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 Status: Claims 1, 4-15 and 17-23 are pending.
Terminal Disclaimer
The terminal disclaimer filed on September 12, 2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11305123 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed on July 21, 2025 have been fully considered but they are not persuasive.
Regarding Claims 1, 14, and 20, Applicant made an argument that Applicant is unable to find in Gerber, “identifying maximum values of the first parameter each from a segment of multiple segments of the pattern of neurostimulation pulses” as recited in claim 1.
This argument has been considered but is not persuasive.
Gerber discloses a stimulation generator delivering stimulation according to the programs in the groups, e.g., simultaneously or a time-interleaved basis, where a therapy group may include a single program or multiple programs (para. [0089]), which reads on “multiple segments of the pattern of neurostimulation pulses”. Gerber discloses that each therapy program specifies values for a set of stimulation parameters, such as amplitude, pulse width, and pulse rate. In addition, each program may specify a particular electrode combination for delivery of stimulation (para. [0089]) and that during the initial programming protocol at least one stimulation threshold is determined for each of electrodes 48 (para. [0090]). Gerber further discloses how these stimulation thresholds are used in para. [0092] and [0158]. Gerber discloses that stimulation thresholds, after being determined, are stored in memory (para. [0093]). The types of thresholds are shown in fig. 14 which shows the relationship between pulse width and amplitude (para. [0165], Fig. 14 of Gerber discloses curve 230 representing an example paresthesia threshold curve as a function of amplitude and pulse width and curve 240 representing an example of a curve for a different diameter nerve fiber, one which may relate to pain/discomfort threshold curves, as a function of amplitude and pulse width. Gerber disclosed that stimulation intensity is a function of the combination of both amplitude of the pulse being applied as well as the pulse width and by varying either the amplitude or the pulse width, changes in the usability range of the other factor may be achieved). Therefore, any values on the curves may be determined, stored, and used to determine appropriate stimulation parameters.
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Claim Rejections - 35 USC § 102/103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-15 and 17-23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Gerber et al. (US 2012/0277621) or, in the alternative, under 35 U.S.C. 103 as obvious over Gerber et al. (US 2012/0277621) in view of Rao et al. (US 2014/0172045).
Re Claim 1, Gerber discloses a method for delivering neurostimulation to a patient using a stimulation device coupled to a plurality of electrodes (abstract, The implantable nerve stimulator has a plurality of electrodes through which stimulation is provided to the nerve target), the method comprising:
controlling the delivery of the neurostimulation from the stimulation device according to a pattern of neurostimulation pulses including one or more stimulation waveforms defined by waveform parameters including a first parameter and a second parameter (para. [0028], number of electrodes, waveforms, stimulation amplitude, pulse width, and frequency defined as a stimulation program. A programming session may yield multiple efficacious stimulation programs, which may remain separate or which may be grouped together in one or more stimulation program groups; para. [0075], processor 50 may control stimulation generator 60 to deliver electrical signals, e.g., as stimulation pulses or continuous waveforms, with pulse current amplitudes (i.e., levels), pulse widths (if applicable), and pulse rates specified by one or more stimulation programs); and
determining the one or more stimulation waveforms using a processor, including:
identifying maximum values of the first parameter each from a segment of multiple segments of the pattern of neurostimulation pulses;
determining respective maximum values of the second parameter using the identified maximum values of the first parameter and a relationship allowing for prediction of needed values of the second parameter using one or more known values of the first parameter, the respective maximum values of the second parameter each limiting the value of the second parameter for the respective segment of the multiple segments; and
determining the one or more stimulation waveforms using constraints including the maximum values of the first parameter and the respective maximum values of the second parameter (Gerber discloses a stimulation generator delivering stimulation according to the programs in the groups, e.g., simultaneously or a time-interleaved basis, where a therapy group may include a single program or multiple programs (para. [0089]), which reads on “multiple segments of the pattern of neurostimulation pulses”. Gerber discloses that each therapy program specifies values for a set of stimulation parameters, such as amplitude, pulse width, and pulse rate. In addition, each program may specify a particular electrode combination for delivery of stimulation (para. [0089]) and that during the initial programming protocol at least one stimulation threshold is determined for each of electrodes 48 (para. [0090]). Gerber further discloses how these stimulation thresholds are used in para. [0092] and [0158]. Gerber discloses that stimulation thresholds, after being determined, are stored in memory (para. [0093]). The types of thresholds are shown in fig. 14 which shows the relationship between pulse width and amplitude (para. [0165], Fig. 14 of Gerber discloses curve 230 representing an example paresthesia threshold curve as a function of amplitude and pulse width and curve 240 representing an example of a curve for a different diameter nerve fiber, one which may relate to pain/discomfort threshold curves, as a function of amplitude and pulse width. Gerber disclosed that stimulation intensity is a function of the combination of both amplitude of the pulse being applied as well as the pulse width and by varying either the amplitude or the pulse width, changes in the usability range of the other factor may be achieved). Therefore, any values on the curves may be determined, stored, and used to determine appropriate stimulation parameters: para. [0165], fig. 14, FIG. 14 is a graph illustrating the relationship between stimulation thresholds, pulse width, and amplitude. Curve 230 represents an example paresthesia threshold curve as a function of amplitude and pulse width. Curve 240 represents an example of a curve for a different diameter nerve fiber, one which may relate to pain/discomfort threshold curves, as a function of amplitude and pulse width. Stimulation intensity is a function of the combination of both amplitude of the pulse being applied as well as the pulse width. By varying either the amplitude or the pulse width, changes in the usability range of the other factor may be achieved; para. [0159]-[0162], [0164], in the course of stimulation threshold determinations, one or both of amplitude and pulse width may be modified to vary stimulation intensity in order to determine one or more stimulation thresholds; para. [0181], [0040], [0038], [0043], threshold determinations using different stimulation parameter values; para. [0029], One aspect of programming an IMD, is determining the acceptable and efficacious stimulation intensities at which to deliver the electrical stimulation to the patient. Stimulation intensities that are efficacious in treating symptoms of a condition, but do not produce unacceptable side effects generally vary from patient to patient, and, as such, may need to be tested for each patient receiving stimulation from an IMD. As used in this disclosure, stimulation intensity may refer to the amount of energy delivered to a patient through electrical stimulation. As such, stimulation intensity may be a function of both the amplitude, e.g., current or voltage, and the pulse width of the stimulation pulses delivered to the patient during an electrical stimulation session. Changes in stimulation intensity, i.e. increases or decreases, may therefore correspond to a change in one or both of the stimulation amplitude and the pulse width; para. [0089] Upon selection of a particular program or program group, processor 50 controls stimulation generator 60 to deliver stimulation according to the programs in the groups, e.g., simultaneously or on a time-interleaved basis. A therapy group may include a single program or multiple programs. In one example, one program group may include multiple prophylactic stimulation programs and another program group stored on memory 52 and executable by processor 50 may include multiple abortive stimulation programs. As mentioned previously, each therapy program specifies values for a set of stimulation parameters, such as amplitude, pulse width, and pulse rate. In addition, each program may specify a particular electrode combination for delivery of stimulation; para. [0090] In one example, during the initial programming protocol at least one stimulation threshold is determined for each of electrodes 48. The stimulation thresholds may be determined based on patient feedback provided to processor 50 via external programmer 26 or programmer 28 and may be stored in memory 52; para. [0091] Based on stimulation threshold(s) for one or more of electrodes 48, the relative location of the electrodes and at least one nerve may be determined or “mapped.”; para. [0092], processor 50 may identify and group, or cluster, one or more individual electrodes 48 or electrode combinations selected from electrodes 48 with similar stimulation thresholds, e.g., similar lower stimulation thresholds like perception or paresthesia thresholds. Processor 50 may, in different circumstances, control stimulation generator 60 to deliver electrical stimulation to patient 16 via the clustered electrodes. In some examples, clusters of electrodes may be chosen based on usability range, i.e. multiple stimulation thresholds and the range of stimulation intensities there between, as well as based on the direction of stimulation produced by multiple electrodes or electrode combinations. In other examples, electrodes may be clustered based on similarity of outcome or the nature of the upper threshold. For example, electrodes that all cause muscle recruitment at some stimulation intensity level may be more suitable for clustering than clustering electrodes with a muscle recruitment upper threshold with electrodes with a pain upper threshold; para. [0093] Stimulation thresholds, after being determined, may be stored in memory 52 and/or memory included in one or both of clinician programmer 26 and patient programmer 28; para. [0158] As a result of the threshold determinations and nerve mapping methods according to this disclosure, a number of electrodes and/or electrode combinations are selected as configured to deliver efficacious therapy to patient 16. During this process, the stimulation parameters by which thresholds are determined and selected electrodes are tested may be held generally constant, except for, e.g., stimulation intensity. For example, a default set pulse width and frequency may be used throughout this process. After efficacious electrodes and electrode combinations have been selected based on the stimulation thresholds and nerve mapping, however, stimulation parameters, including, e.g., amplitude, pulse width, and frequency may be tested for each of the selected electrodes and electrode combinations to further improve the efficacy of stimulation delivered thereby.).
Should Applicant disagree that Gerber discloses the steps of determining the one or more stimulation waveforms using a processor, including: identifying maximum values of the first parameter each from a segment of multiple segments of the pattern of neurostimulation pulses; determining respective maximum values of the second parameter, the respective maximum values of the second parameter each limiting the value of the second parameter for the respective segment of the multiple segments; and determining the one or more stimulation waveforms using constraints including the maximum values of the first parameter and the respective maximum values of the second parameter.
Rao has been relied on to teach the steps of determining the one or more stimulation waveforms using a processor, including: identifying maximum values of the first parameter each from a segment of multiple segments of the pattern of neurostimulation pulses; determining respective maximum values of the second parameter, the respective maximum values of the second parameter each limiting the value of the second parameter for the respective segment of the multiple segments; and determining the one or more stimulation waveforms using constraints including the maximum values of the first parameter and the respective maximum values of the second parameter (para. [0007], [0008], A programming session may require an initial setup for programming parameters and electrode settings, and may sequence through a series of pre-determined configurations in an attempt to optimize therapy for a patient. The settings may be consistent across all programming sessions or may vary depending on therapy (i.e., DBS, PNS, sacral nerve stimulation, SCS, etc.), lead placement, or target area; para. [0019], The pre-programming steps in accordance with the aspects of the present inventions described above may include one or more of: defining one or more initial programming parameters selected from the group consisting of: pulse amplitude, pulse width, pulse frequency, pulse shape, pulse waveform, and pre-pulsing; defining at least one current steering parameter selected from the group consisting of: resolution, focus, start point, end point, directionality, and path; defining an electrode configuration; defining at least one stimulation limitation selected from the group consisting of: maximum pulse amplitude, minimum pulse amplitude, maximum pulse width, minimum pulse width, maximum pulse rate, and minimum pulse rate; and defining a configuration of a lead coupled to the neurostimulator; para. [0075] The steps included in the automated series of pre-programming steps are not limited to those shown in FIG. 10. It should be well understood that the automated series of steps may include other pre-programming steps in addition to, or instead of, the pre-programming steps depicted in FIG. 10. For example, besides pulse rate and pulse width, the series may alternatively or additionally include a step of defining one or more other initial programming parameters, such as pulse amplitude, pulse shape, pulse waveform, and/or pre-pulsing. As another example, instead of setting the subsequent programming session to "navigation mode," the series may alternatively include a step of setting the subsequent programming session to "E-Troll" mode or "manual" mode. As still another example, instead of setting the current steering resolution for the navigation mode or E-Troll mode to coarse, the series may alternatively include a step of setting the current steering resolution to medium or fine. The series may additionally set other current steering parameters, such as focus, start point, end point, directionality, path (for example, the user may trace a desired current steering path), or the like. In still another example, in the case where the subsequent programming session is set to "manual mode," the series may include a step of defining an electrode configuration, which may include anode and cathode placement, and/or current fractionalization. In yet another example, the series may include a step of defining at least one stimulation limitation, such as maximum pulse amplitude, minimum pulse amplitude, maximum pulse width, minimum pulse width, maximum pulse rate, minimum pulse rate, or the like.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gerber by configuring the steps of determining the one or more stimulation waveforms using a processor, including: identifying maximum values of the first parameter each from a segment of multiple segments of the pattern of neurostimulation pulses; determining respective maximum values of the second parameter, the respective maximum values of the second parameter each limiting the value of the second parameter for the respective segment of the multiple segments; and determining the one or more stimulation waveforms using constraints including the maximum values of the first parameter and the respective maximum values of the second parameter, as taught by Rao, for the purpose of setting an optimal and safe therapy for a patient for specific therapy purpose (i.e., DBS, PNS, sacral nerve stimulation, SCS, etc.) and specific target area (para. [0007], [0008], [0019]).
Re Claim 4, Gerber discloses that receiving the maximum values of the first parameter comprises receiving a user-defined worst case for the each segment using a user interface, and the maximum value of the first parameter for the each segment is the value of the first parameter under the user-defined worst case for the each segment (para. [0102], A clinician or patient 16 interacts with user interface 59 in order to, for example, manually select, change or modify programs, or adjust voltage or current amplitude. The user interface 59 is used to perform an initial programming protocol according to this disclosure. The clinician or patient 16 may interact with the user interface 59 to indicate occurrence of a stimulation threshold; para. [0106], Programmer 26 may receive input via user interface 59 from a clinician or patient 16 indicating that a threshold has been reached. In response to such an indication, processor 53 may send a signal to IMD 12 via telemetry module 57 to begin a process of determining which of electrodes 48 is responsible for the threshold, e.g., to control stimulation generator 60 to apply stimulation iteratively at the intensity level at which the patient indicated the threshold occurred for each of electrodes 48 until the electrode that produces the threshold is determined; para. [0135]).
Re Claim 5, Gerber discloses identifying a worst case from the pattern of neurostimulation pulses for the each segment using the processor, wherein the maximum value of the first parameter for the each segment is the value of the first parameter for the each segment under the worst case identified for the each segment (para. [0106], Programmer 26 may receive input via user interface 59 from a clinician or patient 16 indicating that a threshold has been reached. In response to such an indication, processor 53 may send a signal to IMD 12 via telemetry module 57 to begin a process of determining which of electrodes 48 is responsible for the threshold, e.g., to control stimulation generator 60 to apply stimulation iteratively at the intensity level at which the patient indicated the threshold occurred for each of electrodes 48 until the electrode that produces the threshold is determined).
Re Claim 6, Gerber discloses controlling the delivery of the neurostimulation from the stimulation device according to the pattern of neurostimulation pulses including the one or more stimulation waveforms and stimulation fields each defined by a set of active electrodes selected from the plurality of electrodes, and wherein receiving the maximum values of the first parameter comprises receiving the maximum value of the first parameter for each stimulation field of the stimulation fields in the each segment, and determining the maximum values of the second parameter comprises determining the maximum value of the second parameter for the each stimulation field in the each segment (para. [0133], Each of electrodes 48 may include multiple stimulation thresholds, including, e.g., one or more lower thresholds like perception and parasthesia thresholds and one or more upper thresholds like muscle recruitment, discomfort, and pain thresholds. In such cases, examples according to this disclosure may be employed to identify all or some of the multiple stimulation thresholds associated with each of electrodes 48. Examples according to this disclosure may be employed to determine any of a number of different combinations of different stimulation thresholds for any of a number of different combinations of electrodes 48 connected to IMD 12, or other implanted electrodes connected to another implantable stimulator; para. [0165], fig. 14, Stimulation intensity is a function of the combination of both amplitude of the pulse being applied as well as the pulse width. By varying either the amplitude or the pulse width, changes in the usability range of the other factor may be achieved; para. [0152], The electrodes of array 98 may be activated to produce an electrical stimulation field of a particular shape. For example, more complex combinations of electrodes in array 98 than a monopole or bipole may be selected to produce stimulation fields of varying sizes, shapes, and that emanate from the electrodes, or, in other words, are steered in different directions from the selected electrodes. Different stimulation parameters, including amplitude, pulse width, and frequency may also be employed in such electrode combinations to tailor the shape, size and direction of the field produced by the electrodes of array 98 selected for stimulation).
Re Claim 7, Gerber disclose that the first parameter is one of a pulse amplitude and a pulse width, the second parameter is the other of the pulse amplitude and the pulse width, and determining the respective maximum values of the second parameter using the received maximum values of the first parameter and the relationship comprises determining the respective maximum values of the second parameter using the identified maximum values of the first parameter and a strength-duration curve (para. [0165], fig. 14, FIG. 14 is a graph illustrating the relationship between stimulation thresholds, pulse width, and amplitude. Curve 230 represents an example paresthesia threshold curve as a function of amplitude and pulse width. Curve 240 represents an example of a curve for a different diameter nerve fiber, one which may relate to pain/discomfort threshold curves, as a function of amplitude and pulse width. Stimulation intensity is a function of the combination of both amplitude of the pulse being applied as well as the pulse width. By varying either the amplitude or the pulse width, changes in the usability range of the other factor may be achieved).
Re Claim 8, Gerber discloses determining the strength-duration curve for each stimulation field of the stimulation fields using information including data collected from the patient (para. [0165], fig. 14, FIG. 14 is a graph illustrating the relationship between stimulation thresholds, pulse width, and amplitude. Curve 230 represents an example paresthesia threshold curve as a function of amplitude and pulse width. Curve 240 represents an example of a curve for a different diameter nerve fiber, one which may relate to pain/discomfort threshold curves, as a function of amplitude and pulse width. Stimulation intensity is a function of the combination of both amplitude of the pulse being applied as well as the pulse width. By varying either the amplitude or the pulse width, changes in the usability range of the other factor may be achieved; para. [0133], Each of electrodes 48 may include multiple stimulation thresholds, including, e.g., one or more lower thresholds like perception and parasthesia thresholds and one or more upper thresholds like muscle recruitment, discomfort, and pain thresholds. In such cases, examples according to this disclosure may be employed to identify all or some of the multiple stimulation thresholds associated with each of electrodes 48. Examples according to this disclosure may be employed to determine any of a number of different combinations of different stimulation thresholds for any of a number of different combinations of electrodes 48 connected to IMD 12, or other implanted electrodes connected to another implantable stimulator).
Re Claim 9, Gerber discloses that identifying the maximum values of the first parameter comprises identifying a highest pulse amplitude for the each segment (para. [0038], stimulation thresholds may be employed in the context of programming an IMD to deliver efficacious therapy to a patient by facilitating selection of stimulation parameters, e.g., stimulation amplitude and/or pulse width, and individual electrodes or combinations of electrodes that are likely to produce effective results for the patient; para. [0069]; para. [0165], fig. 14, FIG. 14 is a graph illustrating the relationship between stimulation thresholds, pulse width, and amplitude. Curve 230 represents an example paresthesia threshold curve as a function of amplitude and pulse width. Curve 240 represents an example of a curve for a different diameter nerve fiber, one which may relate to pain/discomfort threshold curves, as a function of amplitude and pulse width. Stimulation intensity is a function of the combination of both amplitude of the pulse being applied as well as the pulse width. By varying either the amplitude or the pulse width, changes in the usability range of the other factor may be achieved; para. [0159], [0161], [0164], in the course of stimulation threshold determinations, one or both of amplitude and pulse width may be modified to vary stimulation intensity in order to determine one or more stimulation thresholds; para. [0181], [0040], [0038], [0043], threshold determinations using different stimulation parameter values).
Re Claim 10, Gerber disclose that identifying the maximum values of the first parameter comprises identifying a longest pulse width for the each segment (para. [0038], stimulation thresholds may be employed in the context of programming an IMD to deliver efficacious therapy to a patient by facilitating selection of stimulation parameters, e.g., stimulation amplitude and/or pulse width, and individual electrodes or combinations of electrodes that are likely to produce effective results for the patient; para. [0165], fig. 14, FIG. 14 is a graph illustrating the relationship between stimulation thresholds, pulse width, and amplitude. Curve 230 represents an example paresthesia threshold curve as a function of amplitude and pulse width. Curve 240 represents an example of a curve for a different diameter nerve fiber, one which may relate to pain/discomfort threshold curves, as a function of amplitude and pulse width. Stimulation intensity is a function of the combination of both amplitude of the pulse being applied as well as the pulse width. By varying either the amplitude or the pulse width, changes in the usability range of the other factor may be achieved; para. [0159], [0162], [0164], one of the stimulation parameters that may be tested to improve efficacy is pulse width. Pulse width, in addition to amplitude, contributes to stimulation intensity. Thus, in the course of stimulation threshold determinations, one or both of amplitude and pulse width may be modified to vary stimulation intensity in order to determine one or more stimulation thresholds. Another effect of varying pulse widths is that it may modify the stimulation thresholds and usability range of an electrode through which stimulation is delivered at a given amplitude with the varying pulse widths. Thus, by manipulating pulse widths, for example, usability ranges may be increased or decreased and the entire range including a lower and an upper stimulation threshold may be shifted up or down the stimulation intensity scale. In this manner, to some degree, varying pulse widths may be employed to modulate stimulation thresholds and usability ranges for various electrodes implanted within a patient; para. [0181], [0040], [0038], [0043], threshold determinations using different stimulation parameter values).
Re Claim 11, Gerber disclose that identifying the maximum values of the first parameter comprises identifying a highest pulse frequency for the each segment (para. [0114], pulse widths and pulse rates may be selectively controlled by stimulation control module 64 by selectively activating current regulators in current regulator array 66, e.g., on a pulse-by-pulse basis, at selected times and for selected durations; para. [0159], programmer 26 may be employed, e.g., by a clinician and/or patient 16 to control stimulation generator 60 to delivery therapy via different ones and/or combinations of electrodes 48A-48Q selected as a result of the foregoing threshold determinations and nerve mapping. In particular, signals received from programmer 26, for example, may cause processor 50 to modify one or more stimulation parameters used to deliver stimulation therapy via the selected electrodes and/or electrode combinations to test different potentially efficacious stimulation programs including an electrode or combination and particular stimulation parameter values. Stimulation parameters may be tested within a range of values that may be known to be appropriate for particular nerves and/or conditions, [0160], para. [0181], [0040], [0038], [0043], threshold determinations using different stimulation parameter values)
Re Claim 12, Gerber discloses that identifying the maximum values of the first parameter comprises identifying a most efficient waveform shape in producing a response in the patient for the each segment (para. [0152], The electrodes of array 98 may be activated to produce an electrical stimulation field of a particular shape. For example, more complex combinations of electrodes in array 98 than a monopole or bipole may be selected to produce stimulation fields of varying sizes, shapes, and that emanate from the electrodes, or, in other words, are steered in different directions from the selected electrodes. Different stimulation parameters, including amplitude, pulse width, and frequency may also be employed in such electrode combinations to tailor the shape, size and direction of the field produced by the electrodes of array 98 selected for stimulation; para. [0114], Regulator array 66 may also control the shape of the pulses to control the rise time, overshoot, or overall shape (triangle versus square); para. [0075], [0077], processor 50 may control stimulation generator 60 to deliver electrical signals, e.g., as stimulation pulses or continuous waveforms specified by programs).
Re Claim 13, Gerber discloses that identifying the maximum values of the first parameter comprises identifying a largest amount of pulse charge for the each segment (para. [0115], Current regulator array 66 may be used to slowly increase the amount of current to each electrode 48, thereby increasing stimulation intensity during a threshold determination processes. In other examples, current regulator array 66 may be used to provide stimulation at different intensities to different electrodes based on a predetermined relationship; para. [0038], stimulation thresholds may be employed in the context of programming an IMD to deliver efficacious therapy to a patient by facilitating selection of stimulation parameters, e.g., stimulation amplitude and/or pulse width, and individual electrodes or combinations of electrodes that are likely to produce effective results for the patient; para. [0069]; para. [0165], fig. 14, FIG. 14 is a graph illustrating the relationship between stimulation thresholds, pulse width, and current or voltage amplitude. Curve 230 represents an example paresthesia threshold curve as a function of amplitude and pulse width. Curve 240 represents an example of a curve for a different diameter nerve fiber, one which may relate to pain/discomfort threshold curves, as a function of amplitude and pulse width. Stimulation intensity is a function of the combination of both amplitude of the pulse being applied as well as the pulse width. By varying either the amplitude or the pulse width, changes in the usability range of the other factor may be achieved; para. [0159], [0161], [0164], in the course of stimulation threshold determinations, one or both of amplitude and pulse width may be modified to vary stimulation intensity in order to determine one or more stimulation thresholds; para. [0181], [0040], [0038], [0043], threshold determinations using different stimulation parameter values).
Re Claims 14, 15, 17-20, Claims 14, 15, 17-20 are rejected under substantially the same basis as claims 1-7.
Re Claims 21, 22, and 23, Gerber discloses that the waveform parameters further comprise one or more additional second parameters, and further comprising determining respective maximum values of each additional second parameter of the one or more additional second parameters using the identified maximum values of the first parameter and a relationship allowing for prediction of needed values of the each additional second parameter using one or more known values of the first parameter, the respective maximum values of the each additional second parameter each limiting the value of the each additional second parameter for the respective segment of the pattern of neurostimulation pulses, wherein the first parameter, the second parameter, and the one or more additional second parameters are selected from a group of stimulation parameters consisting of a pulse amplitude, a pulse width, a pulse frequency, a pulse shape, and a pulse charge (para. [0158] As a result of the threshold determinations and nerve mapping methods according to this disclosure, a number of electrodes and/or electrode combinations are selected as configured to deliver efficacious therapy to patient 16. During this process, the stimulation parameters by which thresholds are determined and selected electrodes are tested may be held generally constant, except for, e.g., stimulation intensity. For example, a default set pulse width and frequency may be used throughout this process. After efficacious electrodes and electrode combinations have been selected based on the stimulation thresholds and nerve mapping, however, stimulation parameters, including, e.g., amplitude, pulse width, and frequency may be tested for each of the selected electrodes and electrode combinations to further improve the efficacy of stimulation delivered thereby; fig. 14, para. [0165], FIG. 14 is a graph illustrating the relationship between stimulation thresholds, pulse width, and amplitude. Curve 230 represents an example paresthesia threshold curve as a function of amplitude and pulse width. Curve 240 represents an example of a curve for a different diameter nerve fiber, one which may relate to pain/discomfort threshold curves, as a function of amplitude and pulse width. If the two curves (230, 240) are results of two different fiber types or different fiber diameters, then stimulating at different points on the curves may allow selectivity with respect to the different outcomes afforded by the different nerve fibers. Depending on whether amplitude or pulse width is being modulated during stimulation therapy, the other parameter may be changed to provide an improved usability range of the other; para. [0159]-[0164] discloses ranges of pulse rate/frequency, amplitude and pulse width).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, December 4, 2025Examiner, Art Unit 3792