DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/11/2025 was filed. 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 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 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
It is appropriate for the Examiner to determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance to the Subject Matter Eligibility Test as recited in the following Steps: 1, 2A, and 2B, see MPEP 2106(III.).
Patent Subject Matter Eligibility Test: Step 1:
First, the Examiner is to establish whether the claim falls within any statutory category including a process, a machine, manufacture, or composition of matter, see MPEP 2106.03(II.) and MPEP 2106.03(I).
Claims 1-20 are related to methods. Accordingly, these claims are all within at least one of the four statutory categories.
Patent Subject Matter Eligibility Test: Step 2A- Prong One:
Step 2A of the Subject Matter Eligibility Test demonstrates whether a clam is directed to a judicial exception, see MPEP 2106.04(I.). Step 2A is a two-prong inquiry, where Prong One establishes the judicial exception. Regarding Prong One of Step 2A, 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. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes, see MPEP 2106.04(II.)(A.)(1.) and 2106.04(a)(2).
Independent claim 19 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, claim 19 recites:
A method to manage adverse health conditions in a population, the method comprising:
providing a digital communication network (DCN) for a plurality of members of a population to interact with each other and the DCN;
transmitting an invitation to an individual member of the plurality of members to conduct a first test of a biological marker related to the adverse health condition;
providing instructions to the individual member to test the biological marker;
receiving, through the DCN, a first test result of the biological marker;
enabling the individual member to share the first test result with other members of the plurality of members through the DCN;
transmitting an invitation to the individual member to conduct a second test of the biological marker;
receiving, through the DCN, a second test result of the biological marker;
enabling the individual member to share at least one of the first test result, the second test result, and a difference in the first test result and the second test result with other members of the plurality of members through the DCN; and
prioritizing communications presented to the individual member from other members of the DCN that have levels of the biological marker which are improved over time.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity”, more specifically managing interactions between people as the following abstract limitations recite managing adverse health conditions in a population:
An invitation to an individual member of the plurality of members to conduct a first test of a biological marker related to the adverse health condition, which recites an abstract limitation of a communication to the member to invite them to conduct the test,
providing instructions to the individual member to test the biological marker, which is an abstract limitation of a communication of instructions to the member,
receiving a first test result of the biological marker, which is an abstract limitation of a communication of the first test result,
enabling the individual member to share the first test result with other members of the plurality of members, which is an abstract limitation of a communication of the individual member to the other members regarding sharing the result,
an invitation to the individual member to conduct a second test of the biological marker, which is an abstract limitation of a communication regarding conducting a second test to the individual member,
receiving a second test result of the biological marker, which is an abstract limitation of a communication for receiving the second test result,
enabling the individual member to share at least one of the first test result, the second test result, and a difference in the first test result and the second test result with other members of the plurality of members, which is an abstract limitation of a communication to other members of sharing the first, second, and difference in results,
prioritizing communications presented to the individual member from other members that have levels of the biological marker which are improved over time, which is an abstract limitation of a communication to others that is prioritized based on improved levels of biomarkers.
The claim limitations as a whole recite steps for managing adverse health conditions in a population, which recites social activity steps of communications between individuals and therefore recite managing interactions between people and is a certain method of organizing human activity.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., DCN) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 20 recites further limitations describing the biological marker as a chronic systemic inflammation level and an auto antibody level used in the above abstract steps, further describing the abstract idea.
Regarding claim 1:
A method to manage adverse health conditions in a population, the method comprising:
providing a digital communication network (DCN) for a plurality of members of a population to interact with each other and the DCN;
transmitting an invitation to an individual member of the plurality of members to test a biological marker related to the adverse health condition;
providing instructions to the individual member to test the biological marker;
receiving, through the DCN, a test result of the biological marker; and
enabling the individual member to share the test result with other members of the plurality of members through the DCN.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity”, more specifically managing interactions between people as the following abstract limitations recite managing adverse health conditions in a population:
An invitation to an individual member of the plurality of members to test a biological marker related to the adverse health condition, which recites an abstract limitation of a communication to the member to invite them to conduct the test,
providing instructions to the individual member to test the biological marker, which is an abstract limitation of a communication of instructions to the member,
receiving a test result of the biological marker, which is an abstract limitation of a communication of the test result,
enabling the individual member to share the test result with other members of the plurality of members, which is an abstract limitation of a communication of the individual member to the other members regarding sharing the result.
The claim limitations as a whole recite steps for managing adverse health conditions in a population, which recites social activity steps of communications between individuals and therefore recite managing interactions between people and is a certain method of organizing human activity.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., DCN) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claims 2, 3 recite further limitations describing the biological marker as a chronic systemic inflammation level and an auto antibody level and as related to different diseases used in the above abstract steps, further describing the abstract idea. Claims 4-6 recite further abstract limitations describing the instructions for sending the user a sampling kit to test the biological marker at home where the sampling kit collects stool and comprises of an accelerometer, further describing the abstract idea. Claim 7 recites further abstract limitations describing the prioritization of communications presented to the individual member that have levels of biological marker which are improved over time, further describing the abstract idea. Claim 8 recites further abstract limitations comprising prioritizing messages presented to the individual member which are from other members engaged in actions aimed at improving respective levels of their biological marker, further describing the abstract idea. Claim 9 recites further abstract limitations of an invitation to the individual member to conduct a subsequent test of the marker, further describing the abstract idea. Claim 10 recites further abstract limitations of determining a change in the marker based on test results and subsequent test results from the subsequent test, further describing the abstract idea. Claim 11 recites further abstract limitations reciting prioritizing messages as claims that are to be sent, further describing the abstract idea. Claim 12 recites further abstract limitations of generating the invitation algorithmically, further describing the abstract idea.
Regarding claim 15:
A method to manage adverse health conditions in a population, the method comprising:
providing a digital communication network (DCN) for a plurality of members of a population to interact with each other and the DCN;
transmitting an invitation to an individual member of the plurality of members to conduct a first test and at least a second test of a biological marker related to the adverse health condition;
providing instructions to the individual member to conduct the first test and the second test of the biological marker;
receiving, through the DCN, a first test result from the first test and a second test result from the second test of the biological marker; and
enabling the individual member to share at least one of the first test result, the second test result, and a difference in the first test result and the second test result with other members of the plurality of members through the DCN.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity”, more specifically managing interactions between people as the following abstract limitations recite managing adverse health conditions in a population:
An invitation to an individual member of the plurality of members to conduct a first test and at least a second test of a biological marker related to the adverse health condition, which recites an abstract limitation of a communication to the member to invite them to conduct the tests,
providing instructions to the individual member to conduct the first test and the second test of the biological marker, which is an abstract limitation of a communication of instructions to the member,
receiving a first test result from the first test and a second test result from the second test of the biological marker, which is an abstract limitation of a communication of the test results,
enabling the individual member to share at least one of the first test result, the second test result, and a difference in the first test result and the second test result with other members of the plurality of members, which is an abstract limitation of a communication of the individual member to the other members regarding sharing the result.
The claim limitations as a whole recite steps for managing adverse health conditions in a population, which recites social activity steps of communications between individuals and therefore recite managing interactions between people and is a certain method of organizing human activity.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., DCN) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 16 recites further abstract limitations describing a suggestion of a medical intervention to be sent to the individual member based on the difference in the first test result and the second result, further describing the abstract idea. Claim 17 recites further abstract limitations of sharing the first and second results and a difference of them, and where there is a suggestion of a medical intervention to a subset of members based on the difference and where the members share differences, further describing the abstract idea. Claim 18 recites further abstract limitations of sharing the first and second results and a difference of them, and where there is sending info about an availability of the intervention paid for by a risk holder based on the partial difference in the results, further describing the abstract idea.
Patent Subject Matter Eligibility Test: Step 2A- Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrates 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 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 exceptions into a “practical application,” see MPEP 2106.04(II.)(A.)(2.) and 2106.04(d)(I.).
In the present case at claim 19, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A method to manage adverse health conditions in a population, the method comprising (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)):
providing a digital communication network (DCN) for a plurality of members of a population to interact with each other and the DCN (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f));
transmitting (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) an invitation to an individual member of the plurality of members to conduct a first test of a biological marker related to the adverse health condition;
providing instructions to the individual member to test the biological marker;
receiving, through the DCN (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)), a first test result of the biological marker;
enabling the individual member to share the first test result with other members of the plurality of members through the DCN;
transmitting an invitation to the individual member to conduct a second test of the biological marker;
receiving, through the DCN, a second test result of the biological marker;
enabling the individual member to share at least one of the first test result, the second test result, and a difference in the first test result and the second test result with other members of the plurality of members through the DCN; and
prioritizing communications presented to the individual member from other members of the DCN that have levels of the biological marker which are improved over time.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitation of the overall computer implemented method, providing a digital communication network (DCN) for a plurality of members of a population to interact with each other and the DCN, transmitting the invitation, and receiving information via the DCN, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [0062, 0063] of the Applicant’s Specification recites the generic computing system using computing devices to perform the method. [0067, 0078, 0080, 0117] recites the use of the generically configured digital communication network to connect the devices to establish communications and sending information over the network. The additional elements recite the use of generic computing components and network with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer.
Claims 1 and 15 recite similar additional elements as claim 19 and are analyzed in a similar manner.
Taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to manage adverse health conditions in a population, implement/use the above-noted judicial exception 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, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception, see MPEP 2106.04(d), 2106.05(a), 2106.05(b).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Claim 13 recites further additional elements of transmitting the invitation from another member in the DCN, which recites the use of the generic network and mere generic computer implementation. Claim 14 recites the use of a generic bot to generate communications, further reciting the mere computer implementation. Claims 17 and 18 recite additional elements of conducting the first and second tests, which recites insignificant pre solution activity as these steps are to gather data for the abstract idea related to sharing the results of the tests.
Thus, taken alone and in ordered combination, the additional elements do not integrate the at least one abstract idea into a practical application.
Patent Subject Matter Eligibility Test: Step 2B:
Regarding Step 2B of the Subject Matter Eligibility Test, the independent claims 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 claim does not integrate the abstract idea into a practical application, see MPEP 2106.05(II.). Further, it may need to be established, when determining whether a claim recites significantly more than a judicial exception, that the additional elements recite well understood, routine, and conventional activities, see MPEP 2106.05(d).
Regarding the additional limitation of the overall computer implemented method, providing a digital communication network (DCN) for a plurality of members of a population to interact with each other and the DCN, transmitting the invitation, and receiving information via the DCN, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f) and MPEP § 2106.05(d)(II), specifically “buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)”). [0062, 0063] of the Applicant’s Specification recites the generic computing system using computing devices to perform the method. [0067, 0078, 0080, 0117] recites the use of the generically configured digital communication network to connect the devices to establish communications and sending information over the network. The additional elements recite the use of generic computing components and network with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer and does not recite significantly more than the judicial exception. The use of a network to merely send and receive the information recites well understood, routine, and conventional activity.
Claims 1 and 15 recite similar additional elements as claim 19 and are analyzed in a similar manner.
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exceptions 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.
For the reasons stated, the claims fail the Subject Matter Eligibility Test and therefore claims 1-20 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-18 are rejected under 35 USC 102(a)(1) as being anticipated by US 20230049589 A1 to Ferro Jr. et al. (“Ferro”):
Regarding claim 1:
Ferro teaches a method to manage adverse health conditions in a population, the method comprising: ([0012]- overall system described. [0172]- system for managing patients in a network for their diseases including communicable diseases such as COVID-19 (interpreted as adverse health conditions in a population).)
providing a digital communication network (DCN) for a plurality of members of a population to interact with each other and the DCN; ([0064]- system uses a network to connect devices of the users.)
transmitting an invitation to an individual member of the plurality of members to test a biological marker related to the adverse health condition; ([0066, 0068]- proctors interact with the patients taking the test kits. [0172]- test kits can be a nasal swab test for COVID, for example (interpreted as the first test of a biological marker). [0071]- request sent to begin testing session)
providing instructions to the individual member to test the biological marker; ([0060]- patient receives step-by-step instructions for test administration for the kit)
receiving, through the DCN, a test result of the biological marker; and ([0066, 0072]- test results are received and reported)
enabling the individual member to share the test result with other members of the plurality of members through the DCN. ([0072, Figure 4]- transmit results to state and third part reporting and send to telehealth consulting (interpreted as the member sending results to other members of the DCN))
Regarding claim 3:
Ferro teaches all of the limitations of claim 1. Ferro further teaches wherein the biological marker is related to at least one of: inflammation, auto-immune disease, metabolic disease, diabetes, obesity, rheumatoid arthritis (RA), Crohn's disease, Psoriasis, eczema, cardiovascular diseases (CVD), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), asthma, depression, anxiety, social isolation, risk of falling, and a prodromal form of the adverse health condition. ([0172]- COVID)
Regarding claim 4:
Ferro teaches all of the limitations of claim 1. Ferro further teaches wherein providing instructions to the individual member test the biological marker comprising sending the user a sampling kit to test the biological marker at home. ([0064]- at-home test kit sent to user patient)
Regarding claim 5:
Ferro teaches all of the limitations of claim 4. Ferro further teaches wherein the sampling kit is configured to collect at least one of: stool, blood, and saliva. ([0133]- mouth swab (indicates saliva).)
Regarding claim 8:
Ferro teaches all of the limitations of claim 1. Ferro further teaches prioritizing messages presented to the individual member which are from other members of the DCN engaged in actions aimed at improving respective levels of their biological marker. ([0159]- testing priority based on factors.)
Regarding claim 9:
Ferro teaches all of the limitations of claim 1. Ferro further teaches transmitting an invitation to the individual member to conduct a subsequent test of the biological marker. ([0071]- request sent to begin testing session. [0009]- request for a second proctored examination session can be initiated in the system)
Regarding claim 10:
Ferro teaches all of the limitations of claim 9. Ferro further teaches determining a change in the biological marker based on test result and a subsequent test result from the subsequent test. ([0066]- results are received (because second results can be received as noted in [0009], it can be interpreted that second test results of the biological marker can be received through the DCN))
Regarding claim 12:
Ferro teaches all of the limitations of claim 1. Ferro further teaches wherein the invitation to test the biological marker is algorithmically generated. ([0135]- eligibility for testing based on machine learning review.)
Regarding claim 13:
Ferro teaches all of the limitations of claim 1. Ferro further teaches wherein the invitation to test the biological marker is transmitted from another member in the DCN. ([0065]- request for test.)
Regarding claim 14:
Ferro teaches all of the limitations of claim 1. Ferro further teaches transmitting one or more communications regarding the biological marker created by a bot in the DCN. ([0113]- machine learning monitoring.)
Regarding claim 15:
Ferro teaches a method to manage adverse health conditions in a population, the method comprising: ([0012]- overall system described. [0172]- system for managing patients in a network for their diseases including communicable diseases such as COVID-19 (interpreted as adverse health conditions in a population).)
providing a digital communication network (DCN) for a plurality of members of a population to interact with each other and the DCN; ([0064]- system uses a network to connect devices of the users.)
transmitting an invitation to an individual member of the plurality of members to conduct a first test and at least a second test of a biological marker related to the adverse health condition; ([0066, 0068]- proctors interact with the patients taking the test kits. [0172]- test kits can be a nasal swab test for COVID, for example (interpreted as the first test of a biological marker). [0071]- request sent to begin testing session. [0009]- request for a second proctored examination session can be initiated in the system (indicates a second test).)
providing instructions to the individual member to conduct the first test and the second test of the biological marker; ([0060]- patient receives step-by-step instructions for test administration for the kit)
receiving, through the DCN, a first test result from the first test and a second test result from the second test of the biological marker; and ([0066]- results are received (because second results can be received as noted in [0009], it can be interpreted that second test results of the biological marker can be received through the DCN).)
enabling the individual member to share at least one of the first test result, the second test result, and a difference in the first test result and the second test result with other members of the plurality of members through the DCN. ([0072, Figure 4]- transmit results to state and third part reporting and send to telehealth consulting (interpreted as the member sending first results to other members of the DCN).)
Regarding claim 16:
Ferro teaches all of the limitations of claim 15. Ferro further teaches transmitting a suggestion of a medical intervention to the individual member based on the difference in the first test result and the second test result. ([0198]- recommend test result interpretations)
Regarding claim 17:
Ferro teaches all of the limitations of claim 15. Ferro further teaches wherein each member of the plurality of members conducted the first test and the second test and shared least one of the first test result, the second test result, and a difference in the first test result and the second test result within the DCN, and wherein the method further comprises transmitting a suggestion of a medical intervention to a subset of members based on the difference in the first test result and the second test result, wherein the subset of members have similar differences. ([0072, Figure 4]- transmit results to state and third part reporting and send to telehealth consulting (interpreted as the member sending first results to other members of the DCN))
Claims 2, 6, 7, 11, 18 are rejected under 35 USC 102(a)(1) for their dependency to the independent claims. Ferro does not teach aspects of Claims 19, 20 including but not limited to: “receiving, through the DCN, a second test result of the biological marker; enabling the individual member to share at least one of the first test result, the second test result, and a difference in the first test result and the second test result with other members of the plurality of members through the DCN; and prioritizing communications presented to the individual member from other members of the DCN that have levels of the biological marker which are improved over time.”
The following references have been considered as relevant, however have not been used in the above rejections:
US-20220367054-A1 to Gnanasambandam et al. teaches of determining the risk of a patient where results are managed in profiles.
US-20230307112-A1 to Rosenberg et al. teaches of healthcare telecommunications and using comorbidity data to generate treatment plans.
WO-2022019963-A1 to Luthra et al. teaches of a communications network to transmit and display results of a diagnostic test to others.
NPL “Using information and communication technology in home care for communication between patients, family members, and healthcare professionals: a systematic review” to Lindberg et al. teaches of communication technology for communicating results between patients and other entities.
Conclusion
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/CONSTANTINE SIOZOPOULOS/
Examiner
Art Unit 3686
Prosecution Insights