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 06/24/2026. As directed by the amendment: no claims have been amended, claims 1-68 have been cancelled, and claims 69-88 have been added. Thus, claims 69-88 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 06/04/2026, 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 Therefore, the rejection has been withdrawn.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) in view of Sachs et al. (WO2019126080A1)(IDS) (Hereinafter Sachs)(citations from US 20200391021).
Claim Objections
Claim 70 is objected to because of the following informalities: the phrase “normalized signals” should be amended to recite “normalized movement signals”. Appropriate correction is required.
Claim 76 is objected to because of the following informalities: the limitation is missing an “or” and should be amended to recite “or a shape of the second stimulation signals”. Appropriate correction is required.
Claim 86 is objected to because of the following informalities: the phrase “pulse phases” should be amended to recite “positive and negative pulse phases”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 81-83 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 81 has been amended to include the limitation, " wherein the fatigue score is based on a normalized measurement captured over time ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for determining a normalized muscle response via the equation provided in [0056] and [0154]-[0156] of the PG Pub US 20230001205. However, the specification does not provide support for the broad genus of a normalized measurement as a normalized measurement can be any signal that is measured, whereas the specification specifies the normalized signal has to be done to the muscle response based on movement of the muscle.
A subgenus is not necessarily implicitly described by a genus encompassing it and a species upon which it reads, see In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972). MPEP 2163.
Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " wherein the fatigue score is based on a normalized measurement captured over time”. Therefore, the new claim limitations introduce new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 69-88 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 69 and 88, the phrase “the second stimulation signals change at least one location of stimulation application within target muscle tissue” is unclear how it is possible for the signals to change the location in which stimulation is applied. Examiner suggests clarifying that the second stimulation signals are applied to different electrodes of the electrode array to change the location of the applied stimulation.
Regarding claim 70, it is unclear if the “movement signals” of line 1, are the same or different than the “movement signals” of claim 69 line 4.
Regarding claim 71, it is unclear if the “stimulation signal” of lines 3-5 are the same or different than the first and second stimulation signals of claim 69 because the calculated movement is supposed to be based (not claimed as such but can be implied) on the first stimulation signals.
Regarding claim 71, it is unclear if the “physical movement” of lines 2, 3, and 4 are the same or different than one another.
Regarding claim 83, it is unclear how changing the at least one location within the target muscle tissue can be done to a second muscle because a target muscle tissue implies a change in location to the same muscle, and not to a separate and different muscle. It is also noted that this contradiction is also based on the recitation of “target muscle tissue” in claims 69, 81, and 83.
Regarding claim 84, it is unclear if the “movement” of line 1, is the same or different than the calculated “movement” of claim 69 line 6.
Claim 86 recites the limitation "the range" in lines 2-4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 88, it is unclear if the “movement” of line 12, is the same or different than the calculated “movement” of line 8.
Regarding claim 88, it is unclear if the “target muscle tissue” of line 19, is the same or different than the calculated “target muscle tissue” of line 4.
Dependent claims 70-87 are rejected due to their dependency on claim 69.
Claim Interpretation
Regarding claim 69, the measuring of the movement signals is not claimed to be based on the first stimulation signals, unlike claim 88.
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) 69, 71-72, 74-78, 84-85, and 87-88 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 claims 69 and 88, Hamilton teaches A method/ A system for electrically stimulating muscles (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/system comprising:
an electrode array configured to be placed in electrical contact with skin of the subject in a vicinity of target muscle tissue ([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.”);
a pulse generator configured to generate stimulation signals for application to the target muscle tissue through the electrode array ([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.”);
at least two movement sensors … configured to measure movement at a mid-region within the electrode array (Fig. 4 (430) [0031] “Surface EMG [first movement sensor] and movement sensor data [second movement sensor] can be synthesized to determine trunk muscle activity (amplitudes and timing) and sensor thresholds for classifying wheelchair propulsion activity (e.g. ramp ascent versus level propulsion) and cycle phasing.” [0032] “The present invention employs a system (e.g. surface EMG and 3D sensor data) to match the input with the functional requirements.” Examiner notes that the claims do not provide a specific location of the sensors in relation to the electrodes, and the placement of the electrode array in relation to the target muscle. Therefore, “mid-region” will be interpreted as any location where muscle contraction can be detected from the placement of the electrode array.); and
at least one processor (Abstract “a programmed microprocessor”) configured to:
receive movement signals from the at least two movement sensors while first stimulation signals are applied (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 [while first stimulation is applied] 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.”);
calculate movement at the mid-region within the electrode array based on the received movement signals (Fig. 6 delta calculations for EMG and acceleration.);
based at least in part on the calculated movement at the mid-region, determine adjusted second stimulation signals for application to the skin through the electrode array ([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.” Examiner notes that the “mid-region” location is claimed broadly, but also noted that the sensors are capable of being placed in the middle of the muscle or .); and
control the pulse generator to generate the second stimulation signals, wherein the second stimulation signals change at least one location of stimulation application within target muscle tissue, (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.”).
However, Hamilton does not teach at least two movement sensors configured to be arranged about the electrode array and that the electrode array is not physically moved. 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 at least two movement sensors configured to be arranged about the electrode array and configured to measure movement at a mid-region within the electrode array… without physically moving the electrode array (Fig. 3 [0124] “Most, if not all, of the sensors described below may be included in system 10 as part of skin patch 12” [0125] “a preferred sensor 15 disposed on skin patch 12 is a muscle contraction sensor. This may be, for example, an accelerometer to sense motion associated with muscle contraction… Another type of sensor 15 is a muscle integrity sensor, which could sense when a muscle is beginning to break down… an EMG or MMG reading indicating muscle damage” Since the sensors are attached to the skin patch 12, which includes the electrode array for stimulation, the electrode array is not moved because stimulation can be applied to different electrodes of choice.) 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 71, Hamilton teaches wherein the calculated movement at the mid- region includes at least one of: an onset of a physical movement at the mid-region in response to a stimulation signal, a modification of a physical movement at the mid-region in response to the stimulation signal, or a disappearance of a physical movement at the mid-region in response to the stimulation signal ([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.” [0016] “FES cycling uses knowledge from the machine itself (e.g. crank angle and/or cadence) [modification of physical movement] to adjust the timing of muscle activation.’).
Regarding claim 72, Hamilton teaches further comprising sensing at least one physiological parameter of the subject using 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 74, Hamilton and Sachs teach the invention of claim 69. However, Hamilton does not teach at least one sensor includes an electrocardiogram (ECG) sensor, a sensor configured to detect breathing of the subject, a Galvanic Skin Response (GSR) sensor, or a sensor configured to measure blood oxygenation. 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 one sensor includes an electrocardiogram (ECG) sensor, a sensor configured to detect breathing of the subject, a Galvanic Skin Response (GSR) sensor, or a sensor configured to measure blood oxygenation ([0125] “Sensor 15 alternatively may include one or more vital signs sensors, which monitor respiratory rate, heart rate, blood pressure or temperature. Physiological parameters also may be used to guide the therapy or for safety purposes. For example, ECG signals”) 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 at least one sensor includes an electrocardiogram (ECG) sensor, a sensor configured to detect breathing of the subject, a Galvanic Skin Response (GSR) sensor, or a sensor configured to measure blood oxygenation of Sachs, because such a modification would allow to adjust the stimulation regimen based on feedback.
Regarding claim 75, 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 ([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 76, Hamilton teaches wherein the adjusted second stimulation signals associated with at least one adjusted parameter selected from: an intensity of the second stimulation signals, a duration of the second stimulation signals, a shape of the second stimulation signals ([0051] “This is accomplished by adjusting the frequency and/or pulse width during stimulation treatment in response to the work output measured.”).
Regarding claim 77, 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 electrode array includes between 2 and 10 electrodes configured to be placed in electrical contact with the skin of the subject (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 78, 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 electrode array is less 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 84, Hamilton teaches wherein calculating movement at the mid-region within the electrode array includes calculating muscle contraction at the mid-region in response to the first stimulation signals ([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. Closed-loop FES devices are systems, which provide feedback information on muscle activity and/or joint position, thus allowing constant modification of stimulation parameters, which are required for complex activities such as walking.’).
Regarding claim 85, 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 the second stimulation signals have a symmetric bi-phasic rectangular pulse shape with 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 87, 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 the second stimulation signals are provided as 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) 70 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) and Sinderby et al. (US 6901286)(Hereinafter Sinderby).
Regarding claim 70, Hamilton and Sachs teach the invention of claim 69. However, Hamilton in view of Sachs do not teach receiving movement signals from each of the at least two movement sensors; normalizing the movement signals based on weights associated with geometric distances of the at least two sensors from the mid-region; and aggregating the normalized signals to calculate movement at the mid-region. Sinderby, in the same field of endeavor, teaches an array of electrodes and the measuring of EMG for measuring muscle contractions (Abstract), and further teaches further comprising receiving movement signals from each of the at least two movement sensors; normalizing the movement signals based on weights associated with geometric distances of the at least two sensors from the mid-region; and aggregating the normalized signals to calculate movement at the mid-region (Col. 2 lines 29-48 “and the weighting function comprises correction features for: the relative location of the center of the electrically active region and the electrodes; the distance separating the center of the electrically active region and the electrodes; the size of the electrically active region; and the inter-electrode distance; the weighting function comprises correction features for both cancellation and distance damping effects; the electrically active region of the subject's muscle comprises a center, the array of electrodes comprises a series of electrodes with an inter-electrode distance, each EMG signal is detected through at least two electrodes of the array, and applying the weighting function comprises: detecting the position of the center of the electrically active region about the array of electrodes; relating the weighting function to the position of the center of the electrically active region with respect to the electrodes of the series; weighting each EMG signal by means of the weighting function related to the position of the center of the electrically active region with respect to the electrodes of the series” Col. 9 lines 18-21 “known filtering strategies [normalize] should be used to optimize the spectral distributions of wanted and disturbance signals. The optimization is performed by varying sign, strength, and spectral (complex) contents of the weighting filter W(n).” Claim 1 “combining the weighted signals and thereby producing the higher quality electromyographic signal.”) to produce a higher quality signal (Claim 1). 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 receiving movement signals from each of the at least two movement sensors; normalizing the movement signals based on weights associated with geometric distances of the at least two sensors from the mid-region; and aggregating the normalized signals to calculate movement at the mid-region of Sinderby, because such a modification would allow to produce a higher quality signal.
Claim(s) 73 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) and Ng et al. (US 20200298004)(Hereinafter Ng).
Regarding claim 73, Hamilton and Sachs teach the invention of claim 69. However, Hamilton in view of Sachs do 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 is configured to detect breathing of the subject, and wherein calculating the adjusted second stimulation signals is performed, 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 in view of Sachs, 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) 79 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) and Schwarz et al. (US 10583287)(Hereinafter Schwarz).
Regarding claim 79, Hamilton and Sachs teach the invention of claim 69. However, Hamilton in view of Sachs do 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 target muscle tissue 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 in view od 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) 80 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) and Fahey et al. (US 20100217349)(Hereinafter Fahey).
Regarding claim 80, Hamilton and Sachs teach the invention of claim 69. However, Hamilton in view of Sachs do 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 using a vacuum source to apply vacuum to the skin of the subject in proximity of the target muscle tissue ([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 in view of Sachs, 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) 81-83 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), Lee et al. (US 8620439)(Hereinafter Lee) and Su et al. (US 20130072998)(Hereinafter Su).
Regarding claim 81, Hamilton and Sachs teach the invention of claim 69. However, Hamilton in view of Sachs do 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 further comprising estimating a fatigue score of the target muscle tissue, wherein the fatigue score is based on a normalized measurement captured over time, and wherein calculating the adjusted second stimulation signals is based on the 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 Hamilton in view 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.
Regarding claim 82, Hamilton and Sachs teach the invention of claim 69. However, Hamilton in does 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 further comprising detecting muscle fatigue of the target muscle tissue based on the estimated fatigue score, and wherein generating the second stimulation signals is based on the detected 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, 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 83, claim 69 is obvious over Hamilton in view of Sachs. However, Hamilton, does 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 further comprising: detecting fatigue of a first muscle within the target muscle tissue based on the estimated fatigue score; and changing the at least one location within the target muscle tissue from the first muscle to a second muscle based at least in part on the detected 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, 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) 86 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 86, Hamilton and Sachs teach the invention of claim 69. 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 the pulse phases is in the range of 100-400 microseconds ([s), (ii) a length of an interphasic rest period is within the range of 40-100 microseconds ( s), ([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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fahey (US 8892210) and Tamaki (US 10500396).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOUSSA HADDAD/Examiner, Art Unit 3796
Prosecution Insights