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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 February 2026 has been entered.
Introductory Remarks
In response to communications filed on 23 February 2026, claim(s) 1-5, 7, 10-12, 14, 15, 17, and 18 is/are amended per Applicant’s request. Claim(s) 13 is/are cancelled. Claim(s) 22-24 is/are new. Therefore, claims 1-12 and 14-24 are presently pending in the application, of which, claim(s) 1, 14, and 17 is/are presented in independent form.
No IDS has been received since the mailing of the last Office action.
The previously raised 112 rejections are withdrawn in view of the amendments to the claims.
Examiner’s Note
The rejections below group claims that may not be identical, but whose language and scope are so substantively similar as to lend themselves to grouping, in the interests of clarity and conciseness. Any citation to the instant specification herein is made to the PGPub version (if applicable). The examiner notes that no statement has been entered regarding the inventorship of individual claims as required under 37 CFR 1.56, and therefore assumes that all claims have the same inventorship or are directed to inventions that were commonly owned as of the effective filing date of the invention.
Claim Objections
Claim 1 is objected to because of the following informalities: it recites a prediction computerized module implements the model to determine the main predictive output, and at least one intermediate prediction data at at [sic] least one future intermediate time point preceding the main future time point”. 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 1-12, 14-21, and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) mental process steps of assessing confidence in a prediction. In this analysis, only those claim limitations stipulated as additional elements are considered to be limitations distinct from the abstract idea itself.
With respect to the independent claims, claim 1 is representative. Claim 1 recites, “the temporal predictive model being adapted to determine a predictive output for a time-based physiological parameter representative of a physiological characteristic of a subject for a predetermined future time point based on real time-based physiological data representative of the subject”, “the main predictive output being prediction data for a predetermined main future time point, the main predictive output being made at a present time point”, “a prediction [] module implements the model to determine the main predictive output, and at least one intermediate prediction data at at [sic] least one future intermediate time point preceding the main future time point”, “at said at least one future intermediate time point, a comparison [] module determines a comparison score between the at least one intermediate prediction data and corresponding real data representative of the subject at the same intermediate future time point”, “at a confidence time point, a confidence assessment [] module assigns or denies confidence in the at least one main time-based predictive output according to a confidence assessment method based on the comparison score determined by the comparison module”, and “wherein, if, at the confidence time point, the confidence assessment computerized module assigns confidence in the main time-based predictive output according to the confidence assessment method based on the comparison score determined by the comparison module, then[:] an active system comprising the medical device is controlled according to the main predictive output to adjust a treatment delivered to the subject, another computerized module is implemented on the main predictive output, and/or a temporary confidence is assigned to the temporal predictive model.”, which are merely mentally processing data (i.e., to make predictions and assess the confidence in those predictions). This can be exemplified as predicting the outcome of a race (e.g., estimate to complete a 1600m run in 5 minutes with 75s split times), wherein each lap time is compared to the lap time estimate to refine the estimate for the overall time as the race progresses. Humans clearly have performed this for millennia.
The additional elements in the claim are: “a computerized method…, the method implemented by one or more processors”, “a prediction computerized module”, “comparison computerized module”, and “a confidence assessment computerized module”. (Emphasis added). The judicial exception is not integrated into a practical application because the additional elements amount to nothing more than implementation of the abstract idea in a computer environment and/or is merely using a computer as a tool to perform the concept. See MPEP 2016.04(d)(I) and 2106.05(f).
The claim does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional elements amount to nothing more than mere instructions to apply the exception using generic computer component(s). These cannot provide an inventive concept, and thus the claims are patent-ineligible.
The other independent claims adds further generic computing components in the form of “a computerized system” (claim 14), “a computerized method” (claim 17), and “controlling an active system of the system” (claim 17), which do nothing to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea.
Dependent claim 2 adds only additional abstract idea limitations and the additional element of “a continuous glycemia monitoring system”. The claims offer no specifics about the continuous glycemia monitoring system, and therefore it is construed as that which is already well-known, routine, and conventional in the art. See e.g. IT 2020/00027375 A1 (“To limit the onset of hypoglycemia events, there are currently various monitoring systems such as, for example, the "CGM Dexcom G5 Mobile" device which is a continuous glycemia monitoring device”); RU 2019134219 A (“MEDICAL SENSOR SYSTEM, IN PARTICULAR SYSTEM FOR CONTINUOUS GLYCEMIA MONITORING”); Lodwig, Volker, et al. "Current Trends in Continuous Glycemia Monitoring," published in Journal of diabetes science and technology, 8.2 (2014), 390-396, retrieved on 16 September 2025, retrieved from the Internet <URL: https://pmc.ncbi.nlm.nih.gov/articles/PMC4455393/pdf/10.1177_1932296814525826.pdf>. In view of its wide usage in the art, a continuous glycemia monitoring system is well-known, routine, and conventional in the art and is merely extra-solution activity in the claim. Given its nature as well-known, routine, and conventional in the art, the claim limitations, viewed taken individually and in combination do not amount to significantly more than the abstract idea.
Dependent claim 15 adds only additional abstract idea limitations and the additional element of “a computer program”. This amounts to nothing more than implementation of the abstract idea on a generic computing device.
Dependent claims 3-12, 16, 18-21, and 24 add nothing more than additional abstract idea limitations, which again do nothing to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea.
Dependent claims 22 and 23 are considered patent eligible.
Allowable Subject Matter
Claims 22 and 23 are allowable.
Response to Arguments
Applicant's arguments filed 23 February 2026 have been fully considered but they are not persuasive. The applicant’s arguments are addressed in the order they were raised by the applicant.
First, applicant argues, and the examiner agrees, that the rejections under 35 USC 112 are overcome.
Second, with respect to the rejections under 35 USC 101, the applicant argues that the independent claims control a medical device. This is not correct. The claims close with three options that can occur is the confidence assessment assigns confidence in the predictive output; these options are conjoined with an “and/or”. Therefore, under the broadest reasonable interpretation, only one of the options must occur. The last option is to assign yet another value (“a temporary confidence is assigned to the temporal predictive model”), and does nothing to integrate the abstract idea into a practical application.
The applicant then argues that the invention provides a technical improvement in, essentially confidence modeling. This is an abstract idea and any improved abstract idea does not amount to a patentable invention.
Then the applicant argues that the claims are incapable of being performed mentally. This was addressed in the last action, and the applicant is directed to the examiner’s comments there.
The applicant continues arguing that the claims are applied to control a physical system. With regards to claims 22 and 23, the applicant is correct. With regards to the other claims, this is not correct as established supra.
The applicant further argues that the analysis does not meet the Office’s burden to establish ineligibility. The examiner respectfully disagrees.
Finally, the applicant argues that: the claims integrate operations into a specific medical device control application; the MPEP recognizes that claims reciting a technological solution to a technological problem support eligibility; and the order combination of elements is not shown to be well-understood, routine and conventional. As to the first point, this is addressed supra in the remarks. As to the second point, there is no technological solution claimed for claims 1-12, 14-21, and 24, merely a mental one. As to the third point, the Berkheimer memo only applies to elements considered “additional” or extraneous to the abstract idea itself within the claim. The elements that the applicant points to are either not claimed (“real time comparison against physiological sensor data”), not part of the broadest reasonable interpretation of the claims (“medical device control”), or are the mental process itself (“intermediate prediction generation” and “confidence assignment or denial”). Therefore, the applicant is essentially arguing that the abstract idea itself is a novel ordering of elements, which even if true does not convey patentability.
Conclusion
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/TYLER J TORGRIMSON/ Primary Examiner, Art Unit 2165