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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 10/30/2025. As directed by the amendment: Claims 29, 31, 33, 35, 37, 54, and 58-61 have been amended, no claims have been cancelled, and claims 66-68 have been added. Claims 53 were previously withdrawn due to a Restriction Requirement. Thus, claims 29, 31, 33, 35, 37, 51-52, and 54-68 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see page 7, filed 10/30/2025, 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 The rejection of the claims has been withdrawn.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 7-11, filed 10/30/2025, with respect to the claim(s) under 35 U.S.C. 102/103 have been fully considered and are persuasive. Amendments obviate the rejection of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hamilton et al. (US 20130123568) (Hereinafter Hamilton).
Claim Rejections - 35 USC § 102
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.
Claim(s) 29, 35, 51-52, 54, 62, and 66, and 68 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamilton et al. (US 20130123568) (Hereinafter Hamilton).
Regarding claims 29 and 68, Hamilton teaches A method for electrically stimulating one or more muscles of a subject (Abstract “A universal closed-loop functional electrical stimulation system comprising at least one electrode assembly adapted to deliver an electrical stimulation signal to the central nervous system, peripheral nervous system, or muscles of a user”), the method comprising:
placing at least two electrodes configured to be placed in electrical contact with skin of said subject in a vicinity of the one or more muscles ([0039] “the present invention may employ more than 10 electrodes. The electrodes may be embedded in the wearable garment associated with the present invention. It is possible to employ more than 100 electrodes. By employing a large number of electrodes, the system is able to stimulate multiple muscles. Preferably, 8 to 10 muscles may be stimulated.” This presumes the use of 10 electrodes per muscle, but also a minimum of 2 electrodes used for 2 different muscles for stimulation, which both encompass the claimed language.), and at least two accelerometers arranged in a predetermined pattern in relation to a center point or region of the one or more muscles, wherein said predetermined pattern is configured to allow measurement of said one or more muscles movement and/or acceleration at a center region of the one or more muscles, wherein said at least two accelerometers are configured to measure movement of said on or more muscles in one or more degrees-of-freedom ([0034] “The algorithm will in turn determine the appropriate signal pattern for the functional electrical stimulator (or FES) 14 to apply to the appropriate location in the nervous system and hence to the appropriate muscle(s) 16… a motion sensor 20, such as a 3-axis sensor, will provide another feedback signal for the processor 12. By comparing the required or desired stimulation pattern, as inputted from the application section 10, the electrical signal to be outputted via the FES 14 can be adjusted.” [0038] “3-Axis accelerometer” [0054] “Sensing of muscle movement, as well as other key factors like fatigue, combined with capabilities for constant FES adjustment based upon that sensing enable real-world "natural" movement. This is facilitated via real-time feedback and closed-loop control.” See Fig. 1 which uses 2 3-axis sensors [which are accelerometers] for different muscle groups used for closed loop stimulation, seen in Fig. 10.);
operating a pulse generator to generate an electrical pulse for application to the one or more muscles through the at least two electrodes ([0003] “FES systems use electronics to generate electrical impulses. These impulses are transcutaneous, typically transferred through surface electrodes to stimulate contraction/activity of the muscles that are otherwise dysfunctional or not operating optimally.” [0013] “An algorithm, that may be stored and controlled by the FES microprocessor, activates channels to stimulate peripheral nerves and trigger muscle contractions to produce functionally useful movements that allow patients to sit, stand, walk, and grasp.”);
measuring, through said at least two accelerometers, movement of said one or more muscles at said center region in response to said application of said electrical pulse (Fig. 10 (1010) [0033] “an automated adaptive FES system comprising at least one electrode assembly adapted to deliver an electrical stimulation signal to …muscles of a user, a sensor system adapted to detect a mechanical response to a muscle stimulation signal of at least one muscle associated with a muscle group stimulated through the nervous system or proximate to the electrode assembly, and an electrical stimulation device operably coupled to at least one electrode assembly and the sensor system, the electrical stimulation device including a control system operable to automatically receive feedback from at least one characteristic of the muscle from the detected muscle response and adjust at least one parameter of the muscle stimulation signal in real-time and in response thereto to deliver an adjusted muscle stimulation signal;” [0038] “3-Axis accelerometer” [0034] “a motion sensor 20, such as a 3-axis sensor, will provide another feedback signal for the processor 12.”); and
adjusting, by a control processor operatively coupled to the stimulating unit and the pulse generator, said operating, based, at least in part, on said measuring (Fig. 10 [0033] “an automated adaptive FES system…the electrical stimulation device including a control system operable to automatically receive feedback from at least one characteristic of the muscle from the detected muscle response and adjust at least one parameter of the muscle stimulation signal in real-time and in response thereto to deliver an adjusted muscle stimulation signal; and a programmed microprocessor for controlling said electrical stimulation and receiving input from said sensor system, including means for comparing said electrical stimulation and said mechanical response based upon the input from the sensor system or a data base of preferred responses and the means for comparing, wherein the electrical stimulation and the detected muscle response comprises a plurality of reaction pulses.” [0059] “After the stimulation settings are adjusted or if no changes are needed, the process resumes at 1030, where sensor devices are detected, such as EMG and/or body position sensors (angle accelerometers and gyroscopes). At 1040, those devices default settings may be adjusted. If the settings are adjusted, the sensor points for the selected program (arms, trunk, leg, hands) are listed at 1050.”).
Regarding claim 35, Hamilton teaches further comprising sensing at least one physiological parameter of the subject through a sensing unit comprising at least one sensor ([0059] “After the stimulation settings are adjusted or if no changes are needed, the process resumes at 1030, where sensor devices are detected, such as EMG and/or body position sensors (angle accelerometers and gyroscopes).” [0049] “junction conductivity reading circuitry has been designed into the EMG circuit that allows dynamic conductivity readings to be taken in real-time.”).
Regarding claim 51, Hamilton teaches wherein adjusting said operating comprises adjusting at least one parameter of said electrical pulse based, at least in part, on said measuring ([0051] “This is accomplished by adjusting the frequency and/or pulse width during stimulation treatment in response to the work output measured.”).
Regarding claim 52, Hamilton teaches wherein said at least one parameter comprises one or more of, an intensity of said electrical pulse, a duration of said electrical pulse, a shape of said electrical pulse, or any combination thereof ([0051] “This is accomplished by adjusting the frequency and/or pulse width during stimulation treatment in response to the work output measured.”).
Regarding claim 54, Hamilton teaches wherein the at least one physiological parameter of the subject includes a parameter selected from the group consisting of: body movements, body position, heart rate (HR) heart rate variability (HRV), oxygen saturation, and a rate of respiration, and wherein the at least one sensor is configured to measure the physiological parameter selected from the group ([0030] “the present invention will provide a new quantifiable assessment tool for thoracic motor function using a trunk garment with imbedded electrophysiological sensors, which will record axial muscle recruitment and trunk extension, flexion, lateral flexion, and rotation in individuals with paralysis during unsupported sitting via surface EMGs and measure trunk excursion during specific activity-based tasks (i.e. seated forward reach and lateral lean) using body position sensors.”).
Regarding claim 62, Hamilton teaches wherein said measuring comprises measuring contraction of said one or more muscles in response to said electrical pulse ([0033] “an automated adaptive FES system…the electrical stimulation device including a control system operable to automatically receive feedback from at least one characteristic of the muscle from the detected muscle response and adjust at least one parameter of the muscle stimulation signal in real-time and in response thereto to deliver an adjusted muscle stimulation signal; and a programmed microprocessor for controlling said electrical stimulation and receiving input from said sensor system, including means for comparing said electrical stimulation and said mechanical response based upon the input from the sensor system or a data base of preferred responses and the means for comparing, wherein the electrical stimulation and the detected muscle response comprises a plurality of reaction pulses.”).
Regarding claim 66, Hamilton teaches wherein said method is a method of Electrical Muscle Stimulation (EMS) training ([0067] “The integrated monitoring of vital functions and outcome neurological measures with distance management, while controlling the surface sensory and stimuli system to evaluate, monitor and train a variety of neurological and autonomic functions.”).
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) 55-56, 63, and 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al. (US 20130123568) (Hereinafter Hamilton) in view of Sachs et al. (WO2019126080A1)(IDS) (Hereinafter Sachs)(citations from US 20200391021).
Regarding claim 55, Hamilton teaches the invention of claim 29. However, Hamilton does not teach two electrodes comprise an array of between 2 and 10 electrodes. Sachs, in the same field of endeavor, teaches the stimulation of muscles and using acceleration sensors for feedback for adjusting stimulation (Abstract), and further teaches wherein the at least two electrodes comprise an array of between 2 and 10 electrodes (Fig. 9 [0156] “As mentioned above with respect to FIG. 11, the process of delivering a stimulating current, receiving feedback regarding muscle contraction and patient pain, turning on/off electrodes 36 of sets 34a, 34b, and delivering a new stimulating current, may be repeated as many times as necessary.”) to adjust the stimulation regimen based on feedback ([0102]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with the two electrodes comprise an array of between 2 and 10 electrodes of Sachs, because such a modification would allow to adjust the stimulation regimen based on feedback.
Regarding claim 56, Hamilton teaches the invention of claim 29. However, Hamilton does not teach a distance between any two adjacent electrodes in the array is not greater than 2 cm. Sachs, in the same field of endeavor, teaches the stimulation of muscles and using acceleration sensors for feedback for adjusting stimulation (Abstract), and further teaches wherein a distance between any two adjacent electrodes in the array is not greater than 2 cm ([0120] “Each electrode 36 may range in size from about 2 mm squared to about 6 cm squared…In order to provide desired stimulation of nerve tissue beneath the skin surface to promote muscle contraction, electrode sets 34a, 34b will typically be spaced at least about 3 cm from each other, when measured from the center of each set 34a, 34b.” Examiner notes that if the two electrodes are circular electrodes with an area of 6 cm2, the radius of the circle is approximately 1.38 cm. Because the spacing between two adjacent electrodes are 3 cm apart, from the center of each set, the spacing between adjacent electrodes, excluding the portion of the electrode is .24 cm, which is less than 2 cm. ) to adjust the stimulation regimen based on feedback ([0102]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with a distance between any two adjacent electrodes in the array is not greater than 2 cm of Sachs, because such a modification would allow to adjust the stimulation regimen based on feedback.
Regarding claim 63, Hamilton teaches the invention of claim 29. However, Hamilton does not teach operating comprises operating said pulse generator to generate said electrical pulse with symmetric bi-phasic rectangular pulse shape comprising equal positive and negative pulse phases. Sachs, in the same field of endeavor, teaches the stimulation of muscles and using acceleration sensors for feedback for adjusting stimulation (Abstract), and further teaches wherein said operating comprises operating said pulse generator to generate said electrical pulse with symmetric bi-phasic rectangular pulse shape comprising equal positive and negative pulse phases ([0096] “To generate a biphasic stimulation pattern, the first pulse is immediately followed by another pulse having equal amplitude of opposite polarity.” [0094] “The delivery of direct electrical currents, i.e. DC [rectangular], could damage tissue.”) to adjust the stimulation regimen based on feedback ([0102]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with operating comprises operating said pulse generator to generate said electrical pulse with symmetric bi-phasic rectangular pulse shape comprising equal positive and negative pulse phases of Sachs, because such a modification would allow to adjust the stimulation regimen based on feedback.
Regarding claim 65, Hamilton teaches the invention of claim 29. However, Hamilton does not teach operating comprises operating said pulse generator to generate said electrical pulse for the application of said electrical pulse in pulse bursts having a frequency of between 20-70 Hz and a duration of between 0.5-15 seconds. Sachs, in the same field of endeavor, teaches the stimulation of muscles and using acceleration sensors for feedback for adjusting stimulation (Abstract), and further teaches wherein said operating comprises operating said pulse generator to generate said electrical pulse for the application of said electrical pulse in pulse bursts having a frequency of between 20-70 Hz and a duration of between 0.5-15 seconds ([0219] “One embodiment of contraction stimulation system for OA would use tetanic frequencies of 20-75 Hz, with an on time of 4 to 10 seconds, and off time of 4-10 seconds.” [0143] “Electrical stimulation unit 32 also may deliver a combined waveform having a low frequency square wave and high frequency sine wave bursts, where the high frequency sine wave bursts penetrate deep into the tissue and cause the stimulation of the motor point.”) to adjust the stimulation regimen based on feedback ([0102]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with operating comprises operating said pulse generator to generate said electrical pulse for the application of said electrical pulse in pulse bursts having a frequency of between 20-70 Hz and a duration of between 0.5-15 seconds of Sachs, because such a modification would allow to adjust the stimulation regimen based on feedback.
Claim(s) 31 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al. (US 20130123568) (Hereinafter Hamilton)in view of Lee et al. (US 8620439)(Hereinafter Lee).
Regarding claim 31, Hamilton teaches the invention of claim 29. However, Hamilton does not teach a normalized response value of a ratio between movement of muscle and a reference movement prior to application of electrical pulse. Lee, in the same field of endeavor, teaches electrical stimulation of the muscle to observe muscle fatigue while measuring acceleration (Col. 1 lines 47-67), and further teaches further comprising calculating, by said control processor, a normalized response value of said one or more muscles to said electrical pulse based on said movement measurements performed through said at least two accelerometers, wherein said normalized response value represents a ratio between said movement of said muscle and a reference movement of said one or more muscles before said application (Col. 6 lines 44-47 “The fatigue index output unit 340 determines a fatigue index [normalized response value] as a ratio of a difference between the initial median frequency and the final median frequency to the initial median frequency.”) to quantitatively monitor muscle strengthen exercises for muscle restoration (Col. 1 lines 24-34). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with the normalized response value of a ratio between movement of muscle and a reference movement prior to application of electrical pulse of Lee, because such a modification would allow to quantitatively monitor muscle strengthen exercises for muscle restoration.
Regarding claim 33, Hamilton teaches the invention of claim 29. However, Hamilton does not teach a treatment protocol with a succession of pulses configured to generate a specified level of muscle fatigue based on a fatigue score. Lee, in the same field of endeavor, teaches electrical stimulation of the muscle to observe muscle fatigue while measuring acceleration (Col. 1 lines 47-67), and further teaches further comprising modifying, by said control processor, a treatment protocol for a user, wherein said treatment protocol comprises a succession of electrical pulse applications, and wherein each of said applications is configured to generate a specified level of fatigue in said one or more muscles, based, at least in part, on said normalized response value (See Fig. 4 where first electric pulse/stimulation is sent to detect EMG (400), calculation of the fatigue index occurs (420), and adjustment of electrical stimulation occurs according to the fatigue index. Examiner notes the successive electrical pulses between the calculations allows for this process to occur over and over.) to quantitatively monitor muscle strengthen exercises for muscle restoration (Col. 1 lines 24-34). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with the treatment protocol with a succession of pulses configured to generate a specified level of muscle fatigue based on a fatigue score of Lee, because such a modification would allow to quantitatively monitor muscle strengthen exercises for muscle restoration.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al. (US 20130123568) (Hereinafter Hamilton) in view of Ng et al. (US 20200298004)(Hereinafter Ng).
Regarding claim 37, Hamilton teaches the invention of claim 29. However, Hamilton does not teach an accelerometer for detecting breathing and adjusting in response to a phase of the user. Ng, in the same field of endeavor, teaches neuromuscular electrical stimulation based on collected data from sensors (Abstract), and further teaches wherein the at least one sensor comprises a sensor configured to detect breathing of the subject, and wherein the control processor is configured to perform said adjusting, at least in part, in response to identifying a phase of a breathing cycle of the subject ([0132] “Next, the accelerometer sensor on the chest may record the relative x-axis positions of the sensor, i.e. inspiration (x.sub.inp)−expiration (x.sub.exp), during rib-cage expansion. FIG. 7F is a schematic 700f showing how an accelerometer sensor configured to determine movements in three dimensions (xyz sensor) is used with a neuromuscular electrical stimulation (NMES) device for electrical stimulation based on breathing (exhalation/inhalation) according to various embodiments. If intra-abdominal pressure is deemed a major contribution to the lower limb venous return, NMES may be applied to the soleus, the posterior tibialis (TP), the flexor digitorum longus (FDL), and/or the flexor hallucis longus (FHL) during which the intra-abdominal pressure during physiological standing is the lowest at the point of maximum exhalation x.sub.exp, i.e. when the rib cage circumference is the smallest. The stimulation may be applied for the duration that is equivalent to the period of exhalation (time duration when the x-position of the chest sensor is between a maximum value x.sub.inpmax and a minimum value x.sub.expmin).”) to enhance lower limb venous return in the standing position ([0132]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with the accelerometer for detecting breathing and adjusting in response to a phase of the user of Ng, because such a modification would allow to enhance lower limb venous return in the standing position.
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al. (US 20130123568) (Hereinafter Hamilton) in view of Fahey et al. (US 20100217349)(Hereinafter Fahey).
Regarding claim 58, Hamilton teaches the invention of claim 29. However, Hamilton does not teach a vacuum source to apply vacuum in proximity to the skin. Fahey, in the same field of endeavor, teaches a muscle stimulation device to induce muscle contractions (Abstract and [0003]), and further teaches further comprising a vacuum source configured to apply vacuum to the skin of the subject in proximity of the one or more muscles to be stimulated ([0113] “moisture build-up in the region of stimulation may be reduced by preventing warm air from reaching the cold source/skin interface, which can be accomplished by reducing or eliminating the air between the cooling element and the skin. Suction and/or vacuum pumps can be used remove the air.”) to avoid excess skin moisture during NMES with surface cooling ([0112]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with the vacuum source to apply vacuum in proximity to the skin of Fahey, because such a modification would allow to avoid excess skin moisture during NMES with surface cooling.
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al. (US 20130123568) (Hereinafter Hamilton) in view of Schwarz et al. (US 10583287)(Hereinafter Schwarz).
Regarding claim 57, Hamilton teaches the invention of claim 29. However, Hamilton does not teach a heat source to heat the skin up to 20 degrees C. Schwarz, in the same field of endeavor, teaches an external muscle stimulation device via electrotherapy (Abstract), and further teaches further comprising a heat source configured to heat the skin in proximity of the one or more muscles to be stimulated by up to 20 degrees Celsius (Col. 20 lines 26-27 “In one method, the patient's surface (epidermis) temperature may be maintained in a range between 20° C. to 44° C.” Col. 5 lines 5-7 “According another embodiment RF therapy and electrotherapy may be also combined with any one or more other treatment energy sources: e.g. heating energy source”) to minimize discomfort and influence tissue penetration of the therapy (Col. 4 lines 36-41). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with the heat source to heat the skin up to 20 degrees C of Schwarz, because such a modification would allow to minimize discomfort and influence tissue penetration of the therapy.
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al. (US 20130123568) (Hereinafter Hamilton) in view of in view of Sachs et al. (WO2019126080A1) (Hereinafter Sachs)(citations from US 20200391021) and Fahey et al. (US 20190269903)(IDS)(Hereinafter Fahey).
Regarding claim 64, Hamilton teaches the invention of claim 29. However, Hamilton does not teach ) a length of each of said pulse phases is in the range of 100-400 microseconds (ps), (ii) a length of an interphasic rest period is within the range of 40-100ps. Sachs, in the same field of endeavor, teaches the stimulation of muscles and using acceleration sensors for feedback for adjusting stimulation (Abstract), and further teaches wherein (i) a length of each of said pulse phases is in the range of 100-400 microseconds (ps), (ii) a length of an interphasic rest period is within the range of 40-100ps, ([0096] “each phase of the pulse, i.e. the positive and the negative pulses, lasts for 50 microseconds to 2 milliseconds, but most pulses used in LAMES systems commonly have duration of between 200 microseconds and 1 millisecond.”) to adjust the stimulation regimen based on feedback ([0102]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with a length of each of said pulse phases is in the range of 100-400 microseconds (ps), (ii) a length of an interphasic rest period is within the range of 40-100ps of Sachs, because such a modification would allow to adjust the stimulation regimen based on feedback.
However, Hamilton in view of Sachs does not teach an amplitude with phase pulses at 20-100 mA. Fahey, in the same field of endeavor, teaches the stimulation of a target muscle using an electrode while sensing a muscle that detects contractions (Abstract), and further teaches (ii) an amplitude of each of said pulse phases is in the range of 20-100 mA ([0152] “the current level chosen to be sufficiently low that little to no muscle contraction is induced. Sensing electrode data may be recorded during each of these energy delivery periods. Following this, the current level may be increased to an amplitude (ex. 50-80 mA)”) to produce muscle contractions ([0152]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton in view of Sachs, with the heat source to heat the skin up to 20 degrees C of Schwarz, because such a modification would allow to minimize discomfort and influence tissue penetration of the therapy.
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al. (US 20130123568) (Hereinafter Hamilton) in view of Lee et al. (US 8620439)(Hereinafter Lee) and Su et al. (US 20130072998)(Hereinafter Su).
Regarding claim 59, Hamilton teaches the invention of claim 29. However, Hamilton does not teach an estimating fatigue score based on normalized response values over time and modifying the operating based on the fatigue score. Su, in the same field of endeavor, teaches the electrical stimulation controlled by a processor based on physiological responses of muscle contractions (Abstract), similar to the device of Hamilton, and further teaches comprising estimating, by said control processor, a fatigue score of said one or more muscles, wherein said fatigue score is based, at least in part, on said normalized response value calculated over time, and wherein said adjusting comprises adjusting said operating based on said estimated fatigue score ([0101] “Information related to sensed bladder contractions, bladder impedance and/or posture of patient 14 may be recorded for long-term storage and retrieval by a user, or used by control module 50 for adjustment of stimulation parameters, such as amplitude, pulse width, and pulse rate.” [0140] “The stimulation parameter values for the second stimulation therapy are generally different than those for the first stimulation therapy… Stimulation parameter values for the second stimulation therapy also or alternatively may be selected to more efficaciously reduce a contraction frequency of bladder 12. Stimulation parameter values for the second stimulation therapy may also be selected to minimize muscle fatigue. Muscle fatigue may occur when the force-generating ability of a muscle decreases as a result of the electrical stimulation.” [0211] “FIG. 10 is a graph that illustrates a change in bladder contraction frequency in response to electrical stimulation… For each test run (i.e., each 45 minute observation), a frequency of bladder contractions was determined at approximately 5 minute intervals. The determined frequencies of bladder contractions were then normalized (i.e., divided by) by a frequency of bladder contractions of the test subject at time zero. The normalized bladder contraction frequencies are graphed in FIG. 10.” Examiner notes that the frequency contractions of Fig. 10 and [0211] can be used for reducing contraction frequency caused by fatigue by changing the stimulation parameters in [0140].) to reduce a contraction frequency ([0140]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Sachs, with the estimating fatigue score based on normalized response values over time and modifying the operating based on the fatigue score of Su, because such a modification would allow to reduce a contraction frequency.
Claim(s) 60-61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al. (US 20130123568) (Hereinafter Hamilton) in view of Lee et al. (US 8620439)(Hereinafter Lee) and Su et al. (US 20130072998)(Hereinafter Su), Sachs et al. (WO2019126080A1)(IDS) (Hereinafter Sachs)(citations from US 20200391021).
Regarding claim 60, claim 59 is obvious over Hamilton in view of Lee and Su. However, Hamilton, Su, and Lee do not teach detecting muscle fatigue of said one or more muscles based on said estimated fatigue score, and wherein said adjusting said operating comprises discontinuing application of said electrical pulse to said one or more muscles based on said muscle fatigue. Sachs, in the same field of endeavor, teaches the stimulation of muscles and using acceleration sensors for feedback for adjusting stimulation (Abstract), and further teaches comprising detecting muscle fatigue of said one or more muscles based on said estimated fatigue score, and wherein said adjusting said operating comprises discontinuing application of said electrical pulse to said one or more muscles based on said muscle fatigue ([0140] “the rate of contraction may be used to assess the state of muscle fatigue.” [0107] “the system may detect muscle fatigue and pause stimulation or change stimulation parameters to allow the muscle to recover. Also alternatively or additionally, some embodiments may change the site of stimulation to allow one set of muscle fibers to rest, while a different set of fibers is stimulated.” [0210] “In another embodiment, the control unit may be configured to terminate the stimulation that is delivered to a muscle group that is fatigued, but at the same time communicate this information to the patient interface unit. If there is remaining time in the planned therapy duration or the therapy goal has not yet been achieved, then the stimulation of another group of muscles may be initiated. This transition between stimulated muscle groups may be accomplished in any one of several ways: If the patch is located so that it covers both the fatigued muscle group and the new muscle group, then the electrodes in the patch may be electrically reconfigured to capture the new muscle group instead of the previous one.”) to adjust the stimulation regimen based on feedback ([0102]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton in view of Lee and Su, with detecting muscle fatigue of said one or more muscles based on said estimated fatigue score, and wherein said adjusting said operating comprises discontinuing application of said electrical pulse to said one or more muscles based on said muscle fatigue of Sachs, because such a modification would allow to adjust the stimulation regimen based on feedback.
Regarding claim 61, claim 59 is obvious over Hamilton in view of Lee and Su. However, Hamilton, Su, and Lee do not teach wherein said one or more muscles comprise muscles, wherein said at least two electrodes comprise electrodes placed over said muscles, wherein said method comprises detecting muscle fatigue of a first muscle of said muscles based on said estimated fatigue score and wherein said adjusting said operating comprises discontinuing application of said electrical pulse to said first muscle, and applying an electrical pulse by a different subset of said electrodes to a second muscle of said muscles, based on said detected muscle fatigue. Sachs, in the same field of endeavor, teaches the stimulation of muscles and using acceleration sensors for feedback for adjusting stimulation (Abstract), and further teaches wherein said one or more muscles comprise muscles, wherein said at least two electrodes comprise electrodes placed over said muscles, wherein said method comprises detecting muscle fatigue of a first muscle of said muscles based on said estimated fatigue score and wherein said adjusting said operating comprises discontinuing application of said electrical pulse to said first muscle, and applying an electrical pulse by a different subset of said electrodes to a second muscle of said muscles, based on said detected muscle fatigue ([0107] “the system may detect muscle fatigue and pause stimulation or change stimulation parameters to allow the muscle to recover. Also alternatively or additionally, some embodiments may change the site of stimulation to allow one set of muscle fibers to rest, while a different set of fibers is stimulated.” [0210] “In another embodiment, the control unit may be configured to terminate the stimulation that is delivered to a muscle group that is fatigued, but at the same time communicate this information to the patient interface unit. If there is remaining time in the planned therapy duration or the therapy goal has not yet been achieved, then the stimulation of another group of muscles may be initiated. This transition between stimulated muscle groups may be accomplished in any one of several ways: If the patch is located so that it covers both the fatigued muscle group and the new muscle group, then the electrodes in the patch may be electrically reconfigured to capture the new muscle group instead of the previous one.”) to adjust the stimulation regimen based on feedback ([0102]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton in view of Lee and Su, with wherein said one or more muscles comprise muscles, wherein said at least two electrodes comprise electrodes placed over said muscles, wherein said method comprises detecting muscle fatigue of a first muscle of said muscles based on said estimated fatigue score and wherein said adjusting said operating comprises discontinuing application of said electrical pulse to said first muscle, and applying an electrical pulse by a different subset of said electrodes to a second muscle of said muscles, based on said detected muscle fatigue of Sachs, because such a modification would allow to adjust the stimulation regimen based on feedback.
Claim(s) 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al. (US 20130123568) (Hereinafter Hamilton) in view of Lee et al. (US 8620439)(Hereinafter Lee) and Marion et al. (“Predicting the effect of muscle length on fatigue during electrical stimulation”, Muscle Nerve 40: 573–581, 2009)(Hereinafter Marion).
Regarding claim 67, Hamilton teaches the invention of claim 29. However, Hamilton does not teach estimating, by said control processor, a fatigue score of said one or more muscles, wherein said fatigue score is based, at least in part, on a ratio between a reference muscle response, and a muscle response according to said calculated normalized response value. Lee, in the same field of endeavor, teaches electrical stimulation of the muscle to observe muscle fatigue while measuring acceleration (Col. 1 lines 47-67), and further teaches comprising estimating, by said control processor, a fatigue score of said one or more muscles, wherein said fatigue score is based, at least in part, on a ratio between a reference muscle response, and a muscle response according to said calculated normalized response value (Col. 6 lines 44-47 “The fatigue index output unit 340 determines a fatigue index [normalized response value] as a ratio of a difference between the initial median frequency and the final median frequency to the initial median frequency.”) to quantitatively monitor muscle strengthen exercises for muscle restoration (Col. 1 lines 24-34). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton, with the estimating, by said control processor, a fatigue score of said one or more muscles, wherein said fatigue score is based, at least in part, on a ratio between a reference muscle response, and a muscle response according to said calculated normalized response value of Lee, because such a modification would allow to quantitatively monitor muscle strengthen exercises for muscle restoration.
However, Hamilton in view of Lee does not teach the ratio between a reference muscle response, and a muscle response according to said calculated normalized response value, at a specific time period during stimulation treatment session. Marion, in the same field of endeavor, teaches the FES stimulation for muscle fatigue (Abstract), and further teaches a ratio between a reference muscle response, and a muscle response according to said calculated normalized response value, at a specific time period during stimulation treatment session (Fig. 2 and Page 577 left col. lines 40-44 “The dependent variables were absolute and relative measured force– time integrals. Relative force–time integrals were normalized to the force–time integral of the first contraction.” Examiner notes that FES (during stimulation) induced fatigue is normalized to a first contraction. Examiner further interprets “stimulation treatment session” as the time in which stimulation is applied, as the application of stimulation is considered a “treatment”, and no treatment was previously recited.) to optimize the accuracy of fatigue contraction prediction (Page 577 left col. lines 40-50). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Hamilton in view of Lee, with the ratio between a reference muscle response, and a muscle response according to said calculated normalized response value, at a specific time period during stimulation treatment session of Marion, because such a modification would allow to optimize the accuracy of fatigue contraction prediction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sasaki et al. (US 20240081774) and Su (US 20230337989).
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 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
/REX R HOLMES/Primary Examiner, Art Unit 3796