DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In response to the amendment filed 12/10/2025; claims 1-7, 9-11,14 and 16-24 are pending; claims 8, 12-13 and 15 have been cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 9-11,14 and 16-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1,10 and 16, the abbreviations: i.e., "NIRS" and “FNIRS” render the claim indefinite because the abbreviation is not clarified in the claims.
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.
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.
Claims 1-7, 9-11,14 and 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dorfmann et al. (US 2012/0319869 A1) in view of Hall et al. (US 2021/0186330 A1)
Re claims 1, 10, 16:
Dorfmann teaches 1. A method for providing biofeedback to a user (Dorfmann, [0006], “the output from the biomonitoring system and using software modules modifies an information display based on the stress threshold”; [0008], “a display management system is notified that a first lower threshold has been exceeded”; [0024], “the warning messages”; [0035], “the operational display control 22 is notified that the drowsiness threshold”), the method comprising:
receiving, by one or more detectors mounted on a wearable device, a first functional signal associated with one or more biometric properties of the user (Dorfmann, [0006], “the output from the biomonitoring system and using software modules modifies an information display based on the stress threshold”; [0008], “a display management system is notified that a first lower threshold has been exceeded”; [0024], “the warning messages”; [0035], “the operational display control 22 is notified that the drowsiness threshold”; [0015], “FIG. 1 including a neura-headset 12 to read the brainwaves”);
processing, by one or more processors, the first signal (Dorfman, [0016], “computer system”);
responsive to processing the first signal, determining, by the one or more processors, a baseline cognitive state of the user based on the first signal and associated with the one or more biometric properties of the user (Dorfmann, [0007], “a biomonitoring sensor package including sensors selected from the set of a neuro-headset to read the brainwaves, sensors to read to heart rate, temperature, perspiration level, respiration and eye movement sensing”; [0035], “The biomonitor system then calculates a current stress value based on the sensor inputs, step 404. A determination is made if a lower initial threshold has been exceeded indicating operator reduced attentiveness”; fig. 4A – 4B, 406 – “Lower Initial Threshold” and 420 – “Upper Initial Threshold” are Baseline cognitive state is based on a biomonitoring senor package includes a plurality of sensors);
iteratively detecting, by the one or more detectors, an instant cognitive state of the users the instant cognitive state associated with the one or more biometric properties of the user (Dorfmann, [0017], “The biomonitoring system 20 will continue reading the biosignals of the operator”; [0008], “A current stress value is calculated based on the biosensor output to determine”);
receiving, from the detecting step, a second signal associated with the one or more biometric properties, the second signal comprising at least one of a second signal and a first electrophysiological signal (Dorfmann, [0007], “a biomonitoring sensor package including sensors selected from the set of”; [0015]);
determining, by the one or more processors, whether the second signal corresponds to one or more thresholds (Dorfmann, figs 4A – 4B, 408 “Lower Secondary Threshold Exceeded?”);
responsive to determining that the second signal corresponds to the one or more thresholds, initiating, by the one or more processors, one or more first feedback actions, wherein the one or more first feedback actions comprise one or more first types of stimulation provided to the user via one or more electrical terminals (Dorfmann, figs 4A – 4B, cognitive value between “lower / upper initial threshold” and “Lower / upper secondary threshold”; 410 – “Activate Additional Tasks” or 428 – “present predetermined task list” are first feedback actions; figs. 4A – 4B, 410, 416, 428, 436));
responsive to initiating the one or more first feedback actions, determining whether the instant cognitive state of the user is between the one or more thresholds and the baseline cognitive state (Dorfmann, figs. 4A – 4B, the system determines whether the cognitive state is not between “Lower Initial Threshold” and “Lower Secondary Threshold” OR not between “Upper Initial Threshold” and “Upper Secondary Threshold””); and
responsive to determining the instant cognitive state of the user is not between the one or more thresholds and the baseline cognitive state, initiating, by the one or more processors, one or more second feedback actions (Dorfmann, figs. 4A – 4B, 408 - “LOWER SECONDARY THRESHOLD EXCEEDED? Yes”; 418 - “UPPER SECONDARY THRESHOLD EXCEEDED? Yes” – 416 – “Activate Vibrator”; 436 – Present Predetermined Task list” – are second feedback actions).
10. A method for providing biofeedback to a user (Dorfmann, [0006], “the output from the biomonitoring system and using software modules modifies an information display based on the stress threshold”; [0008], “a display management system is notified that a first lower threshold has been exceeded”; [0024], “the warning messages”; [0035], “the operational display control 22 is notified that the drowsiness threshold”), the method comprising:
assigning, by one or more processors, a baseline cognitive state to the user based on one or more factors, the baseline cognitive state associated with one or more biometric properties of the user (Dorfmann, [0007], “a biomonitoring sensor package including sensors selected from the set of”; [0015]; [0035], “The biomonitor system then calculates a current stress value based on the sensor inputs, step 404. A determination is made if a lower initial threshold has been exceeded indicating operator reduced attentiveness”; fig. 4A – 4B, 406 – “Lower Initial Threshold” and 420 – “Upper Initial Threshold” are Baseline cognitive state);
iteratively detecting, by one or more detectors mounted on a wearable device, an instant cognitive state of the user, the instant cognitive state associated with the one or more biometric properties of the user (Dorfmann, [0006], “the output from the biomonitoring system and using software modules modifies an information display based on the stress threshold”; [0008], “a display management system is notified that a first lower threshold has been exceeded”; [0024], “the warning messages”; [0035], “the operational display control 22 is notified that the drowsiness threshold”; [0015], “FIG. 1 including a neura-headset 12 to read the brainwaves”), and the one or more detectors (Dorfmann, [0007], “a biomonitoring sensor package including sensors selected from the set of a neuro-headset to read the brainwaves, sensors to read to heart rate, temperature, perspiration level, respiration and eye movement sensing”; [0035], “The biomonitor system then calculates a current stress value based on the sensor inputs, step 404. A determination is made if a lower initial threshold has been exceeded indicating operator reduced attentiveness”; fig. 4A – 4B, 406 – “Lower Initial Threshold” and 420 – “Upper Initial Threshold” are Baseline cognitive state is based on a biomonitoring senor package includes a plurality of sensors);
receiving, from the detecting step, a first functional signal associated with the one or more biometric properties of the user (Dorfmann, [0006], “the output from the biomonitoring system and using software modules modifies an information display based on the stress threshold”; [0008], “a display management system is notified that a first lower threshold has been exceeded”; [0024], “the warning messages”; [0035], “the operational display control 22 is notified that the drowsiness threshold”; [0015], “FIG. 1 including a neura-headset 12 to read the brainwaves”);
processing, by the one or more processors, the first signal (Dorfman, [0016], “computer system”);
responsive to processing the first signal, determining, by the one or more processors, whether the first signal corresponds to one or more thresholds (Dorfmann, figs 4A – 4B, 408 “Lower Secondary Threshold Exceeded?”);
responsive to determining that the first signal corresponds to the one or more thresholds, initiating, by the one or more processors, one or more first feedback actions (Dorfmann, figs 4A – 4B, cognitive value between “lower / upper initial threshold” and “Lower / upper secondary threshold”; 410 – “Activate Additional Tasks” or 428 – “present predetermined task list” are first feedback actions);
responsive to initiating the one or more first feedback actions, determining whether the instant cognitive state of the user is between the one or more thresholds and the baseline cognitive state (Dorfmann, figs. 4A – 4B, the system determines whether the cognitive state is not between “Lower Initial Threshold” and “Lower Secondary Threshold” OR not between “Upper Initial Threshold” and “Upper Secondary Threshold””); and
responsive to determining the instant cognitive state of the user is not between the one or more thresholds and the baseline cognitive state, initiating, by the one or more processors, one or more second feedback actions, wherein the one or more second feedback actions comprise one or more first types of stimulation provided to the user via one or more electrical terminals (Dorfmann, figs. 4A – 4B, 408 - “LOWER SECONDARY THRESHOLD EXCEEDED? Yes”; 418 - “UPPER SECONDARY THRESHOLD EXCEEDED? Yes” – 416 – “Activate Vibrator”; 436 – Present Predetermined Task list” – are second feedback actions; figs. 4A – 4B, 410, 416, 428, 436).
16. A method for providing biofeedback to a plurality of users (Dorfmann, [0006], “the output from the biomonitoring system and using software modules modifies an information display based on the stress threshold”; [0008], “a display management system is notified that a first lower threshold has been exceeded”; [0024], “the warning messages”; [0035], “the operational display control 22 is notified that the drowsiness threshold”), the method comprising:
receiving, by one or more detectors mounted on one or more wearable devices, a respective first functional signal associated with one or more biometric properties of each user of the plurality of users (Dorfmann, [0006], “the output from the biomonitoring system and using software modules modifies an information display based on the stress threshold”; [0008], “a display management system is notified that a first lower threshold has been exceeded”; [0024], “the warning messages”; [0035], “the operational display control 22 is notified that the drowsiness threshold”; [0015], “FIG. 1 including a neura-headset 12 to read the brainwaves”), the one or more detectors (Dorfmann, [0007], “a biomonitoring sensor package including sensors selected from the set of a neuro-headset to read the brainwaves, sensors to read to heart rate, temperature, perspiration level, respiration and eye movement sensing”; [0035], “The biomonitor system then calculates a current stress value based on the sensor inputs, step 404. A determination is made if a lower initial threshold has been exceeded indicating operator reduced attentiveness”; fig. 4A – 4B, 406 – “Lower Initial Threshold” and 420 – “Upper Initial Threshold” are Baseline cognitive state is based on a biomonitoring senor package includes a plurality of sensors);
iteratively detecting, by the one or more detectors, a respective instant cognitive state of each user, the respective instant cognitive state associated with the one or more biometric properties of each user (Dorfmann, [0017], “The biomonitoring system 20 will continue reading the biosignals of the operator”; [0008], “A current stress value is calculated based on the biosensor output to determine”);
receiving, from the detecting step, a respective second signal associated with the one or more biometric properties of at least a first user of the plurality of users, the respective second signal comprising at least one of a second signal and a first electrophysiological signal (Dorfmann, [0007], “a biomonitoring sensor package including sensors selected from the set of”; [0015]);
determining, by the one or more processors, whether the respective second signal corresponds to one or more thresholds (Dorfmann, figs 4A – 4B, 408 “Lower Secondary Threshold Exceeded?”);
responsive to determining that the respective second signal corresponds to the one or more thresholds, initiating, by the one or more processors, one or more first feedback actions associated with at least a second user of the plurality of users, wherein the one or more first feedback actions comprise one or more first types of stimulation provided to the second user via one or more electrical terminals (Dorfmann, figs 4A – 4B, cognitive value between “lower / upper initial threshold” and “Lower / upper secondary threshold”; 410 – “Activate Additional Tasks” or 428 – “present predetermined task list” are first feedback actions; figs. 4A – 4B, 410, 416, 428, 436; figs. 4A – 4B show that a plurality of feedback actions associated with a single user; wherein the first and second feedback actions associated with the single user (same user));
responsive to initiating the one or more first feedback actions, determining whether the respective instant cognitive state of each user is between the one or more thresholds and a respective baseline cognitive state of each user (Dorfmann, figs. 4A – 4B, the system determines whether the cognitive state is not between “Lower Initial Threshold” and “Lower Secondary Threshold” OR not between “Upper Initial Threshold” and “Upper Secondary Threshold””); and
responsive to determining the respective instant cognitive state of each user is not between the one or more thresholds and the respective baseline cognitive state, initiating, by the one or more processors, one or more second feedback actions associated with at least a third user of the plurality of users (Dorfmann, figs. 4A – 4B, 408 - “LOWER SECONDARY THRESHOLD EXCEEDED? Yes”; 418 - “UPPER SECONDARY THRESHOLD EXCEEDED? Yes” – 416 – “Activate Vibrator”; 436 – Present Predetermined Task list” – are second feedback actions).
Dorfman teaches incorporates a biomonitoring sensor package including sensors selected from the set of a neuro-headset to read the brainwaves, sensors to read to heart rate, temperature, perspiration level, respiration and eye movement sensing (Dorfman, [0007]); however, Dorfman does not explicitly disclose a first functional NIRS (fNIRS) signal associated with one or more biometric properties of the user and a second function NIRS (fNIRS) signal. Hall teaches a method and system for assessment of cognitive function of an individual. The method includes having an individual execute a standardized cognitive task, followed by a brain perturbation which either excites or suppresses cognitive ability (Hall, Abstract). Hall further teaches a first functional NIRS (fNIRS) signal associated with one or more biometric properties of the user, the one or more detectors comprising at least a first optical detector configured to detect backscattered light from a light source as the backscattered light travels through tissue of the user (Hall, [0005], “neuroimaging technology is used to produce images of the brain over which certain parameters of brain function are laid. The functional parameters include … continuous wave near infrared spectroscopy (fNIRS)”; [0156], “The system of FIG. 6 includes an fNIRS sensor band 700 … The sensor band 700 is configured for placement over the head of an individual, and includes multiple light sources and sensors embedded therein facing the head surface”; [0173], “This view shows the sensor array area 810, where an fNIRS sensor band can be positioned with its embedded light emitters 812”; [0044], “quantify other parameters of the brain of an individual, such as lower and upper limits of their cognitive abilities”; [0139], “This will allow the upper and lower bounds of performance potentials to be realized. This upper and lower boundary to performance—identifying what is “possible” in relation to performance for a given individual”; [0104], “interventions that are intended to augment prefrontal function, for example via exercise, brain stimulation or computer based cognitive training”). Therefore, in view of Hall, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method described in Dorfman, by providing the neuroimaging technology such as FNIRS as taught by Hall, since neuroimaging technology is used to produce images of the brain over which certain parameters of brain function are laid. The functional parameters include electric signals and blood oxygenation changes that signify underlying neural activity (Hall, [0005]).
Re claims 2 – 3:
2. The method of claim 1, wherein the one or more biometric properties comprise one or more optical biometric properties and one or more non-optical biometric properties (Dorfmann, [0007]; [0015]).
3. The method of claim 2, wherein: the one or more optical biometric properties comprise one or more of tissue oxygenation, heart rate, respiratory rate, oxygen saturation, blood pressure, or combinations thereof; and the one or more non-optical biometric properties comprise one or more of electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), bioimpedance circuitry, thermal properties, mechanical properties, or combinations thereof (Dorfmann, [0007]; [0015]).
Re claim 4:
4. The method of claim 1, wherein the one or more thresholds are based on a level of effort by the user in one or more tasks, a level of engagement of the user in the one or more tasks, a level of fatigue of the user in the one or more tasks, or combinations thereof (Dorfmann, [0025], “work load/stress level”; [0019], “indicate loss of attentiveness or alertness and thus the potential for lapses in attention and behavior”).
Re claim 5:
5. The method of claim 1, wherein the one or more second feedback actions comprise one or more of an optical biometric property reading, a non-optical biometric property reading, one or more second types of stimulation, a content modification, or combinations thereof (Dorfmann, figs. 4A – 4B, 410, 416, 428, 436).
Re claim 6:
6. The method of claim 1, wherein: the one or more first types of stimulation comprise one or more of transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), vagus nerve stimulation (nVNS), transcutaneous electrical nerve stimulation (TENS), transcranial magnetic stimulation (TMS), sound stimulation, optical stimulation, mechanical stimulation, or combinations thereof (Dorfmann, [0002], “recovery stimulation”; [0023], “vibration module”; [0036]; Hall, [0104], “interventions that are intended to augment prefrontal function, for example via exercise, brain stimulation or computer based cognitive training”).
Re claim 7:
7. The method of claim 5, wherein the content modification comprises one or more of a change in task type, a change in task difficulty, a change in training, a change in medical treatment, a delivery of one or more types of therapy, a connection to an artificial intelligence (AI) system, or combinations thereof, and wherein the one or more types of therapy comprise one or more of cognitive therapy, psychological therapy, physical therapy, or combinations thereof (Dorfmann, figs. 4A – 4B, 410, 416, 428, 436; Hall, [0104], “interventions that are intended to augment prefrontal function, for example via exercise, brain stimulation or computer based cognitive training”).
Re claim 9:
9. The method of claim 1, wherein the one or more first and second feedback actions are provided to the user via an environmental property comprising one or more of temperature, pressure, chemical composition, sound, light, motion, or combinations thereof (Dorfmann, figs. 4A – 4B, 410, 416, 428, 436; [0006], “the output from the biomonitoring system and using software modules modifies an information display based on the stress threshold”; [0008], “a display management system is notified that a first lower threshold has been exceeded”; [0024], “the warning messages”; [0035], “the operational display control 22 is notified that the drowsiness threshold”).
Re claim 11:
11. The method of claim 10, wherein the one or more factors comprise one or more of age, sex, gender, education level, profession, medical history, content familiarity, task engagement, task effort, task performance, environmental factors, or combinations thereof (Dorfmann, [0025], “work load/stress level”; [0019], “indicate loss of attentiveness or alertness and thus the potential for lapses in attention and behavior”).
Re claim 14:
14. The method of claim 10, wherein the one or more first feedback actions comprise one or more of an optical biometric property reading, a non-optical biometric property reading, one or more second types of stimulation, a content modification, or combinations thereof (Dorfmann, [0007]; [0015]).
Re claim 17:
17. The method of claim 16, wherein: the one or more biometric properties comprise one or more optical biometric properties and one or more non-optical biometric properties; the one or more optical biometric properties comprise one or more of tissue oxygenation, heart rate, respiratory rate, oxygen saturation, blood pressure, or combinations thereof; and the one or more non-optical biometric properties comprise one or more of electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), bioimpedance circuitry, thermal properties, mechanical properties, or combinations thereof (Dorfmann, [0007]; [0015]).
Re claim 18:
18. The method of claim 16, wherein the one or more thresholds are based on one or more of a level of effort by each user in one or more tasks, a level of engagement of each user in the one or more tasks, a level of fatigue of each user in the one or more tasks, or combinations thereof (Dorfmann, [0025], “work load/stress level”; [0019], “indicate loss of attentiveness or alertness and thus the potential for lapses in attention and behavior”).
Re claim 19:
19. The method of claim 16, wherein the one or more second feedback actions comprise one or more of an optical biometric property reading, a non-optical biometric property reading, one or more second types of stimulation, a content modification, or combinations thereof (Dorfmann, figs. 4A – 4B, 410, 416, 428, 436).
Re claim 20:
20. The method of claim 16, wherein: at least two of the first, second, and third users are the same person (Dorfmann, figs. 4A – 4B show that a plurality of feedback actions associated with a single user; wherein the first and second feedback actions associated with the single user (same user).
Re claims 22 - 23:
Dorfman does not explicitly disclose the first optical detector and the first non-optical detector are housed within the wearable device. Hall teaches the limitations: 22. The method of claim 21, wherein the first optical detector and the first non-optical detector are housed within the wearable device. 23. The method of claim 1, wherein the one or more electrical terminals are housed within the wearable device (Hall, figs. 6; fig. 7A – 7B; [0156], “The system of FIG. 6 includes an fNIRS sensor band 700, an rTMS coil 702, virtual reality goggles 704, an rTMS device 706, an fNIRS console 708, and a computer (not shown)”). Therefore, in view of Hall, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method described in Dorfman, by integrating sensors into a wearable device as taught by Hall, so that the device can be readily use by a subject without connecting separate components (Hall, Abstract, “fitted helmet with integrated neuroimaging sensors”). Furthermore, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Re claim 24:
24. The method of claim 2, wherein: the one or more optical biometric properties comprise one or more of tissue oxygenation, oxygen saturation, blood pressure, or combinations thereof; and the one or more non-optical biometric properties comprise one or more of electrooculography (EOG), electromyography (EMG), bioimpedance circuitry, or combinations thereof (Dorfmann, [0007]; [0015]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7, 9-11,14 and 16-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JACK YIP/Primary Examiner, Art Unit 3715