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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/27/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
This Office Action is responsive to the response filed May 27, 2025.
Claims 1, 7, and 13 have been amended.
Claims 12, and 16-17 were previously cancelled.
Claims 1-11, 13-15, and 18-23 are currently pending and have been fully examined.
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 1-11, 13-15, and 18-23 is/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.
Step 1
The claim(s) recite(s) subject matter within a statutory category as processes (claims 1, 7, and 13), which are recited as methods that perform the steps and/or functions of:
Claim 1
Receiving therapy data associated with the PWD, wherein the therapy data comprises insulin dosing data received from an insulin delivery device and glucose data received from a glucose sensor;
Analyzing, via at least one hardware processor, the therapy data to identify one or more trends indicated in the therapy data, wherein the one or more trends comprise a glucose level for the PWD falling below a glucose target range or rising above the glucose target range during an overnight period;
Determining a recommendation insight based on a trigger condition in a predefined rule, wherein the trigger condition is triggered based on the identified one or more trends, and wherein the recommendation insight is associated with a list of predefined textual content, wherein the list or predefined textual content comprises a plurality of recommendations, the plurality of recommendations comprising an updated long acting insulin dose to bring the glucose level for the PWD within the target glucose range during the overnight period after the updated long acting insulin dose is administered;
transmitting, to the health care provider graphical dashboard for display on a health care provider device, the plurality of recommendations;
receiving, from the health care provider device via the HCP graphical dashboard, a selection from the plurality of recommendations, wherein the selection comprises one or more of the plurality of recommendations;
transmitting, to the PWD graphical dashboard for display on the insulin delivery device or the user device, the selected recommendation of the plurality of recommendations and a message associated with the recommendation insight, wherein the message includes information relating to a real-time glucose level;
receiving, from the insulin delivery device, additional therapy data associated with the PWD; and
updating the recommendation insight based on the additional therapy data.
Claim 7
Claim 7 recites the same limitations as claim 1 with the following exceptions:
transmitting a “list of predefined textual content” rather than “plurality of recommendations” to the HCP graphical dashboard to receive a selection
transmitting “the selection of the list of predefined textual content and a selectable message along with the predefined textual content” rather than “the selected recommendation of the plurality of recommendations and a message associated with the recommendation insight” to the PWD graphical dashboard
wherein selecting the selectable message causes the graphical dashboard to display an additional view associated with the real-time glucose level
omitting the “updating the recommendation insight…” limitation.
Claim 13
Claim 13 recites the same limitations as claim 7 other than receiving therapy data from a continuous glucose monitor rather than a glucose sensor, and the message transmitted to the PWD graphical dashboard is “associated with the updated long acting insulin dose, wherein the message includes a real-time glucose level for the PWD generated by the continuous glucose monitor” without causing the graphical dashboard to display an additional view associated with the real-time glucose level. Claim 13 also recites the additional limitations not recited in claim 1:
based at least partially on the identified one or more trends pre-defined rules defining conditions for determining insights, determining at least one behavior insight, at least one insulin dosing insight, and at least one positive insight, the at least one behavior insight, the at least one insulin dosing insight, and the at least one positive insight comprising clinical advice for managing the insulin therapy of the PWD;
receiving, at the dialog box, insulin therapy information related to managing insulin therapy of the PWD; and
transmitting the insulin therapy information to a health care provider device of a health care provider caring for the patient.
Step 2A: Prong 1
When taken individually and as a whole, the steps corresponds to concepts identified as abstract ideas by the courts, such as “certain methods of organizing human activity”, which are interactions between individuals that can include: fundamental economic principles or practices; commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); and managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
The claim is directed to a system to perform the process of providing treatment recommendations for a patient, which is performed by the system analyzing therapy data to identify one or more trends indicated in the therapy data, determining a recommendation insight based on a trigger condition in a predefined rule, wherein the trigger condition is triggered based on the identified one or more trends, and wherein the recommendation insight is associated with a list of predefined textual content, wherein the list of predefined textual content comprises a plurality of recommendations, receiving a selection from a health care provider, wherein the selection comprises one or more of the plurality of recommendations, and updating the recommendation insight based on additional therapy data.
This is managing the behavior of the patient and the health care provider by determining recommended therapies for the patient, receiving a selection of predefined therapy recommendation options from the health care provider, and updating the recommendations based on additional data. This is providing rules and/or instructions for the patient and health care provider to follow in order to provide the best treatment for the patient.
Additionally, the limitation in the analysis step that defines the one or more trends as comprising a glucose level for the PWD falling below a glucose target range or rising above the glucose target range during an overnight period describes a mathematical concept because it is identifying a mathematical relationship in the data (i.e., it determines the relationship of the PWD’s glucose level to a target range of glucose levels for the PWD). Because this mathematical concept is part of the analysis that goes into making the treatment recommendations, it is considered to be a part of the overall abstract idea of providing treatment recommendations for the user (see July 2024 Subject Matter Eligibility Examples, pg. 7-8).
The additional limitations in claim 13 are similarly directed towards determining additional insights for the patient and receiving additional information from a patient in response to instructions to provide that information in a dialog box. These are also part of the certain methods of organizing human activity.
Step 2A: Prong 2
The claims do not include additional elements that are sufficient to be considered a practical application because the additional elements (underlined above) amount to: insignificant extra-solution activity (MPEP 2106.05(g)), generally linking the application of the abstract idea to a particular field of use or technological environment (2106.05(h)), or mere instructions to apply it with a computer (MPEP 2106.05(f)), as discussed below.
Insignificant Extra-Solution Activity
The steps of receiving different types of information from different devices are examples of mere data gathering, which is an insignificant extra-solution activity (MPEP 2106.5(g)).
The steps specifying the types of data to be used, such as “wherein the therapy data comprises insulin dosing data received from an insulin delivery device and glucose data received from a glucose sensor” and “the one or more trends comprise a glucose level for the PWD falling below a glucose target range or rising above the glucose target range during an overnight period”, and also specifying that the content provided to the provider must be predefined textual content are examples of selecting by type or source the data to be manipulated, which is an extra-solution activity (MPEP 2106.05(g)).
The steps of transmitting the information to each of the respective devices for display are examples of necessary data outputting. Necessary data outputting is an insignificant extra-solution activity (MPEP 2106.05(g)).
Insignificant extra-solution activities are not sufficient to integrate the abstract idea into a practical application or cause the claim to amount to significantly more than the abstract idea (MPEP 2106.05(g))
Generally Linking Implementation a Particular Technological Environment or Field of Use
The steps that describe the health care provider, the patient, and the information as being all related to diabetes or insulin therapy, such as “the plurality of recommendations comprising an updated long acting insulin dose to bring the glucose level for the PWD within the target glucose range during the overnight period after the updated long acting insulin dose is administered” are steps that are used to generally link the performance of organizing the human activity to the field of diabetes management.
The steps reciting generically recited components of a computer system, such as the dashboards being displayed at a device with one or more processors, memory and a display, only serve to generally link the implementation of the abstract idea to a technological environment, which would be a networked system of generic computers capable of displaying a user interface.
Generally linking the application of the abstract idea to a particular field of use or technological environment is not sufficient to integrate the abstract idea into a practical application or cause the claim to amount to significantly more than the abstract idea (MPEP 2106.05(h)).
Mere Instructions to Apply the Abstract Idea Using a Computer
The steps reciting the use of computer components, such as analyzing, via at least one hardware processor; determining, via the at least one hardware processor; displaying, on the display of a device; or receiving, at the dialog box or medical information portion, serve as mere instructions to apply the abstract idea using a computer. Mere instructions to apply the abstract idea using a computer are not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.05(f)).
Step 2B
The claims also do not include additional elements that are sufficient to be considered a significantly more than the abstract idea because the additional elements amount to: insignificant extra-solution activity (MPEP 2106.05(g)), mere instructions to apply it with a computer (MPEP 2106.05(f)), generally linking the application of the abstract idea to a particular field of use or technological environment (MPEP 2106.05(h)), or a well-understood, routine, and conventional limitation (MPEP 2106.05(d)), as discussed below.
The steps addressed above in Step 2A: Prong 2, when considered again under Step 2B are not considered to make the claims amount to significantly more than the abstract idea because those steps, when considered additionally with regards to Step 2B, are still considered to be either insignificant extra-solution activity, mere instructions to apply an abstract idea with a computer, or generally linking the application of the abstract idea to a particular field of use or technological environment, which are types of limitations that are not sufficient to make the claims amount to significantly more than the abstract idea (MPEP 2106.05.I.A).
The steps recited as either being part of the abstract idea or insignificant extra-solution activity are all examples of at least one of: storing and retrieving data from a memory (accessing the data that is to be displayed), sending and receiving data over a network (receiving data from the different devices and transmitting information between the devices), electronic recordkeeping (updating the recommendation insight), or performing repetitive calculations (generating the recommendation insights based on the patient’s data). All of those functions have been identified as well-understood, routine, and conventional functions of a generic computer that are not significantly more than the abstract idea when claimed broadly or as an extra-solution activity (MPEP 2106.05(d).II).
The recited computer components (e.g., at least one hardware processor, a patient device and a provider device, where each device comprises one or more processors, memory and a display) are all generically recited components (see specification, par. [0048], [0188], [0190]). The non-computer components recited in the claims (e.g., the insulin delivery device) is recited in the specification as one of several types of generic insulin delivery devices (see par. [0056], which describes example insulin delivery devices as “infusion pumps, injection pens, and inhalers”). Commercially available components, generic computer components, and specially-programmed computer components performing the functions of a generic computer are not considered to be amount to significantly more than the abstract idea (MPEP 2106.05(b)).
When considered as a whole, the components do not provide anything that is not present when the component parts are considered individually. Using the broadest reasonable interpretation, the system as a whole is a set of user devices connected over a network facilitating the patient’s diabetes therapy management by receiving information from each party and providing that information and generated recommendations over the network. This is a system of connected generic computers performing the abstract idea and insignificant extra-solution activities through these generically described devices performing well-understood, routine, and conventional functions of a generic computer (MPEP 2106.05(d).II).
Dependent Claim Analysis
Claims 18, 2-6, and 21-23 are ultimately dependent from Claim(s) 1 and includes all the limitations of Claim(s) 1. Therefore, claim(s) 2-6 recite the same abstract idea of certain methods of organizing human activity of claim 1.
Claims 18 and 20-21 recite additional limitations that amount to selecting by type or source the data to be manipulated because they are determining the types of data that are to be used to generate the recommendation insights. Selecting by type or source the data to be manipulated is a type of insignificant extra-solution activity that is not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.05(g)).
Claims 2-3 all recite additional limitations that describe providing the information to the patient with diabetes, which is the insignificant extra-solution activity of necessary data outputting (MPEP 2106.05(g)), and this data outputting is done by sending and receiving information over a network, which is a well-understood, routine, and conventional function of a generic computer when claimed broadly or as an insignificant extra-solution activity (MPEP 2106.05(d).II).
Claims 4-6 all recite additional limitations that amount to mere data gathering and selecting by type and source the data to be manipulated because they all describe receiving information from either the patient or the provider, and they all specify what type of information and where the data must be received at. Mere data gathering and selecting by type and source the data to be manipulated are both insignificant extra-solution activity (MPEP 2106.05(g)).
Claims 22-23 recite additional limitations that further describe the abstract idea by reciting mathematical concepts (determining the relationship of the percentage of PWD’s glucose levels over a period to the upper and lower thresholds of a target range of glucose levels) and providing instructions (triggering a trigger condition) based upon the determined relationship. The abstract idea and additional elements that are also abstract ideas are not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.04.II.A.2).
Claims 8-11 and 19 are ultimately dependent from Claim(s) 7 and includes all the limitations of Claim(s) 7. Therefore, claim(s) 8-12 and 19 recite the same abstract idea of certain methods of organizing human activity of claim 7.
Claims 8-11 all recite additional limitations describing mere data gathering and selecting by type and source the data to be manipulated because they all describe receiving some kind of information, and they further specify what type of information is to be received. Mere data gathering and selecting by type and source the data to be manipulated are both insignificant extra-solution activity (MPEP 2106.05(g)).
Claim 19 recites the limitation in claim 1 that was omitted from claim 7.
Claims 14-17 are ultimately dependent from Claim(s) 13 and includes all the limitations of Claim(s) 13. Therefore, claim(s) 14-17 recite the same abstract idea of certain methods of organizing human activity of claim 13.
Claims 14-15 recite additional limitations describing mere data gathering and selecting by type and source the data to be manipulated because they all describe receiving some kind of information, and they further specify what type of information is to be received. Mere data gathering and selecting by type and source the data to be manipulated are both insignificant extra-solution activity (MPEP 2106.05(g)).
Claims 16-17 recite additional limitations that are only nominally or tangentially related to the claimed solution. The claims recite the patient dashboard communicating with a clinical decision support system and the provider dashboard receiving information via the clinical decision support system. This limitation only recites the existence of the clinical decision support system, but there is nothing in the claims that requires any use of the clinical decision support other than for routing the information between the patient and the provider. Extra-solution activities that are only nominally or tangentially related to the abstract idea are considered insignificant extra-solution activities (MPEP 2106.05(g)). Additionally, communication between a patient dashboard and a clinical decision support system and transmitting information to the provider via the clinical decision support system are examples of sending and receiving information over a network, which is a well-understood, routine, and conventional function of a generic computer when claimed broadly or as an insignificant extra-solution activity (MPEP 2106.05(d).II).
Response to Arguments
101 Rejections
Applicant's arguments filed May 27, 2025, have been fully considered but they are not persuasive.
Applicant argues that the claims as a whole provide an improvement to the technological field of glucose monitoring systems for diabetes management. Applicant argues that the specification addresses the problem of unsteady overnight glucose levels by identifying glucose trends indicative of problems with long-acting insulin dosing and particularly identifying and associated glucose trends in overnight periods as indicative of a need for a change to long-acting insulin dosing, along with providing a message to the PWD that can include a recommendation based on the identified glucose trends and information related to a real-time glucose level. Applicant argues that amended claim 1 provides a practical application of the alleged abstract idea by linking a pattern of overnight glucose lows to long acting insulin doses, and providing an HCP dashboard that can send (i) recommendations regarding changing a dose of long acting insulin and (ii) messages that include a real-time glucose level associated with the overnight glucose lows to a PWD dashboard.
This argument is not persuasive. The Applicant asserts that, because the specification “identifies a problem in the art that ‘conventional dosing systems do not provide options for changing incorrect behaviors, nor do they … link patterns of behaviors to specific types of dosing, more specifically, identify a behavior pattern and link it to long actin insulin doses or rapid acting insulin doses….’” (Remarks, pg. 10 citing specification, par. [0012]). This describes an improvement to the abstract idea because it is an improved way of managing the behavior of an individual by giving them rules or instructions based on the relationship between past behaviors and medication doses.
Improvements to the abstract idea are not considered to be improvements to computer functionality or other technical field (MPEP 2106.05(a), “However, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”).
Because the purported improvement to technology is an improvement to the abstract idea, the argument that the claimed invention should be eligible under 101 because it provides an improvement to technology is not persuasive.
Any improvement to the technology or technical field comes from the additional elements, which are those limitations beyond the abstract idea. Similarly, any integration of the abstract idea into a practical application comes from the additional elements. The applicant does not argue, nor is it readily apparent from the claims, that any of the underlying technology cited in the claims are improved in functionality. That is, none of the insulin delivery device, the glucose sensor, the hardware processor, the PWD graphical dashboard, the HCP graphical dashboard have an improved functionality. Displaying information (e.g., the result of determining the recommendation insight and any associated messages) is extra-solution activity. This does not merit a particular treatment or prophylaxis, as the independent claims do not affirmatively recite an action that effects a particular treatment or prophylaxis for a medical condition. Per MPEP 2106.04(d)(2), if a limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration. No insulin therapy is ever administered to the patient, only a recommendation and associated information.
Applicant argues that claim 1 recites features similar to those found allowable in claim 1 of Example 42 of the Subject Matter Eligibility Examples because claim 1 of the present application recites features that provide a specific improvement over prior art systems.
This argument is not persuasive. Claim 1 of Example 42 was found to be eligible, but not simply because the claim recited a specific improvement over prior art systems, but because the combination of additional elements as a whole integrated the method of organizing human activity into a practical application and the additional elements recite a specific improvement over prior art systems. Per the updated rejection above, the additional elements are limited to reciting insignificant extra-solution activity (MPEP 2106.05(g)), mere instructions to apply it with a computer (MPEP 2106.05(f)), or generally linking the application of the abstract idea to a particular field of use or technological environment.
As noted above, the HCP dashboard is used to transmit the plurality of recommendations (claim 1), the list of predefined textual content (claims 7 and 13) for selection of one or more of recommendations/predefined textual content. In other words, the dashboard is used to display data and receive user input, in a field of use, in a data gathering and data displaying context, which is extra-solution activity. The PWD graphical dashboard is used to display the selected recommendations/predefined textual content along with associated messages that include information relating to a real-time glucose level. Similar to the HCP dashboard, the PWD dashboard is used to display data, in a field of use, in a data gathering and data displaying context, which is extra-solution activity.
The recited glucose sensor (claims 1 and 7) and continuous glucose monitor (claim 13) to receive therapy data is deemed to be directed towards data gathering; the claim does not recite any details on how the glucose sensor/monitor constitutes an improvement in gathering therapy data. Thus, the glucose sensor and monitor are deemed to be generally linking the application of the abstract idea to a particular field of use or technological environment
The hardware processor is used in an “apply it” manner to determine recommendation insights.
The insulin delivery device or user device (claims 1 and 13) is cited in a step to receive insulin therapy information. The claims do not recite any details on any improved functionality in this regard and is therefore regarded as generally linking the application of the abstract idea to a particular field of use or technological environment.
For at least the foregoing reasons, the arguments against the 101 rejection are not persuasive and the 101 rejections will be sustained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER H CHOI whose telephone number is (469)295-9171. The examiner can normally be reached M-F 930am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Namrata Boveja can be reached at 571-272-8105. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681