DETAILED ACTION
Applicant’s response, filed 30 May 2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Claim Status
Claims 1, 2, 4, 9, 10, 13-19, 38, and 39 are pending and examined herein.
Claims 1, 2, 4, 9, 10, 13-19, 38, and 39 are rejected.
Priority
Claims 1, 2, 4, 9, 10, 13-19, 38, and 39 are granted the claim to the benefit of priority to foreign application JP2018-051268 filed 19 March 2018. Thus, the effective filling date of claims 1, 2, 4, 9, 10, 13-19, 38, and 39 is 19 March 2018.
Claim Interpretation
The claim interpretation of claims 1, 19, and 38 reciting contingent limitations in Office action mailed 30 January 2025 is withdrawn in view of the amendment of “determining the assessment target mutation as a re-scoring target based on determining that the first score is less than the association threshold” received 30 May 2025.
Claim Rejections - 35 USC § 112
The rejection on the ground of 112/b of claims 1, 2, 4, 9, 10, 13-19, 38, and 39 in Office action mailed 30 January 2025 is withdrawn in view of the amendment of “a neurodegenerative disease" and “a cardiac disease” received 30 May 2025.
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, 2, 4, 9, 10, 13-19, 38, and 39 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.
(Step 1)
Claims 1, 2, 4, 9, 10, 13-18 and 38, and 39 fall under the statutory category of a machine and claim 19 falls under the statutory category of a process.
(Step 2A Prong 1)
Under the BRI, the instant claims recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mental process”, such as procedures for evaluating, analyzing or organizing information, and forming judgement or an opinion. Along with abstract ideas of the type that is in the grouping of a “mathematical concept”, such as mathematical relationships and mathematical equations. The instant claims further fall under the grouping of a law of nature (genotype-phenotype correlations between mutations and traits).
Independent claims 1, 19, and 38 recite a mental process of assign a first score showing an association with a trait in the database information to the assessment target mutation based on the database information, compare the first score of the assessment target mutation with an association threshold, determine the assessment target mutation as a re-scoring target based on determining that the first score is less than the association threshold, re-assign a second score weighted to the first score based on a density curve or according to a distance on a chromosome to the re-scoring target assessment target mutation based on the region mutation information, wherein the density curve is obtained by interpolation using a kernel function, set the second score as an assessment score of the re-scoring target assessment target mutation, and a graph of a numerical matrix showing the relationship between a plurality of assessment target mutations and an assessment score for each trait, wherein the assessment score for a neurodegenerative disease and the assessment score for a cardiac disease are clustered.
Independent claims 1, 19, and 38 recite mathematical concepts of re-assign a second score weighted to the first score based on a density curve or according to a distance on a chromosome to the re-scoring target assessment target mutation based on the region mutation information, wherein the density curve is obtained by interpolation using a kernel function.
Claims 1, 19, and 38 recite a law of nature of assigning a first score showing an association with a trait to the assessment target mutation, a graph of a numerical matrix showing the relationship between a plurality of assessment target mutations and an assessment score for each trait wherein the assessment score for a neurodegenerative disease and the assessment score for a cardiac disease are clustered, this is a genotype-phenotype correlation which is a naturally occurring correlation.
Dependent claim 2 further recites a mental process of setting the first scoring as an assessment score of the assessment target mutation when the first score of the assessment target mutation satisfies the threshold. Dependent claim 9 further recites a mental process and mathematical concept of determining a score of the assessment target mutation for each of the plurality of databases based on the database information, integrate the scores of the respective databases by using an optimized machine learning model and set the integrated score as the first score of the assessment target mutation. Dependent claim 10 further recites a mental process and mathematical concept of determining the integrated score by a weighted linear sum using the scores of the respective databases. Dependent claim 13 further recites a mental process of compare the assessment score with the association threshold and determine an assessment target mutation whose assessment score satisfies the association threshold as a mutation associated with the trait in the database information. Claims 14-18 further recite a mental process of considering the content of the data. Dependent claim 39 further recites a mental process by further limiting the length of the contiguous sequence to be at least 100,00 bases long.
The claims require a process of analyzing mutation information of a gene mutation, assigning a first score showing an association with a trait to the assessment target mutation, comparing a first score to a threshold, determining the score is less than a threshold, analyzing region mutation information, re-assign a second score weighted to the first score based on a density curve or according to a distance on a chromosome to the re-scoring target assessment target mutation based on the region mutation information, set the second score as an assessment score of the re-scoring target assessment target mutation. The BRI of the claim is a series of comparisons and evaluations performed using data. The human mind is capable analyzing data, assigning scores showing associations, comparing scores against a threshold, determining if a score is below a threshold, re-assigning a score which is weighted to the first score based on a density curve function or according to a distance on a chromosome, and setting a second score an assessment score of the re-scoring target assessment target mutation. Further, the claims require mathematical concepts and calculations because assigning a score based on a density curve or distance are verbal equivalents describing the mathematical calculation to be performed.
Therefore, claims 1, 2, 4, 9, 10, 13-18 and 38, and 39 recite an abstract idea and law of nature.
(Step 2A Prong 2)
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). Integration into a practical application is evaluated by identifying whether there are any additional elements recited in the claim and evaluating those additional elements to determine whether they integrate the exception into a practical application.
The additional element in claim 1 of a generic computer that is capable of communicating with a database in which information is stored and generic computer that performs a judicial exception does not integrate the judicial exception into a practical application because this limitation is simply applying the judicial exception to a generic computer without an improvement to computer technology.
The additional element in claims 1, 4, 19 and 38 of receiving data (i.e. “acquiring mutation information…”, “acquiring, as region mutation information, a gene mutation…”, and “acquire mutation information on a plurality of gene mutations common to the sample group”) does not integrate the judicial exception into a practical application because it is insignificant extra solution activity of mere data gathering. It is noted that the content of the data gathered does not change the performance of the computer receiving data and the content of the data falls under the abstract idea.
The additional element in claims 14 and 16 of a storage and storing information does not integrate the judicial exception into a practical application because this is simply applying the judicial exception to a generic computer without an improvement to computer technology.
The additional element in claims 1, 15, 17, 18, 19, and 38 of outputting information does not integrate the judicial exception into a practical application because this is insignificant extra solution activity.
The additional element in claim 19 of a computer that is capable of communicating with a database in which information is stored and the use of a generic computer for performing the judicial exception does not integrate the exception into a practical application because this is simply applying the judicial exception to a generic computer without an improvement to computer technology.
The additional element in claim 38 of a non-transitory computer readable storage medium with the program to cause a computer to perform the judicial exception and a generic computer that is capable of communicating with a database in which information is stored do not integrate the judicial exception into a practical application because this is simply applying the judicial exception to a generic computer readable medium.
Thus, the additional elements do not integrate the judicial exceptions into a practical application and claims 1, 2, 4, 9, 10, 13-18 and 38, and 39 are directed to the abstract idea and law of nature.
(Step 2B)
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 additional element in claim 1, 19, and 38 of using a generic computer to perform a judicial exception is conventional (see MPEP 2106.05(b) and MPEP 2106.05(d)(II)).
The additional element in claims 1, 4, 19, and 38 of receiving data is conventional (see MPEP 2106.05(b) and MPEP 2106.05(d)(II)).
The additional element in claim 1, 15, 17, 18, 19, and 38 of outputting data is conventional (see MPEP 2106.05(b) and MPEP 2106.05(d)(II)).
The additional element in claims 14 and 16 of storing data is conventional (see MPEP 2106.05(b) and MPEP 2106.05(d)(II)).
The additional element in claim 38 of a non-transitory computer readable medium that stores instructions that when executed causes a generic computer to perform judicial exceptions is conventional (see MPEP 2106.05(b) and MPEP 2106.05(d)(II)).
The combination of additional elements of using a generic computer, receiving data, outputting data, and storing data is conventional (see MPEP 2106.05(b) and MPEP 2106.05(d)(II)).
The combination of additional elements of using a generic computer and non-transitory computer readable medium is conventional (see MPEP 2106.05(b) and MPEP 2106.05(d)(II)).
Thus, the additional elements alone or in combination do not amount to significantly more than the judicial exception.
Response to Arguments
Applicant's arguments filed 30 May 2025 have been fully considered but they are not persuasive.
Applicant argues the claims do not recite the alleged law of nature (genotype-phenotype correlations between mutations and traits even if involving the alleged law of nature. See also USPTO Subject Matter Eligibility Guidance Example claim 39. For example, claim 1 in this application recites: "....acquire mutation information of a gene mutation common to a sample group....", and the claim of the USPTO's example 39 recites: "...collecting a set of digital facial images from a database...". Yet, those features in example 39 were, according to the USPTO's guidance about that example 39, not directed to either an abstract idea or life sciences, but instead patent eligible under 35 USC 101. Applicant further argues “although faces and mutations both occur naturally, face images and mutation information do not occur naturally. As such, like the USPTO's example 39, the pending claims, even if related to what naturally occurs, do not attempt to, and do not, claim anything that naturally occurs. And finding otherwise would be in contradiction to the USPTO's example 39 since if its "face images" features are not directed to life sciences, even if faces naturally occur, then the "mutation information" and any other features of the pending claims, even if mutations naturally occur, are also not directed to life sciences/law of nature since images and information in those claim contexts do not naturally occur (Reply p. 11-12).
This argument has been fully considered but found to be not persuasive. Example 39 has a different fact pattern of training process for a neural network which includes augmenting digital images. Unlike the instant claims, Example 39 does not claim a naturally occurring correlation. The MPEP states at 2106.04(b)(I) “the courts have identified the following concepts and products as examples of laws of nature or natural phenomena… a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017)… the natural relationship between a patient’s CYP2D6 metabolizer genotype and the risk that the patient will suffer QTc prolongation after administration of a medication called iloperidone, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117, 1135-36, 126 USPQ2d 1266, 1281 (Fed. Cir. 2018)”. This MPEP section shows that a naturally occurring correlation falls under a law of nature. The instant claims are directed to a relationship (correlation) between target mutations and traits which are naturally occurring correlations. Further the step of “....acquire mutation information of a gene mutation common to a sample group....” is interpreted as follows: the step of receiving the information is an additional element (which is addressed under step 2A prong 2 and Step 2B) and the contents of the information is part of the abstract idea (which is addressed under step 2A prong 1). Example 39 recites a receiving step that would be part of the additional element (but is not characterized in this manner due to the lack of judicial exceptions). Digital facial images do not have a mental analog (i.e. they do not exist outside the context of a computer). Further, Example 39 requires the data to be digital images and the human mind is not capable of manipulating digital images. However, “Mutation information of a gene mutation common to a sample group” is data that is not tied to the context of a device and may be held in the human mind for analysis.
Applicant argues “Claim features are alleged to be directed to mathematical concepts. See page 5 of the Office Action for example. But, even if mathematical concepts might be involved, the mathematical concepts themselves are not actually recited in the claims. Therefore, requested that the rejection be withdrawn at Step 2A Prong 1 for this additional reason” (Reply p. 13-14)
This argument has been fully considered but found to be not persuasive. The MPEP states at 2106.04(a)(2)(I)(C) “There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation”. The step of re-assign a second score weighted to the first score based on a density curve or according to a distance on a chromosome to the re-scoring target assessment target mutation based on the region mutation information, wherein the density curve is obtained by interpolation using a kernel function is a mathematical calculation due to the weighting of the second score to the first score which is a calculation.
Applicant argues the instant disclosure clearly requires computer technology for the alleged "mental process" features, and there is no art or factual evidence that one of ordinary skill in the art would have actually thought that any of the claim features refer to something performed in the human mind, which the claims do not. And so, the "mental processes" part of the rejection is traversed as exceeding a broadest reasonable interpretation as inconsistent with the specification and inconsistent with ordinary and customary meanings or what one of ordinary skill in the art would have understood the claims to mean. And regardless, that the claims regard "10,000 bases long" features, the claim features therefore cannot be practically performed in the human mind. See SRI Int'l, Inc. v. Cisco 12 Systems, Inc., 930 F.3d 1295, 1304 (Fed. Cir. 2019) (declining to identify the claimed collection and analysis of network data as abstract because "the human mind is not equipped to detect suspicious activity by using network monitors and analyzing network packets as recited by the claims"), and the human mind similarly is not equipped to practically perform those claim features in this application (Reply p. 12-13).
This argument has been fully considered but found to be not persuasive. The MPEP states at 2106.04(a)(2)(III)(C) that “claims can recite a mental process even if they are claim as being performed on a computer” and that a consideration for determining that claims recite a mental process when performed on a computer is if a computer is being used as a tool to perform a mental process. In the instant case, the BRI of assigning/re-assigning scores, comparing scores to thresholds, determining a score is below a threshold, setting a score, and a graph generation are all steps that encompass analyzing/evaluating data, making observations/judgments about data, and organizing data which are all activities the human mind is capable of performing. The generic computer interacts with these abstract ideas as a tool to perform them. Further, the recitation of 10,000 bases long limits that length of the contiguous sequence in which another gene mutation is located which is acquired and does not limit the judicial exceptions (i.e. only limits the content of the data that is acquired). It is noted that acquiring data is an additional element of receiving data and the content of the data does not change the step of a computer receiving data.
Applicant argues instant disclosure describes technical problems and solutions such as "even when it cannot be apparently determined that a gene mutation at a single position is associated with a trait, by referring to information on an associated region of the gene mutations, it is possible to pick a gene mutation having a possibility of showing an associating with the trait. Therefore, the association between the gene mutation and the trait can be assessed more efficiently" as noted at originally-filed paragraph [0011] such that it is possible to correctly determine an association between the assessment target mutation and the traits. This improvement is considered to correspond to "Evaluating Improvements in the Functioning of a Computer, or an Improvement to Any Other Technology or Technical Field in Step 2A Prong Two" described in MPEP2106.04(d)(1) (Reply p. 14).
This argument has been fully considered but found to be not persuasive. The MPEP states at 2106.05(a)(II) “an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology”. Applicant points to associations between gene mutations and traits can be assessed more efficiently as providing the technical improvement. This is an improved abstract idea of analyzing mutation data which is not an improvement to technology. Thus, the claim does not provide an improvement to a technology. Further, the system requires a processor and capability to receive information from storage which a generic computer is capable of doing. Thus, the hardware is interpreted as a generic computer which performs judicial exceptions. Further, MPEP 2106.05(a) states “It is important to note that the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. In addition, the improvement can be provided by one or more additional elements in combination with the recited judicial exception” and the argument provided does not point to an improvement which is realized in the additional elements of the claims.
Claim Rejections - 35 USC § 102
The rejection on the ground of 102 of claim 19 in Office action mailed 30 January 2025 is withdrawn in view of the amendment of “determining the assessment target mutation as a re-scoring target based on determining that the first score is less than the association threshold received 30 May 2025.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/J.E.H./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685