DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s arguments filed in the reply on September 21, 2026 were received and fully considered. Claims 23, 25-28, and 33 were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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 23-28, 31, and 33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 23 follows.
Regarding claim 23, the claim recites a system for determining a failure in a monitoring or insulin treatment of a patient. Thus, the claim is directed to a system/product, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
PNG
media_image1.png
468
634
media_image1.png
Greyscale
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
PNG
media_image2.png
242
642
media_image2.png
Greyscale
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception and outputting fail to integrate claims into a practical application. MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they pertain to highly generalized structural limitations and/or generic alert/outputting step that is widely known in the art of CGM devices.
Dependent claim 24 recites “a continuous subcutaneous insulin infusion pump”, which also fail to add significantly more to the abstract independent claim as they are highly generalized and pertain to widely understood, routine, and conventional components in CGM devices.
Dependent claim 25 recites “a discrete-time Kalman filter predictor”, which is not patent eligible as this merely further limits the abstract idea.
Dependent claim 26 recites “an audible alarm”, which also fails to integrate the claims into a practical application as this merely pertains to extra-solution activity. MPEP 2106.05(g).
Dependent claim 27 recites “a visual notification”, which also fails to integrate the claims into a practical application as this merely pertains to extra-solution activity. MPEP 2106.05(g).
Dependent claim 28 recites “a vibration”, which also fails to integrate the claims into a practical application as this merely pertains to extra-solution activity. MPEP 2106.05(g).
Dependent claim 31 recites “a mathematical description of the glucose-insulin relationship expected in the patient”, which is not patent eligible as this merely further limits the abstract idea.
Dependent claim 33 recites “wherein the model is selected from the group consisting of a modified version of a numerical algorithm for subspace state space system identification (N4SID), a numerical algorithm for subspace state identification designed to handle closed-loop systems including a glucose-insulin model, black-box input-output models, an autoregressive with exogenous inputs (ARX) model, an autoregressive-moving average with exogenous inputs (ARMAX) model, Box-Jenkins nonparametric models based on stable splines, or neural networks, and combinations thereof”, which is not patent eligible as this merely further limits the abstract idea.
Therefore, claims 23-28, 31, and 33 are not patent eligible under 35 USC 101.
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 112B rejections and 35 USC 103 rejections raised in the previous office action were persuasive in view of amendment. Therefore, these rejections are withdrawn.
Applicant's arguments filed with respect to the 35 USC 101 rejections raised in the previous office action have been fully considered, but they are not persuasive. Examiner maintains that the claims, as amended, recites an abstract idea (mathematical calculations and/or mental process) that is not integrated into a practical application. While the claims recite operation of physical components, these additional/structural limitations fail to integrate the claims into a practical application for the following reasons. First, the additional/structural limitations are recited at a high level of generality. Moreover, they pertain to mere extra-solution activity (data gathering of known glucose data and insulin data) which fails to integrate the claims into a practical application. Additionally, the amended limitation “alert generating device… to generate… the alert” fails to integrate the claims into a practical application, i.e. displaying a result, via a generic alert also corresponds to extra-solution activity. Applicant also argues that the claims, as a whole, is not directed to a mathematical calculation or a mental process. Examiner respectfully disagrees as the inventive concept appears to lie within the abstract idea, while the highly generalized structural limitations merely pertain to extra-solution activity. Furthermore, nothing from the claims suggest that the skilled artisan would not be able to practically perform the steps mentally (aided by pen/paper), having first obtained known glucose/insulin data. The mere fact that large quantities of data are obtained (in real time, continuously, etc.) does not render the claims impractical of being performed mentally by the skilled artisan. In any event, the claims expressly recite mathematical relationships which are merely being implemented on a generic processor. For at least these reasons, the 35 USC 101 rejections are maintained. Please see corresponding rejection headings and response to arguments section below for more detail.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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, Alexander Valvis can be reached at 5712724233. 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.
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights