulate the vagus nerve only during exhalation in the manner of Garcia) in order to facilitate treatment of migraines, either in addition to or in place of Hamner’s cardiac dysfunction treatment (Garcia at Pg. 2, First Paragraph).
The combination of Hamner, Stahman and Garcia does not expressly disclose:
and delivering a second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate the second peripheral nerve during only the exhalation phase or only the inhalation phase of the respiratory cycle;
However, Hamner teaches delivering stimulation to the first and second peripheral nerve effectors simultaneously (Hamner at Para. [0015], “The second electrical nerve stimulation signal can occur simultaneously or substantially simultaneously with delivering the first electrical nerve stimulation signal;” Hamner at Claim 58, “…wherein delivering the second electrical nerve stimulation signal occurs simultaneously with delivering the first electrical nerve stimulation signal.”).
Keeping in line with the teachings of Hamner, it would have been obvious to further modify the device of combined Hamner, Stahman and Garcia such that the second electrical nerve stimulation signal stimulates a second peripheral nerve “during only the exhalation phase … of the respiratory cycle” because (1) Hamner teaches delivering stimulation to the first and second peripheral nerve effectors simultaneously (Hamner at Para. [0015]; Hamner at Claim 58) and (2) because Garcia teaches stimulating the vagus nerve only during exhalation to facilitate treatment of migraines, as explained above (see Garcia at Pg. 2, First Paragraph; Pg. 5, Second Paragraph). Stimulating the vagus nerve only during exhalation in the manner of Garcia while delivering both stimulations simultaneously in the manner of Hamner results in delivering the second stimulation in the manner claimed.
Regarding Claim 115, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 113 as explained above.
Hamner additionally discloses:
wherein the second peripheral nerve is selected from the group comprising the median nerve, the ulnar nerve, or the radial nerve (Para. [0013], “The first peripheral nerve could be an upper extremity nerve, such as, for example, the median nerve, the radial nerve, the medial cutaneous nerve, the lateral cutaneous nerve, the musculocutaneous nerve, or the ulnar nerve;”).
Regarding Claim 117, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 113 as explained above.
Hamner additionally discloses:
further comprising monitoring sympathetic and parasympathetic activity in the patient or other user. (Para. [0099], “This interbeat data can also be used to denote an individual's sympathetic and parasympathetic activity levels.”).
Regarding Claim 118, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 117 as explained above.
Hamner additionally discloses:
wherein monitoring sympathetic and parasympathetic activity comprises receiving data from a sensor that measures at least one of electrodermal activity, heart rate variability, thermometry, pupillometry and electrocardiogram information of the patient or other user. (Para. [0013], “The method can also include receiving an input relating to autonomic nervous system activity of the patient, including, for example, receiving data from a sensor that measures heart rate variability of the patient;…”).
Regarding Claim 119, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 113 as explained above.
Hamner additionally discloses:
wherein at least one of the first electrical nerve stimulation signal and the second electrical nerve stimulation signal comprises burst stimulation. (Claim 8, “ …wherein the first electrical nerve stimulation signal comprises burst stimulation.”).
Regarding Claim 122, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 113 as explained above.
Hamner additionally discloses:
wherein stimulating the second peripheral nerve is during only the exhalation phase of the respiratory cycle. (Para. [0015], “The second electrical nerve stimulation signal can occur simultaneously or substantially simultaneously with delivering the first electrical nerve stimulation signal;” Claim 58, “…wherein delivering the second electrical nerve stimulation signal occurs simultaneously with delivering the first electrical nerve stimulation signal.”).
As explained above, Hamner’s “simultaneous” first and second stimulations results in stimulating the second peripheral nerve during only the exhalation phase of the respiratory cycle in the method of Hamner as modified by Stahmann and Garcia.
Regarding Independent Claim 133, Hamner teaches:
A wearable neurostimulation system for transcutaneously stimulating peripheral nerves of a patient or other user near or on an ear regulated by a rhythmic biological signal, the system comprising: (Title, “Systems and methods for treating cardiac dysfunction through peripheral nerve stimulation;” Para. [0109], “Stimulation of the tragus can occur, for example, noninvasively via a plug, earpiece, or other device that can include electrodes for transcutaneous electrical stimulation in some cases. FIG. 3D illustrates an embodiment of a tragus stimulator 392 with an earbud configuration positioned in the tragus 398 of the ear 390.”);
a first peripheral nerve effector configured to be positioned proximate a first location on a skin surface on an ear of the patient or other user; (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
a second peripheral nerve effector configured to be positioned at a second location of the patient or other user; (Para. [0110], “In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
a first biomedical sensor configured to detect activity relating to a rhythmic biological signal of the patient or other user (Para. [0161], “In one embodiment, the therapy unit with the inflatable wrist band or arm cuff has a pressure sensor, such as a piezo-resistive transducer, to measure heart rate, blood pressure, or other cardiac parameters, in addition to the stimulation electronics and electrodes.”).
and convert the detected activity into a corresponding rhythmic detection signal; (Para. [0098], “In some embodiments, the responsiveness of stimulation could be dependent on one, two, or more sensors housed in the device to collect, store, and analyze biological measures about the wearer …. Using standard statistical analysis, machine learning, deep learning, or big data techniques, such as a logistical regression or a Naive Bayesian classifier, these biological measures can be analyzed to assess the wearer's activity state, such as sedentary versus active, level of stress and the like, which in turn, can serve as a predictor for changes in blood pressure, cardiac arrhythmias, or cardiac dyssynchrony.”);
wherein the activity comprises respiratory activity; (Para. [0096], “The housing can use a plurality of sensors to collect, store, and analyze biological measures about the wearer including, but not limited to … respiratory rate…”);
a controller in operable communication with the first biomedical sensor, (Para. [0014], “ The system can include, for example, a controller; a first peripheral nerve effector configured to be positioned on a patient's skin on an extremity of the patient; and/or at least one biomedical sensor or data input source configured to provide feedback information.”);
the controller configured to analyze the rhythmic detection signal and recognize one or more features of the rhythmic biological signal of the patient or other user in real-time, (Para. [0107], “ Stimulation parameters, such as frequency or pulse width among others, nerve target locations (e.g., tibial and/or saphenous nerves for example) or dosing regimen (e.g., duration or time of day of stimulation sessions) could be adjusted based on estimations of sympathetic and/or parasympathetic activity. In some embodiments, significant changes in sympathetic and/or parasympathetic activity can be used to predict the onset of a ventricular and/or atrial dyssynchrony or heart rhythm abnormalities, and the device can start stimulation to prevent or reduce the duration of the dyssynchrony event. Adjustments could be made in real-time…”);
wherein the controller is configured to generate a first electrical nerve stimulation signal to the first peripheral nerve effector to transcutaneously stimulate a first peripheral nerve … (Para. [0014], “ The controller can be configured to generate a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate a first peripheral nerve sufficient to modify at least one brain or spinal cord autonomic feedback loop relating to the cardiac arrhythmia or hypertension;” Para. [0099], “ In some embodiments, a system can sense an increase or decrease in HRV of about or more than about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 75%, 100%, or more over a baseline value (or target desired HRV value) and institute a change in one, two, or more stimulation modality parameters accordingly.”);
and wherein the controller is configured to generate a second electrical nerve stimulation signal to the second peripheral nerve effector to transcutaneously stimulate a second peripheral nerve … (Para. [0014], “The controller can be configured to generate a second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate a second peripheral nerve sufficient to modify at least one brain or spinal cord autonomic feedback loop relating to the cardiac arrhythmia or hypertension.”).
Hamner does not disclose:
wherein the first biomedical sensor is configured to measure a phase of a respiratory cycle based on an assessment of sounds associated with the respiratory activity;
wherein the controller is configured to generate a first electrical nerve stimulation signal to the first peripheral nerve effector to transcutaneously stimulate a first peripheral nerve upon detection of an exhalation phase of the respiratory cycle
and wherein the controller is configured to generate a second electrical nerve stimulation signal to the second peripheral nerve effector to transcutaneously stimulate a second peripheral nerve upon detection of the exhalation phase of the respiratory cycle
Stahmann describes “Methods and systems for detecting medical disorders through synergistic use of one or more medical devices…” (Abstract). Stahmann is reasonably pertinent to the problem faced by the inventor and is thus analogous art.
Stahmann teaches:
wherein the first biomedical sensor is configured to measure a phase of a respiratory cycle based on an assessment of sounds associated with the respiratory activity (Para. [0111], “For example, respiration sounds may be detectable using the accelerometer of a CRM or a patient-external microphone.”)
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 method of Hamner with the teachings of Stahmann (i.e., to use a microphone to monitor respiration in the manner of Stahmann) in order to prevent interference from patient movement from degrading respiration sound detection (Stahmann at Para. [0111]).
Garcia describes “Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) in migraine patients” (Title). Garcia is analogous art.
Garcia teaches:
wherein the controller is configured to generate a first electrical nerve stimulation signal to the first peripheral nerve effector to transcutaneously stimulate a first peripheral nerve upon detection of an exhalation phase of the respiratory cycle; (Pg. 5, Second Paragraph, “Stimulation was gated, with 0.5-second delay, after peak inhalation (i.e. during exhalation, for eRAVANS) or after peak exhalation (i.e. during inhalation, for iRAVANS).”);
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 method of combined Hamner and Stahmann with the teachings of Garcia (i.e., to use onset of exhalation as features of the measured rhythmic biological signal, and to stimulate the vagus nerve only during exhalation in the manner of Garcia) in order to facilitate treatment of migraines, either in addition to or in place of Hamner’s cardiac dysfunction treatment (Garcia at Pg. 2, First Paragraph).
The combination of Hamner, Stahman and Garcia does not expressly disclose:
and wherein the controller is configured to generate a second electrical nerve stimulation signal to the second peripheral nerve effector to transcutaneously stimulate a second peripheral nerve upon detection of the exhalation phase of the respiratory cycle
However, Hamner teaches delivering stimulation to the first and second peripheral nerve effectors simultaneously (Hamner at Para. [0015], “The second electrical nerve stimulation signal can occur simultaneously or substantially simultaneously with delivering the first electrical nerve stimulation signal;” Hamner at Claim 58, “…wherein delivering the second electrical nerve stimulation signal occurs simultaneously with delivering the first electrical nerve stimulation signal.”).
Keeping in line with the teachings of Hamner, it would have been obvious to further modify the device of combined Hamner, Stahman and Garcia such that the second electrical nerve stimulation signal stimulates a second peripheral nerve “upon detection of the exhalation phase of the respiratory cycle” because (1) Hamner teaches delivering stimulation to the first and second peripheral nerve effectors simultaneously (Hamner at Para. [0015]; Hamner at Claim 58) and (2) because Garcia teaches stimulating the vagus nerve only during exhalation to facilitate treatment of migraines, as explained above (see Garcia at Pg. 2, First Paragraph; Pg. 5, Second Paragraph). Stimulating the vagus nerve only during exhalation in the manner of Garcia while delivering both stimulations simultaneously in the manner of Hamner results in delivering the second stimulation in the manner claimed.
Regarding Claim 134, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 133 as explained above.
Hamner additionally discloses:
wherein the first peripheral nerve is an auricular branch of a vagus nerve. (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
Regarding Claim 135, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 133 as explained above.
Hamner additionally discloses:
wherein the second peripheral nerve is on a wrist. (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
Regarding Claim 136, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 133 as explained above.
Hamner additionally discloses:
wherein the second electrical nerve stimulation signal is offset at a preselected time interval from the first electrical nerve stimulation signal (Para. [0015], “Delivering the second electrical nerve stimulation signal can be offset temporally from delivering the first electrical nerve stimulation signal, such as between about 1.0 millisecond to about 2.1 milliseconds in some cases.”).
Regarding Claim 137, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 133 as explained above.
Hamner additionally discloses:
wherein the controller is further configured to adjust one or more of the first electrical nerve stimulation signal and the second electrical nerve stimulation signal based on the one or more features of the rhythmic biological signal (Para. [0015], “ The method can also include adjusting the first electrical nerve stimulation signal upon identifying abnormal sympathetic activity in the patient. The method can also include adjusting the second electrical nerve stimulation signal upon identifying abnormal parasympathetic activity in the patient.”).
Regarding Claim 139, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 133 as explained above.
Stahmann additionally teaches:
wherein the first biomedical sensor comprises a microphone (Para. [0111], “For example, respiration sounds may be detectable using the accelerometer of a CRM or a patient-external microphone.”)
Claim 121 is rejected under 35 U.S.C. 103 as being unpatentable over over previously cited WO 2018039458 A1 to Hamner et al. (“Hamner”) in view of US 20050076909 A1 to Stahmann et al. (“Stahmann”), Garcia RG, Lin RL, Lee J, Kim J, Barbieri R, Sclocco R, Wasan AD, Edwards RR, Rosen BR, Hadjikhani N, Napadow V. Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation in migraine patients. Pain. 2017 Aug;158(8):1461-1472 (“Garcia”) as applied to Claim 113 above, and further in view of previously cited U.S. Patent Publication No. 2017/0087364 A1 to Cartledge et al. ("Cartledge").
Regarding Claim 121, the combination of Hamner, Stahmann and Garcia renders obvious the entirety of Claim 113 as explained above.
Hamner does not disclose:
further comprising delivering a third electrical nerve stimulation signal transcutaneously to stimulate one or more additional nerves selected from the group consisting of the trigeminal nerve, greater auricular nerve, auriculotemporal nerve, and the lesser occipital nerve
Cartledge describes a “Transcutaneous electrostimulator and methods for electric stimulation” (Title). Cartledge is analogous art.
Cartledge teaches:
further comprising delivering a third electrical nerve stimulation signal transcutaneously to stimulate one or more additional nerves selected from the group consisting of the trigeminal nerve, greater auricular nerve, auriculotemporal nerve, and the lesser occipital nerve(Para. [0270], “Second, the Helix Cuff 1610 is surprisingly comfortable and, after a short time, the user no longer feels its presence. This is because the measures for attaching the Helix Cuff 1610 to the ear use geometric constraints without applying constant pressure on the auricular surface. As is known, constant pressure on auricular surfaces is uncomfortable, such as the pressure exerted by clip-on earrings. In addition, the attachment zone of the Helix Cuff 1610 resides on an especially inactive nerve. For such a small part of the anatomy, four different sensory nerves connect to the external ear. As shown in the diagram of FIG. 19, these nerves are (1) the greater auricular nerve, (2) the lesser occipital nerve, (3) the auricular branch of the vagus nerve, and (4) the auriculotemporal nerve. The greater auricular nerve is a branch of the cervical plexus. It innervates the posteromedial, posterolateral, and inferior auricle (lower two-thirds both anteriorly and posteriorly). The lesser occipital nerve innervates a small portion of the helix. The auricular branch of the vagus nerve innervates the concha and most of the area around the auditory meatus. Finally, the auriculotemporal nerve originates from the mandibular branch of the trigeminal nerve. It innervates the anterosuperior and anteromedial aspects of the auricle. It is known that in the perimeter portion of the ear (sections 2 and 4) are less influential than the portion of the ear lobe (section 1) and that the lesser occipital nerve communicates with a zone that is less influential than the other three;” Para. [0024], “Other embodiments can have electrodes placed on both sides of the user's head but each respective electrode pair (or set) is only on one side of the user's head;” Para. [0273], “One Helix Cuff 1610 can be placed on both ears with equal comfort and ease, independent of the particular geometries of the two ears;” Para. [0472]);
More specifically, the “third electrical nerve stimulation signal” is delivered by a second of Cartledge’s “helix cuffs,” which Cartledge indicates may be used additively.
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 Hamner, Stahmann and Garcia with the teachings of Cartledge (i.e., to additionally include in the device of Hamner such a “third electrical nerve stimulation signal” in the form of Cartledge’s “helix cuff” to stimulate the trigeminal nerve) in order to treat headaches and migraines (Cartledge at Para. [0427])
Claims 123-125 and 127-128 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited WO 2018039458 A1 to Hamner et al. (“Hamner”) in view of Garcia RG, Lin RL, Lee J, Kim J, Barbieri R, Sclocco R, Wasan AD, Edwards RR, Rosen BR, Hadjikhani N, Napadow V. Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation in migraine patients. Pain. 2017 Aug;158(8):1461-1472 (“Garcia”)
Regarding Independent Claim 123, Hamner teaches:
A method of transcutaneously neuromodulating one or more peripheral nerves of a patient or other user with a wearable neuromodulation device regulated by a measured rhythmic biological signal, the method comprising: (Title, “Systems and methods for treating cardiac dysfunction through peripheral nerve stimulation;” Para. [0022], “The system can include, for example, a wearable device that includes a controller; a first peripheral nerve effector configured to be positioned on a patient's skin on an extremity of the patient; and at least one biomedical sensor or data input source configured to provide feedback information.”);
positioning a first peripheral nerve effector proximate a skin surface on a first location of the patient or other user to neuromodulate a first peripheral nerve of the patient or other user; (Para. [0110], “In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
positioning a second peripheral nerve effector proximate a skin surface on a second location of the patient or other user to neuromodulate a second peripheral nerve of the patient or other user; (Para. [0110], “In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
measuring a rhythmic biological signal of the patient or other user and determining one or more features of the measured rhythmic biological signal of the patient or other user, (Para. [0161], “In one embodiment, the therapy unit with the inflatable wrist band or arm cuff has a pressure sensor, such as a piezo-resistive transducer, to measure heart rate, blood pressure, or other cardiac parameters, in addition to the stimulation electronics and electrodes.”);
wherein the measured rhythmic biological signal is respiratory activity (Para. [0096], “The housing can use a plurality of sensors to collect, store, and analyze biological measures about the wearer including, but not limited to … respiratory rate…”);
delivering a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate the first peripheral nerve… (Para. [0014], “ The controller can be configured to generate a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate a first peripheral nerve sufficient to modify at least one brain or spinal cord autonomic feedback loop relating to the cardiac arrhythmia or hypertension;” Para. [0099], “ In some embodiments, a system can sense an increase or decrease in HRV of about or more than about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 75%, 100%, or more over a baseline value (or target desired HRV value) and institute a change in one, two, or more stimulation modality parameters accordingly.”);
and delivering a second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate the second peripheral nerve… (Para. [0014], “The controller can be configured to generate a second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate a second peripheral nerve sufficient to modify at least one brain or spinal cord autonomic feedback loop relating to the cardiac arrhythmia or hypertension.”);
wherein the first peripheral nerve is a vagus nerve, (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
and the second peripheral nerve is a nerve other than the vagus nerve, (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
and wherein the first peripheral nerve effector and the second peripheral nerve effector are not placed within an inner ear or an ear canal of an ear of the patient or other user (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
Hamner does not disclose:
and wherein the one or more features comprise an exhalation phase and an inhalation phase of the respiratory activity;
delivering a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate the first peripheral nerve during only the exhalation phase
and delivering a second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate the second peripheral nerve during only the exhalation phase or only the inhalation phase
Garcia describes “Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) in migraine patients” (Title). Garcia is analogous art.
Garcia teaches:
and wherein the one or more features of the measured rhythmic biological signal comprise an onset of an inhalation phase of the respiratory cycle and the onset of an exhalation phase of the respiratory cycle; (Pg. 5, Second Paragraph, “Stimulation was gated, with 0.5-second delay, after peak inhalation (i.e. during exhalation, for eRAVANS) or after peak exhalation (i.e. during inhalation, for iRAVANS).”);
delivering a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate the first peripheral nerve during only the exhalation phase of the respiratory cycle (Pg. 5, Second Paragraph, “Stimulation was gated, with 0.5-second delay, after peak inhalation (i.e. during exhalation, for eRAVANS) or after peak exhalation (i.e. during inhalation, for iRAVANS).”)
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 method of Hamner with the teachings of Garcia (i.e., to use onset of inhalation and exhalation as features of the measured rhythmic biological signal, and to stimulate the vagus nerve only during exhalation in the manner of Garcia) in order to facilitate treatment of migraines, either in addition to or in place of Hamner’s cardiac dysfunction treatment (Garcia at Pg. 2, First Paragraph).
The combination of Hamner and Garcia does not expressly disclose:
and wherein the controller is configured to generate a second electrical nerve stimulation signal to the second peripheral nerve effector to transcutaneously stimulate a second peripheral nerve upon detection of the exhalation phase of the respiratory cycle
However, Hamner teaches delivering stimulation to the first and second peripheral nerve effectors simultaneously (Hamner at Para. [0015], “The second electrical nerve stimulation signal can occur simultaneously or substantially simultaneously with delivering the first electrical nerve stimulation signal;” Hamner at Claim 58, “…wherein delivering the second electrical nerve stimulation signal occurs simultaneously with delivering the first electrical nerve stimulation signal.”).
Keeping in line with the teachings of Hamner, it would have been obvious to further modify the device of combined Hamner and Garcia such that the second electrical nerve stimulation signal stimulates a second peripheral nerve “upon detection of the exhalation phase of the respiratory cycle” because (1) Hamner teaches delivering stimulation to the first and second peripheral nerve effectors simultaneously (Hamner at Para. [0015]; Hamner at Claim 58) and (2) because Garcia teaches stimulating the vagus nerve only during exhalation to facilitate treatment of migraines, as explained above (see Garcia at Pg. 2, First Paragraph; Pg. 5, Second Paragraph). Stimulating the vagus nerve only during exhalation in the manner of Garcia while delivering both stimulations simultaneously in the manner of Hamner results in delivering the second stimulation in the manner claimed.
Regarding Claim 124, the combination of Hamner and Garcia renders obvious the entirety of Claim 123 as explained above.
Hamner additionally discloses:
wherein measuring the rhythmic biological signal of the patient or other user and determining the one or more features of the measured rhythmic biological signal of the patient or other user is in real-time. (Para. [0107], “ Stimulation parameters, such as frequency or pulse width among others, nerve target locations (e.g., tibial and/or saphenous nerves for example) or dosing regimen (e.g., duration or time of day of stimulation sessions) could be adjusted based on estimations of sympathetic and/or parasympathetic activity. In some embodiments, significant changes in sympathetic and/or parasympathetic activity can be used to predict the onset of a ventricular and/or atrial dyssynchrony or heart rhythm abnormalities, and the device can start stimulation to prevent or reduce the duration of the dyssynchrony event. Adjustments could be made in real-time…”);
Regarding Claim 125, the combination of Hamner and Garcia renders obvious the entirety of Claim 123 as explained above.
Hamner additionally discloses:
further comprising delivering the second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate the second peripheral nerve during only the exhalation phase(Para. [0015], “The second electrical nerve stimulation signal can occur simultaneously or substantially simultaneously with delivering the first electrical nerve stimulation signal;” Claim 58, “…wherein delivering the second electrical nerve stimulation signal occurs simultaneously with delivering the first electrical nerve stimulation signal.”).
As explained above, Hamner’s “simultaneous” first and second stimulations results in stimulating the second peripheral nerve during only the exhalation phase of the respiratory cycle in the method of Hamner as modified by Stahmann and Garcia.
Regarding Claim 127, the combination of Hamner and Garcia renders obvious the entirety of Claim 123 as explained above.
Hamner additionally discloses:
wherein at least one of the first location or the second location is on an ear of the patient or other user. (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
Regarding Claim 128, the combination of Hamner and Garcia renders obvious the entirety of Claim 123 as explained above.
Hamner additionally discloses:
wherein at least one of the first location or the second location is not on an ear of the patient or other user. (Para. [0110], “ In one embodiment, a system can include a stimulator on the wrist to target median nerve and a stimulator in the ear to target the auricular branch of the vagus nerve.”);
Claim 126 is are rejected under 35 U.S.C. 103 as being unpatentable over previously cited WO 2018039458 A1 to Hamner et al. (“Hamner”) in view of Garcia RG, Lin RL, Lee J, Kim J, Barbieri R, Sclocco R, Wasan AD, Edwards RR, Rosen BR, Hadjikhani N, Napadow V. Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation in migraine patients. Pain. 2017 Aug;158(8):1461-1472 (“Garcia”) as applied to Claim 123 above, and further in view of Hu, H., Li, S. & Li, S. Pain modulation effect of breathing-controlled electrical stimulation (BreEStim) is not likely to be mediated by deep and fast voluntary breathing. Sci Rep 5, 14228 (2015) (“Hu”)
Regarding Claim 126, the combination of Hamner and Garcia renders obvious the entirety of Claim 123 as explained above.
The combination of Hamner and Garcia does not disclose:
further comprising delivering the second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate the second peripheral nerve during only the inhalation phase
Hu describes “Voluntary breathing-controlled electrical stimulation (BreEStim), a novel non-invasive and non-pharmacological treatment protocol for neuropathic pain management…” (Abstract). Hu is analogous art.
Hu teaches:
further comprising delivering the second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate the second peripheral nerve during only the inhalation phase; (Pg. 3, Second Paragraph, “A pair of trimmed surface electrodes (2 × 2 cm2) was placed on the medial aspect of the distal forearm where the median nerve travels from the forearm to hand. The two electrodes were separated approximately 10 mm. An electrical stimulator (Digitimer, UK, model D185-HB4) was controlled by the experimental computer via a customized LabView (National Instrument, Austin, TX) program. Similar to the Breathing-only session, subjects were instructed to take self-initiated fast and deep inhalation without preceding or following voluntary exhalation. A single-pulse electrical stimulus would be trigged once the airflow rate reached a preset threshold (40% of its peak value) (Fig. 1) during voluntary inhalation.”)
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 method of combined Hamner and Garcia with the teachings of Hu (i.e., to stimulate the median nerve only during inhalation in the manner of Hu) in order to increase pain threshold (Hu at Pg. 5, First Paragraph).
Claim 138 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited WO 2018039458 A1 to Hamner et al. (“Hamner”) in view of Garcia RG, Lin RL, Lee J, Kim J, Barbieri R, Sclocco R, Wasan AD, Edwards RR, Rosen BR, Hadjikhani N, Napadow V. Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation in migraine patients. Pain. 2017 Aug;158(8):1461-1472 (“Garcia”) as applied to Claim 123 above, and further in view of US 20050076909 A1 to Stahmann et al. (“Stahmann”).
Regarding Claim 138, the combination of Hamner and Garcia renders obvious the entirety of Claim 123 as explained above.
The combination of Hamner and Garcia does not disclose:
wherein measuring the rhythmic biological signal of the patient or other user comprises assessment of sounds using a microphone
Stahmann describes “Methods and systems for detecting medical disorders through synergistic use of one or more medical devices…” (Abstract). Stahmann is reasonably pertinent to the problem faced by the inventor and is thus analogous art.
Stahmann teaches:
wherein measuring the rhythmic biological signal of the patient or other user comprises assessment of sounds using a microphone (Para. [0111], “For example, respiration sounds may be detectable using the accelerometer of a CRM or a patient-external microphone.”)
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 method of Hamner and Garcia with the teachings of Stahmann (i.e., to use a microphone to monitor respiration in the manner of Stahmann) in order to prevent interference from patient movement from degrading respiration sound detection (Stahmann at Para. [0111]).
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.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796