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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1, 3-7, 9, 17, and 19 are objected to because of the following informalities: these claims recite grammatical errors.
Regarding Claim 1, the limitation “comprising” recited within the preamble of the claim should recited “comprises”.
Regarding Claim 1, there are limitations recited within the rest of the claim that are improper. The limitation "to be worn" in line 3 of the claim should recite "configured to be worn". Additionally, the limitation "comprise" in line 5 of the claim should recite "comprises". Furthermore, the limitation "temperature on auditory canal temperature" in line 9 of the claim should recite "temperature on an auditory canal temperature". Lastly, the limitation "where the effect of heart rate and…" in lines 9-10 of the claim is improper grammar since there are multiple effects being monitored. This limitation should recite "where the effects of heart rate and…".
Claim 3, the limitation "insertion into auditory canal" should recite "insertion into an auditory canal". Additionally, the limitation "an earbud to fit to the user's ear" should recite "an earbud configured to fit to the user's ear". Furthermore, the limitation “in contact with the concha part of the user’s ear” should recite “configured to be in contact with the concha part of the user’s ear”.
Claim 4, the limitation “back of the user’s ear where the third temperature sensor” should have a grammatical break within the text to identify where the “second extension” language stops and the “third temperature sensor” language begins. This could be written as “back of the user’s ear; wherein the third temperature sensor”.
Claim 5, the limitation "has an elongate structure extends" is not proper grammar. The claim should recite "an elongated structure wherein the elongate structure extends to the…". Additionally, the limitation “concha of the user’s ear where the third temperature sensor” should have a grammatical break within the text to identify where the “second extension” language stops and the “third temperature sensor” language begins. This could be written as “concha of the user’s ear; wherein the third temperature sensor”. Furthermore, the limitation “installed at a position in contact with the cymba concha” should recite “installed at a position configured to be in contact with the cymba concha”.
Claim 6, the spelling of the limitation "minimising" is more commonly accepted as "minimizing".
Claim 7, the limitation "where the effect of heart rate and…" in lines 3-4 of the claim is improper grammar since there are multiple effects being monitored. This limitation should recite "where the effects of heart rate and…". Additionally, the limitation "temperature on auditory canal temperature" in line 4 of the claim should recite "temperature on an auditory canal temperature".
Claim 9, the spelling for the limitation "utilises" is more commonly accepted as "utilizes".
Claim 17, the limitation "to be worn" in lines 3-4 of the claim should recite "configured to be worn". Additionally, the limitation "comprise" in line 4 of the claim should recite "comprises". Furthermore, the limitation "temperature on auditory canal temperature" should recite "temperature on an auditory canal temperature". Lastly, the limitation "where the effect of heart rate and…" in line 10 of the claim is improper grammar since there are multiple effects being monitored. This limitation should recite "where the effects of heart rate and…".
Claim 19, the limitation “where” is recited in the first line of the claim but the more accurate use of this terminology would be “wherein” to ensure the language is inclusive for what elements follow. Additionally, spelling for the limitation "utilises" is more commonly accepted as "utilizes".
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “analysis unit” recited in Claims 1, 3, and 17-18, “control module” recited in Claim 3, “elastic member” recited in Claim 6, and “data processing module” recited in Claim 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Regarding “analysis unit”, the specification fails to provide any structure within the specification apart from “user interface”, and therefore it is unclear what type of structure this limitation carries. Regarding “control module”, the specification fails to provide any structure within the specification and therefore it is unclear what type of structure this limitation carries. Regarding “elastic member”, the specification provides the following structure: ”a skin-friendly material, such as silicone, rubber or other suitable materials, so that detection unit200 can be worn comfortably for long period”. Regarding “data processing module”, the specification fails to provide any structure within the specification and therefore it is unclear what type of structure this limitation carries.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitations “analysis unit”, “control module”, and “data processing module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding Claim 1, the limitation “the user’s ear” is unclear. Since a user typically has two ears, it is unclear which ear the system should be worn in or if that decision matters. It should recite “a detection unit to be worn in an ear of the user”. Further regarding Claim 1, it’s unclear if the system itself detects the over-heating state recited in the second to last line of the claim. There’s no positive recitation of an element of the system being configured to perform that last limitation.
Regarding Claim 4, the limitation "installed at a position in contact with the eminence of concha of the user’s ear" is unclear. The current wording reads as if the "third temperature sensor" is installed upon the user rather than within the device that the user is wearing. This is being interpreted to mean "installed at a position within the device that is configured to be in contact with the eminence of concha of the user’s ear".
Regarding Claim 5, the limitation "installed at a position in contact with the cymba concha" is unclear. The current wording reads as if the "third temperature sensor" is installed upon the user rather than within the device that the user is wearing. This is being interpreted to mean "installed at a position within the device that is configured to be in contact with the cymba concha".
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 17 follows.
STEP 1
Regarding Claim 17, the claim recites a series of steps or acts, including measuring physiological data of the user by a plurality of sensors; sending the measured physiological data to an analysis unit; computing core temperature of the user; determining an over-heating state when the computed core temperature of the user is above a threshold; and generating a warning signal to alert the user. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining an over-heating state when the computed core temperature of the user is above a threshold sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 17 recites generating a warning signal, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The generation of the warning signal does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the generated warning signal, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 17 recites additional steps of measuring physiological data of the user by a plurality of sensors; sending the measured physiological data to an analysis unit; and computing core temperature of the user. The measuring, sending, and computing steps are recited at a high level of generality such that they amount to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the measuring, sending, and computing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding Claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited “detection unit” is a generic device configured to perform measuring physiological data from one or more sensor as mere pre-solution data gathering; the “analysis unit” and “prediction model” are a generic computer programs configured to perform calculating a core temperature of a person as well as perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Dependent Claims 2-16 and 18-20 fail to add something more to the abstract independent claims as they generally recite steps pertaining to data gathering and processing. Additionally, dependent Claims 10 and 11 recite mathematic formulas which are drawn to an Abstract Idea.
The measuring, sending, computing, determining, and generating steps recited in the independent claims, Claims 1 and 17, maintain a high level of generality even when considered in combination with the dependent claims.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claims 3-6, the applicant cannot claim parts of the human tissue and/or body. The applicant has claimed “in contact with the concha part of the user’s ear” in Claims 3-6 and “installed at a position in contact with the cymba concha” in Claim 5. These elements cannot be claimed since “ear”, “concha”, and “cymba concha” are parts of the body.
Claims 3-6 each improperly recite human tissue as part of the claimed invention. It is suggested that the applicant amend the claims to recite that “configured to be in contact with the concha part of the user’s ear” in order to remove the recitation of human tissue (emphasis added) in Claim 3 and “configured to be installed at a position in contact with the cymba concha” in order to remove the recitation of human tissue (emphasis added) in Claim 5. Claims 4-6 are rejected due to their dependency on Claim 3.
Accordingly, Claims 1-20 are not patent eligible and are rejected under 35 U.S.C. 101.
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, 7-8, 12-13, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et. al.'155 (U.S. Patent Application 20190117155) in view of Mark Buller’811 (U.S. Patent Application 20170238811).
Regarding Claim 1, Cross et. al.’155 discloses a system for continuous monitoring of core body temperature (Tc) of a user (Paragraph [0098] - For example, the processor 1810 can be configured to compute the following temperature measurements: absolute core body temperature continuously), the system comprising:
a detection unit to be worn in the user's ear for measuring physiological data of the user by a plurality of sensors installed at the detection unit wherein the physiological data to be measured comprise first auditory canal temperature (Tac1), second auditory canal temperature (Tac2), external auricle temperature (Tea), and heart rate (HR) of the user (Paragraph [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, rather than radiative heat; Paragraph [0172] - Embodiments can be used to measure temperature and time of onset of a physiological change due to response to drugs or other chemicals that illicit an autonomic or endocrine response in the form of a skin or core body temperature change, physiological response due to stress or other emotions, physical activity, and a pre-determined amount of heart rate change. Embodiments can be used to measure the difference in temperature or time of occurrence for any of the above); and
an analysis unit connected to the detection unit via a communication link for computing Tc of the user with a prediction model using the physiological data measured by the detection unit where the effect of external environmental temperature on auditory canal temperature of the user is taken into account (Paragraph [0089] - Temperature can be measured at or near Location 2 and the faceplate over a range of environmental temperatures in order to derive the heat balance equation; Paragraph [0098] - For example, 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; Paragraph [0172] - Embodiments can be used to measure temperature and time of onset of a physiological change due to response to drugs or other chemicals that illicit an autonomic or endocrine response in the form of a skin or core body temperature change, physiological response due to stress or other emotions, physical activity, and a pre-determined amount of heart rate change. Embodiments can be used to measure the difference in temperature or time of occurrence for any of the above); wherein
an over-heating state is detected when the computed Tc of the user is above a threshold level (Paragraph [0098] - A signal indicative of the absolute core body temperature 1830 is provided at an output 1818 of the processor 1810. The processor 1810 may be configured to generate one or more alerts based on a comparison between temperature measurements and one or more thresholds. For example, 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 et. al.’155 fails to explicitly disclose computing Tc of the user with a prediction model using the physiological data measured by the detection unit where the effect of heart rate is taken into account. Mark Buller’811 teaches using heart rate to estimate core body temperature (Paragraph [0007] - Heart rate is a convenient observation of the expected core body temperature at steady state or a leading indicator of core body temperature as it contains information about both heat production (through the Fick (1855) equation and VO.sub.2) and heat transfer since heart rate is related to skin profusion). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cross et. al.’155 to include the effects of heart rate when calculating a core body temperature of a user since heart rate has been shown to provide accurate core body temperature estimations in previous studies as seen in Mark Buller’811 (Paragraph [0006] - use heart rate with ambient temperature modifiers to account for skin blood flow (Yokota et al 2008). This real-time model provided accurate group-mean core body temperature estimates in a number of different environmental and clothing conditions).
Regarding Claim 7, Cross et. al.’155 in view of Mark Buller’811 discloses the system outlined in Claim 1 above. Additionally, Cross et. al.’155 discloses wherein the analysis unit comprising: a data processing module for receiving the physiological data measured by the detection unit and computing Tc of the user with the prediction model using the physiological data where the effect of external environmental temperature on auditory canal temperature of the user is taken into account (Paragraph [0089] - Temperature can be measured at or near Location 2 and the faceplate over a range of environmental temperatures in order to derive the heat balance equation; Paragraph [0098] - For example, 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; Paragraph [0172] - Embodiments can be used to measure temperature and time of onset of a physiological change due to response to drugs or other chemicals that illicit an autonomic or endocrine response in the form of a skin or core body temperature change, physiological response due to stress or other emotions, physical activity, and a pre-determined amount of heart rate change. Embodiments can be used to measure the difference in temperature or time of occurrence for any of the above).
Cross et. al.’155 fails to explicitly disclose computing Tc of the user with a prediction model using the physiological data measured by the detection unit where the effect of heart rate is taken into account. Mark Buller’811 teaches using heart rate to estimate core body temperature (Paragraph [0007] - Heart rate is a convenient observation of the expected core body temperature at steady state or a leading indicator of core body temperature as it contains information about both heat production (through the Fick (1855) equation and VO.sub.2) and heat transfer since heart rate is related to skin profusion). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cross et. al.’155 to include the effects of heart rate when calculating a core body temperature of a user since heart rate has been shown to provide accurate core body temperature estimations in previous studies as seen in Mark Buller’811 (Paragraph [0006] - use heart rate with ambient temperature modifiers to account for skin blood flow (Yokota et al 2008). This real-time model provided accurate group-mean core body temperature estimates in a number of different environmental and clothing conditions).
Regarding Claim 8, Cross et. al.’155 in view of Mark Buller’811 discloses the system outlined in Claim 1 above. Additionally, Cross et. al.’155 discloses wherein the analysis unit further comprising: a user interface for displaying the computed Tc and/or the measured physiological data of the user, and allowing the user to change Tc computation parameters; and a memory for storing the computed Tc and/or the measured physiological data of the user (Paragraph [0088] - It is noted that, although not necessary, individual calibration can be used to improve the accuracy of an individual system by either entering two geometrical human parameters obtained from deep ear impression, one parameter from a standard ear impression and one from a tympanometry volume measurement or from calibration using a reference thermometer; Paragraph [0104] - The processor 1910 is configured to calculate an absolute core body temperature 1930 using temperature signals produced by the distal and proximal temperature sensors 1804, 1806 and a heat balance equation 1922 stored in the memory 1920. Temperature measurements and alerts, such as those described above, can be communicated to the user and/or other devices via the output 1918 of the processor 1910).
Regarding Claim 12, Cross et. al.’155 in view of Mark Buller’811 discloses the system outlined in Claim 1 above. Additionally, Cross et. al.’155 discloses wherein the analysis unit can be in the form of a smart device installed with a software application to compute Tc of the user and display the computed Tc and/or the measured physiological data of the user (Paragraph [0104] - For example, temperature measurements, alerts, physiologic, and diagnostic information generated by the processor 1910 can be presented on a display 1925 of a device (e.g., smartphone)).
Regarding Claim 13, Cross et. al.’155 in view of Mark Buller’811 discloses the system outlined in Claim 1 above. Additionally, Cross et. al.’155 discloses wherein the physiological data of the user are measured repeatedly according to a pre-defined time interval so that Tc of the user can be monitored continuously (Paragraph [0098] - For example, the processor 1810 can be configured to compute the following temperature measurements…a magnitude of variation in core body temperature over any specified time interval within or up to one day (diurnal, nocturnal)).
Regarding Claim 17, Cross et. al.’155 discloses a method for continuous monitoring of core body temperature (Tc) of a user (Paragraph [0098] - For example, the processor 1810 can be configured to compute the following temperature measurements: absolute core body temperature continuously), the method comprising:
measuring physiological data of the user by a plurality of sensors installed at a detection unit to be worn in the user's ear wherein the physiological data to be measured comprise first auditory canal temperature (Tac1), second auditory canal temperature (Tac2), external auricle temperature (Tea) and heart rate (HR) of the user (Paragraph [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, rather than radiative heat; Paragraph [0172] - Embodiments can be used to measure temperature and time of onset of a physiological change due to response to drugs or other chemicals that illicit an autonomic or endocrine response in the form of a skin or core body temperature change, physiological response due to stress or other emotions, physical activity, and a pre-determined amount of heart rate change. Embodiments can be used to measure the difference in temperature or time of occurrence for any of the above);
sending the measured physiological data to an analysis unit connected to the detection unit via a communication link (Paragraph [0099] - The processor 1810 can communicate temperature measurements and related alerts in various ways (e.g., via a wireless or wired communication link));
computing Tc of the user by the analysis unit with a prediction model using the physiological data measured by the detection unit where the effect of external environmental temperature on auditory canal temperature of the user is taken into account (Paragraph [0089] - Temperature can be measured at or near Location 2 and the faceplate over a range of environmental temperatures in order to derive the heat balance equation; Paragraph [0098] - For example, 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; Paragraph [0172] - Embodiments can be used to measure temperature and time of onset of a physiological change due to response to drugs or other chemicals that illicit an autonomic or endocrine response in the form of a skin or core body temperature change, physiological response due to stress or other emotions, physical activity, and a pre-determined amount of heart rate change. Embodiments can be used to measure the difference in temperature or time of occurrence for any of the above);
determining an over-heating state when the computed Tc of the user is above a threshold level (Paragraph [0098] - For example, 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); and
generating a warning signal to alert the user when the over-heating state is determined (Paragraph [0098] - A signal indicative of the absolute core body temperature 1830 is provided at an output 1818 of the processor 1810. The processor 1810 may be configured to generate one or more alerts based on a comparison between temperature measurements and one or more thresholds).
Cross et. al.’155 fails to explicitly disclose computing Tc of the user with a prediction model using the physiological data measured by the detection unit where the effect of heart rate is taken into account. Mark Buller’811 teaches using heart rate to estimate core body temperature (Paragraph [0007] - Heart rate is a convenient observation of the expected core body temperature at steady state or a leading indicator of core body temperature as it contains information about both heat production (through the Fick (1855) equation and VO.sub.2) and heat transfer since heart rate is related to skin profusion). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cross et. al.’155 to include the effects of heart rate when calculating a core body temperature of a user since heart rate has been shown to provide accurate core body temperature estimations in previous studies as seen in Mark Buller’811 (Paragraph [0006] - use heart rate with ambient temperature modifiers to account for skin blood flow (Yokota et al 2008). This real-time model provided accurate group-mean core body temperature estimates in a number of different environmental and clothing conditions).
Regarding Claim 18, Cross et. al.’155 in view of Mark Buller’811 discloses the system outlined in Claim 17 above. Additionally, Cross et. al.’155 discloses displaying the computed Tc and/or the measured physiological data on the analysis unit (Paragraph [0209] - displaying at least the absolute body core temperature on a display of the diagnostic instrument); and
storing the computed Tc and/or the measured physiological data in the analysis unit (Paragraph [0175] - Embodiments can be used to store a cumulative moving average, or exponential moving average of core temperature with varying window sizes).
Regarding Claim 20, Cross et. al.’155 in view of Mark Buller’811 discloses the system outlined in Claim 17 above. Additionally, Cross et. al.’155 discloses wherein the step of measuring the physiological data of the user is repeated according to a pre-defined time interval so that Tc of the user can be monitored continuously (Paragraph [0098] - For example, the processor 1810 can be configured to compute the following temperature measurements: absolute core body temperature continuously).
Claims 2-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cross et. al.'155 (U.S. Patent Application 20190117155) in view of Mark Buller’811 (U.S. Patent Application 20170238811) as applied to Claim 1 above, and further in view of Zhang et. al.'661 (WO Patent Publication 2017015661).
Regarding Claim 2, Cross et. al.’155 in view of Mark Buller’811 discloses the system outlined in Claim 1 above. Additionally, Cross et. al.’155 discloses wherein the plurality of sensors comprising: a first temperature sensor for measuring the Tac1; a second temperature sensor for measuring the Tac2; a third temperature sensor for measuring the Tea (Paragraph [0064] - According to various embodiments, a productized implementation of the ear-worn device 400 includes at least one temperature sensor at site 2 for measuring temperature at Location 2 of the ear canal. In some embodiments, in addition to a temperature sensor at site 2, the ear-worn device 400 includes one or more temperature sensors situated at one or more additional sites (e.g., site 7 or at the faceplate region 448)), but fails to disclose an optical sensor for measuring the HR. Zhang et. al.’661 teaches using an optical sensor to measure heart rate (Paragraph [0013] – Additional sensors (e.g., electrical sensors, optical sensors, etc.) may also be included for determining other non-temperature parameters such as heart rate). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cross et. al.’155 in view of Mark Buller’811 to include optical sensors as a way to monitor and measure heart rate as seen in Zhang et. al.’661. Cross et. al.’155 recites generic sensors to monitor heart rate and the act of merely choosing a type of sensor, such as an optical sensor, would fall within a finite number of identified, predictable solutions, with a reasonable expectation of success for those of ordinary skill in the art as “obvious to try”.
Regarding Claim 3, Cross et. al.’155 in view of Mark Buller’811 and further in view of Zhang et. al.'661 discloses the system outlined in Claim 2 above. Additionally, Cross et. al.’155 discloses wherein the detection unit comprising: an earbud to fit to the user's ear (Paragraph [0084] - thermistors mounted directly to the receiver of a standard earbud hearing device); a second extension member extends from the earbud and in contact with the concha part of the user's ear wherein the third temperature sensor is installed at the second extension member for measuring the Tea (Paragraph [0142] - Locations 1 and 2 are located in the posterior and anterior sides of the ear canal while location 7 is located inside the tragus. Locations 4 and 5 are adjacent to the posterior concha and location 6 is located adjacent to the cymba concha); and a control module for receiving and sending the measured physiological data to the analysis unit, and alerting the user when the over-heating state is detected (Paragraph [0098] - A signal indicative of the absolute core body temperature 1830 is provided at an output 1818 of the processor 1810. The processor 1810 may be configured to generate one or more alerts based on a comparison between temperature measurements and one or more thresholds). Cross et. al.’155 fails to disclose a first extension member extends from the earbud for insertion into auditory canal of the user's ear wherein the first temperature sensor, the second temperature sensor and the optical sensor are installed at the first extension member for measuring the Tac1, Tac2 and HR respectively. Zhang et. al.’661 teaches temperature sensors and optical sensors disposed on a first extension member of an ear device (Figure 15; Paragraph [0175] - As illustrated in FIG. 15 and in some variations discussed above, temperature measurement may be achieved by forming a sealed environment in the ear canal and using a thermistor or other type of temperature sensors 1521 to continuously measure the heat radiated by the blood vessel and organs in the inner ear. Heart rate, breathing rhythm, blood oxygen level, blood pressure measurement 1525 may be achieved by using an optical sensor or other types of sensors which consists of several light emitting diodes with different wavelength and a receiver). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cross et. al.’155 in view of Mark Buller’811 to include temperature and optical sensors within a first extension member as a way to monitor and measure heart rate and temperature without ambient air affecting or blocking the readings as seen in Zhang et. al.’661 (Paragraph [0020] - This seal may plug or otherwise close the ear canal, allowing thermal equilibration of the ear canal where the temperature sensor is positioned. This may allow stable readings from temperature sensor (e.g., thermistor)). Cross et. al.’155 recites generic sensors to monitor heart rate and the act of merely choosing a type of sensor, such as an optical sensor, would fall within a finite number of identified, predictable solutions, with a reasonable expectation of success for those of ordinary skill in the art as “obvious to try”.
Regarding Claim 4, Cross et. al.’155 in view of Mark Buller’811 and further in view of Zhang et. al.'661 discloses the system outlined in Claim 3. Additionally, Cross et. al.’155 discloses wherein the second extension member has an auricular hook structure to encircle around the back of the user's ear where the third temperature sensor is installed at a position in contact with the eminence of concha of the user's ear (Paragraph [0079] - In yet another aspect, the methods described in embodiments 1 and 3-9 above can be used to mount a thermistor in the ear-supported component of a behind-the-ear (BTE) or receiver-in-canal (RIC) device in order to obtain a measured temperature which can be used to derive a factor to compensate for changes in ear canal temperature measured via a thermistor mounted to a receiver/speaker due to changes in environmental temperature or draft).
Regarding Claim 5, Cross et. al.’155 in view of Mark Buller’811 and further in view of Zhang et. al.'661 discloses the system outlined in Claim 3. Additionally, Cross et. al.’155 discloses wherein the second extension member has an elongate structure extends to the cymba concha of the user's ear where the third temperature sensor is installed at a position in contact with the cymba concha (Paragraph [0142] - Locations 4 and 5 are adjacent to the posterior concha and location 6 is located adjacent to the cymba concha).
Regarding Claim 6, Cross et. al.’155 in view of Mark Buller’811 and further in view of Zhang et. al.'661 discloses the system outlined in Claim 3 above. Additionally, Cross et. al.’155 discloses wherein the detection unit further comprising: an elastic member for sealing the auditory canal thereby minimizing air exchange between the auditory canal and external environment (Paragraph [0132] - The thermistor leads were run through the battery door and the door was sealed with Room-Temperature-Vulcanization (Momentive RTV118) silicone to prevent a draft).
Regarding Claim 15, Cross et. al.’155 in view of Mark Buller’811 and further in view of Zhang et. al.'661 discloses the system outlined in Claim 2 above. Additionally, Cross et. al.’155 discloses wherein the first and second temperature sensors are thermocouple sensors (Paragraph [0066] - Other temperature sensors can be used in a temperature sensing device of the present disclosure, including thermocouples).
Regarding Claim 16, Cross et. al.’155 in view of Mark Buller’811 and further in view of Zhang et. al.'661 discloses the system outlined in Claim 2 above, but fails to disclose wherein the third temperature sensor is an infrared sensor. However, Cross et. al.’155 does disclose that an infrared (IR) sensor can be used to monitor environmental temperatures (Paragraph [0149] - Pompei and Pompei were able to obtain an environmental temperature from the handheld probe with an IR sensor). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cross et. al.’155 to include an IR sensor to measure environmental temperature as it would be obvious to try choosing from a finite number of identified, predictable solutions (the type of sensors that have been used in prior art), with a reasonable expectation of success.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cross et. al.'155 (U.S. Patent Application 20190117155) in view of Mark Buller’811 (U.S. Patent Application 20170238811) as applied to Claim 1 above, and further in view of Ellis et. al.'850 (U.S. Patent Application 20180242850).
Regarding Claim 9, Cross et. al.’155 in view of Mark Buller’811 discloses the system outlined in Claim 1 above. Additionally, Cross et. al.’155 discloses wherein the prediction model utilizes a machine learning algorithm to compute Tc of the user with an acceptable mean bias of less than ±0.27°C where the measured physiological data are used to derive a decision tree to predict Tc of the user (Paragraph [0155] - shows the results when the derived heat balance equation was applied to the data in order to calculate the core body temperature from the temperature obtained from the faceplate and Location 2 thermistors alone. All calculated core temperatures were well within +/−0.5° C. defined as acceptable to inform temperature as a health indicator and the limits-of-agreements (1.96σ) were calculated to be +/−0.27° C; Paragraph [0174] - A neural network or SVM (support vector machine) algorithm can be used to calculate the core and environmental temperatures and wind speed), but fails to disclose wherein the prediction model is a random forest prediction model. Ellis et. al.'850 teaches using a random forest prediction model and decision tree that utilizes machine learning to understand data (Paragraph [0061] - In examples, Block S130 and/or other portions of the method 100 (e.g., in relation to any suitable models) can employ machine learning approaches including any one or more of: supervised lea