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 .
Status of Claims
2. Claims 1-20 are pending and currently under consideration for patentability under 37 CFR 1.104.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-10 and 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9, line 1 recites “the multichannel waveform” which lacks antecedent basis. It appears that claim 9 should potentially depend from claim 8.
Claim 10, line 5 recites “the extraneous movement” which lacks antecedent basis.
Claim 19, line 1 recites “The wearable device of claim 18” which is confusing because claim 18 is a method claim. Examiner suggests --The method of claim 18--.
Claim 20, the last two lines recite “the extraneous movement” which lacks antecedent basis.
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.
Claim(s) 1-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moaddeb et al. (2021/0330547).
Regarding claim 1, Moaddeb discloses a wearable device for vibratory stimulation (wearable tremor control system 100, Fig. 8), comprising:
a sensor (sensing elements 132, 134, Fig. 8) configured to receive data (configured to sense physiological signals indicative of tremor, see lines 8-14 of [0040]) and generate sensor output (“signals are received from one or more of the sensing elements 132, 134 that are in a range that is indicative to active tremor” see para. [0040]);
a processor (circuit board 190 with controller 192, Fig. 15) in communication with the sensor (“controller 192 and/or the App 189 may be configured (via software or firmware) to receive one or more signals from the sensing elements 132, 134, and to automatically adjust the vibration mode, either turning it on or off, or adjusting it between low, medium, and high vibration” see [0047]);
a memory (memory unit 197, Fig. 15; see App 189, Fig. 18, which comprises “a computer program embodied in a non-transitory computer readable medium” see lines 30-32 of [0046]) communicatively connected to the processor (“memory unit 197 which is configured to store data, such as patient data, calibration data, treatment programs, treatment data, … and measurement algorithms” see lines 19-24 of [0046]; see also the App 189, Fig. 18, that “allows the users to control and modify the operation of the wearable tremor control system. The application may comprise a computer program embodied in a non-transitory computer readable medium, that when executing on one or more computers … provides one or more operation instructions to the wearable tremor control system 100” see para. [0046]), the memory containing instructions configuring the processor to:
receive the sensor output (“controller 192 and/or the App 189 may be configured (via software or firmware) to receive one or more signals from the sensing elements 132, 134” see lines 12-15 of [0047]);
determine a symptom of a movement disorder of a user based on the sensor output (tremor frequency, “a derived function of the dominant tremor frequency that is measured or calculated by the sensing elements 132, 134” see the last sentence of [0047]);
calculate a waveform output based on the symptom of the movement disorder (the vibration waveform is calculated as a derived function of the dominant tremor frequency, “vibration elements 136, 138 may be configured to operate at a derived function of the dominant tremor frequency that is measured or calculated by the sensing elements 132, 134” see the last sentence of [0047]); and
command a transducer (the vibration element(s) 136, 138, Fig. 15) in communication with the processor to apply the waveform output (the vibration(s)) to the user to reduce the symptom of the movement disorder (“the vibration elements 136, 138 are caused to activate in a manner which is proportional to or matches in some way the reduction or increase in amplitude, intensity and/or prevalence of tremor.” See lines 17-22 of [0047]. The vibration operates at frequencies between 1-30 Hz which “can be very effective at dampening the shaking of a patient’s limb … configured to abate or completely stop the shaking caused by one or more forms of tremor” see lines 18-24 of [0040]).
Regarding claim 2, Moaddeb discloses wherein the symptom of a movement disorder is one of stiffness, rigidity, freezing, paralysis, paresis, dyskinesia, or a combination thereof (the symptom is a tremor frequency, and a tremor is an involuntary movement, i.e., dyskinesia).
Regarding claim 3, Moaddeb discloses wherein the transducer is further configured to apply the waveform output (vibration output) to a proprioceptive nerve of the user (configured to apply vibrations to the wrist/forearm area of the user as seen in Fig. 5. There are a plurality of proprioceptive nerves in this area).
Regarding claim 4, Moaddeb discloses wherein the proprioceptive nerve is in a proprioceptive tissue of one of flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, or a combination thereof (these tissues are generally in the forearm and wrist area, which is where the vibration is applied as seen in Fig. 5).
Regarding claim 5, Moaddeb discloses wherein the transducer is positioned to apply the waveform output (vibration) to one of a C5, C6, C7, C8, or T1 dermatomes (the wrist area, such as in Fig. 5, corresponds to dermatomes C7, C8).
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.
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb et al. (2021/0330547) in view of Rosenbluth et al. (2019/0001129).
Regarding claim 6, Moaddeb is silent regarding wherein the processor is further configured to determine extraneous movement of the user by processing the sensor output to remove noise unrelated to the extraneous movement of the user.
Rosenbluth teaches a related multi-modal stimulation device for treating tremor (Fig. 1, see Title) including a processor (processor 797, Fig. 7A) and sensor (sensor 780, Fig. 7A). The processor is configured to determine extraneous movement of the user by processing the sensor output to remove noise unrelated to the extraneous movement of the user (“The algorithm will extract motion data in the 4 to 12 Hz range to remove motions that are not attributable to the tremor. This may be done using any combination of notch filters, low pass filters, weighted-frequency Fourier linear combiners, or wavelet filters. As each patient has a dominant frequency, this range may be narrowed based on specific knowledge of the patient's tremor or tremor history” see para. [0196]). Thus, the processor extracts information about tremors from the stream of movement data provided by the sensors (see para. [0195], [0197]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Moaddeb to be configured to determine extraneous movement of the user by processing the sensor output to remove noise unrelated to the extraneous movement of the user as taught by Rosenbluth, so information about the tremor can be extracted and thus distinguished from sensed motions that are not attributable to the tremor.
Regarding claim 7, the modified Moaddeb/Rosenbluth device discloses wherein the processor is further configured to: calculate a frequency of the waveform output that reduces an amplitude of the extraneous movement (the vibration waveform is calculated as a derived function of the dominant tremor frequency, “vibration elements 136, 138 may be configured to operate at a derived function of the dominant tremor frequency that is measured or calculated by the sensing elements 132, 134” see the last sentence of [0047] of Moaddeb. The vibration is intended to reduce tremor, which will reduce an amplitude of the tremor); and apply the frequency of the waveform output to reduce the amplitude of the extraneous movement (the vibration elements 136, 138 are caused to activate in a manner which is proportional to or matches in some way the reduction or increase in amplitude, intensity and/or prevalence of tremor.” See lines 17-22 of [0047] of Moaddeb. The vibration operates at frequencies between 1-30 Hz which “can be very effective at dampening the shaking of a patient’s limb … configured to abate or completely stop the shaking caused by one or more forms of tremor” see lines 18-24 of [0040] of Moaddeb).
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb et al. (2021/0330547) in view of Tass (2021/0401664).
Regarding claim 8, Moaddeb is silent regarding wherein the processor is further configured to generate a multichannel waveform output and apply the multichannel waveform output to the user through the transducer.
Tass teaches a related wearable vibrotactile stimulation device (Fig. 12A, Figs. 15-16) for treating brain disorders (treatment of Parkinson’s and movement disorders such as essential tremor and dystonia, see para. [0007]). Tass includes a processor (controller 10, Figs. 15-16) configured to generate a multichannel waveform output and apply the multichannel waveform output to the user (“Burst-like vibrotactile multi-channel stimulation with both high-frequency and low-frequency vibratory bursts can be delivered via 3 or more channels (e.g., fingertips).” See the last two sentences of [0070]) through one or more transducers (vibratory stimulators 11-14, Figs. 15-16). The multichannel stimulation helps “disrupt abnormal neuronal synchrony” to provide long-lasting relief of symptoms (see all of para. [0005]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and transducer of Moaddeb to be further configured to generate a multichannel waveform output and apply the multichannel output to the user through the transducer as taught by Tass because the multi-channel stimulation helps disrupt abnormal neuronal synchrony, which is beneficial in providing long-lasting relief of symptoms related to brain and/or movement disorders.
Regarding claim 9, Moaddeb is silent regarding wherein each channel of the multichannel waveform is calculated to target specific proprioceptive channels of the user.
Tass teaches a related wearable vibrotactile stimulation device (Fig. 12A, Figs. 15-16) for treating brain disorders (treatment of Parkinson’s and movement disorders such as essential tremor and dystonia, see para. [0007]). Tass includes a processor (controller 10, Figs. 15-16) configured to generate a multichannel waveform output and apply the multichannel waveform output to the user (“Burst-like vibrotactile multi-channel stimulation with both high-frequency and low-frequency vibratory bursts can be delivered via 3 or more channels (e.g., fingertips).” See the last two sentences of [0070]) through one or more transducers (vibratory stimulators 11-14, Figs. 15-16). The multichannel stimulation helps “disrupt abnormal neuronal synchrony” to provide long-lasting relief of symptoms (see all of para. [0005]). Each channel of the multichannel waveform will target specific proprioceptive channels based upon where the transducer(s) are located.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and transducer of Moaddeb to be further configured to generate a multichannel waveform output and apply the multichannel output to the user through the transducer, with each channel calculated to target specific proprioceptive channels of the user as taught by Tass because the multi-channel stimulation helps disrupt abnormal neuronal synchrony, which is beneficial in providing long-lasting relief of symptoms related to brain and/or movement disorders.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb et al. (2021/0330547) in view of Heldman et al. (2014/0074179).
Regarding claim 10, Moaddeb discloses that stimulation parameters including frequency may be adjusted (“Parameters that may be adjusted, randomly, or non-randomly, by the controller 192 include: time of application of energy (mechanical, electrical, etc.), length of interval of time between application of energy, number of repetitions of application of energy, particular operational frequency of a non-static mode of energy (e.g., applying ultrasound at varying pulse rates), amplitude of the applied energy, timing of particular combinations of more than one element of a particular type of energy, or of two or more different types of energy. Any of these parameters can be increased or decreased.” see [0059]), but is silent regarding wherein the processor is further configured to provide a train of waveform outputs through the transducer, wherein each waveform output of the train of waveform outputs has a frequency greater than a previous waveform output until the waveform output reaches a frequency with an output-to-input ratio that results in a suppressed output of the extraneous movement.
Heldman teaches a related wearable device for movement disorder therapy (Fig. 1), wherein the processor (“micro-controller or processor” described in para. [0086]) configured to provide a train (series) of waveform outputs through a transducer (electrical stimulation electrodes, such as for deep brain stimulation, see para. [0005]), wherein each waveform output of the train of waveform outputs has a frequency greater than a previous waveform output until the waveform output reaches a frequency with an output-to-input ratio that results in a suppressed output of the extraneous movement (see the trained tuning algorithm in Fig. 16, there is an initial set of stimulation parameters 200 that are increased incrementally at 202, and then it is determined whether there are any side effects 204 or if symptoms improve 206, and the parameters continue to increase until they reach their maximum setting or until symptoms are not improving. See para. [0190]: “If, however, the depicted algorithm determines that a) the subject's symptoms did improve under the provided therapy parameters or settings 206; b) symptoms did not improve and fewer than eight parameters/settings or groups thereof have been tested 214; or c) at least eight parameters/settings or group have been tested, but there has been some improvement within the last four iterations 216, then the algorithm next determines whether the therapy parameters or settings are being provided at a maximum value for one of those parameters or settings 208--in the depicted case pulse amplitude. Pre-determined parameter or settings limits may be defined to keep the therapy device operating within safe limits in order to protect the subject. If the specific parameter or setting that is being tested (in the depicted case, pulse amplitude) has not reached its maximum value, then the algorithm may again increase the value of that parameter or setting 202 and repeat the process. If the maximum value has already been reached for the particular parameter or setting, then that variable cannot be increased any further, and the algorithm determines whether another individual parameter or setting is at its maximum level 210--in the depicted case frequency. If the frequency has not reached its maximum value yet, then the algorithm reduces the amplitude to zero, increases the frequency 220 and then again begins the iterative process by initially increasing the amplitude 202 to provide therapy to the subject at the new levels of parameters or settings” and see para. [0191]: “This decision process is repeated by the intelligent algorithm until it determines that the best combination of contact(s) and parameters or settings has been achieved, resulting in an optimized therapy that takes into account the subject's side effects, symptoms, and/or other constraints”). Although Heldman is adjusting a parameter (frequency) of deep brain stimulation, one of ordinary skill in the art would have recognized that this guess-and-check type of optimization algorithm would be equally applicable to other stimulation modalities, including vibration frequency. Based upon Moaddeb, the symptom that would be intended to be reduced is the tremor frequency and/or amplitude.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Moaddeb to provide a train of waveform outputs through the transducer, wherein each waveform output of the train of waveform outputs has a frequency greater than a previous waveform output until the waveform output reaches a frequency with an output-to-input ratio that results in a suppressed output of the extraneous movement as generally taught by Heldman because this algorithm helps determine the particular stimulation parameters that are best suited to reduce symptoms while taking into account possible side effects.
Claim(s) 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb et al. (2021/0330547) in view of Ross et al. (2021/0402172).
Regarding claim 11, Moaddeb discloses a method of reducing symptoms of a movement disorder through a wearable device (wearable tremor control system 100, Fig. 8), comprising:
receiving, through a sensor of a wearable device (sensing elements 132, 134, Fig. 8), data of a user (configured to sense physiological signals indicative of tremor, see lines 8-14 of [0040]);
generating sensor output based on the data of the user (“signals are received from one or more of the sensing elements 132, 134 that are in a range that is indicative to active tremor” see para. [0040]);
communicating the sensor output to a processor (circuit board 190 with controller 192, Fig. 15; “controller 192 and/or the App 189 may be configured (via software or firmware) to receive one or more signals from the sensing elements 132, 134, and to automatically adjust the vibration mode, either turning it on or off, or adjusting it between low, medium, and high vibration” see [0047]) of the wearable device (100, Fig. 15);
determining, at the processor, a symptom of a movement disorder based on the sensor output (tremor frequency, “a derived function of the dominant tremor frequency that is measured or calculated by the sensing elements 132, 134” see the last sentence of [0047]. The sensor data is communicated to the processor, see para. [0040]);
calculating, at the processor (“controller 192 and/or the App 189 may be configured (via software or firmware) to receive one or more signals from the sensing elements 132, 134, and to automatically adjust the vibration mode, either turning it on or off, or adjusting it between low, medium, and high vibration” see [0047]), a waveform output (vibration waveform) based on the symptom of the movement disorder (the vibration waveform is calculated as a derived function of the dominant tremor frequency, “vibration elements 136, 138 may be configured to operate at a derived function of the dominant tremor frequency that is measured or calculated by the sensing elements 132, 134” see the last sentence of [0047]); and
commanding a transducer (the vibration element(s) 136, 138, Fig. 15) in communication with the processor to apply the waveform output (the vibration(s)) to the user (“the vibration elements 136, 138 are caused to activate in a manner which is proportional to or matches in some way the reduction or increase in amplitude, intensity and/or prevalence of tremor.” See lines 17-22 of [0047]).
Moaddeb does not specifically state the symptom of the movement disorder is determined at the processor. However, utilizing a processor to evaluate sensor output is well known in the art.
For example, Ross teaches a related wearable tremor treatment device (neurostimulation device 100, Fig. 1A; see also Fig. 1C) including a processor (hardware processor(s) 108, Fig. 1A), a sensor (sensor(s) 112, Fig. 1A, which may include an inertial measurement unit see the last sentence of [0068]) generating sensor output (“IMU can generate data from its sensors responsive to motion, movement, or vibration felt by the device … enable detection of voluntary and/or involuntary motion of the user” see the last two sentences of [0069]), and a transducer (electrode(s) 102 and stimulation circuitry 104, Fig. 1A; “the stimulation signals other than electric stimulation signals are vibrational stimulation signals” see para. [0011]). The system determines, at the processor, a symptom of a movement disorder (a tremor frequency) based on the sensor output (“one or more hardware processors can receive raw signals in time domain from the one or more sensors. The one or more hardware processors can separate the raw signals into a plurality of frames. In some instances, for each of the plurality of frames, the one or more hardware processors can execute one or more of the following operations: transform the raw signals into a frequency domain; calculate a first energy in a first frequency band of the transformed signal for a respective frame; calculate a second energy in a second frequency band of the transformed signal for the respective frame, wherein the second frequency band includes a first frequency corresponding to a tremor” see para. [0020]). Thus, the processor determines a tremor frequency based on the sensor output and one of ordinary skill in the art would recognize that making this determination at a central processor is a suitable equivalent to determining tremor frequency at the sensor itself, and provides advantages in that the sensor may merely be an off the shelf IMU sensor (“the IMU is an off the shelf component” see lines 4-5 of [0069]) rather than a specialized sensor that determines a tremor frequency.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor and processor of Moaddeb to have the sensor be an IMU and have the processor perform the step of determining the symptom of the movement disorder (i.e., the tremor frequency) as taught by Ross because having the central processor make this determination is a suitable equivalent to determining tremor frequency at the sensor itself, and provides advantages in that the sensor may merely be an off the shelf IMU sensor (“the IMU is an off the shelf component” see lines 4-5 of [0069]) rather than a specialized sensor that determines a tremor frequency.
Regarding claim 12, the modified Moaddeb/Ross method discloses wherein the symptom of a movement disorder is one of stiffness, rigidity, freezing, paralysis, paresis, dyskinesia, or a combination thereof (the symptom is a tremor frequency, and a tremor is an involuntary movement, i.e., dyskinesia).
Regarding claim 13, the modified Moaddeb/Ross method discloses further comprising applying the waveform output (vibration output) to a proprioceptive nerve of the user (configured to apply vibrations to the wrist/forearm area of the user as seen in Fig. 5 of Moaddeb. There are a plurality of proprioceptive nerves in this area).
Regarding claim 14, the modified Moaddeb/Ross method discloses wherein the proprioceptive nerve is in a proprioceptive tissue of one of flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, or a combination thereof (these tissues are generally in the forearm and wrist area, which is where the vibration is applied as seen in Fig. 5 of Moaddeb).
Regarding claim 15, the modified Moaddeb/Ross method discloses wherein the transducer is positioned within the wearable device to apply the waveform output (vibration) to one of a C5, C6, C7, C8, or T1 dermatomes (the wrist area, such as in Fig. 5 of Moaddeb, corresponds to dermatomes C7, C8).
Claim(s) 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb et al. (2021/0330547) in view of Ross et al. (2021/0402172) as applied to claim 11 above, and further in view of Rosenbluth et al. (2019/0001129).
Regarding claim 16, the modified Moaddeb/Ross method is silent regarding determining, by the processor, extraneous movement of the user by processing the sensor output to remove noise unrelated to the extraneous movement of the user.
Rosenbluth teaches a related multi-modal stimulation device for treating tremor (Fig. 1, see Title) including a processor (processor 797, Fig. 7A) and sensor (sensor 780, Fig. 7A). The processor is configured to determine extraneous movement of the user by processing the sensor output to remove noise unrelated to the extraneous movement of the user (“The algorithm will extract motion data in the 4 to 12 Hz range to remove motions that are not attributable to the tremor. This may be done using any combination of notch filters, low pass filters, weighted-frequency Fourier linear combiners, or wavelet filters. As each patient has a dominant frequency, this range may be narrowed based on specific knowledge of the patient's tremor or tremor history” see para. [0196]). Thus, the processor extracts information about tremors from the stream of movement data provided by the sensors (see para. [0195], [0197]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Moaddeb/Ross to be configured to determine extraneous movement of the user by processing the sensor output to remove noise unrelated to the extraneous movement of the user as taught by Rosenbluth, so information about the tremor can be extracted and thus distinguished from sensed motions that are not attributable to the tremor.
Regarding claim 17, the modified Moaddeb/Ross/Rosenbluth method discloses wherein the processor is further configured to: calculate a frequency of the waveform output that reduces an amplitude of the extraneous movement (the vibration waveform is calculated as a derived function of the dominant tremor frequency, “vibration elements 136, 138 may be configured to operate at a derived function of the dominant tremor frequency that is measured or calculated by the sensing elements 132, 134” see the last sentence of [0047] of Moaddeb. The vibration is intended to reduce tremor, which will reduce an amplitude of the tremor); and apply the frequency of the waveform output to reduce the amplitude of the extraneous movement (the vibration elements 136, 138 are caused to activate in a manner which is proportional to or matches in some way the reduction or increase in amplitude, intensity and/or prevalence of tremor.” See lines 17-22 of [0047] of Moaddeb. The vibration operates at frequencies between 1-30 Hz which “can be very effective at dampening the shaking of a patient’s limb … configured to abate or completely stop the shaking caused by one or more forms of tremor” see lines 18-24 of [0040] of Moaddeb).
Claim(s) 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb et al. (2021/0330547) in view of Ross et al. (2021/0402172) as applied to claim 11 above, and further in view of Tass (2021/0401664).
Regarding claim 18, the modified Moaddeb/Ross method is silent regarding further comprising: generating, by the processor, a multichannel waveform; and applying the multichannel waveform output to the user through the transducer.
Tass teaches a related wearable vibrotactile stimulation device (Fig. 12A, Figs. 15-16) for treating brain disorders (treatment of Parkinson’s and movement disorders such as essential tremor and dystonia, see para. [0007]). Tass includes a processor (controller 10, Figs. 15-16) configured to generate a multichannel waveform output and apply the multichannel waveform output to the user (“Burst-like vibrotactile multi-channel stimulation with both high-frequency and low-frequency vibratory bursts can be delivered via 3 or more channels (e.g., fingertips).” See the last two sentences of [0070]) through one or more transducers (vibratory stimulators 11-14, Figs. 15-16). The multichannel stimulation helps “disrupt abnormal neuronal synchrony” to provide long-lasting relief of symptoms (see all of para. [0005]).
Regarding claim 19, the modified Moaddeb/Ross/Tass method discloses wherein generating the multichannel waveform comprises generating a plurality of channels of waveform (for the plurality of transducers, see Figs. 15-16 of Tass), where each channel of the multichannel waveform is calculated to target specific proprioceptive channels of the user (Each channel of the multichannel waveform will target specific proprioceptive channels based upon where the transducer(s) are located).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb et al. (2021/0330547) in view of Ross et al. (2021/0402172) as applied to claim 11 above, and further in view of Heldman et al. (2014/0074179).
Regarding claim 20, Moaddeb discloses that stimulation parameters including frequency may be adjusted (“Parameters that may be adjusted, randomly, or non-randomly, by the controller 192 include: time of application of energy (mechanical, electrical, etc.), length of interval of time between application of energy, number of repetitions of application of energy, particular operational frequency of a non-static mode of energy (e.g., applying ultrasound at varying pulse rates), amplitude of the applied energy, timing of particular combinations of more than one element of a particular type of energy, or of two or more different types of energy. Any of these parameters can be increased or decreased.” see [0059]), but is silent regarding providing, through the transducer, a train of waveform outputs, wherein each waveform output of the train of waveform outputs has a frequency greater than a previous waveform output until the waveform output reaches a frequency with an output-to-input ratio that results in a suppressed output of the extraneous movement.
Heldman teaches a related wearable device for movement disorder therapy (Fig. 1), wherein the processor (“micro-controller or processor” described in para. [0086]) configured to provide a train (series) of waveform outputs through a transducer (electrical stimulation electrodes, such as for deep brain stimulation, see para. [0005]), wherein each waveform output of the train of waveform outputs has a frequency greater than a previous waveform output until the waveform output reaches a frequency with an output-to-input ratio that results in a suppressed output of the extraneous movement (see the trained tuning algorithm in Fig. 16, there is an initial set of stimulation parameters 200 that are increased incrementally at 202, and then it is determined whether there are any side effects 204 or if symptoms improve 206, and the parameters continue to increase until they reach their maximum setting or until symptoms are not improving. See para. [0190]: “If, however, the depicted algorithm determines that a) the subject's symptoms did improve under the provided therapy parameters or settings 206; b) symptoms did not improve and fewer than eight parameters/settings or groups thereof have been tested 214; or c) at least eight parameters/settings or group have been tested, but there has been some improvement within the last four iterations 216, then the algorithm next determines whether the therapy parameters or settings are being provided at a maximum value for one of those parameters or settings 208--in the depicted case pulse amplitude. Pre-determined parameter or settings limits may be defined to keep the therapy device operating within safe limits in order to protect the subject. If the specific parameter or setting that is being tested (in the depicted case, pulse amplitude) has not reached its maximum value, then the algorithm may again increase the value of that parameter or setting 202 and repeat the process. If the maximum value has already been reached for the particular parameter or setting, then that variable cannot be increased any further, and the algorithm determines whether another individual parameter or setting is at its maximum level 210--in the depicted case frequency. If the frequency has not reached its maximum value yet, then the algorithm reduces the amplitude to zero, increases the frequency 220 and then again begins the iterative process by initially increasing the amplitude 202 to provide therapy to the subject at the new levels of parameters or settings” and see para. [0191]: “This decision process is repeated by the intelligent algorithm until it determines that the best combination of contact(s) and parameters or settings has been achieved, resulting in an optimized therapy that takes into account the subject's side effects, symptoms, and/or other constraints”). Although Heldman is adjusting a parameter (frequency) of deep brain stimulation, one of ordinary skill in the art would have recognized that this guess-and-check type of optimization algorithm would be equally applicable to other stimulation modalities, including vibration frequency. Based upon Moaddeb, the symptom that would be intended to be reduced is the tremor frequency and/or amplitude.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Moaddeb to provide a train of waveform outputs through the transducer, wherein each waveform output of the train of waveform outputs has a frequency greater than a previous waveform output until the waveform output reaches a frequency with an output-to-input ratio that results in a suppressed output of the extraneous movement as generally taught by Heldman because this algorithm helps determine the particular stimulation parameters that are best suited to reduce symptoms while taking into account possible side effects.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Giuffrida et al. (2014/0005743, 9,877,680, and 12,263,009) discloses a related wearable treatment device for a movement disorder. Jung (2022/0296894) discloses a related wearable treatment device for a movement disorder, providing vibratory stimulation. Khaled (2021/0244316) discloses a related wearable treatment device for a movement disorder that has a tremor analysis module to determine the frequency and magnitude of the tremors. Harper et al. (2022/0211319) discloses a related vibratory stimulation device for treating movement disorders. Maloney et al. (2018/0000685) discloses a related wearable treatment device for a movement disorder. Sifferlin (2019/0183724) discloses a related wearable treatment device for a movement disorder, applying vibratory stimulation. Pracar et al. (2015/0073310) discloses a related wearable treatment device for a movement disorder, with sensors to determine tremor intensity, and filtration to isolate tremor motion. Powers III et al. (2019/0365286) discloses a related wearable tremor sensing device that filters the signal to isolate tremor motion. Zhang et al. (2018/0356890) discloses a related wearable treatment device for a movement disorder, with sensors for determining involuntary movement of the user. Denison et al. (2009/0082691) discloses a related tremor sensing device that filters the signal to be manually tuned to the patient’s tremor frequency. Choi et al. (2023/0123383) discloses a related neurostimulation device that uses filtering to isolate tremor frequencies around 5 Hz. Zilm et al. (4,306,291) discloses a related tremor measurement device that filters out non-tremor-associated motion. Gesotti (7,369,896) discloses a related system for treating movement disorders, using multi-channel electrical or vibratory stimulation. Brokaw et al. (9,974,478) discloses a related wearable treatment device for treating a movement disorder, where the subject wears accelerometers, the sensor signal is filtered to distinguish movement types, and provides a vibratory stimulus. Wong et al. (9,802,041) discloses a related wearable treatment device for a movement disorder, including filtration of a sensor signal to distinguish tremor frequency. Giuffrida et al.
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