DETAILED ACTION
Status of Claims
This is a Final Office Action in response to the arguments and/or amendments filed on 27 July 2026.
Claim(s) 16, 20, 22, 24, 27, and 28 is/are amended.
Claim(s) 16-35 is/are currently pending and have been examined.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 27 July 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 16-35 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 16, which is representative of claims 20 and 24, recites in part, a method for predicting a status of an infusion site, the method comprising:
applying, values of selected metrics, and the selected metrics include at least one glucose variability metric, at least one glucose risk metric, and total insulin bolus;
operating,
based on the output, determining that the infusion site has failed or is likely to have failed.
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of evaluating data to predict whether an infusion site has failed. This concept describes a mental process that a care provider should follow to monitor an insulin pump similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such, these limitation set forth a method of organizing human activity. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claim 16 recites the additional element of an electronic controller. Claim 20 recites the additional element of a non-transitory computer-readable medium. Claim 24 recites the additional element of a controller including a processor and memory. These additional elements are all recited at an extremely high level of generality and are interpreted as generic computing devices used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not integrate the abstract idea into a practical application. The claims further recite the additional element of a trained machine learning model. At the level of generality claimed, this additional element amounts to instructions to implement the abstract idea with a computing device. As previously noted, such additional elements do not integrate an abstract idea into a practical application.
The claims further recite the additional element of receiving physiological glucose data from a glucose sensor and insulin delivery data from an insulin delivery device. This additional element does not impose a meaningful limit on the claim, and instead actually amounts to necessary data gathering for the identified abstract idea. As such, this additional element is considered insignificant extra-solution activity and thus does not integrate the abstract idea into a practical application.
There are no further additional elements. When considered as a combination, the additional elements amount to instructions to implement the abstract idea and insignificant extra-solution activity with a computing device. As such the combination of additional elements does not integrate the abstract idea into a practical application. Because the additional elements, individually and as a combination, do not integrate the claims into a practical application the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite additional elements that amount to instructions to implement the abstract idea with generic computing devices. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not amount to significantly more.
As previously noted, the claims recite an additional element of receiving physiological glucose data from a glucose sensor and insulin delivery data from an insulin delivery device. Per MPEP 2106.05(d)(II), receiving data over a network is a conventional computer function. Galley et al. (US 2006/0276771 A1) suggests the conventionality of such devices processing such data (“In implementations that include an implanted glucose sensor, the system 10 may be a fully closed-loop system operable in a conventional manner to automatically monitor blood glucose and deliver insulin, as appropriate, to maintain blood glucose at desired levels.” See at least [0046]). And finally the specification references this functionality (“physiological glucose data may be generated by and received from a sensor (e.g., a CGM coupled to the patient), and insulin delivery data may be generated by and received from a medical delivery device (e.g., a pump coupled to the patient)” [0066]) without technical detail and in a manner that suggests this is a conventional operation. As such, this additional element appears to be conventional, which at Step 2B further supports the determination that this additional element is insignificant extra-solution activity. As such, this additional element does not amount to significantly more.
There are no further additional elements. When considered as a combination, the additional elements continue to amount to instructions to implement the abstract idea and insignificant extra-solution activity with generic computing devices. As such, the combination of additional elements does not amount to significantly more. Therefore, when considered individually and as a combination, the additional elements of the independent claims do not amount to significantly more than the abstract idea. Thus the independent claims are not patent eligible.
Dependent claims 17-19, 21-23, and 25-33 further describe the above identified abstract idea, but the claims continue to recite an abstract idea, albeit a narrowed one. Dependent claim 19 also recites calculating a linear regression. This limitation describes a mathematical concept. Thus claim 19 set forth concepts that fall within different groupings of abstract ideas. As such, per MPEP 2106.04(II)(B), these concepts are considered together as a single abstract idea for further analysis. Dependent claims 18, 19, 21, 22, 25, 27-30, 32 and 33 recite no further additional elements. The previously identified additional elements, individually and as a combination, continue to fail to integrate the narrowed abstract idea into a practical application for the same reasons as provided above. As such these claims are determined to be directed to an abstract idea. Further, the previously identified additional elements, individually and as a combination, continue to fail to amount to significantly more than the narrowed abstract idea for the same reasons as provided above. Claims 17 and 26 recites the additional element of a graphical user interface. At the level of generality claimed, this additional element amounts to data output for the abstract idea. As such, this additional element is considered insignificant extra-solution activity and does not integrate the narrowed abstract idea into a practical application. When considered in combination with the previously identified additional elements, the additional elements only generally link the abstract idea and insignificant extra-solution to a technological environment involving a computing device. As such the additional elements do not integrate the narrowed abstract idea into a practical application, and the claim is determined to be directed to an abstract idea. Further, as the additional elements only generally link the abstract idea and insignificant extra-solution to a technological environment involving a computing device, the additional elements do not amount to significantly more than the narrowed abstract idea. Claims 23 and 31 recites the additional element of retraining the machine learning model. However, this additional element also amounts to instructions to implement the narrowed abstract idea with a computing device. Claim 34 recites the additional element of a medication delivery device. At the level of generality claimed, this additional element amounts to necessary data gathering for the abstract idea which requires use of insulin delivery data. As such, this additional element is considered insignificant extra-solution activity and does not integrate the narrowed abstract idea into a practical application. When considered in combination with the previously identified additional elements, the additional elements only generally link the abstract idea and insignificant extra-solution to a technological environment involving a computing device. As such the additional elements do not integrate the narrowed abstract idea into a practical application, and the claim is determined to be directed to an abstract idea. Further, as the additional elements only generally link the abstract idea and insignificant extra-solution to a technological environment involving a computing device, the additional elements do not amount to significantly more than the narrowed abstract idea. Claim 35 recites the additional element of a glucose measurement device. At the level of generality claimed, this additional element amounts to necessary data gathering for the abstract idea which requires use of insulin delivery data. As such, this additional element is considered insignificant extra-solution activity and does not integrate the narrowed abstract idea into a practical application. When considered in combination with the previously identified additional elements, the additional elements only generally link the abstract idea and insignificant extra-solution to a technological environment involving a computing device. As such the additional elements do not integrate the narrowed abstract idea into a practical application, and the claim is determined to be directed to an abstract idea. Further, as the additional elements only generally link the abstract idea and insignificant extra-solution to a technological environment involving a computing device, the additional elements do not amount to significantly more than the narrowed abstract idea. Because the dependent claims remain directed to an abstract idea without reciting significantly more, the dependent claims are not patent eligible.
Response to Arguments
Applicant’s Argument Regarding 112(b) Rejections of claim 22: Amended claim 20, to which claim 22 depends, now includes a reference to “selected metrics.”
Examiner’s Response: Applicant's amendments filed 27 July 2026 have been fully considered and they resolve the identified issue. The rejection under 112(b) is withdrawn.
Applicant’s Argument Regarding 101 Rejections of claims 16-35:
Calculating statistically significant p values across multiple data streams and feeding those values, together with additional input data, into a trained machine learning model is not a step that can practically be performed in the human mind, nor is it analogous to a clinician’s subjective symptom evaluation. See MPEP 2106.04(a)(2)(III)(A) (a claim does not recite a mental process where the claimed calculations cannot practically be performed in the human mind). Accordingly, amended claim 16 is not properly characterized as reciting a mental process or a method of organizing human activity.
This particular, multi-stage combination of device derived inputs, regression-based generation of p values, and a machine-learning-based output generation reflects a specific technical means of improving the accuracy and reliability of infusion site failure detection – a specific improvement to the functioning of an infusion monitoring system.
The Office Action at page 13 acknowledges, in connection with original claim 27, that “the prior art does not appear to suggest using p values of regression coefficients as inputs to a trained machine learning model in either the field of insulin pump control or anomaly detection more broadly.” This acknowledgement supports that the specific ordered combination of elements now recited in amended claim 16 is unconventional.
Examiner’s Response: Applicant's arguments filed 27 July 2026 have been fully considered but they are not persuasive.
Examiner notes that neither the current nor prior rejection identifies the present claims as falling in the mental processes grouping of abstract ideas. Further, the instructions of MPEP 2106.04(a)(2)(III)(A) does not apply to the methods of organizing human activity sub-grouping. Additionally, while the rejection notes a similarity to In re Meyer (which applicant asserts to be non-analogous without explanation), it does not rely on that analogy to determine that the claims describe an abstract idea falling in the managing personal behavior sub-grouping of the methods of managing personal behavior grouping. Note that this sub-grouping also includes assigning hair designs to balance head shape and a series of instructions of how to hedge risk.
Per MPEP 2106.05(a), “If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement.” Here, the disclosure does not appear to provide any technical details of the asserted improvement.
Applicant’s argument appears to ultimately be that the claims are eligible based on the novelty of the claims. Such arguments are plainly contrary to current USPTO guidance. Per MPEP 2106.05, “the search for an inventive concept should not be confused with a novelty or non-obviousness determination.”
Applicant’s Argument Regarding 102 Rejections of claims 16, 18-21, 23-25, 30, 31, 34, and 35 and 103 Rejections of claims 17, 26, 32, and 33: Meneghetti fails to disclose or suggest at least applying a regression model or algorithm to physiological glucose data and insulin delivery data to generate predictive data comprising p values of selected metrics, wherein the selected metrics include a glucose variability metric, a glucose risk metric and total insulin bolus, as recited in amended independent claims 16, 20, and 24.
Examiner’s Response: Applicant's arguments and amendments filed 27 July 2026have been fully considered and they are persuasive. The rejections under 102 and 103 are withdrawn.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 of the prior office action dated 27 January 2026.
Conclusion
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 Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm 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, Kambiz Abdi can be reached at (571) 272-6702. 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.
/Bion A Shelden/ Primary Examiner, Art Unit 3685 2026-09-05
Prosecution Insights