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 12/10/2025. As directed by the amendment: Claims 1-2, and 6-7 have been amended, claims 5 and 13-28 have been cancelled, and claim 29 have been added. Thus, claims 1-4, 6-12, and 29 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 5-6, filed 12/10/2025, regarding 35 U.S.C. 102 and 103 and amendments to the claim have been fully considered but they are not persuasive. Applicant argues on page 5 that “Brouns discloses, in Figs. 1 and 2, a programmable device 100 for use with stimulation therapy. As shown in Figs. 1 and 2, the device 100 is a handheld device, not a device worn by a user. One of skill in the art understands that a handheld device is a device "designed to be operated while being held in the hand"”. Examiner disagrees because the paragraph of Brouns that the Applicant is referencing, [0194], is citing the camera as an input device, and not part of the handheld device. Nevertheless, Brouns does teach the sensor 300, that is worn on a user, can be a camera ([0014] “At least one sensor 300 may be placed on various parts of the user's 50 body” [0166] “The sensor 300 of such a closed-loop neuromodulation system can be or include at least one of an … infrared camera”). Therefore, the rejection has been maintained.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-4, 6-12, and 29 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the phrase “a video camera worn by a user” is claiming the user, as the sensor are worn by the user. Examiner suggests to amend the claim to recite “a video camera configured to be worn by a user”.
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) 1, 8, 10, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verity et al. (WO2018220374A1)(Hereinafter Verity)(citations are from US 20200139115) in view of Brouns et al. (US 20220409904)(Hereinafter Brouns).
Regarding claim 1, Verity teaches A rehabilitation system (Abstract “The present invention relates to an apparatus and a method for neuromuscular stimulation which is useful for stimulation of weak muscles in general, in sports clinical mode for muscle growth and endurance and in clinical mode for muscular rehabilitation.”) comprising:
…configured to monitor movement of a body part ([0038] “EMG block 14 is in bidirectional communication with control block 10. In the embodiment shown there is a single channel EMG block for a single muscle, but multi-channel EMG may also be employed, e.g. two, three or four channels or even more, in which case there will be additional blocks corresponding to the block 14.”);
a neuromuscular electrical stimulation (NMES) device configured to be worn on the body part and having electrodes arranged to apply NMES to the body part when the NMES device is worn on the body part ([0037] “Muscle stimulation electrodes 24a, 24b are connected by leads to the output of the switch network 22. The electrodes may be skin adhesive which is more convenient for general non-hospital use e.g. compared to surgically implanted electrodes.” Examiner interprets the NMES device to be the electrodes.); and
an electronic processor (Fig. 1(10)) programmed to:
obtain a stimulation pattern that when applied to the body part by the NMES device is effective to cause the body part to perform an intended action ([0040] “As the patient's voluntary contraction increased about 4 microvolts EMG the stimulation would start from zero mA linearly (or otherwise depending on the setting selected) such that at a level of 15 microvolts the maximum stimulation pulses of 30 mA would be achieved. As soon as the patient relaxed their voluntary contraction below 15 microvolts the stimulation would (immediately) proportionally reduce until it stopped altogether when they relaxed to below 4 microvolts.”);
apply the stimulation pattern to the body part using the NMES device ([0040] “As the patient's voluntary contraction increased about 4 microvolts EMG the stimulation would start from zero mA linearly (or otherwise depending on the setting selected) such that at a level of 15 microvolts the maximum stimulation pulses of 30 mA would be achieved. As soon as the patient relaxed their voluntary contraction below 15 microvolts the stimulation would (immediately) proportionally reduce until it stopped altogether when they relaxed to below 4 microvolts.”);
and stop the application of the stimulation pattern to the body part in response to … indicating the body part has performed the intended action ([0040] “As the patient's voluntary contraction increased about 4 microvolts EMG the stimulation would start from zero mA linearly (or otherwise depending on the setting selected) such that at a level of 15 microvolts the maximum stimulation pulses of 30 mA would be achieved. As soon as the patient relaxed their voluntary contraction below 15 microvolts the stimulation would (immediately) proportionally reduce until it stopped altogether when they relaxed to below 4 microvolts.”).
However, Verity does not teach wherein the electronic processor is programmed to stop the application of the stimulation pattern to the body part in response to the video of the body part acquired by the video camera indicating the body part has performed the intended action. Brouns, in the same field of endeavor, teaches receiving feedback from a sensor relating to physical activity to adjust electrical neurostimulation (Abstract), and further teaches wherein the at least one sensor comprises:
a video camera worn by a user ([0014] “At least one sensor 300 may be placed on various parts of the user's 50 body” [0166] “The sensor 300 of such a closed-loop neuromodulation system can be or include at least one of an … infrared camera”);
wherein the electronic processor is programmed to stop the application of the stimulation pattern to the body part in response to the video of the body part acquired by the video camera indicating the body part has performed the intended action ([0194] “As such, these sensors could be used to register a flick of the wrist or other type of gesture. This gesture could then be used to control therapy. For example, a user 50 rotating the wrist back and forth 2 times, could trigger a stop of stimulation”) and that the camera, IMU/accelerometer, and EMG data are interchangeable sensors for measuring movement ([0138]) to provide multiple ways of providing feedback ([0194]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity, with wherein the electronic processor is programmed to stop the application of the stimulation pattern to the body part in response to the video of the body part acquired by the video camera indicating the body part has performed the intended action of Brouns, because such a modification would allow to provide multiple ways of providing feedback.
Regarding claim 8, Verity teaches wherein the electronic processor is further programmed to:
identify the intended action based on at least one of (i) the video of the body part acquired by the video camera and/or (ii) EMG acquired from the body part ([0040] “As the patient's voluntary contraction increased about 4 microvolts EMG the stimulation would start from zero mA linearly (or otherwise depending on the setting selected) such that at a level of 15 microvolts the maximum stimulation pulses of 30 mA would be achieved. As soon as the patient relaxed their voluntary contraction below 15 microvolts the stimulation would (immediately) proportionally reduce until it stopped altogether when they relaxed to below 4 microvolts.”).
Regarding claim 10, Verity teaches wherein the electronic processor is further programmed to record at least a maximum stimulation level applied to the body part using the NMES device (See Fig. 5 of all recorded stimulation levels and frequencies including the maximum frequency.).
Regarding claim 29, Brouns teaches wherein the video camera is configured to acquire video from a point of view of the user's eyes (See Fig. 1 where camera 300 is on the user. Because a human would be capable of moving their wrist/arm up to their face to obtain movements, the video camera would be capable of acquiring at the POV from the user’s eyes, as the structure of the camera is capable of taking video from the POV of the user’s eyes. Examiner notes that if Applicant would like to claim structure of glasses with a camera for obtaining the video from the POV of a user’s eyes, that Applicant should actively recite the structure in the claim.).
Claim(s) 2-3, 9, and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verity et al. (WO2018220374A1)(Hereinafter Verity)(citations are from US 20200139115) in view of Brouns et al. (US 20220409904)(Hereinafter Brouns) and Robison et al. (US 11931571)(Hereinafter Robison).
Regarding claim 2, Verity teaches wherein the electronic processor is programmed to apply the stimulation pattern to the body part using the NMES device with a ramping stimulation level ([0040] “As the patient's voluntary contraction increased about 4 microvolts EMG the stimulation would start from zero mA linearly (or otherwise depending on the setting selected) such that at a level of 15 microvolts the maximum stimulation pulses of 30 mA would be achieved.”) by:
applying the stimulation pattern to the body part using the NMES device with a stimulation level at an initial stimulation level that is too low to produce functional electrical stimulation of the body part ([0040] “The user is then asked to make their best efforts for a maximal (voluntary) contraction of the muscle in the absence of any electrical stimulation pulses during which time the EMG from these electrodes (which consists almost entirely of the voluntary EMG component) is measured such that the maximum and minimum reading of EMG readily achieved, is noted. The muscle is then stimulated via module 20 with these same electrodes to achieve a maximal comfortable contraction such that the device retains this value of stimulation current (mA)… the minimum EMG achieved to be 4 microvolts and the maximum 15 microvolts rms,”).
However, Verity does not teach wherein the electronic processor is programmed to stop the application of the stimulation pattern to the body part in response to the video of the body part acquired by the video camera indicating the body part has performed the intended action. Brouns, in the same field of endeavor, teaches receiving feedback from a sensor relating to physical activity to adjust electrical neurostimulation (Abstract), and further teaches wherein the at least one sensor comprises:
a video camera worn by a user ([0014] “At least one sensor 300 may be placed on various parts of the user's 50 body” [0166] “The sensor 300 of such a closed-loop neuromodulation system can be or include at least one of an … infrared camera”) and that the camera, IMU/accelerometer, and EMG data are interchangeable sensors for measuring movement ([0138]) to provide multiple ways of providing feedback ([0194]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity, with wherein the electronic processor is programmed to stop the application of the stimulation pattern to the body part in response to the video of the body part acquired by the video camera indicating the body part has performed the intended action of Brouns, because such a modification would allow to provide multiple ways of providing feedback.
However, Verity in view of Brouns do not teach in response to the at least one sensor indicating the body part is not performing the intended action with the stimulation pattern applied to the body part at the initial stimulation level, increasing the stimulation level above the initial stimulation level. Robinson, in the same field of endeavor, teaches measuring movement, measured by sensors like EMG and videos, corresponding to electrical stimulation for muscle and knee extension (Abstract), and further teaches in response to the … indicating the body part is not performing the intended action with the stimulation pattern applied to the body part at the initial stimulation level, increasing the stimulation level above the initial stimulation level (Col. 21 lines 15-19 “The iterative actuations may continue through varying permutations of electrode configurations, with pauses in between each actuation, and then alter the electrical signal by incrementing the frequency by 5 Hz to produce a second electrical signal. The module 225 may then apply this second electrical signal through the same permutations of electrode configurations, pausing between each actuation to receive user feedback of the second electrical signal as applied through a particular electrode configuration.” Col. 20 lines 51-57 “For example, if the comparison indicates that the stimulated movement is not as strong (e.g., the amplitude of the signals are not as high) as the neurotypical movement, the module 225 may adjust the actuation instructions by changing the electrodes used to apply the electrical stimulation or the amplitude of the electrical signal.”) to calibrate stimulation to a user’s movement (Col. 20 lines 51-57). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity in view of Brouns, with the teach in response to the at least one sensor indicating the body part is not performing the intended action with the stimulation pattern applied to the body part at the initial stimulation level, increasing the stimulation level above the initial stimulation level of Robinson, because such a modification would allow to calibrate stimulation to a user’s movement.
Regarding claim 3, claim 1 is obvious over Verity and Brouns. However, Verity in view of Brouns do not teach wherein the increasing of the stimulation level above the initial stimulation level comprising ramping the stimulation level as a function of time. Robinson, in the same field of endeavor, teaches measuring movement, measured by sensors like EMG and videos, corresponding to electrical stimulation for muscle and knee extension (Abstract), and further teaches wherein the increasing of the stimulation level above the initial stimulation level comprising ramping the stimulation level as a function of time (Col. 21 lines 15-19 “The iterative actuations may continue through varying permutations of electrode configurations, with pauses in between each actuation, and then alter the electrical signal by incrementing the frequency by 5 Hz to produce a second electrical signal.” The stimulation must occur during a period of time and in before and after time period pauses.) to calibrate stimulation to a user’s movement (Col. 20 lines 51-57). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity in view of Brouns, with wherein the increasing of the stimulation level above the initial stimulation level comprising ramping the stimulation level as a function of time of Robinson, because such a modification would allow to calibrate stimulation to a user’s movement.
Regarding claim 9, claim 1 is obvious over Verity and Brouns. However, Verity in view of Brouns do not teach present a prompt of an activity script indicating the intended action. Robinson, in the same field of endeavor, teaches measuring movement, measured by sensors like EMG and videos, corresponding to electrical stimulation for muscle and knee extension (Abstract), and further teaches wherein the electronic processor is further programmed to:
present a prompt of an activity script indicating the intended action (Fig. 5 and Col. 28 lines 4-6 “As shown in the GUIs 600a-b, the heading 510 indicates that the actuation is applied to the left tibialis anterior [intended action].”) to adjust stimulation based on camera video (Col. 18 lines 10-27). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity in view of Brouns, with present a prompt of an activity script indicating the intended action of Robinson, because such a modification would allow to adjust stimulation based on camera video.
Regarding claim 11, claim 1 is obvious over Verity and Brouns. However, Verity in view of Brouns do not teach wherein the electronic processor is programmed to obtain the stimulation pattern from a non-transitory storage medium using a look-up table associating intended actions with corresponding stimulation patterns. Robinson, in the same field of endeavor, teaches measuring movement, measured by sensors like EMG and videos, corresponding to electrical stimulation for muscle and knee extension (Abstract), and further teaches wherein the electronic processor is programmed to obtain the stimulation pattern from a non-transitory storage medium using a look-up table associating intended actions with corresponding stimulation patterns (Col. 4 lines 2-7 “The measured movement data may be representative of neurotypical movement measured from a general population of users. The model can be trained using a training set with measured movement data associated with respective actuation instructions.” Col. 32 lines 25-27 “Such a computer program may be stored in a computer readable storage medium”) to adjust stimulation based on camera video (Col. 18 lines 10-27). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity in view of Brouns, with wherein the electronic processor is programmed to obtain the stimulation pattern from a non-transitory storage medium using a look-up table associating intended actions with corresponding stimulation patterns of Robinson, because such a modification would allow to adjust stimulation based on camera video.
Regarding claim 12, claim 1 is obvious over Verity and Brouns. However, Verity in view of Brouns do not teach wherein the body part is a hand and the NMES device comprises an NMES sleeve configured to be worn on an arm and/or hand. Robinson, in the same field of endeavor, teaches measuring movement, measured by sensors like EMG and videos, corresponding to electrical stimulation for muscle and knee extension (Abstract), and further teaches wherein the body part is a hand and the NMES device comprises an NMES sleeve configured to be worn on an arm and/or hand (Col. 11 lines 61-65 “The dynamometer may be communicatively coupled to a wearable stimulation array that is worn at the user's hand or forearm, and the measurements from the dynamometer and sensors at the array may be used to adjust actuation instructions to assist the user in gripping objects.”) to adjust stimulation based on camera video (Col. 18 lines 10-27). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity in view of Brouns, with wherein the body part is a hand and the NMES device comprises an NMES sleeve configured to be worn on an arm and/or hand of Robinson, because such a modification would allow to adjust stimulation based on camera video.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verity et al. (WO2018220374A1)(Hereinafter Verity)(citations are from US 20200139115) in view of Brouns et al. (US 20220409904)(Hereinafter Brouns) and ‘398 et al. (KR102027398B1)(Hereinafter ‘398)(see attached machine translation regarding citations).
Regarding claim 4, claim 1 is obvious over Verity and Brouns. However, Verity in view of Brouns do not teach the electronic processor is programmed to apply the stimulation pattern to the body part using the NMES device with the ramping stimulation level implemented as a ramping of a scaling factor applied to the electrode group stimulation level for each subset of electrodes. ‘398, in the same field of endeavor, teaches an electrical stimulation device for training muscle rehabilitation using a worn device by measuring muscle contraction (Abstract), and further teaches wherein:
the stimulation pattern is defined as one or more subsets of electrodes of the NMES device and an electrode group stimulation level for each respective subset of electrodes (See Fig. 7 and 8 where each row is its own subset of electrodes with their own stimulation intensity level.), and
the electronic processor is programmed to apply the stimulation pattern to the body part using the NMES device with the ramping stimulation level implemented as a ramping of a scaling factor applied to the electrode group stimulation level for each subset of electrodes (Fig. 8a-c show the changes in intensity (701-1, 701-2, and 701-3 have different intensity values, see page 8 lines 30-35) for the subsets by ramping up or down the intensity based on the selected stimulus module. Examiner interprets the phrase “scaling factor” as a numerical value. In the instant case, the increase and decrease in intensity values for the subset of electrodes are ramped up or down based on the alternation between the first, second, and third stimulus module.) to rehabilitate muscles using a predefined stimulation pattern (Pages 8-9 lines 1-36 and lines 1-10). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity in view of Brouns, with the electronic processor is programmed to apply the stimulation pattern to the body part using the NMES device with the ramping stimulation level implemented as a ramping of a scaling factor applied to the electrode group stimulation level for each subset of electrodes of ‘398, because such a modification would allow to rehabilitate muscles using a predefined stimulation pattern.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verity et al. (WO2018220374A1)(Hereinafter Verity)(citations are from US 20200139115) in view of Brouns et al. (US 20220409904)(Hereinafter Brouns) and Robison et al. (US 11931571)(Hereinafter Robison).
Regarding claim 6, claim 1 is obvious over Verity and Brouns. However, Verity in view of Brouns do not teach wherein the at least one sensor further comprises the electronic processor further programmed to process the video of the body part acquired by the video camera to determine whether the body part has performed the intended action. Robinson, in the same field of endeavor, teaches measuring movement, measured by sensors like EMG and videos, corresponding to electrical stimulation for muscle and knee extension (Abstract), and further teaches wherein the at least one sensor further comprises the electronic processor further programmed to process the video of the body part acquired by the video camera to determine whether the body part has performed the intended action (Col. 18 lines 28-40 “The actuation coordination module 224 may process image or video data captured by a remote sensor (e.g., a camera communicatively coupled to the wearable stimulation array 200). For example, a user installs cameras throughout their home (e.g., as part of an assisted living or a remote care environment), where the cameras capture the user walking and transmit the captured images to the wearable stimulation array 200. The module 224 may perform image processing or apply machine learning on the captured data to recognize the position of the user's legs over time and determine a likely, upcoming movement in the user's gait cycle. The module 224 may identify each movement in a gait cycle.”) to adjust stimulation based on camera video (Col. 18 lines 10-27). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity in view of Brouns, with wherein the at least one sensor further comprises the electronic processor further programmed to process the video of the body part acquired by the video camera to determine whether the body part has performed the intended action of Robinson, because such a modification would allow to adjust stimulation based on camera video.
Regarding claim 7, claim 1 is obvious over Verity and Brouns. However, Verity in view of Brouns do not teach wherein the electronic processor is programmed to apply the stimulation pattern to the body part using the NMES device in response to the detection of the trigger from a video camera. Robinson, in the same field of endeavor, teaches measuring movement, measured by sensors like EMG and videos, corresponding to electrical stimulation for muscle and knee extension (Abstract), and further teaches wherein the electronic processor is further programmed to:
detect a trigger to perform the intended action based on the video of the body part acquired by the video camera;
wherein the electronic processor is programmed to apply the stimulation pattern to the body part using the NMES device in response to the detection of the trigger (Col. 6 lines 19-35 “The wearable stimulation arrays 110a-c applies electrical stimulation or other types of actuation to increase the mobility of its users. The wearable stimulation arrays 110a-c monitor a user's movement to determine current movement [trigger] (e.g., using IMUs or pressure sensors) or intended movement (e.g., using EMG sensors), and applies actuation based on the monitored movement. … For example, the wearable stimulation array 110a is communicatively coupled to the sensor 111, which may be a camera configured to capture image data of the user's movement [trigger] for determining an appropriate actuation instruction.”) to adjust stimulation based on camera video (Col. 18 lines 10-27). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Verity in view of Brouns, with wherein the electronic processor is programmed to apply the stimulation pattern to the body part using the NMES device in response to the detection of the trigger from a video camera of Robinson, because such a modification would allow to adjust stimulation based on camera video.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796 /Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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