DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s arguments filed in the reply on March 5, 2026 were received and fully considered. Claims 1 was amended. Please see below for more detail.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/09/2026 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 1-16 and 19-22 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.
Regarding Claim 1, the claim(s) recites “responsive to receiving the user-specified information, generating a plurality of projections of the user's glucose level at least partially based on the one or more events and one or more parameters,
wherein at least one value of the one or more parameters utilized to generate each projection of the plurality of projections is different than at least one value of the same one or more parameters utilized to generate each of the other plurality of projections, and
wherein each projection of the plurality of projections includes a plurality of projected glucose levels over time;
comparing each projection of the plurality of projections to the set of data that represents the actual glucose values for the user;
selecting a projection of the plurality of projections that represents a nonlinear best fit to the set of data that represents the actual glucose values for the user;
based at least partially on the selected projection of the user's glucose level that represents the best fit to the set of data generating…:
an optimal trajectory of the user's glucose levels within the selected projection of the user's glucose level, an upper curve above the optimal trajectory, and a lower curve below the optimal trajectory, the upper curve and the lower curve defining a confidence band around the optimal trajectory;
a set of therapeutic recommendations comprising:
a first therapeutic recommendation based on the optimal trajectory;
a second therapeutic recommendation based on an upper boundary of the upper curve defining the confidence band; and
a third therapeutic recommendation based on a lower boundary of the lower curve defining the confidence band,
wherein the width of the confidence band at each point in time represent a degree of confidence in the estimate glucose value represented by the selected projection at each point in time.” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“receiving user-specified information about one or more events influential on the user's glucose level;”
“receiving a set of data that represents actual glucose values for the user, wherein at least some of the actual glucose values occurred later in time than a start time of the one or more events influential on the user's glucose level;”
“displaying a single curve including a portion representing actual glucose values and a nonlinear portion representing the selected projection of the user's glucose level, the displayed single curve being a fit to a plot, the plot comprising:
the actual glucose values of the user extending from a first time to a second time with respect to a time line; and
the selected projection of the user's glucose level that represents the best fit to the set of data, the projection of the user's glucose level extending from the second time to a third time with respect to the time line; and
based at least partially on the selected projection of the user's glucose level that represents the best fit to the set of data, … outputting:
an optimal trajectory of the user's glucose levels within the selected projection of the user's glucose level, an upper curve above the optimal trajectory, and a lower curve below the optimal trajectory, the upper curve and the lower curve defining a confidence band around the optimal trajectory;
a set of therapeutic recommendations comprising:
a first therapeutic recommendation based on the optimal trajectory;
a second therapeutic recommendation based on an upper boundary of the upper curve defining the confidence band; and
a third therapeutic recommendation based on a lower boundary of the lower curve defining the confidence band,”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, computer-based interfaces and computer-based processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of making multiple predictions based on patient data, identifying the most likely prediction, and providing recommendations and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Dependent claims 2-16 and 19-22 also do not add significantly more to the exception as they merely adds more mental steps, clarifies how the mental steps are performed, adds general fields of use limitations to perform the extrasolution data gathering, adds details to the extrasolution data gathering, and adds generic postsolution activity.
Allowable Subject Matter
Claim(s) 1-16 and 19-22 would be allowable if rewritten or amended to overcome the rejection(s) under 35 USC 101 rejections set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record does not fairly teach or suggest is creating an upper curve and lower curve based on a confidence band around an optimal trajectory and providing multiple therapeutic recommendations around the predicted behavior of these curves.
The reference of Budiman teaches generating confidence band around predicted glucose values and teaches that multiple therapeutic recommendations may be generated.
Mault provides multiple simultaneous therapeutic recommendations in a display with respect to a single curve.
Johnson et al (US 2008/0065165) describes an analysis where a confidence metric both applies to analysis output and resulting therapy decisions in the context of heart arrhythmias as seen in stored reference tables. A single therapeutic recommendation is provided to the user and/or healthcare provider.
Zheng et al (US 2014/0031658) teaches generating a patient specific model of glucose and generating predictions from the model comprising a generating an upper curve and lower curve based on a confidence band around the model trajectory. Here, a single therapeutic recommendation is provided.
Thus, the prior art teaches providing multiple therapeutic recommendations, but only on the basis of a single optimal curve.
Response to Arguments
Applicant’s arguments filed 3/05/2026 with respect to the 35 USC 101 rejection have been fully considered, but are not persuasive for the reasons given previously. Furthermore, the amendments filed 3/05/2026 with respect to the 35 USC 101 rejection have been fully considered, but are not persuasive as they merely add generic postsolution activity steps and do not add more than the judicial exception. Specifically, while the second and third therapeutic recommendations are provided based on separate likely scenarios for the patients, they are merely displayed and do not necessarily lead to the application of a particular treatment. Further, the system utilized has no additional hardware and continues to be comprised of generic computing elements such as a computer and display. Finally, as to an improvement, the identification of the optimal trajectory, upper curve defined around a confidence band of the optimal trajectory, and the lower curve defined around a confidence band of the optimal trajectory along with the generation of respective therapeutic recommendations are based on what amounts to mental steps and therefore the generation of these curves and recommendations cannot be the basis of an improvement. Next an “outputting” of these values is a generic postsolution activity, not even tied to a display. Even if these results were positively tied to a display, these results would still be tied to a computer environment and not reflect a material change in the patient’s care (i.e. no improvement). One could also consider whether a patient’s care is improved by multiple therapeutic recommendations over a single recommendation of high confidence as the multiple therapeutic recommendations can generate confusion or hesitation in following a single course of treatment. The rejection stands.
Applicant’s amendments and arguments filed 12/15/2025 with respect to the 35 USC 103(a) rejections have been fully considered, and are persuasive. The rejections are withdrawn for reasons given above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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