DETAILED ACTION
Status
This communication is in response to the application filed on 6 March 2025. Claims 1-20 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 .
Priority
Applicant’s claim for the benefit under 35 U.S.C. 119(e) to U.S. Provisional Application No. 63/562,908, filed on 8 March 2024, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 25 August 2025 was filed after the mailing date of the application on 6 March 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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; receive a first measure of a biological marker from a first member of the population, wherein the biological marker correlates to the chronic medical condition; receive a second measure of the biological marker from the first member; identify that the first member has an increasing level of the biological marker; analyze a plurality of communications in the DCN between the members of the population; determine at least one communication from a second member of the population that includes an experience of the second member regarding an intervention to decrease the level of the biological marker; and present the at least one communication from the second member to the first member.
Independent claims 15 and 17 are analyzed in the same manner as claim 1 since claim 15 only additionally indicating a particular type of medical condition (“prodromal chronic systemic inflammation (CSI)” – which is indicated at dependent claim 2), and claim 17 is broader than claim 1 since eliminating the first and fifth elements of claim 1 as well as some phrasing at elements 6 and 7 of claim 1.
The dependent claims (claims 2-14, 16, and 18-20) appear to be encompassed by the abstract idea of the independent claims since they merely indicate a particular type of medical condition or disease (claims 2, 14, 16, and 18), receiving a third 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 the 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
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion).
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.
NOTICE
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 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.
Claim Rejections - 35 USC § 103
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 of this title, 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.
Claims 1-5, 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (U.S. Patent Application Publication No. 2021/0134461) in view of Tran et al. (U.S. Patent Application Publication No. 2018/0001184, hereinafter Tran).
Claim 1: Neumann discloses 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 (see Neumann at least at, e.g., ¶ 0023, network and network interface, where “[e]xamples of a network include, but are not limited to, a wide area network (e.g., the Internet, an enterprise network), a local area network (e.g., a network associated with an office, a building, a campus or other relatively small geographic space), a telephone network, a data network associated with a telephone/voice provider (e.g., a mobile communications provider data and/or voice network), a direct connection between two computing devices, and any combinations thereof. A network may employ a wired and/or a wireless mode of communication”; citation hereafter by number only) ;
receive a first measure of a biological marker from a first member of the population, wherein the biological marker correlates to the chronic medical condition (0031, “a biological marker 120 may include any result of any medical test, physiological assessment, cognitive assessment, psychological assessment, or the like. System 100 may receive at least a biological marker 120 from one or more other devices; system 100 may alternatively or additionally perform one or more assessments and/or tests to obtain at least a biological marker 120, and/or one or more portions thereof, on system 100. For instance, at least biological marker 120”);
receive a second measure of the biological marker from the first member (0123, “For instance in non-limiting illustrative examples, simulation machine-learning process 1144 may output a prognosis that contains a numerical value that is a percent decrease in a biological marker that was associated with a diagnostic 1112 that a treatment was expected to address” – indicating an intervention, i.e., treatment, was provided as a communication, 0137, “Computing device 104 is further configured to receive updated biological marker 120 data, where updated biological marker 120 data is more recent in time than when a first user data, compute, using the classification machine-learning model 1104 and the updated biological marker data 1156, a numerical difference between a first figure of merit of the first prognosis with an updated figure of merit, and determine a prognosis state as a function of a numerical difference between the first figure of merit and the updated figure of merit”);
determine at least one communication from a second member of the population that includes an experience of the second member regarding an intervention to decrease the level of the biological marker (0123, “output a prognosis that contains a numerical value that is a percent decrease in a biological marker that was associated with a diagnostic 1112 that a treatment was expected to address”); and
present the at least one communication from the second member to the first member (0123, “For instance in non-limiting illustrative examples, simulation machine-learning process 1144 may output a prognosis that contains a numerical value that is a percent decrease in a biological marker that was associated with a diagnostic 1112 that a treatment was expected to address” – indicating an intervention, i.e., treatment, was provided/presented as a communication).
Neumann, however, does not appear to explicitly disclose identify that the first member has an increasing level of the biological marker; analyze a plurality of communications in the DCN between the members of the population. Where Neumann indicates a percent decrease in a biological marker (see Neumann at 0123), Tran teaches a “system [that] enables a medical model that separates patients into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient based on their predicted response or risk of disease” (Tran at 0151), where “as the system finds increasing patterns as well as obtains feedback in pattern recognizer, the system may evaluate the effectiveness of intervention(s)” (Tran at 0269), via “analyzing spatial communications with the user such as emails and social network postings when linked with variations in geospatial activity, sleep duration” and “the progress or failure in the treatment can be reviewed, and the system can make recommendations on ways to improve the treatment based on the totality of data received for the patient and from a population of similar patients” (Tran at 0398) and that “data can be generated for various blood sugar level and treatments provided to the patients suffering from same or substantially similar level of diabetes. The diabetes disease analytic data 900 shows the different levels of blood sugar (for both men and women) such as for example, but not limited to, 50, 100, 150, 200, 250, and the like, and the treatments provided to the majority of patients having similar or same levels of diabetes” (Tran at 0440). Therefore, the Examiner understands and finds that to identify increasing levels, analyze communications, and apply the analysis to similar levels is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to tailor the intervention(s) to the individual patient based on their predicted response.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the condition treatment of Neumann with the tailoring of Tran in order to identify increasing levels, analyze communications, and apply the analysis to similar levels so as to tailor the intervention(s) to the individual patient based on their predicted response.
The rationale for combining in this manner is that to identify increasing levels, analyze communications, and apply the analysis to similar levels is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to tailor the intervention(s) to the individual patient based on their predicted response as explained above.
Claim 2: Neumann in view of Tran discloses the method of claim 1, wherein the chronic medical condition is at least one of chronic systemic inflammation (CSI) and prodromal CSI (Neumann at 0045, diabetes, cardiovascular, 0076, rheumatoid arthritis, 0105 and 0107, diabetes; Tran at 0208, obesity and diabetes).
Claim 3: Neumann in view of Tran discloses the method of claim 1, further comprising: receive a third measure of the biological marker from the first member; and identify that the first member has a decreasing level of the biological marker based on the third measure of the biological marker and the second measure of the biological marker (Neumann at 0123, “For instance in non-limiting illustrative examples, simulation machine-learning process 1144 may output a prognosis that contains a numerical value that is a percent decrease in a biological marker that was associated with a diagnostic 1112 that a treatment was expected to address”).
Claim 4: Neumann in view of Tran discloses the method of claim 1, further comprising: receive a third measure of the biological marker from the first member; identify that the first member at least one of the same or an increasing level of the biological marker based on the third measure of the biological marker and the second measure of the biological marker; and analyze communications in the DCN between the members of the population; determine at least one communication from a third member of the population that includes an experience of the third member regarding an intervention to decrease the level of the biological marker; and present the at least one communication from the third member to the first member (Neumann at 0023, 0031, 0123, 0137; Tran at 0151, 0269, 0398, 0440, as at the combination above and using the rationale as at the combination above).
Claim 5: Neumann in view of Tran discloses the method of claim 1, wherein the at least one communication comprises a plurality of communications from a plurality of members, and wherein the method further comprises: prioritizing the plurality of communications based on the level of the biological marker and the information about the first member; and present the plurality of communications to the first member in a prioritized order based on the prioritization (Tran at 0440, as at the combination above and using the rationale as at the combination above).
Claim 9: Neumann in view of Tran discloses the method of claim 4, wherein identifying the first member is based on an increase of the level of the biological marker between repeated tests (Neumann at 0023, 0031, 0123, 0137; Tran at 0151, 0269, 0398, 0440, as at the combination above and using the rationale as at the combination above).
Claim 10: Neumann in view of Tran discloses the method of claim 1, wherein the intervention is a pharmaceutical intervention (Neumann at 0042, “A ‘treatment,’ as used herein is any medication, pharmaceutical, surgery, medical intervention”, etc., 0107, “a treatment may be a prescription administered by a medical professional”).
Claim 11: Neumann in view of Tran discloses the method of claim 10, wherein the pharmaceutical intervention comprises weight loss drugs (Neumann at 0042, “A ‘treatment,’ as used herein is any medication, pharmaceutical, surgery, medical intervention”, etc.. 0046, “priority treatment that includes a treatment plan consisting of first addressing dietary issues”).
Claim 12: Neumann in view of Tran discloses the method of claim 1, wherein the intervention is a lifestyle intervention (Neumann at 0046, dietary issues, 0051, “initiate an anti-inflammatory diet”, 0052, “to place a first treatment facet that contains a diet low in uric acid ahead of a second treatment facet that contains a recommendation to initiate heavy metal detoxification).
Claim 13: Neumann in view of Tran discloses the method of claim 12, wherein the lifestyle intervention comprises at least one of: fasting, intermittent fasting, stress reduction. improving sleep behaviors, improving mood, reducing anxiety, improving relationships and dietary changes (Neumann at 0046, dietary issues, 0051, “initiate an anti-inflammatory diet”, 0052, “to place a first treatment facet that contains a diet low in uric acid ahead of a second treatment facet that contains a recommendation to initiate heavy metal detoxification).
Claim 14: Neumann in view of Tran discloses the method of claim 1, wherein the disease is at least one of:
a metabolic disease, such as obesity, diabetes, Cardiovascular disease, Complement Factor H, Chronic Kidney Disease, and Nonalcoholic steatohepatitis (Neumann at 0045, 0105, and 0107, diabetes; Tran at 0208, obesity and diabetes);
an autoimmune disease, such as, Rheumatoid arthritis, Crohn's disease, eczema, psoriasis, psoriatic arthritis, and Type 1 diabetes (Neumann at 0076, rheumatoid arthritis, 0105 and 0107; Tran at 0450, cardiovascular);
an inflammation moderated lung disease, such as, Chronic obstructive pulmonary disease and Asthma, and
an oncological disease (Tran at 0327, 0345, 0373, oncology drug regimens).
Claims 15-20 are rejected on the same basis as claims 1, 2, 3, and 14 above since Neumann discloses the same methods, including for prodromal CSI (i.e., delay of onset – see pertinent prior art as below, for claim 15; Neumann in view of Tran as cited above, and also Tran at 0153, “reduce the impact or delay the onset of certain diseases”) and metabolic syndrome (for claim 16) (Neumann at 0071, metabolism, Tran at 0335, 0338, 0396, metabolomic conditions, analysis, and tests
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Neumann in view of Tran in further view of Janigro et al. (U.S. Patent Application Publication No. 2019/0053744, hereinafter Janigro).
Claim 6: Neumann in view of Tran discloses the method of claim 1, but does not appear to explicitly disclose wherein a measure of the biological marker is received from an at home sampling kit provided to the first member for testing. Janigro, though, teaches that “Among the different reasons that made the use of brain biomarkers a holy grail for neurology, is the minimally invasive nature of the process required to obtain blood. While typically a venipuncture is required this is clearly less morbid than CSF sampling or use of intravascular contrast agents such as gadolinium or iodinated contrast agents. In addition, imaging modalities such as CT scans expose the patient to radiation. Last, but perhaps not least, is the cost differential between state-of-the-art medical imaging and a simple blood test. However practical a blood draw may be, it is preferred to use saliva as a biomarkers origin, for several reasons including the fact that sampling of saliva is usually economical, safe, easy and can be performed without the help of health care workers, allowing home-based sampling. Saliva contains little interference from other proteins, has virtually no cellular components, clotting or red blood cells, which improves the diagnostic approach because no centrifugation is required. The present invention utilizes considerations related to intrapersonal variability for blood biomarkers can be easily adapted to salivary markers, since the ratio saliva:blood can be estimated or experimentally determined, and an algorithm for such application was developed” (Janigro at 0016), as well as using a questionnaire to collect information (Janigro at 0050 and 0051, see also 0110). Therefore, the Examiner understands and finds that to use a home sampling kit, such as for blood and/or saliva collection as well as questionnaires (i.e., a psychosocial instrument) is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide relatively easy data collection with algorithms available to correlate the data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the condition treatment of Neumann in view of Tran with the home kit of Janigro in order to use a home sampling kit, such as for blood and/or saliva collection as well as questionnaires (i.e., a psychosocial instrument) so as to provide relatively easy data collection with algorithms available to correlate the data.
The rationale for combining in this manner is that to use a home sampling kit, such as for blood and/or saliva collection as well as questionnaires (i.e., a psychosocial instrument) is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide relatively easy data collection with algorithms available to correlate the data as explained above.
Claim 7: Neumann in view of Tran in further view of Janigro discloses the method of claim 6, wherein the at home sampling kit is configured to collect at least one of: blood and saliva (Janigro at 0016, 0050, 0051, 0110, as at the combination above and using the rationale as at the combination above).
Claim 8: Neumann in view of Tran in further view of Janigro discloses the method of claim 6, wherein the sampling kit is a psychosocial instrument (Janigro at 0016, 0050, 0051, 0110, as at the combination above and using the rationale as at the combination above).
Conclusion
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”
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685
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