Response to Amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5-8, 11-14, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cuddihy et al. (US 20130053653 A1) in view of Heit et al. (US 20110190594 A1).
In regard to claim 1, Cuddihy teaches a method for monitoring a status of a user and providing feedback to the user (Cuddihy, Fig. 1), the method comprising: using a radar disposed within a vicinity of the user (Cuddihy, Para. 21, the range-gated radar system 108 monitors the subject 102 relaxing or sleeping on the bed 112 disposed in the designated space 102) and detecting a plurality of signals associated with one or more vital signs of the user at a predetermined time (Cuddihy, Para. 22, While monitoring the subject 102, the radar system 108 transmits electromagnetic signals towards the desired portions of the designated space 104 such as the bed 112 and senses corresponding echo signals reflected from the subject 102 disposed on the bed 112; the radar system 108 employs the antenna 110 to transmit and receive one or more pulse sequences that are sensitive to not only gross body motion but also physiological motion such as heartbeat and respiration of the subject 102; Para. 27, the processing unit 116 monitors the subject 102 over a designated period of time and stores the corresponding motion, heartbeat and respiration data for further evaluation); processing the plurality of signals (Cuddihy, Para. 25, the processing unit 116 filters the reflected radar signals to extract motion, heartbeat and respiration data into signal frames based on their corresponding frequency band characteristics. The processing unit 116 then uses the extracted values to determine a health condition of the subject 102); determining a classification associated with the one or more vital signs of the user (Cuddihy, Para. 26, the processing unit 116 performs spectral evaluation of the extracted heartbeat and respiration frames to determine if the subject 102 is suffering from conditions such as arrhythmia, bradycardia, tachycardia, bradypnea, tachypnea and/or apnea); storing the classification associated with the one or more vital signs of the user at the predetermined time (Cuddihy, Para. 27, the motion, respiration and heartbeat data captured and stored when the subject 102 is healthy is used as a baseline for evaluation. In another embodiment, the processing unit 116 uses the motion, respiration and heartbeat data captured and stored when the subject 102 is unhealthy as a baseline for evaluating improvement and/or degradation of the subject's health); continuing the detecting, processing, and storing for a plurality of other predetermined times to create a history of the one or more vital signs of the user (Cuddihy, Para. 27, the motion, respiration and heartbeat data captured and stored when the subject 102 is healthy is used as a baseline for evaluation. In another embodiment, the processing unit 116 uses the motion, respiration and heartbeat data captured and stored when the subject 102 is unhealthy as a baseline for evaluating improvement and/or degradation of the subject's health); capturing using the radar a plurality of current signals associated with the one or more vital signs of the user at a current time (Cuddihy, Para. 28, the processing unit 116 compares the measured heartbeat and respiration data with corresponding baseline values for early detection of changes in cardiac function that indicate an increased risk of heart disease); processing the plurality of current signals and the history of the one or more vital signs of the user to identify a current task to be outputted to a party (Cuddihy, Para. 29, the processing unit 116 evaluates the changes for tracking recovery, medication effects, or predicting increased risk of impending health impairment. By way of example, the processing unit 116 evaluates the changes and aids a medical practitioner in recommending specific sleep hygiene for monitoring subjects suffering from traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD), who rarely experience "regular" periods of sleep); outputting the current task to the party to improve the status of the user when the current task is performed and wherein the current task is related to an emotional state, a mental condition, insomnia, menopause, hot flashes, or obesity of the user (Cuddihy, Para. 29, the processing unit 116 evaluates the changes and aids a medical practitioner in recommending specific sleep hygiene for monitoring subjects suffering from traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD), who rarely experience "regular" periods of sleep; The processing unit 116, thus, provides information to aid in adapting the treatment and suggesting behavior that benefits the health of the subject 102; Para. 48, The processing unit 116 then compares the determined characteristics and patterns with stored motion, heartbeat and/or respiration patterns indicative of potential health conditions to identify if the subject 102 is suffering from a specific ailment such as apnea, arrhythmia or sleep disturbance).
Cuddihy does not specifically teach the current task including a wind down routine; and initiating the wind down routine for the user based on the history of the one or more vital signs or activities of daily life of the user, and wherein the history of the one or more vital signs or activities of daily life of the user includes at least a heart rate of the user or a breathing rate of the user.
However, Heit teaches the current task including a wind down routine (Para. 96, The system of the invention may use tactile feedback to prompt the patient to leave the bed if the patient has not been able to initiate sleep within a predetermined length of time. Likewise, the system of the invention can assist with the sleep restriction part of CBT. Sleep restriction therapy may allocate a fixed time window every night in which the patient is instructed to try to sleep. Patients are instructed not to try to initiate sleep earlier, and they are instructed not to rise later than prescribed); and initiating the wind down routine for the user based on the history of the one or more vital signs or activities of daily life of the user, and wherein the history of the one or more vital signs or activities of daily life of the user includes at least a heart rate of the user or a breathing rate of the user (Para. 39, If a sleep breathing disorder is diagnosed by the sleep specialist, he may initiate a separate treatment of the disorder; After that, the specialist may use the system to monitor sleep quality to identify whether or not the patient still experiences symptoms of insomnia. In order to treat insomnia symptoms, the specialist can initiate non-pharmacological cognitive behavior treatment at the patient's home).
Cuddihy and Heit are analogous are because they both pertain to health condition monitoring system.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have non-pharmacological cognitive behavior treatment providing wind down routine (as taught by Heit) resulting in predictable result of improving quality of sleep in insomnia patients.
In regard to claim 2, Combination of Cuddihy and Heit teach the method of claim 1, wherein the current task comprises a cognitive behavior therapy (Heit, Para. 14, Non-pharmacological treatment, e.g., cognitive behavior treatment for insomnia (CBT) or psychotherapy, has been shown to improve quality of sleep in insomnia patients).
In regard to claim 3, Combination of Cuddihy and Heit teach the method of claim 2, wherein the cognitive behavior therapy comprises one or more of an audio message, a mechanical vibration, a light emitted, an on-screen instruction, or changing an environmental setting (Heit, Para. 96, One part of remote delivery of CBT can include educational videos and text that can be reviewed interactively using electronic questionnaires or games. While the system of the invention can certainly offer (pre-loaded) audio/visual and textual education material, the system can also assist with various other parts of CBT treatment that traditionally require the feedback of a clinician).
In regard to claim 5, Combination of Cuddihy and Heit teach the method of claim 1, wherein the current task is related to a stimulus control for the user (Heit, Para. 96, During stimulus control therapy, patients may be instructed to get out of bed if they cannot fall asleep. After getting out of bed, the patients are further instructed to engage in a relaxing activity until they feel tired again. It may be counterproductive for insomnia patients to frequently check the clock as they are trying to fall asleep).
In regard to claim 6, Combination of Cuddihy and Heit teach the method of claim 1, wherein the current task comprises one or more of a plurality of pre-trained therapies based on an age, a sex, or a body mass index of the user (Heit, Fig. 7; Para. 43, DPU 24 may be used to instruct the patient in setting up the system and in the use of the sensors mentioned above. Delivery of treatment may be done mostly by standardized content stored on DPU 24. This content may include, but is not limited to, audio-visual instructions as well as interactive educational and motivational information stored in text form. Depending on therapy progress, the clinician may change this content or add to the content. The clinician may, for example, change the frequency, the duration, and the succession of particular exercises of CBT, or hold real-time therapy sessions with the patient using the remote audio/video conferencing capabilities of the system. As clinicians may observe symptoms and therapy progress by virtue of increased or decreased measures of sleep quality for the individual patient, clinicians may not need to monitor patients during their sleep activity in real-time. The data acquired in real-time can be stored for future analysis or reference).
In regard to claim 7, Combination of Cuddihy and Heit teach the method of claim 1, wherein the mental condition comprises one or more of depression and anxiety (Heit, Para. 8, Chronic insomnia can be caused by substance abuse, mental disorders such as depression, breathing disorders, or by other sleep disorders such as periodic limb movement).
In regard to claim 8, Combination of Cuddihy and Heit teach the method of claim 1, wherein outputting the current task comprises transmitting the current task to the party by text message, voice message, a light notification, or a mechanical vibration (Heit, Para. 96, One part of remote delivery of CBT can include educational videos and text that can be reviewed interactively using electronic questionnaires or games. While the system of the invention can certainly offer (pre-loaded) audio/visual and textual education material, the system can also assist with various other parts of CBT treatment that traditionally require the feedback of a clinician).
In regard to claim 11, Cuddihy teaches the method of claim 1, wherein the plurality of signals comprises one or more of a motion signal, a vital organ signal, a spatial location of the user, or a spatial configuration of the user (Cuddihy, Para. 23, the radar system 108 transmits two pulses at a high repetition rate (on the order of 5 MHz) for a carrier in the 5.8 GHz ISM band for monitoring movements of the subject 102. The radar system 108 then receives signals reflected from subject 102 and determines one or more motion and physiological parameters of the subject 102 using the received signals).
In regard to claim 12, Cuddihy teaches the method of claim 1, wherein the one or more vital signs comprises a heart rate or a breathing rate (Cuddihy, Para. 43, The processing unit 116 uses the extracted features and estimated rates and values for identifying a health condition of the subject 102. The processing unit 116, for example, uses the extracted breathing rate or pattern to determine if the subject 102 is suffering from bradypnea (slow breathing), tachypnea (fast breathing), apnea (interrupted breathing) or cardiac pulmonary respiratory disease that require increased respiratory effort. Similarly, the processing unit 116 uses the determined heart rate and motion to identify underlying health conditions such as bradycardia (slow heartbeat), tachycardia (fast heartbeat), arrhythmia (irregular heartbeat) and/or sleep fragmentation).
In regard to claim 13, Cuddihy teaches the method of claim 1, wherein the party is the user or a third party (Cuddihy, Para. 29, the processing unit 116 evaluates the changes for tracking recovery, medication effects, or predicting increased risk of impending health impairment. By way of example, the processing unit 116 evaluates the changes and aids a medical practitioner in recommending specific sleep hygiene for monitoring subjects suffering from traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD), who rarely experience "regular" periods of sleep).
In regard to claim 14, Cuddihy teaches the method of claim 11, wherein the third party comprises a family member of the user, a caretaker, or an emergency response team (Cuddihy, Para. 29, the processing unit 116 evaluates the changes for tracking recovery, medication effects, or predicting increased risk of impending health impairment. By way of example, the processing unit 116 evaluates the changes and aids a medical practitioner in recommending specific sleep hygiene for monitoring subjects suffering from traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD), who rarely experience "regular" periods of sleep).
In regard to claim 20, the claim is interpreted and rejected for the same reasons as stated in the rejection of claim 1 as stated above.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cuddihy et al. (US 20130053653 A1) in view of Heit et al. (US 20110190594 A1) and further in view of Stoian et al. (US 20130331662 A1).
In regard to claim 4, Combination of Cuddihy and Heit do not specifically teach the method of claim 1, wherein the current task comprises a breathing exercise.
However, the concept of providing feedback on breathing when a user exhibiting poor breathing is well known in the art as also taught by Stoian. Stoian teaches Any or all of these measures or metrics could be analyzed based on a time of day, a certain timeframe, or other time-related component. In addition to the above, second level algorithms could include feedback to the user when they are exhibiting poor breathing and should take a deep breath or some other breathing exercise, an interactive breathing exercise coach and feedback tool, or a daily tracker to give feedback on certain poor breathing times of day or events tied to poor breathing. An algorithm could also automatically detect any event that a physician currently diagnoses by listening to a stethoscope, such as a wheeze or stridor. Algorithms used to detect certain physiological states, breathing metrics or respiratory include those that are manually developed and automated pattern recognition techniques such as neural networks (Para. 48).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include an interactive breathing exercise as a CBT (as taught by Stoian) resulting in predictable result of giving feedback on certain poor breathing events.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cuddihy et al. (US 20130053653 A1) in view of Heit et al. (US 20110190594 A1) and further in view of Cuddihy et al. (US 20070123754 A1).
In regard to claim 18, Cuddihy (653) and Heit do not teach the method of claim 1, further comprising attenuating a plurality of signals detected by the sensing device that are from targets unrelated to the user.
However, the concept of having a tag identifying the patient is well known in the art as also taught by Cuddihy (754). Cuddihy (754) teaches patient 112 is located in a home 302. The device 102 is employable with other worn devices and/or other devices placed around the home 302 of the patient 112. The device 102 helps identify the patient 112 when the device 102 is employed with other devices for measuring activity of the patient 112 (Para. 34). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include a device with the patient (as taught by Cuddihy (754)) resulting in predictable result of the system recognize the patient around other targets.
In regard to claim 19, Combination of Cuddihy (653), Heit, and Cuddihy (754) teach the method of claim 1, further comprising identifying the user when another target is adjacent the user (Cuddihy (754), Para. 34, patient 112 is located in a home 302. The device 102 is employable with other worn devices and/or other devices placed around the home 302 of the patient 112. The device 102 helps identify the patient 112 when the device 102 is employed with other devices for measuring activity of the patient 112).
Response to Arguments
Applicant's arguments filed on 10/21/2025 have been fully considered but they are not persuasive. In that remarks, applicant's argues in substance:
Applicant argues: " The Examiner cites paragraph 96 of Heit as teaching the claimed "wind down routine," but this citation is misplaced. Paragraph 96 specifically states: "The system of the invention may use tactile feedback to prompt the patient to leave the bed if the patient has not been able to initiate sleep within a predetermined length of time." This describes prompting a patient to get out of bed when they cannot fall asleep, which is the opposite of a wind down routine. A wind down routine, by definition, is a series of calming activities designed to prepare someone for sleep - not to prompt them to leave their bed. Claim 1 recites "initiating the wind down routine for the user based on the history of the one or more vital signs," which contemplates beginning preparatory sleep activities, not instructing someone to abandon their sleep attempt. Heit's Sleep Restriction Therapy Is Not a Wind Down Routine, The Examiner also cites Heit's discussion of sleep restriction therapy as teaching a wind down routine. However, sleep restriction therapy involves "allocat[ing] a fixed time window every night in which the patient is instructed to try to sleep" and instructing patients "not to try to initiate sleep earlier, and they are instructed not to rise later than prescribed." (Paragraph 96) This is fundamentally different from a wind down routine, as it merely sets time boundaries for sleep attempts rather than providing calming preparatory activities.”
Examiner's Response: Examiner respectfully submits that a fixed time window every night in which the patient is instructed to try to sleep would the wind down routine where the user is instructed to lay down trying to sleep/relax before falling asleep.
Applicant argues: “This describes human-initiated treatment by a medical professional, not system-initiated wind down routines based on historical heart rate or breathing rate data as claimed. Claim 1 recites automatic initiation "based on the history of the one or more vital signs or activities of daily life of the user," where the history specifically "includes at least a heart rate of the user or a breathing rate of the user.”
Examiner’s Response: Examiner respectfully submits Heit teaches system of the invention allocates a fixed time window every night in which the patient is instructed to try to sleep which is done automatically every night by the system. Moreover claim 1 does not recite automatic initiation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARMIN AKHTER whose telephone number is (571)272-9365. The examiner can normally be reached on Monday - Thursday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Davetta W Goins can be reached on (571) 272.2957. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARMIN AKHTER/
Examiner, Art Unit 2689
/DAVETTA W GOINS/Supervisory Patent Examiner, Art Unit 2689