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 .
Response to Arguments
Rejection Under 101
Applicant's arguments filed 01/26/2026 have been fully considered.
Applicant argues that the amended claims are not directed to an abstract idea because they recite specific technical implementations with meaningful limits, not mental processes or organizing human activity in the abstract. The independent claims recite updating the mappings based on feedback from treatment. This improves the system over time through machine learning and is not a mental process nor is it organizing human activity.
In response to Applicant’s argument, as discussed below in the updated rejection, the claims are directed to organizing human activity since the limitations of this claim encompass an organizing medical information in order to make a recommendation for treatment of the patient. Additionally, Examiner notes that machine learning is not recited in the claim and therefore the argument that it helps to improve the system is moot.
The claims recite determining an effectiveness and updating the genetic information by comparing contextual information. This effectiveness determination through a technical comparison goes beyond the abstract idea and recites a specific method of processing data types.
In response to Applicant’s argument, the limitations at issue are considered to be part of the abstract idea and thus fall under the abstract idea grouping of organizing human activity. See the updated rejection below.
The feedback loop recited in the amended claim creates a system that learns and improves from treatment results making future recommendations more accurate and specific. This is an improvement in the system capability and not merely abstract data organization.
In response to Applicant’s argument, the limitations at issue are considered to be part of the abstract idea and thus fall under the abstract idea grouping of organizing human activity. See the updated rejection below.
Claim 8 recites specific database structures that go beyond generic data storage. The databases provide a complete technical picture of nutrients obtained by consuming a particular food that is stored in the food micronutrient database.
In response to Applicant’s argument, the storage and databases are construed to be additional elements that amounts to invoking the use of computers to carry out the abstract idea and the act of storing different data in different databases amounts to insignificant extrasolution activity by merely selecting types of data to be gathered for storage. See the updated rejection below.
Claim 8 recites the mapping is updated based on feedback after treatment. The feedback increases accuracy and specificity of the mapping itself, which is a technical improvement to the system.
In response to Applicant’s argument, the limitations at issue are part of the abstract idea and thus fall under the abstract idea grouping of organizing human activity. See the updated rejection below.
Claim 15 addresses the Board’s specific concern by reciting a particular treatment for a particular condition. The claims now recite identifying a medical condition, recommending a particular route of nutrition based on the medical condition and the cost and effectiveness of the recommendation. This is a particular treatment that provides meaningful limits that distinguish the claim from the abstract data organization.
In response to Applicant’s argument, as discussed in the Patent Board Decision dated 07/18/2025 the claims do not recite a particular treatment. See Decision pgs. 7-9. Similarly to what the decision concluded, the amended claims collect broadly defined data on which to make the recommendations. The amended claims do not recite a specific condition and treatment when the condition and treatment can be selected from among many options. For example, the claims recite “identifying… a food, an oral supplement, a topical treatment…” as a treatment for the patient. Similarly, there is no specific condition recited. Thus there is no particular treatment recited.
Applicant argues that the amended claims integrate the abstract idea into a practical application based on the improvement from the feedback, mapping updates, determining effectiveness through contextual comparison, and database architecture.
In response to Applicant, the additional elements do not amount to a practical application due to the recitation of a high level of generality. With regards to new amendments about the feedback, mapping updates, and effectiveness comparisons, the limitations are part of the abstract idea and not additional elements. The databases are considered an additional element but is recited at a high level of generality and used for its intended purpose. See the updated rejection below.
Claim 15 recites a particular treatment for a particular condition which represents a practical application.
In response to Applicant, as previously discussed above in “F”, the claims do not recite a particular treatment for a particular condition and thus do not recite a practical application. See above for further explanation.
Examiner characterized the computer components as generic and the data gathering as insignificant extrasolution activity. The amended claims do not merely recite generic computer components performing routine functions. The continuously updated mapping, feedback driven improvement mechanism, the technical comparison of contextual information to stored treatment outcomes, and the specific database structures all represent specific technical implementations that integrate the abstract idea into a practical application.
In response to Applicant, as previously discussed most of the limitations at issue are part of the abstract idea and not part of the practical application analysis. The use of databases to collect and store data amounts to invoking the use of computers and the use of different databases to store different data amounts to insignificant extrasolution since this is merely determining what data type needs to be gathered. Therefore, the additional elements do not amount to a practical application. See the updated rejection for further clarification.
The combination of elements recited in the amended claims is not well understood, routine or conventional and amounts to significantly more. The combination of elements in the various amended claims creates a system that improves over time through machine learning from actual treatment outcomes. This combination is not conventional. Examiner has not provided evidence that the systems with the updated mappings based on feedback, combined with effectiveness determinations through comparison are well understood, routine, and conventional.
In response to Applicant, Applicant’s argument appears to be directed to the amendment and is therefore moot. However, in the rejection below in the 101 analysis under Step 2B the evidence required for well understood, routine and conventional is provided. Examiner also notes that machine learning is not recited in the claims. Although claims are interpreted in light of the specification, limitations from the specification are not read into the claims.
Claim 8 recites specific databases structures that amount to significantly more and goes beyond routine data gathering and represents specific implementations designed to enable accurate nutrient recommendations.
In response to Applicant, the databases amount to nothing more than merely invoking the use of computers and insignificant extrasolution activity . As discussed in Step 2B the Berkheimer evidence demonstrates that the databases are well understood, routine and conventional. See the updated rejection below.
The determination of effectiveness through comparison recited in claim 1 is not conventional data comparison.
In response to Applicant, the limitation at issue is part of the abstract idea and is not considered an additional element. See the updated rejection below.
The Examiner cited to the Board decision for the proposition that using genetic tests to collect data is well understood, routine, and conventional. The amended claims recite continuously improving the system and the ordered combination of elements is a technical advancement that amounts to significantly more than the judicial exception.
In response to Applicant, the evidence required by the MPEP for the well understood, routine, and conventional analysis is properly provided in the analysis below. The Board decision was merely noted for additional context. See the updated rejection for clarification in light of the amendments.
The amended claims are analogous to Examples 47-49 and integrate the abstract idea into a practical application.
In response to Applicant, the Examples 47-49 provided in Applicant’s response to arguments to do not match the actual Examples 47-49 in the July 2024 Guidance. Therefore, applicant’s arguments are unpersuasive.
Examiner relied on the Board decision which found the claims do not recite a particular treatment. Applicant has amended claim 15 to recite a particular treatment.
In response to Applicant, see “F” which explains why claim 15 does not recite a particular treatment.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 1-7, 15-20 are drawn to a method, which is within the four statutory categories (i.e. process). Claims 8-14 are drawn to a system, which is within the four statutory categories (i.e. apparatus).
Step 2A of the Alice/Mayo Test - Prong One
The independent claim 8 (and substantially similar with independent claim 1, 15) recites:
A system for creating a context-based personalized nutrition recommendation, the system comprising:
a plurality of electronic devices each comprising a device processor and memory and configured to receive:
genetic information of an individual of a plurality of individuals, determined by a genetic test configured to determined genetic information of a corresponding individual; and
medical information of the individual, therapeutic objectives of the individual, and lifestyle information of the plurality of individuals;
a plurality of sensors each in communication with a corresponding electronic device, the plurality of sensors comprising a position sensor, an accelerometer, and a heart rate monitor, wherein each electronic device is configured to determine an updated location of each of the plurality of individuals real-time air quality data based on location data from the position sensor, and wherein the electronic device is configured to determine fitness data of the individual based on motion data from the accelerometer and heart rate data from the heart rate monitor; and
a server comprising a server processor and memory, wherein the memory is configured to store: a food micronutrient database including food nutrient data for a plurality of foods, wherein the food nutrient data for each food includes proximates data, inorganics data, micronutrients data, vitamin fractions data, fatty acid compositions data, and bioactive compounds data; an oral supplement micronutrient database including nutrient data for a plurality of oral supplements; a topical treatment database including nutrient data for a plurality of topical treatments; an inhaled nutrition therapy database including nutrient data for a plurality of inhaled nutrition therapies; an intravenous nutrition therapy database including nutrient data for a plurality of intravenous nutrition therapy formulas; an intramuscular nutrition therapy database including nutrient data for a plurality of intramuscular nutrition therapy formulas; and a mapping of genetic information, medical information, therapeutic objectives, lifestyle information, air quality data, and fitness data to one or more micronutrients, wherein the mapping is continuously updated based on feedback received after individuals are treated with an identified micronutrient and a recommended route of delivering the micronutrient, wherein treatment of multiple individuals with different genetic information, medical information, therapeutic objectives, lifestyle information, air quality data, and fitness data improves accuracy and specificity of the mapping, wherein the server is in communication with the electronic device, and is configured to:
receive, over the network in real time, updated data comprising food data, oral supplement data, topical treatment data, inhaled nutrition therapy data, intravenous nutrition therapy data, intramuscular nutrition therapy data;
receive, over the network in real time, an updated mapping of the genetic information, the medical information, the therapeutic objectives, the lifestyle information, the air quality data, and the fitness data;
use the updated mapping to identify the one or more micronutrients for each of the plurality of individuals based on the updated data, the updated genetic information of each of the individuals determined by the genetic test, the medical information, the therapeutic objectives, the lifestyle information, the fitness data of each of the plurality of individuals and the air quality data;
identify at least two of a food from the updated food data, an oral supplement from the updated oral supplement data, a topical treatment from the updated topical treatment data, an inhaled nutrition treatment from the inhaled nutrition treatment data, an intravenous nutrition therapy formula from the intravenous nutrition therapy data, and an intramuscular nutrition therapy formula from the intramuscular nutrition therapy data that provide the identified one or more micronutrients;
determine an effectiveness for the individual of each of the at least two based on the genetic information of each of the plurality of individuals determined by the genetic test, the medical information, the therapeutic objectives, the lifestyle information, the fitness data, and the air quality data by comparing contextual information of the individual to stored treatment outcomes from other individuals having similar contextual information;
recommend one of the at least two based on a cost and the effectiveness for the individual of each of the food, the oral supplement, the topical treatment, the inhaled nutrition treatment, the intravenous nutrition therapy formula, and the intramuscular nutrition therapy formula, wherein the effectiveness for the individual is based on the genetic information of the individual determined by the genetic test, the medical information of the individual, the therapeutic objectives of the individual, the lifestyle information of the individual, the fitness data of the individual, and the real-time air quality data;
receive feedback on the effectiveness of the recommended on of the at least two; and
update the mapping based on the feedback to improve future recommendations for the individual and for other individuals.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules or instructions), but for the recitation of generic computer components. For example, but for the system with an electronic device, plurality of sensors, processor, memory, server, network, wearable devices, genetic tests, databases, the limitations of this claim encompass an organizing medical information in order to make a recommendation for treatment of the patient. If a claim limitation, under its broadest reasonable interpretation, covers management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Any differences in the other independent claims is construed as part of the abstract idea unless discussed below in the analysis. Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-7, 9-14, and 16-20 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
The independent claim 8 (and substantially similar with independent claim 1, 15) recites:
A system for creating a context-based personalized nutrition recommendation, the system comprising: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a plurality of electronic devices each comprising a device processor and memory and configured to receive: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
genetic information of an individual of a plurality of individuals, determined by a genetic test (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g)), and (general linking to a technological environment as noted below, see MPEP 2106.05(h)) configured to determined genetic information of a corresponding individual; and
medical information of the individual, therapeutic objectives of the individual, and lifestyle information of the plurality of individuals;
a plurality of sensors each in communication with a corresponding electronic device, the plurality of sensors comprising a position sensor, an accelerometer, and a heart rate monitor, wherein each electronic device is configured (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) to determine an updated location of each of the plurality of individuals real-time air quality data based on location data from the position sensor, and wherein the electronic device is configured to determine fitness data of the individual based on motion data from the accelerometer and heart rate data from the heart rate monitor; and
a server comprising a server processor and memory, wherein the memory is configured to store: a food micronutrient database including food nutrient data for a plurality of foods, wherein the food nutrient data for each food includes proximates data, inorganics data, micronutrients data, vitamin fractions data, fatty acid compositions data, and bioactive compounds data; an oral supplement micronutrient database including nutrient data for a plurality of oral supplements; a topical treatment database including nutrient data for a plurality of topical treatments; an inhaled nutrition therapy database including nutrient data for a plurality of inhaled nutrition therapies; an intravenous nutrition therapy database including nutrient data for a plurality of intravenous nutrition therapy formulas; an intramuscular nutrition therapy database including nutrient data for a plurality of intramuscular nutrition therapy formulas; and a mapping of genetic information, medical information, therapeutic objectives, lifestyle information, air quality data, and fitness data to one or more micronutrients, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) and (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g))wherein the mapping is continuously updated based on feedback received after individuals are treated with an identified micronutrient and a recommended route of delivering the micronutrient, wherein treatment of multiple individuals with different genetic information, medical information, therapeutic objectives, lifestyle information, air quality data, and fitness data improves accuracy and specificity of the mapping, wherein the server is in communication with the electronic device, and is configured to: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
receive, over the network in real time (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), updated data comprising food data, oral supplement data, topical treatment data, inhaled nutrition therapy data, intravenous nutrition therapy data, intramuscular nutrition therapy data;
receive, over the network in real time (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), an updated mapping of the genetic information, the medical information, the therapeutic objectives, the lifestyle information, the air quality data, and the fitness data;
use the updated mapping to identify the one or more micronutrients for each of the plurality of individuals based on the updated data, the updated genetic information of each of the individuals determined by the genetic test (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), the medical information, the therapeutic objectives, the lifestyle information, the fitness data of each of the plurality of individuals and the air quality data;
identify at least two of a food from the updated food data, an oral supplement from the updated oral supplement data, a topical treatment from the updated topical treatment data, an inhaled nutrition treatment from the inhaled nutrition treatment data, an intravenous nutrition therapy formula from the intravenous nutrition therapy data, and an intramuscular nutrition therapy formula from the intramuscular nutrition therapy data that provide the identified one or more micronutrients;
determine an effectiveness for the individual of each of the at least two based on the genetic information of each of the plurality of individuals determined by the genetic test (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), the medical information, the therapeutic objectives, the lifestyle information, the fitness data, and the air quality data by comparing contextual information of the individual to stored treatment outcomes from other individuals having similar contextual information;
recommend one of the at least two based on a cost and the effectiveness for the individual of each of the food, the oral supplement, the topical treatment, the inhaled nutrition treatment, the intravenous nutrition therapy formula, and the intramuscular nutrition therapy formula, wherein the effectiveness for the individual is based on the genetic information of the individual determined by the genetic test (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), the medical information of the individual, the therapeutic objectives of the individual, the lifestyle information of the individual, the fitness data of the individual, and the real-time air quality data;
receive feedback on the effectiveness of the recommended on of the at least two; and
update the mapping based on the feedback to improve future recommendations for the individual and for other individuals.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the system with an electronic device, plurality of sensors, processor, memory, server, network, wearable devices, genetic tests, databases, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0007], [0028], [0030]-[0031], [0043], [0048], [0060], [0077]-[0080] see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of using genetic tests to collect data, memory and databases for storing different types of data amounts to selecting a particular data source or type of data to be manipulated and data gathering, see MPEP 2106.05(g))
generally link the abstract idea to a particular technological environment or field of use (such as genetic tests to determine genetic information, see MPEP 2106.05(h))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-7, 9-14, and 16-20 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea, and claims 2-7, 9-14, and 16-20 additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using he system with an electronic device, plurality of sensors, processor, memory, server, network, wearable devices, genetic tests, databases, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0007], [0028], [0030]-[0031], [0043], [0048], [0060], [0077]-[0080]); using a server, processor, memory, network, different databases, etc. e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application. (See MPEP 2106.05(g)): The courts have recognized the following laboratory techniques, such as using genetic tests to determine information, as well-understood, routine, conventional activity (e.g., see MPEP 2106(d)(II)): Analyzing DNA to provide sequence information or detect allelic variants (e.g., see Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546); using genetic tests to collect data, e.g., applying conventional diagnostic methods to detect a natural phenomenon, CareDx, Inc. v. Natera, Inc., 40 F.4th 1371, 1378 (Fed. Cir. 2022) {as noted in the PTAB decision dated 07/18/2025}; using memory for storing different data e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
generally linking the abstract idea to a particular technological environment or field of use. The following represent examples that courts have identified as generally linking the abstract idea to a particular technological environment (e.g. see MPEP 2106.05(h)): Limiting the abstract idea data related to genetic testing, because limiting application of the abstract idea to genetic testing is simply an attempt to limit the use of the abstract idea to a particular technological environment (e.g. see Electric Power Group, LLC v. Alstom S.A.).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea, and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
Subject Matter Free of Prior Art
Claims 1-20 are free of prior art over Neumann (US 2021/0005304) in view of Hanlon et al. (US 2012/0290327), Donalds (US 2018/0032682), and Berthon et al., “Nutrition and Respiratory Health—Feature Review”, March 5, 2015, Nutrients, Vol. 7, 1618-1643. The prior art references, or reasonable combination thereof, could not be found to disclose, or suggest all of the limitations found in the independent claims. The closest prior art is Neumann (US 2021/0005304), which teaches a diagnostic engine configured to record biological extraction from a user and generate a diagnostic output using the extraction and training data. Hanlon et al. (US 2012/0290327) teaches a nutrition assessment and tools for enabling users to achieve health-related goals based on their needs. Donalds (US 2018/0032682) teaches using user data, such as, physiological data, emotional affect data, or both, to determine a user state. Berthon et al., “Nutrition and Respiratory Health—Feature Review” teaches relationships between dietary patterns, nutrition intake and weight status at different stages in life. The references taken solely, or in combination, fail to provide the required limitations, and modification of any complementary combination of the references of record would be impermissible hindsight and not provide any advantages over their present application. The dependent claims are also free of prior art due to their corresponding dependency of the independent claims.
Conclusion
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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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686