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 .
Claim Objections
Claims 11 and 20 are objected to because of the following informalities: the claims include a typographical error “severer” in lieu of “severe”. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9, 11-18, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panteloupos et al. (U.S. Patent Application Publication No. 2023/0293028) hereinafter referred to as Panteloupos; in view of Zhuo et al. (U.S. Patent Application Publication No. 2017/0215749) hereinafter referred to as Zhuo
Regarding claim 1, Panteloupos teaches a calibrated system for measuring and monitoring vital signs of a user, the system comprising:
a wearable device (Fig. 9A-B), the wearable device comprises an optical module (¶[0175]) and an electrocardiogram (ECG) module (¶¶[0119-0120]);
at least one processor; and a non-transitory machine-readable medium comprising instructions stored therein, which when executed by the at least one processor, cause the processor to perform operations (¶[0142]) comprising:
establishing a user initial profile based on an initial information (¶[0136] initiate sensors);
determining a user baseline profile from the initial information, vital signs measurements received from the wearable device for a time period (Fig. 4, ¶[0139] baseline during a rest state, ¶[0189] for tracking baseline parameters);
determining a user reference model based on the user baseline profile (Fig. 4, step 412, ¶[0138]);
receiving actual vital signs measurements in real time (¶[0326] real time capture and transmission) from the wearable device (¶[0140] PTT sensors on wearable device);
comparing the actual vital signs measurements with the user reference model (¶[0138] reference model for a user derived from calibration process, ¶[0141] checking for if recalibration is required entails checking user context, including looking for significant change in user’s vital signs);
interpreting whether a result of the comparison between the actual vital signs measurements and the user reference model is within predetermined parameters (¶[0141] user context, looking for “significant change has occurred in perfusion properties when stationary” therefore, the predetermined parameters are insignificant change); and
providing a feedback based on the interpretation of the result of the comparison between the actual vital signs measurements and the user reference model (¶[0141], Fig. 4, recalibration is a feedback to the model in step 412).
Panteloupos further teaches an oscillometric module (¶[0126]) but does not teach the oscillometric module on the wearable device. Panteloupos further does not teach the user reference model comprising zone indicators.
Attention is brought to the Zhuo reference, which teaches an oscillometric module on a wearable device (¶¶[0074-0076] finger ring or wrist wearable), with a user reference model comprising zone indicators (¶[0063], ¶[0164]); comparing the actual vital signs measurements with the user reference model (¶[0135]); interpreting whether a result of the comparison between the actual vital signs measurements and the user reference model is within predetermined parameters (¶[0135]); providing a feedback based on the interpretation of the result of the comparison between the actual vital signs measurements and the user reference model (¶¶[0164-0165]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable system of Panteloupos to include an oscillometric sensor in a wearable, and additional blood pressure health zone indicators with comparison, interpretation, and feedback, as taught by Zhuo, because the sensor and wearable device of Zhuo increases user comfort (Zhuo ¶[0138]) and deep learning algorithms with demographic and physiological information can improve accuracy of the calculation (Zhuo ¶[0148]).
Regarding claim 2, Panteloupos as modified teaches the system according to claim 1.
Panteloupos further teaches wherein the wearable device further comprises an accelerometer and/or a gyroscope (¶[0112]) that are configured to determine the positioning of the wearable device during receiving the vital signs measurements by the processor (¶[0142], ¶[0144]) and a user activity state (¶[0167] activity information).
Regarding claim 3, Panteloupos as modified teaches the system according to claim 1.
Panteloupos further teaches wherein the oscillometric module comprises:
a cuff configured to inflate using a pump and deflate (Fig. 7, inflatable cuff) using an electric valve (¶[0149]);
a pump driver (Fig. 7, inflating cuff); and
a pressure sensor (¶[0150]) to determine user’s systolic and diastolic blood pressure.
Regarding claim 4, Panteloupos as modified teaches the system according to claim 1.
Panteloupos further teaches wherein the ECG module comprises:
a first electrode; a second electrode (¶[0115] first and second electrode for ECG); and
a plurality of electric sensors configured to collect ECG datapoints that are converted into an ECG waveform by the processor, wherein the ECG module is configured to automatically switch an ECG algorithm depending on a hand selection of the wearable device (¶[0115] second electrode contact for ECG depends on hand contact to the second electrode).
Regarding claim 5, Panteloupos as modified teaches the system according to claim 4.
Panteloupos further teaches wherein the first electrode is located on a bottom of the wearable device, the bottom being closest to the user’s wrist, and the second electrode is located on a front of the wearable device (¶[0115], Figs. 13A-B).
Regarding claim 6, Panteloupos as modified teaches the system according to claim 1.
Panteloupos further teaches wherein the optical module comprises:
an optical sensor (Fig. 12, ¶[0212]);
a light-emitting diode (LED) (Fig. 12, LEDs); and
a photodetector (Fig. 12, Photodetector).
Regarding claim 7, Panteloupos as modified teaches the system according to claim 1.
Panteloupos further teaches wherein the operations further comprise:
determining a rest activity state of the user (¶[0139], ¶[0280] resting);
establishing an assigned position of the wearable device (Fig. 6, “Calibrating by Holding an Arm at Different Positions”, and ¶[0142], ¶[0141] one user context for recalibrating is a specific position of the hand of the user);
assigning a validation period (¶[0141], one user context for recalibrating is a specific position of the hand of the user);
determining a first blood pressure measurement by the oscillometric module (Fig. 6, step 604, ¶[0143]);
determining a second blood pressure measurement by the optical module (Fig. 6, step 614, ¶[0146]);
comparing the first blood pressure measurement to the second blood pressure measurement (Fig. 6, step 6014, ¶[0146]); and
if the second blood pressure measurement is measurably different from the first blood pressure measurement, calibrating the optical module based on the first blood pressure measurement (Fig. 6, steps 614 and 616, ¶[0146]).
Regarding claim 8, Panteloupos as modified teaches the system according to claim 1.
Panteloupos further teaches wherein the vital signs measurements comprise skin temperature (¶[0165], ¶[0168]), blood pressure (¶[0172]), heart rate (¶[0172]), respiration rate (¶[0172]), ECG pulse rate (¶[0241] ECG pulse wave timing), and functional oxygen saturation (¶[0201]).
Regarding claim 9, Panteloupos as modified teaches the system according to claim 1.
Panteloupos further teaches wherein the user initial profile comprises name (¶[0341] user profiles can be searched by name) a non-medical information of the user (¶[0341] e-mail address).
Panteloupos does not teach wherein the user initial profile comprises gender and age.
Attention is brought to the Zhuo reference, which further teaches wherein the user initial profile comprises gender, age and a non-medical information of the user (¶[0040]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the blood pressure system of Panteloupos to include additional demographic information, as taught by Zhuo, because Zhuo teaches increased accuracy of blood pressure measurements (Zhuo ¶[0039]).
Regarding claim 11, Panteloupos as modified teaches the system according to claim 1.
Zhuo further teaches wherein the zone indicators comprise normal, insignificant deviation, and severe deviation (¶[0063]).
Regarding claim 12, Panteloupos as modified teaches the system according to claim 1.
Panteloupos further teaches wherein the feedback is displayed as a text, a voice, and/or an animation on a user device (¶[0368]).
Regarding claims 13-18 and 20/21, the claims are directed to a method comprising substantially the same subject matter as the system of claims 1-2, 7-9, and 11/7 and are rejected under substantially the same sections of Panteloupos and Zhuo.
Claim(s) 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panteloupos and Zhuo as applied to claims 1 and 13 above, and further in view of Sampson (U.S. Patent Application Publication No. 2020/0085380) hereinafter referred to as Sampson.
Regarding claim 10/19, Panteloupos as modified teaches the system/method according to claim 1/13.
Panteloupos further teaches wherein the user reference model (¶[0384] mathematical model) comprises reference parameters, the reference parameters comprise guidelines (¶[0384]), deviations inherent in a disease (¶[0383]), medication treatment of the user (¶[0172] medication intake), life style of the user (¶[0381]), and the vital signs measurements for a predetermined period of time (¶[0381] biometric monitoring).
Panteloupos as modified does not teach reference parameters comprising anamnesis.
Attention is brought to the Sampson reference, which teaches reference parameters comprising anamnesis (¶[0022] user’s past medical history, user input ¶¶[0082-0087]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system/method of Panteloupos as modified to include anamnesis as a parameter reference to a user model, because Sampson teaches that taking into account a user’s medical history can reduce false alarms (Sampson ¶[0022]).
Conclusion
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792