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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/29/2025 has been entered.
Status of Amendments
Claims 1-16 and 18-20 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Amendment to the Claims and Remarks filed on 08/29/2025.
Claims 1, 9, 15, and 18 are amended claims.
Claims 2-8, 10-14, 16, and 19-20 are original claims.
Claim 17 has been cancelled and will not be considered at this time.
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 1-16 and 18-20 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 1-16 and 18-20 are drawn to systems, which are statutory categories of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 1 recites a system to receive a first information associated to an array of contextual data relating to said at least one user; receive a second information, associated to said at least one user for detecting physiological data of said at least one user, wherein storing an array of physiological data; determine a behavioral event relating to autism spectrum disorder affecting said at least one user based on said array of physiological data in combination with said array of contextual data,; receive a notification relating to said behavioral event associated to autism spectrum disorder said notification comprises a first set of instructions that causes to provide at least one user with haptic feedback, the haptic feedback is configured to stimulate behavioral learning by training said at least one user to reduce or discontinue from said behavioral event, wherein repeated use of said haptic feedback over time teaches said at least one user new behavior in response to said behavioral event as part of a behavioral management plan for the autism spectrum disorder affecting said at least one user; and a reward notification is generated relating to said behavioral event relating to autism spectrum disorder, said reward notification providing comprises a second set of instructions based on said behavioral event, said second set of instructions provides said at least one user with a reward feedback when said user satisfactorily exhibits said new behavior.
Independent claim 9 recites a system for receive a first information associated to an array of contextual data relating to said patient; receive a second information, associated to said patient, for detecting physiological data of said patient, wherein said storing an array of physiological data; determine completion of a portion of said therapy exercise relating to said patient based on said array of physiological data in combination with said array of contextual data, and provide said patient with haptic feedback to stimulate behavioral learning by training teach said patient to complete said therapy exercise, wherein repeated use of said haptic feedback over time teaches the patient a new behavior to overcome the behavior associated with autism spectrum disorder as part of a behavioral management plan for the patient: and wherein provides said patient with a reward feedback when the patient satisfactorily exhibits the new behavior, said reward feedback affirming the patient's new behavior.
Independent Claim 15 recites a system for receive a first information associated to an array of contextual data relating to said at least one user; receive a second information associated to said at least one use for detecting physiological data of said at least one user, wherein storing an array of physiological data; determine the behavioral event associated with the comorbidity of autism spectrum disorder affecting said at least one user based on said array of physiological data in combination with said array of contextual data, said comorbidity selected from the at least one of anxiety attacks, physical form detection, force production, neurological disorders, eating disorders, smoking, and post-traumatic stress disorder (PTSD), receive a first set of instructions to based on said behavioral event associated with the comorbidity of autism spectrum disorder, said first set of instructions providing said at least one user with haptic feedback to stimulate behavioral learning by training said at least one user to reduce or discontinue from said behavioral event, wherein repeated use of said haptic feedback over time teaches said at least one user new behavior in response to said behavioral event associated with the comorbidity of autism spectrum disorder to overcome the comorbidity as part of a behavioral management plan said at least one user affected by autism spectrum disorder; provides a second set of instructions to said based on said behavioral event, said second set of instructions provided provides said at least one user with a reward feedback when said user satisfactorily exhibits said new behavior.
These steps amount to certain methods of organizing human activity which includes functions relating to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people – also note MPEP § 2106.04(a)(2)(II) stating certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping).
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
The claims recite the additional elements of at least one processor, at least one computer system, a non-transitory memory, at least one wearable device, a second memory, and one or more sensors.
These elements are recited at a high-level of generality such that it amounts to mere instructions to apply the exception because this is an example of applying the abstract idea by use of general-purpose computer which does not integrate the abstract idea into a practical application.
Claims 1, 9, and 15 recite wherein when the at least one user provides an acknowledgment confirming or rejecting the determined behavioral event, the wearable device responds to the acknowledgment by increasing the rate at which the physiological data is transmitted to the processor the increased transmission rate is initiated during the behavioral event and continues for a defined interval associated with the behavioral event. This limitation is recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer.
As discussed above with respect to integration of the abstract idea into a
practical application, the claims recite the additional elements of at least one processor, at least one computer system, a non-transitory memory, at least one wearable device, a second memory, and one or more sensors.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
Claims 1, 9, and 15 recite wherein when the at least one user provides an acknowledgment confirming or rejecting the determined behavioral event, the wearable device responds to the acknowledgment by increasing the rate at which the physiological data is transmitted to the processor the increased transmission rate is initiated during the behavioral event and continues for a defined interval associated with the behavioral event. As per MPEP § 2106.05(d)(II), transmitting data amounts to well-understood, routine, conventional activity as a computer function. As such, this additional element does not amount to significantly more.
For the reasons stated, these claims fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. § 101.
Analysis of Dependent Claims
Dependent claims 3 and 12 recite the array of physiological data is selected from the group consisting of Electrocardiography (ECG), Heart Rate (HR), Heart Rate Variability (HRV), Photoplethysmography (PPG), Pulse-Rate-Variability (PRV), Inter-Beat-Interval (IBI), Electrodermal Activity (EDA), Body Temperature, Respiratory Rate (RR), Blood Pressure (BP), Electromyography (EMG), Peripheral Capillary Oxygen Saturation (Sp02), Peripheral Capillary -14- Deoxygenation (SpD02), Inertial Measurement Unit (IMU), Global Positioning System (GPS), Speed (distance per time), Acceleration (distance per time squared), and Force (Newtons).
Dependent claims 4 and 13 recite the array of contextual data is selected from the group consisting of user-inputted information, personal demographic & health information, calendar events, Rated Perceived Exertion (RPE), Emotional Perceived Exertion (EPE), dietary, exercise/exercise completion, assessments of professionals/health care professionals/care providers/therapist, environmental conditions, geographical location, altitude, temperature, humidity, and audio.
Dependent claim 5 recites behavioral event is selected from the group consisting of behavioral dysregulation, anxiety attacks, autism spectrum disorder (ASD), strokes, seizures, labor contractions/when to push during labor, physical form detection, force production, Sudden infant death syndrome (SIDS), neurological disorders, dysregulation, physical therapy, eating disorders, smoking, post-traumatic stress disorder (PTSD), and gaming.
Dependent claim 6 recites a computer system further provides a corrective action to said at least one user upon detection of said behavioral event.
Dependent claim 7 recites the corrective action is selected from the group consisting of alleviation, resolutive, or reminder action of the correct or incorrect behavior may be pulsation (making the heart tempo to reduce beats per minute), comprised of compression of user, visually, audibly/haptic reminder to user of what to do in accordance to prior procedure as indicated by health care professionals and other caregivers, visual, written, and auditory feedback.
Dependent claim 8 recites the corrective action is used for alleviation and/or self-correction of intended addressable behaviors.
Dependent claim 10 recites the feedback is selected from the group consisting of auditory response, haptic response, and visual response.
Dependent claim 14 recites the carry-over therapy exercise is selected from the group consisting of engagement or compliance with prescribed activities, coping mechanisms, and participation in interactions with the computer system with wearable technology.
Dependent claim 16 recites the detected behavioral event is selected from the group consisting of emotional, physiological, musculoskeletal, neuromusculoskeletal, mental, and contextual experiences affecting said at least one user.
Dependent claim 18 recites at least one wearable device is capable of being worn on the wrist, forearm, bicep, foot, ankle, leg, chest, head, neck, or pelvic region.
Dependent claim 19 recites at least one wearable device is configured to be worn with an article of clothing.
Dependent claim 20 recites at least one wearable device is configured to be worn as an accessory to the at least one user's body, wherein the array of sensors is communicatively connected to said at least one user's body.
Each of these steps of the preceding dependent claims 3-8, 10, 12-14, 16, and 18-20 only serve to further limit or specify the features of independent claims 1, 9, or 15 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
Dependent claims 2 and 11 recite the computer system is selected from the group consisting of mobile compatible web applications, native mobile and/or computer/desktop applications, web applications, third-party plug-ins, third-party smart devices, and primary party smart devices. The computer system is an additional element, which is mere instructions to apply the exception and does not provide a practical application or significantly more for the same reasons.
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) 1-8, 15-16, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (US 20110245633 A1) in view of Shalon (US 20110125063 A1) in view of Pacione (US 20140257055 A1) in view of Ravindran (US 10885719 B1) in view of Sobol (US 20190209022 A1).
As per Claim 1, Goldberg teaches a platform system for remotely monitoring at least one behavioral event related to autism spectrum disorder affecting at least one user, the platform system configured to teach the at least one user away from the at least one behavioral event, the platform system comprising:
at least one processor; ([Para. 0008] remote processors)
and at least one computer system including a non-transitory memory communicatively coupled to the one or more processors, wherein the one or more processors are configured to execute instructions stored in the non-transitory memory. The instructions causing the one or more processors to: ([Para. 0011] electronic device such as a mobile phone, a smart phone, a digital personal assistant, a laptop computer, a tablet, an e-reader, a desktop computer, a television, a gaming device, or a remote server. Preferably, the transmitter wirelessly transmits the data to the electronic device in real-time. Suitable wireless transmitter systems include but are not limited to an IrDA, a Bluetooth.TM., a UWB, a Z-Wave, ANT, RFID, or a ZigBee transmitter system/network. The wearer’s profile data can be transferred through these means to enable personalized displays on any of the associated electronic devices, stored profiles for initializing new sensors, or profiles to initialize new treatment providers. [Para. 0097] the centralized computer infrastructure supporting proprietary data storage and analysis to include clinical summary reports, computed metrics, and correlations with logged activities. For example, data can be wirelessly transmitted from the wearable biosensor device to an electronic device via any number of wireless protocols including, but not limited to Bluetooth.TM., RFID, cellular, home, and corporate networks. Patients and clinicians can access the data stored on the centralized computing infrastructure, for example, via a website, to generate summary reports, or add additional data. Examiner interprets that the data storage is indicative of memory.)
receive a first information associated to an array of contextual data relating to said at least one user; ([Para. 0097] The centralized computer infrastructure supporting proprietary data storage and analysis to include clinical summary reports, computed metrics, and correlations with logged activities.)
receive a second information, from at least one wearable device associated to said at least one user, said at least one wearable device having one or more sensors for detecting physiological data of said at least one user, wherein said at least one wearable device having a second memory for storing an array of physiological data detected by said one or more sensors; ([Para. 0008] a wearable biosensor device that includes at least one sensor for measuring physiological data, memory for storing the accumulated physiological data over time, an on-board processor for deriving a psychological profile based upon said accumulated physiological data, and an interface for displaying information concerning said psychological profile. Para. 0011 further teaches the wearable device can further include a transmitter for conveying the psychological profile or detected/accumulated physiological data directly to an associated electronic device such as a mobile phone, a smart phone, a digital personal assistant, a laptop computer, a tablet, an e-reader, a desktop computer, a television, a gaming device, or a remote server.)
determine a behavioral event relating to autism spectrum disorder affecting said at least one user based on said array of physiological data in view of combination with said array of contextual data, said processor communicating said behavioral event relating to autism spectrum disorder to said computer system ([Para. 0009] that subjective data, reported by the patient, and treatment data, reported by the clinician, is combined with these physiological measurements to produce a cumulative data profiles tied to the individual wearer. [Para. 0021] detecting, diagnosing, monitoring and treating one or more psychological disorders and/or psychological states, including autism.[Para. 0051] the wearable biosensor device 10 contains a processor configured for analyzing and deriving data indicative of a psychological state based on the physiological data collected by the biosensor. The processor analyzes the detected physiological data (i.e. physiological data) in real-time based on a personalized calibration file (information specific to the wearer (i.e. contextual data)) that is stored on the device. The wearable biosensor device then transmits the detected and/or derived data over a personal area network to an electronic device 9 such as a mobile phone, a smart phone, a digital personal assistant, a personal laptop computer, a desktop computer, a tablet, a television, a gaming device, or an e-reader. [Para. 0097] the data detected and stored on-board the wearable biosensor devices of the invention is transmitted to a centralized computer infrastructure supporting proprietary data storage and analysis to include clinical summary reports, computed metrics, and correlations with logged activities. Examiner interprets the subjective and treatment data to be indicative of contextual data.)
receive a notification relating to said behavioral event associated autism spectrum disorder to said processor of said at least one wearable device, (Para. 0021] detecting, diagnosing, monitoring and treating one or more psychological disorders and/or psychological states, including autism. [Para. 0070] the device can map patterns of the physiological and motion data to personalized signals or alerts indicative of a likely anxiety attack, panic attack, or other states that the wearer would like to know about, or used to alert other people or devices for assistance, by using, for example, text messages or emails to inform family and clinicians of recent symptomatic events. [Para. 0071] real-time alerts specific to the wearer are increasingly updated and improved based on increasing physiological and/or physical data obtained from the wearer. [Para. 0089] where the processor is on-board the wearable biosensor device, the gathered user feedback is transmitted back to the wearable biosensor device. [Para. 0094] the "alert" can alternatively be transmitted to a centralized computing infrastructure which can store and further process the data or send alerts to caregivers in the form of phone calls, text messages, emails, etc.)
Goldberg does not explicitly disclose, however Shalon discloses
said notification comprises a first set of instructions that causes at least one wearable device to provide at least one user with haptic feedback, the haptic feedback is configured to stimulate behavioral learning by training teach said at least one user to reduce or discontinue from said behavioral event ([Para. 0047] monitor an eating behavior of a subject and provide real-time feedback for modifying such behavior. [Para. 0055] a system which can be worn by the user in a comfortable and concealed location on the body. Examiner interprets the ability of the system to be worn by the user to be indicative of a wearable device. [Para. 0195-0196] system 10 can also be configured for modifying a behavior of the subject. In order to enable such function, system 10 further includes a feedback element 24 which can provide the subject with feedback according to a behavior detected by system 10. Feedback element 24 can be a speaker, a vibrating element, an electrode or any element capable of providing the subject with sensory information (auditory, tactile etc.). Examiner interprets vibrating element to be indicative of haptic feedback. [Para. 0386] The systems can also be used to monitor and modify behaviors associated with eating disorders such as bulimia and anorexia, as well as to other behaviors including snoring, sleep apnea, bruxism, smoking, alcohol consumption, drug addiction, exercise and physical training, stuttering, panic disorders, attention deficit, hyperactivity disorders, or other disorders that have unique physiological, sound or motion characteristics (i.e. activities) that can be identified and monitored.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a wearable device treating psychological disorders as taught by Goldberg and the haptic feedback as taught by Shalon, with the motivation of providing a plan to modify user behavior (Shalon Para. 0005).
Goldberg/ Shalon do not explicitly disclose, however Pacione discloses
,wherein repeated use of said haptic feedback over time teaches said at least one user new behavior in response to said behavioral event; ([Para. 0085] Feedback may also be provided to a user directly through sensor device in the form of tactile feedback such as vibration. Such feedback may be a reminder or an alert to eat a meal or take medication or a supplement such as a vitamin, to engage in an activity such as exercise or meditation, or to drink water when a state of dehydration is detected. [Para.0029] The energy balance and feedback subsystem provides feedback on behavioral strategies to achieve energy balance proactively. A feedback and coaching engine analyzes the data generated by the system to provide the user with a variety of choices depending on the progress of the user. [Para. 0036] The system may also provide feedback to the user in the form of a periodic or intermittent status report. The status report may be an alert located in a box on a location of the screen and is typically set off to attract the user's attention. Status reports and images are generated by creating a key string based on the user's current view and state and may provide information to the user about their weight loss goal progress. This information may include suggestions to meet the user's calorie balance goal for the day. [Para. 0034] he summary data could provide detailed information about the daily energy intake, daily energy expenditure, weight changes, body fat composition changes and nutrient information if the user has been consistently logging the foods consumed. Reports containing information for a certain time period, such as 7 days, 30 days, 90 days and from the beginning of the system usage may also be provided.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a wearable device treating psychological disorders as taught by Goldberg, the haptic feedback as taught by Shalon, and incorporate the repeated use of said haptic feedback and summation of behavior reports as taught by Pacione, with the motivation of providing a system that may be used as part of a behavioral modification program for calorie control, weight control or general fitness (Pacione Para. 0002).
Goldberg/ Shalon/ Pacione do not explicitly disclose, however Ravindran discloses
as part of a behavioral management plan for the autism spectrum disorder affecting said at least one user; ([Col. 1 Lines 43-50] treating or supplementing the treatment of a subject for a mental or neurodevelopmental disorder, such as autism, using a virtual or augmented reality system. The method can comprise placing the subject in a virtual world using a virtual or augmented reality system that provides visual, auditory, and/or haptic stimulation, monitoring the subject's interaction with the virtual and real world, and measuring the subject's progress toward one or more therapeutic goals.)
and a reward notification is generated relating to said behavioral event relating to autism spectrum disorder, said reward notification providing comprises a second set of instructions, said second set of instructions provides said at least one user with a reward feedback when said user satisfactorily exhibits said new behavior. ([Col. 9, Lines 22-28] The system can provide the user with prompts of varying supportiveness to complete a task if there is a specific task to complete. The system can reward the user for succeeding in such tasks. Such reward may be, for example, an image, audio or video that is pleasing to the user, a pleasing stimulus, or a compliment from a third party (e.g., supervisor). [Col. 19, Lies 9-10 and Lines 15-20] FIG. 6B shows the user 605 using the user device 610 immersed in a virtual reality or augmented reality experience 615. The user 605 may be capable of adding one or more train tracks using just the user's 605 gaze, receive colorful train beads as rewards, such as from a rewards dispenser, for successfully completing one or more tasks in the module (e.g., adding a train track with the user's 605 gaze). Examiner interprets the completion of the task to be indicative of a user satisfactorily exhibiting new behavior.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a wearable device treating psychological disorders as taught by Goldberg, the haptic feedback as taught by Shalon, the repeated use of said haptic feedback and summation of behavior reports as taught by Pacione, and incorporate a behavioral management plan for autism spectrum disorder and reward notification as taught by Ravindran, with the motivation of providing therapeutic methods that can help autistic individuals gain social and communication skills (Ravindran Col. 1 Lines 26-27).
Goldberg/ Shalon/ Pacione/ Ravindran do not explicitly teach, however Sobol teaches
,wherein when the at least one user provides an acknowledgment confirming or rejecting the determined behavioral event, the wearable device responds to the acknowledgment by increasing the rate at which the physiological data is transmitted to the processor. the increased transmission rate is initiated during the behavioral event and continues for a defined interval associated with the behavioral event; ([Para. 0127] BLE beacon 200 broadcasts a radio signal through its RF connection such that the contents of its data package is made up of a combination of letters and numbers transmitted on a regular interval. [Para. 0128] The one or more room beacons 200A each send out their respective UUIDs at regular intervals (such as about ten times every second, although depending on the settings, such frequency can be increased or decreased). [Para. 0165] A portion of the machine code may be dedicated to controlling sampling intervals for various forms of the LEAP data, particularly those data signals that have significant temporal components such as activity data. In one non-limiting example, such sampling intervals can be made to take place in various fractions of a second (such as 0.01 second, 0.1 second or the like), various multiples of a second (such as 1 second, 2 seconds, 5 seconds, 10 seconds or the like) or as fractions or multiples of larger time intervals, depending on the accuracy needs associated with the data being acquired.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a wearable device treating psychological disorders as taught by Goldberg, the haptic feedback as taught by Shalon, the repeated use of said haptic feedback and summation of behavior reports as taught by Pacione, a behavioral management plan for autism spectrum disorder and reward notification as taught by Ravindran, and incorporate changing sampling rate of a wearable device as taught by Sobol, with the motivation of using patient data to proactively identify salient indicators of changing health of the wearer of the device (Sobol Para. 0002).
As per Claim 2, Goldberg/ Shalon/ Pacione/ Ravindran/ Sobol disclose the platform system of claim 1 Goldberg further discloses wherein the computer system is selected from the group consisting of mobile compatible web applications, native mobile and/or computer/desktop applications, web applications, third-party plug-ins, third-party smart devices, and primary party smart devices. ([Para. 0011] electronic device such as a mobile phone, a smart phone, a digital personal assistant, a laptop computer, a tablet, an e-reader, a desktop computer, a television, a gaming device, or a remote server. Para. 0097 further teaches the centralized computer infrastructure supporting proprietary data storage and analysis to include clinical summary reports, computed metrics, and correlations with logged activities. Examiner interprets the electronic devices to be indicative of a primary party smart devices.)
As per Claim 3, Goldberg/ Shalon/ Pacione/ Ravindran/ Sobol disclose the platform system of claim 1 wherein Goldberg further discloses the array of physiological data is selected from the group consisting of Electrocardiography (ECG), Heart Rate (HR), Heart Rate Variability (HRV), Photoplethysmography (PPG), Pulse-Rate-Variability (PRV), Inter-Beat- Interval (IBI), Electrodermal Activity (EDA), Body Temperature, Respiratory Rate (RR), Blood Pressure (BP), Electromyography (EMG), Peripheral Capillary Oxygen Saturation (Sp02), Peripheral Capillary Deoxygenation (SpD02), Inertial Measurement Unit (IMU), Global Positioning System (GPS), Speed (distance per time), Acceleration (distance per time squared), and Force (Newtons). ([Para. 0009] plurality of physiological data/parameters, including but not limited to heart rate, pulse rate, beat-to-beat heart rate variability, electrocardiography (ECG), respiration rate, skin temperature, core body temperature, heat flow off the body, galvanic skin response (GSR), electromyography (EMG), electroencephalography (EEG), electrooculography (EOG), blood pressure, hydration level, muscle pressure, activity level, body position, or a combination thereof. )
As per Claim 4, Goldberg/ Shalon/ Pacione/ Ravindran/ Sobol disclose the platform system of claim 1 Goldberg further discloses wherein the array of contextual data is selected from the group consisting of user-inputted information, personal demographic & health information, calendar events, Rated Perceived Exertion (RPE), Emotional Perceived Exertion (EPE), dietary, exercise/exercise completion, assessments of professionals/health care professionals/care providers/therapist, environmental conditions, geographical location, altitude, temperature, humidity, and audio. ([Para. 0009] subjective data, reported by the patient, and treatment data, reported by the clinician, is combined with these physiological measurements to produce a cumulative data profiles tied to the individual wearer. [Para. 0097] Patients and clinicians can access the data stored on the centralized computing infrastructure, for example, via a website, to generate summary reports, or add additional data. The dashboard is used by clinicians and their caregivers, to diagnose psychological disorders, monitor and inform treatment decisions, and can be used to teach patients how to better self-manage their condition. Such embodiments of this dashboard include, but are not limited to, graphs and figures specific to the wearer and updated as new information is available, including, but not limited to, the physiological data, effects of treatment, reports of overall patterns, and self-report information from the Activity and Annotate Panel. [Para. 0091] Activity Panel 13 is a GUI that allows a user to self-report his or her current activities, such as when experiencing stress or depression. For example, an Activity Panel may allow a user to select Commute, Working, Personal, Fun, Exercise, Relaxing, Eating, Meeting, Talking or Other, or to input text associated with their experiences. Over time these entries are sorted based on various factors such the most frequent selections, the time of day, and the geospatial location.)
As per Claim 5, Goldberg/ Shalon/ Pacione/ Ravindran/ Sobol disclose the platform system of claim 1 Goldberg further discloses wherein said behavioral event is selected from the group consisting of behavioral dysregulation, anxiety attacks, autism spectrum disorder (ASD), strokes, seizures, labor contractions/when to push during labor, physical form detection, force production, Sudden infant death syndrome (SIDS), neurological disorders, dysregulation, physical therapy, eating disorders, smoking, post-traumatic stress disorder (PTSD), and gaming. ([Para. 0021] methods for detecting, diagnosing, monitoring and treating one or more psychological disorders and/or psychological states, including but not limited to anxiety disorders, post-traumatic stress disorder, obsessive-compulsive disorder, panic disorder, phobic disorders, depression, bipolar disorder, a psychotic disorder, and addiction, autism, attention deficit hyperactivity disorder, schizophrenia, stroke recovery, traumatic brain injury, eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge/compulsive over-eating, purging, etc.) and pain management. Para. 0032 further teaches the wearable
biosensor devices include one or more sensors, such as a galvanic skin response
(GSR) sensor, a temperature sensor, a heart rate sensor, an oxygen saturation sensor,
a blood pressure sensor, or a combination thereof. Preferably, the wearable biosensor
devices at least include a GSR sensor. Optionally, the wearable devices can further include an accelerometer and/or a global positioning system (GPS).)
As per Claim 6, Goldberg/ Shalon/ Pacione/ Ravindran/ Sobol disclose the platform system of claim 1 Goldberg further disclose wherein said computer system further provides a corrective action to said at least one user upon detection of said behavioral event. ([Para. 0006] the personalized profile is regularly and/or continuously updated based on ongoing monitoring with the wearable biosensor device, including the wearer's response patterns to previous treatment/therapeutic stimuli and their on-going response to new stimuli. The wearable sensor device checks a detected physiological state against the personalized profile to determine when to present an appropriate real-time therapeutic stimulus, such as cognitive behavioral therapy, exposure therapy, and/or relaxation techniques. As such, the invention provides devices and methods that enable "personalized medicine" for mental health treatments on-demand and driven by the wearer's current mental state. Examiner interprets therapeutic stimulus/ stimuli as being indicative of corrective action.)
As per Claim 7, Goldberg/ Shalon/ Pacione/ Ravindran/ Sobol disclose the platform system of claim 6 Goldberg further disclose wherein the corrective action is selected from the group consisting of alleviation, resolutive, or reminder action of the correct or incorrect behavior may be pulsation (making the heart tempo to reduce beats per minute), comprised of compression of user, visually, audibly/haptic reminder to user of what to do in accordance to prior procedure as indicated by health care professionals and other caregivers, visual, written, and auditory feedback. ([Para. 0086] that upon receipt of the data and/or instructions from the wearable biosensor device, the electronic device presents, displays or plays a select media file in real-time to the individual wearing the biosensor device (e.g., on a display screen or through speakers contained within the electronic device) based on the personalized profile of the wearer and reflecting previous responses to real-time treatments, thereby providing a therapeutic stimulus (including but not limited to cognitive behavioral therapy, exposure therapy, and breathing techniques such as deep breathing exercises and meditative techniques, photographs, audio, video, and text) to the individual wearing the device in real-time.)
As per Claim 8, Goldberg/ Shalon/ Pacione/ Ravindran/ Sobol disclose the platform system of claim 6 Goldberg further disclose wherein the corrective action is used for alleviation and/or self-correction of intended addressable behaviors. ([Para. 0006] determines when to present an appropriate real-time therapeutic stimulus, such as cognitive behavioral therapy, exposure therapy, and/or relaxation techniques. As such, the invention provides devices and methods that enable "personalized medicine" for mental health treatments on-demand and driven by the wearer's current mental state. [Para. 0010] that the information displayed to the wearer on the interface of the biosensor device, or on associated/connected devices, can be an alert of instructions to the user (e.g., to "take a deep breath ", or "relax"), or a visual stimulus (e.g., an image of a calming scene, a picture of a loved one, an amusing video, an inspiration phrase or quote).)
As per Claim 15, Goldberg teaches a platform system for remotely monitoring one or more behavioral event associated with a comorbidity of autism spectrum disorder affecting at least one user, the platform system comprising:
at least one processor; ([Para. 0008] remote processors)
and at least one computer system including a non-transitory memory communicatively coupled to the one or more processors, wherein the one or more processors are configured to execute instructions stored in the non-transitory memory, the instructions causing the one or more processors to: ([Para. 0011] electronic device such as a mobile phone, a smart phone, a digital personal assistant, a laptop computer, a tablet, an e-reader, a desktop computer, a television, a gaming device, or a remote server. Preferably, the transmitter wirelessly transmits the data to the electronic device in real-time. Suitable wireless transmitter systems include but are not limited to an IrDA, a Bluetooth.TM., a UWB, a Z-Wave, ANT, RFID, or a ZigBee transmitter system/network. The wearer’s profile data can be transferred through these means to enable personalized displays on any of the associated electronic devices, stored profiles for initializing new sensors, or profiles to initialize new treatment providers. [Para. 0097] the centralized computer infrastructure supporting proprietary data storage and analysis to include clinical summary reports, computed metrics, and correlations with logged activities. For example, data can be wirelessly transmitted from the wearable biosensor device to an electronic device via any number of wireless protocols including, but not limited to Bluetooth.TM., RFID, cellular, home, and corporate networks. Patients and clinicians can access the data stored on the centralized computing infrastructure, for example, via a website, to generate summary reports, or add additional data. Examiner interprets that the data storage is indicative of memory.)
receive a first information associated to an array of contextual data relating to said at least one user; ([Para. 0097] The centralized computer infrastructure supporting proprietary data storage and analysis to include clinical summary reports, computed metrics, and correlations with logged activities.)
receive a second information, from at least one wearable device associated to said at least one user, said at least one wearable device to an array of sensors for detecting physiological data of said at least one user, wherein said at least one wearable device having a second memory for storing an array of physiological data detected by said array of sensors; ([Para. 0008] a wearable biosensor device that includes at least one sensor for measuring physiological data, memory for storing the accumulated physiological data over time, an on-board processor for deriving a psychological profile based upon said accumulated physiological data, and an interface for displaying information concerning said psychological profile. Para. 0011 further teaches the wearable device can further include a transmitter for conveying the psychological profile or detected/accumulated physiological data directly to an associated electronic device such as a mobile phone, a smart phone, a digital personal assistant, a laptop computer, a tablet, an e-reader, a desktop computer, a television, a gaming device, or a remote server.)
determine the behavioral event associated with the comorbidity of autism spectrum disorder affecting said at least one user based on said array of physiological data of combination with said array of contextual data, said comorbidity selected from the at least one of anxiety attacks, physical form detection, force production, neurological disorders, eating disorders, smoking, and post-traumatic stress disorder (PTSD), ([Para. 0051] the wearable biosensor device 10 contains a processor configured for analyzing and deriving data indicative of a psychological state based on the physiological data collected by the biosensor. The processor analyzes the detected physiological data in real-time based on a personalized calibration file (information specific to the wearer) that is stored on the device. The wearable biosensor device then transmits the detected and/or derived data over a personal area network to an electronic device 9 such as a mobile phone, a smart phone, a digital personal assistant, a personal laptop computer, a desktop computer, a tablet, a television, a gaming device, or an e-reader. [Para. 0009] subjective data, reported by the patient, and treatment data, reported by the clinician, is combined with these physiological measurements to produce a cumulative data profiles tied to the individual wearer. [Para. 0021] methods for detecting, diagnosing, monitoring and treating one or more psychological disorders and/or psychological states, including but not limited to anxiety disorders post-traumatic stress disorder, obsessive-compulsive disorder, panic disorder, phobic disorders, depression, bipolar disorder, a psychotic disorder, and addiction, autism, attention deficit hyperactivity disorder, schizophrenia, stroke recovery, traumatic brain injury, eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge/compulsive over-eating, purging, etc.) and pain management. [Para. 0097] the data detected and stored on-board the wearable biosensor devices of the invention is transmitted to a centralized computer infrastructure supporting proprietary data storage and analysis to include clinical summary reports, computed metrics, and correlations with logged activities. Examiner interprets the subjective and treatment data to be indicative of contextual data.)
Goldberg does not explicitly disclose, however Shalon discloses
receive a first set of instructions to said at least one wearable device based on said behavioral event associated with the comorbidity of autism spectrum disorder, said first set of instructions providing said at least one user with haptic feedback to stimulate behavioral learning by training said at least one user to reduce or discontinue from said behavioral event, ([Para. 0047] monitor an eating behavior of a subject and provide real-time feedback for modifying such behavior. [Para. 0055] a system which can be worn by the user in a comfortable and concealed location on the body. Examiner interprets the ability of the system to be worn by the user to be indicative of a wearable device. [Para. 0195-0196] system 10 can also be configured for modifying a behavior of the subject. In order to enable such function, system 10 further includes a feedback element 24 which can provide the subject with feedback according to a behavior detected by system 10. Feedback element 24 can be a speaker, a vibrating element, an electrode or any element capable of providing the subject with sensory information (auditory, tactile etc.). Examiner interprets vibrating element to be indicative of haptic feedback. [Parra. 0386] The systems can also be used to monitor and modify behaviors associated with eating disorders such as bulimia and anorexia, as well as to other behaviors including snoring, sleep apnea, bruxism, smoking, alcohol consumption, drug addiction, exercise and physical training, stuttering, panic disorders, attention deficit, hyperactivity disorders, or other disorders that have unique physiological, sound or motion characteristics (i.e. activities) that can be identified and monitored.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a wearable device treating psychological disorders as taught by Goldberg and incorporate the haptic feedback as taught by Shalon, with the motivation of providing a plant to modify user behavior (Shalon Para. 0005).
wherein repeated use of said haptic feedback over time teaches said at least one user new behavior in response to said behavioral event ([Para. 0085] Feedback may also be provided to a user directly through sensor device in the form of tactile feedback such as vibration. Such feedback may be a reminder or an alert to eat a meal or take medication or a supplement such as a vitamin, to engage in an activity such as exercise or meditation, or to drink water when a state of dehydration is detected. [Para.0029] The energy balance and feedback subsystem provides feedback on behavioral strategies to achieve energy balance proactively. A feedback and coaching engine analyzes the data generated by the system to provide the user with a variety of choices depending on the progress of the user. [Para. 0036] The system may also provide feedback to the user in the form of a periodic or intermittent status report. The status report may be an alert located in a box on a location of the screen and is typically set off to attract the user's attention. Status reports and images are generated by creating a key string based on the user's current view and state and may provide information to the user about their weight loss goal progress. This information may include suggestions to meet the user's calorie balance goal for the day. [Para. 0034] he summary data could provide detailed information about the daily energy intake, daily energy expenditure, weight changes, body fat composition changes and nutrient information if the user has been consistently logging the foods consumed. Reports containing information for a certain time period, such as 7 days, 30 days, 90 days and from the beginning of the system usage may also be provided.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a wearable device treating psychological disorders as taught by Goldberg, the haptic feedback as taught by Shalon, and incorporate repeated use haptic feedback over time teaches and summation of behavior reports as taught by Pacione, with the motivation of providing a system that may be used as part of a behavioral modification program for calorie control, weight control or general fitness (Pacione Para. 0002).
Goldberg/ Shalon/ Pacione do not explicitly disclose, however Ravindran discloses
associated with the comorbidity of autism spectrum disorder to overcome the comorbidity as part of a be