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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/27/2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks pages 9-13, filed 04/27/2026, with respect to the rejection(s) of claim(s) 1, 3-16, 19, and 20 under 35 USC 103 have been fully considered and are persuasive. The examiner agrees that that amended limitations of independent claim 1 are not taught by the references used in the previous office action. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Zhang (US 20180214028 A1).
In response to the applicant’s argument that the examiner’s reference, Cross, fails to teach measuring the air temperature in the ear canal, the examiner notes that a new reference, Zhang, is now being relied upon to teach this element of the claim.
Claim Rejections - 35 USC § 103
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.
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, and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cross (US 20190117155 A1) in view of Ishler (US 20050043603 A1), Melkoniemi (US 20160081628 A1), and Zhang (US 20180214028 A1).
Regarding claim 1, Cross teaches a method for determining a state of over-heating or a risk of over-heating of a subject, comprising the steps of:
providing a first temperature monitor at a first location in an ear canal of the subject [Figure 4B Item 4];
providing a second temperature monitor [Figure 4B Item 1] at a second location in the ear canal of the subject, the second location being deeper in the ear canal than the first location [0064, Figs. 4A-B];
the first temperature monitor and second temperature monitor each being configured to monitor the temperature of the ear canal at their respective locations to provide an observation of a temperature gradient [0142 “…thermistors were placed through the shell in each of the 7 locations in the left and right shells in order to evaluate the temperature gradient across the ear”];
obtaining an initial temperature gradient of the ear canal of the subject from the first and second temperature monitors [0142].
Cross teaches obtaining a temperature gradient [0142], but fails to teach obtaining a subsequent temperature gradient of the air in the ear canal of the subject or detecting a change in the temperature gradient by comparing the initial temperature gradient to the subsequent temperature gradient.
Ishler teaches obtaining a subsequent temperature gradient of the ear canal of the subject [claim 5 “…measuring the instant temperature differential…”];
detecting a change in the temperature gradient by comparing the initial gradient to the subsequent temperature gradient [claim 5 “…calculating the difference between the instant temperature differential and the base line temperature differential…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross and incorporate the teachings of Ishler to include obtaining a subsequent temperature gradient of the air in the ear canal of the subject and detecting a change in the temperature gradient by comparing the initial gradient to the subsequent temperature gradient. Doing so configures the system to monitor the temperature change over time until the rate of change approaches zero and an accurate measurement may be obtained.
Cross teaches observing a temperature gradient [0059 “…the heat balance equation can characterize a temperature gradient of the ear…”], but fails to teach the temperature gradient is between the first and second temperature monitors.
Ishler teaches observing a temperature gradient between the first and second temperature monitors [claim 5, “…applying an external sensor at the tragus of the person's ear and obtaining a temperature measurement; (ii.) applying an external sensor at the antihelix of the person's ear and obtaining a temperature measurement; (iii.) calculating the temperature differential between the tragus temperature and the antihelix temperature to obtain a base line temperature differential”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross and incorporate the teachings of Ishler to include observing a temperature gradient between the first and second temperature monitors. Doing so provides a representation of the temperature at different locations and compared to reference information to provide an analysis of the patient’s condition.
Cross teaches determining a health state from the acquired data [see para. 0175], but fails to explicitly teach the temperature gradients are used to determine a state of overheating or risk of overheating.
Melkoniemi teaches the temperature gradients are used to determine a state of overheating or risk of overheating [0017 “Absolute values are also taken into account to detect zero gradient during hyperthermia or fever…”, the examiner is interpreting “hyperthermia” as equivalent to a state of “overheating”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross and incorporate the teachings of Melkoniemi to include the temperature gradients are used to determine a state of overheating or risk of overheating. Doing so configures the system to monitor the temperature across different locations, which potentially “… implicates peripheral vasoconstriction and reduced perfusion and microcirculation”, as recognized by Melkoniemi para. 0013.
The combination of Cross and Ishler teach measuring a temperature gradient across two sensors and wherein the first temperature monitor and the second temperature monitor are located on an extension of a plug [see Cross Fig. 4B, the “extension” containing temperature monitors, Items 1 and 2], but fail to explicitly teach measuring the temperature of air in the ear canal and wherein the extension is a cylindrical protrusion, wherein the first and second temperature monitors are placed on a same side and along a longitudinal axis of the extension, wherein the longitudinal axis of the extension extends from the plug into the ear canal, and wherein the extension is configured to be located in the ear canal.
Zhang teaches measuring the temperature of air in the ear canal [0019 “…the insertion shaft may be small, and may include an sealing member that is configured to seal the distal end of the insertion shaft in the ear so that the temperature within the portion of the ear where the temperature sensor is positioned is in equilibrium, which may be particularly helpful for resistive temperature sensors (such as thermistors) that do not contact the ear”]; and
wherein the extension is a cylindrical protrusion [see Fig. 2A Item 110], wherein the temperature monitor are placed on a side and along a longitudinal axis of the extension [0020 “The temperature sensor may be positioned anywhere on the insertion shaft. For example, the temperature sensor may be present at the distal end of the shaft and configured so that it does not contact the ear. Alternatively the sensor may be positioned, e.g., on a side of the insertion shaft, so that it is immediately adjacent to or contacts the ear canal”], wherein the longitudinal axis of the extension extends from the plug into the ear canal [see Fig. 2A], and wherein the extension is configured to be located in the ear canal [see Fig. 2A].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Cross and Ishler with the teachings of Zhang to include measuring the temperature of air in the ear canal and wherein the extension is a cylindrical protrusion, wherein the temperature monitor are placed on a side and along a longitudinal axis of the extension, wherein the longitudinal axis of the extension extends from the plug into the ear canal, and wherein the extension is configured to be located in the ear canal. Doing so configures the system to allow the use resistive temperature sensors and to shape the extension so that the device may be configured to be comfortably worn, as recognized by Zhang para. 0019.
Regarding claim 3, Cross, Ishler, Melkoniemi, and Zhang teach the method for determining a state of over-heating or a risk of over-heating of a subject, as claimed in claim 1, wherein the step of determining a state of over-heating or risk of over-heating if the change in temperature gradient between the first and second temperature monitors [Ishler claim 5] is beyond a pre-determined threshold level [Cross 0098 “The processor 1810 may be configured to generate one or more alerts based on a comparison between temperature measurements and one or more thresholds”] comprises:
referencing the change in temperature gradient between the first and second temperature monitors against the initial temperature gradient [Ishler claim 5 “…calculating the difference between the instant temperature differential and the base line temperature differential…”] between the first and second temperature monitors [Ishler claim 5].
Regarding claim 6, Cross, Ishler, Melkoniemi, and Zhang teach the method for determining a state of over-heating or a risk of over-heating of a subject, as claimed in claim 1 wherein the step of obtaining the temperature gradient between the first and second temperature monitors of an ear canal of the subject further comprises:
sending the temperature obtained by the first temperature monitor and the temperature obtained by the second temperature monitor to a remote device to deduce the temperature gradient [Cross 0116 “remote server”].
Regarding claim 7, Cross, Ishler, Melkoniemi, and Zhang teach the method for determining a state of over-heating or a risk of over-heating of a subject, as claimed in claim 6, wherein the step of sending the temperature obtained by the first temperature monitor and the temperature obtained by the second temperature monitor to the remote device is done wirelessly [Cross 0116 “wireless communication”].
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Cross, Ishler, and Melkoniemi as applied to claim 3 above, and further in view of Lawson (US 20110105910).
Regarding claim 4, Cross, Ishler, Melkoniemi, and Zhang teach the method for determining a state of over-heating or a risk of over-heating of a subject, as claimed in claim 3, wherein Ishler teaches observation of a temperature gradient between the first and second temperature monitors [Ishler claim 5], but fail to teach requiring an observation of a steepening of the temperature gradient; and requiring an observation of an increase in temperature of the air at the second location in the ear canal.
Lawson teaches requiring an observation of a steepening of the temperature gradient [0063 “…a minimum slope of temperature versus distance…”]; and requiring an observation of an increase in temperature of the air at the second location in the ear canal [0063 “…a minimum threshold temperature…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross, Ishler, Melkoniemi, and Zhang and incorporate the teachings of Lawson to include requiring an observation of a steepening of the temperature gradient and requiring an observation of an increase in temperature of the air at the second location in the ear canal. Doing so configures the system to monitor the temperature change over time until the rate of change approaches zero and an accurate measurement may be obtained.
Regarding claim 5, Cross, Ishler, Melkoniemi, and Zhang teach the method for determining a state of over-heating or a risk of over-heating of a subject, as claimed in claim 3, wherein Ishler teaches observation of a temperature gradient between the first and second temperature monitors [Ishler claim 5], but fail to teach requiring an observation of a steepening of the temperature gradient, requiring an observation of an increase in temperature of the air at the second location in the ear canal, and requiring an observation of an increase in temperature of the air in the first location in the ear canal.
Lawson teaches requiring an observation of a steepening of the temperature gradient [0063 “…a minimum slope of temperature versus distance…”];
requiring an observation of an increase in temperature of the air at the second location in the ear canal [0063 “…a minimum threshold temperature…”]; and
requiring an observation of an increase in temperature of the air in the first location in the ear canal [0063 “…a minimum threshold temperature…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross, Ishler, Melkoniemi, and Zhang and incorporate the teachings of Lawson to include requiring an observation of a steepening of the temperature gradient, requiring an observation of an increase in temperature of the air at the second location in the ear canal, and requiring an observation of an increase in temperature of the air in the first location in the ear canal. Doing so configures the system to monitor the temperature change over time until the rate of change approaches zero and an accurate measurement may be obtained.
Claims 8-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cross in view of Ishler, Melkoniemi, Zhang, Levin (US 20160213354 A1) and Larsen (US 9211069 B2).
Regarding claim 8, Cross teaches a device for performing the method for determining a state of overheating or a risk of overheating of a subject as claimed in claim 1 [see claim 1 rejection above using Cross, Ishler, Melkoniemi, and Zhang], comprising
a first temperature monitor [Cross Figure 4B Item 4] arranged to measure the temperature in the ear canal at a first location in the ear canal;
a second temperature monitor [Cross Figure 4B Item 1] arranged to measure the temperature in the ear canal at a second location in the ear canal; and
the second location being deeper in the ear canal than the first location [Cross 0064, Figures 4A and 4B].
The combination of Cross, Ishler, Melkoniemi, and Zhang fail to teach a plug suitable for restricting air flow through the opening of the ear canal.
Larsen teaches a plug suitable for restricting air flow through the opening of the ear canal [col. 2 lns. 9-10].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross, Ishler, Melkoniemi, and Zhang and incorporate the teachings of Larsen to include a plug suitable for restricting air flow through the opening of the ear canal. Doing so prevents environmental factors interfering in the acquisition of accurate temperature measurements.
The combination of Cross, Ishler, Melkoniemi, and Zhang fail to teach measuring the temperature of air in the ear canal.
Levin teaches measuring the temperature of air in the ear canal [0026 ”… measuring the temperature of the air inside the ear canal…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross, Ishler, Melkoniemi, and Zhang and incorporate the teachings of Levin to include the first temperature monitor and the second temperature monitor each monitoring the temperatures of the air in the ear canal. Doing so provides the system a contactless means to measure core body temperature from within the ear canal.
Regarding claim 9, Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen teach the device in claim 8, further comprising
an extension extending from the plug [Levin Figures 2B-2C];
the first temperature monitor and the second temperature monitor being located on the extension [Levin Figure 2B-2C Item 310, 0026 “ear temperature measuring device 110 includes one, two, or more temperature sensing elements”].
Regarding claim 10, Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen teach the device as claimed in claim 8, where the extension cantilevers from the plug to be eccentrically positioned in the ear canal when the device is worn [Levin Figures 2B-2C].
Regarding claim 11, Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen teach the as claimed in claim 8, wherein the extension [Larsen Figure 7 Item 740] has a diameter smaller than the diameter of the ear canal [Larsen col. 9 lns. 56-64].
Regarding claim 14, Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen teach the device as claimed in claim 8, wherein the extension has a length of less than 1cm [Larsen col. 2 lns. 46-48].
Regarding claim 15, Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen teach the device as claimed in claim 8, wherein device further comprises: a speaker [Larsen Figure 7 Item 750].
Regarding claim 16, Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen teach the device as claimed in claim 8, wherein the temperature monitors are comprised in at least three temperature monitors [Cross 0063 “In the particular configuration shown in FIGS. 4A and 4B, a total of seven temperature sensors 450, implemented as thermistors, were positioned at sites 1-7 for left and right ear-worn devices 400”];
a third temperature monitor [Cross Figure 4B Item 3] arranged to measure the temperature of air restricted in the ear canal at a third location in the ear canal [Cross 0064 “Temperature data was acquired from the temperature sensors 450 at each of the seven sites of the left and right ear-worn devices 400 for the two test subjects”]; and
the third location being between the first location [Cross Figure 4B Item 4] and the second location [Cross Figure 4B Item 1].
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen as applied to claim 11 above, and further in view of Zapala (US 20130184607 A1).
Regarding claim 12, Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen teach the device as claimed in claim 11, but fails to teach the extension has a diameter less than 0.5 centimetres.
Zapala teaches teach the extension [0020, “channel”] has a diameter less than 0.5 centimetres [0020, “a diameter between 2 mm and 20 mm”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen and incorporate the teachings of Zapala to include teach the extension has a diameter less than 0.5 centimetres. Doing so ensures the device fits comfortably and snugly within the ear canal of a user.
Regarding claim 13, Cross, Ishler, Melkoniemi, Zhang, Levin, and Larsen teach the as claimed in claim 11, but fails to teach the extension has a diameter less than 0.3 centimetres.
Zapala teaches teach the extension [0020, “channel”] has a diameter less than 0.3 centimetres [0020, “a diameter between 2 mm and 20 mm”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross, Ishler, Melkoniemi, Levin, and Larsen and incorporate the teachings of Zapala to include teach the extension has a diameter less than 0.3 centimetres. Doing so ensures the device fits comfortably and snugly within the ear canal of a user.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Cross, Ishler, Melkoniemi, and Zhang as applied to claim 1 above, and further in view of Larsen (US 9211069 B2).
Regarding claim 19, Cross, Ishler, Melkoniemi, and Zhang teach the method for determining a state of overheating or a risk of overheating of a subject as claimed in claim 1, wherein Ishler teaches obtaining the initial temperature gradient between the first and second temperature monitors [Ishler claim 5], but fail to teach the step of inserting a plug into the opening of the ear canal to restrict air flow through the opening of the ear canal, the plug being inserted prior to obtaining the initial temperature gradient.
Larsen teaches the step of inserting a plug into the opening of the ear canal to restrict air flow through the opening of the ear canal, the plug being inserted prior to obtaining the initial temperature gradient [col. 2 lns. 9-10 “sealing tip”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross, Ishler, Melkoniemi, and Zhang and incorporate the teachings of Larsen to include the step of inserting a plug into the opening of the ear canal to restrict air flow through the opening of the ear canal, the plug being inserted prior to obtaining the initial temperature gradient. Doing so prevents environmental factors interfering in the acquisition of accurate temperature measurements.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Cross, Ishler, Melkoniemi, and Zhang as applied to claim 1 above, and further in view of Boesen (US 20170111725 A1).
Regarding claim 21, Cross, Ishler, Melkoniemi, and Zhang teach the method for determining a state of over-heating or a risk of over-heating of a subject as claimed in claim 1, wherein Cross further teaches generating an alert when temperature crosses a threshold [Cross 0098 “The processor 1810 may be configured to generate one or more alerts based on a comparison between temperature measurements and one or more thresholds”], but fails to explicitly teach generating an alert upon determining a state of over-heating or a risk of over-heating of the subject.
Boesen teaches generating an alert upon determining a state of over-heating or a risk of over-heating of the subject [0023 “…the user may be played an alert indicating “you may be overheating, consider drinking water and taking a break”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Cross, Ishler, Melkoniemi, and Zhang and incorporate the teachings of Boesen to include generating an alert upon determining a state of over-heating or a risk of over-heating of the subject. Doing so configures the system to notify the user of their condition so that correction and/or treatment may be carried out to prevent harm.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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/JONATHAN M HANEY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791
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