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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/13/2025 has been entered.
Response to Arguments
Applicant’s arguments, see page 9, filed 08/13/2025, with respect to 35 U.S.C. 112 have been fully considered and are persuasive. The rejection of the claims has been withdrawn.
Applicant’s arguments, see pages 9-21, filed 08/13/2025, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered. Applicant describes the references on pages 9-18. Applicant then argues on page 19 that “Cadwell adjusts levels only to determine threshold estimates that are used not for applying stimulation therapy, but instead to indicate to a surgeon when a tool gets dangerously close to a nerve.” Although Applicant is correct to point this out, Cadwell solves a common problem with Yonce, that being able to determine a minimum sensation for the nerve for detecting efficacy of the stimulation.
Applicant further argues on page 19 that “By the explicit language of claim 20, the stimulation is applied at a constant current amplitude. It is the modulation of pulse parameter that is controlled to remain between the thresholds of evoked response and patient tolerance. Cadwell does not disclose modulating any parameter, including current amplitude or pulse width, to maintain the pulses within any range, let alone a range defined at an upper bound by a tolerance limit and a lower bound by an evoked response threshold.” Examiner agrees. Applicant also argues on page 20 that “The only reason set forth in the official action for modifying Yonce in view of the teachings of Cadwell is to “decrease the energy demands of the neuromonitoring device and provide a longer life.” This makes no sense. First, Yonce is not a neuromonitoring device, so modifying it to “decrease the energy demands of the neuromonitoring device” makes no sense. Second, there is no evidence that Yonce is plagued with problems of energy demands. Nor is there any evidence Cadwell teaches anything that would improve the energy efficiency of a system such as Yonce.” Examiner agrees.
Applicanty lastly argues on pages 20-21 that “Paragraph [0103], however, stands only for the idea of interpolation and has nothing to do with controlling stimulation pulse parameters at a selected current between the evoked response and patient tolerance thresholds. In McCabe, the use of interpolation is wholly different. Interpolation in McCabe is used to determine points within the transition zone, that is points that possess cardiac capture strength but not phrenic nerve activation strength. The use of interpolation in McCabe is merely for transition zone identification, not for closed-loop stimulation control. This transition zone identification is done pre-use (/.e., pre-surgery) and can be overridden by the surgeon. See, paragraph [0104] et seg..” Examiner disagrees because the interpolation is used for phrenic nerve activation strength used for identifying undesirable testing at specific pulse parameters ([0103]) in the range provided in Fig. 8, which reads on the limitation of interpolating the range. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yonce et al. (US 20140142662)(Hereinafter Yonce) in view of Kong (US 20200179694)(Hereinafter Kong), McCabe et al. (US 20100305637)(Hereinafter McCabe), and Emborg et al. (US 20120059432)(Hereinafter Emborg).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 102(a)(1)/102(a)(2)/103 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/295,145 and 16/295,086, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The claim recitation of “the control unit being configured to execute a stimulation control algorithm to select the pulse parameter from a range of pulse parameters associated with the current amplitude parameter, the range of pulse parameters being defined at an upper bound by a subject tolerance limit and at a lower bound by an evoked response threshold” is nowhere to be found in the disclosures of 16/295,145 and 16/295,086.
Based on the information given by applicant and an inspection of the patent applications, the Examiner has concluded that the subject matter defined in this application is supported by disclosure in provisional application serial No. 62/931,342, filed 11/06/2019, Accordingly, the subject matter defined in claims 20-37 have an effective filing date of 11/06/2019. Should the Applicant disagree with the Examiner’s factual determination above, it is incumbent upon the Applicant to provide the serial number and specific page number(s) of any parent application filed prior to 11/06/2019, which specifically supports the particular claim limitation for each and every claim limitation in all the pending claims which applicant considers to have been in possession of and fully enabled for prior to 11/06/2019.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 20-25, 29-31, 33, 35, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yonce et al. (US 20140142662)(Hereinafter Yonce) in view of Kong (US 20200179694)(Hereinafter Kong), McCabe et al. (US 20100305637)(Hereinafter McCabe), and Emborg et al. (US 20120059432)(Hereinafter Emborg).
Regarding claims 20 and 38, Yonce teaches An apparatus for applying transcutaneous electrical stimulation to a peripheral nerve of a subject to treat a condition of the subject (Abstract “A tibial nerve stimulation therapy device configured to provide an electrical stimulation therapy to branches of the tibial nerve includes a plurality of stimulation electrodes, a stimulation circuit configured to generate electrical stimulation pulses, a sensing circuit configured to generate an output signal indicative of an electromyogram (EMG) signal”), comprising:
a plurality of stimulation electrodes (Fig. 3 [0026] “a stimulation circuit or pulse generator 104 and one or more electrodes 106. Embodiments of the electrodes 106 include transcutaneous surface or patch electrodes that engage the skin of the ankle area 102.”);
one or more recording electrodes ([0034] “the circuit 104 includes a sensing circuit 140 that is configured to sense an electromyogram (EMG) signal generated by the patient in response to the application of a stimulation therapy (i.e., electrical stimulation pulses) to the tibial nerve 112 through a sense electrode. In some embodiments, the sense electrode comprises one or more of the electrodes 106.”);
a wearable structure for supporting the stimulation electrodes and the one or more recording electrodes in a predetermined arrangement on the subject’s skin (Fig. 3 (100)); and
a control unit for controlling operation of the stimulation electrodes and the one or more recording electrodes, wherein the control unit is configured to energize the stimulation electrodes according to stimulation parameters to apply stimulation to the peripheral nerve, and to detect physiological responses to the stimulation applied to the peripheral nerve by the stimulation electrodes using the one or more recording electrodes ([0040] “the controller 126 that include an identification of a candidate pair of the electrodes 106, which are selected at 170. The candidate pair of electrodes 106 are enabled by the controller 126 through the closing of one or more of the switches 130. At 172, a stimulation pulse is applied at a maximum or other preset high power level based on a candidate stimulation pulse parameter. At 174, the EMG response from the patient is sensed, such as using the sensing circuit 140, and analyzed by the controller 126. If the controller 126 determines that an EMG response from the patient is not sensed or does not meet a threshold requirement at 174, the candidate settings are adjusted by selecting a new candidate pair of electrodes 106 using the controller 126, as indicated at 176”);
However, Yonce does not teach the stimulation parameters comprise a pulse parameter and a current amplitude parameter, wherein the control unit is also configured to identify a range of pulse parameters defined at an upper bound by a subject tolerance limit and at a lower bound by an evoked response threshold. Kong, in the same field of endeavor, teaches the TENS stimulation for therapeutic pain relief for calibrating user sensation (Abstract and [0005]-[0006]), and further teaches wherein the stimulation parameters comprise a pulse parameter and a current amplitude parameter, wherein the control unit is also configured to identify a range of pulse parameters defined at an upper bound by a subject tolerance limit and at a lower bound by an evoked response threshold ([0140] “electrotactile sensation threshold is the target sensation for the calibration process. However, other electrotactile sensation levels, such as electrotactile pain threshold, “strong yet not painful” level, and electrotactile tolerance threshold, may be the target sensation for the calibration process. Electrotactile sensation threshold is the lowest stimulation intensity and is generally a well understood concept. Therefore, it is a preferred target in the initial calibration process.”) to distinguish between the sensations felt by a user ([0140]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce, with the stimulation parameters comprise a pulse parameter and a current amplitude parameter, wherein the control unit is also configured to identify a range of pulse parameters defined at an upper bound by a subject tolerance limit and at a lower bound by an evoked response threshold of Kong, because such a modification would allow to distinguish between the sensations felt by a user.
However, Yonce in view of Cadwell does not teach the interpolation of pulse parameters and to modulate within the interpolated range of pulse parameters at a constant current. McCabe, in the same field of endeavor, teaches the phrenic nerve activation/stimulation via electrodes and stimulation parameters while sensing patient activity ([0009]), and further teaches the control unit being configured to execute a stimulation control algorithm to control the energization of the stimulation electrodes to maintain a selected current amplitude parameter while applyinq stimulation to the peripheral nerve ([0186] “If the pacing voltage is above the lower boundary of the transition zone, then the algorithm may continue searching for an acceptable pacing output configuration by changing a pacing output configuration parameter such as the pulse width or electrode combination, for example.”), wherein the control unit is further configured to determine an interpolated range of pulse parameters within the range of pulse parameters and to modulate the pulse parameter of the applied stimulation within the interpolated range of pulse parameters while maintaining the selected current amplitude parameter ([0103] “The capture and phrenic nerve activation strength-duration plots 810, 820 can then be completed by interpolation and extrapolation based on, for example, an exponential fit. Extrapolation and interpolation can also allow the relationships between pulse parameters and stimulation for a particular device configuration to be characterized beyond what the device itself is programmed to, or capable of, performing.” [0106] “system analyzing FIG. 8 may select a pacing pulse parameter (e.g., voltage) above the capture strength-duration plot 810 but below the transition zone 890 as a setting that will reliably capture the appropriate chamber (e.g., left ventricle) without occasionally activating the phrenic nerve.”) to optimize stimulation parameters by avoiding undesirable stimulation ([0103]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce, with the interpolation of pulse parameters and to modulate within the interpolated range of pulse parameters at a constant current of McCabe, because such a modification would allow to minimize battery consumption and uncomfortable testing.
However, Yonce in view of Cadwell and McCabe does not teach the algorithm controlling the stimulation of the electrodes at a constant current amplitude. Emborg, in the same field of endeavor, teaches the electric stimulation of the spinal cord and receiving feedback from a sensor and uses an algorithm for adjustment based on the feedback (Abstract), and further teaches the control unit being configured to execute a stimulation control algorithm to control the energization of the stimulation electrodes to maintain a selected current amplitude parameter (Fig. 2 [0036] “The electrode impedance is known to vary significantly over time, and thus it is preferred that electric stimulations with a constant current are used…However, it is preferred that the amplitude of the stimulation S can be varied on purpose so as to adapt the stimulation S intensity to the sensed feedback.” [0037] “the control algorithm CA can be designed such that an optimal gait can be obtained by appropriately determining a control signal CS that selects to stimulate the foot FT appropriately by one or more of the stimulations S1-S4, and especially the stimulations S1-S4 should be applied at the most optimal time during the step cycle”) to adapt the intensity based on the sensed feedback ([0036]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce, with the algorithm controlling the stimulation of the electrodes at a constant current amplitude of Emborg, because such a modification would allow to m adapt the intensity based on the sensed feedback.
Regarding claim 21, Yonce teaches wherein the control unit is further configured to modulate the selected pulse parameter within the interpolated range of pulse parameters associated with the selected current amplitude parameter using closed-loop control to maintain evoked physiological responses detected by the one or more recording electrodes (Fig. 7 shows the closed-loop based on the detecting EMG how to adjust the stimulation power level.).
Regarding claim 22, claim 20 is obvious over Yonce, Caldwell, McCabe, and Emborg. However, Yonce does not teach an upper and lower bound for a range of pulse parameters and amplitudes that are interpolated. McCabe, in a similar field of endeavor, teaches cardiac pacing of a nerve (Abstract) by delivering different pulses ([0050]), similar to the device on Yonce, and further teaches the in wherein the control unit is further configured to determine additional interpolated ranges of pulse parameters within ranges of pulse parameters associated with current amplitude parameters other than the selected current amplitude ([0098]-[0103]) to minimize battery consumption and uncomfortable testing ([0103]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce, with the upper and lower bound for a range of pulse parameters and amplitudes that are interpolated of McCabe, because such a modification would allow to minimize battery consumption and uncomfortable testing.
However, Yonce in view of Cadwell and McCabe does not teach the algorithm controlling the stimulation of the electrodes at a constant current amplitude. Emborg, in the same field of endeavor, teaches the electric stimulation of the spinal cord and receiving feedback from a sensor and uses an algorithm for adjustment based on the feedback (Abstract), and further teaches the control unit being configured to execute a stimulation control algorithm to control the energization of the stimulation electrodes to maintain a selected current amplitude parameter (Fig. 2 [0036] “The electrode impedance is known to vary significantly over time, and thus it is preferred that electric stimulations with a constant current are used…However, it is preferred that the amplitude of the stimulation S can be varied on purpose so as to adapt the stimulation S intensity to the sensed feedback.” [0037] “the control algorithm CA can be designed such that an optimal gait can be obtained by appropriately determining a control signal CS that selects to stimulate the foot FT appropriately by one or more of the stimulations S1-S4, and especially the stimulations S1-S4 should be applied at the most optimal time during the step cycle”) to adapt the intensity based on the sensed feedback ([0036]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce, with the algorithm controlling the stimulation of the electrodes at a constant current amplitude of Emborg, because such a modification would allow to m adapt the intensity based on the sensed feedback.
Regarding claim 23, Cadwell teaches wherein the control unit is further configured to maintain the current amplitude at the selected current amplitude parameter and to modulate the selected pulse parameter within the interpolated range of pulse parameters associated with the maintained current amplitude parameter using closed-loop control to maintain evoked physiological responses detected by the one or more recording electrodes ([0107] “In addition to (or in lieu of) the current of a stimulus signal, other stimulus characteristics, for example voltage or pulse width, may be used to produce the different stimulus levels and locate various points along the EMG response trend and determine stimulation characteristics that may be used to guide a surgical tool. FIG. 13 shows examples of using varying current and varying pulse width to produce a neuromonitoring approach similar to the monitoring and detection approaches discussed above.” Closed loop of Fig. 28-30.).
Regarding claim 24, Yonce teaches wherein the pulse parameter comprises at least one of a pulse frequency, a pulse duration, and a pulse-width- modulation (PWM) parameter ([0038] “the stimulation therapy settings include an identification of a pair of the electrodes 106 that will receive the electrical stimulation pulses from the stimulation circuit 104 during a stimulation therapy, and/or at least one parameter defining the electrical stimulation pulses generated by the stimulation circuit 104, such as a power level (e.g., duty cycle, pulse width, voltage level, current level, etc.) for the electrical stimulation pulses.”).
Regarding claim 25, Yonce teaches wherein the control unit is further configured to:
attempt to detect via the one or more recording electrodes an EMG response to stimulation therapy ([0034] “the circuit 104 includes a sensing circuit 140 that is configured to sense an electromyogram (EMG) signal generated by the patient in response to the application of a stimulation therapy (i.e., electrical stimulation pulses) to the tibial nerve 112 through a sense electrode. In some embodiments, the sense electrode comprises one or more of the electrodes 106.”);
in response to not detecting an EMG response, detecting an EMG response that fails to reach a predetermined threshold signal strength, or detecting an EMG response with a noise level that exceeds a predetermined threshold, deliver stimulation therapy under open-loop control without EMG feedback (Contingent Clause due to the use of “in response to”-under BRI, this limitation is not required. See MPEP 2111.04(II). In the instant case, because EMG can be detected, this limitation is not required.);
in response to detecting an EMG response, determine an EMG detection rate for the EMG response and, in response to the EMG detection rate, select a closed-loop control regime for energizing the stimulation electrodes according to the stimulation parameters to apply stimulation to the peripheral nerve ([0051] “If the controller 126 determines that a sufficient EMG signal is sensed at 240, the candidate pair of electrodes 106 is designated as the new final candidate pair of electrodes 106, and the current pulse power or stimulation level set at 238 is designated as the final candidate pulse power, at 244.”).
Regarding claim 29, Yonce teaches wherein the control unit is configured to determine an automatically detected foot, right or left, upon which the apparatus is worn by monitoring the physiological responses ([0034] “the circuit 104 includes a sensing circuit 140 that is configured to sense an electromyogram (EMG) signal generated by the patient in response to the application of a stimulation therapy (i.e., electrical stimulation pulses) to the tibial nerve 112 through a sense electrode. In some embodiments, the sense electrode comprises one or more of the electrodes 106. In some embodiments, a sense electrode is placed on the foot of the patient for better sensing of the associated EMG signal.” The foot is automatically detected when EMG signal is sensed.).
Regarding claim 30, Yonce teaches wherein the wearable structure comprises an ankle brace and the stimulating electrodes are configured so that a set of right foot electrodes are positioned adjacent the peripheral nerve when worn on the right foot, and so that a set of left foot electrodes are positioned adjacent the peripheral nerve when worn on the left foot (Fig. 3 [0025] “As used herein the "ankle area" refers to the ankle and the foot of the patient. Accordingly, as used herein, embodiments describing attaching or positioning electrodes to the ankle area of a patient include attaching or positioning electrodes on the foot of the patient.” The device can be used on either foot as the electrodes can be positioned near the tibia nerve.).
Regarding claim 31, Yonce teaches wherein the control unit is configured to select whether to use the left-side electrodes or right-side electrodes in response to determining a foot upon which the apparatus is worn (Claim 5 “further comprising a plurality of pulse routing switches each connected in series with one of the stimulation electrodes, wherein the controller is configured to selectively open or close each of the pulse routing switches to route the electrical stimulation pulses to the identified pair of electrodes.”).
Although Yonce does not explicitly select the electrodes based on the foot, Yonce selects the best electrodes to use based on the EMG signal ([0040]) and tibial nerve location to optimize the stimulation level sent to the foot ([0039]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce, with the select the electrodes based on the foot, because such a modification would allow to optimize the stimulation level sent to the foot.
Regarding claim 33, Yonce teaches wherein the control unit is configured to receive from the subject a left/right foot selection, and wherein the control unit is further configured to block stimulation in response to the left/right foot selection not matching the automatically detected foot (Claim 5 “further comprising a plurality of pulse routing switches each connected in series with one of the stimulation electrodes, wherein the controller is configured to selectively open or close each of the pulse routing switches to route the electrical stimulation pulses to the identified pair of electrodes.”).
Although Yonce does not explicitly select the electrodes based on the foot, Yonce selects the best electrodes to use based on the EMG signal ([0040]) and tibial nerve location to optimize the stimulation level sent to the foot ([0039]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce, with the select the electrodes based on the foot, because such a modification would allow to optimize the stimulation level sent to the foot.
Regarding claim 35, Yonce teaches wherein the stimulation electrodes, the one or more recording electrodes, and electrical traces that electrically connect the stimulation electrodes and the one or more recording electrodes to the control unit are directly applied to the wearable structure by spraying or deposition (The process as claimed is indistinguishable from the product obtained from the prior art. Therefore, the process anticipates the product.).
The patentability of a product does not depend on the preparation process steps. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." Inre Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). It is Applicant burden to show that the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yonce et al. (US 20140142662)(Hereinafter Yonce) in view of Kong (US 20200179694)(Hereinafter Kong), McCabe et al. (US 20100305637)(Hereinafter McCabe), Emborg et al. (US 20120059432)(Hereinafter Emborg), and Gharib (US 9392953)(Hereinafter Gharib).
Regarding claim 28, claim 20 is obvious over Yonce, Kong, McCabe, and Emborg. Yonce in view of Cadwell does not teach a closed loop regime with a minimum EMG detection rate threshold is a percent EMG response rate and modulating stimulating parameters to maintain EMG setpoint above EMG detection rate, the EMG response strength point is percentage feedback to determine EMG detection rate, and modulating to maintain MEG response strength. Gharib, in the same field of endeavor, teaches electrical stimulation of nerves while measuring EMG (muscle contraction) (Col. 2 lines 27-42), and further teaches wherein the control unit is configured to select as the closed-loop control regime an EMG appearance and strength control regime in which a minimum EMG detection rate threshold is determined as a percentage of the EMG response detection rate, and the stimulation parameters are modulated to maintain the EMG response detection rate at or above the minimum EMG detection rate, and wherein an EMG response strength setpoint is determined as a percentage of an EMG feedback response strength of the feedback used to determine the EMG detection rate, and the stimulation parameters are modulated to maintain the EMG feedback response strength at the EMG response strength setpoint (Col. 27-28 lines 60-67 and lines 1-14 See Fig. 32 where the minimum EMG detection rate is the setpoint sensitivity that is at a predetermined minimum threshold level (at a percentage of 0%) where the parameters are modulated up to 50% above the EMG detection rate/setpoint sensitivity, thereby maintaining the EMG response strength at EMG setpoint. Neurophysiologic monitoring occurs at the end. ) to commence the neurophysiologic monitoring (Col. 27-28 lines 60-67 and lines 1-14). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce in view of Cadwell, with the closed loop regime with a minimum EMG detection rate threshold is a percent EMG response rate and modulating stimulating parameters to maintain EMG setpoint above EMG detection rate, the EMG response strength point is percentage feedback to determine EMG detection rate, and modulating to maintain MEG response strength of Gharib, because such a modification would allow to commence the neurophysiologic monitoring.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yonce et al. (US 20140142662)(Hereinafter Yonce) in view of Kong (US 20200179694)(Hereinafter Kong), McCabe et al. (US 20100305637)(Hereinafter McCabe), and Emborg et al. (US 20120059432)(Hereinafter Emborg), and Ironi et al. (US 20180345020)(Hereinafter Ironi).
Regarding claim 32, claim 20 is obvious over Yonce, Kong, McCabe, and Emborg. Yonce does not teach elongated recording electrodes across the width of the bottom of a foot at spaced locations. Ironi, in the same field of endeavor, teaches a garment with a plurality of electrodes for sensing and stimulation (Abstract), and further teaches wherein the one or more recording electrodes have an elongated configuration and are positioned on the wearable structure to extend laterally across a width of the bottom of a subject's foot at spaced locations along a length of the foot so as to extend across longitudinal muscle groups of the subject’s foot from which an elicited response is to be recorded ([0085]-[0087]) to modulate electrical stimulation based on the muscle contractions ([0027]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce in view of Cadwell, with the elongated recording electrodes across the width of the bottom of a foot at spaced locations of Ironi, because such a modification would allow to modulate electrical stimulation based on the muscle contractions.
Claim(s) 34 and 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yonce et al. (US 20140142662)(Hereinafter Yonce) in view of Kong (US 20200179694)(Hereinafter Kong), McCabe et al. (US 20100305637)(Hereinafter McCabe), Emborg et al. (US 20120059432)(Hereinafter Emborg), and Hamner et al. (US 20210101007)(Hereinafter Hamner).
Regarding claim 34, claim 20 is obvious over Yonce, Kong, McCabe, and Emborg. Yonce in view of Cadwell does not teach the connection of the electrodes and traces to a controller and the electrodes and traces are formed on one or more layers on flexible conductive material. Hamner, in the same field of endeavor, teaches the use of stimulation electrodes to stimulate nerves (Abstract), and further teaches wherein the stimulation electrodes, the one or more recording electrodes, and electrical traces that electrically connect the stimulation electrodes and the one or more recording electrodes to the control unit comprise a single component in which the electrodes and traces are formed as one or more layers of electrically conductive material that are supported on a flexible substrate attached to the wearable structure ([0123] “The strip 806 and the band 800 can have electrical contacts and a flexible circuit so that the electrodes are electrically connected to the controller 810. To accommodate various body part sizes, the disposable strip 806 can be provided with a variety of electrode spacings. This allows one band size to accommodate users with different body part sizes.” [0119] “Electrical contacts and/or traces in the band 14 and/or housing 12 transmit the stimulation waveform from the pulse generator to the electrodes 16, which can be disposable.” [0097] “dry electrodes can be utilized, such as dry electrodes that include a conductive backing layer (e.g., a metal foil material, such as disposed on a flexible polymer substrate) and a skin contact layer disposed on the conductive backing layer, that can include for example a polymer, plastic, or rubber material, and a conductive filler material (e.g., powder, fine particulate material, metal, carbon, mixtures thereof, or porous material treated with a conductive coating) dispersed substantially evenly throughout the silicone, plastic, or rubber material.”) to provide overall compactness for ease of wear without affecting gait ([0097]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce in view of Cadwell, with the connection of the electrodes and traces to a controller and the electrodes and traces are formed on one or more layers on flexible conductive material of Hamner, because such a modification would allow to provide overall compactness for ease of wear without affecting gait.
Regarding claim 36, claim 20 is obvious over Yonce and Cadwell. Yonce in view of Cadwell does not teach the connection of the electrodes and traces to a controller and the electrodes and traces are formed on one or more layers on flexible conductive material. Hamner, in the same field of endeavor, teaches the use of stimulation electrodes to stimulate nerves (Abstract), similar to the device of Yonce in view of Cadwell, and further teaches wherein the electrical traces can be configured to have a curved/bent/waved appearance so as to be deformable in response to the wearable structure being stretched, twisted, folded, or otherwise deformed during use ([0123] “The strip 806 and the band 800 can have electrical contacts and a flexible circuit so that the electrodes are electrically connected to the controller 810. To accommodate various body part sizes, the disposable strip 806 can be provided with a variety of electrode spacings. This allows one band size to accommodate users with different body part sizes.” [0119] “Electrical contacts and/or traces in the band 14 and/or housing 12 transmit the stimulation waveform from the pulse generator to the electrodes 16, which can be disposable.” During application of the band, the band is bent/flexible.) to provide overall compactness for ease of wear without affecting gait ([0097]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce in view of Cadwell, with the e connection of the electrodes and traces to a controller and the electrodes and traces are formed on one or more layers on flexible conductive material of Hamner, because such a modification would allow to provide overall compactness for ease of wear without affecting gait.
Regarding claim 37, claim 20 is obvious over Yonce and Cadwell. Yonce in view of Cadwell teaches wherein the control unit is configured to record information related to the application of stimulation therapy and transmit the information to a patient controller, the patient controller being configured to transmit the information to a server wherein optimized therapy is determined by (Abstract of Yonce “The depicted embodiment includes a computer interface allowing EMG signal data recorded by the EMG feedback monitor to be sent to a computer system [server].”) but does not teach the patient diary entries which are a compilation of quantitative summary used for the correlation of stimulation schedule and feedback history to optimize therapy. Hamner, in the same field of endeavor, teaches the use of stimulation electrodes to stimulate nerves (Abstract), similar to the device of Yonce in view of Cadwell, and further teaches wherein the controller is configured to record information related to the application of stimulation therapy and transmit the information to a patient controller, the patient controller being configured to transmit the information to a server wherein optimized therapy is determined by ( [0154] “The interval could also be optimized using machine learning algorithms, such as deep learning, na?ve Bayesian networks, neural networks, and/or crowdsourced or otherwise aggregated datasets from multiple users with data (e.g., device usage, symptom tracking, autonomic activity) stored on a remote centralized server (e.g., the cloud).”):
compiling a quantitative summary of stimulation including stimulation history/schedule, stimulation parameters, elicited muscle responses, and an effect the stimulation had on the subject as recorded in patient diary entries ([0145] “Theta burst stimulation (TBS) is a patterned form of repetitive stimulation that uses high frequency pulses [stimulation parameters] separated by varying inter-burst intervals. …The number of sessions and the spacing interval between individual sessions of stimulation can also have an effect on the duration of the induced response. The level of muscle relaxation before or during stimulation can also affect the resulting direction or amplitude of plasticity induction suggesting that homeostatic mechanisms [muscle response/ effect of stimulation]are in place that adjust the threshold for plasticity depending on prior synaptic activity.” [0146] “Each illustrate examples of TBS including a burst of 3 stimuli at 50 Hz (20 ms between each stimulus) [stimulation parameters] which was repeated at inter-burst intervals of 200 ms (5 Hz) [schedule].”); and
implementing informatics to correlate a stimulation profile (current amplitudes, voltages, pulse profiles), a feedback history (EMG data), and the patient diary entries so that, over time, the stimulation profile can be used to optimize therapy for each individual patient, thus improving patient outcomes ([0154] “Theta burst stimulation intersession interval variation [patient diary entries] can have a significant effect of varying the spacing intervals between stimulation sessions [stimulation profile]. Prolongation of the duration of symptom improvement may improve the tolerability of chronic repetitive stimulation… In some embodiments, the intersession interval can be varied according to a predetermined algorithm or schedule. In some embodiments, the intersession interval can be varied based on feedback based on data from an accelerometer or electromyography… The interval could also be optimized using machine learning algorithms [informatics], such as deep learning, na?ve Bayesian networks, neural networks, and/or crowdsourced or otherwise aggregated datasets from multiple users with data (e.g., device usage, symptom tracking, autonomic activity) stored on a remote centralized server (e.g., the cloud).”) to provide overall compactness for ease of wear without affecting gait ([0097]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Yonce in view of Cadwell, with the patient diary entries which are a compilation of quantitative summary used for the correlation of stimulation schedule and feedback history to optimize therapy of Hamner, because such a modification would allow to provide overall compactness for ease of wear without affecting gait.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yoo et al. (US 20190001135), Charlesworth et al. (US 20220143393)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796