DETAILED ACTION
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) submitted October 30, 2025. Claims 1 – 6, 8, 18, 22, and 31 are amended. Claims 17 and 30 were previously cancelled. Claims 1 – 16, 18 – 22, 26 – 29, and 31 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 30, 2025 has been entered.
Claim Rejections - 35 USC § 112
The rejection of Claims 1, 8, 18, and 22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn based upon the arguments presented in the remarks dated October 30, 2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 16, 18 – 29, and 31 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 One
Claims 1 – 16, 18 – 29, and 31 are drawn to a method and system which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 1 recites a method for prioritizing the presentation of information about patients with diabetes (PWDs) receiving insulin- based therapy, comprising: receiving blood glucose data for at least one patient of a selectable list of patients with diabetes (PWDs) receiving insulin-based therapy, wherein the PWDs of the selectable list of PWDs includes two or more PWDs, wherein the PWDs are associated with a provider caring for the PWDs; receiving therapy data for at least one PWD of the selectable list of PWDs; detecting a pattern in the blood glucose data of the at least one patient of the selectable list of PWDs; determining a probability of one or more missed doses based on the pattern in the blood glucose data; when the probability of one or more missed doses is greater than a threshold probability, determining the pattern in the blood glucose data indicates one or more missed doses and determining one or more therapy insights relating to an intervention to address the pattern in the blood glucose data indicative of one or more missed doses for at least one PWD of the selectable list of PWDs, wherein the therapy insights comprise a recommendation; receiving a selection of a therapy insight on the one or more therapy insights; updating a total number of therapy insights associated with the at least one patient of the selectable list of PWDs based on the selection of the therapy insight; updating an order of the selectable list of patients based on a number of the one or more therapy insights associated with each patient of the selectable list of patients such that patients associated with a higher number of the one or more therapy insights are ordered above patients associated with a lower number of the one or more therapy insights; displaying the selectable list of PWDs, the selectable list of PWDs comprising a column portion comprising an indication of a total number of the one or more therapy insights for each PWD of the selectable list of PWDs.
Independent claim 8 recites a method for prioritizing presenting therapy insights that includes comprising receiving blood glucose data for at least one patient of a selectable list of patients with diabetes (PWDs) receiving insulin-based therapy, wherein the PWDs of the selectable list of PWDs includes two or more PWDs, wherein the PWDs are associated with a provider caring for the PWDs; receiving or determining insulin therapy data for at least one PWD of the selectable list of PWDs; detecting a pattern in the blood glucose data of the at least one patient of the selectable list of PWDs; determining a probability of one or more missed doses based on the pattern; displaying the insulin therapy data; displaying the selectable list of PWDs; determining or receiving one or more therapy insights corresponding to at least one PWD of the selectable list of PWDs, the one or more therapy insights generated based in part on the probability of one or more missed doses, wherein the one or more therapy insights include a content relating to an intervention to address the pattern, wherein the one or more therapy insights comprise a recommendation to review educational material; when the probability of one or more missed doses is greater than a threshold probability, determining the pattern indicates one or more missed doses and displaying the one or more therapy insights; receiving a selection of a therapy insight of the one or more therapy insights; updating a total number of therapy insights associated with the at least one patient of the selectable list of PWDs based on the selection of the therapy insight; sorting an order of PWDs within the selectable list of PWDs based partially on a total number of determined therapy insight associated with respective PWDs; displaying and associating the one or more therapy insights with respective PWDs within the selectable list of PWDs, the column portion of the selectable list of PWDs comprising an indication of a total number of determined therapy insights for each PWD of the selectable list of PWDs.
Independent claim 18 recites a method for prioritizing the presenting of therapy insights that includes receiving blood glucose data for at least one patient of a selectable list of patients with diabetes (PWDs) receiving insulin-based therapy, wherein the PWDs of the selectable list of PWDs includes two or more PWDs, wherein the PWDs are associated with a provider caring for the PWDs; receiving or determining insulin therapy data for at least one patient of the selectable list of patients; detecting a pattern in the blood glucose data for the at least one patient of the selectable list of patients; determining a probability of one or more missed doses based on the pattern; when the probability of one or more missed doses is greater than a threshold probability, determining the pattern indicates one or more missed doses, displaying the selectable list of PWDs, and associating at least one therapy insight with a PWD within a column portion of the selectable list of PWDs, the column portion of the selectable list of PWDs comprising an indication of a total number of therapy insights for each PWD of the selectable list of PWDs the at least one therapy insight being generated based in part on the probability of one or more missed doses, wherein the at least one therapy insight relates to an intervention to address the pattern indicative of one or more missed doses and includes a recommendation for a reminder to administer insulin for meals; receiving a selection of a therapy insight of the one or more therapy insights at the device; updating a total number of therapy insights associated with the at least one patient of the selectable list of PWDs based on the selection of the therapy insight; updating an order of the selectable list of patients based on a number of the one or more therapy insights associated with each patient of the selectable list of patients such that patients associated with a higher number of the one or more therapy insights are ordered above patients associated with a lower number of the one or more therapy insights; displaying and associating an insulin therapy recommendation corresponding to the therapy insight with a PWD within the selectable list of PWDs exhibiting the sorted order of PWDs, the insulin therapy recommendation generated based in part on the insulin therapy data of the PWD, wherein the insulin therapy recommendation includes second pre-generated content corresponding to the insulin-based therapy of the PWD.
Independent claim 22 recites providing clinical advice, related to behaviors of a patient with diabetes (PWD), to a health care provider (HCP) caring for the PWD, comprising: receive one or more of blood glucose data or insulin therapy data; based at least partially on the blood glucose data, detect a clinically relevant pattern in the blood glucose data; determine a probability of one or more missed doses based on the clinically relevant pattern; identify a predefined behavior of a PWD responsive to the detected clinically relevant pattern, wherein the predefined behavior of the PWD is related to insulin-based management of a person's diabetes; and when the probability of one or more missed doses is greater than a threshold value, determine that the clinically relevant pattern indicates one or more missed doses and generate a therapy insight associated with the identified predefined behavior of the PWD, wherein the therapy insight is related to an intervention to address the clinically relevant pattern indicative of one of more missed doses and comprises a recommendation; receive the therapy insight and the recommendation; display a selectable list of patients with diabetes (PWDs) receiving insulin-based therapy, wherein the PWDs of the selectable list of PWDs includes two or more PWDs; update a total number of therapy insights associated with the PWD of the selectable list of PWDs based on the therapy insight; updating an order of the selectable list of patients based on a number of the one or more therapy insights associated with each patient of the selectable list of patients such that patients associated with a higher number of the one or more therapy insights are ordered above patients associated with a lower number of the one or more therapy insights; display and associate the received, selected one or more therapy insight within a PWD column portion of the selectable list of PWDs, the column portion of the selectable list of PWDs comprising an indication of a total number of determined therapy insights for each PWD of the selectable list of PWDs.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that “This disclosure relates to presenting insulin-based therapy insights that includes pre-generated content at an electronic device. In particular embodiments, automated provisioning of clinical advice systems, devices, and methods are disclosed, which may be utilized with insulin injection devices, including components adapted to provide a user with therapy insights based, at least in part on, identified predefined behaviors.” (paragraph 2 of the published specification). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address a need that exists for patients (PWD) and Healthcare Providers (HC) to “quickly and efficiently identify therapy trends or behavior trends from therapy data and then communicate therapy or behavior recommendations to the patient” (paragraph 38 of the published specification). This problem is addressed such that the “…. interfaces disclosed herein enable an HCP to access supporting data for insights highlighted within various reports to guide an HCP in clinical decision support.” (paragraph 40 of the published specification). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “health care provider (HCP) device”, “a blood glucose sensor and at a computing system having at least one processor, and at least one memory”, “computing system”, “HCP device”, “communicating the selected therapy insight to a device of the PWD”, “communicating the selected therapy insight to a PWD display”, “automatically”, “HCP display”
Claims 2 – 3, 5 – 6, 9 – 10, 12 – 13, 16, 20: “HCP device”
Claim 4: “HCP device”, “automatically”
Claim 6: “HCP device”
Claim 8: “pre-generated content at a health care provider (HCP) device”, “a blood glucose sensor and at a computing system having at least one processor and at least one memory”, “HCP device”, “computing system”, “automatically”, “communicating, by the HCP device, the selected therapy insight and the contextually relevant message to a PWD display, wherein the contextually relevant message is displayed on the PWD display as a pop-up message over the selected therapy insight, wherein the pop-up message is replaced by the selected therapy insight in response to selection of a button on the pop-up message”
Claims 11, 14 – 15: “pre-generated”, “HCP device”
Claim 18: “pre-generated content at a health care provider (HCP) device”, “a blood glucose sensor and at a computing system having at least one processor and at least one memory”, “HCP device”, “computing system”, “automatically”, “communicating, by the HCP device, the selected therapy insight and the contextually relevant message to a PWD display, wherein the contextually relevant message is displayed on the PWD display as a pop-up message over the selected therapy insight, wherein the pop-up message is replaced by the selected therapy insight in response to selection of a button on the pop-up message”
Claim 19: “displaying, by the HCP device, an icon to cause the at least one therapy insight and the contextually relevant message to be sent to the PWD”, “in response to receiving, by the HCP device, a selection of the icon, sending, by the HCP device, the at least one therapy insight and the contextually relevant message to the PWD display”
Claim 21: “displaying, by the HCP device, an icon to cause the therapy insight to be sent to the PWD”, “in response to receiving, by the HCP device, a selection of the icon, sending, by the HCP device, the therapy insight to the PWD display”
Claim 22: “system for providing pre-generated content”, “an insight determination system comprising at least one processor”, “at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause an insights determination system of the system to [perform]”, “a health care provider (HCP) device”, “communicate the therapy insight and the recommendation to a display associated with a patient with diabetes (PWD)”, “automatically”
Claims 23 – 29: “system”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0046] 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 l00A and/or external resources, and/or provide other functionality attributed herein to client computing platform(s ). By way of non-limiting example, a given client computing platform may include one or more of a desktop computer, a laptop computer, a handheld computer, a tablet computer, a NetBook, a smart phone, a gaming console, a media console, a set top box, a kiosk, and the like.
[0195] The embodiments described herein may include the use of a special-purpose or general-purpose computer including various computer hardware or software modules, as discussed in greater detail below.
[0196] Embodiments described herein may be implemented using computer-readable media for carrying or having computer-executable instructions or data structures stored thereon. Such computer-readable media may be any available media that may be accessed by a general-purpose or special-purpose computer. Special-purpose computer is intended to be interpreted broadly and encompasses embedded systems, microcontrollers, application specific integrated circuits, digital signal processors, and general-purpose computers programmed for specific purposes. Segments (e.g., code segment or data segment) may refer to a portion (e.g., address) of memory, virtual memory, or an object file.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent Claim Analysis
Dependent claim(s) 2 – 7, 9 – 16, 19 – 21, 23 – 29, and 31 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
Claims 1 – 16, 18 – 29, and 31 rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al., herein after Anderson (U.S. Publication Number 2018/0296143 A1) in view of Gordon et al., herein after Gordon (U.S. Publication Number 2003/0167185 A1) further in view of Shrager et al., herein after Shrager (U.S. Publication Number 2020/0411199 A1) and Estes (U.S. Publication Number 2010/0094251 A1) were withdrawn in the Office Action dated June 30, 2025.
Response to Arguments
Applicant's arguments filed October 30, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were received.
35 U.S.C. § 101 Rejection
The Applicant argues claim 1 recites features similar to those of Example 37 of the Subject Matter Eligibility Examples from the 2019 Revised Patent Subject Matter Eligibility Guidance. The Examiner respectfully disagrees. Example 37 recites “A method of rearranging icons on a graphical user interface (GUI) of a computer system, the method comprising: receiving, via the GUI, a user selection to organize each icon based on a specific criteria, wherein the specific criteria is an amount of use of each icon; determining, by a processor, the amount of use of each icon over a predetermined period of time; and automatically moving the most used icons to a position on the GUI closest to the start icon of the computer system based on the determined amount of use.” The abstract idea is to determine the amount of use of each icon over a predetermined period of time, and falls within the grouping of Mental Processes. Other than reciting “by a processor”, nothing in the claim precludes the step from practically being performed in the mind. The additional elements of Example 37 recite a specific manner of automatically displaying icons to the user based on usage which provides a specific improvement over prior systems, resulting in an improved user interface for electronic devices. The present claims differ such that the additional elements include “health care provider (HCP) device”, “a blood glucose sensor and at a computing system having at least one processor, and at least one memory”, “computing system”, “HCP device”, “communicating the selected therapy insight to a device of the PWD”, “communicating the selected therapy insight to a PWD display”, “automatically”, “HCP display”. The claim, as a whole, merely describes how to generally “apply” the concept of presenting insulin-based therapy insights that includes pre-generated content at an electronic device (as described in the Applicant’s specification). The claimed computer components are recited at a high level of generality and are merely invoked as tools to provide a user with therapy insights based on identified predefined behaviors. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea. The Applicant’s published specification recites:
[0046] 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 l00A and/or external resources, and/or provide other functionality attributed herein to client computing platform(s ). By way of non-limiting example, a given client computing platform may include one or more of a desktop computer, a laptop computer, a handheld computer, a tablet computer, a NetBook, a smart phone, a gaming console, a media console, a set top box, a kiosk, and the like.
Accordingly, the claim as a whole does not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
The Applicant argues claim 1 recites features that are not merely instructions to implement an abstract idea on a computer, but recite significantly more. The Examiner respectfully disagrees. The Applicant’s specification states “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 l00A and/or external resources, and/or provide other functionality attributed herein to client computing platform(s ). By way of non-limiting example, a given client computing platform may include one or more of a desktop computer, a laptop computer, a handheld computer, a tablet computer, a NetBook, a smart phone, a gaming console, a media console, a set top box, a kiosk, and the like.” (paragraph 46 of the published specification). The generic computer cited by the Applicant is a general link to execute the abstract idea. The processor, as used in the recited claims, is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
The Applicant argues claim 8 integrates the alleged abstract idea into a practical application by providing a technical solution. The Examiner respectfully disagrees. The additional elements of the present claims fail to integrate the exception into a practical application of the exception. MPEP 2106.04(d) states the phrase “integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, MPEP 2106.04(d) recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
The rejection of Claims 18 and 22 are maintained for the reasons given above with respect to claims 1 and 8.
Conclusion
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KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682