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 .
Response to Amendment
The amendment, filed 09/08/2025, has been entered. The examiner notes claims 1, 3-16, and 19-20 are pending.
Response to Arguments
Applicant's arguments, see Remarks pages 9-12, filed 09/08/2025, with respect to the 35 USC 103 rejection of claims 1, 3-16, and 19 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to the applicant’s argument that the examiner’s references do not explicitly teach measuring air temperature of the ear, the examiner respectfully disagrees. The examiner notes that reference Cross teaches “The differences in precision of these double sensor systems and the present system developed in the ear may be due to the location and interface of the devices to the body, the different use of a material or air in between the sensors and/or the empirical methods used to derive the core body temperature” in para. 0163. While the examiner notes that measuring the air may not be the primary or intended purpose of the system disclosed in Cross, the air temperature is measured in between sensors during use nonetheless and is considered a possible cause for slight differences between temperature readings of the various sensors.
Therefore, the 35 USC 103 rejections of claims 1, 3-16, and 19 are maintained.
Applicant’s arguments, see Remarks page 12, filed 09/08/2025, with respect to the claim objection to claim 9, has been fully considered and are persuasive. The amendment has resolved the claim objection. The claim objection to claim 9 has been withdrawn.
Applicant’s arguments, see Remarks pages 12-13, filed 09/08/2025, with respect to the 35 USC 112 rejection of claims 8-16 have been fully considered and are persuasive. The amendment has resolved the 35 USC 112 issue. The 35 USC 112 rejection of claims 8-16 has been withdrawn.
The examiner believes that new claim 20 is the correct avenue to distinguish the claimed invention from examiner’s reference, Cross, but still needs some alterations to differentiate from the prior art. The examiner recommends changing the limitations to read as follows:
“…wherein the first temperature monitor and the second temperature monitor are located on an extension of a plug, and wherein the extension is a cylindrical protrusion and the first and second sensor are placed on the same side and along the longitudinal axis of the extension and wherein the extension is configured to be located in the ear canal” or something of the like utilizing the disclosure.
The applicant may also wish to further define the “axis” of the extension/protrusion/shaft relative the plug. It is noted that the Applicant should ensure no new matter is entered. The examiner notes the above recommendations would distinguish the applicant’s invention from Cross. However, no formal acknowledgment towards allowability can be made without further search and consideration.
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, 6-7, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cross (US 20190117155 A1) in view of Ishler (US 20050043603 A1) and Melkoniemi (US 20160081628 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 air in 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 air in 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.
Ischler teaches obtaining a subsequent temperature gradient of the air in 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 Ischal 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.
Ischal 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 anthelix of the person's ear and obtaining a temperature measurement; (iii.) calculating the temperature differential between the tragus temperature and the anthelix 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 Ischal 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.
Regarding claim 3, Cross, Ischal, and Melkoniemi 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 [Ischal 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 [Ischal claim 5 “…calculating the difference between the instant temperature differential and the base line temperature differential…”] between the first and second temperature monitors [Ischal claim 5].
Regarding claim 6, Cross, Ischal, and Melkoniemi 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, Ischal, and Melkoniemi 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”].
Regarding claim 20, Cross, Ischal, and Melkoniemi teach the method for determining a state of overheating or a risk of overheating of a subject as claimed in claim 1, wherein the first temperature monitor and the second temperature monitor [Cross Fig. 4B Items 1 and 2, the examiner notes that there are seven temperature sensor sites numbered 1-7] are located on an extension of a plug [Cross Fig. 4B Item 444, see also Cross 0063], and wherein the extension is centrically located in the ear canal and along an axis of the ear canal [Cross 0065, item 444 is inserted into the ear which would fit centrally on the ear canal axis].
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Cross, Ischal, and Melkoniemi as applied to claim 3 above, and further in view of Lawson (US 20110105910).
Regarding claim 4, Cross, Ischal, and Melkoniemi 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 Ischal teaches observation of a temperature gradient between the first and second temperature monitors [Ischal 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, Ischal, and Melkoniemi 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, Ischal, and Melkoniemi 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 Ischal teaches observation of a temperature gradient between the first and second temperature monitors [Ischal 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, Ischal, and Melkoniemi 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 Ischal, Melkoniemi, 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, Ischal, and Melkoniemi], comprising
a first temperature monitor [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 [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 [0064, Figures 4A and 4B].
Cross fails 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 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.
Cross fails 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 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, Ischal, Melkoniemi, 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, Ischal, Melkoniemi, 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, Ischal, Melkoniemi, 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, Ischal, Melkoniemi, 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, Ischal, Melkoniemi, 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, Ischal, Melkoniemi, 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, Ischal, Melkoniemi, Levin, and Larsen as applied to claim 11 above, and further in view of Zapala (US 20130184607 A1).
Regarding claim 12, Cross, Ischal, Melkoniemi, 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, Ischal, Melkoniemi, 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, Ischal, Melkoniemi, 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, Ischal, 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, Ischal, and Melkoniemi as applied to claim 1 above, and further in view of Larsen (US 9211069 B2).
Regarding claim 19, Cross, Ischal, and Melkoniemi teach the method for determining a state of overheating or a risk of overheating of a subject as claimed in claim 1, wherein Ischal teaches obtaining the initial temperature gradient between the first and second temperature monitors [Ischal 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, Ischal, and Melkoniemi 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.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791