DETAILED ACTION
Claims 1-20 are hereby the present claims under consideration
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 .
Claim Rejections - 35 USC § 112(b)
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 1 recites “a processor configured to determine a work status of the user indicative of an activity level of the user” but it is unclear what this determination entails. It is unclear what the inputs to the determination are, what the determination itself entails, and what the outputs of the determination are. It is unclear what the meets and bounds of “work status” and “activity level” are intended to encompass and how such metrics are determined. For the purposes of this examination, the limitation will be interpreted as any metric or measure related to a user’s movement, exertion, or other types of activity. This rejection is further applied to the similar limitations of claims 14 and 19
Claim 1 recites “determine a core body temperature of the user based on the ear canal temperature detected by the first temperature sensor, the ambient temperature detected by the second temperature sensor, and the work status of the user” but it is unclear what this determination entails. It is unclear how the recited inputs are being converted into the recited output. For the purposes of this examination, the limitation will be interpreted as any method of determining a core body temperature using the recited inputs. This rejection is further applied to the similar limitations of claims 14 and 19
Claims 2-13 are rejected by virtue of their dependence on claim 1.
Claims 15-18 are rejected by virtue of their dependence on claim 14.
Claim 20 is rejected by virtue of their dependence on claim 19.
Claim 2 recites “wherein the processor is further configured to determine the core body temperature of the user based on a heart rate of the user” but it is unclear what element of the system determines, generates, or otherwise obtains the heart rate of the user. It is further unclear how the heart rate of the user is utilized in the determination of the core temperature. It is further unclear if the limitation “determine the core body temperature of the user” is meant to be further limit the similar recitation of claim 1 or is meant to be a separate determination. For the purposes of this examination, the limitation will be interpreted as any use of a heart rate parameter in a core temperature determination.
Claim 10 recites “customized to fit” but it is unclear if this recitation is intended to convey some form of molding process to customize the device to a particular user or if any device which fits in the ear may be considered “customized to fit”. For the purposes of this examination, the limitation will be interpreted as “configured to fit” such that any device that fits in the ear is “customized” for such a purpose.
Claim 12 recites “determine a situation in which the first temperature sensor and the second temperature sensor are exposed to an equal temperature; and calibrate the first temperature sensor and the second temperature sensor relative to the equal temperature” but it is unclear what such a determination entails. It is unclear what factors are considered or what measurements taken by sensors would provide an indication that the first and second temperature sensors are exposed to an equal temperature. It is further unclear what the calibration operation entails. It is unclear what “calibrate the first temperature sensor and the second temperature sensor relative to the equal temperature” intends to convey. It is unclear what the calibrating the sensors relative to the equal temperature entails and how such an equal temperature is determined. For the purposes of this examination, the limitation will be interpreted as any calibration method applied to the sensors using a known temperature.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 13-14, and 19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a processor configured to determine a work status of the user indicative of an activity level of the user” but the specification does not recite the particular algorithm used to perform this determination. In particular, paragraphs 0027 and 0035 recite this limitation in purely functional language. The specification does not detail how the work status or activity level is calculated, from what parameters they may be calculated from, and further does not define the meets and bounds of these limitations. This rejection is further applied to claims 14 and 19.
Claim 13 recites “wherein the determining of the work status is based on information received from the motion sensor” paragraphs 0027 and 0035 recite this limitation is purely functional language. The specification does not describe the particular algorithm or processing steps utilized to convert the input motion data into the determined work status. The specification further does not define the meets and bound of work status.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-20 are directed to a method of processing temperature, activity, and heart rate signals using a computational algorithm, which is an abstract idea. Claims 1-20 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] determine a work status of the user indicative of an activity level of the user; and
[B1] determine a core body temperature of the user based on the ear canal temperature detected by the first temperature sensor, the ambient temperature detected by the second temperature sensor, and the work status of the user
These elements [A1]-[B1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] a first temperature sensor configured to detect an ear canal temperature within the ear canal
[B2] a second temperature sensor configured to detect ambient temperature outside of the ear canal
[C2] a processor
These elements [A2]-[C2] of claim 1 do not integrate the exception into a practical application of the exception. In particular the elements [A2]-[B2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [C2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations of [A2] and [B2] are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than a temperature sensor detecting temperature in the ear canal and the ambient environment. Such temperature sensors are conventional as evidenced by Applicant’s lack of a particular description as to their structure and method of operation and further evidenced by:
U.S. Patent Application Publication No. US 2022/0157452 A1 (Kreuzer) discloses that various types of temperature sensors including infrared and contact temperature sensors as well as heart rate sensors are known in the art and can all be miniaturized and arranged in a conventional hearing aid (paragraph 0011 of Kreuzer )
Further, the element [C2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-13 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 4: a flow temperature sensor, in infrared (IR) thermometer, or a contact temperature sensor;
Claim 5: an infrared (IR) thermometer; and
Claim 5: a hollow core optical waveguide.
Claim 6: the hollow core optical fiber has a funnel shape
Claim 7: the hollow core optical fiber has a tube shape
Claim 8: the housing having a faceplate that is configured to face outside of the ear canal when the hearing device is worn by the user; and the second temperature sensor is positioned on the faceplate
Claim 9: a behind the ear (BTE) component; wherein the second temperature sensor is positioned on the BTE component
Claim 10: wherein the hearing device is customized to at least partially fit within the ear canal of the user
Claim 13: a motion sensor
Each of these claim limitations does not integrate the exception into a practical application. In particular, the elements of claims 4-5 and 13 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the elements of claims 6-7 impart only well-known structural configurations of a conventional infrared sensor. Additionally claims 8-10 impart only conventional construction limitation to the hearing device and associated temperature sensor. Furthermore the element of claim 10 merely adds the words “apply it” (or an equivalent) with the judicial exception. The element of claim 10 merely states that the hearing device fits in the ear which is typical for the construction of hearing devices
Each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. Each of the above elements may be considered well-known, routine, and/or conventional due to Applicant’s lack of a particular description within the specification regarding their respective structure and mode of operation. These elements are further considered well-known, routine, and/or conventional as evidenced by:
Claims 4-7:
U.S. Patent Application Publication No. US 2004/0057494 A1 (Tsao) discloses that infrared radiation thermometers including hollow tube-shaped waveguides for determining temperature from the ear are known in the art (Paragraph 0012, Fig. 1)
US Patent Number US 5368038 A hereinafter Fraden teaches that field of view of a sensor may be determined by the shape of its associated waveguide (Col 3 lines 6-8). Fraden teaches that the field of view of the infrared sensor can be customized by altering the shape of the end of the optical waveguide to suit the desired use. This optimization may include forming the end of the waveguide into a cone to condense light from a wider field of view (Col 6 lines 33-40; Col 6 line 67- Col 7 line 15; Figs. 5-10). The teachings of Fraden are considered well-known in the art as they rely upon universal principles of light refraction. Such principles are used for similar purposes in:
US Patent Number US 9055924 B2 (Roth) teaches the use of a parabolic infrared condenser (Fig. 1 reference 120; Col 4 line 52- Col 5 line 27);
US Patent Number US 9357930 B2 (Quinn) teaches that the optical waveguide may have a variety of shaped including conical. The shape of the inner wall of the waveguide assists in altering the field of view and focusing the radiation as it enters the tip (Col 7 lines 10-40; Figs. 6-9)
US Patent Application Publication Number US 2017/0211993 A1 (Larson) teaches that the shape of the end of the waveguide may be optimized to change the acceptable angle of incidence, or field of view, of the entering light (Paragraphs 0032-0033; Figs. 4-7)
Thus, the construction of the hollow optical waveguide as claimed in claims 6-7 is considered well-known, routine, and/or conventional in light of known principles of light reflection and the numerous uses of such a construction in the art.
Claims 8-10:
US Patent Application Publication Number US 2022/0142575 A1 (Cosinuss) teaches that behind the ear hearing aids are conventional (Paragraph 0033)
US Patent Application Publication Number US 2019/0117155 A1 (Cross) teaches that various form factors for ear-worn devices including hearing aids are typical. Such form factors include behind the ear style devices and earbuds. Such devices typically include a variety of components (Paragraph 0115)
US Patent Application Publication Number US 2013/0296731 A1 (Kidmose) teaches that behind the ear style device such as hearing aids are well known (Paragraph 0060)
US Patent Application Publication Number US 2017/0078785 A1 (Qian) teaches that earbuds are conventional and may be instrumented with various physiological sensors (Paragraph 0032)
US Patent Application Publication Number US 2017/0119314 A1 (Just) teaches that earbud devices which measure physiological parameters are conventional (Paragraph 0006)
U.S. Patent Application Publication No. US 2009/0198112 A1 (Park) teaches that environmental temperature sensors are well-known (Paragraph 0044);
U.S. Patent Application Publication No. US 2021/0290102 A1 (Burwinkle) teaches that ear-worn deices are typical and such devices typically include an enclosure such as a housing or shell and that the internal components of the hearing device are typically disposed within or on the shell. Typical Hearing devices may further include sensors such as motion sensors (Paragraph 0038)
Thus, the particular form factor and placements of the temperature sensors are considered well-known, routine, and conventional as the various form factors of hearing devices are well known and the use of environmental temperature sensors is well known and the positioning of internal components on the shell of hearing device is typical. Instrumented hearing devices are considered well-known.
Claim 13
U.S. Patent Application Publication No. US 2021/0290102 A1 (Burwinkle) teaches that ear-worn deices are typical and such devices typically include an enclosure such as a housing or shell and that the internal components of the hearing device are typically disposed within or on the shell. Typical Hearing devices may further include sensors such as motion sensors (Paragraph 0038)
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the sensors are nothing more than a temperature sensor detecting temperature in the ear canal and in the ambient environment and motion sensors for detecting movement of the device. Such sensors are conventional as evidenced above.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 14 and 19 recites substantially the same abstract idea as claim 1 and are rejected on the same basis as claim 1.
Claims 14 and 19 recite only additional elements already addressed in the above rejection of claims 1-13 with the exception of:
[A2] a core body temperature processing system of claim 19
These element does not integrate the exception into a practical application of the exception. The element [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Claims 15-18 and 20 depend from claims 14 and 19 respectively, and recite the same abstract idea as claims 14 and 19. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claims 15-16: an external device including a processor
Claim 17: an additional hearing device
Claim 20: a heart rate sensor
Each of these claim limitations do not integrate the exception into a practical application. In particular, the element of claim 20 is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the elements of claim 15-16 are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Additionally, the element of claim 17 is a mere duplication of the elements of claims 1, 14, and/or 19 and does not qualify as significantly more for the same reasons presented above with respect to the corresponding elements in claim 1.
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the heart rate sensor is a generic heart rate sensor for determining a pulse rate which is well-known as evidenced by Applicant’s lack of a particular description regarding the sensors structure and method of operation and further in view of Kreuzer (as provided above with respect to the rejection of claim 1).
Also, the limitations from claims 15-16 are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of processing and communication with sensors) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
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)(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 1-2, 8-10, 13-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Larsen US Patent Application Publication Number US 2019/0373377 A1 hereinafter Larsen
Regarding claim 1, Larsen teaches a hearing device configured to be at least partially inserted into an ear canal of a user (Abstract; Paragraph 0009: the housing configured to be positioned at least partially in the ear canal of the user), the hearing device comprising:
a first temperature sensor configured to detect an ear canal temperature within the ear canal (Paragraphs 0007, 0019, and 0048-0049: the temperature sensor in the in the ear part of the device is arranged in the ear canal and measured temperature in the ear canal);
a second temperature sensor configured to detect ambient temperature outside of the ear canal (Paragraphs 0019, 0048, and 0059: the reference temperature sensor included in the behind the ear portion and/or on the faceplate of the in the ear style devices); and
a processor (Paragraph 0048: a temperature processor) configured to:
determine a work status of the user indicative of an activity level of the user (Paragraphs 0017 and 0024: the motion sensor provides indication of movement, or a work status, based on the measured motion, or activity level, of the user); and
determine a core body temperature of the user based on the ear canal temperature detected by the first temperature sensor, the ambient temperature detected by the second temperature sensor, and the work status of the user (Paragraphs 0048-0049: the core body temperature is estimated based on the temperature from the sensors inside the ear canal and the reference temperature sensors outside the ear canal; Paragraphs 0017 and 0024: movement may also be considered in the temperature calculation).
Regarding claim 2, Larsen discloses the hearing device of claim 1. Larsen further discloses the hearing device wherein the processor is further configured to determine the core body temperature of the user based on a heart rate of the user (Paragraphs 0048 and 0061-0063: the hearing aid can include additional sensors to determine parameters such as heart rate and may further include these additional measurements in the algorithm to improve accuracy of core body temperature calculation).
Regarding claim 8, Larsen discloses the hearing device of claim 1. Larsen further discloses the hearing device wherein: the hearing device further includes a housing having a faceplate that is configured to face outside of the ear canal when the hearing device is worn by the user; and the second temperature sensor is positioned on the faceplate (Paragraph 0059: the device may be an in-the-ear (ITE) style device and the ambient temperature sensor may be arranged on the faceplate of the device).
Regarding claim 9, Larsen discloses the hearing device of claim 1. Larsen further discloses the hearing device, further comprising a behind-the-ear (BTE) component, wherein the second temperature sensor is positioned on the BTE component (Paragraphs 0048 and 0052).
Regarding claim 10, Larsen discloses the hearing device of claim 1. Larsen further discloses the hearing device, wherein the hearing device is customized to fit at least partially within the ear canal of the user (Paragraphs 0048-0049 and 0059: the hearing device is configured to fit at least partially in the ear canal and is thus considered “customized” to fit at least partially in the ear canal of the user).
Regarding claim 13, Larsen discloses the hearing device of claim 1. Larsen further discloses the hearing device further comprising a motion sensor, wherein the determining of the work status is based on information received from the motion sensor (Paragraphs 0017 and 0024: the motion sensor provides indication of movement, or a work status, based on the measured motion, or activity level, of the user).
Regarding claim 14, Larsen discloses a system (Abstract; Paragraph 0016: the hearing device and external device) comprising:
a hearing device configured to be at least partially inserted into an ear canal of a user (Abstract; Paragraph 0009: the housing configured to be positioned at least partially in the ear canal of the user), the hearing device comprising:
a first temperature sensor configured to detect ear canal temperature within the ear canal (Paragraphs 0007, 0019, and 0048-0049: the temperature sensor in the in the ear part of the device is arranged in the ear canal and measured temperature in the ear canal); and
a second temperature sensor configured to detect ambient temperature outside of the ear canal (Paragraphs 0019, 0048, and 0059: the reference temperature sensor included in the behind the ear portion and/or on the faceplate of the in the ear style devices); and
a processor (Paragraph 0048: a temperature processor) configured to:
determine a work status of the user indicative of an activity level of the user (Paragraphs 0017 and 0024: the motion sensor provides indication of movement, or a work status, based on the measured motion, or activity level, of the user); and
determine a core body temperature value of the user based on the ear canal temperature detected by the first temperature sensor, the ambient temperature detected by the second temperature sensor, and the work status of the user (Paragraphs 0048-0049: the core body temperature is estimated based on the temperature from the sensors inside the ear canal and the reference temperature sensors outside the ear canal; Paragraphs 0017 and 0024: movement may also be considered in the temperature calculation).
Regarding claim 15, Larsen discloses the system of claim 14. Larsen further discloses the system further comprising an external device that is communicatively coupled with the hearing device and is configured to present information associated with the core body temperature to the user (Paragraphs 0014 and 0016: the external device in wired or wireless communication with the temperature processor with a user interface for providing the user with health related information; the external device may be a smartphone).
Regarding claim 16, Larsen discloses the system of claim 15. Larsen further discloses the system wherein the processor is included in the external device that is communicatively coupled with the hearing device (Paragraphs 0016 and 0063: the processing requirements of the system may be offloaded to another device such as a smartphone to improve battery life).
Regarding claim 17, Larsen discloses the system of claim 14. Larsen further discloses the system further comprising an additional hearing device (Paragraph 0015: hearing aids positioned at opposite ears of a user; Paragraph 0026: two hearing aids may be used with similar sensors arranged in each; Paragraph 0040: the system includes two hearing devices; Paragraph 0062: having two independent sensor systems, one in each ear, to improve accuracy) configured to be at least partially inserted into an additional ear canal of a user, the additional hearing device comprising: a third temperature sensor configured to detect ear canal temperature within the additional ear canal; and a fourth temperature sensor configured to detect ambient temperature outside of the additional ear canal, wherein the processor is further configured to determine an additional value of the work status of the user indicative of an activity level of the user, and to determine an additional core body temperature value of the user based on the ear canal temperature detected by the third temperature sensor, the ambient temperature detected by the fourth temperature sensor, and the additional value of the work status (Paragraphs 0015, 0026, 0040, and 0062: the system may include two hearing devices with similar components and operation. The claimed additional hearing aid is rejected in the same manner as the hearing aid of claim 14 since it includes the same components and Larsen teaches a system with two similar devices. The additional hearing aid is further a mere duplication of parts).
Regarding claim 18, Larsen discloses the system of claim 17. Larsen further discloses the system wherein the processor is further configured to determine a core body temperature of the user based on the core body temperature value and the additional core body temperature value (Paragraph 0062: the two independent sensor systems may be considered together to improve accuracy).
Regarding claim 19, Larsen discloses a method (Abstract) comprising:
obtaining, by a core body temperature processing system (Paragraph 0048: a temperature processor), a first temperature reading from a first temperature sensor provided in a hearing device and configured to detect ear canal temperature within an ear canal of a user of the hearing device (Paragraphs 0007, 0019, and 0048-0049: the temperature sensor in the in the ear part of the device is arranged in the ear canal and measured temperature in the ear canal);
obtaining, by the core body temperature processing system (Paragraph 0048: a temperature processor), a second temperature reading from a second temperature sensor configured to detect ambient temperature outside of the ear canal (Paragraphs 0019, 0048, and 0059: the reference temperature sensor included in the behind the ear portion and/or on the faceplate of the in the ear style devices);
obtaining, by the core body temperature processing system (Paragraph 0048: a temperature processor), a work status of the user indicative of an activity level of the user (Paragraphs 0017 and 0024: the motion sensor provides indication of movement, or a work status, based on the measured motion, or activity level, of the user); and
determining, by the core body temperature processing system (Paragraph 0048: a temperature processor), a core body temperature of the user based on the first temperature reading, the second temperature reading, and the work status of the user (Paragraphs 0048-0049: the core body temperature is estimated based on the temperature from the sensors inside the ear canal and the reference temperature sensors outside the ear canal; Paragraphs 0017 and 0024: movement may also be considered in the temperature calculation).
Regarding claim 20, Larsen discloses the method of claim 19. Larsen further discloses the method, further comprising obtaining, by the core body temperature processing system, a heart rate of the user, wherein the core body temperature of the user is further determined based on the heart rate of the user (Paragraphs 0048 and 0061-0063: the hearing aid can include additional sensors to determine parameters such as heart rate and may further include these additional measurements in the algorithm to improve accuracy of core body temperature calculation).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen US Patent Application Publication Number US 2019/0373377 A1 hereinafter Larsen as applied to claim 1 above and further in view of Honeywell US Patent Application Publication Number US 2017/0211993 A1 hereinafter Honeywell.
Regarding claim 3-5, Larsen discloses the hearing device of claim 1. Larsen fails to further disclose the hearing device wherein the determining of the core body temperature includes using a linear regression model to estimate the core body temperature; wherein the first temperature sensor is a flow temperature sensor, an infrared (IR) thermometer, or a contact temperature sensor; wherein: the first temperature sensor is an infrared (IR) thermometer; and the hearing device further includes a housing a having a hollow core optical waveguide configured to enhance coupling efficiency of IR radiation from tissue in the ear canal to the IR thermometer.
Honeywell teaches an apparatus for measuring body core temperature includes a light guide with an internally reflective tube. The light guide is coupled to an earpiece (Abstract). Thus, Honeywell falls within the same field of endeavor as Applicant’s invention.
Honeywell teaches a system for determining core body temperature that utilizes infrared sensors that detect infrared radiation from an infrared source. The device includes a light guide which can be a hollow tube which connects the infrared sensor to the infrared source (Paragraph 0028). The light guide allows the thermopile to be located outside of the ear canal and thus the thermopile is able to be larger with a higher sensitivity than would otherwise be possible if it was located within the ear canal (Paragraph 0015). Honeywell further teaches that linear regression analysis may be used to determine an equation for determining core body temperature from the measured infrared radiation (Paragraph 0024).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the infrared sensor with hollow core optical waveguide and linear regression analysis taught by Honeywell into the device of Larsen because the use of an infrared thermal sensor is a simple substitution of one known element (the temperature sensor of Larson) with another known element (the temperature sensor of Honeywell) with no surprising technical effect. Additionally, the incorporation of the hollow optical waveguide of Honeywell allows the device of modified Larsen to utilize a larger and more sensitive thermopile for infrared sensing as taught by Honeywell (Paragraph 0015). Finally, the use of linear regression analysis to determine the core body temperature is a simple substitution of one known element (the calculation method of Larsen) for another known element (the calculation method of Honeywell) with no surprising technical effect.
Regarding claims 6-7 Larsen in view of Honeywell teaches the hearing device of claim 5. Modified Larsen fails to further disclose the hearing device wherein the hollow core optical waveguide has a funnel shape or a tube shape.
Honeywell teaches that the end of light guide that interrogates the infrared source may have a variety of shapes. The shapes include a flared, or funnel, shape. Honeywell teaches that the particular shape and dimensions of the light guide are a matter of routine optimization and experimentation to best fit the light guide for the particular use case since the size, shape, and reflectivity of the light guide can be altered to change the acceptable angle of incidence of reflected light which alters the thermopiles field of view (Paragraphs 0032-0034; Figs. 4-7). The light guide may further be a tube (Paragraph 0028).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the variable shape of the light guide as taught by Honeywell into the device of modified Larsen because Honeywell teaches that the shape and other factors of the hollow light guide may be optimized for the particular use case of the light guide and may be optimized to increase or decrease the desired field of view of the infrared sensor.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Larsen US Patent Application Publication Number US 2019/0373377 A1 hereinafter Larsen as applied to claim 1 above and further in view of LeBoeuf US Patent Application Publication Number US 2008/0146890 A1 hereinafter LeBoeuf.
Regarding claim 11, Larsen discloses the hearing device of claim 1. Larsen fails to further disclose the hearing device wherein the processor is further configured to direct the hearing device to provide an audio notification that informs the user of the core body temperature.
Larsen discloses that the device may be connected to an external device with a user interface to provide the user with health related information including the estimated core body temperature (Paragraph 0016).
LeBoeuf teaches a wearable apparatus for monitoring various physiological and environmental factors (Abstract). Thus, LeBoeuf falls within the same field of endeavor as Applicant’s invention.
LeBoeuf teaches an earpiece module which serves a biofeedback system for alerting the user. The alerts may be generated if the user is meeting their physiological targets or exceeding safe limits including core body temperature. The feedback may also be used to present processed vital signs collected from the sensors audibly to the user (Paragraph 0078-0079).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of Larsen to be able to provide feedback through audio or other means through the in-ear hearing device in addition to the user interface of the external device because such feedback may allow the system to be more user friendly and accommodate a wider variety of user types who may be unable to interpret a visual display or may simply prefer an audio output.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Larsen US Patent Application Publication Number US 2019/0373377 A1 hereinafter Larsen as applied to claim 1 above and further in view of Elbadry US Patent Application Publication Number US 2019/0358387 A1 hereinafter Elbadry.
Regarding claim 12, Larsen discloses the hearing device of claim 1. Larsen fails to further disclose the hearing device wherein the processor is further configured to: determine a situation in which the first temperature sensor and the second temperature sensor are exposed to an equal temperature; and calibrate the first temperature sensor and the second temperature sensor relative to the equal temperature.
Elbadry teaches a patient monitoring system having one or more sensors (Abstract). Thus, Elbadry is reasonably pertinent to the problem at hand.
Elbadry teaches the use of a docking station with a medical device wherein the docking station may charge, sterilize, and/or perform calibration processes for the medical device. Elbadry teaches that the calibration processes may include calibrating temperature sensors of the device while it is docked in the docking station using a fluid of known temperature (Paragraph 0110). It is further noted that while Elbadry is directed towards catheter system which utilize fluids, the teachings of using a docking station to calibrate, sterilize, and charge a medical device is applicable to any form medical device.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement docking station which calibrates sensors while the device is charging as taught by Elbadry into the device of Larsen in order to charge the hearing devices and perform calibration operations on its sensors because the docking station may allow the system to recalibrate and adjust for drift frequently since the station may be a known temperature itself and contain air of a known temperature which provides the sensors of the device with a known value to perform calibrations against and may improve accuracy of the device when in use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication Number US 20220014834 A1 (Au) teaches an ITE hearing instrumentality, for use in an ear canal, that includes a housing, a receiver located within the housing, an earpiece on the housing that is configured to mount the housing within the ear canal, and at least one biometric sensor on the earpiece (Abstract)
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791