DETAILED ACTION
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) submitted January 20, 2026. Claims 16, 18, and 20 are cancelled (Claims 4 – 5, 7 – 8, 25, and 27 were previously cancelled). Claims 30 – 32 are new. Claims 1 – 3, 6, 9 – 15, 17, 19, 21 – 24, 26, and 28 – 32 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 20, 2026 has been entered.
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 – 3, 6, 9 – 15, 17, 19, 21 – 24, 26, and 28 – 32 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 One
Claims 1 – 3, 6, 9 – 15, 17, 19, 21 – 24, 26, and 28 – 32 are drawn to a method, device, and non-transitory computer-readable storage medium, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1, 22, and 23 recite a method of detecting a missed bolus, the method comprising: determine a missed bolus for an insulin management system comprising: receiving blood glucose values and bolus information regarding a person with diabetes, the blood glucose values and the bolus information relating to a period of time, wherein the bolus information comprises aggregated bolus timing data; generating based on the blood glucose values and the bolus information, a meal probability density for the person with diabetes, wherein the meal probability density is based at least in part on the aggregated bolus timing data; classifying, based on the blood glucose values and the bolus information, one or more time periods of the period of time as relating to ingestion of a meal by the person with diabetes, wherein the classifying comprises providing the aggregated bolus timing data, including at least one classifier; performing regression analysis on the classified one or more time periods to identify a first time period that corresponds to a beginning of the meal, and that indicates no bolus; determining, based on the regression analysis and the meal probability density, a missed bolus event with the meal; and, outputting a real time alert when missed bolus event is detected.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which recites “The insulin treatment device further comprises a user interface, wherein the insulin treatment device is configured for issuing an alert regarding the person using the user interface, the alert issued based on the missed bolus event being associated with the meal” (paragraph 9 of the published specification). If a claim limitation, under its broadest reasonable interpretation, covers fundamental economic principles or practices and/or managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements:
Claims 1: “computer-implemented method using a machine learning model”, “processor”, “supervised machine learning model”, “first machine learning set”, “wherein the performing comprises providing at least an output of the first machine learning set to a second machine learning set including at least one regressor”, “display of an electronic device”
Claims 2 – 3, 9, 11 – 15, 17 – 19, 21, 28, 31, 32: “computer-implemented method”
Claim 6: “computer-implemented method”, “receiving data inferred by a pen cap …. capping event of the pen cap on the insulin pen”
Claim 10: “computer-implemented method”, “classifier based on a kernel smoothed density”
Claim 22: “an insulin management system using a machine learning model to determine a missed bolus”, “input device”, “at least one processor in communication with the input device, the processor coupled to a memory storing instructions that when executed cause the processor to perform operations”, “supervised machine learning model”, “first machine learning set”, “wherein the performing comprises providing at least an output of the first machine learning set to a second machine learning set including at least one regressor”, “display of an electronic device”
Claim 23: “a computer program product stored in a non-transitory storage medium, the computer program product comprising a machine learning model to determine a missed bolus for an insulin management system, the computer program product including instructions that when executed by at least one processor cause the at least one processor to perform operations”, “supervised machine learning model”, “first machine learning set”, “wherein the performing comprises providing at least an output of the first machine learning set to a second machine learning set including at least one regressor”, “display of an electronic device”
Claim 29: “computer-implemented method”, “supervised machine learning model”
Claim 30: “computer-implemented”, “training, by the processor, the at least one classifier of the first machine learning set and the at least one regressor of the second machine learning … an output of the at least one regressor is based at least in part on a range of outputs of the at least one classifier”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0041] Some examples herein refer to a mobile communication device. As used herein a mobile communication device includes, but is not limited to, a mobile phone, a smartphone, a wearable electronic device (e.g., a smart watch), a tablet, a laptop computer, a portable computer, and similar devices. A mobile communication device includes one or more processors, a non-transitory storage device (e.g., a memory and/or a hard drive) holding executable instructions for operating the mobile communication device, wireless communication components, and one or more input and/or output devices (e.g., a touchscreen, display, or keyboard). The mobile communication device can operate according to one or more application programs stored locally on the mobile communication device, or remotely (e.g., when using cloud computing), or combinations thereof. The mobile communication device can execute at least one operating system in order to perform functions and services.
[0170] The computing device 2000 includes, in some embodiments, at least one processing device 2002 ( e.g., a processor), such as a central processing unit (CPU). A variety of processing devices are available from a variety of manufacturers, for example, Intel or Advanced Micro Devices. In this example, the computing device 2000 also includes a system memory 2004, and a system bus 2006 that couples various system components including the system memory 2004 to the processing device 2002. The system bus 2006 is one of any number of types of bus structures that can be used, including, but not limited to, a memory bus, or memory controller; a peripheral bus; and a local bus using any of a variety of bus architectures.
[0171] Examples of computing devices that can be implemented using the computing device 2000 include a desktop computer, a laptop computer, a tablet computer, a mobile computing device (such as a smart phone, a touchpad mobile digital device, or other mobile devices), or other devices configured to process digital instructions.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 3, 6, 9 – 21, 24, 26, and 28 – 29 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
The rejection of Claim(s) 1 – 3, 18 – 20, and 22 – 23 under 35 U.S.C. 103 as being unpatentable over Estes (U.S. Publication Number 2010/0094251 A1) in view of Datye et al., herein after Datye (Datye, K. A., Boyle, C. T., Simmons, J., Moore, D. J., Jaser, S. S., Sheanon, N., Kittelsrud, J. M., Woerner, S. E., & Miller, K. M. (2018). Timing of meal insulin and its relation to adherence to therapy in Type 1 diabetes. Journal of Diabetes Science and Technology, 12(2), 349-355. https://doi.org/10.1177/193229681772852) further in view of Zheng et al., herein after Zheng (Zheng, M., Ni, B., & Kleinberg, S. (2019). Automated meal detection from continuous glucose monitor data through simulation and explanation. Journal of the American Medical Informatics Association, 26(12), 1592-1599. https://doi.org/10.1093/jamia/ocz159) were withdrawn in the Office Action mailed February 11, 2025.
The rejection of Claim(s) 4 – 6, 8 – 17, and 21 under 35 U.S.C. 103 as being unpatentable over Estes (U.S. Publication Number 2010/0094251 A1) in view of Datye et al., herein after Datye (Datye, K. A., Boyle, C. T., Simmons, J., Moore, D. J., Jaser, S. S., Sheanon, N., Kittelsrud, J. M., Woerner, S. E., & Miller, K. M. (2018). Timing of meal insulin and its relation to adherence to therapy in Type 1 diabetes. Journal of Diabetes Science and Technology, 12(2), 349-355. https://doi.org/10.1177/193229681772852) and Zheng et al., herein after Zheng (Zheng, M., Ni, B., & Kleinberg, S. (2019). Automated meal detection from continuous glucose monitor data through simulation and explanation. Journal of the American Medical Informatics Association, 26(12), 1592-1599. https://doi.org/10.1093/jamia/ocz159) further in view of Constantin et al., herein after Constantin (WO 2019/157102 A1) were withdrawn in the Office Action mailed February 11, 2025.
Response to Arguments
Applicant's arguments filed January 20, 2026 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Claim Rejections under 35 USC § 101
The Applicant argues claims 1, 22, and 23 are integrated into a practical application that utilizes a two-stage supervised machine learning protocol using aggregated bolus timing data to improve accuracy of missed bolus detection and provide a real time alert when a missed bolus is detected, thereby improving the functioning of insulin management technology. The Examiner respectfully disagrees.
The Examiner submits in Enfish, for example, the Court found that "the claims at issue focused not on asserted advances in uses to which existing computer capabilities could be put, but on a specific improvement in how computer could carry out one of their basic functions of storage and retrieval of data”. Here, the focus of the claims is not on such an improvement in computers as tools, but on abstract ideas that use computers as tools. The claims here do not require any nonconventional computer, network or display components, or even a "non-conventional and non-generic arrangement of known, conventional pieces”. This conclusion is supported by the Applicant’s published specification: “[0170] The computing device 2000 includes, in some embodiments, at least one processing device 2002 ( e.g., a processor), such as a central processing unit (CPU). A variety of processing devices are available from a variety of manufacturers, for example, Intel or Advanced Micro Devices. In this example, the computing device 2000 also includes a system memory 2004, and a system bus 2006 that couples various system components including the system memory 2004 to the processing device 2002. The system bus 2006 is one of any number of types of bus structures that can be used, including, but not limited to, a memory bus, or memory controller; a peripheral bus; and a local bus using any of a variety of bus architectures.” and “[0171] Examples of computing devices that can be implemented using the computing device 2000 include a desktop computer, a laptop computer, a tablet computer, a mobile computing device (such as a smart phone, a touchpad mobile digital device, or other mobile devices), or other devices configured to process digital instructions.” Further the claims, unlike Enfish, use existing computers as tools in aid of processes focused on abstract Ideas.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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/KRISTINE K RAPILLO/Examiner, Art Unit 3682
/K.K.R/Examiner, Art Unit 3682
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