Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/20/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 7/20/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1, 4, 5, 8-9, 11-13, 18 has/have been amended;
Claim(s) 14-17, 20 is/are canceled;
Claim(s) 1-13, 18-19 is/are presently pending.
Response to Arguments
With regard to claim rejections under 35 USC 103, Applicant’s arguments have been fully considered but are moot in light of new grounds of rejection due to claim amendment(s).
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.
Claim(s) 1-11, 13, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robison (US 20220175555 A1; 6/9/2022; cited in previous office action) in view of Nazari (US 20160106344 A1; 4/21/2016; cited in previous office action) and further in view of Sharma (US 20200405188 A1; 12/31/2020).
Regarding claim 1, Robison teaches a device for overcoming freezing of gait (FoG) ([0123]), the device comprising:
sized and shaped to be worn on a leg of a human subject (Fig. 7A-8B; [0106] “leggings”; [0107] “stretch material”).
Robison does not teach a sleeve sized and shaped to be worn on a leg of a human subject. Note that Robison teaches stretch material over legs (Fig. 7A-8B; [0106] “leggings”; [0107] “stretch material”). However, for the sake of clarity and to avoid doubt, Nazari teaches in the same field of endeavor (Abstract; [0054] “Parkinson’s disease”) a sleeve sized and shaped to be worn on a leg of a human subject (Fig. 14; [0065] “stretchable fabric”; [0066]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison to include this feature as taught by Nazari because this is a suitable shape for treating movement disorders (Fig. 11; Fig. 14; [0054]; [0065]-[0066]), furthermore, this would be an obvious change in shape; MPEP 2144.04.
In the combination of Robison and Nazari, Robison teaches an array of electrodes carried by the sleeve and positioned to make surface contact with skin of the leg when the sleeve is worn on by the human subject (Fig. 7A-7B; [0106]); and
a controller in communication with the array of electrodes (Fig. 1; [0034]), said controller being operative to:
receive muscle activity data from the array of electrodes indicative of muscle activity in the leg (Fig. 1; Fig. 3; [0062]-[0063]; [0106]; [0123]);
identify an onset of a FoG episode based on a disrupted pattern in the received muscle activity data of a subset of the array of electrodes (Fig. 2; Fig. 3; Fig. 10, 10002; [0123] “motor symptoms of PD…gait freezes”; the reference is teaching using machine learning to learn templates/model of intended movement and detect differences when actual movement and intended movement occurs which reads on the recited “disrupted pattern”); and
trigger energization of a subset of the array of electrodes in response to identification of the onset of the FoG episode to mitigate against the FoG episode (Fig. 4; Fig. 10 “Determine actuation signals…Apply the actuation signals to one or more…”; [0012]; [0040] “actuators 12 may have varying types including electric”; [0043] “The actuators 122 may implement templated sequencing, applying actuation signals based on templates associated with particular movements… the templates include a sequence of mappings between specific events in a movement that corresponds to the beginning of ending of a specific muscle firing. The sequence of mappings are organized chronologically in the order in which the events occur in a movement. For example, a template for a gait can include events associated with a foot leaving the ground followed by events associated with a leg lift, swing, and finally, the heel of the foot striking the ground to complete the gait.”; [0058] “The user-specific modifications may include adjustments to actuation strategies with predefined actuation parameters such…actuators used (i.e., in an arrayed actuation configuration where an array of actuators is used to augment movement)”; [0071] “An actuation strategy…for an arrayed orientation of multiple actuators coupled to the mobility augmentation system 130, which actuators are used to apply the signals.”; [0113] “the system 130 uses the actuators 122 to apply the determined 1003 actuation signals to target locations on the user's body.”; [0091]; [0123] “four-channel FES array that activates different muscles. The location and duration of the FES can be customized to the patient's needs.”).
The combination of Robison and Nazari does not teach triggering energization of the subset of the array of electrodes (which is the same subset that received muscle activity data in previous limitation). However, Sharma teaches in the same field of endeavor (Fig. 1-2) teach triggering energization of the subset of the array of electrodes (which is the same subset that received muscle activity data in previous limitation) ([0028] “same electrodes 14 are used to detect the EMG signals and also to deliver the NMES”; [0030] “EMG recording and stimulation can be done on the same electrodes”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison and Nazari to include this feature as taught by Sharma because this enables using same electrodes to both detect and stimulate ([0028]).
Regarding claim 2, in the combination of Robison, Nazari, and Sharma, Robison teaches wherein the muscle activity data comprises electromyography (EMG) measurements obtained via the array of electrodes (Fig. 1; Fig. 3; [0062]-[0063]; [0106]; [0123]).
Regarding claim 3, in the combination of Robison, Nazari, and Sharma, Robison teaches wherein the sleeve further includes an inertial measurement unit (IMU) that is responsive to movement of the leg (Fig. 3; [0004]; [0062]; [0091]-[0092]).
Regarding claim 4, in the combination of Robison, Nazari, and Sharma, Robison teaches wherein the controller is further operative to:
obtain motion data from the IMU indicative of movement of the leg (Fig. 3; [0004]; [0062]; [0091]-[0092]); and
determine a phase of a gait cycle the subject is in based on the obtained motion data (Fig. 4-5; Fig. 14; [0063]-[0062]; [0123]).
Regarding claim 5, the combination of Robison, Nazari, and Sharma teaches wherein the controller comprises:
a decoder that processes the muscle activity data received from the electrodes to identify the onset of the FoG episode (Robison Fig. 2-3; Fig. 10-11; Fig. 12-13; [0062]-[0063]; [0123]); and
a stimulator that provides an electrical signal to the subset of the array of electrodes to thereby energize the subset of the array of electrodes (Robison Fig. 2-3; Fig. 10-11; Fig. 12-13; [0062]-[0063]; [0091]-[0092]; [0123]; Sharma [0028] “same electrodes 14 are used to detect the EMG signals and also to deliver the NMES”; [0030] “EMG recording and stimulation can be done on the same electrodes”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison and Nazari to include this feature as taught by Sharma because this enables using same electrodes to both detect and stimulate ([0028]).
Regarding claim 6, in the combination of Robison, Nazari, and Sharma, Robison teaches wherein the FoG episode is identified by detecting a deviation in the muscle activity data received from the electrodes from muscle activity data recognized as corresponding to a normal gait (Fig. 2-3; Fig. 10-11; [0063]-[0064]; [0123]).
Regarding claim 7, in the combination of Robison, Nazari, and Sharma, Robison teaches wherein the onset of the FoG episode is identified within less than or equal to 1 second from a time that the FoG episode begins to be onset (Fig. 3; Fig. 10; Fig. 12-13; [0123]; [0127]-[0128]; [0129]; the reference teaches especially in Fig. 12-13 that the system responds within the claimed time frame).
Regarding claim 8, the combination of Robison, Nazari, and Sharma teaches wherein the energization of the subset of the array of electrodes occurs within less than or equal to one second from a time that the onset of the FoG episode is identified (Robison Fig. 3; Fig. 10; Fig. 12-13; [0123]; [0127]-[0128]; [0129]; the reference teaches especially in Fig. 12-13 that the system responds within the claimed time frame; Sharma [0028] “same electrodes 14 are used to detect the EMG signals and also to deliver the NMES”; [0030] “EMG recording and stimulation can be done on the same electrodes”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison and Nazari to include this feature as taught by Sharma because this enables using same electrodes to both detect and stimulate ([0028]).
Regarding claim 9, the combination of Robison, Nazari, and Sharma teaches wherein the energization of the subset of the array of electrodes provides one of functional electrical stimulation (FES) (Robison Fig. 3) and neuromuscular electrical stimulation (NMES) to one or more muscles of the leg corresponding to positions of the subset of the array of electrodes (Robison Fig. 7A-8B), such that the one or more muscles of the leg are induced to contract accordingly (Robison Fig. 10; [0091]; [0106]; [0123]; Sharma [0028] “same electrodes 14 are used to detect the EMG signals and also to deliver the NMES”; [0030] “EMG recording and stimulation can be done on the same electrodes”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison and Nazari to include this feature as taught by Sharma because this enables using same electrodes to both detect and stimulate ([0028]).
Regarding claim 10, the combination of Robison, Nazari, and Sharma teaches wherein the sleeve is stretchable and constricts about the leg when worn by the subject so that the array of electrodes are pressed against the skin of the leg (Robison Fig. 7A-8B; [0106] “leggings”; [0107] “stretch material”; Nazari Fig. 14; [0065] “stretchable fabric”; [0066]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison to include this feature as taught by Nazari because this is a suitable shape for treating movement disorders (Fig. 11; Fig. 14; [0054]; [0065]-[0066]), furthermore, this would be an obvious change in shape; MPEP 2144.04.
Regarding claim 11, Robison teaches an apparatus providing walking assistance for a subject with a neurological impairment ([0123]), the apparatus comprising:
device arranged to be fitted on a leg of the subject (Fig. 7A-8B; [0106] “leggings”; [0107] “stretch material”).
Robison does not teach a sleeve arranged to be fitted on a leg of the subject. Note that Robison teaches stretch material over legs (Fig. 7A-8B; [0106] “leggings”; [0107] “stretch material”). However, for the sake of clarity and to avoid doubt, Nazari teaches in the same field of endeavor (Abstract; [0054] “Parkinson’s disease”) a sleeve arranged to be fitted on a leg of the subject (Fig. 14; [0065] “stretchable fabric”; [0066]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison to include this feature as taught by Nazari because this is a suitable shape for treating movement disorders (Fig. 11; Fig. 14; [0054]; [0065]-[0066]), furthermore, this would be an obvious change in shape; MPEP 2144.04.
The combination of Robison and Nazari teaches an array of electrodes carried by the sleeve and positioned to make contact with a skin of the leg when the sleeve is fitted to the subject (Robison Fig. 7A-7B; [0106]; Nazari claims 13-14); and
at least one processor carried by the sleeve and which executes computer program code from at least one memory, wherein the at least one memory and the computer program code are configured, with the at least one processor (Robison Fig. 1; [0034] “For example, the devices 120a and 120b may include additional components such as one or more processors (e.g., a general purpose processor and digital signal processor)… the mobility augmentation system 130 may perform the functionality of the controller 121 (i.e., the controller 121 is encompassed within the system 130).”; [0035] “The mobility augmentation devices 120a and 120b may have various, wearable form factors such as… leggings… any wearable form factor suitable for targeting a particular muscle group on a user's body, or a combination thereof.”; Nazari [0065] “wearable device 16 may further comprise a microcontroller…microcontroller can be a processor”), to cause the apparatus at least to:
collect electromyography (EMG) data from the array of electrodes, the EMG data being indicative of muscle activity in the leg (Robinson Fig. 1; Fig. 3; [0062]-[0063]; [0106]; [0123]);
identify an onset of a freezing of gait (FoG) episode based on a disrupted pattern in the received muscle activity data of a subset of the array of electrodes (Fig. 2; Fig. 3; Fig. 10, 10002; [0123] “motor symptoms of PD…gait freezes”; the reference is teaching using machine learning to learn templates/model of intended movement and detect differences when actual movement and intended movement occurs which reads on the recited “disrupted pattern”); and
trigger energization of a subset of the array of electrodes in response to identification of the onset of the FoG episode to mitigate against the FoG episode (Fig. 4; Fig. 10 “Determine actuation signals…Apply the actuation signals to one or more…”; [0012]; [0040] “actuators 12 may have varying types including electric”; [0043] “The actuators 122 may implement templated sequencing, applying actuation signals based on templates associated with particular movements… the templates include a sequence of mappings between specific events in a movement that corresponds to the beginning of ending of a specific muscle firing. The sequence of mappings are organized chronologically in the order in which the events occur in a movement. For example, a template for a gait can include events associated with a foot leaving the ground followed by events associated with a leg lift, swing, and finally, the heel of the foot striking the ground to complete the gait.”; [0058] “The user-specific modifications may include adjustments to actuation strategies with predefined actuation parameters such…actuators used (i.e., in an arrayed actuation configuration where an array of actuators is used to augment movement)”; [0071] “An actuation strategy…for an arrayed orientation of multiple actuators coupled to the mobility augmentation system 130, which actuators are used to apply the signals.”; [0113] “the system 130 uses the actuators 122 to apply the determined 1003 actuation signals to target locations on the user's body.”; [0091]; [0123] “four-channel FES array that activates different muscles. The location and duration of the FES can be customized to the patient's needs.”).
The combination of Robison and Nazari does not teach triggering energization of the subset of the array of electrodes (which is the same subset that received muscle activity data in previous limitation). However, Sharma teaches in the same field of endeavor (Fig. 1-2) teach triggering energization of the subset of the array of electrodes (which is the same subset that received muscle activity data in previous limitation) ([0028] “same electrodes 14 are used to detect the EMG signals and also to deliver the NMES”; [0030] “EMG recording and stimulation can be done on the same electrodes”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison and Nazari to include this feature as taught by Sharma because this enables using same electrodes to both detect and stimulate ([0028]).
Regarding claim 13, in the combination of Robison, Nazari, and Sharma, Robison teaches wherein the sleeve further includes an inertial measurement unit (IMU) that is responsive to movement of the leg (Fig. 3; [0004]; [0062]; [0091]-[0092]) and wherein the at least one memory and the computer program code are configured, with the at least one processor (Fig. 1; Fig. 3; [0034]), to further cause the apparatus at least to:
obtain motion data from the IMU indicative of movement of the leg (Fig. 3; [0004]; [0062]; [0091]-[0092]).
Regarding claim 18, Robison teaches a method for detecting and overcoming freezing of gait (FoG) ([0123]), the method comprising:
monitoring muscle activity of a leg of a subject with an array of electrodes positioned in contact with a skin of the leg (Fig. 7A-8B; [0106] “leggings”; [0107] “stretch material”).
Robison does not teach the array of electrodes being carried by a sleeve worn on the leg. Note that Robison teaches stretch material over legs (Fig. 7A-8B; [0106] “leggings”; [0107] “stretch material”). However, for the sake of clarity and to avoid doubt, Nazari teaches in the same field of endeavor (Abstract; [0054] “Parkinson’s disease”) the array of electrodes being carried by a sleeve worn on the leg (Fig. 14; [0065] “stretchable fabric”; [0066]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison to include this feature as taught by Nazari because this is a suitable shape for treating movement disorders (Fig. 11; Fig. 14; [0054]; [0065]-[0066]), furthermore, this would be an obvious change in shape; MPEP 2144.04.
In the combination of Robison and Nazari, Robison teaches identifying an onset of a FoG episode based on the monitored muscle activity, wherein the identifying comprises detecting, at a location on the leg, a deviation in the monitored muscle activity of a subset of the array of electrodes corresponding to an altered pattern of muscle activity underlying the onset of the FoG episode (Fig. 2; Fig. 3; Fig. 10, 10002; [0123] “motor symptoms of PD…gait freezes”; the reference is teaching using machine learning to learn templates/model of intended movement and detect differences when actual movement and intended movement occurs which reads on the recited “altered pattern”); and
selectively energizing of a subset of the array of electrodes in response to identification of the onset of the FoG episode to remediate the FoG episode (Fig. 3; Fig. 4; Fig. 10 “Determine actuation signals…Apply the actuation signals to one or more…”; [0012]; [0040] “actuators 12 may have varying types including electric”; [0043] “The actuators 122 may implement templated sequencing, applying actuation signals based on templates associated with particular movements… the templates include a sequence of mappings between specific events in a movement that corresponds to the beginning of ending of a specific muscle firing. The sequence of mappings are organized chronologically in the order in which the events occur in a movement. For example, a template for a gait can include events associated with a foot leaving the ground followed by events associated with a leg lift, swing, and finally, the heel of the foot striking the ground to complete the gait.”; [0058] “The user-specific modifications may include adjustments to actuation strategies with predefined actuation parameters such…actuators used (i.e., in an arrayed actuation configuration where an array of actuators is used to augment movement)”; [0071] “An actuation strategy…for an arrayed orientation of multiple actuators coupled to the mobility augmentation system 130, which actuators are used to apply the signals.”; [0113] “the system 130 uses the actuators 122 to apply the determined 1003 actuation signals to target locations on the user's body.”; [0091]; [0123] “four-channel FES array that activates different muscles. The location and duration of the FES can be customized to the patient's needs.”).
The combination of Robison and Nazari does not teach selectively energizing of the subset of the array of electrodes (which is the same subset that received muscle activity data in previous limitation). However, Sharma teaches in the same field of endeavor (Fig. 1-2) teach triggering energization of the subset of the array of electrodes (which is the same subset that received muscle activity data in previous limitation) ([0028] “same electrodes 14 are used to detect the EMG signals and also to deliver the NMES”; [0030] “EMG recording and stimulation can be done on the same electrodes”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison and Nazari to include this feature as taught by Sharma because this enables using same electrodes to both detect and stimulate ([0028]).
Regarding claim 19, in the combination of Robison, Nazari, and Sharma, Robison teaches monitoring motion of the leg (Fig. 3; [0004]; [0062]; [0091]-[0092]); and
determining a phase of the subject's gait within a gait cycle base at least in part on the monitored motion (Fig. 4-5; Fig. 14; [0063]-[0062]; [0123]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robison, Nazari, and Sharma as applied to claim 11 above, and further in view of Sharma (US 20200406035 A1; 12/31/2020; cited in previous office action); hereinafter Sharma ‘035.
Regarding claim 12, the combination of Robison, Nazari, and Sharma does not teach wherein the identifying of the onset of the FoG episode includes muscle unit (MU) decomposition of the EMG data. Note that Robison does teach identifying onset of FoG using muscle unit sensors (Fig. 2-3; Fig. 10; [0123] “motor symptoms of PD…gait freezes”). However, Sharma ‘035 teaches in the same field of endeavor (Abstract; Fig. 1) muscle unit (MU) decomposition of the EMG data (Fig. 2; [0017]; [0030]; [0041]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Robison, Nazari, and Sharma to include this feature as taught by Sharma ‘035 because this enables increased accuracy in EMG signal processing (Fig. 2; [0017]; [0030]).
Conclusion
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
