Prosecution Insights
Last updated: July 17, 2026
Application No. 18/955,453

AUTONOMOUS MANAGEMENT OF A DIABETIC CONDITION BASED ON MEALTIME AND ACTIVITY DETECTION

Final Rejection §101
Filed
Nov 21, 2024
Priority
Mar 04, 2019 — continuation of 11/031,116 +1 more
Examiner
SIOZOPOULOS, CONSTANTINE B
Art Unit
3686
Tech Center
3600 — Transportation & Electronic Commerce
Assignee
Roche Diabetes Care Inc.
OA Round
2 (Final)
58%
Grant Probability
Moderate
3-4
OA Rounds
1y 4m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
100 granted / 171 resolved
+6.5% vs TC avg
Strong +38% interview lift
Without
With
+38.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
33 currently pending
Career history
206
Total Applications
across all art units

Statute-Specific Performance

§101
39.5%
-0.5% vs TC avg
§103
33.5%
-6.5% vs TC avg
§102
23.7%
-16.3% vs TC avg
§112
2.1%
-37.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 171 resolved cases

Office Action

§101
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 . Response to Arguments In view of the current amendments, the rejection under Double Patenting is withdrawn. Regarding the arguments against the rejection of claims under 35 USC 101, the Examiner respectfully disagrees. Applicant argues that the claims do not recite an abstract idea of certain methods of organizing human activity as the Examiner has apparently analyzed the claims at a high level of generality. Examiner asserts that under Step 2A Prong One, the limitations are properly analyzed as a part of the abstract idea in detail as each limitation is analyzed and considered as a whole in this step. Due to the amendments, this analysis is updated in the rejection below. Further, the dependent claims have been analyzed in consideration with the previously analyzed independent claim to be a part of the abstract idea, and are further abstract as noted in Step 2A Prong 1. It should be noted that limitations such as “performing management of a diabetic condition based on the activity score being above the activity threshold” is recited at a high level of generality. Applicant further argues that claim 1 specifically integrates any alleged abstract idea into a practical application by performing management of a diabetic condition based on the claimed activity score being above the activity threshold. Examiner asserts that the limitation of “performing management of a diabetic condition based on the activity score being above the activity threshold” is recited at a high level of generality compared to a more specific implementation of information being communicated to treat an extreme diabetic state. As noted in the rejection below under Step 2A Prong 2, the indicators are used to gather information that are to be used for the abstract idea. Regarding claim 1, there is no indication of a particular technology improvement regarding the management of the diabetic condition. Claim 1 makes no mention of specific control of a device to manage an insulin pump or to provide specific guidance or alerts to a user at certain times to treat a user. However, claims 9 and 17, as indicated below, recite practical applications and would be allowable if written in independent form. Regarding the arguments against the rejection of claims under 35 USC 102, Examiner agrees and therefore this rejection is withdrawn. 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 1-17 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more. It is appropriate for the Examiner to determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance to the Subject Matter Eligibility Test as recited in the following Steps: 1, 2A, and 2B, see MPEP 2106(III.). Patent Subject Matter Eligibility Test: Step 1: First, the Examiner is to establish whether the claim falls within any statutory category including a process, a machine, manufacture, or composition of matter, see MPEP 2106.03(II.) and MPEP 2106.03(I). Claims 1-17 are related to a method. Accordingly, these claims are all within at least one of the four statutory categories. Patent Subject Matter Eligibility Test: Step 2A- Prong One: Step 2A of the Subject Matter Eligibility Test demonstrates whether a clam is directed to a judicial exception, see MPEP 2106.04(I.). Step 2A is a two-prong inquiry, where Prong One establishes the judicial exception. Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes, see MPEP 2106.04(II.)(A.)(1.) and 2106.04(a)(2). Representative independent claim 1 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 1 recites: A method comprising: determining an activity score based on a respective value of each of a plurality of activity indicators associated with a user that indicate an elevated exercise activity level, wherein each respective value of the plurality of activity indicators contributes to the activity score, wherein the activity score is used to detect when the user is engaging in, has engaged in, or will engage in the elevated exercise activity level, and wherein the plurality of activity indicators comprise at least one of: a heartrate indicator received via a sensor configured to detect blood flow or a heartbeat of the user received via a heartrate monitor, wherein the heartrate indicator indicates the elevated exercise activity level when the detected blood flow or heartbeat of the user is above a prestored value associated with the user, and wherein the heartbeat indicator indicates a lower exercise activity level when the detected blood flow or heartbeat of the user is at or below the prestored value associated with the user; a location indicator received via sensor or user device that indicates a location associated with the user, wherein the location indicator indicates the elevated exercise activity level when the location of the user is identified as being associated with a presorted location at which increase user activity is to occur, and wherein the location indicator indicates a lower exercise activity level when the location of the user is identified as being associated with another location; or a keyword indicator that indicates at least one keyword of a pre-scheduled event, wherein the keyword indicator indicates the elevated exercise activity level when the at least one keyword comprises at least one activity-related word, and wherein the keyword indicator indicates a lower exercise activity level with the at least one keyword fails to comprise the at least one activity-related word; determining that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators, wherein the activity score being above the activity threshold indicates the exercise activity level associated with the user being at least a threshold deviation from a normal activity level based on the respective value associated with each of the plurality of activity indicators; and performing management of a diabetic condition based on the activity score being above the activity threshold. The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity”, more specifically managing personal behavior as the following abstract limitations recite steps for performing management of a diabetic condition based on the activity score being above an activity threshold for a user: “determining” an activity score based on a respective value of each of a plurality of activity indicators associated with a user that indicate an elevated exercise activity level, wherein each respective value of the plurality of activity indicators contributes to the activity score, wherein the activity score is used to detect when the user is engaging in, has engaged in, or will engage in the elevated exercise activity level, which are abstract limitations for the analysis of the activity indicators and of the elevated exercise activity using values of the indicators of a user for the management of the diabetic condition for the user, “determining” that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators, wherein the activity score being above the activity threshold indicates the exercise activity level associated with the user being at least a threshold deviation from a normal activity level based on the respective value associated with each of the plurality of activity indicators, which is an abstract limitation of analysis of activity using the activity thresholds to be used for the management of the diabetic condition for the user, “performing” management of a diabetic condition based on the activity score being above the activity threshold, which is an abstract limitation for the management of the health of the user. The claim limitations as a whole recite steps for performing management of a diabetic condition based on the activity score being above a activity threshold for a user, which recites social activity steps for the management of the health of the user and therefore recite managing personal behavior and is a certain method of organizing human activity. Any limitations not identified above as part of the abstract idea are deemed “additional elements” and will be discussed in further detail below. Accordingly, the claim as a whole recites at least one abstract idea. Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below: Claim 2 recites further detail of the abstract activity threshold as indicating that a threshold number of activity indicators have been detected, further describing the abstract idea. Claim 3 describes the activity threshold as being configured by the user, further describing the abstract idea. Claim 4 recites further abstract limitations of a form of the diabetic condition management is performed depending on the activity indicators or the score, further describing the abstract idea. Claim 5 recites further abstract limitations further describing the activity indicators as comprising a respective weight to determine the activity score, further describing the abstract idea. Claim 7 recites further detail of the management of the condition as instruction for a user to “control” a basal rate of the insulin pump, further describing the abstract idea. Claim 8 recites further abstract limitation of instruction for “delivering” a meal bolus of insulin to a user via the insulin pump, further describing the abstract idea. Claim 9 recites further abstract limitations of detecting the exercise activity levels based on thresholds, further describing the abstract idea. Claim 17 recites further abstract limitations describing of preventing the management of the diabetic condition from being performed prior to the score being determined, further describing the abstract idea. Patent Subject Matter Eligibility Test: Step 2A- Prong Two: Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrates the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exceptions into a “practical application,” see MPEP 2106.04(II.)(A.)(2.) and 2106.04(d)(I.). In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”): A method comprising: determining an activity score based on a respective value of each of a plurality of activity indicators associated with a user that indicate an elevated exercise activity level, wherein each respective value of the plurality of activity indicators contributes to the activity score, wherein the activity score is used to detect when the user is engaging in, has engaged in, or will engage in the elevated exercise activity level, and wherein the plurality of activity indicators comprise at least one of: a heartrate indicator received via a sensor configured to detect blood flow or a heartbeat of the user received via a heartrate monitor, wherein the heartrate indicator indicates the elevated exercise activity level when the detected blood flow or heartbeat of the user is above a prestored value associated with the user, and wherein the heartbeat indicator indicates a lower exercise activity level when the detected blood flow or heartbeat of the user is at or below the prestored value associated with the user; a location indicator received via sensor or user device that indicates a location associated with the user, wherein the location indicator indicates the elevated exercise activity level when the location of the user is identified as being associated with a presorted location at which increase user activity is to occur, and wherein the location indicator indicates a lower exercise activity level when the location of the user is identified as being associated with another location; or a keyword indicator that indicates at least one keyword of a pre-scheduled event, wherein the keyword indicator indicates the elevated exercise activity level when the at least one keyword comprises at least one activity-related word, and wherein the keyword indicator indicates a lower exercise activity level with the at least one keyword fails to comprise the at least one activity-related word (merely data gathering steps as noted below, see MPEP 2106.05(g) and Symantec); determining that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators, wherein the activity score being above the activity threshold indicates the exercise activity level associated with the user being at least a threshold deviation from a normal activity level based on the respective value associated with each of the plurality of activity indicators; and performing management of a diabetic condition based on the activity score being above the activity threshold. For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application. Regarding the additional limitations of: a heartrate indicator received via a sensor configured to detect blood flow or a heartbeat of the user received via a heartrate monitor, wherein the heartrate indicator indicates the elevated exercise activity level when the detected blood flow or heartbeat of the user is above a prestored value associated with the user, and wherein the heartbeat indicator indicates a lower exercise activity level when the detected blood flow or heartbeat of the user is at or below the prestored value associated with the user; a location indicator received via sensor or user device that indicates a location associated with the user, wherein the location indicator indicates the elevated exercise activity level when the location of the user is identified as being associated with a presorted location at which increase user activity is to occur, and wherein the location indicator indicates a lower exercise activity level when the location of the user is identified as being associated with another location; or a keyword indicator that indicates at least one keyword of a pre-scheduled event, wherein the keyword indicator indicates the elevated exercise activity level when the at least one keyword comprises at least one activity-related word, and wherein the keyword indicator indicates a lower exercise activity level with the at least one keyword fails to comprise the at least one activity-related word; these are merely pre-solution activities. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). [0063] of the Applicant’s Specification recites interactions with the user’s device to acquire the activity indicators for location, or [0044, 0079, 0081] for the devices used to gather the heartrate indicator, for example. [0044, 0047, 0048, 0097] describes the prestored data used when gathering the data. The use of the user devices to acquire the indicators are used to perform actions for the system including data gathering for the abstract idea, and thus recites insignificant pre-solution activities. Taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to perform management of a diabetic condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception, see MPEP 2106.04(d), 2106.05(a), 2106.05(b). The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below: Claim 6 recites additional elements of a user device that can autonomously perform the diabetic condition management, however because of this generic device generically automating part of the abstract idea, these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). Claim 10 recites further detail of the keyword indicators that are gathered for the abstract idea; however, this still merely recites insignificant pre-solution activity. Claim 11 recites further detail of the blood flow data that are gathered using user devices and further detail of the heartrate indicators for the abstract idea, however this still merely recites insignificant pre-solution activity. Claim 12 similarly describes the heartrate indicator is detected based on change in acceleration of the user device, however this still merely recites insignificant pre-solution activity. Claim 13 similarly describes the heartrate indicator as being detecting using the user device based on deviation from heartrate from a previously stored threshold, however this still merely recites insignificant pre-solution activity. Claim 14 recites further detail of the keyword indicator as being detected and collected based on calendar planning accessed from a user device, however this still merely recites insignificant pre-solution activity. Claim 15 recites further detail of the location indicator as being detected based on pre scheduled events cross referenced with a list of locations, however this still merely recites insignificant pre-solution activity. Claim 16 recites further detail of the location indicator coming from GPS location and locations of a business with increased activity from the user, however this still merely recites insignificant pre-solution activity. However, claim 9 recites elements of controlling the insulin pump based on different activity indicators as claimed, reciting a practical application. Claim 17 additionally recites additional elements resulting in a technology improvement and practical application. Thus, taken alone and in ordered combination, the additional elements do not integrate the at least one abstract idea into a practical application. Patent Subject Matter Eligibility Test: Step 2B: Regarding Step 2B of the Subject Matter Eligibility Test, the independent claim does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application, see MPEP 2106.05(II.). Further, it may need to be established, when determining whether a claim recites significantly more than a judicial exception, that the additional elements recite well understood, routine, and conventional activities, see MPEP 2106.05(d). Regarding the additional limitations of: a heartrate indicator received via a sensor configured to detect blood flow or a heartbeat of the user received via a heartrate monitor, wherein the heartrate indicator indicates the elevated exercise activity level when the detected blood flow or heartbeat of the user is above a prestored value associated with the user, and wherein the heartbeat indicator indicates a lower exercise activity level when the detected blood flow or heartbeat of the user is at or below the prestored value associated with the user; a location indicator received via sensor or user device that indicates a location associated with the user, wherein the location indicator indicates the elevated exercise activity level when the location of the user is identified as being associated with a presorted location at which increase user activity is to occur, and wherein the location indicator indicates a lower exercise activity level when the location of the user is identified as being associated with another location; or a keyword indicator that indicates at least one keyword of a pre-scheduled event, wherein the keyword indicator indicates the elevated exercise activity level when the at least one keyword comprises at least one activity-related word, and wherein the keyword indicator indicates a lower exercise activity level with the at least one keyword fails to comprise the at least one activity-related word; these are merely pre-solution activities. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information)”). [0063] of the Applicant’s Specification recites interactions with the user’s device to acquire the activity indicators for location, or [0044, 0079, 0081] for the devices used to gather the heartrate indicator, for example. [0044, 0047, 0048, 0097] describes the prestored data used when gathering the data. The use of the user devices to acquire the indicators are used to perform actions for the system including data gathering for the abstract idea, and thus recites insignificant pre-solution activities and does not recite significantly more than the judicial exception. The interconnected devices such as the GPS and other user devices to forward and send the indicator data for the method recites well understood, routine, and conventional activities. The dependent claims (not including claims 9 and 17) do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exceptions for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application. Claims 1-17 are rejected under 35 USC 101 as being directed to non-statutory subject matter. Claims 9 and 17 are rejected as they are dependent on claim 1. However, claims 9 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following references have been previously considered, however do not teach aspects of the current invention individually nor in combination: US 20190236465 A1 to Vleugels teaches of detecting eating events and controlling a microdosing apparatus to release insulin based on a confidence level of an eating event occurring. WO 2018031803 A1 to Cabrera et al. teaches of glucose monitoring and using insulin data along with data from calendar events and location to determine when eating is occurring. NPL “Insulin pump therapy guidelines for successful outcomes” to Scheiner et al. teaches of consideration of meal time activity when using insulin pump. The above references do not teach aspects of the current invention including but not limited to: “determining that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators, wherein the activity score being above the activity threshold indicates the exercise activity level associated with the user being at least a threshold deviation from a normal activity level based on the respective value associated with each of the plurality of activity indicators” Conclusion 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 CONSTANTINE SIOZOPOULOS whose telephone number is (571)272-6719. The examiner can normally be reached Monday-Friday, 8AM-5PM 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, Jason B Dunham can be reached at (571) 272-8109. 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. /CONSTANTINE SIOZOPOULOS/ Examiner Art Unit 3686
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Prosecution Timeline

Nov 21, 2024
Application Filed
Jan 21, 2026
Non-Final Rejection mailed — §101
Apr 20, 2026
Response Filed
Jul 01, 2026
Final Rejection mailed — §101 (current)

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Prosecution Projections

3-4
Expected OA Rounds
58%
Grant Probability
97%
With Interview (+38.1%)
3y 0m (~1y 4m remaining)
Median Time to Grant
Moderate
PTA Risk
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