DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/25 has been entered. Claims 1, 11, and 18 have been amended. Claims 1-20 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,804,306 and claims 1-12 of U.S. Patent No.10,853,900. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims of the previously patented claims anticipate and/or are an obvious variant of the currently pending claims. The previously patented claims are an obvious variant of the currently pending claims. The currently pending claims only further teach transmitting one more messages according to a timeline and according to divergence-based optimization technique applied to the model. Transmitting messages according to a timeline to a computing device and applying divergence-based optimization as broadly recited are features that were old and well-known at the time of the previously patented claims. Therefore the claims in the previous patent in view of the features of transmitting messages according to a timeline and according to divergence-based optimization are an obvious variant of the currently pending claims.
The previously patented claims teach the same framework as the current claims -
generating adherence-related outputs (probabilities/scores/risk stratification) based on patient/treatment data and historical data; and
using those outputs to provide individualized guidance/communications and/or drive treatment administration decisions.
The data intake/adherence evaluation and prediction/scoring features are not patentably distinct.
The pending claims teach messaging “according to a timeline” generated from adherence likelihood data. Examiner maintains that this difference does not render the pending claims patentably distinct because specifying that messages are delivered “according to a timeline” is a predictable, routine scheduling refinement of any reminder system. Under KSR, it is obvious to apply a known technique (scheduled/triggered messaging) to a known system (adherence prediction and guidance) to yield predictable results (better timing and engagement). The “timeline” limitation therefore represents an obvious variant.
Pending claim 1 further recites generating a score using “divergence-based optimization applied to the computer-implemented model.” This limitation also is not patentably distinct over the reference patents because the particular choice of an optimization objective (including divergence-based objectives or loss functions) is a known technique for training or calibrating predictive models. A person of ordinary skill in the art would have recognized numerous interchangeable optimization models to fit models to adherence outcomes. Therefore, The applying “divergence-based optimization” is an obvious variant of the reference patents’ model-based scoring.
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 1-5, 9-15, and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-10 are drawn to a system for predicting adherence to a treatment, which is within the four statutory categories (i.e. machine). Claims 11-17 are drawn to a computer program product for predicting adherence to a treatment, which is within the four statutory categories (i.e. article of manufacture). Claims 18-20 are drawn to a method for predicting adherence to a treatment, which is within the four statutory categories (i.e. process).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A treatment administration system comprising a computer-implemented model having a learning component and a predictive component, and at least one programmable processor executing logic code causing the treatment administration system to perform operations comprising:
determining treatment adherence patterns, in response to receiving first data and second data;
extracting a combined set of variables from the first data, the first data collected from treatment adherence patterns associated with one or more treatments administered to the plurality of treatment subjects;
determining a likelihood of adherence to a first treatment regimen for a first treatment subject, based on the combined set of variables populating the computer- implemented model, the likelihood of adherence being determined in response to computing one or more values for the combined set of variables by using data associated with at least one treatment subject at a plurality of stages of the first treatment regimen,
transmitting one or more messages according to a timeline to a computing device to provide optimized treatment to the first treatment subject in accordance with the one or more messages, the timeline generated based on data characterizing the determined likelihood of adherence, and
wherein the first treatment regimen is administered to the first treatment subject according to a first score generated for the first treatment subject based on the determined likelihood of adherence of the first treatment subject according to divergence-based optimization applied to the computer-implemented model using the treatment adherence patterns associated with the one or more treatments administered to the plurality of treatment subjects..
The limitations of determining treatment adherence patterns; extracting variables; determining a likelihood of adherence; and transmitting messages as drafted and detailed above, are steps that, under its broadest reasonable interpretation, recites steps for organizing human interactions. The claimed invention is a method that organizes medical data and determines treatment adherence patterns and transmits messages based on the patterns. This is a method of managing treatment adherence data between people thus falling into one category of abstract idea (managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions -- see MPEP § 2106.04(a)(2), subsection II). That is other than reciting “a computer-implemented model”; and “computing device” language, nothing in the claim element precludes the steps from practically being performed between people or by a person. If a claim limitation, under its broadest reasonable interpretation, covers interactions between people or managing personal behavior or relationships then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A treatment administration system comprising a computer-implemented model having a learning component and a predictive component, and at least one programmable processor executing logic code causing the treatment administration system to perform operations comprising:
determining treatment adherence patterns, in response to receiving first data and second data;
extracting a combined set of variables from the first data, the first data collected from treatment adherence patterns associated with one or more treatments administered to the plurality of treatment subjects;
determining a likelihood of adherence to a first treatment regimen for a first treatment subject, based on the combined set of variables populating the computer- implemented model, the likelihood of adherence being determined in response to computing one or more values for the combined set of variables by using data associated with at least one treatment subject at a plurality of stages of the first treatment regimen,
transmitting one or more messages according to a timeline to a computing device to provide optimized treatment to the first treatment subject in accordance with the one or more messages, the timeline generated based on data characterizing the determined likelihood of adherence, and
wherein the first treatment regimen is administered to the first treatment subject according to a first score generated for the first treatment subject based on the determined likelihood of adherence of the first treatment subject according to divergence-based optimization applied to the computer-implemented model using the treatment adherence patterns associated with the one or more treatments administered to the plurality of treatment subjects.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application. The additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception, see MPEP 2106.05(f).
the recitations performing the functions by the computer amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraph [0027] of the present Specification.
The recitation of wherein the first treatment regimen is administered to the first treatment subject according to a first score generated for the first treatment subject based on the determined likelihood of adherence of the first treatment subject according to divergence-based optimization applied to the computer-implemented model using the treatment adherence patterns associated with the one or more treatments administered to the plurality of treatment subjects recites only the idea of a solution or outcome (i.e. claim fails to recite details of how a solution to a problem is accomplished).
The claim teaches generally administering a “first treatment regimen” according to a first score. This does not amount to a particular treatment and merely teaches instructions to apply an exception. See MPEP 2106.04 (d)(2).
generally link the abstract idea to a particular technological environment or field of use, see MPEP 2106.05(h)– for example, the recitation merely limits the abstract idea to the field of medicine and transmitting messages to a computing device merely limits the abstract ideas to computers. Furthermore, the limitations of a computer-implemented model and at least one programmable processor executing logic code generally link the recited abstract idea to a computer environment.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Independent claim 1 does not include additional elements that are sufficient to amount to “significantly more” than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and generally linking the abstract idea to a particular technological environment or field of use and the same analysis applies with regards to whether they amount to “significantly more.” Therefore, the additional elements do not add significantly more to the at least one abstract idea.
As per claim 11, the claim teaches limitations similar to claim 1 and the same abstract idea (“mental processes”) for the same reasons as stated above. Claim 11 further teaches a computer program product to perform the functionality taught by claim 1. These limitations of a non-transitory machine-readable medium and processor as generally recited, amount to mere instructions to apply an exception, see MPEP 2106.05(f) and generally link the abstract idea to a particular technological environment or field of use, see MPEP 2106.05(h). Independent claim 11 is directed to an abstract idea.
As per claim 18, the claim teaches limitations similar to claim 1 and the same abstract idea (“mental processes”) for the same reasons as stated above. Claim 18 further teaches a computer-implemented model to perform the functionality taught by claim 1. These limitations of a learning and predictive component and computer processors, as generally recited, amount to mere instructions to apply an exception, see MPEP 2106.05(f) and generally link the abstract idea to a particular technological environment or field of use, see MPEP 2106.05(h). Independent claim 18 is directed to an abstract idea.
Furthermore, for similar reasons as representative independent claim 1, analogous independent claims 11 and 18 do not recite additional elements that integrate the judicial exception into a practical application nor add significantly more.
The following dependent claims further the define the abstract idea or are also directed to an abstract idea itself:
Dependent claims 3, 4, 9, 13-14 and 19 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract).
In relation to claims 5 and 15 these claims specify delivering messages which is a certain method of organizing human activity, under its broadest reasonable interpretation, covers interactions between people or managing personal behavior or relationships
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 2, 10, 12, and 20: These claims specify administering a treatment regimen which thus does no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the at least one abstract idea is performed (see MPEP § 2106.05(e)).
The dependent claims further do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-5, 9-15, and 18-20 are ineligible under 35 USC §101.
Subject Matter free from Prior Art
Claims 1-20 teach subject matter free from prior art.
Weickert (2008/0228525), teaches a system that is able to generate a report including a diagnosis of an individual’s health and adherence of an individual to a treatment prescribed by a physician in the past. The physician can modify a treatment based on this report. (see paras. [0047] — [0067], Tables 1-5).
Glauser (8,589,175) teaches identifying scientific data about efficacy and tolerability of therapeutic modalities (treatments). (see paras. [00135] — [00148)).
Brown (WO-0137174-A1) teaches a method and system and computer program product for remotely measuring one's adherence to a diet program.
Ozminokowski (Ozminkowski, Ronald J; White, Alan J; Hassol, Andrea; Murphy, Michael. “General health of end stage renal disease program beneficiaries.” Health Care Financing Review 19.n1: p121 (24). Superintendent of Documents. (Oct 1997 -Dec 1997)) teaches expanding methods used to assess health status among ESRD patients and obtaining health information and health status and its determinants.
Shargie (Shargie, Estifanos Biru; Lindtjorn, Bernt. “Determinants of treatment adherence among smear-positive pulmonary tuberculosis patients in Southern Ethiopia.” Pl o S Medicine 4.2: 280(8). Public Library of Science. (Feb 2007)) teaches determinants of treatment adherence among smear-positive pulmonary tuberculosis patients in Southern Ethiopia.
The closest prior art of record teaches comparing and analyzing treatment data but fails to expressly teach:
determining treatment adherence patterns, in response to receiving first data and second data;
extracting a combined set of variables from the first data, the first data collected from treatment adherence patterns associated with one or more treatments administered to the plurality of treatment subjects;
determining a likelihood of adherence to a first treatment regimen for a first treatment subject, based on the combined set of variables populating the computer-implemented model, the likelihood of adherence being determined in response to computing one or more values for the combined set of variables by using data associated with at least one treatment subject at a plurality of stages of the first treatment regimen;
transmitting one or more messages according to a timeline to a computing device to provide optimized treatment to the first treatment subject in accordance with the one or more messages, the timeline generated based on data characterizing the determined likelihood of adherence.
No final decision on patentability has been made in light of pending rejections.
Response to Arguments
Applicant begins arguments on pg. 9 of the 11/24/25 Remarks traversing the current rejection of the pending claims under 35 USC 101. Examiner disagrees with Applicant’s characterization of the rejection of the claims under 35 USC 101 as being conclusory with no rational underpinnings. A prima facie case is made when the rejection: i. identifies and clearly articulates the judicial exception recited in the claims, ii. identifies any additional elements recited in the claims, and iii. explains why the additional elements do not amount to a practical application nor significantly more than the exception. Examiner submits that the rejection above under 35 USC 101 does clearly identify the judicial exception, identifies any additional elements and then further clearly explains why the additional elements do not amount to a practical application nor significantly more.
Applicant next argues that the claims are similar to Example 49 from the 2024 Subject Matter Eligibility Examples. Examiner disagrees as Applicant’s reliance on Example 49 is not persuasive. Example 49 expressly concludes that Claim 1 is ineligible because it recites an abstract idea and does not integrate the exception into a practical application, while Claim 2 is eligible because it requires administering a particular treatment (Compound X eye drops) to certain patients. In contrast, the instant claims do not require administering any particular drug, dosage, frequency, or device-controlled therapeutic act. Rather, the claims primarily recite generating adherence likelihoods/scores and transmitting messages on a timeline to influence adherence. The “administered according to a score… according to divergence-based optimization” language is a result-oriented statement and does not impose a specific treatment step comparable to administering Compound X eye drops in Example 49.
Next on pg. 12, Applicant asserts Applicant asserts the claims are integrated into a practical application because they “optimize administration of proper medical treatments” and analogizes those claims found eligible in Vanda. Examiner disagrees.
Applicant relies on the “wherein the first treatment regimen is administered … according to a first score… according to divergence based optimization…” clause. Examiner agrees all limitations are considered; however, this clause does not require the system to perform a specific therapeutic intervention or control a medical device in a particular technical way. Instead, it recites a result—i.e., that treatment is administered “according to” a score and “according to” an optimization technique applied to a model—without specifying a particular drug, dosage, delivery parameter, device setting, or other concrete treatment action.
In contrast, Vanda involved claims requiring specific treatment steps (administering a drug at a dosage range based on a test result) that tied the analysis to a specific therapeutic act. Here, the claims do not require administering a specific treatment in a specific manner; rather, they cover a broad concept of optimizing adherence via scoring and messaging. Thus, the analogy to Vanda is not persuasive.
On pg. 12, of the Remarks Applicant next argues that the new amendments “conform to the mandate” of Diehr and 2015 PEG Example 25. Applicant argues that the pending claims are similar to the aforementioned examples because the pending claims provide for “performing a detailed analysis of factors associated with the likelihood of adherence of different treatment subjects to one or more treatment regiments and accordingly optimize the administration of the treatment with reference to a calculated timeline.” Examiner does not find this argument persuasive.
In Diehr, the computer repeatedly calculated an equation and then automatically controlled the physical process (opening a press) in a manner tied to a concrete manufacturing operation. In the present claims, the system does not similarly control a physical process or device with defined operational parameters; it generates a score/timeline and transmits messages. The “optimized treatment” language is broad and does not impose a specific technical control scheme comparable to Diehr. Accordingly, the additional elements do not integrate the abstract idea into a practical application.
On pg. 17 of the Remarks, Applicant cites to Enfish and McRO, and other decisions relating to software improvements. Examiner has considered these authorities but finds them distinguishable because the present claims do not recite a specific improvement to computer functionality, nor do they recite specific rules/structures that meaningfully constrain the claim to a particular technical solution as in Enfish or McRO.
On pg. 25 of the Remarks Applicant notes that Applicant is not adverse to filing a Terminal Disclaimer but requests a proper grounds of rejection be established. Although, proper grounds were established in the previous Office Action, the Double Patenting rejection has been updated to incorporate Applicant’s newly added limitations.
Conclusion
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LINH GIANG "MICHELLE" LE
PRIMARY EXAMINER
Art Unit 3686
/LINH GIANG LE/Primary Examiner, Art Unit 3686 2/6/26