DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. This office action is responsive to the amendment filed on 07/20/2026. As directed by the amendment: claims 1-2, 10-11, and 19 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Claim Rejections - 35 USC § 103
3. 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.
4. 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.
5. Claim(s) 1, 3-4, 8-9, 10, 12-13, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prochazka et al. (US 5,562,707) in view of Cordo (US 2013/0116606) and
Greenberg et al. (US 2010/0145236).
Regarding claim 1, Prochazka discloses a wearable device for reducing tremor of a subject using data filtering (fig. 1, stimulator device 18), the device comprising:
one or more motion sensors (fig. 1, wrist position sensor 14) configured to be positioned on a hand or wrist of the subject (fig. 1, wrist position sensor 14 is positioned on the wrist of the user) and to generate data corresponding to a tremor frequency of the subject (col. 5, lines 26-29 state that wrist position sensor 14 is a linear variable displacement transducer which creates a displacement signal, see col. 9, lines 22-25, and col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle which requires that a tremor frequency be known);
a processor (fig. 9, microprocessor 92) configured to:
receive the data from the one or more motion sensors (fig. 9, shows the wrist sensor 91, which can include sensor 14 according to col. 7, lines 1-3, and feeds into microprocessor 92 via signal conditioner 91a);
filter the data to remove a portion of the data outside of a tremor frequency that are not attributable to the tremor (col. 9, lines 20-24 state that the microcontroller digitally filters the sampled displacement signal according to each tremor cycle);
extract the tremor frequency of the subject from the data (col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle, and col. 3, lines 56-60 states that the sensor is to set stimulus parameters of the selected programs, which would include the frequency of the tremor if the out-of-phase sections of each tremor cycle is when stimulus is provided); and
set one or more stimulation parameters (col. 8, lines 52-56 state that the microcontroller provides the pulse train for activating the electrodes) based, at least in part, on the tremor frequency (col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle).
Prochazka further discloses the use of electrodes (fig. 12, 123 and 124) for rapid stimulation of motor points on the patient’s hand (col. 9, lines 12-16), the microcontroller provides a pulse train used to activate the electrode contacts in the glove (col. 8, lines 52-56), and user movements for adjusting stimulus intensity (col. 8, lines 23-26), but does not expressly disclose one or more mechanical effectors configured to apply vibrotactile stimulation to a wrist of the subject sufficient to stimulate one or more nerves or proprioceptors and the processor is configured to set stimulation parameters of the vibrotactile stimulation applied by the one or more mechanical effectors or the motion sensor comprises one or more multi-axis accelerometers..
However, Cordo teaches of a wearable maintenance therapy device that imparts vibratory stimuli to reduce symptomatic relapse of spasticity (abstract) that includes mechanical effectors ([0007] states a vibrator actuator is held in place on the patient’s limb [0019] to provide proprioceptive input from the vibrated muscle to activate sensory areas of the patient’s central nervous system) where programmable control circuitry controls vibration characteristics ([0007]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of Prochazka with the vibrator actuators as taught by Cordo to provide muscle vibrations which can mitigate the effects of dysfunctional patterns of muscle contraction (Cordo [0006]) such as essential tremor (Cordo [0029]).
The modified device of Prochazka reads on one or more mechanical effectors configured to apply vibrotactile stimulation to a wrist of the subject sufficient to stimulate one or more nerves or proprioceptors (Cordo [0007] states a vibrator actuator is held in place on the patient’s limb [0019] to provide proprioceptive input from the vibrated muscle to activate sensory areas of the patient’s central nervous system) and the processor is configured to set stimulation parameters of the vibrotactile stimulation applied by the one or more mechanical effectors (Cordo [0007] states that the programmable control circuitry controls vibration characteristics), but does not expressly disclose that the motion sensor comprises one or more multi-axis accelerometers.
However, Greenberg teaches of a system for continuous monitoring of movement disorders such as Parkinson’s disease and essential tremor ([0050]) which uses a sensor module (fig. 2, 200) to characterize the symptoms of movement disorders ([0028]) and includes multi-axis accelerometers (fig. 2, 202), gyroscopes (fig. 2, 203), and magnetometers (fig. 2, 201).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the wrist position sensor of Prochazka with the sensor module as taught by Greenberg as a simple substitution of one known element for another to obtain a predictable result of being able to characterize a tremor (Greenberg [0028] states that the sensor module characterizes the symptoms of movement disorders, Prochazka col. 5, lines 26-29 state that wrist position sensor 14 is a inductive transducer).
The further modified device of Prochazka reads on the motion sensor comprises one or more multi-axis accelerometers (Greenberg fig. 2, x,y,z axis analog accelerometers 202).
Regarding claim 3, the modified device of Prochazka reads on the limitations of claim 1 and further reads on wherein the one or more mechanical effectors (Cordo [0007] vibrator actuator) are configured to apply the vibrotactile stimulation to the wrist of the subject (Prochazka fig. 12, electrodes 123 and 124 are placed on the wrist of the subject, Cordo fig. 1, shows vibrator actuator 20 also on the wrist of the subject) sufficient to stimulate one or more proprioceptors (Cordo [0019] to provide proprioceptive input from the vibrated muscle to activate sensory areas of the patient’s central nervous system), and wherein the one or more proprioceptors comprise pressure receptors (Cordo [0019] vibration on the muscle will be received by the patient’s pressure receptors).
Regarding claim 4, the modified device of Prochazka reads on the limitations of claim 1 and further reads on the processor is configured to execute one or more algorithms stored in memory of the wearable device (Prochazka col. 3, lines 53-60 states that after putting the device on, pre-stored programs of cyclical stimulation can be selected).
Regarding claim 8, the modified device of Prochazka reads on the limitations of claim 1 and further reads on the one or more mechanical effectors comprise one or more vibrotactile units (Cordo fig. 1, vibrator actuator 20 imparts a localized vibration, see [0019]).
Regarding claim 9, the modified device of Prochazka reads on the limitations of claim 1 and further reads on the electronic circuit being battery-powered (Prochazka col. 2, lines 26-27), but does not expressly state that the device comprises a rechargeable battery.
However, Cordo teaches of a wearable maintenance therapy device that imparts vibratory stimuli to reduce symptomatic relapse of spasticity (abstract) that includes a rechargeable battery (fig. 1, 44).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Prochazka with the rechargeable battery as taught by Cordo to power the electronic circuity of Prochazka (Prochazka col. 2, lines 26-27).
Regarding claim 10, Prochazka discloses a wearable device for reducing tremor of a subject using data filtering (fig. 1, stimulator device 18), the device comprising:
one or more sensors (fig. 1, wrist position sensor 14) configured to be positioned on a hand or wrist of the subject (fig. 1, wrist position sensor 14 is positioned on the wrist of the user) and to generate data corresponding to a tremor characteristics of the subject (col. 5, lines 26-29 state that wrist position sensor 14 is a linear variable displacement transducer which creates a displacement signal, see col. 9, lines 22-25);
a processor (fig. 9, microprocessor 92) configured to:
receive the data from the one or more sensors (fig. 9, shows the wrist sensor 91, which can include sensor 14 according to col. 7, lines 1-3, and feeds into microprocessor 92 via signal conditioner 91a);
filter the data to remove a portion of the data that is not attributable to the tremor (col. 9, lines 20-24 state that the microcontroller digitally filters the sampled displacement signal according to each tremor cycle);
extract the one or more tremor characteristics of the subject from the data (col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle, and col. 3, lines 56-60 states that the sensor is to set stimulus parameters of the selected programs, which would include the frequency of the tremor if the out-of-phase sections of each tremor cycle is when stimulus is provided); and
set one or more parameters (col. 8, lines 52-56 state that the microcontroller provides the pulse train for activating the electrodes) based, at least in part, on the one or more tremor characteristics (col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle).
Prochazka further discloses the use of electrodes (fig. 12, 123 and 124) for rapid stimulation of motor points on the patient’s hand (col. 9, lines 12-16), the microcontroller provides a pulse train used to activate the electrode contacts in the glove (col. 8, lines 52-56), and user movements for adjusting stimulus intensity (col. 8, lines 23-26), but does not expressly disclose one or more mechanical effectors configured to non-invasively apply vibrotactile stimulation to a wrist of the subject sufficient to stimulate one or more nerves or proprioceptors and the processor is configured to set one or more parameters of the vibrotactile stimulation applied by the one or more mechanical effectors or the motion sensor comprises one or more multi-axis accelerometers..
However, Cordo teaches of a wearable maintenance therapy device that imparts vibratory stimuli to reduce symptomatic relapse of spasticity (abstract) that includes mechanical effectors ([0007] states a vibrator actuator is held in place on the patient’s limb [0019] to provide proprioceptive input from the vibrated muscle to activate sensory areas of the patient’s central nervous system) where programmable control circuitry controls vibration characteristics ([0007]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of Prochazka with the vibrator actuators as taught by Cordo to provide muscle vibrations which can mitigate the effects of dysfunctional patterns of muscle contraction (Cordo [0006]) such as essential tremor (Cordo [0029]).
The modified device of Prochazka reads on one or more mechanical effectors configured to apply vibrotactile stimulation to a wrist of the subject sufficient to stimulate one or more nerves or proprioceptors (Cordo [0007] states a vibrator actuator is held in place on the patient’s limb [0019] to provide proprioceptive input from the vibrated muscle to activate sensory areas of the patient’s central nervous system) and the processor is configured to set stimulation parameters of the vibrotactile stimulation applied by the one or more mechanical effectors (Cordo [0007] states that the programmable control circuitry controls vibration characteristics), but does not expressly disclose that the motion sensor comprises one or more multi-axis accelerometers.
However, Greenberg teaches of a system for continuous monitoring of movement disorders such as Parkinson’s disease and essential tremor ([0050]) which uses a sensor module (fig. 2, 200) to characterize the symptoms of movement disorders ([0028]) and includes multi-axis accelerometers (fig. 2, 202), gyroscopes (fig. 2, 203), and magnetometers (fig. 2, 201).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the wrist position sensor of Prochazka with the sensor module as taught by Greenberg as a simple substitution of one known element for another to obtain a predictable result of being able to characterize a tremor (Greenberg [0028] states that the sensor module characterizes the symptoms of movement disorders, Prochazka col. 5, lines 26-29 state that wrist position sensor 14 is a inductive transducer).
The further modified device of Prochazka reads on the motion sensor comprises one or more multi-axis accelerometers (Greenberg fig. 2, x,y,z axis analog accelerometers 202).
Regarding claim 12, the modified device of Prochazka reads on the limitations of claim 10 and further reads on the vibrotactile stimulation comprises vibration applied to the wrist of the subject (Prochazka fig. 12, electrodes 123 and 124 are placed on the wrist of the subject, Cordo fig. 1, shows vibrator actuator 20 also on the wrist of the subject) sufficient to stimulate at least the one or more proprioceptors (Cordo [0019] to provide proprioceptive input from the vibrated muscle to activate sensory areas of the patient’s central nervous system), and wherein the one or more proprioceptors comprise pressure receptors (Cordo [0019] vibration on the muscle will be received by the patient’s pressure receptors).
Regarding claim 13, the modified device of Prochazka reads on the limitations of claim 10 and further reads on the processor is configured to execute one or more algorithms stored in memory of the wearable device (Prochazka col. 3, lines 53-60 states that after putting the device on, pre-stored programs of cyclical stimulation can be selected).
Regarding claim 15, the modified device of Prochazka reads on the limitations of claim 10 and further reads on the one or more parameters of the vibrotactile stimulation comprise a frequency (Prochazka col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle, and col. 3, lines 56-60 states that the sensor is to set stimulus parameters of the selected programs, which would include the frequency of the tremor if the out-of-phase sections of each tremor cycle is when stimulus is provided).
Regarding claim 16, the modified device of Prochazka reads on the limitations of claim 10 and further reads on wherein the one or more parameters of the vibrotactile stimulation comprise a phase (Prochazka col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle meaning the phase of the tremor cycle is known).
Regarding claim 17, the modified device of Prochazka reads on the limitations of claim 10 and further reads on the one or more mechanical effectors comprise one or more vibrotactile units (Cordo fig. 1, vibrator actuator 20 imparts a localized vibration, see [0019]).
Regarding claim 18, the modified device of Prochazka reads on the limitations of claim 10 and further reads on the electronic circuit being battery-powered (Prochazka col. 2, lines 26-27), but does not expressly state that the device comprises a rechargeable battery.
However, Cordo teaches of a wearable maintenance therapy device that imparts vibratory stimuli to reduce symptomatic relapse of spasticity (abstract) that includes a rechargeable battery (fig. 1, 44).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Prochazka with the rechargeable battery as taught by Cordo to power the electronic circuity of Prochazka (Prochazka col. 2, lines 26-27).
Regarding claim 19, the modified device of Prochazka reads on the limitations of claim 10 and further reads on the one or more parameters of the vibrotactile stimulation (Prochazka col. 8, lines 52-56 state that the microcontroller provides the pulse train for activating the electrodes, and col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle) are configured to stimulate the one or more nerves or proprioceptors sufficient to reduce the tremor of the subject (Cordo [0029] gives an example use of the device which uses the vibrator actuator to apply a vibration therapy that reduces essential tremor in the patient’s hand).
Regarding claim 20, the modified device of Prochazka reads on the limitations of claim 19 and further reads on the tremor is a hand tremor (Cordo [0029] states that an example use of the device with a vibrational actuator is for ablating the hand tremor of the patient, and Prochazka col. 1, lines 7-13 states the device is intended to be used for restoring motor functions in people with a hand tremor).
6. Claim(s) 2, 5-7, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prochazka in view of Cordo and Greenberg as applied to claim 1 and 10 above, and further in view of DiLorenzo (US 7,231,254).
Regarding claim 2, the modified device of Prochazka reads on the limitations of claim 1 and further reads on the device allowing adjustment of vibrotactile stimulation amplitude (col. 8, lines 23-26 states user movements can be used to adjust stimulus intensity) and the one or more motion sensors further comprise one or more gyroscopes (Greenberg fig. 2, sensor module 200 includes gyroscopes 203), but does not expressly read on the processor is configured to adjust the one or more stimulation parameters in a closed loop.
However, DiLorenzo also teaches of a closed-loop control method where adjustments are made after observing previous stimulation parameters and the patient’s response to therapy to adjust pulse width, amplitude, and frequency (col. 15, lines 32-47).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the microprocessor of Prochazka with the program for adjusting stimulation parameters as taught by DiLorenzo to provide real-time optimal control of disease state (DiLorenzo col. 16 lines 60-67 and col. 17, lines 1-6).
Regarding claim 5, the modified device of Prochazka reads on the limitations of claim 1, and further reads on adjusting the stimulation parameters (Prochazka col. 3, lines 58-60), but does not expressly disclose the processor is configured to operate in a closed- loop control manner to optimize the one or more stimulation parameters.
However, DiLorenzo teaches of a neurological control system where the sensed tremor characteristics include magnitude, frequency, duration, and frequency of occurrence where any changes cause changes in treatment parameters (col. 16, lines 60-67) using a closed-loop control method where adjustments are made after observing previous stimulation parameters and the patient’s response to therapy to adjust pulse width, amplitude, and frequency (col. 15, lines 32-47).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the microprocessor of Prochazka with the program for adjusting stimulation parameters as taught by DiLorenzo to provide real-time optimal control of disease state (DiLorenzo col. 16 lines 60-67 and col. 17, lines 1-6).
Regarding claim 6, the modified device of Prochazka reads on the limitations of claim 1, and further reads on adjusting the stimulus strength (Prochazka col. 3, lines 58-60) and other parameters such as pulse parameters (col. 6, lines 60-61), but does not expressly disclose that the one or more stimulation parameters of the vibrotactile stimulation comprise a frequency.
However, DiLorenzo teaches of a neurological control system where the sensed tremor characteristics include magnitude, frequency, duration, and frequency of occurrence where any changes cause changes in treatment parameters (col. 16, lines 60-67) using a closed-loop control method where adjustments are made after observing previous stimulation parameters and the patient’s response to therapy to adjust pulse width, amplitude, and frequency (col. 15, lines 32-47).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the microprocessor of Prochazka with the program for adjusting stimulation parameters as taught by DiLorenzo to provide real-time optimal control of disease state (DiLorenzo col. 16 lines 60-67 and col. 17, lines 1-6).
Regarding claim 7, the modified device of Prochazka reads on the limitations of claim 6 and further reads on the one or more stimulation parameters of the vibrotactile stimulation comprise a phase (Prochazka col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle, and DiLorenzo col. 15, lines 32-47 states interpulse interval can be adjusted, meaning the stimulus phase can be adjusted to align with the out-of-phase portion of the tremor).
Regarding claim 11, the modified device of Prochazka reads on the limitations of claim 10 and further reads on the one or more parameters of the vibrotactile stimulation comprise a frequency (Prochazka col. 9, lines 20-24 states that muscles are stimulated out-of-phase with each tremor cycle, and col. 3, lines 56-60 states that the sensor is to set stimulus parameters of the selected programs, which would include the frequency of the tremor if the out-of-phase sections of each tremor cycle is when stimulus is provided) and the one or more motion sensors further comprise one or more gyroscopes (Greenberg fig. 2, sensor module 200 includes gyroscopes 203), but does not expressly read on the processor is configured to adjust the one or more stimulation parameters in a closed loop.
However, DiLorenzo also teaches of a closed-loop control method where adjustments are made after observing previous stimulation parameters and the patient’s response to therapy to adjust pulse width, amplitude, and frequency (col. 15, lines 32-47).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the microprocessor of Prochazka with the program for adjusting stimulation parameters as taught by DiLorenzo to provide real-time optimal control of disease state (DiLorenzo col. 16 lines 60-67 and col. 17, lines 1-6).
Regarding claim 14, the modified device of Prochazka reads on the limitations of claim 10, and further reads on adjusting the stimulation parameters (Prochazka col. 3, lines 58-60), but does not expressly disclose the processor is configured to operate in a closed- loop control manner to optimize the one or more parameters.
However, DiLorenzo teaches of a neurological control system where the sensed tremor characteristics include magnitude, frequency, duration, and frequency of occurrence where any changes cause changes in treatment parameters (col. 16, lines 60-67) using a closed-loop control method where adjustments are made after observing previous stimulation parameters and the patient’s response to therapy to adjust pulse width, amplitude, and frequency (col. 15, lines 32-47).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the microprocessor of Prochazka with the program for adjusting stimulation parameters as taught by DiLorenzo to provide real-time optimal control of disease state (DiLorenzo col. 16 lines 60-67 and col. 17, lines 1-6).
Response to Arguments
7. Applicant's arguments filed 07/20/2026 have been fully considered but they are not persuasive.
Applicant argues, see “Remarks” page 5 paragraph 6 through page 6 paragraphs 1-2 regarding claims 2, 5-7, 11, and 14 that DiLorenzo (col. 12, lines 42-44) does not disclose that the motion sensors are configured to be positioned on a hand or wrist of the subject. However, DiLorenzo was relied on previously to illustrate that accelerometers could be used similarly to the wrist position sensor of Prochazka (fig. 1, 14). Prochazka already disclosed the sensor being positioned at the wrist of the user to characterize a patient’s tremor (Prochazka col. 2, lines 28-31).
Conclusion
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Partin et al. (US 2010/0056878) discloses a method for obtaining data representative of a physiological parameter (such as tremor) which uses inertial sensors integrated with a mobile telephonic device which may be a multi-axis accelerometer and/or a gyroscope.
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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