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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP2024-038430, filed on 03/12/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/25/2025 is considered by the examiner.
Drawings
The drawing submitted on 02/25/2025 is considered by the examiner.
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 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) " analyze data regarding genetic information according to a purpose of a data analysis and obtain analysis result data; and generate a prompt for inputting into a language model, the prompt instructing to interpret the analysis result data based on gene-related information related to the analysis result data and the purpose of the data analysis and obtain an interpretation result of the analysis result data based on the prompt and the language model.", as drafted is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer component (Claim 1, apparatus, processing circuitry and language model, Claims 19, language model, and Claim 20, non-transitory computer- readable medium and language model). That is other than reciting, in Claim 1, apparatus, processing circuitry and obtaining interpretation result of the analysis result data based on the prompt and the language model; Claims 19, obtaining interpretation result of the analysis result data based on the prompt and the language model; and Claim 20, non-transitory computer- readable media and obtaining interpretation result of the analysis result data based on the prompt and the language model; nothing in the claims element precludes the steps from practically being performed in the mind. For example, but for the apparatus, processing circuitry, language model, and non-transitory computer- readable medium (Claims 1 and 19-20 respectively), language, analyzing, obtaining, and generating, in the context of this claims encompasses, a person having an article/document containing genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information upon the subject matter expert explain the article in a plain language to him. 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. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements - using an apparatus comprising processing circuitry and language model (Claim 1), language model (Claim 19) and computer- readable medium and language model (Claim19) in steps to obtain interpretation result of the analysis result data. The computer and language model in all steps is recited at a high level of generality (i.e. as a generic processor performing a generic computer function to obtain interpretation result of the analysis result data) such that it amounts no more than mere instructions to apply the exception using a generic computer component. These limitations only recite the outcomes of “interpretation result of the analysis result data " based on prompt and language model, without any details about how the computer function to generate a prompt based on gene-related information associating the obtain analysis result data and how the language model of the computer functioned to interpret the analysis results data. Accordingly, this additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above these recited limitations amounts mere instruction to implement an abstract idea on computer or merely use a computer as a tool to perform an abstract idea. See MPEP 2106.05(f).
Even when viewed in combination, these additional elements represent mere instruction to apply an exception and do not integrate the recited judicial exemption into a practical application, which cannot provide an inventive concept.
Regarding claim 2, which depends on Claim 1 and include all limitation of Claim 1, recites, " wherein the processing circuitry obtains a template for creating the prompt, the template including a first variable for storing the analysis result data, a second variable for storing the gene-related information related to the analysis result data, and a third variable for storing the purpose of the data analysis, and stores the analysis result data in the first variable of the template, stores the genetic information in the second variable, and stores the purpose of the data analysis in the third variable to generate the prompt " similarly covers performance of the limitation in the mind but for the recitation of generic computer components, and thus falls within the "Mental Processes" grouping of abstract ideas. For example, the person asks the subject matter expert with the genetic information article indicating explanation of gene-related information, purpose for explanation and understands the article analysis report goal associated gene-related information upon the subject matter expert explain the article in a plain language to him.
Regarding claim 3, which depends on Claim 1 and include all limitation of Claim 1, recites, “wherein the processing circuitry evaluates a quality of the interpretation result, regenerates the prompt according to an evaluation result, and obtains an interpretation result of the analysis result data based on the regenerated prompt and the language model” similarly covers performance of the limitation in the mind but for the recitation of generic computer components, and thus falls within the "Mental Processes" grouping of abstract ideas. For example, the person further asks the subject matter expert to further clarify part of the interpretation associated article reports and understands the article analysis report goal associated gene-related information upon the subject matter expert explain the article in a plain language to him.
Regarding claim 4, which depends on Claim 3 and include all limitation of Claim 3, recites, “an output device configured to output the interpretation result; and an input device configured to receive information as an input, wherein the processing circuitry obtains additional information with respect to the prompt from the input device and regenerates the prompt further based on the obtained additional information” similarly covers performance of the limitation in the mind but for the recitation of generic computer components (input output device), and thus falls within the "Mental Processes" grouping of abstract ideas. For example, the person further asks the subject matter expert to clarify/explain another part associated article reports based on the past articles associated gene-related reports.
Regarding claim 5, which depends on Claim 4 and include all limitation of Claim 4, recites, “wherein the obtained additional information includes a user's question with respect to the interpretation result, and the processing circuitry obtains the interpretation result of the analysis result data and an answer to the question based on the regenerated prompt and the language model.” similarly covers performance of the limitation in the mind but for the recitation of generic computer components (processing circuitry and language model), and thus falls within the "Mental Processes" grouping of abstract ideas. For example, the person further asks the subject matter expert to further clarify part of the interpretation associated article reports and understands the article analysis report goal associated gene-related information upon the subject matter expert explain the article in a plain language to him.
Regarding claim 6, which depends on Claim 4 and include all limitation of Claim 4, recites, “wherein the obtained additional information includes an interpretation result obtained in a past for a data analysis with a purpose same as the purpose of the data analysis, and the processing circuitry obtains information explaining a difference between the interpretation result of the analysis result data and the interpretation result obtained in the past based on the regenerated prompt and the language model” similarly covers performance of the limitation in the mind but for the recitation of generic computer components (processing circuitry and language model), and thus falls within the "Mental Processes" grouping of abstract ideas. For example, the person further asks the subject matter expert to clarify/explain another part associated article reports based on the past articles associated gene-related reports and understands the article analysis report goal difference associated gene-related information upon the subject matter expert explains the article report difference in a plain language to him.
Regarding claim 7, which depends on Claim 1 and include all limitation of Claim 1, recites, “wherein the processing circuitry searches a first database that stores plural kinds of gene-related information based on the analysis result data, and retrieves the gene-related information related to the analysis result data.” similarly covers performance of the limitation in the mind but for the recitation of generic computer components (processing circuitry and language model), and thus falls within the "Mental Processes" grouping of abstract ideas. For example, a person having an article/document containing genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information upon the subject matter expert explains the article in a plain language to him, based on his knowledge on the subject.
Regarding claim 8, which depends on Claim 7 and include all limitation of Claim 7, recites, “wherein the processing circuitry searches a second database that stores plural other kinds of gene-related information different from the gene-related information based on the analysis result data, and retrieves other gene-related information related to the analysis result data, and generates the prompt further based on the obtained other gene- related information.” similarly covers performance of the limitation in the mind but for the recitation of generic computer components (processing circuitry and language model), and thus falls within the "Mental Processes" grouping of abstract ideas. For example, the person having another article/document containing genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information upon the subject matter expert explains the article in a plain language to him based on his knowledge on the subject.
Regarding claim 9, which depends on Claim 1 and includes all limitation of Claim 1, recites, “wherein the analysis result data includes plural genes according to the purpose of the data analysis” similarly covers performance of the limitation in the mind but for the recitation of generic computer components (processing circuitry and language model), and thus falls within the "Mental Processes" grouping of abstract ideas. For example, a person having an article/document containing plural genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information upon the subject matter expert explain the article in a plain language to him.
Regarding claim 10, which depends on Claim 9 and includes all limitation of Claim 9, recites, “wherein the gene-related information includes information of genes that are putative targets for the genes included in the analysis result data.” similarly covers performance of the limitation in the mind but for the recitation of generic computer components (processing circuitry and language model), and thus falls within the "Mental Processes" grouping of abstract ideas. For example, a person having an article/document containing plural genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information upon the subject matter expert explains the article’s important gene-related information and goal in a plain language to him.
Regarding claim 11, which depends on Claim 10 and includes all limitation of Claim 10, recites, “wherein the processing circuitry generates the prompt further based on other gene-related information which is different from the gene-related information and which is related to the analysis result data, and the other gene-related information is information of papers related to the genes included in the analysis result data.” similarly covers performance of the limitation in the mind but for the recitation of generic computer components (processing circuitry and language model), and thus falls within the "Mental Processes" grouping of abstract ideas. For example, the person further asks the subject matter expert to clarify/explain another part associated article reports based on the past articles associated gene-related reports and understands the article analysis report goal difference associated gene-related information upon the subject matter expert explains the article report difference in a plain language to him.
Regarding claim 12, which depends on Claim 1 and includes all limitation of Claim 1, recites, “wherein the processing circuitry performs the data analysis by executing an analysis algorithm according to the purpose of the data analysis.” which requires mathematical calculation and thus falls within the mathematical grouping of abstract idea.
Regarding claim 13, which depends on Claim 12 and includes all limitation of Claim 12, recites, “wherein the data analysis is a meta-analysis” which requires mathematical calculation and thus falls within the mathematical grouping of abstract idea.
Regarding claim 14, which depends on Claim 1 and includes all limitation of Claim 1, recites, “wherein the data related to the genetic information is a dataset that includes measurement data regarding genes for plural samples” similarly covers performance of the limitation in the mind but for the recitation of generic computer components, and thus falls within the "Mental Processes" grouping of abstract ideas. For example, a person having an article/document containing genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information associated measurement data of plural sample in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information upon the subject matter expert explains the article in a plain language to him.
Regarding claim 15, which depends on Claim 1 and includes all limitation of Claim 1, recites, “wherein the processing circuitry searches a third database that stores plural data related to genetic information based on at least one of the purpose of the data analysis and a search condition of the data related to the genetic information, and retrieves the data related to the genetic information.” similarly covers performance of the limitation in the mind but for the recitation of generic computer components, and thus falls within the "Mental Processes" grouping of abstract ideas. For example, a person having an article/document containing genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information associated measurement data of plural sample in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information upon the subject matter expert based on his knowledge about the subject explains the article in a plain language to him.
Regarding claim 16, which depends on Claim 1 and includes all limitation of Claim 1, recites, “wherein the search condition includes at least one of a condition that specifies a database to be used for the search and a condition that specifies measuring instrument used to measure the genetic information, and the processing circuitry searches a database that meets the search condition or searches for data in which the genetic information is measured by the measuring instrument” similarly covers performance of the limitation in the mind but for the recitation of generic computer components, and thus falls within the "Mental Processes" grouping of abstract ideas. For example, a person having an article/document containing genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information associated measurement data and instrument to measure of plural sample in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information associated measurement instrument used to measure genetic information and data upon the subject matter expert based on his knowledge explains the article associated measurement instrument used to measure genetic information and data in a plain language to him.
Regarding claim 17, which depends on Claim 15 and includes all limitation of Claim 15, recites, “wherein the data related to the genetic information and each of the data in the third database are a dataset that includes measurement data regarding genes for plural samples, and the processing circuitry retrieves plural datasets from the third database, and selects, based on a number of samples in each of the obtained plural datasets and measurement target genes in each of the obtained plural datasets, some of the obtained plural datasets, and analyzes the selected plural datasets to obtain the analysis result data” similarly covers performance of the limitation in the mind but for the recitation of generic computer components, and thus falls within the "Mental Processes" grouping of abstract ideas. For example, a person having an article/document containing genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information associated target gene, measurement data and instrument to measure of plural sample in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information associated target gene, measurement instrument used to measure genetic information and data upon the subject matter expert based on his knowledge explains the article associated measurement instrument used to measure genetic information and data in a plain language to him.
Regarding claim 18, which depends on Claim 17 and includes all limitation of Claim 17, recites, “wherein the data related to the genetic information and each of the data in the third database are a dataset that includes measurement data regarding genes for plural samples, and the processing circuitry retrieves plural datasets from the third database, and selects, based on a number of samples in each of the obtained plural datasets and measurement target genes in each of the obtained plural datasets, some of the obtained plural datasets, and analyzes the selected plural datasets to obtain the analysis result data” similarly covers performance of the limitation in the mind but for the recitation of generic computer components, and thus falls within the "Mental Processes" grouping of abstract ideas. For example, a person having an article/document containing genetic information analysis report/results, asked a subject matter expert person to explain/clarify the genetic information associated target gene, measurement data and instrument to measure of plural sample in the article, and goal or purpose of the analysis reports of the article for him to understand. The person understands the article analysis report goal associated gene-related information associated target gene, measurement instrument used to measure genetic information and data upon the subject matter expert based on his knowledge associated a number of samples in each of the obtained plural datasets and measurement target genes in each of the obtained plural datasets in a plain language to him.
Even when viewed in combination, these additional elements in claims 2-18 represent mere instruction to apply an exception and do not integrate the recited judicial exemption into a practical application, which cannot provide an inventive concept.
Allowable Subject Matter
Claims 1-20 objected as being rejected under 35 U.S.C. 101, but would be allowable upon overcoming the pending rejection under 35 U.S.C. 101.
Claims 1-20 are allowed.
The following is an examiner’s statement of reasons for allowance:
The pending application inventive scope is: The system automates both the analysis and the explanation of genetic data. It first searches and selects appropriate datasets, then performs meta-analysis, and finally feeds the results plus gene-related context into a language model prompt. By combining statistical analysis with gene knowledge and natural-language generation, the system produces an interpretation tailored to the user’s analysis purpose [0027]-[0036], [0039]-[0050].
The prior art of records Davis et al. (WO 2022/098588 A1) teach: Using natural language processing techniques to read DNA sequences as if they were text. The system breaks DNA into smaller pieces, such as k-mers, and turns those pieces into numerical representations called word embeddings. It then applies two different machine-learning models to the same DNA data and combines their outputs to find important genetic elements. The main use case is finding cis-regulatory elements in maize, especially drought-responsive elements. The system can also filter out already-known elements so it focuses on novel candidates. In some embodiments, attention weights, saliency, or feature weights help rank which DNA fragments matter most. The inventors emphasize combining multiple models rather than trusting a single classifier. They also use expression GWAS data to link candidate elements to upstream transcriptional regulators. The pipeline is designed to improve confidence in biological findings and reduce unnecessary wet-lab testing. Example figures show enrichment of known drought elements, discovery of a TAGCTA-like novel motif, and validation in drought-related traits. [0004]-[0007], [0040]-[0044], [0083]-[0090], [0128]-[0149], [0158]-[0160].
The prior art of records Luis Balaguer et al. (US 2025/0245215 A1) teach: Invention uses a custom prompt generator to transform a user’s natural-language question into a prompt that instructs an LLM to call a database lookup tool. The LLM interprets the request, decides what sequence is being sought, and controls the lookup tool to retrieve the correct database record. In some implementations, the lookup is staged through multiple tools: gene identifier lookup, sequence identifier lookup, and final sequence retrieval. The system can also ask the user for clarification when the query is ambiguous ([0030]-[0036], [0041-0047], [0051-0053], [0071-0074] and [0080]).
The prior arts of record alone or in combination failed to teach independent claims 1, and 19-20, “analyze data regarding genetic information according to a purpose of a data analysis and obtain analysis result data; and generate a prompt for inputting into a language model, the prompt instructing to interpret the analysis result data based on gene-related information related to the analysis result data and the purpose of the data analysis and obtain an interpretation result of the analysis result data based on the prompt and the language model.”
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The pertinent art of records Ismagilov et al.(US 2026/0268205 a1) teach: The invention models molecular detection as a probabilistic workflow and outputs a probability distribution for target abundance rather than a single deterministic value [0021]-[0027], [00334]-[00339]. It does this by combining the target count, reference count, and an anchoring value for the reference molecule, with optional sample quantity and workflow-specific stochastic modeling [0045]-[0054], [00304]-[00308]. These distributions can be generated by non-AI or AI models and then used as training or inference data for downstream AI tasks [0019]-[0020], [00241]-[00243], [00247]-[00257]. The result is a “probability-enhanced” AI and measurement framework intended to improve accuracy, precision, and confidence in biomarker-based decisions [0010]-[0013], [001752]-[001756].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMAD K ISLAM whose telephone number is (571)270-5878. The examiner can normally be reached Monday -Friday, EST (IFP).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Paras Shah can be reached at 571-270-1650. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMAD K ISLAM/Primary Examiner, Art Unit 2653
