DETAILED ACTION
Applicant’s response, filed 04/02/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. 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 .
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 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.
Claim Status
Claims 1-27, 29, 32-29, 73, 75-81, and 92-96 are pending.
Claims 92-93 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, as set forth in the Non-Final Office Action dated 10/28/2024.
Claims 3-4, 8, 38, 30-31, 40-72, 74, and 79-91 are canceled.
Claims 1-2, 5-7, 9-27, 29, 32-39, 73, 75-78, 94-96 are rejected.
Priority
Applicant's claim for the benefit of a prior-filed application, PCT/EP2019/077252, filed October 8, 2019, is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to App. No. EPO18199156.3, filed October 8, 2018. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Accordingly, each of claims 1-39, 73, and 75-81 are afforded the effective filing date of October 8, 2018.
Drawings
The Drawings submitted April 8, 2021 are accepted.
Claim Rejections- 35 USC § 112
The outstanding rejections to the claims are withdrawn in view of the amendments submitted herein as claim 7 has been amended to depend from claim 1.
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, 5-7, 9-27, 29, 32-39, 73, 75-78, and 94-96 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more. The arguments are therefore unpersuasive, so the rejections are maintained.
Response to Applicant Arguments
1. Applicant submits the claims are directed to a specific age-indicator workflow applied to DNA methylation data, not to age determination or mathematical manipulation untethered from those limitations [p. 14, par. 1].
It is respectfully found not persuasive. The claims are directed to inputting DNA methylation data of individuals data gathering) and using LASSO (mathematical concept) and output a subset and coefficient from the LASSO as the age indicator. Therefore the workflow comprises data gathering and mathematical concepts which are abstract ideas.
2. Applicant submits the claims cannot be practically performed as claimed merely by thinking about age or writing an age estimate on paper [p. 14, par. 2].
It is found not persuasive. As stated in the previous 101 rejection many steps can be performed on pen and paper for example determining the quality of the age indicator, determining the age of the individuals, and determining at least one statistical parameter, judging if the statistical parameter(s) indicate(s) an acceptable quality, determining the domain boundaries. The age indicator and determination of age are from a combination of data gathering, mathematical concepts and mental processes together.
3. Applicant submits treating those limitations as mere data gathering omits the ordered combination that the claims actually require [p. 15, par. 2].
It is respectfully found not persuasive. In step 2A prong 2, a claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d).III). The additional elements found in the claims are mere data gathering elements which do not integrate into a practical application.
4. Applicant submits the rejection therefore cannot disregard the ordered LASSO-then-stepwise-regression workflow when assessing whether the claims provide significantly more [p. 15, par. 3].
It is respectfully found not persuasive. The steps of data gathering are extra-solution activity and therefore do not amount to significantly more than the judicial exception. The steps directed to data from a first larger group of 98 individuals was analyzed with the intention of establishing a model having a clearly reduced number of CpGs to be considered while maintaining a high statistical significance of all parameters. To this end, first a LASSO regression was executed; note that LASSO regression is a technique well known in the art and that soft- ware packages to implement Lasso regression are readily available [p. 100, par. 6].
5. Applicant submits claim 73 is also rejected as allegedly non-statutory because "data carrier" allegedly reads on carrier waves or transitory propagating signals [p. 16, par. 3].
It is found persuasive that the claim is now falls within at least one of the four categories of patent eligible subject matter. However, the additional element of a non-transitory computer readable media does not integrate claim 1 into a practical application.
Claim Rejections - 35 USC § 102
The outstanding rejections to the claims are withdrawn in view of the arguments submitted. The prior art of record does not disclose an ordered workflow in which the training data set is evaluated with a regression method comprising LASSO, thereby determining a reduced training data set, and stepwise regression is then applied to that reduced training data set, where the reduced training data set comprise at least some data of the training data set and exclude DNA methylation levels of genomic DNA sequences eliminated by LASSO.
Claim Rejections - 35 USC § 103
The outstanding rejections to the claims are withdrawn in view of the arguments submitted. The prior art of record does not disclose an ordered workflow in which the training data set is evaluated with a regression method comprising LASSO, thereby determining a reduced training data set, and stepwise regression is then applied to that reduced training data set, where the reduced training data set comprise at least some data of the training data set and exclude DNA methylation levels of genomic DNA sequences eliminated by LASSO.
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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/D.M.B./Examiner, Art Unit 1685 /Soren Harward/Primary Examiner, TC 1600
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