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 12/4/2023. Claims 1-15 have been examined and are currently pending.
Priority
Acknowledgment is made by the applicant’s claim for a provisional application filed on 6/9/2021. The Applicant further claims benefit of continuation of PCT/JP2022/023287, filed on 6/9/2022.
Response to Amendment
The amendment 12/4/2023 cancelled no claim. No claim was previously cancelled. No new claims are added. Claims 4-5, 9-15 have been amended. Claims 1-15 are considered and pending.
Specification
Modifications made to page 1 to the original specification are acknowledged.
Modifications made to the title to the original specification are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/5/2023, 5/20/2025, 6/29/2026, follows the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 1-15 are 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 1, 6, 11 recite “calculating …a scale of dependence of a multifactorial of disease….”, it is unclear what it refers to, how it is defined, how determined/measured, and thus unclear how it is calculated.
Claim 1, 6, 11 recite “calculating …a scale of dependence of a multifactorial of disease…. on causative genes, it is unclear what it refers to, how it is defined, what are considered as causative or related genes, and thus unclear how to calculate a scale of dependence.
The claim and the specification do not define or describe how “a scale of dependence”, “causative genes”, is determined/measured/calculated. As there is no metes and bounds how to determine/measured, and thus unclear how to calculate a scale of dependence, and render the claim to be indefinite.
Dependent claims 2-5, 7-10, and 12-15 are dependent of claims 1, 6, and 11 respectively. Therefore, they are rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph for the same reason as indicated above.
Correction and clarification are required.
Claim 2, 7, 12 recites “distribute….data of the first gene….”, “distribute….data of the second gene….”, it is unclear what first gene, second gene refer to, how it is defined, arranged/determined, and thus unclear how to distribute on the feature space.
The claim and the specification do not define or describe how first gene, second gene is determined. As there is no metes and bounds how to determine/measured, and thus unclear how to distribute, and render the claim to be indefinite.
Claim 3, 8, 13 depending on claim 2, 7, 12, recites “distribute….data of the third gene….”, in light of the 112 2nd rejection on claim 2, 7, 12, it is unclear what the third gene refers to, how it is defined, arranged/determined, and thus unclear how to distribute on the feature space.
The claim and the specification do not define or describe how first gene, second gene is determined. As there are no metes and bounds how to be measured, and thus unclear how to distribute, and render the claim to be indefinite.
Claim 5,10, 15 recites “perform linear regression analysis and excludes a specific combination including….”, it is unclear what kind of data, how much data are used to perform the linear regression analysis.
The claim and the specification do not define or describe the specifics of data used to perform the linear regression to result in selection of gene, and thus unclear how to perform and calculate, and render the claim to be indefinite.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-15 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 1-15) 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 6 (Step 2A, Prong I): is directed to multiple abstract ideas including “Certain Methods of Organizing Human Activity”, and “Mental process”.
Independent Claim 6,
calculating, for combinations of genes included in a gene data set, a scale of dependence of a multifactorial disease or a sporadic disease on causative genes, and the multifactorial disease or the sporadic disease on related genes; and
selecting a combination including a predetermined number of genes from among the data set based on the scale.
fall within “Certain Methods of Organizing Human Activity” grouping of abstract idea because the instant claims recite “calculating a scale of dependence of a multifactorial disease…, selecting a predetermined number of genes…“ which are human activities and/or interactions 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 6, 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 observe/calculate data, can observe/select data.
Independent claim 6, 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. The additional element (a computer) is not significant more than the abstract ideas described above. Other than reciting “using a computer” nothing in the claim element precludes the step from practically being performed in the mind or by paper and pens. There is no specificity regarding any technology, just broadly, executing the programming instructions, couple of databases to store data, to receive/obtain/calculate/select data over internet.
Further, the components (i.e. a computer) described in independent claims 8 add nothing of substance to the underlying abstract idea. It relates to the computer system claims, the limitations appear to be performed by a generic computing system/device. These components are 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 conventional activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/obtain/generate/compare/identify 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 6).
Dependent claims 7-10 merely add further details of the abstract steps/elements recited in claim 6 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 7-10 are also non-statutory subject matter.
Independent claim 1, 11: Alice Corp. also establishes that the same analysis should be used for all categories of claims. Therefore, independent system/apparatus claim 1, and product claim 11, is also rejected as ineligible subject matter under 35 U.S.C. 101 for substantially the same reasons as the method claim(s) 6.
Further, the components (i.e., a processor, a device, a computer-readable storage medium) described in independent claim 1, 11, add nothing of substance to the underlying abstract idea. Similarly, as it relates to the computer system claims, the limitations appear to be performed by a generic computing system/device. These components are 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 sensing/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 encoder/decoder/computer components to receive/access/select/calculate /transmit/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 6).
According to MPEP 2106.05 (d), elements that the Courts have recognized as well-understood, routine, conventional activity in particular fields are e.g., "Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward
information); Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93” (evidence required by Berkeimer memo). Further, according to Berkheimer memo 04/19/2018, section III.A.1, “A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a)”.
Applicant’s Specification indicates a general-purpose computer performs the instant steps and demonstrates the well-understood, routine, conventional nature of the information processing device (a processor/a memory/a computer) in any computing implementation. Thus, evidence has been provided to show these additional elements are well-understood, routine, conventional activity according to Berkheimer memo. Therefore, for the above-mentioned reasons, viewed as a whole, even in combination, the above steps do not amount to significantly more/do not provide an inventive concept.
Dependent claim 2-5, 12-15, merely add further details of the abstract steps/elements recited in claim 1, and 11 respectively, 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 claim 15 is also non-statutory subject matter.
Viewed as a whole, the claims (1-15) do not provide meaningful limitations 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 does not provide 'significantly more' than the abstract idea and is non-statutory subject matter.
Prior Art Rejection
Considering the numerous 112 2nd rejections above, no meaningful search can be conducted.
Further search will be performed upon resolving the above 112 2nd issues.
The prior art made of record and relied upon is considered pertinent to applicant’s disclosure. (please see PTO-892).
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Neumann (US 2021/0104330),
Berlin et al. (US 2005/0021240) .
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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