DETAILED ACTION
1. 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
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/20/2026 has been entered.
3. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
4. Claims 1, 2, 4, 5, 10, 11, 14, 20-27 and 30 have been amended; claim 28 has been canceled; and new claims 31 and 32 have been added. Therefore, claims 1-27, and 29-32 are pending in this application.
Claim Rejections - 35 USC § 101
5. Non-Statutory (Directed to a Judicial Exception without an Inventive Concept/Significantly More)
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 1-27, and 29-32 are rejected under 35 U.S.C.101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The current claims fall within one of the four statutory categories of invention (MPEP 2106.03).
Step 2A [Wingdings font/0xE0] Prong One:
The claim(s) recite a judicial exception, namely an abstract idea, as shown below:
— Considering each of claims 1, 20 and 30 as representative claims, the following claimed limitations recite an abstract idea:
Claims 1 and 30:
prompt a user to provide one or more goals to achieve during a portion of a treatment period [based on] plurality of lessons and/or activities;
provide to a lesson or and/or activity to the user;
collect at least one response or biometric data from the user; and
generate using one or more models, one or more goals for the user to achieve during the treatment period based on the at least one response or biometric data;
[present] to the user a subsequent lesson and/or a subsequent activity.
Claim 20:
present, during a treatment period, a plurality of lessons based on cognitive behavioral therapy, the plurality of lessons corresponding to at least one interactive skill-based activity; [
submit a treatment goal during at least one portion of the treatment period;
responsive to receiving lesson completion data, direct the user to adjust at least one of a dietary intake or a physical-activity behavior.
Thus, the limitations identified above recite an abstract idea since the limitations correspond to certain methods of organizing human activity, and/or mental processes, which are part of the enumerated groupings of abstract ideas identified according to the current eligibility standard (see MPEP 2106.04(a)).
For instance, the current claims correspond to managing personal behavior; wherein a user is prompted to provide information—namely, one or more gorals to be achieved during a treatment period; and the user is also presented with a lesson and/or an activity; and furthermore, based on the analysis of data (i.e., response or biometric data) collected from the user, the user is presented with (i) one or more new goals that the user is required to achieve during the treatment period, and also (ii) a subsequent lesson/activity, etc.
Similarly, given the limitations that recite the process of: prompting the user to provide one or more goals to achieve during a portion of a treatment period; providing a lesson and/or an activity to the user; collecting data (i.e., collecting response or biometric data) from the user; and generating, using a mathematical model, one or more goals for the user to achieve, etc., the claims overlap the group mental processes; such as, limitations that can be performed in the human mind and/or using a pen and paper (e.g., an evaluation, an observation, and/or a judgement process, etc.).
Step 2A [Wingdings font/0xE0] Prong Two:
The current claims recite additional element(s), wherein (i) each of claims 1-27 and 29-32 implements a processor(s), (ii) none of claims 20-25 and 29 implements any machine learning algorithm, and (iii) each of claims 1-19, 26, 27 and 30-32 further executes a machine learning algorithm; and accordingly, the above computer elements are utilized to facilitate the claimed steps and/or functions regarding: prompting a user to provide information (e.g., “prompting, by one or more processors, a user to provide one or more goals for the user to achieve . . . a plurality of lessons and/or a plurality of activities for improving hemoglobin Ale and/or liver fat of the user”); presenting one or more content items to the user (e.g., “provid[ing] . . . a lesson and/or an activity . . .”, per claims 1 and 30; “present, via a device, a digital therapeutic during a treatment period . . . lessons corresponding to at least one interactive skill-based activity”, per claim 20); collecting input(s) from the user (e.g., “collect[ing] . . . at least one response or biometric data from the user”, per claims 1 and 30; “submit, by the user via the digital therapeutic, a treatment goal . . . receiving lesson completion data”, per claim 20); analyzing the collected input(s) and generating pertinent result(s)/information (e.g., “generat[ing] . . . using one or more machine-learning (ML) models, one or more new goals for the user . . . administer[ing] to the user via the digital therapeutic application a subsequent lesson and/or a subsequent activity”, per claims 1 and 30; “responsive to receiving lesson completion data, transmit a prompt directing the user to adjust at least one of a dietary intake or a physical-activity behavior . . .”, per claim 20), etc.
However, the claimed additional element(s) fail to integrate the abstract idea into a practical application since the additional element(s) are utilized merely as a tool to facilitate the abstract idea. Thus, when each claim is considered as a whole, the additional element(s) fail to integrate the abstract idea into a practical application since they fail to impose meaningful limits on practicing the abstract idea. For instance, when each of the claims is considered as a whole, none of the claims provides an improvement over the relevant existing technology.
The observations above confirm that the claims are indeed directed to an abstract idea.
Step 2B
Accordingly, when the claim(s) is considered as a whole (i.e., considering all claim elements both individually and in combination), the claimed additional elements do not provide meaningful limitations to transform the abstract idea into a patent-eligible application of the abstract idea such that the claim(s) amounts to “significantly more” than the abstract idea itself (also see MPEP 2106). The claimed additional elements are directed to conventional computer elements, which are serving merely to perform conventional computer functions.
Accordingly, when each of the current claims is considered as a whole (e.g., see the discussion under Prong Two above regarding such consideration of the claim as a whole), none of the claims recites an element—or a combination of elements—directed to an inventive concept.
It is also worth to note that the utilization of the conventional computer/network technology to facilitate the presentation of pertinent content items to the user, based on the analysis of data collected regarding the user; such as, the process of collecting one or more inputs/responses from a user in response to a content item(s) presented to the user (e.g., a content item in the form of a lesson/questionnaire), including generating one or more results to the user based on the analysis of the collected inputs (e.g., generating a performance result(s), a recommendation(s)), etc., is directed to a well-understood, routine, conventional activity in the art (e.g., see US 2016/0086509; US 2005/0113649; US 2012/0083669, etc.).
The above observation confirms that the current claimed invention fails to amount to “significantly more” than an abstract idea.
It is worth noting that the above analysis already encompasses each of the current dependent claims (i.e., claims 2-19, 21-27, 29, 31 and 32). Particularly, each of the dependent claims also fails to amount to “significantly more” than the judicial exception since each dependent claim is directed to a further judicial exception, and/or a further conventional computer element(s) utilized to facilitate the judicial exception.
Accordingly, the findings above demonstrate that none of the claims implements an element—or a combination of elements—directed to an inventive concept (e.g., none of the current claims is reciting an element—or a combination of elements—that provides a technological improvement over the existing/conventional technology).
► Applicant’s arguments directed to section §101 have been fully considered (the arguments filed on 04/20/2026). However, the arguments are not persuasive at least for the following reasons:
Firstly, regarding Prong One of Step 2A, Applicant appears to be attempting to identify the limitations of claim 1, which are assumed to be beyond a mental process (see page 13 of the argument). Applicant subsequently concludes that “[s]uch exemplary limitations cannot practically be performed in the human mind. For example, the human mind cannot prompt a user to provide one or more goals to achieve via a digital therapeutic application (e.g., a software application) or provide a digital therapeutic application. The human mind cannot also, for example, generate one or more other goals using one or more ML models” (emphasis added).
However, Applicant does not appear to properly apply the inquiry established under Prong One of Step 2A. For instance, Prong One of Step 2A does not require one to consider any of the computer elements that the claim is reciting (e.g., the computer application or software, the machine learning algorithm, the processor that executes the algorithm, etc.). Instead, while excluding the computer elements, which are part of the additional elements, Prong One requires one to identify only the limitations that recite a judicial exception (e.g., an abstract idea). Thus, similar to the analysis presented in the previous office-action, a human—such as a physician—can perform the following limitations of claim 1 mentally and/or using a pen and paper:
the physician prompts—verbally or using a written message on a paper—the user to provide one or more goals that the user wants to achieve during a portion of a treatment period;
the physician also organizes and/or presents one or more lessons and/or activities to the user (e.g., lessons in the form of one or more books, etc.), including activities and/or lesson materials for improving the health conditions of the user (e.g., improving hemoglobin A1c and/or liver fat of the user);
the physician then evaluates the user based on the user’s reaction or response to one of the lessons and/or activities being presented;
the physician further drafts, using a model/template (e.g., a table/chart that associates one or more responses with one or more corresponding goals, etc.), one or more new goals that the user is required to achieve during the treatment period based on the user’s responses;
the physician further presents to the user a subsequent lesson or activity, etc.
The observation above once again demonstrates that the current claims do recite an abstract idea—such as, a mental process. See Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) (“[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.”); also see Versata Dev. Grp. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015) (‘‘Courts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.”). Consequently, Applicant’s arguments are not persuasive.
Similarly, regarding the group certain methods of organizing human activity, Applicant asserts, “claim 1, however, is not directed to any of the methods of organizing human activity, including managing personal behavior . . . claim 1 is directed to specific technical features that are not descriptive of any of the aforementioned methods of organizing human activity . . . claim 1 includes the specific technical features . . . providing a digital therapeutic application to a user using one or more processors that can administer lessons and/or activities for improving hemoglobin A1c and/or liver fat . . . generating one or more new goal(s) for the user to achieve using one or more ML models . . . are not descriptive of managing personal behavior, nor any of the aforementioned methods of organizing human activity” (emphasis added).
However, here also Applicant appears to be relying on the computer elements (e.g., the processor utilized to execute the digital therapeutic application; the machine learning model utilized to generate new goals to the user, etc.) in order to challenge the finding presented under Prong One of Step 2A. However, as already pointed out above, Prong One does not consider any of the claimed computer elements. Instead, it requires one to identify only the limitations that recite a judicial exception. Consequently, Applicant’s alleged technical features are not relevant to challenge the Office’s finding under Prong One.
Moreover, the claims require the user to provide/specify one or more goals, which the user is required to achieve during a given time period; and subsequently, the user is presented with a lesson and/or an activity that the user is required to perform in order to achieve the specified goal(s). Accordingly, the fact above is sufficient to confirm managing personal behavior (e.g., teaching), which is one of the sub-groupings under certain method of organizing human activity. This is because the lesson or activity, which is presented to the user, is teaching the user how to achieve one or more of the gorals. So far, Applicant fails to consider the fact above. Consequently, Applicant’s arguments are still not persuasive.
Secondly, regarding Prong Two of Step 2A, Applicant is asserting that “[c]laim 1, considered as a whole, reflects a particular technical solution to the technical problem for a need for digitally-delivered therapy can be widely disseminated to large patient populations and personalized to an individual patient. Claim 1 provides a technical solution to this problem by utilizing machine learning model(s) trained on vast quantities of other patient data and responses to personalize digital therapy to individual patients in large patient populations (See [0077] of Specification” (emphasis added). Applicant has also emphasized some additional paragraphs from the specification (i.e., [0055], [0133], [0134], [0145]).
However, neither Applicant’s assertions nor any of the sections cited from the specification demonstrates any technological improvement over the relevant existing technology. This is because the process of training one or more machine-learning models using desired data (e.g., patient data, disease data, remediation data, etc.), including the use of such trained models to generate pertinent information (e.g., one or more lessons and/or activities, etc.) to a user based on the analysis of the user’s health conditions, etc., is already part of the existing computer/network technology. In this regard, except for the generic description presented in the specification regarding the use of one or more machine learning models, the specification does not provide any description regarding any new or advanced machine learning technology.
Similarly, the process of distributing, over a wired and/or wireless communication network, pertinent content (e.g., one or more lessons) to one or more users is also part of the existing computer/network technology. In fact, this is one of the fundamental features of the existing Internet technology.
The observations above confirm that neither the current claims nor the original specification implements an element—or a combination of elements—that provides a technological improvement over the relevant existing technology. Instead, the current claims, including the original disclosure, are utilizing the existing computer/network technology—merely as a tool—to facilitate an abstract idea; such as, presenting the user with pertinent information—such as, a lesson material; wherein the lesson material is selected based on the analysis of one or more goals received from the user, etc.
Thus, none of Applicant’s conclusory assertions, “[c]laim 1 incorporates the technical solution to the technical problem of personalizing digital therapy to individual patients while disseminating digital therapy to large patient populations”, “claim 1 integrates the alleged judicial exception into a practical application because it recites elements that reflect an improvement to a technology or technical field, and specifically, an improvement in personalizing digital therapy to individual patients while disseminating digital therapy to large patient populations by personalizing goals for individual patients”, is persuasive. In particular, Applicant appears to be mistaking some of the benefits, which the existing computer/network technology is providing to the user (e.g., its capability to disseminate digital therapy to large patient populations; its capability to personalize digital therapy to individual patients), for an alleged technological improvement.
In addition, while citing additional paragraphs from the specification ([0172] and [0210] of the specification), Applicant is asserting that “[c]laim 1, considered as a whole, covers a particular treatment or prophylaxis being a digital therapeutic application for improving hemoglobin A1c and/or liver fat of a user . . . Claim 1 incorporates the particular treatment or prophylaxis by reciting that a ‘digital therapeutic application comprises a plurality of lessons and/or a plurality of activities for improving hemoglobin A1c and/or liver fat of the user’ . . . it recites elements that effect a particular treatment or prophylaxis, and specifically, a digital therapeutic application for improving hemoglobin A1c and/or liver fat of the user. ” (emphasis added).
However, Applicant fails to properly apply the inquiry for determining whether a given claim is reciting limitations that effect a “particular” treatment or prophylaxis for a disease/medical condition; see MPEP 2106.04(d)(2). For instance, despite asserting that claim 1 “ecites elements that effect a particular treatment or prophylaxis”, Applicant fails to identify the element (if any)—or the combination of elements (if any)—that supposedly effects a particular treatment or prophylaxis. Instead, Applicant is relying on the claimed “digital therapeutic application”, which provides a lesson or an activity to the user. However, regardless of the specific content of the lesson being presented, such process of presenting the user with a lesson and/or an activity has nothing to do with a limitation(s) that effects a particular treatment or prophylaxis for a disease or a medical condition. This is because the above is merely presenting content/information to the user, as opposed to administering a “particular” treatment for treating a specific disease or medical condition. In this regard, the particularity of the content/topic of the lesson above, whether it is about hemoglobin A1c and/or liver fat, is immaterial since the content/topic is not even a treatment, much less one that effects a “particular” treatment or prophylaxis for a disease or medical condition. Instead, it is merely nonfunctional descriptive matter. Consequently, neither Applicant’s current arguments nor any of the sections that Applicant citied from the specification demonstrates a claimed (or a disclosed) limitation—or a combination of limitations—that supposedly effect a particular treatment or prophylaxis for a disease or medical condition.
Furthermore, Applicant asserts that “[c]laim 1 imposes meaningful limits on the alleged judicial exception and integrates the alleged judicial exception into a practical application . . . claim 1 recites a combination of steps directed to prompting a user to provide one or more goals to achieve via a digital therapeutic application, providing a lesson and/or activity via the digital therapeutic application . . . claim 1 recites a method for improving the hemoglobin A1c and/or liver fat of a user after a treatment period for a digital therapeutic application comprising lessons and/or activities for improving the hemoglobin Ale and/or the liver fat of the user. This imposes meaningful limits on the alleged judicial exception, and integrates the alleged judicial exception into a practical application” (emphasis added).
However, except for summarizing the limitations that claim 1 is reciting, Applicant fails to show whether any of the limitations—or any combination of the limitations—is integrating the abstract idea into a patent-eligible practical application. Given the claimed and disclosed implementation, it is worth noting that the claimed and disclosed technology is indeed the existing computer/network technology. Accordingly, an integration (if any) of the abstract idea into a patent-eligible practical application is demonstrated if any of the claims (or even the disclosure as a whole) is implementing an element—or a combination of elements—that provides a technological improvement. In contrast, simply summarizing the features of the existing computer/network technology; such as, prompting a user to provide an input (e.g., prompting a user to provide one or more goals to achieve via a digital therapeutic application), proving the user with pertinent lesson material (e.g., providing a lesson and/or activity via the digital therapeutic application), and/or emphasizing the specific content/topic of the lesson (e.g., lessons and/or activities intended for improving the hemoglobin A1c and/or the liver fat of the user), etc., alone or in combination, do not constitute integrating the abstract idea into a patent-eligible practical application. Consequently, Applicant’s arguments are not persuasive.
Thirdly, regarding Prong One of Step 2A, as applied to claim 20, Applicant is asserting that “amended claim 20 recites limitations that the human mind is not equipped to perform, such as ‘present, via a device, a digital therapeutic during a treatment period, the digital therapeutic comprising a plurality of lessons based on cognitive behavioral therapy for improving hemoglobin A1c and/or liver fat of the user.’ This exemplary limitation cannot practically be performed in the human mind. For example, the human mind cannot provide a digital therapeutic (e.g., a software application) that provides lessons for improving hemoglobin Ale and/or liver fat of the user” (emphasis added).
However, similar to the points made with respect to claim 1, here also Applicant is relying on the computer elements to challenge the findings under Prong One. In constant, as repeatedly pointed out above, Prong One does not require one to consider any of the computer elements. Instead, while excluding the claimed computer elements, Prong One requires one to identify merely the limitations that recite the judicial exception. Thus, regarding claim 20, a human—such as a physician—performs the following limitations mentally and/or using a pen and paper:
the physician organizes and/or presents, verbally and/or using a pen and paper, one or more lessons and/or activities to the user (e.g., lessons in the form of one or more books, etc.), including cognitive behavioral therapy for improving the health conditions of the user (e.g., improving hemoglobin A1c and/or liver fat of the user);
the user submits to the physician a treatment goal during a portion of the treatment period;
the physician, responsive to receiving a verbal or a written lesson completion report from the user, prompts the user to adjust at least one of a dietary intake or a physical-activity behavior, etc.
The observation above confirms that claim 20 (including its dependent claims) does recite an abstract idea—such as, the group mental processes. Consequently, Applicant’s arguments are not persuasive.
Similarly, regarding the group certain methods of organizing human activity, Applicant asserts, “claim 20, however, is not directed to any of the aforementioned methods of organizing human activity, including managing personal behavior, because amended claim 20 is directed to specific technical features that are not descriptive of any of the aforementioned methods of organizing human activity . . . present a digital therapeutic application to a user that can at least provide lessons for improving hemoglobin A1c and/or liver fat . . . transmit a prompt . . . technical features are not descriptive of managing personal behavior, nor any of the aforementioned methods of organizing human activity” (emphasis added).
However, once again Prong One does not consider any of the clamed computer elements, including the so-called digital therapeutic application. Thus, while incorrectly applying the Prong One inquiry, Applicant is once again attempting to challenge the finding under Prong One while relying on the computer elements (also see the discussion presented above in this regard).
In addition, similar to the analysis presented regarding claim 1, current claim 20 also recites certain methods of organizing human activity. This is because the user is presented with a lesson material during a given treatment period; and the user also submits a goal during the portion of the above period. In addition, once the user has completed the lesson, the user is prompted to adjust a dietary or a physical activity behavior. Accordingly, the above is indeed teaching the user regarding a dietary intake or a physical-activity behavior that supposedly improves the condition of the user.
The observations above confirm that claim 20 does recite abstract idea, per the groups (i) certain methods of organizing human activity, and also (ii) mental processes. Consequently, Applicant’s arguments are not persuasive.
Regarding Prong Two of Step 2A, it noted that Applicant is repeating the same argument presented with resect to claim 1 (e.g., see pages 21-22 of the current argument). Thus, the Office directs Applicant to the response presented above; namely, the response presented with respect to claim 1, since the same rationale applies to claim 20.
In addition, regarding the Office’s analysis presented in the previous office action (page 8 of the previous office action), Applicant appears to be attempting to disregard the fundamental inquiry under Prong One of Step 2A. In particular, while misapplying the court’s analysis regarding Enfish LLC v. Microsoft Corp., 822 F.3d 1327, 1339 (Fed. Cir. 2016), Applicant concludes, “Applicant respectfully disagrees that Step 2A, Prong One excludes computer-elements when determining whether the claim recites an abstract idea” (emphasis added).
However, unlike Applicant’s theory, the court’s eligibility decision regarding Enfish is based on identifying the additional elements that achieved the technological improvement. Accordingly, the above outcome has nothing to do with Prong One. This is once again because Prong One does not consider the additional elements (e.g., computer elements). Instead, Prong One of Step 2A requires one only to identify the limitations that recite the judicial exception; see MPEP 2106.07(a), (emphasis added).
For Step 2A Prong One, the rejection should identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception. For example, if the claim is directed to an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim and explain why it is an abstract idea.
In contrast, Applicant’s appears simply disregard the inquiry set forth under Prong One of Step 2A. Thus, at least for the reasons discussed above, the Office concludes that none of the current claims—when considered as a whole—implements an inventive concept that amounts to “significantly more” than an abstract idea.
Claim Rejections - 35 USC § 103
6. The following is a quotation of 35 U.S.C.103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
Note that the one or more citations (paragraphs or columns) presented in this office action regarding the teaching of a cited reference(s) are exemplary only. Accordingly, such citation(s) are not intended to limit/restrict the teaching of the reference(s) to the cited portion(s) only. Applicant is required to evaluate the entire disclosure of each reference; such as additional portions that teach or suggest the claimed limitations.
● Claims 1-17, 20-27 and 30-32 are currently rejected under 35 U.S.C.103 as being unpatentable over Petrov 2016/0086509.
Regarding claim 1, Petrov teaches the following claimed limitations: a method, comprising: prompting, by one or more processors, a user to provide one or more goals for the user to achieve via a digital therapeutic application during a portion of a treatment period, wherein the digital therapeutic application comprises a plurality of lessons and/or a plurality of activities providing, by one or more processors, a lesson and/or an activity via a digital therapeutic application to the user ([0016]; [0018]; [0019]: e.g., a user downloads an application from a website, or access a website; and wherein the application presents the user with a user interface, which allows the user to provide various information, including preferences and goals; and the application also presents, at one or more periods, the user with one or more content items—such as, activities, nutrition and/or lesson materials); collecting, by the one or more processors, at least one response or biometric data from the user ([0018]; [0031], lines 1-6; [0033]: e.g., the system collects one or more parameters from the user; such as: the user’s response to one or more questions related to the user’s activities; biometric data tracked via one or more devices, etc.); and generating, by the one or more processors using a machine-learning (ML) model, one or more new goals for the user to achieve during the treatment period based on the at least one response or biometric data ([0034]: [0035]; [0048]: e.g., based on the analysis of the collected information, the system identifies one or more outcomes; including the weak and strong areas of the user; and thereby, the system generates to the user one or more suitable plans; such as, providing one or more modified goals, one or more action plans regarding activities targets, etc.; and the system’s software already includes artificial intelligence modeling—i.e., machine learning modeling— to perform the above processes); administering to the user via the digital therapeutic application a subsequent lesson and/or a subsequent activity ([0018]; [0031]: e.g., the user provides answers to one or more questions, wherein the answers are evaluated; and the system identifies a pertinent goal to the user to perform, etc. The above indicates the process of administering to the user via the digital therapeutic application a subsequent lesson and/or a subsequent activity).
Petrov does not expressly describe that the lessons and/or the activities being presented to the user are intended for improving hemoglobin A1c and/or liver fat of the user.
However, the above is describing merely the content (e.g., the topic) of the information—such as the lesson material—being presented to the user; and thus, such content is directed to nonfunctional descriptive material.
Moreover, Petrov already teaches that the system first asks the user one or more health conditions, including type-2 diabetes (see [0033] lines 16-26); and subsequently, the system generates a personalized program to the user, including dynamically adjusted treatment plans ([0034]; [0035]; [0037]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Petrov’s system; for example, by incorporating an option that allows the user to specify one or more specific health conditions that he/she is required to manage, so the user provides one or more of his/her specific health condition (e.g., the user indicating a kidney issue that he/she is trying to manage; or the user indicating hemoglobin A1c that he/she is trying to manage, etc.); and wherein the system generates a personalized lesson and/or treatment program that is customized to address the user’s specific health issues (e.g., lesson materials that teach the user the best way to cope with such health issues; one or more recommended activities and/or dietary habits to improve the specific heath issues, etc.); and furthermore, the system dynamically updates the program based on feedback received from the user regarding the level of his/her progress (e.g., by comparing the condition of the user with that of a healthy individual, etc.); so that the user would have a better chance to improve his/her overall health.
Regarding claims 2-6 and 10, Petrov teaches the claimed limitations as discussed above per claim 1 since each of claims 2-6 depends from claim 1 directly or indirectly.
In this regard, each of claims 2-6 and 10 is directed merely to the process of evaluating the user’s progress towards a goal(s); and subsequently providing pertinent lesson and/or activity to the user based on the evaluation. In this regard, the specific content (i.e., the topic) of the information presented to the user (e.g., the topic of the lesson, etc.) does not have any patentable weight since it is merely nonfunctional descriptive matter. Accordingly, the modification discussed per claim 1 already addresses each of the above claims.
Petrov teaches the claimed limitations as discussed above per claim 1. Petrov further teaches:
Regarding claim 7, receiving or identifying, by the one or more processors, an indication of performance of one or more actions to cause an update in a treatment plan ([0036]; [0037]: e.g., the system evaluates one or more actions that the user is performing—such as, evaluating whether the user is performing a walking exercise, etc.; and thereby, the system generates one or more personalized treatment plans and/or therapeutic recommendation to the user);
Regarding claim 8, wherein the one or more actions comprise (i) repeating a current lesson and/or activity, (ii) repeating an earlier lesson and/or activity, or (iii) skipping at least one of the plurality of lessons and/or plurality of activities ([0036]: e.g., based on one or more of the user’s actions being evaluated, the system also provides one or more action plan items in order to modify behavior already performed; and accordingly, the one or more actions already comprises at least repeating the current or earlier activity);
Regarding claim 9, the treatment plan comprises a series of lessons and/or activities to address one or more maladaptive beliefs corresponding to dietary or lifestyle behaviors of the user, wherein updating the treatment plan is based at least on performance by the user in reaching previously-set goals ([0018]; [0035] to [0037]: e.g., the treatment plan, which the system is generating to the user, is already intended to address one or more lifestyle behaviors of the user—such as, encouraging the user to walk the stairs instead of taking the elevator, and/or ride a bike instead of watching TV, etc.; and accordingly, the system modifies the treatment plan based on comparing the user’s actual performance of an activity to a suggested activity, i.e., a previous goal. For instance, the system alters the action plan and motivational triggers when it determines that the user has not started riding a bike as suggested, etc.);
Regarding claim 11, interfacing, by the one or more processors, with the user to cause at least one of (i) an acceptance of the one or more goals to be achieved or (ii) an identification of one or more new goals to be achieved ([0016]; [0035]; [0036]: e.g., the system already generates an interface in order receive inputs from the user; and furthermore, once one or more suggested activities [i.e., goals] are presented to the user, as part of the action plan, the user accepts a suggested activity—such as, the user accepting walking the stairs instead of taking the elevator, etc. The above indicates the process of interfacing with the user to cause at least one of (i) an acceptance of the one or more goals to be achieved);
Regarding claim 12, the one or more lessons or activities correspond to addressing a cardiometabolic disorder of the user, the cardiometabolic disorder comprises at least one of type 2 diabetes, gestational diabetes, hypertension, obesity, dyslipidemia, hyperlipidemia, hypertriglyceridemia, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, hypercholesterolemia and familial hypercholesterolemia, heart disease, coronary artery disease, or chronic kidney disease ([0014]; [0018]; [0019]; [0043]: e.g., the one or more activities and/or educational materials, which the system is presenting to the user is, already intended to helps the user to manage a cardiometabolic disorder; such as, type 2 diabetes, heart disease, etc.);
Regarding claim 13, the plurality of lessons and/or the plurality of activities correspond to at least one of exploring beliefs, type 2 diabetes, blood sugar, protein, affordability, activity, hunger, weight, comfort food, control, loyalty, ability to change, healing, power of beliefs, stress, response to stress, sleep, connection, opportunity, meaning, purpose, strength or resistance activities, caring for oneself, empowerment, craving, or evolving ([0014]; [0018]; [0019]; [0044]: e.g., the one or more activities and/or educational materials, which the system is presenting to the user is, already intended to helps the user manage one or more issues; type 2 diabetes, goals of weight loss, etc.);
Regarding claim 14, updating, by the one or more processors using the ML model, one or more subsequent lessons and/or activities based on the at least one response or biometric data ([0035] to [0037]; [0048]: e.g., the user’s performance regarding one or more suggested activities are tracked and evaluated; and accordingly, based on whether the user has performed the suggested activities, the system adjusts the treatment plan or the therapeutic recommendation by adjusting one or more of the activities that the user is required to perform It is also worth to note that the system already utilizes artificial intelligence modeling, i.e., machine learning modeling, to perform the processes above. Thus, the system already updates, using the ML model, one or more subsequent lessons or activities based on the at least one response or biometric data);
Regarding claim 15, transmitting, by the one or more processors, one or more personalized notifications corresponding to at least one of a reminder, nudge, or reward ([0018]; [0020]; [0035]; [0041]; [0041]: e.g., the system helps the user to achieve one or more desired activities by providing one or more reminders regarding one or more of the activities to be performed. Note that the “nudge” and “reward” are optional limitations given the claim language “at least one”).
Regarding claim 16, Petrov teaches the claimed limitations as discussed above per claim 15.
Petrov further teaches, the reminder corresponds to a push notification to the user for the plurality of lessons and/or the plurality of activities ([0018]; [0020]; [0035]; [0041]: e.g., as already pointed out above per claim 15, the system helps the user to achieve one or more desired activities by providing one or more reminders regarding one or more of the activities to be performed. Accordingly, the above indicate the push notification presented to the user regarding the one or more activities).
Note that the portion of the claim, “wherein the nudge corresponds to a notification to the user encouraging the user to a next lesson . . . one or more milestones corresponding to at least one of a medication, or a biometric of the user”, is relying on the optional limitations recited per claim 15.
Thus, Petrov is not necessarily required to teach any of the optional limitations since Petrov already teaches the process of providing a reminder to the user—such as, a push notification to the user for the one or more lessons or activities.
Regarding claim 17, Petrov teaches the claimed limitations as discussed above per claim 1.
Petrov further teaches, the plurality of lessons and/or the plurality of activities correspond to one or more interactive lessons and/or activities, and wherein the at least one response or biometric data is collected via voluntary user input on the digital therapeutic application or in response to a prompt, and wherein the at least one response comprises at least one of an audio recording, a video recording, a photograph, or a journal entry ([0016]; [0017]; 0022]; [0031]; [0057]: e.g., the system already provides one or more interactive lessons or activities to the user; and furthermore, the system allows the user to provide one or more responses or biometric data related to the user’s activities; such as, the user answering questions in a questionnaire and/or filling out statistic information, etc. Accordingly, such implementation, which allows the user to answer questions in a questionnaire and/or filling out statistic information, indicates the process of collecting the responses or biometric data, via voluntary user input on the digital therapeutic application or in response to a prompt; and wherein, the at least one response comprises at least a journal entry).
Regarding claim 20, Petrov teaches the claimed limitations: a system, comprising: one or more processors coupled with memory, configured to: present, via a device, a digital therapeutic during a treatment period, the digital therapeutic comprising a plurality of lessons ([0016];[0018]; [0019]: e.g., a computer-based system that comprises one or more computing devices, including a mobile phone that a user uses; and thereby, the system presents the user with one or more therapeutic lessons related to nutrition and/or physical activities), the plurality of lessons corresponding to at least one interactive skill-based activity; submit, by the user via the digital therapeutic, a treatment goal during at least one portion of the treatment period ([0016]; [0020]; [0031]; [0033]; [0041]: e.g., the system presents the user with one or more questions—such as, questions regarding completion of scheduled activities; questions related to one or more categories—such as: fitness, ability, etc. Thus, such process, which requires the user to provide responses regarding one or more activities that the user has accomplished, etc., already indicates that the at least one lesson corresponds to at least one interactive skill-based activity; and furthermore, besides allowing the user to provide preferences and goals, the user is also presented with instructions to complete one or more lessons during one or more periods of a treatment); and responsive to receiving lesson completion data, transmit a prompt directing the user to adjust at least one of a dietary intake or a physical-activity behavior ([0034]; [0035]; [0041]: e.g., based on the analysis of the user’s responses regarding one or more of: the activities user has completed and/or the activities the user has failed to complete, the user’s nutritional intake, etc., the system requires the user to modify one or more of his/her activities and/or nutritional intake; such as, specific foods to increase, specific foods to avoid, suggested activities and levels, etc. The above indicates the process of transmitting, responsive to receiving lesson completion data, a prompt directing the user to adjust at least one of a dietary intake or a physical-activity behavior).
Petrov does not expressly describe that the lesson above is based on cognitive behavioral therapy for improving hemoglobin Ale and/or liver fat of the user; however, the above is merely indicating the content (i.e., the subject matter or topic) of the lesson being presented to the user; and accordingly, the above is nonfunctional descriptive matter.
Similarly, the limitation, “the improvement in the hemoglobin A1c and/or the liver fat of the user comprises at least a percent relative to a respective baseline level of the hemoglobin A1c and/or the liver fat of the user”, is merely indicating old and well-known evaluation that one performs to estimate the progress—or the deterioration—of a condition; such as, comparing the result of the user’s condition with that of the norm or baseline.
In this regard, Petrov already teaches that the system provides the user with pertinent educational material based on the success or failure of the user towards a goal ([0019]); and furthermore, the system first asks the user one or more health conditions, including type-2 diabetes (see [0033] lines 16-26); and subsequently, the system generates a personalized program to the user, including dynamically adjusted treatment plans ([0034]; [0035]; [0037]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Petrov’s system; for example, by incorporating an option that allows the user to specify one or more specific health conditions that he/she is required to manage, so the user provides one or more of his/her specific health condition (e.g., the user indicating a kidney issue that he/she is trying to manage; or the user indicating hemoglobin A1c that he/she is trying to manage, etc.); and wherein the system generates a personalized lesson and/or treatment program that is customized to address the user’s specific cognitive, behavioral and/or health issues (e.g., lesson materials that teach the user the best way to cope with such health issues; one or more recommended activities and/or dietary habits to improve the specific heath issues, etc.); and furthermore, the system dynamically updates the program based on feedback received from the user regarding the level of his/her progress (e.g., by comparing the condition of the user with that of a healthy individual, etc., etc.); so that the user would have a better chance to improve his/her overall health.
Petrov teaches the claimed limitations as discussed above per claim 20. Petrov further teaches:
Regarding claim 21, wherein presenting the digital therapeutic further comprises presenting one or more treatment goals corresponding to one or more selections from the group consisting of exercise, exercise minutes, exercise types, diet, meals consumed, and medication ([0031]; [0033]; [0036]: e.g., the system already allows the user to select at least one goal; such as, the user accepting a walking exercise, etc.);
Regarding claim 22, transmit a prompt directing the user to either accept the one or more treatment goals or identify other treatment goals ([0031]; [0033]; [0036]: e.g., the system already permits the user to select a goal, or identifies a goal; and furthermore, per one of the exemplary scenarios, the user accepts a suggested goal; such as, a walking exercise in the form of walking the stairs);
Regarding claim 23, the digital therapeutic comprises a treatment plan, wherein
the one or more processors are further configured to: responsive to an extent to which the user achieves one or more goals, dynamically adjust the treatment plan ([0035] to [0037]: e.g., based on the analysis of performance data related to the user—such as, completion of suggested activities; deficiencies/surplus in nutrition, fitness, etc., the system generates to the user detailed plan of action, including dynamically adjusted treatment plan, etc.);
Regarding claim 24, one or more of the plurality of lessons is specific to treating type-2 diabetes such that the digital therapeutic is understanding, addressing, or controlling particular human physiological attributes, physiological responses, or developing certain desirable behaviors ([0014]; [0033] to [0037]: e.g., the lessons are directed to managing or treating various types of diseases, including type-2 diabetes; such as, helping the user to understand the benefit of performing physical activities and/or proper nutrition; encouraging the user to modify his/her behavior by providing the user with a treatment/therapeutic plan with suggested activities, nutrition, etc.);
Regarding claim 25, one or more of the plurality of lessons and/or at least one activity relates to one or more of exploring beliefs, Type 2 Diabetes, blood sugar, protein, affordability, exercise, hunger, weight, comfort food, control, loyalty, ability to change, healing, power of beliefs, stress, response to stress, sleep, connection, opportunity, meaning, purpose, strength/resistance exercise, caring for ourselves, empowerment, craving, or evolving ([0014]; [0028]; [0035]; [0044]: e.g., one or more of the lessons and/or activities already relates to one or more of: type-2 diabetes, exercise, or weight, etc.);
Regarding claim 26, provide a progress overview generated by a machine-learning (ML) model to the user device ([0007]; [0015]; [0047]; [0048]: e.g., the system already allows the user to track his/her progress regarding one or more goals; and wherein, the system already utilizes artificial intelligence modeling, which is a form of machine learning, in order to perform the above processes);
Regarding claim 27, responsive to receiving lesson or activity completion data, generate or recommend, by the ML model, one or more new lessons of the digital therapeutic ([0035] to [0037]; [0041]; [0048]: e.g., based on the analysis of the user’s completion status regarding one or more suggested activities, the system presents the user with detailed plan of action or a treatment plans that includes one or more modified activities, etc., and wherein, the system utilizes artificial intelligence modeling to perform the above processes. The above indicates the process of generating/recommending, responsive to receiving lesson/activity completion data, one or more new lessons of the digital therapeutic using the ML model).
Regarding claim 30, Petrov teaches the following claimed limitations: a non-transitory computer readable medium (CRM) comprising one or more instructions
stored thereon and executable by one or more processors to: prompt a user to provide one or more goals for the user to achieve via a digital therapeutic application during a portion of a treatment period, wherein the digital therapeutic application comprises a plurality of lessons and/or a plurality of activities provide a lesson and/or an activity via a digital therapeutic application to the user ([0016]; [0018]; [0019]: e.g., a user downloads an application from a website, or access a website; and wherein the application presents the user with a user interface, which allows the user to provide various information, including preferences and goals; and the application also presents, at one or more periods, the user with one or more content items—such as, activities, nutrition and/or lesson materials); collect at least one response or biometric data from the user ([0018]; [0031], lines 1-6; [0033]: e.g., the system collects one or more parameters from the user; such as: the user’s response to one or more questions related to the user’s activities; biometric data tracked via one or more devices, etc.); and generate, using a machine-learning (ML) model, one or more new goals for the user to achieve during the treatment period based on the at least one response or biometric data ([0034]: [0035]; [0048]: e.g., based on the analysis of the collected information, the system identifies one or more outcomes; including the weak and strong areas of the user; and thereby, the system generates to the user one or more suitable plans; such as, providing one or more modified goals, one or more action plans regarding activities targets, etc.; and the system’s software already includes artificial intelligence modeling—i.e., machine learning modeling— to perform the above processes); administer to the user via the digital therapeutic application a subsequent lesson and/or a subsequent activity ([0018]; [0031]: e.g., the user provides answers to one or more questions, wherein the answers are evaluated; and the system identifies a pertinent goal to the user to perform, etc. The above indicates the process of administering to the user via the digital therapeutic application a subsequent lesson and/or a subsequent activity).
Petrov does not expressly describe that the lessons and/or the activities being presented to the user are intended for improving hemoglobin A1c and/or liver fat of the user.
However, the above is describing merely the content (e.g., the topic) of the information—such as the lesson material—being presented to the user; and thus, such content is directed to nonfunctional descriptive material.
Moreover, Petrov already teaches that the system first asks the user one or more health conditions, including type-2 diabetes (see [0033] lines 16-26); and subsequently, the system generates a personalized program to the user, including dynamically adjusted treatment plans ([0034]; [0035]; [0037]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Petrov’s system; for example, by incorporating an option that allows the user to specify one or more specific health conditions that he/she is required to manage, so the user provides one or more of his/her specific health condition (e.g., the user indicating a kidney issue that he/she is trying to manage; or the user indicating hemoglobin A1c that he/she is trying to manage, etc.); and wherein the system generates a personalized lesson and/or treatment program that is customized to address the user’s specific health issues (e.g., lesson materials that teach the user the best way to cope with such health issues; one or more recommended activities and/or dietary habits to improve the specific heath issues, etc.); and furthermore, the system dynamically updates the program based on feedback received from the user regarding the level of his/her progress (e.g., by comparing the condition of the user with that of a healthy individual, etc.); so that the user would have a better chance to improve his/her overall health.
Regarding each of claims 31 and 32, Petrov teaches the claimed limitations as discussed per claim 1 above.
Each of the limitations, “the improvement in the hemoglobin A1c and/or the liver fat of the user is relative to a respective baseline level of the hemoglobin A1c and/or the liver fat of the user” (per claim 31), and “after the treatment period, determining . . . the improvement in the hemoglobin A1c and/or the liver fat of the user” (per claim 32), is already addressed per the modification discussed with respect to claim 1. This is because the modified system already dynamically updates the lesson and/or the treatment program, based on the analysis of the feedback received from the user regarding his/her progress (i.e., by comparing the condition of the user with that of a healthy individual, etc.).
Accordingly, the above already indicates that the improvement in the hemoglobin A1c and/or the liver fat of the user is relative to a corresponding respective baseline level (as required per claim 31); and furthermore, the system determines the improvement in the improvement in the hemoglobin A1c and/or the liver fat of the user (as required per claim 32).
Note that the motivation discussed with respect to claim 1 also applied to each of claims 31 and 32 since each of these claims is directly dependent on claim 1.
● Claims 18, 19 and 29 are rejected under 35 U.S.C.103 as being unpatentable over Petrov 2016/0086509 in view of Bergantino 2005/0113649.
Regarding each of claims 18, 19, and 29, Petrov teaches the claimed limitations as discussed above per claim 1 or claim 20.
Petrov does not describe “administering an effective amount of any one or more of: metformin, sulfonylureas, sglt2 inhibitors, glp-1 analogues, insulin . . . bromocriptine, or pramlintide” (per claim 18); and “the user is taking a medication for type 2 diabetes, the medication selected from any one of: metformin, sulfonylureas . . . bromocriptine, or pramlintide” (per each of claims 19 and 29).
However, Bergantino discloses a system/method for managing a user’s health; wherein the system incorporates an exercise management module that recommends, based on the analysis of the user’s exercise/activity, one or more activities to the user ([0025]); and also, a medication management module that recommends, based on the analysis of the user’s health condition (e.g., the blood sugar of a diabetic user), a suitable dosage of a medication—such as insulin—that the user is required to take ([0045]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the invention of Petrov in view of Bergantino; for example, by upgrading the system algorithm; so that, besides recommending one or more lessons/activities to the user, the system also recommends, based on health data gathered via health questionnaire and/or one or more biometric devices (e.g., data indicating the blood sugar level of a diabetic user, etc.), one or more suitable doses of one or more specific medications that the user is required to take (e.g., a suitable does of insulin, etc.); so that, the user takes the medication as recommended; and accordingly, the user would have a better chance to easily improve his/her health condition in reasonable amount of time.
Response to Arguments.
7. Applicant’s arguments directed to the prior art have been fully considered (the arguments filed on 04/20/2026). In particular, while referring to the newly amended limitation (e.g., “. . . a plurality of activities for improving hemoglobin A1c and/or liver fat of the user”), Applicant is challenging the rejection set forth in the previous office action under section §102 (pages 23-24 of the argument), and also under section §103 (pages 25-26 of the argument).
However, a new ground of rejection currently presented under section §103 already address the current claim amendment. It is worth noting that Applicant’s current argument, directed to Petrov, is merely indicating the missing of: (i) a lesson and/or an activity intended for improving “the hemoglobin Ale and/or the liver fat of the user”, and/or (ii) an improvement evaluation that is based on “a percent relative to a respective baseline level of the hemoglobin Ale and/or the liver fat of the user”. No argument is presented to challenge any obviousness analysis (e.g., any reason why the new limitation may not be obvious over Petrov). Nevertheless, the current obviousness analysis, which is directed to the newly added limitations, already demonstrates the reason why each of the above features is still obvious over the teaching of Petrov (e.g., see the obviousness analysis presented per each of claims 1 and 20).
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUK A GEBREMICHAEL whose telephone number is (571) 270-3079. The examiner can normally be reached from 7:00 AM - 3:00 PM.
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/BRUK A GEBREMICHAEL/Primary Examiner, Art Unit 3715
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