DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20 are pending and examined on the merits.
Priority
The instant application filed on 2/13/2023 claims the benefit of priority to U.S. Provisional Patent Application No. 63/309,431 filed on 2/11/2022. Thus, the effective filing date of the claims is 2/11/2022.
The applicant is reminded that amendments to the claims and specification must comply with 35 U.S.C. § 120 and 37 C.F.R. § 1.121 to maintain priority to an earlier-filed application. Claim amendments may impact the effective filing date if new subject matter is introduced that lacks support in the originally filed disclosure. If an amendment adds limitations that were not adequately described in the parent application, the claim may no longer be entitled to the priority date of the earlier filing.
Information Disclosure Statement
The IDS form filed on 7/29/2024 has been entered and considered. A signed copy of the corresponding 1449 form with any deficiencies noted has been included with this Office action. The information disclosure statement filed July 28, 2021 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Specifically, there is no English translation for Cite No 25. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-9 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 8, the written description of the instant specification does not explicitly disclose how "bootstrapping and rank ordering based on weights determined by the primer-directed amplification" is meant to be carried out. There are no details regarding what data from "primer-directed amplification" is to be used (gel migration time, fluorescence intensity, etc.) for weighting said features. To further prosecution, the limitation is interpreted as stated below in the section regarding 35 USC 112(b).
Claim 9 rejected due to dependency on claim 8.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-9 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites "the disease agent transcriptome comprises a subset of mRNA transcripts produced by primer-directed amplification, the subset of mRNA transcripts comprising one or more weighted features selected by bootstrapping and rank ordering based on weights determined by the primer-directed amplification". It is not clear how "the primer-directed amplification" is used in determining feature weights for "a subset of mRNA transcripts". Furthermore, it is not clear on what data the "bootstrapping and rank ordering" is being performed on. The instant specification does not illuminate the matter beyond this limitation statement. To further prosecution, the limitation is interpreted as "the disease agent transcriptome comprises a subset of mRNA transcripts produced by primer-directed amplification".
Claim 9 rejected due to dependency on claim 8.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon without significantly more. 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:
Claim 1, 15, and 20: “determining a deviation of the disease agent viability score from a viability threshold of the universal transcriptome signature for viability” provides an evaluation (determining a deviation of the viability score requires evaluating score data) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
“determining a treatment recommendation based on the viability state of the disease agent” provides an evaluation (determining a treatment recommendation requires evaluating the viability state) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 10 and 16: “comparing the viability state of the disease agent to one or more single-drug treatment viability states of the disease agent” provides a comparison (comparing viability states) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
“a determination of another deviation of the one or more single-drug treatment viability scores from the viability threshold of the universal transcriptome signature for viability” provides an evaluation (determining a deviation of the viability score requires evaluating score data) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 11 and 17: “comparing the viability state of the disease agent and the one or more single-drug treatment viability states of the disease agent with a multi-drug viability state” provides a comparison (comparing viability states) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 13: “evaluating an efficacy of a drug treatment for the disease agent” provides an evaluation (evaluating drug treatment efficacy) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
These recitations are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or are mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Additionally, while claims 15-20 recite performing some aspects of the analysis on “A computer-program product tangibly embodied in a non-transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform a set of actions” (claim 15) and “a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform a set of actions” (claim 20), there are no additional limitations that indicate that this requires anything other than carrying out the recited mental processes or mathematical concepts 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 it falls within the “Mental processes” grouping of abstract ideas. As such, claims 1-20 recite an abstract idea (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). The judicial exceptions listed above are not integrated into a practical application because the claims do not recite an additional element or elements that reflects an improvement to technology. Specifically, the claims recite the following additional elements:
Claim 1, 15, and 20: “accessing a disease agent transcriptome of a disease agent” provides insignificant extra-solution activities (obtaining data is a pre-solution activity involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
“applying a classifier to the disease agent transcriptome” provides insignificant extra-solution activities (applying a data model is a pre-solution activity involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
“outputting the treatment recommendation” provides insignificant extra-solution activities (outputting data is a post-solution activity involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 10 and 16: “application of the classifier to a plurality of single-drug treatment transcriptomes of the disease agent grown under a plurality of single-drug treatment conditions” provides insignificant extra-solution activities (applying a data model is a pre-solution activity involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 11 and 19: “application of the classifier to an average of a plurality of disease agent transcriptomes and one or more single drug treatment transcriptomes” provides insignificant extra-solution activities (applying a data model is a pre-solution activity involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 14: “facilitating the treatment recommendation for a host of the disease agent” provides insignificant extra-solution activities (outputting data (as interpreted from the spec in para.0058) is a post-solution activity involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 15: “A computer-program product tangibly embodied in a non-transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform a set of actions” provides insignificant extra-solution activities (running instructions on generic computer components) that do not serve to integrate the judicial exceptions into a practical application.
Claim 20: “a microfluidic device for receiving a sample of a host subject and producing disease agent transcriptome data of a disease agent from the sample” provides insignificant extra-solution activities (receiving samples and producing transcriptome data are pre-solution activities involving sample and data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
“a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform a set of actions” provides insignificant extra-solution activities (running instructions on generic computer components) that do not serve to integrate the judicial exceptions into a practical application.
The steps for obtaining, accessing, and outputting data, applying data models, and receiving samples for transcriptomic processing on a microfluidic device are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre- and post-solution activities involving data and sample gathering and manipulation steps (see MPEP 2106.04(d)(2)). Furthermore, the limitations regarding implementing program instructions do not indicate that they require anything other than mere instructions to implement the abstract idea in a generic way or in a generic computing environment. As such, this limitation equates 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. Therefore, claims 1-20 are directed to an abstract idea (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 are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application, or equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
As discussed above, there are no additional elements to indicate that the claimed “A computer-program product tangibly embodied in a non-transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform a set of actions” (claim 15) and “a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform a set of actions” (claim 20) 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. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. Additionally, the limitations for obtaining, accessing, and outputting data, applying data models, and receiving samples for transcriptomic processing on a microfluidic device are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Furthermore, no inventive concept is claimed by these limitations as they are demonstrated to be well-understood, routine, and conventional, as evidenced by Shembekar et al. (page 1 col 2 paragraph 2 "Microfluidic chips are usually manufactured using soft lithography.10 This procedure requires specialized equipment and typically also a clean room facility. However, non-expert labs can get custom-made microfluidic devices manufactured by companies and service facilities such as Dolomite, Microfluidic Chip Shop or the Stanford Microfluidics Foundry") and Ou et al. (page 1 abstract "A microfluidic device as a pivotal research tool in chemistry and life science is now widely recognized. Indeed, microfluidic techniques have made significant advancements in fundamental research, such as the inherent heterogeneity of single-cells studies in cell populations, which would be helpful in understanding cellular molecular mechanisms and clinical diagnosis of major diseases. Single-cell analyses on microdevices have shown great potential for precise fluid control, cell manipulation, and signal output with rapid and high throughput").
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 1-20 are not patent eligible.
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 1-4 and 6-20 rejected under 35 U.S.C. 103 as being unpatentable over O'Hara et al. (US-20190087533).
Regarding claims 1, 15, and 20, O'Hara teaches accessing a disease agent transcriptome of a disease agent (Para.0106 "Next-generation sequencing applies to genome sequencing, genome resequencing, transcriptome profiling (RNA-Seq), DNA-protein interactions (ChIP-sequencing), and epigenome characterization" and para.0133 "Methods described may characterize viability and infection risk by analyzing sequence data").
O'Hara also teaches generating a disease agent viability score by applying a classifier to the disease agent transcriptome, the classifier defining a universal transcriptome signature for a viability of the disease agent in a plurality of different host-relevant contexts (Para.0133 "Methods described may characterize viability and infection risk by analyzing sequence data and comparing to a database which includes information on pathogenicity of strains in order to generate two reports: 1) a viability estimate (generated by calculating a number of population genetic estimates at multiple time points), and 2) a risk estimate (based on comparison to a database which contains data on the pathogenicity of strains of microbes, data collected on rates of infection, and statistical modeling)", para.0085 "For example, the use of Bayesian models on next-generation population genomic data have revealed possibilities of differentiating between demographic and evolutionary signatures", and para.0135 "Populations which show evidence of selection (e.g., selective sweeps) that may be differentiated from demographic signatures are reported as having a higher probability of being viable").
O'Hara also teaches generating a viability state of the disease agent by determining a deviation of the disease agent viability score from a viability threshold of the universal transcriptome signature for viability (Para.0157 "Deviation from unity may indicate positive (dN/dS >1) or negative (dN/dS <1) selection operating at the protein level, which is evidence of evolution by selection. As described herein, deviation from unity provides support for the population being viable").
O'Hara also teaches determining a treatment recommendation based on the viability state of the disease agent (Para.0084 "An additional concern of grave importance is the ability of some populations of bacteria to survive treatment of one or multiple antibiotic treatments" and para.0139 "This invention may also characterize antibiotic resistance in microbial populations. This may involve identifying antibiotic resistance loci based on a database and calculating population genetic estimates described above to explore whether antibiotic resistant genes are under selection or are evolving. In which case, cleaning procedures and disease treatment may be modified by the hospital or clinicians to relieve these selective pressures").
O'Hara also teaches outputting the treatment recommendation (Para.0163 "Inferential statistical analyses of the genomic data may be combined with environmental and medical observations to further interpret results of this system and methods. This approach may be used to make recommendations to the appropriate entities to combat pathogens identified, such as recommendations on specific cleaning products to use, or the use of other preventative strategies and/or empiric antimicrobial therapy").
And specific to claim 20, O'Hara also fairly suggests use of a microfluidic device for receiving a sample to produce transcriptomic data (Para.0127).
It is recognized that the citations and evidence provided above are derived from potentially different embodiments of a single reference. Nevertheless, it 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 to employ combinations and sub-combinations of these complementary embodiments, because O'Hara et al. explicitly motivates doing so at least in para.0269 "The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to make and use the assay, screening, and therapeutic methods of the invention, and are not intended to limit the scope of what the inventors regard as their invention" and otherwise motivating experimentation and optimization. Additionally, doing so merely combines prior art elements according to known methods to yield predictable results.
Regarding claims 2 and 4, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also teaches the classifier was trained using a training data set comprising a plurality of viable disease agent transcriptomes, and wherein the classifier was tested on a testing data set comprising a first set of untreated disease agent transcriptomes and a second set of treated disease agent transcriptomes, the training data set and the testing data set derived from the disease agent being grown under the plurality of different host-relevant contexts with drug treatment and without drug treatment to define the universal transcriptome signature for viability; and the classifier is a single-class support vector machine (Para.0176 "(ii) Semi-supervised learning which combines both labeled and unlabeled examples to generate an appropriate function or classifier. (iii) Reinforcement learning in which the algorithm learns a policy of how to act given an observation of the world", and as the semi-supervised learning does not require multi-class labeled data.
Regarding claim 3, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also teaches the viability threshold is set as a lower limit of a viable transcriptome space defined by the classifier (Para.0157 "Deviation from unity may indicate positive (dN/dS >1) or negative (dN/dS <1) selection operating at the protein level, which is evidence of evolution by selection. As described herein, deviation from unity provides support for the population being viable" would lead one skilled in the art to determine a threshold of "deviation from unity" for viability).
Regarding claim 6, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also teaches the disease agent is a cell, and the disease agent transcriptome is obtainable from the cell (Para.0059 describes "microbial cells" used as the sample from which RNA is sequenced).
Regarding claim 7, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also teaches the disease agent is Mycobacterium tuberculosis and a host of the disease agent is a mammal (Para.0007 "In an embodiment, the bacteria are selected from the group consisting of [. . .] Mycobacterium tuberculosis" and para.0067 "The term “subject” as used herein is meant to include vertebrates, preferably a mammal. Mammals include, but are not limited to, humans, camels, horses, goats, sheep, cows, dogs, cats, and the like").
Regarding claim 8, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also teaches the disease agent transcriptome comprises a subset of mRNA transcripts produced by primer-directed amplification (as interpreted above) (Para.0235 "The primers of the invention embrace oligonucleotides of sufficient length and appropriate sequence so as to provide specific initiation of polymerization on a significant number of nucleic acids in the polymorphic locus").
Regarding claim 9, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also teaches the primer-directed amplification is reverse transcription loop-mediated isothermal amplification (LAMP) (Para.0242 "Preferably, the method of amplifying is by PCR, as described herein and as is commonly used by those of ordinary skill in the art. Alternative methods of amplification have been described and can also be employed as long as the methylated and non-methylated loci amplified by PCR using the primers of the invention are similarly amplified by the alternative means" fairly suggests other types of PCR methods may be used).
Regarding claims 10 and 16, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also teaches comparing the viability state of the disease agent to one or more single-drug treatment viability states of the disease agent; the one or more single-drug treatment viability states produced by generating one or more single-drug treatment viability scores by an application of the classifier to a plurality of single-drug treatment transcriptomes of the disease agent grown under a plurality of single-drug treatment conditions (as indicated for claim 1).
O'Hara also teaches generating the one or more single-drug treatment viability states by a determination of another deviation of the one or more single-drug treatment viability scores from the viability threshold of the universal transcriptome signature for viability (Para.0157 "Deviation from unity may indicate positive (dN/dS >1) or negative (dN/dS <1) selection operating at the protein level, which is evidence of evolution by selection. As described herein, deviation from unity provides support for the population being viable").
Regarding claims 11-12 and 17-19, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also fairly suggests comparing the viability state of the disease agent and the one or more single-drug treatment viability states of the disease agent with a multi-drug viability state, the multi-drug viability state imputed by an application of the classifier to an average of a plurality of disease agent transcriptomes and one or more single drug treatment transcriptomes; and the average is a geometric mean (while O'Hara does not explicitly teach comparing viability states of single-drug treatments and multi-drug treatments, the authors do suggest analyzing data from "combination therapy" which includes data from multi-drug treatments, and it would have been obvious to one of ordinary skill in the art to use a geometric mean as an average, as such a modification represents a predictable variation of known techniques).
Regarding claim 13, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also teaches determining the treatment recommendation comprises evaluating an efficacy of a drug treatment for the disease agent (Para.0046 "By “effective amount” is meant the amount required to ameliorate the symptoms of a disease (e.g., a microbial infection) relative to an untreated patient. The effective amount of active compound(s) used to practice the present invention for therapeutic treatment of a disease varies depending upon the manner of administration, the age, body weight, and general health of the subject").
Regarding claim 14, O'Hara teaches the methods of Claims 1 on which this claim depends/these claims depend, respectively. O'Hara also teaches facilitating the treatment recommendation for a host of the disease agent (Para.0163 "Inferential statistical analyses of the genomic data may be combined with environmental and medical observations to further interpret results of this system and methods. This approach may be used to make recommendations to the appropriate entities to combat pathogens identified, such as recommendations on specific cleaning products to use, or the use of other preventative strategies and/or empiric antimicrobial therapy").
Claim 5 rejected under 35 U.S.C. 103 as being unpatentable over O'Hara et al. (US-20190087533) as applied to claims 1-4 and 6-20 above, and further in view of Haiminen et al. (US-20130289890).
O'Hara et al. are applied to claims 1-4 and 6-20.
Regarding claim 5, O'Hara teaches the method of Claim 1 on which this claim depends/these claims depend.
O'Hara does not explicitly teach the disease agent viability score is a weighted sum of a plurality gene expression ranks generated by the classifier and rank normalized.
However, Haiminen teaches rank normalization of transcriptome sequence data, which would be an obvious method to apply for scoring viability using transcript data (Para.0001 "This disclosure relates generally to the field of messenger ribonucleic acid sequencing, and more particularly to differential expression (DE) analysis of transcriptome sequencing data based on rank normalization").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of O'Hara as taught by Haiminen in order to assign a viability score using a variation of the calculation used by O'Hara, which calculated a viability score by slightly different means (Para.0133 "a viability estimate (generated by calculating a number of population genetic estimates at multiple time points)"). One skilled in the art would have a reasonable expectation of success because both methods are concerned with analysis of transcriptomic data.
Conclusion
No claims are allowed.
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/R.A.P./Examiner, Art Unit 1686
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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