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 .
Status of Claims
Claims 1-20 were previously pending and subject to a non-final Office Action having a notification date of March 2, 2026 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on June 2, 2026 (the “Amendment”), amending claims 1, 4, 6, and 8 and canceling claims 2, 3, 19, and 20.
The present Final Office Action addresses pending claims 1 and 4-18 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112
These rejections are withdrawn in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
In relation to the claim rejections under 35 USC 101 set forth in the non-final Office Action, these rejections are now withdrawn when currently pending claims 1 and 4-18 are considered in view of the 2019 Revised Patent Subject Matter Eligibility Guidance (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 update issued by the USPTO as incorporated into the MPEP) and Applicant’s remarks in the Amendment.
Specifically, while the independent claims include limitations that recite at least one mental process abstract idea (e.g., managing a treatment regimen for a GLP1 agonist for achieving a predetermined target weight for a patient), they also recite a treatment step (e.g., treating obesity in a patient via administering a dose of a GLP1 agonist to the patient in a treatment regimen and, in conjunction with the administration of the dose of the GLP1 agonist, engaging in a directed digital therapeutic program a) including a behavioral regimen configured to manage patient weight loss and b) that synchronizes a timing of the behavioral regimen with a timing of the administration of the dose of the GLP1 agonist all to achieve the predetermined target weight for the patient) that is particular and integrates the mental analysis steps into a practical application, has more than a nominal or insignificant relationship to the abstract idea, and is not merely extra-solution activity or a field of use. MPEP 2106.04(d)(2).
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §103
Applicant’s arguments are moot in view of the new grounds of rejection as necessitated by the Amendment.
Claim Objections
Claim 16 is objected to because of the following informalities: Because claim 16 recites a "second" upper calorie intake threshold and a "second" lower patient satiety threshold, it appears that claim 16 should depend from claim 15 which recites a "first" upper calorie intake threshold and a "second" lower patient satiety threshold rather than from claim 8. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries 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.
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, 4, 5, 8, 10, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2023/0386677 to Ferro et al. ("Ferro") in view of U.S. Patent No. 8,410,047 to Bock et al. ("Bock"):
Regarding claim 1, Ferro discloses a method for treating obesity in a patient ([0002], [0009], [0010], [0081]-[0085], [0093], [0098]-[0102], [0106]-[0107] disclose use of a system including a computer-vision techniques and virtual proctoring platform that monitors/manages patients administering weight loss drugs associated with a weight loss treatment program (which can be for treating obesity per [0078]), the method comprising:
administering a dose of a [weight loss drug] to the patient in a treatment regimen ([0093], [0098] disclose administering a dosage of a weight loss drug to the patient as part of a weight loss treatment program); and,
in conjunction with the administration of the dose of [the weight loss drug], engaging in a directed digital therapeutic program, that comprises a behavioral regimen configured to manage weight loss…., and that manages the treatment regimen for the [weight loss drug] ([0057], [0071], [0089], [0098]-[0102], [0106]-[0107], [0140]-[0145] discuss how the platform can engage with the patient to collect patient data; determine whether the patient is correctly administering the drug dosage, predict future weight loss/gain of the patient; dynamically adjust the patient's treatment plan (behavioral regimen); generate and send messages to the patient with recommendations regarding dosing changes (managing treatment regimen for the weight loss drug), behavioral changes/eating/sleep/exercises (behavioral regimens), etc. (collectively, a directed digital therapeutic program including a behavioral regimen for managing weight loss and the treatment regimen for the weight loss drug)) with the objective of achieving a predetermined target weight for the patient ([0082] discloses how the platform leverages 3D models and anthropometric measurements of the patient to manage the patient over the course of the weight loss treatment program while [0056]-[0057] discloses how the 3D models can be based on an input target weight for the patient; therefore, the objective is achieving a predetermined target weight for the patient; also, [0110] discloses desired weight loss).
However, Ferro might be silent regarding the weight loss drug specifically being a GLP1 agonist and the digital therapeutic program specifically synchronizing a timing of the behavioral regimen with a timing of the administration of the dose of the GLP1 agonist.
Nevertheless, Bock teaches (1:16-18; 5:59-67) that it was known in the weight management drug administration art to coordinate administration of a GLP-1 agonist in connection with a meal (a behavioral/caloric intake regimen), such as up to four hours before/after a meal, up to 3 hours before/after a meal, etc. in order to effectively treat obesity by decreasing appetite, increasing or maintaining metabolic rate, or the like (3:36-41; 5:24-43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the weight loss drug of Ferro to be a GLP1 agonist as taught by Bock because such agonists are known to treat obesity by addressing satiety in patients, because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention, and because there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the digital therapeutic program of Ferro to specifically synchronize a timing of the behavioral regimen with a timing of the administration of the dose of the GLP1 agonist similar to as taught by Bock in order to effectively treat obesity by decreasing appetite, increasing or maintaining metabolic rate, or the like. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 4, the Ferro/Bock combination discloses the method of claim 1, further including wherein the behavioural regimen comprises a calorie intake regimen and/or a physical activity regimen ([0057] of Ferro discloses how the behavioral recommendations can include exercises (physical activity regimen); also, [0140]-[0145] of Ferro disclose various PT/exercise programs (physical activity regimen)).
Regarding claim 5, the Ferro/Bock combination discloses the method of claim 1, further including wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
receiving a patient initial weight ([0056] of Ferro discloses determining current user inputs such as the patient's current weight); and
setting a calorie intake regimen based on the patient initial weight and the target weight ([0057] of Ferro discloses determining recommended caloric intake based on the current user inputs (i.e., which includes the patient's current weight per [0056] of Ferro) and the input targets (which includes the target weight per [0056] of Ferro).
Regarding claim 8, the Ferro/Bock combination discloses the method of claim 5, further including wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
receiving patient progress data comprising one or more of: patient weight loss data, patient calorie intake data, patient motivation score, patient satiety score, patient side effect data and patient activity data ([0100], [0111] of Ferro disclose adjusting the drug dose based on patient weight loss data);
adjusting a GLP1 dosage of the treatment regimen and/or the calorie intake regimen based on the patient progress data ([0100], [0111] of Ferro disclose adjusting the drug dose (which is a GLP1 agonist per the above combination with Bock) based on patient weight loss data).
Regarding claim 10, the Ferro/Bock combination discloses the method of claim 8, further including wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
during a weight loss phase of the treatment, adjusting a GLP1 dosage of the treatment regimen and/or the calorie intake regimen based on the patient progress data ([0100], [0111] of Ferro disclose adjusting the drug dose (which is a GLP1 agonist per the above combination with Bock) based on observed/predicted patient weight loss data (during a weight loss phase of the treatment)) to provide a weight loss trajectory towards the target weight ([0111] discloses how the adjustment is in accordance with the weight loss treatment plan while [0082] discloses how the platform leverages 3D models and anthropometric measurements of the patient to manage the patient over the course of the weight loss treatment program and [0056]-[0057] discloses how the 3D models can be based on an input target weight for the patient; adjusting the dosage "in accordance with the weight loss treatment plan" in [0111] is to move the patient's weight to the "target weight" (i.e., provide a weight loss trajectory towards the target weight)).
Regarding claim 17, the Ferro/Bock combination discloses the method of claim 8, further including wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
increasing a GLP1 dosage of the treatment regimen if: the patient weight loss data represents a weight loss that is less than an acceptable weight loss trajectory; the patient calorie intake data represents a calorie intake greater than a third upper calorie intake threshold; or the patient satiety score is less than a third lower patient satiety threshold ([0100], [0111] of Ferro discloses adjusting the drug administered to the patient (which is a GLP1 agonist per the above combination with Bock) based on observed/predicted patient weight loss data in accordance with the weight loss plan such as by lowering the drug dosage if the patient is making rapid weight loss progress; accordingly, if the patient is not making rapid weight loss progress (patient weight loss data represents a weight loss that is less than an acceptable weight loss trajectory), then the drug dosage would instead be increased).
Regarding claim 18, the Ferro/Bock combination discloses the method of claim 8, further including wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
decreasing a GLP1 dosage of the treatment regimen if: the patient weight loss data represents a weight loss greater than an acceptable weight loss trajectory; or the patient side effect data is representative of a level of side effects greater than a side effect intolerance threshold ([0100], [0111] of Ferro discloses adjusting the drug administered to the patient (which is a GLP1 agonist per the above combination with Bock) based on observed/predicted patient weight loss data in accordance with the weight loss plan such as by lowering the drug dosage if the patient is making rapid weight loss progress (patient weight loss data represents a weight loss that is greater than an acceptable weight loss trajectory)).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2023/0386677 to Ferro et al. ("Ferro") in view of U.S. Patent No. 8,410,047 to Bock et al. ("Bock"), and further in view of U.S. Patent App. Pub. No. 2021/0052703 to Yu et al. ("Yu"):
Regarding claim 6, the Ferro/Bock combination discloses the method of claim 1, further including wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
setting a calorie intake ([0057] of Ferro discloses determining recommended caloric intake)…
However, the Ferro/Bock combination appears to be silent regarding setting a calorie intake allowance of a calorie intake regimen based on a GLP1 dosage of the treatment regimen.
Nevertheless, Yu teaches ([0022]) that it was known in the weight management art to administer a low-calorie diet (calorie intake allowance of a calorie intake regimen) along with a dose of a GLP-1 agonist to effectively treat overweight patients such as those with type 2 obesity.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set a calorie intake allowance of a calorie intake regimen based on a GLP1 dosage of the treatment regimen in the system of the Ferro/Bock combination similar to as taught by Yu to effectively treat overweight patients such as those with type 2 obesity. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 7, the Ferro/Bock/Yu combination discloses the method of claim 6, further including wherein the method sets a timing of the calorie intake regimen in accordance with a timing of a satiety effect of the GLP1 dosage (Bock teaches (1:16-18; 5:59-67) coordinating administration of a GLP-1 agonist (and thus its satiety effect per 2:35-67; 4:19-30) in connection with a meal (a caloric intake regimen), such as up to four hours before/after a meal, up to 3 hours before/after a meal, etc. in order to effectively treat obesity by decreasing appetite, increasing or maintaining metabolic rate, or the like (3:36-41; 5:24-43); similar to as discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the method of the Ferro/Bock/Yu combination to set a timing of the calorie intake regimen in accordance with a timing of a satiety effect of the GLP1 dosage similar to as taught by Bock to effectively treat obesity by decreasing appetite, increasing or maintaining metabolic rate, or the like. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2023/0386677 to Ferro et al. ("Ferro") in view of U.S. Patent No. 8,410,047 to Bock et al. ("Bock"), and further in view of U.S. Patent App. Pub. No. 2020/0168310 to Westin et al. ("Westin"):
Regarding claim 9, the Ferro/Bock combination discloses the method of claim 8, but appears to be silent regarding adjusting the GLP1 dosage if an elapsed time exceeds a dosage effect time threshold.
Nevertheless, Westin teaches ([0128]-[0135] and steps 212, 214, 216 in Figure 2) that it was known in the prescription dosage parameter evaluation art to assess whether a symptom score is less than a threshold after a predetermined period of time and to determine further dosage parameters (i.e., adjust dosage parameters) if the symptom score is not less than the threshold after the predetermined time. In other words, if the symptom score is not less than the threshold after the predetermined period of time, this indicates that the elapsed time has exceeded a time for the prescription dosage to have a particular reduction in symptoms (i.e., have an "effect") and thus that the dosage parameters are to be adjusted. This arrangement advantageously facilitates administration of accurate doses of medicaments for patients and reduces side effects that can otherwise occur from over/under/imprecise dosing ([0001], [0003], [0007]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the GLP1 dosage of the Ferro/Bock combination if an elapsed time exceeds a dosage effect time threshold similar to as taught by Westin to advantageously facilitate administration of accurate doses of medicaments for patients and reduce side effects that can otherwise occur from over/under/imprecise dosing. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2023/0386677 to Ferro et al. ("Ferro") in view of U.S. Patent No. 8,410,047 to Bock et al. ("Bock"), and further in view of U.S. Patent App. Pub. No. 2018/0108272 to Ahmad et al. ("Ahmad"):
Regarding claim 11, the Ferro/Bock combination discloses the method of claim 8, but appears to be silent regarding wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by transitioning from a weight loss phase to a weight maintenance phase if the patient weight loss data indicates a rate of weight loss has been less than a threshold weight loss rate for a period of time exceeding a stability time threshold.
Nevertheless, Ahmad teaches that it was known in the weight management art for a health coaching system and mobile application to provide personalized, machine-automated coaching (i.e., provide a digital therapeutic program) to a user in relation to weight loss programs ([0025]-[0029]) and to classify the user as being in a fat burn stage (weight loss phase) or a neutral phase (weight maintenance phase) ([0061], [0098], Figures 7-9). For instance, when the user's weight is stable over a particular time period without any aberrant readings (which would necessarily correspond to a rate of the user's weight loss being less than some threshold weight loss for a period of time exceeding a "stability time threshold"), the system transitions the user from the fat burn (weight loss) stage to the fat neutral (weight maintenance) phase ([0098] and Figures 7-9) which advantageously keeps the user apprised of their progress to allow the user to more effectively manage their weight ([0132]-[0134]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the digital therapeutic program of the Ferro/Bock combination to manage the patient weight loss and the treatment regimen by transitioning from a weight loss phase to a weight maintenance phase if the patient weight loss data indicates a rate of weight loss has been less than a threshold weight loss rate for a period of time exceeding a stability time threshold similar to as taught by Ahmad to advantageously keep the user apprised of their progress to allow the user to more effectively manage their weight, because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention, and because there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2023/0386677 to Ferro et al. ("Ferro") in view U.S. Patent No. 8,410,047 to Bock et al. ("Bock"), further in view of U.S. Patent App. Pub. No. 2002/0025972 to Hinz ("Hinz"):
Regarding claim 12, the Ferro/Bock combination discloses the method of claim 8, but appears to be silent regarding wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
during a weight maintenance phase of the treatment, adjusting a GLP1 dosage of the treatment regimen and/or the calorie intake regimen based on the patient progress data to maintain the patient weight within a threshold range of the target weight.
Nevertheless, Hinz teaches that it was known in the weight management art to administer a weight loss medication to a patient over a period of time to induce weight loss ([0043]-[0055]) and to maintain the patient on lower doses of the medication (adjust the dosage) after the patient reaches the goal/target weight as part of long term maintenance (during a weight maintenance phase of treatment) to prevent weight regain ([0065]) (to maintain the patient within a threshold range of the target weight) to advantageously provide comprehensive pharmacologic therapy for treatment of obesity which is flexible to a patient's needs through the provision of an effective therapeutic range of weight loss medication ([0021]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the digital therapeutic program of the Ferro/Bock combination to manage the patient weight loss and the treatment regimen by: during a weight maintenance phase of the treatment, adjusting a GLP1 dosage of the treatment regimen and/or the calorie intake regimen based on the patient progress data to maintain the patient weight within a threshold range of the target weight similar to as taught by Hinz to advantageously provide comprehensive pharmacologic therapy for treatment of obesity which is flexible to a patient's needs through the provision of an effective therapeutic range of weight loss medication. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 13, the Ferro/Bock combination discloses the method of claim 8, but further including wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
during a weight loss phase of the treatment or a weight maintenance phase of the treatment, adjusting a GLP1 dosage of the treatment regimen ([0100], [0111] of Ferro disclose adjusting the drug dose (which is a GLP1 agonist per the above combination with Bock) based on observed/predicted patient weight loss data (during a weight loss phase of the treatment))…
However, the Ferro/Bock combination might be silent regarding such GLP1 dosage adjusting being to maintain the patient satiety within a threshold patient satiety range.
Nevertheless, Hinz teaches that it was known in the weight management art to administer a weight loss medication to a patient over a period of time to induce weight loss via appetite suppression/satiety ([0043]-[0055]) and to maintain the patient on lower doses of the medication (adjust the dosage) after the patient reaches the goal/target weight as part of long term maintenance (during a weight maintenance phase of treatment) to prevent weight regain ([0065]) (which would thus necessarily maintain the patient's satiety within some threshold patient satiety range as the weight loss medication induces suppression/satiety as noted per [0043]-[0055]) to advantageously provide comprehensive pharmacologic therapy for treatment of obesity which is flexible to a patient's needs through the provision of an effective therapeutic range of weight loss medication ([0021]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the adjustment of the GLP1 dosage of the Ferro/Bock combination to maintain the patient satiety within a threshold patient satiety range similar to as taught by Hinz to advantageously provide comprehensive pharmacologic therapy for treatment of obesity which is flexible to a patient's needs through the provision of an effective therapeutic range of weight loss medication. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2023/0386677 to Ferro et al. ("Ferro") in view of U.S. Patent No. 8,410,047 to Bock et al. ("Bock"), and further in view of Int'l Pub. No. WO 2008/072056 to Gossellin et al. ("Gossellin"):
Regarding claim 14, the Ferro/Bock combination discloses the method of claim 8, but appears to be silent regarding wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
during a drug withdrawal phase of the treatment, reducing a GLP1 dosage of the treatment regimen and adjusting the calorie intake regimen based on the patient progress data to maintain the patient weight within a threshold range of the target weight and stop administration of the GLP1 agonist.
Nevertheless, Gossellin teaches (20:3-8) that it was known in the weight management art to reduce a dosage of a weight loss medication and adjust caloric intake/feeding regimens to stabilize and maintain weight reductions achieved at the end of a weight loss phase (which corresponds to a target weight per 10:4-5) before discontinuation of the drug to advantageously treat a subject suffering from obesity with an amount of a weight loss drug effective to induce weight loss but low enough to reduce negative side effects (1:33-37).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the digital therapeutic program of the Ferro/Bock combination to manage the patient weight loss and the treatment regimen by: during a drug withdrawal phase of the treatment, reducing a GLP1 dosage of the treatment regimen and adjusting the calorie intake regimen based on the patient progress data to maintain the patient weight within a threshold range of the target weight and stop administration of the GLP1 agonist similar to as taught by Gossellin to advantageously treat a subject suffering from obesity with an amount of a weight loss drug effective to induce weight loss but low enough to reduce negative side effects. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2023/0386677 to Ferro et al. ("Ferro") in view of U.S. Patent No. 8,410,047 to Bock et al. ("Bock"), and further in view of Int'l Pub. No. WO 2016/0196766 to Lundin ("Lundin"):
Regarding claim 15, the Ferro/Bock combination discloses the method of claim 8, but appears to be silent regarding wherein the digital therapeutic program manages the patient weight loss and the treatment regimen by:
increasing a calorie intake allowance of the calorie intake regimen if:
the patient calorie intake data represents a calorie intake greater than a first upper calorie intake threshold;
the patient motivation score is less than a motivation score threshold; or
the patient satiety/hunger score is less than a first lower patient satiety threshold.
Nevertheless, Lundin teaches ([0090[) that it was known in the weight management art to increase a user's food allowance to motivate the dieter to be active (which necessarily connotes that the user's motivation "score" is less than some motivation score "threshold") to advantageously avoid exercise-induced muscle loss due to insufficient energy intake.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the digital therapeutic program of the Ferro/Bock combination to manage the patient weight loss and the treatment regimen by: increasing a calorie intake allowance of the calorie intake regimen if: the patient motivation score is less than a motivation score threshold similar to as taught by Lundin to advantageously avoid exercise-induced muscle loss due to insufficient energy intake. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Neither the Ferro/Bock combination nor any other prior art appears to further disclose or suggest
the digital therapeutic program to manage the patient weight loss and the treatment regimen by: increasing a calorie intake allowance of the calorie intake regimen and increasing a GLP 1 dosage of the treatment regimen if: the patient calorie intake data represents a calorie intake greater than a second upper calorie intake threshold; the patient motivation score is less than a motivation score threshold; or the patient satiety score is less than a second lower patient satiety threshold.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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