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 .
Claim Status: Claims 1-20 are pending.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 2, 6, 7, 9, and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Leuthardt (US 20240261572).
Re Claim 1, Leuthardt discloses a system for aligning therapeutic neurostimulation with a patient training regimen for regaining abilities after neurological trauma, the system comprising:
a wearable neurostimulation device configured to be donned on a head of a wearer, the wearable neurostimulation device comprising at least two electrodes (fig. 2, para. [0050], the first electrode 115 and the second electrode 120); and
one or more sensors, each sensor of the one or more sensors i) integrated into the wearable neurostimulation device, and/or ii) in communication with a controller of the wearable neurostimulation device (para. [0055], [0044], [0045], [0046], [0047] discloses connection of sensors to user computer device and VNS controller, fig. 1), wherein
each sensor of the one or more sensors is configured to produce sensor signals indicative of behaviors of the wearer of the wearable neurostimulation device (para. [0045], [0061], The sensors 140 can be used to determine the optimal taVNS parameters to enhance motor learning by recording invasive cortical physiology; para. [0046], The sensors 140 include stereotactic electroencephalography (sEEG). The sensors 140 can then be used to monitor the effects of stimulation parameters on the subject's brain activity, especially during motor tasks. The user computer device 125 can collect electrophysiological, behavioral, and kinematic data in order to fully characterize the effects of taVNS on motor learning. Other sensors 140 can include, but are not limited to, temperature, brain wave activity, galvanic response, blood pressure, heart rate, and/or any other attribute or statistic of the patient that is desired);
wherein the controller is configured to
collect, from each respective sensor of the one or more sensors, a time sequence of the sensor signals (para. [0045], [0046], [0063]),
analyze the time sequence of the sensor signals of each respective sensor of the one or more sensors to identify performance of a training protocol (para. [0056], During the activity, the user computer device 125 and the sensors 140 measure 350 the patient's statistics, para. [0058], The exoskeleton 135 may be configured to provide assistance to the patient during the exercise treatment. The patient may perform the exercise treatment without an exoskeleton 135, and just perform exercises while receiving VNS. Other forms that can guide the physical activity could be wearable, virtual reality, and software visualization presented on a tablet, mobile phone, or personal computer; para. [0046], parameter monitoring may be performed by monitoring a subject while they engage in a motor learning task paradigm (Serial Reaction Time Task, SRTT)), and
responsive to identifying the performance, activate stimulation therapy via the at least two electrodes of the wearable neuro stimulation device (para. [0056], the exoskeleton 135 could be placed on the patient's arm and the activity is helping the patient perform exercises with that arm. During the activity, the VNS controller 105 is continuing to apply 320 vagal nerve stimulation to the patient.), wherein
the stimulation therapy comprises directing non-invasive stimulation pulses via the at least two electrodes (fig. 2, para. [0050], the first electrode 115 and the second electrode 120) to the auricular branch of the vagus nerve (ABVN) and/or to the auriculotemporal nerve (ATN) (para. [0038], non-invasive stimulation of the vagus nerve, specifically the auricular branch; para. [0050], the first electrode 115 and the second electrode 120 are placed along the concha of the ear to stimulate the vagus nerve where the auricular branch travels in the pinna of the ear; para. [0054], pulse parameters) to induce neuronal plasticity (para. [0035], the use of vagus nerve stimulation (VNS) as a means to promote neuroplasticity), thereby promoting creation of new neural pathways corresponding to the training protocol (para. [0056], the exoskeleton 135 could be placed on the patient's arm and the activity is helping the patient perform exercises with that arm. During the activity, the VNS controller 105 is continuing to apply 320 vagal nerve stimulation to the patient.), and
activating the stimulation therapy comprises initiating the non-invasive stimulation pulses within 100 milliseconds of the performance (para. [0056], [0057], [0058], the exoskeleton 135 could be placed on the patient's arm and the activity is helping the patient perform exercises with that arm. During the activity, the VNS controller 105 is continuing to apply 320 vagal nerve stimulation to the patient.).
Re Claim 2, Leuthardt discloses that the training protocol is designed to support skill rehabilitation after stroke or traumatic brain injury (TBI) (para. [0015]).
Re Claim 6, Leuthardt discloses that analyzing the time sequence of the sensor signals of each respective sensor comprises applying one or more machine learning classifiers to recognize the performance of the training protocol (para. [0079], [0081], para. [0051]-[0053], [0056], the model also includes historical information for the current patient based on previous treatments).
Re Claim 7, Leuthardt discloses that the one or more machine learning classifiers were trained based at least in part on historic sensor data capturing one or more physiological characteristics of the wearer such that the one or more machine learning classifiers are customized to the wearer (para. [0053], The user computer device 125 generates 315 appropriate parameters for taVNS stimulation of the patient based on historical analysis of a plurality of historical patients and their gamma activity to different taVNS parameters and also based on their patient attributes. In some embodiments, the user computer device 125 trains an artificial intelligence and/or machine learning model based on the historical data for the plurality of patients. The model also includes historical information for the current patient based on previous treatments.)
Re Claim 9, Leuthardt discloses that the controller is configured to, prior to the performance of the training protocol, prompt the wearer to perform the training protocol (para. [0044], [0047], the exoskeleton 135 assists the patient in flexing and extending the fingers in coordination with changes in their own electrophysiological activity; para. [0056], activate the exoskeleton 135).
Re Claim 10, Leuthardt discloses that the controller is configured to, at least one minute prior to the performance of the training protocol, deliver a priming stimulation therapy configured to prepare a cognitive pathway for a training session comprising the training protocol (para. [0048], The user computer device 125 may use the gamma band activity as a guideline of when to adjust the output of the VNS controller 105 to maximize the gamma band activity. 20-minutes of taVNS can induce a temporary post-stimulation increase in gamma activity. The decay of the stimulation-induced gamma augmentation indicates that taVNS-induced physiological changes are transient and return to normal within approximately five minutes after stimulation. Increases in gamma power in the sensory cortex have been tied to increased attention and network engagement with a motor task. Since taVNS can cause a robust increase in this frequency band, these combination shows that taVNS is an effective approach for enhancing motor learning in chronic stroke patients by creating a more active overall brain state; para. [0055], [0056], fig. 3 discloses performing activity 345 after gamma band activity is optimized.).
Claims 1, 3, 4, 8, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Badran et al. (US 2021/0205606A1).
Examiner notes: These grounds of rejection are given in order to address dependent claims 3, 4, 8, 11, and 12 which are not rejected with Leuthardt.
Re Claim 1, Badran discloses a system for aligning therapeutic neurostimulation with a patient training regimen for regaining abilities after neurological trauma, the system comprising:
a wearable neurostimulation device configured to be donned on a head of a wearer (para. [0043], wearable 122, para. [0038], one or more electrodes secured adjacent to a cranial nerve using an adhesive, a clip, a patch, an ear plug, a head band, a neck brace, a collar, a head covering, and the like.), the wearable neurostimulation device comprising at least two electrodes (para. [0037], therapy through electrodes; para. [0038], The auricular branch of the vagus nerve can be accessed in a variety of ways, including but not limited to the ear canal, the tragus, the cymba conchae, the outer ear, the mastoid, and combinations thereof. Stimulation can be administered using one or more electrodes secured adjacent to a cranial nerve.); and
one or more sensors, each sensor of the one or more sensors i) integrated into the wearable neurostimulation device (fig. 1B, para. [0043], Wearable 122 comprises an assortment of sensing and stimulating components. The at least one electrode 124 includes stimulating electrodes and can also include sensing electrodes.), and/or ii) in communication with a controller of the wearable neurostimulation device (fig. 1B, para. [0044], Computer platform 134 comprises a wired or wireless transmitter 138 for transmitting instructions to wearable 122, a wired or wireless receiver 140 to collected data from bottle 102, wearable 122, or both, a non-transitory computer-readable medium 142 connected to a processor to store instructions and collected data), wherein
each sensor of the one or more sensors is configured to produce sensor signals indicative of behaviors of the wearer of the wearable neurostimulation device (para. [0023], electromyography electrode placement for muscle activation detection; para. [0063], fig. 4, measuring muscle activation using the at least one sensing electrode that surpasses a minimum threshold 208);
wherein the controller is configured to
collect, from each respective sensor of the one or more sensors, a time sequence of the sensor signals (para. [0023], electromyography electrode placement for muscle activation detection; para. [0063], fig. 4, measuring muscle activation using the at least one sensing electrode that surpasses a minimum threshold 208),
analyze the time sequence of the sensor signals of each respective sensor of the one or more sensors to identify performance of a training protocol (para. [0023], electromyography electrode placement for muscle activation detection; para. [0063], muscle activation from sucking, fig. 4, measuring muscle activation using the at least one sensing electrode that surpasses a minimum threshold 208), and
responsive to identifying the performance, activate stimulation therapy via the at least two electrodes of the wearable neurostimulation device (fig. 4, administering stimulation using stimulation electrodes to the cranial nerve in response to the measurement of muscle activation surpassing the minimum threshold 210; para. [0063]-[0065], Using EMG in a closed-loop taVNS system is a safe and effective way to trigger taVNS stimuli in infants), wherein
the stimulation therapy comprises directing non-invasive stimulation pulses via the at least two electrodes to the auricular branch of the vagus nerve and/or to the auriculotemporal nerve (para. [0008], [0016], [0038], [0040], the auricular branch of the vagus nerve) to induce neuronal plasticity, thereby promoting creation of new neural pathways corresponding to the training protocol (fig. 4, administering stimulation using stimulation electrodes to the cranial nerve in response to the measurement of muscle activation surpassing the minimum threshold 210; para. [0063]-[0065], Using EMG in a closed-loop taVNS system is a safe and effective way to trigger taVNS stimuli in infants; para. [0067], cranial nerve stimulation facilitates their rehabilitation, enhances neuroplasticity, and facilitates motor learning), and
activating the stimulation therapy comprises initiating the non-invasive stimulation pulses within 100 milliseconds of the performance (fig. 4, fig. 5, para. [0063], Vagal Nerve Stimulation (VNS) can increase neural plasticity, and when paired with rehabilitation, can enhance motor learning. The goal of the present study is to develop a closed-loop automatic system that pairs taVNS with muscle activation from sucking, using electromyography (EMG) as a trigger.).
Re Claim 3, Badran discloses that the training protocol comprises performing a physical action involving moving a body part (para. [0063]-[0065], sucking); the one or more sensors comprises one or more motion sensors and/or one or more electromyographic (EMG) sensors (para. [0063]-[0065], EMG); and identifying the performance comprises detecting when the physical action is initiated (para. [0063]-[0065], muscle activation from sucking, using electromyography (EMG)).
Re Claim 4, Badran discloses that the performing comprises a measurable attempt at the performance (para. [0063]-[0065], muscle activation from sucking, using electromyography (EMG)); and detecting when the physical action is initiated comprises detecting, via EMG signals from one or more EMG sensors of the one or more sensors, sensor data corresponding to an attempt at moving the body part (para. [0063]-[0065], muscle activation from sucking, using electromyography (EMG)).
Re Claim 8, Badran discloses that the stimulation therapy is activated for a therapeutic time period of up to five seconds (para. [0060], the duration of stimulation on and off periods can be selected from about 0.1 seconds, 0.5 seconds, 1.5 seconds, 2 seconds, 2.5 seconds, 3 seconds, 3.5 seconds, 4 seconds, 4.5 seconds, 5 seconds).
Re Claim 11, Badran discloses that the controller is configured to repeat the analyzing and the activating for multiple iterations of the performance of the training protocol (para. [0008], the measuring step and the administering step are repeated in a closed loop; para. [0056], fig. 4, step 208 and step 210 are repeated in a closed loop system).
Re Claim 12, Badran discloses that the controller is configured to collect feedback data related to the performance of the training protocol, wherein the feedback data is analyzed to adjust one or more stimulation parameters for a future stimulation therapy responsive to the performance of the training protocol (para. [0047], Computer platform 134 can be used to adjust the timing and intensity of electrode stimulation in wearable 122 according to data received from bottle 102, wearable 122, or both. The timing and intensity of electrode stimulation in wearable 122 is adjusted automatically to maintain measurable parameters within thresholds set by computer platform 134. Measurable parameters include but are not limited to heart rate, blood pressure, muscle activation rate, neural patterns, bottle volume, bottle position, and the like; para. [0063])
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.
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt (US 20240261572) in view of Welle et al. (US 2022/0370804).
Re Claim 13, Leuthardt discloses a system for providing rehabilitative neurostimulation therapy after neurological trauma, the system comprising:
a wearable neurostimulation device configured to be donned on a head of a wearer, the wearable neurostimulation device comprising at least two electrodes (fig. 2, para. [0050], the first electrode 115 and the second electrode 120);
one or more sensors, each sensor of the one or more sensors i) integrated into the wearable neurostimulation device, and/or ii) in communication with a controller of the wearable neurostimulation device (para. [0055], [0044], [0045], [0046], [0047] discloses connection of sensors to user computer device and VNS controller, fig. 1); and
the controller, wherein the controller is configured to
after a stroke or a traumatic brain injury (TBI) experienced by a wearer of the wearable neurostimulation device (para. [0023], enhance functional recovery in chronic stroke patients), deliver a first stimulation therapy to the wearer via the at least two electrodes of the wearable neurostimulation device (para. [0041], electrical stimulation performed twice a day, daily; para. [0057], In other embodiments, the exercise treatment only takes a few minutes, but the length of the treatment increases incrementally over time, where the patient works up to being able to handle longer exercise treatments. In other embodiments, the patient may receive treatment for one side of the body, the other, or both either serially or simultaneously),
wherein the first stimulation therapy is configured to curtail potential damage stemming from the stroke or TBI (para. [0023], enhance functional recovery in chronic stroke patients), and
after the first stimulation therapy, deliver a second stimulation therapy coordinated with a training regimen for supporting the wearer in regaining abilities compromised by the stroke or TBI (para. [0041], electrical stimulation performed twice a day, daily; para. [0057], In other embodiments, the exercise treatment only takes a few minutes, but the length of the treatment increases incrementally over time, where the patient works up to being able to handle longer exercise treatments. In other embodiments, the patient may receive treatment for one side of the body, the other, or both either serially or simultaneously),
wherein delivering the second stimulation therapy comprises collecting, from each respective sensor of the one or more sensors, a time sequence of sensor signals (para. [0045], [0046], [0063]),
analyzing the time sequence of sensor signals of each respective sensor of the one or more sensors to identify evidence of participation by the wearer in the training regimen (para. [0056], During the activity, the user computer device 125 and the sensors 140 measure 350 the patient's statistics, para. [0058], The exoskeleton 135 may be configured to provide assistance to the patient during the exercise treatment. The patient may perform the exercise treatment without an exoskeleton 135, and just perform exercises while receiving VNS. Other forms that can guide the physical activity could be wearable, virtual reality, and software visualization presented on a tablet, mobile phone, or personal computer; para. [0046], parameter monitoring may be performed by monitoring a subject while they engage in a motor learning task paradigm (Serial Reaction Time Task, SRTT)), and
responsive to identifying the evidence of participation, activating the second stimulation therapy via the at least two electrodes of the wearable neurostimulation device (para. [0056], the exoskeleton 135 could be placed on the patient's arm and the activity is helping the patient perform exercises with that arm. During the activity, the VNS controller 105 is continuing to apply 320 vagal nerve stimulation to the patient.),
wherein the second stimulation therapy comprises directing non-invasive stimulation pulses via the at least two electrodes (fig. 2, para. [0050], the first electrode 115 and the second electrode 120) to i) the auricular branch of the vagus nerve (ABVN) and/or ii) the auriculotemporal nerve (ATN) (para. [0038], non-invasive stimulation of the vagus nerve, specifically the auricular branch; para. [0050], the first electrode 115 and the second electrode 120 are placed along the concha of the ear to stimulate the vagus nerve where the auricular branch travels in the pinna of the ear; para. [0054], pulse parameters) to induce neuronal plasticity (para. [0035], the use of vagus nerve stimulation (VNS) as a means to promote neuroplasticity), thereby promoting creation of new neural pathways corresponding to the training regimen (para. [0056], the exoskeleton 135 could be placed on the patient's arm and the activity is helping the patient perform exercises with that arm. During the activity, the VNS controller 105 is continuing to apply 320 vagal nerve stimulation to the patient.).
Leuthardt is silent regarding wherein the first stimulation therapy is delivered at least once within fourteen days of the stroke or TBI.
Welle discloses vagus nerve stimulation paired with motor learning to treat traumatic brain injury (abstract, para. [0043]) and teaches a stimulation therapy is delivered at least once within fourteen days of the stroke or TBI (para. [0043], [0044], first performing a motor learning task at least 2 days, at least 3 days, at least 5 days, at least 7 days, at least 10 days, at least 14 days, at least 21 days, at least 28 days, at least 40 days, or at least 60 days after a traumatic injury can improve outcome of a subject in need of such a treatment such as subject suffering from a traumatic brain injury (TBI) or concussion; para. [0045], motor learning tasks include more than one task alone or in combination with VNS; fig. 8-10, para. [0016]-[0018], motor learning task participation and vagus nerve stimulation).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Leuthardt, by configuring the first stimulation therapy to be delivered at least once within fourteen days of the stroke or TBI, as taught by Welle, for the purpose of remyelination and cognitive and motor function recovery following traumatic injury (para. [0043]).
Re Claim 14, Leuthardt discloses that each sensor of the one or more sensors is configured to generate signals related to at least one of a motion or a sound produced by the wearer of the wearable neurostimulation device (para. [0061], During this task, the sensors 140 will collect electrophysiological, behavioral, and kinematic data in order to fully determine the effect of taVNS on motor learning).
Re Claim 15, Leuthardt discloses that activating the second stimulation therapy comprises initiating the non-invasive stimulation pulses within 100 milliseconds of the evidence of participation (para. [0056], [0057], [0058], the exoskeleton 135 could be placed on the patient's arm and the activity is helping the patient perform exercises with that arm. During the activity, the VNS controller 105 is continuing to apply 320 vagal nerve stimulation to the patient.).
Re Claim 16, Leuthardt discloses that the second stimulation therapy is delivered at least one day after the first stimulation therapy (para. [0041], electrical stimulation performed twice a day, daily; para. [0057], In other embodiments, the exercise treatment only takes a few minutes, but the length of the treatment increases incrementally over time, where the patient works up to being able to handle longer exercise treatments. In other embodiments, the patient may receive treatment for one side of the body, the other, or both either serially or simultaneously; para. [0023], enhance functional recovery in chronic stroke patients).
Re Claim 17, Leuthardt’s disclosure reads on the limitation “wherein the first stimulation therapy is delivered in a hospital setting, and the second stimulation therapy is delivered outside of the hospital setting”.
Since the system of Leuthardt has the claimed structures in claim 13, its therapies are capable of being delivered in the hospital setting or outside of the hospital setting.
Examiner notes: This is a device claim, and the first stimulation therapy and the second stimulation therapy need to be capable of being delivered in the described settings. The locations that the first stimulation therapy and the second stimulation therapy are delivered are intended use and do not have the proper patentable weight.
Re Claim 18, Leuthardt discloses that the controller is configured to: analyze signals collected by one or more medical device sensors included in or in communication with one or more medical devices in the hospital setting; and based on the analyzing, adjust one or more parameters of the first stimulation therapy (para. [0053], the user computer device 125 generates 315 appropriate parameters for taVNS stimulation of the patient based on historical analysis of a plurality of historical patients and their gamma activity to different taVNS parameters and also based on their patient attributes. the model also includes historical information for the current patient based on previous treatments; para. [0055], fig. 3, measure gamma activity 325, adjusting taVNS to determine optimized gamma activity 335; para. [0047], the user computer device 125 adjusts the output of the VNS controller 105 to maximize the patient's results and enhance the BCI therapy; para. [0054], healthcare provider applies vagal nerve stimulation to the patient).
Re Claim 19, Leuthardt discloses that the second stimulation therapy is delivered while the wearer is monitored by a clinician (para. [0056], [0057], During the activity, the user computer device 125 and the sensors 140 measure 350 the patient's statistics. The patient statistics may be analyzed to determine the patient's progress as well as a notification of when the patient should discontinue the treatment session; para. [0054], healthcare provider applies vagal nerve stimulation to the patient).
Re Claim 20, Leuthardt discloses that the controller is configured to, after delivering the first stimulation therapy (para. [0041], electrical stimulation performed twice a day, daily; para. [0057], In other embodiments, the exercise treatment only takes a few minutes, but the length of the treatment increases incrementally over time, where the patient works up to being able to handle longer exercise treatments. In other embodiments, the patient may receive treatment for one side of the body, the other, or both either serially or simultaneously; para. [0023], enhance functional recovery in chronic stroke patients) and prior to delivering the second stimulation therapy (para. [0056], During the activity, the VNS controller 105 is continuing to apply 320 vagal nerve stimulation to the patient.), deliver a priming stimulation therapy (para. [0048], fig. 3, apply vagal nerve stimulation to patient 320) configured to prepare a cognitive pathway for a training session comprising the training regimen (para. [0048], The user computer device 125 may use the gamma band activity as a guideline of when to adjust the output of the VNS controller 105 to maximize the gamma band activity. 20-minutes of taVNS can induce a temporary post-stimulation increase in gamma activity. The decay of the stimulation-induced gamma augmentation indicates that taVNS-induced physiological changes are transient and return to normal within approximately five minutes after stimulation. Increases in gamma power in the sensory cortex have been tied to increased attention and network engagement with a motor task. Since taVNS can cause a robust increase in this frequency band, these combination shows that taVNS is an effective approach for enhancing motor learning in chronic stroke patients by creating a more active overall brain state; para. [0055], [0056], fig. 3 discloses performing activity 345 after gamma band activity is optimized.).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, January 5, 2026Examiner, Art Unit 3792