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 .
Status of Claims
Claims 1, 4-7, 9, 10, 12, 15-19 and 22 have been amended.
Claims 23-25 are newly presented.
Claims 1, 4-7, 9, 10, 12, 14-20, 22-25 as presented September 26, 2025 are currently pending and considered below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 26, 2025 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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, 4-7, 9, 10, 12, 14-20, 22-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 4-7, 9, 10, 12, 14, 15 and 22-25 recite a method for presenting insulin therapy recommendations with therapy insight to a PWD, which is within the statutory category of a process. Claims 16-20 recite a method for presenting insulin therapy data to a dashboard of an electronic device of a PWD, which is within the statutory category of a process.
Step 2A - Prong One:
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. Representative independent claim 1 includes limitations that recite at least one abstract idea.
Specifically, independent claim 1 recites: A method for presenting insulin therapy setting recommendations associated with a therapy insight for a person with diabetes (PWD) at an electronic device, comprising:
receiving, from a blood glucose sensor and at a device having one or more processors, a memory and a display, blood glucose data for a PWD receiving insulin-based therapy, wherein the PWD is associated with a provider caring for the PWD;
receiving, at the device, insulin therapy data for the PWD;
based at least partially on one or more predetermined patterns respectively pre-associated with behavior trends and one or more of the blood glucose data or the insulin therapy data, identifying a behavior trend of the PWD represented in the one or more of the blood glucose data or the insulin therapy data, wherein the behavior trend is associated with the blood glucose data after each meal consumed over a period;
selecting one or more therapy insights reflecting the identified behavior trend
providing the one or more therapy insights to a provider device associated with the provider, wherein the one or more therapy insights includes a percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period;
wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a threshold percentage, determining one or more insulin therapy recommendations;
displaying, on the provider device, the one or more insulin therapy recommendations;
responsive to the provider device receiving a selection of one of the one or more insulin therapy recommendations, receiving, at the electronic device, the selected insulin therapy recommendation from the provider device;
responsive to receiving the selected insulin therapy recommendation from the provider device, displaying on the display of the electronic device, the selected insulin therapy recommendation; and
administering, by an insulin delivery device, insulin to the PWD according to the selected insulin therapy recommendation.
The underlined limitations are directed to methods of organizing human activity. The claim recites steps of receiving blood glucose and insulin therapy data, identifying a behavioral trend, selecting a therapy insight, providing the selected therapy insight to the provider, determining and displaying an insulin therapy recommendation and receiving and displaying the selected therapy recommendation. These steps, under its broadest reasonable interpretation, are categorized as methods of organizing human activity, specifically associated with managing personal behavior or relationships or interactions between people (e.g. providing insulin therapy recommendations to a person with diabetes). Therefore, the limitation falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a). Any limitation not identified above as part of methods of organizing human activity, are deemed “additional elements” and will be discussed further in detail below. The abstract idea for Claim 16 is identical as the abstract idea for Claim 1. Accordingly, claims 1 and 16 recite at least one abstract idea.
Similarly, dependent claims 4, 6, 7, 9, 10, 12, 14, 15 and 22-25 further narrow the abstract idea described in the independent claims. Claims 4, 6, 7, 9, 10, 12, 14, 15 further describe the selected insulin therapy recommendations. Claims 22-25 describe the first insulin therapy recommendation. Claims 9, 10, 12 and 15 partially narrow the abstract idea as described above, and also introduce additional element(s) which will be discussed in Step 2A Prong 2 and Step 2B. These limitations only serve to further limit the abstract idea and hence, are directed toward fundamentally the same abstract ideas as independent claims 1 and 16.
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. More specifically, it must be determined whether any additional elements in the claim beyond the abstract idea integrate 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 exception into a "practical application."
In the present case, claims 1, 4-7, 9, 10, 12, 14-20, 22-25 as a whole do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. The additional elements or combination of additional elements, beyond the above-noted at least one abstract idea will be described as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the “abstract idea(s)”).
Specifically, independent claim 1 recites: A method for presenting insulin therapy setting recommendations associated with a therapy insight for a person with diabetes (PWD) at an electronic device, comprising:
receiving, from a blood glucose sensor and at a device having one or more processors, a memory and a display, blood glucose data for a PWD receiving insulin-based therapy, wherein the PWD is associated with a provider caring for the PWD;
receiving, at the device, insulin therapy data for the PWD;
based at least partially on one or more predetermined patterns respectively pre-associated with behavior trends and one or more of the blood glucose data or the insulin therapy data, identifying a behavior trend of the PWD represented in the one or more of the blood glucose data or the insulin therapy data, wherein the behavior trend is associated with the blood glucose data after each meal consumed over a period;
selecting one or more therapy insights reflecting the identified behavior trend
providing the one or more therapy insights to a provider device associated with the provider, wherein the one or more therapy insights includes a percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period;
wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a threshold percentage, determining one or more insulin therapy recommendations;
displaying, on the provider device, the one or more insulin therapy recommendations;
responsive to the provider device receiving a selection of one of the one or more insulin therapy recommendations, receiving, at the electronic device, the selected insulin therapy recommendation from the provider device;
responsive to receiving the selected insulin therapy recommendation from the provider device, displaying on the display of the electronic device, the selected insulin therapy recommendation; and
administering, by an insulin delivery device, insulin to the PWD according to the selected insulin therapy recommendation.
The claim recites the additional elements of devices, insulin delivery device, processors, memory, display, sensor and administering insulin according to the selected insulin therapy recommendation that implement the identified abstract idea. The devices, processors, memory, display and sensor are not described by the applicant and are recited at a high-level of generality (i.e., a generic processor performing generic computer functions of receiving and displaying) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Regarding the processor, the specification states in paragraph 46: A given client computing platform may include one or more processors configured to execute computer program modules. The computer program modules may be configured to enable an expert (e.g., an administrator) or user associated with a given client computing platform to interface with CDS system lO0A and/or external resources, and/or provide other functionality attributed herein to client computing platform(s). Regarding the memory and device, the specification states in paragraph 205: By way of example, and not limitation, such computer-readable media may include non-transitory computer-readable storage media including Random Access Memory (RAM), Read-Only Memory (ROM), Electrically Erasable Programmable Read-Only Memory (EEPROM), Compact Disc Read-Only Memory (CD-ROM) or other optical disk storage, magnetic disk storage or other magnetic storage devices, flash memory devices (e.g., solid-state memory devices), or any other storage medium which may be used to carry or store desired program code in the form of computer-executable instructions or data structures and which may be accessed by a general-purpose or special-purpose computer. Combinations of the above may be included within the scope of computer-readable media. Regarding the display and GUI, the specification states in paragraph 179: Mobile application 1125, in various embodiments, may execute on any suitable mobile computing device that can store and execute a mobile application that is adapted to display and input therapy relevant information wirelessly received from the other components of the system as well as from a graphical user interface that enables user to interact with the application. In one embodiment, mobile device 1120 can also store and execute a trusted mobile application within a trusted execution environment (hardware and/or software) that is not, generally speaking, accessible to users or devices communicating with mobile device 1120 but that is accessible to other applications executing on mobile device 1120. Regarding the sensor, the specification states in paragraph 49: In various embodiments, blood glucose data 108 may be provided from any suitable glucose sensor. In some embodiments, a glucose sensor may be a continuous glucose monitor (CGM), a flash glucose monitor, a blood glucose meter (BGM), or any other suitable sensor. The administering of insulin according to the selected insulin therapy recommendation merely adds the words "apply it" to the judicial exception. Per MPEP 2106.04(d)(2), a claim that recites "administering a suitable medication to a patient" is “not particular” and is “merely instructions to "apply" the exception in a generic way”. In addition, the insulin delivery device is recited at a high-level of generality such that it is generally linking the use of a judicial exception to a particular technological environment or field of use, and thus, does not integrate a judicial exception into a practical application.
The dependent claims 5, 9, 12, 15 and 17-20 recite additional element(s) beyond those already recited in the independent claims that implement the identified abstract idea. Claim 5 recites an insulin pen. Claims 9 and 17-20 recite the first and second layer of the GUI. Claims 9, 15 and 19 recite icons. Claim 10 recites a representation of an insulin delivery device. Claims 12 and 18 recite a swipe gesture and/or scrolling. However, these functions do not integrate a practical application more than the abstract idea because:
the first and second layer of the GUI and icons represents mere instructions to apply the abstract idea on a computer (i.e., merely invoking the computer structure as a tool used to execute the limitations); and,
the insulin pen, representation of an insulin delivery device, swipe gesture and scrolling generally link the use of a judicial exception to a particular technological environment or field of use.
Accordingly, the claims as a whole do not integrate the abstract idea into a practical application as they do not impose any meaningful limits on practicing the abstract idea.
Step 2B
Regarding Step 2B, representative independent claim 1 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.
When viewed as a whole, claims 1, 4-7, 9, 10, 12, 14-20, 22-25 do not include additional limitations that are sufficient to amount to significantly more than the judicial exception because the claims recite processes that are routine and well-known in the art and simply implements the process on a computer(s) is not enough to qualify as "significantly more."
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of devices, processors, memory, display, sensor and administering insulin according to the selected insulin therapy recommendation amount to no more than mere instructions to apply the exception. Mere instructions to apply an exception cannot provide an inventive concept (“significantly more”). In addition, the additional elements of the insulin delivery device generally link the use of a judicial exception to a particular technological environment or field of use, and thus, do not amount to significantly more than the judicial exception.
The dependent claims 5, 9, 12, 15 and 17-20 recite additional element(s) beyond those already recited in the independent claims that implement the identified abstract idea. Claim 5 recites an insulin pen. Claims 9 and 17-20 recite the first and second layer of the GUI. Claims 9, 15 and 19 recite icons. Claim 10 recites a representation of an insulin delivery device. Claims 12 and 18 recite a swipe gesture and/or scrolling. However, these functions are not deemed significantly more than the abstract idea because:
the first and second layer of the GUI and icons represents mere instructions to apply the abstract idea on a computer (i.e., merely invoking the computer structure as a tool used to execute the limitations); and,
the insulin pen, representation of an insulin delivery device, swipe gesture and scrolling generally link the use of a judicial exception to a particular technological environment or field of use.
Therefore, claims 1, 4-7, 9, 10, 12, 14-20, 22-25 are rejected under 35 USC §101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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, 4-7, 16 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong (US 2017/0053552 A1) in further view of Budiman (US 2014/0350369 A1), Phillips (US 2017/0076052 A1) and Wei (US 2018/0197628 A1).
Regarding claim 1, Zhong teaches: A method for presenting insulin therapy setting recommendations associated with a therapy insight for a person with diabetes (PWD) at an electronic device, comprising:
receiving, from a blood glucose sensor and at a device having one or more processors, a memory and a display, blood glucose data for a PWD receiving insulin-based therapy, wherein the PWD is associated with a provider caring for the PWD; receiving, at the device, insulin therapy data for the PWD; (the glycemic insights system is implemented on a device that includes at least one processor, a suitable amount of memory and a display element; the system collects input data for a patient with diabetes from an insulin infusion device and a glucose sensor [0056]-[0057], [0067], [0043]; data collected includes blood glucose, insulin data and behavior data [0081]-[0107]; the system optimizes the delivery of insight messages of a patient to healthcare providers [0076])
based at least partially on one or more predetermined patterns respectively pre-associated with behavior trends and one or more of the blood glucose data or the insulin therapy data, identifying a behavior trend of the PWD represented in the one or more of the blood glucose data or the insulin therapy data, wherein the behavior trend is associated with the blood glucose data after each meal consumed over a period; (patient data collected includes blood glucose, insulin data and behavior data [0081]-[0107]; the patient historical data is reviewed to find matching occurrences corresponding to a detected insight event occurrence, where there is an association between specific situations and particular patterns; the system may maintain a predefined list of particular patterns including in relation to insight events, and the patterns are mapped to one or more glycemic outcomes corresponding to a status of a blood sugar level, such as high, low, variable, in range, etc.; glycemic outcomes are associated with a defined window of time (i.e. period) [0113]-[0116], [0125], [0012], [0045]; the trigger (i.e. a behavioral trend) is the insight event, a detectable status or condition or combination thereof that initiates an action and causes the generation of glycemic insights; triggers may be due to associations between meal bolus amount and type, and post-meal glucose profiles, and correlations and causality between food intake and diabetes management can be found; the system can maintain a list of different insight events or times that are of interest (i.e. blood glucose after each meal) for purposes of triggering the generation of glycemic insights [0051], [0121], [0124], [0125], [0175]-[0190], [0223]-[0232])
selecting one or more therapy insights reflecting the identified behavior trend; (a trigger can initiate the generation of a glycemic insight message, initiate the processing of generated insight messages for delivery, initiate the delivery of a particular insight message or the like [0051]; a predefined set of selectable message content can be utilized for one or more categories of the glycemic insight message (construed as selecting from a list of predetermined therapy insights) [0125]; the glycemic insight message includes information regarding the trigger to the insight, factors associated with the glycemic outcome and historical outcomes; for ex. glycemic insight message may be delivered with a trigger of occurring shortly following the bolus delivery with the following text "2.0 Units of bolus with carbohydrate <20 grams have been commonly found to result in a low glucose pattern in your history." [0118], [0125], [0127]-[0131])
providing the one or more therapy insights to a provider device associated with the provider […]; (see above; the glycemic insight message may be delivered to the healthcare provider; the system is implemented on various computing platforms and the glycemic insight messages are delivered to a client device owned and operated by a user such as a healthcare provider [0076], [0258], [0053])
While Zhong teaches the therapy insights including predetermined text and further teaches providing the selected one or more therapy insights, Zhong fails to teach:
wherein the therapy insights includes a percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period;
wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a threshold percentage, determining one or more insulin therapy recommendations;
displaying, on the provider device, the one or more insulin therapy recommendations; responsive to the provider device receiving a selection of one of the one or more insulin therapy recommendations, receiving, at the electronic device, the selected insulin therapy recommendation from the provider device;
However, Budiman in the analogous art of providing diabetes therapy management ([0152]) teaches:
wherein the therapy insights includes a percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period; (meal markers are used to bin data, e.g. post-Lunch values are those values after a recorded meal event between 10 am and 3 pm, to allow for accurate differentiation of points into meal bins, e.g. see [0246]; control grid based algorithms process glucose data for specific time periods of the day or relative time periods related to key events; calculating “time-above-target” (tAT), which is a percentage of glucose data exceeding a threshold, a high hyperglycemia risk can be determined if tAT exceeds a certain metric, e.g. see [0152], [0256]-[0263])
wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a threshold percentage, determining one or more insulin therapy recommendations; (if “time-above-target” (tAT) exceeds a threshold percentage for a period, e.g. tAT_HYPER , therapy recommendations can be determined; boundaries defined by tAT_HYPER can create zones on a control grid, wherein the zones can be mapped to assessments of the patient’s glycemic control or to clinical recommendations, e.g. see [0256]-[0264]; recommendations, including insulin therapy, are generated based on analysis of specific time periods, including meal-related periods; glucose data collected for multiple days can be grouped into these time periods, e.g. overnight/fasting, post breakfast, post lunch, post dinner, and the Control Grid algorithm run for each group; this is useful for generating recommendations that are specific to time periods; for patients whose treatment is multiple daily injections of insulin, the time-period targeted recommendations may be specific to insulin needs during these time of day, e.g. see [0152])
displaying, on the provider device, the one or more insulin therapy recommendations; responsive to the provider device receiving a selection of one of the one or more insulin therapy recommendations, receiving, at the electronic device, the selected insulin therapy recommendation from the provider device; (the Control Grid with therapy recommendations may be displayed to the health-care provider (HCP); the parameters of the Control Grid may be modified by the HCP via a popup screen for the HCP, and the algorithm is rerun, generating new recommendations, e.g. see [0140], [0151]; the algorithm may be implemented remotely and the HCP on the computing device is notified of the titration recommendations and must approve it; the remote computer would then download the titration recommendation; a patient device includes a glucose meter and software interface that can receive titration recommendations, e.g. see [0239]; [0250]-[0253] discuss reminders and warnings to the patient to communicate recommendations and prompt patient behaviors)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include the therapy insights includes a percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period, when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a threshold percentage, determining one or more insulin therapy recommendations, displaying, on the provider device, the one or more insulin therapy recommendations, responsive to the provider device receiving a selection of one of the one or more insulin therapy recommendations, receiving, at the electronic device, the selected insulin therapy recommendation from the provider device as taught by Budiman, for the purposes of providing more accurate treatment recommendations for meal-specific problems (Budiman [0245]-[0246]).
Zhong and Budiman do not teach:
responsive to receiving the selected insulin therapy recommendation from the provider device, displaying on the display of the electronic device, the selected insulin therapy recommendation;
However, Phillips in the analogous art of providing diabetes therapy management ([0009], [0028]) teaches:
responsive to receiving the selected insulin therapy recommendation from the provider device, displaying on the display of the electronic device, the selected insulin therapy recommendation; (a prompt may be a user interface for conveying information to the patient regarding the health condition or management plan, on a user device including mobile devices and other mobile computing devices, e.g. smartphones, computers, etc. (i.e. devices with a display) [0046], [0038]; when the provider agrees with the recommended [treatment] management plan, or specifies further modifications to it, the system can send the new management plan as a prompt to the patient for confirmation that the new plan was received, along with rationales and education appropriate for that patient [0127], [0025]; the system may transmit similar information to the patient as provided in the user interface of Fig. 6 to the provider, where final recommended dosages and implemented changes to the management plan along with rationales that describe a justification for making the recommended changes in treatment management; a user interface of a patient displaying a recommendation for a change in the medication regimen of decreasing the dinnertime insulin dosage (i.e. one or more insulin therapy recommendations) with a rationale that at least one fasting glucose was below safe levels and data related to fasting glucose levels [0126], Fig. 6, [0115], [0121])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong and Budiman to include responsive to receiving the selected insulin therapy recommendation from the provider device, displaying on the display of the electronic device, the selected insulin therapy recommendation as taught by Phillips, for the purposes helping improve patient adherence to the recommendations (Phillips [0126]).
Zhong, Budiman and Phillips do not teach:
administering, by an insulin delivery device, insulin to the PWD according to the selected insulin therapy recommendation.
However, Wei in the analogous art of analyzing insulin and blood glucose data of a patient to provide medication dose recommendations ([0002], [0011], [0036]) teaches:
administering, by an insulin delivery device, insulin to the PWD according to the selected insulin therapy recommendation. (“All embodiments of method 1800 can include actually administering the recommended insulin…based on the recommendation made.” [0245]; “cause the user's drug delivery device 160 to administer medication…such as by administration of a bolus dose or by a modification to a basal dosage profile or schedule. This can be done…without the user's approval” [0160])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong, Budiman and Phillips to include administering, by an insulin delivery device, insulin to the PWD according to the selected insulin therapy recommendation as taught by Wei, for the purposes of “treat[ing] a potential or actual high glucose condition” (Wei [0160]).
Regarding claim 4, Zhong, Budiman, Phillips and Wei teach the method of claim 1 as described above.
Zhong does not teach:
wherein the selected insulin therapy recommendation comprises one or more of recommended changes to meal insulin dosing, recommended changes to a number of insulin units of meal insulin dosing, recommended changes to correction insulin dosing, recommended changes to a number of insulin units of correction insulin dosing, wherein the one or more recommended changes comprise changes to insulin therapy settings of the insulin delivery device
However, Wei in the analogous art teaches:
wherein the selected insulin therapy recommendation comprises one or more of recommended changes to meal insulin dosing, recommended changes to a number of insulin units of meal insulin dosing, recommended changes to correction insulin dosing, recommended changes to a number of insulin units of correction insulin dosing, wherein the one or more recommended changes comprise changes to insulin therapy settings of the insulin delivery device (“a recommendation to increase the meal bolus can be generated…If accepted, the meal bolus amount recommendation will be used as the meal bolus insulin amount and repeated the next time the meal is selected.” [0227]; “the recommended meal bolus insulin amount, which in this example is 2.0 units of rapid-acting insulin” [0211])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include the selected insulin therapy recommendation as described above, wherein the one or more recommended changes comprise changes to insulin therapy settings of the insulin delivery device as taught by Wei, for the purposes of “treat[ing] a potential or actual high glucose condition” (Wei [0160]).
Regarding claim 5, Zhong, Budiman, Phillips and Wei teach the method of claim 1 as described above.
Zhong further teaches:
wherein the insulin delivery device is an insulin pen (“In some scenarios, a smart insulin pen or other type of smart insulin delivery device can be the source of this data.” [0101]).
Regarding claim 6, Zhong, Budiman, Phillips and Wei teach the method of claim 4 as described above.
Zhong does not teach:
responsive to a selection on the display of the electronic device to accept the selected insulin therapy recommendation […]
However, Phillips in the analogous art teaches:
responsive to a selection on the display of the electronic device to accept the selected insulin therapy recommendation […] (“If the patient agrees with the new management plan ( e.g., changing the dosages of the medications), the provider can be notified that the patient has reviewed and agreed to the new plan” [0127]; the user device communicates with health monitoring devices, which may be devices and/or applications configured to collect and/or transmit health information, including drug (insulin) delivery pumps [0038], [0040]-[0041])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include responsive to a selection on the display of the electronic device to accept the selected insulin therapy recommendation as taught by Phillips, for the purposes of helping improve patient adherence to the recommendations (Phillips [0126]).
Zhong and Phillips do not teach:
automatically updating the insulin therapy settings of the insulin delivery device to align with the selected insulin therapy recommendation
However, Wei in the analogous art teaches:
automatically updating the insulin therapy settings of the insulin delivery device to align with the selected insulin therapy recommendation (“a recommendation to increase the meal bolus can be generated…If accepted, the meal bolus amount recommendation will be used as the meal bolus insulin amount and repeated the next time the meal is selected.” [0227]; “An output issued at 320 can cause the user's drug delivery device 160 to administer medication…such as by administration of a bolus dose or by a modification to a basal dosage profile or schedule. This can be done…automatically” [0160])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong and Phillips to include automatically updating the insulin therapy settings of the insulin delivery device to align with the selected insulin therapy recommendation as taught by Wei, for the purposes of “implement[ing] accurate therapy for the user” which can “reduce the occurrence of errors in medication administration” (Wei [0162]).
Regarding claim 7, Zhong, Budiman, Phillips and Wei teach the method of claim 4 as described above.
Zhong further teaches:
responsive to a selection on the display of the electronic device to accept the selected insulin therapy recommendation, transmitting instructions corresponding to updating of the insulin therapy settings to the insulin delivery device
However, Phillips in the analogous art teaches:
responsive to a selection on the display of the electronic device to accept the selected insulin therapy recommendation […] (“If the patient agrees with the new management plan ( e.g., changing the dosages of the medications), the provider can be notified that the patient has reviewed and agreed to the new plan” [0127]; the user device communicates with health monitoring devices, which may be devices and/or applications configured to collect and/or transmit health information, including drug (insulin) delivery pumps [0038], [0040]-[0041])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include responsive to a selection on the display of the electronic device to accept the selected insulin therapy recommendation as taught by Phillips, for the purposes of helping improve patient adherence to the recommendations (Phillips [0126]).
Zhong and Phillips do not teach:
transmitting instructions corresponding to updating of the insulin therapy settings to the insulin delivery device
However, Wei in the analogous art teaches:
transmitting instructions corresponding to updating of the insulin therapy settings to the insulin delivery device (“An output issued at 320 can supply information directly to the user's medication or treatment program… in determining whether a modification to a user's treatment profile…is warranted or to prompt the user” [0159]; “An output issued at 320 can cause the user's drug delivery device 160 to administer medication…such as by administration of a bolus dose or by a modification to a basal dosage profile” [0160]; “The drug delivery device can be configured to communicate directly with reader device”; “Drug delivery device 160 can include instructions…These instructions can also cause calculation of insulin delivery amounts and durations [0052]; “a recommendation to increase the meal bolus can be generated…If accepted, the meal bolus amount recommendation will be used as the meal bolus insulin amount and repeated the next time” [0227])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong and Phillips to include transmitting instructions corresponding to updating of the insulin therapy settings to the insulin delivery device as taught by Wei, for the purposes of “implement[ing] accurate therapy for the user” which can “reduce the occurrence of errors in medication administration” (Wei [0162]).
Regarding claim 16, Zhong teaches: A method for presenting insulin therapy data on a person with diabetes (PWD) dashboard at PWD device, comprising:
at a device with one or more processors, memory and a display: receiving, from a blood glucose sensor, blood glucose data for a PWD receiving insulin- based therapy, wherein the PWD is associated with a provider caring for the PWD; receiving insulin therapy data for the PWD; (the glycemic insights system is implemented on a device that includes at least one processor, a suitable amount of memory and a display element; the system collects input data for a patient with diabetes from an insulin infusion device and a glucose sensor [0056]-[0057], [0067], [0043]; data collected includes blood glucose, insulin data and behavior data [0081]-[0107]; the system optimizes the delivery of insight messages of a patient to healthcare providers [0076])
based at least partially on one or more predetermined patterns respectively pre-associated with behavior trends and one or more of the blood glucose data or the insulin therapy data, identifying a behavior trend of the PWD represented in the one or more of the blood glucose data or the insulin therapy data, wherein the behavior trend is associated with the blood glucose data after each meal consumed over a period; (patient data collected includes blood glucose, insulin data and behavior data [0081]-[0107]; the patient historical data is reviewed to find matching occurrences corresponding to a detected insight event occurrence, where there is an association between specific situations and particular patterns; the system may maintain a predefined list of particular patterns including in relation to insight events, and the patterns are mapped to one or more glycemic outcomes corresponding to a status of a blood sugar level, such as high, low, variable, in range, etc.; glycemic outcomes are associated with a defined window of time (i.e. period) [0113]-[0116], [0125], [0012], [0045]; the trigger (i.e. a behavioral trend) is the insight event, a detectable status or condition or combination thereof that initiates an action and causes the generation of glycemic insights; triggers may be due to associations between meal bolus amount and type, and post-meal glucose profiles, and correlations and causality between food intake and diabetes management can be found; the system can maintain a list of different insight events or times that are of interest (i.e. blood glucose after each meal) for purposes of triggering the generation of glycemic insights [0051], [0121], [0124], [0125], [0175]-[0190], [0223]-[0232])
selecting one or more therapy insights reflecting the identified behavior trend; (a trigger can initiate the generation of a glycemic insight message, initiate the processing of generated insight messages for delivery, initiate the delivery of a particular insight message or the like [0051]; a predefined set of selectable message content can be utilized for one or more categories of the glycemic insight message (construed as selecting from a list of predetermined therapy insights) [0125]; the glycemic insight message includes information regarding the trigger to the insight, factors associated with the glycemic outcome and historical outcomes; for ex. glycemic insight message may be delivered with a trigger of occurring shortly following the bolus delivery with the following text "2.0 Units of bolus with carbohydrate <20 grams have been commonly found to result in a low glucose pattern in your history." [0118], [0125], [0127]-[0131])
providing the one or more therapy insights to a provider device associated with the provider […]; (see above; the glycemic insight message may be delivered to the healthcare provider; the system is implemented on various computing platforms and the glycemic insight messages are delivered to a client device owned and operated by a user such as a healthcare provider [0076], [0258], [0053])
While Zhong teaches the therapy insights including predetermined text and further teaches providing the selected one or more therapy insights, Zhong fails to teach:
wherein the therapy insights includes a percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period;
wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a threshold percentage, determining one or more insulin therapy recommendations;
displaying, on a provider device, the one or more insulin therapy recommendations, wherein the one or more insulin therapy recommendations comprises an adjustment to a meal dose of insulin; responsive to the provider device receiving a selection of one of the one or more insulin therapy recommendations, receiving, at the PWD device, the selected insulin therapy recommendation from the provider device;
However, Budiman in the analogous art teaches:
wherein the therapy insights includes a percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period; (meal markers are used to bin data, e.g. post-Lunch values are those values after a recorded meal event between 10 am and 3 pm, to allow for accurate differentiation of points into meal bins, e.g. see [0246]; control grid based algorithms process glucose data for specific time periods of the day or relative time periods related to key events; calculating “time-above-target” (tAT), which is a percentage of glucose data exceeding a threshold, a high hyperglycemia risk can be determined if tAT exceeds a certain metric, e.g. see [0152], [0256]-[0263])
wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a threshold percentage, determining one or more insulin therapy recommendations; (if “time-above-target” (tAT) exceeds a threshold percentage for a period, e.g. tAT_HYPER , therapy recommendations can be determined; boundaries defined by tAT_HYPER can create zones on a control grid, wherein the zones can be mapped to assessments of the patient’s glycemic control or to clinical recommendations, e.g. see [0256]-[0264]; recommendations, including insulin therapy, are generated based on analysis of specific time periods, including meal-related periods; glucose data collected for multiple days can be grouped into these time periods, e.g. overnight/fasting, post breakfast, post lunch, post dinner, and the Control Grid algorithm run for each group; this is useful for generating recommendations that are specific to time periods; for patients whose treatment is multiple daily injections of insulin, the time-period targeted recommendations may be specific to insulin needs during these time of day, e.g. see [0152])
displaying, on a provider device, the one or more insulin therapy recommendations, wherein the one or more insulin therapy recommendations comprises an adjustment to a meal dose of insulin; responsive to the provider device receiving a selection of one of the one or more insulin therapy recommendations, receiving, at the PWD device, the selected insulin therapy recommendation from the provider device; (see above; the Control Grid with therapy recommendations may be displayed to the health-care provider (HCP); the parameters of the Control Grid may be modified by the HCP via a popup screen for the HCP, and the algorithm is rerun, generating new recommendations, e.g. see [0140], [0151]; Table 6 links “Control Zone” derived from the Control Grid analysis to “Medication Guidance Output”, including adjustment to insulin therapy recommendations such as “Increase RA dinner dose”; the algorithm may be implemented remotely and the HCP on the computing device is notified of the titration recommendations and must approve it; the remote computer would then download the titration recommendation; a patient device includes a glucose meter and software interface that can receive titration recommendations, e.g. see [0239]; [0250]-[0253] discuss reminders and warnings to the patient to communicate recommendations and prompt patient behaviors)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include the therapy insights includes a percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period, when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a threshold percentage, determining one or more insulin therapy recommendations, displaying, on the provider device, the one or more insulin therapy recommendations, responsive to the provider device receiving a selection of one of the one or more insulin therapy recommendations, receiving, at the electronic device, the selected insulin therapy recommendation from the provider device as taught by Budiman, for the purposes of providing more accurate treatment recommendations for meal-specific problems (Budiman [0245]-[0246]).
Zhong and Budiman do not teach:
responsive to receiving the selected insulin therapy recommendation from the provider device, displaying, on the display of the PWD device, the selected insulin therapy recommendation;
However, Phillips in the analogous art teaches:
responsive to receiving the selected insulin therapy recommendation from the provider device, displaying, on the display of the PWD device, the selected insulin therapy recommendation; (a prompt may be a user interface for conveying information to the patient regarding the health condition or management plan, on a user device including mobile devices and other mobile computing devices, e.g. smartphones, computers, etc. (i.e. devices with a display) [0046], [0038]; when the provider agrees with the recommended [treatment] management plan, or specifies further modifications to it, the system can send the new management plan as a prompt to the patient for confirmation that the new plan was received, along with rationales and education appropriate for that patient (i.e. displaying the one or more positive therapy insights or the one or more negative therapy insight and the insulin therapy recommendation received from the provider device) [0127], [0025]; the system may transmit similar information to the patient as provided in the user interface of Fig. 6 to the provider, where final recommended dosages and implemented changes to the management plan along with rationales that describe a justification for making the recommended changes in treatment management; a user interface of a patient displaying a recommendation for a change in the medication regimen of decreasing the dinnertime insulin dosage (i.e. one or more insulin therapy recommendations) with a rationale that at least one fasting glucose was below safe levels (i.e. the selected therapy insight) and data related to fasting glucose levels (i.e. contextual information related to the one or more positive therapy insights or the one or more negative therapy insights) [0126], Fig. 6, [0115], [0121])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong and Budiman to include displaying the one or more positive or negative therapy insights along with contextual information and the insulin therapy recommendation as taught by Phillips, for the purposes helping improve patient adherence to the recommendations (Phillips [0126]).
Zhong, Budiman and Phillips do not teach:
administering, by an insulin delivery device, the meal dose of insulin to the PWD according to the selected insulin therapy recommendation.
However, Wei in the analogous art teaches:
administering, by an insulin delivery device, the meal dose of insulin to the PWD according to the selected insulin therapy recommendation. (“All embodiments of method 1800 can include actually administering the recommended insulin…based on the recommendation made.” [0245]; “cause the user's drug delivery device 160 to administer medication…such as by administration of a bolus dose…This can be done…without the user's approval” [0160]; “the recommended meal bolus insulin amount” [0211]; the “meal bolus…is a one time injection or infusion for the purpose of compensating for a meal” [0009])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong, Budiman and Phillips to include administering, by an insulin delivery device, the meal dose of insulin to the PWD according to the selected insulin therapy recommendation as taught by Wei, for the purposes of “treat[ing] a potential or actual high glucose condition” (Wei [0160]).
Regarding claim 23, Zhong, Budiman, Phillips and Wei teach the method of claim 1 as described above.
Zhong does not teach:
wherein the one or more insulin therapy recommendations comprise a first insulin therapy recommendation and a second insulin therapy recommendation, wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a first threshold percentage, determining the first insulin therapy recommendation,
wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during a period exceeds a second threshold percentage and is less than the first threshold percentage, determining the second insulin therapy recommendation, and wherein the second insulin therapy recommendation is different from the first insulin therapy recommendation
However, Budiman in the analogous art teaches:
wherein the one or more insulin therapy recommendations comprise a first insulin therapy recommendation and a second insulin therapy recommendation, wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during the period exceeds a first threshold percentage, determining the first insulin therapy recommendation, (“Multiple levels of rule checks could be designed for hyperglycemia control” [0285]; “Example rule-based control zone assignment algorithm”, which checks if “Hyperglycemia control” is “Above Target (>=20% above high threshold)” (i.e. a first threshold percentage) and is considered zone “3”; Table 6 maps specific zones to different recommendations, where the recommendation for zone “3” is to “Increase LA [long acting insulin] dose” (i.e. the first insulin therapy recommendation))
wherein when the percentage of times the blood glucose data exceeded a blood glucose level threshold after each meal consumed during a period exceeds a second threshold percentage and is less than the first threshold percentage, determining the second insulin therapy recommendation, and wherein the second insulin therapy recommendation is different from the first insulin therapy recommendation (“Example rule-based control zone assignment algorithm”, which checks if “Hyperglycemia control” is “Within Target (<20% above high threshold)” (i.e. a second threshold percentage) and is considered zone “1”; Table 6 maps specific zones to different recommendations, where the recommendation for zone “1” is to “Decrease LA [long acting insulin] dose” (i.e. the second insulin therapy recommendation))
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include determining the first insulin therapy recommendation and the second insulin therapy recommendation as taught by Budiman, for the purposes of “correctly identifying glycemic patterns” and “making therapeutic decisions to address patterns” (Budiman [0003]).
Regarding claim 24, Zhong, Budiman, Phillips and Wei teach the method of claim 23 as described above.
Zhong does not teach:
wherein the first threshold percentage is greater than or equal to 75% and the second threshold percentage is greater than or equal to 25% and less than 75%
However, Budiman in the analogous art teaches:
wherein the first threshold percentage is greater than or equal to 75% and the second threshold percentage is greater than or equal to 25% and less than 75% (the “Example rule-based control zone assignment algorithm” for “Hyperglycemia control” is “Above Target (>=20% above high threshold)” (i.e. a first threshold percentage) and “Within Target (<20% above high threshold)” (i.e. a second threshold percentage); “Note that any desired percentile may be used as a measure. Some choices will be more practical than others.”; “G75 and G10…may be good choices” (the 75th percentile as an upper boundary for glucose is a known, standard design choice) [0268])
Budiman teaches defining the tiers of the first threshold percentage and the second threshold percentage by percentage ranges. The selection of specific values within or outside those ranges, e.g. 20% or 75%, is a matter of design choice. A person of ordinary skill in the art would find it obvious to adjust these percentage ranges based on the desired control. See MPEP 21044.05.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include the first threshold percentage is greater than or equal to 75% and the second threshold percentage is greater than or equal to 25% and less than 75% as taught by Budiman, for the purposes of “correctly identifying glycemic patterns” and “making therapeutic decisions to address patterns” (Budiman [0003]).
Regarding claim 25, Zhong, Budiman, Phillips and Wei teach the method of claim 23 as described above.
Budiman teaches the second insulin therapy recommendation as described above.
Zhong does not teach:
wherein the insulin therapy recommendation comprises a recommendation to adjust a meal dose of insulin based on a meal size.
However, Wei in the analogous art teaches:
wherein the insulin therapy recommendation comprises a recommendation to adjust a meal dose of insulin based on a meal size (“ranking meals can include best or optimal meals for a certain dosage, not enough food for a certain dosage, and too much food for a certain dosage” [0234]; if the glucose is above a threshold, “a recommendation to increase the meal bolus can be generated” [0227]; meal portion size options the user may provide include “e.g., 8 ounces, 10 ounces, 6 ounces” to understand “glycemic impact” and dosing [0114], [0108], [0159])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include the insulin therapy recommendation comprises a recommendation to adjust a meal dose of insulin based on a meal size as taught by Wei, for the purposes of improving “meal assessment and detection, correlation to analyte levels, and medication dose determination” (Wei [0010]).
Claims 9, 10, 12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong, Budiman, Phillips and Wei in further view of Bayston (US 2016/0216874 A1) and Blomquist (US 2012/0232521).
Regarding claim 9, Zhong, Budiman, Phillips and Wei teach the method of claim 4 as described above.
Zhong, Budiman, Phillips and Wei teach the one or more positive therapy insights, the selected insulin therapy recommendation and contextual information related to the one or more therapy insights as described above.
Zhong further teaches:
[…] displaying: […] a first selectable icon (displaying icons as active elements that can be selected by the user to display additional details related to the selected insight [0199])
Zhong does not teach:
responsive to a selection on the display of the electronic device to view the selected insulin therapy recommendation, displaying […] corresponding to the selected insulin therapy recommendation;
a recommended changes portion comprising at least a portion of insulin dosing, wherein the displaying of […] the recommended changes portion replaces the […] displaying of the layer of GUI
However, Phillips in the analogous art teaches:
responsive to a selection on the display of the electronic device to view the selected insulin therapy recommendation, displaying […] corresponding to the selected insulin therapy recommendation; (once the patient indicates agreement to the health condition management plan (construed as a selection to view recommended changes to insulin therapy settings), it is updated and stored in the database [0025]; the user device of the patient may include an application suite for the system; the user device communicates with health monitoring devices, which may be devices and/or applications configured to collect and/or transmit health information, including drug (insulin) delivery pumps (construed as the pump displaying recommended changes to insulin therapy settings) [0038], [0040]-[0041])
a recommended changes portion comprising at least a portion of insulin dosing, wherein the displaying of […] the recommended changes portion replaces the […] displaying of the layer of GUI (displaying on the GUI the recommendations for changes in insulin dosing, Fig. 6 – items 630 and 640)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include displaying the recommended changes to insulin therapy settings in response to a selection and a recommended changes portion as taught by Phillips, for the purposes of helping improve patient adherence to the recommendations (Phillips [0126]).
Zhong and Phillips do not teach:
displaying a header portion
However, Wei in the analogous art teaches:
displaying a header portion (first section of a screen showing current blood glucose level and trend, and bolus insulin amount [0211], Fig. 10C - 1022)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong, Budiman, Phillips and Wei to include displaying a header portion when viewing changes to insulin therapy settings as taught by Wei. This provides the user with interfaces that are engaging and easy to understand (Wei [0013]).
Zhong, Budiman, Phillips and Wei do not teach:
displaying, on the display of the electronic device, a first layer and a second layer of a graphical user interface (GUI), the second layer at least partially overlaying the first layer
displaying within the first layer of the GUI
displaying within the second layer of the GUI
However, Bayston in the analogous art of displaying content for a user on a GUI ([0007]-[0009], [0046 teaches:
displaying, on the display of the electronic device, a first layer and a second layer of a graphical user interface (GUI), the second layer at least partially overlaying the first layer (displaying on the user interface an upper layer of content (construed as the second layer) overlapping a lower layer of content (construed as the first layer) [0046], [0043], Fig. 4A)
displaying within the first layer of the GUI (displaying on the user interface a lower layer of content (construed as the first layer) [0046], [0043], Fig. 4A)
displaying within the second layer of the GUI (displaying on the user interface an upper layer of content (construed as the second layer) [0046], [0043], Fig. 4A)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong, Budiman, Phillips and Wei to include displaying a second layer partially overlaying a first layer of a GUI, displaying within the first layer of the GUI and displaying within the second layer of the GUI as taught by Bayston. By providing partial layering of content of an application, the content of the lower layer can still be exposed including selectable inputs (Bayston [0046]).
Zhong, Budiman, Phillips, Wei and Bayston do not teach:
a second selectable icon corresponding to current insulin therapy settings;
However, Blomquist in the analogous art of analyzing insulin and blood glucose data of a patient to provide insulin dosing for greater control of blood glucose levels ([0004]-[0007]) teaches:
a second selectable icon corresponding to current insulin therapy settings; (the user activates the menu function to get to the history menu where current and previous insulin dosing can be viewed [0077]-[0079])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong, Budiman, Phillips, Wei and Bayston to include a second selectable icon corresponding to current insulin therapy settings as taught by Blomquist. This provides the user with options in operating their insulin pump to meet their needs (Blomquist [0024]).
Regarding claim 10, Zhong, Budiman, Phillips, Wei, Bayston and Blomquist teach the method of claim 9 as described above.
Zhong does not teach:
wherein the recommended changes portion further comprises: […] an insulin delivery device configured to deliver insulin according to the selected insulin therapy recommendation or an identifier of an insulin delivery to the PWD according to the selected insulin therapy recommendation
However, Phillips in the analogous art teaches:
wherein the recommended changes portion further comprises: […] an insulin delivery device configured to deliver insulin according to the selected insulin therapy recommendation or an identifier of an insulin delivery to the PWD according to the selected insulin therapy recommendation (once the patient indicates agreement to the health condition management plan, it is updated and stored in the database [0025]; the user device of the patient may include an application suite for the system; the user device communicates with health monitoring devices, which may be devices and/or applications configured to collect and/or transmit health information, including drug (insulin) delivery pumps (construed as the pump configured to deliver insulin) [0038], [0040]-[0041])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include displaying the recommended changes to insulin therapy settings in response to a selection and a recommended changes portion as taught by Phillips, for the purposes of helping improve patient adherence to the recommendations (Phillips [0126]).
Zhong and Phillips do not teach:
a representation of an insulin delivery device
However, Blomquist in the analogous art teaches:
a representation of an insulin delivery device (the screen displays a shape of a syringe to indicate the amount of insulin remaining in the device [0040], Fig. 2 – item 154)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong and Phillips to include a representation of an insulin devices as taught by Blomquist. This provides the user with an illustrative way to be aware of the amount if insulin remaining (Blomquist [0040]).
Regarding claim 12, Zhong, Budiman, Phillips, Wei, Bayston and Blomquist teach the method of claim 9 as described above.
Zhong does not teach:
in response to receiving a swipe gesture on the display of the electronic device, displaying at least a portion of an additional insulin dosing, wherein the portion of the additional insulin dosing replaces the portion of the insulin dosing […]
Blomquist further teaches:
in response to receiving a swipe gesture on the display of the electronic device, displaying at least a portion of an additional insulin dosing, wherein the portion of the additional insulin dosing replaces the portion of the insulin dosing […] (the user scrolls to select the amount to lower their blood glucose (construed as the user scrolling in a swipe gesture), and the insulin pump calculates and displays the recommended bolus amount, which is the recommended correction bolus plus the amount of the meal bolus [0178]-[0179])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include displaying at least a portion of an additional insulin dosing in response to a swipe gesture as taught by Blomquist, for the purposes of allowing the user to correct a high blood glucose level and deliver additional insulin to work against carbohydrates that they plan to consume (Blomquist [0179]).
Zhong and Blomquist do not teach:
displaying at least a portion of an additional insulin dosing while maintaining display of the header portion
However, Wei in the analogous art teaches:
displaying at least a portion of an additional insulin dosing while maintaining display of the header portion (the header of the meal name, for example “milk and cheerios”, is maintained while displaying meal insulin and correction insulin amounts, if necessary, Fig. 15 – item 1026, Fig. 11 – item 1026)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong and Blomquist to include maintaining displaying of a header portion as taught by Wei. This provides the user with interfaces that are engaging and easy to understand (Wei [0013]).
Regarding claim 14, Zhong, Budiman, Phillips, Bayston, Wei and Blomquist teach the method of claim 12 as described above.
Zhong does not teach:
wherein the additional insulin dosing comprises meal insulin dosing and the additional insulin dosing comprises correction insulin dosing
Blomquist further teaches:
wherein the additional insulin dosing comprises meal insulin dosing and the additional insulin dosing comprises correction insulin dosing (the user scrolls to select the amount to lower their blood glucose, and the insulin pump calculates and displays the recommended bolus amount, which is the recommended correction bolus plus the amount of the meal bolus [0178]-[0179]).
Regarding claim 15, Zhong, Budiman, Phillips, Bayston, Wei, and Blomquist teach the method of claim 9 as described above.
Zhong does not teach:
in response to selection of the second selectable icon on the display of the electronic device, displaying the current insulin therapy settings, wherein the current insulin therapy settings replaces the recommended changes to the insulin therapy settings
However, Blomquist in the analogous art teaches:
in response to selection of the second selectable icon on the display of the electronic device, displaying the current insulin therapy settings, wherein the current insulin therapy settings replaces the recommended changes to the insulin therapy settings (from the home page which displays the insulin basal rate according to the first basal schedule, the user activates the menu function to get to the history menu where current insulin dosing can be viewed [0041], [0077]-[0079]; Fig. 6: 152 – insulin therapy settings, 294 – insulin summary for the current date)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include displaying the current insulin therapy setting as taught by Blomquist. This provides the user with insulin dosing information for the current data (Blomquist [0077]-[0079]).
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong, Budiman, Phillips, Wei in further view of Bayston.
Regarding claim 17, Zhong, Budiman, Phillips, Wei and Bayston teach the method of claim 16 as described above.
Zhong, Budiman, Phillips and Wei teach the one or more positive therapy insights, the selected insulin therapy recommendation and contextual information related to the one or more therapy insights as described above.
Zhong further teaches:
wherein the insulin therapy data includes one or more of a glucose level duration portion, a sensor use portion, an average glucose portion, a low glucose events portion, a high glucose events portion and a recommendations history portion (patient data collected includes blood glucose, glucose sensor data, insulin data and behavior data [0081]-[0107], [0043]; the user’s historical glucose values such as an average, which is determined to either higher or lower to current glucose levels [0110]; median or mean glucose [0198]; the system stores and maintains historical event/outcome combinations for a user [0013])
Zhong does not teach:
in response to a selection to view insulin therapy data subsequent to administering the meal dose of insulin to the PWD, displaying the insulin therapy data subsequent to administering the meal dose of insulin to the PWD, wherein the displaying of the insulin therapy data replaces the displaying of the indication of the selected insulin therapy recommendation
However, Wei in the analogous art teaches:
in response to a selection to view insulin therapy data subsequent to administering the meal dose of insulin to the PWD, displaying the insulin therapy data subsequent to administering the meal dose of insulin to the PWD, wherein the displaying of the insulin therapy data replaces the displaying of the indication of the selected insulin therapy recommendation (the recommended meal bolus amount is displayed on the user interface, and the user may select historical traces to display alongside the user’s current glucose trace as an overlay, e.g. see [0214], [0211]-[0212])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong to include displaying of the insulin therapy data replacing the displaying of the indication of the behavior change recommendation in response to the selection as taught by Wei. This provides the user with interfaces that are engaging and easy to understand (Wei [0013]).
Zhong, Budiman, Phillips and Wei do not teach:
displaying, on the display of the device, a first layer and a second layer of a graphical user interface (GUI), the first layer at least partially overlaying the second layer
displaying within the first layer of the GUI
displaying within the second layer of the GUIs
However, Bayston in the analogous art teaches:
displaying, on the display of the device, a first layer and a second layer of a graphical user interface (GUI), the first layer at least partially overlaying the second layer (displaying on the user interface an upper layer of content (construed as the first layer) overlapping a lower layer of content (construed as the second layer) [0046], [0043], Fig. 4A)
displaying within the first layer of the GUI (displaying on the user interface an upper layer of content (construed as the first layer) [0046], [0043], Fig. 4A)
displaying within the second layer of the GUIs (displaying on the user interface a lower layer of content (construed as the second layer) [0046], [0043], Fig. 4A)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong, Budiman, Phillips and Wei to include displaying a first layer partially overlaying a second layer of a GUI, displaying within the first layer of the GUI and displaying within the second layer of the GUI as taught by Bayston. By providing partial layering of content of an application, the content of the lower layer can still be exposed including selectable inputs (Bayston [0046]).
Regarding claim 20, Zhong, Budiman, Phillips, Wei and Bayston teach the method of claim 17 as described above.
Zhong further teaches:
wherein the insulin therapy data comprises at least one plot of insulin therapy data (a glucose profile plot of aggregated historical sensor traces following a bolus of 2 units and < 20 gram of carbohydrates [0130])
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong, Budiman, Phillips, Wei and Bayston in further view of Mensinger (US 2014/0012511 A1).
Regarding claim 18, Zhong, Budiman, Phillips, Wei and Bayston teach the method of claim 17 as described above.
Zhong, Budiman, Phillips, Wei and Bayston do not teach:
in response to a swipe gesture on the PWD device, scrolling through one or more of the glucose level duration portion, the sensor use portion, the average glucose portion, the low glucose events portion, the high glucose events portion and the recommendations history portion
However, Mensinger in the analogous art of analyzing patient blood glucose data to improve their management of diabetes ([0008]-[0009]) teaches:
in response to a swipe gesture on the PWD device, scrolling through one or more of the glucose level duration portion, the sensor use portion, the average glucose portion, the low glucose events portion, the high glucose events portion and the recommendations history portion (the user may slide the bar on the trend graph of the blood glucose data with their finger to view glucose data for a desired window of time [0184], Fig. 3A - 308)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong, Budiman, Phillips, Wei and Bayston to include scrolling through one more types of insulin therapy data in response to a swipe gesture as taught by Mensinger. These types of features are useful in providing the diabetic more information to manage their blood glucose (Mensinger [0008]).
Regarding claim 19, Zhong, Budiman, Phillips, Wei and Bayston teach the method of claim 17 as described above.
Zhong further teaches:
a first time duration […] associated with a first time duration of insulin therapy data; (the glycemic outcome of percentage of time of hypoglycemia is associated with a defined window of time [0110])
a second time duration […] associated with a second time duration of insulin therapy data; (the glycemic outcome of percentage of time of severe hyperglycemia is associated with a defined window of time [0110])
Zhong does not teach:
a first time duration icon
a second time duration icon
in response to receiving selection of the first time duration icon on the PWD device, displaying the data corresponding to the first time duration and replacing the data corresponding to the second time duration
However, Mensinger in the analogous art teaches:
a first time duration icon (the user can select a time select icon, for example 6 hours, adjusting the window of time of the blood glucose trend graph to 6 hours [0184]-[0185], Fig. 3A - 311)
a second time duration icon (the user can select another time select icon, for example 3 hours, which adjusts the window of time of the blood glucose trend graph to 3 hours [0184]-[0185], Fig. 3A - 311)
in response to receiving selection of the first time duration icon on the PWD device, displaying the data corresponding to the first time duration and replacing the data corresponding to the second time duration (the user can select a time select icon, for example 6 hours, adjusting the window of time of the blood glucose trend graph to 6 hours [0184]-[0185], Fig. 3A - 311)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong, Budiman, Phillips, Wei and Bayston to include a first time duration icon, a second time duration icon and a response to a selection of the first time duration icon as taught by Mensinger. These types of features are useful in providing the diabetic more information to manage their blood glucose (Mensinger [0008]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong, Budiman, Phillips and Wei in further view of Blomquist.
Regarding claim 22, Zhong, Budiman, Phillips and Wei teach the method of claim 23 as described above.
Zhong, Budiman, Phillips and Wei teach the selected insulin therapy recommendation as described above.
Zhong, Budiman, Phillips and Wei do not teach:
wherein the first insulin therapy recommendation comprises a recommendation to increase a meal dose of insulin by a predetermined percentage
However, Blomquist teaches:
wherein the first insulin therapy recommendation comprises a recommendation to increase a meal dose of insulin by a predetermined percentage (providing a correction bolus by increasing a bolus of insulin based on a predetermined percentage, e.g. 20%, [0151]; the increased bolus may be in response to meal intake [0177]-[0179])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Zhong, Budiman, Phillips and Wei to include increasing a meal dose of insulin by a predetermined percentage as taught by Blomquist, for the purposes of providing customized or personalized therapy recommendations (Blomquist [0024], [0151]).
Response to Arguments
Regarding the rejection under 35 U.S.C. § 101 of Claims 1, 4-7, 9, 10, 12, 14-20, 22-25, the Examiner has considered the Applicant’s arguments; however, these arguments are not persuasive.
Applicant argues the amended independent claims integrates a judicial exception into a practical application.
The Examiner respectfully disagrees. MPEP 2106.04(d)(2) indicates that a practical application may be present when the abstract idea effects a particular treatment or provides a particular prophylaxis for a disease or medical condition. A particular treatment or prophylaxis is present when: (a) there is a particular treatment or prophylaxis that occurs when the claim is implemented; (b) the treatment or prophylaxis has more than a nominal connection/correlation to the abstract idea; and (c) the administration is more than extra-solution activity or a field of use. Applicant's claimed invention does not provide for a particular treatment or prophylaxis because, while the claim recites that a treatment or prophylaxis is administered to the patient, there is no particularity to the treatment; the claim does not state what the actual treatment or prophylaxis is, how often it is applied, the amount or concentration of treatment, the length of treatment, etc. Because a particular treatment or prophylaxis is not present in the claims, a practical application is not present. Hence, the claim limitation “administering, by an insulin delivery device, insulin to the PWD according to the selected insulin therapy recommendation” is analogous to “administering a suitable medication to a patient” which is not particular enough. This limitation is “merely instructions to “apply” the exception in a generic way” (MPEP 2106.04(d)2)).
Regarding the rejection under 35 U.S.C. § 103 of Claims 1, 4-7, 9, 10, 12, 14-20, 22-25, the Examiner has considered the Applicant’s arguments; however, these arguments are not persuasive.
Applicant argues the “cited references have not been shown to disclose therapy insights that include a percentage of times the blood glucose data exceeded a blood glucose level threshold after a meal, and then determining one or more insulin therapy recommendations when the percentage of times exceeds a threshold percentage.”
The Examiner respectfully disagrees. Budiman’s calculation of “Time Above Target” acts on discrete glucose data points ([0256]-[0263]). Determining that a patient was above target for 20% of a duration is equivalent to determining that 20% of the data points (times) exceeded the threshold. Under the broadest reasonable interpretation, the “percentage of times” the data exceeded a threshold encompasses the percentage of data points exceeding the threshold. Budiman teaches an “episode detection algorithm” that searches continuous data to identify discrete “episodes of clinical interest” including “High Glucose/Hyperglycemia (readings above a threshold)” ([0163]-[0164]).
Furthermore, the glucose data is grouped into post-meal bins, including post-breakfast, post-lunch and post-dinner ([0152]). By running the “Control Grid” algorithms on these specific post-meal bins, Budiman explicitly teaches determining the percentage of times the data exceeded the threshold specifically during the periods following each meal.
Applicant argues the “cited references further have not been shown to disclose or suggest providing recommendations to adjust a meal dose of insulin.”
The Examiner respectfully disagrees. Table 6 of Budiman, under the “Medication Guidance Output” column, explicitly lists the recommendation of “Increase RA [rapid acting insulin] dinner dose”. Budiman discloses a system where a provider selects parameters to generate a specific insulin recommendation including adjustment to meal doses ([0151], Table 6), which are communicated to the patient. Paras. [0239] and [0250]-[0253] demonstrate the patient’s device capability to receive and display alerts and guidance.
Conclusion
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 THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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.
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/A.A./Examiner, Art Unit 3686
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681