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 are pending in the present application with claims 1 and 19 being independent.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 16/860,665 and 17/851,164 (“Prior Applications”), fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of the present application.
Specifically, independent claims 1 and 19 (and thus dependent claims 2-18 and 20 by virtue of their dependency) in the present application recite one or more of a "digital therapeutic program," "predetermined target weight," and "calorie intake regimen." However, the Prior Applications do not disclose or support these limitations. Claims 1-20 in the present application also recite other limitations not disclosed or supported by the Prior Applications.
Accordingly, claims 1-20 of the present application are not entitled to the benefit of the Prior Applications and thus the effective filing date of claims 1-20 of the present application is June 5, 2023, the actual filing date of the present application.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 4, "GLP1" should be changed to --the GLP1--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 8-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the caloric intake regimen" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the caloric intake regimen" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claims 9-18 are rejected based on their dependency from claim 8.
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 1-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 1-19 are directed to a method (i.e., a process) and claim 20 is directed to an apparatus (i.e., a machine). Accordingly, claims 1-20 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A method for treating obesity in a patient, the method comprising:
administering a dose of a GLP1 agonist to the patient in a treatment regimen; and,
in conjunction with the administration of the dose of GLP1 agonist, engaging in a directed digital therapeutic program that manages patient weight loss and the treatment regimen for the GLP1 agonist with the objective of achieving a predetermined target weight for the patient.
The Examiner submits that the foregoing underlined limitations recite: (a) “certain methods of organizing human activity” because "managing" patient weight loss and a treatment regimen for the GLP1 agonist with the objective of achieving a predetermined target weight for the patient relates to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). These recitations, under their broadest reasonable interpretation, are similar to the concept of a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
Furthermore, the foregoing underlined limitations recite (b) “mental processes” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). For instance, a person could practically in their mind with pen and paper analyze various types of patient data (e.g., BG levels, weight progress data, etc.) and existing GLP1 agonist dosing/treatment schedules to monitor/determine adjusted GLP1 agonist dosing/schedules and/or various behavioral regimens (e.g., in relation to eating, exercise, etc.) with the objective of achieving a predetermined target weight for the patient. These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis found to be "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Representative independent claim 19 includes limitations that recite at least one abstract idea. Specifically, independent claim 19 recites:
A method for providing a co-therapy to a patient suffering from obesity, wherein the co-therapy comprises a GLP1 agonist for administering to the patient according to a treatment regimen and a digital therapeutic program comprising a behavioural regimen for administering using an electronic device, wherein the method comprises:
receiving personalised patient data;
setting a GLP1 dosage of the treatment regimen based on the personalised patient data;
setting a calorie intake regimen of the behavioural regimen based on the personalised patient data;
outputting the GLP1 dosage and the calorie intake regimen.
The Examiner submits that the foregoing underlined limitations recite: (a) “certain methods of organizing human activity” because receiving personalised patient data; setting a GLP1 dosage of the treatment regimen based on the personalised patient data; setting a calorie intake regimen of the behavioural regimen based on the personalised patient data; and outputting the GLP1 dosage and the calorie intake regimen as part of providing co-therapy to a patient suffering from obesity relates to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). These recitations, under their broadest reasonable interpretation, are similar to the concept of a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
Furthermore, the foregoing underlined limitations recite (b) “mental processes” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). For instance, a person could practically in their mind with pen and paper receive personalised patient data (e.g., via visually reviewing); set a GLP1 dosage of the treatment regimen based on the personalised patient data (e.g., via basic mental calculations); set a calorie intake regimen of the behavioural regimen based on the personalised patient data (e.g., via basic mental calculations); and output the GLP1 dosage and the calorie intake regimen (e.g., via writing it down). These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis found to be "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Accordingly, the claims recite at least one abstract idea.
Furthermore, dependent claims 2-18 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claim 2 recites a behavioural regimen for managing the patient weight loss which just further defines the at least one abstract idea discussed above.
-Claim 3 calls for synchronising a timing of the behavioural regimen with a timing of the administration of the dose of the GLP1 agonist which just further defines the at least one abstract idea discussed above.
-Claim 4 recites how behavioural regimen comprises a calorie intake regimen and/or a physical activity regimen which just further defines the at least one abstract idea discussed above.
-Claim 5 calls for managing the patient weight loss and treatment regimen by receiving a patient initial weight and setting a calorie intake regimen based on the patient initial weight and the target weight which just further defines the at least one abstract idea discussed above.
-Claim 6 calls for managing the patient weight loss and the treatment regimen by setting a calorie intake allowance of the calorie intake regimen based on a GLP1 dosage of the treatment regimen which just further defines the at least one abstract idea discussed above.
-Claim 7 calls for setting a timing of the calorie intake regimen in accordance with a timing of a satiety effect of the GLP1 dosage which just further defines the at least one abstract idea discussed above.
-Claim 8 calls for managing 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; and adjusting a GLP1 dosage of the treatment regimen and/or the calorie intake regimen based on the patient progress data which just further defines the at least one abstract idea discussed above.
Claim 9 calls for adjusting the GLP1 dosage if an elapsed time exceeds a dosage effect time threshold which just further defines the at least one abstract idea discussed above.
-Claim 10 calls for managing 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 to provide a weight loss trajectory towards the target weight which just further defines the at least one abstract idea discussed above.
-Claim 11 calls for managing 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 which just further defines the at least one abstract idea discussed above.
-Claim 12 calls for managing 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 which just further defines the at least one abstract idea discussed above.
-Claim 13 calls for managing 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 to maintain the patient satiety within a threshold patient satiety range which just further defines the at least one abstract idea discussed above.
-Claim 14 calls for managing 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 which just further defines the at least one abstract idea discussed above.
-Claim 15 calls for managing 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 which just further defines the at least one abstract idea discussed above.
-Claim 16 calls for managing the patient weight loss and the treatment regimen by increasing a calorie intake allowance of the calorie intake regimen and increasing a GLP1 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 which just further defines the at least one abstract idea discussed above.
-Claim 17 calls for managing 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 which just further defines the at least one abstract idea discussed above.
-Claim 18 calls for managing 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 which just further defines the at least one abstract idea discussed above.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
Independent Claim 1:
A method for treating obesity in a patient, the method comprising:
administering a dose of a GLP1 agonist to the patient in a treatment regimen (extra-solution activity as noted below, see MPEP § 2106.05(g)); and,
in conjunction with the administration of the dose of GLP1 agonist, engaging in a directed digital therapeutic program that (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)) manages patient weight loss and the treatment regimen for the GLP1 agonist with the objective of achieving a predetermined target weight for the patient.
Independent Claim 19:
A method for providing a co-therapy to a patient suffering from obesity, wherein the co-therapy comprises a GLP1 agonist for administering to the patient according to a treatment regimen (extra-solution activity as noted below, see MPEP § 2106.05(g)) and a digital therapeutic program comprising a behavioural regimen for administering using an electronic device (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)), wherein the method comprises:
receiving personalised patient data;
setting a GLP1 dosage of the treatment regimen based on the personalised patient data;
setting a calorie intake regimen of the behavioural regimen based on the personalised patient data;
outputting the GLP1 dosage and the calorie intake regimen.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the "digital therapeutic program" that facilitates management/administration of the weight loss/treatment/behavioral regimen, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of administering the dose of the GLP1 agonist to the patient suffering from obesity, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea because all uses of the abstract idea of managing a patient's treatment regimen of the GLP1 agonist require such GLP1 agonist to be administered to the patient (see MPEP § 2106.05(g)).
For these reasons, independent claims 1 and 19 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, independent claims 1 and 19 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claim 20: This claim calls for an apparatus including one or more processors and memory for carrying out the method of claim 19 which just amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, independent claims 1 and 19 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the "digital therapeutic program" that facilitates management/administration of the weight loss/treatment/behavioral regimen, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations directed to administering the dose of the GLP1 agonist to the patient suffering from obesity which the Examiner submits merely adds insignificant extra-solution activity to the abstract idea (see MPEP § 2106.05(g)) as discussed above, the Examiner has reevaluated this limitations and determined it to not be unconventional as it is a conventional manner of suppressing appetite as disclosed in the background of Applicant's specification at 3:8-18 and is the most popular medical option for significant weight loss effects as evidenced by NPL "Finding Diet Drugs That Work" at page 1.
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claim 20: This claim calls for an apparatus including one or more processors and memory for carrying out the method of claim 19 which just amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Therefore, claims 1-20 are ineligible under 35 USC §101.
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 1-5, 8, 10, and 17-20 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 App. Pub. No. 2025/0306033 to Acosta et al. ("Acosta"):
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 manages patient weight loss and the treatment regimen for the [weight loss drug] ([0057], [0071], [0089], [0098]-[0102], [0106]-[0107] 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; generate and send messages to the patient with recommendations regarding dosing changes, behavioral changes/eating/sleep/exercises, etc. (collectively, a directed digital therapeutic program that manages 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 appears to be silent regarding the weight loss drug specifically being a GLP1-agonist.
Nevertheless, Acosta teaches ([0066]) that it was known in the weight loss management art to administer a GLP-1 agonist to an obese patient with abnormal satiety to treat the obesity.
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 specifically be a GLP-1 agonist as taught by Acosta because GLP-1 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).
Regarding claim 2, the Ferro/Acosta combination discloses the method of claim 1, further including wherein the digital therapeutic program comprises a behavioural regimen for managing the patient weight loss ([0057], [0071] of Ferro disclose behavioral recommendations for the patient to manage the weight loss; also, [0140]-[0145] disclose various PT/exercise programs).
Regarding claim 3, the Ferro/Acosta combination discloses the method of claim 2, further including wherein the digital therapeutic program synchronises a timing of the behavioural regimen with a timing of the administration of the dose of the GLP1 agonist (while Ferro appears to be silent regarding wherein the digital therapeutic program specifically synchronises a timing of the behavioural regimen with a timing of the administration of the dose of the GLP1 agonist, Acosta nevertheless teaches (end of [0067]) that it was known in the healthcare informatics art to administer/perform pharmacotherapy agents (e.g., GLP-1 agonist per [0066]), before, after, or at the same time as (i.e., synchronize timing) one or more additional therapies such as increased physical activity, behavioral/lifestyle modifications, etc. ("behavioral regimen") which would advantageously allow for development of a weight loss approach that is best tailored to a particular patient thereby improving therapeutic outcomes. 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 to synchronise a timing of the behavioural regimen with a timing of the administration of the dose of the GLP1 agonist to advantageously allow for development of a weight loss approach that is best tailored to a particular patient thereby improving therapeutic outcomes, 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 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). 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)).
Regarding claim 4, the Ferro/Acosta combination discloses the method of claim 2, 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/Acosta 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/Acosta 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 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 GLP-1 agonist per the above combination with Acosta) based on patient weight loss data).
Regarding claim 10, the Ferro/Acosta 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 GLP-1 agonist per the above combination with Acosta) 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/Acosta 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 GLP-1 agonist per the above combination with Acosta) 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/Acosta 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 GLP-1 agonist per the above combination with Acosta) 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)).
Regarding claim 19, Ferro discloses a method for providing a co-therapy to a patient suffering from obesity ([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]), wherein the co-therapy comprises a [weight loss drug] for administering to the patient according to 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 a digital therapeutic program comprising a behavioural regimen for administering using an electronic device ([0057], [0071], [0089], [0098]-[0102], [0105]-[0107] 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; generate and send messages to the patient's user device (electronic device) with recommendations regarding dosing changes, behavioral changes/eating/sleep/exercises, etc. (collectively, a directed digital therapeutic program that manages weight loss and the treatment regimen for the weight loss drug)), wherein the method comprises:
receiving personalised patient data ([0010], [0088], and [0100] disclose obtaining patient data and determining/adjusting weight loss drug dosages);
setting a [weight loss drug] dosage of the treatment regimen based on the personalised patient data ([0010], [0088], and [0100] disclose obtaining patient data and determining/adjusting weight loss drug dosages);
setting a calorie intake regimen of the behavioural regimen based on the personalised patient data ([0057] of Ferro discloses determining recommended caloric intake based on the current user inputs (i.e., which includes the patient's current weight (personalized patient data) per [0056] of Ferro));
outputting the GLP1 dosage and the calorie intake regimen ([0106] discloses sending a message to the patient regarding the drug dosage and [0057] discloses providing the calorie intake regimen to the user).
However, Ferro appears to be silent regarding the weight loss drug specifically being a GLP1-agonist.
Nevertheless, Acosta teaches ([0066]) that it was known in the weight loss management art to administer a GLP-1 agonist to an obese patient with abnormal satiety to treat the obesity.
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 specifically be a GLP-1 agonist as taught by Acosta because GLP-1 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).
Regarding claim 20, Ferro discloses an apparatus (computing system 800 in Figure 8) comprising one or more processors (CPU 806) and computer readable memory (memory 810) including instructions (instructions in [0149]) which when executed by the one or more processors carry out the method of claim 19 (per the Ferro/Acosta combination as discussed in relation to claim 19).
Claim 6 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 App. Pub. No. 2025/0306033 to Acosta et al. ("Acosta"), and further in view of U.S. Patent App. Pub. No. 2021/0052703 to Yu et al. ("Yu"):
Regarding claim 6, the Ferro/Acosta 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/Acosta 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/Acosta 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.
Claim 7 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 App. Pub. No. 2025/0306033 to Acosta et al. ("Acosta") and U.S. Patent App. Pub. No. 2021/0052703 to Yu et al. ("Yu"), and further in view of U.S. Patent No. 8,410,047 to Bock et al. ("Bock"):
Regarding claim 7, the Ferro/Acosta/Bock combination discloses the method of claim 6, but appears to be silent regarding wherein the method sets a timing of the calorie intake regimen in accordance with a timing of a satiety effect of the GLP1 dosage.
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 (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)
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 method of the Ferro/Acosta/Bock 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 App. Pub. No. 2025/0306033 to Acosta et al. ("Acosta"), and further in view of U.S. Patent App. Pub. No. 2020/0168310 to Westin et al. ("Westin"):
Regarding claim 9, the Ferro/Acosta 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/Acosta 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 App. Pub. No. 2025/0306033 to Acosta et al. ("Acosta"), and further in view of U.S. Patent App. Pub. No. 2018/0108272 to Ahmad et al. ("Ahmad"):
Regarding claim 11, the Ferro/Acosta 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/Acosta 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 of U.S. Patent App. Pub. No. 2025/0306033 to Acosta et al. ("Acosta"), and further in view of U.S. Patent App. Pub. No. 2002/0025972 to Hinz ("Hinz"):
Regarding claim 12, the Ferro/Acosta 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/Acosta 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/Acosta 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 GLP-1 agonist per the above combination with Acosta) based on observed/predicted patient weight loss data (during a weight loss phase of the treatment))…
However, the Ferro/Acosta 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/Acosta 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 App. Pub. No. 2025/0306033 to Acosta et al. ("Acosta"), and further in view of Int'l Pub. No. WO 2008/072056 to Gossellin et al. ("Gossellin"):
Regarding claim 14, the Ferro/Acosta 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/Acosta 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 App. Pub. No. 2025/0306033 to Acosta et al. ("Acosta"), and further in view of Int'l Pub. No. WO 2016/0196766 to Lundin ("Lundin"):
Regarding claim 15, the Ferro/Acosta 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/Acosta 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686