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 .
Response to Amendment
The amendment filed on 11/13/2025 has been entered. Claims 1-8, 12-13 and 15-19 have been amended. Claims 9-11 and 14 have been cancelled. Claims 1-8, 12-13 and 15-19 remain pending.
The previously raised objections for Claims 1-18 are withdrawn because the issues have been properly corrected.
The previously raised rejections under 35 U.S.C. 112(b) and 112(f) are withdrawn because the issues have been properly corrected.
Response to Arguments
In Pages 9-10 of Remarks, the Applicant argues that the present application "uses only normal motions without any external stimulation", but in rejecting Claims 1, 10 and 14, the prior art Burwinkel “explicitly teaches to use external stimuli”. The Examiner respectfully disagrees. In the original Claims 1, 10 and 14, disregarding external stimulation was not claimed, and instead, original Claims 10 and 14 recited using a microphone as a stimulation sensor to detect external stimulation, which can be interpreted as a way of using potential external stimulation. In the amended Claim 1, the limitation of external stimulation being disregarded is explicitly included, so as a response, new rejection for this claim can be found in the section of 35 U.S.C. 103 below.
In Page 10 of Remarks, the Applicant argues that the prior art Ackland is “to detect which kind of activity the user is performing”, “such systems are used for smart watches”, so “is not related to the detection of a disease based on a motion disorder”; further in Page 11, the Applicant argues that “Ackland's disclosure is not related with the concepts taught by Burwinkel”. The Examiner respectfully disagrees. Ackland is an invention for analyzing “data from a monitoring device worn by a user” (Abstract), focusing on analyzing movement of a subject (the term “movement” is recited 418 times in Ackland). Therefore, Ackland’s method is not limited to be used in smart watches, but can be applied in any wearable devices for measurement or analysis of a subject’s motion, and can be considered to be closely related to the present application and Burwinkel.
In Pages 10-11 of Remarks, the Applicant argues that in previous rejection of Claims 9 and 11, the cited “doing the housework” from the prior art Ackland is not an external stimulation, so Ackland does not teach to disregard external stimulation. The Examiner respectfully disagrees. The term “doing the housework” is not an external stimulation in Ackland, but is a type of movement that should be disregarded from measurement of a user's activity. This is similar or analogous to the present application, where external stimulation should be disregarded when a user's motion disorder is to be measured.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7-8, 10, 12-13 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burwinkel et al (US 20220361787 A1; hereafter Burwinkel), in view of Ackland et al (US 20130053990 A1; hereafter Ackland).
With regard to Claim 1, Burwinkel discloses a system for detecting motion disorder (Burwinkel, Para 0021 “the qualified response can include a reaction motion”; Para 0094 “ … determine the impact of an event(s) … such as the effects of a brain injury …”) of a user of a head-wearable device (Burwinkel, Para 0005; “Embodiments herein relate to ear-worn devices …”) comprising:
at least one motion sensor (Burwinkel, Para 0146; “the motion sensors can be disposed in a fixed position with respect to the head of a patient, such as worn on or near the head or ears”), providing motion data of the user of the head-wearable device (Burwinkel, Para 0053; “…include a signal from the motion sensor indicative of at least one of eye movement, head movement, or a body movement.”),
the head wearable device comprising a processing unit for processing the motion data provided by the at least one motion sensor, a memory for storage of the motion data processed by the processing unit (Burwinkel, Para 0109; “Components of an ear-worn device herein can include a control circuit, digital signal processor (DSP), memory (such as non-volatile memory) …”), and a microphone forming a stimulation sensor that is configured to detect an external stimulation (Burwinkel, Para 0048; “the stimulus can include the ear-worn device wearer's name as detected with the microphone”; Para 0161; “… the qualified response comprises sound detected with the microphone exceeding a threshold value.”);
said processing unit having a processor, which is adapted to perform the following steps:
a) analyzing the motion data and thereby generating analyzed motion data, the step of analyzing comprising classifying the motion data to different motion classes (Burwinkel discloses classifying motion data based on magnitude , directionality and timing of motion. Para 0093; “the evaluation can include evaluating 106 one or more of the magnitude of response (e.g., does the response cross a threshold magnitude), the directionality of the response (e.g., does the directionality of the response match any directionality of the stimulus), the timing of the response (e.g., does the response come at a time that is physiologically possible to qualify as a response), and the like.”),
b) storing the analyzed motion data (Burwinkel, Para 0133; “The memory storage device 1424 can be used to store data from sensors as described herein and/or processed data generated using data from sensors as described herein.”),
c) comparing analyzed motion data with reference motion data (Burwinkel, Para 0094; “… a response time based on the most recently detected response along with previously detected responses. … a change in response time over a most recent value, an average value, or a statistical value. … comparing a response time against comparable device wearer response time(s), such as device wearers of similar age, sex, condition, etc.”), and wherein the reference motion data is selected from a group of previously stored analyzed motion data of the same motion class (previously detected responses) and external reference motion data (comparable device wearer response time),
d) submitting a warning signal if the motion data of movements that are taken into account differs from the reference motion data (Burwinkel, Para 0094; “… issue an alert … in response to a determined longitudinal trend or event crossing a threshold value.”), and
wherein said processor is adapted to decide, based on signals presented by said stimulation sensor, whether an external stimulation has occurred (Burwinkel, Para 0087; “the ear-worn device can operate in a passive mode wherein it does not itself deliver a stimulus or cause a stimulus to be delivered, but rather it detects an event which could serve as a stimulus.”).
Burwinkel does not clearly and explicitly disclose wherein movements that are stimulated by an external stimulation are disregarded and not taken into account.
Ackland in the same field of endeavor discloses wherein movements that are stimulated by an external stimulation are disregarded and not taken into account (Ackland, Para 0480; “random impacts such as doing the housework … can be disregarded by an algorithm as not walking or running.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burwinkel, as suggested by Ackland, in order to disregard the movements stimulated by an external stimulation. One of ordinary skill in the art would have been motivated to make the modification for the benefit of accurately characterizing the type or class of motions of interest (Ackland, Para 0009; “… classifying exercise and/or activity related data into different activities to provide an accurate representation of a particular exercise session or form of activity, or to at least provide the public with a useful choice”).
With regard to Claim 2, Burwinkel and Ackland disclose the system according to claim 1. Burwinkel further discloses wherein based on a number of different analyzed motion data a baseline is extracted, wherein the baseline represents the reference motion data with which the analyzed motion data is compared (Burwinkel, Para 0101; “a set of previously measured response times … can be evaluated to determine a mean, a standard deviation, etc.”).
With regard to Claim 3, Burwinkel and Ackland disclose the system according to claim 1. Burwinkel further discloses wherein the processor is adapted to analyze transitions (reactions) between motions, wherein a transition behavior representing the analyzed transitions is stored as the analyzed motion data (Burwinkel, Para 0105; “Reactions typically require the frontal lobe of the brain to evaluate signals and send instructions to the motor cortex of the brain, before motor control signals pass through the spinal cord and to the site of muscles being activated.”).
With regard to Claim 4, Burwinkel and Ackland disclose the system according to claim 3. Burwinkel further discloses wherein in step c) the current transition behavior (the amount of time between the stimulus and the qualified response) is compared with a reference (a population ear-worn device wearers) transition behavior (Burwinkel, Para 0095; “the ear-worn device is configured to compare the amount of time between the stimulus and the qualified response for the ear-worn device wearer to one or more statistical measures relating to the amount of time between stimuli and qualified responses for a population ear-worn device wearers.”).
With regard to Claim 5, Burwinkel and Ackland disclose the system according to claim 4. Burwinkel further discloses wherein a duration of an initial motion is detected (Burwinkel, Para 0094; “the ear-worn device can be configured to evaluate the measured amount of time between the stimulus and the qualified response”), wherein the initial motion is followed by a following motion (Burwinkel, Para 0099; “The response can be detected movement.”), and wherein the duration is a parameter of the transition behavior.
With regard to Claim 7, Burwinkel and Ackland disclose the system according to claim 1. Burwinkel further discloses wherein the at least one motion sensor is selected from at least one of the following sensors: a. an accelerometer; b. a gyroscope; c. a magnetometer (Burwinkel, Para 0145; “Motion sensors herein can include inertial measurement units (IMU), accelerometers, gyroscopes, barometers, altimeters, and the like.”).
With regard to Claim 8, Burwinkel and Ackland disclose the system according to claim 1. Burwinkel further discloses wherein the motion sensor is part of the head wearable device (Burwinkel, Para 0148; “the sensor package can be part of an ear-worn device”).
With regard to Claim 12, Burwinkel and Ackland disclose the system according to claim 1. Burwinkel further discloses wherein the processor is adapted to decide based on the signals presented by the stimulation sensor, if an external stimulation has occurred (Burwinkel, Para 0087; “the ear-worn device can operate in a passive mode wherein it does not itself deliver a stimulus or cause a stimulus to be delivered, but rather it detects an event which could serve as a stimulus.”), and if so, the motion data provided by the motion sensor is analyzed to determine if there has been a reaction of the user (Burwinkel, Para 0100; “not every detected movement, nerve signal, etc. amounts to a response to a stimulus. As such, the sensed aspects must be evaluated to determine whether it is reflective of a response.”).
With regard to Claim 13, Burwinkel and Ackland disclose the system according to claim 12. Burwinkel further discloses wherein the motion data is analyzed to determine a delayed reaction of the user with respect to the stimulation (Burwinkel, Para 0094; “the ear-worn device can be configured to evaluate the measured amount of time between the stimulus and the qualified response …”).
With regard to Claim 16, Burwinkel and Ackland disclose the system according to claim 1. Burwinkel further discloses wherein the processor is adapted to detect only conscious movements of the user and not uncontrolled movements (Burwinkel, Para 0092; “… not all movements or other detectable actions amount to qualified responses to the stimulus. For example, a device wearer with Parkinson's may have a tremor causing a significant degree of spurious movement which is unrelated to a stimulus.”).
With regard to Claim 17, Burwinkel and Ackland disclose the system according to claim 1. Burwinkel further discloses wherein the processor does not carry out any gait analyses (Burwinkel does not disclose carrying out any gait analyses.).
With regard to Claim 18, Burwinkel and Ackland disclose the system according to claim 1. Burwinkel further discloses wherein the head wearable device is a hearing aid for hearing impaired people (Burwinkel, Para 0109; “Ear-worn devices herein, including hearing aids and hearables (e.g., wearable earphones) …”).
With regard to Claim 19, Burwinkel discloses a method for detecting motion disorder (Burwinkel, Para 0021 “the qualified response can include a reaction motion”; Para 0094 “ … determine the impact of an event(s) … such as the effects of a brain injury …”) of a user of a head-wearable device (Burwinkel, Para 0005; “Embodiments herein relate to ear-worn devices …”), the method comprising the steps
providing motion data of the user of the head-wearable device with the help of at least one motion sensor (Burwinkel, Para 0053; “…include a signal from the motion sensor indicative of at least one of eye movement, head movement, or a body movement.”),
processing the motion data provided by the at least one motion sensor and storing of the motion data processed by the processing unit in a memory unit (Burwinkel, Para 0109; “Components of an ear-worn device herein can include a control circuit, digital signal processor (DSP), memory (such as non-volatile memory) …”), the processing of the motion data comprising the following steps:
e) analyzing the motion data and thereby generating analyzed motion data (Burwinkel discloses analyzing motion data. Para 0093; “the evaluation can include evaluating 106 one or more of the magnitude of response (e.g., does the response cross a threshold magnitude), the directionality of the response (e.g., does the directionality of the response match any directionality of the stimulus), the timing of the response (e.g., does the response come at a time that is physiologically possible to qualify as a response), and the like.),
f) storing the analyzed motion data (Burwinkel, Para 0133; “The memory storage device 1424 can be used to store data from sensors as described herein and/or processed data generated using data from sensors as described herein.”),
g) comparing the analyzed motion data with reference motion data, wherein the reference motion data is selected from the group of previously stored motion data of the same motion class and external reference motion data (Burwinkel, Para 0094; “… a response time based on the most recently detected response along with previously detected responses. … a change in response time over a most recent value, an average value, or a statistical value. … comparing a response time against comparable device wearer response time(s), such as device wearers of similar age, sex, condition, etc.”),
h) submitting a warning signal if the analyzed motion data of movements that are taken into account differs from the reference motion data (Burwinkel, Para 0094; “… issue an alert … in response to a determined longitudinal trend or event crossing a threshold value.”), and
deciding, based on signals presented by the stimulation sensor, whether an external stimulation has occurred (Burwinkel, Para 0087; “the ear-worn device can operate in a passive mode wherein it does not itself deliver a stimulus or cause a stimulus to be delivered, but rather it detects an event which could serve as a stimulus.”).
Burwinkel does not clearly and explicitly disclose wherein movements that are stimulated by an external stimulation are disregarded and not taken into account.
Ackland in the same field of endeavor discloses wherein movements that are stimulated by an external stimulation are disregarded and not taken into account (Ackland, Para 0480; “random impacts such as doing the housework … can be disregarded by an algorithm as not walking or running.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burwinkel, as suggested by Ackland, in order to disregard the movements stimulated by an external stimulation. One of ordinary skill in the art would have been motivated to make the modification for the benefit of accurately characterizing the type or class of motions of interest (Ackland, Para 0009; “… classifying exercise and/or activity related data into different activities to provide an accurate representation of a particular exercise session or form of activity, or to at least provide the public with a useful choice”).
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Burwinkel and Ackland, in view of Heldman et al (US 20140074179 A1; hereafter Heldman).
With regard to Claim 6, Burwinkel and Ackland disclose a system according to claim 1 as discussed above, but do not explicitly and clearly disclose wherein in step a) for classifying the motion data a motion signal provided by the motion sensor is analyzed with the help of signal analyses.
Heldman in the same field of endeavor discloses wherein for classifying the motion data a motion signal provided by the motion sensor is analyzed with the help of signal analyses (Heldman, Para 0026; “Following measurement of symptomatic movement, the next step in objective quantification of a subject's movement disorder symptoms is the extraction of statistical kinematic features from the acquired movement data via processing.” Para 0026 of Heldman also lists a variety of kinematic features or parameters that can be useful in analyzing motion data). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burwinkel and Ackland, as suggested by Heldman, in order to analyze motion signal. One of ordinary skill in the art would have been motivated to make the modification for the benefit of quantitatively assessing movement disorder for optimal therapeutic management (Heldman, Para 0031; “In order to determine what a desired or optimal level of therapy parameters might be, the subject's symptoms or side effects must first be measured and quantified.”).
With regard to Claim 15, Burwinkel and Ackland disclose a system according to claim 1 as discussed above, but do not explicitly and clearly disclose wherein the motion data is recorded, analyzed and stored over a term of at least one of weeks, months and even years.
Heldman in the same field of endeavor discloses wherein the motion data is recorded, analyzed and stored over a term of at least one of weeks, months and even years (Heldman, Para 0024; “… the movement disorder diagnostic device continuously senses, measures and quantifies the subject's external body movements over extended periods of time, such as hours, days, weeks or months.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burwinkel and Ackland, as suggested by Heldman, in order to measure and store the motion data for extended periods of time. One of ordinary skill in the art would have been motivated to make the modification for the benefit of examining the trend in a subject’s symptoms over a long period of time (Heldman, Para 0126; “… keeping the movement disorder monitoring device of the present invention in a subject's home for even longer periods of time, such as months or even years, may be desired as a way to better understand a subject's symptoms over a greater duration of time and would provide powerful ways to examine trending in a subject's symptoms over a period of months, years, or even decades.”).
Conclusion
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.
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/L.Z./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798