DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements filed on 08/14/2024 have been received and fully considered.
Claim Objections
Claims 11 and 13 are objected to because of the following informalities:
Claim 11 line 4 “processing unit,;” should be corrected to “processing unit[[,]];” for the sake of proper punctuation.
Claim 13 line 1 “further comprising quantify” should be corrected to “further comprising quantifying” for the sake of clarity.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-2 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,839,583 (hereinafter “ ‘583 “).
Regarding claim 1, ‘583 discloses a wearable device for mitigating a movement disorder of a subject, the device comprising: a sensor configured to be attached to the subject and to provide a sensor output; a processing unit operationally coupled to the sensor and configured to quantify the sensor output; and an actuator configured to be attached to the subject and operationally coupled to the processing unit, wherein the actuator is configured to stimulate proprioceptive nerves of the subject; wherein the processing unit is further configured, as part of a feedback loop including the sensor, the actuator, and the subject, to adjust parameters of an output of the actuator in a manner to reduce symptoms of the movement disorder as measured by the sensor (Claim 1).
Regarding claim 2, claim 1 of ‘583 discloses the wearable device of claim 1, and ‘583 further discloses wherein the sensor output is related to involuntary movement of a body part attributable to a movement disorder of the subject (Claim 2).
Regarding claim 6, claim 1 of ‘583 discloses the wearable device of claim 1, and ‘583 further discloses wherein the processing unit is further configured to, as part of the feedback loop, generate new stimulation parameters through a stimulation selection algorithm (Claim 1).
Claims 4 and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘583 in view of US20210330547A1 to Moaddeb et al. (hereinafter “Moaddeb”).
Regarding claims 4 and 8-10, ‘583 discloses the wearable device of claim 1, but ‘583 does not disclose wherein the actuator is a vibration motor and is further configured to output a stimulation waveform to the proprioceptive nerves of the subject, wherein the actuator is an ultrasonic emitter, wherein the ultrasonic emitter is configured to produce sound waves that stimulate the proprioceptive nerves of the subject, and wherein the ultrasonic emitter is configured to generate an ultrasonic wave having a frequency of about 1 MHz. However, Moaddeb teaches a wearable tremor reduction system which teaches all of the above bolded limitations (Fig. 8 vibration elements 136, 138; Paragraph 0040 discloses the vibration elements deliver vibration to the user’s arm to counteract tremors; Examiner notes that the proprioceptive nerves are stimulated via mechanical vibrations applied to the skin of the user; Examiner further notes the vibration stimulation inherently is outputted as a stimulation waveform; Paragraph 0054 discloses the at least one vibration element may be an ultrasound transducer; Paragraph 0054 discloses the at least one vibration element may be an ultrasound transducer; Examiner notes an ultrasonic transducer inherently performs the function of converting electrical energy into high-frequency sound waves; Paragraph 0054 discloses the ultrasound transducer may vibrate at a frequency of 15kHz to about 1MHz).
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 wearable device of claim 1 of ‘583 to include a vibration motor to output stimulation waveform to the proprioceptive nerves of the subject, wherein the actuator is an ultrasonic emitter, wherein the ultrasonic emitter is configured to produce sound waves that stimulate the proprioceptive nerves of the subject, and wherein the ultrasonic emitter is configured to generate an ultrasonic wave having a frequency of about 1 MHz, as taught by Moaddeb, in order to provide treatment for a user’s tremors (Paragraphs 0001 & 0040).
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 6, 8-12, 14-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US20210330547A1 to Moaddeb et al. (hereinafter “Moaddeb”).
Regarding claim 1, Moaddeb discloses a wearable device for mitigating a movement disorder of a subject (Fig. 8 system 100), the device comprising:
a sensor configured to be attached to the subject and to provide a sensor output (Fig. 8 sensing elements 132, 134; Paragraph 0040 discloses the sensors sense movement of a user);
a processing unit (Fig. 15 controller 192) operationally coupled to the sensor and configured to quantify the sensor output (Paragraph 0047 discloses the controller receives signals from the sensing elements and uses those signals to adjust the vibrations delivered to the user); and
an actuator configured to be attached to the subject and operationally coupled to the processing unit, wherein the actuator is configured to stimulate proprioceptive nerves of the subject (Fig. 8 vibration elements 136, 138; Paragraph 0040 discloses the vibration elements deliver vibration to the user’s arm to counteract tremors; Examiner notes that the proprioceptive nerves are stimulated via mechanical vibrations applied to the skin of the user);
wherein the processing unit is further configured, as part of a feedback loop including the sensor, the actuator, and the subject, to adjust parameters of an output of the actuator in a manner to reduce symptoms of the movement disorder as measured by the sensor (Paragraph 0084 discloses the control unit may be configured to provide a feedback loop, wherein the amount of activity in the delivery mode is dependent upon the measured signals in the sense mode. The algorithm of the feedback loop may be automatically or manually adjusted.).
Regarding claim 2, Moaddeb discloses the wearable device of claim 1, and Moaddeb further discloses wherein the sensor output is related to involuntary movement of a body part attributable to a movement disorder of the subject (Paragraph 0040 discloses the sensing elements 132, 134 sense physiological signals including tremors in the form of repetitive wave forms).
Regarding claim 4, Moaddeb discloses the wearable device of claim 1, and Moaddeb further discloses wherein the actuator is a vibration motor and is further configured to output a stimulation waveform to the proprioceptive nerves of the subject (Fig. 8 vibration elements 136, 138; Paragraph 0040 discloses the vibration elements deliver vibration to the user’s arm to counteract tremors; Examiner notes that the proprioceptive nerves are stimulated via mechanical vibrations applied to the skin of the user; Examiner further notes the vibration stimulation inherently is outputted as a stimulation waveform).
Regarding claim 6, Moaddeb discloses the wearable device of claim 1, and Moaddeb further discloses wherein the processing unit is further configured to, as part of the feedback loop, generate new stimulation parameters through a stimulation selection algorithm (Paragraph 0084 discloses the control unit may be configured to provide a feedback loop, wherein the amount of activity in the delivery mode is dependent upon the measured signals in the sense mode. The algorithm of the feedback loop may be automatically or manually adjusted.).
Regarding claim 8, Moaddeb discloses the wearable device of claim 1, and Moaddeb further discloses wherein the actuator is an ultrasonic emitter (Paragraph 0054 discloses the at least one vibration element may be an ultrasound transducer).
Regarding claim 9, Moaddeb discloses the wearable device of claim 8, and Moaddeb further discloses wherein the ultrasonic emitter is configured to produce sound waves that stimulate the proprioceptive nerves of the subject (Paragraph 0054 discloses the at least one vibration element may be an ultrasound transducer; Examiner notes an ultrasonic transducer inherently performs the function of converting electrical energy into high-frequency sound waves, and the proprioceptive nerves are inherently stimulated as discussed in the rejection of claim 4 above).
Regarding claim 10, Moaddeb discloses the wearable device of claim 8, and Moaddeb further discloses wherein the ultrasonic emitter is configured to generate an ultrasonic wave having a frequency of about 1 MHz (Paragraph 0054 discloses the ultrasound transducer may vibrate at a frequency of 15kHz to about 1MHz).
Regarding claim 11, Moaddeb discloses a method of mitigating a movement disorder (Paragraph 0001 discloses the invention pertains to methods for controlling the effects of tremors), comprising:
receiving data at a sensor configured to be attached to a subject; generating, at the sensor, sensor output based on the data (Fig. 8 sensing elements 132, 134; Paragraph 0040 discloses the sensors sense movement of a user);
communicating the sensor output from the sensor to a processing unit (Fig. 15 controller 192; Paragraph 0047 discloses the controller receives signals from the sensing elements and uses those signals to adjust the vibrations delivered to the user); and
stimulating, through an actuator in communication with the processing unit, proprioceptive nerves of the subject based on the sensor output (Fig. 8 & 19 vibration elements 136, 138, electrodes 252, 254, 256; Paragraph 0040 & 0059 disclose the vibration elements deliver vibration to the user’s arm to counteract tremors; Examiner notes that the proprioceptive nerves are stimulated via mechanical vibrations/electrical stimulations applied to the skin of the user; Examiner further notes any one of the electrodes or vibration elements may be the actuator),
wherein the processing unit is configured, as part of a feedback loop including the sensor, the actuator, and the subject, to adjust parameters of an output of the actuator in a manner to reduce symptoms of a movement disorder of the subject (Paragraph 0059 & 0084 discloses the control unit may be configured to provide a feedback loop, wherein the amount of activity in the delivery mode is dependent upon the measured signals in the sense mode. The algorithm of the feedback loop may be automatically or manually adjusted).
Regarding claim 12, Moaddeb discloses the method of claim 11, and Moaddeb further discloses wherein the sensor output is related to involuntary movement of a body part attributable to a movement disorder of the subject (Fig. 8 sensing elements 132, 134; Paragraph 0040 discloses the sensors sense tremor movement (i.e. involuntary movement) of a user).
Regarding claim 14, Moaddeb discloses the method of claim 11, and Moaddeb further discloses wherein the actuator is a vibration motor and is configured to output a stimulation waveform to the proprioceptive nerves of the subject (Fig. 8 vibration elements 136, 138; Paragraph 0040 discloses the vibration elements deliver vibration to the user’s arm to counteract tremors; Examiner notes that the proprioceptive nerves are stimulated via mechanical vibrations applied to the skin of the user).
Regarding claim 15, Moaddeb discloses the method of claim 14, and Moaddeb further discloses wherein the sensor output includes vibration data (Fig. 8 sensing elements 132, 134, vibration elements 136, 138; Paragraph 0040 discloses the vibration elements deliver vibration to the user’s arm to counteract tremors; Examiner notes that the data received from the vibration elements is vibration data, which is then sent to the controller for processing).
Regarding claim 16, Moaddeb discloses the method of claim 11, and Moaddeb further discloses further comprising, as part of the feedback loop, generating new stimulation parameters through a stimulation selection algorithm by the processing unit (Paragraph 0084 discloses the control unit may be configured to provide a feedback loop, wherein the amount of activity in the delivery mode is dependent upon the measured signals in the sense mode. The algorithm of the feedback loop may be automatically or manually adjusted.).
Regarding claim 17, Moaddeb discloses the method of claim 11, and Moaddeb further discloses further comprising activating the actuator based on a passive sensing of the sensor, wherein the passive sensing includes sensing of a movement disorder of the subject (Fig. 8 sensing elements 132, 134; Paragraph 0040 discloses the sensors sense tremor movement of a user; Examiner notes the sensing elements are passively sensing the user’s movement as they operate automatically when the device is turned on).
Regarding claim 18, Moaddeb discloses the method of claim 11, and Moaddeb further discloses wherein the actuator is an ultrasonic emitter (Paragraph 0054 discloses the at least one vibration element may be an ultrasound transducer).
Regarding claim 19, Moaddeb discloses the method of claim 18, and Moaddeb further discloses further comprising producing, through the ultrasonic emitter, sound waves that stimulate the proprioceptive nerves of the subject (Paragraph 0054 discloses the at least one vibration element may be an ultrasound transducer; Examiner notes an ultrasonic transducer inherently performs the function of converting electrical energy into high-frequency sound waves, and the proprioceptive nerves are inherently stimulated as discussed in the rejection of claim 4 above).
Regarding claim 20, Moaddeb discloses the method of claim 11, and Moaddeb further discloses wherein the actuator is an electric stimulation device (Fig. 19 stimulation electrodes 252, 254, 256).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb in view of US20190001121A1 to Lara et al. (hereinafter “Lara”).
Regarding claim 3, Moaddeb discloses the wearable device of claim 1, and Moaddeb further discloses wherein the processing unit is further configured to quantify a frequency of the sensor output (Paragraph 0040 discloses the sensing elements 132, 134 sense a wave form; Paragraph 0047 discloses the controller may receive the sensed signals from the sensing elements to automatically adjust the vibration mode; Paragraph 0052 discloses the frequency characteristic may be a mean frequency of a wave of energy).
Moaddeb does not disclose wherein the processing unit quantifies an amplitude of the sensor output. However, Lara teaches a system and method for processing biosignals representing amplitudes of sensor output related to movement disorders (Fig. 1 biosignal processing system 100; Paragraph 0022 “Generally. The systems and methods described herein may receive sensor data from a set of biosignal sensors (e.g., biosignal sensors on a lead) coupled to a first processing system including an analogy signal preprocessor and a second processing system including a digital signal processor (DSP). Signal characteristics from electrophysiological signal data such as frequency, amplitude, and phase.” Paragraph 0050 discloses the biosignal processing system uses stimulators to reduce tremors associated with Parkinson’s Disease.).
Regarding claim 13, Moaddeb discloses the method of claim 11, Moaddeb further discloses wherein further comprising quantify, through the processing unit, a frequency of the sensor output (Paragraph 0040 discloses the sensing elements 132, 134 sense a wave form; Paragraph 0047 discloses the controller may receive the sensed signals from the sensing elements to automatically adjust the vibration mode; Paragraph 0052 discloses the frequency characteristic may be a mean frequency of a wave of energy).
Moaddeb does not disclose wherein the processing unit quantifies an amplitude of the sensor output. However, Lara teaches a system and method for processing biosignals representing amplitudes of sensor output related to movement disorders (Fig. 1 biosignal processing system 100; Paragraph 0022 “Generally. The systems and methods described herein may receive sensor data from a set of biosignal sensors (e.g., biosignal sensors on a lead) coupled to a first processing system including an analogy signal preprocessor and a second processing system including a digital signal processor (DSP). Signal characteristics from electrophysiological signal data such as frequency, amplitude, and phase.” Paragraph 0050 discloses the biosignal processing system uses stimulators to reduce tremors associated with Parkinson’s Disease.).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb in view of US20180264263A1 to Rosenbluth et al. (hereinafter “Rosenbluth”).
Regarding claim 5, Moaddeb discloses the wearable device of claim 1, but Moaddeb does not disclose wherein the processing unit is further configured to filter sensor crosstalk of sensor input of the sensor by subtracting an output waveform of the output of the actuator from a sensed waveform of the sensor input. However, Rosenbluth teaches a device and method for controlling tremor which filters sensor crosstalk of sensor input of the sensor by subtracting an output waveform of the output of the actuator from a sensed waveform of the sensor input (Paragraph 0197 discloses the motion sensor data is subject to an algorithm which extracts motion data that are not attributable to the tremor; Paragraph 0197 also discloses that if a patient has a known tremor frequency determined by the sensors, the data at other frequencies is removed; Thus examiner notes that any output waveform from other movements (i.e. motion due to the actuator) is subtracted from the sensed waveform of the sensor input before key characteristics of the tremor are analyzed).
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 controller of Moaddeb to filter sensor crosstalk by subtracting an output waveform of the actuator from the sensed waveform of the sensor input, as taught by Rosenbluth, in order to remove motions that are not attributable to the tremor (Paragraph 0197).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Moaddeb in view of WO2017192028A1 to Mohd et al. (hereinafter “Mohd”).
Regarding claim 7, Moaddeb discloses the wearable device of claim 6, but Moaddeb does not disclose perform feature extraction of the sensor output to generate extracted features of a sensed waveform of the sensor output. However, Mohd teaches a method of quantifying a tremor of a subject based on filtered signals (Paragraphs 0015- 0016 disclose a filtering process for removing signal noise and other artifacts from the tremor data; Examiner notes that the filter results in an extracted feature; Paragraph 0036 discloses the tremor data processing algorithm is based on detected movements.).
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 controller of Moaddeb to further include filtering tremor signals, as taught by Mohd, in order to remove detected non-tremulous motion (Paragraph 0037).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-10758732-B1 to Heldman; US-10596379-B2 to Arlotti; US-20170087416-A1 to Hu; US-20160147841-A1 to Gray; US-20150182160-A1 to Kim; US-20140074179-A1 to Heldman; US-20130018283-A1 to Halkias; US-20110213278-A1 to Horak; US-20090198148-A1 to Lonky; US-5913308-A to Forbes; US-20120046579-A1 to Radl; US-20180356890-A1 to Zhang; US-10646135-B2 to Peacock; and US-20180365194-A1 to Grado.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRANDY LEE can be reached at 571-270-3525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799