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 .
Status of Claims
The amendments and remarks filed on 12JAN2026 have been entered and considered.
Claims 1-8, & 10-12 are currently pending.
No claims have been amended, withdrawn, or added.
Claim 12 was canceled.
Claims 1-8, & 10-11 are under examination.
Response to Arguments
Applicant's amendments filed 12JAN2026 regarding the claim objection have been fully considered and have been found to obviate the objection. Therefore, the claim objection has been withdrawn.
Applicant's amendments filed 12JAN2026 regarding the rejection under 35 USC 112(a)have been fully considered and have been found to obviate the rejection. Therefore, the 112(a) rejection has been withdrawn.
Applicant's arguments filed 12JAN2026 regarding the rejection under 35 USC 101 have been fully considered and have been found to obviate the rejection. Therefore, the 101 rejection has been withdrawn.
Applicant's arguments filed 12JAN2026 regarding the rejections under 35 USC 103(a) have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Page 10-11 of the Remarks):
The pre-pulse/post-pulse functionality described by Crosby is a conventional waveform control that is designed to control the neurons that are activated by the stimulation energy. The pre-pulse/post-pulse functionality has been found to allow greater selectivity in the fibers that are activated/de-activated. Importantly, the entire pre-pulse/post-pulse modality takes place within milliseconds, and would be undertaken at the stage that a neuromodulation block is initially being established. The Crosby teachings of Para. 0278 offer an approach to initially implementing a sensory transmission block and to the extent the pre-pulse/post-pulse functionality were controlled by an algorithm, that algorithm would be effectuating an Initial Control Functionality. In distinct contrast, the '869 Application includes a neural stimulation algorithm that is programmed to automatically initiate neuromodulation to block abnormal neural activity - e.g., by implementing a pre-pulse/post-pulse regimen as described by Crosby -- and to thereafter automatically adjust stimulus intensity and frequency from the initial neuromodulation frequency after the selective sensory transmission block is achieved to improve neuromodulation efficiency, i.e., Adjustment Control Functionality. Crosby describes within-pulse waveform shaping strategies, such as pre-pulses, main pulses, and post-pulses that occur within a single stimulation cycle lasting microseconds to a few milliseconds. The approach described by Crosby relies on transient membrane polarization and short-lived ion channel state biasing during spike initiation. In contrast, the claimed method employs a state- dependent, multi-phase neuromodulation strategy that takes place not in millisecond time scale, but seconds and tens of seconds scale. The method claimed in the '869 Application first intentionally induces a conduction block and, only after the block is established, dynamically reduces stimulation intensity and/or frequency to maintain the blocked state. This approach operates on distinct physiological timescales (seconds and tens of seconds) and is fundamentally different from within-pulse conditioning or waveform biasing, as disclosed by Crosby.
The applicant argues that Crosby shows a short term selectivity while the instant application shows an extended neuromodulation blocking period. The examiner is not persuaded by this argument as the features being argued are not reflected in the claim limitations. The claim does not provide any time limitation or further designation to the system other than stating a closed loop control. Therefore, the examiner maintains that the references teach the claim limitations as cited.
Applicant states (see Pages 11-12 of the Remarks):
The cited references, including Crosby, do not establish a sustained conduction block. Rather, the prior art techniques modulate neural activity by shaping activation, inactivation, or deactivation probabilities of axons. By contrast, the claimed method relies on a selective sensory transmission block, where the blocking phase persists long enough to create a stable non-transmissive state. Importantly, once the block is achieved, it can be maintained with reduced stimulation parameters, an approach neither taught nor suggested by the cited references. Crosby focuses on peripheral nerve stimulation, where the target nerve typically contains both sensory and motor axons. As a result, complex biased waveforms are required to preferentially affect sensory fibers while avoiding motor activation. In contrast, the claimed method targets neural tissue within the intervertebral foraminal canal, which is predominantly sensory. This anatomical distinction eliminates the need for waveform biasing to avoid motor side effects and enables a direct sensory block strategy that is not applicable or suggested in the cited art. There is nothing in Para. 0278 of Crosby - nor, more generally, in the Crosby publication as a whole - that would motivate a skilled practitioner to provide a system for electrical stimulation to effectuate selective sensory transmission block that includes, inter alia, a neural stimulation algorithm programmed to automatically adjust stimulus intensity and frequency from an initial neuromodulation frequency (that was effective to effectuate selective sensory transmission block) after the selective sensory transmission block was achieved, to improve neuromodulation efficiency. With specific reference to the proposed Kim/Crosby combination, Dr. Feng opined that it would not have been obvious to develop/implement a neural stimulation algorithm programmed to implement Adjustment Control Functionality as disclosed and claimed in the '869 Application.
However, the examiner is not persuaded. The arguments regarding the version of sensory block being applied by Crosby versus the instant application is moot as the claims do not require any specific modality of sensory block, merely stating a system for electrical stimulation to effectuate selective sensory transmission block as applied to a intervertebral foraminal canal for one or more targeted afferents to effectuate selective sensory transmission block. There is no limitation requiring a timing window which the program works within or a specified version of stimulation that would differentiate the claim limitations than what can be cited by the prior art references. The references Kim and Crosby are cited in combination to teach the claim limitations, where Kim discloses sensory blocking focusing on areas such as the intervertebral foraminal canal. Crosby cites an algorithm for sensory block which is adjusted based on the targeted fibers (Par 0728). Since the claim limitations do not reflect the full inventive concept as is being argued one would think to combine the references since both teach sensory transmission block where Crosby’s algorithm could be used to automate the functions in Kim, as both references cite selective stimulation . Since Crosby shows that any fibers can be targeted during stimulation, one would understand that this can be any combination of fibers as seen fit for the application of the user. Therefore, the examiner maintains that the cited references teach the claim limitations.
Claim Rejections - 35 USC § 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 10, & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US Patent No. 7450993; Previously Cited), in view of Crosby et al. (US Publication No. 20220241589; Previously Cited).
Regarding claim 1, Kim discloses a system for electrical stimulation to effectuate selective sensory transmission block (Kim Abstract “Still other embodiments of the present invention provide stimulation systems and components for selective stimulation and/or neuromodulation of one or more dorsal root ganglia through implantation of an electrode on, in or around a dorsal root ganglia in combination with a pharmacological agent.; Column 11 Lines 32-38 “This stimulation electrode pattern provides pain blocking/relief in the indicated region R4 of the body (i.e., FIG. 7B). It is to be appreciated that the electrode placement and blocking region patterns illustrated by FIGS. 4A-7B may be modified using information such as in FIGS. 3B and 3C for targeted placement to specific portions of the body depending upon individual needs.”), the system adapted to deliver electrical simulation to one or more targeted afferents within an intervertebral foraminal canal of an individual (Kim Column 7 Lines 60-64 “Embodiments of the present invention are particularly well suited for providing pain control since the sensory fibers running through the dorsal root ganglion 40 may be specifically targeted.”; Column 8 Lines 20-27; wherein the dorsal root ganglion being one of an area focus of stimulation in the reference shows that the targeted area in in the foraminal canal); comprising: one or more stimulating electrodes (Kim Column 10 Lines 48-49 “several monopolar stimulating electrodes”) a processor (Kim Column 11 Lines 9-14 “These pain treatment regimes may be programmed into a suitable electronic controller or computer controller system (described below) to store the treatment program, control and monitor the system components execution of the stimulation regime as the desired therapeutic regime is executed.”), adapted to run a neural stimulation algorithm (Kim Column 25 Lines 55-57 “The control electronics 106 includes a microcontroller 103 having conventional features such as program memory 103.1, parameter and algorithm memory 103.2”; Column 27 Lines 18-21 “In another aspect, the controller 103 controls the output of the DC-DC converter 113 to deliver a stimulation signal according to an algorithm for blocking pain signals.”); at least one recording electrode that is adapted to be positioned or implanted at a dorsal root of the individual (Kim Column 12 Lines 25-29 “One illustrative example includes the placement of sensing electrodes in the sensory nervous system above and below the DRG level having the implanted electrode(s). Implant the electrode into the targeted DRG.”); wherein the at least one recording electrode is adapted to communicate sensed afferent neural activities (Kim Column 25 Lines 9-16 “In another embodiment, delivery of a pharmacological agent elsewhere in the pain pathway is downstream of the dorsal root ganglion. In another specific embodiment, stimulation is provided to a nerve ganglion in the sympathetic nervous system and a dorsal root ganglion up stream of or otherwise positioned to influence or block signals originating from the nerve ganglion.”; Figure 25 showing the target as the afferent neural pathways described in figure.).
Kim does not disclose wherein the neural stimulation algorithm is adapted to automatically initiate neuromodulation to block abnormal neural activity; and wherein the neural stimulation algorithm is adapted to drive closed-loop, intelligent control of the one or more stimulating electrodes based at least in part on sensed information communicated by the at least one recording electrode ; and to automatically adjust stimulus intensity and frequency from the initial neuromodulation frequency after the selective sensory transmission block is achieved to improve neuromodulation efficiency ; wherein the electrical stimulation is delivered at an initial neuromodulation frequency that is selected at least in part based on conduction velocity of the one or more targeted afferents to effectuate selective sensory transmission block. Crosby in a similar field of electrical stimulation for chronic pain relief teaches wherein the neural stimulation algorithm is adapted to automatically initiate neuromodulation to block abnormal neural activity (Crosby ¶0049 “The first and second parameters are modified by an automated algorithm that tests each combination of parameters to elicit the predetermined recorded nerve and/or muscle response.”); and wherein the neural stimulation algorithm is adapted to drive closed-loop, intelligent control of the one or more stimulating electrodes based at least in part on sensed information communicated by the at least one recording electrode (Crosby ¶0271 “In one aspect, an automated program, system, or algorithm analyzes the recorded nerve and/or muscle activity and instructs, informs, or guides the relocation of one or more electrodes, selection of one or more different electrodes, and/or changes in one or more stimulation parameters to achieve the desired, wanted, or optimal response”; ¶0306-¶0307; ¶0266; ¶0050 “The method may also include positioning the stimulating electrode to within a therapeutically effective distance from at least one target peripheral nerve independent of a distance from a nerve using analysis of recorded neural and/or muscle feedback and applying stimulation parameters to optimize activation of a sufficient number of target peripheral nerve fibers to produce relief of pain, wherein the stimulation parameters are informed by analysis of recorded peripheral neural and/or muscle feedback.”); and to automatically adjust stimulus intensity and frequency from the initial neuromodulation frequency after the selective sensory transmission block is achieved to improve neuromodulation efficiency (Crosby ¶0278 “In an embodiment, an asymmetrical biphasic pulse train with a rectangular cathodic and exponentially decaying anodic phase is used to stimulate the target peripheral nerve with a pulse duration (or width) optimally tuned to selectively activate a sufficient number of target fibers, and non-limiting examples of alternative stimulus waveforms may include the use of one or more pre-pulses (e.g., pulses that occur before the primary depolarizing or activating pulse of the waveform and may prime for activation, activate, deactivate, inactivate, and/or block one or more populations of fibers) and/or post-pulses (e.g., pulses that occur after the primary depolarizing or activating pulse of the waveform and may prevent, arrest, or stop activation, activate, deactivate, inactivate, and/or block one or more populations of fibers) to enable activation of a sufficient number of target fibers and/or deactivation of non-target fibers and/or while avoiding activation of non-target fibers and/or off-target fibers and/or avoiding and/or preventing unwanted effects in off-target fibers (see FIGS. 21-26).”.); wherein the electrical stimulation is delivered at an initial neuromodulation frequency that is selected at least in part based on conduction velocity of the one or more targeted afferents to effectuate selective sensory transmission block. (Crosby ¶0278 “In an embodiment, an asymmetrical biphasic pulse train with a rectangular cathodic and exponentially decaying anodic phase is used to stimulate the target peripheral nerve with a pulse duration (or width) optimally tuned to selectively activate a sufficient number of target fibers, and non-limiting examples of alternative stimulus waveforms may include the use of one or more pre-pulses (e.g., pulses that occur before the primary depolarizing or activating pulse of the waveform and may prime for activation, activate, deactivate, inactivate, and/or block one or more populations of fibers) and/or post-pulses (e.g., pulses that occur after the primary depolarizing or activating pulse of the waveform and may prevent, arrest, or stop activation, activate, deactivate, inactivate, and/or block one or more populations of fibers) to enable activation of a sufficient number of target fibers and/or deactivation of non-target fibers and/or while avoiding activation of non-target fibers and/or off-target fibers and/or avoiding and/or preventing unwanted effects in off-target fibers (see FIGS. 21-26).”; Where each fiber group has a specific conduction velocity).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify the neuromodulation system of Kim with wherein the neural stimulation algorithm is adapted to automatically initiate neuromodulation to block abnormal neural activity; and wherein the neural stimulation algorithm is adapted to drive closed-loop, intelligent control of the one or more stimulating electrodes based at least in part on sensed information communicated by the at least one recording electrode ; and to automatically adjust stimulus intensity and frequency from the initial neuromodulation frequency after the selective sensory transmission block is achieved to improve neuromodulation efficiency ; wherein the electrical stimulation is delivered at an initial neuromodulation frequency that is selected at least in part based on conduction velocity of the one or more targeted afferents to effectuate selective sensory transmission block., as taught by Crosby by integrating Crosby’s algorithm into the system of Kim. The motivation to integrate the algorithm of Crosby into the system of Kim would to be to create a stimulation system able to maintain the desired, wanted, or optimal response that will improve battery life of the stimulation system by reducing the time at which stimulation is delivered at non-optimal, excessive, superfluous, or unnecessarily high parameters or intensities (Crosby ¶0272).
Regarding claim 2, Kim does not disclose wherein the selection of the initial neuromodulation frequency is based on a linearly proportional relationship between to the conduction velocity of the one or more targeted afferents and an optimal blocking frequency for the one or more targeted afferents. Crosby further teaches wherein the selection of the initial neuromodulation frequency is based on a linearly proportional relationship between to the conduction velocity of the one or more targeted afferents and an optimal blocking frequency for the one or more targeted afferents. (Crosby ¶0257 “Patient sensation may instead be used to indicate electrode location relative to the target peripheral nerve as indicator(s) of lead placement (distance from the peripheral nerve to electrode contact). Any combination of stimulus parameters that evoke sensation(s) may be used. The stimulation parameters may include, but are not limited to frequency, pulse duration, amplitude, duty cycle, patterns of stimulus pulses, and waveform shapes. Some stimulus parameters may evoke a more desirable response (e.g., comfortable sensations are felt in a greater percentage of the region of pain compared to other, less desirable stimulus parameters) or a sensation that may be correlated with or specific to the specific target nerve fiber(s) within the target peripheral nerve. As a non-limiting example, it is contemplated that certain frequencies (e.g., 100 Hz or 12 Hz) may evoke sensation(s) or comfortable paresthesia(s) in the region(s) of pain or in alternate target region(s).”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify the neuromodulation system of Kim with methods for wherein the selection of the initial neuromodulation frequency is based on a linearly proportional relationship between to the conduction velocity of the one or more targeted afferents and an optimal blocking frequency for the one or more targeted afferents, as taught by Crosby by integrating Crosby’s selection criteria into the system of Kim. The motivation to integrate the algorithm of Crosby into the system of Kim would to be to create a stimulation system able to maintain the desired, wanted, or optimal response that will improve battery life of the stimulation system by reducing the time at which stimulation is delivered at non-optimal, excessive, superfluous, or unnecessarily high parameters or intensities (Crosby ¶0272).
Regarding claim 3, Kim further discloses wherein the one or more afferents within the intervertebral foraminal canal are selected from the group consisting of a dorsal root (Kim Figure 16 as described in Column 17 Lines 29-33; Column 17 Lines 50-55 “For purposes of discussion, these embodiments have been described in the context of stimulation a DRG. It is to be appreciated that the techniques and structures described herein may also be used to stimulate other nerve root ganglion, other neural structures or other anatomical features.”), dorsal root ganglion (DRG), (Kim Column 17 Lines 43-45) T-junction, (Kim Column 7 Lines 49-57) spinal nerve (Abstract “techniques for applying neurostimulation to the spinal cord and nervous system.”; Column 5 Line 65-67) and combinations thereof (Kim Column 17 Lines 50-55).
Regarding claim 4, Kim further discloses wherein the electrical stimulation delivers a temporal and spatial summation of multichannel stimulation (Kim Figure 14B showing the electrode 115B in a temporal summation configuration; Figure 13B showing electrode 115A in a spatial summation configuration.).
Regarding claim 5, Kim further discloses wherein the one or more stimulating electrodes comprises at least two stimulating electrodes, and wherein the at least two stimulating electrodes deliver stimulation energy individually or simultaneously. (Kim Column 8 Lines 64-67 “As such, embodiments of the present invention may be used to create a wide variety of stimulation control schemes, individually or overlapping, to create and provide zones of treatment.”; Column 28 Lines 26-31 “FIG. 28 illustrates another stimulation system embodiment of the present invention. In the illustrative embodiment, a pulse generator 2806 is connected to four individually controlled microelectrodes 115 implanted in four separate nerve root ganglion, here dorsal root ganglions DRG1 through DRG4”).
Regarding claim 6, Kim further discloses wherein the selective sensory transmission block is effected in a sub-population of unmyelinated C-fibers (Kim Column 5 Lines 46-47 “FIG. 25 is a illustration of Na and Ca channel blocking targets to mitigate c-fiber activity”).
Regarding claim 10, Kim does not disclose wherein the initial neuromodulation frequency is less than about 5 Hz. Crosby further teaches wherein the initial neuromodulation frequency is less than about 5 Hz. (Crosby ¶0271 “The algorithm may adjust stimulation intensity by varying one or more parameters including, as non-limiting examples, the frequency of pulses (e.g., varying in increments of 1 Hz, less than 1 Hz, or greater than 1 Hz within 0.01-100 Hz, 0.1-300 Hz, 1-20 Hz, 20-50 Hz, 20-100 Hz, 50-200 Hz, 1-1000 Hz, 1-5,000 Hz, 1-10,000 Hz, 1-20,000 Hz, 1-100,000 Hz, etc.)”).Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify the neuromodulation system of Kim with methods for starting at an initial neuromodulation frequency which is less than about 5 Hz., as taught by Crosby by integrating Crosby’s frequency ranges into the system of Kim for the purposes of creating a stimulation system able to maintain the desired, wanted, or optimal response that will improve battery life of the stimulation system by reducing the time at which stimulation is delivered at non-optimal, excessive, superfluous, or unnecessarily high parameters or intensities (Crosby ¶0272).
Regarding claim 11, Kim discloses a method for electrical stimulation to effectuate selective sensory transmission block, (Kim Abstract “Some other embodiments of the present invention provide methods for selective neurostimulation of one or more dorsal root ganglia as well as techniques for applying neurostimulation to the spinal cord and nervous system.”), providing one or more stimulating electrodes (Kim Column 10 Lines 48-49 “several monopolar stimulating electrodes”) adapted to deliver electrical simulation to one or more targeted afferents within an intervertebral foraminal canal of an individual (Kim Column 7 Lines 60-64 “Embodiments of the present invention are particularly well suited for providing pain control since the sensory fibers running through the dorsal root ganglion 40 may be specifically targeted.”; Column 8 Lines 20-27) at least one recording electrode that is adapted to be positioned or implanted at a dorsal root of the individual (Kim Column 12 Lines 25-29 “One illustrative example includes the placement of sensing electrodes in the sensory nervous system above and below the DRG level having the implanted electrode(s). Implant the electrode into the targeted DRG.”); a processor that is adapted to run a neural stimulation algorithm, (Kim Column 25 Lines 55-57 “The control electronics 106 includes a microcontroller 103 having conventional features such as program memory 103.1, parameter and algorithm memory 103.2”; Column 27 Lines 18-21 “In another aspect, the controller 103 controls the output of the DC-DC converter 113 to deliver a stimulation signal according to an algorithm for blocking pain signals.”); wherein the at least one recording electrode is adapted to communicate sensed afferent neural activities to the processor, (Kim Column 12 Lines 25-29 “One illustrative example includes the placement of sensing electrodes in the sensory nervous system above and below the DRG level having the implanted electrode(s). Implant the electrode into the targeted DRG.”).
Kim does not disclose wherein the neural stimulation algorithm is adapted to drive closed-loop, intelligent control of the one or more stimulating electrodes based at least in part on sensed information communicated by the at least one recording electrode; and to automatically adjust stimulus intensity and frequency from the initial neuromodulation frequency after the selective sensory transmission block is achieved to improve neuromodulation efficiency; wherein the electrical stimulation is delivered at an initial neuromodulation frequency that is selected at least in part based on conduction velocity of the one or more targeted afferents to effectuate selective sensory transmission block. Crosby in a similar field of electrical stimulation for chronic pain relief teaches wherein the neural stimulation algorithm is adapted to drive closed-loop, intelligent control of the one or more stimulating electrodes based at least in part on sensed information communicated by the at least one recording electrode (Crosby ¶0271 “In one aspect, an automated program, system, or algorithm analyzes the recorded nerve and/or muscle activity and instructs, informs, or guides the relocation of one or more electrodes, selection of one or more different electrodes, and/or changes in one or more stimulation parameters to achieve the desired, wanted, or optimal response”; ¶0306-¶0307; ¶0266; ¶0050 “The method may also include positioning the stimulating electrode to within a therapeutically effective distance from at least one target peripheral nerve independent of a distance from a nerve using analysis of recorded neural and/or muscle feedback and applying stimulation parameters to optimize activation of a sufficient number of target peripheral nerve fibers to produce relief of pain, wherein the stimulation parameters are informed by analysis of recorded peripheral neural and/or muscle feedback.”); and to automatically adjust stimulus intensity and frequency from the initial neuromodulation frequency after the selective sensory transmission block is achieved to improve neuromodulation efficiency (Crosby ¶0278 “In an embodiment, an asymmetrical biphasic pulse train with a rectangular cathodic and exponentially decaying anodic phase is used to stimulate the target peripheral nerve with a pulse duration (or width) optimally tuned to selectively activate a sufficient number of target fibers, and non-limiting examples of alternative stimulus waveforms may include the use of one or more pre-pulses (e.g., pulses that occur before the primary depolarizing or activating pulse of the waveform and may prime for activation, activate, deactivate, inactivate, and/or block one or more populations of fibers) and/or post-pulses (e.g., pulses that occur after the primary depolarizing or activating pulse of the waveform and may prevent, arrest, or stop activation, activate, deactivate, inactivate, and/or block one or more populations of fibers) to enable activation of a sufficient number of target fibers and/or deactivation of non-target fibers and/or while avoiding activation of non-target fibers and/or off-target fibers and/or avoiding and/or preventing unwanted effects in off-target fibers (see FIGS. 21-26).”.); wherein the electrical stimulation is delivered at an initial neuromodulation frequency that is selected at least in part based on conduction velocity of the one or more targeted afferents to effectuate selective sensory transmission block. (Crosby ¶0278 “In an embodiment, an asymmetrical biphasic pulse train with a rectangular cathodic and exponentially decaying anodic phase is used to stimulate the target peripheral nerve with a pulse duration (or width) optimally tuned to selectively activate a sufficient number of target fibers, and non-limiting examples of alternative stimulus waveforms may include the use of one or more pre-pulses (e.g., pulses that occur before the primary depolarizing or activating pulse of the waveform and may prime for activation, activate, deactivate, inactivate, and/or block one or more populations of fibers) and/or post-pulses (e.g., pulses that occur after the primary depolarizing or activating pulse of the waveform and may prevent, arrest, or stop activation, activate, deactivate, inactivate, and/or block one or more populations of fibers) to enable activation of a sufficient number of target fibers and/or deactivation of non-target fibers and/or while avoiding activation of non-target fibers and/or off-target fibers and/or avoiding and/or preventing unwanted effects in off-target fibers (see FIGS. 21-26).”; Where each fiber group has a specific conduction velocity).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify the neuromodulation system of Kim with the neural stimulation algorithm is adapted to drive closed-loop, intelligent control of the one or more stimulating electrodes based at least in part on sensed information communicated by the at least one recording electrode; and to automatically adjust stimulus intensity and frequency from the initial neuromodulation frequency after the selective sensory transmission block is achieved to improve neuromodulation efficiency; wherein the electrical stimulation is delivered at an initial neuromodulation frequency that is selected at least in part based on conduction velocity of the one or more targeted afferents to effectuate selective sensory transmission block, as taught by Crosby. The motivation to integrate the algorithm of Crosby into the system of Kim would to be since changing frequencies to target different neural fibers is based in part on the different conduction velocities of the fibers, the combination allows for a stimulation system able to maintain the desired, wanted, or optimal response that will improve battery life of the stimulation system by reducing the time at which stimulation is delivered at non-optimal, excessive, superfluous, or unnecessarily high parameters or intensities (Crosby ¶0272).
Claims 7 & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US Patent No. 7450993; Previously Cited), in view of Crosby et al. (US Publication No. 20220241589; Previously Cited), and Bennett et al. (US Publication No. 20120310301; Previously Cited).
Regarding claim 7, Kim combined with Crosby teaches the claim limitations of claims 1 & 6, but does not disclose wherein the selective sensory transmission block functions to block slow-conducting C-fibers and Aδ-fibers to stop nociceptive signals from transmitting to the spinal cord, thereby facilitating treatment of pain arising from visceral organs that lack fast-conducting A fibers. Bennet in a similar field of endeavor of pain management systems using neural fiber stimulation teaches wherein the selective sensory transmission block functions to block slow-conducting C-fibers and Aδ-fibers to stop nociceptive signals from transmitting to the spinal cord, thereby facilitating treatment of pain arising from visceral organs that lack fast-conducting A fibers (Bennett ¶0024 “According to a still further aspect of a method according to the present invention, the afferent nerve fibers may be one or more of a plurality of types of axons, including A.alpha. axons, such as Ia and Ib axons, A.beta. axons, A.delta. axons, and/or C axons”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify the neuromodulation system of Kim combined with Crosby with a selective sensory transmission block that functions to block slow-conducting C-fibers and Aδ-fibers, as taught by Bennett by integrating Bennett’s programming into the system of Kim and Crosby. The motivation to integrate the methods of Bennett into the system of Kim and Crosby would to be to utilize lower stimulation energy levels than conventional non-direct, non-specific stimulations systems (Kim Column 8 Lines 7-9).
Regarding claim 8, Kim further discloses wherein the one or more stimulating electrodes comprise at least two stimulating electrode leads, (Kim Column 8 Lines 64-67 “As such, embodiments of the present invention may be used to create a wide variety of stimulation control schemes, individually or overlapping, to create and provide zones of treatment.”; Column 28 Lines 26-31 “FIG. 28 illustrates another stimulation system embodiment of the present invention. In the illustrative embodiment, a pulse generator 2806 is connected to four individually controlled microelectrodes 115 implanted in four separate nerve root ganglion, here dorsal root ganglions DRG1 through DRG4”), wherein each of the at least two of the stimulating electrode leads which delivers stimuli at a frequency below the initial neuromodulation frequency that would be selected in the absence of a plurality of stimulating electrode leads. (Kim Column 34 Lines 34-39 “Embodiments of the present invention provide stimulation energy via one or more electrodes placed on, in or in proximity to the targeted neural tissue. The intimate nature of the electrode placement allows substantially less stimulation energy to be used to achieve a comparable neurostimulation level.”).
Kim discloses the claim limitations of claim 1, but does not disclose wherein the at least two stimulating electrode leads selectively block a sub-population of C-fibers and slow-conducting Aδ fibers by delivering combined stimulation from the at least two stimulating electrode leads at a T-junction for the sub-population of C-fibers and slow-conducting Aδ. Bennett teaches wherein the at least two stimulating electrode leads selectively block a sub-population of C-fibers and slow-conducting Aδ fibers by delivering combined stimulation from the at least two stimulating electrode leads at a T-junction for the sub-population of C-fibers and slow-conducting Aδ (Bennett ¶0024 “According to a still further aspect of a method according to the present invention, the afferent nerve fibers may be one or more of a plurality of types of axons, including A.alpha. axons, such as Ia and Ib axons, A.beta. axons, A.delta. axons, and/or C axons”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify the neuromodulation system of Kim combined with Crosby with a method for stimulation wherein the at least two stimulating electrode leads selectively block a sub-population of C-fibers and slow-conducting Aδ fibers by delivering combined stimulation from the at least two stimulating electrode leads at a T-junction for the sub-population of C-fibers and slow-conducting Aδ, as taught by Bennett by integrating Bennett’s methods into the system of Kim and Crosby. The motivation to integrate the methods of Bennett into the system of Kim and Crosby would to be to utilize lower stimulation energy levels than conventional non-direct, non-specific stimulations systems (Kim Column 8 Lines 7-9).
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 extension fee 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 date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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