DETAILED ACTION
This action is responsive to the “REPLY TO THE NON-FINAL OFFICE ACTION DATED DECEMBER 29, 2025” filed 18 March 2026. The Examiner acknowledges the amendments to claims 1 and 11. Claims 1-20 are pending, with claims 8-10 and 16-18 standing as previously withdrawn.
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 Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 11 and those dependent therefrom is/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 11 recites the limitation “compensating said output signals with reference to said temperature” [lines 21-22], which is considered indefinite, as claim 11 defines two separate temperature measurements of a first measured temperature [“measuring said temperature of said flexible membrane” (line 15)] and a second measured temperature [“re-measuring said temperature of said flexible membrane” (line 17)], such that it is unclear which temperature is referred to in the indefinite limitation. For examination purposes, the Examiner has interpreted either measured temperature to be applicable in light of any art applied under § 102 or § 103.
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.
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.
Claim(s) 1-7, 11-15, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mamigonians (US-20190365300-A1) in view of Caduff (US-20090312615-A1, previously presented), Park (US-20180274990-A1, previously presented), and Bocquet (US-20180085036-A1).
Regarding claim 1, Mamigonians teaches
An apparatus for performing non-invasive medical examinations in response to generated electric fields, comprising:
a plurality of insulated electrodes mounted on a flexible dielectric membrane [A plurality of electrically insulated substantially parallel electrodes are mounted on the dielectric membrane 106 (Mamigonians ¶0050)];
a dielectric spacer having a first surface in contact with said flexible dielectric membrane and a second surface [a plastic support 315 is located on rods 311 to 314 to support the dielectric membrane 106. In an embodiment, the plastic support is derived from an acetyl material, selected such that electrical properties of this material do not change with respect to changes in temperature and humidity experienced within the operational environment (Mamigonians ¶0053, Fig. 4), wherein defining the plastic support 315 by its electrical properties to not change with respect to changes in temperature and humidity is considered to define dielectric properties]; and
a temperature sensor configured to determine an internal temperature of the apparatus [An additional temperature sensor and a humidity sensor may also be included within the housing (Mamigonians ¶0046); In an embodiment, temperature data and humidity are also measured and recorded. Temperature may be measured at the position of the finger, by detector 107 and inside the apparatus itself. Thus, all four measurements may be used to compensate measured values to improve overall accuracy. For glucose measurement, the aim is to obtain results that are at least as accurate, and preferably more accurate, than the results obtained using known invasive techniques (Mamigonians ¶0096)],
wherein the apparatus is configured to:
measure an internal temperature of the apparatus [environment data is measured twice during each layering procedure. Firstly, at the start of forward layering and secondly at the start of reverse layering (Mamigonians ¶0105), wherein internal device temperature 1813/1823 is defined as environment data (Mamigonians ¶0104, Fig. 18)];
produce an output signal by energizing one of said plurality of insulated electrodes and monitoring an alternative one of said plurality of insulated electrodes [Electronics within the evaluation apparatus, as described with reference to FIG. 6, generates energization pulses for application to any of the electrodes 1 to 15 as a transmitter electrode. In addition, output signals may be monitored from any remaining one of the electrodes as a receiver electrode, wherein a peak value of an output signal is indicative of permittivity and a decay rate of an output signal is indicative of conductively. Thus, during each energization operation, an energized transmitter electrode and a monitored receiver electrode define a capacitively coupled electrode pair (Mamigonians ¶0115); Consequently, capacitive coupling procedures are performed that capacitively couple selected pairs of the electrodes by producing electric fields that penetrate the tissue to produce monitored output data (Mamigonians ¶0092); The apparatus described herein evaluates an amount of a substance contained within blood circulating within human body tissue. Concentrations of many different substances may be evaluated, provided that they change the dielectric properties of the blood. These include inorganic, organic and bio-chemical substances. Features of the embodiment will be described with reference to an evaluation of glucose levels (Mamigonians ¶0109)];
re-measure said internal temperature of the apparatus [Mamigonians ¶0105].
However, Mamigonians fails to explicitly disclose wherein the dielectric spacer has a window between said first surface and said second surface of the dielectric spacer; wherein the temperature sensor comprises an infra-red sensor located on said second surface and configured to receive infra-red radiation from said flexible dielectric membrane via said window to determine a temperature of said flexible dielectric membrane; wherein the measured temperatures are measured temperatures of the flexible dielectric membrane.
Caduff discloses non-invasive systems and methods for assessing glucose levels in a subject’s blood using electric fields, wherein Caduff discloses employing an infrared temperature sensor configured to receive infrared radiation from an electrode arrangement to determine a temperature of said electrode arrangement [Control unit/evaluation circuitry 1 operates the various sensor modules 2-8 (or part thereof) to measure a number of parameters that depend on the user's state (e.g. electric and optical response of the tissue), the state of the user's surroundings (e.g. ambient temperature), as well as on the state of the apparatus itself (e.g. the temperature within the apparatus). Evaluation circuitry 1 combines the various measured parameters, e.g. using multidimensional calibration data and/or algorithmic rules, to calculate a signal or display a value indicative of the glucose level (Caduff ¶0041); Advantageously, several temperatures are measured. These include surrounding environmental temperature, the temperature within the apparatus and on the electrode arrangement, as well as the superficial skin temperature. These measurements can be made using a range of detectors including thermocouples or infrared radiation detection methods (Caduff ¶0115)]. However, Caduff is non-specific regarding the implementation of the infrared temperature sensor.
Park discloses non-contact infrared temperature sensors, wherein Park discloses implementing a window between an infrared temperature sensor and a target of the infrared temperature sensor to allow the temperature sensor to receive infrared radiation [A temperature sensor 1331 is disposed at an end of the first body 1100 to sense a temperature. The temperature sensor 1331 may be implemented as a non-contact type infrared sensor. The infrared sensor receives the infrared energy emitted from the body by an IR sensor and converts it into a measurable electrical signal (Park ¶0056); The oblique surface 1123 forms a certain angle from the temperature sensor 1331 and is formed in a direction in which the size of the first hole h1 widens as the distance from the temperature sensor 1331 increases. The certain angle is formed to be equal to or greater than an angle corresponding to the sensing range of the temperature sensor 1331. That is, the first hole h1 is formed to include the sensing range of the temperature sensor 1331 (¶0058, Fig. 3A)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Mamigonians to employ an infra-red sensor located on said second surface and configured to receive infra-red radiation from said flexible dielectric membrane via said window to determine a temperature of said flexible dielectric membrane; and wherein the apparatus is further configured to measure said temperature of said flexible dielectric membrane, so as to accommodate for the temperature of the electrodes during measuring, which is understood to affect analyte measurements [Caduff ¶0041]; and to further employ locating the infra-red sensor on said second surface and a window between said first surface and said second surface of the dielectric spacer, as this modification would amount to merely applying known techniques [positioning the sensor within the apparatus and among the circuitry; window to allow for IR radiation to be received by an IR temperature sensor] to a known device (method, or apparatus) ready for improvement to yield predictable results [allow an IR temperature sensor to receive IR radiation] [MPEP § 2143(I)(D)].
However, while Mamigonians is considered to disclose analyzing temperature between the measured temperature before energizing and the measured temperature after energizing [the procedure of forward dynamic layering followed by reverse dynamic layering produces twenty-eight common electrode data sets, which include common electrode data sets 2301, 2302, 2701 and 2201, along with all the others making up a complete layering data set 2901. Furthermore, in this embodiment, the procure also records force data 1811, finger temperature data 1812, internal temperature data 1813 and humidity data 1814. In an alternative embodiment, this environment data is recorded separately for forward layering and reverse layering (Mamigonians ¶0140)], Mamigonians in view of Caduff and Park fails to explicitly disclose wherein the apparatus is configured to treat said output signal as being invalid based on a discrepancy between said temperature measured before said energizing of said one of said plurality of insulated electrodes and said temperature re-measured after said energizing of said one of plurality of insulated electrodes.
Bocquet discloses systems and methods for using an electrode to measure electrophysiological data, wherein a temperature of the electrode is measured using an infrared sensor to determine if the electrode is too hot relative to a known range to obtain a measurement, wherein measurement is prevented upon determining that the electrode is too hot [In addition, each base advantageously comprises a thermal sensor 166, preferably an infrared sensor adapted to measure, preferably before the electrochemical conductance of the skin, the temperature of at least one electrode 110 (sensor shown only on the base 160′ to clarify the figures). Depending on the temperature of the electrodes, the thermal sensor 166 can prevent the start of a measurement protocol. Indeed, it has been found that when contact with cold electrodes, a phenomenon of vasoconstriction limits the electrochemical phenomena in the ion channels of the sweat glands and degrades the conductance measurements of the skin. It is therefore preferable for the electrodes to have a temperature greater than or equal to 18° C. in order to start the measurement. Furthermore, in order to ensure the correct operation of the control electronics, it is preferable that the electrodes are not too hot. The temperature of the electrodes 110 must therefore lie in a range between 18° C. and 35° C. in order to obtain a measurement under good conditions. The thermal sensor 166 advantageously communicates with the control circuit 130, which blocks the conductance measurement if the temperature of the electrodes is outside this range (Bocquet ¶0082-0083); A second preliminary step 320 comprises a check of the temperature of the electrodes. This step is advantageously carried out before any measurement of conductance of the skin… If the temperature is outside the acceptable range, the temperature sensor 166 communicates a negative signal to the control circuit 130, preventing the implementation of the measurement protocol (Bocquet ¶0104)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Mamigonians in view of Caduff and Park to employ wherein the apparatus is configured to treat said output signal as being invalid based on a discrepancy between said temperature measured before said energizing of said one of said plurality of insulated electrodes and said temperature re-measured after said energizing of said one of plurality of insulated electrodes, as Bocquet indicates that electrodes that are outside of an operable temperature range fail to define good conditions for providing measurements [Bocquet ¶0083].
Regarding claim 2, Mamigonians in view of Caduff, Park, and Bocquet teaches
The apparatus of claim 1, wherein sides of said window defined by said dielectric spacer are angled to present a wider opening on said first surface, at a position of said flexible dielectric membrane, compared to said second surface at a position of said infra-red sensor [see § 103 modification of claim 1; wherein as depicted in Park Fig. 3A, the window (h1) comprises sides that are angled to be widen away from the IR temperature sensor (see oblique surface 1123)].
Regarding claim 3, Mamigonians in view of Caduff, Park, and Bocquet teaches
The apparatus of claim 1, wherein:
said non-invasive medical examinations detect a concentration of one or more chemicals within circulating blood [Mamigonians ¶0143];
said plurality of insulated electrodes are configured to be contacted by a finger [a membrane-exposing orifice 103, presenting an application region arranged to make skin contact. In this embodiment, contact is made against the skin of a finger (Mamigonians ¶0044, Fig. 1)]; and
said plurality of insulated electrodes are substantially linear and substantially parallel [A plurality of electrically insulated substantially parallel electrodes are mounted on the dielectric membrane 106 (Mamigonians ¶0050, Fig. 2)].
Regarding claim 4, Mamigonians in view of Caduff, Park, and Bocquet teaches
The apparatus of claim 3, comprising additional insulated electrodes, wherein said additional insulated electrodes are:
substantially linear and parallel [Mamigonians ¶0050, Fig. 2];
mounted on opposite side of said flexible dielectric membrane [in addition to a first group of substantially parallel electrodes mounted on the top surface of the dielectric membrane, a second group of substantially parallel electrodes are mounted on the underside of the dielectric membrane 106 (Mamigonians ¶0050, Fig. 2)]; and
substantially orthogonal to said plurality of insulated electrodes [The orientation of the second group of electrodes is offset with respect to the orientation of the first group of electrodes. In this embodiment, the first group of electrodes are mutually orthogonal to the second group of electrodes (Mamigonians ¶0051, Fig. 2)].
Regarding claim 5, Mamigonians in view of Caduff, Park, and Bocquet teaches
The apparatus of claim 3, further comprising a processor, wherein said processor is configured to:
select a first set of n electrodes from said plurality of insulated electrodes [it is possible for a first layering operation to be performed using the first group, followed by a second layering operation being performed using the second group. Conventional position detection is also possible by sequentially energizing electrodes of one of these groups while monitoring selected electrodes of the other group (Mamigonians ¶0051); Layering is achieved by coupling electrodes of a first set (selected from a group) and then repeating a scanning operation by coupling electrodes in a second set, selected from the same group. Thus, layering operations performed by the first group of electrodes 902 achieve a layering operation in the direction of the second arrow 905. Similarly, the second group of electrodes 903 achieve a similar layering operation in the direction of the first arrow 904 (Mamigonians ¶0074, Fig. 9)]; and
establish capacitively coupled electrode pairs, in which each of said first set of n electrodes is capacitively coupled with a second set of m electrodes from said plurality of insulated electrodes [Mamigonians ¶¶0051, 0074; a decision is made as to whether it is possible to perform capacitive coupling procedure that capacitively couple selected pairs of the electrodes by producing electric fields that penetrate the tissue to produce monitored output signals (Mamigonians ¶0077)], wherein
each said second set of m electrodes are a nearest neighbouring electrodes to an electrode selected from said first set of n electrodes [Mamigonians ¶¶0051, 0074, 0077, Fig. 9]; and
a number of electrodes present in said second set of m electrodes represents a degree of layering [Mamigonians ¶¶0051, 0074, 0077, Fig. 9].
Regarding claim 6, Mamigonians in view of Caduff, Park, and Bocquet teaches
The apparatus of claim 4, wherein said dielectric spacer comprises a raised portion arranged to extend into an opening within an upper circuit board to support said flexible dielectric membrane [wherein as depicted in Mamigonians Fig. 4, the support 315 (dielectric spacer) having a thickness and being positioned within the circuit board 201 is considered to read on the claimed limitation].
Regarding claim 7, Mamigonians in view of Caduff, Park, and Bocquet teaches
The apparatus of claim 5, wherein:
said intermediate circuit board is in contact with a force sensor [the intermediate board 316 includes an electrically conductive ground plane to provide electrical shielding to the lower side of the membrane 106 (Mamigonians ¶0054, Fig. 4); Movement is restrained by a metal ball 407 extending from a force sensor 408, wherein the metal ball 407 is in contact with the ground plane 405 attached intermediate board 316 (Mamigonians ¶0058, Fig. 4)]; and
said processor is configured to inhibit examination procedures when an applied force is below a predetermined threshold [In this embodiment, a device measures applied force thereby allowing a processor to compare force data against a predetermined level. A minimum level of pressure is required to ensure that a reliable contact is made between the subject's finger and the electrode supporting membrane 106. Thus, testing is inhibited if the force data is not above this predetermined level (Mamigonians ¶0047)].
However, Mamigonians in view of Caduff and Park fails to explicitly disclose wherein said infra-red sensor is located on an intermediate circuit board.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Mamigonians in view of Caduff, Park, and Bocquet to employ wherein said infra-red sensor is located on an intermediate circuit board, as this modification would amount to merely applying known techniques [positioning the sensor within the apparatus and among the circuitry] to a known device (method, or apparatus) ready for improvement to yield predictable results [position a sensor on circuitry; allow an IR temperature sensor to receive IR radiation] [MPEP § 2143(I)(D)].
Regarding claim 11, Mamigonians teaches
A method of performing non-invasive medical examinations, in response to generated electric fields, comprising the steps of:
locating human tissue in contact with a plurality of insulated electrodes mounted on a flexible dielectric membrane [a membrane-exposing orifice 103, presenting an application region arranged to make skin contact. In this embodiment, contact is made against the skin of a finger (Mamigonians ¶0044, Fig. 1); A plurality of electrically insulated substantially parallel electrodes are mounted on the dielectric membrane 106 (Mamigonians ¶0050)]; and
selecting a transmitting electrode and a monitoring electrode from said plurality of insulated electrodes, such that electric fields penetrate said human tissue [it is possible for a first layering operation to be performed using the first group, followed by a second layering operation being performed using the second group. Conventional position detection is also possible by sequentially energizing electrodes of one of these groups while monitoring selected electrodes of the other group (Mamigonians ¶0051); Layering is achieved by coupling electrodes of a first set (selected from a group) and then repeating a scanning operation by coupling electrodes in a second set, selected from the same group. Thus, layering operations performed by the first group of electrodes 902 achieve a layering operation in the direction of the second arrow 905. Similarly, the second group of electrodes 903 achieve a similar layering operation in the direction of the first arrow 904 (Mamigonians ¶0074, Fig. 9); a decision is made as to whether it is possible to perform capacitive coupling procedure that capacitively couple selected pairs of the electrodes by producing electric fields that penetrate the tissue to produce monitored output signals (Mamigonians ¶0077)], wherein:
a first surface of a dielectric spacer is in contact with said flexible dielectric membrane [a plastic support 315 is located on rods 311 to 314 to support the dielectric membrane 106. In an embodiment, the plastic support is derived from an acetyl material, selected such that electrical properties of this material do not change with respect to changes in temperature and humidity experienced within the operational environment (Mamigonians ¶0053, Fig. 4), wherein defining the plastic support 315 by its electrical properties to not change with respect to changes in temperature and humidity is considered to define dielectric properties];
a temperature sensor configured to determine an internal temperature of the apparatus [An additional temperature sensor and a humidity sensor may also be included within the housing (Mamigonians ¶0046); In an embodiment, temperature data and humidity are also measured and recorded. Temperature may be measured at the position of the finger, by detector 107 and inside the apparatus itself. Thus, all four measurements may be used to compensate measured values to improve overall accuracy. For glucose measurement, the aim is to obtain results that are at least as accurate, and preferably more accurate, than the results obtained using known invasive techniques (Mamigonians ¶0096)], and further comprising the steps of:
measuring said internal temperature of the apparatus [environment data is measured twice during each layering procedure. Firstly, at the start of forward layering and secondly at the start of reverse layering (Mamigonians ¶0105), wherein internal device temperature 1813/1823 is defined as environment data (Mamigonians ¶0104, Fig. 18)];
producing output signals derived from said monitoring electrode [Electronics within the evaluation apparatus, as described with reference to FIG. 6, generates energization pulses for application to any of the electrodes 1 to 15 as a transmitter electrode. In addition, output signals may be monitored from any remaining one of the electrodes as a receiver electrode, wherein a peak value of an output signal is indicative of permittivity and a decay rate of an output signal is indicative of conductively. Thus, during each energization operation, an energized transmitter electrode and a monitored receiver electrode define a capacitively coupled electrode pair (Mamigonians ¶0115); Consequently, capacitive coupling procedures are performed that capacitively couple selected pairs of the electrodes by producing electric fields that penetrate the tissue to produce monitored output data (Mamigonians ¶0092); The apparatus described herein evaluates an amount of a substance contained within blood circulating within human body tissue. Concentrations of many different substances may be evaluated, provided that they change the dielectric properties of the blood. These include inorganic, organic and bio-chemical substances. Features of the embodiment will be described with reference to an evaluation of glucose levels (Mamigonians ¶0109)];
re-measuring said internal temperature of the apparatus [Mamigonians ¶0105];
compensating said output signals with reference to said temperature [An additional temperature sensor and a humidity sensor may also be included within the housing. In this way, each data set produced during a scanning operation may include temperature data and humidity data in addition to data representing a degree of applied force or pressure (Mamigonians ¶0046].
However, Mamigonians fails to explicitly disclose a window is provided between said first surface and a second surface of said dielectric spacer; wherein the temperature sensor is an infra-red sensor located on said second surface and is configured to receive infra-red radiation from said flexible dielectric membrane via said window, to determine a temperature of said flexible dielectric membrane, wherein the measured temperatures are measured temperatures of the flexible dielectric membrane.
Caduff discloses non-invasive systems and methods for assessing glucose levels in a subject’s blood using electric fields, wherein Caduff discloses employing an infrared temperature sensor configured to receive infrared radiation from an electrode arrangement to determine a temperature of said electrode arrangement [Control unit/evaluation circuitry 1 operates the various sensor modules 2-8 (or part thereof) to measure a number of parameters that depend on the user's state (e.g. electric and optical response of the tissue), the state of the user's surroundings (e.g. ambient temperature), as well as on the state of the apparatus itself (e.g. the temperature within the apparatus). Evaluation circuitry 1 combines the various measured parameters, e.g. using multidimensional calibration data and/or algorithmic rules, to calculate a signal or display a value indicative of the glucose level (Caduff ¶0041); Advantageously, several temperatures are measured. These include surrounding environmental temperature, the temperature within the apparatus and on the electrode arrangement, as well as the superficial skin temperature. These measurements can be made using a range of detectors including thermocouples or infrared radiation detection methods (Caduff ¶0115)]. However, Caduff is non-specific regarding the implementation of the infrared temperature sensor.
Park discloses non-contact infrared temperature sensors, wherein Park discloses implementing a window between an infrared temperature sensor and a target of the infrared temperature sensor to allow the temperature sensor to receive infrared radiation [A temperature sensor 1331 is disposed at an end of the first body 1100 to sense a temperature. The temperature sensor 1331 may be implemented as a non-contact type infrared sensor. The infrared sensor receives the infrared energy emitted from the body by an IR sensor and converts it into a measurable electrical signal (Park ¶0056); The oblique surface 1123 forms a certain angle from the temperature sensor 1331 and is formed in a direction in which the size of the first hole h1 widens as the distance from the temperature sensor 1331 increases. The certain angle is formed to be equal to or greater than an angle corresponding to the sensing range of the temperature sensor 1331. That is, the first hole h1 is formed to include the sensing range of the temperature sensor 1331 (¶0058, Fig. 3A)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Mamigonians to employ wherein the temperature sensor is an infra-red sensor configured to receive infra-red radiation from said flexible dielectric membrane via said window, to determine a temperature of said flexible dielectric membrane, wherein the measured temperatures are measured temperatures of the flexible dielectric membrane, so as to accommodate for the temperature of the electrodes during measuring, which is understood to affect analyte measurements [Caduff ¶0041]; and to further employ a window between said first surface and a second surface of said dielectric spacer; wherein the infra-red sensor located on said second surface, as this modification would amount to merely applying known techniques [positioning the sensor within the apparatus and among the circuitry; window to allow for IR radiation to be received by an IR temperature sensor] to a known device (method, or apparatus) ready for improvement to yield predictable results [allow an IR temperature sensor to receive IR radiation] [MPEP § 2143(I)(D)].
However, while Mamigonians is considered to disclose analyzing temperature between the measured temperature before energizing and the measured temperature after energizing [the procedure of forward dynamic layering followed by reverse dynamic layering produces twenty-eight common electrode data sets, which include common electrode data sets 2301, 2302, 2701 and 2201, along with all the others making up a complete layering data set 2901. Furthermore, in this embodiment, the procure also records force data 1811, finger temperature data 1812, internal temperature data 1813 and humidity data 1814. In an alternative embodiment, this environment data is recorded separately for forward layering and reverse layering (Mamigonians ¶0140)], Mamigonians in view of Caduff and Park fails to explicitly disclose the method further comprising steps of treating said output signals as being invalid based on a discrepancy between said temperature obtained from said re-measuring step compared to said temperature obtained from said measuring step; and wherein the compensation of said output signals is when said output signals are considered to be valid.
Bocquet discloses systems and methods for using an electrode to measure electrophysiological data, wherein a temperature of the electrode is measured using an infrared sensor to determine if the electrode is too hot relative to a known range to obtain a measurement, wherein measurement is prevented upon determining that the electrode is too hot [In addition, each base advantageously comprises a thermal sensor 166, preferably an infrared sensor adapted to measure, preferably before the electrochemical conductance of the skin, the temperature of at least one electrode 110 (sensor shown only on the base 160′ to clarify the figures). Depending on the temperature of the electrodes, the thermal sensor 166 can prevent the start of a measurement protocol. Indeed, it has been found that when contact with cold electrodes, a phenomenon of vasoconstriction limits the electrochemical phenomena in the ion channels of the sweat glands and degrades the conductance measurements of the skin. It is therefore preferable for the electrodes to have a temperature greater than or equal to 18° C. in order to start the measurement. Furthermore, in order to ensure the correct operation of the control electronics, it is preferable that the electrodes are not too hot. The temperature of the electrodes 110 must therefore lie in a range between 18° C. and 35° C. in order to obtain a measurement under good conditions. The thermal sensor 166 advantageously communicates with the control circuit 130, which blocks the conductance measurement if the temperature of the electrodes is outside this range (Bocquet ¶0082-0083); A second preliminary step 320 comprises a check of the temperature of the electrodes. This step is advantageously carried out before any measurement of conductance of the skin… If the temperature is outside the acceptable range, the temperature sensor 166 communicates a negative signal to the control circuit 130, preventing the implementation of the measurement protocol (Bocquet ¶0104)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Mamigonians in view of Caduff and Park to employ steps of treating said output signals as being invalid based on a discrepancy between said temperature obtained from said re-measuring step compared to said temperature obtained from said measuring step; and wherein the compensation of said output signals is when said output signals are considered to be valid, as Bocquet indicates that electrodes that are outside of an operable temperature range fail to define good conditions for providing measurements [Bocquet ¶0083].
Regarding claim 12, Mamigonians in view of Caduff, Park, and Bocquet teaches
The method of claim 11, further comprising the step of angling sides of said window defined by said dielectric spacer to present a wider opening on said first surface, at a position of said flexible dielectric membrane, compared to said second surface at a position of said infra-red sensor [see § 103 modification of claim 1; wherein as depicted in Park Fig. 3A, the window (h1) comprises sides that are angled to be widen away from the IR temperature sensor (see oblique surface 1123)].
Regarding claim 13, Mamigonians in view of Caduff, Park, and Bocquet teaches
The method of claim 11, wherein:
said step of locating human tissue comprises locating a finger in contact with said plurality of insulated electrodes [Mamigonians Fig. 1];
said non-invasive medical examinations detect a concentration of one or more chemicals within circulating blood [Mamigonians ¶0143]; and
said plurality of insulated electrodes are substantially linear and substantially parallel [Mamigonians ¶0050, Fig. 2]].
Regarding claim 14, Mamigonians in view of Caduff, Park, and Bocquet teaches
The method of claim 13, wherein said dielectric spacer comprises a raised portion arranged to extend into an opening within an upper circuit board to support said flexible dielectric membrane during said step of locating a finger [wherein as depicted in Mamigonians Fig. 4, the support 315 (dielectric spacer) having a thickness and being positioned within the circuit board 201 is considered to read on the claimed limitation].
Regarding claim 15, Mamigonians in view of Caduff, Park, and Bocquet teaches
The method of claim 11, wherein:
said intermediate circuit board is in contact with a force sensor [Mamigonians ¶¶0054, 0058, Fig. 4]; and
a processor is configured to perform a step of inhibiting further operation when an applied force is below a predetermined threshold [Mamigonians ¶0047].
However, Mamigonians in view of Caduff, Park, and Bocquet fails to explicitly disclose wherein said infra-red sensor is located on an intermediate circuit board.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Mamigonians in view of Caduff, Park, and Bocquet to employ wherein said infra-red sensor is located on an intermediate circuit board, as this modification would amount to merely applying known techniques [positioning the sensor within the apparatus and among the circuitry] to a known device (method, or apparatus) ready for improvement to yield predictable results [position a sensor on circuitry; allow an IR temperature sensor to receive IR radiation] [MPEP § 2143(I)(D)].
Regarding claim 19, Mamigonians in view of Caduff, Park, and Bocquet teaches
The method of claim 11, further comprising the step of:
developing instructions and reference data for a processor to facilitate said step of producing output signals by a process of machine learning [In an embodiment, processing step 1103 is performed using a machine learning system. In this embodiment, plural learning output data blocks are produced for a first selection of subjects, for which the extent to which a substance under investigation (such as glucose) is present, is known (Mamigonians ¶0106); At step 1903, the machine learning system is trained in response to the data received at step 1901 and step 1902, whereafter at step 1904, a question is asked as to whether another block is to be considered. When answered in the affirmative, the next output data block is read at step 1901 (Mamigonians ¶0112, Fig. 19)].
Regarding claim 20, Mamigonians in view of Caduff, Park, and Bocquet teaches
The method of claim 19, wherein said process of machine learning comprises the steps of evaluating many examinations in which tissue characteristics are known and a temperature of an evaluating membrane is also known, from which said reference data is developed [Mamigonians ¶0106; Again, an output data block, of the type described with reference to FIG. 18, is read at step 1905. At step 1906, this data block is processed against the trained data produced by the procedures described above. Thereafter, at step 1907, output information is produced and from this, results are displayed at step 1104 (Mamigonians ¶0114), wherein Mamigonians Fig. 18 defines internal apparatus temperature as measured data to determine glucose, such that based on the § 103 modification of claim 11 above, the measured temperature is considered to be membrane temperature].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 9, filed 18 March 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections for reference characters not mentioned in the specification have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 9, with respect to the previously presented specification objection have been fully considered and are persuasive. The specification objection has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 9-11, with respect to the rejection(s) of claim(s) 1, 11, and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mamigonians (US-20190365300-A1) in view of Caduff (US-20090312615-A1, previously presented), Park (US-20180274990-A1, previously presented), and Bocquet (US-20180085036-A1).
The Applicant asserts that the previously cited references of Mamigonians ’613 [previously cited as Zedsen], Caduff, and Park fail to teach or suggest the amended limitations of claims 1 and 11, wherein the apparatus is “configured to measure said temperature of said flexible dielectric membrane; produce an output signal by energizing one of said plurality of insulated electrodes and monitoring an alternative one of said plurality of insulated electrodes; re-measure said temperature of said flexible dielectric membrane; and treat said output signal as being invalid based on a discrepancy between said temperature measured before said energizing of said one of said plurality of insulated electrodes and said temperature re-measured after said energizing of said one of said plurality of insulated electrodes”. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 and 11 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. Mamigonians (US-20190365300-A1) [hereinafter referred to as Mamigonians ‘300 in Response to Arguments; and noted as not the same as the previously presented Zedsen (referred to as Mamigonians by Applicant) reference (US-20200337613-A1), hereinafter Mamigonians ‘613 in Response to Arguments] in view of Caduff (US-20090312615-A1, previously presented), Park (US-20180274990-A1, previously presented), and Bocquet (US-20180085036-A1) is considered to disclose operations to measure an internal temperature of the apparatus [Mamigonians ‘300 ¶¶0104-0105, Fig. 18], produce an output signal by energizing one of said plurality of insulated electrodes and monitoring an alternative one of said plurality of insulated electrodes [Mamigonians ‘300 ¶¶0092, 0109, 0115], re-measure said internal temperature of the apparatus [Mamigonians ‘300 ¶0105], and compensating said output signals with reference to said determined temperature [Mamigonians ‘300 ¶0046]; and wherein the Examiner notes that Bocquet discloses proper operating conditions for a measured temperature of an electrode, wherein when the measured temperature of the electrode is outside of the proper operating conditions, the electrode fails to define good conditions for providing measurements [Bocquet ¶0083].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Huang (US-20210330262-A1) discloses a non-invasive blood glucose system comprising electrodes configured to measure a concentration of blood glucose [Huang ¶¶0022-0023]; wherein Huang discloses that based on a level of ambient temperature being outside of a range of acceptable temperature, as measured by a temperature sensor within a housing of the system [see first temperature sensor 15 as positioned in Huang Fig. 4a], the system is configured to treat a signal output by the electrodes as being invalid [Huang ¶0027]
Hayter (US-20130158376-A1) discloses systems and methods for monitoring blood glucose and compensating the monitored blood glucose based on temperature measurements [Hayter ¶¶0048-0049], wherein Hayter discloses operations to continuously measure a temperature of the blood glucose sensor itself in order to compensate for temperature based on the temperature of the blood glucose sensor as measured at different points in time [Hayter ¶¶0059, 0113]
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
Prosecution Insights