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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24 November 2025 has been entered.
Status of Claims
Claims 1-26 are pending and currently under consideration for patentability; claims 1 and 11 have been amended.
Response to Arguments
Applicant’s arguments dated 24 November 2025 have been fully considered, but they are not persuasive or 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.
Applicant has amended the independent claims to recite that pulse morphology data is conditioned on environmental factors, arguing that the previously applied prior art does not disclose or suggest such limitations. The Examiner has addressed the amended limitations in the updated text of the rejection below. The Examiner briefly responds to Applicant’s arguments herein.
Applicant argues that Tzvieli does not disclose or suggest the use of a statistical distribution based on previously acquired pulse morphology data that has been conditioned on environmental factors. Applicant states that Tzvieli “at most teaches considering environmental factors as additional inputs/contexts and training under varied conditions” (Arguments, p. 13). The Examiner respectfully disagrees and submits that Applicant may be using an overly narrow interpretation of the reference. For example, when stating that some features values utilized by the computer may be generated based on additional source of data, including time of day, day of month, day in the year, as well as measures of environment such as temperature, humidity, and air quality, Tzvieli describes that the environmental factors have been accounted for in generating the feature vectors that are used in the comparisons. If Tzvieli teaches considering environmental factors, as stated by Applicant and with which Examiner agrees, then it stands to reason that the contributions of these environmental factors to the collected data are considered. Therefore, the Examiner respectfully submits that Tzvieli, at the very least, suggests conditioning pulse morphology data based on environmental factors.
Applicant traverses the Examiner’s position that Honda determines when pulse morphology data falls outside a preset range. The Examiner has clarified the interpretation of the Tzvieli and Honda references as pertains to this limitation in the updated text of the rejection below. The Examiner respectfully maintains that the source of the data and the nature of the data being gathered is not as relevant to this discussion as the fact that Honda describes identifying data that falls outside of a given range. It is this teaching - identifying data that falls outside of a given range - upon which the Examiner relies in making the obviousness rejection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 7-15, and 17-26 are rejected under 35 U.S.C. 103 as being unpatentable over Tzvieli et al. (US 2020/0085312 A1) in view of Honda et al. (US 2001/0008953 A1).
Regarding claims 1 and 11, Tzvieli describes a method and system, comprising:
continuously receiving, by a processor of a computing device ([0106]), from a psychological and physiological sensing device worn on a head of a subject, sensor data from a plurality of sensors fixed to the PPS device ([0123])
wherein the computing device communicates with the PPS device ([0106])
wherein the plurality of sensors comprises at least one left-temple photoplethysmography sensor configured to be coupled to a left-temple region of the head and at least one right-temple PPG sensor configured to be coupled to a right-temple region of the head ([0123], [0180] - [0181])
wherein the at least one left-temple PPG sensor is configured to detect pulsating blood flow in blood vessels proximal to the left-temple region and the at least one right-temple PPG sensor is configured to detect pulsating blood flow in blood vessels to the right-temple region ([0081], [0134])
continuously detecting, by the processor, from the sensor data from the at least one left-temple PPG sensor and the at least one right-temple PPG sensor, a left-temple PPG signal and a right-temple PPG signal ([0180] - [0181])
continuously determining, by the processor, at least one pulse morphology data of pulses related to the pulsating blood flow from the left-temple PPG signal and the right-temple PPG signal ([0157])
wherein the least one pulse morphology data of each pulse in the left-temple PPG signal and the right-temple PPG signal comprises a pulse amplitude of each pulse ([0157])
storing, by the processor, the at least one pulse morphology data of the pulses in the left-temple PPG signal and the right-temple PPG signal in a memory of the computing device ([0106], [0175])
determining, by the processor, a possibility of a cardiac dysfunction ([0100]), a cerebral dysfunction ([0483]), or both in the subject based on a comparison of at least one current pulse morphology data from the left-temple PPG signal with at least one current pulse morphology data from the right-temple PPG signal ([0147] - [0149], [0160])
outputting, by the processor, an alert of the possibility of the cardiac dysfunction, the cerebral dysfunction, or both, in the subject on an output device of the computing device ([0231])
wherein the determining of the possibility of the cardiac dysfunction, the cerebral dysfunction, or both, comprises determining whether pulse morphology data falls outside a statistical distribution ([0157]), the statistical distribution being determined based at least in part on previously acquired pulse morphology data for the subject ([0128] - [0129], [0158]) and conditioned on environmental factors ([0098])
Regarding claims 1 and 11, although Tzvieli describes generating the alert based on pulse morphology data, Tzvieli does not explicitly disclose identifying data that falls outside a preset number of standard deviations from a mean in order to generate the alert. However, Honda also describes a method of analyzing patient physiological data ([0026]), including determining when data falls outside a preset number of standard deviations from a mean ([0042] - [0043]). As Honda is also directed towards measuring patient physiological data and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a statistical analysis technique similar to that described by Honda in order to generate the alert described by Tzvieli, as doing so advantageously allows the resulting method to alert the user when outlier data is measured.
Regarding claims 2 and 12, Tzvieli describes wherein the output device is a display, a speaker for generating an alarm, or both ([0231]).
Regarding claims 3 and 13, Tzvieli describes wherein the computing device is a computer ([0106]).
Regarding claims 4 and 14, Tzvieli describes wherein the cerebral dysfunction comprises a hemorrhagic stroke or an ischemic stroke ([0125]).
Regarding claims 5 and 15, Tzvieli describes wherein the plurality of sensors comprises at least one electroencephalogram sensor ([0098]).
Regarding claims 7 and 17, Tzvieli describes wherein the plurality of sensors comprises at least one left-temple electrocardiogram sensor configured to be coupled to the left-temple region and at least one right-temple ECG sensor configured to be coupled to the right-temple region of the head ([0098], [0123], [0180]).
Regarding claims 8 and 18, Tzvieli describes
continuously detecting, by the processor, an ECG signal from a difference between the sensor data from the at least one left-temple ECG sensor and the at least one right-temple ECG sensor ([0098], [0157])
computing, by the processor, a velocity of the pulsating blood flow in the blood vessels proximal to the left-temple region ([0084], [0086]) based in part on a difference between the timestamp of a current QRS complex in the ECG signal and the timestamp of a current pulse in the left-temple PPG signal ([0138] - [0139])
computing, by the processor, a velocity of the pulsating blood flow in the blood vessels proximal to the right-temple region ([0084], [0086]) based in part on a difference between the timestamp of a current QRS in the ECG signal and the timestamp of a current pulse in the right-temple PPG signal ([0138] - [0139])
Honda describes continuously determining, by the processor, at least one ECG morphology data in the ECG data, wherein the at least one ECG morphology data comprises a timestamp of each QRS complex ([0005]).
Regarding claims 9 and 19, Tzvieli describes wherein the plurality of sensors comprises an accelerometer ([0264]).
Regarding claims 10 and 20, Tzvieli describes compensating, by the processor, for noise in the left-temple PPG signal and the right-temple PPG signal caused by movements of the subject by using the output data of the accelerometer ([0109], [0135]).
Regarding claim 21, Tzvieli describes wherein the PPS device further comprises a bridge of an adjustable length with a first end fixed to the at least one left-temple sensor and a second end fixed to the at least one right-temple sensor ([0102], [0123]), wherein the adjustable length ensures that the at least one left-temple sensor is positioned over the left-temple region of the subject and the at least one right-temple sensor is positioned over the right-temple region of the subject, respectively ([0123]).
Regarding claim 22, Tzvieli describes wherein the at least one left-temple sensor and the at least one right-temple sensor each comprise electrodes for contacting the left-temple region and the right-temple region respectively of the subject ([0098], electrodes being well-known for use as ECG, EEG, and GSR sensors).
Regarding claim 23, Tzvieli describes wherein the PPS device further comprises an electronic circuitry housing fixed to the bridge and comprising electronic circuitry ([0106]).
Regarding claim 24, Tzvieli describes wherein the bridge comprises a lumen, wherein the at least one left-temple sensor and the at least one right-temple sensor are electrically coupled to the electronic circuitry by wires within the lumen ([0197]; figure 19A).
Regarding claim 25, Tzvieli describes wherein the plurality of sensors comprises at least one electroencephalogram sensor coupled to a forehead of the subject ([0098], [0146]), wherein a cable electrically couples the at least one EEG sensor to the electronic circuitry in the electronic circuitry housing ([0197]; figure 19A).
Regarding claim 26, Tzvieli describes wherein the PPS device further comprises a power unit, wherein a cable electrically couples the power unit to the electronic circuitry to enable the power unit to power the electronic circuitry ([0106], the power unit is contained within the housing, necessitating that it is electrically wired to the other components).
Claims 6 and16 are rejected under 35 U.S.C. 103 as being unpatentable over Tzvieli in view of Honda, further in view of Kinrot et al. (US 2012/0203121 A1).
Regarding claims 6 and 16, Tzvieli in view of Honda suggests the method according to claim 5 and the system according to claim 15, including
continuously detecting, by the processor, from the sensor data from the at least one EEG sensor, at least one EEG signal (Tzvieli: [0098])
continuously determining, by the processor, brain activity features from the at least one EEG signal (Tzvieli: [0446])
determining, by the processor, a possibility of a cardiac output reduction, a cardiac output problem, or any combination thereof, in the subject (Tzvieli: [0157])
outputting, by the processor, an alert of the possibility of the cardiac output reduction, the cardiac output problem, or any combination thereof in the subject on the output device of the computing device (Tzvieli: [0231])
Regarding claims 6 and 16, Tzvieli and Honda do not explicitly disclose
continuously determining, by the processor, a blood oxygen level from the sensor data from the at least one right-temple PPG sensor, at least one left-temple PPG sensor, or both
determining, by the processor, a possibility of a condition in the subject based in part on
the comparison between the at least one current pulse morphology data from the left-temple PPG signal and the at least one historical pulse morphology data from the left-temple PPG signal stored in the memory
the comparison between the at least one current pulse morphology data from the right-temple PPG signal and the at least one historical pulse morphology data from the right-temple PPG signal stored in the memory
the brain activity features
the blood oxygen level
However, Kinrot also describes using a psychological and physiological sensing device worn on a head of a subject ([0005]), including
continuously determining, by the processor, a blood oxygen level from the sensor data from the at least one right-temple PPG sensor, at least one left-temple PPG sensor, or both ([0045])
determining, by the processor, a possibility of a cerebrovascular condition in the subject ([0007]) based in part on
the comparison between the at least one current pulse morphology data from the left-temple PPG signal and the at least one historical pulse morphology data from the left-temple PPG signal stored in the memory ([0008] - [0009], [0066] - [0067])
the comparison between the at least one current pulse morphology data from the right-temple PPG signal and the at least one historical pulse morphology data from the right-temple PPG signal stored in the memory ([0008] - [0009], [0066] - [0067])
the brain activity features ([0067] - [0068])
the blood oxygen level ([0067] - [0068])
As Kinrot is also directed towards patient monitoring and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate blood oxygen measurements and comparisons similar to those described by Kinrot when using the method described by Tzvieli and Honda, as doing so advantageously allows the resulting method to screen for a larger number of conditions within the patient.
Statement on Communication via Internet
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Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796