DETAILED ACTION
Status
This Final Office Action is in response to the communication filed on 13 July 2026. Claims 2, 16, and 18 have been cancelled, claims 11, 3-5, 10, 12-15, 17, and 19-20 have been amended, and no new claims have been added. Therefore, claims 1, 3-15, 17, and 19-20 are pending and presented for examination.
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 .
Response to Amendment
A summary of the Examiner’s Response to Applicant’s amendment:
Applicant’s amendment does not overcome the rejection(s) under 35 USC § 101; therefore, the Examiner maintains the rejection(s) while updating phrasing in keeping with current examination guidelines.
Applicant’s amendment overcomes the rejection(s) under 35 USC §§ 102 and/or 103; therefore, the Examiner indicates allowability over the prior art.
Applicant’s arguments are found to be not persuasive; please see the Response to Arguments below.
Claim Interpretation
The Examiner notes that a “disease” is recited at dependent claims 14 and 16, where this is interpreted as being synonymous with a/the medical condition. Therefore, no rejection for lack of antecedent basis is currently being made. If, however, Applicant traverses this interpretation or indicates a disease as being different than/from a/the medical condition, the “new” interpretation that may then be required would be considered as based on the traversal and not a new grounds of rejection.
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.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to methods, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a method to manage progression of a chronic medical condition in an individual, the method comprising: providing a digital communication network (DCN) for members of a population to interact with each other and the DCN; receiving a first measure of a biological marker from a first member of the population, wherein the biological marker correlates to the chronic medical condition, the chronic medical condition comprising Crohn's disease and the biological marker comprises cytokines; receiving a second measure of the biological marker from the first member; identifying, based on a difference between the first measure and the second measure, that the first member has an increasing level of the biological marker; analyzing a plurality of communications in the DCN between the members of the population; determining, based on the increasing level of the biological marker of the first member, at least one communication from a second member of the population that includes an experience of the second member regarding dietary changes that decreased a level of the biological marker of the second member; generating a dietary change intervention comprising a change to the first member's diet based on decreasing a level of the biological marker of the first member and the experience of the second member regarding the dietary changes; presenting the dietary change intervention and the at least one communication from the second member to the first member receiving a third measure of the biological marker from the first member after implementation of the dietary change intervention; identifying, based on a difference between the third measure and the second measure, that the first member has at least one of the same or another increasing level of the biological marker; and generating an updated dietary change intervention comprising an updated change to the first member's diet to decrease the at least one of the same or another increasing level of the biological marker.
Independent claims 15 and 17 are analyzed in the same manner as claim 1 since claim 15 apparently only rephrases very slightly the “receiving a first measure …” limitation, and claim 17 is broader than claim 1 since eliminating the fifth element of claim 1 as well as some phrasing at some elements of claim 1.
The dependent claims (claims 3-14 and 19-20) appear to be encompassed by the abstract idea of the independent claims since they merely indicate a further condition or disease (claim 14), receiving a fourth measure to identify decreasing or increasing marker levels, including presenting a third member’s intervention communication (claims 3-4 and 19-20), prioritizing and presenting communications based on marker level (claim 5), using a home sample kit, including for blood and saliva and/or a psychosocial instrument (claims 6-8), identifying the member based on a marker level increase between repeated tests (claim 9), and/or a second intervention being pharmaceutical (including a weight loss drug), and/or a lifestyle (including fasting, intermittent fasting, stress reduction. improving sleep behaviors, improving mood, reducing anxiety, improving relationships and dietary changes) (claims 10-13).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of identifying and presenting a communication regarding an intervention purported to decrease a biological marker level; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Certain methods of organizing human activity (e.g. … commercial or legal interactions such as … advertising, marketing or sales activities/behaviors, or business relations; and/or managing personal behavior or relationships between people such as social activities, teaching, and following rules or instructions); and/or
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion).
Since the claims relate to passing on, or providing, recommendations from population members, the Examiner notes that the primary (or emphasized) grouping would appear to be certain methods of organizing human activities – the communications of others are (or would be) advertising or marketing foods or diet plans/changes, as well as the managing of personal behavior (such as diet) and the relationships between people regarding their recommendations made through social connections on the DCN. Although mental processes are implicated in the observations and evaluations of diet and its effects, the primary focus appears to be on the recommendations as noted above.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are providing a digital communication network (DCN) and using the DCN (for communication and data source) (at ;. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant ¶ 0102 (as submitted, 0104 as published) indicates that “an apparatus for performing these operations…. can be a general-purpose computer [such as] general-purpose machines employing one or more processors coupled to one or more computer readable medium.”
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore, the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Allowable Subject Matter
Claims 1, 3-15, 17, and 19-20 are indicated as allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
The closest art of record appears to be Neumann (U.S. Patent Application Publication No. 2021/0134461), indicating a DCN, measures of biomarkers, and the change in the biomarkers.
Tran et al. (U.S. Patent Application Publication No. 2018/0001184, hereinafter Tran) teaches modeling interventions and/or products to find response patterns to evaluate effectiveness, including using emails and social network postings for progress or failure review for patients having similar or same level of disease.
Sen (U.S. Patent Application Publication No. 2014/0280063) teaches a health prosumer (HP) agent, also referred to as HPA (where “prosumer” is a producer and/or consumer of information (Sen at 0021)) uses specified conditions, such as Crohn’s disease, for information input in a social network so as to analyze the information for performing and answering user queries (Sen at 0022, 0031, 0034).
Oh (U.S. Patent Application Publication No. 2016/0011207) discusses cytokines in relation to Crohn’s disease (Oh at 0080, 0097, 0104-0105 et. seq.).
However, it does not appear reasonable to combine the various references to arrive at the currently claimed invention.
Response to Arguments
Applicant's arguments filed 13 July 2026 have been fully considered but they are not persuasive.
Applicant first argues the 101 rejection (Remarks at 8-10), alleging that “the independent claims have the practical application of effecting a particular treatment for a disease, and in particular, Crohn's disease” (Id. at 9). MPEP § 2106.04(d)(2) indicates that “Examiners should keep in mind that in order to qualify as a ‘treatment’ or ‘prophylaxis’ limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition” and “When determining whether a claim applies or uses a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant.
a. The Particularity Or Generality Of The Treatment Or Prophylaxis ….
b. Whether The Limitation(s) Have More Than A Nominal Or Insignificant Relationship To The Exception(s) …. [and]
c. Whether The Limitation(s) Are Merely Extra-Solution Activity Or A Field Of Use”
The Examiner notes first that the abstract idea is analogous to people merely talking to each other (e.g., “when I had that condition, I did [ABC] and my [DEF] levels went from [XXX] to [YYY] – maybe you should try doing what I did”).
Second, any treatment is very general in nature – it is merely any suggested dietary change(s), without any apparent limitations or checking for validity (i.e., if the second member says they had decreased levels, it is apparently taken as absolutely true even if undocumented, a placebo effect, a paid-for influencer or advertiser testimonial, etc.).
Third, the dietary changes appear to have potentially or possibly have no more than a nominal or insignificant relationship to the exception – i.e., the providing of messages suggesting a dietary change as the abstract idea exception is not impacted by any potential treatment (i.e., implementing the dietary change). The claims specifically recite that the presented dietary change is implemented, but must have little or no impact – the difference between the third and second measure must be “the same or another increasing level”. The ensuing updated dietary change intervention is not required to be implemented.
Fourth, the abstract idea is the identifying and presenting of the recommendation – although the initial recommendation would appear to be required to be implemented, it is (as indicated above) required to be ineffective, and the updated suggestion for intervention is not implemented. This all appears to be merely extra-solution activity in relation to the presenting of the information.
Therefore, the Examiner is not persuaded by Applicant’s argument(s).
Applicant then argues the prior art rejections (Remarks at 10-12); however, the prior art rejections are withdrawn and the argument is therefore considered moot and not persuasive.
Conclusion
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 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hyperinsulinemia, Cleveland Clinic, dated 20 September 2022, downloaded from https://my.clevelandclinic.org/health/diseases/24178-hyperinsulinemia on 8 April 2026, indicating “Hyperinsulinemia happens when you have a higher amount of insulin in your blood than what's considered normal” and “In most cases, hyperinsulinemia results from insulin resistance, which happens when cells in your muscles, fat and liver don’t respond as they should to insulin. The development of insulin resistance typically increases insulin production (hyperinsulinemia) so that your body can maintain healthy blood sugar levels” (at 1).
Health and Psychosocial Instruments (HaPI), University of North Carolina Charlotte (UNCC), dated 8 January 2024, downloaded 8 April 2026 from https://library.charlotte.edu/health-and-psychosocial-instruments-hapi#:~:text=Health%20and%20Psychosocial%20Instruments%20(HaPI)%20is%20an%20essential%20database%20that,%2C%20communication%2C%20and%20organizational%20behavior, indicating “Health and Psychosocial Instruments (HaPI) is an essential database that provides in-depth information about behavioral measurement tools across a variety of disciplines, including medicine, nursing, public health, psychology, social work, sociology, communication, and organizational behavior.”
Frank et al., Stress in the Clinical Setting: The Brief Encounter Psychosocial Instrument, The Journal of Family Practice, Vol. 26, No. 5, pp. 533-539, 1988, downloaded 8 April 2026 from https://d1wqtxts1xzle7.cloudfront.net/45205599/Stress_in_the_clinical_setting_the_Brief20160429-19672-zf8gyk-libre.pdf?1461954984=&response-content-disposition=inline%3B+filename%3DStress_in_the_clinical_setting_the_Brief.pdf&Expires=1775674683&Signature=ZpwC6YwmFDHlg~r1TZED7Q-AunOfdi9Rqvfrq5Er62UW3lfVkvjCxTZzD3T81iHCn3sFC1Z17wYlPuMV7WWjgBOB6ZUBs5UsoH-yOMoCgm2WwztVQ7k0n3NzVR6hx42ldA96oUk~RCnI3hZ8IFkGDx8BiBfIwL6z3tIjptc0HJ5R0QrW~MmgZIXTidrerSb3KHomCyVFMrzDsbjGXP9mbzrfaA8sMa3kjX41xFLOAqYt5iNEJK8f5Jmfp7UAd5p0LZyio5HF5zWy60Pxl-YDaQamH~ALzjfuIdInylKsvxspI9Kl2rqb320KyRTEQL81TOLHtnQjNbF5p5gyw6b09A__&Key-Pair-Id=APKAJLOHF5GGSLRBV4ZA, indicating the development and introduction o the Brief Encounter Psychosocial Instrument (at Abstract).
Tabanelli et al., Available instruments for measurement of psychosocial factors in the work environment. Int Arch Occup Environ Health 82, 1–12 (2008). https://doi.org/10.1007/s00420-008-0312-6, downloaded 8 April 2026 from https://link.springer.com/article/10.1007/s00420-008-0312-6, indicating “A total of 33 instruments were identified (26 questionnaires, 7 observational), many (11 questionnaires, 5 observational) linked to national institutions/intiatives [sic]. Accessibility of relevant information (on the internet or elsewhere) regarding the instruments varied widely.” (at Abstract, Results).
r/lifehacks, Best things to take to reduce blood pressure? Reddit post and ensuing thread from “3y ago” (therefore posted in 2023), with responses from Mediocre_Pool_Rocket and others indicating various interventions such as “quit drinking”, stopping lisinipril, giving up caffeine, etc. (each at p. 1, but other suggestions continuing through other comments).
Prodrome definition and meaning, Merriam-Webster, downloaded 9 April 2026 from https://www.merriam-webster.com/dictionary/prodrome, indicating “symptoms that signal the impending onset of disease or illness”.
Słowińska-Solnica et al., Pro-inflammatory and anti-inflammatory cytokines as candidate markers in the diagnosis and assessment of Crohn's disease activity. Arch Med Sci. 2022 Aug 11;21(3):808-816. doi: 10.5114/aoms/152645. PMID: 40741265; PMCID: PMC12305762. Downloaded 9 September 2026 from https://pmc.ncbi.nlm.nih.gov/articles/PMC12305762/, indicating “We studied 49 CD patients assigned to the active (33 patients) and inactive (16 patients) disease subgroups and 31 healthy controls. Serum cytokines were measured using ELISA. Cytokine levels and their multiplication results were compared between the groups and their diagnostic characteristics were assessed.” (at Abstract, Material and methods) and “Serum IFN-γ, IL-19 and some of the results of the studied cytokine levels’ multiplication showed promising diagnostic performance in the diagnosis of CD and its active form” (at Abstract, Conclusions)
Hurtado-Lorenzo et al., Precision Nutrition Initiative: Toward Personalized Diet Recommendations for Patients With Inflammatory Bowel Diseases, Crohn's & Colitis 360, Volume 2, Issue 4, October 2020, otaa087, https://doi.org/10.1093/crocol/otaa087, downloaded 9 September 2026 from https://academic.oup.com/crohnscolitis360/article/2/4/otaa087/5930790, indicating “Diet has been consistently ranked by patients and caregivers through the IBD Partners crowdsourcing and voting process as one of the most critical research priorities in the field” (at p. 3).
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685
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