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 .
Remarks
Claims 1-27, filed 06/20/2024, are currently pending and are under consideration.
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.
Claims 1-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoo et al. (US Patent Application Publication 2019/0001135), hereinafter Yoo.
Regarding claim 1, Yoo discloses a neurostimulation system (e.g. Abstract) comprising:
a neurostimulation device for controllably delivering neural stimuli (e.g. Par. [0046]), the neurostimulation device comprising:
a stimulus source configured to deliver neural stimuli via one or more implantable electrodes to a neural pathway of a patient (e.g. Pars. [0218]-[0220]: different embodiments of an implantable neurostimulation device (implantable electrodes) with a stimulation generator); and
a control unit configured to control the stimulus source to deliver each neural stimulus according to a stimulus intensity parameter (e.g. Par. [0065]: control module for controlling the other modules; Fig. 2: control module 40); and
a processor (e.g. Par. [0061]; Par. [0058]) configured to:
ramp a value of the stimulus intensity parameter up to or down from a predetermined target intensity while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the ramping value of the stimulus intensity parameter (e.g. Par. [0180]: ramping protocol to discover different thresholds of stimulation for producing sensation, recruitment, discomfort, and pain; Fig. 10A; Par. [0198]: ramping protocol described),
wherein the ramp traverses stimulus intensities below a predetermined threshold at a faster rate than stimulus intensities above the predetermined threshold (e.g. Par. [0180]: ramping protocol to discover different thresholds of stimulation for producing sensation, recruitment, discomfort, and pain, the user can give feedback based on pain/discomfort and the stimulation can be adjusted, so the stimulation below a threshold is at a faster rate than above a threshold).
Regarding claim 16, Yoo discloses an automated method of controlling a neurostimulation device to deliver neural stimuli (e.g. Abstract; Par. [0046]), the method comprising:
ramping a value of a stimulus intensity parameter up to or down from a predetermined target intensity, and instructing the neurostimulation device to deliver the neural stimuli according to the ramping value of the stimulus intensity parameter via one or more implanted electrodes (e.g. Par. [0180]: ramping protocol to discover different thresholds of stimulation for producing sensation, recruitment, discomfort, and pain; Fig. 10A; Par. [0198]: ramping protocol described; Pars. [0218]-[0220]: different embodiments of an implantable neurostimulation device (implantable electrodes) with a stimulation generator); and
wherein the ramp traverses stimulus intensities below a predetermined threshold at a faster rate than stimulus intensities above the predetermined threshold (e.g. Par. [0180]: ramping protocol to discover different thresholds of stimulation for producing sensation, recruitment, discomfort, and pain, the user can give feedback based on pain/discomfort and the stimulation can be adjusted, so the stimulation below a threshold is at a faster rate than above a threshold).
Regarding claims 2 and 17, Yoo further discloses wherein the processor is configured to ramp the value of the stimulus intensity parameter up to the predetermined target intensity by: stepping the stimulus intensity parameter to the predetermined threshold (e.g. Fig. 10A: different threshold levels 502a, b, c, d); and ramping the stimulus intensity parameter linearly from the predetermined threshold to the predetermined target intensity at a ramp rate, wherein the stepping is rapid compared to the ramp rate (e.g. Par. [0180]: ramping can be linear; Fig. 10A).
Regarding claims 3 and 18, Yoo further discloses wherein the stepping is vertical (e.g. Fig. 10A).
Regarding claims 4 and 19, Yoo further discloses wherein the processor is configured to ramp the value of the stimulus intensity parameter down from the predetermined target intensity by: ramping the stimulus intensity parameter linearly down from the predetermined target intensity to the predetermined threshold at a ramp rate, and stepping the stimulus intensity parameter down from the predetermined threshold, wherein the stepping is rapid compared to the ramp rate (e.g. Fig. 10A: different threshold levels 502a, b, c, d; Par. [0180]: ramping can be linear).
Regarding claims 5 and 20, Yoo further discloses wherein the stepping is vertical (e.g. Fig. 10A).
Regarding claims 6 and 21, Yoo further discloses wherein the processor is configured to ramp the value of the stimulus intensity parameter up to the predetermined target intensity by: ramping the stimulus intensity parameter exponentially to the predetermined threshold (e.g. Par. [0180]: ramping can be exponential); and ramping the stimulus intensity parameter linearly from the predetermined threshold to the predetermined target intensity at a ramp rate (e.g. Par. [0180]: ramping can be linear).
Regarding claims 7 and 22, Yoo further discloses wherein the processor is configured to ramp the value of the stimulus intensity parameter down from the predetermined target intensity by: ramping the stimulus intensity parameter linearly down from the predetermined target intensity to the predetermined threshold at a ramp rate (e.g. Par. [0180]: ramping can be exponential); and ramping the stimulus intensity parameter exponentially down from the predetermined threshold (e.g. Par. [0180]: ramping can be linear).
Regarding claims 8 and 23, Yoo further discloses wherein the processor is configured to calculate the ramp rate as the predetermined target intensity divided by a predetermined ramp time (e.g. Par. [0079]).
Regarding claims 9 and 24, Yoo further discloses wherein the predetermined threshold is governed by a physiological threshold for the one or more implantable electrodes (e.g. Par. [0179]: perception threshold).
Regarding claims 10 and 25, Yoo further discloses wherein the predetermined threshold is governed by a perceptual marker for the one or more implantable electrodes (e.g. Par. [0179]: perception threshold).
Regarding claims 11 and 26, Yoo further discloses wherein the processor is further configured to cease ramping the value of the stimulus intensity parameter upon expiry of a first timeout period since receipt of a communication from the neurostimulation device (e.g. Par. [0180]: the up-ramping feature stops when reaching a pain threshold, for one cycle, the timing of the ramping waveform is preprogrammed and would either stop ramping due to a user input or reaching the end of the waveform; Par. [0198]: for the calibration process, if a user response is not received in a defined time period then an automatic protocol takes effect: “In step 528 the stimulus is presented to the user and in step 530 the response of the user is sensed or otherwise obtained. If the response is not detected the method returns to step 526 and the stimulus is adjusted according to the assessment protocol in the absence of a user response”).
Regarding claims 12 and 27, Yoo further discloses wherein the processor is further configured to ramp down (e.g. Par. [0180]: once a user-indicated pain threshold is met, a ramp down feature is implemented towards a sensation level: “stimulation intensity is then decreased. The user can then be asked to indicate thresholds as the intensity decreases from pain towards sensation, or patient input is only prompted for by the user device 32 on the upward slope”), upon expiry of a second timeout period since the expiry of the first timeout period without receiving a communication from the neurostimulation device, the value of the stimulus intensity parameter, while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter (e.g. Par. [0180]: for one cycle, the timing of the ramping waveform is preprogrammed and would either down-ramp due to a user input or the programmed waveform; Par. [0198]: for the calibration process, if a user response is not received in a defined time period then an automatic protocol takes effect: “In step 528 the stimulus is presented to the user and in step 530 the response of the user is sensed or otherwise obtained. If the response is not detected the method returns to step 526 and the stimulus is adjusted according to the assessment protocol in the absence of a user response”).
Regarding claim 13, Yoo further discloses wherein the stimulus intensity parameter is an amplitude of a stimulus current pulse (e.g. Par. [0181]: the intensity is the amplitude).
Regarding claim 14, Yoo further discloses wherein the processor is part of the control unit (e.g. Par. [0061]).
Regarding claim 15, Yoo further discloses wherein the processor is part of an external computing device in communication with the neurostimulation device (e.g. Par. [0061]: remote computers).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thacker et al. (US 9,295,840) is directed toward programming patient therapy devices.
Laighin et al. (US 2014/0343625) is directed towards a device for muscle stimulation.
Single et al. (US 2023/0310867) is directed towards a feedback loop control of neuromodulation devices.
Liu et al. (US 2020/0254257) is directed towards electrical stimulation for modulating targeted neural tissue.
Libbus et al. (US 2016/0129259) is directed towards a neurostimulation titration process.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796