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 .
The following is a non-final, first office action on the merits, in response to application filed 2/22/2023 and amendment filed on 9/26/2023. Claims 1-9, 26-28, 37-47, 49, 73 have been examined and are currently pending.
Priority
Acknowledgment is made of applicant's claim for a provisional application filed on 8/25/2020. The Applicant claims benefit of continuation of PCT/US21/47619, filed on 8/25/2021. However, receipt is not acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have not been placed of record in the file.
Response to Amendment
The amendment filed on 9/26/2023 cancelled claim 10-25, 29-36, 48, 50-72, 74-116. No claims were previously cancelled. No new claims are added. Claim 4-6, 26, 28, 40-44, 49 has been amended. Therefore, claims 1-9, 26-28, 37-47, 49, 73 are pending and addressed below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/26/2023 follows the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being 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 1-9, 26-28, 37-47, 49, 73 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Alice Corp. also establishes that the same analysis should be used for all categories of claims, regardless of a system/apparatus, a method, or a product claim.
The claimed invention (Claims 1-9, 26-28, 37-47, 49, 73) is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) abstract ideas including “Certain Methods of Organizing Human Activity”, “an idea “of itself”, which have been identified/found by the courts as abstract ideas in new 101 memos of the subject matter eligibility in here (https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility) including 2019 Revised Patent Subject Matter Eligibility Guidance. This judicial exception is not integrated 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 because It/they is/are recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications:
Independent claim 1 (Step 2A, Prong I): is directed to multiple abstract ideas including “Certain Methods of Organizing Human Activity”, and “Mental process”.
Claim 1, Steps of,
determining sequence data of a plurality of sequence fragments associated with a plurality of genomic regions, wherein the sequence data comprises a plurality of sequence reads, wherein the plurality of sequence reads are sequenced from the plurality of sequence fragments from a plurality of samples, wherein each sample of the plurality of samples is labeled as a tumor derived or a non-tumor derived;
determining at least one of: epigenetic data or fragmentomic data associated with the plurality of sequence fragments;
determining, based on at least a portion of the sequence data and at least a portion of at least one of: the epigenetic data or fragmentomic data, a plurality of features for a predictive model; training, based on a first portion of the sequence data and at least one of: the epigenetic data or fragmentomic data, the predictive model according to the plurality of features;
testing, based on a second portion of the sequence data and at least one of: the epigenetic data or fragmentomic data, the predictive model; and
outputting, based on the testing, the predictive model.
fall within “Certain Methods of Organizing Human Activity” grouping of abstract idea because the instant steps “determining data, training a predictive model, testing the model, displaying/outputting the model”, which are human activities and/or interactions between users/people/devices and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer.
In addition, claim 1, steps mentioned above also falls within the abstract “Mental Processes” grouping of abstract ideas since these limitation covers performance of the limitations in the mind. For example, a human being can evaluate/determine data, can observe/train a model, can observe/test the model, can observe/display the model.
Further, steps of (“outputting….”) are considered as “insignificant extra-solution activity” to the judicial exception since they are merely displaying/presenting data/information
Independent claim 1, Step 2A (Prong II): Accordingly, the claim recites an abstract idea(s) as pointed out above. This judicial exception(s) is/are not integrated into a practical application as the claim recites no additional element that are significant more than the abstract ideas. In particular, there is no machine/hardware/computer to actually perform the abstract steps mentioned above, thus nothing in the claim element precludes the step from practically being performed in the mind, and is simply organized information through human activity or merely mental tasks, and is part of, or a related, judicial exception and does not meaningfully limit the application of the identified judicial exception, and as such does not constitute significantly more.
There is no specificity regarding any technology, just broadly, execute the programming instructions to determine data, train data, test data, present/display data. There are no additional elements, for example, hardware processor of a machine to actually perform all of the steps at all. The steps are mainly determining data, training data, testing data, presenting/displaying data. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Accordingly, there is neither improvement to another technology or technical field nor an improvement to the functioning of the computer itself, and does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Independent claim 1, (step 2B):
No additional element is recited and add nothing of substance to the underlying abstract idea; thus, they are not significantly more than the identified abstract idea. This component is merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic computer components recited as performing generic computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/send/display information over communication network/internet does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in claim 1).
Dependent claims 2-9, 26-28, are merely add further details of the abstract steps/elements recited in claim 1 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Therefore, dependent claims 2-9, 26-28, are also non-statutory subject matter.
Similarly, Independent method claim 37 and 73 are also rejected as ineligible subject matter under 35 U.S.C. 101 for substantially the same reasons as the method claim(s) 1.
Dependent claims 38-47, 49, are merely add further details of the abstract steps/elements recited in claim 37, without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Therefore, dependent claims 38-47, 49 are also non-statutory subject matter.
Viewed as a whole, the claims (1-9, 26-28, 37-47, 49, 73) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
Thus, the claims do NOT recite limitations that are “significantly more” than the abstract idea because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment.
Thus, the claimed invention, as a whole, does not provide 'significantly more' than the abstract idea, and is non-statutory subject matter.
Prior art Rejection
Independent claims 1, 37, 73, as a whole recite a combination of limitations that has Not been found as define over prior art of record (the combination of Gross et al. (US 2020/0340064, Finkle et al. (US 2022/0367010), Hubbell et al. (US 2019/0316209), Jiang et al. (US 2019/0206510), Peters et al. (US 2020/0327959), and
NPL1---Ivanov M, Baranova A, Butler T, Spellman P, Mileyko V. Non-random fragmentation patterns in circulating cell-free DNA reflect epigenetic regulation. BMC Genomics. 2015;16 Suppl 13(Suppl 13):S1. doi: 10.1186/1471-2164-16-S13-S1. Epub 2015 Dec 16. PMID: 26693644; PMCID: PMC4686799. (Year: 2015)
NPL2--Kang S, Li Q, Chen Q, Zhou Y, Park S, Lee G, Grimes B, Krysan K, Yu M, Wang W, Alber F, Sun F, Dubinett SM, Li W, Zhou XJ. CancerLocator: non-invasive cancer diagnosis and tissue-of-origin prediction using methylation profiles of cell-free DNA. Genome Biol. 2017 Mar 24;18(1):53. oi: 10.1186/s13059-017 (Year: 2017)
and the other references does not teach all the claimed features.
Allowable Subject Matter
Claims 1-9, 26-28, 37-47, 49, 73 are deemed to be allowed in light of the specification, amendments filed on 2/22/2023, 9/26/2023. As to the prior art rejections, upon further search and consideration, it is found that claims 1-9, 26-28, 37-47, 49, 73are allowable subject to outstanding 101 rejections.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with, and pending remedy to outstanding issues cited above. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Abdueva (US 2019/0352695, teaches using sequence information in a macroscale and global manner, with or without somatic variant information, to assess a fragmentome profile that can be representative of a tissue of origin, disease, progression),
Jaimovich et al. (US 2019/0385700, teaches determining the cellular origin of cell-free nucleic acid (cfNA) fragments from cfNA samples, such as liquid biopsy samples).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN M LI whose telephone number is (571)270-5489. The examiner can normally be reached on Mon-Thurs, 8:30am--5pm. Fax is 571-270-6489.
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/SUN M LI/Primary Examiner, Art Unit 3685
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