DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
7-12, 17-18 and 29-30
Pending:
1-6, 13-16 and 19-28
Withdrawn:
6 and 23-24
Examined:
1-5, 13-16, 19-22 and 25-28
Independent:
1
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 3/13/2025 filing receipt, this application claims priority to as early as 11/1/2023. At this point in examination, all claims have been interpreted as being accorded this priority date.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The objections to the drawings are withdrawn.
The objections to the specification, title and abstract are withdrawn.
The 112/b rejections are withdrawn, however new rejections are applied.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Claims 1-5, 7-22 and 25-30 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1
(e)... said computer processing
Requires but lacks antecedent
1
(d)... pathway, ...pathway...;
(e)... (1)... pathways impacted... and
(2) a level of impact on pathways...
The relationships are unclear among the recited instances of "pathway" and "pathways" at least because it is not clear which instances are required to refer to the same pathways.
2
said plurality of nucleic acid sequences
Requires but lacks antecedent
26
said impact score... is determined... according to the following rules and scores: ...
The relationship is unclear between the claim 26 recitation to the left here and the claim 26 recited table. The relationships are unclear between the table elements and the recited "method." The relationships are unclear between the table columns and the recited "method." For example, it is unclear how to interpret the recited table elements as steps of the recited "method." Also, although claims are interpreted in light of the specification, examples from the specification are not imported into the claims as limitations absent a clearly limiting definition in the specification (MPEP 2145.VI pertains). Also, a claim should recite only one sentence-ending period (MPEP 608.01(m) pertains).
26
A. Biochemical impact...
The relationships are unclear between the various recited elements, i.e. nouns, in the table versus similar instances recited in claims 25, 22, 21 and 1, from which claim 26 depends. These issues are due at least to a lack of grammatical articles preceding the nouns in the table and generally a lack of clarity regarding antecedent basis.
27
impact scores that are part of the same metabolic pathway
The recited "impact scores" does not make clear the relationship to the "impact scores" of claim 21. The relationship is unclear between this recited "impact scores" and the claim 21 recited "an impact score for each..." If the two pluralities of impact scores, in claims 21 and 27, are the same but for the conditional (i.e. "part of the same metabolic pathway), then this may be made explicit. It may help to recite the following or an equivalent: in claim 21 "...determining a set of impact scores comprising one impact score for each of said one or more nutrigenetic aberrations" and in claim 27 "grouping or summing impact scores from a sub-set of the set of impact scores, wherein the sub-set comprises one or more impact scores in the same metabolic pathway."
Claim rejections - 112/a
The following is a quotation of 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.
Regarding issues of written description support stemming even from the original claims and original disclosure, MPEP 2161.01.I (e.g. 6th para.), 2163.I and 2163.I.A pertain: "[O]riginal claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed" (MPEP 2161.01.I,6th para.).
Written description
Claims 1-5, 13-16, 19-22 and 25-28 are rejected under 112/a as failing to comply with the written description requirement. The claims read on subject matter which is not described in the specification in such a way as to reasonably convey to PHOSITA that the inventors, at the time the application was filed, had possession of the claimed invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted. With regard to any suggested amendment(s) below to overcome a rejection, equivalent amendments also would be acceptable.
Claim 1 recites "processing said biological sample ... using one or more nutrigenetic
assays to generate... nucleic acid sequences," and claim 4 recites "...wherein said one or more nutrigenetic assays comprise one or more of:..." The specification discloses the same list of assays as claim 4 (e.g. at [8]), but the specification does not detail how such assays would yield the claim 1 recited nucleic acid sequences. It would not have been clear to PHOSITA how assays having the disclosed names would have resulted in nucleic acid sequences, for example not in the way that a sequencing would result in a nucleic acid sequence.
Claim rejections - 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 USC 102 and 103 is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 USC 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 USC 102(b)(2)(C) for any potential 35 USC 102(a)(2) prior art against the later invention.
Response to arguments regarding Claim Rejections - 35 USC 102 and 103
In view of the amendments, new rejections have been applied.
Claims 1-5, 13-16 and 19-20 are rejected under 35 USC 103 as unpatentable over Kaput (US 20100113892 as cited on the 5/5/2025 IDS) in view of Menschik (US7234064 as cited on the attached "Notice of References Cited" form 892).
Regarding claim 1, steps (a-b), obtaining and processing, Kaput teaches sequencing methods within Kaput's overall context of "PERSONALIZED NUTRITION AND DIET USING NUTRGENOMICS AND PHYSIOLOGICAL DATA" (Kaput: title; [86]; and entire document).
Regarding claim 1, step (c), processing genetic information to detect a nutrigenetic aberration, Kaput teaches in paragraph [0028] “The term "Biological information" as used herein refers to any information, analysis, measurement, data, statistical correlation, compound, composition, element, etc., that is obtained from a biological source, information such as, but not limited to, such as physiological information, pharmacological information, pharmacokinetic information, biochemical information, immunological information, endocrinological information, genetic information, genomic information, SNP information, and epigenetic information.”
Regarding claim 1, step (d), processing a nutrigenetic aberration to determine a pathway-specific biological state corresponding to a training response pathway, a fatty acid pathway, a vitamin A pathway, a vitamin B6 pathway, a vitamin B 12 pathway, a folate pathway, a vitamin C pathway, a vitamin E pathway, a choline pathway, an iron overload pathway, a gluten pathway, a celiac pathway, or a cannaboid metabolism pathway, Kaput teaches in paragraph [0069] “Genetic and physiological data may be collected by patient survey or by direct genetic or physiological analysis. Genetic testing may focus on specific genes and alleles of genes associated with various disease states, such as diabetes and obesity.”
Regarding claim 1, step (e), generating an electronic report indicative of the pathway-specific biological state, wherein the report comprises a graphical depiction of (1) pathways impacted by the nutrigenetic aberration and (2) a level of impact, Kaput teaches in the abstract “the invention provides systems for research and commercial purposes, particularly for research for improving dietary constituents, personalized nutrition and diets, and of nutrient-gene interactions involved in diseases. The invention further relates to a method for doing business encompassing establishing and running a nutrigenomic research super-market and providing validated nutrient intake data to health care practitioners.” Kaput teaches the gathering of data relating to (1-2) above as described for step (d) above. Kaput teaches "second generation" and "third generation" reporting (Kaput: [4]; and entire document), and Menschik further teaches reporting (Menschik: abstract; and entire document).
Regarding claim 1, steps (f-j), Kaput does not teach the recited access control and transmission, but Menschik does (Menschik: abstract; and entire document).
Claim 2 is directed to the method of claim 1 but further specifies that the plurality of nucleic acid sequences comprises DNA, RNA or a combination thereof.
Regarding claim 2, wherein said plurality of nucleic acid sequences comprises deoxyribonucleic acid (DNA) sequences, ribonucleic acid (RNA) sequences, or a combination thereof, Kaput teaches in paragraph [0037] “These clinical, genetic, and nutrigenomic data are obtained by high throughput analyses of DNA, RNA…”.
Claim 3 is directed to the method of claim 1 but further specifies that the biological sample used is from either saliva, a cheek swab, blood, plasma, serum urine, or a combination of those.
Regarding claim 3, wherein said biological sample is selected from the group consisting of saliva, cheek swab, blood, plasma, serum, urine, and a combination thereof, Kaput teaches in paragraph [0037] “These clinical, genetic, and nutrigenomic data are obtained by high throughput analyses… some of which are identical to data obtained from clinical tests (for example, cholesterol levels, glucose levels, lipid levels, and the like) as well as measurements of liver and other tissue activity (for example, using absorption, distribution, metabolism, and excretion (ADME) assays)” and in paragraph [0048] “The biological information can be metabolic information, such as but not limited to, samples taken from tissue, such as liver, muscle, lung, blood, prostate, breast, pancreas, gut, stomach, heart, cerebrospinal fluid, urine, lymph nodes, lymph, and the like”.
Claim 4 is directed to the method of claim 1 but further specifies that nutrigenetic assays comprise one or more of SNP panel assay, a pharmacology genetics assay, an ancestry genetics assay, a medical genetics assay, a pharmacogenetics assay, a sports performance genetics assay, a health screening, a test for a specific disease risk, a migraine test, a thyroid test, an eczema test, and a cancer genetics assay.
Regarding claim 4, wherein said one or more nutrigenetic assays comprise one or more of. a single nucleotide polymorphism (SNP) panel assay, a pharmacology genetics assay, an ancestry genetics assay, a medical genetics assay, a pharmacogenetics assay, a sports performance genetics assay, a health screening, a test for a specific disease risk, a migraine test, a thyroid test, an eczema test, and a cancer genetics assay, Kaput teaches in paragraph [0083] “Assays to measure physiological and metabolic values are well known to those of skill in the art. For example, electrocardiograms, blood flow, blood pressure analysis, renal flow, neurological activity, lung capacity, lung permeability, muscle strength, and the like are routinely performed by those of skill in the art” and in paragraph [0086] “There are various art-recognized assays for assessing the methylation state at particular CpG sequences, once the sequence region comprising them has been identified so that specific primers and/or probes can be constructed. Such assays include: DNA sequencing methods…”.
Claim 5 is directed to the method of claim 1 but further specifies that the nutrigenetic aberration comprise a SNP, CNV, indel, fusion or translocation.
Regarding claim 5, wherein said one or more nutrigenetic aberrations comprise one or more of: single nucleotide polymorphisms (SNPs), copy number variants (CNVs), insertions or deletions (indels), fusions, and translocations, Kaput teaches in paragraph [0028] “The term "Biological information" as used herein refers to any information, analysis, measurement, data, statistical correlation, compound, composition, element, etc., that is obtained from a biological source, information such as, but not limited to, such as physiological information, pharmacological information, pharmacokinetic information, biochemical information, immunological information, endocrinological information, genetic information, genomic information, SNP information, and epigenetic information”.
Claim 13 is directed to the method of claim 1 but further specifies that the identified biological state be based in part on one or more of a diagnosis of a disease or disorder, a prognosis of a disease or disorder, a risk of having a disease or disorder, a treatment history of a disease or disorder, a history of previous treatment for a disease or disorder, a history of prescribed medications, a history of prescribed medical devices, age, height, weight, sex, smoking status, and one or more symptoms of said subject.
Regarding claim 13, wherein (d) further comprises identifying said one or more biological states of said subject based at least in part on one or more of: a diagnosis of a disease or disorder, a prognosis of a disease or disorder, a risk of having a disease or disorder, a treatment history of a disease or disorder, a history of previous treatment for a disease or disorder, a history of prescribed medications, a history of prescribed medical devices, age, height, weight, sex, smoking status, and one or more symptoms of said subject, Kaput teaches in paragraph [0048] “The biological information can be physiological measurements, such as, but not limited to, body mass index (BMI), heart rate, heart volume, heart output, blood pressure (both systolic, diastolic, and the like), blood flow, blood enzymes, blood pH, breathing rate, lung capacity, oxygen uptake, carbon dioxide removal, muscle strength, liver enzymes, kidney excretion rates, levels of circulating metabolites and carrier proteins, such as but not limited to, HDL, LDL, cholesterol, glucose, insulin, lipids, HbA1c, biomarkers of inflammation, TNF-.alpha., leukotrienes, prostaglandins, and hormones; and quality of life assessments”, all of which can be considered symptoms of said subject.
Claims 14 and 16, claim 14 is directed to the method of claim 1 but further specifies that the nutrigenetic aberrations be used at least in part to generate a nutrigenetic health regimen for said subject. Claim 16 depends from claim 14.
Regarding claim 14, further comprising generating a nutrigenetic health regimen for said subject based at least in part on said identified one or more nutrigenetic aberrations, Kaput teaches in paragraph [0028] “The term "Biological information" as used herein refers to any information, analysis, measurement, data, statistical correlation, compound, composition, element, etc., that is obtained from a biological source, information such as, but not limited to, such as physiological information, pharmacological information, pharmacokinetic information, biochemical information, immunological information, endocrinological information, genetic information, genomic information, SNP information, and epigenetic information” and in claim 57 “A method for providing an individual with a personalized diet for said individual, the personalized diet optimised to reduce the likelihood that said individual will succumb to a disease or disorder”.
Regarding claim 16, the regimen is taught as described for claim 14, and the report is taught as described for claim 1, a report, in a BRI, inherently being a form of graphical user interface. Also, Kaput teaches a PDA ([4]).
Claim 15 is directed to the method of claim 14 and thus 1 but further specifies that said nutrigenetic regimen comprise recommendations to prevent the onset of a disease or disorder, or, further specifies that said nutrigenetic health regimen comprises recommendations related to diet, exercise, sports training, supplements, functional tests, blood tests, brain management, behavior change, skin care, environmental exposure, stress management, or mental health.
Regarding claim 15, wherein said nutrigenetic health regimen comprises recommendations to prevent onset of a disease or disorder, delay onset of a disease or disorder, reverse a disease or disorder, or maintain a physiological or health state of said subject, Kaput teaches in claim 57 “A method for providing an individual with a personalized diet for said individual, the personalized diet optimised to reduce the likelihood that said individual will succumb to a disease or disorder”.
Further regarding claim 15, wherein said nutrigenetic health regimen comprises recommendations related to one or more of: diet, exercise, sports training, supplements, functional tests, blood tests, brain management, behavior change, skin care, environmental exposure, stress management, and mental health, Kaput teaches in claim 57 “A method for providing an individual with a personalized diet for said individual, the personalized diet optimised to reduce the likelihood that said individual will succumb to a disease or disorder”.
Claim 19 is directed to the method of claim 1 but further specifies the processing of the nutrigenetic aberrations using a trained algorithm to identify one or more biological states.
Regarding claim 19, wherein (d) comprises processing said identified one or more nutrigenetic aberrations using a trained algorithm to identify said one or more biological states, Kaput teaches in claim 63 “A system for providing an individual with a personalized diet for said individual, the personalized diet optimised to reduce the likelihood that said individual will succumb to a disease or disorder, the system comprising: a computer loaded with a software operating system comprising an algorithm programmed to analyze a statistical correlation between two sets of data”.
Regarding claim 20, Kaput teaches therapy.
Combining Kaput and Menschik
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the medical data processing of Kaput using the related teaching of Menschik. As motivation to combine, an advantage taught by Menschik of modifying methods such as those of Kaput would have been the teaching of Menschik that "A topic of great importance to the medical community is the means by which these existing systems can be integrated within and across given healthcare enterprises" (Menschik: col. 1, lines 59-61). Thus, PHOSITA would have been motivated to modify Kaput using the above techniques of Menschik in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Kaput and Menschik are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Menschik to the related teaching of Kaput.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 21-22, 25 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kaput in view of Menschik as applied to claim 1 above, and further in view of Harrington (as cited on the 5/5/2025 IDS).
Claim 21 is directed to the method of claim 1 but further specifies determining an impact score for each of the nutrigenetic aberrations.
Claim 22 is directed to the method claim 21 and thus 1 but further specifies that said impact score be determined based at least in part on a scientific or clinical validity of said given nutrigenetic aberration.
Claim 25 is directed to the method of 22 and thus 21 and 1 but further specifies that determining said impact score should be based on the biochemical impact, clinical dysfunction or manifestation, existence of an intervention, measurables and biomarkers or probability of benefit from an intervention.
Kaput teaches the method of claim 1 as specified above.
Kaput does not teach the use of an impact score for nutrigenetic aberrations.
Harrington teaches on page 1, column 1, paragraph 1, under Abstract “Nutrigenetics offers the potential to improve diet-related disease prevention and therapy, but is not without its own challenges” and on page 5, column 2, paragraph 2, under Future Challenges, “As genotype does not change over the life course, developing genetic risk scores based on GWAS findings offers the potential for earlier detection of high-risk individuals”. These risk scores as described here read on the use of an impact score determined by a nutrigenetic aberration based upon its clinical dysfunction, as we are talking about a risk score for a genetic variant based upon its clinical dysfunction (here T2D).
Regarding claim 27, since claim 21 reads on embodiments having only one nutrigenetic aberration, then at least for those embodiments, the recited grouping and summing are not required.
Claim 28 depends from claim 27 and is therefore similarly optional.
It would have been obvious at the time of invention to modify the teachings of Kaput which teaches the method of claims 1 to include impact scores for nutrigenetic aberrations (here risk scores) that capture the individual’s risk for a disease. One would have had a reasonable expectation of success given that Harrington specifically point this out as a next step in the field of Nutrigenetics. Therefore, it would be obvious to one with ordinary skill in the art to incorporate this aspect into the method and be successful.
Claim rejections - 101
35 USC 101 reads:
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.
For each rejection below, dependent claims are rejected similarly as not remedying the rejection, unless otherwise noted.
Response to arguments regarding Claim Rejections - 35 USC 101 -- Abstract idea
Applicant states (emphasis removed/added, applicant remarks: p. 15, 1st-2nd para.):
...the claimed invention encompasses improved methods for management of nutrigenetic data of a subject, based on analysis of pathway-specific biological states that are transmitted over a computer network and presented via a user interface, which provides improvements in nutrigenetic reporting technology.
... the additional elements recite a specific improvement over prior art systems by allowing a subject to (1)..., (2)..., and (3)...
It is understood that Applicant is asserting an improvement argument (MPEP 2106.04(d) and (d)(1) pertain).
Consistent with case law cited in MPEP 2111, 2106 and USPTO 101 Guidance and in order to make the record clear, one way of placing an improvement argument clearly on the record is, as described in the 1st bulletized suggestion at the end of the rejection, to show that: a particular improvement is identified (assertion of general "improvement" cannot suffice); there is a clear difference, apparent through comparison with the most relevant conventional technology (since there can be no improvement without a difference); and any improvement is either explicitly recited or inherent to the claims, but in either case must apply to all claimed embodiments within the recited claim scope.
It is not yet clear what is the particularly asserted improvement. For example, the remarks assert "improvement by allowing the subject to...," but a statement as to what is done is insufficient. What is needed is a comparison to the previous state of the technology field and an assertion as to the benefit derived.
Applicant states (emphasis removed/added, applicant remarks: p. 16, 3rd para.):
With respect to the Step 2B analysis, claim 1 recites physical elements that, when considered as an ordered combination, are not routinely performed by those of skill in the art.
It cannot be agreed that the asserted physical nutrigenetic assays and data reporting and transmission are non-conventional as evidenced by Kaput and Menschik as discussed in the rejections.
Judicial exceptions (JE) to 101 patentability
Claims 1-5, 13-16, 19-22 and 25-28 are rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more JEs (i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature), as identified below. Any elements or combination of elements beyond the JE(s) (i.e. "additional elements") are conventional and do not constitute significantly more than the JE(s). Thus, no claim includes additional elements amounting to significantly more than the JE(s), as explained below.
In Alice, citing Mayo and Bilski, two Mayo/Alice questions determine eligibility under 101: First, is a claim directed to a JE? And second, if so, does the claim recite significantly more than the JE?
MPEP 2106 organizes JE analysis into Steps 1, 2A (1st & 2nd prongs) and 2B as follows below.
MPEP 2106 and the following USPTO website provide further explanation and case law citations: www.uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter? -- MPEP 2106.I and 2106.03
[Step 1: claims 1-5, 13-16, 19-22 and 25-28: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- abstract idea -- MPEP 2106.I and 2106.04
Preliminarily, in a 1st prong of Step 2A, elements of independent claim 1 are interpreted as directed to the abstract idea of generating a nutrigenetic profile including the JE elements of "(c) processing...," "(d) processing..." and "(e) generating...," each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below.
BRIs of the claims are analogous to an abstract idea in the form of at least a mental process, at least equivalent to a computer-implemented process, including obtaining and comparing intangible data (e.g. Cybersource, Synopsys and Electric Power Group). In a BRI, it is not clear that the claim embodiments are limited so as to require complexity precluding analogy to a mental process.
The preceding case law examples are cited for the basic form of their identified abstract ideas, and analogy to these example abstract ideas need not be within the same technology field, 101 analysis generally being assumed to be neutral with respect to technology field.
As in Alice (at 306, as cited in the MPEP above) and Bilski (as cited in Alice, id), an abstract idea may comprise multiple abstract elements or steps (i.e. from Alice: "a series of steps" at 306) and need not be a single equation, relationship or principle.
It is not clear that the identified elements must represent other than an abstract idea according to any relevant analysis or case law.
[Step 2A, 1st prong, abstract idea: claim 1: YES]
Step 2A, 2nd prong: If the claims recite a judicial exception under the 1st prong, then is the judicial exception integrated into a practical application? -- MPEP 2106.I and 2106.04(d)
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using 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, as discussed in MPEP § 2106.05(e).
In Step 2A, 1st prong above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B.
Here in Step 2A, 2nd prong, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
At this point in examination it is not yet the case that any of the Step 2A, 2nd prong considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement (e.g. specification: [3, 77, 88, 90, 97]).
[Step 2A, 2nd prong: claim 1: NO]
Step 2B: Do the claims recite a non-conventional arrangement of additional elements in addition to the identified JEs? -- MPEP 2106.I and 2106.05
Addressing the second Mayo/Alice question, all elements of claims 1 and 29-30 are part of one or more identified JEs (as described above), except for elements identified here as conventional elements in addition to the above judicial exceptions:
The recited "receiving..." are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g).
The recited steps (f-j) are conventional elements of a computing environment, as exemplified by Menschik (US7234064 as cited on the attached "Notice of References Cited" form 892).
It is emphasized that, outside of an improvement argument, analysis of what is conventional generally pertains to the above-identified additional elements and not to elements identified as part of a JE.
[Step 2B: claim 1: NO]
Summary and conclusion regarding claim 1
Summing up the above analysis of claim 1, viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the identified JE(s), into patent eligible subject matter, and it is not clear that any claim is sufficiently analogous to controlling case law identifying an example of an eligible claim.
Remaining claims
Claims 2-5, 13-16, 19-22 and 25-28 add elements which also are part of the identified JEs for the same reasons described above regarding the independent claims and therefore do not provide the something significantly more necessary to satisfy 101.
While claim 20 recites a providing said subject with a therapeutic intervention, using diagnostics to provide a non-specific therapeutic intervention would have been conventional, and such an intervention does not satisfy the Step 2A, 2nd prong, 2nd consideration regarding therapy because the intervention is neither clearly recited as physical nor with sufficient specificity.
None of the dependent claim elements provides the something significantly more than the identified JE(s) necessary to satisfy 101.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
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 application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
Response to arguments regarding double patenting
Applicant states (emphasis removed/added, applicant remarks: p. 20):
Applicant respectfully traverses the double patenting, for at least the reason that the instant claims encompass patentably distinct subject matter as compared to the '170 Application.
Applicant's remarks are understood to be conclusory, and the rejection is maintained.
Double patenting rejections of instant claims 1-5, 13-16, 19-22 and 25-28
Instant claims 1-5, 13-16, 19-22 and 25-28 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference application 17/493,170 in view of Kaput and Harrington.
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
Each reference patent and application recites claims which involve detection of one or more nutrigenetic aberrations and determination of one or more pathway-specific biological states.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Citations to art
In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well.
Conclusion
No claim is allowed.
Applicant's amendments necessitated the new grounds for rejection in this action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Inquiries
Information regarding the filing, management and status of patent applications which are published (available to all users) or unpublished (available to registered users) may be obtained from the Patent Center: https://patentcenter.uspto.gov. Further is available at https://www.uspto.gov/patents/apply/patent-center, and information about filing in DOCX format is available at https://www.uspto.gov/patents/docx.
The Electronic Business Center (EBC) at 866-217-9197 (toll-free) is available for additional questions, and assistance from a Customer Service Representative is available at 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686