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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed on 12/17/2025. Currently claims 1 and 5-16 are pending.
Response to Arguments
Applicant has cancelled claims 17-18 and 22-30 rending any further discussion of these specific claims moot based on the change of status for these claims
Applicant’s arguments, see pg. 5, filed 12/17/2025, with respect to the previous rejection of claims 1, 4-16 rejected under 35 USC 112(a) and/or 35 USC 112(b) have been fully considered and are persuasive. The previous 112 rejections of claims 1, 4-16 has been withdrawn.
Applicant’s arguments, see pgs. 5-8, filed 12/17/2025, with respect to the rejection(s) of:
claim(s) 1 and 4-16 rejected under 35 USC 103 as being unpatentable over Malchano in view of Mirelman in view of Montgomery
have been fully considered and are persuasive based on applicant’s amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the additional reference of Novak et al (US 20070203435) as outlined below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 4-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malchano in view of Mirelman et al (US 20140276130) hereafter known as Mirelman in view of Montgomery.
Independent claim:
Regarding claim 1:
A method of improving gait in a subject [see abstract… “The present disclosure describes a method for neuromodulating a subject” and para 88… “As stated above, the present systems and methods may be used to alleviate symptoms associated with inherited ataxias. Hereditary ataxias are characterized by slowly progressive incoordination of gait”], the method comprising:
exposing the subject to audio, visual, tactile, and/or vibrational sensory stimuli at
one or more stimulation frequencies in a stimulation frequency range of 5-145 Hz [see para 274… “The modulation frequency can be a predetermined or desired frequency. The modulation frequency can correspond to a desired stimulation frequency of neural oscillations. The modulation frequency can be set to facilitate or cause brainwave entrainment. The NS 905 can set the modulation frequency to a frequency in the range of 0.1 Hz to 10,000 Hz. For example, the NS 905 can set the modulation frequency to 0.1 Hz, 1 Hz, 5 Hz, 10 Hz, 20 Hz, 25 Hz, 30 Hz, 31 Hz, 32 Hz, 33 Hz, 34 Hz, 35 Hz, 36 Hz, 37 Hz, 38 Hz, 39 Hz, 40 Hz, 41 Hz, 42 Hz, 43 Hz, 44 Hz, 45 Hz, 46 Hz, 47 Hz, 48 Hz, 49 Hz, 50 Hz, 60 Hz, 70 Hz, 80 Hz, 90 Hz, 100 Hz, 150 Hz, 200 Hz, 250 Hz, 300 Hz, 400 Hz, 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4,000 Hz, 5000 Hz, 6,000 Hz, 7,000 Hz, 8,000 Hz, 9,000 Hz, or 10,000 Hz. While it is not explicitly stated that delta activity is promoted, based on paras 58-59 of applicant’s written disclosure received on 3/29/2024, stimulus of a 10 Hz audio signal is disclosed as resulting in increased delta activity (i.e. improve delta activity) with delta activity understood to be in the range of .5-4 Hz. As Malchano discloses using a 10 Hz, delta activity clearly is improved when a subject is exposed to the 10 Hz audio stimuli]
while the subject is engaging in an activity involving a repetitive physical motion, wherein the activity is walking [see para 162… “worn during physical activity, such as walking or running” and para 396… “In some embodiments, the NOS 1605 can adjust or change the mode of stimulation or a type of signal based on feedback received from a feedback component 1640a-n. The stimuli orchestration component 1610 can adjust the mode of stimulation or type of signal based on feedback on the subject, feedback on the environment, or a combination of feedback on the subject and the environment. Feedback on the subject can include, for example, physiological information, temperature, attention level, level of fatigue, activity (e.g., sitting, laying down, walking, biking, or driving), vision ability, hearing ability, side effects (e.g., pain, migraine, ringing in ear, or blindness), or frequency of neural oscillation at a region or portion of the brain (e.g., EEG probes).” Malchano implies in cited sections including the activity of walking during the time stimuli are applied. Walking is a repetitive physical motion]
continuing to expose the subject to the audio, visual, tactile, and/or vibrational sensory stimuli to reach brain entrainment [see para 274… “The modulation frequency can be a predetermined or desired frequency. The modulation frequency can correspond to a desired stimulation frequency of neural oscillations. The modulation frequency can be set to facilitate or cause brainwave entrainment.”]
Also, Malchano is directed to alleviating symptoms of incoordination of gait [see para 88… “As stated above, the present systems and methods may be used to alleviate symptoms associated with inherited ataxias. Hereditary ataxias are characterized by slowly progressive incoordination of gait”], using the stimuli to help treat motor function and cognitive diseases [see para 461 and para 105… “alleviating symptoms of brain atrophy. Symptoms may include a loss of neurons, memory loss, blurred vision, aphasia, impaired balance, paralysis, decreases in cortical volume, increases in CSF volume, loss of motor control”], using the repetitive physical activity of walking as feedback to adjust stimuli [see para 162… “worn during physical activity, such as walking or running” and para 396… “In some embodiments, the NOS 1605 can adjust or change the mode of stimulation or a type of signal based on feedback received from a feedback component 1640a-n. The stimuli orchestration component 1610 can adjust the mode of stimulation or type of signal based on feedback on the subject, feedback on the environment, or a combination of feedback on the subject and the environment. Feedback on the subject can include, for example, physiological information, temperature, attention level, level of fatigue, activity (e.g., sitting, laying down, walking, biking, or driving), vision ability, hearing ability, side effects (e.g., pain, migraine, ringing in ear, or blindness), or frequency of neural oscillation at a region or portion of the brain (e.g., EEG probes).”].
However, Malchano is silent as to the frequency at which a person walks during the method. Thus, Malchano fails to fully disclose that the subject is engaging in an activity involving a repetitive physical motion specifically “performed at delta frequencies in a delta frequency range of .5-4 Hz to promote neural activity in the subject at the delta frequencies, wherein the activity is walking, wherein the walking is characterized by multiple steps, each step having a step duration”. Also, Malchano fails to explicitly disclose continuing the stimuli until an effect on neural activity in the subject at the delta frequencies is observed. Thus, Malchano fails to fully disclose “continuing to apply the audio, visual, tactile, and/or vibrational sensory stimuli while varying the stimulation frequency”, “detecting an improvement in gait rhythmicity in the walking, wherein the improvement in gait rhythmicity is defined as a reduction in a step duration variance”, “identifying a detected stimulation frequency and at which the improvement in gait rhythmicity is observed;” or “applying the audio, visual, tactile, and/or vibrational sensory stimuli at the detected stimulation frequency to improve gait rhythmicity” as claimed.
Mirelman discloses in the analogous art of treating individuals with neurological disorders that result in gait impairment [see abstract and paras 3-4…. “The present invention, in some embodiments thereof, relates to diagnosing, monitoring and/or treating persons with a fall risk and/or other pathological conditions” and “Gait impairments and falls are ubiquitous among older adults and patients with common neurological diseases.”] that normal walking has a frequency pattern of .5-3 Hz and collecting data on users who perform walking at this frequency (i.e. thereby fully reciting “performed at delta frequencies in a delta frequency range of .5-4 Hz to promote neural activity in the subject at the delta frequencies, wherein the activity is walking, wherein the walking is characterized by multiple steps, each step having a step duration”) [see paras 238-239… in particular “Acceleration signal from the lower back has a repeatable pattern in frequencies between 0.5-3 Hz for normal walk.” And “The resultant signal enables detection of gait by searching for local maxima which represents one gait cycle. Only windows at which 2-15 steps are detected are considered as walking. This range was chosen since gait typically exists in the range of 0.5-3 Hz where 0.5 Hz means a step each two seconds and 3 Hz means 3 steps a second.” Please note that while a step duration is not explicitly recited, it is implicitly recited because walking inherently has a step duration of some type.]
Montgomery discloses in the analogous art of physiological diagnosis and treatment of an individual’s movement [see abstract… “Embodiments of the present invention relate generally to biofeedback method and system and more specifically to a method and system for correcting movement in a person using biofeedback.”] a known way to correct a user’s movement is to apply stimuli in the form of music (i.e. sound) and to use biofeedback of a user’s movement from physiological sensors to adjust volume and frequency (i.e. frequency) to help adjust a user’s movement to a reference movement (i.e. increase in limb rhythmicity) [see para 67… “The music is altered in terms of volume and/or rhythm as a function of the measured physical activity of the user's muscles. The purpose is to make any music useful to delivering rhythmic auditory stimulation (RAS)… If the user needs to modify some behavior, such as a rhythmic behavior, with respect to the reference movement, such as to improve his gait, then the audio output (e.g., the music) is altered in some way until the user makes the modification, such as in its rhythm, by enhancing the volume of the rhythm or frequency of the tempo” And para 41… “The process typically begins by setting a target or reference movement that the person would like to or is required to achieve. For example, a stroke victim may have a limp on one side, which was created by the stroke. In order to overcome the limp, a target or reference movement will be normal walking without a limp. This reference movement is programmed into a hardware component such as flash memory or a software database contained in the device. This hardware and software database can be updated manually, via a button or automatically, such as in the case of a patient walking into a doctor's office, which wirelessly updates the database. Depending on the person's injury or disability, the target movement may not initially be the end result (e.g., full movement with no limp) that will eventually be achieved, but will be adjusted or calibrated periodically as progress is made, to eventually attain the end result (e.g., full movement with no limp).” And para 60… “Sensors suitable to the task of measuring movement parameters include, but are not limited to, accelerometers placed on an arm, leg, torso, head, or the like.”]
Novak discloses in the analogous art of gait diagnostics [see abstract… “A device and method for stimulating a foot of a subject based on ambulatory feedback can impact various characteristics of the subject's gait.”] that a known way to improve gait rhythmicity is to provide a stimulus of 70 Hz (i.e. in a stimulation frequency range of 5-145 Hz) and a known observation for this improvement can be seen in a decrease in stride variability (i.e. a decrease in step variance) when a user is walking [see para 46… “The accumulated evidence appears to indicate that the stride time variability is a good measure of gait unsteadiness. The stride-to-stride variability is increased in the subjects with history of falls and it is an independent predictor of falling. The data suggest that the vibratory stimulation of the soles operating in the closed-loop mode may improve the gait profile by reducing the gait variability and therefore it might be useful for treatment of the gait and balance disorders.” And para 48… “Three vibratory stimulation devices (VD) were embedded into elastic insoles with one VS located below the heel and two VD located below the forefoot areas. The insoles were inserted in shoes used by the test subjects. The VD delivered the 70 Hz vibration pulse stimulus that was activated by the heel and forefoot touch and turned-off during the swing phase. Six minute hallway walking was studied with and without S-VS. Gait characteristics were measured using the force sensitive foot switches. In the PD group, S-VS increased walking speed (p<0.005), cadence (p<0.05), stride duration (p<0.005), stride length (p<0.005), and decreased stride variability (p<0.005). In the control group, S-VS decreased stride variability (p<0.05), while the other locomotion parameters remained unchanged.”]
Since Malchano is silent as to the frequency of walking performed (i.e. the repetitive physical motion) and Mirelman discloses a frequency between .5-3 Hz Is a known frequency for normal walking, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Malchano’s walk pattern to be at a frequency of .5-3 Hz similarly to that disclosed by Mirelman (i.e. thereby disclosing “subject is engaging in an activity involving a repetitive physical motion performed at delta frequencies in a delta frequency range of .5-4 Hz to promote neural activity in the subject at the delta frequencies , wherein the activity is walking, wherein the walking is characterized by multiple steps, each step having a step duration”) because this is a known frequency for normal walking used in the analogous art of treatment of individuals with neurological disorders.
Since Malchano in view of Mirelman is directed to using audio stimulation and using a user’s physiological data related to movement as feedback to alleviate symptoms of incoordination of gait of patients, but is silent as to how this feedback is used to control stimuli and Montgomery teaches a known way to use feedback to adjust stimuli includes measuring properties of a user’s walking and continually adjusting an audio stimuli’s volume and frequency (i.e. frequency) until a user reaches a reference movement without a limp (i.e. an increase in limb rhythmicity), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Malchano to use sound stimuli of music and biofeedback from physiological sensors to adjust the sound stimuli’s frequency and intensity to help an individual suffering from incoordination of gait to reach movement without incoordination of gait similarly to that of Montgomery (i.e. thereby reciting the missing step of continuing to apply as claimed).
Since Malchano in view of Mirelman in view of Montgomery discloses one independent way to determine improved gait rhythmicity (i.e. observation of no limp) and Novak discloses another independent way to determine improved gait rhythmicity (i.e. observation of decreased step duration variance), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Malchano in view of Mirelman in view of Montgomery to also analyze a reduction in a step duration variance as well as observing the removal of a limp in gait (i.e. thereby fully reciting the missing steps of detecting an improvement in gait rhythmicity as claimed, identifying a detected stimulation frequency as claimed and applying the stimuli as claimed) because one of ordinary skill would expect the combination of two independent ways of determining improved gait rhythmicity would lead to a better improvement in improving the gait (and if not an improvement then at least the same level of improvement) than either way alone.
Regarding claim 5, see rejection to claim 1 which discloses the motion is performed at a frequency of .5-3 Hz which recites the claimed range.
Regarding claim 6-7:
Malchano in view of Mirelman in view of Montgomery in view of Novak discloses the invention substantially as claimed including all the limitations of claim 1 which includes improving gait. Additionally Malchano in view of Mirelman in view of Montgomery in view of Novak discloses collecting feedback information from accelerometers and gyroscopes [see para 312 of Malchano… “Feedback component 960 can include, for example, a feedback sensor 1405 such as a temperature sensor, heart or pulse rate monitor, physiological sensor, ambient noise sensor, microphone, ambient temperature sensor, blood pressure monitor, brain wave sensor, EEG probe, electrooculography (“EOG”) probes configured measure the corneo-retinal standing potential that exists between the front and the back of the human eye, accelerometer, gyroscope, motion detector, proximity sensor, camera, microphone, or photo detector.”] and that this feedback is sent to a side effects management module understood to be a type of controller that adjusts the acoustic stimuli [see para 310 of Malchano … in particular… “The side effects management module 930 can cause a change in the parameter of the audio signal in response to feedback information. The side effect management module 930 can receive feedback from the feedback monitor 935. The side effects management module 930 can determine to adjust a parameter of the audio signal based on the feedback.”].
However, Malchano in view of Mirelman in view of Montgomery in view of Novak fails to disclose “wherein the method decreases a level of variation in gait of the subject by at least 5%” as recited by claim 5 or “wherein the level of variation in gait is measured by comparing a difference in at least one of: velocity, stride length, stride width, cadence, gait phases, and electrical activity produced by muscles in the subject” as recited by claim 6.
Mirelman further discloses in the analogous art of treating individuals with neurological diseases that result in gait impairment [see abstract and paras 3-4…. “The present invention, in some embodiments thereof, relates to diagnosing, monitoring and/or treating persons with a fall risk and/or other pathological conditions” and “Gait impairments and falls are ubiquitous among older adults and patients with common neurological diseases.”] a data processor (or a type of controller) [see para 101… “In an exemplary embodiment of the invention, one or more tasks according to exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions”] that uses accelerometers and gyroscopes to evaluate gait including specifically gait velocity for the purpose of determining the best treatment and reducing side effects [see para 210… in particular… “The integrated system could provide an assessment of the impairments and/or deliver the most appropriate type of intervention which could improve their rehabilitation”]. Also, Mirelman notes that changes of 5% or more in gait indicate high risk of falling [see para 195 in particular…. “In an exemplary embodiment of the invention, gait assessment is done using accelerometers and gyroscopes to assess spatial temporal parameters of gait (e.g., gait velocity and stride time) as well as measures of consistency (i.e., gait variability and gait regularity). Optionally, in healthy older individuals, it is expected to observe gait speed in a range between 0.8 m/s-1.4 m/s with a mean stride average of 1.2 sec and gait variability of approximately 2%. These parameters will change dramatically in individuals with high risk of falls (e.g., slower gait speed and gait variability of as much as 5% or more).”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Malchano in view of Mirelman in view of Montgomery in view of Novak’s controller to use the feedback sensors of accelerometers and gyroscopes to determine gait velocity variance and to continuing to treat until changes of at least 5% or more similarly to that disclosed by Mirelman as this would result in alleviating symptoms of poor gait and also significantly reduce the associated high risk of falling with said poor gait.
Regarding claim 8, see Fig. 26 and para 46 of Malchano [see “FIG. 26 is a table depicting a summary of efficacy findings resulting from the human clinical trial, including p-values, treatment differences”] which discloses how the method is directed to use on humans.
Regarding claim 9, see para 109 of Malchano [see “In some embodiments, combined visual and auditory signals are provided by such headphones and glasses worn together at the same time. In some embodiments, visual and auditory signals are delivered separately by glasses or headphones worn at different times. An example embodiment includes a pair of glasses, with LEDs on the interior of the glasses providing visual stimulus and headphones providing auditory stimulus.”] which discloses using a headphone to produce the auditory signals.
Regarding claims 10-13, see Fig. 28 element 2805 and para 714 of Malchano [see “A graph 2805 shows a series of scheduled stimulation pulses included in a single therapy session along a time axis. As shown, the pulses occur during intervals labeled as T1, T2, T3, T4, T5, and T6. In this example, the intervals T5 and T6 do not include any scheduled stimulation pulses. It should be understood that the graph 2805 may represent pulses of any modality (e.g., visual stimulation pulses or auditory stimulation pulses).”] and para 648 of Malchano [see “The time intervals can refer to absolute times, time periods, number of cycles, or other event. The time interval from t.sub.0 to t.sub.8 can be, for example, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 7 minutes, 10 minutes, 12 minutes, 15 minutes, 20 minutes or more or less. The time interval can be cut short or terminated by the subject or responsive to feedback information. The time intervals can be adjusted based on profile information or by the subject via an input device.”]. These sections describe time intervals of treatment referred as T4 and T5 which are at least a first and second time period, respectively and these sections also describe how no stimuli is applied during T5 (i.e. two time periods where the second time period no stimuli is applied as recited in claims 10 and 13). Also, these sections describe T4 (first time period) and T5 (second time period) as being 1 minute each (i.e. time is equal in claim 11), but also include situations where one of these time periods is cut short which would make the two unequal in time (i.e. claim 12).
Regarding claims 14-16, see para 461 of Malchano [see “In some embodiments, the subject may have Parkinson's disease.”] discloses using the device on individuals with Parkinson’s disease which recites claims 14-15. Additionally, para 461 of Malchano [see “In some embodiments, the subject may have early onset dementia.”] discloses using the device on individuals with dementia which recites claim 16.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792