DETAILED ACTION
Applicant’s response filed 1/29/2026 has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied.
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 .
Status of the Claims
Claims 1-15 and 21-35 are pending and under consideration in this action. Claims 16-20 were canceled in the amendment filed 1/29/2026.
Priority
The instant application is 371 of PCT/IB2020/056467, filed 7/9/2020, which claims priority to U.S. Provisional Application number 62/871,931, filed 7/9/2019, as reflected in the filing receipt mailed 6/3/2022. The claim for domestic benefit for claims 1-15 and 21-35 is acknowledged. As such, the effective filing date of claims 1-15 and 21-35 is 7/9/2019.
Specification
The objection to the Specification is withdrawn in view of Applicant’s amendments to the Specification filed 1/29/2026 (Applicant’s Remarks, Pg. 10).
Claim Objections
The objection to claims 2, 22, and 33 are withdrawn in view of Applicant’s amendments to the claims filed 1/29/2026 (Applicant’s Remarks, Pg. 10).
Claim Rejections - 35 USC § 112(b)
The rejection of claims 10, 12-13, 15, 20, 30, 32-33 and 35 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments or cancellation of the claims filed 1/29/2026 (Applicant’s Remarks, Pg. 10).
Claim Rejections - 35 USC § 101
Maintained Rejections
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 1-15 and 21-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite both (1) mathematical concepts (mathematical relationships, formulas or equations, or mathematical calculations) and (2) mental processes, i.e., concepts performed in the human mind (including observations, evaluations, judgements or opinions) (see MPEP § 2106.04(a)).
Any newly recited portion is necessitated by claim amendment.
Step 1:
In the instant application, claims 1-15 are directed towards a method, and claims 21-35 are directed towards a system, which falls into one of the categories of statutory subject matter (Step 1: YES).
Step 2A, Prong One:
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong One). The following instant claims recite limitations that equate to one or more categories of judicial exceptions:
Claim 1 recites a mathematical concept (i.e., calculation using algorithms) in “for each of a set of hypothetical meals, each hypothetical meal having a meal size and a meal time, calculating, by the electronic device, a test statistic by: determining, using a linear Kalman filter, an innovation parameter and an innovation covariance parameter based on the subject model parameters, a previous state of the subject, and the meal size and the meal time of the hypothetical meal, wherein the innovation parameter is indicative of a difference between an actual glucose measurement and a predicted glucose measurement; and calculating the test statistic based on the determined innovation parameter and the innovation covariance parameter"; a mental process (i.e., an evaluation of the value compared to a threshold) in "comparing each calculated test statistic to a given threshold"; and a mental process (i.e., an evaluation of the test statistic above a threshold to determine the unannounced meal) in “in response to the calculated test statistic being above the given threshold, determining that the unannounced meal has been consumed by the subject”.
Claims 2 and 22 recite a mathematical concept (i.e., an estimation using an algorithm with input parameters) in "estimating the subject model parameters based on: the actual glucose measurements, and the past subject model parameters".
Claims 4 and 24 recite a mental process (i.e., an evaluation of the test statistic) in "wherein the test statistic being above the given threshold is indicative of the Kalman filter being inconsistent".
Claims 5 and 25 recite a mathematical concept (i.e., an estimation using an algorithm) in "wherein said estimating the subject model parameters comprises using a maximum posteriori probability (MAP) estimate".
Claims 6 and 26 recite a mathematical concept (i.e., an estimation using an algorithm with input parameters) in "wherein said estimating [the subject model parameters] is further based on: previous glucose measurements, previous insulin measurements and previous consumed meals".
Claims 7 and 27 recite a mental process (i.e., an evaluation of the test statistic) in "wherein the test statistic being above the given threshold is indicative of the innovation parameter not being: independent and identically distributed with a zero-mean Gaussian distribution with a covariance corresponding to the covariance of the innovation parameter".
Claims 8 and 28 recite a mental process (i.e., an evaluation of the parameters) in “wherein the subject model parameters represent a glucoregulatory system of the subject”.
Claims 9 and 29 recite a mental process (i.e., an evaluation of false positives to determine the threshold) in "wherein the given threshold is based on a predetermined number of false positives".
Claims 10 and 30 recite a mental process (i.e., an evaluation of parameters for input into the model) in "initializing the past subject model parameters based on: a daily total dose, a basal insulin, and a carbohydrate ratio of the subject".
Claims 12 and 32 recite a mental process (i.e., an evaluation of a logged meal based on parameters) in "determining an insulin bolus for the unannounced meal based on: a remaining meal size, a patient carbohydrate ratio, and a glucose level".
Claims 13 and 33 recite a mathematical concept (i.e., using an algorithm to determine output parameters) in "determining, based on the innovation parameter and the innovation covariance parameter, a meal amount and a meal time of the unannounced meal".
Claims 14 and 34 recite a mathematical calculation in "wherein the calculated test statistic is representative of a cumulative sum of a correlation between the innovation parameter and a glucose change based on the meal amount and the meal time weighted by the innovation covariance parameter".
Claims 15 and 35 recites a mathematical calculation in "wherein the given threshold is determined based on a: given false positive rate for a random variable with a zero-mean Gaussian distribution and covariance proportional to a square of a most probable glucose increase due to a most probable meal amount and meal time weighted by the innovation covariance parameter".
Claim 21 recites a mathematical concept in “for each of a set of hypothetical meals, each hypothetical meal having a meal size and a meal time, calculating a test statistic by: determining, using a linear Kalman filter, an innovation parameter and an innovation covariance parameter based on the subject model parameters, a previous state of the subject, and the meal size and the meal time of the hypothetical meal, wherein the innovation parameter is indicative of a difference between an actual glucose measurement and a predicted glucose measurement”; a mathematical concept in “calculating the test statistic based on the determined innovation parameter and the innovation covariance parameter”; a mental process (i.e., a comparison of data) in “comparing each calculated test statistic to a given threshold”; and a mental process (i.e., an evaluation of the test statistic above a threshold to determine the unannounced meal) in “in response to the calculated test statistic being above the given threshold, determining that the unannounced meal has been consumed by the subject”.
These recitations are similar to the concepts of collecting information, and displaying certain results of the collection and analysis is Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)), and organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships.
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification, and are determined to be directed to mental processes that in the simplest embodiments are not too complex to practically perform in the human mind. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Specifically, claims 1 and 21 involve nothing more than calculating a test statistic using a linear Kalman filter, an innovation parameter, and an innovation covariance parameter, and determining an unannounced meal based on the test statistic being above a threshold. The step of calculating a test statistic, us under the BRI, performed using mathematical operations. The instant Specification (see Para. [0119]) discloses that the Kalman filter, also known as linear quadratic estimation, is a set of equations implementing a predictor-corrector type estimator to minimize an estimated covariance when conditions are respected. Additionally, the step of determining an unannounced meal based on the test statistic being above a threshold is something that, under the BRI, one could perform mentally. Therefore, the claimed steps are not further defined beyond something that reads on performing a calculation using a computer as a tool, and merely looking at data and making a determination. As such, said steps are directed to judicial exceptions. The instant claims must therefore be examined further to determine whether they integrate the abstract idea into a practical application (Step 2A, Prong One: YES).
Step 2A, Prong Two:
In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP § 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP § 2106.04(d)(I)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP § 2106.04(d)(III)). The following independent claims recite limitations that equate to additional elements:
Claim 1 recites “an electronic device”; “receiving actual glucose measurements of the subject transmitted by a glucose monitor over a communication network”; “receiving subject model parameters of a state-based model of the subject”; “outputting an indication of the unannounced meal to at least one of a display-interface and an insulin delivery system”; and “delivering an insulin bolus to the subject based on the indication of the unannounced meal”.
Claim 21 recites “an electronic device comprising a processor, a display-interface, and a non-transitory storage medium operatively connected to the processor, the storage medium comprising computer-readable instructions”; “an insulin delivery system including at least one of an infusion pump and an injection device”; “a glucose sensor operatively connected to the electronic device and configured to transmit glucose measurements of the subject to the electronic device”; “receiving subject model parameters of a state-based model of the subject”, and “outputting an indication of the unannounced meal to the electronic device”.
Regarding the above cited limitations in claims 1 and 21 of (i) an electronic device; and (ii) an electronic device comprising a processor, a display-interface, and a non-transitory storage medium operatively connected to the processor, the storage medium comprising computer-readable instructions. These limitations require only a generic computer component, which does not improve computer technology. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983.
Regarding the above cited limitations in claims 1 and 21 of (iii) receiving actual glucose measurements of the subject transmitted by a glucose monitor over a communication network; (iv) receiving subject model parameters of a state-based model of the subject; (v) an insulin delivery system including at least one of an infusion pump and an injection device; and (vi) a glucose sensor operatively connected to the electronic device and configured to transmit glucose measurements of the subject to the electronic device. These limitations equate to insignificant, extra-solution activity of mere data gathering because these limitations gather data before or after the recited judicial exceptions of calculating a test statistic and comparing the test statistic to a threshold to determine the unannounced meal (see MPEP § 2106.04(d)).
Regarding the above cited limitations in claims 1 and 21 of (vii) outputting an indication of the unannounced meal to at least one of a display-interface and an insulin delivery system; and (viii) outputting an indication of the unannounced meal to the electronic device. This limitation equates to an extra-solution activity of generally outputting a result, which is incidental to the primary process of calculating a test statistic and comparing the test statistic to a threshold to determine the unannounced meal (see MPEP § 2106.05(g)).
Regarding the above cited limitation in claim 1 of (ix) delivering an insulin bolus to the subject based on the indication of the unannounced meal. This limitation equates to an extra-solution “apply it” step because this limitation is physically used to deliver an insulin bolus to the subject when an unannounced meal is detected without providing any details about how, for example, the insulin bolus dosage is determined for any subject (see MPEP § 2106.05(f)).
Additionally, none of the recited dependent claims recite additional elements which would integrate the judicial exception into a practical application. Specifically, claims 2, 11, 22, and 31 recite data gathering steps analogous to claims 1 and 21 above; and claims 3 and 23 recites extra-solution activity of generally outputting an indication of an insulin bolus analogous to claims 1 and 21 above. As such, claims 1-15 and 21-35 are directed to an abstract idea (Step 2A, Prong Two: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant independent claims recite the same additional elements described in Step 2A, Prong Two above.
Regarding the above cited limitations in claims 1 and 21 of (i) an electronic device; and (ii) an electronic device comprising a processor, a display-interface, and a non-transitory storage medium operatively connected to the processor, the storage medium comprising computer-readable instructions. These limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept (see MPEP § 2106.05(d) and MPEP § 2106.05(f)).
Regarding the above cited limitations in claims 1 and 21 of (iii) receiving actual glucose measurements of the subject transmitted by a glucose monitor over a communication network; (iv) receiving subject model parameters of a state-based model of the subject; and (vi) a glucose sensor operatively connected to the electronic device and configured to transmit glucose measurements of the subject to the electronic device. These limitations do not include any specific steps acquiring glucose measurements or subject model parameters. Under the BRI, these limitations are merely receiving data for the subsequent step of calculating a test statistic and comparing the test statistic to a threshold to determine the unannounced meal. Therefore, these limitations equate to receiving/transmitting data over a network, which the courts have established as a WURC limitation of a generic computer in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
Regarding the above cited limitations in claims 1 and 21 of (v) an insulin delivery system including at least one of an infusion pump and an injection device; (vii) outputting an indication of the unannounced meal to at least one of a display-interface and an insulin delivery system; (viii) outputting an indication of the unannounced meal to the electronic device; and (ix) delivering an insulin bolus to the subject based on the indication of the unannounced meal. These limitations when viewed individually and in combination, are WURC limitations as taught by Harvey et al. (Design of the Glucose Rate Increase Detector: A Meal Detection Module for the Health Monitoring System. Journal of Diabetes Science and Technology 8(2): 307-320 (2014); cited in the IDS dated 1/6/2022). Harvey et al. discloses a Glucose Rate Increase Detector, designed to operate in parallel to the glucose controller to detect meal events and safely trigger a meal bolus (Abstract). Harvey et al. further discloses a block diagram of the fully automated system, including an insulin pump, glucose controller, and continuous glucose monitor (limitation (v)) (Pg. 310, Fig. 2). In the automated system, the detection of a meal and bolus recommendation are relayed to the glucose controller (limitations (vii) and (viii)) (Pg. 310, Fig. 2). Harvey et al. further discloses in automatic mode, a medium-sized meal bolus or a correction to low normal glucose levels is calculated and delivered automatically (limitation (ix)) (Pg. 309, Col. 2, Para. 1 – Pg. 310, Col. 1, Para. 1).
These additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the instant claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1-15 and 21-35 are not patent eligible.
Response to Arguments under 35 U.S.C. 101
Applicant’s arguments filed 1/29/2026 have been fully considered but they are not persuasive.
1. Applicant argues that amended independent claims 1 and 21 do not recite an abstract idea. For example, amended claim 1 recites: receiving, by an electronic device, actual glucose measurements of the subject transmitted by a glucose monitor over a communication network; outputting an indication of the unannounced meal to at least one of a display-interface and an insulin delivery system; and delivering an insulin bolus to the subject based on the indication of the unannounced meal. At least the above recited steps do not involve an abstract idea. Amended claim 21 recites similar steps that do not recite an abstract idea (Applicant’s Remarks, Pg. 10-11).
It is respectfully submitted that Applicant’s arguments are not persuasive for the following reasons:
Examiner agrees that the limitations recited by Applicant above do not recite abstract ideas. However, the following limitations in amended claim 1 do recite abstract ideas, as described in Step 2A, Prong One above: “for each of a set of hypothetical meals, each hypothetical meal having a meal size and a meal time, calculating, by the electronic device, a test statistic by: determining, using a linear Kalman filter, an innovation parameter and an innovation covariance parameter based on the subject model parameters, a previous state of the subject, and the meal size and the meal time of the hypothetical meal, wherein the innovation parameter is indicative of a difference between an actual glucose measurement and a predicted glucose measurement; and calculating the test statistic based on the determined innovation parameter and the innovation covariance parameter"; "comparing each calculated test statistic to a given threshold”; and “in response to the calculated test statistic being above the given threshold, determining that the unannounced meal has been consumed by the subject”. Since the claim recites abstract ideas, further examination of the additional elements of the claim is performed to determine if the additional elements integrate the judicial exceptions into a practical application (Step 2A, Prong Two above). The limitations indicated by Applicant above correspond to a data-gathering step, an extra solution activity of displaying results, and an extra-solution “apply it” step, respectively (see Step 2A, Prong Two analysis above). Therefore, the claim is directed to an abstract idea. Further analysis of these limitations under Step 2B above shows that these limitations correspond to receiving/transmitting data over a network, and as WURC limitations taught by Harvey et al., respectively (see Step 2B analysis above). Similar arguments apply for amended claim 21. Therefore, amended claims 1 and 21 do not amount to significantly more than the judicial exception, and this argument is not persuasive.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 8-9, 13-14, 21, 28-29, and 33-34 under 35 U.S.C. 102(a)(1) as being anticipated by Mahmoudi et al. is withdrawn in view of Applicant’s amendments to the claims filed 1/29/2026 and Applicant’s Remarks were found persuasive (Applicant’s Remarks, Pg. 11-12). Mahmoudi et al. does not disclose the calculation of a test statistic using a linear Kalman filter incorporating the meal size and meal time of a hypothetical meal or comparison of the calculated test statistic to a threshold, as disclosed in amended claims 1 and 21.
Claim Rejections - 35 USC § 103
The rejection of claims 2-3, 6, 10-12, 22-23, 26, and 30-32 under 35 U.S.C. 103 as being unpatentable over Mahmoudi et al. in view of Cinar et al. is withdrawn in view of Applicant’s amendments to the claims filed 1/29/2026 and Applicant’s Remarks were found persuasive (Applicant’s Remarks, Pg. 11-12). Cinar et al. discloses the use of a Kalman filter for state estimation, but does not disclose the calculation of a test statistic using a linear Kalman filter incorporating the meal size and meal time of a hypothetical meal or comparison of the calculated test statistic to a threshold, as disclosed in amended claims 1 and 21.
The rejection of claims 4 and 24 under 35 U.S.C. 103 as being unpatentable over Mahmoudi et al. in view of Wang et al. is withdrawn in view of Applicant’s amendments to the claims filed 1/29/2026 and Applicant’s Remarks were found persuasive (Applicant’s Remarks, Pg. 11-12). Wang et al. discloses the use of an extended Kalman filter, but does not disclose the calculation of a test statistic using a linear Kalman filter incorporating the meal size and meal time of a hypothetical meal or comparison of the calculated test statistic to a threshold, as disclosed in amended claims 1 and 21.
The rejection of claims 5 and 25 under 35 U.S.C. 103 as being unpatentable over Mahmoudi et al. in view of Yates et al. is withdrawn in view of Applicant’s amendments to the claims filed 1/29/2026 and Applicant’s Remarks were found persuasive (Applicant’s Remarks, Pg. 11-12). Yates et al. discloses the use of a maximum posteriori probability (MAP) estimate, but does not disclose the use of a linear Kalman filter to calculate a test statistic, as disclosed in amended claims 1 and 21.
The rejection of claims 7, 16, 18-20, and 27 under 35 U.S.C. 103 as being unpatentable over Mahmoudi et al. in view of Xie et al. is withdrawn in view of Applicant’s amendments to the claims filed 1/29/2026 and Applicant’s Remarks were found persuasive (Applicant’s Remarks, Pg. 11-12). Xie et al. also does not disclose the calculation of a test statistic using a linear Kalman filter incorporating the meal size and meal time of a hypothetical meal or comparison of the calculated test statistic to a threshold, as disclosed in amended claims 1 and 21.
The rejection of claim 17 under 35 U.S.C. 103 as being unpatentable over Mahmoudi et al. in view of Xie et al. and Cinar et al. is withdrawn in view of Applicant’s amendments to the claims filed 1/29/2026 and Applicant’s Remarks were found persuasive (Applicant’s Remarks, Pg. 11-12). Xie et al. and Cinar et al. do not disclose the use of a linear Kalman filter to calculate a test statistic for the same reasons as disclosed above.
Conclusion
No claims allowed.
Claims 1-15 and 21-35 appear to be free from the prior art because the prior art does not fairly suggest or teach the calculation of a test statistic using a linear Kalman filter incorporating the meal size and meal time of a hypothetical meal or comparison of the calculated test statistic to a threshold. The closest prior art is Mahmoudi et al. (Sensor-based detection and estimation of meal carbohydrates for people with diabetes. Biomedical Signal Processing and Control 48: 12-25 (2019); previously cited). Mahmoudi et al. discloses a meal detection algorithm based on continuous glucose monitoring data, with steps of receiving glucose measurements and model parameters, using a Kalman filter to estimate a meal size, and calculating a bolus insulin dose if an unannounced meal is detected. However, Mahmoudi et al. does not teach the calculation of a test statistic using the linear Kalman filter incorporating the meal size and meal time of a hypothetical meal or comparison of the calculated test statistic to a threshold, as disclosed in instant claims 1 and 21. Claims 2-15 and 22-35 appear to be free from the prior art due to their dependency on claims 1 and 21.
THIS ACTION IS MADE FINAL. 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.
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/D.P.S./Examiner, Art Unit 1687
/Lori A. Clow/Primary Examiner, Art Unit 1687