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
The Amendment filed June 12, 2026 has been entered. Claims 1 and 4-9 remain pending in the application.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 4-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US 2019/0336016 A1) (“Zhao”) in view of LeBoeuf et al. (US 2022/0313098 A1) (“LeBoeuf”).
Regarding claim 1, Zhao discloses A wearable apparatus for determining one or more physiological parameters of a user (Abstract and entire document), comprising:
an earphone body to be worn at an ear of the user (FIG. 2-5 and [0022], “In an embodiment, the front end 106 is placed at a location on the body with a relatively higher capillary density (for example, fingertips, toes, or earlobes). FIG. 2 illustrates front ends 204, 212, and 220 placed at the great toe 202 of the foot 200, the tip of the index finger 210 of hand 208, and the earlobe 218 of the ear 216.”);
an optical sensor arranged at the earphone body, the optical sensor comprising a multiple light emitter for emitting a multi- wavelength composite light comprising a mixture of monochromatic light onto the user's ear, and a photodetector for detecting reflected or transmitted light from the ear to obtain a multi-wavelength photoplethysmogram (MWPPG) signal (FIG. 2-5 and [0028], ppg sensor, and [0038 – 0039], “The capillary sensing module comprises multi-wavelength LEDs 500, a photodiode 504,”); and
a processing module adapted to process the obtained MWPPG signal to determine the one or more physiological parameters ([0051 – 0052]);
wherein the MWPPG signal comprises a plurality of PPG signals corresponding to different penetration depths under a skin of the ear ([0039], “multi-wavelength LEDs 506”);
the plurality of PPG signals comprising: a first PPG signal comprising a first pulsatile information of a capillary layer of the ear, the first pulsatile information being derived from a first wavelength having a penetration depth of a capillary layer of the ear (FIG. 5b and [0039], “the multi-wavelength LEDs 506 can emit blue light 518, yellow light 520, and infrared (IR) light 522 into the skin…. Blue PPG mainly reflects capillary pulsation since blue light 518 can only reach the superficial skin capillaries 512. Yellow PPG further contains arteriole pulsation information since the yellow light 520 goes deeper into the communicating arterioles 514 in the dermis. Red PPG also contains the artery pulsation due to the penetration ability of IR light 522 into the arteries 516 in the subcutaneous layer. In one embodiment, as seen in FIG. 5c, the raw infrared (IR) PPG signal and yellow PPG signal are adopted as the artery oscillation 532 and arteriole oscillation 534, respectively.”);
a second PPG signal comprising a second pulsatile information of the capillary layer and an arteriole layer of the ear, the second pulsatile information being derived from a second wavelength having a penetration depth of the capillary layer and the arteriole layer of the ear (FIG. 5b and [0039], “the multi-wavelength LEDs 506 can emit blue light 518, yellow light 520, and infrared (IR) light 522 into the skin…. Blue PPG mainly reflects capillary pulsation since blue light 518 can only reach the superficial skin capillaries 512. Yellow PPG further contains arteriole pulsation information since the yellow light 520 goes deeper into the communicating arterioles 514 in the dermis. Red PPG also contains the artery pulsation due to the penetration ability of IR light 522 into the arteries 516 in the subcutaneous layer. In one embodiment, as seen in FIG. 5c, the raw infrared (IR) PPG signal and yellow PPG signal are adopted as the artery oscillation 532 and arteriole oscillation 534, respectively.”);
a third PPG signal comprising a third pulsatile information of the capillary layer, the arteriole layer and an arterial layer of the ear, the third pulsatile information being derived from a third wavelength having a penetration depth of the capillary layer, the arteriole layer and the arterial layer of the ear (FIG. 5b and [0039], “the multi-wavelength LEDs 506 can emit blue light 518, yellow light 520, and infrared (IR) light 522 into the skin…. Blue PPG mainly reflects capillary pulsation since blue light 518 can only reach the superficial skin capillaries 512. Yellow PPG further contains arteriole pulsation information since the yellow light 520 goes deeper into the communicating arterioles 514 in the dermis. Red PPG also contains the artery pulsation due to the penetration ability of IR light 522 into the arteries 516 in the subcutaneous layer. In one embodiment, as seen in FIG. 5c, the raw infrared (IR) PPG signal and yellow PPG signal are adopted as the artery oscillation 532 and arteriole oscillation 534, respectively.”);
wherein relationship among the first PPG signal, the second PPG signal, and the third PPG signal and the respective pulsatile information are processed to determine the one or more physiological parameters of the user ([0038 – 0041], “The oscillometric signals detected or derived from the multi-wavelength PPG sensor are treated as the volume oscillometric signals of the blood vessels. The volume oscillation signals at least include artery oscillation 532, arteriole oscillation 534 and capillary oscillation 536. The contact pressure values corresponding to the peaks of the artery oscillation 532, arteriole oscillation 534 and capillary oscillation 536 are registered as the mean arterial blood pressure 526, the mean arteriolar blood pressure 528, and the mean capillary blood pressure 530, respectively.”);
wherein the processing module comprises: a pre-processing unit configured to perform pre-processing of the multi-wavelength PPG signal to obtain a pre-processed multi-wavelength PPG signal, the pre-processing comprising filtering and noise reduction processing of the multi-wavelength PPG signal ([0039], “In another embodiment, the artery oscillation signal 532 and arteriole oscillation signal 534 are reconstructed from the multi-wavelength PPG signals to remove any unwanted oscillation component.” Performs filtering/noise reduction as preprocessing step to remove unwanted signal to have a preprocessed multi-wavelength PPG signal);
Zhao fails to disclose a physiological parameter estimation unit configured to input the pre-processed multi-wavelength PPG signal into a pre- built physiological system mathematical model or a deep learning model trained by taking the multi-wavelength PPG signal as a sample and a blood pressure signal as a label, to obtain the physiological parameters.
However, in the same field of endeavor, LeBoeuf teaches a physiological parameter estimation unit configured to input the pre-processed multi-wavelength PPG signal into a pre- built physiological system mathematical model or a deep learning model trained by taking the multi-wavelength PPG signal as a sample and a blood pressure signal as a label, to obtain the physiological parameters ([0163] multi-wavelength ppg, preprocessed. See further [0174], “The high-acuity physiological assessment generated by the waveform analysis engine 300 may comprise blood pressure. (Just as an example, generating a blood pressure assessment may comprise processing waveform features over a plurality of PPG waveforms using a machine learning model.)” input processed multi-wavelength ppg signal into machine learning model to output blood pressure and other physiological parameters see also [0217]).
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 apparatus as taught by Zhao to include a physiological parameter estimation unit configured to input the pre-processed multi-wavelength PPG signal into a pre- built physiological system mathematical model or a deep learning model trained by taking the multi-wavelength PPG signal as a sample and a blood pressure signal as a label, to obtain the physiological parameters as taught by LeBoeuf to reduce processing resources ([0174]).
Regarding claim 4, Zhao as modified discloses The wearable apparatus for determining a physiological parameter according to claim 1, Zhao as modified fails to disclose further comprising an accelerometer, wherein the accelerometer is arranged at the earphone body; the pre-processing unit is adapted to perform the noise reduction processing according to an accelerometer signal collected by the accelerometer.
However, in the same field of endeavor, LeBoeuf teaches further comprising an accelerometer, wherein the accelerometer is arranged at the earphone body; the pre-processing unit is adapted to perform the noise reduction processing according to an accelerometer signal collected by the accelerometer ([0101] – [ 0103] discussing motion, acceleration sensor and processing to remove noise).
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 apparatus as taught by Zhao as modified to include further comprising an accelerometer, wherein the accelerometer is arranged at the earphone body; the pre-processing unit is adapted to perform the noise reduction processing according to an accelerometer signal collected by the accelerometer as taught by LeBoeuf to remove noise ([0103]).
Regarding claim 5, Zhao as modified discloses The wearable apparatus for determining a physiological parameter according to claim 1, Zhao as modified further discloses further comprising a pressure sensor, wherein the pressure sensor is optionally arranged at the earphone body; the physiological parameter estimation unit is adapted to calibrate the physiological system mathematical model according to the pressure signal collected at different body positions of the user by the pressure sensor (Zhao FIG. 5a, pressure sensor 502 and [0042 – 0045] discussing calibrating the pressure signal to the light signal for the pre-processed signal input into the model).
Regarding claim 6, Zhao as modified discloses The wearable apparatus for determining a physiological parameter according to claim 1, Zhao as modified fails to disclose further comprising a biological sensor, wherein the biological sensor is arranged at the earphone body; the physiological parameter estimation unit is adapted to calibrate the physiological system mathematical model according to a bio-electrical signal of the ear collected by the biological sensor.
However, in the same field of endeavor, LeBoeuf teaches further comprising a biological sensor, wherein the biological sensor is arranged at the earphone body; the physiological parameter estimation unit is adapted to calibrate the physiological system mathematical model according to a bio-electrical signal of the ear collected by the biological sensor ([0101] discussing implementing other sensors including biological sensors).
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 apparatus as taught by Zhao as modified to include further comprising a biological sensor, wherein the biological sensor is arranged at the earphone body; the physiological parameter estimation unit is adapted to calibrate the physiological system mathematical model according to a bio-electrical signal of the ear collected by the biological sensor as taught by LeBoeuf for including additional relevant information in the model ([0101]).
Regarding claim 7, Zhao as modified discloses The wearable apparatus for determining a physiological parameter according to claim 1, Zhao as modified further discloses further comprising a communication module, wherein the communication module is arranged at the earphone body, wherein when the processing module is arranged at the earphone body, the communication module is adapted to transmit the multi-wavelength PPG signal to the processing module, and the communication module is adapted to output the physiological parameter obtained by the processing module; wherein when the processing module is arranged to separate from the earphone body, the communication module is adapted to transmit the multi-wavelength PPG signal to the processing module (Zhao [0051] – 0052] including on device and remote processing including wireless transmission involved in remote processing).
Regarding claim 9, Zhao as modified discloses The wearable apparatus for determining a physiological parameter according to claim 1, Zhao as modified further discloses wherein the earphone body is at least one of an in-ear earphone body and an ear-hook earphone body (Zhao FIG. 2).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao in view of LeBoeuf in further view of Trapero Martin et al. (US 11,116,448 B1) (“Trapero Martin”).
The wearable apparatus for determining a physiological parameter according to claim 1,
Zhao as modified further discloses wherein the blood pressure signal comprises a mean blood pressure, a diastolic blood pressure, a systolic blood pressure, a beat-to-beat blood pressure and a tonoarteriogram (Zhao [0032 – 0033], mbp, dbp, sbp, ptt different locations and signals of ppg interpreted as the tonoarteriogram, continuous measurement is interpreted as beat-to-beat bp).
Zhao as modified fails to disclose wherein the physiological parameter further comprises a heart rate and a blood oxygen saturation level;
However, in the same field of endeavor, LeBoeuf teaches wherein the physiological parameter further comprises a heart rate and a blood oxygen saturation level (Col. 37, “Pulse oximetry via the optical sensors 1883 can be used to non-invasively obtain heart rate (HR) and peripheral oxygen saturation (SpO2) of patients based on photoplethysmography (PPG), an optical principle for the measurement of blood volume changes in the microvascular bed of tissue beneath the skin.”);
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 apparatus as taught by Zhao as modified to include wherein the physiological parameter further comprises a heart rate and a blood oxygen saturation level as taught by Trapero Martin to monitor for other important health indicators (Col. 37).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 4-9 have been considered but are moot because the new ground of rejection does not solely rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The amendments have changed the scope of the claims and required new mappings.
The new mappings include previously recited Zhao and thus those arguments will be addressed. Applicant's arguments filed June 12, 2026 have been fully considered but they are not persuasive. With respect to the arguments regarding Zhao, see last paragraph of page 10 through first half of page 11, contending that Zhao fails to disclose, “an earphone body carrying a multi-wavelength optical sensor, obtaining from the ear an MWPPG signal comprising multiple PPG signals corresponding to different penetration depths, assigning those PPG signals to the recited capillary, capillary plus arteriole and capillary plus arteriole plus arterial layers pulsatile information, and processing by the pre-processing unit and the physiological parameter estimation unit, and determining physiological parameters by processing relationships among those layered ear PPG signals.” However, Zhao does disclose these features as is newly mapped above, required because of the amendments. Zhao does not disclose newly recited feature of the physiological parameter estimation unit explicitly inputting the pre-processed multi-wavelength signal into a model as newly claimed which has required the new mappings and newly cited art. Zhao does disclose the first features argued. See Zhao FIG. 2-5 and [0022], “In an embodiment, the front end 106 is placed at a location on the body with a relatively higher capillary density (for example, fingertips, toes, or earlobes). FIG. 2 illustrates front ends 204, 212, and 220 placed at the great toe 202 of the foot 200, the tip of the index finger 210 of hand 208, and the earlobe 218 of the ear 216.” Showing an earphone body carrying a multi-wavelength optical sensor as discloses in Zhao [0038 – 0039], “[0039], “the multi-wavelength LEDs 506 can emit blue light 518, yellow light 520, and infrared (IR) light 522 into the skin…. Blue PPG mainly reflects capillary pulsation since blue light 518 can only reach the superficial skin capillaries 512. Yellow PPG further contains arteriole pulsation information since the yellow light 520 goes deeper into the communicating arterioles 514 in the dermis. Red PPG also contains the artery pulsation due to the penetration ability of IR light 522 into the arteries 516 in the subcutaneous layer. In one embodiment, as seen in FIG. 5c, the raw infrared (IR) PPG signal and yellow PPG signal are adopted as the artery oscillation 532 and arteriole oscillation 534, respectively.”; processor [0051] – [0052] to determine physiological parameters based on the multi-wavelength signal, see Zhao [0041], “The oscillometric signals detected or derived from the multi-wavelength PPG sensor are treated as the volume oscillometric signals of the blood vessels. The volume oscillation signals at least include artery oscillation 532, arteriole oscillation 534 and capillary oscillation 536. The contact pressure values corresponding to the peaks of the artery oscillation 532, arteriole oscillation 534 and capillary oscillation 536 are registered as the mean arterial blood pressure 526, the mean arteriolar blood pressure 528, and the mean capillary blood pressure 530, respectively.”. Thus disclosing exactly the features applicant contends are missing. The arguments are not persuasive.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791
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