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 .
Drawings
The drawings are objected to because:
The drawings appear to be photographs (Figs 3-4). Photographs are not ordinarily permitted unless it is the only practicable medium to depict the claimed invention. See 37 CFR 1.84(b) and (l).
The reference characters “260” (Fig 2A), “700” (Fig 7), “800” (Fig 8), “900” (Fig 9A) are not found in the instant specification.
The reference characters “702” (paragraph 0077) and “904” (paragraph 0088) are not found in the drawings.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “plurality of first transducers” and “plurality of second transducers” that correspond to leg muscles of the user of Claims 1-20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The use of terms “DeepSole”, “Zeno”, “Nvidia” (paragraphs 0072, 0073, 0075-0078, 0080, 0145-0148, 0154-0160, 0169, 0173), which are trade names or marks used in commerce, have been noted in this application. Each term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
The phrase “first transducer” should be changed to –first transducers—for consistency (Claim 1, Line 7).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2, 7, and 9 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.
Claim 2 states “a respective corresponding muscle” (Lines 2-3). This statement is indefinite because it is unclear if the respective corresponding muscle is the same as the muscles of the right leg and/or the left leg. It appears the applicant was trying to say they’re the same. However, it is possible that the respective corresponding muscle could be in reference to a completely new set of muscles. Therefore, the number of muscles involved cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same as the muscles in the right and left legs. Similar rejections are applied to Claim 7 (Lines 1-2) and Claim 9 (Line 2).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 14, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner et al. (US 2020/0093400 A1) alone.
Regarding Claim 14, Hamner discloses an apparatus for modifying a subject’s gait (apparatus of Fig 4), the apparatus comprising: at least two pressure sensors (400, Fig 4; insole can have pressure sensors, such as strain or piezoelectric sensors, to measure ground reaction pressure or force of the individual, paragraph 0098; pressure sensors implies at least two); a first transducer (402, Fig 4; insole can also have an array of stimulation affectors to provide feedback, which may include cuing, to the individual, paragraph 0098); and a processor configured to track the subject’s gait cycle responsively to signals from the at least two pressure sensors (diagnosis can include performing a diagnostic assessment of the patient using the wearable sensors described herein, such as IMU, accelerometers, pressure sensors, and EMG, to determine various gait parameters, paragraph 0162; stimulation can be timed with key gait events such as foot strike, toe off, early stance phase, and late stance phase, for example, which can be detected in real time by sensors during the gait cycle as described herein, sensors can include EMG, IMU, or pressure sensors in the shoe or insoles or on the base of the foot, for example, paragraph 0157; a processor must be involved to track sensor data and determine stimulation timing) and, based on the tracked gait cycle, actuate the first transducer to provide feedback to the subject in synchronicity with a first portion of the subject’s gait cycle (stimulation can be timed with key gait events such as foot strike, toe off, early stance phase, and late stance phase, for example, which can be detected in real time by sensors during the gait cycle as described herein, sensors can include EMG, IMU, or pressure sensors in the shoe or insoles or on the base of the foot, for example, paragraph 0157; a processor must be involved to track sensor data and determine stimulation timing). It is noted that Applicant has not claimed the specific portion of the subject’s gait cycle.
The current embodiment of Hamner fails to explicitly disclose a first transducer configured for positioning proximate to a first leg muscle of the subject.
However, an alternate embodiment of Hamner teaches a first transducer configured for positioning proximate to a first leg muscle of the subject (the sensor(s) and affector(s) may be combined into a single device, or they may be separate devices, wherein they are capable of rapid wireless or wired communication, as illustrated in FIG. 2F, paragraph 0095; the wearable unit is in communication, either wired or wirelessly, with a separate stimulation unit that provides transcutaneous stimulation to a location different from that of the wearable unit, paragraph 0126; the wearable unit is in communication with an electrical stimulation unit that applies stimulation to a predetermined or predetermined set or subset of muscles that affect gait pattern (e.g., soleus, gastrocnemius, quadriceps) and a sensor unit that measures muscle activity (e.g., electromyogram (EMG)), device can be applied to multiple locations on the lower extremity, including, but not limited to, the top of the foot, the head of the gastrocnemius, or above the knee across the quadriceps muscle group, paragraph 0154) since it is known to stimulate a muscle of the leg to affect the gait pattern and since it is known to have the affector or stimulation unit to be separate from the rest of the wearable device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to relocate the stimulation unit to be on a leg muscle like the quadriceps muscles, as taught by Hamner, since it is known to stimulate a muscle of the leg to affect the gait pattern and since it is known to have the affector or stimulation unit to be separate from the rest of the wearable device.
Regarding Claim 17, Hamner teaches the at least two pressure sensors are configured for positioning at the subject’s shoe (400 shown to be inside the insole of a shoe, Figs 4, 6, 15, and 16; insole can have pressure sensors, such as strain or piezoelectric sensors, to measure ground reaction pressure or force of the individual, paragraph 0098; sensors can include EMG, IMU, or pressure sensors in the shoe or insoles or on the base of the foot, for example, paragraph 0157).
Regarding Claim 18, Hamner teaches an accelerometer, wherein the processor is configured to track the subject’s gait cycle responsively to signals from the at least two pressure sensors and the accelerometer (insole can have pressure sensors, such as strain or piezoelectric sensors, to measure ground reaction pressure or force of the individual, and could have accelerometers, gyroscopes, and magnetometers to measure the position and orientation of the individual's lower limb, paragraph 0098; the measurement unit could employ accelerometers, gyroscopes, and/or a magnetometer attached to the individual's foot or ankle or shoe or sock to measure foot progression angle, which can be used to provide feedback to the individual about toe-in/toe-out of their gait, paragraph 0101; diagnosis can include performing a diagnostic assessment of the patient using the wearable sensors described herein, such as IMU, accelerometers, pressure sensors, and EMG, to determine various gait parameters, paragraph 0162).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner et al. (US 2020/0093400 A1) in view of Mantovani et al. (US 2020/0215324 A1) and Roh (US 2015/0134080 A1).
Regarding Claim 15, Hamner teaches the claimed invention of Claim 14. Hamner fails to teach a second transducer configured for positioning proximate to a second leg muscle of the subject, wherein the processor is configured to actuate the second transducer to provide feedback to the subject in synchronicity with a second portion of the subject’s gait cycle.
However, Mantovani, of the same field of endeavor, teaches apparatus, systems, and methods for real-time gait modulation (Abstract) including a second transducer configured for positioning proximate to a second leg muscle of the subject (first upper leg array 118 and the second upper leg array 120 can be positioned in proximity to a hamstring muscle of the user when the first elastic sleeve 102 is worn on a thigh of the user, paragraph 0050) since these muscles are known to be stimulated with appropriate timing relative to the gait cycle (paragraph 0059).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place an additional transducer or stimulation unit to be proximate to another leg muscle, like the hamstring muscles, as taught by Mantovani, since these muscles are known to be stimulated with appropriate timing relative to the gait cycle (Mantovani: paragraph 0059). Having additional transducers for the additional leg muscles ensures a better synchronization of muscle activation throughout a gait cycle.
Hamner-Mantovani combination fails to explicitly teach the processor is configured to actuate the second transducer to provide feedback to the subject in synchronicity with a second portion of the subject’s gait cycle.
However, Roh, of the same field of endeavor, teaches a wearable robot with EMG sensors (Abstract) including activation of the quadriceps muscles in synchronicity with a first portion of the subject’s gait cycle (right quadriceps muscle group shown to reach highest activation at OT and gradually decreases when OT goes to heel rise (HR) or between 10% to 30% of gait cycle, Fig 4; in a period between the opposite toe off OT and the heel rise HR, both the hamstring muscles and quadriceps femoris muscle are activated at a point when the tibialis anterior is deactivated and the triceps surae muscle is activated, paragraph 0106) and activation of the hamstring muscles in synchronicity with a second portion of the subject’s gait cycle (right hamstring muscles show muscle activation between TV and IC or between 90% to 100% of gait cycle, Fig 4; hamstring muscles and quadriceps femoris muscle are activated at an initial state of walking, paragraph 0105) since these would be the expected muscle activations and timings found within a gait cycle (Figs 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the transducers or stimulation units to activate in synchronization with different portions of the gait cycle, as taught by Roh, since these would be the expected muscle activations and timings found within a gait cycle (Roh: Figs 3-4). This would ensure the muscles are activated at the proper timing throughout a gait cycle.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner et al. (US 2020/0093400 A1) in view of Basta et al. (US 2016/0007885 A1).
Regarding Claim 19, Hamner teaches the claimed invention of Claim 14. Hamner fails to teach the processor is configured to actuate the first transducer upon detection of a change in stride characteristic of the tracked gait cycle.
However, Basta, of the same field of endeavor, teaches an integrated unweighted gait training system (Abstract) including the processor is configured to actuate the first transducer upon detection of a change in stride characteristic of the tracked gait cycle (the plurality of gait parameters of a user on a treadmill can be one or more of speed, cadence, left/right stride length, left/right stride time, foot placement phase asymmetry and stride time jitter, paragraph 0020; the biofeedback can be an electronic stimulation sequence that starts a muscle firing sequence in the user, paragraph 0032; feedback provided to a user can further include one or a variety of types of biofeedback providing in conjunction with the integrated gait therapy system, paragraph 0031; the step of providing a biofeedback signal to the user based upon patient worn sensor inputs is performed when the user is using the patient worn sensor in an environment outside of the integrated unweighting gait training system, paragraph 0033; input from a foot fall or foot impact sensor such as an accelerometer, load cell or acoustic sensor, paragraph 0036) since it is known that changes in the stride time or stride time jitter is a form of gait abnormality (paragraph 0173).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor to track changes in the stride, as taught by Basta, since it is known that changes in the stride time or stride time jitter is a form of gait abnormality (Basta: paragraph 0173).
Regarding Claim 20, Hamner teaches the claimed invention of Claim 14. Hamner fails to teach the processor is configured to actuate the first transducer upon detection of a change in stride length of the tracked gait cycle.
However, Basta, of the same field of endeavor, teaches an integrated unweighted gait training system (Abstract) including the processor is configured to actuate the first transducer upon detection of stride length of the tracked gait cycle (the plurality of gait parameters of a user on a treadmill can be one or more of speed, cadence, left/right stride length, left/right stride time, foot placement phase asymmetry and stride time jitter, paragraph 0020; the biofeedback can be an electronic stimulation sequence that starts a muscle firing sequence in the user, paragraph 0032; feedback provided to a user can further include one or a variety of types of biofeedback providing in conjunction with the integrated gait therapy system, paragraph 0031; the step of providing a biofeedback signal to the user based upon patient worn sensor inputs is performed when the user is using the patient worn sensor in an environment outside of the integrated unweighting gait training system, paragraph 0033; input from a foot fall or foot impact sensor such as an accelerometer, load cell or acoustic sensor, paragraph 0036) since it is known to track and consider the stride length to provide biofeedback to the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor to track the stride length, as taught by Basta, since it is known to track and consider the stride length to provide biofeedback to the user.
Hamner-Basta combination fails to explicitly teach detection of a change in stride length.
However, Basta further teaches changes in the stride time or stride time jitter is a form of gait abnormality (paragraph 0173).
Therefore, though Basta does not explicitly mention changes in stride length, one of ordinary skill in the art would obviously want to track changes in the stride length and adjust the gait cycle through stimulation to improve the user’s gait cycle. Thus, it would be obvious for one of ordinary skill in the art to modify the processor to track changes in stride length to similarly track abnormalities in the user’s gait cycle and adjust the gait cycle through stimulation. Changes in the stride length would obviously be expected for people who cannot walk in a constant pace.
Claims 1, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner et al. (US 2020/0093400 A1) in view of Caban et al. (US 2020/0147384 A1).
Regarding Claim 1, Hamner discloses an apparatus for modifying a subject’s gait (apparatus of Fig 18; devices, methods and systems for modifying or altering gait kinematics, Abstract), the apparatus comprising: a plurality of first transducers, each of which is configured for positioning proximate to a respective muscle of a leg of the subject (the wearable unit is in communication with an electrical stimulation unit that applies stimulation to a predetermined or predetermined set or subset of muscles that affect gait pattern (e.g., soleus, gastrocnemius, quadriceps) and a sensor unit that measures muscle activity (e.g., electromyogram (EMG)), device can be applied to multiple locations on the lower extremity, including, but not limited to, the top of the foot, the head of the gastrocnemius, or above the knee across the quadriceps muscle group, paragraph 0154); and a processor configured to track the subject’s gait cycle and, based on the tracked gait cycle, actuate each of the plurality of first transducers at respective portions of the subject’s gait cycle over multiple gait cycles (stimulation can be timed with key gait events such as foot strike, toe off, early stance phase, and late stance phase, for example, which can be detected in real time by sensors during the gait cycle as described herein, sensors can include EMG, IMU, or pressure sensors in the shoe or insoles or on the base of the foot, for example, paragraph 0157; include one or more inertial measurement units (IMU) 208 (e.g., motion sensors such as accelerometers, gyroscopes, magnetometers, bend sensors), force sensors (e.g., strain sensors), muscle and/or nerve activity sensors (e.g., electrodes to measure EMG or microneurography) that communicate with a device control unit that processes measurement data to calculate one or more key gait parameters, such as gait kinematics (e.g., foot-progression angle, knee angle, step width etc.), kinetics (e.g., ground reaction force), muscle activation, or conduction of pain signals to the central nervous system, paragraph 0092).
Hamner fails to explicitly disclose a plurality of second transducers, each of which is configured for positioning proximate to a respective muscle of another leg of the subject. In other words, Hamner fails to explicitly disclose a plurality of transducers configured for positioning proximate to a respective muscle of each leg of the subject.
However, Caban, of the same field of endeavor, teaches a control system for a movement reconstruction and/or restoration system for a patient (Abstract) including a plurality of transducers configured for positioning proximate to a respective muscle of each leg of the subject (one electrode 22a for FES is attached to the left leg of the patient P and one electrode 22a for FES is attached to the right leg of the patient P, paragraph 0266; it could be generally possible that each leg of the patient P is equipped with two or more electrodes 22a for FES, paragraph 0267; it could be generally possible that the one or more electrodes 22a for FES are placed at any other position(s) of the legs of the patient P, paragraph 0269) since it is known to provide multiple electrodes or stimulators on both left and right legs.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide multiple stimulators or stimulation units on both left and right legs, as taught by Caban, since it is known to provide multiple electrodes or stimulators on both left and right legs. This addition would improve upon the device’s purpose of ensuring stimulation of the muscles in synchronization with the timing of key gait events. By stimulating multiple muscles on both legs, the device can assist the user in better coordinating the movement of their legs in relation to the gait cycle.
Regarding Claim 7, the current Hamner-Caban combination fails to teach each of the first transducers and each of the second transducers comprises a vibrator configured to couple vibration into a respective leg muscle.
However, Hamner further teaches the transducer comprises a vibrator configured to couple vibration into a leg muscle (device also houses one or more affectors to provide sensory feedback, which could be in the form of vibration (e.g., vibration motor), paragraph 0093; sensory feedback to the wearer could be in the form of vibrotactile sensation (e.g., vibration motors), paragraph 0094; the wearable device could house a vibration motor to apply a vibrational stimulation simultaneously with electrical stimulation, paragraph 0115; feedback can be detectable stimulation which can be auditory, vibratory, or electrical, for example, paragraph 0156) since it is a known form of feedback to control contraction of a muscle and to improve perception of feedback (paragraph 0115).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace electrical stimulation with vibrational stimulation or add vibrational stimulation with electrical stimulation, as taught by Hamner, since it is a known form of feedback to control contraction of a muscle and to improve perception of feedback (Hamner: paragraph 0115).
Regarding Claim 8, Hamner discloses a method for modifying a subject’s gait (apparatus of Fig 18; devices, methods and systems for modifying or altering gait kinematics, Abstract), the method comprising: positioning each of a plurality of first transducers proximate to a respective muscle of a leg of the subject (the wearable unit is in communication with an electrical stimulation unit that applies stimulation to a predetermined or predetermined set or subset of muscles that affect gait pattern (e.g., soleus, gastrocnemius, quadriceps) and a sensor unit that measures muscle activity (e.g., electromyogram (EMG)), device can be applied to multiple locations on the lower extremity, including, but not limited to, the top of the foot, the head of the gastrocnemius, or above the knee across the quadriceps muscle group, paragraph 0154); tracking the subject’s gait cycle; and actuating each of the plurality of first transducer at respective portions of the subject’s gait cycle over multiple gait cycles based on the tracked gait cycle (stimulation can be timed with key gait events such as foot strike, toe off, early stance phase, and late stance phase, for example, which can be detected in real time by sensors during the gait cycle as described herein, sensors can include EMG, IMU, or pressure sensors in the shoe or insoles or on the base of the foot, for example, paragraph 0157; include one or more inertial measurement units (IMU) 208 (e.g., motion sensors such as accelerometers, gyroscopes, magnetometers, bend sensors), force sensors (e.g., strain sensors), muscle and/or nerve activity sensors (e.g., electrodes to measure EMG or microneurography) that communicate with a device control unit that processes measurement data to calculate one or more key gait parameters, such as gait kinematics (e.g., foot-progression angle, knee angle, step width etc.), kinetics (e.g., ground reaction force), muscle activation, or conduction of pain signals to the central nervous system, paragraph 0092).
Hamner fails to explicitly disclose a plurality of second transducers, each of which is configured for positioning proximate to a respective muscle of another leg of the subject. In other words, Hamner fails to explicitly disclose a plurality of transducers configured for positioning proximate to a respective muscle of each leg of the subject.
However, Caban, of the same field of endeavor, teaches a control system for a movement reconstruction and/or restoration system for a patient (Abstract) including positioning a plurality of transducers proximate to a respective muscle of each leg of the subject (one electrode 22a for FES is attached to the left leg of the patient P and one electrode 22a for FES is attached to the right leg of the patient P, paragraph 0266; it could be generally possible that each leg of the patient P is equipped with two or more electrodes 22a for FES, paragraph 0267; it could be generally possible that the one or more electrodes 22a for FES are placed at any other position(s) of the legs of the patient P, paragraph 0269) since it is known to provide multiple electrodes or stimulators on both left and right legs.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide multiple stimulators or stimulation units on both left and right legs, as taught by Caban, since it is known to provide multiple electrodes or stimulators on both left and right legs. This addition would improve upon the device’s purpose of ensuring stimulation of the muscles in synchronization with the timing of key gait events. By stimulating multiple muscles on both legs, the device can assist the user in better coordinating the movement of their legs in relation to the gait cycle.
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner et al. (US 2020/0093400 A1) and Caban et al. (US 2020/0147384 A1) as applied to Claims 1 and 8, and in further view of Roh (US 2015/0134080 A1).
Regarding Claim 2, Hamner-Caban combination teaches the claimed invention of Claim 1. Hamner-Caban combination also teaches the use of muscle and/or nerve activity sensors including electrodes measuring EMG that communicate with a device control unit that processes measurement data to calculate one or more key gait parameters, such as gait kinematics, and muscle activation (Hamner: paragraph 0092) and having the stimulation timed with key gait events that are detected in real time by sensors including EMG sensors during the gait cycle (Hamner: paragraph 0157). Hamner-Caban combination fails to explicitly teach the processor is configured so that each of the respective portions is synchronized to a respective time during which a respective corresponding muscle has its highest activation.
However, Roh, of the same field of endeavor, teaches a wearable robot with EMG sensors (Abstract) including the processor is configured so that each of the respective portions is synchronized to a respective time during which a respective corresponding muscle has its highest activation (controller 200 may detect a walking assist starting point based on the EMG signal transmitted from the first EMG sensor 330 (hereinafter referred to as ‘first EMG signal’) and the EMG signal transmitted from the second EMG sensor 340 (hereinafter referred to as ‘second EMG signal’), paragraph 0122; onset/offset detector 240A may detect an onset point and an offset point from the first EMG signal on which boundary value processing is performed, the onset point refers to a time point when a muscle is activated, and the offset point refers to a time point when the muscle is inactivated, paragraph 0128; for example, the walking assist starting point detector 250A may detect a time when the first EMG signal, connected to the tricep surae muscle, rises and a time when the second EMG signal, connected to the tibialis anterior muscle, falls, paragraph 0130; Fig 4 shows the different muscles being activated on a single leg throughout an entire gait cycle) since it is known to utilize the activation levels of muscles to determine a phase of the gait cycle via EMG signals.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller/processor to track activation levels of muscles, as taught by Roh, since it is known to utilize the activation levels of muscles to determine a phase of the gait cycle via EMG signals. As known in gait kinematics, the various muscles of the leg will activate at different times throughout the gait cycle. Roh merely further supports this fact and shows that muscle activation can be tracked to figure out the phases of the gait cycle.
Regarding Claim 9, Hamner-Caban combination teaches the claimed invention of Claim 8. Hamner-Caban combination also teaches the use of muscle and/or nerve activity sensors including electrodes measuring EMG that communicate with a device control unit that processes measurement data to calculate one or more key gait parameters, such as gait kinematics, and muscle activation (Hamner: paragraph 0092) and having the stimulation timed with key gait events that are detected in real time by sensors including EMG sensors during the gait cycle (Hamner: paragraph 0157). Hamner-Caban combination fails to explicitly teach each of the respective portions is synchronized to a respective time during which a respective corresponding muscle has its highest activation.
However, Roh, of the same field of endeavor, teaches a wearable robot with EMG sensors (Abstract) including the processor is configured so that each of the respective portions is synchronized to a respective time during which a respective corresponding muscle has its highest activation (controller 200 may detect a walking assist starting point based on the EMG signal transmitted from the first EMG sensor 330 (hereinafter referred to as ‘first EMG signal’) and the EMG signal transmitted from the second EMG sensor 340 (hereinafter referred to as ‘second EMG signal’), paragraph 0122; onset/offset detector 240A may detect an onset point and an offset point from the first EMG signal on which boundary value processing is performed, the onset point refers to a time point when a muscle is activated, and the offset point refers to a time point when the muscle is inactivated, paragraph 0128; for example, the walking assist starting point detector 250A may detect a time when the first EMG signal, connected to the tricep surae muscle, rises and a time when the second EMG signal, connected to the tibialis anterior muscle, falls, paragraph 0130; Fig 4 shows the different muscles being activated on a single leg throughout an entire gait cycle) since it is known to utilize the activation levels of muscles to determine a phase of the gait cycle via EMG signals.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller/processor to track activation levels of muscles, as taught by Roh, since it is known to utilize the activation levels of muscles to determine a phase of the gait cycle via EMG signals. As known in gait kinematics, the various muscles of the leg will activate at different times throughout the gait cycle. Roh merely further supports this fact and shows that muscle activation can be tracked to figure out the phases of the gait cycle.
Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner et al. (US 2020/0093400 A1) and Caban et al. (US 2020/0147384 A1) as applied to Claims 1 and 8, and in further view of Mantovani et al. (US 2020/0215324 A1).
Regarding Claim 3, Hamner-Caban combination teaches the claimed invention of Claim 1. Hamner-Caban combination also teaches the device can be applied to multiple locations on the lower extremity, including, but not limited to, the top of the foot, the head of the gastrocnemius, or above the knee across the quadriceps muscle group (Hamner: paragraph 0154) and it could be generally possible that the one or more electrodes 22a for FES are placed at any other position(s) of the legs of the patient P (Caban: paragraph 0269). Hamner-Caban combination fails to explicitly teach the plurality of first transducers includes a right tibialis anterior transducer, a right rectus femoris transducer, and a right biceps femoris transducer, and wherein the plurality of second transducers includes a left tibialis anterior transducer, a left rectus femoris transducer, and a left biceps femoris transducer.
However, Mantovani, of the same field of endeavor, teaches apparatus, systems, and methods for real-time gait modulation (Abstract) including a plurality of transducers includes a tibialis anterior transducer (the first lower leg array 114 and the second lower leg array 116 can be positioned in proximity to a tibialis anterior muscle of the user when the second elastic sleeve 104 is worn on the lower leg of the user, paragraph 0049), a rectus femoris transducer (upper leg electrode array 134 can be adhered (e.g., via biocompatible adhesives, gels, stick pads, straps, bands, etc.) to the quadricep muscles, or the rectus femoris muscle of the user, paragraph 0061; one or more electrode arrays 108 can also be positioned in proximity to the quadricep muscles, and the rectus femoris muscle of the user, paragraph 0063; the rectus femoris muscle is well-known to be part of the group of quadricep muscles), and a biceps femoris transducer (first upper leg array 118 and the second upper leg array 120 can be positioned in proximity to a hamstring muscle of the user when the first elastic sleeve 102 is worn on a thigh of the user, paragraph 0050; the biceps femoris muscle is well-known to be part of the group of hamstring muscles) since these muscles are known to be stimulated with appropriate timing relative to the gait cycle (paragraph 0059).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the transducers to be proximate to these particular leg muscles on both legs, as taught by Mantovani, since these muscles are known to be stimulated with appropriate timing relative to the gait cycle (Mantovani: paragraph 0059). It is noted that Applicant has not further limited the claim limitation to target solely the biceps femoris muscle out of the other muscles involved in the group of hamstring muscles.
Regarding Claim 10, Hamner-Caban combination teaches the claimed invention of Claim 8. Hamner-Caban combination also teaches the device can be applied to multiple locations on the lower extremity, including, but not limited to, the top of the foot, the head of the gastrocnemius, or above the knee across the quadriceps muscle group (Hamner: paragraph 0154) and it could be generally possible that the one or more electrodes 22a for FES are placed at any other position(s) of the legs of the patient P (Caban: paragraph 0269). Hamner-Caban combination fails to explicitly teach the plurality of first transducers includes a right tibialis anterior transducer, a right rectus femoris transducer, and a right biceps femoris transducer, and wherein the plurality of second transducers includes a left tibialis anterior transducer, a left rectus femoris transducer, and a left biceps femoris transducer.
However, Mantovani, of the same field of endeavor, teaches apparatus, systems, and methods for real-time gait modulation (Abstract) including a plurality of transducers includes a tibialis anterior transducer (the first lower leg array 114 and the second lower leg array 116 can be positioned in proximity to a tibialis anterior muscle of the user when the second elastic sleeve 104 is worn on the lower leg of the user, paragraph 0049), a rectus femoris transducer (upper leg electrode array 134 can be adhered (e.g., via biocompatible adhesives, gels, stick pads, straps, bands, etc.) to the quadricep muscles, or the rectus femoris muscle of the user, paragraph 0061; one or more electrode arrays 108 can also be positioned in proximity to the quadricep muscles, and the rectus femoris muscle of the user, paragraph 0063; the rectus femoris muscle is well-known to be part of the group of quadricep muscles), and a biceps femoris transducer (first upper leg array 118 and the second upper leg array 120 can be positioned in proximity to a hamstring muscle of the user when the first elastic sleeve 102 is worn on a thigh of the user, paragraph 0050; the biceps femoris muscle is well-known to be part of the group of hamstring muscles) since these muscles are known to be stimulated with appropriate timing relative to the gait cycle (paragraph 0059).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the transducers to be proximate to these particular leg muscles on both legs, as taught by Mantovani, since these muscles are known to be stimulated with appropriate timing relative to the gait cycle (Mantovani: paragraph 0059). It is noted that Applicant has not further limited the claim limitation to target solely the biceps femoris muscle out of the other muscles involved in the group of hamstring muscles.
Claims 4-6 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner et al. (US 2020/0093400 A1), Caban et al. (US 2020/0147384 A1), and Mantovani et al. (US 2020/0215324 A1) as applied to Claims 3 and 10, and in further view of Roh (US 2015/0134080 A1).
Regarding Claim 4, Hamner-Caban-Mantovani combination teaches the claimed invention of Claim 3. Hamner-Caban-Mantovani combination also teaches the use of muscle and/or nerve activity sensors including electrodes measuring EMG that communicate with a device control unit that processes measurement data to calculate one or more key gait parameters, such as gait kinematics, and muscle activation (Hamner: paragraph 0092), having the stimulation timed with key gait events that are detected in real time by sensors including EMG sensors during the gait cycle (Hamner: paragraph 0157), and stimulating the muscles with appropriate timing relative to the gait cycle (Mantovani: paragraph 0059). Hamner-Caban-Mantovani combination fails to explicitly teach the processor is configured to (a) actuate the right tibialis anterior transducer during a first portion of the gait cycle, starting from right heel strike, (b) actuate the right rectus femoris transducer during a second portion of the gait cycle, (c) actuate the left biceps femoris transducer during a third portion of the gait cycle, (d) actuate the left tibialis anterior transducer during a fourth portion of the gait cycle, (e) actuate the left rectus femoris transducer during a fifth portion of the gait cycle, (f) actuate the right biceps femoris transducer during a sixth portion of the gait cycle.
However, Roh, of the same field of endeavor, teaches a wearable robot with EMG sensors (Abstract) including the activation of the right tibialis anterior muscle during a first portion of the gait cycle, starting from right heel strike (initial contact (IC) to opposite toe (OT) off shows a right heel strike, Fig 3; right tibialis anterior shows muscle activation between IC and OT or between 0%-10% of gait cycle, Fig 4; tibialis anterior is activated (contracted) in the initial contact IC, and the lifted toes of the right leg are dropped and the tibialis anterior is gradually deactivated (released) after the initial contact IC, paragraph 0107), activation of the right rectus femoris muscle during a second portion of the gait cycle (right quadriceps muscle group shown to reach highest activation at OT and gradually decreases when OT goes to heel rise (HR) or between 10% to 30% of gait cycle, Fig 4; in a period between the opposite toe off OT and the heel rise HR, both the hamstring muscles and quadriceps femoris muscle are activated at a point when the tibialis anterior is deactivated and the triceps surae muscle is activated, paragraph 0106), activation of the left biceps femoris muscle during a third portion of the gait cycle (between tibia vertical (TV) to IC, the right hamstring muscles is activated, Fig 4; left leg movement between HR to opposite initial contact (OI) shown to transition similarly to right leg movement between TV to IC, Fig 3; based on this, the left hamstring muscles must obviously be activated between HR to OI or between 30% to 50% of gait cycle, Fig 4), activation of the left tibialis anterior muscle during a fourth portion of the gait cycle (right tibialis anterior shows muscle activation between IC and OT or between 0%-10% of gait cycle, Fig 4; left leg movement between OI to toe off (TO) shown to transition similarly to right leg movement between IC and OT, Fig 3; based on this, the left tibialis anterior muscle must obviously be activated between OI to TO or between 50% to 60% of gait cycle, Fig 4), activation of the left rectus femoris muscle during a fifth portion of the gait cycle (right quadriceps muscle group shown to reach highest activation at OT and gradually decreases when OT goes to HR or between 10% to 30% of gait cycle, Fig 4; left leg movement between TO to TV shown to transition similarly to right leg movement between OT to HR, Fig 3; based on this, the left quadriceps muscles must obviously be activated between TO to TV or between 60% to 90% of gait cycle, Fig 4), and activation of the right biceps femoris muscle during a sixth portion of the gait cycle (right hamstring muscles show muscle activation between TV and IC or between 90% to 100% of gait cycle, Fig 4; hamstring muscles and quadriceps femoris muscle are activated at an initial state of walking, paragraph 0105) since these would be the expected muscle activations and timings found within a gait cycle (Figs 3-4).
It is noted that it is well-known that the rectus femoris muscle is part of the quadriceps muscle group and the biceps femoris muscle is part of the hamstring muscle group. It is also noted that Applicant has not further limited the claim limitation to target solely the biceps femoris muscle or solely the rectus femoris muscle out of the other muscles involved in the group of hamstring muscles and group of quadriceps muscles respectively.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulators to be in synchronization with the expected muscle activations of muscles throughout the gait cycle, as taught by Roh, since these would be the expected muscle activations and timings found within a gait cycle (Roh: Figs 3-4). Roh merely further establishes that these muscle activations of the various muscles throughout the gait cycle are well-known and shows they can be tracked over time via EMG signals. Thus, one of ordinary skill in the art would be capable of using the teachings of Roh to time the stimulation of the muscles in synchronization with the different phases and timings of the gait cycle to ensure the gait cycle is properly followed by the user.
Regarding Claim 5, Hamner-Caban-Mantovani-Roh combination teaches the first, second, third, fourth, fifth, and sixth portions of the gait cycle are all non-overlapping (Roh: IC to OT (first), OT to HR (second), HR to OI (third), OI to TO (fourth), TO to TV (fifth), and TV to IC (sixth) are non-overlapping, Fig 4).
Regarding Claim 6, Hamner-Caban-Mantovani combination teaches the claimed invention of Claim 3. Hamner-Caban-Mantovani combination also teaches the use of muscle and/or nerve activity sensors including electrodes measuring EMG that communicate with a device control unit that processes measurement data to calculate one or more key gait parameters, such as gait kinematics, and muscle activation (Hamner: paragraph 0092), having the stimulation timed with key gait events that are detected in real time by sensors including EMG sensors during the gait cycle (Hamner: paragraph 0157), and stimulating the muscles with appropriate timing relative to the gait cycle (Mantovani: paragraph 0059). Hamner-Caban-Mantovani combination fails to explicitly teach the processor is configured to (a) actuate the right tibialis anterior transducer from 0 - 10% of the gait cycle, starting from right heel strike, (b) actuate the right rectus femoris transducer from 10 – 30% of the gait cycle, (c) actuate the left biceps femoris transducer from 30 - 40% of the gait cycle, (d) actuate the left tibialis anterior transducer from 40 – 60% of the gait cycle, (e) actuate the left rectus femoris transducer from 60 – 75% of the gait cycle, and (f) actuate the right biceps femoris transducer from 87 – 100% of the gait cycle.
However, Roh, of the same field of endeavor, teaches a wearable robot with EMG sensors (Abstract) including activation of the right tibialis anterior muscle from 0 – 10% of the gait cycle, starting from right heel strike (initial contact (IC) to opposite toe (OT) off shows a right heel strike, Fig 3; right tibialis anterior shows muscle activation between IC and OT or between 0%-10% of gait cycle, Fig 4; tibialis anterior is activated (contracted) in the initial contact IC, and the lifted toes of the right leg are dropped and the tibialis anterior is gradually deactivated (released) after the initial contact IC, paragraph 0107), activation of right rectus femoris muscle from 10 – 30% of gait cycle (right quadriceps muscle group shown to reach highest activation at OT and gradually decreases when OT goes to heel rise (HR) or between 10% to 30% of gait cycle, Fig 4; in a period between the opposite toe off OT and the heel rise HR, both the hamstring muscles and quadriceps femoris muscle are activated at a point when the tibialis anterior is deactivated and the triceps surae muscle is activated, paragraph 0106), activation of left biceps femoris muscle from 30 to 40% of the gait cycle (between tibia vertical (TV) to IC, the right hamstring muscles is activated, Fig 4; left leg movement between HR to opposite initial contact (OI) shown to transition similarly to right leg movement between TV to IC, Fig 3; based on this, the left hamstring muscles must obviously be activated between HR to OI or between 30% to 50% of gait cycle, Fig 4), activation of left tibialis anterior muscle from 40 to 60% of the gait cycle (right tibialis anterior shows muscle activation between IC and OT or between 0%-10% of gait cycle, Fig 4; left leg movement between OI to toe off (TO) shown to transition similarly to right leg movement between IC and OT, Fig 3; based on this, the left tibialis anterior muscle must obviously be activated between OI to TO or between 50% to 60% of gait cycle, Fig 4), activation of left rectus femoris muscle from 60 to 75% of the gait cycle (right quadriceps muscle group shown to reach highest activation at OT and gradually decreases when OT goes to HR or between 10% to 30% of gait cycle, Fig 4; left leg movement between TO to TV shown to transition similarly to right leg movement between OT to HR, Fig 3; based on this, the left quadriceps muscles must obviously be activated between TO to TV or between 60% to 90% of gait cycle, Fig 4), and activation of right biceps femoris muscle from 87 to 100% of the gait cycle (right hamstring muscles show muscle activation between TV and IC or between 90% to 100% of gait cycle, Fig 4; hamstring muscles and quadriceps femoris muscle are activated at an initial state of walking, paragraph 0105) since these would be the expected muscle activations and timings found within a gait cycle (Figs 3-4).
It is noted that it is well-known that the rectus femoris muscle is part of the quadriceps muscle group and the biceps femoris muscle is part of the hamstring muscle group. It is also noted that Applicant has not further limited the claim limitation to target solely the biceps femoris muscle or solely the rectus femoris muscle out of the other muscles involved in the group of hamstring muscles and group of quadriceps muscles respectively.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulators to be in synchronization with the expected muscle activations of muscles throughout the gait cycle, as taught by Roh, since these would be the expected muscle activations and timings found within a gait cycle (Roh: Figs 3-4). Roh merely further establishes that these muscle activations of the various muscles throughout the gait cycle are well-known and shows they can be tracked over time via EMG signals. Thus, one of ordinary skill in the art would be capable of using the teachings of Roh to time the stimulation of the muscles in synchronization with the different phases and timings of the gait cycle to ensure the gait cycle is properly followed by the user.
Regarding Claim 11, Hamner-Caban-Mantovani combination teaches the claimed invention of Claim 10. Hamner-Caban-Mantovani combination also teaches the use of muscle and/or nerve activity sensors including electrodes measuring EMG that communicate with a device control unit that processes measurement data to calculate one or more key gait parameters, such as gait kinematics, and muscle activation (Hamner: paragraph 0092), having the stimulation timed with key gait events that are detected in real time by sensors including EMG sensors during the gait cycle (Hamner: paragraph 0157), and stimulating the muscles with appropriate timing relative to the gait cycle (Mantovani: paragraph 0059). Hamner-Caban-Mantovani combination fails to explicitly teach the actuating comprises (a) actuating the right tibialis anterior transducer during a first portion of the gait cycle, starting from right heel strike, (b) actuating the right rectus femoris transducer during a second portion of the gait cycle, (c) actuating the left biceps femoris transducer during a third portion of the gait cycle, (d) actuating the left tibialis anterior transducer during a fourth portion of the gait cycle, (e) actuating the left rectus femoris transducer during a fifth portion of the gait cycle, (f) actuating the right biceps femoris transducer during a sixth portion of the gait cycle.
However, Roh, of the same field of endeavor, teaches a wearable robot with EMG sensors (Abstract) including the activation of the right tibialis anterior muscle during a first portion of the gait cycle, starting from right heel strike (initial contact (IC) to opposite toe (OT) off shows a right heel strike, Fig 3; right tibialis anterior shows muscle activation between IC and OT or between 0%-10% of gait cycle, Fig 4; tibialis anterior is activated (contracted) in the initial contact IC, and the lifted toes of the right leg are dropped and the tibialis anterior is gradually deactivated (released) after the initial contact IC, paragraph 0107), activation of the right rectus femoris muscle during a second portion of the gait cycle (right quadriceps muscle group shown to reach highest activation at OT and gradually decreases when OT goes to heel rise (HR) or between 10% to 30% of gait cycle, Fig 4; in a period between the opposite toe off OT and the heel rise HR, both the hamstring muscles and quadriceps femoris muscle are activated at a point when the tibialis anterior is deactivated and the triceps surae muscle is activated, paragraph 0106), activation of the left biceps femoris muscle during a third portion of the gait cycle (between tibia vertical (TV) to IC, the right hamstring muscles is activated, Fig 4; left leg movement between HR to opposite initial contact (OI) shown to transition similarly to right leg movement between TV to IC, Fig 3; based on this, the left hamstring muscles must obviously be activated between HR to OI or between 30% to 50% of gait cycle, Fig 4), activation of the left tibialis anterior muscle during a fourth portion of the gait cycle (right tibialis anterior shows muscle activation between IC and OT or between 0%-10% of gait cycle, Fig 4; left leg movement between OI to toe off (TO) shown to transition similarly to right leg movement between IC and OT, Fig 3; based on this, the left tibialis anterior muscle must obviously be activated between OI to TO or between 50% to 60% of gait cycle, Fig 4), activation of the left rectus femoris muscle during a fifth portion of the gait cycle (right quadriceps muscle group shown to reach highest activation at OT and gradually decreases when OT goes to HR or between 10% to 30% of gait cycle, Fig 4; left leg movement between TO to TV shown to transition similarly to right leg movement between OT to HR, Fig 3; based on this, the left quadriceps muscles must obviously be activated between TO to TV or between 60% to 90% of gait cycle, Fig 4), and activation of the right biceps femoris muscle during a sixth portion of the gait cycle (right hamstring muscles show muscle activation between TV and IC or between 90% to 100% of gait cycle, Fig 4; hamstring muscles and quadriceps femoris muscle are activated at an initial state of walking, paragraph 0105) since these would be the expected muscle activations and timings found within a gait cycle (Figs 3-4).
It is noted that it is well-known that the rectus femoris muscle is part of the quadriceps muscle group and the biceps femoris muscle is part of the hamstring muscle group. It is also noted that Applicant has not further limited the claim limitation to target solely the biceps femoris muscle or solely the rectus femoris muscle out of the other muscles involved in the group of hamstring muscles and group of quadriceps muscles respectively.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulators to be in synchronization with the expected muscle activations of muscles throughout the gait cycle, as taught by Roh, since these would be the expected muscle activations and timings found within a gait cycle (Roh: Figs 3-4). Roh merely further establishes that these muscle activations of the various muscles throughout the gait cycle are well-known and shows they can be tracked over time via EMG signals. Thus, one of ordinary skill in the art would be capable of using the teachings of Roh to time the stimulation of the muscles in synchronization with the different phases and timings of the gait cycle to ensure the gait cycle is properly followed by the user.
Regarding Claim 12, Hamner-Caban-Mantovani-Roh combination teaches the first, second, third, fourth, fifth, and sixth portions of the gait cycle are all non-overlapping (Roh: IC to OT (first), OT to HR (second), HR to OI (third), OI to TO (fourth), TO to TV (fifth), and TV to IC (sixth) are non-overlapping, Fig 4).
Regarding Claim 13, Hamner-Caban-Mantovani combination teaches the claimed invention of Claim 10. Hamner-Caban-Mantovani combination also teaches the use of muscle and/or nerve activity sensors including electrodes measuring EMG that communicate with a device control unit that processes measurement data to calculate one or more key gait parameters, such as gait kinematics, and muscle activation (Hamner: paragraph 0092), having the stimulation timed with key gait events that are detected in real time by sensors including EMG sensors during the gait cycle (Hamner: paragraph 0157), and stimulating the muscles with appropriate timing relative to the gait cycle (Mantovani: paragraph 0059). Hamner-Caban-Mantovani combination fails to explicitly teach the actuating comprises (a) actuating the right tibialis anterior transducer from 0 - 10% of the gait cycle, starting from right heel strike, (b) actuating the right rectus femoris transducer from 10 – 30% of the gait cycle, (c) actuating the left biceps femoris transducer from 30 - 40% of the gait cycle, (d) actuating the left tibialis anterior transducer from 40 – 60% of the gait cycle, (e) actuating the left rectus femoris transducer from 60 – 75% of the gait cycle, and (f) actuating the right biceps femoris transducer from 87 – 100% of the gait cycle.
However, Roh, of the same field of endeavor, teaches a wearable robot with EMG sensors (Abstract) including activation of the right tibialis anterior muscle from 0 – 10% of the gait cycle, starting from right heel strike (initial contact (IC) to opposite toe (OT) off shows a right heel strike, Fig 3; right tibialis anterior shows muscle activation between IC and OT or between 0%-10% of gait cycle, Fig 4; tibialis anterior is activated (contracted) in the initial contact IC, and the lifted toes of the right leg are dropped and the tibialis anterior is gradually deactivated (released) after the initial contact IC, paragraph 0107), activation of right rectus femoris muscle from 10 – 30% of gait cycle (right quadriceps muscle group shown to reach highest activation at OT and gradually decreases when OT goes to heel rise (HR) or between 10% to 30% of gait cycle, Fig 4; in a period between the opposite toe off OT and the heel rise HR, both the hamstring muscles and quadriceps femoris muscle are activated at a point when the tibialis anterior is deactivated and the triceps surae muscle is activated, paragraph 0106), activation of left biceps femoris muscle from 30 to 40% of the gait cycle (between tibia vertical (TV) to IC, the right hamstring muscles is activated, Fig 4; left leg movement between HR to opposite initial contact (OI) shown to transition similarly to right leg movement between TV to IC, Fig 3; based on this, the left hamstring muscles must obviously be activated between HR to OI or between 30% to 50% of gait cycle, Fig 4), activation of left tibialis anterior muscle from 40 to 60% of the gait cycle (right tibialis anterior shows muscle activation between IC and OT or between 0%-10% of gait cycle, Fig 4; left leg movement between OI to toe off (TO) shown to transition similarly to right leg movement between IC and OT, Fig 3; based on this, the left tibialis anterior muscle must obviously be activated between OI to TO or between 50% to 60% of gait cycle, Fig 4), activation of left rectus femoris muscle from 60 to 75% of the gait cycle (right quadriceps muscle group shown to reach highest activation at OT and gradually decreases when OT goes to HR or between 10% to 30% of gait cycle, Fig 4; left leg movement between TO to TV shown to transition similarly to right leg movement between OT to HR, Fig 3; based on this, the left quadriceps muscles must obviously be activated between TO to TV or between 60% to 90% of gait cycle, Fig 4), and activation of right biceps femoris muscle from 87 to 100% of the gait cycle (right hamstring muscles show muscle activation between TV and IC or between 90% to 100% of gait cycle, Fig 4; hamstring muscles and quadriceps femoris muscle are activated at an initial state of walking, paragraph 0105) since these would be the expected muscle activations and timings found within a gait cycle (Figs 3-4).
It is noted that it is well-known that the rectus femoris muscle is part of the quadriceps muscle group and the biceps femoris muscle is part of the hamstring muscle group. It is also noted that Applicant has not further limited the claim limitation to target solely the biceps femoris muscle or solely the rectus femoris muscle out of the other muscles involved in the group of hamstring muscles and group of quadriceps muscles respectively.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulators to be in synchronization with the expected muscle activations of muscles throughout the gait cycle, as taught by Roh, since these would be the expected muscle activations and timings found within a gait cycle (Roh: Figs 3-4). Roh merely further establishes that these muscle activations of the various muscles throughout the gait cycle are well-known and shows they can be tracked over time via EMG signals. Thus, one of ordinary skill in the art would be capable of using the teachings of Roh to time the stimulation of the muscles in synchronization with the different phases and timings of the gait cycle to ensure the gait cycle is properly followed by the user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art cited of interest including:
US 20190269352 A1 discusses gait modification through the use of pressure sensors in the foot.
US 20160199208 A1 discusses muscle stimulation to modify gait.
US 20070203435 A1 discusses stride variability is tied with gait abnormalities.
US 20070250134 A1 discusses determining variability and asymmetry of gait and that symptoms can result in variable gait.
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/BRIAN T KHONG/ Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/ Primary Examiner, Art Unit 3785
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