DETAILED ACTION
Applicant’s response filed 09/17/2025 has been fully considered. The following rejections and/or objections are either reiterated or newly applied.
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 .
Claim Status
Claims 1-84 are cancelled by Applicant.
Claims 85-104 are currently pending and are herein under examination.
Claims 85-104 are rejected.
Claim 85 is objected.
Priority
The instant application claims domestic benefit to U.S. Provisional Application No. 63/167,830 filed 03/30/2021 and to U.S. Provisional Application No. 63/055,518 filed 07/23/2020. The claim to domestic benefit for claims 85-104 is not acknowledged because none of the priority documents disclose the following limitations in independent claims 85 and 101: an adaptive machine learning model, adapting a recommendation in real time using the adaptive machine learning model, a secure communication module, cannot be performed by a human unaided by the system, and monitoring user compliance and feedback. As such, the effective filing date for claims 85-104 is 07/22/2021.
Withdrawn Rejections
35 USC 112(b)
The rejection of claims 85-100 is withdrawn in view of claim amendments.
35 USC 102
The rejection of claims 101 and 104 under 35 U.S.C. 102(a)(1) as being anticipated by Bagaev et al. is withdrawn in view of claim amendments and Applicant argument. Applicant’s arguments are persuasive regarding Bagaev not disclosing an adaptive machine learning model or monitoring via a user interface user compliance and feedback (pg. 7, sec. A and pg. 8, sec. B of Applicant’s remarks filed 09/17/2025).
35 USC 103
The rejection of claims 85, 89-90, 92-93 and 97-98 under 35 U.S.C. 103 as being unpatentable over Bagaev et al. in view of Kim et al. is withdrawn in view of claim amendments and Applicant argument. Applicant’s arguments regarding claim 85 are persuasive because neither Bagaev nor Kim disclose an adaptive machine learning model or monitoring via a user interface user compliance and feedback (pg. 7, sec. A and pg. 8, sec. B of Applicant’s remarks filed 09/17/2025).
The rejection of claims 86 and 87 under 35 USC 103 as being unpatentable over Bagaev et al. in view of Kim et al. and in further view of Wald et al. is withdrawn because the rejection of claim 85 is withdrawn.
The rejection of claim 94 under 35 USC 103 as being unpatentable over Bagaev et al. in view of Kim et al. and in further view of Shimodaira et al. is withdrawn because the rejection of claim 85 is withdrawn.
The rejection of claim 95 under 35 USC 103 as being unpatentable over Bagaev et al. in view of Kim et al. and in further view of Dou et al. and Barbosa et al. is withdrawn because the rejection of claim 85 is withdrawn.
The rejection of claim 96 under 35 USC 103 as being unpatentable over Bagaev et al. in view of Kim et al. and in further view of Rebbeck and Nakayama et al. is withdrawn because the rejection of claim 85 is withdrawn.
The rejection of claims 88, 91 and 99-100 under 35 USC 103 as being unpatentable over Bagaev et al. in view of Kim et al. and in further view of Blander et al. is withdrawn because the rejection of claim 85 is withdrawn.
The rejection of claims 102 and 103 under 35 USC 103 as being unpatentable over Bagaev et al. in view of Blander et al. is withdrawn because the rejection of claim 101 is withdrawn.
Claim Objections
The objection to claims 85, 87-88, 96-97 and 101 are withdrawn in view of claim amendments.
Claim 85 is objected to because of the following informalities:
Claim 85, step (iv)(b), recites “system; (c), which should recite “system; and (c)”.
Claim 85, step (v), recites “provider; (vi)” which should be “provider; and (vi)”.
Appropriate correction is required.
Claim Interpretation
35 USC 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are described below:
Claims 85 and 89 recite “(iii) extract, using a non-generic genetic analysis engine, a plurality of gene sets from the raw genetic data” and “the genetic analysis engine is configured to detect rare genetic variants and incorporate them into the risk assessment using a propriety variant weighting algorithm.”
Claim 85 recites “(v) output, via a secure communication module, a genetic profile report.”
Claim 93 recites “a module configured to track user compliance with the recommended intervention and to adapt future recommendations based on compliance data.”
Claim 101 recites “(ii) assign, using a non-generic genetic analysis engine, a value to each gene set.”
Claim 101 recites “output, via a secure communication module, the health profile information and intervention information.”
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
These limitations are performed by a computer processor. As such, they are being interpreted as computer-implemented means-plus-function limitations. The structure for a computer-implemented means-plus-function limitation is the algorithm that performs the function (MPEP § 2181.II.B). Below are the algorithms in the instant disclosure that recite structure:
Non-generic genetic analysis engine: there is no recitation of “non-generic genetic analysis engine” in the disclosure. There is no algorithm for detecting rare genetic variants or incorporating them into a risk assessment using a propriety variant weighting algorithm. There is also no mention of a proprietary variant weighting algorithm. As such, any algorithm and or hardware that performs these limitations will read on the non-generic genetic analysis engine.
Module: there is no mention of a module nor an algorithm for tracking user compliance with the intervention nor adapting future recommendations based on compliance data. As such, any algorithm capable of performing the functions of the module will read on the module.
Secure communication module: there is no recitation of a “secure communication module” in the disclosure. As such, any algorithm or hardware capable of securely outputting data will read on the structure of a secure communication module.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
35 USC 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 85-104 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is newly recited as necessitated by claim amendment.
Claims 85 and 101 recite new matter. Neither the instant specification, instant drawings, nor priority documents disclose the following limitations in claims 85 and 101: “a genetic sequencing module”, “real-time”, “an adaptive machine learning model”, “cannot be performed by a human unaided by the system”, and “monitor, via the user interface, user compliance and feedback and adapt the intervention recommendation in real time using the machine learning model.”
Regarding 35 USC 112(f), claims 85, 89, 93 and 101 fail to comply with the written description requirement because they do not adequately link or associate adequately described particular structure, material, or acts to perform the function recited in the claim identified to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. As discussed in Claim Interpretation, claims 85, 89, 93 and 101 recite functions for a non-generic genetic analysis engine, a secure communication module, and a module that invoke 35 U.S.C. 112(f). Neither the specification nor the drawings disclose sufficient algorithms or associated structures that perform the functions of these computer-implemented means-plus-function limitations. Thus, in accordance with MPEP § 2181.IV, the instant specification does not provide written description support for the non-generic genetic analysis engine, the secure communication module, and the module because there is no corresponding sufficient algorithm in the disclosure.
Furthermore, claims dependent from the above rejected claims are also rejected due to being dependent on a rejected claim.
35 USC 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 85-104 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This rejection is newly recited as necessitated of claim amendment.
Claim 85, step (iv), recites “the gene sets” which renders the claim indefinite. It is unclear which gene sets are being referenced because there is “a plurality of gene sets” recited in step (iii). To overcome this rejection, clarify which gene sets are being referenced.
Furthermore, claims 86-100 are also rejected because they depend on claim 85, which is rejected, and because they do not resolve the issue of indefiniteness.
Claim 88 recites “wherein the genetic report is delivered as an interactive electronic document containing embedded decision support tools for healthcare provides” which renders the claim indefinite. The limiting effect of the wherein clause is unclear. It is unclear whether the claim recites an intended use of the report by “is delivered”, or if the claim requires an active step of delivering the report as an interactive electronic document. See MPEP 2111.04.I. To overcome this rejection, clarify if the claim requires an active step of delivering as an interactive electronic document.
Claim 89 recites the relative term “rare” which renders the claim indefinite. The term “rare” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Because rare is a subjective term, the metes and bounds of what constitutes a “rare” genetic variant is unclear.
Claim 89 recites the phrase “a propriety variant weighting algorithm” which renders the claim indefinite. It’s unclear whether the phrase refers to a specific algorithm owned by a specific company as indicated by proprietary, or if the phrase means is meant to be interpreted as any variant weighting algorithm. To overcome this rejection, clarify how the phrase should be interpreted.
Claim 97, recites “the weighted gene set values” which lacks antecedent basis. Claim 85 recites weighted risk scores, but there is no mention of weighted gene set values. To overcome this rejection, provide antecedent basis.
Furthermore, claims 98-99 are also rejected because they depend on claim 97, which is rejected, and because they do not resolve the issue of indefiniteness.
Claim 100 recites “the identified risk” which lacks antecedent basis. To overcome this rejection, provide antecedent basis.
Claim 101, step (iii), recites “the classification” which renders the claim indefinite. It is unclear which classification is being referenced because in step (iii) each health category has a classification. To overcome this rejection, clarify which classification is being referenced.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present case, claim 101 step (iii) recites a broad recitation of “assign … a classification … in one or more health categories”. Claim 101 step (iv) recites a narrower limitation of the broad recitation of “the assigned classifications”, which indicates more than one classification. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Furthermore, claims 102-104 are also rejected because they depend on claim 101, which is rejected, and because they do not resolve the issue of indefiniteness.
Claims 85, 89, 93 and 101 recite the following limitations that invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: a non-generic genetic analysis engine, a secure communication module, and a module. See Claim Interpretation. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claims 85, 89, 93 and 101 are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 85-104 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and a natural phenomenon without significantly more.
Any newly recited portions herein are necessitated by claim amendment.
Step 1:
Step 1 asks whether the claims recite statutory subject matter. In the instant application, claims 85-100 recite a system and claims 101-104 recite a system. As such, these claims recite statutory subject matter (Step 1: YES).
Step 2A, Prong 1:
Claims that recite statutory subject matter are analyzed under Step 2A, Prong 1 to determine if they recite any concepts that equate to an abstract idea, law of nature or natural phenomena. The instant claims recite the following limitations that equate to one or more categories of judicial exception:
Claim 85 recites “(iii) extract, using a non-generic genetic analysis engine, a plurality of gene sets from the raw genetic data, wherein each gene set comprises at least one gene selected from a predetermined panel; (iv) process the gene sets and user input using an adaptive machine learning model configured to: (a) dynamically assign weighted risk scores to each gene set based on genotype, phenotype, and user input; (b) generate, in real time, a personalized risk assessment for at least one health condition, wherein the risk assessment is based on a non-linear combination of gene set scores and user input, and cannot be performed by a human unaided by the system; (c) generate, in real time, a personalized intervention recommendation comprising at least one of dietary, lifestyle, medical, or environmental interventions, wherein the recommendation is dynamically updated based on subsequent user input and genetic data; (vi) monitor, via the user interface, user compliance and feedback, and adapt the intervention recommendation in real time using the machine learning model.”
Claim 86 recites “wherein the adaptive machine learning model is configured to incorporate real-time responses to preliminary questions, including lifestyle, environmental, and health status questions, and to update the risk assessment and intervention recommendation based on such responses”
Claim 87 recites “wherein the adaptive machine learning model comprises a decision tree ensemble algorithm configured to integrate multi-gene interactions and real-time user feedback to improve prediction accuracy over time.”
Claim 89 recites “wherein the genetic analysis engine is configured to detect rare genetic variants and incorporate them into the risk assessment using a proprietary variant weighting algorithm.”
Claim 91 recites “wherein the adaptive machine learning model assigns numerical weights to gene sets based on genotype, and combines these weights using a non-linear function to generate a classification for each health category.”
Claim 92 recites “wherein the risk assessment includes a quantitative rating and a qualitative risk category for each health condition evaluated.”
Claim 93 recites “further comprising a module configured to track user compliance with the recommended intervention and to adapt future recommendations based on compliance data.”
Claim 97 recites “wherein the adaptive machine learning model predicts a health state of the user and/or subject based on the weighted gene set values, and the genetic profile report includes the predicted health state.”
Claim 98 recites “wherein the predicted health state includes a risk of one or more of irregular ovulation, premature ovarian failure, lifelong risk of estrogen toxicity, polycystic ovarian syndrome, endometriosis, vascular inflammation, fibromyalgia, or breast cancer.”
Claim 99 recites “wherein the predicted health state includes a risk of one or more of low testosterone, male pattern baldness, benign prostate hyperplasia, ability to develop lean muscle, low libido, or complications from hormone replacement therapy.”
Claim 100 recites “wherein the intervention recommendation includes dietary, lifestyle, and environmental recommendations for mitigating the identified risk.”
Claim 101 recites “(ii) assign, using a non-generic genetic analysis engine, a value to each gene set; (iii) assign, using an adaptive machine learning model, a classification to the user and/or subject in one or more health categories, wherein each category corresponds to at least one gene set, and the classification is based on the values assigned to the corresponding gene set(s) and real-time user input; (iv) obtain, using the processor, health profile information and intervention information associated with the assigned classifications; (vi) monitor user compliance and feedback, and adapt the intervention information in real time using the machine learning model.”
Claim 103 recites “wherein the adaptive machine learning model assigns numerical weights to gene sets based on genotype, and combines these weights using a non-linear function to generate a classification for each health category.”
Claim 104 recites “wherein the classification includes a quantitative rating and a qualitative risk category for each health condition evaluated.”
Limitations reciting a mental process.
Claims 85-87, 89, 91, 93, 97, 101 and 103 contain limitations recited at such a high level of generality that they equate to a mental process because they are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), which the courts have identified as concepts that can be practically performed in the human mind. The paragraphs below discuss the broadest reasonable interpretation (BRI) of the limitations in these claims that recite a mental process.
The BRI of step (iii) in claim 85 includes writing down genes associated with a chromosome number and base position in a raw genetic data file typically associated with an rsID, such as that provided by 23andMe. The BRI of steps (iv)(a)-(iv)(c) includes a human performing the operations of an adaptive random forest or XGBoost on pen and paper to assign scores to gene sets, generate a risk assessment, and generate a personalized intervention recommendation. The BRI of step (vi) includes inputting new data into the model to update the recommendation. The BRI of real time in these steps includes a human performing operations as data is received, which includes updating parameters of a model. The BRI of step (vi) includes making observations and performing further calculations using the model.
The BRI of claims 86-87 includes a human inputting new data into the adaptive random forest and performing its operations. The BRI of claim 89 includes following the operations of a variant weighting algorithm. The BRI of claims 91 and 103 includes performing operations of a decision tree to assign weights and perform calculations of a function to generate a classification. The BRI of claim 93 includes analyzing data and inputting new data into the decision tree ensemble to update the recommendation. The BRI of claim 97 includes using a human using pen and paper to perform operations of the decision tree ensemble to make a prediction.
The BRI of claim 101 step (ii) includes following operations of an algorithm to assign data a value. The BRI of step (iii) includes using pen and paper to classify gene sets by performing operations of a decision tree. The BRI of obtaining health profile information and intervention information includes collecting data. The BRI of monitoring user compliance and feedback includes analyzing data and inputting new data into the decision tree ensemble to update the recommendation.
The limitations of claims 92, 98-100 and 104 are included in the recited judicial exception in claims 85, 97 and 101 because they further limit the risk assessment, predicted health state, and classification.
Limitations reciting a mathematical concept.
Claims 85, 87, 91, 101 and 103 recite limitations that equate to a mathematical concept because they are similar to the concepts of organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)), which the courts have identified as mathematical concepts. The paragraphs below discuss the broadest reasonable interpretation (BRI) of the limitations in these claims that recite a mathematical concept.
The BRI in claim 85 step (iv)(b) includes calculating weighted risk scores. The BRI in claim 85 step (iv)(b) includes calculations and generating risk scores. The BRI of claims 91 and 103 includes performing calculations of a non-linear function to create a classification. The BRI in claims 85, 87, 91, 101 and 103 of an adaptive machine learning algorithm that may be a decision tree ensemble includes using a function to perform calculations such as adaptive entropy. The BRI in claim 101 step (iv) includes using a SVM to calculate classifications.
Limitations reciting a natural phenomenon.
Claims 97-99 recite limitations that equate to a natural phenomenon because they are similar to the concept of a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017), which the courts have established as a natural phenomenon. These claims predict a health state such as cancer and baldness based on genotype and phenotype data, which is a natural phenomenon
As such, claims 85-104 recite an abstract idea and a natural phenomenon (Step 2A, Prong 1: YES).
Additional Elements:
Once limitations have been identified that recite a judicial exception, the claims are evaluated for additional elements. The additional elements are then analyzed under Step 2A, Prong 2 then Step 2B. The instant claims recite the following additional elements:
Claim 85 recites “A computer-implemented assessment system comprising: a processor and a memory storing instructions that, when executed by the processor, cause the system to: (i) receive, from a genetic sequencing module, raw genetic data of a user and/or subject; (ii) receive, from a user interface, real-time lifestyle and health input from the user and/or subject; (v) output, via a secure communication module, a genetic profile report comprising the risk assessment and intervention recommendation to the user and/or a healthcare provider”
Claim 88 recites “wherein the genetic profile report is delivered as an interactive electronic document containing embedded decision support tools for healthcare providers, and wherein the report includes interactive elements that allow real-time adjustment of recommendations based on additional user or provider input.”
Claim 90 recites “wherein the plurality of gene sets includes at least one set comprising a single gene and at least one set comprising two or more genes, and wherein the risk assessment is based on both single-gene and multi-gene interactions.”
Claim 94 recites “wherein at least one gene set comprises one or more of CYPl 7 A 1, CYPl 9A 1, SRD5A2, UGT2B 15, UGT2B 17, CYPIAI, CYP1A2, CYPlBl, CYP3A4, COMT, SOD2, or GPx”
Claim 95 recites “wherein at least one gene set comprises two or more genes chosen from MTHFR. SHMT1, MTRR, MTR, MTHFR-2. and combinations thereof.”
Claim 96 recites “wherein at least one gene set comprises two or more genes chosen from GSTT1, GSTMI, or GSTP1, and combinations thereof.”
Claim 101 recites “A system for providing intervention information to a user and/or subject, comprising: a processor and a memory storing instructions that, when executed by the processor, cause the system to: (i) receive, from a genetic sequencing module, raw genetic data of the user and/or subject, the genetic data including a plurality of gene sets, each set comprising one or more genes; (v) output, via a secure communication module, the health profile information and intervention information to the user and/or a healthcare provider”
Claim 102 recites “wherein the plurality of gene sets includes at least one set comprising a single gene and at least one set comprising two or more genes.”
These above recited additional elements are analyzed below under both Step 2A, Prong 2 and Step 2B:
Step 2A, Prong 2:
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exception is not integrated into a practical application because the claims do not recite additional elements that reflect an improvement to a computer, technology, or technical field (MPEP § 2106.04(d)(1) and 2106.5(a)), require a particular treatment or prophylaxis for a disease or medical condition (MPEP § 2106.04(d)(2)), implement the recited judicial exception with a particular machine that is integral to the claim (MPEP § 2106.05(b)), effect a transformation or reduction of a particular article to a different state or thing (MPEP § 2106.05(c)), nor provide some other meaningful limitation (MPEP § 2106.05(e)). Rather, the claims include limitations that equate to an equivalent of the words “apply it” and/or to instructions to implement an abstract idea on a computer (MPEP § 2106.05(f)), insignificant extra-solution activity (MPEP § 2106.05(g)), and field of use limitations (MPEP § 2106.05(h)). The paragraphs below discuss the additional elements recited above in the instant claims.
Regarding in claims 85-104 the system comprising a processor and memory, there are no limitations that these components require anything other than a generic computer and/or generic computing system. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983.
Regarding the additional elements in claims 85 and 101 of receiving raw genetic data from a genetic sequencing module, receiving from a user interface lifestyle and health input, and outputting via a secure communication module, these limitations equate to insignificant extra-solution activity of necessary data gathering and data outputting. They gather data necessary to perform the abstract ideas of assigning classification to health categories and generating risk assessments and intervention recommendations, then output the result of the abstract idea.
Regarding the additional elements in claims 88, 90, 94-96 and 102, these limitations further limit the data being gathered, which equates to field of use limitations.
As such, claims 85-104 are directed to an abstract idea and a natural phenomenon (Step 2A, Prong 2: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). These claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these claims recite additional elements that equate to instructions to apply the recited exception in a generic way and/or in a generic computing environment (MPEP § 2106.05(f)) and to well-understood, routine and conventional (WURC) limitations (MPEP § 2106.05(d)). The paragraphs below discuss the additional elements recited above in the instant claims.
Regarding the system comprising a processor and memory in claims 85-104, there are no limitations that these components require anything other than a generic computer and/or generic computing system. Therefore, these limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept in Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Regarding the additional elements in claims 85 and 101 of receiving raw genetic data, receiving lifestyle and health input, and outputting the report/profile/intervention. These limitations equate to receiving/transmitting data over a network, which the courts have established as WURC limitation of a generic computer in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014). Regarding the additional elements in claims 88, 90, 94-96 and 102, these limitations also equate to transmitting/receiving data over a network because they limit the type of data but do not change the fact that data is being transmitted/received.
Regarding the additional elements in claims 85 and 101 of storing instructions in memory, these limitations equate to storing information in memory, which the courts have established as a WURC function of a generic computer in Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015).
Regarding claims 85 and 101 of a processor, memory, and secure communication module, these additional elements are WURC as taught by Jin et la. (“Jin”; EEE access 7 (2019): 61656-61669; newly cited). Jin discloses a review on secure and privacy-preserving medical data sharing in computer systems (abstract). Jin states that data encryption is a basic requirement to guarantee data security and privacy (pg. 61659, col. 1, para. 2). Jin lists several methods for encryption based medical data sharing (pg. 61659, sec. 2).
When these additional elements are considered individually and in combination, they do not provide an inventive concept because they equate to WURC functions/components of a generic computer in combination with a secure communication module as taught by Jin. Therefore, these additional elements do not transform the claimed judicial exception into a patent-eligible application of the judicial exception and do not amount to significantly more than the judicial exception itself (Step 2B: No).
As such, claims 85-104 are not patent eligible.
Response to Arguments under 35 USC 101
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive.
Applicant argues a technical improvement (pg. 4, sec. A of Applicant’s remarks). Applicant’s arguments are not persuasive for the following reasons:
The limitations in the first two bullet points refer to limitations that have been identified as reciting a judicial exception. MPEP 2106.05(a) recites “the judicial exception alone cannot provide the improvement.”
Regarding Enfish, Applicant appears to argue that the claims improve computer functionality. However, no argument has been made as to exactly how computer functionality is improved.
Regarding McRO, Applicant appears to argue that the instant claims cannot be performed mentally and are thus patent eligible. It is not clear which limitations Applicant believes cannot be performed mentally. If Applicant refers to claim 85 step (iv)(b) limitation “cannot be performed by a human unaided by the system”, it is noted that the system in claim 85 is a generic computer. MPEP 2106.04(a)(2)(C) discusses how performing a mental process on a generic computer still recites a mental process.
Applicant argues integration in a practical application (pg. 4, sec. B of Applicant’s remarks). Applicant’s arguments are not persuasive for the following reasons:
Regarding the first bullet point, generation of the personalized medical intervention is part of the recited judicial exception. The judicial exception alone cannot provide an improvement (MPEP 2106.05(a)).
Regarding the second bullet point, MPEP 2106.04(a)(2)(C) discusses how performing a mental process on a generic computer still recites a mental process. The BRI of real-time includes performing data integration as it is received, wherein a human can perform data integration upon receiving data. Regarding secure data handling, it appears that Applicant refers to claim 85 step (v) which recites an additional element equating to necessary data outputting of the abstract idea. Data outputting does not integrate the judicial exception into a practical application.
Regarding DDR Holdings, it is unclear which computer technology problem is being solved and which additional elements in the instant claims solve the problem.
Applicant argues that the claims recite more than generic computer implementation (pg. 5, sec. C of Applicant’s remarks). Applicant’s arguments are not persuasive for the following reasons:
Regarding the first and third bullet point, the non-generic genetic analysis engine and adaptive machine learning algorithm have not been identified as reciting generic computer components. Rather, they are part of the judicial exception. The secure communication module has been interpreted in Step 2B as encryption software performed by the processor, rather than a physical component. The generic computer components identified in claims 85 and 101 are the processor and memory. As such, the systems of claims 85 and 101 do not recite more than generic computer components.
Regarding the second bullet point, Applicant appears to refer to claim 85 step (vi). This limitation recites a mental process. Only additional elements are evaluated for whether they are well-understood, routine, or conventional.
Applicant argues a particular transformation (pg. 5, sec. D of Applicant’s remarks). Applicant’s arguments are not persuasive for the following reasons:
MPEP 2106.05(c) recites, for data, mere "manipulation of basic mathematical constructs [i.e.,] the paradigmatic abstract idea, has not been deemed a transformation.” In the instant case, using genetic data and lifestyle data to generate a risk assessment and intervention recommendation (both of which are data) does not recite a particular transformation. This is in contrast to Diamond v. Diehr where raw, uncured synthetic rubber was transformed into precision-molded synthetic rubber, wherein the article being transformed was something physical.
Applicant argues that the claims do not preempt all ways of analyzing genetic data or making medical recommendations (pg. 5, sec. E of Applicant’s remarks). Applicant’s arguments are not persuasive for the following reasons:
MPEP 2106.04.I recites “While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, 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) … It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible. Diamond v. Diehr, 450 U.S. 175, 191-92 n.14, 209 USPQ 1, 10-11 n.14 (1981) ("We rejected in Flook the argument that because all possible uses of the mathematical formula were not pre-empted, the claim should be eligible for patent protection").
Although the instant claims do not preempt all ways of analyzing genetic data or making medical decisions, the claims are still directed to an abstract idea under the Alice/Mayo test.
Conclusion
No claims are allowed.
Claims 85-104 are free from the prior art because the prior art does not fairly teach or suggest the following newly recited limitations in combination: in claim 85 “(iv) process the gene sets and user input using an adaptive machine learning model configured to: (a) dynamically assign weighted risk scores to each gene set based on genotype, phenotype, and user input; (b) generate, in real time, a personalized risk assessment for at least one health condition, wherein the risk assessment is based on a non-linear combination of gene set scores and user input. and cannot be performed by a human unaided by the system” and in claim 101 “(iii) assign, using an adaptive machine learning model, a classification to the user and/or subject in one or more health categories, wherein each category corresponds to at least one gene set, and the classification is based on the values assigned to the corresponding gene set(s) and real-time user input; (vi) monitor user compliance and feedback, and adapt the intervention information in real time using the machine learning model.”
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/N.A.A./Examiner, Art Unit 1687
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685