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 .
Applicant's response filed 11/25/2025 has been fully considered. The following rejections
and/or objections are either reiterated or newly applied.
Status of Claims
Claim 15 and 17-19 canceled.
Claims 1-14, 16, and 20-22 pending and examined on the merits.
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.
Withdrawn Rejections
35 USC § 112(b)
The rejection of claims 1-22 under 35 U.S.C. 112(b) withdrawn in view of Applicant's claim amendments filed on 11/25/2025.
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 1-14, 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:
Claims 1, 20, and 22: “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” provides an evaluation (analyzing data to determine a result) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
“detect missed boluses if glucose levels of the user increase by more than a maximum allowable glucose 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” provides an evaluation (detecting 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.
“generating a user notification when the detector determines the at least one first signal indicates the user missed an insulin bolus” provides an evaluation (generating a user notification based on a determination) 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” 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.
“changing the bolus-consideration time period, the maximum allowable glucose increase threshold, and the predetermined glucose-consideration time window” provides an evaluation (changing parameters 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.
“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 determine a result) 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 “device comprising: []; memory storing computer-executable instructions; and a processor configured to execute the instructions” and a “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”, 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 1-14, 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: “a continuous glucose monitor (CGM) configured to regularly measure glucose levels of a 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.
“receiving, at a computing device, at least one first signal representative of a plurality of glucose measurements for a user and insulin dosing information for the user, the insulin dosing information comprising a time of administration for at least one insulin bolus”, “receiving, at the computing device, contextual information regarding the user”, and “receiving, at the computing device, at least one second signal representative of additional glucose measurements and additional insulin dosing information for the user” provide insignificant extra-solution activities (receiving data are pre-solution activities involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 20: “device comprising: []; memory storing computer-executable instructions; and a processor configured to execute the instructions” 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 are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre-solution activities involving data gathering 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 1-14, 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 “computer system comprising: one or more processors; a memory; and one or more programs, wherein the one or more programs are stored in the memory and are configured to be executed by the one or more processors, the one or more programs including instructions” nor “computer programs comprising instructions which, when executed by a computer system, cause the computer system to perform a method” 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 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 demonstrated to 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 1-14, 16, and 20-22 are not patent eligible.
Response to Arguments under 35 USC § 101
Applicant’s arguments filed 11/25/2025 are fully considered but they are not persuasive.
Applicant asserts "that since claim 1 is now expressly applied with, or by use of, a particular machine [] claim 1 now integrates any judicial exception into a practical application" (Remarks 11/25/2025 Page 1). Examiner notes that a CGM in communication with a computing device is an additional element that does not serve to integrate the judicial exceptions into a practical application because it is merely an insignificant pre-solution activity involving data gathering steps (as indicated above). Furthermore, applicant argues that the amendment of determining whether the user has missed an insulin bolus "goes beyond reciting merely the idea of a solution or outcome bet instead details a specific solution to an identified problem" (Remarks 11/25/2025 Pages 1-2). Examiner also notes above that determining a missed bolus based on a threshold glucose level over a period of time and changing parameters involves making determinations based on data or experience, both of which may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
The Examiner also 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 gathering, inputting, and outputting data (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.
Therefore, the rejection of claim 1 under 35 USC 101 is maintained. All other claims depend from this independent claim; therefore, their rejection is likewise maintained.
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 1-22 rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US- 20170220751).
Regarding claims 1, 20, and 22, Davis teaches a method for detecting missed insulin boluses (Para.0044 "Advantages of the embodiments and aspects may include, in certain embodiments, one or more of the following. Problems that may be solved by the decision-support application/functionality may include, but are not limited to: missed boluses").
Davis also teaches communicably connecting a computing device with a continuous glucose monitor (CGM) configured to regularly measure glucose levels of a user (Para.0025 "The sensor may form part of an analyte concentration monitor. The analyte concentration monitor may be a CGM").
Davis also teaches receiving at least one first signal representative of a plurality of glucose measurements for a user and insulin dosing information for the user, the insulin dosing information comprising a time of administration for at least one insulin bolus (Para.0218 "In some cases derived data requires a time duration over which to analyze or an analysis of a pattern to determine. For example, a determination of insulin sensitivity or an insulin resistance may require analysis of data taken over a time duration. In a specific implementation, insulin resistance can change throughout the menstrual cycle of female diabetics. The decision-support application/functionality can use a resulting cycle of insulin resistance, e.g., including incorporating insulin consumption as well as glucose values, to determine a predictive insulin resistance alert to provide to the user. For example, the patient could receive a reminder at the beginning of the day that historically in their cycle their blood sugar tends to go higher or lower. Such a prompt [may] help the patient be more conscientious of how they could expect their blood sugar to behave.").
Davis also teaches or fairly suggests an analysis of glucose measurements over time following a meal event, wherein a missed insulin bolus is indicated when the latest glucose measurement is greater than a (first or second) predetermined threshold (sensitivity level) within a given time period after the meal event; and receiving, at the computing device, at least one second signal representative of additional glucose measurements and additional insulin dosing information for the user; and the detector is configured to detect missed boluses if glucose levels of the user increase by more than a maximum allowable glucose 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.0100 " The determination of insulin sensitivity, as well as the determination of other types of sensitivities, are discussed in greater detail below, but here it will be noted that knowledge of insulin sensitivity may be based on, e.g., real-time analysis of data from CGM, activity monitors, and insulin pump data, as well as on data from retrospective analysis of such sensors as well as data from, e.g., an electronic health record"; Para.0142 "The system model of the patient is defined by a number of parameters, preferably two or more, that influence diabetes control. In many cases the system model of the patient will involve consideration of one or more sensitivities, which are described below in the context of correlative parameters of which the user is unaware."; and Para.0153 "In many cases the calculated insight corresponds to a perturbation sensitivity that the user is cognitively unaware of, or of which it is difficult for the user to determine. These include: sensitivities to foods (including considerations of food types, amounts, and timing of consuming); sensitivities to therapy (e.g., sensitivities to insulin or other diabetes medications, again including type, amount, and timing); sensitivity to exercise (again based on type, amount, and timing); sensitivity to sleep (again based on type, amount, and timing, as well as other sensitivities, and combinations of the above. Determinations of such sensitivities may be by analysis of sensor data, e.g., CGM sensor data, in combination with other data, e.g., that corresponding to meals, exercise, or sleep.", and using thresholds for alert settings based on insulin sensitivity would be obvious to one skilled in the art to combine with the suggestion of detecting missed boluses by the variety of parameters also recited in the disclosure of Davis: para.0222 "Derived data may also include data determined about recognized patterns, where the patterns are recognized by analysis of historical data over time. Exemplary recognized patterns include patterns of nightly hypoglycemia, postprandial highs, post exercise lows, or the like" and para.0205 "As each patient generally has a different insulin sensitivity (but this sensitivity may be learned using the decision-support application/functionality described here), multiple thresholds are generally needed for alert settings").
Davis also teaches generating a user notification when the detector determines the at least one first signal indicates the user missed an insulin bolus (Para.0118 "In this implementation as well, the decision-support application 132 will typically provide an output to a display, to provide a user prompt or notification of decision-support therapy recommendations. The same may further ask for confirmation prior to dosing.").
Davis also teaches receiving, at the computing device, contextual information regarding the user (Para.0018 "data known about the user may be employed to stratify the user into one or more of a number of user profiles. As above, the user-desired functionality may then be modified according to the parameterized model and the determined user profile.").
Davis also teaches or fairly suggests 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; and 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.0019 "In yet another implementation, a first set of data may be used as inputs to a decision-support application/functionality, while a second set may be used as variables that affect how the decision-support application/functionality operates, e.g., affects the type of user interface provided", and para.0153 suggests incorporation of time and/or other parameters for the purposes of reconfiguring the detector when coupled with para.0205: para.0153 "In many cases the calculated insight corresponds to a perturbation sensitivity that the user is cognitively unaware of, or of which it is difficult for the user to determine. These include: sensitivities to foods (including considerations of food types, amounts, and timing of consuming); sensitivities to therapy (e.g., sensitivities to insulin or other diabetes medications, again including type, amount, and timing); sensitivity to exercise (again based on type, amount, and timing); sensitivity to sleep (again based on type, amount, and timing, as well as other sensitivities, and combinations of the above. Determinations of such sensitivities may be by analysis of sensor data, e.g., CGM sensor data, in combination with other data, e.g., that corresponding to meals, exercise, or sleep" and para.0205 "As each patient generally has a different insulin sensitivity (but this sensitivity may be learned using the decision-support application/functionality described here), multiple thresholds are generally needed for alert settings").
While Davis is not explicitly only for detecting or flagging missed insulin boluses, it is among the suggested use cases for the invention (para.0044 "Problems that may be solved by the decision-support application/functionality may include, but are not limited to: missed boluses"). 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 Davis in order to support diabetes-related decisions around missed boluses. One skilled in the art would have a reasonable expectation of success because both approaches use glucose measurement and other data to predict a user's behavior and issue results to help the user decide how to manage their diabetes.
Regarding claim 2, Davis also teaches the detector exhibits a different false positive rate when the detector is configured according to the second sensitivity level than when the detector is configured according to the first sensitivity level (Figure 22 demonstrates manual setting of thresholds by the user, which enables setting a first and second sensitivity threshold. As such, when the user adjusts the threshold this will necessarily change the true and false positive and negative rates of the test, thus changing the sensitivity of the detector).
Regarding claim 3, Davis teaches the methods of Claim 1 on which this claim depends. Davis also teaches the contextual information comprises manual user-input instructing the detector to use a different sensitivity level than the first sensitivity level (Para.0022 "Additional data pertaining to the user may be received from various sources, including other sensors and user input" and para.0250 " In this implementation, and referring to FIGS. 22(A) and 22(B), a user can, on the user interface, touch the actual threshold line on the graph and drag it to the alert threshold they desire. A pop-up value informs the user of the current exact value of the threshold. When the user takes their finger off the line, a pop-up will ask the user if the threshold is correct. This functionality mitigates accidental touch and drag. In a variation, the graph could be one allowing the user to follow daily trends and set alerts corresponding to their daily activities.").
Regarding claim 4, Davis teaches the methods of Claim 1 on which this claim depends. Davis also teaches the contextual information comprises manual user-input indicating the detector had detected a false missed insulin bolus (para.0392 "During real-time use of the bolus calculator, the user may also be shown their last insulin dose, which can be updated if it is incorrect. Trend adjustments offer additional safety mitigations for incorrect estimates of insulin on board by reducing the suggested insulin dose when glucose is falling, i.e., when insulin is acting. When the CGM app is linked with an insulin app, the current insulin-on-board may be taken directly from the insulin app" and para.0432 "In another variation, in the app, there may be at least one confirmation screen at the time of bolus calculation to verify that the information entered by the user is correct. The confirmation screen may be modulated (whether the confirmation screen is provided vs. skipped) depending on whether the entered values are typical for that user, or to visually highlight user inputs that seem atypical in the confirmation screen. Typical vs. atypical values could be based on aggregate data across many users, and could be refined based on individual users over time. This is a similar idea to credit card fraud protection, where atypical behavior is immediately flagged and triggers verification with the credit card holder that a purchase was not fraudulent. Similarly as with credit cards, there may be a mode that a user provides (such as a “holiday mode”) that causes the app to use looser criteria for flagging atypical behavior for a set period of time, analogous to notifying a credit card company that you will be vacationing in a foreign country ahead of time.").
Regarding claims 5-8, Davis teaches the methods of Claim 1 on which these claims depend. Davis also teaches: the contextual information comprises a current time of day; the contextual information comprises data measured by a wearable sensor worn by the user, wherein the data includes at least one of physiological data and accelerometer data; 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; and the contextual information indicates an exercise event by the user (Para.0100 "Other factors that may bear on insulin sensitivity or ISF may include correlations with time of day, pain, and/or exercise; heart rate variability, stroke volume, other cardiovascular health related to metabolic issues; ability to distribute insulin; temperature; insulin type, based on insulin sensitivity measurements, profiles, peaks, time between peaks; atmospheric pressure (thus “airplane mode” may be an input); whatever activity affects the patient or user the most; and so on").
Regarding claim 9, Davis teaches the methods of Claim 6 on which this claim depends. Davis also teaches the contextual information indicates a sleep event by the user (Para.0153 "Determinations of such sensitivities may be by analysis of sensor data, e.g., CGM sensor data, in combination with other data, e.g., that corresponding to meals, exercise, or sleep.").
Regarding claim 10, Davis teaches the methods of Claim 1 on which this claim depends. Davis also teaches the contextual information comprises a geographical location of the user (Para.0185 "For example, meal data may be determined by user input, but also by GPS, from pattern data or from an app such as a camera.").
Regarding claim 11, Davis teaches the methods of Claim 1 on which this claim depends. Davis also teaches the contextual information further comprises data from a database indicating whether the user has previously ingested food at the geographical location (Para.0318 "Such goals may be mapped with timing elements, e.g., by integration with calendars, mapped with GPS data, e.g., the user location may indicate mealtime or whether they are at home").
Regarding claim 12, Davis teaches the methods of Claim 1 on which this claim depends. Davis also teaches the contextual information further comprises data from a database indicating whether other users have previously ingested food at the geographical location (Para.0256 "The output may also be provided to a different device 278, e.g., which may be the device of a follower or other user to whom the subject user has shared their data.", in light of para.0318 used for claim 11 would enable a user to view which GPS locations other users had ingested food).
Regarding claim 13, Davis teaches the methods of Claim 1 on which this claim depends. Davis also teaches the contextual information further comprises data designating the user’s current location as being a location where people are likely to ingest food (Para.0322 "For example, her CGM app may inform her of the best time to dose for her upcoming pizza meal. In some cases, using GPS, pattern data, or the like, the system may accurately guess that she is going to eat pizza, rather than having such data explicitly entered into the app.").
Regarding claim 14, Davis teaches the methods of Claim 1 on which this claim depends. Davis also teaches the contextual information comprises data indicating whether the user is driving (Para.0190 "Sensors such as accelerometers and GPS may be conveniently used to provide data about exercise or activity performed by the user. In some cases GPS or other sensors may be employed to determine other types of activity data, e.g., if a user is driving, which may in turn inform how an output to a user may be displayed, e.g., on a smart watch versus on a smart phone.").
Claim 15 cancelled.
Regarding claim 16, Davis teaches the methods of Claim 1 on which this claim depends. Davis also teaches the first sensitivity level is more sensitive to missed boluses than the second sensitivity level (Figure 22 demonstrates manual setting of thresholds by the user, which could easily set a first sensitivity greater than a second.).
Claim 17 cancelled.
Claim 18 cancelled.
Claim 19 cancelled.
Regarding claim 20, Davis teaches the methods of Claim 1 on which this claim’s methods are a duplicate of. Davis also teaches a device that can be configured for missed bolus detection that includes a communication device linked to glucose sensors, memory storing instructions, and a processor for executing instructions (Para.0021 "The support application/functionality may be implemented as instructions on a computer-readable medium, as firmware, or as an ASIC, it may be situated as part of sensor electronics, a dedicated receiver, or a mobile device such as a smart phone and/or smart watch. Larger devices such as tablets, laptops, and desktop computers may also be employed. It will be understood that the application/functionality may be embodied as modules on these devices, and the modules and functionality may spread across multiple such devices.").
Regarding claim 21, Davis teaches the methods of Claim 1 on which this claim depends. Davis also teaches the communication device is further configured to establish one or more communication links with a remote server via a network (Para.0115 "Measurements or other data may be transmitted from the dedicated receiver or smart watch to server 115 and/or a HCP 117, or to the follower device 114 as noted above, e.g., for notification, authorization, confirmation, approval, or for other purposes" and para.0272 "More generally, measurements from the sensor of analyte concentration can be transmitted via the sensor electronics to smart devices as well as to servers for subsequent analysis and calculations.").
Response to Arguments under 35 USC § 103
Applicant’s arguments filed 11/25/2025 are fully considered but they are not persuasive.
Applicant asserts "that since claim 1 is now expressly applied with, or by use of, a particular machine [] claim 1 now integrates any judicial exception into a practical application" (Remarks 11/25/2025 Page 1). Examiner notes that a CGM in communication with a computing device is an additional element that does not serve to integrate the judicial exceptions into a practical application because it is merely an insignificant pre-solution activity involving data gathering steps (as indicated above). Furthermore, applicant argues that the amendment of determining whether the user has missed an insulin bolus "goes beyond reciting merely the idea of a solution or outcome bet instead details a specific solution to an identified problem" (Remarks 11/25/2025 Pages 1-2). Examiner also notes above that determining a missed bolus based on a threshold glucose level over a period of time and changing parameters involves making determinations based on data or experience, both of which may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
The Examiner also 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 gathering, inputting, and outputting data (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.
Therefore, the rejection of claim 1 under 35 USC 101 is maintained. All other claims depend from this independent claim; therefore, their rejection is likewise maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US-11963801 in view of Davis et al. (US- 20170220751). Although the claims at issue are not identical, they are not patentably distinct from each other because both involve collecting, storing, and analyzing glucose measurement data. They are both also methods for identifying patterns in glucose data to indicate to the user a recommendation. Finally, both involve meal time and exercise data, manual entry of data, and displaying data.
While US-11963801 does not explicitly teach notification of a missed bolus or the amendments to claim 1 filed 11/25/2025, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Davis as described above for claim 1 of the instant application, in order to support diabetes-related decisions around missed boluses (para.0044 "Problems that may be solved by the decision-support application/functionality may include, but are not limited to: missed boluses"). One skilled in the art would have a reasonable expectation of success because both approaches use glucose and other data to try to predict a user's behavior and issue results to help the user decide how to manage their diabetes.
Additionally, US-11963801 does not explicitly teach the limitations of claims 3, 4, 6-14, nor 16-19. However, Davis teaches these limitations as outlined above in “Claim Rejections - 35 USC § 103”.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Application No. 17/625,180 in view of Davis et al. (US- 20170220751). Although the claims at issue are not identical, they are not patentably distinct from each other because both involve collecting glucose measurements from a glucose sensor, analyzing the measurements to determine a change based on comparison to a threshold, and outputting a result to the user. They both also involve capturing inputs from the user regarding consumed meals.
While US-11963801 does not explicitly teach notification of a missed bolus or the amendments to claim 1 filed 11/25/2025, it does describe a method of detecting meals consumed by a patient, the meal and the meal time being unknown, which implies that an insulin bolus may have been missed. In this way, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Davis as described above for claim 1 of the instant application, in order to support diabetes-related decisions around missed boluses (para.0044 "Problems that may be solved by the decision-support application/functionality may include, but are not limited to: missed boluses"). One skilled in the art would have a reasonable expectation of success because both approaches use glucose and other data to try to predict a user's behavior and issue results to help the user decide how to manage their diabetes.
Additionally, 17/625,180 does not explicitly teach the limitations of claims 3, 4, 6-14, nor 16-19. However, Davis teaches these limitations as outlined above in “Claim Rejections - 35 USC § 103”.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TH REE-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 finaI action.
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/R.A.P./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686