DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Continued Examination Under 37 CFR 1.114
3. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/29/2026 has been entered.
Response to Arguments
4. Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1-5, 10-11, 13, 15-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Savchenko WO 2021150148 (herein referred to as “Savchenko”), and in view of Goldstein U.S. 2022/0061767 (herein referred to as “Goldstein”) and Boesen U.S. 2018/0121623 (herein referred to as “Boesen”).
7. Regarding Claim 1, Savchenko teaches a device (Fig. 1), comprising:
a. an in-ear fixture configured to fit in an ear canal of a user (Fig. 1, ref num 101; Fig. 6A, ref num 603 in ear canal, ref num 605; para 0057, “earpiece 603 is positioned in the ear 605…inside the ear canal”);
b. a first electrode (Fig. 1, ref num 103; Fig. 2, ref num 207; para 0046, “the cover 207 serves a purpose of the first electrode also illustrated as 103 on Fig. 1) mounted on the in-ear fixture (Fig. 2, ref num 207 is on earpiece, ref num 201) and configured to receive a first electronic signal from a skin in the ear canal of the user (Fig. 8, ref num 801, 802; para 0055, “the purpose of the in-ear insert 511 is to establish an electrical contact with the skin in the ear of the user and transmit electrical signals from the skin”; also see Fig. 5; para 0038, “electrodes 103…for the purpose of measuring ECG signals”);
d. an external microphone (Fig. 1, ref num 115 and Fig. 3, ref num 319) coupled to receive an external acoustic signal, propagating through an environment of the user (para 0041, “audio received from a microphone 115”; Fig. 7, ref nums 705 and 706 indicate environment acoustic signal); and
e. a processor (Fig. 1, ref num 113), the processor configured to identify a cardiovascular condition, or a neurologic condition of the user based on at least one of the first electronic signal, the internal acoustic signal, and the external acoustic signal (Fig. 7, ref nums 702, 703, 704; Fig. 8, para 0064).
Savchenko fails to teach (c) an internal microphone coupled to receive an internal acoustic signal, propagating through the ear canal of the user, and (e) that the processor identifies the condition when the first electronic signal exceeds a pre-selected threshold, as well that the processor is coupled to an augmented reality headset.
Goldstein teaches a device of analogous art (Figs. 1A, 1B, 2A and 5D, ref num 20), wherein the device comprises an internal microphone (Fig. 5E, ref num 54; para 0221, “an acoustic port 54 that can capture sound from the ear canal via an ear canal microphone”) coupled to receive an internal acoustic signal, propagating through the ear canal of the user (para 0221, “an acoustic port 54 that can capture sound from the ear canal via an ear canal microphone”). The device also receives a first electronic signal (para 0117, “sensors can constitute biometric, physiological, environmental, acoustical, or neurological among other classes of sensors”; Fig. 1B, ref num 5A; para 0165 describes the various electronic signals that are received”), an external acoustic signal (para 0188, “one or more ambient microphones 32 and 34”; Fig. 1B, ref num 3A; para 0126, “ module 3A can include one or more of an ambient microphone… or other external microphones… the signal from the ear canal microphone and the ambient microphone”), and an additional signal selected from an optical signal or motion signal (Fig. 1B, ref num 3B; para 0118, “gesture control 3B, can be a motion detector for detecting certain user movements”). The processor of the device (Fig. 1B, ref num 4) comprises a multimodal monitoring function, in which multiple parameters are monitored and processed in order to determine a user’s condition, such as a cardiovascular condition or a neurologic condition (para 0105, ““multimodal” refers to monitoring of at least two different parameters such as sound pressure level and blood pressure or heart rate… different capture or harvested from acoustic, biologic, neurologic, motion, or vision sensors”; para 0118, “earpiece can be a multimodal device that can be controlled by not only voice using a speech or voice recognition engine 3A… but by other user inputs such as gesture control 3B, or other user interfaces 3C”; para 0120). The multimodal monitoring combines these various signals in order to identify the desired information, such as diagnosis of a condition (para 0125, “the device can include one or more sensors 5 operationally coupled to the processor 4. The sensors can be biometric and/or environmental… sensors can also detect physiological changes… sensors can include electrodes or contactless sensors and provide neurological readings… sensors can also include transducers or microphones for sensing acoustic information. Other sensors can detect motion… in a multimodal, multisensory embodiment, a combination of sensors can be used to make emotional or mental state assessments or other anticipatory determinations”; para 0240, “multimodal embodiment can be used… [as] part of a cardiovascular monitoring system for disease diagnosis”). The processor is also coupled to an augmented reality headset (Fig. 1B, ref num 4 is coupled to ref num 3C; para 0118, “the user interface 3C can be… augmented reality (AR) “glasses”). By combining various signals received by the processor to identify a condition, this provides the benefit of more clearly determining the condition in the context of typical daily activity of the user, as well enhance the interpretation and analysis of these signals relating to the semantics of the user (para 0105). The augmented reality headset provides the processor with feedback output to communicate with the user, which is a common practice when identifying a condition of a user (para 0150). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to include an internal microphone for receiving an internal acoustic signal so that the processor may combine the various signals to have a multimodal monitoring function when identifying the user’s condition, since this type of monitoring improves the interpretation and analysis of the signals in order to clearly identify the condition and provide feedback, via an AR headset, to the user.
Boesen teaches a device of analogous art (Fig. 1), wherein the device is configured to measure a first electronic signal from a skin in the ear canal of a user (Fig. 3, ref num 306; para 0078, “the contact sensors 306 may be utilized to determine that the wireless earpieces 302 are positioned within the ears of the user. For example, conductivity of skin or tissue within the user's ear may be utilized to determine that the wireless earpieces are being worn. In other embodiments, the contact sensors 306 may include pressure switches, toggles, or other mechanical detection components for determining that the wireless earpieces 302 are being worn. The contact sensors 306 may measure or provide additional data points and analysis that may indicate the biometric information of the user”). The electronic signal is used to identify a condition of the user when it exceeds a pre-selected threshold (para 0078, “The contact sensors 306 may measure or provide additional data points and analysis that may indicate the biometric information of the user”; para 0109, “The sensors may read various user biometrics that may be utilized by the logic (e.g., processing and comparison against user supplied or predefined thresholds) to determine the health or medical status of the user… The wireless earpieces may utilize any number of libraries, databases, or other information, settings, parameters, or thresholds to determine a status or condition of a user”). By identifying the condition via a pre-selected threshold of the signal, the user may then receive assistance and treatment for the condition (para 0103). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to determine whether the signal exceeds a pre-selected threshold in order to identify a condition, so that the user may treat said condition appropriately and not prematurely.
8. Regarding Claim 2, Savchenko teaches a second electrode mounted on an outer side of the in-ear fixture (Fig. 2, ref num 203), the second electrode configured to receive a signal when the user closes a bodily loop by contacting the second electrode with a finger (para 0047, “electrode 203 is designed to establish a contact with the finger of a user”).
9. Regarding Claim 3, Savchenko teaches the first electrode is a contact electrode configured to transmit a current from the skin in the ear canal of the user (para 0055, “The purpose of the in-ear insert 511 is to establish an electrical contact with the skin in the ear of the user and transmit electrical signals from the skin via the nozzle 513 and the electrical wire 507 to the first electrode contact inside the electronic unit 501, illustrated as 103 on Fig. 1”).
10. Regarding Claim 4, Savchenko teaches a second electrode mounted on the of the in-ear fixture (Fig. 1, ref num 104), the second electrode configured to receive a second electronic signal from the skin in the ear canal of the user (Fig. 8, ref num 801, 802; para 0055, “the purpose of the in-ear insert 511 is to establish an electrical contact with the skin in the ear of the user and transmit electrical signals from the skin”; also see Fig. 5; para 0038, “electrodes 103 and 104 used…for the purpose of measuring ECG signals”).
11. Regarding Claim 5, Savchenko fails to teach the pre-selected threshold corresponds to a measure of electrical contact between the first electrode and the skin in the ear canal of the user.
Boesen teaches the pre-selected threshold corresponds to a measure of electrical contact between the first electrode and the skin in the ear canal of the user (para 0078, “the contact sensors 306 may be utilized to determine that the wireless earpieces 302 are positioned within the ears of the user. For example, conductivity of skin or tissue within the user's ear may be utilized to determine that the wireless earpieces are being worn”; para 0109, “the sensors may read various user biometrics that may be utilized by the logic (e.g., processing and comparison against user supplied or predefined thresholds)… The wireless earpieces may utilize any number of libraries, databases, or other information, settings, parameters, or thresholds to determine a status or condition of a user”). This ensures there is contact between the electrode and the skin in the ear canal of the user (para 0078). By identifying the condition via a pre-selected threshold of the signal, the user may then receive assistance and treatment for the condition (para 0103). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to determine whether the signal exceeds a pre-selected threshold in order to identify a condition, so that the user may treat said condition appropriately and not prematurely.
12. Regarding Claim 10, Savchenko teaches the processor is configured to determine a heart rate of the user from the first electronic signal (para 0064).
13. Regarding Claim 11, Savchenko fails to teach the processor is configured to determine a brain activity from the first electronic signal that corresponds to an acoustic stimulus received in the external microphone.
Goldstein teaches the processor is configured to determine a brain activity from the first electronic signal that corresponds to an acoustic stimulus received in the external microphone (para 0129, “BCI 5b can operate cooperatively with other user interfaces (8A or 3C)… evoked potential tests measure the brain’s response to stimuli that are delivered through sigh, hearing, or touch… brainstem auditory evoked potentials, generated by delivering clicks to the ear… the signals obtained by the contactless sensors are transmitted to a computer, where they are typically amplified, averaged, and displayed… purpose of the evoked potential tests include… assessing brain function”; para 0131, “user interfaces 3C can provide external device inputs that can be processed by the processor(s) 4… microphones”). By determining brain activity from the first electronic signal, this may initiate communication to an operator, physician, or user based on thresholds of certain data parameters (para 0153, “The communication can be initiated based on a match reflecting common interests or a relative match based on meeting certain thresholds of certain data parameters. For example, a sudden elevated heartbeat, blood pressure, or certain brainwave activity may be used as a trigger for initiating communication”), which may ultimately lead to diagnosing/identifying a condition of the patient (para 0154-0155). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to determine a brain activity from the first electronic signal corresponding to an acoustic stimulus, as this determination aids in identifying a condition of the patient.
14. Regarding Claim 13, Savchenko teaches a buffered amplifier coupled to the first electrode (Fig. 1, ref num 109) and configured to provide an amplified first electronic signal to the processor (para 0038, “The output of the AFE 109 is an amplified analog signal related to ECG. The output of the AFE 109 is passed to an analog input of microcontroller (MCU) 113”).
15. Regarding Claim 15, Savchenko teaches a computer-implemented method (Figs. 1 and 7-9) comprising:
a. receiving, from a first electrode (Fig. 1, ref num 103; Fig. 2, ref num 207; para 0046, “the cover 207 serves a purpose of the first electrode also illustrated as 103 on Fig. 1), a first electrical signal from a skin in a first ear canal (Fig. 8, ref num 801, 802; para 0055, “the purpose of the in-ear insert 511 is to establish an electrical contact with the skin in the ear of the user and transmit electrical signals from the skin”; also see Fig. 5; para 0038, “electrodes 103…for the purpose of measuring ECG signals”) of a user of an in-ear device (Fig. 1, ref num 101; Fig. 6A, ref num 603 in ear canal, ref num 605; para 0057, “earpiece 603 is positioned in the ear 605…inside the ear canal”);
b. forming a waveform with the first electronic signal (para 0008, “The apparatus can notify the user audibly about heart activity and transmit ECG waveform data”); and,
c. identifying one of a heart activity or a brain activity of the user based on the first electronic signal (Fig. 7, ref num 703 and 704).
Savchenko fails to teach identifying one of a heart or a brain activity of the user when the first electronic signal exceeds a pre-selected threshold.
Goldstein teaches a method of analogous art (Figs. 1A and 1B; para 0105), wherein the method comprises receiving a first electronic signal (para 0117, “sensors can constitute biometric, physiological, environmental, acoustical, or neurological among other classes of sensors”; Fig. 1B, ref num 5A; para 0165 describes the various electronic signals that are received”) and an additional signal selected from an optical signal or a motion signal (Fig. 1B, ref num 3B; para 0118, “gesture control 3B, can be a motion detector for detecting certain user movements”). The method further comprises a multimodal monitoring function (Fig. 1B, ref num 4), in which multiple parameters are monitored and processed in order to identify one of a heart or a brain activity of the user (para 0105, ““multimodal” refers to monitoring of at least two different parameters such as sound pressure level and blood pressure or heart rate… different capture or harvested from acoustic, biologic, neurologic, motion, or vision sensors”; para 0118, “earpiece can be a multimodal device that can be controlled by not only voice using a speech or voice recognition engine 3A… but by other user inputs such as gesture control 3B, or other user interfaces 3C”; para 0120). The multimodal monitoring function combines these various signals in order to identify the desired information, such as diagnosis of a condition, or identifying user activity (para 0125, “the device can include one or more sensors 5 operationally coupled to the processor 4. The sensors can be biometric and/or environmental… sensors can also detect physiological changes… sensors can include electrodes or contactless sensors and provide neurological readings… sensors can also include transducers or microphones for sensing acoustic information. Other sensors can detect motion… in a multimodal, multisensory embodiment, a combination of sensors can be used to make emotional or mental state assessments or other anticipatory determinations”; para 0240, “multimodal embodiment can be used… [as] part of a cardiovascular monitoring system for disease diagnosis”). By combining various signals to identify a condition, this provides the benefit of more clearly determining the condition/activity in the context of typical daily activity of the user, as well enhance the interpretation and analysis of these signals relating to the semantics of the user (para 0105). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Savchenko to combine various signals to have a multimodal monitoring function when identifying the user’s condition/activity, since this type of monitoring improves the interpretation and analysis of the signals in order to clearly identify said condition.
Boesen teaches a device of analogous art (Fig. 1), wherein the device is configured to measure a first electronic signal from a skin in the ear canal of a user (Fig. 3, ref num 306; para 0078, “the contact sensors 306 may be utilized to determine that the wireless earpieces 302 are positioned within the ears of the user. For example, conductivity of skin or tissue within the user's ear may be utilized to determine that the wireless earpieces are being worn. In other embodiments, the contact sensors 306 may include pressure switches, toggles, or other mechanical detection components for determining that the wireless earpieces 302 are being worn. The contact sensors 306 may measure or provide additional data points and analysis that may indicate the biometric information of the user”). The electronic signal is used to identify a condition of the user when it exceeds a pre-selected threshold (para 0078, “The contact sensors 306 may measure or provide additional data points and analysis that may indicate the biometric information of the user”; para 0109, “The sensors may read various user biometrics that may be utilized by the logic (e.g., processing and comparison against user supplied or predefined thresholds) to determine the health or medical status of the user… The wireless earpieces may utilize any number of libraries, databases, or other information, settings, parameters, or thresholds to determine a status or condition of a user”). By identifying the condition via a pre-selected threshold of the signal, the user may then receive assistance and treatment for the condition (para 0103). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to determine whether the signal exceeds a pre-selected threshold in order to identify a condition, so that the user may treat said condition appropriately and not prematurely.
16. Regarding Claim 16, Savchenko teaches the method of claim 15, as well as receiving, from a second electrode, a second electronic signal from the skin in the first ear canal of the user of the in-ear device (Fig. 1, ref num 104; Fig. 8, ref num 801, 802; para 0055, “the purpose of the in-ear insert 511 is to establish an electrical contact with the skin in the ear of the user and transmit electrical signals from the skin”; also see Fig. 5; para 0038, “electrodes 103 and 104 used…for the purpose of measuring ECG signals”); and removing an interference from the first electronic signal with the first electronic signal (para 0034, “measure electrical signals captured by electrodes…filter the ECG signal”).
17. Regarding Claim 18, Savchenko teaches the method of claim 15, as well as receiving an acoustic signal from an external microphone in the in-ear device in response to an acoustic stimulus (Fig. 1, ref num 115 and Fig. 3, ref num 319; para 0041, “audio received from a microphone 115”; Fig. 7, ref nums 705 and 706 indicate environment acoustic signal); correlating the acoustic signal with the first electronic signal (Fig. 9, ref num 901); and assessing a user response to the acoustic stimulus based on the heart activity or brain activity and the acoustic stimulus (Fig. 9, ref num 906; Fig. 8, ref num 804 and 805).
18. Regarding Claim 19, Savchenko teaches the method of claim 15, as well as identifying a heart activity of the user further includes performing a spectral analysis on the waveform to identify a p-wave, a QRS-complex, and a T-wave complex in an electrocardiogram (see Claim 8, “the MCU (113) is configured to: determine, based on the digital ECG, one or more of heart activity data, the heart activity data including PQRST complexes”).
19. Regarding Claim 20, Savchenko teaches the method of claim 15, as well as measuring a change in the electric property within a user’s skin, and assessing a fit of the in-ear device within a user’s ear based on the change in the electrical property (para 0055, “The first electrode is comprised of a soft in-ear insert 511 fitted snugly over the nozzle 513. The soft in-ear insert is made from an electrically conductive rubber or latex material. The purpose of the in-ear insert 511 is to establish an electrical contact with the skin in the ear of the user and transmit electrical signals from the skin via the nozzle 513 and the electrical wire 507 to the first electrode contact inside the electronic unit 501”).
20. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Savchenko, Goldstein, and Boesen, and further in view of Shute U.S. 2019/0343480 (herein referred to as “Shute”).
21. Regarding Claim 6, Savchenko teaches a second electrode configured to receive a second electronic signal from the skin in the ear canal of the user (Fig. 8, ref num 801, 802; para 0055, “the purpose of the in-ear insert 511 is to establish an electrical contact with the skin in the ear of the user and transmit electrical signals from the skin”; also see Fig. 5; para 0038, “electrodes 103 and 104 used…for the purpose of measuring ECG signals”).
However, Savchenko fails to teach the processor is configured to reduce a noise background from the first electronic signal with the second electronic signal.
Shute teaches a device of analogous art (Fig. 3), wherein the device has a processor that is configured to reduce a noise background from a first electronic signal with a second electronic signal (Figs. 7A-7B; para 0048, 0104 shows the two electronic signals; para 0021, “processor configured to identify a first motion interference component from the first physiologic signal and a second motion interference component from the second physiologic signal, the first and second motion interference components each indicative of physical activity. The processor may generate the composite signal by filtering the sensed first or second physiologic signal to remove or attenuate the respective motion interference component.”) This improves the signal quality that is obtained by the processor in order to achieve the desired function of the device, such as identifying a condition of the patient (para 0036, “he systems and methods discussed herein also algorithmically improve heart sound signal quality through active noise and motion interference cancellation… or detecting various cardiac events”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to reduce a noise background in order to improve the signal quality to the processor.\
22. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Savchenko, Goldstein, and Boesen, and further in view of Lisy U.S. 9,579,060 (herein referred to as “Lisy”).
23. Regarding Claim 7, Savchenko fails to teach the first electrode includes multiple needles that increase a surface contact with the skin in the ear canal of the user, reduces a resistivity, and secures the first electrode to the skin in the ear canal of the user, further wherein the needles are supported by a structure that includes an elastomeric material between the needles, and the elastomeric material includes at least one of a compressible material having a very low modulus and is able to be stretched between the needles.
Lisy teaches a device of analogous art (Figs. 1A-1C) comprising a first electrode (Fig. 1A, ref num 12). The first electrode includes multiple needles that increase a surface contact with the skin in the ear canal of the user (Col. 20, lines 8-14, “A penetrator is another surface feature that can be used in the dry electrode… The penetrator can take many shapes, including, but not limited to, pyramidal, needle-like”), reduces resistivity and secures the first electrode to the skin (Col. 20, lines 16-23, “readily penetrates the skin, preferably anchors the device in place to prevent motion artifacts or any substantial movement, increases the surface area of the device in contact with the skin and lower layers of the epidermis, and is capable, in part, of transmitting an electric potential which can be measured from the skin and lower layers of the epidermis through the penetrator”). The needles are supported by a structure that includes an elastomeric material, such that it has a compressible material having a low modulus and is able to be stretched (Col. 8, lines 21-26, “he dry electrodes are formed by coating, deposition, or impregnation of a conductive material onto or into a pliant material that has been molded or etched to have the surface features. In such case, preferably, the conductive material is silver/silver chloride and the pliant material is a polymer, elastomer, foam, or rubber”). It would have been an obvious matter of design choice to make the different portions of the electrode whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the electrode be made with an elastomeric material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
24. Claims 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Savchenko, Goldstein, and Boesen, and further in view of Kirszenblat U.S. 2018/0235540 (herein referred to as “Kirszenblat”).
25. Regarding Claim 8, Savchenko fails to teach the first electrode is coated with at least one of a gold layer, a silver layer, a silver chloride layer, or a combination thereof.
Kirszenblat teaches a device of analogous art (Fig. 3), wherein the device comprises a first electrode (Fig. 5, ref nums 502) that is coated with a silver-based conductive coating (para 0021, 0078). This improves the data collection of biological information form the first electrode (para 0021, 0078). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to have the first electrode coated with a silver layer, since it has been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination”- MPEP 2144.07 In the instant case, one of ordinary skill in the art would recognize the benefits or suitability of the disclosed materials (e.g. cost-effectiveness, manufacturing feasibility, etc.).
26. Regarding Claim 12, Savchenko teaches a second electrode in a second in-ear fixture and configured to receive a second electronic signal from the skin in a second ear canal of the user (Fig. 8, ref num 801, 802; para 0055, “the purpose of the in-ear insert 511 is to establish an electrical contact with the skin in the ear of the user and transmit electrical signals from the skin”; also see Fig. 5; para 0038, “electrodes 103 and 104 used…for the purpose of measuring ECG signals”).
Savchenko fails to teach an instrumental amplifier with a parallel impedance coupling to the first electrode and the second electrode, and configured to amplify a difference signal between the first electronic signal and the second electronic signal and to provide the difference signal to the processor.
Kirszenblat teaches a device of analogous art (Fig. 3), wherein the device comprises a first and second electrode (Fig. 5, ref nums 502 and 504) and an instrumental amplifier (Fig. 5, ref num 510) with a parallel impedance coupling to the first and second electrodes (see Fig. 5, ref num 510 is in parallel coupling with ref nums 502 and 504). The amplifier is configured to amplify a difference signal between the first electronic signal and the second electronic signal (para 0056, “Signals from input buffers 506 and 508 are connected to inputs of a differential amplifier 510. The differential amplifier 510 amplifies the difference between the electrode signals and suppresses unwanted common mode interference signals”) and to provide the difference signal to the processor (Fig. 5, ref num 510 provides the difference signal to the processor at ‘To DAQ’). This process leads to deriving an ECG of the user of the device, which allows for a cardiovascular condition to be determined (para 0005). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to include an instrumental amplifier in order to produce the same expected result of measuring an ECG to identify a cardiovascular condition.
27. Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Savchenko, Goldstein, and Boesen, and further in view of Komeilipoor U.S. 2023/0309860 (herein referred to as “Komeilipoor”).
28. Regarding Claim 9, Savchenko fails to teach the processor is configured to synchronize a waveform with the first electronic signal and a waveform with a second electronic signal from an opposite ear of the user and to determine a gaze direction based on a comparison between the first electronic signal and the second electronic signal.
Goldstein teaches synchronizing waveforms between different electronic signals (para 0106, 0108, 0109) in order to assess environment features of the user (para 0106). This provides clean data in real-time (para 0109). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to have the processor synchronize various signals in order to achieve clean data in real-time.
Komeilipoor teaches a device of analogous art (Fig. 3) wherein the device comprises an in-ear fixture (Fig. 3, ref num 300) and a processor (Fig. 1, ref num 102; para 0047, “processing unit 102”). The processor is configured to determine a gaze direction based on a comparison between a first electronic signal from one ear and a second electronic signal from an opposite ear (para 0059, “detects a gaze direction and blink of a user based on electrooculogram and electromyogram signals recorded from the in-ear sensors 301 and around-ear sensors 302… The horizontal and vertical gaze direction (right, left, up, down and center) as well as the angle of the gaze relative to the head is computed based on approximations of voltage ratios and/or subtraction or other interactions between and within the right and left in-ear sensors 301”). By using signals from both ears, the signal quality is increased which helps determine the gaze direction of the user, as well as provide additional information about the state of the user (para 0059). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Savchenko to determine the gaze direction using signals from both ears, as this improves the signal quality and provides additional information about the user of the device.
29. Regarding Claim 17, Savchenko teaches the method of claim 15, but fails to teach receiving, from a second electrode, a second electronic signal from the skin in the first ear canal of the user of the in-ear device (Fig. 1, ref num 104; Fig. 8, ref num 801, 802; para 0055, “the purpose of the in-ear insert 511 is to establish an electrical contact with the skin in the ear of the user and transmit electrical signals from the skin”; also see Fig. 5; para 0038, “electrodes 103 and 104 used…for the purpose of measuring ECG signals”).
Savchenko fails to teach identifying an eye gaze direction based on the first electronic signal and the second electronic signal.
Komeilipoor teaches a device of analogous art (Fig. 3) wherein the device comprises an in-ear fixture (Fig. 3, ref num 300) and a processor (Fig. 1, ref num 102; para 0047, “processing unit 102”). The processor is configured to determine a gaze direction based on a comparison between a first electronic signal from one ear and a second electronic signal from an opposite ear (para 0059, “detects a gaze direction and blink of a user based on electrooculogram and electromyogram signals recorded from the in-ear sensors 301 and around-ear sensors 302… The horizontal and vertical gaze direction (right, left, up, down and center) as well as the angle of the gaze relative to the head is computed based on approximations of voltage ratios and/or subtraction or other interactions between and within the right and left in-ear sensors 301”). By using signals from both ears, the signal quality is increased which helps determine the gaze direction of the user, as well as provide additional information about the state of the user (para 0059). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Savchenko to determine the gaze direction using signals from both ears, as this improves the signal quality and provides additional information about the user of the device.
30. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Savchenko, Goldstein, and Boesen, and further in view of Howard U.S. 2019/0380597 (herein referred to as “Howard”).
31. Regarding Claim 14, Savchenko fails to teach an optical sensor configured to provide an optical signal to the processor, wherein the processor is configured to identify a cardiovascular condition of the user based on the first electronic signal and the optical signal.
Howard teaches a device of analogous art (Fig. 1), wherein the device comprises an optical sensor configured to provide an optical signal to a processor (Fig. 31; para 0094, “Photoplethysmography (PPG) is a simple optical method that can be used to detect changes in blood volume flowing through the microvascular tissue… With suitable amplification and filtering, be it electronic or digital, all these signals can be extracted for subsequent pulse wave analysis”). The processor is further configured to identify a cardiovascular condition based on a first electronic signal and the optical signal (para 0096, “using a multimodal sensor design, where data from the photodetector may be correlated with data from an electrical probe at the same site”; para 0067, “These electrodes detect the tiny electrical changes on the skin that arise from the heart muscle's electrophysiologic pattern of depolarizing and repolarizing during each heartbeat. It is commonly performed to detect any cardiac problems”; para 0086, “Some signals, such as heart rate and breathing rate may be correlated with data taken from other sensors, such as the optical system used for pulse oximetry”; para 0006, “and a data processing device adapted to process digital data representing the monitored physical or physiological parameters to determine a condition or activity of the human body”). This type of multimodal system allows for the signal quality to be improved during transmission (para 0096). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Savchenko to include an optical sensor in order to identify a cardiovascular condition of the patient, as using a multimodal sensor system improves the quality of the signal for the identification of the condition.
Conclusion
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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