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 IDS filed 8/2/2023 has been considered by the Examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of India application INDIA 202121004712 filed 02/03/2021 is acknowledged.
Claim Status
Claims 1-20 are pending and are examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “harbours” in page 4 2nd para 1st line, which should reads as “harbors”. Claims 9 and 15 have similar problems. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: claim 5 recites “normalised” in page 12 1st para 1st line, and in page 15 2nd para 2nd line again, which should reads as “normalized”. Claims 12 and 19 have similar problems. Appropriate correction is required.
Claim 3 recites “generation of a” at the 3rd step line 1 (page 10). “Generation of” should read as “generating” to be in parallel to other steps in claim 3.
Claim Rejections - 35 USC § 112—First Paragraph
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 1-20 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.
Claim 1 recites (page 6, penultimate para, lines 1-2) “receiving a plurality of gut samples of an individual at two-time stamps, via the one or more hardware processors, wherein the two-time stamps comprise a time stamp 1 and a time stamp 2 at which the two samples have been collected”. The disclosure provides no description on how “one or more hardware processors” are configured to receive the gut samples. Under a broadest reasonable interpretation (BRI) some automated machines such as a robot would be needed to hand gut samples under the command of the processors. A processor cannot hand gut samples directly. However, the disclosure discloses no such a machine or robot. Claim 1 hence lacks written description for claim limitations. Claims 9 and 15 have similar problems.
Claim 8 recites “genetically engineering (a) a plurality of microbial pathways for production of one or more beneficial metabolites, or/and (b) the plurality of microbial pathways for degradation/elimination of one or more harmful metabolites into the genetic makeup of gut microorganisms”. However, the disclosure barely provides a definition for “genetic engineering” at [032]. The disclosure does not have enough description which enable an ordinary skilled person to modify (or to create) pathways for production of one or more beneficial metabolites, or for degradation/elimination of one or more harmful metabolites.
Claim 14 recites “the one or more hardware processors are configured by the instructions to implement the personalized therapeutic intervention further comprises administering a genetically engineered bacteria”. The disclosure provides no description on how the “hardware processors are configured by the instructions to implement the personalized therapeutic intervention comprises administering”. Under a broadest reasonable interpretation (BRI) some automated machine such as a robot would be needed to execute the command of the processors. However, the disclosure discloses no such a machine or robot. Claim 14 hence lacks written description for claim limitations.
Claim Rejections - 35 USC § 112—Second Paragraph
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 1-20 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 “ProbMap” in page 5 line 10. There is a description in the disclosure on how ProbMap is generated at [0119], but a short explanation as to what “ProbMap” stands for upon the first appearance in the claims is not provided. It is unclear what the metes and bounds of ProMap are intended to be. Claims are indefinite over “ProbMap”.
Claims 9 and 15 have similar problems.
Claim 1 recites “TAXA_SET_P”, “TAXA_SET_A” in page 8 2nd step; and “TAXA_NET”, TAXA_SET_FN”, TAXA_SET_FN_COM”, TAXA_SET_INTERSECT”, TAXA_SET_NEW” in page 8 3rd step; all without explanation. It is unclear what the metes and bounds of these acronyms. Claims 9 and 15 have similar problem. Claims hence are indefinite over these abbreviations.
Claims 1, 9 and 15 all recite “receiving a plurality of gut samples of an individual at two-time stamps, via the one or more hardware processors”. It is not clear how the hardware processors can receive a gut sample. The disclosure at [0008, 0009, 0019] reiterates this claim limitation. The “gut sample” is a biological sample as confirmed by the disclosure at [0121-0122] and by claims 4, 11 and 18. Claims hence are indefinite over this operation that handing biological samples via hardware processors. It is unclear if the gut sample should be interpreted as data or a physical sample.
Claim 1 recites (page 6, penultimate para, lines 1-2) “receiving a plurality of gut samples of an individual at two-time stamps, via the one or more hardware processors, wherein the two-time stamps comprise a time stamp 1 and a time stamp 2 at which the two samples have been collected”. The disclosure provides no description on how “one or more hardware processors” are configured to receive the gut samples. Claims 9 and 15 have similar problems. It is not clear how this “receiving a plurality of gut samples of an individual at two-time stamps, via the one or more hardware processors” is achieved. Claims 1, 9 and 15 are hence indefinite.
Claim 8 recites “genetically engineering (a) a plurality of microbial pathways for production of one or more beneficial metabolites, or/and (b) the plurality of microbial pathways for degradation/elimination of one or more harmful metabolites into the genetic makeup of gut microorganisms”. However, the disclosure barely provides a definition for “genetic engineering” at [032]. The disclosure does not have enough description which enable an ordinary skilled person to modify (or to create) pathways for production of one or more beneficial metabolites, or for degradation/elimination of one or more harmful metabolites. It is not clear how “genetically engineering (a) a plurality of microbial pathways” is achieved. Claim 8 is hence indefinite.
Claim 14 recites “the one or more hardware processors are configured by the instructions to implement the personalized therapeutic intervention further comprises administering a genetically engineered bacteria”. The disclosure provides no description on how the “hardware processors are configured by the instructions to implement the personalized therapeutic intervention comprises administering”. It is not clear how this “administering” is achieved. Claim 14 hence is indefinite.
Claim 4 recites the limitation "the sample processing technique" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 11 and 18 have similar problems.
Claim 4 recites the limitation "the pathway abundance matrices" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claims 11 and 18 have similar problems.
Claim 4 is indefinite when reciting “generating a pathway abundance” in the last step. It sounds like something is missing after “pathway abundance”. Pathway abundance map? Or pathway abundance matrix? Or something else. It is not clear what kind of information relating to a pathway abundance will be generated.
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 non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 1-8 are to “a processor implemented method”, with a series functional steps. So a process.
Claims 9-14 are to “a system” comprising an input/output interface; one or more memories; and one or more hardware processors. So a machine or manufacturer.
Claims 15-20 are to “One or more non-transitory machine-readable information storage mediums” comprising one or more executable instructions. So a machine or manufacturer.
Step 2A Prong One: Identification of Abstract Ideas
The claim(s) recite(s):
Generating a set of knowledge bases using the set of input data, via the one or more hardware processors, wherein the set of knowledge bases comprises a genus function map (FGmap), a genome metabolite pathway (GMP) map, a taxa association reference profile (TAXA_NET) graph, a TAXA-food constituent network, a food-constituent network and a ProbMap;
This step recites generating a set of knowledge bases from the set of input data,
which is a data manipulation and re-organization that convert received data into the database format, that is achievable in the human mind. Hence this step equates to an abstract idea of mental processes.
Generating the FGmap and the GMP map, wherein the FGmap is a matrix associated with a function of the plurality of bacterial genera belonging to one of the plurality of taxonomic group and the plurality of metabolic pathways as columns, wherein a first pre-defined indicator indicates one of (a) a presence of the metabolic pathway and (b) an absence of the metabolic pathway and the GMP is a matrix of the plurality of bacterial strains as rows and the plurality of metabolic pathways as columns, wherein a second pre-defined indicator indicates one of (a) a presence of the metabolic pathway and (b) an absence of the metabolic pathway;
This step recites generating two maps of association matrixes, which is a data manipulation and re-organization that converts received data into the database format, that is achievable in the human mind. Meanwhile generating association matrixes requires calculation of correlations. Hence this step equates to abstract ideas of mental processes and mathematical concepts.
Generating the TAXA_NET graph based on the plurality of taxonomic groups and the FGmap, wherein the TAXA_NET graph is a undirected, wherein each node in the TAXA_NET graph corresponds to a taxonomic group from the plurality of taxonomic groups and edges indicate a positive relationship between a pair of the taxonomic group wherein each taxa from a plurality of nodes is associated with the function of the plurality of taxonomic groups from the FGmap, wherein the positive relationship comprises one of a mutualism, a syntrophic, a commensalism and a cooperation;
This step recites generating a graph of nodes and edges and a map of association matrixes, which is a data manipulation and re-organization that converts existing data into the network format, that is achievable in the human mind. Meanwhile generating an association matrix requires calculation of correlations. Hence this step equates to abstract ideas of mental processes and mathematical concepts.
Generating the TAXA-food constituent network based on a plurality of food constituents for each taxa of the TAXA_NET, wherein the TAXA-food constituent network is an undirected network of each taxa in association with a food constituent used by the taxa as a source of metabolism or nutrition;
This step recites generating a graph of nodes and edges, which is a data manipulation and re-organization that converts existing data into the network format, that is achievable in the human mind. Hence this step equates to abstract ideas of mental processes.
Generating the food-constituent network based on a plurality of food items for each food constituent of the TAXA-food constituent network, wherein the food-constituent network is an undirected network of each food-constituent present in a food item; and
This step recites generating a graph of nodes and edges, which is a data manipulation and re-organization that converts existing data into the network format, that is achievable in the human mind. Hence this step equates to abstract ideas of mental processes.
Generating a transpose of the GMP to obtain the ProbMap, wherein the ProbMap is a matrix with rows comprising each metabolite from the plurality of metabolites and the plurality of metabolic pathways and columns comprising the plurality of bacterial strains, probiotics, prebiotics, diet components capable of biosynthesis and/or degradation of the corresponding plurality of metabolites;
This step recites generating a map of association matrixes, which requires calculation of correlations. Hence this step equates to abstract ideas of mathematical concepts.
Generating a taxa abundance matrix for the plurality of gut samples, via the one or more hardware processors, wherein the taxa abundance matrix comprises of a taxa set 1 and a taxa set 2, where the taxa set 1 and the taxa set 2 is generated using the time stamp 1 and the time stamp 2;
Under a Broadest Reasonable Interpretation (BRI), the taxa abundance values are plotted against a two-dimension graph of using the time stamp 1 and the time stamp 2 as the x-axis and the y-axis. This plotting procedure can be accomplished in the human mind, with the help of a pen and pencil. Therefore, this step recites an abstract idea of mental processes.
Generating a pathway abundance for each of the plurality of gut-samples obtained at the time stamp 1 and the time stamp 2 using the taxa abundance matrix and the FGmap, via the one or more hardware processors, wherein the pathway abundance is generated using a sample processing technique, wherein the pathway abundance for each time stamp is indicative of presence of the plurality of metabolic pathways of the GMP in the gut microbiome of the individual at the corresponding time stamp;
Under a Broadest Reasonable Interpretation (BRI), generating a pathway abundance for each of the plurality of gut-samples obtained at the time stamp 1 and the time stamp 2 using the taxa abundance matrix and the FGmap requires correlation of multiple datasets. Therefore this step is an abstract idea of mathematical concepts.
Identifying a perturbed pathway, where the perturbed pathway indicates a deterioration in the gut health of the individual, wherein the perturbed pathway is identified based on a comparison of the pathway abundance of the plurality of gut-samples obtained at the time stamp 1 and the time stamp 2 using a statistical technique,
“Identifying a perturbed pathway” reads on a judgement/decision-making activity that is achievable in the human mind. Hence this step equates to an abstract idea of mental processes.
Determining an initial set of personalized therapeutics and diet recommendation, wherein the initial set of personalized therapeutics and diet comprises at least one of: a personalized therapeutic and a personalized dietary regimen using the ProbMap, wherein the initial set of personalized therapeutics and diet recommendation is a row corresponding to the identified perturbed pathway, wherein the personalized therapeutic is determined as (a) the plurality of bacterial strains possessing the perturbed pathway or (b) the plurality of bacterial strains possessing the pathway for degradation or/and biosynthesis of a probable metabolite, wherein the probable metabolite is a metabolite corresponding to the perturbed pathway in the ProbMap;
“Determining an initial set of personalized therapeutics and diet recommendation” reads on an opinion/judgement activity that is achievable in the human mind. Hence this step equates to an abstract idea of mental processes.
Identifying a taxa set in the taxa abundance matrix obtained at the time stamp 2, wherein the taxa set comprises of a TAXA_SET_P and a TAXA_SET_A, where the TAXA_SET_P comprises a predefined first value for the one or more of the beneficial pathway in one of the FGmap and the GMP, and the TAXA_SET_A comprises a predefined second value for the one or more of harmful pathways in one of the FGmap and the GMP;
“Identifying a taxa set in the taxa abundance matrix” reads on a judgement/decision-making activity that is achievable in the human mind. Hence this step equates to an abstract idea of mental processes.
Identifying a set of first neighbors for each of the taxa in the TAXA_SET_P at the time stamp 2 from the TAXA_NET graph, wherein the set of first neighbors are immediate neighbors of the TAXA_SET_P comprising of a TAXA_SET_FN, a TAXA_SET_FN_COM, a TAXA_SET_INTERSECT, a TAXA_SET_NEW; and
“Identifying a set of first neighbors for each of the taxa” reads on a judgement /decision-making activity that is achievable in the human mind. Hence this step equates to an abstract idea of mental processes.
Recommending a personalized therapeutic intervention for improving gut health of the individual, via the one or more hardware processors, wherein the therapeutic intervention comprises recommending one of (a) a prebiotic cocktail, (b) a probiotic cocktail (c) optimized diet based on the identified first neighbors using the set of knowledge bases and the initial set of personalized therapeutics and diet recommendation;
“Recommending a personalized therapeutic intervention for improving gut health of the individual” reads on an opinion/judgement activity that is achievable in the human mind. Hence this step equates to an abstract idea of mental processes.
Step 2A Prong Two: Consideration of Practical Application
The claims result in a process of Recommending a personalized therapeutic intervention for improving gut health of the individual, which reads on an abstract idea of mental processes. The claims do not recite any additional elements that integrate the abstract idea/judicial exception into a practical application.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses 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 more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
receiving a set of input data, via one or more hardware processors, wherein the set of input data comprises data associated with a plurality of metabolites, a plurality of metabolic pathways, a plurality of taxonomic groups, information on nutrients, probiotics, prebiotics, supplements for replenishment or degradation of the plurality of metabolites, a plurality of food constituents, a plurality of food items, a microbial abundance matrix for healthy cohorts, a plurality of diet optimization pre-requisite parameters (claims 1, 9 and 15);
receiving a plurality of gut samples of an individual at two-time stamps, via the one or more hardware processors, wherein the two-time stamps comprise a time stamp 1 and a time stamp 2 at which the two samples have been collected (claims 1, 9 and 15);
extracting a plurality of nucleic acids from the plurality of gut sample based on a nucleic acid extraction technique (claims 4, 11 and 18);
generating a plurality of nucleotide sequences from the extracted plurality of nucleic acid using a sequencer (claims 4, 11 and 18);
administering a genetically engineered bacteria, wherein the genetically engineered bacteria comprise of genetically engineering (a) a plurality of microbial pathways for production of one or more beneficial metabolites, or/and (b) the plurality of microbial pathways for degradation/elimination of one or more harmful metabolites into the genetic makeup of gut microorganisms (claims 8 and 14);
A system, comprising: an input/output interface; one or more memories; and one or more hardware processors (claim 9); and
One or more non-transitory machine-readable information storage mediums (claim 15).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because receiving input data and gut samples are insignificant extra-solution activities because they are necessary for data analysis.
The claims do not include additional elements that are sufficient to amount of significantly more than the judicial exception because it is routine and conventional to perform the acts of extracting acids from the two gut samples and analyzing the nucleic acids (MPEP2106.05(d).II):
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: [AltContent: rect]
iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017); [AltContent: rect]
v. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546; and
vii. Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014).
Other elements of the method include computing system and components which are recitation of generic computer structures that serve to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry. Receiving input data is an insignificant extra-solution activity. Receiving gut samples is routine and well-known in the clinical industry. As to administering a genetically engineered bacteria, neither claim 8 nor claim 14 specify where to administer the genetically engineered bacteria. However, in the daily life, it is well-known and routine for people to administer probiotics into their guts when they consume probacteria products.
Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Regarding the 35 USC 102/103
The claims are art free because of the specific integrated knowledgebase architecture and the case-based recommendation logic with cocktail recommendations. These two concepts are captured in the following combination of claim limitations:
generating a set of knowledge bases using the set of input data, via the one or more hardware processors, wherein the set of knowledge bases comprises a genus function map (FGmap), a genome metabolite pathway (GMP) map, a taxa association reference profile (TAXA_NET) graph, a TAXA-food constituent network, a food-constituent network and a ProbMap wherein the generation of the set of knowledge bases comprises:
generating the FGmap and the GMP map, wherein the FGmap is a matrix associated with a function of the plurality of bacterial genera belonging to one of the plurality of taxonomic group and the plurality of metabolic pathways as columns, wherein a first pre-defined indicator indicates one of (a) a presence of the metabolic pathway and (b) an absence of the metabolic pathway and the GMP is a matrix of the plurality of bacterial strains as rows and the plurality of metabolic pathways as columns, wherein a second pre-defined indicator indicates one of (a) a presence of the metabolic pathway and (b) an absence of the metabolic pathway;
generating the TAXA_NET graph based on the plurality of taxonomic groups and the FGmap, wherein the TAXA_NET graph is a undirected, wherein each node in the TAXA_NET graph corresponds to a taxonomic group from the plurality of taxonomic groups and edges indicate a positive relationship between a pair of the taxonomic group wherein each taxa from a plurality of nodes is associated with the function of the plurality of taxonomic groups from the FGmap, wherein the positive relationship comprises one of a mutualism, a syntrophic, a commensalism and a cooperation;
generating the TAXA-food constituent network based on a plurality of food constituents for each taxa of the TAXA_NET, wherein the TAXA-food constituent network is an undirected network of each taxa in association with a food constituent used by the taxa as a source of metabolism or nutrition;
generating the food-constituent network based on a plurality of food items for each food constituent of the TAXA-food constituent network, wherein the food-constituent network is an undirected network of each food-constituent present in a food item;
generating a transpose of the GMP to obtain the ProbMap, wherein the ProbMap is a matrix with rows comprising each metabolite from the plurality of metabolites and the plurality of metabolic pathways and columns comprising the plurality of bacterial strains, probiotics, prebiotics, diet components capable of biosynthesis and/or degradation of the corresponding plurality of metabolites;
identifying a perturbed pathway, where the perturbed pathway indicates a deterioration in the gut health of the individual, wherein the perturbed pathway is identified based on a comparison of the pathway abundance of the plurality of gut-samples obtained at the time stamp 1 and the time stamp 2 using a statistical technique, wherein the perturbed pathway is identified based on one of below cases:
Case A: a decrease in the pathway abundance of the set of beneficial pathways, wherein the decrease is an indicative of a decrease in the set of beneficial microbes, or
Case B: an increase in the pathway abundance of the set of harmful pathways wherein the increase is indicative of an increase in the set of harmful microbes, or
Case C: a decrease in the pathway abundance of the set of beneficial pathways and increase in the pathway abundance of the set of harmful pathways indicative of an increase in set of harmful microbes and decrease in the set of beneficial microbes;
determining an initial set of personalized therapeutics and diet recommendation, wherein the initial set of personalized therapeutics and diet comprises at least one of: a personalized therapeutic and a personalized dietary regimen using the ProbMap, wherein the initial set of personalized therapeutics and diet recommendation is a row corresponding to the identified perturbed pathway, wherein the personalized therapeutic is determined as (a) the plurality of bacterial strains possessing the perturbed pathway or (b) the plurality of bacterial strains possessing the pathway for degradation or/and biosynthesis of a probable metabolite, wherein the probable metabolite is a metabolite corresponding to the perturbed pathway in the ProbMap;
identifying a taxa set in the taxa abundance matrix obtained at the time stamp 2, wherein the taxa set comprises of a TAXA_SET_P and a TAXA_SET_A, where the TAXA_SET_P comprises a predefined first value for the one or more of the beneficial pathway in one of the FGmap and the GMP, and the TAXA_SET_A comprises a predefined second value for the one or more of harmful pathways in one of the FGmap and the GMP;
identifying a set of first neighbors for each of the taxa in the TAXA_SET_P at the time stamp 2 from the TAXA_NET graph, wherein the set of first neighbors are immediate neighbors of the TAXA_SET_P comprising of a TAXA_SET_FN, a TAXA_SET_FN_COM, a TAXA_SET_INTERSECT, a TAXA_SET_NEW; and
recommending a personalized therapeutic intervention for improving gut health of the individual, via the one or more hardware processors, wherein the therapeutic intervention comprises recommending one of (a) a prebiotic cocktail, (b) a probiotic cocktail (c) optimized diet based on the identified first neighbors using the set of knowledge bases and the initial set of personalized therapeutics and diet recommendation, wherein the personalized therapeutic intervention comprises of at least one or more of:
For Case A (a decrease in the pathway abundance of the set of beneficial microbes) recommending a prebiotic cocktail, a probiotic cocktail and an optimized diet, wherein the prebiotic cocktail, probiotic cocktail and the optimized diet replenishes the plurality of beneficial microbes and helps growth of the beneficial microbes,
For Case B (an increase in the pathway abundance of the set of harmful microbes) recommending an optimized diet, wherein the optimized diet promotes growth of the plurality of beneficial microbes and inhibits growth of harmful microbes, and
For Case C (a decrease in the pathway abundance of the set of beneficial microbes and increase in the pathway abundance of the set of harmful microbes) recommending a prebiotic cocktail, probiotic cocktail and an optimized diet, wherein the prebiotic cocktail, probiotic cocktail and the optimized diet to replenishes the plurality of beneficial microbes, helps growth of beneficial microbes and inhibits growth of harmful microbes.
The combination is not obvious. Claims 9 and 15 recite similar limitations. The claims hence are free from art.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zeevi, et al. "Personalized nutrition by prediction of glycemic responses." Cell 163.5 (2015): 1079-1094. Newly cited.
Sen et. al. "Metabolic modeling of human gut microbiota on a genome scale: an overview." Metabolites 9.2 (2019): 22. Newly cited.
Turnbaugh et al. (“The gut microbiome as a biomarker and therapeutic target for treating obesity or an obesity related disorder”, WO2008076696A2, Published Jun. 26, 2008. Newly cited.
Patnode et al. (“Compositions and methods to affect human gut microbes”, WO2021016129A1, Published Jan. 28, 2021; priority Jul. 19, 2019. Newly cited.
Zeevi disclosed a personalized diets created with the help of an accurate predictor of blood glucose response that integrates parameters such as dietary habits, physical activity, and gut microbiota may successfully lower post-meal blood glucose and its long-term metabolic consequences. Zeevi is strong for personalized diet recommendations using gut microbiota and algorithmic prediction. It is weaker for the target claim’s particular named knowledge bases, pathway matrices, and TAXA_NET/ProbMap architecture.
Sen disclosed a taxonomic and functional profiling of the gut microbiome by next-generation sequencing (NGS) has unveiled substantial richness and diversity. Sen is strong for the general computational architecture: metagenomics, metabolic capabilities, personalized microbiota models, diet microbiome interactions, microbe interactions, and food/diet constraints. It does not disclose the exact target names FGmap, GMP, TAXA_NET, ProbMap.
Turnbaugh presented an invention relates to the gut microbiome as a biomarker and therapeutic target for energy harvesting, weight loss or gain, and/or obesity in a subject. Turnbaugh is strong for treating gut microbiome status as a biomarker/ therapeutic target, monitoring bacterial abundance, and formulating diet using glycans/fiber preferred by microbial taxa. It is weaker for the specific processor-implemented graph/matrix knowledgebase arrangement.
Patnode disclosure results obtained with these biosensors could facilitate ongoing efforts to use machine learning algorithms that integrate a variety of parameters, including biomarkers of host physiologic state and features of the microbiota, to develop more personalized nutritional recommendations. Patnode is very close temporally and teaches dietary components, metabolic pathways/CAZymes, microbiome features, machine-learning-based personalized nutritional recommendations, and food prototypes optimized for microbiota.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUOZHEN LIU whose telephone number is (571)272-0224. The examiner can normally be reached Monday-Friday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D Riggs can be reached at (571) 270-3062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GL/
Patent Examiner
Art Unit 1686
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights