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 11/12/2025 and 02/26/2026 were 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.
Response to Arguments
Regarding the arguments against the rejection of claims under 35 USC 101, Examiner respectfully disagrees. Applicant argues that the limitations do not recite a mental process and the use of the “model” as recited is not claimed as a free-standing mathematical relationship, but rather a tool applied to empirically measure chemical concentrations obtained from spatially resolved sampling of a biological sample. Examiner asserts, as noted in the below rejection, recitation of the “model” is recited at a high level of generality where it can be used as a part of a mental process. As noted in the Step 2A Prong 2 part of the below analysis, the steps related to the sampling of the biological samples and gathering the data at each position along the reference lines along a growth axis recites insignificant pre-solution activity related to data gathering. There is no indication to an improvement to a technical field. The generation of the contribution data set, under broadest reasonable interpretation, recites analysis that can practically be performed in the human mind. Further, the physical sampling at different positions indeed recites a physical step in a particular manner as claimed, however this is merely used for the data gathering for the abstract idea, and therefore does not show a practical application, see MPEP 2106.05(g)(III.).
Applicant further argues that the claims amount to significantly more than the judicial exception and the Office does not show evidentiary support. Examiner asserts that the sampling as claimed still recites sampling during different periods of time as noted in [0086], which still recites insignificant extra solution activity and still recites well understood, routine, and conventional activity, see MPEP 2106.05(d)(I) where support from the Specification and use of recognized court cases are sufficient.
Regarding the arguments against the rejection of claims under 35 USC 102, Examiner agrees and therefore this rejection is withdrawn.
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 131, 133, 137-138, 141, 151, 153, and 155-167 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 153 is related to system, and claims 131, 133, 137-138, 141, 155-167 are also related to a method (i.e., a process). Claim 151 is related to a “non-transitory” processor readable media storing instructions. 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 131 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 131 recites:
A method for outputting one or more quantitative metrics of one or more exposomic signatures of a first subject that represents an effect of an intervention on the first subject, comprising:
(a) receiving a biological sample from the first subject;
(b) sampling each respective position in a plurality of positions along a reference line on the biological sample, thereby obtaining a plurality of chemical samples for the respective subject, each chemical sample in the plurality of chemical samples corresponding to a different position in the plurality of positions, wherein the plurality of positions comprises:
one or more positions representing a period of growth prior to the intervention,
one or more positions representing a period of growth during the intervention, and
one or more positions representing a period of growth after the intervention;
(c)determining a first dataset that includes a plurality of traces, each trace in the plurality of traces being a concentration of a corresponding chemical, in a plurality of chemicals, over time collectively determined from the plurality of chemical samples
(d) applying, for each chemical in the plurality of chemicals, a model as a function of time relative to the intervention to the concentration of the respective chemicals measured from the plurality of positions, to generate a corresponding contribution data set representing the contribution of the intervention to the concentration of the respective chemicals in the first subject as a function of time,
(e) evaluating a change in chemical dynamics in response to the intervention using the corresponding contribution data set, for each of the plurality of chemicals; wherein the intervention comprises an environmental input, a pharmaceutical compound, a diet, a supplement, a nutraceutical, or any combination thereof.
The Examiner submits that the foregoing underlined limitations constitute a “mental process”, as the following abstract limitations are related to evaluations that can be practically performed in the human mind:
“determining” a first dataset that includes a plurality of traces, each trace in the plurality of traces being a concentration of a corresponding chemical, in a plurality of chemicals, over time collectively determined from the plurality of chemical samples, which are abstract limitations of analysis of the traces of chemicals over time from the samples to generate the dataset,
“applying” for each chemical in the plurality of chemicals, a model as a function of time relative to the intervention to the concentration of the respective chemicals measured from the plurality of positions, to generate a corresponding contribution data set representing the contribution of the intervention to the concentration of the respective chemicals in the first subject as a function of time, which recites abstract limitations of analysis using an abstract “model” as a function of time for the chemicals to generate the contribution data set, where the representation of the contribution as a function of time is also abstract under broadest reasonable interpretation,
“evaluating” a change in chemical dynamics in response to the intervention using the corresponding contribution data set, for each of the plurality of chemicals; wherein the intervention comprises an environmental input, a pharmaceutical compound, a diet, a supplement, a nutraceutical, or any combination thereof, which are abstract limitations of analysis of the change in chemical dynamics in response to the intervention using the previously generated contribution dataset for each of the chemicals.
Accordingly, the claim as a whole recites the steps for generating quantitative metrics of one or more exposomic signatures of a first subject that represents an effect of an intervention on the first subject that can practically be performed in the human mind.
Claims 151 and 153 recite the similar abstract idea as claim 131.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., receiving) 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 157 recites further abstract limitations describing the intervention, further describing the abstract idea. Claim 158 recites further abstract limitations of modifying the nutraceutical intervention based on the steps of (d). further describing the abstract idea. Claims 159 and 160 recite further abstract limitations of “evaluating” a change in metabolism of metabolites in response to the intervention, 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, 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”):
Regarding claim 131:
A method for outputting one or more quantitative metrics of one or more exposomic signatures of a first subject that represents an effect of an intervention on the first subject (merely post solution activity as noted below, see MPEP 2106.05(g) and buySAFE, Inc. v. Google, Inc.), comprising:
(a) receiving a biological sample from the first subject;
(b) sampling each respective position in a plurality of positions along a reference line on the biological sample, thereby obtaining a plurality of chemical samples for the respective subject, each chemical sample in the plurality of chemical samples corresponding to a different position in the plurality of positions, wherein the plurality of positions comprises:
one or more positions representing a period of growth prior to the intervention,
one or more positions representing a period of growth during the intervention, and
one or more positions representing a period of growth after the intervention (merely data gathering steps as noted below, see MPEP 2106.05(g) and Mayo);
(c)determining a first dataset that includes a plurality of traces, each trace in the plurality of traces being a concentration of a corresponding chemical, in a plurality of chemicals, over time collectively determined from the plurality of chemical samples
(d) applying, for each chemical in the plurality of chemicals, a model as a function of time relative to the intervention to the concentration of the respective chemicals measured from the plurality of positions, to generate a corresponding contribution data set representing the contribution of the intervention to the concentration of the respective chemicals in the first subject as a function of time,
(e) evaluating a change in chemical dynamics in response to the intervention using the corresponding contribution data set, for each of the plurality of chemicals; wherein the intervention comprises an environmental input, a pharmaceutical compound, a diet, a supplement, a nutraceutical, or any combination thereof.
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 limitations of:
receiving a biological sample from the first subject and
sampling each respective position in a plurality of positions along a reference line on the biological sample, thereby obtaining a plurality of chemical samples for the respective subject, each chemical sample in the plurality of chemical samples corresponding to a different position in the plurality of positions, wherein the plurality of positions comprises: one or more positions representing a period of growth prior to the intervention, one or more positions representing a period of growth during the intervention, and one or more positions representing a period of growth after the intervention,
these are merely pre-solution activities. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). [0053] of the Applicant’s Specification recites the receiving of a biological sample from a subject and [0086] further describes the sampling along a reference line on the biological sample. Even though there are specific limitations as to when the sampling is to occur along the different positions, these steps are used to perform data gathering for the abstract idea, and thus recite insignificant pre-solution activities. Claims 151 and 153 recite similar additional elements.
Regarding the additional limitation of outputting one or more quantitative metrics of one or more exposomic signatures of a first subject that represents an effect of an intervention on the first subject, this is merely post-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g)). [0141] of Applicant’s specification recites generically outputting the result of the abstract idea and how an output of information can be generally given as a notification as described in [0094], and therefore recites impractical application. Claims 151 and 153 recite similar additional elements.
As shown, claims 151 and 153 recite the same and other additional limitations as to claim 131. Further in claim 151, regarding the other additional limitation of a non-transitory computer readable storage medium, wherein the non-transitory computer readable storage medium stores instructions, which when executed by a computer system, cause the computer system to perform a method, the Examiner submits that this limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [0079] of the Applicant’s Specification recites the generic computing components of the non-transitory storage medium. [0050] recites the use of the generic computer system. The additional elements recite the use of generic computing components 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. Claim 153 recites other additional limitations of: a computer system comprising: one or more processors; and memory addressable by the one or more processors, the memory storing at least one program for execution by the one or more processors, the at least one program comprising instructions. The Examiner submits that this limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [0050] of the Applicant’s Specification recites the use of generic processors and memory of the generic computer system. The additional elements recite the use of generic computing components 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.
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 for each of the independent claims 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 calculate one or more features of the one or more exposomic signatures, 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 133 recites further detail of the sample for the insignificant pre-solution activity of data gathering. Claim 137 recites further detail of the measurement of the signatures for the insignificant pre-solution activity of data gathering. Claim 138 recites further detail of the measurement of signals for the insignificant pre-solution activity of data gathering. Claim 141 recites further detail of the subject from where the sample is taken for the insignificant pre-solution activity of data gathering. Claims 155 and 156 recite further detail of the sample for the insignificant pre-solution activity of data gathering. Claims 161-163 further describes the insignificant pre solution activity by further describing the period of time of growth after intervention. Claim 164 further describes the chemicals that are sampled, further describing the insignificant pre solution activity. Claims 165-167 recites further the models that are being used as computer-implemented models to carry out the abstract idea, however this limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components.
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 claims 131, 151 and 153:
Regarding the additional limitations of:
receiving a biological sample from the first subject and
sampling each respective position in a plurality of positions along a reference line on the biological sample, thereby obtaining a plurality of chemical samples for the respective subject, each chemical sample in the plurality of chemical samples corresponding to a different position in the plurality of positions, wherein the plurality of positions comprises: one or more positions representing a period of growth prior to the intervention, one or more positions representing a period of growth during the intervention, and one or more positions representing a period of growth after the intervention,
these are merely pre-solution activities. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968”). [0053] of the Applicant’s Specification recites the receiving of a biological sample from a subject and [0086] further describes the sampling along a reference line on the biological sample. Even though there are specific limitations as to when the sampling is to occur along the different positions, these steps are used to perform data gathering for the abstract idea, and thus recite insignificant pre-solution activities. Claims 151 and 153 recite similar additional elements. The receiving of biological samples and applying an action to determine the signatures recites similar biological testing and determination from a biological system for insignificant extra solution activity as the example in Mayo, and thus recites well understood, routine, and conventional activities.
Regarding the additional limitation of outputting one or more quantitative metrics of one or more exposomic signatures of a first subject that represents an effect of an intervention on the first subject, these are merely post-solution activities. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g) 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)”). [0141] of Applicant’s specification recites generically outputting the result of the abstract idea and how an output of information can be generally given as a notification as described in [0094], and therefore recites impractical application. Claims 151 and 153 recite similar additional elements. The outputting of the metrics recites the transmission of the information to another device, thus reciting well understood, routine, and conventional activity.
As shown, claims 151 and 153 recite the same and other additional limitations as to claim 131. Further in claim 151, regarding the other additional limitation of a non-transitory computer readable storage medium, wherein the non-transitory computer readable storage medium stores instructions, which when executed by a computer system, cause the computer system to perform a method, the Examiner submits that this limitation amounts 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 “storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93”). [0079] of the Applicant’s Specification recites the generic computing components of the non-transitory storage medium. [0050] recites the use of the generic computer system. The additional elements recite the use of generic computing components 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. Claim 153 recites other additional limitations of: a computer system comprising: one or more processors; and memory addressable by the one or more processors, the memory storing at least one program for execution by the one or more processors, the at least one program comprising instructions. The Examiner submits that this limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components. [0050] of the Applicant’s Specification recites the use of generic processors and memory of the generic computer system. The additional elements recite the use of generic computing components 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. Memory storing instructions for the method recites well understood, routine, and conventional activities.
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 131, 133, 137-138, 141, 151, 153, and 155-167 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
The following references have been considered as relevant, however have not been used in the above rejection:
US 20210005327 A1 to Anwar et al. teaches of a system described for processing biological sample of an individual to measure disease risk markers for the individual to predict health status, where the sample includes exposomic markers.
US-20180330824-A1 to Athey et al. teaches of a system to use input biometric data including exposomes, genetics and other environmental factors to make predictions of drug risks using pharmaceutical phenotypes.
WO-2020232033-A1 to Michuda et al. teaches of identifying a diagnosis for cancer by using a classifier to analyze genomic data.
NPL “Computational resources associating diseases with genotypes, phenotypes and exposures” to Zhang et al. teaches of associating factors such as genetics and environmental factors such as exposomes with diseases.
These references do not teach aspects of the current invention, including but not limited to: “sampling each respective position in a plurality of positions along a reference line on the biological sample, thereby obtaining a plurality of chemical samples for the respective subject, each chemical sample in the plurality of chemical samples corresponding to a different position in the plurality of positions” and “determining a first dataset that includes a plurality of traces, each trace in the plurality of traces being a concentration of a corresponding chemical, in a plurality of chemicals, over time collectively determined from the plurality of chemical samples (d) applying, for each chemical in the plurality of chemicals, a model as a function of time relative to the intervention to the concentration of the respective chemicals measured from the plurality of positions, to generate a corresponding contribution data set representing the contribution of the intervention to the concentration of the respective chemicals in the first subject as a function of time”
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CONSTANTINE SIOZOPOULOS/
Examiner
Art Unit 3686