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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/21/2026 has been entered.
Response to Amendment
This Office Action is in response to the Amendment filed 01/21/2026. As directed by the Amendment, claims 1, 3, 5, 6, 11-15, and 17-20 are amended. Claims 1-20 are pending in the application.
The rejections made to claims 1-10 under 35 USC § 112(b) pertaining to lack of structure carrying out the step of calibrating the temperature signals using infrared radiation have been withdrawn in light of Applicant’s amendments. However, the rejections made to claims 1-20 (particularly claims 1, 5, 11, 15, and 17) under 35 USC § 112(b) pertaining to overlapping and redundant limitations involving calibration using infrared radiation are maintained, as Applicant did not amend to eliminate overlapping and redundant limitations. Examiner notes that Applicant includes a Claim Rejections - 35 USC § 112. However, Applicant briefly addresses 102 rejections under the 112 section (Examiner notes that there were no 35 USC § 102 rejections made in the previous Office Action) and does not address the redundancy issue in the Remarks filed 01/21/2026.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/21/2026, with respect to the rejections of claims 1-20 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Soreefan et al. (US 20200105407 A1). Prior art Goldstein (US 20170112671 A1 – Cited by Applicant) discloses the amended details of infrared emitter and detector components, while newly found prior art Soreefan et al. discloses details of utilizing infrared radiation to calibrate temperature signals of a subject (see below in updated claim rejections).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 5, 11, 15, and 17 have overlapping and redundant limitations pertaining to calibration using infrared radiation. Dependent claims 5, 15, and 17 should be updated to be consistent with their respective independent claims.
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.
Claims 1-3, 5, 6, 8-11, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Goldstein (US 20170112671 A1 – Cited by Applicant) in view of Soreefan et al. (US 20200105407 A1), hereinafter Soreefan.
Regarding claim 1, Goldstein discloses a device, comprising:
an in-ear fixture configured to seal an ear canal of a user [earpiece modules will be illustrated and described for insertion within the ear canal of the human body, see in ¶ 0056; blood gas levels and skin temperature may also be measured within the ear canal as well, see in ¶ 0057; Body temperature, including core and skin temperature, can be monitored in real-time by integrating compact infrared sensors into an earpiece module, according to some embodiments of the present invention, see in ¶ 0200];
a temperature sensor mounted on the in-ear fixture and configured to receive a temperature signal from the ear canal of the user [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 … temperature sensors, see in ¶ 0064; see in Fig. 1A];
an infrared emitter coupled to the in-ear fixture and configured to emit infrared radiation into the ear canal; an infrared detector coupled to the in-ear fixture and configured to receive the infrared radiation from tissue in the ear canal [infrared sensors integrated into the earpiece module, see in ¶ 0200; Examiner notes that an infrared sensor consists of both emitting and detecting components]; and
a processor [Processing 4, see in Fig. 1A; one or more processors 4, see in ¶ 0064] that is coupled to an augmented reality headset [a pair of virtual reality (VR) or augmented reality (AR) “glasses”, see in ¶ 0065], the processor configured to identify a health condition of the user based on the temperature signal [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, see in ¶ 0002].
Goldstein fails to disclose that the processor is configured to calibrate the temperature signal based on the received infrared radiation to adjust for tissue emissivity of the ear canal.
However, Soreefan discloses the processor is configured to calibrate the temperature signal based on the received infrared radiation [see in ¶ 0075 and ¶ 0092].
Goldstein and Soreefan are both analogous to the claimed invention because they are in the same field of temperature measurement systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Goldstein to incorporate the teachings of Soreefan to include that the processor is configured to calibrate the temperature signal using infrared radiation to adjust for tissue emissivity of the ear canal in order to calibrate the system for improved levels of temperature accuracy [see in ¶ 0092].
Regarding claim 2, and substantially similar limitations in claim 18, Goldstein, as modified, discloses the device of claim 1, wherein the temperature sensor is a contact sensor including a thermocouple electrode adjacent to a skin portion of the ear canal of the user [Thermistors, thermocouples, and other temperature-dependent transducers can also be incorporated for monitoring body temperature. These sensors can be very compact and thus can be integrated throughout an earpiece module, see in ¶ 0200]. Examiner notes that it is known in the art that thermocouples produce a temperature-dependent voltage as a result of the Seebeck effect, in which the voltage can be interpreted to measure temperature.
Regarding claim 3, Goldstein, as modified, discloses the device of claim 1, wherein the temperature sensor comprises the infrared detector configured to receive an infrared radiation emitted from a body of the user and transmitted through the ear canal [Body temperature, including core and skin temperature, can be monitored in real-time by integrating compact infrared sensors into an earpiece module, see in ¶ 0200].
Regarding claim 5, and substantially similar limitations in claims 15 and 17, Goldstein, as modified, discloses the device of claim 1, wherein the infrared emitter is configured for calibration of the temperature signal.
Goldstein fails to disclose that the calibration is based on an emissivity and an absorptivity of the tissue in the ear canal of the user for a radiation bandwidth used by the temperature sensor.
However, Soreefan discloses that calibration is based on an emissivity and an absorptivity for a radiation bandwidth used by the temperature sensor [see in ¶ 0041, ¶ 0081, and ¶ 0092].
Goldstein and Soreefan are both analogous to the claimed invention because they are in the same field of temperature measurement systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Goldstein to incorporate the teachings of Soreefan to include the that calibration is based on an emissivity and an absorptivity of the tissue in the ear canal of the user for a radiation bandwidth used by the temperature sensor to adjust for tissue emissivity of the ear canal in order to calibrate the system for improved levels of temperature accuracy [see in ¶ 0092].
Regarding claim 6, Goldstein, as modified, discloses the device of claim 1, wherein the temperature sensor is an optical sensor operating with the infrared radiation, the optical sensor including a lens to collect the infrared radiation from a selected point in the ear canal [Such sensors can include non-invasive contactless sensors that have electrodes for EEGs, ECGs, transdermal sensors, temperature sensors, transducers, microphones, optical sensors, motion sensors or other biometric, neurological, or physiological sensors that can monitor brainwaves, heartbeats, breathing rates, vascular signatures, pulse oximetry, blood flow, skin resistance, glucose levels, and temperature among many other parameters, see in ¶ 0064; Data from the sensors can be sent to the processor directly or wirelessly using appropriate wireless modules 6A and communication protocols such as Bluetooth, WiFi, NFC, RF, and Optical such as infrared for example, see in ¶ 0064; see in ¶ 0200].
Regarding claim 8, Goldstein, as modified, discloses the device of claim 1, wherein the temperature sensor includes an electrical sensor including at least one of a thermocouple or a thermistor [Thermistors, thermocouples, and other temperature-dependent transducers can also be incorporated for monitoring body temperature, see in ¶ 0200].
Regarding claim 9, Goldstein, as modified, discloses the device of claim 1, wherein the processor is configured to combine a waveform with the temperature signal and a waveform with a second temperature signal from an opposite ear of the user to form a combined temperature waveform with reduced noise [two earpiece modules 20 may be utilized, according to some embodiments of the present invention; one for each ear of a person … Dual-ear analysis with two earpiece modules can be used, for example, to compare the core temperature of each tympanic membrane in order to gauge brain activity comparing each brain hemisphere, see in ¶ 0163].
Regarding claim 10, Goldstein, as modified, discloses the device of claim 1, further comprising at least one microphone or a motion sensor configured to provide a cardiovascular signal, wherein the health condition of the user is based on the temperature signal and the cardiovascular signal [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, see in ¶ 0187].
Regarding claim 11, Goldstein discloses a computer-implemented method [see in ¶ 0093], comprising:
receiving, from a temperature sensor, a temperature signal indicative of an inner body temperature of a user of an in-ear device [see in ¶ 0057 and ¶ 0064];
forming a temperature waveform with the temperature signal [wearable monitoring device 20 is capable of measuring and transmitting sensor information in real-time over a duration of time, the physiological and environmental sensors (5A) can be used to sense the aforementioned parameters over time, enabling a time-dependent analysis of the user's health and environment as well as enabling a comparison between the user's health and environment, see in ¶ 0118; Examiner notes that if several sensor data points are collected over time, a sensor data (in this case temperature data) waveform is created];
emitting, from an infrared emitter, infrared radiation into an ear canal; receiving, from an infrared detector, the infrared radiation from tissue in the ear canal [infrared sensors integrated into the earpiece module, see in ¶ 0200; Examiner notes that an infrared sensor consists of both emitting and detecting components]; and
identifying a health condition of the user of the in-ear device based on the temperature waveform [The received physiological and/or environmental, acoustic or neurological information is analyzed to identify a physiological condition, health, level of safety of the person and/or environmental condition in a vicinity of the person, and an advertisement is selected for a product or service related to an identified physiological and/or environmental condition, see in ¶ 0097].
Goldstein fails to disclose the step of calibrating the temperature signal based on the received infrared radiation to adjust for tissue emissivity of the ear canal.
However, Soreefan discloses the step of calibrating the temperature signal based on the received infrared radiation [see in ¶ 0092].
Goldstein and Soreefan are both analogous to the claimed invention because they are in the same field of temperature measurement systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Goldstein to incorporate the teachings of Soreefan to include the step of calibrating the temperature signal using infrared radiation to adjust for tissue emissivity of the ear canal in order to calibrate the system for improved levels of temperature accuracy [see in ¶ 0092].
Regarding claim 16, Goldstein, as modified, discloses computer-implemented method of claim 11, further comprising receiving, from at least one microphone or a motion sensor, a cardiovascular signal, wherein identifying the health condition of the user is based on the temperature waveform and the cardiovascular signal [sensors can include non-invasive contactless sensors that have electrodes for EEGs, ECGs, transdermal sensors, temperature sensors, transducers, microphones, optical sensors, motion sensors or other biometric, neurological, or physiological sensors that can monitor brainwaves, heartbeats, breathing rates, vascular signatures, pulse oximetry, blood flow, skin resistance, glucose levels, and temperature among many other parameters, see in ¶ 0064; sensors for monitoring physiological and/or environmental parameters associated with influenza may monitor changes in core body temperature, voice pitch changes, pulse rate changes, etc. in a subject, or group of subjects, wearing a module 20, and this information may be processed into a prediction of the onset of influenza for the subject or group of subjects, see in ¶ 0160].
Regarding claim 19, Goldstein, as modified, discloses the computer-implemented method of claim 11, wherein identifying the health condition of the user comprises identifying a pattern in the temperature waveform indicative of a disease onset [sensors for monitoring physiological and/or environmental parameters associated with influenza may monitor changes in core body temperature, voice pitch changes, pulse rate changes, etc. in a subject, or group of subjects, wearing a module 20, and this information may be processed into a prediction of the onset of influenza for the subject or group of subjects, see in ¶ 0160].
Claims 4, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Goldstein (US 20170112671 A1 – Cited by Applicant) in view of Soreefan (US 20200105407 A1), further in view of Laurence et al. (US 20100160809 A1), hereinafter Laurence.
Regarding claim 4, and substantially similar limitations in claims 12 and 13, Goldstein, as modified, discloses the device of claim 1. Goldstein fails to disclose that the temperature sensor comprises a filter to select a radiation bandwidth based on a signal range and a range of bodily temperatures.
However, Laurence discloses a temperature sensor comprises a filter to select a radiation bandwidth based on a signal range and a range of bodily temperatures [IR bandpass filters are used to restrict the wavelength range of the emissions that are detected … Unless corrected for wavelength (or otherwise) these surface emissions will cause errors in measuring the desired (internal) emissions that, in most cases, will be most representative of the core temperature, see in ¶ 0099].
Goldstein and Laurence are both analogous to the claimed invention because they are in the same field of temperature measuring systems. Examiner notes that although Goldstein deals with in ear measurements and Laurence is involved in temperature measurements from the eye, both references are concerned with collecting temperatures using infrared (IR) sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have further modified Goldstein to incorporate the teachings of Laurence and include that the temperature sensor also has a filter to selectively choose a bandwidth, in order to selectively detect the core temperature of the targeted tissue.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Goldstein (US 20170112671 A1 – Cited by Applicant) in view of Soreefan (US 20200105407 A1), further in view of Quinn et al. (WO 2011053526 A2 – Cited by Applicant), hereinafter Quinn.
Regarding claim 7, Goldstein, as modified, discloses the device of claim 1. Goldstein fails to disclose that the temperature sensor is an optical sensor operating with infrared radiation in a bandwidth within 2 and 4 microns, or within 8 and 14 microns.
However, Quinn discloses a temperature sensor is an optical sensor operating with infrared radiation in a bandwidth within 2 and 4 microns, or within 8 and 14 microns [emission spectra tend to peak in the mid-infrared range, at wavelengths around 10 microns, see in ¶ 0006].
Goldstein and Quinn are both analogous to the claimed invention because they are in the same field of ear temperature measurement systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have further modified Goldstein to incorporate the teachings of Quinn and include that the optical sensor operates with infrared radiation in a bandwidth around 10 microns, as that is the range in which emission spectra tends to peak [see in ¶ 0006].
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Goldstein (US 20170112671 A1 – Cited by Applicant) in view of Soreefan (US 20200105407 A1), further in view of Martin et al. (BEST PRACTICE GUIDE - USE OF INFRARED EAR THERMOMETERS TO PERFORM TRACEABLE NON-CONTACT MEASUREMENTS OF HUMAN BODY TEMPERATURE, 3rd Version, BIPM.org, May 2021), hereinafter Martin.
Regarding claim 14, Goldstein, as modified, discloses the computer-implemented method of claim 11. Goldstein fails to disclose that the method further comprises modeling a black body emitter having a selected emissivity of the ear canal of the user within a selected bandwidth, and determining the inner body temperature based on the selected emissivity of the ear canal.
However, Martin discloses that an ideal blackbody has an emissivity of 1 and is a perfect emitter of thermal radiation [see on pg. 6] and that the auditory canal, near the tympanic membrane, is likely to have an effective emissivity close to an ideal blackbody cavity, therefore the emissivity of the ear canal has been generally assumed to be approximately 1.0 [see on pg. 9].
Goldstein and Martin are both analogous to the claimed invention because they are in the same field of ear temperature measurement systems using IR. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have further modified Goldstein to incorporate the teachings of Martin and include that the method has an emitter that models a blackbody emitter with emissivity that is suitable for the ear canal in order to measure the inner body temperature, in order to obtain the most reliable temperature value [see on pg. 10].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Goldstein (US 20170112671 A1 – Cited by Applicant) in view of Soreefan (US 20200105407 A1), further in view of Kirschen et al. (Gregory W. Kirschen, Daniel D. Singer, Henry C. Thode, Adam J. Singer, Relationship between body temperature and heart rate in adults and children: A local and national study, The American Journal of Emergency Medicine, Volume 38, Issue 5, 2020, Pages 929-933, ISSN 0735-6757), hereinafter Kirschen.
Regarding claim 20, Goldstein, as modified, discloses the computer-implemented method of claim 11. Goldstein fails to disclose that identifying the health condition of the user comprises correlating the temperature waveform with cardio-respiratory vital signs of the user.
However, Kirschen discloses the correlation between body temperature and heart rate and their associations with emergency department patients [see abstract].
Goldstein and Kirschen are both analogous to the claimed invention because they are in the same field of measuring body temperature along with other vital signs. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have further modified Goldstein to incorporate the teachings of Kirschen and include that identifying a health condition of the user involves correlating the temperature value with cardiorespiratory vital signs of the user, as they provide critical information regarding hemodynamic and physiological status [see abstract: background].
Conclusion
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/HY KHANH DOAN/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791