DETAILED ACTION
Applicant's response, filed 05/06/2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-19 are rejected.
Priority
The instant application claims domestic benefit to U.S. Provisional Patent Application 63231320, filed 8/10/2021. Domestic benefit is acknowledged. As such, the effective filing date of claims 1-19 is 08/10/2021.
Specification
The objection to the specification is withdrawn in light of the amendments.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and natural phenomenon without significantly more. Any newly recited portions herein are necessitated by claim amendment.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea or natural phenomenon:
Claim 1 recites (c) processing the first biomarker data set and historical biomarker data setusing at least one algorithm… to identify at least one correlation between the first biomarker data set and historical biomarker data set;
Using an algorithm to identify a correlation is a mathematical relationship because it involves making a series of mathematical calculations, and the correlation is itself a relationship between the two data sets based on a mathematical equation. A human being is capable of identifying a correlation between two lists of numbers (the biomarker data sets) using a pen and paper to carry out the steps of the algorithm, making it a mental process.
Claim 1 continues with (d) generating at least one suggested intervention predicted to improve health, performance, or a combination thereof based on the at least one statistically significant correlation;
A human being can use a previously derived correlation to think of an improvement to health using that correlation. This makes it a type of mental process.
Claim 1 continues with (e) generating a report comprising the at least one suggested intervention including statistical analysis and interpretation of the first biomarker data set in conjunction with the historical biomarker data set;
A human being could generate a report including statistical analyses of two data sets, making it a mental process.
Claim 3 recites the step of generating a second biomarker data set from the same or different one or more livestock animals in need of improvement in health, performance, or a combination thereof from which the first biomarker data set was obtained, wherein upon generation of a second biomarker data set, steps (b)-(g) are repeated
This is a mental process for the same reasons as claim 1 above, since it is a restatement of it. A human being could carry out the algorithm steps for two animals, think of a report, and then ask the rancher if they could, e.g. give both animals water, thereby confirming acceptance of it.
Claim 4 recites assigning a score to each of one or more of observed traits selected from the group consisting of tissue inflammation severity, lymphoid immunity, microbial organism presence, mucosa integrity, hyperplasia, immune cell infiltration, cell sloughing, necrosis, vascularization, and overall architecture
Assigning a score based on data is a mental process and a mathematical relationship because a human being could practically perform the visual confirmation of e.g. inflammation and then write down a score with a pen and paper. The score reflects a numerical representation of the observed trait, establishing a mathematical relationship to the observed trait.
Claim 5 recites the method of claim 1, wherein the at least one intervention includes feeding the livestock a customized feedstock recipe, modifying water intake, and administering one or more supplements, medicaments, enzymes, prebiotics, or probiotics to the livestock.
This only further limits the possibility space of the decisions made in the generated suggested intervention of claim 1, making it part of the mental process of claim 1.
Claim 6 recites that the customized feedstock recipe includes a change in protein, vitamin, mineral or caloric intake
Making the choice to change nutrient intake based on data is a mental process because A human could think to feed an animal more proteins, vitamins, minerals, or calories.
Claim 8 recites that the gastrointestinal microbiota analysis includes the step(s) of: evaluating microbiome diversity including alpha diversity and beta diversity; performing microbiome differential abundance analysis; or a combination thereof
Evaluating alpha diversity and beta diversity, as well as performing differential abundance analysis are mathematical relationships because they are verbal equivalents to algorithms and mathematical methods for evaluating statistical patterns in microbiota. A human being can perform the steps of these analyses with a pen and paper, making them mental processes.
Claim 10: (c) processing the first biomarker data set and the historical biomarker data set using at least one algorithm executed by the at least one processor to identify at least one statistically significant correlation between the first biomarker data set and the historical biomarker data set;
Using an algorithm to identify a correlation is a mathematical relationship because it involves making a series of mathematical calculations, and the correlation is itself a relationship between the two data sets based on a mathematical equation. A human being is capable of identifying a correlation between two lists of numbers (the biomarker data sets) using a pen and paper to carry out the steps of the algorithm, making it a mental process.
Claim 10: (d) generating, based on the at least one statistically significant correlation, at least one suggested intervention predicted to improve health, performance, or a combination thereof for the one or more livestock animals;
A human being can use a previously derived correlation to think of an improvement to health using that correlation. This makes it a type of mental process.
Claim 10: (e) generating a report comprising: (i) the at least one suggested intervention, and (ii) statistical analysis and interpretation of the first biomarker data set in conjunction with the historical biomarker data set;
A human being could generate a report including statistical analyses of two data sets, making it a mental process.
11. (New) The method of claim 10, wherein identifying the at least one statistically significant correlation comprises performing a regression analysis between at least one microbial feature and at least one gene expression feature.
Regression can be performed by a human being using a pen and paper, making it a mathematical concept and a mental process.
12. (New) The method of claim 10, wherein processing the first biomarker data set and the historical biomarker data set comprises analyzing relationships between gastrointestinal microbiota data, gut gene expression data, and histopathological data.
A human being can analyze relationships between data types, making it a mental process.
13. (New) The method of claim 10, wherein the report further comprises: (i) an overview of gastrointestinal data; and (ii) one or more intervention predicted to improve health, performance, or a combination thereof.
A human being could write down these concepts in a report based on analyses of the data, making it a mental process
14. (New) The method of claim 10, wherein the at least one algorithm comprises a bioinformatics workflow that transforms sequence data into diversity measures and taxonomic information.
There are embodiments of a general “bioinformatics workflow” that could be performed by a human being, making it a mental process.
15. (New) The method of claim 10, wherein the historical biomarker data set is standardized and aggregated prior to processing.
Standardization and aggregation are verbal equivalents for mathematical concepts
18. (New) The method of claim 10, wherein the statistical analysis includes identification of differentially abundant microbial taxa associated with the at least one suggested intervention.
Differential abundance identification is a mathematical algorithm that could be performed by a human being with a pen and paper
19. (New) The method of claim 10, wherein the report further comprises at least one visualization of relationships between biomarker data and the at least one suggested intervention.
A human being can make charts that visualize data with a pen and paper, making it a mental process
While claim 1 recites performing some aspects of the analysis with a processor or “computer”, there are no additional limitations that indicate that this processor or computer requires anything other than carrying out the recited mental process or mathematical concept in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the “Mental processes” grouping of abstract ideas. As such, claims 1-9 recites an abstract idea and natural phenomenon (Step 2A, Prong 1 : YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment. Specifically, the claims recite the following additional elements:
Claim 1 recites A computer-implemented method for improving health, performance, or a combination thereof for one or more livestock animals
Claim 1 recites (a) obtaining a first biomarker data set from one or more livestock animals in need of improvement in health, performance, or a combination thereof, the first biomarker data set including biomarker data obtained from histopathological tissue analysis, gut gene expression analysis, gastrointestinal microbiota analysis, or a combination thereof;
Claim 1 continues, “executed by at least one processor”
Claim 1 continues with (b) obtaining a historical biomarker data set from a database, wherein the historical data set includes: (i) data previously measured from histopathological tissue analysis, gut gene expression analysis, gastrointestinal microbiota analysis, or a combination thereof; (ii) data obtained from one or more external databases; or (iii) a combination thereof;
Claim 1 continues with (f) transmitting the report to an owner of the livestock, wherein the report is viewable on a livestock owner interface;
Claim 1 continues with (g) confirming or denying acceptance of the report by the livestock owner via the livestock owner interface, wherein an acceptance signal is transmitted to at least one processor.
Claim 2 recites that upon confirming acceptance of the report, the livestock owner introduces the at least one intervention to the one or more livestock animals
Claim 3 recites that steps (b)-(g) of claim 1 are repeated, which includes the additional elements of steps (b) and (f)
Claim 7 recites The method of claim 1, wherein the gut gene expression data is obtained from a livestock host gene selected from the group consisting of interleukins (IL), tumor necrosis factor alpha (TNF-alpha), transforming growth factor beta (TGF-beta), interferon gamma (IFN- gamma), cluster of differentiation (CD) genes, occludin, zonula occludens, claudins, mucin genes, nuclear factor kappa B (NFkB), lipopolysaccharide induced TNF factor (LITAF), toll-like receptors (TLR), secretory IgA (slgA), and beta-defensins.
Claim 9 recites The method of claim 1, wherein the one or more external databases is in wireless communication with one or more data services which aid in and provide third party historical biomarker data related to disease diagnosis, prescriptions medicines, health assessment data, histopathological tissue analysis, gut gene expression analysis, and gastrointestinal microbiota analysis.
Claim 10 recites A computer-implemented method for improving health, performance, or a combination thereof for one or more livestock animals, the method comprising, by at least one processor executing instructions stored in memory:
Claim 10 continues: (a) obtaining a first biomarker data set from one or more livestock animals, the first biomarker data set comprising:(i) biomarker data obtained from histopathological tissue analysis,(ii) biomarker data obtained from gut gene expression analysis, and(iii) biomarker data obtained from gastrointestinal microbiota analysis;
Claim 10 continues: (b) obtaining a historical biomarker data set from a database, the historical biomarker data set comprising previously measured biomarker data from a plurality of livestock animals;
Claim 10 continues: (f) transmitting the report to a livestock owner interface; and
Claim 10 continues: (g) receiving, via the livestock owner interface, an indication of acceptance or rejection of the suggested intervention.
16. (New) The method of claim 10, wherein the livestock owner interface comprises a cloud-hosted dashboard configured to display the report.
17. (New) The method of claim 10, wherein the gastrointestinal microbiota analysis comprises generating sequence data and deriving taxonomic classification and diversity measures therefrom.
There are no limitations that indicate that the claimed processor, “livestock owner interface,” “computer,” or the formats of the provided data require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
The additional elements of claim 1, 7, 9, and 17 do not add a meaningful limitation to the abstract idea because they amount to mere data gathering steps that would be required for the claimed mental processes. The cloud hosted dashboard of claim 16 is a mere data output limitation. These limitations serve to gather data that is used as input or output for the abstract idea and there is no indication that the abstract idea has any impact on those data gathering steps. The courts have indicated that mere data gathering or output activity is insignificant extra-solution activity that does not provide a practical application (see MPEP 2106.05(g)).
The limitation in claim 2 for introducing the intervention does not recite a “particular” treatment as there is no indication of the type of drug or treatment that is applied that would have more than a nominal or insignificant relationship to the exception. Rather, this limitation is an “apply it” step that merely applies the exception in a generic way and does not integrate the recited exception into a practical application (see MPEP 2106.04(d)(2)). As such, claims 1-9 are directed to an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 2 : NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment. The instant claims recite additional elements enumerated above, in the section on step 2A.
As discussed above, there are no additional limitations to indicate that the claimed processor, “computer” or “livestock owner interface” requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
The additional elements of claim 1, 7, and 17 place limitations upon the receipt of biomarker data from livestock animals as an input for the method. Determining the level of a biomarker in blood has been found to be a conventional laboratory technique that amounts to insignificant extra-solution activity, 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) (see MPEP 2106.05(g)). Applicant considers the gut gene expression data of claims 1, 7, and 17 to be a biomarker by their own admission in the language of claim 1. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546 has also been found by the courts to be a form of insignificant extra-solution activity that is well understood, routine and conventional.
Claims 1, 9 and 10 have other additional elements which place limitations upon the receipt of data from external databases. Selecting information based upon types for collection, analysis and display has been identified by the courts as a type of insignificant extra-solution activity, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016) (see MPEP 2106.05(g)). Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information) has also been identified by the courts as a well understood, routine and conventional activity.
The limitation in claim 2 for introducing the intervention equates to mere instructions to apply the judicial exception in a generic way because the treating step is so generically recited. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. Evidentiary reference The Spur Line (The Spur Line Ranch and Pet Supply, thespurline.com/nutrition-services, 07/2021, previously cited) shows an animal consulting and feeding service was publicly available and on sale before the effective filing date (¶ 1), making animal feeding well understood, routine and conventional. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself ( Step 2B : No).
As such, claims 1-19 are not patent eligible.
Response to Arguments - 35 USC § 101
Applicant's arguments filed 05/06/2026 have been fully considered but they are not persuasive.
In argument (B) on page 2, applicant asserts that the claims are not directed to a mental process because the data types are generated with laboratory techniques, and the resulting data is too high-dimensional (pg 2 ¶ 1). However, these laboratory techniques are not part of the scope of the claims, only the generated data. Regardless of the size or dimensionality of the data, these limitations are still an abstract idea because the limitations still recite a mathematical concept, which is distinct from a mental process. Merely requiring that the mental process is performed with a computer does not negate that it is a mental process if the claims merely recite performing a mental process on a generic computer (see MPEP 2106.04(a).III.C).Additionally, the claim language is open enough that a very small calculation between just two individual values would meet the scope of these claims, which would be possible to perform with a pen and paper, which meets the mental process criteria.
Applicant asserts in (C) on page 3 that the act of introducing interventions to livestock integrates the claims into a practical application. However, the intervention is so broadly recited that it amounts to an “apply it” limitation that does not provide a practical application (see Step 2A prong two in the 101 rejection above). Applicant describes an “end to end” workflow that ties acceptance of the report to changes in the management of the livestock. This is not commensurate in scope with claim 1, which recites acceptance of the report and a generation of a suggested intervention, but acceptance of the report necessitates implementation of the intervention only in claim 2. An additional element needs to be recited in the claim in order to provide a practical application.
Applicant asserts in (D) on page 3 that the method represents an improvement in the use of computing systems to analyze biological data and generate actionable outputs, and provides significantly more under 2B because it has elements such as biomarker acquisition, integration with historical datasets, identification of correlations, and generation of a report. The first two of these elements are additional elements which were explained to be well understood, routine, and conventional under step 2B in the 101 rejections above. The last two of these elements are mental processes, which was explained in the section on step 2A prong 1. Under step 2B, the judicial exceptions cannot provide the inventive concept (MPEP 2106.05.I). Therefore, the additional elements do not provide significantly more.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The following rejections have been withdrawn in light of the claim amendments:
Robey, Butterwick, and The Spur Line
Robey, Butterwick, and The Spur Line in further view of Crunick
Robey, Butterwick, and The Spur Line in further view of Warda
Claims 1, 4-6, 9-10, 15-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Robey et al. (WO2004050835A2, IDS document; previously cited) (hereafter “Robey”) in view of Butterwick et al. (US20200058405A1, IDS document, previously cited) (hereafter “Butterwick”), Dodds et al. (AU2009330384B2, newly cited), and Tran (US20200267936A1, newly cited). This rejection is newly recited and necessitated by claim amendment.
Regarding claim 1, applicant sets forth a series of method steps:
(a) obtaining a first biomarker data set from one or more livestock animals in need of improvement in health, performance, or a combination thereof, the first biomarker data set including biomarker data obtained from histopathological tissue analysis, gut gene expression analysis, gastrointestinal microbiota analysis, or a combination thereof
Claim 1 of Robey sets a limitation for “determining a microbial profile in a biological sample with one or more animals” and defines a microbial profile as “representations of individual strains, subspecies, species, and/or genera of microorganisms with a community,” (specification page 6 lines 10-12) which would be an example of gastrointestinal microbiota analysis.
(b) obtaining a historical biomarker data set from a database, wherein the historical data set includes: (i) data previously measured from histopathological tissue analysis, gut gene expression analysis, gastrointestinal microbiota analysis, or a combination thereof; (ii) data obtained from one or more external databases; or (iii) a combination thereof;
Robey claim 1: "comparing said profile with a control microbial profile to determine a microbial profile index". The control microbial profile of Robey meets the limitations to be considered equivalent to the historical biomarker data set of the instant application.
Robey claim 28: “The method of claim 1, wherein said control microbial profile is from a control biological sample taken from said animal prior to or subsequent to the taking of said biological sample.”
(c) processing the first biomarker data set and historical biomarker data set using at using at least one algorithm executed by at least one processor to identify at least one statistically significant correlation between the first biomarker data set and historical biomarker data set;
Dodds teaches finding statistically significant (Dodds pg 42 ¶ 1) correlations between historical and present biomarker data to make animal nutrition recommendations (Dodds abstract).
(d) generating at least one suggested intervention predicted to improve health, performance, or a combination thereof based on the at least one statistically significant correlation;
Robey teaches finding statistically significant correlations: “Performance data were analyzed as a randomized complete block design and differences between treatments were compared using Student's t-test.” (pg 24 ¶ 3)
Butterwick (specification ¶ 102): "calculating, based on the one or more biomarker inputs of the first animal, the difference between the weight of the first animal and the recommended growth weight of an ideal animal of the same species in a similar growth stage, determining if the difference is within two centiles of the recommended growth weight and displaying a recommendation on the graphical user interface based on the determination, wherein the recommendation includes a tailored intervention step if the difference is not within about two centiles of the recommended growth weight". This is an example of a suggested health intervention based on a mathematical relation, which could have been the result of a t-test instead of a comparison between two curves.
(e) generating a report comprising the at least one suggested intervention; (f) transmitting the report to an owner of the livestock, wherein the report is viewable on a livestock owner interface;
Robey is silent as to this.
Butterwick (spec ¶ 102): "displaying a recommendation on the graphical user interface based on the determination". The recommendation of Butterwick includes at least one suggested intervention, thus making it equivalent to the report of the instant application. The display and GUI of Butterwick are intended for owners of livestock (spec ¶ 1).
(g) confirming or denying acceptance of the report by the livestock owner via the livestock owner interface, wherein an acceptance signal is transmitted to at least one processor.
Figure 3H of Tran describes an “AI consultant” that transmits a nutrition recommendation to a treating doctor’s computer system, who confirms or denies acceptance of the recommendation, with that information being sent back to the AI consultant.
Regarding claim 10, applicant sets forth a series of method steps:
obtaining a first biomarker data set from one or more livestock animals, the first biomarker data set comprising:(i) biomarker data obtained from histopathological tissue analysis,(ii) biomarker data obtained from gut gene expression analysis, and(iii) biomarker data obtained from gastrointestinal microbiota analysis;
Claim 1 of Robey sets a limitation for “determining a microbial profile in a biological sample with one or more animals” and defines a microbial profile as “representations of individual strains, subspecies, species, and/or genera of microorganisms with a community,” (specification page 6 lines 10-12) which would be an example of gastrointestinal microbiota analysis.
Claim 28 of Robey states that determining a microbial profile comprises histological analysis, which is used to make an index for downstream analysis in claim 1.
Dodds’ invention is focused on obtaining and processing gene expression data (Dodds pg 42 ¶ 1). The genes analyzed for expression include interleukins (pg 48, table 3), which the instant application states are a kind of gut gene expression data (¶ 81).
(b) obtaining a historical biomarker data set from a database, the historical biomarker data set comprising previously measured biomarker data from a plurality of livestock animals;
Robey claim 1: "comparing said profile with a control microbial profile to determine a microbial profile index". The control microbial profile of Robey meets the limitations to be considered equivalent to the historical biomarker data set of the instant application.
(c) processing the first biomarker data set and historical biomarker data set using at using at least one algorithm executed by at least one processor to identify at least one statistically significant correlation between the first biomarker data set and historical biomarker data set;
Dodds teaches finding statistically significant (Dodds pg 42 ¶ 1) correlations between historical and present biomarker data to make animal nutrition recommendations (Dodds abstract).
(d) generating at least one suggested intervention predicted to improve health, performance, or a combination thereof based on the at least one statistically significant correlation;
Robey teaches finding statistically significant correlations: “Performance data were analyzed as a randomized complete block design and differences between treatments were compared using Student's t-test.” (pg 24 ¶ 3)
Butterwick (specification ¶ 102): "calculating, based on the one or more biomarker inputs of the first animal, the difference between the weight of the first animal and the recommended growth weight of an ideal animal of the same species in a similar growth stage, determining if the difference is within two centiles of the recommended growth weight and displaying a recommendation on the graphical user interface based on the determination, wherein the recommendation includes a tailored intervention step if the difference is not within about two centiles of the recommended growth weight". This is an example of a suggested health intervention based on a mathematical relation, which could have been the result of a t-test instead of a comparison between two curves.
(e) generating a report comprising: (i) the at least one suggested intervention, and (ii) statistical analysis and interpretation of the first biomarker data set in conjunction with the historical biomarker data set; (f) transmitting the report to an owner of the livestock, wherein the report is viewable on a livestock owner interface;
Robey is silent as to this.
Butterwick (spec ¶ 102): "displaying a recommendation on the graphical user interface based on the determination". The recommendation of Butterwick includes at least one suggested intervention, thus making it equivalent to the report of the instant application. The display and GUI of Butterwick are intended for owners of livestock (spec ¶ 1), and contain charts based on comparisons of biomarker data sets (¶ 124).
(g) receiving, via the livestock owner interface, an indication of acceptance or rejection of the suggested intervention.
Figure 3H of Tran describes an “AI consultant” that transmits a nutrition recommendation to a treating doctor’s computer system, who confirms or denies acceptance of the recommendation, with that information being sent back to the AI consultant.
Regarding claims 1 and 10, an invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. The text of Robey provides for characterizing animal performance based on a microbial profile, and for monitoring the effects of feed on the microbial profile. In the text of Butterwick, there is a teaching to generate suggested health interventions, and to transmit and display them to livestock-owning customers, based on correlations between biomarker data, such as the microbial profiles of Robey. In their background section, Butterwick states they were motivated to create “systems and methods to determine ideal body weight for animals and provide recommendations and/or tailored interventions when such animal growth deviates from target” (Butterwick spec ¶ 6). Tran teaches having a treating doctor confirm or deny acceptance of a generated health intervention, in order to have human oversight (¶ 273). There would be a reasonable expectation of success to a person of ordinary skill in the art in attempting to combine the inventions, as the method of Butterwick is based on biomarker correlations in animal health data, which is found in Robey, and both are directed towards making recommendations about animal feeding, which is the goal of Tran’s service. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Robey with the method of Butterwick and Tran, in order to help livestock owners maintain proper animal growth.
Regarding claims 1 and 10, An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching, suggestion, or motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. There is a teaching to find statistically significant (Dodds pg 42 ¶ 1) correlations between historical and present biomarker data to make improved animal nutrition recommendations (Dodds abstract) in the text of Dodds. There would be a reasonable expectation of success in making this combination to a person of ordinary skill in the art, as all the art is related to animal nutrition recommendation. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Robey, Butterwick and Tran by using the statistically significant correlations between historical and present biomarker data found in Dodds, in order to increase the effectiveness of the nutrition recommendation (Dodds abstract).
Regarding claim 4, observed traits such as mucosa integrity and necrosis are scored (Robey spec page 7 lines 26-31: “GIT tissues can be excised and histologically evaluated for the number, size, shape, mucosal-cell turnover and condition of the Villi.”) as part of the histopathological analysis step of Robey (Claims 1, 23, 24).
Regarding claims 5 and 6, Robey is silent as to the details of a customized feedstock recipe.
Regarding claim 5, feeding the livestock a customized feedstock recipe (Butterwick spec ¶ 92: “For example, if the animal is ‘overweight,’ intervention recommendations may include… ‘adjust and decrease food intake.’”), modifying water intake (Butterwick spec ¶ 123-127: the pet owner logs other biomarkers daily, such as… modifying water intake… Given the new input, the optimal animal growth application may recommend an updated and/or additional intervention), and administering one or more supplements, medicaments, enzymes, prebiotics, or probiotics (Butterwick spec ¶ 75: “Such intervention can also include prebiotic or probiotic supplements.”) to the livestock is taught by Butterwick.
Regarding claim 6, that the customized feedstock recipe includes a change in protein, vitamin, mineral or caloric intake is taught by Butterwick (Butterwick spec ¶ 92: " Conversely, if the dog is “underweight,” intervention recommendations may include “supplement dry dog food with high protein wet dog food once per day” or “monitor and schedule visit with veterinarian.”")
Regarding claims 4-6, an invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. The text of Robey provides for histopathological analysis data to be part of the biomarker input data. In the text of Butterwick, there is a teaching to create customized feedstock recipes using animal health correlations. There would be a reasonable expectation of success to a person of ordinary skill in the art in attempting to combine the two inventions, as both inventions use biomarker input data to create correlations, thus making it trivial to use those correlations as terms in a recommendation system. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Robey with the method of Butterwick, in order to help livestock owners maintain proper animal growth.
Regarding claim 9, Robey is silent as to receiving information from an external database.
Regarding claim 9, that the system receives information from an external database is taught by Butterwick (Butterwick spec ¶ 97: "At operation 620, the one or more first biomarker inputs of the first animal are compared to at least one predetermined reference biomarker input stored in a reference database. ")
Regarding claim 9, an invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Robey uses many types of biomarker data as input. In the text of Butterwick, there is a teaching to include input from reference databases. There would be a reasonable expectation of success to a person of ordinary skill in the art in attempting to combine the two inventions, as there would be no issue with incorporating internet-gathered data of the same type. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Robey with the method of Butterwick, in order to increase the amount of data available for analysis.
Regarding claim 15, Butterwick teaches standardization and aggregation (¶ 64).
Regarding claim 16, Butterwick states: “Furthermore, the embodiments described herein employ various computer-implemented operations which can be adapted to be part of a computer system, the cloud, etc.” (¶ 131).
Regarding claim 19, Butterwick teaches the creation of charts based on comparisons of biomarker data sets (¶ 124).
Regarding claims 15, 16, and 19, an invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Robey and Butterwick are the same time of livestock monitoring system. In the text of Butterwick, there is a teaching to standardize and aggregate data, have a cloud-based system, and create charts for the livestock report. There would be a reasonable expectation of success to a person of ordinary skill in the art in attempting to combine the two inventions, as there would be no issue with incorporating these minor changes into the system of Robey. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Robey with the method of Butterwick, in order to adapt the system to special purposes, such as a distributed cloud operation (Butterwick ¶ 131).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Robey, Butterwick, Dodds and Tran as applied to claims 1, 4-6 and 9 above, and in further view of Crunick et al. (US20150080990A1, IDS document) (hereafter “Crunick”).
Regarding claim 3, that the process of claim 1 is repeated in multiple animals is taught by Robey (the “plurality of animals” of claims 2 and 30.)
Regarding claim 2, Robey is silent as to the introduction of the intervention.
Claim 2 states that upon confirming acceptance of the report, the livestock owner introduces the at least one intervention to the one or more livestock animals.
Regarding claim 2, Paragraph 83 of Crunick’s specification reads: "The stored treatment protocol module 210 is configured to generate a menu of treatment protocols from which the operator may select a treatment for the tissues of the patient, as well as to implement the treatment protocol selected from the menu by the operator."
Regarding claims 2-3, an invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. In the text of Crunick, there is a teaching for the operator (“livestock owner”) to implement a treatment protocol (“introduce the intervention”). There would be a reasonable expectation of success to a person of ordinary skill in the art in attempting to combine the two inventions, as the livestock owner could easily implement the interventions given to them by the system. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Robey, Butterwick, Dodds and Tran with the method of Crunick, to make sure the recommendations are put in place, ensuring that the animals’ health and performance is actually improved by the method.
Claims 7-8 and 11-14, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Robey, Butterwick, Dodds and Tran as applied to claims 1, 4-6 and 9-10 above, and in further view of Warda (Front. Microbiol. 11:69, 2020).
Regarding claims 7-8, Robey is silent as to the genes analyzed for recommendation, and as to the aspects of microbiota analysis.
Regarding claim 7, that gut gene expression is obtained from livestock host genes such as interleukins and TNF is taught by Warda (Warda page 3 right col 3rd paragraph: Colons of ADR-159 fed animals had 0.49 times lower expression levels of IL-12α (ANOVA, p < 0.0005) compared to the colons of the standard fed animals. In contrast IL-17f (ANOVA, p = 0.0038) expression levels in colons of ADR-159 fed animals were 2.38 times higher (Figure 6). No significant differences were observed for IL-12β, IFN-γ, TNF, IL-1β, IL-6, IL-18, IL-10, IL-22, IL-23α, and CXCL1 expression levels.)
Regarding claim 8, that microbiota analysis includes alpha-and-beta diversity analysis and differential abundance analysis is taught by Warda (Warda page 8 left col 1st paragraph: “The phyloseq package (McMurdie and Holmes, 2013) was used to calculate alpha and beta diversity. Alpha diversity comparisons were performed using a MannWhitney test, while beta diversity was via an Adonis test from the vegan package. The differential abundance of the genera and RSVs was carried out with DESeq2 (Love et al., 2014).”)
Regarding claims 11 and 12, Warda compared expression of genes in the colon with Citrobacter levels (fig. 6).
Regarding claim 13, Warda measured cecum SCFA levels, a part of gut health data, in their “report” or research paper (fig. 7). Butterwick (specification ¶ 102) teaches an intervention report.
Regarding claim 14, Warda teaches a bioinformatics workflow that transforms sequence data into diversity measures and taxonomic information (Warda page 3 right col 3rd paragraph).
Regarding claim 17, Warda generated sequence data and derived taxonomy and diversity (abstract).
Regarding claim 18, differential abundance analysis was carried out by Warda (Warda page 8 left col 1st paragraph).
Regarding claims 7-8, 11-14, and 17-18, an invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. In the text of Warda, there is a teaching to conduct gut gene expression analysis of cytokines such as IL and TNF, and a teaching to calculate alpha/beta diversity as well as differential abundance analysis. There would be a reasonable expectation of success to a person of ordinary skill in the art in attempting to combine the two inventions, as the methods requiring adaptation to the task of feedstock recommendation are explained in detail in Warda and its references. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Robey, Butterwick, Dodds, and Tran with the method of Warda, in order to incorporate metagenomics data into the recommendations.
Response to Arguments - 35 USC § 103
Arguments against the rejection based on Robey and Butterwick
Is an introductory statement, not an argument, that applicant traverses the 103 rejection, and has amended their claims.
Regarding (B), Applicant argues that the references do not teach a combination of histopathological tissue analysis, gene expression analysis, gastrointestinal microbiota analysis. However, claim 1 stipulates the data types as “histopathological tissue analysis, gene expression analysis, gastrointestinal microbiota analysis, or a combination thereof.” The “or” language means that the references do not have to teach the combination, only one of the data types is sufficient.
Regarding (C), Applicant argues the control data set of Robey is not a historical biomarker data set. The examiner disagrees because of claim 28 of Robey. The examiner disagrees that the references do not teach the amended limitation for a statistically significant correlation, as this is found in Butterwick. See the updates to the office action.
Argument (D) is not relevant to the new rejection.
Regarding (E), applicant asserts that the examiner has not provided a motivation to combine the references. However, a rationale was provided in the office action based on the teaching/suggestion/motivation test.
Regarding (F), applicant argues that the histological analysis of Robey is too observational to be used from downstream analysis. Claim 28 of Robey states that determining a microbial profile comprises histological analysis, which is used to make an index for downstream analysis in claim 1. The arguments against claims 5 and 6 are based on claim amendments to the independent claim, which have been addressed. The argument against claim 9 contradicts the examiner’s original statement without providing more information.
Arguments against the rejection based on the above and Crunick
Regarding the arguments against claim 2, applicant has not responded to the rationale that a person of ordinary skill in the art could have combined the operator-driven acceptance of Crunick with the variable reporting of the combination of Robey, Butterwick and The Spur Line. The control architecture is obvious in light of the combination. Regarding claim 3, applicant is arguing about a more limited embodiment than the claim scope. While Robey may or may not have been envisioning an iterative reprocessing, the only limitation of the claim 3 is that the steps are repeated for a second data set, which is found in Robey.
Arguments against the rejection based on the above and Warda
Regarding (B), Applicant argues that nothing bridges Warda with the other references such that a person of ordinary skill in the art would think to combine the references. However, Robey is directed to creating microbial profiles of animals, and includes microbial analysis methods such as histopathological analysis. A person of ordinary skill in the art would seek out similar methods of microbial profiling.
Regarding (C), murines are mammals with immune systems similar to livestock. A person of ordinary skill in the art would think to apply methods from a murine experiment to an experiment on other types of animals. Claim 7 is a “selected from the group consisting of” claim and does not require all of the embodiments to be read on by another disclosure. Robey’s teaching of microbial profiling, which includes many kinds of genetic analysis methods, bridges the references to each other.
Regarding (D) and (E), Robey’s microbial profiling includes 16S rDNA genotyping, which is the basis of the microbiome analysis found in Warda (abstract). This provides the ability for the methods of Warda to be integrated into the method of Robey.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5 and 6 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. US 10,806,130 B2 (hereafter “Moreno”) in view of Warda. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, Claim 1 of Moreno states:
“1. A method of managing livestock health in real-time, the method comprising obtaining real-time livestock sensor data from at least one sensor located on or around one or more livestock, the data comprising at least one of livestock weight, livestock activity level, livestock ammonia level, body temperature, body weight, water intake, or body pH; analyzing, by processor, the real-time livestock sensor data to detect at least one anomaly in the livestock weight, livestock activity level, livestock ammonia level, body temperature, body weight, water intake, or body pH; generating a customized livestock health management plan that includes a tailored feedstock recipe adapted to cure the at least one detected anomaly upon being fed to the livestock; transmitting the livestock health management plan wirelessly to at least one livestock owner interface; and confirming or denying acceptance of the livestock health management plan by the livestock owner; wherein upon confirmation of acceptance of the livestock health management plan, a wireless signal is sent to a feedstock producer including instructions to manufacture the customized feedstock recipe for the livestock owner.”
The “generating a customized livestock health management plan” of Moreno teaches the generating an intervention, and generating a report of steps (d) and (e) of claim 1.
The “transmitting the livestock health management plan wirelessly to at least one livestock owner interface; and confirming or denying acceptance of the livestock health management plan by the livestock owner” teaches steps (f) and (g) of claim 1.
Moreno is silent as to the use of biomarker data of the types listed in (a) of claim 1, as to the historical data set of (b) of claim 1, and the biomarker dataset processing of step (c) of claim 1.
Regarding step (a), the use of gut gene expression data and histopathological tissue analysis is taught by Warda (page 4 left col ¶ 2, page 5 right col).
Regarding steps (b) and (c), the use of external biomarker data to process the input data to find correlations is taught by Warda (page 5 right col ¶ 3).
Moreno teaches claim 10 for the same reason as claim 1.
Regarding claim 2, the “confirming or denying acceptance of the livestock health management plan by the livestock owner” in claim 1 of Moreno is the same language as that of claim 2, thus teaching it.
Regarding claim 3, the same arguments for claim 1 apply, as this is a restatement of claim 1 with a different set of input data, which is fully within the scope of the prior art combination listed.
Regarding claim 5, claim 8 of Moreno teaches that the “health management plan” or intervention includes “at least one prescribed medicament,” which reads on “administering one or more… medicaments.”
Regarding claim 6, “the customized feedstock recipe includes a change in protein, vitamin, mineral or caloric intake” of claim 7 of Moreno is the same language as that of claim 6, thus teaching it.
Regarding claims 1-3, 5 and 6, an invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. In the text of Warda, there is a teaching to use gut gene expression analysis and histopathological tissue analysis. There would have been a reasonable expectation of success to a person of ordinary skill in the art in attempting to combine the two inventions, as these data types have no distinguishing features that make them unable to be used as input for a recommendation system like that of Moreno. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Moreno with the methods of Warda, in order to make more informed recommendations to the livestock owners about their animals’ health.
As such, claims 1-3, 5 and 6 and 10 are rejected due to nonstatutory double patenting.
Response to Arguments - Double Patenting
Applicant relies on similar reasoning to the arguments against the 103 rejections of claims 7-8. See the arguments above. A person of ordinary skill in the art could have adapted these techniques from mice to livestock animals, as there is no biological reason why they could not.
Conclusion
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/G.M.H./ Examiner, Art Unit 1685
/OLIVIA M. WISE/ Supervisory Patent Examiner, Art Unit 1685
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