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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/05/2026 has been entered.
Response to Amendment
The amendment filed 03/05/2026 has been entered. Cancellation of claim 5 and amendments to claims 1, 8, 15, 17-18, and 20 are acknowledged. Claims 1-4, 6-13 and 15-20 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-13, and 15-20 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.
Claims 1 and 15 recite the limitation “and wherein the third temperature sensor is spaced apart from a linear arrangement of the first stack, the second stack, and the heat source in a second horizontal direction that perpendicularly intersects the first horizontal direction”. A second horizontal direction cannot be perpendicular to the first horizontal direction. As such, the limitation is unclear.
Claims 2-4, 6-13, and 16-20 are rejected due to dependency.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 5-8 and 11-16, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarden et al. (US 20120215113 A1) in view of Bowman (US 20030120162 A1).
Regarding claim 1, Yarden discloses an electronic device (abstract) comprising: a sensor (abstract) comprising: a first stack of temperatures sensors comprising two temperatures sensors arranged vertically along a thickness direction of the electronic device (Fig 4C element 94 and 92) and a thermal insulator positioned between the two temperature sensors (Fig 4C element 96); and a second stack of temperature sensors (Fig 5B elements 102 wherein the first and second stack may be on the lower row left , [0037]: “Within the temperature sensor module… comprising one or more temperature sensors (FIGS. 4A-4C)”, wherein the temperature sensors referred to in the figures comprise the stacked sensor disclosed by Fig 4C), comprising two temperatures sensors arranged vertically in the thickness direction and a thermal insulator between the two temperature sensors of the second stack of temperature sensors (Fig 4C elements 92-96); a third temperature sensor configured to contact a surface of a user at a position where a blood vessel does not pass (Fig 5B element 102, [0064]: “on which are mounted temperature sensors 102 (FIGS. 5A-5C)”, wherein the third temperature sensor may be any sensor 102 on the top most row, [0038], wherein the device may be placed in an orientation such that the third sensor does not contact a blood vessel), and wherein the third temperature sensor is spaced apart from a linear arrangement of the first stack and the second stack in a second horizontal direction that perpendicularly intersects the first horizontal direction (Fig 5C); at least one processor configured to ([0021]: “processing unit”); correct the temperature measurements from the first and second stacks by subtracting a temperature measured by the third temperature sensor ([0089-0091], wherein the temperature measurements are subtracted across all three equations); estimate a blood temperature difference between two opposing sides of the heat source in the first horizontal direction, based on the corrected temperature ([0025]: “calculating a temperature of the sub-surface heat source from the temperature-dependent readings at the two or more locations.”, [0089-0091]).
Yarden fails to disclose a heat source; wherein the heat source is positioned between the temperatures sensor and the second temperature sensors in a first horizontal direction, wherein the first temperatures, the second temperatures sensors, and the heat source are linearly arranged in the first horizontal direction; and at least one processor configured to control the heat source to periodically turn on and off to generate heat while the electronic device is in contact with the user, obtain temperature measurements from the first stack and the second stack during an off-time period of the heat source; and estimate blood flow information of the user based on the blood temperature difference.
Bowman discloses an electronic device (title) comprising: a sensor ([0008]: “temperature sensors”): a heat source ([0012]: “a source of thermal energy”); a first temperature sensor ([0028]: “temperature sensors 19 and 20 at two different locations for measuring temperatures T1 and T2, respectively.”); a second temperature sensor ([0028]); wherein the heat source is positioned between the temperatures sensor and the second temperature sensors in a first horizontal direction (Fig 2 element 21), wherein the first temperatures, the second temperatures sensors, and the heat source are linearly arranged in the first horizontal direction (Fig 2 elements 19 and 20); and at least one processor ([0030]: “a digital microprocessor”) configured to: control the heat source to periodically turn on and off to generate heat while the electronic device is in contact with the user ([0031]: “The source 21 of thermal energy is alternately turned on and off”), obtain temperature measurements from the first stack and the second stack during an off-time period of the heat source ([0010]: “The difference between the average temperature differences which occurs when the thermal energy is turned off, referred to as the falling temperature change, is similarly determined”); estimate a blood temperature difference between two opposing sides of the heat source in the first horizontal direction, based on the temperature ([0008]: “The sensors detect the temperature difference between the two locations.”); and estimate blood flow information of the user based on the blood temperature difference ([0031]: “The quantity of blood flowing past the thermal energy source, i.e., the cardiac output, can be derived from such temperature difference measurements”).
As Bowman discloses determining heat profiles in the vicinity of a blood vessel ([0011]), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the electronic device disclosed by Yarden to include the heat source disclosed by Bowman in order to raise the blood temperature to obtain a more accurate temperature reading with relation to cardiac output in a blood vessel (Bowman [0011]). It would have further been obvious to estimate the blood flow information as disclosed by Bowman in order to obtain a more robust data set.
Regarding claim 2, Yarden further discloses wherein the two temperatures sensors in each of the first stack of temperatures sensors and the second stack of temperatures sensors correspond to an upper temperature sensor and a lower temperature sensor (Fig 4C elements 92 and 96), and wherein the at least one processor is further configured to: calculate a first temperature difference between the lower temperature sensor of the first stack of temperatures sensors and the lower temperature sensor of the second stack of temperatures sensors ([0074]: “solving for the core body temperature are generated based on the heat flux between each base sensor 92 and its respective secondary sensor 94, as this heat flux may be equated to the heat flux reaching each base sensor”) and a second temperature difference between the upper temperature sensor of the first stack of temperatures sensors and the upper temperature sensor of the second stack of temperatures sensors ([0074]: ), and estimate the blood temperature difference based on the first temperature difference and the second temperature difference ([0089]-[0091]).
Regarding claim 3, Yarden discloses wherein the at least one processor is further configured to: obtain an objective function that uses a relational expression between the first temperature difference and the blood temperature difference and a relational expression between the second temperature difference and the blood temperature difference ([0089-0091]); and obtain the blood temperature difference at which the objective function is minimized ([0092]: " A linear regression analysis is then applied to find the vector β=<β1, β2, β0> that will minimize the error in the above equation and thus give an accurate reading of Tb=β0. The vector β may be calculated using the formalism:").
Regarding claim 4, Yarden further discloses wherein the two temperatures sensors in each of the first stack of temperatures sensors and the second stack of temperatures sensors correspond to an upper temperature sensor and a lower temperature sensor (Fig 4C), wherein the at least one processor is further configured to correct the temperatures measurements the lower temperature sensor in the first stack of temperatures sensors and the lower temperature sensor in the second stack of temperatures sensors based on the temperature measured by the third temperature sensor ([0089-0091], wherein the equations include several steps wherein temperature measurements are subtracted).
Regarding claim 6, Bowman discloses wherein the blood flow information comprises at least one of a blood flow velocity, a blood flow direction, a core body temperature, and a blood glucose change ([0045]: " can be used to determine the instantaneous or beat-to-beat blood velocity V(t).”).
Regarding claim 7, Bowman discloses wherein the at least one processor is further configured to estimate the blood flow velocity based on the blood temperature difference by using an estimation model that defines a correlation between the blood temperature difference and the blood flow velocity ([0053-0054]: " For example, the relationship between required sensor power and local fluid velocity, V(t), is given by a correlation of the form: P(t)=4πkaΔT( t) [1÷C 1 Pr n (2ap V(t)/μ)m].”).
Regarding claim 8, Yarden discloses wherein the at least one processor is further configured to: estimate heat flux based on a difference between the temperatures measured by the two temperatures sensors of the first stack of temperatures sensors or the two temperatures sensors of the second stack of temperatures sensor ([0075]: “heat flux equations for solving for the unknown variables are generated by taking two temperature readings at two body surface locations and by interpolating additional temperature values at one or more intermediate locations”), and estimate the core body temperature based on the estimated heat flux ([0075]: “i.e., the core body temperature, T”).
Regarding claim 10, Yarden further discloses herein at least one of the two temperatures sensors of the first stack of temperatures sensors and the second stack of temperatures sensors is a thermistor ([0052]: “temperature sensor or a thermistor,”).
Regarding claim 11, Yarden further discloses the heat source may be 500 microns or less (as modified by Bowman above [0056]: “Pad dimensions are typically 1 mm by 0.5 mm”) . However, Yarden does not explicitly disclose the heat source has a diameter of 1 mm to 10 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of Sanborn to between 1 mm to 10 mm as applicant appears to have placed no criticality on the claimed range (applicant’s specification para [0047]) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 12, Yarden further discloses a distance between a center and the two opposing sides of the heat source is within 8.4 mm. ([0056]: “PCB 100 has a width of 15 to 30 mm”, wherein half of the distance would be 7.5mm).
Regarding claim 13, Yarden further discloses wherein a distance between the first stack of temperatures sensors and the second stack of temperatures sensors is within 0.4 mm to 10 mm ([0056]: “Typical spacing between the pads, measured from the center of one pad to the center of the next closest pad, is 3 to 7 mm”). However, Yarden does not explicitly disclose the distance within 0.4 mm to 10 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of Sanborn to between within 0.4 mm to 10 mm as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 15, Yarden discloses a first stack of temperatures sensors comprising two temperatures sensors arranged vertically along a thickness direction of the electronic device (Fig 4C element 94 and 92) and a thermal insulator positioned between the two temperature sensors (Fig 4C element 96); and a second stack of temperature sensors (Fig 5B elements 102 wherein the first and second stack may be on the lower row left , [0037]: “Within the temperature sensor module… comprising one or more temperature sensors (FIGS. 4A-4C)”, wherein the temperature sensors referred to in the figures comprise the stacked sensor disclosed by Fig 4C), comprising two temperatures sensors arranged vertically in the thickness direction and a thermal insulator between the two temperature sensors of the second stack of temperature sensors (Fig 4C elements 92-96); correcting the temperature measurements from the first and second stacks by subtracting a temperature measured by a third temperature sensor (Fig 5B element 102, [0064]: “on which are mounted temperature sensors 102 (FIGS. 5A-5C)”, wherein the third temperature sensor may be any sensor 102 on the top most row, [0089-0091]), estimating a blood temperature difference between two opposing sides oin the horizontal direction, based on the corrected temperature measurements ([0025]: “calculating a temperature of the sub-surface heat source from the temperature-dependent readings at the two or more locations.”, [0089-0091]), and wherein the third temperature sensor is spaced apart from a linear arrangement of the first stack and the second stack in a second horizontal direction that perpendicularly intersects the first horizontal direction (Fig 5C).
Yarden fails to disclose a method of estimating blood flow information by an electronic device, the method comprising: controlling a heat source to periodically turn on and off to generate heat while the electronic device is in contact with a user; obtaining temperature measurements from a first stack of temperatures sensors and a second stack of temperatures sensors during an off-time period of the heat source; estimating blood flow information of the user based on the blood temperature difference, wherein the first stack of temperatures sensors, the second stack of temperatures sensors, and the heat source are linearly arranged in the first horizontal direction.
Bowman discloses a method of estimating blood flow information (title), the method comprising: controlling a heat source to periodically turn on and off to generate heat while the electronic device is in contact with a user ([0031]: “The source 21 of thermal energy is alternately turned on and off”); obtaining temperature measurements from a first temperature sensor and a second temperature sensor ([0028]: “temperature sensors 19 and 20 at two different locations for measuring temperatures T1 and T2, respectively.”) during an off-time period of the heat source ([0010]: “The difference between the average temperature differences which occurs when the thermal energy is turned off, referred to as the falling temperature change, is similarly determined”), . comprising: a sensor ([0008]: “temperature sensors”, ); and estimating blood flow information of the user based on the blood temperature difference ([0031]: “The quantity of blood flowing past the thermal energy source, i.e., the cardiac output, can be derived from such temperature difference measurements”). wherein the first temperatures, the second temperatures sensors, and the heat source are linearly arranged in the first horizontal direction (Fig 2 elements 19 and 20).
As Bowman discloses determining heat profiles in the vicinity of a blood vessel ([0011]), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the electronic device disclosed by Yarden to include the heat source disclosed by Bowman in order to raise the blood temperature to obtain a more accurate temperature reading with relation to cardiac output (Bowman [0011]). It would have further been obvious to estimate the blood flow information as disclosed by Bowman in order to obtain a more robust data set.
Regarding claim 16, Yarden further discloses wherein the two temperatures sensors in each of the first stack of temperatures sensors and the second stack of temperatures sensors correspond to an upper temperature sensor and a lower temperature sensor (Fig 4 C), and wherein the at least one processor is further configured to: calculate a first temperature difference between the lower temperature sensor of the first stack of temperatures sensors and the lower temperature sensor of the second stack of temperatures sensors ([0074]: “solving for the core body temperature are generated based on the heat flux between each base sensor 92 and its respective secondary sensor 94, as this heat flux may be equated to the heat flux reaching each base sensor”) and a second temperature difference between the upper temperature sensor of the first stack of temperatures sensors and the upper temperature sensor of the second stack of temperatures sensors ([0074]), and estimate the blood temperature difference based on the first temperature difference and the second temperature difference ([0089-0091]).
Regarding claim 17, Yarden further discloses wherein the two temperatures sensors in each of the first stack of temperatures sensors and the second stack of temperatures sensors correspond to an upper temperature sensor and a lower temperature sensor (Fig 4C), and wherein the correcting the temperature measurements from the first and second stacks comprises correcting the temperatures measured by the lower temperature sensor in the first stack of temperatures sensors and the lower temperature sensor in the second stack of temperatures sensors based on the temperature measured by the third temperature sensor ([0089-0091]).
Regarding claim 19, Bowman discloses wherein the at least one processor is further configured to estimate the blood flow velocity based on the blood temperature difference by using an estimation model that defines a correlation between the blood temperature difference and the blood flow velocity ([0045]: "an be used to determine the instantaneous or beat-to-beat blood velocity V(t).”).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarden in view of Bowman in further view of Tikhonenko et al. (WO 2022211660 A1), hereinafter Tikhonenko.
Regarding claim 9, Yarden as modified by Bowman discloses the device of claim 6, but fails to disclose wherein upon estimating the blood flow velocity, the at least one processor is further configured to: calculate a difference between the estimated blood flow velocity and a reference blood flow velocity estimated at a reference time; and predict a change in blood glucose compared to the reference time based on the difference between the estimated blood flow velocity and a reference blood flow velocity.
Tikhonenko discloses a method of measuring glucose concentration (abstract) wherein upon estimating the blood flow velocity, the at least one processor is further configured to: calculate a difference between the estimated blood flow velocity and a reference blood flow velocity estimated at a reference time (page 3 para 10: “ calculate the glucose level related to the velocity of blood in a vessel, using the glucose level obtained from a clinical blood test as a primary reference”); and predict a change in blood glucose compared to the reference time based on the difference between the estimated blood flow velocity and a reference blood flow velocity (page 3 para 9: “and thus determine the increase or decrease in blood glucose associated with the increase or decrease in the speed of blood in the blood vessel.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Sanborn as modified by Ikeda to include the estimation of a glucose level as disclosed by Tikhonenko in order to expand the function of the device to further measure blood glucose noninvasively (Tikhonenko page 2 para 4).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarden in view of Bowman in view of Ikeda et al. (US 20170184523 A1)
Regarding claim 20, Yarden as modified by Ikeda discloses a main body (Figs 2A and 2B, [0019] “The apparatus may include a housing, which contains the one or more temperature sensors”), wherein the main body comprises a front surface on which a display is disposed (Fig 2 A element 42), and a rear surface on which the sensor is disposed (Fig 2B element 24 and temperature sensor element 60), wherein the first stack of temperatures sensors, the second stack of temperatures sensors, and the heat source are linearly arranged in a line, on the rear surface of the main body (Fig 2B element 24 and Fig 5B element 60), and wherein the first stack of temperatures sensors and the second stack of temperatures sensors are positioned at equal distances from a center of the heat source, on the two opposing sides of the heat source (Fig 5B, as modified by Bowman).
Yarden as modified by Bowman fails to disclose wherein the electronic device is a wristwatch comprising a main body and a strap.
Ikeda discloses and electronic device that is a wristwatch comprising a main body and a strap ([0188]: “by interlocking the plurality of links 46 with each other, such as pieces of a metal band of a wristwatch,”, Fig 18).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Yarden as modified by Bowman the wristwatch body disclosed by Ikeda in order to ensure convenience and comfort during measurement (Ikeda [0108]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6-13, and 15-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shi (US 20180028072 A1) – discloses a wearable thermometer patch with four temperature sensors (see fig 4).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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