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 .
Specification
The abstract of the disclosure is objected to because it needs to be more descriptive of the invention. It currently only has eighteen words, which do not adequately describe the invention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-21 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Shelton et al. (hereinafter ‘Shelton’, U.S. PGPub No. 2023/0321444).
In regards to claim 1, Shelton discloses a system for vagus nerve stimulation, comprising: a stimulator implanted in a subject and configured to deliver electrical stimulation to a vagus nerve of the subject via one or more electrodes or electrode pairs ([0057]: "FIG. 1 is a diagram 100 illustrating an exemplary embodiment of a VNS system for treating epilepsy using a VNS stimulator 110 implanted under the skin in the chest of a patient and coupled via a lead wire 104 to a cuff electrode 108 on the vagus nerve 102. In the example shown, four electrode pairs 112 (for a total of 8 electrodes) are used to contact the vagus nerve. ") and a controller configured to control delivery of the electrical stimulation to the vagus nerve of the subject, by titrating a pulse amplitude of stimulation delivered via at least one of the one or more electrodes, based on (a) a predetermined electromyography (EMG) activation threshold for the at least one electrode, and (b) (i) a predetermined neural fulcrum stimulation amplitude for the at least one electrode, or (ii) a stimulation amplitude found to cause a change in a heart rate of the subject ([0059]: "FIG. 2 is a diagram 200 illustrating an exemplary embodiment of a VNS stimulator 204 including a controller 220 with processing circuitry configured to titrate stimulus electrical pulse parameters, including the amplitude of the stimulation pulses, as described in greater detail herein.", [0061]: "The controller 220 may access the memory 214 to receive and process instructions to titrate upward or downward the generated electrical pulses, or to temporarily deactivate the pulse generator 206. In various embodiments, the controller 220 may access information including physical events detected by one or more external sensors (e.g., EMGs, EEGs, EKGs, microphones, etc.).").
In regards to claim 2, Shelton discloses that the controller is further configured to control delivery of the electrical stimulation to the vagus nerve of the subject, by titrating the pulse amplitude of stimulation delivered via at least one of the one or more electrodes, within a range defined by a predetermined electromyography (EMG) activation threshold for the at least one electrode, and a predetermined neural fulcrum stimulation amplitude for the at least one electrode ([0078]: " As another example, once efferent stimulation on the vagus nerve 502 is detected as indicated by EMG readings, or other bodily events are detected relevant to identifying an acceptable stimulation amplitude as described below, the clinician or controller may stop titrating the amplitude, via the controller or other conventional methods used for titrating the stimulus amplitude. In some embodiments, for certain side effects identified by the EMG sensor (e.g., contraction of the larynx), the controller 220 or clinician may determine that a downward titration is necessary.").
In regards to claim 3, Shelton discloses that the controller is further configured to control delivery of the electrical stimulation to the vagus nerve of the subject, by titrating the pulse amplitude of stimulation delivered via at least one of the one or more electrodes, within a range defined by a predetermined electromyography (EMG) activation threshold for the at least one electrode, and a predetermined stimulation amplitude found to cause an increase in heart rate in the subject, for the at least one electrode ([0078]: " As another example, once efferent stimulation on the vagus nerve 502 is detected as indicated by EMG readings, or other bodily events are detected relevant to identifying an acceptable stimulation amplitude as described below, the clinician or controller may stop titrating the amplitude, via the controller or other conventional methods used for titrating the stimulus amplitude. In some embodiments, for certain side effects identified by the EMG sensor (e.g., contraction of the larynx), the controller 220 or clinician may determine that a downward titration is necessary.", [0099]: "Heart Rate Variability (HRV), which can also be measured by an EKG, can be measured so that the efficiency of VNS therapy on patients with epilepsy who have bradycardia or normal heart rate can be compared to patients who have ictal tachycardia.").
In regards to claim 4, Shelton discloses that the one or more electrodes comprises a plurality of electrodes, and the controller is further configured to control delivery of the electrical stimulation to the vagus nerve of the subject, by titrating a pulse amplitude of stimulation delivered via each of the plurality of electrodes, from a predetermined EMG activation threshold for each respective electrode to the predetermined neural fulcrum stimulation amplitude for each respective electrode ([0078]: " As another example, once efferent stimulation on the vagus nerve 502 is detected as indicated by EMG readings, or other bodily events are detected relevant to identifying an acceptable stimulation amplitude as described below, the clinician or controller may stop titrating the amplitude, via the controller or other conventional methods used for titrating the stimulus amplitude. In some embodiments, for certain side effects identified by the EMG sensor (e.g., contraction of the larynx), the controller 220 or clinician may determine that a downward titration is necessary.").
In regards to claim 5, Shelton discloses that the predetermined EMG activation threshold for each electrode comprises a minimum pulse amplitude of stimulation previously determined to evoke an EMG response in the subject ([0087]: "In one embodiment, the stimulation amplitude from the VNS stimulator 204 may be increased for a particular active electrode as long as the EMG sensor does not detect an event like a muscle contraction event coincident with the stimulus pulses. Thereafter, another electrode or cathode, or pair of cathodes, may be titrated upward in a manner similar to the embodiments described above. A unique efferent stimulation threshold may be determined for every anode/cathode pair. The controller 220 can thereupon save these thresholds to the memory 214 (FIG. 2).").
In regards to claim 6, Shelton discloses that the predetermined neural fulcrum stimulation amplitude for each electrode is higher than the respective EMG activation threshold for the electrode, and previously determined to evoke no change in the subject's heart rate during stimulation ([0025]: "In some aspects, the sensor comprises an electromyography (EMG) sensor. In some aspects, the sensor comprises a microphone, and the event comprises a heart rate or an ictal tachycardia event. In some aspects, the sensor comprises a plurality of sensors that detect muscle or neural electrical signals.").
In regards to claim 7, Shelton discloses that the one or more electrodes comprises a plurality of electrodes, and the controller is further configured to select the electrode that has either the lowest EMG activation threshold or the lowest neural fulcrum stimulation amplitude, and to cause delivery of the electrical stimulation to the vagus nerve of the subject, by titrating the pulse amplitude of stimulation delivered via the selected electrode ([0118]: "In a multiple electrode scenario involving electrode pairs, a first cathode may be selected (1112). At 1114, the controller 220 may have the pulse generator 306 deliver stimulation pulses at the previously set stimulus amplitude for the selected cathode.").
In regards to claim 8, Shelton discloses that the system further comprises one or more sensors, each configured to detect or measure a signal indicative of a biomarker of the subject,wherein the controller is further configured to determine a heart rate of the subject based on data received from the one or more sensors, and to control delivery of the electrical stimulation to the vagus nerve of the subject by titrating a pulse amplitude of stimulation delivered via at least one of the one or more electrodes across a range defined by a first amplitude and a second amplitude,wherein (i) the first amplitude is the predetermined EMG activation threshold for the at least one of the one or more electrodes, and (ii) the second amplitude is an amplitude greater than a predetermined neural fulcrum stimulation amplitude for the at least one of the one or more electrodes, and below a predetermined threshold ([0078]: " As another example, once efferent stimulation on the vagus nerve 502 is detected as indicated by EMG readings, or other bodily events are detected relevant to identifying an acceptable stimulation amplitude as described below, the clinician or controller may stop titrating the amplitude, via the controller or other conventional methods used for titrating the stimulus amplitude. In some embodiments, for certain side effects identified by the EMG sensor (e.g., contraction of the larynx), the controller 220 or clinician may determine that a downward titration is necessary.").
In regards to claim 9, Shelton discloses that the controller is further configured to titrate the pulse amplitude of stimulation delivered via at least one of the one or more electrodes downward in response to determining that the heart rate of the subject:(a) has increased following stimulation, when the pulse amplitude of stimulation delivered via at least one of the one or more electrodes is above the predetermined neural fulcrum stimulation amplitude for the at least one of the one or more electrodes, or (b) has exceeded a predetermined threshold ([0096]: "The EKG sensor and/or a microphone or stethoscope can be used to detect these changes in heart rate, including ictal tachycardia events.").
In regards to claim 10, Shelton discloses that the one or more sensors comprises at least one sensor configured to detect or measure a signal indicative of a position and/or activity level of the subject and the controller is further configured to titrate the pulse amplitude of stimulation delivered via at least one of the one or more electrodes downward based on the position and/or activity level of the subject ([0112]: "An EEG, or electroencephalogram, measures electrical activity, including abnormal activity, in the brain. The clinician may place a flexible cap or connected assembly of small electrodes 1004 (here, conducting discs) on the scalp. The signals from the brain flow through the lead wires 1038 to an EEG sensor unit 1035 (similar to the EKG and EMG units).", [0113]: "In measuring brain activity, the EEG can also recognize improvements and therapeutic effects as brain activity stabilizes (e.g., as a result of the pulses generated by VNS stimulator 204). For example, at the outset of titration therapy, the EEG can make measurements as a baseline, and in subsequent sessions over various intervals, the EEG sensor unit 1035 can compare measurements with the baseline measurements. In some embodiments, the EEG sensor unit may include a transceiver or transmitter for sending information to controller 220 on the VNS stimulator 204 (FIG. 2).").
In regards to claim 11, Shelton discloses that the one or more sensors comprise: a) one or more implanted sensors, optionally comprising one or more sensors at least partially contained in a housing of the simulator; b) one or more external sensors, or c) a combination of implanted and external sensors, optionally comprising one or more sensors at least partially contained in a housing of the simulator ([0060]: "In some embodiments, transceiver may further include a wireless transmitter, e.g., for providing feedback to a processor used in a clinician programmer device, or to an external sensor.", [0102]: "Other embodiments may include multiple units corresponding to multiple sensors along with a central processing system housed in one of the units (or another unit) for consolidating and analyzing the data.").
In regards to claim 12, Shelton discloses a method for providing vagus nerve stimulation, comprising: administering stimulation to a vagus nerve of a subject, using an implanted stimulator configured to deliver electrical stimulation to the vagus nerve of the subject via one or more electrodes ([0057]: "FIG. 1 is a diagram 100 illustrating an exemplary embodiment of a VNS system for treating epilepsy using a VNS stimulator 110 implanted under the skin in the chest of a patient and coupled via a lead wire 104 to a cuff electrode 108 on the vagus nerve 102. In the example shown, four electrode pairs 112 (for a total of 8 electrodes) are used to contact the vagus nerve. "), wherein a pulse amplitude of the administered stimulation is set by a controller communicatively linked to the implanted stimulator, the controller being configured to titrate a pulse amplitude of stimulation delivered via at least one of the one or more electrodes, based on a predetermined electromyography (EMG) activation threshold for the at least one electrode, and a predetermined neural fulcrum stimulation amplitude for the at least one electrode ([0059]: "FIG. 2 is a diagram 200 illustrating an exemplary embodiment of a VNS stimulator 204 including a controller 220 with processing circuitry configured to titrate stimulus electrical pulse parameters, including the amplitude of the stimulation pulses, as described in greater detail herein.", [0061]: "The controller 220 may access the memory 214 to receive and process instructions to titrate upward or downward the generated electrical pulses, or to temporarily deactivate the pulse generator 206. In various embodiments, the controller 220 may access information including physical events detected by one or more external sensors (e.g., EMGs, EEGs, EKGs, microphones, etc.).").
In regards to claim 13, Shelton discloses that the controller is further configured to titrate the pulse amplitude of stimulation delivered via at least one of the one or more electrodes, within a range defined by a predetermined electromyography (EMG) activation threshold for the at least one electrode, and a predetermined neural fulcrum stimulation amplitude for the at least one electrode ([0078]: " As another example, once efferent stimulation on the vagus nerve 502 is detected as indicated by EMG readings, or other bodily events are detected relevant to identifying an acceptable stimulation amplitude as described below, the clinician or controller may stop titrating the amplitude, via the controller or other conventional methods used for titrating the stimulus amplitude. In some embodiments, for certain side effects identified by the EMG sensor (e.g., contraction of the larynx), the controller 220 or clinician may determine that a downward titration is necessary.").
In regards to claim 14, Shelton discloses that the one or more electrodes comprises a plurality of electrodes, and the controller is further configured to titrate a pulse amplitude of stimulation delivered via each of the plurality of electrodes, from a predetermined EMG activation threshold for each respective electrode to the predetermined neural fulcrum stimulation amplitude for each respective electrode (above, [0099]: "Heart Rate Variability (HRV), which can also be measured by an EKG, can be measured so that the efficiency of VNS therapy on patients with epilepsy who have bradycardia or normal heart rate can be compared to patients who have ictal tachycardia.").
In regards to claim 15, Shelton discloses that the predetermined EMG activation threshold for each electrode comprises a minimum pulse amplitude of stimulation previously determined to evoke an EMG response in the subject ([0087]: "In one embodiment, the stimulation amplitude from the VNS stimulator 204 may be increased for a particular active electrode as long as the EMG sensor does not detect an event like a muscle contraction event coincident with the stimulus pulses. Thereafter, another electrode or cathode, or pair of cathodes, may be titrated upward in a manner similar to the embodiments described above. A unique efferent stimulation threshold may be determined for every anode/cathode pair. The controller 220 can thereupon save these thresholds to the memory 214 (FIG. 2).").
In regards to claim 16, Shelton discloses that the predetermined neural fulcrum stimulation amplitude for each electrode is higher than the respective EMG activation threshold for the electrode, and previously determined to evoke no change in the subject's heart rate during stimulation ([0025]: "In some aspects, the sensor comprises an electromyography (EMG) sensor. In some aspects, the sensor comprises a microphone, and the event comprises a heart rate or an ictal tachycardia event. In some aspects, the sensor comprises a plurality of sensors that detect muscle or neural electrical signals.").
In regards to claim 17, Shelton discloses that the one or more electrodes comprises a plurality of electrodes, and the controller is further configured to select the electrode that has either the lowest EMG activation threshold or the lowest neural fulcrum stimulation amplitude, and to cause delivery of the electrical stimulation to the vagus nerve of the subject, by titrating the pulse amplitude of stimulation delivered via the selected electrode ([0118]: "In a multiple electrode scenario involving electrode pairs, a first cathode may be selected (1112). At 1114, the controller 220 may have the pulse generator 306 deliver stimulation pulses at the previously set stimulus amplitude for the selected cathode.").
In regards to claim 18, Shelton discloses that the method further comprises the steps of: receiving, by the controller, sensor data indicative of a detection or measurement of a biomarker of the subject, and determining, by the controller, a heart rate of the subject based on the received sensor data, wherein the controller is further configured to titrate the pulse amplitude of stimulation delivered via at least one of the one or more electrodes across a range defined by a first amplitude and a second amplitude, wherein (i) the first amplitude is the predetermined EMG activation threshold for the at least one of the one or more electrodes, and (ii) the second amplitude is an amplitude greater than a predetermined neural fulcrum stimulation amplitude for the at least one of the one or more electrodes, and below a predetermined threshold ([0078]: " As another example, once efferent stimulation on the vagus nerve 502 is detected as indicated by EMG readings, or other bodily events are detected relevant to identifying an acceptable stimulation amplitude as described below, the clinician or controller may stop titrating the amplitude, via the controller or other conventional methods used for titrating the stimulus amplitude. In some embodiments, for certain side effects identified by the EMG sensor (e.g., contraction of the larynx), the controller 220 or clinician may determine that a downward titration is necessary.").
In regards to claim 19, Shelton discloses that the controller is further configured to titrate the pulse amplitude of stimulation delivered via at least one of the one or more electrodes downward in response to determining that the heart rate of the subject: (a) has increased following stimulation, when the pulse amplitude of stimulation delivered via at least one of the one or more electrodes is above the predetermined neural fulcrum stimulation amplitude for the at least one of the one or more electrodes, or (b) has exceeded a predetermined threshold ([0096]: "The EKG sensor and/or a microphone or stethoscope can be used to detect these changes in heart rate, including ictal tachycardia events.").
In regards to claim 20, Shelton discloses a step of: receiving, by the controller, sensor data indicative of a detection or measurement of a position and/or activity level of the subject, wherein the controller is further configured to titrate the pulse amplitude of stimulation delivered via at least one of the one or more electrodes downward based on the position and/or activity level of the subject ([0112]: "An EEG, or electroencephalogram, measures electrical activity, including abnormal activity, in the brain. The clinician may place a flexible cap or connected assembly of small electrodes 1004 (here, conducting discs) on the scalp. The signals from the brain flow through the lead wires 1038 to an EEG sensor unit 1035 (similar to the EKG and EMG units).", [0113]: "In measuring brain activity, the EEG can also recognize improvements and therapeutic effects as brain activity stabilizes (e.g., as a result of the pulses generated by VNS stimulator 204). For example, at the outset of titration therapy, the EEG can make measurements as a baseline, and in subsequent sessions over various intervals, the EEG sensor unit 1035 can compare measurements with the baseline measurements. In some embodiments, the EEG sensor unit may include a transceiver or transmitter for sending information to controller 220 on the VNS stimulator 204 (FIG. 2).").
In regards to claim 21, Shelton discloses that the sensor data indicative of (i) a detection or measurement of a biomarker of the subject, and/or (ii) a position and/or activity level of the subject, is received from: a) one or more implanted sensors, optionally comprising one or more sensors at least partially contained in a housing of the stimulator, b) one or more external sensors, or c) a combination of implanted and external sensors, optionally comprising one or more sensors at least partially contained in a housing of the simulator ([0060]: "In some embodiments, transceiver may further include a wireless transmitter, e.g., for providing feedback to a processor used in a clinician programmer device, or to an external sensor.", [0102]: "Other embodiments may include multiple units corresponding to multiple sensors along with a central processing system housed in one of the units (or another unit) for consolidating and analyzing the data.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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