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 .
Claims 1-11 have been amended. Claims 12-15 are new. Claims 1-15 are pending.
Claim Rejections - 35 USC § 112
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 1-7 and 14 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.
Claim 1 recites “applying a perturbation to the subject associated with the at least one perturbation, wherein the perturbation is associated with a desired health or wellness outcome for individuals in the respective proximal health stratification group matched by the subject, wherein the perturbation is selected based on the respective proximal health stratification group to address a metabolic disorder in the subject.” It is unclear what is meant by “applying a perturbation to the subject associated with the least one perturbation,” rendering the claim indefinite. It is unclear what is meant by “associated” in the claim.
Claims 2-7 and 14 are rejected as they depend from claim 1.
Appropriate correction required.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-7 and 14 are drawn to a method of improving the health or wellness of a subject, which is within the four statutory categories (i.e. process). Claims 8-13 and 15 are drawn to a system for improving the health or wellness of a subject, which is within the four statutory categories (i.e. machine).
Claims 1-7 and 14 (Group I) recite a method of improving the health or wellness of a subject, the method comprising the steps of:
generating a master database, wherein the generating the master database comprises:
collecting continuous digital health data and metabolomic data for a population of individuals of an extended time period (MPEP § 2106.05(g), insignificant extra-solution activity), wherein at least one perturbation is applied to the population of individuals, wherein the at least one perturbation comprises at least one of a clinical treatment, a prophylactic, or a therapy; and
applying a multivariate statistic method to group the population of individuals into one or more health stratification groups, wherein the one or more health stratification groups comprise at least one
digital health phenotypes (DHPs) based on the digital health data or
(ii) metabolic health phenotypes (MHPs) based on the metabolomic data;
(b) at a subsequent time, collecting the digital health data and the metabolomic data for the subject over a time period shorter than the extended time period, wherein the digital health data is collected using at least one digital sensor device (MPEP § 2106.05(f), apply it; MPEP § 2106.05(g), insignificant extra-solution activity), configured to record physiological signals for the subject, wherein the metabolomic data is collected by processing a biological sample of the subject (MPEP § 2106.05(g), insignificant extra-solution activity), to quantify metabolites and metabolite ratios;
(c) determining a subject DHP of the subject and a subject MHP of the subject by comparing the digital health data and the metabolomic data to a respective proximal health stratification group in the master database that the subject matches, wherein the determination is made using the multivariate statistic method; and
(d) applying a perturbation to the subject associated with the at least one perturbation, wherein the perturbation is associated with a desired health or wellness outcome for individuals in the respective proximal health stratification group matched by the subject, wherein the perturbation is selected based on the respective proximal health stratification group to address a metabolic disorder in the subject.
The bolded limitations, given the broadest reasonable interpretation, a certain method of organizing human activity because it recites mathematical relationships, formulas, equations, and/or mathematical calculations and/or fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of abstract idea are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 8-13 and 15 is substantially similar to the abstract idea for Claims 1-7 and 14 (Group I), because the only difference between the claims is they are directed towards different statutory categories.
Claim 8 further recites the additional elements of a master database, at least one device and a computer operatively connected to the at least one digital sensor device. These limitations recite additional elements which are recited at an apply it level. See MPEP § 2106.05(f).
Dependent Claims 2-7 and 9-15 include other limitations, for example Claims 2 and 9 recite wherein the at least one perturbation further comprises at least one of a diet, an exercise, use of a supplement, probiotic, nutraceutical and/or a medication, Claim 3 recites wherein the subject continues to collect the digital health data and/or the metabolomic data and determine the effect of the perturbation on the subject DHP and/or the subject MHP of the subject, wherein the digital health data, the metabolomic data, and the effect is added to the master database (insignificant extra-solution activity, MPEP §2106.05(g)), Claims 4 and 10 recites wherein if the subject experiences a change in the subject DHP and/or the subject MHP which is different than the matched health stratification group, the subject is moved to another health stratification group, or a subgroup may be identified, Claims 5 and 11 recite wherein the master database further comprises one or both of genomic profile data and microbiome profile data from the population of individuals, and the subject collects and compares genomic profile data and/or the microbiome profile data in the matching step to find a matching health stratification group, Claims 6 and 12 recite wherein the time period shorter than the extended time period is a single 24 hour period, Claims 7 and 13 recite wherein the time period shorter than the extended time period is more or less than 24 hours, Claim 14 and 15 recite wherein the metabolites are acylcarnitine and the metabolite ratios are a total acylcarnitine ratio, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 8.
Furthermore, Claims 1-15 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a master database, digital sensor device, at least one device and a computer operatively connected to the at least one digital sensor device, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see pages 11-12 and 20-21, of the present Specification, see MPEP 2106.05(f); and
add insignificant extra-solution activity to the abstract idea – for example, the recitation of using at least one digital sensor device to record physiological signals and processing a biological sample of the subject, which amounts to mere data gathering; the recitation of the data being added to the master database in claim 3, which amounts to an insignificant application, see MPEP 2106.05(g).
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Pages 11-12 and 20-21 of the Specification discloses that the additional elements (i.e. database, device, computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. storing data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the current invention merely recites the storing of data on a database and/or electronic memory; and
Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis); Using well-known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 (Fed. Cir. 2017) – similarly, the current invention merely recites collecting physiological data and processing a biological sample.
Dependent Claims 2-7 and 9-15 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than electronic recordkeeping (e.g. the storing data feature of dependent Claim 3). The remaining additional claims merely further limit the recited abstract idea.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-15 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 02/13/2026 have been fully considered.
Claim Objection
The objection has been withdrawn in view of the amendments.
Claim Rejections - 35 U.S.C. § 101
Applicant argues that the claims “cannot be practically performed in the human mind or by using a human using pen and paper (Remarks, page 10).” This is not persuasive as the claims were not categorized as reciting a mental process, so its irrelevant to the subject matter eligibility rejection.
Applicant asserts that “these steps are also simply not certain methods of organizing human activity as described in the USPTO's 2019 Revised Patent Subject Matter Eligibility Guidance,” citing to Thales Visionix asserting that “the amended claims recite a particular configuration of digital sensor devices and a particular method of using the raw data from those sensors, along with processed metabolomic data from biological samples, to determine health phenotypes and address metabolic disorders in the subject (Remarks, pages 10-11).” The instant claims are nothing like those in Thales. There is not particular requirement for the type of sensor or the configuration of the sensor. The type sensor is not even specified. The sensor is merely used as intended as a tool to collect data. Additionally, the sensor is not even positively recited in claim 1. Furthermore, the claims are steps taken (data analysis) to help treat a patient, which is organizing human activity.
Applicant argues the claims “as a whole integrate the judicial exception into a practical application” because “Claim 1 recites using specific sensor devices to collect physiological data and processing biological samples to quantify metabolites, then using that data to provide targeted health interventions” and citing to Example 46 (Remarks, pages 11-13). The instant claims are nothing like the eligible claims in Example 46 as they send a control signal to a feed dispenser or sorting gate. As indicated in the above rejection, this is mere data gathering and does not result in a practical application. Applicant proceeds to assert that limitations that are abstract result in a practical application. The abstract idea cannot be used to integrate itself into a practical application.
Applicant further asserts that “to the extent the claims recite data collection steps, these steps are directly tied and used to determine, and otherwise limit, the correct treatment to administer to the subject (and which is limited to a metabolic related disorder)…[and] [t]his clinical or prophylactic step provides something significantly more than any alleged judicial exception, and integrates a practical application (see e.g., MPEP 2106.04(d)(2)) (Remarks, page 13).” First, in order to qualify for the treatment or prophylaxis exception, a particular treatment must be administered to the patient for a particular disease or condition. Here, there is neither a particular disease nor a particular treatment. Claim 1 does not specify administering any treatment, let alone a particular one. For example, one cannot “administer” a diet to someone. Furthermore, with respect to claim 8, the perturbation is simply communicated to the subject.
Applicant asserts that “Applicant notes that the additional elements recite a specific improvement over prior art systems by combining digital sensor-collected physiological data with processed metabolomic data from biological samples to identify and address metabolic disorders through targeted perturbations (Remarks, pages 13-14).” Specifically, lack of novelty under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. The distinction between eligibility (under 35 U.S.C. 101) and patentability over the art (under 35 U.S.C. 102 and/or 103) is further discussed in MPEP § 2106.05(d). See MPEP § 2106.05.
Applicant asserts that claims “recite an inventive concept that amounts to
significantly more than any alleged judicial exception under Step 2B of the Alice/Mayo framework” because the “use of sensors combined with molecular signatures is a far more powerful approach for providing precision health and precision medicine approaches tailoring best treatment for each individuals or for adopting personalized approaches to sustain health and prevent, delay, or treat disease (Remarks, page 14).” The sensors are recited at an “apply it” level and are used for their intended purpose to collect health data of the subject. There is no improvement to the sensor resulting from the claimed invention. The improvement resulting from the claims, if any, is to the abstract idea itself.
Applicant states that the claim “represents a specific, unconventional arrangement of data collection, phenotype determination, and treatment application that goes beyond mere data gathering and analysis (Remarks, page 15).” It appears Applicant is conflating novelty and non-obviousness with the Step 2B inquiry, wherein evaluating the additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. As indicated repeated, the sensors or computers are not improved as a result of the claimed invention. The inventive concept is the analysis of the data, which is deemed to be abstract.
Applicant states: “[t]his inventive concept, which is not taught in the cited prior art, amounts to significantly more than any alleged judicial exception. See MPEP 2106.05. The claims do not merely recite well-understood, routine, and conventional activities, but rather a specific technological solution for integrating digital sensor data with metabolomic data to provide personalized health interventions through a dynamic treatment optimization system (Remarks, page 15).” Novelty and non-obviousness are separate inquiries from eligibility. "a claim for a new abstract idea is still an abstract idea (See MPEP § 2106.05).”
Claim Rejections - 35 U.S.C. § 102
Applicant’s arguments are moot in view of the withdrawn rejection in response to the current amendments.
Claim Rejections - 35 U.S.C. § 103
Applicant’s arguments are moot in view of the withdrawn rejection in response to the current amendments.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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