Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/6/2026 has been entered.
Claims 1-4, 6, 7, 9, and 12 have been amended. Claim 13 has been canceled. Claim 16 has been added. Claims 1-12 and 14-16 are currently pending.
Response to Arguments
A. Applicant's arguments with respect to the rejection of claims 1-12 and 14-16 under 35 USC 101 have been fully considered but they are not persuasive.
Applicant argues starting on page 7 of the response that claim 1 is not directed to a method of organizing human activity, asserting that “amended claim 1 is directed to specific technical features that are not descriptive of any of the aforementioned methods of organizing human activity” including “presenting a digital therapeutic to a user that can provide lessons for improving hemoglobin A1c and/or liver fat, and transmitting a prompt.” Examiner respectfully disagrees.
Under Step 2A Prong 1 claims are analyzed to determine whether they recite limitations which fall within the scope of a judicial exception. The analysis provided below in Step 2A Prong 1 identifies the particular limitations which Examiner has construed as falling within the scope of the abstract idea, and which include presenting a therapeutic to a user that can provide lessons for improving hemoglobin A1c and/or liver fat, and transmitting a prompt. As set out below in the rejection of claim 1, these limitations within the abstract idea are drawn to educating an individual by having them complete lesson activities and instructing them to change their dietary or activity behavior in order to treat a medical condition, and may be performed by a clinician treating a patient and as well as constituting management of the personal behavior of the patient themselves. Applicant does not provide further argument addressing why the argued elements do not fall within the scope of a method of organizing human activity.
Applicant further argues starting on page 8 that claim 1 recites an additional element reflecting an improvement in the functioning of a computer or an improvement to another technology or technical field. Applicant asserts that claim 1 “reflects a particular solution to the technical problem of a need for a digitally delivered treatment for improving hemoglobin A1c and/or liver fat of the user,” and that “Claim 1 provides a solution to this problem by presenting a digital therapeutic, or a software application, that includes lessons based on nutritional cognitive behavioral therapy that improve hemoglobin A1c and/or liver fat of the user.” Examiner respectfully disagrees.
As set out in Step 2A Prongs 1 and 2, the delivering of the therapeutic and lessons for improving hemoglobin A1c and/or liver fat of the user fall within the scope of the abstract idea itself. The recitation of the therapeutic being “digital” and presented via a computing device do amount to additional elements, but only amount to mere instructions to implement the abstract idea using computing elements as tools. Examiner notes that “a need for a digitally delivered treatment for improving hemoglobin A1c and/or liver fat of the user” does not itself constitute a technology or technical field, and the use of a computing device or software application to present information for treating a patient does not render it a technology or technical field. Furthermore, the cited paragraphs of the specification do not establish that the additional elements reflect an improvement in the functioning of a computer or an improvement to other technology or technical field. The lessons themselves fall within the scope of the abstract idea, and improvements in HbA1c or liver fat as a result of a patient reading the material and instituting lifestyle changes do not show an improvement in the functioning of a computer or an improvement to other technology or technical field.
Applicant argues starting on page 10 that claim 1 “considered as a whole, covers a particular treatment or prophylaxis of a digital therapeutic for improving hemoglobin A1c and/or liver fat of a user.” Examiner respectfully disagrees that claim 1 satisfies the requirement for a “particular treatment or prophylaxis” under Step 2A Prong 2 and Step 2B.
MPEP 2106.04(d)(2) sets out the requirements for whether a particular treatment and prophylaxis is sufficient to integrate a judicial exception into a practical application under Step 2A Prong 2, stating initially that “[o]ne 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.” (emphasis added).
The specific considerations for whether a claim integrates a recited abstract idea into a practical application by effecting a particular treatment or prophylaxis for a disease or medical condition are:
the particularity or generality of the treatment or prophylaxis;
whether the limitations have more than a nominal or insignificant relationship to the exception; and
whether the limitations are merely extra-solution activity or a field of use.
Initially, the treatment or prophylaxis must be “particular,” i.e. specifically identified. MPEP 2106.04(d)(2) provides the example of a claim reciting mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications, wherein the additional element of “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype” was considered to be “particular.” Conversely, MPEP 2106.04(d)(2) states that the recitation of “administering a suitable medication to a patient” would not constitute a “particular” treatment or prophylaxis in conjunction with the same abstract idea.
The present claims do not recite a particular treatment or prophylaxis based on the above framework. Claim 1 recites presenting a digital therapeutic during a treatment period where the lessons are recited only as “based on nutritional cognitive behavioral therapy for improving hemoglobin A1c and/or liver fat of the user” and “corresponding to at least one interactive skill-based activity.” A lesson “based on nutritional cognitive behavioral therapy” does not meet the requirements for a particular treatment or prophylaxis. While claim 1 recites that the lessons are “for improving hemoglobin A1c and/or liver fat of the user” and that “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,” merely reciting that the improvement is intended to be of a certain level does not render the lessons a particular treatment or prophylaxis.
Applicant lastly argues that claim 1 recites an additional element applying or using a judicial exception in some other meaningful way beyond generally linking the use of the judicial exception, specifically based on the recitation of “a combination of steps directed to presenting a digital therapeutic during a treatment period, submitting a treatment goal, and transmitting a prompt, wherein the improvement comprises at least a percent relative to a respective baseline level.”
Initially, the elements of presenting a therapeutic during a treatment period, submitting a treatment goal, and transmitting a prompt, wherein the improvement comprises at least a percent relative to a respective baseline level fall within the scope of a method of organizing human activity under the analysis in Step 2A Prong 1, and do not constitute additional elements. While the recitation of the therapeutic as “digital” is construed as an additional element, it only amounts to mere instructions to implement the therapeutic using computing elements given the high level of generality with which it is recited and broad disclosure in in the specification. Applicant does not provide further arguments addressing why these elements amount to applying or using the judicial exception in some other meaningful way.
The rejection under 35 USC 101 is maintained.
B. Applicant's arguments with respect to the rejection of claims 1-15 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues starting on page 12 that the cited Appelbaum and Paull references do not teach or disclose the recited element of “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.” Applicant asserts that Appelbaum only discloses that another version of the digital therapeutic was found to reduce A1c by 0.8%, and that it further only discloses “generating a model for predicting an improvement in hemoglobin A1c, which is not the same as the claimed invention here providing a digital therapeutic for treating that yields an improvement in hemoglobin A1c and/or liver fat comprising at least a percent.” Examiner respectfully disagrees.
Examiner initially disagrees with the assertion that Appelbaum only discloses a model for predicting improvement and does not additionally disclose a digital therapeutic for treating a patient and yielding an improvement in hemoglobin A1c and/or liver fat. Paragraphs 7, 39, 82, 159, and 166-173 expressly describe an app presenting lessons to a user on a mobile device, while paragraphs 109 and 163-165 describe the app as providing behavioral therapy and cognitive training. While a model for predicting a level of biomarker improvement is disclosed, the improvement is the result of the patient using the disclosed digital therapeutic. Paragraphs 148, 161, 181, and 195 additionally describe collecting HbA1c at intervals such as 90-days and 180-days, and at the end of the treatment period. While paragraph 146 describes “[a]n earlier version of the app under investigation,” an early version of the app is still a description of the app being disclosed. The recited amount of “at least a percent” is encompassed by the disclosed improvement range of ≥0.4% in paragraph 192, and Figure 2 shows a predicted improvement of 1.3%, i.e. at least a percent.
While Examiner maintains that Appelbaum discloses the argued limitation, Examiner additionally notes that the amount of improvement being “at least a percent relative to a respective baseline level” only amounts to an intended outcome. Claim 1 recites the digital therapeutic as “comprising a plurality of lessons based on nutritional cognitive behavioral therapy for improving hemoglobin A1c and/or liver fat of the user, followed by “wherein 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.” The improvement is an intended effect of the lessons, but is not step performed within the method itself.
The rejection under 35 USC 103 is maintained.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 and 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-12 and 14-16 are drawn to a method, which is within the four statutory categories.
Step 2A(1)
Claim 1 recites, in part, performing the steps of:
presenting a therapeutic during a treatment period, the treatment comprising a plurality of lessons based on nutritional cognitive behavioral therapy for improving hemoglobin A1c and/or liver fat of the user, the plurality of lessons corresponding to at least one interactive skill-based activity;
submitting, by the user via the therapeutic, a treatment goal during at least one portion of the treatment period;
responsive to lesson completion data, transmitting a prompt directing the user to adjust at least one of a dietary intake or a physical-activity behavior;
wherein 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.
These elements amount to a form of managing personal behavior or relationships or interactions between people and therefore fall within the scope of an abstract idea in the form of a method of organizing human activity. Fundamentally the process is that of presenting interactive cognitive behavioral therapy lessons for improving hemoglobin A1c and/or liver fat to a user over a treatment period, receiving a goal from the user during the treatment, and directing the user to adjust their dietary intake or physical activity upon completion in order to reduce their hemoglobin A1c and/or the liver fat. Such a process of educating an individual by having them complete lesson activities and instructing them to change their dietary or activity behavior in order to treat a medical condition may be performed by a clinician treating a patient and also constitute management of the personal behavior of the patient themselves.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claim 1 recites the additional elements of a) the therapeutic being a digital therapeutic, and b) a computing device recited as used to present the digital therapeutic.
Figure 7 and paragraphs 127, 179, and 180 describe computing devices used to present lessons as including phones, tablet computers, desktop computers, or laptop computers. Figure 8 and paragraphs 180-184 additionally describe a central nCBT system providing the lessons as a system including one or more CPUs, GPUs, and storage devices and which communicates over a network. The computing device is construed accordingly as encompassing generic computing devices.
Paragraph 74 states that “[i]n an embodiment, the digital therapeutic may be downloaded to a patient's smartphone to deliver nutritional-CBT,” while paragraphs 127 and 128 describe the lessons and activities as interactive media including text, audio recordings, and video recordings. The “digital” therapeutic is construed accordingly as encompassing the display of media on the computing device.
Each of the above elements amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. The computing device is only recited at a high level of generality as used to present the digital therapeutic while the digital therapeutic is likewise only recited as lessons and interactive skill-based activities presented on a computing device.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claim 1 only recites the computing device and digital therapeutic as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f)
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claim 2 recites wherein the therapeutic further presents 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. These limitations fall within the scope of the abstract idea as set out above.
Claim 2 further recites the additional element of the therapeutic being a digital therapeutic.
As cited above, paragraph 74 states that “[i]n an embodiment, the digital therapeutic may be downloaded to a patient's smartphone to deliver nutritional-CBT,” while paragraphs 127 and 128 describe the lessons and activities as interactive media including text, audio recordings, and video recordings. The “digital” therapeutic is construed accordingly as encompassing the display of media on the computing device.
The recitation of the therapeutic as a “digital” therapeutic only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the digital therapeutic is only recited at a high level of generality as “digital” and as presenting the goals to the user. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 3 recites interacting with the user so that the user either accepts the one or more treatment goals or identifies other treatment goals. These limitations fall within the scope of the abstract idea as set out above.
Claim 4 recites wherein the therapeutic comprises a treatment plan, the method further comprising, responsive to an extent to which the user achieves one or more treatment goals, dynamically adjusting the treatment plan. These limitations fall within the scope of the abstract idea as set out above.
Claim 4 further recites the additional element of the therapeutic being a digital therapeutic.
As cited above, paragraph 74 states that “[i]n an embodiment, the digital therapeutic may be downloaded to a patient's smartphone to deliver nutritional-CBT,” while paragraphs 127 and 128 describe the lessons and activities as interactive media including text, audio recordings, and video recordings. The “digital” therapeutic is construed accordingly as encompassing the display of media on the computing device.
The recitation of the therapeutic as a “digital” therapeutic only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the digital therapeutic is only recited at a high level of generality as “digital” and as comprising a treatment plan. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 5 recites wherein the user has a cardiometabolic disorder selected from the group consisting 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. These limitations fall within the scope of the abstract idea as set out above.
Claim 6 recites wherein one or more of the plurality of lessons is specific to treating type-2 diabetes. These limitations fall within the scope of the abstract idea as set out above.
Claim 7 recites wherein one or more of the plurality of lessons 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. These limitations fall within the scope of the abstract idea as set out above.
Claim 8 recites providing one or more personalized notifications and communicating the one or more personalized notifications to the user via the therapeutic, the one or more personalized notifications selected from the group consisting of reminders, nudges, and rewards. These limitations fall within the scope of the abstract idea as set out above.
Claim 8 further recites the additional element of the therapeutic being a digital therapeutic.
As cited above, paragraph 74 states that “[i]n an embodiment, the digital therapeutic may be downloaded to a patient's smartphone to deliver nutritional-CBT,” while paragraphs 127 and 128 describe the lessons and activities as interactive media including text, audio recordings, and video recordings. The “digital” therapeutic is construed accordingly as encompassing the display of media on the computing device.
The recitation of the therapeutic as a “digital” therapeutic only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the digital therapeutic is only recited at a high level of generality as “digital” and at a high level of generality as used to communicate the notifications to the user. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 9 recites wherein the reminders comprise push notifications to the user regarding one of the plurality of lessons or at least one activity, the nudges comprising notifications to the user to direct the user to a next lesson or activity, or to direct the user to complete or initiate an undone therapy lesson or activity, and the rewards comprise one or more acknowledgements of successful completion of a lesson or activity, or one or more milestones relating to one or more meals, one or more activities, one or more medications, or one or more biometrics of the user. These limitations fall within the scope of the abstract idea as set out above.
Claim 10 recites providing a progress overview. These limitations fall within the scope of the abstract idea as set out above.
Claim 10 further recites the additional element of the computing device used to provide the progress overview.
As cited above, Figure 7 and paragraphs 127, 179, and 180 describe computing devices used to present lessons as including phones, tablet computers, desktop computers, or laptop computers. Figure 8 and paragraphs 180-184 additionally describe a central nCBT system providing the lessons as a system including one or more CPUs, GPUs, and storage devices and which communicates over a network. The computing device is construed accordingly as encompassing generic computing devices.
The recited computing device only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the computing device is only recited at a high level of generality as “providing” the progress overview and is disclosed as encompassing generic computer hardware. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 11 recites responsive to receiving lesson completion data, generating or recommending one or more new lessons of the therapeutic. These limitations fall within the scope of the abstract idea as set out above.
Claim 11 further recites the additional element of the therapeutic being a digital therapeutic.
Paragraph 74 states that “[i]n an embodiment, the digital therapeutic may be downloaded to a patient's smartphone to deliver nutritional-CBT,” while paragraphs 127 and 128 describe the lessons and activities as interactive media including text, audio recordings, and video recordings. The “digital” therapeutic is construed accordingly as encompassing the display of media on the computing device.
The above element only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the digital therapeutic is only recited at a high level of generality as including the lessons and disclosed as digital content presented via a computing device. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 12 recites responsive to receiving activity completion data, generating or recommending one or more new activities of the therapeutic. These limitations fall within the scope of the abstract idea as set out above.
Claim 12 further recites the additional element of the therapeutic being a digital therapeutic.
Paragraph 74 states that “[i]n an embodiment, the digital therapeutic may be downloaded to a patient's smartphone to deliver nutritional-CBT,” while paragraphs 127 and 128 describe the lessons and activities as interactive media including text, audio recordings, and video recordings. The “digital” therapeutic is construed accordingly as encompassing the display of media on the computing device.
The above elements only amount to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the digital therapeutic is only recited at a high level of generality as including the activity and disclosed as digital content presented via a computing device. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 14 recites administering an effective amount of any one or more of: metformin, sulfonylureas, sglt2 inhibitors, glp-1 analogues, insulin, dpp-4 inhibitors, thiazolidinediones, meglitinides, glipizide, glimepiride, glyburide, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin, saxagliptin, linagliptin, alogliptin, canagliflozin, dapagliflozin, empagliflozin, liraglutide, semaglutide, tirzepatide, acarbose, insulin glulisine, insulin lispro, insulin aspart, insulin glargine, insulin detemir, insulin isophane, colesevelam, bromocriptine, or pramlintide. These limitations fall within the scope of the abstract idea as set out above.
Claim 15 recites wherein the user is taking a medication for type 2 diabetes, the medication selected from any one of: metformin, sulfonylureas, sglt2 inhibitors, glp-1 analogues, insulin, dpp-4 inhibitors, thiazolidinediones, meglitinides, glipizide, glimepiride, glyburide, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin, saxagliptin, linagliptin, alogliptin, canagliflozin, dapagliflozin, empagliflozin, liraglutide, semaglutide, tirzepatide, acarbose, insulin glulisine, insulin lispro, insulin aspart, insulin glargine, insulin detemir, insulin isophane, colesevelam, bromocriptine, or pramlintide. These limitations fall within the scope of the abstract idea as set out above.
Claim 16 recites determining the improvement in the hemoglobin A1c and/or the liver fat of the user after the treatment period. These limitations fall within the scope of the abstract idea as set out above.
Claims 1-12 and 14-16 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Appelbaum et al (US Patent Application Publication 2022/0051773) in view of Paull et al (WO 2022/086781).
With respect to claim 1, Appelbaum discloses the claimed method of treating type 2 diabetes or liver disease in a user ([163] and [166] describes treating individuals with type-2 diabetes), the method comprising:
presenting, via a computing device, a digital therapeutic during a treatment period, the digital therapeutic comprising a plurality of lessons based on nutritional cognitive behavioral therapy for improving hemoglobin A1c and/or liver fat of the user ([7], [39], [82], [159], and [166]-[173] describe an app presenting lessons to a user on a mobile device; [109] and [163]-[165] describe the app as providing behavioral therapy and cognitive training involving “identifying and measuring maladaptive thoughts based on misinformed or false underlying core beliefs (e.g., those related to macronutrient fears, the hedonic nature of eating, physical exertion, other perceived barriers to changing lifestyle) that lead to disease-promoting behaviors; 2) replacing these maladaptive core beliefs and thought patterns with adaptive ways of thinking developed from rational reflection; 3) providing collaborative (between participant and device) construction of behavioral exercises to test core beliefs; and 4) using additional validated behavioral techniques to enhance a participant's capacity to solve problems, plan behaviors, and cope with interfering emotions or thoughts”, as well as identification, assessment, and self-examination of diabetes-related beliefs. This description is construed as describing a form of cognitive behavioral therapy addressing the user’s nutrition; Figure 2, [146], [148], [163], and [181] identify the modules as cognitive behavioral therapy modules for reducing HbA1c and as being presented over treatment periods such as 90-days), the plurality of lessons corresponding to at least one interactive skill-based activity ([166] and [172] describe users completing skill-based exercises related to the lessons);
receiving lesson completion data ([194] describes tracking the number of therapy lessons completed);
transmitting a prompt directing the user to adjust at least one of a dietary intake or a physical-activity behavior ([8], [39], [61], [82], [172], and [173] describe providing diet and exercise tasks to the user);
wherein 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 ([146], [148], [163], [181], and [192]-[195] describe the therapy regimen providing the diet and exercise tasks and lessons to reduce the user’s HbA1C value by a percentage vs beginning baseline value, where Examiner notes that “at least a percent” is encompassed by ≥0.4%; Figure 2 shows an expected HbA1c improvement of 1.3% from the patient’s baseline. Furthermore, while the cited art teaches this limitation, Examiner notes that the recitation of “wherein 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” only constitutes an intended purpose or outcome of the lesson, especially given that the improvement is recited in the context of the lessons based on nutritional cognitive behavioral therapy being “for improving” hemoglobin A1c and/or the liver fat, and does not serve to further limit the claim in view of the prior art);
but does not expressly disclose:
submitting, by the user via the digital therapeutic, a treatment goal during at least one portion of the treatment period, and
transmitting the prompt responsive to lesson completion data.
However, Paull teaches that it was old and well known in the art of patient education before the effective filing date of the claimed invention to have a user submit a treatment goal via a digital therapeutic during a treatment period (Figures 18A-18D, [157], and [362] describe providing a user with a menu of goal choices as well as fields for the user to enter custom inputs) and to transmit a prompt responsive to lesson completion data (Figures 9B, 9C, 18A-18D, [241], [243], [244], and [362] describe requiring that a user confirm completion of particular lessons before the app will transmit information on adjusting diet and exercise, such as via eating routine/exercise goals and lessons of eating patterns and physical activity. Examiner notes that the broadest reasonable construction of “responsive to lesson completion data” includes requiring lesson completion data as a prerequisite. Figures 11A and 11B, [246], and [338]-[341] provide another example of transmitting a prompt for a user to complete an activity responsive to lesson completion data).
Therefore it would have been obvious to one of ordinary skill in the art of patient education before the effective filing date of the claimed invention to modify the system of Appelbaum to have a user submit a treatment goal via a digital therapeutic during a treatment period and to transmit a prompt responsive to lesson completion data as taught by Paull since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Appelbaum already discloses treatment goals as well as both receiving lesson completion data and transmitting prompts directing the user to adjust at least one of a dietary intake or a physical-activity behavior, and having the user submit the treatment goal and transmitting the prompts responsive to the lesson completion data as taught by Paull would perform those same functions in Appelbaum, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 2, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
wherein the digital therapeutic further presents 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 ([50], [67], [109], [120], [159], [173] describe presenting goals, including diet and exercise routines, minutes of exercise, number of meals consumed, and medication adherence).
With respect to claim 3, Appelbaum/Paull teach the method of claim 2. Appelbaum does not expressly disclose interacting with the user so that the user either accepts the one or more treatment goals or identifies other treatment goals.
However, Paull teaches that it was old and well known in the art of patient education before the effective filing date of the claimed invention to interact with a user so that the user either accepts one or more treatment goals or identifies other treatment goals (Figures 18A-18D, [157], and [362] describe providing a user with a menu of goal choices as well as fields for the user to enter custom inputs).
Therefore it would have been obvious to one of ordinary skill in the art of patient education before the effective filing date of the claimed invention to modify the combination of Appelbaum and Paull to interact with a user so that the user either accepts one or more treatment goals or identifies other treatment goals as taught by Paull since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Appelbaum and Paull already teaches presenting one or more treatment goals corresponding to one or more selections, and interacting with the user so that the user either accepts the one or more treatment goals or identifies other treatment goals as taught by Paull would perform that same function in Appelbaum and Paull, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 4, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
wherein the digital therapeutic comprises a treatment plan, the method further comprising, responsive to an extent to which the user achieves one or more treatment goals, dynamically adjusting the treatment plan (Figure 2, [48], [66], [67], and [173] describe adjusting a patient’s treatment based on the patient accomplishing assigned tasks or parts of the therapy and/or based on a medication score determined using accomplishment of tasks or parts of the therapy).
With respect to claim 5, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
wherein the user has a cardiometabolic disorder selected from the group consisting 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 ([142], [146], and [163] describe users having type-2 diabetes; [12], [110] describes users as having any of hypertension, obesity, dyslipidemia, and hyperlipidemia).
With respect to claim 6, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
wherein one or more of the plurality of lessons is specific to treating type-2 diabetes ([163]-[165], and [167]-[173] describe the lessons specific to type-2 diabetes and providing instructions on understanding, improving, and controlling beliefs, behaviors, personal barriers, agency, hedonic eating, macronutrient fears, maladaptive patterns, exercise, and others).
With respect to claim 7, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
wherein one or more of the plurality of lessons 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 ([139], [163]-[165], and [167]-[173] describe the lessons specific to type-2 diabetes and providing instructions on understanding, improving, and controlling beliefs, behaviors, personal barriers, agency, hedonic eating, macronutrient fears, maladaptive patterns, exercise, and others).
With respect to claim 8, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
providing one or more personalized notifications and communicating the one or more personalized notifications to the user via the digital therapeutic, the one or more personalized notifications selected from the group consisting of reminders, nudges, and rewards ([159] and [166] describe the app asking patients to perform actions such as completing a new behavioral module each week or reporting diet and exercise behaviors, medication adherence, and biometrics each day, which may be construed as either reminders or “nudges”).
With respect to claim 9, Appelbaum/Paull teach the method of claim 8. Appelbaum further discloses:
wherein:
the reminders comprise push notifications to the user regarding one of the plurality of lessons or at least one activity,
the nudges comprising notifications to the user to direct the user to a next lesson or activity, or to direct the user to complete or initiate an undone therapy lesson or activity ([159] and [166] describe the app asking patients to perform actions such as completing a new behavioral module each week or reporting diet and exercise behaviors, medication adherence, and biometrics each day, which may be construed as either reminders or “nudges”), and
the rewards comprise one or more acknowledgements of successful completion of a lesson or activity, or one or more milestones relating to one or more meals, one or more activities, one or more medications, or one or more biometrics of the user.
With respect to claim 10, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
providing, via the computing device, a progress overview ([21], [22], [41], [42], and [50] describe providing the patient with a health score and other information representing their progress which is generated by a machine learning model).
With respect to claim 11, Appelbaum/Paull teach the method of claim 10. Appelbaum further discloses:
receiving lesson completion data ([194] describes tracking the number of therapy lessons completed), and generating or recommending one or more new lessons of the digital therapeutic ([159], [166], [173], and [174] describe recommending new therapy lesson each week);
but does not expressly disclose:
generating or recommending the one or more new lessons responsive to receiving lesson completion data.
However, Paull teaches that it was old and well known in the art of patient education before the effective filing date of the claimed invention to generate or recommend one or more new lessons responsive to receiving lesson completion data ([248], [249], [252]-[254], [256], and [257] describe a machine learning model determining whether a user should progress to a further lesson or revisit previous lessons before progressing, as well as adjusting the order and/or content of intervention modules provided).
Therefore it would have been obvious to one of ordinary skill in the art of patient education before the effective filing date of the claimed invention to modify the combination of Appelbaum and Paull to generate or recommend one or more new lessons responsive to receiving lesson completion data as taught by Paull since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Appelbaum and Paull already teaches recording information on lesson completion and generating or recommending new lessons, and generating or recommending the new lessons responsive to lesson completion data as taught by Paull would perform that same function in Appelbaum and Paull, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 12, Appelbaum/Paull teach the method of claim 10. Appelbaum further discloses:
receiving activity completion data ([8], [50], and [194] describe tracking the number of skills modules completed) and generating or recommending one or more new activities of the digital therapeutic ([166], [172], and [173] describe recommending a new skill-based exercise each week);
but does not expressly disclose:
generating or recommending the one or more new activities responsive to receiving activity completion data.
However, Paull teaches that it was old and well known in the art of patient education before the effective filing date of the claimed invention to generate or recommend one or more new activities responsive to receiving activity completion data ([191]-[193], [226], [248], [249], [252]-[254], and [256]-[257] describe therapy modules including skill-activities and a machine learning model determining whether a user should progress further or revisit previous modules and practice skills before progressing).
Therefore it would have been obvious to one of ordinary skill in the art of patient education before the effective filing date of the claimed invention to modify the combination of Appelbaum and Paull to generate or recommend one or more new activities responsive to receiving activity completion data as taught by Paull since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Appelbaum and Paull already teaches recording information on activity completion and generating or recommending new activities, and generating or recommending the new activities responsive to activity completion data as taught by Paull would perform that same function in Appelbaum and Paull, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 14, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
administering an effective amount of any one or more of: metformin, sulfonylureas, sglt2 inhibitors, glp-1 analogues, insulin, dpp-4 inhibitors, thiazolidinediones, meglitinides, glipizide, glimepiride, glyburide, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin, saxagliptin, linagliptin, alogliptin, canagliflozin, dapagliflozin, empagliflozin, liraglutide, semaglutide, tirzepatide, acarbose, insulin glulisine, insulin lispro, insulin aspart, insulin glargine, insulin detemir, insulin isophane, colesevelam, bromocriptine, or pramlintide (Figure 2 shows a patient taking metformin and liraglutide; [9]-[12] describe a patient taking sulfonylureas, meglitinides, and thiazolidinediones; [9], [11], and [65] describe a clinician adjusting a user’s medication, i.e. administering an effective amount).
With respect to claim 15, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
wherein the user is taking a medication for type 2 diabetes, the medication selected from any one of: metformin, sulfonylureas, sglt2 inhibitors, glp-1 analogues, insulin, dpp-4 inhibitors, thiazolidinediones, meglitinides, glipizide, glimepiride, glyburide, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin, saxagliptin, linagliptin, alogliptin, canagliflozin, dapagliflozin, empagliflozin, liraglutide, semaglutide, tirzepatide, acarbose, insulin glulisine, insulin lispro, insulin aspart, insulin glargine, insulin detemir, insulin isophane, colesevelam, bromocriptine, or pramlintide (Figure 2 shows a patient taking metformin and liraglutide; [9]-[12] describe a patient taking sulfonylureas, meglitinides, and thiazolidinediones).
With respect to claim 16, Appelbaum/Paull teach the method of claim 1. Appelbaum further discloses:
after the treatment period, determining the improvement in the hemoglobin Alc and/or the liver fat of the user (Figure 2, [148], [161], [181], and [195] describe collecting HbA1c at intervals such as 90-days and 180-days, and at the end of the treatment period).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zaharia et al, Improving Insulin Sensitivity, Liver Steatosis And Fibrosis In Type 2 Diabetes By A Food‑Based Digital Education Assisted Lifestyle Intervention Program A Feasibility Study;
Park et al, Testing a Digital Health App for Patients With Alcohol-Associated Liver Disease: Mixed Methods Usability Study;
Canonico et al, Cognitive Behavioral Therapy Delivered Via Digital Mobile Application For the Treatment of Type 2 Diabetes: Rationale, Design, and Baseline Characteristics of a Randomized, Controlled Trial;
Catani et al (US Patent Application Publication 2015/0364057);
Petrov (US Patent Application Publication 2016/0086509);
Iyer et al (US Patent Application Publication 2022/0084646);
Appelbaum et al (US Patent Application Publication 2019/0074080);
Appelbaum et al (US Patent Application Publication 2018/0315499).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM G LULTSCHIK whose telephone number is (571)272-3780. The examiner can normally be reached 9am - 5pm.
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/Gregory Lultschik/Examiner, Art Unit 3682
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