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 .
DETAILED ACTION
Claim(s) 2, 18-19 are cancelled
Claim(s) 1, 10, 14, 16 are amended
Claim(s) 1,3-17 are pending
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 14 August 2025 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Subject Matter Free of Prior Art
Claim(s) 1,3-17 recite subject matter that is free of prior art. In particular, the cited prior art of record fails to teach or suggest the combination of:
Claim 1, 10 describe(s) categorizing the patient into defined categories depending on the resilience score and severity score, as well as the care plan associated with each category.
Claim 10 describe(s) removing a patient from a care plan if the resilience score falls below a threshold and continuing the tracking of resilience after a period of time.
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 1,3-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method, which are within a statutory category. The limitations of:
Claim 1
determining a resilience score, within a range of resilience scores, for the subject, wherein each of a plurality of different resilience domain assessments of the subject contribute to the resilience score;
using the resilience score to enlist the subject in an IBD care coordination program through the resilience score satisfying a care coordination threshold determining an IBD severity score, within a range of IBD severity scores, for the subject based, at least in part, on a risk for one or more IBD complications or surgery to alleviate IBD;
using both the resilience score and the IBD severity score to assign the subject to a category in a plurality of categories, wherein each category in the plurality of categories is associated with a unique combination of a sub-range of the range of resilience scores and a sub- range of the range of IBD severity scores and wherein the plurality of categories consists of a first category, a second category, a third category, and a fourth category, wherein:
the first category comprises a combination of a low resilience score and a high IBD severity score, and is associated with a care plan comprising (i) enrollment in a resilience program, (ii) close disease monitoring of the subject, (iii) tracking one or more of remote symptoms, subject reported outcomes, and biomarkers of the subject associated with IBD, (iv) application of one or more digital behavioral health maintenance and prevention tools associated with IBD, and (v) educational content customized to the subject the second category comprises a combination of a high resilience score and a high IBD severity score, and is associated with a care plan comprising (i) periodic resilience score reassessment, (ii) close disease monitoring of the subject, (iii) tracking one or more of remote symptoms, subject reported outcomes, and biomarkers of the subject associated with IBD, (iv) application of one or more digital behavioral health maintenance and prevention tools associated with IBD, and (v) featured educational content the third category comprises a combination of a low resilience score and a low IBD severity score, and is associated with a care plan comprising (i) enrollment in a resilience program, (ii) tracking one or more of remote symptoms, subject reported outcomes, and biomarkers of the subject associated with IBD, (iii) application of one or more digital behavioral health maintenance and prevention tools associated with IBD, and (iv) educational content customized to the subject;
and the fourth category comprises a combination of a high resilience score and a low IBD severity score and is associated with a care plan comprising (i) periodic resilience score reassessment, (ii) tracking one or more of remote symptoms, subject reported outcomes, and biomarkers of the subject associated with IBD, (iii) application of one or more digital behavioral health maintenance and prevention tools associated with IBD, and (iv) featured educational content; determining at least one time-limited care plan, at a first time point, for the subject based upon the identity of the assigned category within the plurality of categories;
prioritizing the at least one time-limited care plan by an outcome of one or more resilience domain assessments in the plurality of different resilience domain assessments;
and treating the subject with a one time-limited care plan in the at least one time-limited care plan.
Claim 10
determining a resilience score, within a range of resilience scores, for the subject, wherein each of a plurality of different resilience domain assessments of the subject contribute to the resilience score;
using the resilience score to determine whether to enlist the subject in an IBD care coordination program, wherein:
when the resilience score fails to satisfy a care coordination threshold, the subject is not enlisted in the IBD care coordination program, and when the resilience score satisfies the care coordination threshold, the method further comprises performing the IBD care coordination program by a procedure comprising:
determining an IBD severity score, within a range of IBD severity scores, for the subject based, at least in part, on a risk for one or more IBD complications or surgery to alleviate IBD;
using both the resilience score and the IBD severity score to assign the subject to a category in a plurality of categories, wherein each category in the plurality of categories is associated with a unique combination of a sub-range of the range of resilience scores and a sub-range of the range of IBD severity scores;
determining at least one time-limited care plan, at a first time point, for the subject based upon the identity of the assigned category within the plurality of categories;
and prioritizing the at least one time-limited care plan by an outcome of one or more resilience domain assessments in the plurality of different resilience domain assessments, wherein the resilience score satisfies the care coordination threshold and the subject is treated with a one time-limited care plan in the at least one time-limited care plan and wherein the method further comprises: repeating the determining the resilience score after a first predetermined period has elapsed since the first time point, wherein: when the resilience score fails to satisfy the care coordination threshold, the subject is removed from the IBD care coordination program;
when the resilience score fails to satisfy the care coordination threshold and the subject exhibits indications of low resilience, the subject is reassessed to determine an updated resilience score after a second predetermined period has elapsed;
and when the resilience score continues to satisfy the care coordination threshold, the IBD care coordination program is continued.
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claimed invention amounts to managing personal behavior or interaction between people. The claim encompasses treating a patient of IBD by determining resilience score and determining a treatment plan in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
With regards to the analysis of a practical application and/or significantly more, there are no additional elements as they claim is purely directed to an abstract idea.
Claims 3-9,11-17 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 3-7 merely describe(s) resilience domains, which further defines the abstract idea.
Claim(s) 8, 17 merely describe(s) the care plan, which further defines the abstract idea.
Claim(s) 9 merely describe(s) using a questionnaire, which further defines the abstract idea.
Claim(s) 11 merely describe(s) removing the patient from a care plan, which further defines the abstract idea.
Claim(s) 12 merely describe(s) specific inflammatory bowel diseases, which further defines the abstract idea.
Claim(s) 13-16 merely describe(s) ibd severity, which further defines the abstract idea.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1,3-17, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
Cites Vanda Pharmaceuticals Inc v. West-Ward Pharmaceuticals, “method of treatment”. Applicant submits that claims 1 and 10 similarly recite a method of treatment claim that is not "directed to" a judicial exception under step 1 of the Alice test. In particular, claims 1 and 10 are directed to treating the subject with a one time-limited care plan. Claim 8 specifies, for example, that this care plan is a cognitive behavioral therapy, a low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet, or a self-directed hypnosis.
Regarding (a), the Examiner respectfully disagrees. Initially, Claim 10 does not recite a treatment and thus this argument is inapplicable to Claim 10. Claim 1 does not recite a particular treatment at all. There is no indication as to what the treatment is, the amount of treatment, timing of treatment, or anything else that would provide particularity. See MPEP 2106.04(d)(2). The currently-claimed treatment is an “apply it” step because it is merely an instruction to a care provider to apply whatever treatment they feel is proper.
and Claim 10 doesn’t have a treatment step. Unless a particular treatment is being administered in the independent claims, no particular treatment can be found.
Rejection under 35 U.S.C. § 102/103
Regarding the rejection of Claims 1,3-17, the Examiner has amended the independent claims to include subject matter free of art from claim 2. Therefore, Claims 1 and 10 are subject matter free of art.
Conclusion
The prior art made of record and not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
BORODY et al (US Publication No. 20200113949) discloses methods and treatment regimens for treating ulcerative colitis in a subject in need.
Angelides et al (US Publication No. 20200168315) discloses systems and methods for capturing crowd wisdom to be tested for individualized treatment plans.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/JONATHAN C EDOUARD/Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683