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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/17/2026 has been entered and considered. Rejections and/or objections not reiterated from the previous office action mailed 1/28/2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Status of Claims
Claims 1-5, 7, 10-13, 16, and 20-22 pending and examined on the merits.
Claims 6, 8-9, 14-15, and 17-19 cancelled.
Priority
The instant application is a 371 national stage entry of PCT/US2020/038722 filed on 6/19/2020, and claims the benefit of priority to U.S. Provisional Application No. 62/867,284 filed on 6/27/2019. Thus, the effective filing date of the claims is 6/27/2019.
The applicant is reminded that amendments to the claims and specification must comply with 35 U.S.C. § 120 and 37 C.F.R. § 1.121 to maintain priority to an earlier-filed application. Claim amendments may impact the effective filing date if new subject matter is introduced that lacks support in the originally filed disclosure. If an amendment adds limitations that were not adequately described in the parent application, the claim may no longer be entitled to the priority date of the earlier filing.
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, 7, 10-13, 16, and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1: “analyzing, with a detector of the computing device configured at a first sensitivity level, the plurality of glucose measurements and the insulin dosing information to determine whether the at least one first signal indicates the user missed an insulin bolus following a meal event, wherein the detector is configured to detect missed boluses if glucose levels of the user increase by more than a maximum allowable glucose increase threshold within a predetermined glucose-consideration time window of a current time, and the user has not taken an insulin bolus within a predetermined bolus-consideration time period of the current time” and “analyzing, using the detector of the computing device configured at the second sensitivity level, the additional glucose measurements and the additional insulin dosing information to determine whether the at least one second signal indicates the user missed an insulin bolus following a meal event” provides an evaluation (analyzing data to detect a missed bolus based on a threshold glucose level over a period of time involves making determinations based on data or experience) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
“reconfiguring the detector, based at least on the contextual information, to detect missed boluses according to a second sensitivity level that is different from the first sensitivity level when the contextual information indicates the user is sleeping, exercising, or traveling, wherein said reconfiguring comprises at least one of changing the bolus-consideration time period, the maximum allowable glucose increase threshold, and the predetermined glucose-consideration time window” provides an evaluation (changing a threshold based on new information) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
These recitations are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or are mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Additionally, while claims 20-22 recite performing some aspects of the analysis on “A mobile device [. . .] comprising: a communication device configured to establish one or more communication links with at least one of a glucose sensing device, a wearable sensor, and a drug delivery device; memory storing computer-executable instructions; and a processor configured to execute the instructions to implement the method of claim 1” (claim 20) nor “Non-transitory computer-readable media storing computer-executable instructions that, when executed by one or more processors, are operable to cause the one or more processors to implement the method of claim 1” (claim 22), there are no additional limitations that indicate that this requires anything other than carrying out the recited mental processes or mathematical concepts in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental processes” grouping of abstract ideas. As such, claims 1-5, 7, 10-13, 16, and 20-22 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exceptions listed above are not integrated into a practical application because the claims do not recite an additional element or elements that reflects an improvement to technology. Specifically, the claims recite the following additional elements:
Claim 1: “communicably connecting a computing device with a continuous glucose monitor (CGM) configured to regularly measure glucose levels of a user; receiving, at the computing device, at least one first signal representative of a plurality of glucose measurements for the user from the CGM and insulin dosing information for the user, the insulin dosing information comprising a time of administration for at least one insulin bolus”, “measuring, using a wearable sensor worn by the user, sensor data including at least one of physiological data and accelerometer data of the user; receiving, at the computing device, contextual information regarding the user, wherein the contextual information comprises the sensor data measured using the wearable sensor”, and “receiving, at the computing device, at least one second signal representative of additional glucose measurements and additional insulin dosing information for the user” provides insignificant extra-solution activities (measuring and receiving data are pre-solution activities involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
“generating a user notification when the detector determines the at least one first signal indicates the user missed an insulin bolus” provides insignificant extra-solution activities (generating a user notification is a pre-solution activity involving data manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 20: “A mobile device [. . .] comprising: a communication device configured to establish one or more communication links with at least one of a glucose sensing device, a wearable sensor, and a drug delivery device; memory storing computer-executable instructions; and a processor configured to execute the instructions to implement the method of claim 1” provides insignificant extra-solution activities (running instructions on generic computer components) that do not serve to integrate the judicial exceptions into a practical application.
Claim 22: “Non-transitory computer-readable media storing computer-executable instructions that, when executed by one or more processors, are operable to cause the one or more processors to implement the method of claim 1” provides insignificant extra-solution activities (running instructions on generic computer components) that do not serve to integrate the judicial exceptions into a practical application.
The steps for measuring and receiving data, and generating user notifications are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre- and post-solution activities involving data gathering, data manipulation, and sample manipulation steps (see MPEP 2106.04(d)(2)). Furthermore, the limitations regarding implementing program instructions do not indicate that they require anything other than mere instructions to implement the abstract idea in a generic way or in a generic computing environment. As such, this limitation equates to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. Therefore, claims 1-5, 7, 10-13, 16, and 20-22 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application, or equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
As discussed above, there are no additional elements to indicate that the claimed “A mobile device [. . .] comprising: a communication device configured to establish one or more communication links with at least one of a glucose sensing device, a wearable sensor, and a drug delivery device; memory storing computer-executable instructions; and a processor configured to execute the instructions to implement the method of claim 1” (claim 20) nor “Non-transitory computer-readable media storing computer-executable instructions that, when executed by one or more processors, are operable to cause the one or more processors to implement the method of claim 1” (claim 22) requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. Additionally, the limitations for measuring and receiving data, and generating user notifications are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Furthermore, no inventive concept is claimed by these limitations as they are be well-understood, routine, and conventional.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-5, 7, 10-13, 16, and 20-22 are not patent eligible.
Response to Arguments under 35 USC § 101
Applicant’s arguments filed 4/17/2026 are fully considered but they are not persuasive.
Applicant asserts that "amended claim 1 now claims the novel and inventive idea of using a wearable sensor to derive clues about the user's context, circumstances, or condition, and then applying these derived clues to reconfigure the sensitivity level of a missed bolus detector" and "that these amendments now recite additional elements that integrates any judicial exception into a practical application" (Remarks 4/17/2026 page 2). The Examiner notes that MPEP 2106(I) states that if the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). In the “search for an ‘inventive concept’” (the second part of the Alice/Mayo test), the additional elements identified do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception because measuring and receiving data, and generating user notifications (data gathering and manipulation steps) are all well-understood, routine, and conventional techniques that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Therefore, combining insignificant extra-solution activities with any of the identified judicial exceptions would not result in patent eligible subject matter because integrating well-understood, routine, and conventional techniques does not yield “significantly more” to a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon.
Applicant also asserts "that amended claim 1 now recites additional elements that amount to significantly more than the judicial exception" because "claim 1 as a whole now incorporates an 'inventive concept' [because] the claimed method represents an improvement to the technical field of detecting missed boluses and managing glycemic excursions, as it permits for beneficial fine-tuning of a missed bolus detector's sensitivity level" (Remarks 4/17/2026 page 3). Examiner notes below that the prior art of Rack-Gomer et al. (US-20150289823) renders these alleged "novel and inventive" limitations obvious, therefore an argument of an improvement to the technical field is moot (see section "Claim Rejections - 35 USC 103", below).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7, 10-13, 16, and 20-22 rejected under 35 U.S.C. 103 as being unpatentable over Rack-Gomer et al. (US-20150289823).
Regarding claims 1 and 20-22, Rack-Gomer teaches: communicably connecting a computing device with a continuous glucose monitor (CGM) configured to regularly measure glucose levels of a user; and receiving, at the computing device, at least one first signal representative of a plurality of glucose measurements for the user from the CGM and insulin dosing information for the user, the insulin dosing information comprising a time of administration for at least one insulin bolus (Para.0026 "Where the physiological condition is diabetes, the urgency index may be a glycemic urgency index, and the data of the first type may be a glucose concentration, and the received data entered by a user may include a user weight, a user indication of activity level, a user indication of food or drink ingested or to be ingested, anthropometric data, data about prior insulin provided to the user, stress data, health data, data about a placement of the sensor measuring the data of the first type, age, or gender" and para.0122 "In other embodiments, the electronic device 200 may comprise a device or devices other than a smartphone, such as a receiver of a CGM system, a smartwatch, a tablet computer, a mini-tablet computer, a handheld personal digital assistant (PDA), a game console, a multimedia player, a wearable device").
Rack-Gomer also teaches analyzing, with a detector of the computing device configured at a first sensitivity level, the plurality of glucose measurements and the insulin dosing information to determine whether the at least one first signal indicates the user missed an insulin bolus following a meal event, wherein the detector is configured to detect missed boluses if glucose levels of the user increase by more than a maximum allowable glucose increase threshold within a predetermined glucose-consideration time window of a current time, and the user has not taken an insulin bolus within a predetermined bolus-consideration time period of the current time (Para.0201 "Another variable or parameter which may factor into the GUI determination is a level of insulin. The data may be provided directly from an integrated insulin pump or from EMR in the cloud. Such data may include information about the amount of insulin on board, insulin sensitivity, and past, present, and future planned basal and bolus levels. Data may be obtained by sensor data or other electronically communicated data, or may be provided by user entry. One type of information which may be obtained from this data includes the time between an insulin bolus and a meal peak, which can be determined using insulin information and glucose information").
Rack-Gomer also teaches generating a user notification when the detector determines the at least one first signal indicates the user missed an insulin bolus (Para.0015 "The method may comprise, outputting an audible and/or tactile alert on the mobile device and/or overriding other applications or processes operating on the mobile device, such that the indication of the urgency index is displayed on the mobile device regardless of other running applications or processes, when the urgency index reaches or exceeds a threshold indicative of the physiological condition reaching a health risk state, e.g. indicative of risk of an extreme hypoglycemic or hyperglycemic state, unless mediating action is taken by the user").
Rack-Gomer also teaches measuring, using a wearable sensor worn by the user, sensor data including at least one of physiological data and accelerometer data of the user (Para.0027 "The receiving data of a third type may include receiving data from a sensor. Where the physiological condition is diabetes, the urgency index may be a glycemic urgency index and the data of the first type may be a glucose concentration, and the sensor may include at least one of the following: a scale, a glucometer, a thermometer, an accelerometer, a camera, a GPS device, or a microphone").
Rack-Gomer also teaches receiving, at the computing device, contextual information regarding the user, wherein the contextual information comprises the sensor data measured using the wearable sensor (Para.0122 "In other embodiments, the electronic device 200 may comprise a device or devices other than a smartphone, such as a receiver of a CGM system, a smartwatch, a tablet computer, a mini-tablet computer, a handheld personal digital assistant (PDA), a game console, a multimedia player, a wearable device, such as those described above").
Rack-Gomer also teaches reconfiguring the detector, based at least on the contextual information, to detect missed boluses according to a second sensitivity level that is different from the first sensitivity level when the contextual information indicates the user is sleeping, exercising, or traveling, wherein said reconfiguring comprises at least one of changing the bolus-consideration time period, the maximum allowable glucose increase threshold, and the predetermined glucose-consideration time window (Para.0168 "While eating and sleeping have been disclosed elsewhere herein, it will be understood that patterns may be recognized or generated and employed in GUI [glycemic urgency index] determination for other events, such as meetings, work, exercising, and the like. Time-of-day information may be captured from any clock circuit or application, such as those from a server, or from the mobile device or sensor electronics. Patterns may be based on detected events occurring with any sort of periodicity, such as during a cycle of a day, week, or month. Such data is generally available via an analysis of the stored glucose values, and various pattern recognition software applications may be advantageously employed. In some cases, a pattern may be detected, and a user may be prompted to determine if there is a particular cause for the pattern, e.g., a common mealtime, an exercise class occurring at a usual time, and the like. Such prompts may be particularly used when the urgency assessment module is using machine learning to determine daily or other periodic patterns or behaviors of a given user").
Rack-Gomer also teaches receiving, at the computing device, at least one second signal representative of additional glucose measurements and additional insulin dosing information for the user (Para.0163 "In using duration as a factor, the urgency assessment module may use as an input the duration itself, or a time over which a particular urgency state has exceeded a threshold duration, or other related parameters. Such data is generally available via an analysis of the stored glucose values over time" suggests additional glucose measurements and dosing information over time).
Rack-Gomer also teaches analyzing, using the detector of the computing device configured at the second sensitivity level, the additional glucose measurements and the additional insulin dosing information to determine whether the at least one second signal indicates the user missed an insulin bolus following a meal event (Para.0164 "For example, the level of the last glucose peak, or its duration (as measured as a time period over a threshold level or within a range), or the like, may be employed in determinations. The level and/or duration of the last significant excursion or deviation of glucose values away from a baseline (or an otherwise expected value) may be employed in the determination as the same are often indicative of a user's current risk of a glycemic excursion, and in particular are an indicator of a greater likelihood of future excursions or deviations. For example, for a determined GUI of 6, but where a user has undergone many recent excursions or deviations, the GUI may be raised to 7" suggests a reconfigured threshold (a GUI of 7 instead of 6)).
While Rack-Gomer does not explicitly recite the phrase "detecting a missed bolus", the entire focus of the system is the timing of insulin boluses and alerting the user if one is critically needed, therefore the limitations surrounding alerting a user of a missed bolus are heavily implied. Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Rack-Gomer in order to notify the user of a missed bolus of insulin via the fusion of different data parameters over a period of time (Para.0259 "Decision fusion methods may be employed to, e.g., determine whether a given user is likely to be below 55 mg/dL within the next hour. In such methods, different data parameters can be used to make decisions about whether hypoglycemia will occur in a given time period, e.g., within the next hour. Data analysis may be performed to determine the optimal detection parameters and their optimal yes/no decision thresholds, as well as associated sensitivity"). One skilled in the art would have a reasonable expectation of success because both methods are concerned with incorporating measurement and contextual information in order to adjust sensitivity levels for alerting a user regarding their glycemic levels.
Regarding claim 2, Rack-Gomer teaches the methods of Claim 1 on which this claim depends/these claims depend, respectively. The addition of the various physiological information used by the method of Rack-Gomer would necessarily cause the false positive rate to be different when the detector is updated with said information.
Regarding claim 3, Rack-Gomer teaches the methods of Claim 1 on which this claim depends/these claims depend, respectively. Rack-Gomer also teaches the contextual information comprises manual user-input instructing the detector to use a different sensitivity level than the first sensitivity level (Para.0323 "Guidelines for notifications, as well as for alerting and alarming, based on GUI, may be factory-set or may be customizable by the user, who may also set threshold values at which alerts and alarms occur. The system may also provide for changes in alerts based on trends in the GUIs or other factors, either automatically or instigated by the user. As such, the system allows for the dynamic and/or iterative update of urgency indices and states with time, as additional data is received, and based on user actions").
Regarding claim 4, Rack-Gomer teaches the methods of Claim 1 on which this claim depends/these claims depend, respectively. Rack-Gomer also teaches the contextual information comprises manual user-input indicating the detector had detected a false missed insulin bolus (Para.0168 "In some cases, a pattern may be detected, and a user may be prompted to determine if there is a particular cause for the pattern, e.g., a common mealtime, an exercise class occurring at a usual time, and the like" suggests manual user-input prompts for various events).
Regarding claim 5, Rack-Gomer teaches the methods of Claim 1 on which this claim depends/these claims depend, respectively. Rack-Gomer also teaches the contextual information comprises a current time of day (Para.0168 "Time-of-day information may be captured from any clock circuit or application").
Regarding claim 7, Rack-Gomer teaches the methods of Claim 1 on which this claim depends/these claims depend, respectively. Rack-Gomer also teaches the physiological data includes at least one of a heart rate of the user, a blood pressure of the user, an electrocardiogram (ECG) of the user, a blood oxygen saturation level of the user (SpO₂), a muscle oxygen saturation level of the user (SmO₂), a breathing rate, and a body temperature of the user (Para.0027 "The receiving data of a third type may include receiving data from a sensor. [. . .] the sensor may include at least one of the following: a scale, a glucometer, a thermometer, an accelerometer, a camera, a GPS device, or a microphone" and para.0184 "Another such physiological data type includes blood pressure information").
Regarding claim 10-12, Rack-Gomer teaches the methods of Claim 1 on which this claim depends/these claims depend, respectively. Rack-Gomer also teaches: the contextual information comprises a geographical location of the user; the contextual information further comprises data from a database indicating whether the user has previously ingested food at the geographical location; the contextual information further comprises data from a database indicating whether other users have previously ingested food at the geographical location; and the contextual information further comprises data designating the user's current location as being a location where people are likely to ingest food (Para.0199 "Meal data may even be hypothesized (subject to confirmation by the user) by use of GPS or social networking data indicating that a user is near, or has “checked in” at a known favorite restaurant").
Regarding claim 16, Rack-Gomer teaches the methods of Claim 1 on which this claim depends/these claims depend, respectively. Rack-Gomer also teaches the first sensitivity level is more sensitive to missed boluses than the second sensitivity level (The example in para.0164 teaches a more sensitive first sensitivity level (GUI of 6) compared to the second sensitivity level (GUI of 7)).
Response to Arguments under 35 USC § 103
Applicant’s arguments filed 4/17/2026 are fully considered.
Applicant asserts that the amended claim 1 method of "setting a missed bolus detector at different sensitivity levels" by reconfiguring it "to a different level if data from the wearable sensor indicates the user is sleeping, exercising, [or] traveling" "would not have been obvious to a person of skill in the art from the disclosure of Davis" (Remarks 4/17/2026 pages 3-4). Examiner notes above that Davis is no longer the primary prior art reference upon which the 35 USC 103 rejection relies, and that Rack-Gomer in fact teaches or suggests these (and other) limitations (para.0253 "FIG. 14 gives an example of avoiding a false risk state by using acceleration as a parameter or variable in the determination of a GUI [glycemic urgency index]"). Please find additional details above.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US-20170311904, CGM method of analysis and glucose/insulin pattern recognition with high and low alert settings
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert A. Player whose telephone number is 571-272-6350. The examiner can normally be reached Mon-Fri, 8am-5pm.
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/R.A.P./Examiner, Art Unit 1686
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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