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 .
DETAILED ACTION
This action is in reference to the RCE as filed on 20 MARCH 2026.
Examiner notes the remarks and claims appear to be taken from the communication as filed on 23 FEB 2026. Amendments to claims 1, 25, the addition of claims 39-42, as well as cancelation of claims 2-4, 7, 9, 10, 19- 24, 26-28, and addition of claims 35-38.
Claims 1, 5, 6, 8, 11-18, 25, 29-33, 39-42 are present and have been examined.
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, 5, 6, 8, 11-18, 20-22, 25, 29-33, 35-38 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claims 1, 5, 6, 8, 11-18, 20-22, 25, 29-33, 35-38 the independent claims 1, 20, 25 recite systems and methods, i.e. a machine and a process, which are statutory categories of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claims 1, 5, 6, 8, 11-18, 20-22, 25, 29-33, 35-38 the independent claims (claims 1, 25, 42) are directed, in part, to “receiving/storing data regarding insulin therapy treatment of a person with diabetes the data relating to a time period and comprising blood glucose values for the person…and time of administration information; training, by the computer system using a supervised machine learning model a total daily basal dose mismatch regressor based on the blood glucose values and the time of administration information wherein the training comprises generating a feature set having one or more features, wherein the one or more features comprises a time in range; and selecting TDBD mismatch value based on the feature set that optimizes a time in range of the person with diabetes; determining based on the trained TDBD mismatch regressor, a (TDBD) mismatch value…based at least in part on a relationship between a programmed and actual TDBD value…; generating an adjusted insulin therapy setting to increase a time in range of the person with diabetes based on the TDBD mismatch value...and outputting the adjusted insulin therapy setting claim 25 reciting a ”mismatch regression model; to provide the data to the mismatch regression model and determine a total daily basal dose (TDBD) mismatch value… generating an adjusted insulin therapy setting to increase a time in range of the person with diabetes based on the TDBD mismatch value...and outputting the adjusted insulin therapy setting.”
These claim elements are considered to be abstract ideas because they are directed to a mental process, in that the claims ensconce concepts performed in the human mind including observation, evaluation, judgment, and opinion functions. Receiving, obtaining, and storing data regarding insulin therapy of a person with diabetes (observation), as well as determining or “training” on the information (evaluation), in order to generate/obtain/determine the TDBD based on the information (judgement/opinion) is a concept or process performed in the human mind. If a claim limitation, under its broadest reasonable interpretation, covers a concept performed in the human mind, then it/they falls/ fall into the “mental processes” category.
Further, Examiner notes that the “training” of the regression model, and the use of a regression model itself, is mathematical calculation, relationship, formula or equation. If a claim limitation, under its broadest reasonable interpretation covers mathematical concepts (i.e. relationships, formulas, equation), then the claims fall into the “mathematical concepts” category. As such, the claims recite abstract idea(s).
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claims recite additional elements to perform the claim steps: claim 1 recites a “computer system,” while claim 25 recites a “non-transitory storage medium” and “at least one processor,” and claim 42 recites a computer readable storage medium storing instructions when execute by one or more processors, cause the processors to perform operations. Claims 1, 25, 42 recite a glucose sensor and a medication delivery device in communication with the computing elements, as well as a “display” on to which the adjusted therapy is outputted. The computer system, non-transitory storage medium, and processor in claims 1, 25, 42 is/are recited at a high-level of generality such that it amounts no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05f). Examiner finds no improvement to the functioning of the computer or to any other technology or technical field (see MPEP 2106.05a). Instead, the computer system, computer readable medium, and one more processors are found to be no more than a general link of the judicial exception to a particular technological environment or field of use (See MPEP 2106.05h). Similarly, Examiner does not find any improvement to the functioning of the sensor itself, nor the delivery device, and again notes that these are a general link between the technology and the abstract idea. Examiner further notes that receiving data from a sensor, and sending and receiving data between computers, is at best insignificant extra solution activity, as is displaying information on a display (see MPEP 2106.05f). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claims are additionally directed to: claim 1 recites a “computer system,” while claim 25 recites a “non-transitory storage medium” and “at least one processor,” and claim 42 recites a computer readable storage medium storing instructions when execute by one or more processors, cause the processors to perform operations. Claims 1, 25, 42 recite a glucose sensor and a medication delivery device in communication with the computing elements, as well as a “display” on to which the adjusted therapy is outputted. When considered individually, the computer system, non-transitory storage medium, computer readable medium, and at least one processor claim elements only contribute generic recitations of technical elements to the claims. Examiner finds similarly with regard to the insulin devices, sensors, and one or more displays. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification:
At [087] “Examples of computing devices that can be implemented using the computing device 1100 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.”
At [090] “Although the example environment described herein employs a hard disk drive as a secondary storage device, other types of computer readable storage media are used in other embodiments. Examples of these other types of computer readable storage media include magnetic cassettes, flash memory cards, digital video disks, Bernoulli cartridges, compact disc read only memories, digital versatile disk read only memories, random access memories, or read only memories. Some embodiments include non-transitory media. For example, a computer program product can be tangibly embodied in a non-transitory storage medium. Additionally, such computer readable storage media can include local storage or cloud-based storage.”
At [093] “In this example embodiment, a display device 1138, such as a monitor, liquid crystal display device, projector, or touch sensitive display device, is also connected to the system bus 1106 via an interface, such as a video adapter 1140. In addition to the display device 1138, the computing device 1100 can include various other peripheral devices (not shown), such as speakers or a printer.”
At [095] “The computing device 1100 can include at least some form of computer readable media. Computer readable media includes any available media that can be accessed by the computing device 1100. By way of example, computer readable media include computer readable storage media and computer readable communication media.”
At [023] “Insulin delivery devices include, but are not limited to, insulin injection pens, insulin inhalers, insulin pumps, and insulin syringes.”
At [035] “In disclosed embodiments, any suitable glucose sensor may provide blood glucose data 218, for example, a continuous glucose monitor (CGM), a flash glucose monitor, a blood glucose meter (BGM). In the case of CGMs and flash glucose monitors, they may be configured to provide blood glucose data 218 based on interstitial fluid glucose levels of a person, which may be correlated to blood glucose levels. A BGM may be configured to provide blood glucose data based on a blood sample. Accordingly, the term “blood glucose” is not limited herein to using just blood glucose data, values, levels etc., but is also intended to include interstitial fluid glucose levels, intermediate measurements, and legal equivalents thereof.”
At [036]” Insulin dosing data 214 may include dosing event data. Dosing event data may include data about insulin dosing actions at one or more times and may include, for example, a dosing time or time range, type of insulin (e.g., LA insulin and rapid acting (RA) insulin) dosed, brand of insulin, and/or amount of dosed insulin. In some embodiments, dosing event data may include an indication of a dosing mechanism, for example, injection pen, inhaler, or infusion pump.”
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement to the functioning of a computer, or to any other technology or technical field (see MPEP 2106.05a). When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense, or to implement the abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05f). The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 5, 6, 8, 11-18, 29-33, 39-41:
Dependent claims 5, 6, 8, 11-18, 29-33, 39-41 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. These claims recite further limitations regarding the identified abstract ideas of mental processes and mathematical relationships. These claims offer further descriptive limitations of elements found in the independent claims and addressed above. For example, claims 5, 6, 11-18, 39-41 recite various means for computing and adjusting the TDBD including limitations that can be performed in the human mind, as well as additional mathematical functions for the calculations and adjustments to be executed (i.e. functions, training, modeling, etc.). Claim 35 recites additional means of adjusting setting(s). Claims 8, provides limitations as to the output of the information calculated or determine other claims, as well as logistical information such as the types of values and time periods considered in the calculations, which are, as currently claimed, completely performed in the human mind, i.e. a mental process. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Dependent claim 32 is not directed to any additional abstract ideas than those as identified above, however Examiner notes in the interest of compact prosecution that claim 32 does recite the non-abstract element of an insulin pen. Examiner finds that in view of the discussion above regarding the insulin delivery device, the insulin pen itself is not found to constitute a practical application nor significantly more than the abstract idea(s) identified.
Non-Obvious Subject Matter
Claims 1, 5, 6, 8, 11-18, 20-22, 25, 29-33, 35-38 are believed to be free of the prior art.
The closest prior art of record is believed to be:
Patek (US 20200046268 A1),
Hirsch et al (Connecting the Dots: Validation of Time in Range Metrics With Microvascular Outcomes, hereinafter Hirsch).
Booth et al (US 20170053101 A1).
Mensinger et al (US 20190392937 A1 )
Christensen et al (US 20200181222 A1)
Patek teaches: receiving blood glucose values from a sensor, and administration information from the delivery device associated with the sensor, determining a basal dose mismatch for the user using the collected values and the actual values recorded from the sensor, generating an adjusted insulin setting based on the mismatch value, and displaying it. Patek also teaches time spent in range in the sense of a “well controlled” range.
Hirsch teaches: adjusting an insulin therapy setting to increase a time in range, as well as consideration of other factors besides dosing to be adjusted to continue or maximize a time in rage.
Booth teaches a training model to make the determination of a mismatch, as well as the use of simulated data in conjunction with the actual data to train and execute the model itself. The model in Booth is specifically trained in such a manner prior to the execution itself.
Mensinger teaches a TDD ratio, as compared to a basal/bolus doing, and making changes to the dosing based on this ratio based on a goal ratio.
Christensen a hazard ratio indicating an “instantaneous risk ratio of experiencing an event” based administering one of two treatments, including a confidence interval.
However, the references fail to disclose the calculation of the TDBD mismatch value as claimed, and the adjustments therein reflective of this value, as well as the inclusion of the mismatch regressor elements as amended. Examiner finds Applicant’s remarks on pages 12, 13 of the remarks as filed on 10 JUL 2025 to be particularly persuasive with regards to the explanation of the ratio calculated between the two values.
The Examiner hereby asserts that the totality of the evidence neither anticipates nor renders obvious the particular combination of elements as claimed. That is, the Examiner emphasizes the claims as a whole and hereby asserts that the totality of the evidence fails to set forth, either explicitly or implicitly, an appropriate rationale for combining or otherwise modifying the available prior art to arrive at the claimed invention. The combination of features as claimed would not be obvious to one of ordinary skill in the art because any combination of the evidence at hand to reach the combination of features as claimed would require a substantial reconstruction of Applicant’s claimed invention relying on improper hindsight bias.
Response to Arguments
Applicant’s remarks as filed on 23 FEB 2026 are fully considered.
Applicant begins on page 8 with a discussion of the rejection under 35 USC 101. Applicant appears to argue that the amended limitations as presented represent eligible subject matter, Examiner respectfully disagrees. Applicant asserts amendments have been made to reflect an improvement in dosing. Examiner respectfully disagrees – at best the system is adjusting a setting of a device, which may include a basal dose amount. The dose itself is not actually administered. The amended claim as presented does not require an adjustment to a dosing amount as alleged by Applicant, as no actual dose is provided.
On page 9, Applicant discusses Step 2A prong 2, and asserts a practical application is found. Examiner finds Applicant’s remarks helpful, however again Examiner does not find a practical application in the purported improvement to dosing. Examiner notes again that dosing insulin is not itself a technical endeavor for the purposes of the analysis. Examiner also notes that the claim does not require administering the dose itself. This in no way improves the functioning of a computer and instead supports Examiner’s position that this is an application thereof. The elements of TIR are also not themselves a technical problem or solution therein. Examiner does not find analogy to Ex Parte Desjardins as noted by Applicant on page 10, as the issue of TIR does not analogize to the technical issue improved by the algorithm training therein.
On page 11, Applicant argues a finding of significantly more. Examiner respectfully disagrees with Applicant’s conclusions, as again the claims appear to just recite an application of the technology to the abstract idea, rather than an improvement or significantly more. Examiner respectfully disagrees that the claims were not considered as a whole – nor did Examiner conclude they were well understood routine and conventional elements. Examiner provided citations to the specification in support of Examiner’s position that the elements are at best applying the abstract idea. Examiner respectfully notes that Applicant does not identify what about the combination is in fact alleged to be unconventional. Applicant states that a finding of unconventional arrangement may be made, but does not state what about the claimed arrangement is in fact, unconventional.
Applicant’s remarks regarding new claims 39-42 are noted, and are found unpersuasive in view of the discussion of claims 1, 25 as noted above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
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