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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/04/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 05/04/2026. As directed by the amendment: claims 1 and 16 have been amended, claims 2-3, 6-8, 10, 13, 17-20, and 22-26 have been cancelled, and no claims have been added. Thus, claims 1, 4-5, 9, 11-12, 14-16, and 21 are presently under consideration in this application.
Response to Arguments
The Declaration under 37 CFR 1.132 filed 05/04/2026 is insufficient to overcome the rejection of claims 1, 4-5, 9, 11-12, 14-16, and 21 based upon 35 U.S.C. 101 as set forth in the last Office action because: Applicant asserts on pages 1-8 that 1) a technical improvement via the bilateral sensor configuration (para 10), specifically the accelerometer positioning on opposite sides of the body’s plane of symmetry (para 11), 2) solving a technical problem/ technical improvement of reducing false positives by removing non-stroke related movement asymmetries via filtration (para 13) since the prior art only detects stroke during sleep and filtering gravity and passive limb movements enable stroke detection while awake (para 14), 3) filtering is not merely a mathematical operation or abstract idea (para 14), 4) Exhibit A providing evidence that the differential-based asymmetry is beyond the human mental capability, specifically that the system detected minor differences in arm motion and frequency more accurately than routine clinical determination of asymmetries that trained clinicians cannot detect (para 16), and 5) Exhibit A providing evidence that the multi-stage mechanism solves the false positive problem (para 19).
Examiner disagrees because:
Regarding 1, there is not limitation in the claim that recites a specific configuration because the first and second side of the “plane of symmetry” is recited as intended use. Even if the limitation was not intended use, it is routine and conventional to have an accelerometer on the left and right arms/hands for measuring motion, and that is disclosed in [0011]-[0012] of the instant specification, and noted in the 35 U.S.C. 101 rejection filed 11/04/2025.
Regarding 2, the reducing of false positive via removal of gravity and passive limb movements is the asserting of the abstract idea as the improvement. The filtering is implementing the abstract idea on a computer, which is insufficient to show a practical application.
Regarding 3, filtering requires mathematical equations that is the following:
PNG
media_image1.png
342
580
media_image1.png
Greyscale
and therefore a mathematical concept (abstract idea).
Regarding 4, although Applicant may be correct to point that minor differences that cannot be seen easily may not be detected by clinicians, the human mind is still capable of detecting the difference, because the clinical determinations of differences are routine, as noted in the declaration. A clinician with the readouts of accelerometer data, could determine that the event is happening.
Regarding 5, similar to 2, the implementation of the abstract idea on a computer is insufficient to show a practical application. Therefore, the rejection of record is maintained.
Applicant's arguments, see pages 8-13, filed 05/04/2026, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant asserts on page 9 that “This claimed determination of asymmetry cannot practically be performed in the human mind, and thus, cannot be considered a mental process…Processing such multi-dimensional sensor data in real-time to detect stroke symptoms is clearly beyond human mental capability even with the aid of a pen and paper, and thus, cannot be practically performed in the human mind… bilateral accelerometers in real-time to compute differentials and compare against thresholds for stroke detection is beyond human mental capability.” Examiner disagrees because the comparing of the acceleration data for an event can be analyzed by the human mind by observing an abnormality in the data. The filtering of data uses mathematical concepts, as noted above.
Applicant then argues on pages 10 that “the claimed filter that removes "movements of the body resulting from gravity and passive limb mechanics" is tied to the specific physical characteristics of the accelerometer hardware and human movement, not merely an abstract mathematical operation. As such, claim 1 is directed to a specific technological improvement achieved through a particular sensor configuration and data processing methodology.” Examiner disagrees because the wearable sensor with a wearable sensor package to measure position/acceleration are generic acquisition devices that are gathering structures for gathering insignificant extra-solution activity. Further, this additional element fails to integrate the judicial exception into practical application because the wearable accelerometer/gyroscope/orientation sensor is well-understood, routine, and conventional. Further, filtering is a mathematical concept, as shown in the equation above,
Applicant then argues on page 10 that “amended claim 1 recites "a plurality of wearable sensors" including "a first wearable sensor configured to measure movement on a first side of a plane of symmetry the user's body" and "a second wearable sensor configured to measure movement on a second side of the plane of symmetry of the user's body," wherein these sensors include "a sensor package having an accelerometer configured to measure at least one of an inclination, a position, an orientation, or an acceleration of said portion of the user's body." This represents an additional element in the form of a specific physical configuration for capturing bilateral movement data, not a generic data gathering arrangement. This additional element integrates any alleged exception into a practical application, thereby rendering claim 1 patent-eligible.” Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application.
Applicant then argues on page 12 that “filter[ing] the first movement data and the second movement data to remove movements not related to muscle movement of the central nervous system, removal of the movements including removing, from an acceleration vector generated by the accelerometer, movements of the body resulting from gravity and passive limb mechanics." This is not a generic mathematical operation, but rather a specific technical filtering process tied to the physical characteristics of human movement and the accelerometer hardware.” Examiner disagrees because filtering the data is a mathematical concept, which is a form of a transfer function, thereby an abstract idea.
Applicant also argues on page 12 that “Ericson Declaration provides objective evidence establishing that the ordered sequence of (1) asymmetry detection triggering (2) cognitive test prompting, and (3) automated emergency alert upon cognitive test failure, as claimed, constitutes "additional elements demonstrating that the claim as a whole integrates the exception into a practical application, thereby integrating any abstract idea into a practical application. Indeed, at least this ordered sequence affects a specific improvement in the field of stroke detection and emergency response.” Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application.
Applicant lastly argues on pages 11-12 that “the Ericson Declaration, as a whole, provides objective evidence establishing that, in the least, the combination of additional elements (e.g., bilateral wearable sensors with accelerometers, cognitive test prompting upon asymmetry detection, and automated emergency alert generation upon cognitive test failure) and those features allegedly deemed "abstract ideas" (e.g., filtering to remove gravity and passive limb mechanics from the acceleration vector and differential-based asymmetry determination), in claim 1, represents a specific technological improvement in stroke detection systems… Applicants also respectfully traverse the Office's assertion that "the additional limitations are to receiving data, processing data, and generating stroke detection, which are all well-understood, routine, and conventional computer functions." Office Action, page 4. The Office has failed to provide the requisite factual support for this finding as set forth at MPEP § 2106.07(a)(II) ("In the Step 2B inquiry, if the examiner has concluded that particular claim limitations are well understood, routine, conventional activities (or elements) to those in the relevant field, the rejection should support this conclusion in writing with a factual determination.") If the Office intends to maintain that elements of claim 1 are well-understood, routine, and conventional computer functions, Applicants request that the Office provide the requisite factual support for this finding. Applicants reserve the right to address this issue in further detail upon receipt of evidentiary support for the Office's conclusory finding”. There is no limitation in the claim that recites a specific configuration because the first and second side of the “plane of symmetry” is recited as intended use. Even if the limitation was not intended use, it is routine and conventional to have an accelerometer on the left and right arms/hands for measuring motion, and that is disclosed in [0011]-[0012] of the instant specification, and noted in the 35 U.S.C. 101 rejection filed 11/04/2025. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity. Therefore, the rejection is maintained.
Applicant's arguments, see pages 13-17, filed 05/04/2026, regarding 35 U.S.C. 103 have been fully considered and are persuasive. Amendments to the claim obviate the rejection of record. Therefore, the rejection is withdrawn. See updated rejection below.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “a first side of a plane of symmetry the user's body” should include the word “of”, and should recite “a first side of a plane of symmetry of the user's body”. Appropriate correction is required.
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 1, 4-5, 9, 11-12, 14-15 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.
Regarding claim 1, it is unclear if the control device is part of the claimed apparatus, or if the control device is a part of the system that interacts with the apparatus.
Regarding claim 4, it is unclear if the “threshold” of claim 4 is the same or different than the “threshold value” of claim 1.
Claim 12 recites the limitation "the same time" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-5, 9, 11-12, 14-16, and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claims 1 and 16 recites a step determine asymmetry of the user's movement based on the first movement data and the second movement data, wherein determination of the asymmetry of the user's movement includes determining a differential between characteristics of the first movement data and the second movement data, the characteristics determining that the user's movement is asymmetric upon the differential being greater than a threshold value, which is a mental process, and filter the first movement data and the second movement data to remove movements not related to muscle movement of the central nervous system, which is a mathematical concept. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. a data processing device), determining asymmetry, and generating stroke detection do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and generating stroke detection, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 1 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 16 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1 and 16, the following step is an abstract idea:
“determine asymmetry of the user's movement based on the first movement data and the second movement data, wherein determination of the asymmetry of the user's movement includes determining a differential between characteristics of the first movement data and the second movement data, the characteristics determining that the user's movement is asymmetric upon the differential being greater than a threshold value”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could analyze 2 data sets for determining an irregularity in the signals to determine a stroke.
“filter the first movement data and the second movement data to remove movements not related to muscle movement of the central nervous system” , which is a mathematical concept when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(I), the mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. In this case, the filtering of data uses a transfer function, thereby being a mathematical concept.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1 and 16, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a data processing device”, “display”, and “control device” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “wearable sensors”, “accelerometers”, and “sensor package” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “first/second movement data”, “acceleration vector”, “gravity and passive limb mechanics”, “movements”, “characteristics”, “inclination”, “position”, “orientation”, “acceleration”, “speed”, “range”, “energy expenditure”, “asymmetry”, “body gesture”, “first body gesture”, “emergency alert”, “cognitive test” mental and intellectual ability”, and “stroke detection” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
Regarding claims 1 and 16, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a data processing device”, “display”, and “control device” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “wearable sensors”, “accelerometers”, and “sensor package” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “first/second movement data”, “acceleration vector”, “gravity and passive limb mechanics”, “movements”, “characteristics”, “inclination”, “position”, “orientation”, “acceleration”, “speed”, “range”, “energy expenditure”, “asymmetry”, “body gesture”, “first body gesture”, “emergency alert”, “cognitive test” mental and intellectual ability”, and “stroke detection” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claims 1 and 16, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the data processing device, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The motion sensors and accelerometers are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure as shown in [0011]-[0012] of the instant specification that use motion sensors for gathering motor data of a user.
Dependent claims 2-5, 9, 11-12, 14-15, and 21 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1. The dependent claim limitations are directed to the type of data (claims 2-5, 9, 11-12, 14-15, and 21), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1, 4-5, 9, 11-12, 14-16, and 21 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Interpretation
Regarding claim 1, the phrase “stroke detection signal” is not defined in the specification. Examiner interprets the language to mean a stroke condition that is generated.
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.
Claim(s) 1, 4-5, 9, 11-12, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman et al. (US 20180249967) (IDS) (Hereinafter Lederman) in view Lee et al. (US 20190279480) (priority to WO2018101886 published 06/07/2018) (Hereinafter Lee), Abzhandadze et al. (“Feasibility of Cognitive Functions Screened With the Montreal Cognitive Assessment in Determining ADL Dependence Early After Stroke” Front. Neurol. Vol. 9 -2018 , 26 August 2018)(Hereinafter Abzhandadze), and van Hees et al. (“Separating Movement and Gravity Components in an Acceleration Signal and Implications for the Assessment of Human Daily Physical Activity”, PLoS One. 2013 Apr 23;8(4):e61691. doi: 10.1371/journal.pone.0061691)(Hereinafter van Hees).
Regarding claims 1 and 16, Lederman teaches A stroke detection apparatus (Abstract “Devices (100), systems (200), and methods for automatically evaluating a potential stroke condition”) comprising:
A plurality of wearable sensors configured to generate movement data of at least a portion of a user's body ([0051] “The example sensors shown in FIG. 2 include wristbands 216 that can include accelerometers”);
the plurality of wearable sensors including a first wearable sensor configured to measure movement on a first side of a plane of symmetry the user's body (Fig. 6c [0103] “In other cases, the arms will be moved one after the other. The wearable device may thus comprise a button (e.g. button 710 as shown in FIG. 7), so that the user must first lift one arm, then lift their second arm to the same position [second gesture] and press the button on the wearable device.”), and
a second wearable sensor configured to measure movement on a second side of the plane of symmetry of the user's body (Fig. 6d [0103] “In other cases, the arms will be moved one after the other. The wearable device may thus comprise a button (e.g. button 710 as shown in FIG. 7), so that the user must first lift one arm, then lift their second arm to the same position [second gesture] and press the button on the wearable device.”),
wherein the first wearable sensor and the second wearable sensor include a sensor package configured to measure at least one of an inclination, a position, an orientation, or an acceleration of said portion of the user's body ([0051] “non-limiting examples of sensors can include accelerometers, magnetometers, gyroscopes, force gauges, pressure sensors, and any other type of sensor capable of measuring any potential stroke indication.”); and
a data processing device including a processor, the data processing device configured to process first movement data for a first movement received from the first wearable sensor and second movement data for a second movement received from the second wearable sensor ([0047] “processor 206” Fig. 6c and 6d showing the two signals.),
filter the first movement data and the second movement data to remove movements not related to muscle movement of the central nervous system ([0077] “sensor data can be filtered to reduce noise, or to enhance or otherwise emphasize relevant signal characteristics, waveforms, or features.”),
determine asymmetry of the user's movement based on the first movement data and the second movement data ([0075] “A comparison of FIGS. 4a and 4b clearly shows the asymmetry in motor activity that is expected from a stroke condition.”), and
wherein determination of the asymmetry of the user's movement includes determining a differential between characteristics of the first movement data and the second movement data, the characteristics including at least one of movement speed, movement range, energy expenditure or activity ([0075] “The following description refers to sensors and stroke indications as accelerometers and gyroscopes detecting indicators of bilateral motor asymmetries and/or hemiparesis.” [0077] “stroke assessment technology, bilateral asymmetry can be a beneficial stroke indicator. As such, it can be useful to calculate the differences between the left and right features as a measure of the level of bilateral asymmetry according to Equation I:” Examiner notes that accelerometers measure acceleration which is activity.), and
determining that the user's movement is asymmetric upon the differential being greater than a threshold value ([0066] “the processor can continuously or intermittently process incoming sensor data to monitor for a potential stroke indicator or level of a potential stroke indicator above a specified threshold.”),
generate a stroke detection signal based on the asymmetry ([0075] “A comparison of FIGS. 4a and 4b clearly shows the asymmetry in motor activity that is expected from a stroke condition.”)
wherein the first body gesture includes the first movement and the second movement ([0075] “A comparison of FIGS. 4a and 4b clearly shows the asymmetry in motor activity that is expected from a stroke condition.” [0042] “a subject is tested for drift by being asked to hold both arms fully extended in front at shoulder level”)
wherein the data processing device is configured to generate an automated emergency alert in response to determining the user has failed the cognitive test ([0040] “Upon the determination of a stroke or potential stroke condition, family, healthcare providers, emergency responders, or others, can be notified by the device so that swift medical attention can be provided.”).
Although Lederman teaches a FAST test for analyzing arm weakness and speech difficulty, Lederman does not teach a control device prompting a first body gesture and prompting a cognitive test following the determination of an asymmetry. Lee, in the same field of endeavor, teaches a device for monitoring the movement of a user ([0030]) for stroke detection ([0060]), similar to the device of Lederman, and further teaches wherein the data processing device is in communication with a control device configured to prompt the user to perform a first body gesture ([0127] “the computer system 300 prompts the patient to perform the physical actions necessary to assess proper motor function to assess physical symptoms—namely movement of the arms, facial arrangement and/or speech.” [0103] “to which the wearable device is attached (i.e. may not affect the arm (the one arm), of the patient's two arms,to which the device is attached), it is desirable that the patient perform the arm lifts with both arms. In some cases the arms will be moved in unison [first body gesture].” [0112] “The patient may be instructed to recite a predetermined phrase—e.g. using audio commands issued from speaker 316, and/or visual commands issued on display 304.” Display is connected to the CPU of Fig. 3);
wherein a display of the control device is configured to prompt the user to perform a cognitive test when the data processing device determines the asymmetry of the user’s movement ([0099] “To ensure the appropriate measurements are taken by which the computer system 300 can assess the patient, instructions are delivered to the patient. The instructions advise the patient to perform the requisite arm, facial and/or speech functions that can be compared to the corresponding physical symptom baseline(s).” [0112] “The patient may be instructed to recite a predetermined phrase—e.g. using audio commands issued from speaker 316, and/or visual commands issued on display 304.” [0115] “Alternatively, Step 106D may be performed after each of Steps 106A, 106B and/or 106C separately. For example, once movement of the arm(s) has been measured, that movement may be compared to the baseline for arm movement (which may include a baseline for relative arm position during and after movement of both arms). Similarly, the facial arrangement imaged at Step 106B may be compared to the relevant facial arrangement baseline at Step 106D before speech [cognitive test as reading out a prompt requires thinking, see [0111]-[0112]] is received in accordance with Step 106C” In other words, step 106A can be performed by making the determination of arm movement exceeding the threshold thereby determining a stroke and then receiving speech/cognitive tested information to make the further determination.)
wherein the data processing device is configured to generate an automated emergency alert in response to determining the user has failed the cognitive test ([0119] “Emergency services may be contacted after the first failure at Step 106D, and further contacted if future performance of Steps 104 and 106D show that the first performance was a false alarm, if further repetitions are performed. In other words, emergency services may be initially notified of the potential onset of a stroke.”) to improve confidence that the patient is indeed experiencing the onset of a stroke ([0117]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Lederman, with the control device prompting a first body gesture and prompting a cognitive test following the determination of an asymmetry of Lee, because such a modification would allow to improve confidence that the patient is indeed experiencing the onset of a stroke.
However, Lederman in view of Lee does not teach a cognitive test being a mental or intellectual test. Abzhandadze, in the same field of endeavor, teaches the use of a cognitive test following stroke (Abstract), similar to the devices of Lederman and Lee, and further teaches perform a cognitive test when the data processing device determines the asymmetry of the user’s movement, the cognitive test being a test of mental ability or an intellectual test (Pg. 4 left col. lines 6-13 “The study findings suggest that cognitive functions measured with the MoCA administered 36–48 h post stroke can reflect on ADL performance. Furthermore, patients with impaired cognitive functions, older age, and severe neurological deficits at this time are more likely to be dependent. The present findings strengthen the recommendation for using the MoCA in acute stroke settings to identify cognitive changes (20, 21). Additionally, the results provide more knowledge about the possible use of the MoCA as one of the variables associated with ADL dependence.” MoCA is a mental and intellectual test.) to increase the accuracy of stroke diagnosis (Pg. 4 right col. lines 12-20). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Lederman, with the cognitive test being a mental or intellectual test of Abzhandadze, because such a modification would allow to increase the accuracy of stroke diagnosis.
However, Lederman in view of Lee and Abzhandadze does not teach removal of the movements including removing, from an acceleration vector generated by the accelerometer, movements of the body resulting from gravity and passive limb mechanics. Van Hees, in the same field of endeavor, teaches raw acceleration signals used for assessing daily human activity (Abstract), and further teaches removal of the movements including removing, from an acceleration vector generated by the accelerometer, movements of the body resulting from gravity and passive limb mechanics (Pg. 2 left col. lines 37-41 “The main objective of the present study was therefore to evaluate the ability of different methods (metrics) of processing acceleration signals to remove the gravitational component of acceleration by comparison against a reference method under a range of standardised kinematic conditions.” Pg. 4 left col. lines 14-20 “For the robot analyses three metrics for the estimation of acceleration related to movement were evaluated: (i) the Euclidean norm (vector magnitude) of the three raw signals minus 1, referred to as ENMO; (ii) the application of a high-pass frequency filter (4th order Butterworth filter with ω0 = 0.2 Hz) to each raw signal, after which the Euclidean norm was taken from the three resulting signals” In view of the instant specification, specifically [0078], “passive limb mechanics” such as the downward swinging of the arms during walking is a consequence of gravity, and therefore, the removal of gravity is also the removal of passive limb mechanics.) to produce the most accurate acceleration signal (Pg. 4 left col. lines 14-25). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Lederman in view of Lee and Abzhandadze, with the removal of the movements including removing, from an acceleration vector generated by the accelerometer, movements of the body resulting from gravity and passive limb mechanics of van Hees, because such a modification would allow to produce the most accurate acceleration signal.
Regarding claim 4, Lederman teaches wherein the data processing device is configured to generate the stroke detection signal in response to determining that the asymmetry of the user's movement exceeds a threshold ([0066] “the processor can continuously or intermittently process incoming sensor data to monitor for a potential stroke indicator or level of a potential stroke indicator above a specified threshold.”).
Regarding claim 5, Lederman teaches wherein the data processing device is configured to determine the threshold based on historical movement data for the user's body ([0066] “the processor can continuously or intermittently process incoming sensor data to monitor for a potential stroke indicator or level of a potential stroke indicator above a specified threshold…Such can be useful as the threshold can be set according to an individual subject, thus correcting for bilateral asymmetries [this is historic movement as these movements are not typical for that individual subject] that may already be present.”).
Regarding claim 9, Lederman teaches wherein the first wearable sensor is configured to be worn on one of the user's wrists, and
the second wearable sensor is configured to be worn on another of the user's wrists ([0073] “in data that includes accelerometer and gyroscopic data, rotation of the left and right hands [using the sensors of Fig. 2(216)] of the subject can be a useful indicator feature. In other examples, an indicator feature can be any bilateral difference in any feature that is associated with a possible stroke condition.”).
Regarding claim 11, Lederman teaches wherein the plane of symmetry of the user's body is one or more of a sagittal plane, a frontal plane or a transverse plane (0073] “in data that includes accelerometer and gyroscopic data, rotation of the left and right hands [using the sensors of Fig. 2(216)] of the subject can be a useful indicator feature. In other examples, an indicator feature can be any bilateral difference in any feature that is associated with a possible stroke condition.” Left hand is one side of the sagittal plane, the right hand is on the other side of the sagittal plane.).
Regarding claim 12, Lederman teaches wherein the first wearable sensor and the second wearable sensor are configured to measure respective movement data at the same time ([0075] “Sensors, such as accelerometers and gyroscopes, are monitored either continuously or intermittently to detect potential stroke indications such as hemiparesis or other prominent indications.”).
Regarding claim 14, Lederman teaches wherein the first wearable sensor is configured to transmit the first movement data to the data processing device, and the second wearable sensor is configured to transmit the second movement data to the data processing device ([0045] “device 100 can include an input channel 102 for receiving data 104 from a sensor or sensors associated with the subject, and a processor 106 coupled to the input channel 102.”).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman et al. (US 20180249967) (IDS) (Hereinafter Lederman) in view of Lee et al. (US 20190279480) (priority to WO2018101886 published 06/07/2018) (Hereinafter Lee), Abzhandadze et al. (“Feasibility of Cognitive Functions Screened With the Montreal Cognitive Assessment in Determining ADL Dependence Early After Stroke” Front. Neurol. Vol. 9 -2018 , 26 August 2018)(Hereinafter Abzhandadze), and van Hees et al. (“Separating Movement and Gravity Components in an Acceleration Signal and Implications for the Assessment of Human Daily Physical Activity”, PLoS One. 2013 Apr 23;8(4):e61691. doi: 10.1371/journal.pone.0061691)(Hereinafter van Hees), Da-Silva et al. (“Prompting arm activity after stroke: A clinical proof of concept study of wrist-worn accelerometers with a vibrating alert function”, Journal of Rehabilitation and Assistive Technologies Engineering Volume 5: 1–8, 2018) (Hereinafter Da-Silva).
Regarding claim 15, claim 1 is obvious over Lederman, Lee, Abzhandadze, and van Hees. However, Lederman in viuew of Lee, Abzhandadze, and van Hees do not teach the prompting of a user to perform additional gestures in response to determining asymmetry. Da-Silva, in the same field of endeavor, teaches the optimization of motor recovery following a stroke using a wristband that detects a user’s movements (Abstract), similar to the device of Lederman, and further teaches wherein the control device is configured to prompt the user to perform additional body gestures in response to determining the asymmetry of the user's movement (Examiner notes that claim 1 detects a stroke once the asymmetry is determined, so following the stroke determination, the device of Da-Silva may be used to observe further gestures. Pg. 2 right col. lines 12-20 “Participants wore a CueS wristband on their impaired arm for 12 h (8 a.m.–8 p.m.) every day over the four-week programme...If prompted, participants were instructed to increase impaired limb movements, ideally by performing pre-selected activities from a self-directed repetitive functional task practice programme.8 The programme had been previously developed to encourage practice of purposeful movements involving the affected arm which could be easily integrated into activities of daily living such as personal care, eating and drinking. This self-directed practice was recorded by the participant on a patient held log sheet and expanded throughout the four-week programme during twice weekly therapy reviews”) to optimize motor recovery after a stroke through the prompting of movement (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the system of Lederman in view of Lee, Abzhandadze, and van Hees, with the prompting of a user to perform additional gestures in response to determining asymmetry of Da-Silva, because such a modification would allow to optimize motor recovery after a stroke through the prompting of movement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOUSSA HADDAD/Examiner, Art Unit 3796
Prosecution Insights