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 .
This action is non-final.
Response to Arguments
Applicant’s arguments, see page 8, filed 06/18/2025, with respect to Claim Objections and 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection and objection of the claims have been withdrawn.
Applicant’s arguments, see pages 8-11, filed 06/18/2025, with respect to the rejection(s) of claim(s) 1-12 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Verity et al. (WO2018220374A1)(Hereinafter Verity)(citations are from US 20200139115).
Election/Restrictions
Newly submitted claims 21-28 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claims 21-27 are directed to using a proximity sensor to determine that an action has occurred to stop the stimulation pattern and claim 28 is directed to using a proximity sensor and RFID on a location of the body to determine that an action has occurred to stop the stimulation pattern, whereas claims 1-12 are directed to a camera or EMG for determining an action has occurred for the stopping of stimulation; see previously presented claims 5-8. Since the camera was the only previously presented/examined embodiment for the sensor, any new/additional embodiments presented are properly withdrawn based on election by original presentation.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-28 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verity et al. (WO2018220374A1)(Hereinafter Verity)(citations are from US 20200139115).
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:
at least one sensor 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 the at least one sensor 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.”).
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.).
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) 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 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, Verilty does 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 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 (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, 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 anticipated by Verity. However, Verity does 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, 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 anticipated over Verity. However, Verity does 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, 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 anticipated over Verity. However, Verity does 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, 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 anticipated over Verity. However, Verity does 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, 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 ‘398 et al. (KR102027398B1)(Hereinafter ‘398)(see attached machine translation regarding citations).
Regarding claim 4, claim 1 is anticipated over Verity. However, Verity does 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, 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) 5 and 8 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 5, claim 1 is anticipated by Verity. 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 stimulation (Abstract), and further teaches wherein the at least one sensor comprises:
a video camera arranged to acquire video of a body part ([0194] “Another example input device could be a camera and/or an accelerometer and/or gyroscope that is capable of capturing physical movement events.”);
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”) 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.”).
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 anticipated over Verity. However, Verity does 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, 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 anticipated over Verity. However, Verity does 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, 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
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796