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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/18/2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 04/18/2025 (“Amendment”). Claims 1, 6, 7, 10-12, 14, 16, and 21-30 are currently under consideration. The Office acknowledges the amendment to claims 1, 11, 12, 14, 16, 24, 25, 29, and 30.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 14, and 16 are objected to because of the following informalities:
Regarding claims 1, 14, and 16, the recitations of “to determine patient’s core body” should instead read –to determine a patient’s core body--.
Further regarding claim 14, the recitation of “includes integrated first sensor and second sensor” should instead read –includes an integrated first sensor and second sensor--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 6, 7, 10-12, 14, 16, and 21-30 are 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.
Regarding claims 1, 14, and 16, there is no support for the reusable electronic module including a memory and at least one processor. Instead, the specification says that the processor 104 is a reusable module. Fig. 1 shows that this processor is distinct from the memory 106.
Claims 6, 7, 10-12, and 21-30 are rejected because they depend on rejected claims.
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 14 and 21-25 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.
Regarding claim 14, there is insufficient antecedent basis for the recitation of “the adaptive filter,” since the element has been deleted in line 8.
Claims 21-25 are rejected because they depend on rejected 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, 6, 7, 10-12, 14, 16, and 21-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1, 6, 7, and 10-12 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process. Claims 14, 16, and 21-30 are directed to a “wireless sensor device” (or “system”) and a “non-transitory computer readable medium,” which describe one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1, 14, and 16 recite (“set forth” or “describe”) the abstract idea of a mental process, substantially as follows:
continuously determining a core body thermal exchange at the skin surface on the patient body by subtracting the adaptive filter output from the first temperature value; continuously determining the patient body temperature by using the core body thermal exchange; controlling an absolute amplitude level of the core body thermal exchange, wherein the controlling includes subtracting an AC offset and adding a DC calibration value to transform the core body thermal exchange to an absolute scale, wherein the core body thermal exchange includes at least one of: in a case of a first calibration, the AC offset is the value of the core body thermal exchange at a temperature sensor settling period, or in a case of a recalibration, the AC offset is the value of the core body thermal exchange at a time of a recalibration request.
The determining and controlling steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of e.g. the first and second temperature values, they would be able to make thermal exchange calculations therefrom, and would also be able to perform the “controlling,” since that is merely addition and subtraction. There is nothing to suggest an undue level of complexity in the calculations. Therefore, a person would be able to perform the calculations mentally or with pen and paper.
Prong Two: Claims 1, 14, and 16 do not include additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. an electronic module including a memory and a processor, or a system-on-chip board, a non-transitory computer-readable medium, an adaptive filter), and
add insignificant extra-solution activity (the pre-solution activity of: measuring first and second temperature values, using generic data-gathering components (e.g. a single biometric patch biosensor including first and second sensors - recited at a high level of generality), and adaptively filtering the temperature values, using a generic data-processing component (e.g. an adaptive filter with updating filter coefficients to minimize error e)); the post-solution activity of: outputting and displaying a patient temperature, using generic data-output components (e.g. a display screen)).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The outputting or displaying of the calculated body temperature (i.e., the outputting of the result of the abstract idea) is considered mere post-solution activity because the calculation is not seen as e.g. an improvement to the technology and the displayed information need not be seen or acted on in any way. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 14, and 16 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g. because there is no improvement, the data-gathering and outputting are considered mere pre- and post-solution activity.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. subtracting a filter output (claims 10, 23, and 28), providing values to flags (claims 6, 7, 21, 22, 26, and 27), not outputting (or not changing output) until calibration has been performed and/or temperature has settled (claims 11, 12, 24, 25, 29, and 30), etc.).
At Step 2B, the claims are ineligible for the same reasons as described above. E.g., the additional calculations can still be performed in the human mind or else are a part of the pre-solution activity, and the filter and display structure are not detailed enough to be considered a “particular machine.”
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way (e.g. the display is again seen as extra-solution activity because the calculation result is not shown to be an improvement to the technology, and the output need not be acted on or even seen). They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 6, 7, 10-12, 14, 16, and 21-30, are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2011/0158284 (“Goto”) in view of US Patent 10,134,378 (“Empatica”), US Patent Application Publication 2012/0029308 (“Paquet”), and International Patent Application Publication WO 2013/093485 (“Sequoia”).
Regarding claim 1, Goto teaches a method to determine patient’s core body temperature continuously (para [0019]- The temperature distribution of the body surface beneath the thermometer is measured; ¶¶s 0136-0138 - continuous) using a single biometric patch biosensor (Figs. 2 and 3, ¶¶s 0056, 0104-0106, etc. - an electronic thermometer attached to the body) including a first sensor (see Fig. 2, element 20A), a second sensor (see Fig. 2, element 24A), …,and wherein the first sensor and the second sensor are integrated in the single biometric patch biosensor that is attachable to the patient’s skin (as shown in Fig. 2), the method comprising: measuring, by the first sensor (as above), a first temperature value (Tb1) at a skin surface on a patient body (para [0059]- The temperature measuring part 14A includes a body surface sensor 20A as first body surface temperature measurement portion to measure the temperature of the body surface 4A as a first body surface temperature); measuring, by the second sensor (as above), a second temperature value (Tb2) of ambient air surrounding the first sensor (para [0059]- an intermediate sensor 24A as first reference temperature measurement portion (intermediate temperature measurement portion) to measure the temperature of a surface boundary 22A between the heat insulating part 18 and the first heat radiation control part 18A as a first reference temperature; para [0078]- Furthermore, the presence of the first heat radiation control part 18A having the thermal resistance value Ru1 between the open air and the surface boundary 22A of the temperature measuring part 14A causes the temperature to decrease, and the heat release ... at the ambient temperature contact part also causes a further decrease in temperature, leading ultimately to an ambient temperature Tamb. para [0153]: reference temperature measurement portion is also not limited to intermediate temperature measurement portion for measuring an intermediate temperature, and may, for example, be open air temperature measurement portion for measuring the temperature of the open air - also see e.g. Fig. 5(B), showing the sensor at Tb2 as exposed to ambient air); …; continuously determining (¶¶s 0136-0138), by [a computing device] (Abstract, calculation portion – also see Fig. 1, control means 36 and calculation means 42), a core body thermal exchange at the skin surface on the patient body by subtracting [the second temperature value] from the first temperature value (see formula 1; para [0079]- In a steady state, the slope of the graph in FIG. 4 is constant because the thermal flux Q in each part is constant. At this time, if the first body surface temperature Tb1 and the first intermediate temperature Tb2 of the temperature measuring part 14A are known, the thermal flux Qu1 from the surface nearest the body surface sensor 20A of the temperature measuring part 14A to the surface boundary 22A can be calculated from the following formula (1) using the thermal resistance value Ru0); continuously determining (as above), by the [computing device] (as above), the patient’s core body temperature by using the core body thermal exchange (see formula 2; para [0080]- The thermal flux Qs+t in the portion where the surface layer part and the contact/thermal resistance part meet, i.e., the portion from the core of the human body 4 to the body surface 4A (in actual practice, the portion from the core to the contact surface 16A) is expressed by the following formula (2) using the core body temperature Tcore of the human body 4 and the thermal resistance Rs+Rt of the portion from the core of the human body 4 to the body surface 4A; see formula 5; para [0083]- In this case, the thermal resistance value Rs+Rt in the portion from the core of the human body 4 to the body surface 4A is an unknown value. Accordingly, if the second body surface temperature Tb3 and the second intermediate temperature Tb4 in the temperature measuring part 14B can be obtained from the body surface sensor 20B and the intermediate sensor 24B in the same manner as with the temperature measuring part 14A, the core body temperature Tcore will be expressed as in formula (5) below); controlling, by the [computing device] (as above), an absolute amplitude level of the core body thermal exchange (see formula 2; para [0080]- The thermal flux Qs+t in the portion where the surface layer part and the contact/thermal resistance part meet, i.e., the portion from the core of the human body 4 to the body surface 4A (in actual practice, the portion from the core to the contact surface 16A) is expressed by the following formula (2) using the core body temperature Tcore of the human body 4 and the thermal resistance Rs+Rt of the portion from the core of the human body 4 to the body surface 4A.; see formula 3; para [0081]- The thermal resistance value Rt of the contact/thermal resistance part thus varies with a variety of conditions, and it is therefore preferable for the thermal resistance value Rt of the contact/thermal resistance part in the present embodiment to be set so as to be minimized), wherein the controlling the absolute amplitude level of the core body thermal exchange includes subtracting an AC offset of the core body thermal exchange and adding a DC calibration value that transforms a time varying change of trend of the core body thermal exchange to an absolute scale (Goto: see formula 1; para [0079]- In a steady state, the slope of the graph in FIG. 4 is constant because the thermal flux Q in each part is constant. At this time, if the first body surface temperature Tb1 and the first intermediate temperature Tb2 of the temperature measuring part 14A are known, the thermal flux Qu1 from the surface nearest the body surface sensor 20A of the temperature measuring part 14A to the surface boundary 22A can be calculated from the following formula (1) using the thermal resistance value Ru0; para [0128]- The body surface temperatures Tb1, Tb3, Tb5, Tb6, Tb7 and the intermediate temperatures Tb2, Tb4 are thus measured each time the predetermined amount of time elapses, the body surface temperatures Tb1, Tb3 and the intermediate temperatures Tb2, Tb4 are corrected, and the core body temperature Tcore is calculated and stored in the memory part 38; para [0130]- (1) The first body surface temperature Tb1 and the first intermediate temperature Tb2 are obtained from the temperature measuring part 14A, and the second body surface temperature Tb3 and the second intermediate temperature Tb4 are obtained from the temperature measuring part 148. Also, the third body surface temperatures Tb5, Tb6, Tb7 are obtained from the temperature measuring part 14C, whereby the body surface temperatures Tb1, Tb3 and the intermediate temperatures Tb2, Tb4 are corrected by the temperature correction portion 40 on the basis of the third body surface temperatures Tb5, Tb6, Tb7. The core body temperature Tcore of the human body 4 can be calculated by the core body temperature calculation portion 42 from the first body surface temperature Tb1', the first intermediate temperature Tb2', the second body surface temperature Tb3', and the second intermediate temperature Tb4' corrected by the temperature correction portion 40; para [0131]- The temperature distribution of the body surface beneath the thermometer is measured, and the manner in which the temperature distribution within the body varies in comparison with an ideal case is determined. The measurement results are corrected on the basis of the amount of variation, allowing the core body temperature under ideal measurement conditions to be calculated. Specifically, the correct core body temperature can be measured; para [0132]- (2) The body surface temperatures Tb1, Tb3 and the intermediate temperatures Tb2, Tb4 in two types of temperature distribution (thermal flux) can be measured by using the two temperature measuring parts 14A, 14B whose overall thermal resistance values differ from each other. It is therefore possible to calculate the core body temperature Tcore solely from the measured value of the actual temperature. It is accordingly possible to calculate the core body temperature Tcore that corresponds to the actual temperature distribution to a greater degree than in a conventional case where the thermal resistance value Rs from the core of the human body to the surface layer is assumed to be, and set as, a fixed value. A more accurate core body temperature Tcore can thereby be obtained, and the measurement accuracy of the electronic thermometer 2 can be improved; see Fig. 18A-C; para [0114]- FIG. 18(A) shows the temperature distribution before correction, FIG. 18(B) shows the temperature distribution based on the corrective body surface sensors 20C, 20D, 20E for measuring the temperature distribution, and FIG. 18(C) shows the temperature distribution after correction; para [0115]- As shown in FIG. 18(A), the temperature distribution before correction affects the temperature distribution based on the corrective body surface sensors 20C, 20D, 20E for measuring the temperature distribution of FIG. 18(B), and a decrease (error) in temperature is generated by the movement of heat in the horizontal direction at points where the heat insulating part 18 changes from being present to not being present, or vice versa; para [0116]- The temperature distribution after correction is an ideal state of the temperature distribution because the errors are minimized, as shown in FIG. 18(C)), and wherein the core body thermal exchange includes at least one of: in a case of a first calibration, the AC offset is the value of the core body thermal exchange at a temperature sensor settling period (Goto: see formula 1; para [0079]- In a steady state, the slope of the graph in FIG. 4 is constant because the thermal flux Q in each part is constant. At this time, if the first body surface temperature Tb1 and the first intermediate temperature Tb2 of the temperature measuring part 14A are known, the thermal flux Qu1 from the surface nearest the body surface sensor 20A of the temperature measuring part 14A to the surface boundary 22A can be calculated from the following formula (1) using the thermal resistance value Ru0; see Fig. 19, steps S40, SSO, S60; para [0123]- The thermometer assembly 10 receives the temperature measurement initiation signal; drives the body surface sensors 20A, 20B, the corrective body surface sensors 20C, 20D, 20E, and the intermediate sensors 24A, 248; and measures the first body surface temperature Tb1, the second body surface temperature Tb3, and the third body surface temperatures Tb5, Tb6, Tb7 of the body surface 4A, as well as the first intermediate temperature Tb2 and the second intermediate temperature Tb4 at the surface boundaries 22A, 228 (step S50; first, second, and third temperature measuring steps). Temperature information about the body surface temperatures Tb1, Tb3, Tb5, Tb6, Tb7 and about the intermediate temperatures Tb2, Tb4 is converted from an analog signal to a digital signal by the AID converters 26A, 26B, 26C, and is transmitted to the display device 12 by the transceiver portion 28A, 288, 28C. The body surface temperatures Tb1, Tb3, Tb5, Tb6, Tb7, as well as the intermediate temperatures Tb2, Tb4, are preferably measured after a predetermined amount of time has passed, so that the transfer of heat from the core of the human body 4 to the body surface 4A will have reached a steady state (equilibrium state)), or in a case of a recalibration, the AC offset is the value of the core body thermal exchange at a time of a recalibration request (para [0149]- The surface-layer thermal resistance value Rs+Rt inherent to the human body 4 varies only slightly, allowing the previously calculated surface-layer thermal resistance value Rs+Rt to be used in a case where the electronic thermometer 2 is being used again. The time until body temperature measurement is initiated can therefore be reduced when measurement is performed the second or subsequent times. In this case, operating the operation part 34 allows a previously calculated surface-layer thermal resistance value Rs+Rt to be read out and reused if the surface-layer thermal resistance values Rs+Rt for a plurality of human bodies 4 are stored in the memory part 38. When the body temperature measurement step is performed in this case, the operation part 34 may be used to select a measurement object in order to specify the human body 4); outputting, by the [computing device] (as above), the patient’s core body temperature to a display screen (para [0069]- The display device 12 includes transceiver portion 28 for transmitting and receiving signals to and from the thermometer assembly 10, a display part 32 for displaying body temperature measurement results and the like); and displaying the patient’s core body temperature on the display screen (as above).
Goto does not appear to explicitly teach the single biometric patch biosensor including a reusable electronic module, wherein the reusable electronic module includes a memory and at least one processor, or a system-on-chip board, to perform claimed processing functions, passing the first temperature value through an adaptive filter by the electronic module to cancel ambient air temperature fluctuations from the first temperature value at the skin surface and produce an adaptive filter output, or the core body thermal exchange at the skin surface on the body being determined by subtracting the adaptive filter output from the first temperature value.
However, Empatica, in a method for adaptive noise reduction, teaches passing a signal source (Fig. 4, at primary input) through an adaptive filter (Fig. 4, adaptive noise canceller) to cancel noise influences on the signal source (Fig. 4, where the noise source is an input at both the primary input and the reference input), thereby producing an adaptive filter output (Fig. 4, system output). Empatica suggests wherein the core body thermal exchange at the skin surface on the body is determined by subtracting an adaptive filter output from the first temperature value (see Fig. 4, primary input, reference input, system output; [col 10, In 20]- The noise in the reference signal, arising from the noise source, is correlated in some known/unknown way with the source noise component. A filter ("Adaptive Filter") associated with an adaptive noise canceller (e.g., a combination of the filter module 126 and the processing module 128) generates an output y that is an estimate of the source noise component. The estimate of the source noise component is subtracted from the source signal within the adaptive noise canceller to generate an output z that is an estimate of the source component. Some aspect of the output z, such as an error e, is fed back to the adaptive filter for tuning the filter. This error e results in an updated output y that is then subtracted from the primary input (i.e., an output of the filter is subtracted from the primary input). Note that based on col. 3, lines 3-12, this can be applied to skin temperature data, with the noise source being the second temperature value (ambient temperature), thus cancelling ambient air temperature fluctuations). Empatica also teaches that its sensor may be integrated with a device comprising a memory and processor (Fig. 1, col. 3, lines 49-62).
Paquet teaches a reusable biometric patch sensor having an integrated memory and processor (Figs. 2A-2C, sensor 236, processor 202, memory 210 or 219, etc.).
It would have been obvious to one of ordinary skill in the art to make the processor and memory of Goto and Empatica part of the biosensor patch, as in Paquet, and as already contemplated by Empatica (Fig. 1, col. 3, lines 49-62), for the purpose of making the patch stand-alone and self-contained (Paquet: ¶¶s 0010, 0045, 0049, etc.). It would have been obvious to integrate the adaptive filter of Empatica with the system of Goto to enhance the accuracy of body temperature determination (see Empatica, [col 8, In 40]- sudden fluctuations in the source signal and/or the reference signal can be attenuated in the output signal by imposing a more gradual increase/decrease in state noise covariance).
Goto-Empatica-Paquet does not appear to explicitly teach wherein the adaptive filter output is subtracted from the second temperature value to produce an error e, and wherein the error e is fed to the adaptive filter to update filter coefficients to minimize the error e.
However, Sequoia teaches input values of the first temperature value f(n) and a reference second temperature value d(n) are passed through an adaptive filter to produce an adaptive filter output y(n) (see fig. 20; [pg. 11, In 3]- An example of the adaptive algorithm 300 overview is described in Fig 20, where the output of the compound sensor, u(n) 310 is filtered by a transversal filter 320, under the control 325 of an adaptive weight-control mechanism 330 that also takes the output of the compound sensor u(n) 310 as an input. The other input to the adaptive weight-control mechanism 330 is an error signal e(n) 360, derived from the output 340 of the transversal filter 320 being subtracted 350 from a desired response d(n) 370)). Sequoia further teaches updating filter coefficients by minimizing an error according to: e(n) = d(n)-y(n) (Sequoia: [pg.11, in 20]- The error signal for the weight control mechanism is e(n) = d(n) - filter output (i.e. a negative feedback loop), and the M-by-1 tap weight vector; [pg. 11, In 32]- The estimation of the error signal is then e(n) = d(n) - y(n)), wherein the d(n) is the reference ambient air temperature value and wherein the y(n) is the adaptive filter output (see Fig. 20; [pg. 11, In 6]- The other input to the adaptive weight-control mechanism 330 is an error signal e(n) 360, derived from the output 340 of the transversal filter 320 being subtracted 350 from a desired response d(n) 370). This is to say, the adaptive algorithm 300 computes the error between the output from the filter and the desired output of the system. From this computed error, updated tap weights can be computed for the next iteration of samples).It would have been obvious to one of ordinary skill in the art to modify the adaptive filter of the combination as in Sequoia (by subtracting the adaptive filter output from a desired response d(n) to obtain an error which could then be minimized based on updating of filter coefficients) to provide ability to measure thermal characteristic without the need to remove the medium from its surroundings (see Sequoia, [pg. 2, In 35]- The apparatuses and methods provided may allow measurement of the thermal properties of a medium without removal of the medium from its surroundings).
Regarding claims 6, 21, and 26, Goto-Empatica-Paquet-Sequoia teaches all the features with respect to the corresponding claims 1, 14, and 16, as outlined herein. With respect to claim 6, Goto-Empatica-Paquet-Sequoia further teaches initializing a settling time flag (ts_flag) and a calibration flag (cal_flag) with initial values (Goto: para [0122]- The control portion 36 of the display device 12 transmits (step S40) a temperature measurement initiation signal from the transceiver portion 28 when the standby signal is received; (0127) The control portion 36 counts the passage of time from the time of measurement of the body surface temperatures Tb1, Tb3 using a built-in timer, and monitors whether a predetermined amount of time has elapsed (step S100). If the amount of time that has elapsed is equal to or greater than the predetermined amount of time, the process returns to step S40, the control portion 36 transmits a measurement initiation signal to the thermometer assembly 10, and the body surface temperatures Tb1, Tb3, Tb5, Tb6, Tb7 are measured once again, as are the intermediate temperatures Tb2, Tb4).
Claims 21 and 26 are rejected in like manner.
Regarding claims 7, 22, and 27, Goto-Empatica-Paquet-Sequoia teaches all the features with respect to the corresponding claims 6, 21, and 26, as outlined herein. With respect to claim 7, Goto-Empatica-Paquet-Sequoia further teaches wherein the initial values of the settling time flag and the calibration flag are zero (Goto: see Fig. 19; step S100; para [0123]-The thermometer assembly 10 receives the temperature measurement initiation signal; drives the body surface sensors 20A, 20B, the corrective body surface sensors 20C, 20D, 20E, and the intermediate sensors 24A, 24B; and measures the first body surface temperature Tb1, the second body surface temperature Tb3, and the third body surface temperatures Tb5, Tb6, Tb7 of the body surface 4A, as well as the first intermediate temperature Tb2 and the second intermediate temperature Tb4 at the surface boundaries 22A, 22B (step S50; first, second, and third temperature measuring steps); para [0127]- The control portion 36 counts the passage of time from the time of measurement of the body surface temperatures Tb1, Tb3 using a built-in timer, and monitors whether a predetermined amount of time has elapsed (step S100). If the amount of time that has elapsed is equal to or greater than the predetermined amount of time, the process returns to step S40, the control portion 36 transmits a measurement initiation signal to the thermometer assembly 10, and the body surface temperatures Tb1, Tb3, Tb5, Tb6, Tb7 are measured once again, as are the intermediate temperatures Tb2, Tb4).
Claims 22 and 27 are rejected in like manner.
Regarding claims 10, 23, and 28, Goto-Empatica-Paquet-Sequoia teaches all the features with respect to the corresponding claims 1, 14, and 16, as outlined herein. With respect to claim 10, Goto-Empatica-Paquet-Sequoia further teaches wherein the determining the core body thermal exchange at the skin surface on the patient body by subtracting the adaptive filter output from the first temperature value is according to T_x (n) = f(n)-y(n), wherein the T_x (n) is the core body thermal exchange, wherein the f(n) is the first temperature value, and wherein the y(n) is the adaptive filter output (Empatica: Fig. 4, primary input, reference input, system output; [col 10, In 20]- The noise in the reference signal, arising from the noise source, is correlated in some known/unknown way with the source noise component. A filter ("Adaptive Filter") associated with an adaptive noise canceller (e.g., a combination of the filter module 126 and the processing module 128) generates an output y that is an estimate of the source noise component. The estimate of the source noise component is subtracted from the source signal within the adaptive noise canceller to generate an output z that is an estimate of the source component. Some aspect of the output z, such as an error e, is fed back to the adaptive filter for tuning the filter), wherein the f(n) is the first temperature value ([col 10, In 13]-A primary input (e.g., the sensor module 122) generates a source signal (designated by the term "s+n0") based on input that includes a source component ("signal source") and a noise component (e.g., the source noise component)), and wherein the y(n) is the adaptive filter output ([col 10, In 26]- The estimate of the source noise component is subtracted from the source signal within the adaptive noise canceller to generate an output z that is an estimate of the source component)).
Claims 23 and 28 are rejected in like manner.
Regarding claims 11, 24, and 29, Goto-Empatica-Paquet-Sequoia teaches all the features with respect to the corresponding claims 1, 14, and 16, as outlined herein. With respect to claim 11, Goto-Empatica-Paquet-Sequoia further teaches wherein the patient’s core body temperature output is invalidated with a unique numerical code until a settling flag (ts_flag) and a calibration flag (cal_flag) are onset or changed from 0 to 1 (Goto: see Fig. 19, step S100; para [0127]- The control portion 36 counts the passage of time from the time of measurement of the body surface temperatures Tb1, Tb3 using a built-in timer, and monitors whether a predetermined amount of time has elapsed (step S100). If the amount of time that has elapsed is equal to or greater than the predetermined amount of time, the process returns to step S40, the control portion 36 transmits a measurement initiation signal to the thermometer assembly 10, and the body surface temperatures Tb1, Tb3, Tb5, Tb6, Tb7 are measured once again, as are the intermediate temperatures Tb2, Tb4).
Claims 24 and 29 are rejected in like manner.
Regarding claims 12, 25, and 30, Goto-Empatica-Paquet-Sequoia teaches all the features with respect to the corresponding claims 1, 14, and 16, as outlined herein. With respect to claim 12, Goto-Empatica-Paquet-Sequoia further teaches wherein the patient’s core body temperature output is the same as that of an input calibration temperature value until the first sensor is determined to have settled down to a steady state or until a desired settling time duration is elapsed (Goto: para [0123]-Temperature information about the body surface temperatures Tb1, Tb3, Tb5, Tb6, Tb7 and about the intermediate temperatures Tb2, Tb4 is converted from an analog signal to a digital signal by the A/D converters 26A, 26B, 26C, and is transmitted to the display device 12 by the transceiver portion 28A, 28B, 28C. The body surface temperatures Tb1, Tb3, Tb5, Tb6, Tb7, as well as the intermediate temperatures Tb2, Tb4, are preferably measured after a predetermined amount of time has passed, so that the transfer of heat from the core of the human body 4 to the body surface 4A will have reached a steady state (equilibrium state)).
Claims 25 and 30 are rejected in like manner.
Regarding claim 14, Goto teaches a wireless sensor device for continuous monitoring of patient’s core body temperature (para [0029]- The above-described electronic thermometer is characterized in that the display device and the thermometer assembly each include transceiver portion capable of mutually transmitting and receiving information by wireless communication; ¶¶s 0136-0138 - continuous) comprising a single biometric patch biosensor attachable to the patient’s skin (Figs. 2 and 3, ¶¶s 0056, 0104-0106, etc. - an electronic thermometer attached to the body), including a [computing device] (Abstract, calculation portion - also see Fig. 1, control means 36 and calculation means 42), and a display device (para [0069]- The display device 12 includes transceiver portion 28 for transmitting and receiving signals to and from the thermometer assembly 10, a display part 32 for displaying body temperature measurement results and the like), wherein the single biometric patch biosensor also includes integrated first sensor (see Fig. 2, element 20A) and second sensor (see Fig. 2, element 24A) …, and wherein: the first sensor (as above) is configured to: measure a first temperature value (Tb1) at a skin surface on a patient body (para [0059]- The temperature measuring part 14A includes a body surface sensor 20A as first body surface temperature measurement portion to measure the temperature of the body surface 4A as a first body surface temperature); the second sensor (as above) is configured to measure a second temperature value (Tb2) of ambient air surrounding the first sensor (para [0059]- an intermediate sensor 24A as first reference temperature measurement portion (intermediate temperature measurement portion) to measure the temperature of a surface boundary 22A between the heat insulating part 18 and the first heat radiation control part 18A as a first reference temperature; para [0078]- Furthermore, the presence of the first heat radiation control part 18A having the thermal resistance value Ru1 between the open air and the surface boundary 22A of the temperature measuring part 14A causes the temperature to decrease, and the heat release ... at the ambient temperature contact part also causes a further decrease in temperature, leading ultimately to an ambient temperature Tamb. para [0153]: reference temperature measurement portion is also not limited to intermediate temperature measurement portion for measuring an intermediate temperature, and may, for example, be open air temperature measurement portion for measuring the temperature of the open air - also see e.g. Fig. 5(B), showing the sensor at Tb2 as exposed to ambient air); wherein the [computing device] (as above) receives the first and second temperature values and implements by the processor an application stored in the memory to (para [0069]- The display device 12 includes transceiver portion 28 for transmitting and receiving signals to and from the thermometer assembly 10; para [0073]- The control portion 36 includes temperature correction portion 40 for correcting a first body surface temperature Tb1 and a second body surface temperature Tb3 from the body surface sensors 20A, 20B, as well as a first intermediate temperature Tb2 and a second intermediate temperature Tb4 from the intermediate sensors 24A, 24B, on the basis of third body surface temperatures Tb5, Tb6, Tb7 from the corrective body surface sensors 20C, 20D, 20E; para [0069]- and a memory part 38 for accumulating information obtained from the transceiver portion 28; para [0088]- In this case, the memory part 38 is configured to be capable of storing temperature information relating to a plurality of human bodies 4): …; continuously determine (¶¶s 0136-0138) a core body thermal exchange at the skin surface on the patient body by subtracting [the second temperature value] from the first temperature value (see formula 1; para [0079]- In a steady state, the slope of the graph in FIG. 4 is constant because the thermal flux Q in each part is constant. At this time, if the first body surface temperature Tb1 and the first intermediate temperature Tb2 of the temperature measuring part 14A are known, the thermal flux Qu1 from the surface nearest the body surface sensor 20A of the temperature measuring part 14A to the surface boundary 22A can be calculated from the following formula (1) using the thermal resistance value Ru0), continuously determine (as above) a patient’s core body temperature by using the core body thermal exchange (see formula 2; para [0080]- The thermal flux Qs+t in the portion where the surface layer part and the contact/thermal resistance part meet, i.e., the portion from the core of the human body 4 to the body surface 4A (in actual practice, the portion from the core to the contact surface 16A) is expressed by the following formula (2) using the core body temperature Tcore of the human body 4 and the thermal resistance Rs+Rt of the portion from the core of the human body 4 to the body surface 4A; see formula 5; para [0083]- In this case, the thermal resistance value Rs+Rt in the portion from the core of the human body 4 to the body surface 4A is an unknown value. Accordingly, if the second body surface temperature Tb3 and the second intermediate temperature Tb4 in the temperature measuring part 14B can be obtained from the body surface sensor 20B and the intermediate sensor 24B in the same manner as with the temperature measuring part 14A, the core body temperature Tcore will be expressed as in formula (5) below), control an absolute amplitude level of the core body thermal exchange (see formula 3; para [0081]- The thermal resistance value Rt of the contact/thermal resistance part thus varies with a variety of conditions, and it is therefore preferable for the thermal resistance value Rt of the contact/thermal resistance part in the present embodiment to be set so as to be minimized), wherein the controlling the absolute amplitude level of the core body thermal exchange includes subtracting an AC offset of the core body thermal exchange and adding a DC calibration value that transforms a time varying change of trend of the core body thermal exchange to an absolute scale (Goto: see formula 1; para [0079]- In a steady state, the slope of the graph in FIG. 4 is constant because the thermal flux Q in each part is constant. At this time, if the first body surface temperature Tb1 and the first intermediate temperature Tb2 of the temperature measuring part 14A are known, the thermal flux Qu1 from the surface nearest the body surface sensor 20A of the temperature measuring part 14A to the surface boundary 22A can be calculated from the following formula (1) using the thermal resistance value Ru0; para [0128]- The body surface temperatures Tb1, Tb3, Tb5, Tb6, Tb7 and the intermediate temperatures Tb2, Tb4 are thus measured each time the predetermined amount of time elapses, the body surface temperatures Tb1, Tb3 and the intermediate temperatures Tb2, Tb4 are corrected, and the core body temperature Tcore is calculated and stored in the memory part 38; para [0130]- (1) The first body surface temperature Tb1 and the first intermediate temperature Tb2 are obtained from the temperature measuring part 14A, and the second body surface temperature Tb3 and the second intermediate temperature Tb4 are obtained from the temperature measuring part 148. Also, the third body surface temperatures Tb5, Tb6, Tb7 are obtained from the temperature measuring part 14C, whereby the body surface temperatures Tb1, Tb3 and the intermediate temperatures Tb2, Tb4 are corrected by the temperature correction portion 40 on the basis of the third body surface temperatures Tb5, Tb6, Tb7. The core body temperature T core of the human body 4 can be calculated by the core body temperature calculation portion 42 from the first body surface temperature Tb1', the first intermediate temperature Tb2', the second body surface temperature Tb3', and the second intermediate temperature Tb4' corrected by the temperature correction portion 40; para [0131]- The temperature distribution of the body surface beneath the thermometer is measured, and the manner in which the temperature distribution within the body varies in comparison with an ideal case is determined. The measurement results are corrected on the basis of the amount of variation, allowing the core body temperature under ideal measurement conditions to be calculated. Specifically, the correct core body temperature can be measured; para [0132]- (2) The body surface temperatures Tb1, Tb3 and the intermediate temperatures Tb2, Tb4 in two types of temperature distribution (thermal flux) can be measured by using the two temperature measuring parts 14A, 148 whose overall thermal resistance values differ from each other. It is therefore possible to calculate the core body temperature Tcore solely from the measured value of the actual temperature. It is accordingly possible to calculate the core body temperature Tcore that corresponds to the actual temperature distribution to a greater degree than in a conventional case where the thermal resistance value Rs from the core of the human body to the surface layer is assumed to be, and set as, a fixed value. A more accurate core body temperature Tcore can thereby be obtained, and the measurement accuracy of the electronic thermometer 2 can be improved; see Fig. 18A-C; para [0114]- FIG. 18(A) shows the temperature distribution before correction, FIG. 18(B) shows the temperature distribution based on the corrective body surface sensors 20C, 20D, 20E for measuring the temperature distribution, and FIG. 18(C) shows the temperature distribution after correction; para [0115]- As shown in FIG. 18(A), the temperature distribution before correction affects the temperature distribution based on the corrective body surface sensors 20C, 20D, 20E for measuring the temperature distribution of FIG. 18(B), and a decrease (error) in temperature is generated by the movement of heat in the horizontal direction at points where the heat insulating part 18 changes from being present to not being present, or vice versa; para [0116]- The temperature distribution after correction is an ideal state of the temperature distribution because the errors are minimized, as shown in FIG. 18(C)), and wherein the core body thermal exchange includes at least one of: in a case of a first calibration, the AC offset is the value of the core body thermal exchange at a temperature sensor settling period (Goto: see formula 1; para [0079]- In a steady state, the slope of the graph in FIG. 4 is constant because the thermal flux Q in each part is constant. At this time, if the first body surface temperature Tb1 and the first intermediate temperature Tb2 of the temperature measuring part 14A are known, the thermal flux Qu1 from the surface nearest the body surface sensor 20A of the temperature measuring part 14A to the surface boundary 22A can be calculated from the following formula (1) using the thermal resistance value Ru0; see Fig. 19, steps S40, SSO, S60; para [0123]- The thermometer assembly 10 receives the temperature measurement initiation si