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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 22, 2026 has been entered.
Response to Amendment
The Amendment filed March 22, 2026 has been entered. Claims 1-9 remain pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities: “wherein relationship between each PPG signal” appears to recite a type. 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.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0160905 A1) (“Wang”) in view of Zhao et al. (US 2019/0336016 A1) (“Zhao”).
Regarding claims 1-2, Wang discloses A wearable apparatus for determining one or more physiological parameters of a user (Abstract and entire document, see at least [0038] describing wearable devices and blood pressure), comprising:
an earphone body to be worn at an ear of the user ([0038], “The device used by the collection module 110 may be local or remote, may be a large-scale medical device, or a smart wearable device such as a watch, a bracelet, a neck ring, eyeglasses and an earphone.”);
an optical sensor arranged at the earphone body, the optical sensor comprises 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. 1 and [0038] discussing the optical sensors in a wearable device such as the earphones. Also discussed “PPG”. See further FIG. 4 and associated paragraphs, and showing in (A) a singular transmitter. See further [0069], “A light source transmitter in the collection module 110 is lit, and two beams of light with different wavelengths are transmitted by the transmitter simultaneously, types of the beams of light including but not limited to, red light, green light, infrared light, blue light, violet light, yellow light, orange light, and cyan light.”); and
a processing module ([0047], “The engine 100 may include one or more processors. Each module or unit of the engine 100 may be implemented on one or more processors.”);
adapted to process the obtained MWPPG signal, the MWPPG signal comprising a plurality of PPG signals corresponding to different penetration depths under a skin of the ear ([0069], “The two receivers may receive two reflection signals separately, and a first signal received by a first receiver is a physiological signal of the living organism, including a PPG signal of the living organism and a moving/vibrating signal of the living organism.” And [0035], [0038], and FIG. 2 and [0048]. The collected ppg signals are input to the processors for calculating a physiological parameter including a blood pressure signal. Each wavelength inherently penetrates to a different depth);
wherein relationship between each PPG signal and the respective pulsatile information are processed to determine the physiological parameters of the user. ([0050], “The transmitters may be different types of light sources with different wavelengths in different frequency bands, and the light sources belong to spectrums of different frequency bands, including but not limited to a visible spectrum, an infrared spectrum, a far-infrared spectrum or the like. The types of beams of light are specifically, but not limited to, red light, green light, infrared light, blue light, violet light, yellow light, orange light, and cyan light.” Each wavelength has a different penetration depth and is related to a skin attribute at that location. See also [0069], “Since penetrating capacities of the two beams of light are different, a first beam of light may penetrate a skin surface layer of the living organism and reach blood vessels under the skin, and a first reflection signal (or refer to as first reflected light) is obtained after reflected by the living organism. A second beam of light with relatively weak penetrating capacity may not penetrate the skin surface layer and reach depth of the skin, and therefore a second reflection signal (or refer to as second reflected light) is obtained after reflected on the skin surface layer of the living organism.”).
Wang fails to explicitly disclose wherein the plurality of PPG signals of the MWPPG signal comprises: a first PPG signal having a first wavelength comprising a first pulsatile information of a capillary layer of the ear;
a second PPG signal having a second wavelength comprising a second pulsatile information of the capillary layer and an arteriole layer of the ear;
a third PPG signal having a third wavelength c comprising a third pulsatile information of the capillary layer, the arteriole layer and an arterial layer of the ear;
However, in the same field of endeavor, Zhao teaches wherein the plurality of PPG signals of the MWPPG signal comprises: a first PPG signal having a first wavelength comprising a first pulsatile information of a capillary layer of the ear; a second PPG signal having a second wavelength comprising a second pulsatile information of the capillary layer and an arteriole layer of the ear; a third PPG signal having a third wavelength c comprising a third pulsatile information of the capillary layer, the arteriole layer and an arterial layer of the ear (FIG. 5b-5c 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.” Blue = capillary; yellow = arteriole; red/infrared = artery, as claimed);
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 Wang to include wherein the plurality of PPG signals of the MWPPG signal comprises: a first PPG signal having a first wavelength comprising a first pulsatile information of a capillary layer of the ear; a second PPG signal having a second wavelength comprising a second pulsatile information of the capillary layer and an arteriole layer of the ear; a third PPG signal having a third wavelength c comprising a third pulsatile information of the capillary layer, the arteriole layer and an arterial layer of the ear; as taught by Zhao to obtain different physiological information at each different depth ([0039], “The light can travels through different layers of the skin and therefore the multi-wavelength PPG signal can contain different physiological information.”).
Regarding claim 3, Wang discloses The wearable apparatus for determining one or more physiological parameters according to claim 1, wherein the processing module comprises: a pre-processing unit for performing pre-processing of the multi-wavelength PPG signal, the pre-processing comprising filtering and noise reduction processing ([0048], “For example, a preprocessing step may be added between step 210 and step 220, and the preprocessing step may be used to perform a preliminary coarse smoothing or remove significant interference process on two or more collected signals. The processing method may include, but is not limited to, low-pass filtering, bandpass filtering, wavelet transform filtering, a median filtering method, morphological filtering and a curve fitting method.”);
a physiological parameter estimation unit for inputting the pre-processed multi- wavelength PPG signal into a pre-built physiological system mathematical model or a deep learning model to obtain the physiological parameters; the deep learning model is trained by taking the multi-wavelength PPG signal as an sample and the blood pressure signal as a label ([0039], “For example, the collection module 110 may storage data collected every time to the server 170 (e.g., a cloud server) and mark different data of different living organisms accordingly. The module may start a machine learning process according to data of the same living organism at different times or different states and make corresponding adjustments to the collected signals or data according to different features of different living organisms.” And FIG. 7 and [0058] discussing models).
Regarding claim 4, Wang discloses The wearable apparatus for determining one or more physiological parameters according to claim 3, further comprising an accelerometer, wherein the accelerometer is arranged at the earphone body ([0050], “The receiver may be different types of sensor, and may include but is not limited to a photoelectric sensor, a displacement sensor, an acceleration sensor, a vibration sensor, a mechanical sensor, a temperature sensor and a gas sensor.”);
the pre-processing unit is adapted to perform the noise reduction processing according to an accelerometer signal collected by the accelerometer ([0061], “The vital sign obtaining system may remove movement/vibration noise or interference in physiological signals of a living organism well, and the calculated amount thereof is small and the calculation result is accurate.”).
Regarding claim 5, Wang discloses The wearable apparatus for determining one or more physiological parameters according to claim 3, further comprising a pressure sensor, wherein the pressure sensor is optionally arranged at the earphone body ([0050], “The receiver may be different types of sensor, and may include but is not limited to a photoelectric sensor, a displacement sensor, an acceleration sensor, a vibration sensor, a mechanical sensor, a temperature sensor and a gas sensor.”);
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 ([0039], “For example, the collection module 110 may storage data collected every time to the server 170 (e.g., a cloud server) and mark different data of different living organisms accordingly. The module may start a machine learning process according to data of the same living organism at different times or different states and make corresponding adjustments to the collected signals or data according to different features of different living organisms.” And FIG. 7 and [0058] – [0066] discussing models. Depending on the model and bioinformation to be output, the different sensors are used as inputs. See also [0039 -0041] discussing further calibration. [0041], “The environment and other factors may be further considered in the calculation process, and a related calibration factor may be added. For example, a temperature coefficient, a humidity coefficient, an air flow coefficient, a barometric coefficient, a light coefficient, a time coefficient, a coefficient of a physiological or psychological state of a living organism, an age coefficient, or the like, or any combination thereof. “ discussing barometric calibration and other sensor calibration per location).
Regarding claim 6, Wang discloses The wearable apparatus for determining one or more physiological parameters according to claim 3, further comprising a biological sensor, wherein the biological sensor is arranged at the earphone body ([0050], “The receiver may be different types of sensor, and may include but is not limited to a photoelectric sensor, a displacement sensor, an acceleration sensor, a vibration sensor, a mechanical sensor, a temperature sensor and a gas sensor.”);
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 ([0039], “For example, the collection module 110 may storage data collected every time to the server 170 (e.g., a cloud server) and mark different data of different living organisms accordingly. The module may start a machine learning process according to data of the same living organism at different times or different states and make corresponding adjustments to the collected signals or data according to different features of different living organisms.” And FIG. 7 and [0058] – [0066] discussing models. Depending on the model and bioinformation to be output, the different sensors are used as inputs. See also [0039 -0041] discussing further calibration).
Regarding claim 7, Wang discloses The wearable apparatus for determining one or more physiological parameters according to claim 1, further comprising a communication module, wherein the communication module is arranged at the earphone body (FIG. 1 and [0046 – 0047], discussing wired and wireless communication between the devices/servers/modules),
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 ([0042], “The process may be implemented by the system directly, or may be implemented by an externally connected device. “ and [0043] discussing external processing modules and server devices, see [0046 – 0047] discussing communication between the devices);
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 ([0042], “The process may be implemented by the system directly, or may be implemented by an externally connected device. “ and [0043] discussing external processing modules and server devices, see [0046 – 0047] discussing communication between the devices).
Regarding claim 8, Wang discloses The wearable apparatus for determining one or more physiological parameters according to claim 1, wherein the physiological parameter further comprises a heart rate and a blood oxygen saturation level ([0041], “The types of vital signs that may be calculated by the calculation module 130 may include, but are not limited to, one or more of vital signs such as a blood pressure, a pulse rate (PR), blood oxygen saturation, cardiac rate variability, heart murmur, bowel sounds, a pH value, a creatinine content, a transferase content, a body temperature and a carcinoembryonic antigen content.”);
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 ([0041], “For example, but not limited to, a height, a weight, a vital capacity, heartbeat parameters, a blood sugar content, measurement of blood viscidity, a diastolic blood pressure, a systolic blood pressure, measurement of a blood flow parameter, a PPG signal wave crest and wave trough, an ECG signal wave crest and wave trough, a pulse rate, a cardiac rate, a blood lipid content,”).
Regarding claim 9, Wang discloses The wearable apparatus for determining one or more physiological parameters according to claim 1, wherein the earphone body is at least one of an in-ear earphone body and an ear-hook earphone body ([0038], “The device used by the collection module 110 may be local or remote, may be a large-scale medical device, or a smart wearable device such as a watch, a bracelet, a neck ring, eyeglasses and an earphone.” Earphone is considered in ear or over ear earphones).
Response to Arguments
Applicant's arguments filed March 22, 2026 have been fully considered but they are not persuasive. With respect to the arguments regarding the 102 and 103 rejections, the arguments are not persuasive. Wang discloses, see [0069], “A light source transmitter in the collection module 110 is lit, and two beams of light with different wavelengths are transmitted by the transmitter simultaneously, types of the beams of light including but not limited to, red light, green light, infrared light, blue light, violet light, yellow light, orange light, and cyan light.” Thus disclosing the use of a single transmitter to transmit a beam of multiple wavelengths to penetrate different depths as each wavelength described has a different depth, as is inherent, different wavelengths penetrate different depths, and relate to different information within the ear, as the reflectance is penetrating and reflecting at a different depth, or different layer of the ear. See [0069], “Since penetrating capacities of the two beams of light are different, a first beam of light may penetrate a skin surface layer of the living organism and reach blood vessels under the skin, and a first reflection signal (or refer to as first reflected light) is obtained after reflected by the living organism. A second beam of light with relatively weak penetrating capacity may not penetrate the skin surface layer and reach depth of the skin, and therefore a second reflection signal (or refer to as second reflected light) is obtained after reflected on the skin surface layer of the living organism.”. Wang does not explicitly disclose that the first wavelength penetrates specifically to the capillary layer, the second wavelength to the capillary layer and the arteriole layer, and the third wavelength to the capillary layer and the arteriole layer and the arterial layer. This is an inherent characteristic of the wavelength of light. The secondary reference Zhao, used as a teaching reference, teaching the specific wavelengths as well known and inherent to the penetration depth. See Zhao FIG. 5c and [0039], “The light can travels through different layers of the skin and therefore the multi-wavelength PPG signal can contain different physiological information. 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.” This allows for the decomposition of the signal into understanding the different skin layers and the reflectance and information determined, which is analyzed by the processor. Thus, the arguments are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Zhao teaches the motivation of obtaining different physiological information at each different depth ([0039], “The light can travels through different layers of the skin and therefore the multi-wavelength PPG signal can contain different physiological information.” Thus, allowing for the decomposition of the signal into its different wavelength/depths to determine the different physiological parameters respectively corresponding to the wavelength/depths. Thus, the arguments are not persuasive. The arguments regarding dependent claims are moot.
Conclusion
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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/JOSEPH A TOMBERS/Examiner, Art Unit 3791
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