DETAILED ACTION
This office action is based on the claims filed on 07/17/2026.
Claims 1 and 8 have been amended.
Claims 2, 4, and 14-20 have been canceled.
Claims 21-27 are new.
Claims 1, 3, 5-13, and 21-27 are currently pending and have been examined.
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 .
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, 3, 5-13, and 21-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1, 3, 5-7 are drawn to a system, Claims 8-13 are drawn to a method, and Claims 21-27 are drawn to an art of manufacturer, and each of which is within the four statutory categories (i.e., a machine and a process). Claims 1, 3, 5-13, and 21-27 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for evaluating and predicating a health care plan compliance. Collecting a user regimen or care plan data to estimate compliance state over a period of time and predict future compliance based on the user activity to select an intervention and modify the regimen data, are steps that is/are an abstract idea that could have been performed by a human actor interacting with a system to implement the abstract idea performing the steps, which both the instant claims and the abstract idea are defined as Certain Methods of Organizing Human Activity (managing personal behavior or interactions between people, including following rules or instructions).
Independent Claim 1 recites the steps of:
“a non-transitory memory; a processor communicatively coupled to the non-transitory memory, wherein the processor is configured to read a set of instructions to:
receive a compliance event notification related to a regimen data structure including a compliance object having data elements defining a medication dosage, a dosage time interval, a fill date, a fill period, and a time data element indicating an expected exhaustion date for the medication regimen;
receive a compliance event notification for the compliance object, where the notification indicates that the expected exhaustion date has occurred, or is simulated to occur, without a subsequent fill event being detected for the compliance object
execute a trained, randomized compliance prediction model including a Monte Carlo framework integrated with a machine learning framework to iteratively predict a next regimen compliance state for the compliance object for successive prediction time periods beginning with the expected exhaustion date;
when the next regimen compliance state comprises a compliant prescription-fill state, predict at least one parameter of the compliant prescription-fill state by implementing a trained parameter prediction model comprising a tree-based machine learning framework, the at least one parameter comprising a predicted fill period or a predicted exhaustion date;
generate an electronic compliance intervention data structure for the compliance object based on the one of the plurality of intervention categories, the predicted next regimen compliance state, the probability of the predicted next regimen compliance state, and the at least one parameter, the electronic compliance intervention data structure defining one or more electronic intervention communications and a last day data element indicating a last date by which the one or more electronic intervention communications are to be implemented;
select an electronic compliance intervention data structure for the compliance object based on the one of the plurality of intervention categories, the predicted next regimen compliance state, the probability of the predicted next regimen compliance state, and the at least one parameter, the electronic compliance intervention data structure defining one or more electronic intervention communications and a last day data element indicating a last date by which the one or more electronic intervention communications are to be implemented;
cause execution of the electronic compliance intervention data structure by transmitting, before the last date indicated by the last day data element and via the web server, an electronic intervention message to a user computing device associated with the medication regimen, wherein the electronic intervention message causes the user computing device to display an interface element associated with the electronic intervention message; and
modify the regimen data structure in the regimen database to reference the electronic compliance intervention data structure and to store data representative of transmission of the electronic intervention message in association with the compliance object;
receive, after transmission of the electronic intervention message, data indicating a subsequent fill event for the compliance object; and
in response to the subsequent fill event, update the time data element of the compliance object based on the subsequent fill event and a fill amount associated with the subsequent fill event for use in generating a subsequent compliance event notification”
Independent Claim 8 recites similar steps as in Claim 1.
Independent Claim 21 recites similar steps as in Claim 1 including:
“wherein the successive prediction time periods are incremented by a predetermined increment during each iteration
classifying the compliance object in one of a plurality of intervention categories based on the predicted next regimen compliance state and a probability of the predicted next regimen compliance state.”
These limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations by a human user/actor interaction with computing device(s) that constitute Certain Methods of Organizing Human Activity along with mathematical calculations and relationships that constitute Mathematical Concepts (e.g., the randomized prediction model, Monte Carlo framework, extreme gradient boost framework). For example, the limitations of the claim(s) encompass a user the ability to access regimen data to evaluate compliance stated of the regimen and predicated the next compliance state over period of time and select an intervention based on the predicted future compliance state and modify the region data according to the intervention, which are steps that that could have been performed by a human actor using generic computing components/units to implement the abstract idea. These limitations encompass activity of a single person or multiple people and a computer, interacting with other users and with computing system(s) to perform the steps of the claimed invention for evaluating patient safety risk event, which constitutes Certain Methods of Organizing Human Activity. Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “device, processor, non-transitory memory/ non-transitory readable medium, machine learning framework, computing device” are computing components that iteratively takes input data and analyzes said data to determine an output while performing generic computer functions, e.g., “transmitting, before the last date indicated by the last day data element and via the web server, an electronic intervention message to a user computing device associated with the medication regimen”, “causes the user computing device to display...”, “store data representative of transmission of the electronic intervention message in association with the compliance object...” and are recited at a high level of generality and is/are a mere instruction(s) that may be performed by human that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). For example, the machine learning framework is/are recited in the claims in a high level of generality and is described in the specification in an arbitrary form without disclosing a specific algorithm using available data for allowing the model to learn patterns and relationships within the data and implement it to perform the claimed function As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and 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. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f), and mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an inventive concept, See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention."). The claims are not patent eligible.
Dependent Claims 3, 5-7, 9-13, and 22-27 include all of the limitations of claim(s) 1, 8, and 21, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 3, 5, 9-10, 24, and 26-27, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human interaction constituting Certain methods of organizing human activity along with mathematical calculations and relationships, but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “machine learning framework, processor, trained parameter prediction model, web server, link”. In particular, the claims recite the additional elements that implement the identified abstract idea. These computing components are recited at a high level of generality, for example, the machine learning framework/trained parameter prediction model is/are recited in the claims in a high level of generality and is in described in the specification in an arbitrary form without disclosing a specific process how these elements are implemented to perform a task as such is a mere in instruction(s) that may be performed by human that it amounts no more than adding the words "apply it" (or an equivalent), e.g., “implementing trained parameter prediction model, transmit[ting]...”. 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 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 element 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").
As for claims 6-7, 11-13, 22-23, and 25, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human actor interaction with a system along with mathematical calculations and relationships but for, the recitation of the generic devices which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible.
Subject Matter Free of Prior Art
Claims 1, 3, 5-13, and 21-27 have been found by the examiner to be free of prior art. A thorough search of the prior art was conducted, and the examiner could not find a single reference or combination of references with adequate rationale to combine that would teach the claimed invention. Specifically, the examiner, for example, finds that the language:
“receive a compliance event notification for the compliance object, where the notification indicates that the expected exhaustion date has occurred, or is simulated to occur, without a subsequent fill event being detected for the compliance object
execute a trained, randomized compliance prediction model including a Monte Carlo framework integrated with a machine learning framework to iteratively predict a next regimen compliance state for the compliance object for successive prediction time periods beginning with the expected exhaustion date;
generate an electronic compliance intervention data structure for the compliance object based on the one of the plurality of intervention categories, the predicted next regimen compliance state, the probability of the predicted next regimen compliance state, and the at least one parameter, the electronic compliance intervention data structure defining one or more electronic intervention communications and a last day data element indicating a last date by which the one or more electronic intervention communications are to be implemented;
select an electronic compliance intervention data structure for the compliance object based on the one of the plurality of intervention categories, the predicted next regimen compliance state, the probability of the predicted next regimen compliance state, and the at least one parameter, the electronic compliance intervention data structure defining one or more electronic intervention communications and a last day data element indicating a last date by which the one or more electronic intervention communications are to be implemented” in claim 1, 8, and 21, to be free of prior art. In the examiner's search of prior art. The closest prior art was found are:
US 2020/0004583 A1- “Kelly” discloses monitoring activity of a user’s adherence to a medical regimen using a machine learning (ML) implementing random forests to predict the user state for likelihood to adhere or not adhere to medication regimen at a particular time and predict a future adherence state and prompts performing therapeutic action and forecast upcoming state determining optimal prompting time the user is most likely to comply with.
“Kanyongo”- “Machine learning approaches to medication adherence amongst NCD patients: A systematic literature review” discloses using prescription refill datasets to include patient visit frequency, prior prescription information and prior PDC, medication possession ratio, type of disease, treatment adherence, information on long-term care, insurance claims, etc., used to analyze how well NCD patients adhere to their medications.
US 2021/0241873- “Kapaldo” discloses AI model to generate a medical adherence intervention prediction defining at least a preferred intervention channel specific to new or existing medical patient.
US 2007/0061166 - “Ramasubramanian” discloses evaluating a user compliance such that classifying compliance into categories where each category is statically analyzed to determine the compliance level.
US 2019/0074080 “APPELBAUM” discloses managing lifestyle and health interventions collecting subject-specific data for validating compliance parameters associated with therapeutic milestone.
US 2015/0356701 “Gandy” discloses monitoring the adherence and the progress of a user in completing a regimen.
However, the cited references fail to individually disclose, or suggest when combined, the limitations of the claim.
No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention and/or at least the underlined, as disclosed in the claimed invention.
Response to Amendment
Applicant's arguments filed 07/17/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to the 35 U.S.C. § 112(d) rejection on page 13.
In response to the Applicant claims amendment (canceled claim 19-20), examiner withdraws the 112(d) rejection.
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 13-17.
On page 14-15 of the remarks, Applicant argues “Amended claim 1 recites a technical solution to a technical problem, as identified in the specification ... The invention of amended claim 1 also provides an improvement in resource allocation, as noted in the specification...”, Examiner respectfully disagree. Examiner asserts that the claims, given their broadest reasonable interpretation, recite an abstract idea which have been analyzed under Step 2A, Prong One reciting a process for evaluate compliance stated of the regimen and predicated the next compliance state over period of time which define a judicial exception steps while using computing devices to perform the abstract steps, which are steps can be performed by a user interacting with a device(s) for performing the abstract idea which are concepts that falls within the Certain Methods of Organizing Human Activity grouping and sub grouping sub-grouping "managing personal behavior or interactions between people". No where in the claim(s) and/or the specification describes a solution to a technical problem but describing improving a patient regimen compliance. Applicant is encouraged to highlight the section which are alleged to describe such improvement.
On page 15-16 of the remarks, Applicant argues “Those elements control machine-implemented execution of an electronic intervention workflow ... These elements integrate any alleged abstract idea into a practical application”, Examiner respectfully disagree. As described in the rejection above, the claim does not describe a particular improvement of computer’s functionality or a technical field, rather using additional elements, e.g., device, processor, non-transitory memory/ non-transitory readable medium, machine learning framework, computing device, to perform the steps abstract idea through leveraging computing technology in a well understood manner however improving upon an abstract idea does not make the abstract idea any less abstract. For example, the elements argued by the Applicant “i.e. transmitting an electronic intervention message through a web server before the last date, causing a user computing device to display an associated interface element, modifying the regimen data structure to reference the electronic compliance intervention data structure, and storing transmission data in association with the compliance object...”, which is merely instructing a generic computer without defining a specific, unconventional technical improvement to how the computer performs it which is treated as routine data manipulation and recited at a high-level generic function.
In light of the Alice decision and the guidance provided in the 2019 PEG, the features listed in the claims, are not considered an improvement to another technology or technical field, or an improvement to the functioning of the computer itself rather describes an improvement to patient medication adherence by tracking parameters such as medication profile, which is solving a clinical and patient administrative problem, using computers, for assessing the patient compliance. In addition, by relying on computing devices to perform routine tasks more quickly or more accurately is insufficient to render a claim patent eligible (See Alice, 134 S. Ct. at 2359 "use of a computer to create electronic records, track multiple transactions, and issue simultaneous instructions" is not an inventive concept).
On page 16 of the remarks, Applicant argues “Amended claim 1 is analogous to the claims in Ex parte Desjardjns, Appeal No. 2024-000567 (PTAB September 26, 2025, Appeals Review Panel (ARP) Decision)... As in Desjardjns, eligibility is supported because amended claim 1 does not merely invoke machine learning at a high level of generality. Amended claim 1 recites elements reflecting the technical improvements identified in the specification...”, Examiner respectfully disagree. The Appeals Review Panel (ARP) found the Desjardins claims to be directed to methods for training artificial intelligence/machine learning (AI) models and the claims improved the functioning of the computer itself, as such it is not “directed to” an abstract idea under Alice Step 1. In contrast, neither the instant claim(s) of the current application nor the specification describes an improvement to a computing system or any technological field but rather is describing a solution for improving patient regimen/medication compliance via implementing the identified abstract idea which is solving a clinical and/or patient administrative issue for monitoring patient regimen adherence outside a healthcare facility that will help reduce cost and improve care. There are no improvements to another technology or technical field, no improvements to the functioning of the computer itself, transformation or reduction of a particular article to a different state or thing or any other meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment as a result of performing the claimed method. The thrust of Applicant's invention is to improve the abstract idea of through leveraging computing technology (e.g., machine learning, etc.) in a well understood manner. The fact that the judicial exception, identified in the rejection above, relies upon gathering data and tracking patient compliance event and adherence does not impart an improvement to any existing computer, or any other technology or technical field. At best, this gathering of data to be used by the general computing device may improve the abstract idea of patient care delivery (compliance). However, improving upon an abstract idea does not make the abstract idea any less abstract.
Therefore, the Applicant argument is found to be unpersuasive and Examiner remains the 101 rejections of claims which have been updated to address Applicant's argument.
Applicant's arguments with respect to the 35 U.S.C. § 102/103 rejection page 17-21.
In response to the Applicant amendment and remarks, Examiner with draws the 102/103 rejection as mentioned in the above section “Subject Matter Free of Prior Art”.
Prior Art Cited but not Applied
The following document(s) were found relevant to the disclosure but not applied:
US 7,716,065 “Maxwell,” discloses a medication profile of a patient comprising information regarding the expiration of prescriptions, the patient's compliance with the prescriber's directions for usage, and the names of medications being used by a patient where medication information includes the name and contact information for the prescribing physician, instructions for use provided by the prescriber, original prescription date, last filled prescription date, next prescription refill date, the expiration date of the prescription, and, if the patient is past a due date for a prescription, the number of days the patient is past due for a refill.
US 12,087,419 “Taitel” discloses estimating an adherence risk score for a medication taken by a patient.
The references are relevant since it/they disclose predicting a user compliance to medication regimen.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
