DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 56-62, 65-68, 73-78, 81, 84-92, and 95-98 are rejected under 35 U.S.C. 103 as being unpatentable by Hamner(WO 2018039458 A1) (cited previously).
Regarding claim 56, Hamner discloses a system comprising: a control module; a neuro-stimulation unit operationally controlled by said control module and configured to generate an electrical stimulation signal at a frequency of between 40-50 Hz; and at least two electrodes configured to be positioned in simultaneous dermal contact with an inner surface of the wrist of a subject, proximately to a median nerve of the subject, wherein each of said at least two electrodes is connected to said neuro- stimulation unit for delivering said generated electrical stimulation signal from said neuro-stimulation unit to said subject, wherein said electrical stimulation signal is configured to apply a neuromodulation treatment to said subject, to reduce occurrences of an arrhythmia- related condition in said subject(The device could also be responsive to number of episodes of symptoms, including chest pain, dyspnea, lightheadedness, and/or palpitations signifying the presence of arrhythmias[0111], In some embodiments, the treatment device 10 is a wrist-worn device that can include, for example, 1) an array of electrodes 16 encircling the wrist, 2) a skin interface to ensure good electrical contact to the person, 3) an electronics box or housing 12 containing the stimulator or pulse generator 18, sensors 20, and other associated electronics such as a controller or processor 22 for executing instructions, memory 24 for storing instructions[0065]. Typically for nerve excitation in the wrist, two electrodes 200' are placed longitudinally along the nerve with a reasonable spacing of at least 1 cm, as shown in FIG. 2B, which typically results in band width of at least 1 cm where the electrodes are located[0066]. In some embodiments, the intraburst frequency could be about or at least about 10 Hz, 20Hz, 30 Hz, 40 Hz, 50 Hz, 100 Hz, 250 Hz, 500 Hz, 1 kHz, or more[0145]. . In some embodiments, the electrical stimulation signal could have a frequency of about 5 Hz, about 250 Hz, or about 2,000 Hz[0014]). It would be obvious to one of ordinary skill in the art before the effective filing date to assume that the nerve stimulation system of Hammer teaches the ability to stimulate at a frequency between 40-50Hz. The system teaches stimulation at values both greater and less than the claimed range, so it’s obvious the system has the ability to stimulate at the median frequency claimed.
Regarding claim 57, Hamner discloses the system according to claim 56, wherein said control module is configured to predict a current or oncoming occurrence of an arrythmia-related condition with respect to said subject, based on received input data that is indicative of at least one parameter selected from the following categories of parameters: activity status parameters of the subject, prandial status parameters of the subject, and emotional state parameters of the subject, and to operate said neuro-stimulation unit to generate said electrical stimulation signal based, at least in part, on said predicting, wherein said generated electrical stimulation signal is delivered from said neuro-stimulation unit via said at least two electrodes to said subject(The housing can use a plurality of sensors to collect, store, and analyze biological measures about the wearer including, but not limited to, blood pressure, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), muscle activity (e.g., EMG using electrodes), cardiovascular rhythm measures (e.g., heart rate, heart rate variability, or ventricular and/or atrial desynchrony using electrodes to measure ECG, heart rhythm abnormalities), skin conductance (e.g., skin conductance response, galvanic skin response, using electrodes), respiratory rate, skin temperature, pupil diameter, and sleep state (e.g., awake, light sleep, deep sleep, REM). In some embodiments, the device can provide stimulation based on measurements of one or more biological measures, a determination of a person's state, and/or a prediction of cardiac dysrhythmia, cardiac desynchrony, and/or a change in blood pressure[0096]).
Regarding claim 58, Hamner discloses the system according to claim 57, wherein said: i. activity status parameters of the subject indicate that the subject is at least one of: eating, lying down, sleeping, walking, running, exercising, or driving; ii. prandial status parameters of the subject indicate that the subject is at least one of: hungry, currently eating, or recently ate; and iii. emotional state parameters of the subject indicate that the subject is at least one of: stressed, relaxed, in a positive mood, depressed, anxious, or traumatized(In some embodiments, the responsiveness could be dependent on activity. For instance in arrhythmias that may be exacerbated with activity, a motion sensor such as an accelerometer or gyroscope could sense if a person is exercising, for example[0097]. 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 desynchrony[0098]. In one embodiment, the wearable monitor can have a processing unit and memory that collects, stores, processes, and analyzes the biological measures, along with other data input by the wearer[0118]. In some embodiments, the wearable monitor can take user input about events, including diet history, medication history, caffeine intake, alcohol intake, sodium intake, etc[0119]).
Regarding claim 59, Hamner the system according to claim 57, wherein said control module is further configured to receive, as an additional input, data that is indicative of at least one additional parameter with respect to the subject, selected from the group consisting of: fatigue, tightness of the chest, palpitations, dizziness, fainting, headaches, shortness of breath, sensation of "emptiness" in the chest, rapid or fluttering heartbeats, skipping heart beats, pressure in the throat, coldness or chills, dehydration, blood-related parameters, anemia diagnosis, digestion-related symptoms, insomnia, and hormonal data, and wherein said predicting is further based, at least in part, on correlating, in said subject, at least one of said parameters comprising said additional input, with an occurrence of said arrythmia-related condition, wherein said correlating is based on current and historical information associated with occurrences of said arrythmia-related condition in said subject(One embodiment of the system could centrally store biological measures from multiple wearers on a server system (e.g., the cloud), along with other relevant demographic data about each user, including age, weight, height, gender, ethnicity, etc. Data collected from multiple wearers can be analyzed using standard statistical analysis, machine learning, deep learning, or big data techniques, , such as a logistic regression or Naive Bayes classifier (or other classifiers), to improve prediction of cardiac dysrhythmia, cardiac desynchrony, blood pressure or blood pressure changes by determining correlations between biological measures and other recorded events and cardiac dysrhythmia, cardiac desynchrony, and/or increased blood pressure. These correlations can be used to set parameters of the stimulation waveform applied by the therapy unit, determine best time to apply stimulation therapy, and/or adapt the stimulation waveform applied by the therapy unit in real time[0113]).
Regarding claim 60, Hamner discloses the system according to claim 56, wherein said control module is further configured to receive, as input, a heart activity signal of said subject, and wherein said control module is further configured to process said heart activity signal to derive one or more heart activity-related parameters selected from the group consisting of: heart rate variability (HRV), heart rate recovery, heart rate reserve, premature atrial contractions (PAC), ventricular premature contractions, atrial tachycardia, supraventricular tachycardia, RR interval, average interval between normal heart beats (AVNN), standard deviation of NN intervals (SDNN), root mean square of successive differences between normal heartbeats (rMSSD), pNN50, low frequency activity (LF), and high frequency activity (HF)( Assessing at least one of sympathetic and parasympathetic activity of a subject comprises measuring HRV in the subject, such as with a wrist-worn device, and also include measuring heart rate and/or electrodermal activity[0019]).
Regarding claim 61, Hamner discloses the system according to claim 60, wherein said control module is further configured to detect, based on said heart activity-related parameters, a current or oncoming occurrence of an arrythmia-related condition with respect to said subject, and to operate said neuro-stimulation unit to generate said electrical stimulation signal based, at least in part, on said detecting, and wherein said generated electrical stimulation signal is delivered from said neuro-stimulation unit via said at least two electrodes to said subject(The system can include a peripheral nerve stimulator including a pulse generator and at least two electrodes configured to deliver electrical stimulation to a nerve, acupressure point, or meridian in the patient's limbs. The stimulation can be sufficient in some embodiments to reduce one or more of: blood pressure, the occurrence rate of cardiac arrhythmia, duration of cardiac arrhythmia, and cardioversion. The system can also include one, two, or more sensors. The stimulator and/or the sensor could be implantable within a patient or wearable. The stimulator and/or the sensor could be percutaneous or transcutaneous in some embodiments[0011]).
Regarding claim 62, Hamner discloses the system according to claim 56, wherein said control module is further configured to determine that the autonomous nervous system of said subject is in a sympathetic state or a parasympathetic state(Also disclosed herein is a method for treating cardiac arrhythmias or hypertension. The method can include any number of assessing at least one of sympathetic and parasympathetic activity of a subject and determining the presence of abnormal sympathetic or parasympathetic activity in the subject[0019]).
Regarding claim 63, Hamner discloses the system according to claim 62, wherein, when said autonomous nervous system of said subject is in a sympathetic state, said control module is configured to operate said neuro -stimulation unit to generate said electrical stimulation signal at a frequency of between 1-5 Hz(For example, in some embodiments, relatively low frequency stimulation of a target nerve (e.g., below a threshold value, e.g., about 5 Hz) can potentially inhibit the nerve and thus decreases sympathetic activity, while higher frequency stimulation (e.g., above a threshold value, e.g., about 5 Hz) can potentially excite the nerve and thus increases sympathetic activity[0107]).
Regarding claim 65, Hamner discloses the system according to claim 56, further comprising at least one of: an electrocardiogram (ECG) sensor, a photoplethysmogram (PPG) sensor, and an accelerometer(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 including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV),photoplethysmography (PPG), or ventricular and/or atrial desynchrony using electrodes to measure ECG and/or heart rhythm abnormalities)[0098]).
Regarding claim 66, Hamner discloses the system according to claim 65, wherein said control module comprises instructions to perform one or more of: a. detect the cardiac-related parameter of the subject by utilizing the PPG sensor; b. detect the cardiac-related parameter of the subject by utilizing the accelerometer; c. detect the cardiac-related parameter of the subject by utilizing the ECG sensor(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 including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV),photoplethysmography (PPG), or ventricular and/or atrial desynchrony using electrodes to measure ECG and/or heart rhythm abnormalities)[0098]).
Regarding claim 67, Hamner discloses the system according to claim 56, wherein said control module comprises instructions to generate said electrical stimulation signal at a frequency of between 40-50 Hz when said arrhythmia-related condition is one or more of atrial fibrillation (AF), atrial flutter (AFL), atrial tachycardia (AT) and premature atrial complex (PAC)( Other non-limiting examples of arrhythmias that can be treated using systems and methods as disclosed herein can include, for example, long QT syndrome, torsades de pointes, premature atrial contractions, wandering atrial pacemaker, multifocal atrial tachycardia, atrial flutter, supraventricular tachycardia (including PSVT), AV nodal reentrant tachycardia, junctional rhythm, junctional tachycardia, premature junctional complex, premature ventricular contractions, accelerated idioventricular rhythm, monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, and ventricular fibrillation[0061]. The pulse width could be, for example, between about 50 μ8 and about 100μ8, between about 15( s and about 200μ8, between about 300μ8 and about 400μ8, or other ranges included any two of the aforementioned values. In some embodiments, the electrical stimulation signal could have a frequency of about 5 Hz, about 250 Hz, or about 2,000 Hz[0014]).
Regarding claim 68, Hamner discloses the system according to claim 56, wherein said control module comprises instructions to generate said electrical stimulation signal at a frequency of between 1-5 Hz when said arrhythmia-related condition is premature ventricular complex (PVC) or supraventricular tachycardia (SVT)(In some embodiments, the electrical stimulation signal could have a frequency of about 5 Hz, about 250 Hz, or about 2,000 Hz. In some embodiments, a peripheral nerve effector can be positioned on an extremity of the patient offset from one or more nerves, such as the median nerve, radial nerve, or ulnar nerve for example, and targeting a target nerve, such as a cutaneous nerve. The arrhythmia to be treated can be, for example, atrial fibrillation, atrial flutter, supraventricular tachycardia, or ventricular tachycardia[0013]).
Regarding claim 73, Hamner discloses a method comprising: a. providing a system comprising: i. a control module; ii. a neuro-stimulation unit operationally controlled by said control module and configured to generate an electrical stimulation signal at a frequency of between 40-50 Hz; and iii. at least two electrodes configured to be positioned in simultaneous dermal contact with an inner surface of the wrist of a subject, proximately to a median nerve of the subject, wherein each of said at least two electrodes is connected to said neuro- stimulation unit for delivering said generated electrical stimulation signal from said neuro-stimulation unit to said subject; wherein said electrical stimulation signal is configured to apply a neuromodulation treatment to said subject, to reduce occurrences of an arrhythmia- related condition in said subject; and b. placing said at least two electrodes in simultaneous dermal contact with an inner surface of the wrist of said subject, such that each of said at least two electrodes is positioned along a lengthwise axis thereof, proximately, and substantially parallel to, a longitudinal axis of said median nerve(The device could also be responsive to number of episodes of symptoms, including chest pain, dyspnea, lightheadedness, and/or palpitations signifying the presence of arrhythmias[0111], In some embodiments, the treatment device 10 is a wrist-worn device that can include, for example, 1) an array of electrodes 16 encircling the wrist, 2) a skin interface to ensure good electrical contact to the person, 3) an electronics box or housing 12 containing the stimulator or pulse generator 18, sensors 20, and other associated electronics such as a controller or processor 22 for executing instructions, memory 24 for storing instructions[0065]. Typically for nerve excitation in the wrist, two electrodes 200' are placed longitudinally along the nerve with a reasonable spacing of at least 1 cm, as shown in FIG. 2B, which typically results in band width of at least 1 cm where the electrodes are located[0066]. In some embodiments, the intraburst frequency could be about or at least about 10 Hz, 20Hz, 30 Hz, 40 Hz, 50 Hz, 100 Hz, 250 Hz, 500 Hz, 1 kHz, or more[0145]). It would be obvious to one of ordinary skill in the art before the effective filing date to assume that the nerve stimulation system of Hammer teaches the ability to stimulate at a frequency between 40-50Hz. The system teaches stimulation at values both greater and less than the claimed range, so it’s obvious the system has the ability to stimulate at the median frequency claimed.
Regarding claim 74, Hamner discloses the method according to claim 73, further comprising predicting a current or oncoming occurrence of an arrythmia-related condition with respect to said subject, based on received input data that is indicative of at least one parameter selected from the following categories of parameters: activity status parameters of the subject, prandial status parameters of the subject, and emotional state parameters of the subject; and operating said neuro-stimulation unit to generate said electrical stimulation signal based, at least in part, on said predicting, wherein said generated electrical stimulation signal is delivered from said neuro-stimulation unit via said at least two electrodes to said subject(The housing can use a plurality of sensors to collect, store, and analyze biological measures about the wearer including, but not limited to, blood pressure, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), muscle activity (e.g., EMG using electrodes), cardiovascular rhythm measures (e.g., heart rate, heart rate variability, or ventricular and/or atrial desynchrony using electrodes to measure ECG, heart rhythm abnormalities), skin conductance (e.g., skin conductance response, galvanic skin response, using electrodes), respiratory rate, skin temperature, pupil diameter, and sleep state (e.g., awake, light sleep, deep sleep, REM). In some embodiments, the device can provide stimulation based on measurements of one or more biological measures, a determination of a person's state, and/or a prediction of cardiac dysrhythmia, cardiac desynchrony, and/or a change in blood pressure[0096]).
Regarding claim 75, Hamner discloses the method according to claim 74, wherein said control module is further configured to receive, as an additional input, data that is indicative of at least one additional parameter with respect to the subject, selected from the group consisting of: fatigue, tightness of the chest, palpitations, dizziness, fainting, headaches, shortness of breath, sensation of "emptiness" in the chest, rapid or fluttering heartbeats, skipping heart beats, pressure in the throat, coldness or chills, dehydration, blood-related parameters, anemia diagnosis, digestion-related symptoms, insomnia, and hormonal data, and wherein said predicting is further based, at least in part, on correlating, in said subject, at least one of said parameters comprising said additional input, with an occurrence of said arrythmia-related condition, wherein said correlating is based on current and historical information associated with occurrences of said arrythmia-related condition in said subject(In some embodiments, the responsiveness could be dependent on activity. For instance in arrhythmias that may be exacerbated with activity, a motion sensor such as an accelerometer or gyroscope could sense if a person is exercising, for example[0097]. 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 desynchrony[0098]. In one embodiment, the wearable monitor can have a processing unit and memory that collects, stores, processes, and analyzes the biological measures, along with other data input by the wearer[0118]. In some embodiments, the wearable monitor can take user input about events, including diet history, medication history, caffeine intake, alcohol intake, sodium intake, etc[0119]).
Regarding claim 76, Hamner discloses the method according to claim 73, wherein said control module is further configured to receive, as an additional input, a heart activity signal of said subject, and wherein said control module is further configured to process said heart activity signal to derive one or more heart activity-related parameters selected from the group consisting of: heart rate variability (HRV), heart rate recovery, heart rate reserve, premature atrial contractions (PAC), ventricular premature contractions, atrial tachycardia, supraventricular tachycardia, RR interval, average interval between normal heart beats (AVNN), standard deviation of NN intervals (SDNN), root mean square of successive differences between normal heartbeats (rMSSD), pNN50, low frequency activity (LF), and high frequency activity (HF)( Assessing at least one of sympathetic and parasympathetic activity of a subject comprises measuring HRV in the subject, such as with a wrist-worn device, and also include measuring heart rate and/or electrodermal activity[0019]).
Regarding claim 77, Hamner discloses the method according to claim 76, further comprising detecting, based on said one or more heart activity-related parameters, a current or oncoming occurrence of an arrythmia-related condition with respect to said subject; and operating said neuro-stimulation unit to generate said electrical stimulation signal based, at least in part, on said detecting, wherein said generated electrical stimulation signal is delivered from said neuro-stimulation unit via said at least two electrodes to said subject(The system can include a peripheral nerve stimulator including a pulse generator and at least two electrodes configured to deliver electrical stimulation to a nerve, acupressure point, or meridian in the patient's limbs. The stimulation can be sufficient in some embodiments to reduce one or more of: blood pressure, the occurrence rate of cardiac arrhythmia, duration of cardiac arrhythmia, and cardioversion. The system can also include one, two, or more sensors. The stimulator and/or the sensor could be implantable within a patient or wearable. The stimulator and/or the sensor could be percutaneous or transcutaneous in some embodiments[0011]).
Regarding claim 78, Hamner discloses the method according to claim 73, wherein said control module is further configured to determine that the autonomous nervous system of said subject is in a sympathetic state or a parasympathetic state, and to operate said neuro- stimulation unit to generate said electrical stimulation signal based, at least in part, on said determining(Also disclosed herein is a method for treating cardiac arrhythmias or hypertension. The method can include any number of assessing at least one of sympathetic and parasympathetic activity of a subject and determining the presence of abnormal sympathetic or parasympathetic activity in the subject[0019]).
Regarding claim 79, Hamner discloses the method according to claim 78, wherein, when said autonomous nervous system of said subject is in a sympathetic state, said control module is configured to operate said neuro -stimulation unit to generate said electrical stimulation signal at a frequency of between 1-5 Hz( For example, in some embodiments, relatively low frequency stimulation of a target nerve (e.g., below a threshold value, e.g., about 5 Hz) can potentially inhibit the nerve and thus decreases sympathetic activity, while higher frequency stimulation (e.g., above a threshold value, e.g., about 5 Hz) can potentially excite the nerve and thus increases sympathetic activity[0107]).
Regarding claim 81, Hamner discloses the method according to claim 73, wherein said system further comprises at least one of: an electrocardiogram (ECG) sensor, a pho toplethy smogram (PPG) sensor, and an accelerometer; and wherein said control module is configured to receive, as input, data from at least one of said: an electrocardiogram (ECG) sensor, a pho toplethy smogram (PPG) sensor, and an accelerometer that is indicative of at least one parameter selected from the groups of parameters consisting of: activity status parameters of the subject, prandial status parameters of the subject, and emotional state parameters of the subject(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 including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV),photoplethysmography (PPG), or ventricular and/or atrial desynchrony using electrodes to measure ECG and/or heart rhythm abnormalities)[0098]).
Regarding claim 84, Hamner discloses a system comprising: a. a control module; b. a neuro-stimulation unit operationally controlled by said control module and configured to generate an electrical stimulation signal; and c. at least two electrodes configured to be positioned in simultaneous dermal contact with an inner surface of the wrist of a subject, proximately to a median nerve of the subject, wherein each of said at least two electrodes is connected to said neuro- stimulation unit for delivering said generated electrical stimulation signal from said neuro-stimulation unit to said subject(The device could also be responsive to number of episodes of symptoms, including chest pain, dyspnea, lightheadedness, and/or palpitations signifying the presence of arrhythmias[0111], In some embodiments, the treatment device 10 is a wrist-worn device that can include, for example, 1) an array of electrodes 16 encircling the wrist, 2) a skin interface to ensure good electrical contact to the person, 3) an electronics box or housing 12 containing the stimulator or pulse generator 18, sensors 20, and other associated electronics such as a controller or processor 22 for executing instructions, memory 24 for storing instructions[0065]. Typically for nerve excitation in the wrist, two electrodes 200' are placed longitudinally along the nerve with a reasonable spacing of at least 1 cm, as shown in FIG. 2B, which typically results in band width of at least 1 cm where the electrodes are located[0066]. In some embodiments, the intraburst frequency could be about or at least about 10 Hz, 20Hz, 30 Hz, 40 Hz, 50 Hz, 100 Hz, 250 Hz, 500 Hz, 1 kHz, or more[0145]); wherein said control module is configured to: i. receive, as input, a heart activity signal of said subject; ii. detect, based on said heart activity signal, a current or oncoming occurrence of an arrythmia-related condition with respect to said subject; and iii. operate said neuro-stimulation unit to generate said electrical stimulation signal at a frequency of between 40-50 Hz, wherein said generated electrical stimulation signal is delivered from said neuro-stimulation unit via said at least two electrodes to said subject; and wherein said electrical stimulation signal is configured to apply a neuromodulation treatment to said subject, to reduce occurrences of an arrhythmia- related condition in said subject(The system can also be configured to receive 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; and/or receiving data from a sensor that measures at least one of electrodermal activity, thermometry, and ECG information of the patient[0014]. The system can include a peripheral nerve stimulator including a pulse generator and at least two electrodes configured to deliver electrical stimulation to a nerve, acupressure point, or meridian in the patient's limbs. The stimulation can be sufficient in some embodiments to reduce one or more of: blood pressure, the occurrence rate of cardiac arrhythmia[0011]).
Regarding claim 85, Hamner discloses the system according to claim 84, wherein said control module is configured to detect said oncoming occurrence of said arrythmia-related condition, based, at least in part, on detecting, in said heart activity signal, at least one of: premature atrial complexes (PAC), and premature ventricular complexes (PVC), wherein said detecting is based on measuring, in said heart activity signal, a percentage increase in said at least one of PAC and PVC, relative to a baseline measurement in said subject(Other non-limiting examples of arrhythmias that can be treated using systems and methods as disclosed herein can include, for example, long QT syndrome, torsades de pointes, premature atrial contractions, wandering atrial pacemaker, multifocal atrial tachycardia, atrial flutter, supraventricular tachycardia (including PSVT), AV nodal reentrant tachycardia, junctional rhythm, junctional tachycardia, premature junctional complex, premature ventricular contractions, accelerated idioventricular rhythm, monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, and ventricular fibrillation. Targeting those specific nerves and utilizing appropriately customized stimulation results in more effective therapy (e.g., reduced arrhythmia episodes such as fibrillations or fibrillation episodes and/or shorter duration of fibrillation episodes; reduced palpitations/sensation of arrhythmias; improved rate control of arrhythmias such as a decrease in heart rate of about or at least about 10%, 20%, 30%, 40%, or more compared to pre-treatment (with or without cessation of the arrhythmia);[0061]).
Regarding claim 86, Hamner discloses the system according to claim 84, further comprising at least one of: an electrocardiogram (ECG) sensor, a pho toplethy smogram (PPG) sensor, and an accelerometer(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 including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV),photoplethysmography (PPG), or ventricular and/or atrial desynchrony using electrodes to measure ECG and/or heart rhythm abnormalities)[0098]).
Regarding claim 87, Hamner discloses the system according to claim 86, wherein said control module comprises instructions to perform one or more of: a. detect the cardiac-related parameter of the subject by utilizing the PPG sensor; b. detect the cardiac-related parameter of the subject by utilizing the accelerometer; c. detect the cardiac-related parameter of the subject by utilizing the ECG sensor(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 including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV),photoplethysmography (PPG), or ventricular and/or atrial desynchrony using electrodes to measure ECG and/or heart rhythm abnormalities)[0098]).
Regarding claim 88, Hamner discloses the system according to claim 84, wherein said control module comprises instructions to generate said electrical stimulation signal at a frequency of between 40-50 Hz when said arrhythmia-related condition is one or more of atrial fibrillation (AF), atrial flutter (AFL), atrial tachycardia (AT) and premature atrial complex (PAC)( Other non-limiting examples of arrhythmias that can be treated using systems and methods as disclosed herein can include, for example, long QT syndrome, torsades de pointes, premature atrial contractions, wandering atrial pacemaker, multifocal atrial tachycardia, atrial flutter, supraventricular tachycardia (including PSVT), AV nodal reentrant tachycardia, junctional rhythm, junctional tachycardia, premature junctional complex, premature ventricular contractions, accelerated idioventricular rhythm, monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, and ventricular fibrillation[0061]. The pulse width could be, for example, between about 50 μ8 and about 100μ8, between about 15 μ8 and about 200μ8, between about 300μ8 and about 400μ8, or other ranges included any two of the aforementioned values. In some embodiments, the electrical stimulation signal could have a frequency of about 5 Hz, about 250 Hz, or about 2,000 Hz[0014]).
Regarding claim 89, Hamner discloses the system according to claim 84, wherein said control module comprises instructions to generate said electrical stimulation signal at a frequency of between 1-5 Hz when said arrhythmia-related condition is premature ventricular complex (PVC) or supraventricular tachycardia (SVT)( In some embodiments, the electrical stimulation signal could have a frequency of about 5 Hz, about 250 Hz, or about 2,000 Hz. In some embodiments, a peripheral nerve effector can be positioned on an extremity of the patient offset from one or more nerves, such as the median nerve, radial nerve, or ulnar nerve for example, and targeting a target nerve, such as a cutaneous nerve. The arrhythmia to be treated can be, for example, atrial fibrillation, atrial flutter, supraventricular tachycardia, or ventricular tachycardia[0013]).
Regarding claim 90, Hamner discloses the system according to claim 84, wherein said control module is further configured to process said heart activity signal to derive one or more heart activity-related parameters selected from the group consisting of: heart rate variability (HRV), heart rate recovery, heart rate reserve, premature atrial contractions (PAC), ventricular premature contractions, atrial tachycardia, supraventricular tachycardia, RR interval, average interval between normal heart beats (AVNN), standard deviation of NN intervals (SDNN), root mean square of successive differences between normal heartbeats (rMSSD), pNN50, low frequency activity (LF), and high frequency activity (HF), and wherein said detecting is based, at least in part, on said one or more heart activity-related parameters(Assessing at least one of sympathetic and parasympathetic activity of a subject comprises measuring HRV in the subject, such as with a wrist-worn device, and also include measuring heart rate and/or electrodermal activity[0019]).
Regarding claim 91, Hamner discloses the system according to claim 84, wherein said control module is further configured to predict a current or oncoming occurrence of an arrythmia- related condition with respect to said subject, based on received input data that is indicative of at least one additional parameter selected from the group consisting of: an 10 activity status of the subject, a prandial status of the subject, and an emotional state of the subject, and to operate said neuro-stimulation unit to generate said electrical stimulation signal based, at least in part, on said detect(The housing can use a plurality of sensors to collect, store, and analyze biological measures about the wearer including, but not limited to, blood pressure, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), muscle activity (e.g., EMG using electrodes), cardiovascular rhythm measures (e.g., heart rate, heart rate variability, or ventricular and/or atrial desynchrony using electrodes to measure ECG, heart rhythm abnormalities), skin conductance (e.g., skin conductance response, galvanic skin response, using electrodes), respiratory rate, skin temperature, pupil diameter, and sleep state (e.g., awake, light sleep, deep sleep, REM). In some embodiments, the device can provide stimulation based on measurements of one or more biological measures, a determination of a person's state, and/or a prediction of cardiac dysrhythmia, cardiac desynchrony, and/or a change in blood pressure[0096]).
Regarding claim 92, Hamner discloses the system according to claim 84, wherein said control module is further configured to determine that the autonomous nervous system of said subject is in a sympathetic state or a parasympathetic state(Also disclosed herein is a method for treating cardiac arrhythmias or hypertension. The method can include any number of assessing at least one of sympathetic and parasympathetic activity of a subject and determining the presence of abnormal sympathetic or parasympathetic activity in the subject[0019]).
Regarding claim 93, Hamner discloses the system according to claim 92, wherein, when said autonomous nervous system of said subject is in a sympathetic state, said control module is configured to operate said neuro -stimulation unit to generate said electrical stimulation signal at a frequency of between 1-5 Hz( For example, in some embodiments, relatively low frequency stimulation of a target nerve (e.g., below a threshold value, e.g., about 5 Hz) can potentially inhibit the nerve and thus decreases sympathetic activity, while higher frequency stimulation (e.g., above a threshold value, e.g., about 5 Hz) can potentially excite the nerve and thus increases sympathetic activity[0107]).
Regarding claim 95, Hamner discloses the system according to claim 84, further comprising at least one of: an electrocardiogram (ECG) sensor, a photoplethysmogram (PPG) sensor, and an accelerometer(Also disclosed herein is a method for treating cardiac arrhythmias or hypertension. The method can include any number of assessing at least one of sympathetic and parasympathetic activity of a subject and determining the presence of abnormal sympathetic or parasympathetic activity in the subject[0019]).
Regarding claim 96, Hamner discloses the system according to claim 95, wherein said control module comprises instructions to perform one or more of: a. detect the cardiac-related parameter of the subject by utilizing the PPG sensor; b. detect the cardiac-related parameter of the subject by utilizing the accelerometer; c. detect the cardiac-related parameter of the subject by utilizing the ECG sensor(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 including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV),photoplethysmography (PPG), or ventricular and/or atrial desynchrony using electrodes to measure ECG and/or heart rhythm abnormalities)[0098]).
Regarding claim 97, Hamner discloses the system according to claim 84, wherein said control module comprises instructions to generate said electrical stimulation signal at a frequency of between 40-50 Hz when said arrhythmia-related condition is one or more of atrial fibrillation (AF), atrial flutter (AFL), atrial tachycardia (AT) and premature atrial complex (PAC)( Other non-limiting examples of arrhythmias that can be treated using systems and methods as disclosed herein can include, for example, long QT syndrome, torsades de pointes, premature atrial contractions, wandering atrial pacemaker, multifocal atrial tachycardia, atrial flutter, supraventricular tachycardia (including PSVT), AV nodal reentrant tachycardia, junctional rhythm, junctional tachycardia, premature junctional complex, premature ventricular contractions, accelerated idioventricular rhythm, monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, and ventricular fibrillation[0061]. The pulse width could be, for example, between about 50 μ8 and about 100μ8, between about 15 and about 200μ8, between about 300μ8 and about 400μ8, or other ranges included any two of the aforementioned values. In some embodiments, the electrical stimulation signal could have a frequency of about 5 Hz, about 250 Hz, or about 2,000 Hz[0014]).
Regarding claim 98, Hamner discloses the system according to claim 84, wherein said control module comprises instructions to generate said electrical stimulation signal at a frequency of between 1-5 Hz when said arrhythmia-related condition is premature ventricular complex (PVC) or supraventricular tachycardia (SVT)( In some embodiments, the electrical stimulation signal could have a frequency of about 5 Hz, about 250 Hz, or about 2,000 Hz. In some embodiments, a peripheral nerve effector can be positioned on an extremity of the patient offset from one or more nerves, such as the median nerve, radial nerve, or ulnar nerve for example, and targeting a target nerve, such as a cutaneous nerve. The arrhythmia to be treated can be, for example, atrial fibrillation, atrial flutter, supraventricular tachycardia, or ventricular tachycardia[0013]).
Claim(s) 64, 80, and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner(WO 2018039458 A1).
Regarding claim 64, Hamner discloses the system according to claim 62, wherein, when said autonomous nervous system of said subject is in a parasympathetic state, said control module is configured to operate said neuro -stimulation unit to generate said electrical stimulation signal at a frequency of between 40-50 Hz( In other words, in some embodiments, relatively low frequency stimulation of the target nerve (e.g., below a threshold value, e.g., about 5 Hz) can potentially inhibit the nerve and thus decreases parasympathetic activity, while higher frequency stimulation (e.g., above a threshold value, e.g., about 5 Hz) can potentially excite the nerve and thus increases parasympathetic activity[0107]. In some embodiments, the intraburst frequency could be about or at least about 10 Hz, 20Hz, 30 Hz, 40 Hz, 50 Hz, 100 Hz, 250 Hz, 500 Hz, 1 kHz, or more[0145]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Hamner to teach the frequency signal during a parasympathetic state. Hamner teaches the ability to stimulate at a frequency signal above 5 Hz during a parasympathetic state and later teaches frequencies of 40 Hz and 50 Hz. Therefore, it’s obvious that Hamner discloses the claimed material.
Regarding claim 80, Hamner discloses the method according to claim 78, wherein, when said autonomous nervous system of said subject is in a parasympathetic state, said control module is configured to operate said neuro -stimulation unit to generate said electrical stimulation signal at a frequency of between 40-50 Hz(In other words, in some embodiments, relatively low frequency stimulation of the target nerve (e.g., below a threshold value, e.g., about 5 Hz) can potentially inhibit the nerve and thus decreases parasympathetic activity, while higher frequency stimulation (e.g., above a threshold value, e.g., about 5 Hz) can potentially excite the nerve and thus increases parasympathetic activity[0107]. In some embodiments, the intraburst frequency could be about or at least about 10 Hz, 20Hz, 30 Hz, 40 Hz, 50 Hz, 100 Hz, 250 Hz, 500 Hz, 1 kHz, or more[0145]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Hamner to teach the frequency signal during a parasympathetic state. Hamner teaches the ability to stimulate at a frequency signal above 5 Hz during a parasympathetic state and later teaches frequencies of 40 Hz and 50 Hz. Therefore, it’s obvious that Hamner discloses the claimed material.
Regarding claim 94, Hamner discloses the system according to claim 92, wherein, when said autonomous nervous system of said subject is in a parasympathetic state, said control module is configured to operate said neuro -stimulation unit to generate said electrical stimulation signal at a frequency of between 40-50 Hz(In other words, in some embodiments, relatively low frequency stimulation of the target nerve (e.g., below a threshold value, e.g., about 5 Hz) can potentially inhibit the nerve and thus decreases parasympathetic activity, while higher frequency stimulation (e.g., above a threshold value, e.g., about 5 Hz) can potentially excite the nerve and thus increases parasympathetic activity[0107]. In some embodiments, the intraburst frequency could be about or at least about 10 Hz, 20Hz, 30 Hz, 40 Hz, 50 Hz, 100 Hz, 250 Hz, 500 Hz, 1 kHz, or more[0145]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Hamner to teach the frequency signal during a parasympathetic state. Hamner teaches the ability to stimulate at a frequency signal above 5 Hz during a parasympathetic state and later teaches frequencies of 40 Hz and 50 Hz. Therefore, it’s obvious that Hamner discloses the claimed material.
Claim(s) 69-72, 82, 83, 99, and 100 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner in view of Rosenbluth(US 20190001129 A1).
Regarding claim 69, Hamner discloses the system according to claim 56, but fails to explicitly state wherein said control module is further configured to measure an electrical current associated with said electrical stimulation signal between said at least two electrodes, and to determine that a positioning of said at least two electrodes relative to said median nerve of the subject is incorrect when said measured electrical current is lower than a predetermined baseline value.
However, Rosenbluth teaches “ The intensity or amplitude of the electrical stimulation may vary from 0 mA to 500 mA, and a preferred current may be approximately 1 mA to 6 mA (e.g., about 0 mA, about 0.1 mA, about 1 mA, about 6 mA, about 10 mA, about 20 mA, about 30 mA, about 40 mA, about 50 mA, about 100 mA, about 200 mA, about 300 mA, about 400 mA, about 500 mA, and ranges between such values). Certain preferred settings are derived from the clinical study described above that provided a valuable reduction in tremor sustained for a time period. Electrical stimulation can be adjusted in different patients and with different methods of electrical stimulation[0129]. An appropriate combination of electrodes would be selected each time the device is repositioned or based off the detected stimulation needs[0188]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Hamner with the mutli-modal stimulation system of Rosenbluth. Doing so would teach to reconfigure the electrode positions on the patient’s wrist based on stimulation feedback.
Regarding claim 70, Hamner in view of Rosenbluth discloses the system according to claim 69, wherein said predetermined baseline value is determined by measuring an electrical current associated with said electrical stimulation signal between said at least two electrodes, when said at least two electrodes are each positioned along a lengthwise axis thereof proximately, and substantially parallel, to a longitudinal axis of said median nerve(Hamner - The illustrations of FIGS. 2D-2S depict various options for targeting these nerves or regions. In some cases, to stimulate a specific nerve, the active electrode can be aligned directly over the nerve such that the path of electrical current flows from the active electrode through the nerve (and surrounding tissue) to the return electrode[0068]).
Regarding claim 71, Hamner discloses the system according to claim 56, but fails to disclose wherein said control module is configured to increase an intensity of said delivered electrical stimulation signal or issue an indication to the user and/or a health care practitioner to adjust the positioning of a device comprising said control module, said neuro-stimulation unit and said at least two electrodes in response to a received input indicating that the delivered electrical stimulation signal does not cause any sensation in a vicinity of the electrodes or when a measured electrical current is lower than a baseline value.
However, Rosenbluth teaches “The stimulation parameters may be adjusted automatically, or controlled by the user. The stimulation parameters may include on/off, time duration, intensity, pulse rate, pulse width, waveform shape, and the ramp of pulse on and off. The intensity or amplitude of the electrical stimulation may vary from 0 mA to 500 mA, and a preferred current may be approximately 1 mA to 6 mA (e.g., about 0 mA, about 0.1 mA, about 1 mA, about 6 mA, about 10 mA, about 20 mA, about 30 mA, about 40 mA, about 50 mA, about 100 mA, about 200 mA, about 300 mA, about 400 mA, about 500 mA, and ranges between such values. The device may contain closed-loop control of the stimulation to adaptively respond to detected tremor or activity levels. The device enables sensation of tremor through an activity sensor, data logging and systematic adjustment of the stimulation parameters to achieve an optimal tremor reduction[0213]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Hamner with the mutli-modal stimulation system of Rosenbluth. Doing so would teach to adjustments to the system based on stimulation feedback.
Regarding claim 72, Hamner discloses the system according to claim 56, but fails to disclose wherein said control module is configured to reduce an intensity of said electrical stimulation signal in response to a received input indicating that the delivered electrical stimulation signal causes involuntary movement of a portion of the subject's body in the vicinity of the at least two electrodes.
However, Rosenbluth discloses “The device could include a controls module 740 that communicates with the processor 797 and could be used by the user to control stimulation parameters. The controls allow the user to adjust the operation of the device. For example, the controls can be configured to turn the device on, turn the device off, adjust a parameter of the effector, such as the intensity. The device may include a sensor 780 connected to the processor 797 which may detect information of predefined parameters and transmits said parameter information to the processor 797. The device may include a data storage unit 770 connected to the sensor 780 and processor 797; and a power supply 750 may be connected to the processor[0120]. These sensors may also be used to determine activities, such as to distinguish involuntary movements (e.g., tremor) from voluntary movements (e.g., drinking, writing)[0193]. Varying other parameters such as amplitude can be a way to improve waveform comfort. For example, the amplitude of the stimulation can be adjusted based on the threshold necessary to produce strong sensory perception and paresthesia without eliciting motor contraction[0263])”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Hamner with the mutli-modal stimulation system of Rosenbluth. Doing so would teach to adjustments to the system based on stimulation feedback.
Regarding claim 82, Hamner discloses the method according to claim 73, but fails to disclose wherein said control module is further configured to measure an electrical current associated with said electrical stimulation signal between said at least two electrodes, and to determine that a positioning of said at least two electrodes relative to said median nerve of the subject is incorrect when said measured electrical current is lower than a predetermined baseline value.
However, Rosenbluth teaches “ The intensity or amplitude of the electrical stimulation may vary from 0 mA to 500 mA, and a preferred current may be approximately 1 mA to 6 mA (e.g., about 0 mA, about 0.1 mA, about 1 mA, about 6 mA, about 10 mA, about 20 mA, about 30 mA, about 40 mA, about 50 mA, about 100 mA, about 200 mA, about 300 mA, about 400 mA, about 500 mA, and ranges between such values). Certain preferred settings are derived from the clinical study described above that provided a valuable reduction in tremor sustained for a time period. Electrical stimulation can be adjusted in different patients and with different methods of electrical stimulation[0129]. An appropriate combination of electrodes would be selected each time the device is repositioned or based off the detected stimulation needs[0188]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Hamner with the mutli-modal stimulation system of Rosenbluth. Doing so would teach to reconfigure the electrode positions on the patient’s wrist based on stimulation feedback.
Regarding claim 83, Hamner in view of Rosenbluth discloses the method according to claim 82, wherein said predetermined baseline value is determined by measuring an electrical current associated with said electrical stimulation signal between said at least two electrodes, when said at least two electrodes are each positioned along a lengthwise axis thereof proximately, and substantially parallel, to a longitudinal axis of said median nerve(Hamner - The illustrations of FIGS. 2D-2S depict various options for targeting these nerves or regions. In some cases, to stimulate a specific nerve, the active electrode can be aligned directly over the nerve such that the path of electrical current flows from the active electrode through the nerve (and surrounding tissue) to the return electrode[0068]).
Regarding claim 99, Hamner discloses the system according to claim 84, but fails to disclose wherein said control module is further configured to measure an electrical current associated with said electrical stimulation signal between said at least two electrodes, and to determine that a positioning of said at least two electrodes relative to said median nerve of the subject is incorrect when said measured electrical current is lower than a predetermined baseline value.
However, Rosenbluth teaches “ The intensity or amplitude of the electrical stimulation may vary from 0 mA to 500 mA, and a preferred current may be approximately 1 mA to 6 mA (e.g., about 0 mA, about 0.1 mA, about 1 mA, about 6 mA, about 10 mA, about 20 mA, about 30 mA, about 40 mA, about 50 mA, about 100 mA, about 200 mA, about 300 mA, about 400 mA, about 500 mA, and ranges between such values). Certain preferred settings are derived from the clinical study described above that provided a valuable reduction in tremor sustained for a time period. Electrical stimulation can be adjusted in different patients and with different methods of electrical stimulation[0129]. An appropriate combination of electrodes would be selected each time the device is repositioned or based off the detected stimulation needs[0188]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Hamner with the mutli-modal stimulation system of Rosenbluth. Doing so would teach to reconfigure the electrode positions on the patient’s wrist based on stimulation feedback.
Regarding claim 100, Hamner in view of Rosenbluth teaches the system according to claim 99, wherein said predetermined baseline value is determined by measuring an electrical current associated with said electrical stimulation signal between said at least two electrodes, when said at least two electrodes are each positioned along a lengthwise axis thereof proximately, and substantially parallel, to a longitudinal axis of said median nerve(Hamner - The illustrations of FIGS. 2D-2S depict various options for targeting these nerves or regions. In some cases, to stimulate a specific nerve, the active electrode can be aligned directly over the nerve such that the path of electrical current flows from the active electrode through the nerve (and surrounding tissue) to the return electrode[0068]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 2/2/2026, with respect to the 102(a)(1) and 102(a)(2) rejections have been fully considered and are persuasive. The 102 rejections of claims 56-62, 65-68, 73-78, 81, 84-92, and 95-98 have been withdrawn. However, prior art Hammer still maintains a 103 rejection for all claims. Applicant argues that the frequency range of Hammer fails to teach the specific range of the claim from the purpose of reducing arrhythmia occurrences. However, the stimulation range of Hammer includes the claimed frequency range and the purpose of the stimulation of Hammer is to treat arrhythmia with select stimulation activation[0014]. Applicant further argues prior art does not teach “at least two electrodes, positioned in simultaneous dermal contact with an inner surface of the wrist, proximately to a median nerve, and configured to deliver stimulation for arrhythmia reduction”. However, Hammer teaches “FIGS. 2A and 2B illustrate an embodiment of peripheral nerve stimulation, where the median nerve is stimulated by electrodes placed longitudinally along the nerve (FIG. 2B) versus excitation by an array of electrodes circumferentially distributed around the wrist (FIG. 2A)” and contains multiple drawings and written description of a wrist watch stimulation system[Fig. 2A], [Fig. 2B], [Fig. 2U]. The argument that the Hammer device can also be placed elsewhere on the body does not overrule that is Hammer is primarily a wrist wrap device to stimulate around the median nerve, which is the same as the claimed material. Applicant further argues that Hammer fails to disclose what cardiac features are analyzed, how prediction is performed, how prediction accuracy is evaluated, or how prediction alters stimulation parameters in an arrhythmia-specific manner. However, Hammer teaches “Heart rhythm measures can be recorded with optical, electrical, and/or accelerometer-based sensors. In particular, studies have shown that increased stress levels can increase blood pressure. Activities such as exercise, can also affect cardiac rate and/or rhythm, and/or affect blood pressure - measuring accelerometry (motion), heart rate, etc. could help identify these activities and normalize the measurements by similar activities. Additionally, hypertension has been correlated with heart failure - measuring ventricle desynchrony with ECG sensors could help identify the effectiveness of the stimulation to chronically reduce hypertension. Thus, using standard statistical analysis, machine learning, deep learning, or big data techniques,, such as a logistical regression or Naive Bayes classifier, these biological measures can be analyzed to assess a person's state, such as level of stress, which in turn, can serve as a predictor for increases in cardiac dysrhythmia, cardiac desynchrony, and/or blood pressure. In some embodiments, the device can provide stimulation based on measurements of one or more biological measures, a determination of a person's state, and/or a prediction of cardiac dysrhythmia, cardiac desynchrony, and/or a change in blood pressure[0098]”. Hammer teaches obtained physiological parameters, how these parameters are then analyzed by an algorithm, a prediction is produced from said algorithm, and then stimulation is administered based on the prediction. Applicant further argues the application fails to determine whether the subject is in parasympathetic or sympathetic sate and how that effects stimulation parameters. However, Hammer teaches “ In some embodiments, a wearable device, such as a wrist-worn device can include both electrodermal activity (EDA) sensors and heart rate sensors. This combination of data can in some embodiments advantageously and synergistically provide improved estimation of sympathetic and parasympathetic activity than a single measure alone. In some embodiments, the system can include multiple sensors to measure electrodermal activity in conjunction with heart rate and HRV. Data from the multiple sensors can be analyzed by a hardware or software processor and combined to provide a more accurate estimation of sympathetic and/or parasympathetic activity. In some embodiments, the EDA and HR sensors can be disposed in a wrist-worn device that communicates via a wired or wireless connection to the stimulator or to send data to a centralized remote server (e.g., the cloud). 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 desynchrony or heart rhythm abnormalities, and the device can start stimulation to prevent or reduce the duration of the desynchrony event. Adjustments could be made in real-time, or in subsequent stimulation sessions. In some embodiments, stimulation frequency can be adjusted to either increase or decrease autonomic activity modulated by a single specific nerve, or multiple nerves. For example, in some embodiments, relatively low frequency stimulation of a target nerve (e.g., below a threshold value, e.g., about 5 Hz) can potentially inhibit the nerve and thus decreases sympathetic activity, while higher frequency stimulation (e.g., above a threshold value, e.g., about 5 Hz) can potentially excite the nerve and thus increases sympathetic activity. Additionally, pulse width of the stimulation waveform can be adjusted to recruit more or less of a specific fiber type, including cutaneous fibers, which can inhibit sympathetic activity. The same effect can occur with the same or other target nerves to regulate parasympathetic activity. In other words, in some embodiments, relatively low frequency stimulation of the target nerve (e.g., below a threshold value, e.g., about 5 Hz) can potentially inhibit the nerve and thus decreases parasympathetic activity, while higher frequency stimulation (e.g., above a threshold value, e.g., about 5 Hz) can potentially excite the nerve and thus increases parasympathetic activity. Not to be limited by theory, depending on the stimulation parameters for example, in some cases stimulating the target nerve can increase or decrease either sympathetic activity, parasympathetic activity, or both. In some embodiments, stimulation of the saphenous nerve can affect sympathetic activity, and stimulation of the tibial nerve can affect parasympathetic activity[0109]”. Applicant further argues the prior art fails to disclose the specific sequence “: providing a system configured for arrhythmia reduction; placing electrodes along the wrist proximately and parallel to the median nerve; and delivering 40-50 Hz stimulation to reduce arrhythmia occurrences”. However, it is obvious that the Hammer would preform the sequence in this order because one would obviously place the electrodes on the wrist of the patient before delivering stimulation through the electrodes in an effort to reduce the occurrence of arrhythmias, “The system can include a peripheral nerve stimulator including a pulse generator and at least two electrodes configured to deliver electrical stimulation to a nerve, acupressure point, or meridian in the patient's limbs. The stimulation can be sufficient in some embodiments to reduce one or more of: blood pressure, the occurrence rate of cardiac arrhythmia, duration of cardiac arrhythmia, and cardioversion[0011]”. In light of these arguments, a new 103 rejection is made for all claims 56-100.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796