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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/7/26 has been entered.
Status of Claims
Claims 1-20 are rejected.
Response to Arguments
Claim Rejections - 35 USC § 101
Applicant’s arguments, see Remarks, filed 1/7/26, with respect to claims 1-20 have been fully considered and are persuasive. The 101 rejection of claims 1-20 has been withdrawn. Specifically, the specific structural aspects of the in-ear fixture were not found to be a well-understood, routine, and conventional structure.
Claim Rejections - 35 USC § 103
Applicant’s amendments and remarks filed on 1/7/26 merit new grounds of rejection under 35 U.S.C. 103 over Komeilipoor (US 20230199413 filed on 5/28/21), hereinafter referred to as Kom in view of Goldstein (US 20160324478 filed on 5/9/16 as cited in the IDS) and Liu (CN 204145698 filed on 8/25/14).
Applicant’s Remarks on pages 8-10 are directed solely to whether the Kom and Goldstein references teaches the newly amended subject matter. Therefore, this is unpersuasive in view of the Liu reference. Liu relates to the technical field of earphones and heart rate detection, in particular to an earphone capable of detecting heart rate (page 1, ¶2). Liu teaches wherein the waveform represents motion induced by cardiovascular activity within the sealed ear canal (page 5, ¶2-the data collected by the microphone includes not only the pressure change information due to the pulse pressure fluctuation of the blood vessel, but also the pressure change information generated by the human body motion in the ear canal). See the rejection below for additional details and reasoning.
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 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 1-2, 4-7, 9, 11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Komeilipoor (US 20230199413 filed on 5/28/21), hereinafter referred to as Kom, in view of Goldstein (US 20160324478 filed on 5/9/16 as cited in the IDS) and Liu (CN 204145698 filed on 8/25/14).
Regarding claims 1 and 11, Kom teaches a device and a method, comprising: an in-ear fixture configured to seal an ear canal of a user (¶74-a single hearing assistance device 300 including in-ear electrodes 301 , around-ear electrodes 302, and both omnidirectional 304 and directional 303 microphones; ¶81-the in-ear sensors 301 are preferably electrodes, and engage the ear canal of the user’s ear); a motion sensor mounted on the in-ear fixture (¶92-an in-ear hearing device that includes: accelerometer, gyroscope, and magnetometer sensors embedded in the device) and configured to provide a motion signal indicative of an inner body motion or a bulk body motion of the user (¶103-the user's head and eye movements; ¶47-identify the horizontal and vertical movement of the user’s eye); and a processor (¶15-processor) that is coupled to an augmented reality headset (¶93-virtual or augmented reality headset, or a headphone unit that is incorporated into a helmet including the following elements: around-ear electrodes to be placed in or around the ear of the user), wherein the processor (¶15-processor) is configured to: generate a waveform from the motion signal (¶30-the at least one ear sensor comprises at least one in-ear sensor and/or around-ear sensor used to obtain the at least one biosignal consisting of EOG), analyze the waveform (¶1-analyzing the data collected; ¶15) in combination with a signal acquired from an in-ear electrode (¶92-an in-ear hearing device that includes: one or more in-ear dry electrodes for the collection of EEG, EOG, and EMG data from the ear canal of the user, omnidirectional and directional microphones placed on an outward face of the body of the hearable device, as well as accelerometer, gyroscope, and magnetometer sensors embedded in the device); and correlate the analysis with attention focus from a user gaze direction (¶68-the signals can be integrated with signals from an electronic device or system to provide a comprehensive understanding of the user and their environment; said integration being performed using a sensor fusion method for integrating a combination of said auditory attention data, gaze direction data, gaze-head-trunk orientation data, location data, sound data, separated sounds, raw EEG, EOG, and/or EMG signals, and inertial data; ¶85-86) to determine at least one condition of the user (¶15-determine auditory attention of the user; ¶67-understand the conditions of the state and attention of the user). However, Kom does not teach a speaker coupled to provide an audio signal to the user, wherein the waveform represents motion induced by cardiovascular activity within the sealed ear canal, and a cardiovascular or neurologic condition of the user.
Goldstein relates generally to monitoring of health or other status information and, more particularly, to health or status monitoring using a device such as a communication device within a sealed or substantially sealed conduit or cavity (¶2). Goldstein further teaches the invention using the following step:
a speaker coupled to provide an audio signal to the user (¶68-the auditory front end can include an ambient or external microphone as well as an ear canal microphone and speaker; ¶141-speaker 27; ¶174-provide reproduced sound to the ear canal via a speaker) and cardiovascular or neurologic condition of the user (¶193-a device can form part of a cardiovascular monitoring system for disease diagnosis; ¶103-neurological information is analyzed to identify a physiological condition, health, level of safety of the person).
Therefore, 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 invention of Kom to include a speaker coupled to provide an audio signal to the user and a cardiovascular or neurologic condition of the user of Goldstein in order to indicate a potential sleep disorder or heart disease within the context of a typical daily activity (e.g., sleeping, walking or sitting) or within the context of a less typical daily activity (e.g, sprinting to catch a bus or rigorously exercising) (Goldstein, ¶58).
While the combination of Kom and Goldstein teach an in-ear hearing device that includes: accelerometer, gyroscope, and magnetometer sensors embedded in the device (Goldstein, ¶92), the combination fails to teach wherein the waveform represents motion induced by cardiovascular activity within the sealed ear canal.
Liu teaches wherein the waveform represents motion induced by cardiovascular activity within the sealed ear canal (page 5, ¶2-the data collected by the microphone includes not only the pressure change information due to the pulse pressure fluctuation of the blood vessel, but also the pressure change information generated by the human body motion in the ear canal).
Liu relates to the technical field of earphones and heart rate detection, in particular to an earphone capable of detecting heart rate (page 1, ¶2).
Therefore, 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 invention of Kom to include wherein the waveform represents motion induced by cardiovascular activity within the sealed ear canal of Liu because change information of the pressure in the ear canal caused by the movement of the human body has the same vibration frequency, and based on this, a certain filter can be used to eliminate the interference caused by the body movement of the human body (Liu, page 5, ¶2).
Regarding claim 2, the combination of Kom, Goldstein, and Liu teaches the device of claim 1, wherein the motion sensor is a contact microphone (Goldstein, ¶223-ambient and ear canal microphones; ¶195-a microphone or other transducer can monitor for sounds such as snoring or another sensor can monitor for restlessness or other motion; ¶87) and the motion signal is transmitted through a body of the user into a contact point between the motion sensor and the ear canal of the user (Goldstein, ¶160-measuring body motion in real-time via one or more accelerometers inside the wearable monitor; ¶65-exemplary physiological and environmental sensors that may be incorporated into a Bluetooth® or other type of earpiece module include, but are not limited to accelerometers; ¶117).
Therefore, 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 invention of Kom to include wherein the motion sensor is a contact microphone and the motion signal is transmitted through a body of the user into a contact point between the motion sensor and the ear canal of the user of Goldstein because the ear canal provides an optimal location for monitoring internal sounds, such as heartbeat, breathing rate, and mouth motion, and one's own voice via bone conduction (Goldstein, ¶63).
Regarding claim 4, the combination of Kom, Goldstein, and Liu teaches the device of claim 1, wherein the motion sensor is a micro-electronic moving system (Goldstein, ¶130-microelectromechanical systems (MEMS) can be used to collect and store energy from body movements, electromagnetic energy, and other forms of energy in the environment or from the user himself; ¶160-MEMS motion sensors).
Therefore, 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 invention of Kom to include wherein the motion sensor is a micro-electronic moving system of Goldstein in order to correct physiological and/or environmental data for motion artifacts (Goldstein, ¶160).
Regarding claim 5, the combination of Kom, Goldstein, and Lui teaches the device of claim 1, wherein the motion signal is indicative of an inner body motion of the user including one of a heart rate or a respiratory rate (Lui, page 4, ¶1- the estimated signal of the signal generated by the body motion is subtracted from the signal collected by the microphone, and then the heart rate is detected, thereby eliminating the influence of the wearer's body motion on the heart rate detection).
Therefore, 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 invention of Kom to include wherein the motion signal is indicative of an inner body motion of the user including one of a heart rate or a respiratory rate of Liu in order to eliminating the influence of the wearer's body motion on the heart rate detection (Liu, page 4, ¶1).
Regarding claim 6, the combination of Kom, Goldstein, and Lui teaches the device of claim 1, further comprising an electrode mounted on the in-ear fixture, the electrode configured to receive the signal indicative of a cardiovascular activity of the user (Goldstein, ¶70-the sensors can be embedded or formed on or within an expandable element or balloon that is used to occlude the ear canal. Such sensors can include non-invasive contactless sensors that have electrodes for ECGs; ¶193-the electrodes used in an earpiece can use multimodal electrodes that monitor or measure various parameters. For example, the electrode can be used to monitor one or more of cardiac activity (ECG); ¶89).
Therefore, 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 invention of Kom to include an electrode mounted on the in-ear fixture, the electrode configured to receive the signal indicative of a cardiovascular activity of the user of Goldstein in order to indicate a potential sleep disorder or heart disease within the context of a typical daily activity (e.g., sleeping, walking or sitting) or within the context of a less typical daily activity (e.g, sprinting to catch a bus or rigorously exercising) (Goldstein, ¶58).
Regarding claim 7, the combination of Kom, Goldstein, and Lui teaches the device of claim 1, further comprising an electrode mounted on the in-ear fixture, the electrode configured to receive the signal indicative of a neural activity of the user (Goldstein, ¶191-monitoring neurological functioning can be accomplished via electrodes or via non-invasive contactless sensors placed at the ear).
Therefore, 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 invention of Kom to include an electrode mounted on the in-ear fixture, the electrode configured to receive the signal indicative of a neural activity of the user of Goldstein in order to indicate a potential sleep disorder or heart disease within the context of a typical daily activity (e.g., sleeping, walking or sitting) or within the context of a less typical daily activity (e.g, sprinting to catch a bus or rigorously exercising) (Goldstein, ¶58).
Regarding claim 9, the combination of Kom, Goldstein, and Lui teaches the device of claim 1, wherein the processor is configured to determine a heart rate of the user from the motion signal (Lui, page 4, ¶1- the estimated signal of the signal generated by the body motion is subtracted from the signal collected by the microphone, and then the heart rate is detected, thereby eliminating the influence of the wearer's body motion on the heart rate detection).
Therefore, 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 invention of Kom to include wherein the waveform represents motion induced by cardiovascular activity within the sealed ear canal of Liu in order to eliminating the influence of the wearer's body motion on the heart rate detection (Liu, page 4, ¶1).
Regarding claim 14, the combination of Kom, Goldstein, and Lui teaches the computer-implemented method of claim 11, wherein the motion signal is indicative of a bulk body motion of the user (Goldstein, ¶83) and identifying at least one of the cardiovascular or neurologic condition of the user comprises at least one of detecting a fall of the user, a cough of the user, a sneeze of the user, or determining a step count for the user (Goldstein, ¶160-monitor footsteps; ¶119-coughing and sneezing; ¶199-monitor when someone has fallen down; ¶203).
Therefore, 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 invention of Kom to include wherein the motion signal is indicative of a bulk body motion of the user and identifying at least one of the cardiovascular or neurologic condition of the user comprises at least one of detecting a fall of the user, a cough of the user, a sneeze of the user, or determining a step count for the user of Goldstein in order to indicate a potential sleep disorder or heart disease within the context of a typical daily activity (e.g., sleeping, walking or sitting) or within the context of a less typical daily activity (e.g, sprinting to catch a bus or rigorously exercising) (Goldstein, ¶58).
Regarding claim 15, the combination of Kom, Goldstein, and Lui teaches the computer-implemented method of claim 11, further comprising identifying a systolic heart pulse and a diastolic heart pulse from the waveform (Goldstein, ¶188-systolic and diastolic pressure can be measured by monitoring the pressure at which the well-known Korotkoff sound is first heard (systolic), then disappears (diastolic). This technique can also be used to monitor intra-cranial pressure and other internal pressures), wherein identifying at least one of the cardiovascular or neurologic condition of the user based on the waveform comprises identifying features in the systolic heart pulse and the diastolic heart pulse (Goldstein, ¶187- cardiopulmonary functioning can be evaluated by monitoring blood pressure, pulse, cardiac output, and blood gas levels via earpiece modules, and other monitoring apparatus in accordance with some embodiments herein; ¶188).
Therefore, 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 invention of Kom to include identifying a systolic heart pulse and a diastolic heart pulse from the waveform, wherein identifying at least one of the cardiovascular or neurologic condition of the user based on the waveform comprises identifying features in the systolic heart pulse and the diastolic heart pulse of Goldstein in order to monitor intra-cranial pressure and other internal pressures (Goldstein, ¶188).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kom in view of Goldstein and Lui as applied to claim 1 above, and further in view of Tran (US 20200268260 filed on 2/26/19 as cited in the IDS).
Regarding claim 3, the combination of Kom, Goldstein, and Lui teaches the device of claim 1, and the motion signal is indicative of a bulk body motion of the user including one of a sneeze, a cough, a fall, and a step (Goldstein, ¶160-monitor footsteps; ¶119-coughing and sneezing; ¶199-monitor when someone has fallen down; ¶203).
Therefore, 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 invention of Kom to include the motion signal is indicative of a bulk body motion of the user including one of a sneeze, a cough, a fall, and a step of Goldstein in order to indicate a potential sleep disorder or heart disease within the context of a typical daily activity (e.g., sleeping, walking or sitting) or within the context of a less typical daily activity (e.g, sprinting to catch a bus or rigorously exercising) (Goldstein, ¶58).
However, the combination of Kom, Goldstein, and Lui does not teach wherein the motion sensor is an inertial motion unit.
Tran teaches wherein the motion sensor is an inertial motion unit (¶156-the earpiece contains an inertial measurement unit (IMU)).
Tran relates to in-ear monitoring systems (¶1).
Therefore, 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 invention of Kom to include wherein the motion sensor is an inertial motion unit of Tran in order to detect inertial measurement data that corresponds to a positioning, velocity, or acceleration of the intelligent earpiece (Tran, ¶156).
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kom in view of Goldstein and Lui as applied to claim 11 above, and further in view of Jang (US 20170127960 filed on 8/30/16).
Regarding claim 13, the combination of Kom, Goldstein, and Liu teaches the computer-implemented method of claim 11, wherein the motion signal is indicative of an inner body motion (Goldstein, ¶199-a person's body motion and head position can also be monitored by integrating a motion sensor into an earpiece module).
Therefore, 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 invention of Kom to include wherein the motion signal is indicative of an inner body motion of Goldstein because the ear canal provides an optimal location for monitoring internal sounds, such as heartbeat, breathing rate, and mouth motion, and one's own voice via bone conduction (Goldstein, ¶63).
However, the combination of Kom, Goldstein, and Lui does not teach identifying at least one of the cardiovascular or neurologic condition of the user comprises determining at least one of a heart rate and a breathing rate of the user.
Jang teaches identifying at least one of the cardiovascular or neurologic condition of the user comprises determining at least one of a heart rate and a breathing rate of the user (¶66-the regression model is based on a correlation between a heart rate and movement information, the estimation apparatus estimates a heart rate of the user by applying the movement information to a regression model set in advance).
Jang relates to a method and apparatus for estimating a heart rate based on movement information (¶3).
Therefore, 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 invention of Kom to include identifying at least one of the cardiovascular or neurologic condition of the user comprises determining at least one of a heart rate and a breathing rate of the user of Jang in order to provide physical activity information analyzed by estimating a heart rate of a user based on movement information of the user measure (Jang, ¶44).
Regarding claim 19, the combination of Kom, Goldstein, and Liu teaches the computer-implemented method of claim 11, further comprising: receiving, from an electrode, an electronic signal indicative of a cardiovascular activity of the user (Goldstein, ¶70-electrodes for ECGs; ¶89).
Therefore, 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 invention of Kom to include receiving, from an electrode, an electronic signal indicative of a cardiovascular activity of the user of Goldstein in order to indicate a potential sleep disorder or heart disease within the context of a typical daily activity (e.g., sleeping, walking or sitting) or within the context of a less typical daily activity (e.g, sprinting to catch a bus or rigorously exercising) (Goldstein, ¶58).
However, the combination of Kom, Goldstein, and Liu does not teach identifying a correlation of the electronic signal with the waveform, and determining one of a heart rate, a breathing rate, or a blood pressure of the user based on the correlation or a deep neural network algorithm.
Jang teaches identifying a correlation of the electronic signal with the waveform (¶66-the regression model is based on a correlation between a heart rate and movement information), and determining one of a heart rate, a breathing rate, or a blood pressure of the user based on the correlation or a deep neural network algorithm (¶66-the estimation apparatus estimates a heart rate of the user by applying the movement information to a regression model set in advance).
Therefore, 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 invention of Kom to include identifying a correlation of the electronic signal with the waveform, and determining one of a heart rate, a breathing rate, or a blood pressure of the user based on the correlation or a deep neural network algorithm of Jang in order to detect heart rate without noise (Jang, ¶74).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kom in view of Goldstein and Lui as applied to claim 1 above, and further in view of Schwartz (WO 2019226506 filed on 5/20/19).
Regarding claim 8, the combination of Kom, Goldstein, and Liu teaches the device of claim 1. However, the combination of Kom, Goldstein, and Liu does not teach wherein the processor is configured to synchronize the waveform with the motion signal and a waveform with an electronic signal to determine a vital sign of the user.
Schwartz teaches wherein the processor is configured to synchronize the waveform with the motion signal and a waveform with an electronic signal to determine a vital sign of the user (¶174- synchronizing breathing of the subject 801 during the cyclic motion of the subject 801 in FIG. 8a, the desired waveform synchronization is one in which cardio-pulmonary performance or other enhancement of the performance of the subject 801 during the activity is achieved).
Schwartz relates to the field of physiologic monitoring and, more particularly, to devices and systems for monitoring physiologic parameters of a subject (¶1).
Therefore, 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 invention of Kom to include wherein the processor is configured to synchronize the waveform with the motion signal and a waveform with an electronic signal to determine a vital sign of the user of Schwartz in order to maximize or increase a desired output with reduced effort on the part of the subject (Schwartz, ¶129).
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kom in view of Goldstein and Liu as applied to claims 1 and 11 above, and further in view of Klemme (US 20190045298 filed on 1/12/18).
Regarding claim 10, the combination of Kom, Goldstein, and Liu teaches the device of claim 1. However, the combination of Kom, Goldstein, and Liu does not teach wherein the processor is configured to remove one of a noise component or an interference from the audio signal to the user based on the motion signal.
Klemme teaches wherein the processor is configured to remove one of a noise component or an interference from the audio signal to the user based on the motion signal (¶22-the motion data (which can be considered noise relative to the sound data) can be reduced, substantially removed or even eliminated from the signal data; ¶24).
Klemme relates generally to bone conduction and, more particularly, to apparatus and methods for bone conduction context detection (¶1).
Therefore, 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 invention of Kom to include wherein the processor is configured to remove one of a noise component or an interference from the audio signal to the user based on the motion signal of Klemme in order to more accurately generate audio data (Klemme, ¶24).
Regarding claim 18, the combination of Kom, Goldstein, and Liu teaches the computer-implemented method of claim 11, and a speaker mounted in the in-ear device (Goldstein, ¶68-the auditory front end can include an ambient or external microphone as well as an ear canal microphone and speaker; ¶141-speaker 27; ¶174-provide reproduced sound to the ear canal via a speaker).
Therefore, 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 invention of Kom to include a speaker mounted in the in-ear device of Goldstein in order to provide for a text to speech output, or an auditory display, or some form of sonification that provides some form of non-speech audio to convey information or perceptualize data (Goldstein, ¶71).
However, the combination of Kom, Goldstein, and Liu does not teach further comprising filtering, with the waveform, one of a noise component and an interference from an audio signal to a speaker, and providing, with the speaker, the audio signal to the user.
Klemme teaches filtering, with the waveform, one of a noise component and an interference from an audio signal to a speaker (¶54-the filtered signal data can be used to produce, for example, an output (e.g., audio output) that does not include signal interference from user movement(s), such as rotation of the user's head while speaking and/or listening) and providing, with the speaker, the audio signal to the user (¶24-the filtered data can be used to more accurately generate audio data for output via one or more speakers).
Therefore, 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 invention of Kom to include filtering, with the waveform, one of a noise component and an interference from an audio signal to a speaker mounted in the in-ear device, and providing, with the speaker, the audio signal to the user of Klemme in order to remove motion data to not interfere with the quality of audio output by the speaker (Klemme, ¶51).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kom in view of Goldstein and Liu as applied to claim 11 above, and further in view of Shute (US 20190343480 filed on 4/17/19).
Regarding claim 12, the combination of Kom, Goldstein, and Liu teaches the computer-implemented method of claim 11. However, the combination of Kom, Goldstein, and Liu does not teach further comprising receiving, from a second motion sensor in a second in-ear device, a second motion signal indicative of the inner body motion or the bulk body motion, and wherein forming the waveform comprises removing at least one of a noise component or an interference from the motion signal with the second motion signal.
Shute teaches further comprising receiving, from a second motion sensor in a second in-ear device (¶46-physiologic signals recorded by two earpiece devices), a second motion signal indicative of the inner body motion or the bulk body motion (¶48-first and second sensors to sense respectively first and second physiologic signals each representing vibration, motion, or displacement conducted through body tissue; ¶46), and wherein forming the waveform comprises removing at least one of a noise component or an interference from the motion signal with the second motion signal (¶21-filtering the sensed first or second physiologic signal to remove or attenuate the respective motion interference component).
Shute relates generally to medical devices, and more particularly, to systems and methods for detecting heart sound information from a subject's head (¶2).
Therefore, 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 invention of Kom to include receiving, from a second motion sensor in a second in-ear device, a second motion signal indicative of the inner body motion or the bulk body motion, and wherein forming the waveform comprises removing at least one of a noise component or an interference from the motion signal with the second motion signal of Shute in order to remove or attenuate the respective motion interference component using the detected phase relationship (Shute, ¶30).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kom in view of Goldstein and Liu as applied to claim 11 above, and further in view of Goodman (US 20030036685 filed on 9/30/02).
Regarding claim 16, the combination of Kom, Goldstein, and Liu teaches the computer-implemented method of claim 11, further comprising identifying a systolic heart pulse and a diastolic heart pulse from the waveform (Goldstein, ¶188- systolic and diastolic pressure can be measured by monitoring the pressure at which the well-known Korotkoff sound is first heard (systolic), then disappears (diastolic). This technique can also be used to monitor intra-cranial pressure and other internal pressures).
Therefore, 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 invention of Kom to include identifying a systolic heart pulse and a diastolic heart pulse from the waveform of Goldstein in order to monitor intra-cranial pressure and other internal pressures (Goldstein, ¶188).
However, the combination of Kom, Goldstein, and Liu does not teach wherein identifying at least one of the cardiovascular or neurologic condition of the user based on the waveform comprises determining a blood pressure of the user based on an amplitude of the diastolic heart pulse and on an amplitude of the systolic heart pulse.
Goodman teaches wherein identifying at least one of the cardiovascular or neurologic condition of the user based on the waveform comprises determining a blood pressure of the user based on an amplitude of the diastolic heart pulse and on an amplitude of the systolic heart pulse (¶212-an amplitude differential between the systolic and diastolic values (DVPdiff); ¶207-DVP contour have been identified, conventional methods can be used to determine a number of diagnostic values including mean blood pressure, blood pressure, respiratory rate and rhythm, sleep apnea, and autonomic function, and aortic compliance).
Goodman relates to a physiological signal monitoring system and more particularly to a system which allows a user to determine various types of physiological information and which allows a user to electronically access this information over a communication network (¶2).
Therefore, 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 invention of Kom to include wherein identifying at least one of the cardiovascular or neurologic condition of the user based on the waveform comprises determining a blood pressure of the user based on an amplitude of the diastolic heart pulse and on an amplitude of the systolic heart pulse of Goodman in order to determine a number of diagnostic values including mean blood pressure, blood pressure, respiratory rate and rhythm, sleep apnea, and autonomic function, and aortic compliance (Goodman, ¶207).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kom in view of Goldstein and Liu as applied to claim 11 above, and further in view of Newberry (US 20190286233 filed on 8/14/18).
Regarding claim 17, the combination of Kom, Goldstein, and Liu teaches the computer-implemented method of claim 11, further comprising identifying a systolic heart pulse and a diastolic heart pulse from the waveform (Goldstein, ¶188-systolic and diastolic pressure can be measured by monitoring the pressure at which the well-known Korotkoff sound is first heard (systolic), then disappears (diastolic). This technique can also be used to monitor intra-cranial pressure and other internal pressures).
Therefore, 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 invention of Kom to include identifying a systolic heart pulse and a diastolic heart pulse from the waveform of Goldstein in order to monitor intra-cranial pressure and other internal pressures (Goldstein, ¶188).
However, the combination of Kom, Goldstein, and Liu does not teach wherein identifying at least one of the cardiovascular or neurologic condition of the user based on the waveform comprises determining a blood pressure of the user based on a time delay of the diastolic heart pulse relative to the systolic heart pulse.
Newberry teaches wherein identifying at least one of the cardiovascular or neurologic condition of the user based on the waveform comprises determining a blood pressure of the user based on a time delay of the diastolic heart pulse relative to the systolic heart pulse (¶122-time delay between the systolic points and diastolic points; ¶177-provide a status or indication of a health condition; ¶135).
Newberry relates to a system and method of non-invasive detection of neural stimulation or movement, and in particular to a system and method for monitoring neural stimulation or movement using photoplethysmography (PPG) methods (¶3).
Therefore, 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 invention of Kom to include wherein identifying at least one of the cardiovascular or neurologic condition of the user based on the waveform comprises determining a blood pressure of the user based on a time delay of the diastolic heart pulse relative to the systolic heart pulse of Newberry in order to provide a warning or health alert (Newberry, ¶177).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kom in view of Goldstein and Liu as applied to claim 11 above, and further in view of Brockway (US 20160022164 filed on 8/4/15).
Regarding claim 20, the combination of Kom, Goldstein, and Liu teaches the computer-implemented method of claim 11. However, the combination of Kom, Goldstein, and Liu does not teach wherein identifying at least one of the cardiovascular or neurologic condition of the user further comprises performing a spectral analysis on the waveform to identify a p-wave, a QRS-complex, and a T-wave complex in an electro-cardiogram.
Brockway teaches wherein identifying at least one of the cardiovascular or neurologic condition of the user further comprises performing a spectral analysis on the waveform to identify a p-wave, a QRS-complex, and a T-wave complex in an electro-cardiogram (¶149-extracting atrial activity from ECG recordings, spectral analysis of the extracted atrial activity signal can be used to quantify P-wave regularity and frequency).
Brockway relates to the processing of physiological signals, and more particular aspects relate to detection of fiducial points in quasi-periodic signals, such as identifying QRS complexes in an ECG (¶1).
Therefore, 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 invention of Kom to include wherein identifying at least one of the cardiovascular or neurologic condition of the user further comprises performing a spectral analysis on the waveform to identify a p-wave, a QRS-complex, and a T-wave complex in an electro-cardiogram of Brockway in order to discriminate between atrial fibrillation and flutter (Brockway, ¶149).
Conclusion
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/L.N.H./Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792