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 .
Claims 1-6, 8-9, and 12-23 are the currently pending claims hereby under examination. Claims 7 and 10-11 have been canceled.
Claim Objections
Claims 20 and 21 are objected to because of the following informalities:
In claim 20, line 2: “obtaining the thermal equilibrium temperatures of the housing … at the different temperature measurement points” repeats the obtaining step already recited earlier in the claim chain (claim 12), and Applicant is required to revise this limitation to distinguish it as a subsequent obtaining step (for example, by specifying a later time, a new measurement cycle, or a different set of points), or otherwise remove the redundancy; and
In claim 21, lines 10-11: “before the wearable electronic apparatus is put off” uses nonstandard phrasing, and Applicant is required to replace “put off” with standard terminology (for example, “taken off” or “removed”) for grammatical correctness and consistency.
Appropriate correction is required.
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 3-5 and 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 3 recites, “a part that is of the housing and that is located on the third temperature sensor is located outside the ear of the user” (lines 1-3). The limitation is indefinite because it is unclear what “a part … of the housing … located on the third temperature sensor” means, including whether (i) the third temperature sensor is located on a part of the housing, (ii) a part of the housing is located on the third temperature sensor, or (iii) the “temperature measurement point” is on the housing at a location corresponding to the third temperature sensor. This ambiguity affects the claimed spatial relationship and scope of the housing portion relative to the user’s ear. The Examiner is interpreting “a part that is of the housing and that is located on the third temperature sensor” under BRI to mean a portion of the housing on which the third temperature sensor is mounted/disposed or to which it is sensing, and further interpreting “is located outside the ear of the user” to mean that such portion of the housing is positioned outside the ear when the wearable electronic apparatus is worn, but this interpretation is not compelled by the claim language, which remains susceptible to multiple reasonable interpretations.
Claims 4-5 are rejected by virtue of their dependence from claim 3.
Claim 20 recites “determining whether the thermal equilibrium temperatures at the temperature measurement points change compared with the thermal equilibrium temperatures at the determined temperature measurement points” (lines 8-10). The phrase “determined temperature measurement points” is unclear because the claim does not define which temperature measurement points are “determined”, and it is unclear whether this refers to previously used points, previously identified points, or another set of points, rendering the claim indefinite. The Examiner interprets “the determined temperature measurement points” under BRI to mean the temperature measurement points used in a prior core temperature determination, such that the method compares newly obtained thermal equilibrium temperatures to previously used temperatures and recalculates the core temperature if a change is detected; however, the claim language does not clearly define what constitutes the “determined” temperature measurement points, leaving the comparison reference ambiguous.
Claim 21 recites “determining whether the wearable electronic apparatus is worn on an ear of a user again within a second preset time” (lines 6-7). It is unclear what reference event starts the “second preset time” window (for example, removal, power-off, completion of the prior determination, or another event), rendering the claim indefinite. The Examiner is interpreting “within a second preset time” under a broadest reasonable interpretation (BRI) to mean within a predetermined time window measured from a prior reference event associated with completion of a prior use cycle of the wearable electronic apparatus (for example, removal from the ear, being put off, completion of the prior core-temperature determination, or another defined event), but the claim does not specify the triggering reference event for starting the time window.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 12 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cross et al. (US 20190117155 A1), hereto referred as Cross.
Regarding claim 12, Cross teaches a method, applied to a wearable electronic apparatus (Cross, FIG. 3A-D; Title: "Devices and sensing methods for measuring temperature from an ear", Abstract: "An electronic device comprises an enclosure configured for insertion into the ear canal", Cross describes an ear-worn electronic device that is used with a method for measuring the core body temperature); and the method comprising: obtaining thermal equilibrium temperatures at different temperature measurement points of a housing in the wearable electronic apparatus, wherein the temperature measurement points comprise a first temperature measurement point and a second temperature measurement point (Cross, FIG. 18, ¶[0096]: "The system 1800 includes a sensor 1802 which, in the embodiment shown in FIG. 18, includes a distal temperature sensor 1804 and a proximal temperature sensor 1806. The distal temperature sensor 1804 is configured to be located within the ear canal at or near Location 2 ... The proximal temperature sensor 1806 is configured to be positioned at a location spaced apart from a surface of the ear canal and proximal to the distal temperature sensor 1804 in an outer ear direction", Cross shows two temperature sensors disposed at two different locations on the ear-worn enclosure, which correspond to obtaining temperatures at different temperature measurement points of the wearable electronic apparatus housing; FIG. 17, ¶[0152]: "At equilibrium, Linflux = Loutflux so that: K' Internal (Ttympanic membrane - Tinternal) / dinternal = K' exterior (Tinternal - Tfaceplate) / dexterior", Cross expressly describes measuring temperatures at multiple locations and using the equilibrium condition, which corresponds to the claimed thermal equilibrium temperatures at the different temperature measurement points; ¶[0091]: "At equilibrium, [when] the influx and efflux of heat at the interior most location is equal", which defines the “equilibrium” condition of the heat balance model, supporting that the temperature signals used by the heat balance equation correspond to equilibrium conditions and thus correspond to “thermal equilibrium temperature” under a broadest reasonable interpretation, see also ¶[0152]-[0154], also where the "Thermal equilibrium temperature: Refers to a temperature inside or on a surface of the wearable electronic apparatus, when an object such as a wearable electronic apparatus and ears of a user are in a thermal equilibrium process" (Instant Application, ¶[0117])); determining a core temperature of a user based on a thermal equilibrium temperature at the first temperature measurement point and a thermal equilibrium temperature at the second temperature measurement point (Cross, Abstract: "A processor, coupled to the distal and proximal temperature sensors and to memory, is configured to calculate an absolute core body temperature using a heat balance equation stored in the memory and the first and second temperature signals", shows determining the core temperature; FIG. 18, ¶[0097]: "The memory 1820 is configured to store a heat balance equation 1822 ... The processor 1810 is configured to calculate an absolute core body temperature 1830 using the heat balance equation 1822 and temperature signals produced by the distal and proximal temperature sensors 1804, 1806", Cross teaches determining core body temperature using a heat balance equation based on the two measured temperatures from the distal and proximal sensors, which corresponds to determining the core temperature based on the thermal equilibrium temperatures at the first and second temperature measurement points; ¶[0205]: "calculating, using a processor of the device, an absolute core body temperature using the heat balance equation and the first and second temperatures", Cross expressly teaches calculating core body temperature using the heat balance equation and the first and second measured temperatures).
Regarding claim 23, Cross teaches a non-transitory storage medium, wherein the non-transitory storage medium stores computer-executable instructions, and when the computer-executable instructions are executed by a processor, the method according to claim 12 is implemented (Cross, ¶[0097], “The memory 1820 is configured to store a heat balance equation 1822”, Cross teaches a memory storing content used in temperature determination, which corresponds to a non-transitory storage medium storing information used by the processor; ¶[0098], “The memory can be Flash, ferroelectric RAM (FRAM), magnetoresistive RAM (MRAM), and other types of non-volatile memory”, Cross teaches non-volatile memory types, which correspond to a non-transitory storage medium; ¶[0097], “The processor 1810 is configured to calculate an absolute core body temperature 1830 using the heat balance equation 1822 and temperature signals produced by the distal and proximal temperature sensors 1804, 1806”, Cross teaches that the processor performs the core temperature calculation using the stored heat balance equation, which corresponds to executing stored computer-executable instructions to implement the method of claim 12; ¶[0089], “After the heat balance equation is derived for a particular device, the heat balance equation is stored in a memory of an ear-worn device or other type of temperature sensing device”, Cross further teaches storing the equation in device memory for later use by the processor, which corresponds to storing computer-executable instructions that, when executed, implement the claimed method).
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, 6, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Zhu et al. (CN 114052669 A), hereto referred as Zhu.
Regarding claim 1, Cross teaches that a wearable electronic apparatus, comprising a housing (Cross, FIG. 3A-D; Abstract: "An electronic device comprises an enclosure configured for insertion into the ear canal", Cross describes an ear-worn electronic device having an enclosure that functions as a housing; ¶[0131], “Methacrylate in-the-ear (ITE) custom fit shells were manufactured”, Cross teaches an in-the-ear shell formed for use in the ear canal which corresponds to a wearable apparatus housing); a processor (Cross, Abstract, “A processor, coupled to the distal and proximal temperature sensors and to memory, is configured to calculate an absolute core body temperature using a heat balance equation stored in the memory and the first and second temperature signals”, Cross expressly describes a processor in the device); a temperature sensor located in the housing (Cross, FIG. 8-15, 19-21, 24; ¶[0053]: “Embodiments are directed to devices and methods that measure temperature at a preferred location of the ear canal 22 (and other locations within or external of the ear canal as described herein) using a temperature sensor(s) configured to sense conductive and/or convective heat" and ¶[0144], “thermistors were attached under the shell" and ¶[0080]: "a thermistor at the key location (e.g., site 2) in a hearing device 1) inside, under or through the shell wall", Cross teaches thermistors mounted inside the device and/or under the ear shell showing temperature sensor(s) located in the housing); a thermally conductive metal member (Cross, Fig. 8-14; Cross discloses several embodiments of a thermally conductive member for contact with the ear such as: ¶[0070], “The domed insert 1020 can be made of any material, but preferably polymer or metal material”, Cross expressly discloses an insert that can be metal and positioned to increase contact and thermal conductivity with the ear skin, which corresponds to a thermally conductive metal member; additionally ¶[0077], “In a ninth embodiment, the material on the ear side surface of the shell in an area over or around the temperature sensor can be coated using a thermally conductive adhesive or a metal in order to widen the area from which temperature is preferentially acquired from...The high thermal conductive area can extend over inserts or fill areas or beyond those areas”, Cross further teaches a metal deposited on the ear side in an area over and/or around the temperature sensor to preferentially acquire temperature, which also corresponds to a thermally conductive metal member; also ¶[0073]: "A thermally conductive cap 1322 covers the vessel 1324 and is configured to contact the skin 1304 of the ear", showing a conductive cap (that may also be coated in conductive metal) that is integrated into the shell and configured to contact the skin of the ear); a flexible circuit board (Cross, FIG. 11-12, 14; ¶[0072] and [0075], “The thermistor... electrically connected to a flexible or rigid circuit....”, Cross describes a flexible circuit electrically connected to the thermistor where the figures depict the thermistor adjacent to the circuit; ¶[0080]: "a thermistor at the key location (e.g., site 2) in a hearing device... attached directly using adhesives or attached via a subassembly (flex, circuit board, molded or otherwise formed structure)" and ¶[0081]: "a thermistor at the faceplate of a hearing device... attached directly using adhesives or attached via a subassembly (flex, circuit board, molded or otherwise formed structure)", Cross expressly discloses a thermistor attached and supported by a flexible circuit board structure (“flex” is understood by a POSITA to be a flexible circuit board)); and a thermally conductive layer (Cross, FIGS. 8–14; ¶[0070], “The thermistor 1010 (e.g., a glass encapsulated thermistor) can be mounted in the insert 1020 using a liquid curable adhesive 1022 that has a thermal conductivity higher than the ear device matrix 1006”, Cross teaches a thermally conductive adhesive disposed between the thermistor and the insert, corresponding to a thermally conductive layer; Additionally FIGS. 11–14 (elements 1108, 1212, 1308, 1309, 1403, 1405) depict intermediate structures/materials disposed between the flexible or rigid circuit and the ear-facing exterior surface (which may be a cap or metal coating), including inserts, vessels, and conductive members forming a stacked thermal path from the skin-contacting metal portion to the circuit assembly, which under BRI corresponds to a thermally conductive layer disposed between the contact part and the flexible circuit board; additionally Cross has multiple disclosures that the structure(s)/material(s) between the ear contact surface and the thermistor (and the thermistor’s supporting “flexible or rigid circuit”) can be selected and configured to be thermally conductive as seen in ¶[0070]-[0074]); wherein the housing comprises a sound outlet hole (Cross, FIG. 4B and 3A-D; ¶[0131], “Shells were formed with a sound bore hole at the tip”, Cross teaches a sound bore hole in the shell, which corresponds to a sound outlet hole in the housing; ¶[0148], “...the sound bore hole extending just outside the ear shell”, further evidencing a sound outlet hole in the housing); and a contact part (Cross, Figs. 10–14; ¶[0051], “areas that can contact an in-the-ear (ITE)… structure”; ¶[0070], “the interface between the thermistor and the ear can be designed to increase… contact… with the ear skin”; ¶[0077], “the material on the ear side surface of the shell in an area over or around the temperature sensor…”, Cross expressly describes an ear-side shell surface/interface region of the housing configured to contact ear skin at in-ear locations, which corresponds to a contact part configured to be disposed in an ear and in contact with the ear); the temperature sensor comprises a first temperature sensor and a second temperature sensor, the first temperature sensor and the second temperature sensor respectively measure temperatures at different temperature measurement points (Cross, FIG. 4B, 18-21, 24; Abstract, “A distal temperature sensor is situated at a location of the enclosure... A proximal temperature sensor is situated... proximal of the distal temperature sensor”, Cross expressly describes two temperature sensors at different locations, corresponding to different temperature measurement points); wherein the second temperature sensor is located on a same side of the wearable electronic apparatus as the first temperature sensor and is spaced from the sound outlet hole (Cross, FIGS. 4A–4B; ¶[0016], “FIGS. 4A and 4B show different views of an ear-worn device developed by the inventors to determine the preferred location of the ear canal from which temperature measurements can be obtained…”, Cross discloses an ear-worn hearing device including a distal sound outlet opening at the ear-facing end of the housing as depicted in FIGS. 4A–4B and 3A–3D; FIGS. 4A–4B further illustrate candidate thermistor positions along the same ear-facing side of the housing and spaced from the distal sound outlet region; additionally, FIGS. 13–15 and 24 depict multiple thermistor locations disposed on the same side of the housing structure; ¶[0144], “thermistors were attached under the shell at locations 1 and 2 and a third thermistor was placed through the sound bore hole extending just outside the ear shell”, Cross expressly teaches (i) a sound bore hole in the ear shell and (ii) thermistors at other locations under the shell that are different from the sound bore hole location, supporting that at least one thermistor location is spaced from the sound bore hole; ¶[0060], “A distal temperature sensor is situated at a location of the enclosure 322 ... A proximal temperature sensor is situated at a location of the enclosure 322... proximal of the distal temperature sensor in an outer ear direction”, Cross teaches two temperature sensors situated at different locations on the same enclosure, supporting the “same side” aspect to the extent the sensors are both on the same wearable apparatus enclosure while being spatially separated from other shell features such as the sound bore hole; collectively this teaches a second temperature sensor located on the same side as the first temperature sensor and spaced from the sound outlet hole); and the processor is configured to determine a core temperature of a user based on a thermal equilibrium temperature corresponding to the first temperature sensor and a thermal equilibrium temperature corresponding to the second temperature sensor (Cross, Abstract, “A processor, coupled to the distal and proximal temperature sensors and to memory, is configured to calculate an absolute core body temperature using a heat balance equation stored in the memory and the first and second temperature signals", Cross teaches determining core temperature using a stored heat balance equation based on two temperature sensor signals (where the heat balance is equated equilibrium, ¶[0168]); Cross then demonstrates that the heat balance equation is determined ¶[0091]: "At equilibrium, [when] the influx and efflux of heat at the interior most location is equal", which defines the “equilibrium” condition of the heat balance model, supporting that the temperature signals used by the heat balance equation correspond to equilibrium conditions and thus correspond to “thermal equilibrium temperature” under a broadest reasonable interpretation, see also ¶[0152]-[0154]); wherein the contact part is configured to be disposed in an ear of a user and in contact with the ear (Cross, FIGS. 10–14: depict domed ear-facing portions for skin contact, including domed inserts and conductive cap structures positioned at the exterior surface of the housing, corresponding to the claimed contact part disposed in the ear and configured to contact the ear; see also ¶[0051], ¶[0070], ¶[0073]); the thermally conductive metal member is embedded in the contact part and exposed on an outer surface of the housing (Cross, Fig. 13; ¶[0070]: “an insert 1020 which can be installed in the ear device matrix 1006 (e.g., integrated as part of the shell 1002)”, Cross expressly teaches an insert integrated as part of the shell, supporting an “embedded” member within the housing/contact region; ¶[0070]: “The insert 1020 forms a gradually sloping dome 1008 that protrudes into the skin 1004”, Cross expressly teaches the integrated insert forms a dome that protrudes into the skin, supporting that the insert is exposed on an outer surface configured for contact; FIG 10, ¶[0077], “the material on the ear side surface of the shell in an area over or around the temperature sensor can be coated using a thermally conductive adhesive or a metal… The metal can be deposited…”, which teaches a metal layer integrated into the insert (or the like) and exposed at the outer surface; Additionally in another embodiment ¶[0073], “A thermally conductive cap 1322 covers the vessel 1324 and is configured to contact the skin 1304 of the ear…”, Cross discloses a thermally conductive cap positioned at the ear-contacting region of the housing where the cap is integrated into the shell structure and forms part of the exterior ear-contacting portion while being structurally supported by the underlying vessel and housing wall; Under BRI, the conductive cap or metal deposition constitutes a thermally conductive metal member embedded within the ear-contact portion of the housing while being exposed externally); the first temperature sensor is configured to measure a temperature of a position that is on the flexible circuit board and that faces to the first temperature sensor (Cross, FIGS. 11–12, 14; ¶¶[0072], [0075], [0080], [0081], as discussed above regarding the flexible circuit board, Cross expressly teaches a thermistor attached via a flex or circuit-board subassembly, and FIGS. 11–12 and 14 depict the thermistor mounted relative to the flexible circuit structure such that the thermistor measures temperature at its mounted location corresponding to a position on the flexible circuit board that is aligned with the sensor and faces the sensor); the thermally conductive layer is fitted between the flexible circuit board and the thermally conductive metal member on the housing (Cross teaches many variations of a thermally conductive layer between the surface that contacts the ear and the flexible circuit board; Cross, FIGS. 10–14; ¶[0073], “A thermally conductive cap 1322 covers the vessel 1324 and is configured to contact the skin 1304 of the ear”, Cross teaches an ear-contacting thermally conductive member positioned at the exterior of the housing; additionally when a cap or insert is used ¶[0077], “the material on the ear side surface of the shell in an area over or around the temperature sensor can be coated using a thermally conductive adhesive or a metal… The high thermal conductive area can extend over inserts or fill areas…”, Cross further teaches a thermally conductive metal region at the ear-side shell surface further showing that the outer member is conductive metal; ¶[0070], "The domed insert 1020 can be made of any material, but preferably polymer or metal material" and "The thermistor 1010… can be mounted in the insert 1020 using a liquid curable adhesive 1022 that has a thermal conductivity higher than the ear device matrix 1006…”, Cross expressly teaches a thermally conductive insert and an adhesive layer between the insert and the thermistor, either of which may corresponding to a thermally conductive layer in the thermal path; ¶[0072], “The cylindrical cavity 1203 is filled with a composite of materials… having different thermal conductivity…”, Cross further teaches intermediate thermally conductive fill materials disposed within the housing between the ear-contact region and the circuit-supported thermistor; see also FIGS. 11–12, 14 and ¶¶[0072], [0075], [0080], [0081], teaching the thermistor attached via a flexible or rigid circuit subassembly; Collectively, Cross discloses a stacked thermal path from (i) an ear-contacting thermally conductive metal member at the housing exterior, through (ii) one or more thermally conductive intermediate materials (adhesive, fill material, insert, or composite conductive layer), to (iii) a thermistor mounted to a flexible circuit; Under BRI, the thermally conductive adhesive/insert/fill material disposed between the ear-contacting metal region and the circuit-supported thermistor corresponds to a thermally conductive layer fitted between the thermally conductive metal member and the flexible circuit board).
Also regarding claim 1, Cross does not fully teach that the first temperature sensor is located on a side that is of the flexible circuit board and that corresponds to a center of the housing. Rather, Cross teaches a thermistor that is attached and electrically connected to a flexible or rigid circuit, but Cross does not expressly teach the first temperature sensor being located on a particular side of the flexible circuit board such that the sensor corresponds to a center of the housing.
Zhu, however, expressly teaches orienting a human body temperature sensor relative to both a flexible printed circuit board and the interior of the housing. Specifically, Zhu teaches that “The human body temperature sensor 114 includes a first sensor body and a first sensor FPC 116 (Flexible Printed Circuit)” and further that “One end of the first sensor FPC 116 is electrically connected to the first sensor body, and the other end enters the interior of the first housing 111 through the wiring through hole 111-b” (Zhu, p. 12). Zhu also teaches that “the first heat-insulating pad 112 is located on the side of the human body temperature sensor 114 away from the skin contact surface” (Zhu, p. 12), thereby defining a sensor orientation relative to the skin-contact surface and the housing interior. As shown in FIGS. 10 and 13, the sensor body is arranged such that the FPC extends into the interior of the housing while the sensor assembly is positioned on the side oriented away from the skin-contact surface. Under the broadest reasonable interpretation, this corresponds to the first temperature sensor being located on a side of the flexible circuit board that faces toward the center of the housing.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cross in view of Zhu to locate Cross’s first temperature sensor on a side of the flexible circuit board corresponding to a center of the housing. Such a modification would have been feasible because both Cross and Zhu relate to ear-worn housings incorporating temperature sensors mounted via circuit structures, and orienting the sensor relative to the flexible circuit board merely involves selecting the mounting side of the sensor body on an existing flex assembly. One of ordinary skill in the art would have been motivated to make this modification because Zhu expressly teaches arranging the temperature sensor on a defined side relative to the skin-contact surface in order to block the influence of external heat sources, thereby improving temperature measurement stability and accuracy (p. 12). Applying Zhu’s orientation teaching to Cross would predictably improve thermal isolation and measurement reliability in Cross’s ear-worn temperature sensing system.
Regarding claim 6, the modified Cross teaches that the first temperature sensor and the contact part are disposed corresponding to each other (Cross, FIGS. 3A–3D, 10-14; ¶[0057], “a distal temperature sensor is situated at a location of the enclosure 302 that can measure the temperature of ear canal tissue at or immediately adjacent Location 2...”, Cross teaches the first temperature sensor disposed on an ear-contacting portion of the enclosure such that the temperature sensor corresponds to the claimed contact part when the enclosure is inserted into the ear canal; ¶[0059], “FIG. 3C shows a representative ear-worn device positioned relative to a preferred location of the ear canal 22”, Cross further shows the relative positioning of the enclosure at the ear canal location from which the temperature measurement is obtained, supporting that the temperature sensor location corresponds to the ear-contact region of the enclosure; FIGS.10-14: Cross expressly describes FIGS. 10–14 as sectional views showing the temperature sensor mounted to the enclosure or shell, thereby illustrating the physical relationship between the sensor and the ear-contacting shell portion corresponding to the claimed contact part; see also ¶[0070] and ¶[0073]).
Regarding claim 8, the modified Cross teaches that thermal resistance between the second temperature sensor and the ear is greater than thermal resistance between the first temperature sensor and the ear (Cross, ¶[0093]–¶[0094], FIG. 17: “the innermost temperature sensor is positioned to measure temperature T2 at Location 2 and the outermost temperature sensor is positioned to measure temperature T1 (Tfaceplate) at a location more exterior than the innermost temperature sensor (e.g., at the faceplate of the device)”, Cross expressly teaches two temperature measurement points along the ear-shell thermal path, including an innermost sensor at Location 2 and an outermost sensor at the faceplate, with the faceplate sensor located more exterior than the Location 2 sensor, ¶[0151], FIG. 17: “K' interior (Ttympanic membrane - Tinternal) / dinternal”, “K' Exterior (Tinternal - Tfaceplate) / dexterior”, “dinternal is approximately the depth of the internal ear from the shell at the location of the innermost thermistor and the tympanic membrane”, and “dexterior is approximately the depth of the external ear shell from the faceplate to the innermost thermistor location”, Cross expressly defines the resistive heat flow from the ear to the innermost thermistor location using dinternal and separately defines the heat flow from the innermost thermistor location to the faceplate using dexterior, such that the thermal path between the ear and the faceplate sensor includes the internal segment to the innermost thermistor location plus the additional external ear shell segment to the faceplate, thereby showing the faceplate sensor has a greater thermal resistance path to the ear than the innermost sensor, as depicted by the combination of thermal resistors in the figure).
Regarding claim 9, the modified Cross does not fully teach that the thermally conductive metal member is a stainless steel member, a copper member, or an aluminum member. Rather, the modified Cross teaches a thermally conductive metal member configured to contact the ear skin, as shown above in claim 1, including that “A thermally conductive cap 1322 covers the vessel 1324 and is configured to contact the skin 1304 of the ear” (Cross, ¶[0073]), but Cross does not expressly specify that the thermally conductive metal member is stainless steel, copper, or aluminum.
Zhu teaches selecting stainless steel as a material for a heat-conducting cover at a skin-contacting heat transfer structure, stating: “preferably, the heat conduction cover 117 can be made of stainless steel or other materials to have higher heat transfer capacity” (Zhu, ¶[0133]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of Zhu to form the thermally conductive metal member as a stainless steel member. Such a modification would have been feasible because Cross already provides a thermally conductive metal coating or a conductive cap configured to contact the ear skin and Zhu teaches that a skin-contacting heat conduction cover may be made of stainless steel to provide higher heat transfer capacity. The benefit of this modification would have been improved heat transfer through the thermally conductive member to the temperature sensor to enhance measurement responsiveness and reduce thermal lag.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Zhu et al. (CN 114052669 A), hereto referred as Zhu, and further in view of Blank et al. (US 20130341315 A1), hereto referred as Blank.
The modified Cross teaches claim 1 as described above.
The Cross teaches claim 12 as described above.
Regarding claim 2, the modified Cross does not fully teach that the temperature sensor further comprises a third temperature sensor and the third temperature sensor is spaced from the first temperature sensor and the second temperature sensor, to measure an ambient temperature in which the third temperature sensor is located and the processor is configured to determine the core temperature of the user based on the thermal equilibrium temperature corresponding to the first temperature sensor, the thermal equilibrium temperature corresponding to the second temperature sensor, and the ambient temperature. Rather, Cross teaches determining core body temperature based on temperature signals produced by a distal temperature sensor and a proximal temperature sensor using a heat balance equation as shown in claim 1 above. Cross further teaches and embodiment where the proximal temperature sensor 2106 “is situated on or in the enclosure of the handle section 2101, and is configured to produce a temperature signal indicative of the ambient environment exterior of the ear” (Cross, ¶[0109]). Thus, Cross expressly discloses a temperature sensor positioned outside the ear canal and configured to measure ambient environmental temperature, and Cross teaches that the processor is configured to calculate an absolute core body temperature using temperature signals produced by the distal and proximal temperature sensors and a heat balance equation stored in memory (Cross, ¶[0110]). However, Cross does not expressly teach a configuration in which two in-ear temperature sensors are used in combination with a third temperature sensor spaced from both of those sensors to measure an ambient temperature and wherein the processor determines the core temperature of the user based on the thermal equilibrium temperatures corresponding to the first and second temperature sensors and the ambient temperature measured by the third temperature sensor.
Blank teaches an apparatus that includes an ambient temperature sensor spaced away from body-related temperature sensors, and further teaches using that ambient temperature sensor as part of mitigating ambient-environment effects while temperature data is processed by a processor. Specifically, Blank teaches that “The ambient temperature sensor 112 may be used to ensure that the skin temperature sensor 108 and the oven temperature sensor 110 are not affected by the ambient environment. For example, changes detected in the ambient environment using the ambient temperature sensor 112 may be mitigated by the processor 114” (Blank, ¶[0020]). Blank further teaches that “The processor 114 receives temperature data 116 from the plurality of sensors 102” (Blank, ¶[0022]) and figure 3 depicts the ambient sensors as being spaced apart from the other sensors such that it determines an ambient temperature (Blank, FIG. 3.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of Blank to provide a third temperature sensor spaced from the first temperature sensor and the second temperature sensor to measure an ambient temperature, and to determine the core temperature of the user based on the thermal equilibrium temperature corresponding to the first temperature sensor, the thermal equilibrium temperature corresponding to the second temperature sensor, and the ambient temperature. Such a modification would have been feasible because Cross already expressly provides for placement of a temperature sensor outside the ear canal to measure ambient environmental temperature (Cross, ¶[0109]) as well as inside the canal as shown in claim 1 above, and already configures the processor to determine core body temperature using temperature signals from multiple temperature sensors in a heat balance equation framework (Cross, ¶[0110]). Cross therefore establishes both (i) structural accommodation for ambient temperature sensing within the wearable device architecture and (ii) computational use of multiple temperature inputs in determining core body temperature. Incorporating a third temperature sensor spaced from the first and second sensors and using its ambient temperature measurement as an additional input would have been a straightforward extension of Cross’s existing multi-sensor heat balance model. Blank teaches providing an ambient temperature sensor and using the ambient temperature measurement as part of processor-based mitigation of ambient-environment effects on other temperature sensors and the determination of the core temperature (Blank, ¶[0020]) while the processor receives and processes temperature data from multiple sensors (Blank, ¶[0022]). One of ordinary skill in the art would have been motivated to make this modification because adding an explicit ambient temperature input for correction/mitigation predictably improves robustness and accuracy of core temperature determination across changing ambient environments, consistent with Blank’s teaching that ambient conditions can be detected and mitigated by the processor using an ambient temperature sensor (Blank, ¶[0020]) and consistent with Cross’s teaching of compensating for environmental temperatures within a multi-sensor heat-balance-based core temperature computation (Cross, ¶[0094]).
Regarding claim 3, the modified Cross teaches that a part that is of the housing and that is located on the third temperature sensor is located outside the ear of the user (Cross, ¶[0109], “The handle section 2101 is configured as a hand graspable section of the system 2100”, Cross teaches a portion of the device housing, namely the handle section, is configured to be hand-graspable and therefore located outside the ear; ¶[0109], “A proximal temperature sensor 2106 is situated on or in the enclosure of the handle section 2101, and is configured to produce a temperature signal indicative of the ambient environment exterior of the ear”, Cross teaches the temperature sensor is located on or in the enclosure of the handle section and is configured to sense the ambient environment exterior of the ear, which corresponds to the portion of the housing located on the ambient temperature sensor is located outside the ear).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Zhu et al. (CN 114052669 A), hereto referred as Zhu, and further in view of Blank et al. (US 20130341315 A1), hereto referred as Blank, and further in view of Ghoreyshi (US 20210275030 A1), hereto referred as Ghoreyshi.
The modified Cross teaches claim 1 as described above.
Regarding claim 4, the modified Cross does not fully teach that the apparatus further comprises a calculation module wherein the calculation module is located in the housing and the processor is configured to control the calculation module to determine the core temperature based on the thermal equilibrium temperature corresponding to the first temperature sensor, the thermal equilibrium temperature corresponding to the second temperature sensor, and the ambient temperature. Rather, the modified Cross teaches determining core body temperature by computation, including that “A processor, coupled to the distal and proximal temperature sensors and to memory, is configured to calculate an absolute core body temperature using a heat balance equation stored in the memory and the first and second temperature signals” (Cross, Abstract), but Cross does not expressly disclose a separate calculation module located in the housing that is controlled by the processor to determine core temperature.
Ghoreyshi teaches performing the core temperature determination using device processing circuitry that receives multiple sensor measurements and executes stored estimation logic, including that “Controller 114 may include one or more processing units, and may be used to control the operations of the one or more ambient temperature sensors, the one or more skin temperature sensors, storage device 116, user interface device 118, and the like. Controller 114 may also receive measurement results from the one or more ambient temperature sensors and the one or more skin temperature sensors or from storage device 116, and determine the core body temperature based on the measurement results” (Ghoreyshi, ¶[0052]). Ghoreyshi further teaches that the estimation logic and model parameters can be stored in device memory, including that “Storage device 116 may store instructions to be executed by controller 114, the model (e.g., weights or other parameters) used by controller 114 to estimate the cord body temperatures, measurement results from the ambient temperature sensors and the skin temperature sensors, estimated core body temperature, and the like” (Ghoreyshi, ¶[0053]). In this context, Ghoreyshi’s controller, executable instructions, and stored estimation model correspond to implementing the core temperature computation as a discrete calculation function within the device, which supports the claimed “calculation module” concept as a software and or firmware module executed by device processing circuitry.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of Ghoreyshi to include a calculation module located in the housing and controlled by the processor to determine the core temperature based on the thermal equilibrium temperatures corresponding to the first and second temperature sensors and the ambient temperature. Such a modification would have been feasible because Cross already includes a processor and memory within the system configured to calculate core body temperature using temperature signals and a stored heat balance equation, and Ghoreyshi teaches implementing the core temperature estimation function as a dedicated body temperature estimation module within the device processing unit, which is a software and or firmware module that can be executed by the processor and stored in memory within the housing. One of ordinary skill in the art would have been motivated to make this modification because organizing the temperature estimation computation as a distinct calculation module improves software modularity, maintainability, and facilitates updating or replacing the estimation logic while maintaining Cross’s core temperature determination functionality.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Zhu et al. (CN 114052669 A), hereto referred as Zhu, and further in view of Blank et al. (US 20130341315 A1), hereto referred as Blank, and further in view of Ghoreyshi (US 20210275030 A1), hereto referred as Ghoreyshi, and further in view of Pompei (US 20160213260 A1), hereto referred as Pompei, as evidence.
The modified Cross teaches claim 1 as described above.
Regarding claim 5, the modified Cross does not fully teach that the processor is configured to control the calculation module to determine the core temperature based on a formula:
T = (R2(T1 − T2 − b×T3))/R1 + T1 + a×T3
wherein T is the core temperature, T1 is the thermal equilibrium temperature corresponding to the first temperature sensor, T2 is the thermal equilibrium temperature corresponding to the second temperature sensor, T3 is the ambient temperature; R1 is equivalent thermal resistance between the first temperature sensor and the second temperature sensor during a heat transfer process, R2 is equivalent thermal resistance between human tissue and the first temperature sensor during a heat transfer process, and a and b are both adjustment factors. Rather, the modified Cross teaches determining absolute core body temperature using a two-temperature heat-balance model along a thermal path between a more interior temperature measurement location and a more exterior temperature measurement location, including that “This heat balance equation can be used by the ear-worn or other type of temperature sensing device to calculate absolute core body temperature.” (Cross, ¶[0089]). Cross further teaches that its thermal model operates under equilibrium and is expressed as a balance between an internal resistive heat-flow term and an external resistive heat-flow term as shown in figure 17 and: “At equilibrium, Linflux = qeflux so that: K′ Internal (Ttympanic membrane - Tinternal)/dinternal = K′ exterior (Tinternal - Tfaceplate)/dexterior.” (Cross, ¶[0152], FIG. 17). This two-location equilibrium heat-balance model is consistent with a conventional two-temperature thermal-resistance formulation in which core temperature is determined as a linear combination of two measured temperatures weighted by a resistance ratio (as evidenced by Pompei, ¶[0046]: “Tcore=((R1+R2)/R1) (Ts-Ta)+Ta (10)”). When claim 5’s formula is considered in the same linear-combination topology, the portion based on T1 and T2 corresponds to this conventional two-temperature heat-balance structure, and the remaining gap between the modified Cross and claim 5 is the additional third-temperature correction contribution based on T3 and adjustment factors a and b, which Cross does not expressly teach (claim 5 formula when expressed as a linear combination: T=(R2/R1) (T1−T2) + T1 + T3(a−(R2/R1)b)).
Further, the specification of the claim set describes the adjustment factors ‘a’ and ‘b’ as empirically derived and scenario-dependent, such that the added T3 term represents a calibrated correction contribution layered onto the base two-temperature resistance heat-balance equation rather than a new thermodynamic derivation (Instant Application, ¶[0233]: “a processor 30 can control a register to detect the working scenario of the wearable electronic apparatus 100, to determine adjustment factors a and b based on the monitored thermal equilibrium temperature at the ambient temperature measurement point 121, to apply the adjustment factors a and b to formula 4, and to correct the ambient temperature at the ambient temperature measurement point 121 based on the adjustment factors a and b…”; see also ¶[0163], ¶[0166], Table 1, and FIG. 6 that show different values of a and b are selected depending on scenario and temperature range).
Blank teaches using a third ambient temperature measurement to mitigate environmental influence on other temperature sensors and the computed temperature result, stating: “The ambient temperature sensor 112 may be used to ensure that the skin temperature sensor 108 and the oven temperature sensor 110 are not affected by the ambient environment. For example, changes detected in the ambient environment using the ambient temperature sensor 112 may be mitigated by the processor 114.” (Blank, ¶[0020]). Thus, Blank teaches using a processor to apply an ambient-based correction to compensate for environmental effects on temperature measurement. In view of Cross’s conventional two-sensor resistance-based heat-balance equation and Pompei’s express two-point heat-balance formulation, incorporating the ambient measurement as a linearly scaled correction contribution to that existing equation would have been a predictable implementation choice, particularly where, as acknowledged in the Instant Application, the adjustment factors a and b are empirically determined based on operating scenario and monitored ambient conditions (Instant Application, ¶[0233]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross’s two-sensor equilibrium heat-balance calculation by incorporating a third measured temperature term as an empirically tuned correction factor to mitigate environmental influence, in view of Blank and evidenced by Pompei, to determine core temperature based on a formula including a two-sensor heat-balance relationship and an additional third-temperature correction term with adjustment factors, as claimed. Such a modification would have been feasible because Cross already teaches calculating absolute core body temperature using a resistance-based heat balance equation under equilibrium conditions (Cross, ¶[0089]; ¶[0152], FIG. 17), and Pompei demonstrates the conventional closed-form two-temperature resistance equation corresponding to that structure (Pompei, ¶[0046]). Blank provides explicit motivation for incorporating an ambient-based correction to mitigate environmental effects on temperature computation (Blank, ¶[0020]). Further, the Instant Application confirms that the adjustment factors a and b are empirically selected based on working scenario and monitored ambient conditions (Instant Application, ¶[0233]), indicating that the claimed third-temperature term represents a calibrated correction layered onto the known two-temperature model rather than a new thermodynamic derivation. Accordingly, incorporating a linearly scaled ambient correction contribution into Cross’s equilibrium equation would have been a predictable and routine implementation choice to improve robustness and accuracy under varying environmental conditions.
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Blank et al. (US 20130341315 A1), hereto referred as Blank.
The Cross teaches claim 12 as described above.
Regarding claim 13, as shown above in claim 12, Cross teaches determining the core temperature of the user based on the thermal equilibrium temperature at the first temperature measurement point and the thermal equilibrium temperature at the second temperature measurement point comprises: determining the core temperature of the user based on the thermal equilibrium temperature at the first temperature measurement point, the thermal equilibrium temperature at the second temperature measurement point, but does not teach that the temperature measurement points further comprise an ambient temperature measurement point, and the ambient temperature measurement point is located on a side of the wearable electronic apparatus that is opposite to a side in which the first temperature measurement point is located; determining the core temperature of the user based on the thermal equilibrium temperature at the first temperature measurement point, the thermal equilibrium temperature at the second temperature measurement point, and an ambient temperature at the ambient temperature measurement point. Rather, Cross teaches determining core body temperature based on temperature signals produced by a distal temperature sensor and a proximal temperature sensor using a heat balance equation as shown in claim 1 above. Cross further teaches and embodiment where the proximal temperature sensor 2106 “is situated on or in the enclosure of the handle section 2101, and is configured to produce a temperature signal indicative of the ambient environment exterior of the ear” (Cross, ¶[0109]). Thus, Cross expressly discloses a temperature sensor positioned outside the ear canal and configured to measure ambient environmental temperature, and Cross teaches that the processor is configured to calculate an absolute core body temperature using temperature signals produced by the distal and proximal temperature sensors and a heat balance equation stored in memory (Cross, ¶[0110]). However, Cross does not expressly teach using a third measurement point for an ambient temperature that is located on a side of the wearable electronic apparatus that is opposite to a side in which the first temperature measurement point is located, nor does Cross expressly teach determining core temperature further based on the ambient temperature measurement point.
Blank teaches arranging an ambient temperature measurement location on an opposite side of a device from a body-contact side (where the first two sensors reside), and using the ambient temperature as part of processor-based temperature determination. Specifically, Blank depicts an “sensor 310” opposite the “Skin Surface 304”, " sensor 306", and "sensor 308" in FIG. 3 (Blank, FIG. 3), and teaches that “Optionally, the plurality of sensors 102 may also include an ambient temperature sensor 112” and “The optional ambient temperature sensor 112 is configured to detect the temperature of the ambient environment outside of and/or around the thermometer 100” (Blank, ¶[0018]). Blank further teaches that ambient changes “may be mitigated by the processor 114” using the ambient temperature sensor (Blank, ¶[0020]), and that “The processor 114 receives temperature data 116 from the plurality of sensors 102” (Blank, ¶[0022]). In this context, Blank teaches using an ambient temperature sensor located away from the skin-contact side and sensors located near there, and using its ambient temperature measurement as an input to processor operations that mitigate ambient effects on temperature measurement and processing to determine the core body temperature.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cross in view of Blank to further comprise an ambient temperature measurement point located on a side of the wearable electronic apparatus that is opposite to a side in which the first temperature measurement point is located, and to determine the core temperature of the user based on the thermal equilibrium temperature at the first temperature measurement point, the thermal equilibrium temperature at the second temperature measurement point, and an ambient temperature at the ambient temperature measurement point.
Such a modification would have been feasible because Cross already teaches a multi-sensor core temperature determination framework using measured temperatures at different points of an ear-worn housing, and Blank teaches placing an ambient temperature measurement location on an opposite side from a skin-contact surface (Blank, FIG. 3) and processing ambient temperature sensor data together with other temperature sensor data via a processor (Blank, ¶[0022]) to determine a core body temperature. One of ordinary skill in the art would have been motivated to make this modification because incorporating an ambient temperature measurement on an opposite side from the skin-contact side predictably reduces contamination from body heat and improves robustness of temperature determination across ambient environmental changes, consistent with Blank’s teaching that ambient effects on other temperature sensors can be mitigated by the processor using an ambient temperature sensor (Blank, ¶[0020]).
Regarding claim 20, the modified Cross teaches that the method further comprises: obtaining the thermal equilibrium temperatures of the housing in the wearable electronic apparatus at the different temperature measurement points; determining whether the thermal equilibrium temperatures at the temperature measurement points change compared with the thermal equilibrium temperatures at the determined temperature measurement points; and determining the core temperature of the user based on changed thermal equilibrium temperatures at the temperature measurement points when the thermal equilibrium temperatures at the temperature measurement points change (Cross, ¶[0098], “the processor 1810 can be configured to compute the following temperature measurements: absolute core body temperature continuously; 2) an increase in core body temperature over baseline at any given time of day; 3) a magnitude of variation in core body temperature over any specified time interval within or up to one day (diurnal, nocturnal); and 4) phase shifted daily circadian rhythm compared to normal. A threshold can be established for these and other temperature measurements computed by the processor 1810”, Cross teaches repeatedly obtaining updated temperature measurements over time and continuously determining core body temperature and variations over time, which corresponds to repeatedly obtaining equilibrium temperatures and determining core temperature based on the changed equilibrium temperatures when change occurs; ¶[0175], “Embodiments can be used to store a cumulative moving average, or exponential moving average of core temperature with varying window sizes (1 hr, 1 day, 1 week, 1 month, 1 year)”, Cross teaches storing and updating core temperature values across time windows, which further supports repeated measurement and determination of core temperature over time based on updated temperature values).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Blank et al. (US 20130341315 A1), hereto referred as Blank, and further in view of Fraden et al. (US 20050043631 A1), hereto referred as Fraden.
The modified Cross teaches claim 13 as described above.
Regarding claim 14, the modified Cross does not teach that before obtaining thermal equilibrium temperatures at different temperature measurement points of a housing in the wearable electronic apparatus, determining the ambient temperature at the ambient temperature measurement point. Rather, the modified Cross teaches obtaining temperatures from multiple sensors of an ear-worn device (including ambient temperature) and determining core body temperature using those measured temperatures in a heat balance framework. However, it does not expressly teach the specific timing limitation that the ambient temperature is determined before obtaining thermal equilibrium temperatures at the other temperature measurement points.
Fraden teaches obtaining a temperature measurement prior to contact with the user and using that pre-contact measurement in subsequent computation after the device contacts the skin, stating: “before Eq. (1) can be employed, value of Ts should be computed from two temperatures: temperature T1 and T0, where T0 is temperature of first sensor 6 before it touched skin 15” (Fraden, ¶[0028]). Fraden further explains that, during operation, “Temperature of first sensor 6, T0 before the detection is stored and will be used for computing the skin temperature by use of Eq. (2)” (Fraden, ¶[0036]). These disclosures establish a temporal ordering in which a pre-contact sensor temperature is obtained and stored before later contact-based temperature changes are processed.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of Fraden to determine the ambient temperature at the ambient temperature measurement point before obtaining thermal equilibrium temperatures at different temperature measurement points of the housing. Such a modification would have been feasible because the modified Cross already includes an ambient temperature sensor configured to detect ambient environment temperature, and Fraden teaches obtaining and storing a pre-contact sensor temperature before subsequent contact-based computation, therefore taking an initial ambient or baseline measurement before later equilibrium measurements was known and would have been a predictable design choice. The benefit of this modification would have been improved accuracy and stability of the subsequent equilibrium-based temperature determination by establishing an ambient baseline before the device reaches equilibrium with the ear, thereby reducing the impact of environmental temperature variations on the later equilibrium temperature measurements.
Regarding claim 15, the modified Cross does not teach that obtaining an initial temperature at the ambient temperature measurement point, wherein the initial temperature is a temperature at the ambient temperature measurement point before the wearable electronic apparatus is worn on an ear of a user; obtaining a momentary temperature at the ambient temperature measurement point, wherein the momentary temperature is a temperature at the ambient temperature measurement point when the wearable electronic apparatus is worn on the ear of the user within a first preset time; and determining the ambient temperature at the ambient temperature measurement point based on the initial temperature and the momentary temperature. Rather, the modified Cross teaches obtaining temperatures from multiple sensors of an ear-worn device (including ambient temperature) and determining core body temperature using those measured temperatures in a heat balance framework as well as taking an ambient temperature reading before other readings, but it does not expressly teach determining ambient temperature based on a pre-wear initial temperature and a post-wear momentary temperature within a first preset time.
Fraden teaches obtaining a temperature measurement before the sensor contacts the patient and then using a subsequent contact-associated temperature measurement together with the pre-contact temperature in later computation, stating: “before Eq. (1) can be employed, value of Ts should be computed from two temperatures: temperature T1 and T0, where T0 is temperature of first sensor 6 before it touched skin 15” (Fraden, ¶[0028]). Fraden further teaches monitoring temperature change using a preset timing window and detecting a temperature change at the time of contact, stating: “Microcontroller constantly checks temperature changes of sensor 6 over predetermined time intervals td (FIG. 9)” and “Temperature of first sensor 6 stays on a relatively stable level until the probe touches the patient's skin. At this moment, temperature of first Sensor 6 begins to rise” (Fraden, ¶[0036]). These disclosures establish (i) an initial pre-contact temperature, (ii) a contact-associated temperature obtained within predetermined time intervals, and (iii) determining a temperature used in computation based on both the initial and the later measurement, which is conceptually consistent with claim 15’s initial and momentary temperatures and determining ambient temperature based on both.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of Fraden to obtain an initial temperature at the ambient temperature measurement point before the wearable electronic apparatus is worn on the ear, to obtain a momentary temperature at the ambient temperature measurement point when the wearable electronic apparatus is worn on the ear within a first preset time, and to determine the ambient temperature at the ambient temperature measurement point based on the initial temperature and the momentary temperature. Such a modification would have been feasible because the modified Cross already includes an ambient temperature sensor configured to detect ambient environment temperature, and Fraden teaches obtaining an initial pre-contact temperature and using a subsequent contact-associated temperature obtained within predetermined time intervals, and further teaches computing a temperature based on both the initial and later measurements, therefore applying a known pre-wear baseline and early post-wear measurement sequence to the ambient temperature measurement point would have been a predictable implementation choice. The benefit of this modification would have been improved accuracy of ambient temperature determination for subsequent core temperature calculation by compensating for transient thermal effects associated with donning and using the device and by establishing a stable ambient baseline from the pre-wear initial measurement.
Claims 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Blank et al. (US 20130341315 A1), hereto referred as Blank, and further in view of Fraden et al. (US 20050043631 A1), hereto referred as Fraden, and further in view of Zhu et al. (CN 114052669 A), hereto referred as Zhu.
The modified Cross teaches claim 14 as described above.
Regarding claim 16, the modified Cross does not teach that before determining the core temperature of the user based on the thermal equilibrium temperature at the first temperature measurement point and the thermal equilibrium temperature at the second temperature measurement point, correcting the ambient temperature at the ambient temperature measurement point based on a thermal equilibrium temperature at the ambient temperature measurement point. Rather, the modified Cross teaches determining core body temperature using measured temperatures and an equilibrium heat-balance model across a thermal path from an internal ear location toward the ambient environment, including that “For a thermal model of the heat flow through the ITE shell from the inner parts of the ear to the ambient” (Cross, ¶[0151]) and that, “At equilibrium , Linflux = 9eflux so that : K ' Internal ( Ttympanic membrane - Tinternal ) dinternal = K ' exterior ( Tinternal - Tfaceplate ) dexterior” (Cross, ¶[0152]). However, it does not expressly teach correcting an ambient temperature value at an ambient temperature measurement point based on a thermal equilibrium temperature at that ambient temperature measurement point before performing the core-temperature determination.
Zhu teaches that ambient detection temperature can be affected such that it does not accurately represent the true physical state, and that measured temperatures including ambient temperature can be corrected to reduce external environmental interference. Specifically, Zhu teaches that “the detection data of human body temperature sensor or ambient temperature sensor, i.e., human body detection temperature and ambient detection temperature, cannot accurately represent the user's true physical state” (Zhu, ¶[0087]) and further teaches that “The body surface temperature is obtained by correcting the calculated temperature ratio coefficient, which can reduce external environmental interference and improve the accuracy and reliability of the body surface temperature” (Zhu, ¶[0077]). Zhu thus teaches applying a correction associated with ambient-temperature sensing to mitigate environmental interference on computed temperature results.
Blank teaches using an ambient temperature sensor and a processor to mitigate ambient-environment changes that would otherwise affect temperature sensing and processing, stating: “The ambient temperature sensor 112 may be used to ensure that the skin temperature sensor 108 and the oven temperature sensor 110 are not affected by the ambient environment. For example, changes detected in the ambient environment using the ambient temperature sensor 112 may be mitigated by the processor 114” (Blank, ¶[0020]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of Zhu and Blank to correct the ambient temperature at an ambient temperature measurement point based on a thermal equilibrium temperature at the ambient temperature measurement point before determining the core temperature based on the thermal equilibrium temperatures at the first and second temperature measurement points. Such a modification would have been feasible because the modified Cross already operates on an equilibrium heat-balance framework across a thermal path between measured temperature locations and the ambient environment (Cross, ¶¶[0151]–[0152]), Blank expressly motivates mitigating ambient-environment changes via processor-based correction using an ambient temperature sensor (Blank, ¶[0020]), and Zhu teaches that ambient detection temperature can be affected such that it does not accurately represent true conditions and that correction can reduce external environmental interference on temperature computation (Zhu, ¶¶[0087], [0077]). Accordingly, applying a correction to the ambient-temperature value using the ambient point’s equilibrium behavior as an input to the correction would have been a predictable implementation choice within Cross’s equilibrium measurement framework, and would have improved robustness and accuracy of the subsequent equilibrium-based core-temperature determination under varying environmental and device-heating conditions.
Claims 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Blank et al. (US 20130341315 A1), hereto referred as Blank, and further in view of Fraden et al. (US 20050043631 A1), hereto referred as Fraden, and further in view of Zhu et al. (CN 114052669 A), hereto referred as Zhu, and further in view of Zhu et al. (CN 113566975 A), hereto referred as Zhu’975.
The modified Cross teaches claim 14 as described above.
Regarding claim 17, the modified Cross does not teach that the method comprises: detecting a working scenario of the wearable electronic apparatus, wherein the working scenario comprises a low power consumption scenario, a medium power consumption scenario, and a high power consumption scenario, measuring the thermal equilibrium temperatures at the temperature measurement points, and determining an adjustment factor based on the working scenario and the thermal equilibrium temperature at the ambient temperature measurement point. Rather, the modified Cross teaches obtaining temperatures at different temperature measurement points of an ear-worn device housing and determining core body temperature using an equilibrium heat-balance framework across a thermal path from the inner parts of the ear toward the ambient, including that “For a thermal model of the heat flow through the ITE shell from the inner parts of the ear to the ambient” (Cross, ¶[0151]) and that “At equilibrium , Linflux = 9eflux so that : K ' Internal ( Ttympanic membrane - Tinternal ) dinternal = K ' exterior ( Tinternal - Tfaceplate ) dexterior” (Cross, ¶[0152]). However, even in view of the modifications set forth above through claim 16, the modified Cross does not expressly teach detecting a working scenario comprising low, medium, and high power consumption scenarios, nor does it expressly teach determining an adjustment factor based on such a working scenario and a thermal equilibrium temperature at an ambient temperature measurement point.
Blank teaches operating the temperature system in different heater activation states that directly affect power consumption, and further teaches minimizing power consumption by selectively controlling heater operation, stating: “the processor 114 may send signals to the one or more heating elements 106 to activate the one or more heating elements 106 … the processor 114 may send instructions to the one or more heating elements 106 to deactivate the one or more heating elements 106. In this example, the one or more heating elements 106 and the processor 114 balance any heat flux and consume minimal power” (Blank, ¶[0022]) and “In this way, power consumption is kept at a minimum, with the heating elements controlled only as needed to maintain equilibrium with the body temperature detected” (Blank, ¶[0051]).
Zhu’975 teaches repeating measurements under different heating power levels and determining parameters based on the collected data, stating: “(4) Repeat step 3 with different power” (Zhu’975, ¶[n0089]) and "the thermal response characteristic parameters of the unheated temperature... before thermal shock... after thermal shock are extracted for deep temperature estimation....k1, k2,…, b are parameters to be determined, which can be determined by collecting a large amount of data and using optimization algorithms” (Zhu’975, ¶[n0104]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of Blank and Zhu’975 to detect a working scenario comprising low, medium, and high power consumption scenarios (as power consumption relates to device temperature), measure thermal equilibrium temperatures at the temperature measurement points, and determine an adjustment factor based on the working scenario and the thermal equilibrium temperature at an ambient temperature measurement point. Such a modification would have been feasible because the modified Cross already relies on equilibrium temperature measurements and a thermal model referencing the ambient environment (Cross, ¶¶[0151]–[0152]), Blank teaches controlling heater activation and deactivation to balance heat flux while consuming minimal power, thereby establishing distinct operating states associated with different power consumption levels (Blank, ¶¶[0022], [0051]), and Zhu’975 teaches repeating measurements under different heating power levels and determining parameters by collecting data during these states and applying optimization algorithms (Zhu’975, ¶¶[n0089], [n0104]). The benefit of this modification would have been improved robustness and accuracy of temperature computation under varying device self-heating and operating conditions by empirically selecting an adjustment factor appropriate to the current power consumption state.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Blank et al. (US 20130341315 A1), hereto referred as Blank, and further in view of Fraden et al. (US 20050043631 A1), hereto referred as Fraden, and further in view of Zhu et al. (CN 114052669 A), hereto referred as Zhu, and further in view of Zhu et al. (CN 113566975 A), hereto referred as Zhu’975, and further in view of White et al. (US 5405511 A), hereto referred as White.
The modified Cross teaches claim 17 as described above.
Regarding claim 18, the modified Cross does not teach that correcting the ambient temperature at the ambient temperature measurement point based on thermal equilibrium temperature at the ambient temperature measurement point comprises: determining whether the thermal equilibrium temperature at the ambient temperature measurement point is the same as the ambient temperature at the ambient temperature measurement point; determining the core temperature based on the ambient temperature at the ambient temperature measurement point when the thermal equilibrium temperature at the ambient temperature measurement point is the same as the ambient temperature at the ambient temperature measurement point; and when the thermal equilibrium temperature at the ambient temperature measurement point is different from the ambient temperature at the ambient temperature measurement point, determining the ambient temperature at the ambient temperature measurement point as the thermal equilibrium temperature at the ambient temperature measurement point, and continuing to correct the ambient temperature at the ambient temperature measurement point until the thermal equilibrium temperature at the ambient temperature measurement point is the same as the determined ambient temperature at the ambient temperature measurement point. Rather, the modified Cross teaches modeling heat flow and determining core body temperature based on an equilibrium heat-balance framework across a thermal path between an interior temperature location and an exterior temperature location, including that “For a thermal model of the heat flow through the ITE shell from the inner parts of the ear to the ambient” (Cross, ¶[0151]) and that “At equilibrium , Linflux = 9eflux so that : K ' Internal ( Ttympanic membrane - Tinternal ) dinternal = K ' exterior ( Tinternal - Tfaceplate ) dexterior” (Cross, ¶[0152]). However, the modified Cross does not expressly teach determining whether the thermal equilibrium temperature at the ambient temperature measurement point is the same as the ambient temperature at the ambient temperature measurement point, nor determining the ambient temperature at the ambient temperature measurement point as the thermal equilibrium temperature at the ambient temperature measurement point and continuing to correct the ambient temperature at the ambient temperature measurement point until the two are the same.
White describes an ambient temperature estimation procedure that repeatedly compares a newest temperature reading to an older temperature reading and determines whether the difference between those readings satisfies a stability threshold. White explains that “it is determined whether the new sensed temperature Tnew minus the old temperature Told is less than a temperature threshold value AT” (White, col. 6-7, ll. 36-13). White further teaches that when the difference is below the threshold, “the temperature samples are assumed to be essentially identical and no temperature movement is assumed to have been seen during the entire At (indicating that meter 10 is probably at equilibrium). Therefore, no estimation is needed and Tnew may be used as the new ambient temperature” (White, col. 6-7, ll. 36-13). White also teaches that when the threshold is met or exceeded, a new ambient estimate is calculated and the stored ambient value is updated, stating: “If, by contrast, the temperature difference between Tnew and Told is equal to or exceeds the AT threshold value, equation (C) is calculated” and “The previously stored value of Tambient is then updated with the new value” (White, col. 7, ll. 14-40).
White’s determination that two sampled temperature values are “essentially identical” when their difference is less than a defined threshold is a practical implementation of determining whether two temperature values are the same in a sampled sensor system. Further, White’s express statement that such a condition indicates the device is “probably at equilibrium” aligns with Cross’s reliance on equilibrium conditions for accurate temperature-based computation. Thus, both Cross and White use an equilibrium or stability condition to decide when a temperature value should be treated as the appropriate ambient reference for subsequent calculation.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of White to correct the ambient temperature at the ambient temperature measurement point by determining whether the thermal equilibrium temperature at the ambient temperature measurement point and the ambient temperature at the ambient temperature measurement point are the same as indicated by a stability threshold, determining the core temperature based on the ambient temperature when the stability condition is satisfied, and when the stability condition is not satisfied, determining the ambient temperature at the ambient temperature measurement point as the thermal equilibrium temperature at the ambient temperature measurement point and continuing to correct until the two values converge. Such a modification would have been feasible because the modified Cross already relies on equilibrium conditions in a thermal model to support temperature computation (Cross, ¶¶[0151]–[0152]), and White teaches a processor-implemented routine that compares successive temperature readings, treats sufficiently small differences as equilibrium, and updates the stored ambient value when stability is not achieved (White, col. 6, l. 36 – col. 7, l. 25). The benefit of this modification would have been improved robustness of ambient compensation during transient thermal conditions by ensuring that the ambient temperature value used in the core temperature calculation converges to a stable equilibrium reading, thereby reducing error attributable to sensor lag, environmental transitions, or device self-heating effects.
Regarding claim 19, the modified Cross does not teach that the method comprises: determining the core temperature of the user based on the thermal equilibrium temperature at the first temperature measurement point, the thermal equilibrium temperature at the second temperature measurement point, the ambient temperature at the ambient temperature measurement point, and the adjustment factor. As shown in Claim 13 above, the modified Cross already establishes determining core temperature based on a first and second thermal equilibrium temperature and an ambient temperature. As further shown in Claims 16 to 18 above, the combined art already establishes determining an adjustment factor for correcting the ambient temperature and iteratively updating the ambient value until it stabilizes. Thus, the combined art already determines (1) a first equilibrium temperature, (2) a second equilibrium temperature, (3) an ambient temperature, and (4) an adjustment factor used to correct the ambient temperature. However, the combined art still does not expressly teach the specific linkage required by claim 19, namely, determining the core temperature based on the first equilibrium temperature, the second equilibrium temperature, the ambient temperature at the ambient temperature measurement point as corrected using the adjustment factor, and the adjustment factor itself as part of the core temperature determination step.
Zhu teaches that in a wearable physiological temperature determination process, when environmental temperature is corrected using determined parameters, that corrected environmental-related value is incorporated into the subsequent temperature computation step, stating “Then, the body surface temperature is calculated by correcting the current human body temperature, the current environmental temperature, and the temperature ratio coefficient” (Zhu, ¶[0089]). Zhu therefore evidences that corrected environmental temperature terms are integrated into the overall physiological temperature calculation itself rather than remaining isolated as a preprocessing result. Although Zhu determines body surface temperature rather than core temperature, Zhu demonstrates incorporation of corrected environmental temperature values into a wearable physiological temperature computation, thereby evidencing the computational linkage principle missing from the combined art.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of Zhu to determine the core temperature of the user based on the thermal equilibrium temperature at the first temperature measurement point, the thermal equilibrium temperature at the second temperature measurement point, the ambient temperature at the ambient temperature measurement point as corrected using the adjustment factor, and the adjustment factor by incorporating the corrected ambient temperature term within Cross’s heat-balance core temperature calculation framework. Such a modification would have been feasible because the combined art already establishes (i) determining core temperature using the first and second equilibrium temperatures together with an ambient temperature input as shown in claim 13 above, and (ii) correcting the ambient temperature using an adjustment factor and iteratively updating the ambient value until it stabilizes as shown in claims 16 to 18 above, and Zhu evidences that corrected environmental temperature values are used directly within a physiological temperature computation step (Zhu, ¶[0089]). Incorporating the corrected ambient temperature into Cross’s heat-balance equation would have been a predictable application of the same computational integration principle within an analogous wearable temperature-determination context. The benefit of this modification would have been improved accuracy and robustness of the core temperature determination under varying environmental and device-heating conditions by ensuring the ambient-related term used in the heat-balance core temperature calculation reflects the corrected environmental value rather than an uncorrected ambient measurement.
Claims 21 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Blank et al. (US 20130341315 A1), hereto referred as Blank, and further in view of Fraden et al. (US 20050043631 A1), hereto referred as Fraden, and further in view of Siefert et al. (US 20020003832 A1), hereto referred as Siefert.
The modified Cross teaches claim 14 as described above.
Regarding claim 21, the modified Cross does not teach that the method further comprises: determining whether the wearable electronic apparatus is worn on an ear of a user again within a second preset time; and when the wearable electronic apparatus is worn on the ear of the user again within the second preset time, determining the core temperature of the user based on the ambient temperature at the ambient temperature measurement point before the wearable electronic apparatus is put off. The modified Cross teaches determining core temperature using an ear-worn device and a heat-balance equation, including that the processor can compute “absolute core body temperature continuously” and can compute changes “over any specified time interval” (Cross, ¶[0098]). The modified Cross also teaches producing an ambient temperature signal “indicative of the ambient environment exterior of the ear” (Cross, ¶[0109]) and that “Calculated and/or measured temperature can be stored in internal memory” (Cross, ¶[0174]). However, the modified Cross does not expressly teach determining whether the wearable electronic apparatus is worn on an ear of a user again within a second preset time after being put off, nor determining core temperature based on the ambient temperature value at the ambient temperature measurement point from before the wearable electronic apparatus is put off.
Siefert teaches timer-based determination tied to a use-cycle transition and reuse of a previously stored ambient temperature value, stating: “If the probe has not been in the well 17 for a certain time period, such as one minute, the measurement System assumes that the probe is not at ambient temperature and a previously-Saved ambient temperature is used” (Siefert, ¶[0046]). Siefert further teaches using an ambient temperature value in the temperature calculation and selecting between measuring ambient and using a stored ambient value, stating: “The offset coefficient C is used to factor the ambient temperature into the calculation of the predicted temperature” and “the algorithm determines whether to actually measure T or to use a previously Stored value” (Siefert, ¶[0050]). These teachings evidence determining whether a subsequent measurement-use event occurs within a preset time period and, based on that determination, reusing a previously stored ambient temperature value as an input to the temperature computation.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross in view of Siefert to determine whether the wearable electronic apparatus is worn on an ear of a user again within a second preset time, and when the wearable electronic apparatus is worn on the ear of the user again within the second preset time, determine the core temperature of the user based on the ambient temperature at the ambient temperature measurement point before the wearable electronic apparatus is put off. Such a modification would have been feasible because the modified Cross already produces an ambient temperature signal indicative of the ambient environment exterior of the ear (Cross, ¶[0109]) and stores calculated and/or measured temperature in internal memory (Cross, ¶[0174]), thereby providing both the ambient signal and storage capability needed to retain the ambient temperature value measured prior to removal. Siefert teaches monitoring whether a use-cycle transition satisfies a preset time period and, when it does not, using “a previously-Saved ambient temperature” rather than measuring ambient (Siefert, ¶[0046]) and further teaches factoring ambient temperature into a predicted temperature calculation while the algorithm determines whether to measure ambient or use a “previously Stored value” (Siefert, ¶[0050]). Together, these teachings support storing the ambient temperature value generated by Cross prior to removal and reusing that stored ambient value if the apparatus is worn again within the defined time window. The benefit of this modification would have been faster and more reliable core temperature determination after re-wear by reusing a recently stored ambient reference value when the device is worn again within a defined time window, thereby reducing delay and improving responsiveness of temperature computation.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Cross et al. (US 20190117155 A1), hereto referred as Cross, and further in view of Zhu et al. (CN 114052669 A), hereto referred as Zhu, and further in view of McPeak et al. (US 20170094394 A1), hereto referred as McPeak.
The modified Cross teaches claim 1 as described above.
Regarding claim 22, the modified Cross does not teach a wearable electronic device comprising a charging accommodating apparatus, wherein the wearable electronic apparatus is disposed in the charging accommodating apparatus.
McPeak teaches a charging accommodating apparatus configured to receive and house a wearable electronic device. McPeak discloses: “A case for a pair of earbuds includes a housing having cavities to receive the pair of earbuds and charging circuitry that is configured to initiate charging of the pair of earbuds when an earbud detector detects that the earbuds are inserted within the cavities” (McPeak, Abstract). McPeak further teaches: “a case for a pair of earbuds includes a housing having one or more cavities configured to receive the pair of earbuds; a lid attached to the housing and operable between a closed position where the lid is aligned over the one or more cavities and an open position where the lid is displaced from the one or more cavities; and a charging system” (McPeak, ¶[0009]). McPeak also teaches that the charging circuitry is configured to charge the device when inserted, stating: “charging circuitry configured to initiate charging of an earbud battery when the earbud detector detects insertion of an earbud within either the first cavity or the second cavity and configured to cease charging the earbud when the earbud detector detects an earbud is removed from the cavity” (McPeak, ¶[0010]). These disclosures show a charging accommodating apparatus in which a wearable electronic device is disposed and charged when positioned within the case.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Cross to further include a charging accommodating apparatus as taught by McPeak, wherein the wearable electronic apparatus is disposed in the charging accommodating apparatus. Such a modification would have been feasible because Cross teaches an ear-worn wearable electronic device, and McPeak teaches a housing having cavities configured to receive a wearable earbud device and initiate charging when the device is inserted. Incorporating a charging case as taught by McPeak into the Cross device would have been a predictable design choice to provide storage and recharging functionality for the wearable electronic apparatus. The benefit of such a modification would have been enabling convenient storage and recharging of the wearable electronic apparatus when not in use, thereby improving usability and battery management of the device.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791