Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This Office Action represents the first action on the merits.
Claims 16-35 are pending
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 16 September 2025 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Priority
This Application claims priority to PCT Application PCT/EP2024/055851 filed 06 March 2024 and Provisional Application 19166003 filed 17 March 2023
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 16-35 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 16, 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method and system, which are within a statutory category.
Step 2A1
The limitations of:
Claims 16, 31 (Claim 31 being representative)
causing to be displayed, the one or more first […locations…] to capture insulin dose information corresponding to an insulin dose administered to a subject and a time that the insulin dose was administered to the subject;
causing to be displayed, the information captured via one or more second […locations…] and including an additional […location…] that is selectable to request a blood glucose modification recommendation, wherein the one or more second […locations…] capture additional information included in calculating the blood glucose modification recommendation;
determining that the insulin dose was administered to the subject within a threshold amount of time from a current time;
and causing one or more third […locations…] to be displayed that include the blood glucose modification,
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to generate glucose modification recommendations in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “displaying, determining” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a system implemented by a data processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of one or more hardware processors, memory storing computer-readable instructions and one of more computing devices that implements the identified abstract idea. The one or more Hardware processors, memory storing computer-readable instructions and one of more computing devices are not described by the applicant and is recited at a high-level of generality (i.e., a generic computer performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claims further recite the additional elements of one of more first user interfaces, one or more second user interfaces, one of more third user interfaces, one of more computing devices, insulin dose user interface, glucose level user interface, physical activity user interface and a carbohydrate consumption information user interface. The one of more first user interfaces, one or more second user interfaces, one of more third user interfaces, one of more computing devices, insulin dose user interface, glucose level user interface, physical activity user interface and a carbohydrate consumption information user interface merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
The claims do 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 using one or more hardware processors, memory storing computer-readable instructions and one of more computing devices to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a one of more first user interfaces, one or more second user interfaces, one of more third user interfaces, one of more computing devices, insulin dose user interface, glucose level user interface, physical activity user interface and a carbohydrate consumption information user interface were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such the claim is not patent eligible.
Claims 17-30,32-35 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 17 merely describe(s) elements included in the second user interface(s), which further defines the abstract idea.
Claim(s) 18 merely describe(s) determining the blood glucose modification recommendation, which further defines the abstract idea.
Claim(s) 19 merely describe(s) determining an additional insulin dose administered, which further defines the abstract idea.
Claim(s) 20 merely describe(s) determining blood glucose above a threshold, which further defines the abstract idea.
Claim(s) 21 merely describe(s) determining the blood glucose modification recommendation, which further defines the abstract idea.
Claim(s) 22 merely describe(s) displaying interfaces in order, which further defines the abstract idea.
Claim(s) 23 merely describe(s) displaying interfaces, which further defines the abstract idea.
Claim(s) 24 merely describe(s) displaying interfaces, which further defines the abstract idea.
Claim(s) 25 merely describe(s) what the insulin dose information indicates, which further defines the abstract idea.
Claim(s) 26 merely describe(s) what the blood glucose modification recommendation indicates, which further defines the abstract idea.
Claim(s) 27 merely describe(s) capturing input, which further defines the abstract idea.
Claim(s) 28 merely describe(s) displaying interfaces, which further defines the abstract idea.
Claim(s) 29 merely describe(s) displaying interfaces, which further defines the abstract idea.
Claim(s) 30 merely describe(s) displaying information, which further defines the abstract idea.
Claim(s) 29-30 also includes the additional element of “one or more logbook user interface” which is analyzed the same as the “one of more first user interfaces” and does not provide a practical application or significantly more for the same reasons.
Claim(s) 32 merely describe(s) obtaining insulin dose information, which further defines the abstract idea.
Claim(s) 33 merely describe(s) generating interfaces, which further defines the abstract idea.
Claim(s) 34 merely describe(s) determining ratios, recommendations and obtaining data, which further defines the abstract idea.
Claim(s) 35 merely describe(s) determining the blood glucose modification recommendation, which further defines the abstract idea.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16-18, 20-22, 25-31, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Constantin et al (US Publication No. 20190246914).
Regarding Claim 16
Constantin teaches a method comprising:
causing, by one or more computing devices including one or more processors and memory, one or more first user interfaces to be displayed, the one or more first user interfaces including an insulin dose user interface that includes one or more first user interface elements to capture insulin dose information corresponding to an insulin dose administered to a subject and a time that the insulin dose was administered to the subject [Constantin at Para. 0327 teaches input to the decision support engine 104 may also include insulin data 122. Insulin data may, for example, be captured from an insulin delivery device such as a pump or may be received from a smart pen that is configured to track insulin delivery and communicate insulin delivery information to the system, e.g. via wireless communication to a smart device that may relay the information to the decision support engine. Insulin data may also be received from a user, e.g. from a patient or caregiver through a user interface on a smartphone or other computer device];
causing, by the one or more computing devices, one or more second user interfaces to be displayed, the one or more second user interfaces displaying information captured via one or more second user interface elements and including an additional user interface element that is selectable to request a blood glucose modification recommendation, wherein the one or more second user interface elements capture additional information included in calculating the blood glucose modification recommendation [Constantin at Para. 0350 teaches a user-requested insight 128 may include, for example, a user request for guidance about a particular therapy decision at a particular time, e.g. insulin delivery before a meal or in anticipation of an event such as a meeting, physical activity, or sleep, and the decision support engine 104 may provide guidance in response to the request; Constantin at Para. 0372 teaches the guidance module 150 may deliver guidance information to the patient 102, for example via a user interface on a mobile device such as a smart phone];
determining, by the one or more computing devices, that the insulin dose was administered to the subject within a threshold amount of time from a current time [Constantin at Para. 0377 teaches insulin delivery may be received by the model, via a wireless connection on a smart pen, or via user input or from an insulin pump. Insulin delivery information may include insulin volume, and time of delivery. Other parameters, such as insulin action time or duration of insulin action, may also be received as inputs];
and causing, by the one or more computing devices, one or more third user interfaces to be displayed that include the blood glucose modification recommendation [Constantin at Para. 0474 teaches the therapy recommendation may include, for example, guidance regarding delivery of insulin, consumption of carbohydrates, protein, fat, or other nourishment or other food or drink].
Regarding Claim 17
Constantin teaches the method of claim 16,
Constantin further teaches wherein the one or more second user interfaces include:
a glucose level user interface element that captures a blood glucose level of the subject [Constantin at Para. 0369 teaches the sensor system 152 may include a continuous glucose monitor (more detail provided below) that may be configured to measure a glucose level that is calculated to be indicative of the true glucose level 160];
a physical activity user interface element that captures physical activity information of the subject, the physical activity information indicating an amount of physical activity performed by the subject over a period of time [Constantin at Para. 0375 teaches activity may also be provided as an input to the physiology model. Activity information may be provided, for example, by an accelerometer sensor on a wearable device such as a watch, fitness tracker, or patch];
and a carbohydrate consumption information user interface element that captures carbohydrate consumption information of the subject, the carbohydrate consumption information indicating an amount of carbohydrates consumed by the subject over an additional period of time [Constantin at Para. 0374 teaches food consumption may be provided as an input to the physiology model 112. The food consumption information may include information about meals, snacks, and beverages, such as the size, content (carbohydrate, fat, protein), sequence of consumption, and time of consumption. Food consumption may be provided by a user through a via manual entry, or by providing a photograph through an application that is configured to recognize food types and quantities, or by scanning a bar code or menu. In various examples, meal size may be manually entered as calories, quantity (‘three cookies’), menu items (‘Royale with Cheese’), or food exchanges (1 fruit, 1 dairy). In some examples, meals may also be entered with the user's typical items or combinations for this time or context (e.g. workday breakfast at home, weekend brunch at restaurant). In some examples, meal information may be received via a convenient user interface. For example, as shown in FIGS. 25A and 25B, a user interface 2500 may enable a user to indicate on by touching a graph 2502 (or other graphical user interface element) an amount of fat and carbohydrate (and optionally additionally protein) in each meal. FIG. 25A shows a selected point 2504 on the graph 2502 with high carbohydrate (78 grams) and low fat (1.6 gram) content. FIG. 25B shows a selected point 2506 on the graph 2502 with high carbohydrate (78 grams) and low fat (1.6 gram) content. FIG. 25B shows a selected point 2506 on the graph 2502 with low carbohydrate (3 grams) and relatively high fat (20 gram) content. Example meals with similar nutritional content (e.g. carb to fat ratio) may be shown on the user interface].
Regarding Claim 18
Constantin teaches the method of claim 17,
Constantin further teaches wherein the blood glucose modification recommendation is determined in response to determining that the blood glucose level of the subject was captured within an additional threshold amount of time from the current time [Constantin at Para. 0338 teaches in some examples, the system may be designed to improve a patient or caregiver's quality of life by calculating a time to deliver guidance to provide sufficient advance-notice of a potential problem (e.g., high-glucose excursion or low-glucose level) so that a user can adapt their behavior or react to the problem in a timely manner. For example, the system may determine that an excursion (e.g., high-glucose trend) is likely to occur and determine a time to deliver guidance that allows the user to deliver take corrective action (e.g., deliver a correction bolus, or exercise) to counter-act the likely excursion. In some examples, the system may calculate and/or predictable times to deliver guidance, to enable a user to focus on other activities and anticipate delivery of guidance].
Regarding Claim 20
Constantin teaches the method of claim 17,
Constantin further teaches comprising:
determining, by the one or more computing devices, that the blood glucose level of the subject was obtained at greater than a threshold period of time from a current time [Constantin at Para. 0304 teaches a decision support system may use a variety of sources of information to determine guidance, such as patterns or other information relating to eating behavior (e.g., number of meals per day, meal size distribution across meals and snacks, size of treatments for hypoglycemic excursions, or the number of repeat treatments for a hypoglycemic event), insulin dose information (e.g., bolus and basal dose patterns, pump settings or injection patterns, number of boluses per day, amount of trend adjustment, pre-meal bolus patterns, behavior around correction boluses, number of correction boluses per day, behavior patterns (presence and accuracy of carb-counting, incidence of action or inaction in response to hyperglycemia or need for a correction bolus, conditions, thresholds or triggers for corrections (e.g., glucose level, combination of trend and level, food or other factors), awareness of insulin on board, timing of insulin, “pre-bolus” patterns before meals and duration thereof, errors in insulin delivery or therapeutic intervention, exercise timing, exercise duration, and exercise intensity, physiological response to activity), physiological factors (patterns in response to insulin or carbohydrates or other foods, tendency to “rebound” to a hyperglycemic state after a low glucose, impact of illness or medication on insulin sensitivity or glucose levels), responsiveness to guidance (time to acknowledge alert or alarm, behavior in response to alert or alarm (e.g., eating or sleeping or exercise), and glycemic outcomes (e.g., percentage of time below one or more glucose concentration thresholds (e.g., below 70 mg/dL, below 50 mg/dL), percentage of time above one or more glucose concentrations threshold (e.g. above 180 mg/DL, above 250 mg/DL), and number of events below or above one or more thresholds) disease stage and/or treatment type (e.g., Type I honeymoon period, Type II prediabetic stage, Type II oral medication stage, Type II basal insulin stage), etc. Additional example inputs are described below];
and causing, by the one or more computing devices, display of a notification for a more recently obtained blood glucose level of the subject to be entered [Constantin at Para. 0608 teaches selecting the glucose value 3512 in the interface 3501 may bring up a glucose interface 3601 shown in FIG. 36, which may allow a user to enter a glucose value in a blood glucose field 3602 and may allow a user to see, or edit, a correction factor 3604, target glucose concentration level 3606, and correction dose 3608].
Regarding Claim 21
Constantin teaches the method of claim 17,
Constantin further teaches wherein the blood glucose modification recommendation is determined based on the insulin dose information corresponding to the subject, the blood glucose level of the subject, the physical activity information of the subject, and the carbohydrate consumption information of the subject [Constantin at Para. 0315 teaches an example real-time decision support system may also include a processing system that receives CGM data and other information such as insulin delivery, caloric consumption, activity, wellness or sickness status, and other sensed or user-entered information about the status, environment, behavior, or wellness of the patient. CGM data and other data may be combined and processed to develop guidance for delivery to the patient. The guidance may be developed based upon timing factors, such as timing of insulin delivery, calorie consumption, type of calories consumed, information about absorption or digestion times for food or beverage types or quantities or combinations, exercise timing and post-exercise oxygen or calorie consumption, and patient availability or convenience to participate in intervention, such as insulin delivery or delivery change or exercise or a dietary change].
Regarding Claim 22
Constantin teaches the method of claim 16,
Constantin further teaches wherein the one or more first user interfaces, the one or more second user interfaces, and the one or more third user interfaces comprise a series of user interfaces that are displayed in order [Constantin at Para. 0327, 0350, 474 (interpreted to be displayed in order)].
Regarding Claim 25
Constantin teaches the method of claim 16,
Constantin further teaches wherein the insulin dose information indicates an amount of insulin administered to the subject in conjunction with the insulin dose and a time that the insulin dose was administered to the subject [Constantin at Para. 0377 (see Claim 16 for explanation)].
Regarding Claim 26
Constantin teaches the method of claim 16,
Constantin further teaches wherein the blood glucose modification recommendation indicates at least one of an amount of insulin to be administered to the subject, an amount of carbohydrates to be consumed by the subject, an indication to refrain from physical activity for a period of time, an indication to alter an intensity of physical activity, an indication to contact a healthcare practitioner, or an indication regarding blood glucose levels of the subject being outside of a desired range of blood glucose levels [Constantin at Para. 0474 (see Claim 16 for explanation)].
Regarding Claim 27
Constantin teaches the method of claim 16,
Constantin further teaches comprising:
capturing, by the one or more computing devices using the one or more third user interfaces, input indicating one or more actions performed after the blood glucose modification recommendation was determined, wherein the one or more actions include at least one of an additional insulin dose being administered to the subject or consuming an amount of carbohydrates by the subject [Constantin at Para. 0353 teaches In another example, it may be determined that a treatment decision or therapy event (e.g. forgetting to dose insulin before a meal, e.g. missed “pre-bolus”) may justify increased vigilance (e.g. checking of CGM data or awareness of a potential need to deliver therapy) during a time window following the decision or event, which may be communicated via a guidance message, or during the window a guidance message may be delivered under a broader set of conditions (e.g. lower threshold for providing event-driven guidance). In some examples, event-drive alerts may be set based on cumulative glycemic risk or glycemic exposure, e.g. food or caloric or carbohydrate consumption may be tracked and an insulin/glycemic imbalance may be detected, which may be communicated via personal guidance (“Your food or beverage consumption may have exceeded expectations”) or may form the basis for a personal guidance message (“You may need more insulin based on eating or drinking patterns.”) In some examples, a personal guidance message may provide a range of choices that are stratified by risk and rewards].
Regarding Claim 28
Constantin teaches the method of claim 27,
Constantin further teaches comprising:
causing, by the one or more computing devices, the one or more third user interfaces to display one or more differences between the blood glucose modification recommendation and the one or more actions performed after the blood glucose modification recommendation was determined [Constantin at Para. 0438 teaches the decision support system may also determine predicted glucose levels retrospectively or hypothetically to assess treatment parameters or model parameters (to assure model parameters are stable). In some examples, the system may compare predicted values to actual values to assess model parameters].
Regarding Claim 29
Constantin teaches the method of claim 16,
Constantin further teaches comprising:
causing, by the one or more computing devices, one or more logbook user interfaces to be displayed, the one or more logbook user interfaces including user interface elements to capture input indicating information related to at least one of insulin doses administered to the subject, glucose levels of the subject, physical activity performed by the subject, or carbohydrates consumed by the subject [Constantin at Para. 0608 teaches FIGS. 34-37 are illustrations of an example user interface on a device. FIG. 34 shows a user interface 3401 showing fields for an estimated blood glucose value (205 mg/Dl) 3402 and trend (arrow up around the number 205) 3404, insulin on board 3406, a time 3416 and amount 3418 for a last fasting insulin dose, a trend chart 3408 showing a high threshold 3410, a low threshold 3412, and a trend line 3414].
Regarding Claim 30
Constantin teaches the method of claim 29,
Constantin further teaches comprising:
causing, by the one or more computing devices, one or more user interface elements of the one or more first user interfaces or the one or more second user interfaces to display information obtained via the one or more logbook user interfaces [Constantin at Para. 0608 (see Claim 29 for explanation)].
Regarding Claim 31
Constantin teaches a system comprising:
one or more hardware processors; and memory storing computer-readable instructions that, when executed by the one or more hardware processors, cause the one or more hardware processors to perform operations comprising [Constantin at Para. 0588 teaches the processor module 214 may also include a program memory 216 and other memory 218]:
causing one or more first user interfaces to be displayed, the one or more first user interfaces including an insulin dose user interface that includes one or more first user interface elements to capture insulin dose information corresponding to an insulin dose administered to a subject and a time that the insulin dose was administered to the subject [Constantin at Para. 0327 (see Claim 29 for explanation)];
causing one or more second user interfaces to be displayed, the one or more second user interfaces displaying information captured via one or more second user interface elements and including an additional user interface element that is selectable to request a blood glucose modification recommendation, wherein the one or more second user interface elements capture additional information included in calculating the blood glucose modification recommendation [Constantin at Para. 0350, 0372 (see Claim 29 for explanation)];
determining that the insulin dose was administered to the subject within a threshold amount of time from a current time [Constantin at Para. 0377 (see Claim 29 for explanation)];
and causing one or more third user interfaces to be displayed that include the blood glucose modification [Constantin at Para. 0474 (see Claim 29 for explanation)].
Regarding Claim 35
Constantin teaches the system of claim 31,
Constantin further teaches wherein:
the blood glucose modification recommendation is determined based on blood glucose data of the subject that is generated by a sensor that is located at least partially below an epidermis layer of the subject [Constantin at Para. 0325 teaches in some examples, the sensor may be a wearable or implantable sensor that is connected to the patient 102, such as a continuous glucose monitor sensor available from Dexcom™, Abbot™ (e.g., the Libre™ sensor), or Medtronic™ (e.g. the Enlite™ sensor).]:
the blood glucose data is received from at least one of a wearable device or a computing device of the subject [Constantin at Para. 0325];
and an application executed by the computing device of the subject displays the one or more third user interfaces that include the blood glucose modification recommendation [Constantin at Para. 0474 (see Claim 16 for explanation)].
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.
The Examiner notes that the rejection will reference the translated documents (attached) corresponding to any foreign documents recited in the rejection.
Claim 19 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Constantin et al (US Publication No. 20190246914) in view of Veit et al (US Publication No. 8333752).
Regarding Claim 19
Constantin teaches the method of claim 17,
Constantin further teaches comprising:
determining, by the one or more computing devices, that an additional insulin dose was administered to the subject after the threshold period of time from an additional current time [Constantin at Para. 0327 (see Claim 16 for explanation)];
Constantin does not teach and causing, by the one or more computing devices, display of a notification for information related to a more recently administered insulin dose to be entered.
Veit teaches and causing, by the one or more computing devices, display of a notification for information related to a more recently administered insulin dose to be entered [Veit at Para. 33 teaches glucose meter 120 may prompt the user to input the actual dose of insulin allowing for an inventory of insulin remaining in insulin pen 100 to be accessed].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine method of Constantin with the notification of Veit with the motivation to increase convenience, privacy and ease of use for the patient, and enhance portability of system components.
Claim 23 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Constantin et al (US Publication No. 20190246914) in view of Constantin’859 et al (Foreign Publication WO-2021113859-A1).
Regarding Claim 23
Constantin teaches the method of claim 22,
Constantin does not teach wherein the one or more first user interfaces and the one or more second user interfaces are displayed in conjunction with a blood glucose modification recommendation session and the insulin dose information is unable to be modified during the blood glucose modification recommendation session.
Constantin’859 teaches wherein the one or more first user interfaces and the one or more second user interfaces are displayed in conjunction with a blood glucose modification recommendation session and the insulin dose information is unable to be modified during the blood glucose modification recommendation session [Constantin’859 at Para. 0079 teaches when the determination indicates that the person with diabetes has not taken into account the first changed insulin dosage recommendation, the action can include preventing another changed insulin dosage recommendation from being generated to the person with diabetes. For example, the diabetes therapy recommendation system 104 (FIG. 1) can cease to generate insulin dosage recommendations to the person, including, any changed insulin dosage recommendations. When the determination indicates that the person with diabetes has not taken into account the first changed insulin dosage recommendation, the action can include generating a communication without another changed insulin dosage recommendation (Interpreted as insulin dose information unable to be modified. Interpret to combine with interfaces of Constantin)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine method of Constantin with the display of Constantin’859 with the motivation to improve model prediction and avoid over-fitting.
Claim 24, 32-34 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Constantin et al (US Publication No. 20190246914) in view of LIU et al (US Publication No. 20220265179).
Regarding Claim 24
Constantin teaches the method of claim 16,
Constantin further teaches [ … ] … and a second healthcare application integrated with the first healthcare application obtains blood glucose levels corresponding to the subject via one or more blood glucose sensors [Constantin at Para. 0369 (see Claim 17 for explanation)].
Constantin does not teach wherein the one or more first user interfaces, the one or more second user interfaces, and the one or more third user interfaces are displayed by a first healthcare application … [ … ]
LIU teaches wherein the one or more first user interfaces, the one or more second user interfaces, and the one or more third user interfaces are displayed by a first healthcare application LIU at Para. 0054 teaches electronic device 19 may further comprise one or more UIs. The UI may allow one or more interfaces to present information to a user 8, such as a plan or intervention. The UI may be web-based, such as a web page, or a stand-alone application (stand alone application interpreted as healthcare application)] … [ … ]
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine method of Constantin with the application of LIU with the motivation to improve diabetes care.
Regarding Claim 32
Constantin teaches the system of claim 31,
Constantin does not teach wherein:
the insulin dose information is obtained using a first set of computer-readable instructions that are stored in a first storage location and correspond to a first regulatory framework;
and the blood glucose modification recommendation is determined by executing a second set of computer-readable instructions that are stored in a second storage location separate from the first storage location, the second set of computer-readable instructions corresponding to a second regulatory framework.
LIU teaches wherein:
the insulin dose information is obtained using a first set of computer-readable instructions that are stored in a first storage location and correspond to a first regulatory framework [LIU at Para. 0057 teaches in some implementations of system 100, any received data may be stored in the databases in an encrypted form to increase security of the data against unauthorized access and complying with HIPAA privacy, and/or other legal, healthcare, financial, or other regulations (interpret to combine with insulin dose information of Constantin)];
and the blood glucose modification recommendation is determined by executing a second set of computer-readable instructions that are stored in a second storage location separate from the first storage location, the second set of computer-readable instructions corresponding to a second regulatory framework [LIU at Para. 0057 teaches in some implementations of system 100, any received data may be stored in the databases in an encrypted form to increase security of the data against unauthorized access and complying with HIPAA privacy, and/or other legal, healthcare, financial, or other regulations (interpret to combine with glucose modification recommendation of Constantin)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine method of Constantin with the framework of LIU with the motivation to improve diabetes care.
Regarding Claim 33
Constantin/LIU teach the system of claim 32,
Constantin/LIU do further teach wherein the one or more first user interfaces and the one or more second user interfaces are generated by executing at least a portion of the first set of computer-readable instructions [LIU at Para. 0054 teaches electronic device 19 may further comprise one or more U Is. The UI may allow one or more interfaces to present information to a user 8, such as a plan or intervention (interpret o combine with interfaces of Constantin)].
Regarding Claim 34
Constantin/LIU teach the system of claim 32,
Constantin/LIU further teach wherein the memory stores one or more additional computer-readable instructions that, when executed by the one or more hardware processors, cause the one or more hardware processors to perform additional operations comprising:
determining an insulin to carbohydrate ratio that indicates an amount of insulin received by the subject in relation to an amount of carbohydrates consumed by the subject over a period of time, wherein the insulin to carbohydrate ratio is determined using the first set of computer-readable instructions [Constantin at Para. 0399 teaches the system may, for example, determine basal dose, insulin sensitivity, insulin-to-carb ratio, insulin duration of action, or bolus for commonly used meals];
and obtaining insulin sensitivity data that indicates an amount of change in blood glucose levels of the subject in response to one or more amounts of insulin, wherein the insulin sensitivity data is obtained using the first set of computer-readable instructions [Constantin at Para. 0421 teaches for example, the system may track and report insulin sensitivity or changes or trends in insulin sensitivity];
and wherein the blood glucose modification recommendation is determined based on the insulin to carbohydrate ratio and the insulin sensitivity data [Constantin at Para. 0370 teaches the physiology model may provide physiology state information as output, such as a current or projected glucose level or trend, insulin to carb ratio (ICR), insulin sensitivity factor (ISF), basal rate(s), or insulin on board (JOB), all of which may impact the true glucose level 160 and insulin delivery decisions or recommendations made by the guidance module 150 or the patient 102 or a caregiver or clinician].
Conclusion
The prior art made of record and not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Zivitz et al (US Publication No. 10311209) discloses a device and method that provides insulin dosage alterations for various conditions.
El-Khatib et al (US Publication No. 10973979) discloses systems, methods, and devices that provide therapy to a subject.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN C EDOUARD whose telephone number is (571)270-0107. The examiner can normally be reached M-F 730 - 430.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571) 272 - 6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN C EDOUARD/Examiner, Art Unit 3683 /JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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