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 .
2. 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.
3. The following office action is a Final Office Action in response to the communications received on 11/04/2025.
Claims 1-3, 6-9, 12-14, 16, 17, 20, 25, 27 and 30 have been amended; and therefore, claims 1-30 are currently pending in this application.
Claim Rejections - 35 USC § 101
4. 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 1-30 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:
I. 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:
provide to a user one or more lessons or activities; collect at least one response or biometric data from the user corresponding to a lesson and/or an activity; and generate using a model, (a) one or more goals for the user to achieve based on the at least one response or biometric data or (b) a progress overview based on a progress by the user to achieve one or more goals; and in accordance with a determination that the progress satisfies a threshold and the lesson and/or the activity is not formerly completed by the user, [present] to the user a subsequent lesson and/or a subsequent activity.
Claim 20:
present at least one lesson based nutritional cognitive behavioral therapy, the at least one lesson corresponding to at least one interactive skill-based activity; [present] the at least one lesson to the user over a treatment interval; and 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 presented with one or more lessons/activities; and furthermore, based on the analysis of data (i.e., response or biometric data) collected from the user regarding the lesson(s)/activity, the user is presented a progress overview, and/or one or more goals that the user is required to achieve, including subsequent lesson/activity based on the status of the user’s progress, etc.
Similarly, given the limitations that recite the process of collecting data (i.e., collecting response or biometric data) from the user; and thereby generating, using a mathematical model, one or more goals for the user to achieve, and/or progress overview, including the process of determining whether the user’s progress satisfies a threshold, etc., the claims overlap the group mental processes—such as, an evaluation, an observation, and/or a judgement process, etc.
II. In addition, one or more of the current claims also recite a natural phenomenon. For instance, considering claim 20 as a representative claim, the limitation, “wherein adjusting the dietary intake or the physical-activity behavior corresponds to a reduction in at least one biomarker level of the user, the at least one biomarker level corresponding to a characteristic of type 2 diabetes, by at least a percent relative to a baseline level of the at least one biomarker” corresponds to a natural phenomenon since it is merely describing the natural reaction of the body to the user’s activity or diet—such as, the increase in the blood sugar level due to the user’s consumption of carbohydrates, etc.
(Step 2A) [Wingdings font/0xE0] Prong-Two:
The claim(s) recite additional element(s), wherein each of claims 1-30 implements a processor(s), and wherein claims 1-19, 26, 27 and 30) further executes a machine learning algorithm; and the above computer elements are utilized to facilitate the claimed steps and/or functions regarding: presenting one or more content items to a user (e.g., “provid[ing] . . . a digital therapeutic application to a user comprising a plurality of lessons and/or a plurality of activities”, per claims 1 and 30; “present, via a device, a digital therapeutic comprising at least one lesson based on nutritional cognitive behavioral therapy, the at least one lesson corresponding to at least one interactive skill-based activity; transmit instructions to the device to administer the at least one lesson to the user over a treatment interval”, per claim 20); collecting input(s) from the user (e.g., “collect[ing] . . . at least one response or biometric data from the user corresponding to a lesson and/or an activity”, per claims 1 and 30; “receiving lesson completion data”, per c claim 20); analyzing the collected input(s) and generating pertinent result(s)/information (e.g., “generat[ing] . . . using a machine-learning (ML) model, (a) one or more goals for the user to achieve based on the at least one response or biometric data or (b) a progress overview based on a progress by the user to achieve one or more goals”, per claims 1 and 30; “in accordance with a determination that the progress satisfies a threshold and the lesson and/or the activity is not formerly completed by the user, administering 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, none of the current claims, when considered as a whole, 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 and 21-29). 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 11/04/2025). However, the arguments are not persuasive at least for the following reasons:
Firstly, while referring to the 2019 PEG, Applicant is asserting that “claim 1 recites a combination of steps, such as providing a digital therapeutic application to a user, generating goal(s) for the user to achieve or a progress overview based on a progress by the user using a machine-learning model, and administering to the user a subsequent lesson and/or activity via the digital therapeutic application, that cannot be performed outside of a computer, let alone in the human mind . . . claim 1 recites limitations that the human mind is not equipped to perform, such as ‘providing, by one or more processors, a digital therapeutic application to a user . . . ‘generating, by the one or more processors using a machine-learning (ML) model, (a) one or more goals for the user . . . limitations are inherently rooted in computer technology and cannot practically be performed in the human mind. For example, the human mind cannot provide a digital therapeutic application, generate one or more goals or a progress overview using a machine-learning model, or administer a subsequent lesson and/or activity via the digital therapeutic application” (emphasis added). Applicant has also attempted to rely on the recent memorandum (the memo of August 2025) in order to substantiate the above assertion.
However, Applicant does not appear to properly apply the eligibility analysis. It is worth to note that the eligibility analysis, per prong-one of Step 2A, does not consider the computer-elements. Instead, while excluding the computer-elements, prong-one requires one to identify just the judicial exception (e.g., the abstract idea) that the claim is reciting. See MPEP 2106.04(II)(A), (emphasis added):
Prong One
Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether . . . abstract idea is set forth or described in the claim.
Thus, Applicant’s attempt to challenge the Office’s findings presented under prong-one of Step 2A, while relying on the claimed computer-elements (e.g., the computer device which generates a digital therapeutic application, and/or executes a machine-learning model), is certainly not persuasive.
In contrast, when the eligibility test—per prong-one—is properly applied, the current claims do recite a mental process. For instance, considering current claim 1 as an example, a human—such as a therapist—can perform the core of the claimed process mentally—and/or using a pen and paper—as follows:
the therapist organizes and/or presents multiple lessons and/or activities to the user (e.g., lessons in the form of one or more books, etc.);
the therapist then evaluates the user based on the user’s reaction or response to one of the lessons and/or activities being presented;
the therapist 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 goals or progress that the user is required to achieve based on the user’s responses;
the therapist further presents, based on evaluating the user’s record and/or status regarding the goals (e.g., the user achieving—or not achieving—a set threshold; the user formerly completing—or not completing—the lesson/activity, etc.), a subsequent lesson or activity, etc.
The observation above demonstrates that the 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 is asserting that “amended claim 1 is directed to specific technical features, including providing a digital therapeutic application to a user using one or more processors, generating goal(s) for the user to achieve or a progress overview based on a progress by the user using a machine-learning model . . . These exemplary technical features are not descriptive of managing personal behavior, nor any of the aforementioned methods of organizing human activity” (emphasis added).
However, here also Applicant is relying on the claimed computer-elements in order to challenge the Office’s findings per prong-one of Step 2A. In contrast, as already pointed out above (also see MPEP 2106.04(II)(A) cited above), prong-one of Step 2A does not consider any of the claimed computer-elements; rather, it requires one to identify just the judicial exception—i.e., the abstract idea—that the claim is reciting. In this regard, per the current claims, the user is presented with at least one lesson or activity to perform; and furthermore, based on the user’s progress, a subsequent lesson or activity—which the user is required to perform—is presented to the user. Thus, the above indeed corresponds to the group certain methods of organizing human activity; such as, managing personal behavior. For instance, again considering claim 1 as an example, multiple lessons and/or activities are presented to the user, and the user’s response or biometric data to a lesson and/or an activity is gathered; and furthermore, a subsequent lesson and/or activity is presented to the user once a determination is made regarding the user’s progress with respect to one or more goals, which are generated using a model/template that correlates the user’s response or biometric data with one or more goals, etc.
The observation above confirms that the current claims recite an abstract idea; namely, certain method of organizing human activity. Consequently, Applicant’s arguments are not persuasive.
Secondly, regarding prong-two of Step 2A, Applicant asserts that “claim 1 recites ‘administering to the user via the digital therapeutic application a subsequent lesson and/or a subsequent activity’ in accordance with ‘a determination that the progress satisfies a threshold and the lesson and/or the activity is not formerly completed by the user.’ Thus, amended claim 1 recites a ‘specifically identified’ treatment. (MPEP 2106.04(d)(2).) Further, amended claim 1 imposes meaningful limits on the alleged judicial exception and integrates the alleged judicial exception into a practical application . . . amended claim 1 recites a combination of steps directed to providing a digital therapeutic application to a user, collecting at least one response or biometric data corresponding to a lesson and/or an activity, generating one or more goals or a progress overview using a machine-learning model, and administering to the user via the digital therapeutic application a subsequent lesson and/or a subsequent activity in accordance with a determination that the progress satisfies a threshold and the lesson and/or the activity is not formerly completed by the user . . . claim 1 recites administering a subsequent lesson and/or a subsequent activity to the user via a digital therapeutic application, imposes meaningful limits on the alleged judicial exception, and integrates the alleged judicial exception into a practical application” (emphasis added).
However, none of the current claims, when considered as a whole, integrates the claimed abstract idea into a patent-eligible practical application. This is because neither the current claims nor the original disclosure, when considered as a whole, provides a technological improvement over the relevant existing technology. In particular, given the facts presented per the current claims and the original disclosure, the claimed (and the originally disclosed) method/system is utilizing the existing computer/network technology—merely as a tool—to facilitate an abstract idea; such as, presenting information to the user regarding an activity and/or a lesson to be performed; including a subsequent activity based on the analysis of the user’s progress, etc. In contrast, the integration (if any) of the abstract idea into a patent-eligible practical application is demonstrated if the claim(s) recites an element—or a combination of elements—that provides a technological improvement over the existing computer/network technology. Thus, given such lack of technological improvement, neither the claims nor the original disclosure as a whole integrates the abstract idea into a patent-eligible practical application.
In addition, none of the claims corresponds to the patent-eligible “particular” treatment or prophylaxis for a disease or medical condition (see MPEP 2106.04(d)(2), emphasis added),
One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition . . . Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The claims in Vanda recited a method of treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation (a disruption of the heart’s normal rhythm that can lead to serious health problems) in patients having a particular genotype associated with poor drug metabolism . . . the claims recited steps of: (1) performing a genotyping assay to determine if a patient has a genotype associated with poor drug metabolism; and (2) administering iloperidone to the patient in a dose range that depends on the patient’s genotype.
In contrast, as already pointed out above, the core of the current claims is directed to a method/system that provides information to the user—such as, presenting information to the user regarding an activity and/or a lesson to be performed; including presenting additional information to the user regarding a subsequent activity/lesson that the user is required to perform, based on the analysis of the user’s progress to a goal, which is determined using a mathematical model that correlates the user’s biometric data or response to one or more goals, etc. Even when considering some of the claims, such as claims 18, 19 and 29, which supposedly recite the administration of—or the user taking—a medication, none of these claims correspond to a “particular” treatment or prophylaxis for a disease or medical condition (e.g., see the case of Vanda cited above). If anything, the claims above are simply listing multiple medications. Note also that the MPEP provides additional examples that correspond to patent-eligible treatments; again see MPEP 2106.04(d)(2),
Examples of "treatment" and prophylaxis" limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. For example, an immunization step that integrates an abstract idea into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases is considered to be a particular prophylaxis limitation that practically applies the abstract idea. See, e.g., Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011).
In contrast, none of the current claims—considered as a whole—corresponds to a patent-eligible “particular” treatment or prophylaxis for a disease/medical condition. Consequently, Applicant’s arguments are not persuasive.
Of course, when analyzing the current claims per Step 2B, each of the current claims—when considered as a whole—is directed to the conventional and generic arrangement of the additional elements (e.g., the conventional computer/network technology, which is utilized—merely as a tool—to facilitate an abstract idea). Thus, given the conventional and generic arrangement of the additional elements, along with the lack of technological improvement over the relevant existing technology, none of the current claims—when considered as a whole—implements an inventive concept that amounts to “significantly more” than an abstract idea.
● Note that the same type of analysis applies to claim 20. In this regard, claim 20 may have (i) a different lesson content—such as, a lesson based on nutritional cognitive behavioral therapy (which is an abstract idea); or (ii) a message that prompts the user to adjust a dietary intake or a physical activity behavior (which is also an abstract idea).
In this regard, the last limitation per claim 20, namely the limitation, “wherein adjusting the dietary intake or the physical-activity behavior corresponds to a reduction in at least one biomarker level of the user, the at least one biomarker level corresponding to a characteristic of type 2 diabetes, by at least a percent relative to a baseline level of the at least one biomarker”, is merely referring to the natural reaction, which the body normally experiences, in response to (i) a food that the user has consumed, or (ii) a physical activity that the user has performed. In this regard, neither of the above activities, alone or in combination with the rest of the claimed limitations, negates the Office’s ineligibility findings. Nevertheless, the claim requires just one of the two conditions, but not necessarily both conditions (e.g., the natural reaction of the body to a physical activity).
Thus, the analysis presented above per claim 1 already addresses Applicant’s arguments directed to claim 20 (e.g., the arguments presented on pages 12-15).
Claim Rejections - 35 USC § 102
5. The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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 and 30 are rejected under 35 U.S.C.102(a)(1) as being anticipated by Petrov 2016/0086509.
Regarding claim 1, Petrov teaches the following claimed limitations: a method, comprising: providing, by one or more processors, a digital therapeutic application to a user comprising a plurality of lessons and/or a plurality of activities ([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 one or more content items, including: activities, nutrition and/or educational materials); collecting, by the one or more processors, at least one response or biometric data from the user corresponding to a lesson and/or an activity ([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, (a) one or more goals for the user to achieve based on the at least one response or biometric data or (b) a progress overview based on a progress by the user to achieve one or more goals ([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 wherein, the system’s software already includes artificial intelligence modeling—i.e., machine learning modeling— to perform the above processes. Note that part (b) above is merely optional); in accordance with a determination that the progress satisfies a threshold and the lesson and/or the activity is not formerly completed by the user, administering to the user via the digital therapeutic application a subsequent lesson and/or a subsequent activity ([0018]: e.g., if the user's actual activity
level indicates more success in a certain time of day—i.e., satisfies a threshold, then the system suggests additional activity; and similarly, if a certain activity is not adopted by a user—i.e., the activity is not formerly completed by the user, then the system suggests alternative activities, etc.).
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 relying on the optional limitation that claim 1 is reciting; such as, generating, “a progress overview based on a progress by the user to achieve one or more goals” (see lines 6-8 of claim 1). Particularly, claim 1 is requiring the generation of (a) “one or more goals . . .” OR (b) “a progress overview based on a progress by the user to achieve one or more goals”, but NOT both (a) and (b) above.
Thus, the prior art is not necessarily required to teach part (b), since part (b) is merely optional according to claim 1.
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 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: provide a digital therapeutic application to a user comprising a plurality of lessons and/or a plurality of activities ([0016];[0018]; [0019]: e.g., a computer-based system that comprises one or more computing devices, including a mobile phone that a user uses; wherein the user downloads an application from a website, or access a website; and wherein the application presents the user with one or more content items, including: activities, nutrition and/or educational materials); collect at least one response or biometric data from the user corresponding to a lesson and/or an activity ([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, (a) one or more goals for the user to achieve based on the at least one response or biometric data or (b) a progress overview based on a progress by the user to achieve one or more goals ([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 wherein, the system’s software already includes artificial intelligence modeling—i.e., machine learning modeling—to perform the above processes. Note that part (b) above is merely optional); in accordance with a determination that the progress satisfies a threshold and the lesson and/or the activity is not formerly completed by the user, administering to the user via the digital therapeutic application a subsequent lesson and/or a subsequent activity ([0018]: e.g., if the user's actual activity
level indicates more success in a certain time of day—i.e., satisfies a threshold, then the system suggests additional activity; and similarly, if a certain activity is not adopted by a user—i.e., the activity is not formerly completed by the user, then the system suggests alternative activities, etc.).
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 20-28 are currently rejected under 35 U.S.C.103 as being unpatentable over Petrov 2016/0086509.
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 comprising at least one lesson ([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 at least one lesson corresponding to at least one interactive skill-based activity; transmit instructions to the device to administer the at least one lesson to the user over a treatment interval ([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: nutrition, fitness, ability, etc. Thus, such process, which requires the user to provide responses regarding one or more activities and/or nutrition that the user has accomplished, etc., already indicates that the at least one lesson corresponds to at least one interactive skill-based activity; and wherein, an instruction is presented to the user to complete the at least one lesson over a treatment interval); 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).
Note that the limitation, which describes the result of adjusting the dietary intake or the physical activity, i.e., “a reduction in at least one biomarker level of the user . . . a characteristic of type 2 diabetes, by at least a percent relative to a baseline level of the at least one biomarker”, is referring merely to the body’s natural reaction to: a (i) the type and/or amount of food/nutrition, and/or (ii) the type of exercise the user has performed.
Nevertheless, per the teaching of Petrov, the system already proms the user to adjust one or more of: the physical activities being performed, and/or the one or more food items being consumed (e.g., suggesting the user to replace carbohydrate if the system determines that the user’s diet is heavy in carbohydrates, etc.); and accordingly, such adjustment the above already causes a reduction in at least one biomarker level of the user, the at least one biomarker level corresponding to a characteristic of type 2 diabetes, by at least a percent relative to a baseline level of the at least one biomarker.
Although Petrov does not expressly describe that the lesson above is based on nutritional cognitive behavioral therapy, this is merely indicating the subject matter or topic of the lesson.
In this regard, Petrov already teaches that educational material is provided to the user based on success or deficiencies of the user towards a goal; such as, providing the user with educational materials related to alternative food items if the user is consuming high level of carbohydrates, etc. ([0019]).
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 one or more lesson materials that are based on one or more specific topics—such as: lesson materials based on biological factors specific to the user’s condition, lesson materials based on nutritional cognitive behavioral therapy, etc., so that the user would have a better chance to access one or more relevant educational material that help the user to easily achieve one or more of his/her goals, etc.
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 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 goals or identify other 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, the at least one lesson 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, the at least one lesson 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 28, the at least one biomarker comprises biometric data, blood sugar levels, blood pressure, heartbeat, weight, physiological responses, alanine transaminase, or liver fat ([0034]; [0035]; [0041]: e.g., as already pointed out per claim 20, the system requires the user to modify one or more of his/her activities and/or nutritional intake based on the analysis of: the user’s activities , the user’s nutritional intake, etc.,; such as, recommending the user to: increase consumption of specific foods to avoid; modify type or level of activity, replace carbohydrates, etc. Accordingly, one or more of such activities naturally affects—such as reduces—one or more biomarkers; such as blood sugar levels, etc.).
● 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 require