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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1210” is used to designate both the “Shell” and “Patch: Silicone and adhesive” in Fig. 12; “1520” is used to designate both the “EKG SENSOR” and “HR SENSOR” in Fig. 15.
The drawings are objected to because reference character “410” [Fig. 4] does not appear to be directed to anything specifically [the arrow associated with “410” does not appear to point to any particular element].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “patch 1220” [Applicant’s Specification ¶0068].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “105” [Fig. 1]; “1510” [Fig. 15]; “1520” [Fig. 15].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 7-8, 10, and 21 is/are objected to because of the following informalities:
Claim 7 should read “generate [[an]] electrical signals” [line 4].
Claim 7 should read “0.1 - 50 Hz.” [line 6].
Claim 8 should read “generate a first acceleration vector parallel to [[the]] a plane of [[the]] a bed” [line 3].
Claim 10 should read “wherein the muscle is the bicep of the arm, wherein the flex sensor is…” [line 10].
Claim 21 should read “placing [[the]] a wearable device on a subject” [line 2].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 9 and those dependent therefrom is/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 recites the limitation “wherein the flex sensor is positioned in between the two electrodes” [lines 1-2, emphasis applied], wherein the emphasized portion is considered to lack antecedent basis and further render claim 9 indefinite, as claims 1 [from which claim 9 depends] and 9 only define “a plurality of surface electromyogram (sEMG) electrodes” [line 4 of claim 1], wherein the “plurality of” electrodes is considered to be broader than the recited “two” electrodes, such that it is unclear whether the recitation of claim 9 is meant to limit the plurality of electrodes to comprise only two electrodes or whether the two electrodes referred to in claim 9 are meant to be part of the plurality of electrodes. For examination purposes, the Examiner has interpreted either identified interpretation to be applicable in light of any prior art applied under § 102 or § 103.
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.
Examiner’s Note Regarding § 101 Analysis: The Examiner notes that claim(s) 16 and 21 recites a judicial exception [limitations directed towards steps of performing determinations and providing data for output] at Step 2A Prong 1, which is/are considered to be abstract ideas that may be performed in the mind or by hand by merely observing at least a limited amount of known or previously collected data and drawing mental conclusions therefrom. However, the Examiner further notes that claim(s) 16 and 21 recites limitations directed towards a particular wearable device comprising a flex sensor, IMU, and a plurality of sEMG electrodes that is considered to integrate the judicial exception into a practical application at Step 2A Prong 2 and allow the invention to amount to significantly more than the judicial exception at Step 2B.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 9-10 and those dependent therefrom is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 9 recites the limitation “wherein the flex sensor and electrodes are flexible and conform to a surface of an arm along a muscle” [lines 2-3], which is considered to positively recite the human body [see emphasized portion]. The Examiner suggests amending claim 9 to read “wherein the flex sensor and electrodes are flexible and are configured to conform to a surface of an arm along a muscle” to prevent positive recitation of the human body.
Claim 10 recites the limitation “wherein the flex sensor is elongated at curves about the bicep along a direction substantially perpendicular to a long head of the muscle and the sEMG electrodes are oriented in a direction parallel to the long head of the muscle” [lines 1-4], which is considered to positively recite the human body [see emphasized portion]. The Examiner suggests amending claim 10 to read “wherein the flex sensor is configured to be elongated at curves about the bicep along a direction substantially perpendicular to a long head of the muscle and the sEMG electrodes are configured to be oriented in a direction parallel to the long head of the muscle” to prevent positive recitation of the human body.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-4, 16-18, and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dracup (US-20130060167-A1) in view of Ganesh (US-20170340270-A1).
Regarding claim 1, Dracup teaches
A system comprising:
a wearable device [portable device 100 (Dracup Fig. 2); A patient 12 (also known as a "person" or a "user") may wear portable devices, such as portable device 14 generally worn on the user's body, portable devices 16, 18, which may be worn on a limb, such as at the respective wrists or palms of the user's arms, and portable device 20, which may be worn on a leg. An attachment apparatus for attaching a portable device 14,16,18,20 to a person may be used, such as an attachment apparatus selected from a group consisting of a strap, cable, string, band, and leash or any other suitable implement to attach a portable device to a user (Dracup ¶0039)] comprising:
a plurality of surface electromyogram (sEMG) electrodes [FIG. 2 is a block diagram of an exemplary portable device 100. The portable device 100 includes an EDA measuring unit 102, an electromyogram (s-emg) measuring unit 104, an accelerometer/gyroscope unit 106, a control unit 116, and an output unit 118. The EDA measuring unit 102 may be connected to sensors 108, 110. The s-emg measuring unit 104 may be connected to sensors 112, 114 (Dracup ¶0042, Fig. 2)]; and
circuitry [portable device 300 comprises a processor 302, a memory unit 304, an advice system 306, an input system 308, an output system 310, location calculation system 312, motion detection system 314, EDA detection system 316, and a transceiver 318. "System" in items appearing in FIG. 4 may include hardware and/or software components. In other embodiments, system 300 may include additional components and/or may not include all of the components listed above (Dracup ¶0048)] configured to:
measure, sEMG activity of a muscle proximate to the sEMG electrodes based on sEMG signals received from the sEMG electrodes [The s-emg sensors may be arranged to detect electrical activity from muscles using conductive pads placed on the skin of a user. When a muscle beneath a conductive pad is at rest, there is a baseline signal. When a muscle contracts voluntarily, that is, ordinarily, using the muscle to achieve movement or other physical activity, the sensor's signal changes to a certain range of amplitudes and frequencies (Dracup ¶0029)];
measure acceleration and angular velocity based on signals generated by an inertial motion unit (IMU) [Motion detection system 314 may comprise apparatus and software for detecting movement, such as an accelerometer, gyroscope, and the like. Motion detection system 314 may also comprise a motion detector measuring motion data associated with a user 12 (Dracup ¶0059)];
wirelessly communicate the measured sEMG activity and the measured acceleration and angular velocity [Any algorithm in the present invention may be stored on a mobile device located on a remote server and applied to data coming from the mobile device; or stored and accessed at any suitable location (Dracup ¶0026); Post-seizure data 410 may store information about seizures as the seizures are happening, which may be reviewed further at a later date to better determine the characteristics of the seizures that are specific to user 12 so that abnormal motion detection system 10 may more reliably predict and/or detect the seizures of user 12. Additionally or alternatively, post-seizure data 410 may be used for diagnosing and treating a seizure, including data for a particular individual… The data may include images, videos, accelerometer. EDA, s-emg, or other sensor data. The data may include plots, summaries and/or other forms of data. The data may also be analyzed and reviewed later by a medical professional for diagnosis, treatment, and/or other medical purposes (Dracup ¶0063)].
However, Dracup fails to explicitly disclose wherein the wearable device comprises a flex sensor; wherein the circuitry is further configured to measure movement of the muscle based on signals received from the flex sensor; and wherein the wireless communication includes the measured muscle movement.
Ganesh discloses systems and methods for identifying early signs of excessive stress conditions, including seizures [A casual assessment of the relation between antecedent triggers of the stress and the resulting behavior can be mapped by analyzing the chronological data from the sensors. This analysis may aid with the efforts to diagnose the symptoms of conditions such as Autism Spectrum Disorder (ASD) and epilepsy, to understand the factors contributing to the stress, and fine tune the appropriate thresholds of the sensor parameters and therapeutic calming response unique to each patient. Thus, iteratively, the accuracy and reliability of this system at identifying early signs of potential excessive stress conditions such as autistic meltdowns and seizures may be improved (Ganesh ¶0047)], wherein Ganesh discloses wearable devices including a flex sensor and circuitry configured to measure movement of a muscle based on signals received from the flex sensor [Bracelet 201 comprises a controller 101 (not shown), environmental sensor system 102, physiological sensor system 103, and therapy device 104 (Ganesh ¶0030); Sensors 103 that detect physiological stress symptoms, comprising… flex resistors that may detect muscle tension (Ganesh ¶0034); the readings from the environmental sensor system 102 and the physiological sensor system 103, are monitored by the microprocessor 410 (Ganesh ¶0038)], wherein Ganesh further discloses wirelessly transmitting measured data [The information stored in the storage module 406, could be retrieved by the caregiver using the retrieve time stamped sensors data module 518 located on the caregiver mobile device 521, through the mobile device communication interface 520, wearable device communication interface 411, and microprocessor 410 (Ganesh ¶0046)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dracup to employ wherein the wearable device comprises a flex sensor; wherein the circuitry is further configured to measure movement of the muscle based on signals received from the flex sensor; and wherein the wireless communication includes the measured muscle movement, so as to provide additional contextual physiological data indicative of seizures.
Regarding claim 2, Dracup in view of Ganesh teaches
The system of claim 1, further comprising
a remote device configured to:
receive the inertial motion measurements, the measured sEMG activity, and the measured acceleration and angular velocity [Dracup ¶¶0026, 0063];
determine, based on the received measurements, a seizure is occurring in a person wearing the wearable device [Processor 302 may run a program stored on memory unit 304 for detecting seizures, which may be referred to as a seizure detection algorithm. Processor 302 may collect the data from one or more accelerometers, gyroscopes, and/or sensors. Processor 302 may implement a detection and analysis algorithm on the data (Dracup ¶0050)]; and
output a message in response to determination of the seizure [Output system 310 may send an e-mail, text message, make a telephone call and play a particular message, and/or send other forms of messages to alert a concerned party about the occurrence of a seizure (Dracup ¶0058)].
Regarding claim 3, Dracup in view of Ganesh teaches
The system of claim 1, wherein to determine, based on the received signals, a seizure is occurring in a person wearing the wearable device, the processor of the remote device is further configured to:
identify features based on the inertial motion measurements, the measured sEMG activity, and the measured muscle movement; and
classify the features as a seizure event [processor 302 may implement the algorithm to determine whether the motion data retrieved by the motion detector corresponds to the specific type of motion, wherein the specific type of motion is an abnormal motion, including a seizure (Dracup ¶0051); The s-emg sensors may be arranged to detect electrical activity from muscles using conductive pads placed on the skin of a user. When a muscle beneath a conductive pad is at rest, there is a baseline signal. When a muscle contracts voluntarily, that is, ordinarily, using the muscle to achieve movement or other physical activity, the sensor's signal changes to a certain range of amplitudes and frequencies. However, when the muscle is subject to involuntary activity, such as when the body is experiencing a seizure, the signal produced by the sensor will have a different pattern or range. The sensor may monitor both the amplitude and frequency of the electrical signal within the muscle (Dracup ¶0029); See § 103 modification of claim 1 above, Ganesh ¶¶0034, 0047].
Regarding claim 4, Dracup in view of Ganesh teaches
The system of claim 1, wherein the IMU comprises a 3-axis gyroscope and a 3-axis accelerometer [using accelerometers, gyroscopes, and the like to measure movement in various directions, such as the X, Y, and Z directions (Dracup ¶0024)].
Regarding claim 16, Dracup teaches
A wearable device [portable device 100 (Dracup Fig. 2); A patient 12 (also known as a "person" or a "user") may wear portable devices, such as portable device 14 generally worn on the user's body, portable devices 16, 18, which may be worn on a limb, such as at the respective wrists or palms of the user's arms, and portable device 20, which may be worn on a leg. An attachment apparatus for attaching a portable device 14,16,18,20 to a person may be used, such as an attachment apparatus selected from a group consisting of a strap, cable, string, band, and leash or any other suitable implement to attach a portable device to a user (Dracup ¶0039)] comprising:
an inertial motion unit (IMU) configured to collect one or more second signals [Motion detection system 314 may comprise apparatus and software for detecting movement, such as an accelerometer, gyroscope, and the like. Motion detection system 314 may also comprise a motion detector measuring motion data associated with a user 12 (Dracup ¶0059)];
a plurality of surface electromyogram (sEMG) electrodes configured to (i) be placed approximate to a muscle of a subject and (ii) collect one or more third signals [FIG. 2 is a block diagram of an exemplary portable device 100. The portable device 100 includes an EDA measuring unit 102, an electromyogram (s-emg) measuring unit 104, an accelerometer/gyroscope unit 106, a control unit 116, and an output unit 118. The EDA measuring unit 102 may be connected to sensors 108, 110. The s-emg measuring unit 104 may be connected to sensors 112, 114 (Dracup ¶0042, Fig. 2)]; and
a microprocessor configured to perform operations [portable device 300 comprises a processor 302, a memory unit 304, an advice system 306, an input system 308, an output system 310, location calculation system 312, motion detection system 314, EDA detection system 316, and a transceiver 318. "System" in items appearing in FIG. 4 may include hardware and/or software components. In other embodiments, system 300 may include additional components and/or may not include all of the components listed above (Dracup ¶0048)] comprising:
determine multimodal movement data of the muscle based on the one or more second signals, and the one or more third signals, wherein the multimodal movement data specifies at least an acceleration associated with movement of the muscle, an angular velocity associated with movement of the muscle, and sEMG activity associated with the movement of the muscle [The s-emg sensors may be arranged to detect electrical activity from muscles using conductive pads placed on the skin of a user. When a muscle beneath a conductive pad is at rest, there is a baseline signal. When a muscle contracts voluntarily, that is, ordinarily, using the muscle to achieve movement or other physical activity, the sensor's signal changes to a certain range of amplitudes and frequencies (Dracup ¶0029); Dracup ¶0059],
determine whether the multimodal movement data indicates a possible seizure [processor 302 may implement the algorithm to determine whether the motion data retrieved by the motion detector corresponds to the specific type of motion, wherein the specific type of motion is an abnormal motion, including a seizure (Dracup ¶0051); The s-emg sensors may be arranged to detect electrical activity from muscles using conductive pads placed on the skin of a user. When a muscle beneath a conductive pad is at rest, there is a baseline signal. When a muscle contracts voluntarily, that is, ordinarily, using the muscle to achieve movement or other physical activity, the sensor's signal changes to a certain range of amplitudes and frequencies. However, when the muscle is subject to involuntary activity, such as when the body is experiencing a seizure, the signal produced by the sensor will have a different pattern or range. The sensor may monitor both the amplitude and frequency of the electrical signal within the muscle (Dracup ¶0029)], and
provide, for output, data indicating whether the movement indicates a possible seizure [Output system 310 may send an e-mail, text message, make a telephone call and play a particular message, and/or send other forms of messages to alert a concerned party about the occurrence of a seizure (Dracup ¶0058)].
However, Dracup fails to explicitly disclose wherein the wearable device comprises a flex sensor configured to collect one or more first signals; wherein the determined multimodal movement data of the muscle is further based on the one or more first signals.
Ganesh discloses systems and methods for identifying early signs of excessive stress conditions, including seizures [A casual assessment of the relation between antecedent triggers of the stress and the resulting behavior can be mapped by analyzing the chronological data from the sensors. This analysis may aid with the efforts to diagnose the symptoms of conditions such as Autism Spectrum Disorder (ASD) and epilepsy, to understand the factors contributing to the stress, and fine tune the appropriate thresholds of the sensor parameters and therapeutic calming response unique to each patient. Thus, iteratively, the accuracy and reliability of this system at identifying early signs of potential excessive stress conditions such as autistic meltdowns and seizures may be improved (Ganesh ¶0047)], wherein Ganesh discloses wearable devices including a flex sensor and circuitry configured to measure movement of a muscle based on signals received from the flex sensor [Bracelet 201 comprises a controller 101 (not shown), environmental sensor system 102, physiological sensor system 103, and therapy device 104 (Ganesh ¶0030); Sensors 103 that detect physiological stress symptoms, comprising… flex resistors that may detect muscle tension (Ganesh ¶0034); the readings from the environmental sensor system 102 and the physiological sensor system 103, are monitored by the microprocessor 410 (Ganesh ¶0038)], wherein Ganesh further discloses wirelessly transmitting measured data [The information stored in the storage module 406, could be retrieved by the caregiver using the retrieve time stamped sensors data module 518 located on the caregiver mobile device 521, through the mobile device communication interface 520, wearable device communication interface 411, and microprocessor 410 (Ganesh ¶0046)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Dracup to employ wherein the wearable device comprises a flex sensor configured to collect one or more first signals; wherein the determined multimodal movement data of the muscle is further based on the one or more first signals, so as to provide additional contextual physiological data indicative of seizures.
Regarding claim 17, Dracup in view of Ganesh teaches
The apparatus of claim 16, wherein the muscle comprises an arm muscle [Dracup ¶0031; Ganesh ¶0028, Figs. 1-5].
Regarding claim 18, Dracup in view of Ganesh teaches
The apparatus of claim 16, wherein the muscle comprises a leg muscle [Dracup ¶0031].
Regarding claim 20, Dracup in view of Ganesh teaches
The apparatus of claim 16, wherein determining whether the multimodal movement data indicates a possible seizure comprises:
processing the first set of signals, the second set of signals, and the third set of signals;
identifying a set of features associated with the multimodal movement data based on processing the first set of signals, the second set of signals, and the third set of signals [Dracup ¶¶0029, 0050-0051; Ganesh ¶¶0034, 0047];
determining that the set of features include a predetermined feature associated with a seizure condition [Dracup ¶¶0029, 0050-0051; Ganesh ¶¶0034, 0047]; and
determining that the multimodal movement data indicates the possible seizure based on determining that the set of features include the predetermined feature [Dracup ¶¶0029, 0050-0051; Ganesh ¶¶0034, 0047].
Regarding claim 21, Dracup teaches
A method comprising:
placing the wearable device on a subject, wherein the wearable device comprises (ii) an inertial motion unit (IMU) sensor, and (iii), a plurality of surface electromyogram (sEMG) electrodes [portable device 100 (Dracup Fig. 2); A patient 12 (also known as a "person" or a "user") may wear portable devices, such as portable device 14 generally worn on the user's body, portable devices 16, 18, which may be worn on a limb, such as at the respective wrists or palms of the user's arms, and portable device 20, which may be worn on a leg. An attachment apparatus for attaching a portable device 14,16,18,20 to a person may be used, such as an attachment apparatus selected from a group consisting of a strap, cable, string, band, and leash or any other suitable implement to attach a portable device to a user (Dracup ¶0039); Motion detection system 314 may comprise apparatus and software for detecting movement, such as an accelerometer, gyroscope, and the like. Motion detection system 314 may also comprise a motion detector measuring motion data associated with a user 12 (Dracup ¶0059); FIG. 2 is a block diagram of an exemplary portable device 100. The portable device 100 includes an EDA measuring unit 102, an electromyogram (s-emg) measuring unit 104, an accelerometer/gyroscope unit 106, a control unit 116, and an output unit 118. The EDA measuring unit 102 may be connected to sensors 108, 110. The s-emg measuring unit 104 may be connected to sensors 112, 114 (Dracup ¶0042, Fig. 2)];
receiving data indicating (ii) one or more second signals from the IMU sensor, and (iii) one or more third signals from the plurality of sEMG electrodes [processor 302 may implement the algorithm to determine whether the motion data retrieved by the motion detector corresponds to the specific type of motion, wherein the specific type of motion is an abnormal motion, including a seizure (Dracup ¶0051); The s-emg sensors may be arranged to detect electrical activity from muscles using conductive pads placed on the skin of a user. When a muscle beneath a conductive pad is at rest, there is a baseline signal. When a muscle contracts voluntarily, that is, ordinarily, using the muscle to achieve movement or other physical activity, the sensor's signal changes to a certain range of amplitudes and frequencies. However, when the muscle is subject to involuntary activity, such as when the body is experiencing a seizure, the signal produced by the sensor will have a different pattern or range. The sensor may monitor both the amplitude and frequency of the electrical signal within the muscle (Dracup ¶0029)];
determining multimodal movement data of the muscle based on the one or more second signals, and the one or more third signals, wherein the multimodal movement data specifies at least an acceleration associated with movement of the muscle, an angular velocity associated with movement of the muscle, and sEMG activity associated with the movement of the muscle [Dracup ¶¶0029, 0051];
determining that the multimodal movement data indicates a possible seizure [Dracup ¶¶0029, 0051];
providing, for output, data indicating the possible seizure [Output system 310 may send an e-mail, text message, make a telephone call and play a particular message, and/or send other forms of messages to alert a concerned party about the occurrence of a seizure (Dracup ¶0058)].
However, Dracup fails to explicitly disclose wherein the wearable device comprises (i) a flex sensor; wherein data indicating (i) one or more first signals from the flex sensor is received; and wherein determining multimodal movement data of the muscle is further based on the one or more first signals.
Ganesh discloses systems and methods for identifying early signs of excessive stress conditions, including seizures [A casual assessment of the relation between antecedent triggers of the stress and the resulting behavior can be mapped by analyzing the chronological data from the sensors. This analysis may aid with the efforts to diagnose the symptoms of conditions such as Autism Spectrum Disorder (ASD) and epilepsy, to understand the factors contributing to the stress, and fine tune the appropriate thresholds of the sensor parameters and therapeutic calming response unique to each patient. Thus, iteratively, the accuracy and reliability of this system at identifying early signs of potential excessive stress conditions such as autistic meltdowns and seizures may be improved (Ganesh ¶0047)], wherein Ganesh discloses wearable devices including a flex sensor and circuitry configured to measure movement of a muscle based on signals received from the flex sensor [Bracelet 201 comprises a controller 101 (not shown), environmental sensor system 102, physiological sensor system 103, and therapy device 104 (Ganesh ¶0030); Sensors 103 that detect physiological stress symptoms, comprising… flex resistors that may detect muscle tension (Ganesh ¶0034); the readings from the environmental sensor system 102 and the physiological sensor system 103, are monitored by the microprocessor 410 (Ganesh ¶0038)], wherein Ganesh further discloses wirelessly transmitting measured data [The information stored in the storage module 406, could be retrieved by the caregiver using the retrieve time stamped sensors data module 518 located on the caregiver mobile device 521, through the mobile device communication interface 520, wearable device communication interface 411, and microprocessor 410 (Ganesh ¶0046)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Dracup to employ wherein the wearable device comprises (i) a flex sensor; wherein data indicating (i) one or more first signals from the flex sensor is received; and wherein determining multimodal movement data of the muscle is further based on the one or more first signals, so as to provide additional contextual physiological data indicative of seizures.
Regarding claim 22, Dracup in view of Ganesh teaches
The method of claim 21, placing the wearable device on the subject comprises placing the wearable device on an arm of the subject [Dracup ¶0031; Ganesh ¶0028, Figs. 1-5].
Regarding claim 23, Dracup in view of Ganesh teaches
The method of claim 21, placing the wearable device on the subject comprises placing the wearable device on a leg of the subject [Dracup ¶0031].
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dracup in view of Ganesh, as applied to claim 1 above, in further view of Conradsen (US-20150119746-A1).
Regarding claim 6 [written in longhand format to incorporate the subject matter of claim 5 therein], Dracup in view of Ganesh teaches
The system of claim 1.
However, Dracup in view of Ganesh fails to explicitly disclose wherein to measure, based on the sEMG signals received from the sEMG electrodes, sEMG activity of a muscle proximate to the sEMG electrodes, the circuitry is further configured to: receive the signals from the sEMG electrodes; filter the signals, wherein the filtered signals from the sEMG electrodes have a frequency between 100 Hz and 300 Hz; and wherein the circuitry is further configured to: determine the root-mean-square (RMS) of the filtered signals.
Conradsen discloses systems and methods for monitoring seizures, wherein Conradsen discloses circuitry configured for receiving sEMG activity of a muscle proximate to sEMG electrodes [The sensor unit 2 is configured to measure an electromyographic (EMG) signal generated in the body of the subject. The sensor unit 2 may comprise a number of surface electrodes arranged at strategic positions on the surface of one or more muscles or arranged in or near an outer surface of a sensor housing (not shown) which is configured to lie against the surface of a muscle and to be mounted or fixed to the muscle (Conradsen ¶0055)], filtering the signals, wherein the filtered signals from the sEMG electrodes have a frequency between 100 Hz and 300 Hz [The sampled signal 5, shown in FIG. 2a, is then transmitted to one or more filter modules 6a, 6b configured to filter out the sensed signal within different frequency bands. The bandwidth of each frequency band may be determined according to one or more criteria defining a characterizing pattern for one or more of the phases in the seizure. In one embodiment, a first filter module 6a is configured to filter out the sensed signal within a high frequency band B.sub.HF since this band comprises the majority of the characteriztics in power (amplitudes) for a tonic-clonic seizure (an epileptic seizure) compared to the same recorded signal not containing a seizure… In a preferred embodiment, the high frequency band B.sub.HF has a frequency band of 32-512 Hz, preferably 64-256 Hz (Conradsen ¶0058)]; and wherein the circuitry is further configured to determine the root-mean-square (RMS) of the filtered signals [The processor unit 3 may comprise a second analysis module 12 configured to calculate an averaged signal 13, as shown in FIG. 7, for the sensed signal within a predetermined time window. The second analysis module may be configured to apply a root mean square (RMS) function to the sampled signal 5 (Conradsen ¶0067)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dracup in view of Ganesh to employ wherein to measure, based on the sEMG signals received from the sEMG electrodes, sEMG activity of a muscle proximate to the sEMG electrodes, the circuitry is further configured to: receive the signals from the sEMG electrodes; filter the signals, wherein the filtered signals from the sEMG electrodes have a frequency between 100 Hz and 300 Hz; and wherein the circuitry is further configured to: determine the root-mean-square (RMS) of the filtered signals, so as to limit analyzed data to a frequency range considered to comprise the majority of the characteristics in power for a tonic-clonic seizure and facilitate statistical analysis of the measured data, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dracup in view of Ganesh, as applied to claim 1 above, in further view of Lei (US-20100292617-A1).
Regarding claim 7, Dracup in view of Ganesh teaches
The system of claim 1.
However, Dracup in view of Ganesh fails to explicitly disclose wherein to measure, based on signals received from the flex sensor, movement of a muscle proximate to the flex sensors, the circuitry is further configured to: generate an electrical signals based on the voltage of the flex sensor; filter the signals, wherein the filtered signals from the flex sensor signals have a frequency between 0.1 - 50 Hz.
Lei discloses systems and methods for monitoring muscle movement of a user using a flex sensor, wherein Lei further discloses filtering signals from the flex sensor [Referring to FIG. 1, two sensors 11, 12 are placed on the surface of the muscle of a user. Surface vibration of the muscle is detected by the sensors 11, 12 in order to acquire a mechanomyogram (MMG) signal. The vibration amplitude and frequency transmitted via the surface of a contacting muscle reflects the characteristics or the mechanical properties of the muscle during contraction. The MMG signal is a low frequency signal produced by lateral oscillations of contracting skeletal muscle fibers (Lei ¶0040); The output signal from the accelerometer 11 consists of constant time invariant acceleration (gravity), time-varying acceleration (MMG signal) and environmental/background vibrational noise. The MMG signal is extracted from the output signal by passing through a band pass filter between 2 and 40 Hz (Lei ¶0042)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dracup in view of Ganesh to employ wherein to measure, based on signals received from the flex sensor, movement of a muscle proximate to the flex sensors, the circuitry is further configured to: generate an electrical signals based on the voltage of the flex sensor; filter the signals, wherein the filtered signals from the flex sensor signals have a frequency between 0.1 - 50 Hz, so as to eliminate noise and motion artifacts, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dracup in view of Ganesh, as applied to claim 1 above, in further view of Girouard (US-20160296157-A1), hereinafter Girouard ‘157.
Regarding claim 8, Dracup in view of Ganesh teaches
The system of claim 1.
However, Dracup in view of Ganesh fails to explicitly disclose wherein to measure acceleration and angular velocity based on signals generated by an IMU, the circuitry is further configured to: generate a first acceleration vector parallel to the plane of the bed and a second acceleration vector perpendicular to the plane of the bed.
Girouard ‘157 discloses systems and methods for monitoring seizures, wherein Girouard ‘157 discloses measuring acceleration of the user relative to a bed [a detection unit may further include one or more microelectromechanical inertial detection elements, e.g., gyroscopes, magnetometers and/or accelerometers, that may be configured to determine an orientation of the detection unit and therefore of the muscle upon which the detection unit is attached. Therefore, the system herein may, for example, include a description of whether a sensor (and therefore the muscle to which the sensor may be coupled or attached) was oriented in one way or another. For example, whether the detection unit was oriented substantially vertically, e.g., parallel to a normal vector from the ground as common for a patient standing, or show whether the sensor was oriented horizontal to that normal, e.g., perpendicular to that normal vector, as may be common when a patient is lying such as in bed (Girouard ‘157 ¶0132)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of wherein to measure acceleration and angular velocity based on signals generated by an IMU, the circuitry is further configured to: generate a first acceleration vector parallel to the plane of the bed and a second acceleration vector perpendicular to the plane of the bed, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [define measurement axes of the accelerometer based on common activities during which seizures are monitored for] [MPEP § 2143(I)(D)].
Claim(s) 9 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dracup in view of Ganesh, as applied to claim 1 above, in further view of Hamner (US-20200093400-A1).
Regarding claim 9, Dracup in view of Ganesh teaches
The system of claim 1.
However, Dracup in view of Ganesh fails to explicitly disclose wherein the flex sensor is positioned in between the two electrodes, wherein the flex sensor and electrodes are flexible and conform to a surface of an arm along a muscle.
Dracup and Ganesh each disclose positioning sensors on the body of the user, including the user’s arm [When sensors of muscle movement are employed, these sensors may be on a primary embracing attachment intended to have a fight fit around a part of the body (such as around a part of an arm or around a part of a leg, such as around the wrist of an arm or at the ankle) (Dracup ¶0031); Environmental characteristics measuring sensor system 102, patient's physiological characteristics measuring sensor system 103, and therapy device 104 are distributed and fastened to the body of patient 100 (Ganesh ¶0028, Figs. 1-5)].
Hamner discloses systems and methods for monitoring physiological parameters of a user, wherein Hughes discloses a wearable device comprising a flex sensor [The electronics 206, shown in FIG. 2E can include one or more inertial measurement units (IMU) 208 (e.g., motion sensors such as accelerometers, gyroscopes, magnetometers, bend sensors), force sensors (e.g., strain sensors), muscle and/or nerve activity sensors (e.g., electrodes to measure EMG or microneurography) that communicate with a device control unit (Hamner ¶0092)] and sEMG electrodes [Hamner ¶0092]; wherein the flex sensor is positioned in between the two electrodes, wherein the flex sensor and electrodes are flexible and conform to a surface of an arm along a muscle [the electronics board 1000 with various electronic components 1002 (Hamner ¶0121, Fig. 10), wherein the electronics board 1000 is considered to read on the broadest reasonable interpretation of a shuttle, based on the Applicant’s disclosure defining the shuttle as a structural element to secure electronics and related hardware connections (Applicant’s Specification ¶¶0048-0049)]; wherein the wearable device further comprises a housing configured to conform and flex to a muscle, wherein the shuttle is disposed in the housing and at least a portion of the sEMG electrodes outside of the housing for contact with the arm [In other embodiments as shown in FIGS. 11A-11D, the device or system can have many form factors and can include any combination of the form factors described herein. For example, the device could be a fabric garment woven with conductive fabric. Fabric garments can contain electronic fabric with stretch-sensitive fibers for measuring limb position and displacement, and foot pressure, in addition to conductive pathways for electrical stimulation and embedded accelerometers… FIG. 11D illustrates a flexible patch 1106 with two electrodes 1108 to target a single nerve. The flexible patch can be coated with a conductive and adhesive hydrogel. The patch can be made of a flexible material, like silicone, to conform to body (e.g., behind knee). The center housing 1110 contains stimulation electronics, sensors, processor, and power source, for example. The housing 1110 may also include a basic user interface 1112 (i.e., one or more buttons) to control stimulation level and/or display information to user. The patch may or may not communicate wirelessly with an external device (Hamner ¶0122, Fig. 11D); the device is a flexible housing or patch 900 with an adhesive that adheres directly to the wearer's skin… The flexible housing or patch 900 encloses or has a circuit board 904, such as the circuit board described in FIG. 2E (Hamner ¶0118), wherein the stretch-sensitive fibers are considered to be positioned between the electrodes as depicted in at least Fig. 11D of Hamner].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dracup in view of Ganesh to employ wherein the flex sensor is positioned in between the two electrodes, wherein the flex sensor and electrodes are flexible and conform to a surface of an arm along a muscle, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [position sensors of the wearable device in a certain configuration relative to one another] [MPEP § 2143(I)(D)].
Regarding claim 12 [written in longhand format to incorporate the subject matter of claim 11 therein], Dracup in view of Ganesh teaches
The system of claim 1.
However, Dracup in view of Ganesh fails to explicitly disclose wherein the wearable device further comprises a shuttle which receives the sEMG electrodes, flex sensor, and circuitry; and wherein the wearable device further comprises a housing configured to conform and flex to a muscle, wherein the shuttle is disposed in the housing and at least a portion of the sEMG electrodes outside of the housing for contact with the arm.
Dracup and Ganesh each disclose positioning sensors on the body of the user, including the user’s arm [Dracup ¶0031; Ganesh ¶0028, Figs. 1-5].
Hamner discloses systems and methods for monitoring physiological parameters of a user, wherein Hughes discloses a wearable device comprising a flex sensor [Hamner ¶0092], sEMG electrodes [Hamner ¶0092], and circuitry [Hamner ¶0092]; wherein the flex sensor, sEMG electrodes, and circuitry are disposed on a shuttle [the electronics board 1000 with various electronic components 1002 (Hamner ¶0121, Fig. 10), wherein the electronics board 1000 is considered to read on the broadest reasonable interpretation of a shuttle, based on the Applicant’s disclosure defining the shuttle as a structural element to secure electronics and related hardware connections (Applicant’s Specification ¶¶0048-0049)]; wherein the wearable device further comprises a housing configured to conform and flex to a muscle, wherein the shuttle is disposed in the housing and at least a portion of the sEMG electrodes outside of the housing for contact with the arm [In other embodiments as shown in FIGS. 11A-11D, the device or system can have many form factors and can include any combination of the form factors described herein. For example, the device could be a fabric garment woven with conductive fabric. Fabric garments can contain electronic fabric with stretch-sensitive fibers for measuring limb position and displacement, and foot pressure, in addition to conductive pathways for electrical stimulation and embedded accelerometers… FIG. 11D illustrates a flexible patch 1106 with two electrodes 1108 to target a single nerve. The flexible patch can be coated with a conductive and adhesive hydrogel. The patch can be made of a flexible material, like silicone, to conform to body (e.g., behind knee). The center housing 1110 contains stimulation electronics, sensors, processor, and power source, for example. The housing 1110 may also include a basic user interface 1112 (i.e., one or more buttons) to control stimulation level and/or display information to user. The patch may or may not communicate wirelessly with an external device (Hamner ¶0122, Fig. 11D); the device is a flexible housing or patch 900 with an adhesive that adheres directly to the wearer's skin… The flexible housing or patch 900 encloses or has a circuit board 904, such as the circuit board described in FIG. 2E (Hamner ¶0118)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dracup in view of Ganesh to employ wherein the wearable device further comprises a shuttle which receives the sEMG electrodes, flex sensor, and circuitry; and wherein the wearable device further comprises a housing configured to conform and flex to a muscle, wherein the shuttle is disposed in the housing and at least a portion of the sEMG electrodes outside of the housing for contact with the arm, so as to hold electronics and circuitry of the system while maintaining attachment to the user.
Regarding claim 13, Dracup in view of Ganesh and Hamner teaches
The system of claim 12, wherein the flex sensor is disposed inside of the housing, wherein flexure of the housing causes flexure of the flex sensor [See § 103 modification of claim 12 above; Hamner ¶¶0118, 0122, wherein as noted in Hamner ¶0122, form factors can include a flexible housing that encloses the electronics (Hamner ¶0118), and can further include stretch-sensitive fibers].
Regarding claim 14, Dracup in view of Ganesh and Hamner teaches
The system of claim 12, further comprising an adhesive layer attached to an outer surface of the housing, wherein the adhesive layer is configured to attach the wearable device to an arm [See § 103 modification of claim 12 above; Hamner ¶0122].
Claim(s) 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dracup in view of Ganesh and Hamner, as applied to claims 9 and 12 above, in further view of Girouard (US-20180160964-A1), hereinafter Girouard ‘964.
Regarding claim 10, Dracup in view of Ganesh and Hamner teaches
The system of claim 9.
However, while Dracup and Ganesh disclose positioning sensors on the body of the user, including the user’s arm [Dracup ¶0031, Ganesh ¶0028], Dracup in view of Ganesh and Hamner fails to explicitly disclose wherein the flex sensor is elongated at curves about the bicep along a direction substantially perpendicular to a long head of the muscle and the sEMG electrodes are oriented in a direction parallel to the long head of the muscle.
Girouard ‘964 discloses systems and methods for monitoring seizure activity, wherein Girouard discloses positioning EMG electrodes on a patient’s bicep [a patient susceptible to seizures was monitored for seizure activity using EMG electrodes. A sensor was placed on the patient's biceps, EMG signal collected, the collected signal analyzed for the presence of seizure activity, and a seizure was detected (Girouard ‘964 ¶0077)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dracup in view of Ganesh and Hamner to employ wherein the wearable device is configured to be positioned on the user’s bicep, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [position sensors to collect relevant physiological data indicative of seizure activity] [MPEP § 2143(I)(D)]. Based on the above modification, Dracup in view of Ganesh, Hamner, and Girouard ‘964 is considered to render obvious wherein the flex sensor is elongated at curves about the bicep along a direction substantially perpendicular to a long head of the muscle and the sEMG electrodes are oriented in a direction parallel to the long head of the muscle, as each of the flex sensor and electrodes as modified are considered to define three-dimensional structures, such that as positioned on the user’s bicep, the flex sensor and electrodes are considered to read on the claimed relative orientations.
Regarding claim 15, Dracup in view of Ganesh and Hamner teaches
The system of claim 12.
However, while Dracup and Ganesh disclose positioning sensors on the body of the user, including the user’s arm [Dracup ¶0031, Ganesh ¶0028], Dracup in view of Ganesh and Hamner fails to explicitly disclose wherein the muscle is a bicep of an arm.
Girouard ‘964 discloses systems and methods for monitoring seizure activity, wherein Girouard discloses positioning EMG electrodes on a patient’s bicep [Girouard ‘964 ¶0077].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dracup in view of Ganesh and Hamner to employ wherein the muscle is a bicep of an arm, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [position sensors to collect relevant physiological data indicative of seizure activity] [MPEP § 2143(I)(D)].
Claim(s) 19 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dracup in view of Ganesh, as applied to claim 16 above, in further view of Chase (US-20220044804-A1).
Regarding claim 19, Dracup in view of Ganesh teaches
The apparatus of claim 16.
However, Dracup in view of Ganesh fails to explicitly disclose wherein the muscle comprises a torso muscle.
Chase discloses systems and methods for monitoring for seizures, wherein Chase discloses positioning sensors on a user’s chest for collecting relevant physiological data [The wearable device 50 can be worn as an armband, as shown in FIG. 3A, or positioned on the neck, the chest, or on the forearm or the wrist as a bracelet/watch, as shown in FIG. 3B. In all of these cases the wearable device 50 can be positioned as an accessory or integrated into an apparel piece residing on the user (Chase ¶0035); In another example, consider a person with Epilepsy, who may encounter a loss of consciousness and muscle contraction that results in a seizure. During a muscle contraction, muscle fibers emit an electrochemical signal that may be detected through electromyography. Electromyography may be used to obtain benchmark measurement signals to detect if an epileptic individual is experiencing severe muscle contractions. According to principles of this invention, muscle contraction can be automatically detected through the use of wearable physiological sensors to detect electromyography activity and send a notification to a third party (Chase ¶0050)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Dracup in view of Ganesh to employ wherein the muscle comprises a torso muscle, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [position sensors to collect relevant physiological data to identify seizures] [MPEP § 2143(I)(D)].
Regarding claim 24, Dracup in view of Ganesh teaches
The method of claim 21.
However, Dracup in view of Ganesh fails to explicitly disclose placing the wearable device on the subject comprises placing the wearable device on a torso of the subject.
Chase discloses systems and methods for monitoring for seizures, wherein Chase discloses positioning sensors on a user’s chest for collecting relevant physiological data [Chase ¶¶0035, 0050].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Dracup in view of Ganesh to employ placing the wearable device on the subject comprises placing the wearable device on a torso of the subject, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [position sensors to collect relevant physiological data to identify seizures] [MPEP § 2143(I)(D)].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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