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 .
The present Office Action is in response to the Request for Continued Examination dated 11 March 2026.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 March 2026 has been entered.
DETAILED ACTION
In the RCE filed 11 March 2026:
Claims 10-19 are cancelled
Claims 1, 4-7, 9 are amended
Claim 20 is new
Claims 1,3-7, 9 and 20 are pending
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 1,3-7, 9 and 20 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, 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites methods, which are within a statutory category.
Step 2A1
The limitations of:
Claims 1 and 20 (Claim 20 being representative)
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 a care coordination program through the resilience score satisfying a care coordination threshold;
determining an inflammatory bowel disease (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, wherein determining the IBD severity score comprises evaluating one or more objective clinical criteria selected from the group consisting of:
a presence or absence of deep ulcers identified by colonoscopy, a history of IBD-related hospitalization within a defined period, a steroid dependent disease or steroid use within a defined prior period, and a current or historical use of a biologic, small molecule, or immunomodulator, or lack of symptomatic improvement following exposure thereto;
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) tracking remote symptoms or subject reported outcomes 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;
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) tracking remote symptoms or subject reported outcomes associated with IBD, (iii) application of one or more digital behavioral health maintenance and prevention tools associated with IBD, and (iv) 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 remote symptoms or subject reported outcomes 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 remote symptoms or subject reported outcomes 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;
selecting, based on the prioritizing, a specific therapeutic intervention from the time- limited care plan, the specific therapeutic intervention comprising at least one of:
a cognitive behavioral therapy administered according to a predefined session schedule,
a goal-oriented self-management training program,
a positive psychology program,
and a dietary and nutrition optimization regimen implemented according to a defined dietary protocol,
and performing the selected specific therapeutic intervention on the subject over a defined treatment period and monitoring at least one measurable IBD-associated clinical parameter selected from:
an inflammatory biomarker level,
a frequency of bowel movement,
a hospitalization occurrence,
and a risk of IBD-related surgery,
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 claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to generate a treatment plan for IBD in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “determining, using, prioritizing, selecting and performing” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a method implemented by a data processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. 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 3-7, 9 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) 9 merely describe(s) using a questionnaire, which further defines the abstract idea.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1,3-7, 9 and 20, 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:
Amended claim I now further requires performing this specific therapeutic intervention over a defined treatment period and monitoring at least one specific measurable clinical parameter selected from: (i) an inflammatory biomarker level, (ii) a frequency of bowel movement, (iii) a hospitalization occurrence, and (iv) a rising risk of IBD-related surgery. This is no longer an ''apply it'' instruction. It is a defined therapeutic protocol selected through a structured clinical framework and affirmatively performed.
Amended claim 1 culminates in performing a selected specific therapeutic intervention and monitoring at least one measurable IBD-associated clinical parameter over a defined treatment period. This directly affects a physical disease state of the gastrointestinal tract. It is not merely data analysis; it is medical treatment.
The resilience score and IBD severity score are not ends in themselves. They are not claimed as informational outputs. They are (i) used to assign a category tied to defined care plans, (ii) used to prioritize time-limited care plans, (iii) used to select a specific therapeutic intervention, and (iv) followed by actual performance of that intervention. Thus, any evaluative or categorization component is operationally tethered to a defined therapeutic act.
The prior ''apply it'' concern is resolved because amended claim I (i) does not leave treatment open-ended, (ii) does not permit a provider to select any unspecified intervention, (iii) requires selection from a defined group, (iv) requires adherence to predefined schedules, frequencies, or protocols, and (v) requires monitoring specific measurable disease indicators.
This level of specificity places the claim squarely within the category of therapeutic methods. Even if the Examiner maintains that some portion of the claim implicates ''organizing human activity," the claim as a whole recites significantly more. First, amended claim I is limited to a specific disease: Crohn' s disease. Second, the amended claim I includes objective clinical inputs: the IBD severity score must be based on defined, objective medical findings. Third, amended claim I has specifically defined therapeutic interventions. Amended claim I requires a cognitive behavioral therapy administered according to a predefined session schedule, a goal-oriented self-management training program, a positive psychology program, or a dietary and nutrition optimization regimen implemented according to a defined dietary protocol. Fourth, amended claim I is performed over a defined treatment period. Fifth, amended claim I requires monitoring of measurable clinical parameters. In detail, claim I requires monitoring at least one of the following measurable IBD-associated clinical parameters: (i) inflammatory biomarker level, (ii) frequency of bowel movements, (iii) hospitalization occurrence, or (iv) rising risk of IBD-related surgery. This transforms the claim from abstract planning into concrete medical practice.
Amended claim I does not preempt all methods of treating Crohn' s disease, all uses of resilience scoring, all IBD severity stratification systems, all behavioral therapies, or all dietary interventions. It claims a specific integrated framework culminating in defined therapeutic performance and monitoring.
Regarding (a-e), the Examiner respectfully disagrees. The steps argued to treat the disease, except for the nutrition optimization, do not actually treat the disease, they treat the symptoms of the disease. Thus, they are not a particular treatment and represent an “apply it” step. The disease and nutrition optimization nutrition regimen does not provide enough claimed detail such that a person having skill in the art would recognize this as a particular treatment; there is no detail in the claim at all as to what the regime is or how it would treat the particular disease (Crohn’s disease). This too represents an “apply it” step.
Regarding (f), the Examiner respectfully disagrees with Applicant’s assertion. MPEP 2106.04(I) states that “questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B).” Thus, pre-emption concerns are fully addressed and made moot upon application of the two-part Alice Corp. subject matter eligibility analysis, as provided in the basis of rejection. Further, by definition, the claimed invention would preempt the identified abstract idea.
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:
Lewis et al (US Publication No. 20180166174) discloses a method for determining the chronic or specific disease risk level of a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN C EDOUARD whose telephone number is (571)270-0107. The examiner can normally be reached M-F 730 - 430.
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/JONATHAN C EDOUARD/Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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