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 .
Claim Status
Claims 1-20 are pending and examined herein.
Claims 1-20 are rejected.
Claim 1 is objected to.
Priority
Claims 1-20 are granted the claim to the benefit of priority to U.S. Provisional application 62/945800 filed 09 December 2019. Thus, the effective filling date of claims 1-20 is 09 December 2019.
Information Disclosure Statement
The information disclosure statements (IDS) were received on 06 July 2023, 13 December 2023, and 24 December 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Drawings
The drawings received 29 June 2023 are accepted.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “to estimate glucose level…” in line 24 of the claim but should read “to estimate a glucose level…”. Appropriate correction is required.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
(Step 1)
Claims 1-11 fall under the statutory category of a process and claims 12-20 fall under the statutory category of a machine.
(Step 2A Prong 1)
Under the BRI, the instant claims recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mathematical concept”, such as mathematical relationships, mathematical calculations and mathematical equations.
Independent claims 1 and 12 recite mathematical concepts of “determining a generative model for the first glucose sensor, wherein the generative model is configured to generate a simulated measurement… and determining the generative model comprises identifying relationships between…” , “generating a set of simulated measurements using the generative model, wherein generating the set of simulated measurements comprises applying operating conditions observed with respect to a second glucose sensor as inputs to the generative model… with measurements made using the second glucose sensor”, “determining an estimation model based on relationships between the simulated measurements and the reference glucose values…wherein the estimation model is configured to estimate glucose level given one or more sensor measurements from the first glucose sensor”.
Dependent claim 5 recites a mental process of “determining a delivery command for an insulin infusion device based on a glucose level…”. Dependent claims 9 and 19 recite a mathematical concept of “training a first neural network to generate the simulated measurements, using calibration factor values, age values, and reference glucose values…”. Dependent claims 10 and 20 recite a mathematical concept of “training a second neural network to generate an indication of whether an output of the first neural network is plausible give a particular combination of inputs…”.
The claims recite mathematical concepts as determining a generative model for the first glucose sensor (which encompasses deriving a function which maps numerical sensor data to reference glucose values), generating a set of simulated measurements using the generative model (which encompasses utilizing the derived function to produce numerical sensor measurement values), determining an estimation model based on relationships between the simulated measurements and the reference glucose values (which encompasses deriving a function which maps numerical simulated measurements to reference glucose values), and training neural networks (which encompasses applying a backpropagation algorithm and a gradient descent algorithm). The MPEP states “There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation” (see MPEP 2106.04(a)(2)(I)(C)). These steps all recite mathematical concepts of mathematical calculations of deriving functions defining the relationships between numerical values, inputting numerical data into these functions to produce numerical outputs, and adjusting neural network parameters using a backpropagation algorithm and a gradient descent algorithm that implement a series of mathematical calculations. Dependent claims 2-4, 6-8, and 13-18 further limit the mathematical concept recited in the independent claim but do not change their nature as a mathematical concept.
(Step 2A Prong 2)
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). Integration into a practical application is evaluated by identifying whether there are any additional elements recited in the claim and evaluating those additional elements to determine whether they integrate the exception into a practical application.
The additional elements in claims 1 and 12 of obtaining sensor measurements from different instances of the first glucose sensor together with corresponding reference glucose values (i.e., receiving data) and communicating the estimation model to an electronic device (i.e., outputting data) do not integrate the judicial exceptions because this is adding insignificant extra solution activity of data gathering and outputting. These additional elements only interact with the judicial exceptions by providing data to be processed by the judicial exceptions and providing output of the judicial exceptions. It is noted that the content of the data being receiving and the content of the output fall under the judicial exception and do not change the active step of obtaining data in a computer environment and outputting data from a computer environment.
The additional element in claims 1 and 12 of using a generic computer to perform judicial exceptions does not integrate the judicial exceptions into a practical application because this is applying the judicial exception to a generic computer environment without an improvement to computer technology. The additional element of the generic computer only interacts with the judicial exceptions by being utilized as a tool to perform the judicial exceptions.
Thus, the additional elements do not integrate the judicial exceptions into a practical application and claims 1-20 are directed to the abstract idea.
(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 because:
The additional elements in claims 1 and 12 of obtaining sensor measurements from different instances of the first glucose sensor together with corresponding reference glucose values (i.e., receiving data) and communicating the estimation model to an electronic device (i.e., outputting data) are conventional as shown by MPEP 2106.05(b) and MPEP 2106.05(d)(II). It is noted that the content of the data being receiving and the content of the output fall under the judicial exception and do not change the active step of obtaining data in a computer environment and outputting data from a computer environment.
The additional element in claims 1 and 12 of using a generic computer to perform judicial exceptions is conventional as shown by MPEP 2106.05(b) and MPEP 2106.05(d)(II).
Thus, the additional elements are not sufficient to amount to significantly more than the judicial exception because they are conventional.
Conclusion
No claims are allowed.
Claims 1-20 are free of the prior art.
Varsavsky et al. (US 20170209082 A1; newly cited) is made of record for being the closest prior art to the instant claimed invention. Varsavsky et al. shows calibration of sensors with different designs (optical and electrochemical) and estimating a glucose level utilizing data from both the optical and electrochemical sensors. Varsavsky et al. does not show a generative model determined using reference values and a first sensor measurement, generating simulated measurements by applying operating conditions observed with respect to a second glucose sensor using a generative model, or determining an estimation model based on relationships between simulated measurements and the reference glucose values obtained in connection with measurements made using the second glucose sensor.
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/J.E.H./Examiner, Art Unit 1685
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685