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 .
Priority
Claims 1-22 are deemed to have an effective filing date of March 22, 2022, the filing date of the EP patent application claim priority under 35 USC 119 as the certified copy of the EP application is in the English language.
Response to Amendment
This Action is in response to the Amendment filed August 13, 2026.
In view of the Amendment, the objections to the drawings and claims 10 and 13 and the rejection of claim 15 under 35 USC 112(b), as set forth in the Office Action dated 05/13/2026, are withdrawn.
Claims 1, 10, and 15 are amended.
Claims 19-22 are amended.
Claims 6 and 9 are canceled.
Claims 1-5, 7-8, and 10-22 are pending.
Response to Arguments
Applicant's arguments filed 08/13/2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that the claims are not directed merely to evaluating information or to a mental process, the Examiner disagrees. Under the BRI, independent claims 1 and 11, as drafted, are directed to method using a generic sensor and a generic computer. There is no additional structure.
In response to Applicant’s argument that the claims are directed to a specific technological solution for improving the reliability of physiological-state monitoring systems, the Examiner does not see evidence of the claims being directed to specifics, or, to a monitoring system. That is, the claim must include the components or steps of the invention that provide the improvement described in the specification (see MPEP 2106.05(a)). The claims do not mention a physiological-state monitoring system, or outputting an updated reliability assessment rating. Thus, the claimed invention does not directly affect how future physiological metrics are generated.
The specification does not “confirm this technological improvement” as asserted by Applicant on page 11, line 3 of the Amendment dated 08/13/2026. Paragraph [0032] of the instant application’s PG-Pub assesses if one metric respects the boundaries dictated by the other metric(s) (and preferably vice-versa). When the boundary (or boundaries) is not respected, the corresponding metric(s) may be flagged/labelled unreliable so that such unreliable metrics can be ignored in further considerations. Paragraph [0034] states that the first metric and the second metric may be related to each other by a first mathematical function where a first value is determined by inserting the values of the metrics into the function. The first value is then compared to a bound for the value (or a bound of the possible values of the function) and based on the outcome of the comparison, it is assessed whether the first metric and/or the second method are reliable. These paragraphs do not mention adapting or changing a method.
Paragraph [0070] of the PG-Pub is directed to an embodiment including adapting or changing a method for estimating the first metric and/or the second metric based on the reliability rate. That is, the reliability estimations may be used to update the estimations of the first and/or second metric. Paragraph [0072] states that the data discloses for the boundaries for the reliability estimations may be adapted. These features are not present in the claimed invention as drafted. Consequently, the specification does not confirm the technological improvement argued in the remarks accompanying the Amendment filed 08/13/2026. And the claims do not reflect the asserted improvement. It is important to keep in mind that an improvement in the abstract idea itself is not an improvement in technology (see MPEP 2106.05(a)(II)).
With respect to Applicant’s argument that Nogueira (US 2019 0076070) does not compare a first value to a bound of the first value. The Examiner disagrees. The claims compare a value of the first mathematical function (Nogueira’s calculation of a fused SG value) to a bound of the first value (Nogueira’s bound check determines whether the parameters/values are within specified ranges). Paragraph [0012] is written generically reciting a fused SG value is calculated and then performing error detection diagnostics on the fused SG value. Since the fused SG value undergoes an error detection diagnostics that is explained in paragraph [0343] to specific values, it is the Examiner’s position that the instant claims do not preclude this interpretation under the BRI.
With respect to applicant’s argument that Nogueira does not disclose adapting or changing a method for estimating the metrics based on the reliability rating, the Examiner disagrees as “weighting” a glucose value adapts or changes a method. The claims do not recite adapting or changing the method by which the value was estimated.
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 1-5, 7-8, and 22 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.
With respect to claim 1, “adapting or changing a method” is recited (line 11). But it is unclear what is being adapted or changed. Claim 1, line 1 recites a “method for assessing reliability” and claim 1, line 5, recites “a different method and/or algorithm” used for estimating a first metric and a second method independently from each other. The recitation of “a method” in line 13 appears to be adding another method. It is unclear how this additional method relates to the two previously recited methods. Consequently, the scope of claim 1 is vague and indefinite.
In addition, the assessing a reliability rating” in lines 9-10 is based on a comparison of a value of a mathematical function and its bound/limit, where the first and second metric are related by the mathematical function. It is unclear how a method for estimating the first metric and/or second metric can be adapted or changed based on the reliability rating, and how the adaption or change relates to the other steps of the method of claim 1.
Finally, line 13 of claim 1, recites “outputting the assessed reliability rating”, a step that does not reflect the adapting or changing method. It is unclear if or how the “adapting or changing” step is related to the outputting step.
Claims 2-5 and 7-8 are rejected because they depend from an indefinite claim.
With respect to claim 22, a “processor is further configured to adapt or change a method for estimating the first metric …”. However, claim 11, from which claim 22 depends, recites “using a different method and/or algorithm” to estimate independently from each other a first and a second metric. It appears that “a method” in claim 22 is an additional method to that of claim 11. Or is it? How do the “a method” of claims 11 and 22 relate to one another? Consequently, the scope of claim 22 is vague and indefinite.
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 1-5, 7-8 and 10-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea including a mental process and a mathematical concept.
Step 1:
Claims 1-5, 7-8, 10, 16-19, and 22 claim a method (process); and claims 11-15 and 20-21 claim a device, system or non-transitory computer readable storage media (a product/manufacture). Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claims 1-5, 7-8, 10, 16-19, and 22 recite estimating independently from each other a first metric and a second metric using a different method and/or algorithm based on the one or more sensor signals where the first metric is related to the second metric via a mathematical function, determining a first value of the first mathematical function, comparing the first value to a bound of the first value, and assessing a reliability rating for the estimation of the first metric and/or the second metric based on the comparison,. The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitations in the mind with mathematical relationships and insignificant extra-solution activity. With respect to claims 11-15 and 20-21, the device and system recite a processor and insignificant extra-solution activity (i.e., sensor input/sensor, information output/user interface). The non-transitory computer readable storage media implies that a computerized system is performing these limitations and nothing in the claims precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper, to be an abstract idea. In this case, aside from the recitation of the “obtaining” and “outputting the assessed reliability rating” steps (insignificant extra-solution activity), claims 1-5, 7-8, and 10-22 encompass a user observing clinical data and making a judgement using mathematical relationships.
Step 2A, Prong 2:
Claims 1 and 11 recite obtaining one or more sensor signals (extra-solution activity of data gathering), and outputting the assessed reliability rating (post extra-solution activity of data outputting). This judicial exception is not integrated into a practical application because neither the obtaining step nor outputting step integrates the judicial exception of mental process using mathematical relationships into a practical application as both additional elements are tangential to the extra-solution activity of data gathering and do nothing to integrate the mental processes of estimating a first metric and a second metric based on the one or more sensor signals, determining a value of a mathematical function, comparing the value to a bound of the mathematical function and assessing a reliability rate for the estimated metrics based on the comparison abstract idea.
Claim 1, as amended, and claim 22 include adapting or changing a method for estimating the first metric and/or the second metric based on the reliability rating; but, this feature does not result in the abstract idea/judicial exception being integrated into a practical application because the claims, as drafted, recite an adapting or changing feature that does not relate the estimating, determining, comparing, and assessing abstract processes and does nothing to integrate the abstract/mental processes using mathematical relationships into a practical application.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims, taken as a whole, do not integrate the recited judicial exception into a practical application. Thus, the above-identified claims are directed to the judicial exception.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7-8, and 10-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2019/0076070 to Nogueira et al. (hereinafter referred to as “Nogueira”).
Regarding claim 1, Nogueira discloses a method for assessing reliability of an estimated metric relating to a physiological state of a user (e.g., title and abstract: method for calibration and optimization of glucose sensors to improve accuracy and reliability), the method comprising: obtaining one or more sensor signals relating to the physiological state of the user (e.g., paragraph [0002]: sensors sense a variety of physiological parameters); estimating independently from each other a first metric and a second metric using a different method and/or algorithm based on the one or more sensor signals (e.g., paragraphs [0012]: measuring electrode current (Isig) signals for the sensing electrodes, generating electrochemical impedance spectroscopy (EIS) data for the sensing electrodes, based on the Isig signals, EIS-related data, and a plurality of predictive models, a respective sensor glucose (SG) value is calculated/estimated for each predictive model (first metric and second metric), wherein the first metric is related to the second metric by a first mathematical function (e.g., paragraph [0012]: fusing the respective SG values (first and second metrics) to calculate (implies a mathematical function) a single, fused SG value); determining a first value of the first mathematical function (e.g., paragraph [0012]: single, fused SG value); comparing said first value to a bound of the first value (e.g., paragraphs [0012]: error detection analysis; [0343]: the details of the fusion algorithm 3440 for SG fusing includes a bound check to determine whether the parameters/values are within specified ranges – comparative step to bounds of the first value); assessing a reliability rating for the estimation of the first metric and/or the second metric based on said comparison (e.g., paragraphs [0343]- [0349]: the output from each Bound Check and the Noise Check is a respective reliability index (RI) or a reliability rating); adapting or changing a method for estimating the first and/or the second metric based on the reliability rating (e.g., paragraphs [0012]: calculating, by the microcontroller, a modification factor based on physiological calibration factor, an environmental calibration factor, or both and determining, by the microcontroller, whether the calculated modification value is valid …; [0775]: assessment of reliability of sensor glucose values, as well as estimation of sensor-data error direction provides users and systems to assign a corresponding weight to the sensor glucose values of the method thereby changing a method) and outputting the assessed reliability rating (see Fig. 34 – RI is output).
With respect to claim 2-4, Nogueira discloses the method as claimed in claim 1, wherein comparing said first value to the bound of the first value comprises determining whether the first value fulfils a relationship between the first mathematical function and the bound, wherein the bound is a lower bound and/or an upper bound, and wherein comparing said first value to the bound of the first value comprises determining whether the first value is higher than the lower bound and/or lower than the upper bound (e.g., paragraphs [0226]: the analyzation module may compare the sensed impedance against a threshold or target impedance value (bound) and if the measured impedance is lower that the target or threshold impedance (upper bound), the analyzation may determine that the sensor is stabilized and that the sensor signal/reading may be utilized).
As to claim 5, Nogueira discloses the method as claimed in claim 1, wherein the bound is predetermined or wherein the method further comprises estimating the bound based on any of a previous first metric, a previous second metric, a previous first value or the one or more sensor signals (e.g., paragraph [0343]: the bound is predetermined).
As to claim 7, Nogueira discloses the method as claimed in claim 1, further comprising determining a second value of a second mathematical function relating the first mathematical function to the bound, wherein assessing the reliability rating for the estimation of the first metric and/or the second metric is based on the second value (e.g., paragraphs [0343]-[0346]: RI calculation is the second mathematical function, which is related to the bound, and the reliability rating RI is based on the second value of the second mathematical function).
With respect to claim 8, Nogueira discloses the method as claimed in claim 1, wherein assessing the reliability rating comprises assigning a score of a binary or continuous scale to the estimation of the first metric and/or second metric (e.g. paragraphs [0346] and [0348]: RI_sim (similarity index) if RI_sim is less than ), it will be set to zero, and if it is higher than 1, it will be set to one (binary scale and a continuous scale if RI_sim is between 0 and 1).
With respect to claim 10, Nogueira discloses the method as claimed in claim 1, wherein the one or more sensor signals comprise at least one of an acceleration signal, a gyroscope signal, a heart rate signal, a respiration signal, an oxygen saturation signal, a motion signal, a force signal, a pressure signal, an electromyography signal, a temperature signal, a calorie expenditure signal, a global positioning system signal, a camera signal, a radar signal, a speed measurement signal, a torque measurement signal, an electrocardiography signal, an electroencephalography signal, photoplethysmography signal, a barometer signal, a muscle tone signal, a sweat level signal, a stress level signal, a skin conductance signal, a galvanic skin response signal, an inertial measurement signal; or a blood pressure signal (e.g., paragraph [0838]: a heart rate measurement may be obtained from the wearable device – that is, one of the sensors of the obtaining step of claim 1 may be a heart rate sensor).
Referring to claim 11, Nogueira discloses a device for assessing reliability of an estimated metric relating to a physiological state of a user (e.g., title and abstract: method for calibration and optimization of glucose sensors to improve accuracy and reliability), the device comprising: a sensor input configured to obtain one or more sensor signals relating to the physiological state of the user (e.g., paragraph [0002]: sensors sense a variety of physiological parameters); a processor (e.g., paragraph [0185]: disclose methods may include a processor in a sensor electronics device) configured to: - estimate independently from each other a first metric and a second metric using a different method and/or algorithm based on the one or more sensor signals (e.g., paragraphs [0012]: measuring electrode current (Isig) signals for the sensing electrodes, generating electrochemical impedance spectroscopy (EIS) data for the sensing electrodes, based on the Isig signals, EIS-related data, and a plurality of predictive models, a respective sensor glucose (SG) value is calculated/estimated for each predictive model (first metric and second metric), wherein the first metric is related to the second metric by a first mathematical function (e.g., paragraph [0012]: fusing the respective SG values (first and second metrics) to calculate (implies a mathematical function) a single, fused SG value); - to determine a first value of the first mathematical function (e.g., paragraph [0012]: single, fused SG value); - to compare said first value to a bound of the first value (e.g., paragraphs [0012]: error detection analysis; [0343]: the details of the fusion algorithm 3440 for SG fusing includes a bound check to determine whether the parameters/values are within specified ranges – comparative step to bounds of the first value); and - to assess a reliability rating for the estimation of the first metric and/or the second metric based on said comparison (e.g., paragraphs [0343]- [0349]: the output from each Bound Check and the Noise Check is a respective reliability index (RI) or a reliability rating); and an information output configured to output the assessed reliability rating (see Fig. 34 – RI is output and paragraph [0775]: an indicator of how reliable the system is displayed when SG is displayed to the user).
With respect to claim 12, Nogueira discloses a system for assessing reliability of an estimated metric relating to a physiological state of a user (e.g., title and abstract), the system comprising: a sensor configured to measure one or more sensor signals relating to the physiological state of the user (e.g., paragraph [0002]); the device as claimed in claim 11 (see rejection of claim 11 above); and a user interface configured to issue the reliability rating of the device (e.g. paragraphs [0204]: microcontroller 410 may transfer the measurements of the physiological characteristic values to a display, an external device, a computer, a personal digital assistant, a pager, a cellular phone, etc.; [0775]: an indicator of how reliable the system is displayed when SG is displayed to the user; [0837]: RPM and REM values are determined to be valid … Information on which supported RPM and REM values are “actionable” is input in to the system through a user interface).
As to claim 13, Nogueira discloses the system as claimed in claim 12, wherein the sensor comprises at least one of an accelerometer, a gyroscope, a heart rate, a respiration sensor, an oxygen saturation sensor, a motion sensor, a force sensor, a pressure sensor, an electromyography sensor, a temperature sensor, a calorie expenditure sensor, a global positioning system sensor, a camera, a radar, a speed measurement sensor, a torque measurement sensor, an electrocardiography sensor, an electroencephalography sensor, photoplethysmography sensor, a barometer sensor, a muscle tone sensor, a sweat level sensor, a stress level sensor, a skin conductance sensor, a galvanic skin response sensor, an inertial measurement sensor; or a blood pressure sensor (e.g., paragraph [0838]: a heart rate measurement may be obtained from the wearable device – that is, the sensor of claim 12 may include a heart rate sensor).
With respect to claim 14, Nogueira discloses the system as claimed in claim 12, wherein the sensor is a remote sensor or a wearable sensor (e.g., paragraphs [0005]: remote sensor; and [0838]: wearable sensor).
As to claim 15, Nogueira discloses a non-transitory computer-readable medium storing a computer program comprising program code that, when executed by a processor, causes a computer to carry out the steps of the method of claim 1 (e.g., paragraph [0185]: computer program products where flowchart can be implemented by programming instructions).
With respect to claims 16-18, Nogueira discloses the method as claimed in claim 1, wherein the first metric/second metric comprises at least one of walking speed, step rate, step length, heart rate, energy expenditure or activity type (e.g., paragraph [0844]: one of more of activity level (activity type), heart rate status information are received, and then are separately evaluated validity where valid measurements are combined to generate a physiological calibration factor).
As to claims 19-21, Nogueira discloses the method as claimed in claim 1, the device as in claim 11, and the non-transitory computer-readable medium as claimed in claim 15, wherein the first mathematical function represents a third metric different from the first metric and from the second metric (e.g., paragraph [0012]: SG values (first and second metrics) and fused SG values (third metric)), and wherein the bound is a physiological or anatomical bound of the third metric (e.g., . paragraph [0012] where the bound is related to physiological or anatomical bound of the third metric, which is a fused sensor glucose calculation).
With respect to claim 22, Nogueira discloses the device as claimed in claim 11, wherein the processor is further configured to adapt or change a method for estimating the first metric and/or the second metric based on the reliability rating (e.g., paragraphs [0012]: calculating, by the microcontroller, a modification factor based on physiological calibration factor, an environmental calibration factor, or both and determining, by the microcontroller, whether the calculated modification value is valid …; [0775]: assessment of reliability of sensor glucose values, as well as estimation of sensor-data error direction provides users and systems to assign a corresponding weight to the sensor glucose values of the method thereby changing a method) and outputting the assessed reliability rating (see Fig. 34 – RI is output).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
