DETAILED ACTION
Applicant’s response, filed 02/23/2026, 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 Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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.
Restriction election
Applicant’s election without traverse of Group I (claims 94-96) in the reply filed on 10/24/25 is acknowledged.
Claims 97-98 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claim Status
Claims 94-98 are pending.
Claims 97-98 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1-93 are canceled.
Claims 94-96 are under examination.
Claims 94-96 are rejected.
Priority
The instant Application claims domestic benefit to US provisional application 17/286775, filed 04/08/2021 and claim for the benefit of a prior-filed application, PCT/EP2019/077252, filed 10/08/2019, is acknowledged.
Accordingly, each of claims 94-96 are afforded the effective filing date of 10/08/2019.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 06/12/2025 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS document is included with this Office Action.
Drawings
The Drawings submitted 06/12/2025 are accepted.
Specification
The objection to the disclosure is maintained is objected to for the following informalities. It is noted that for purposes of the instant Office Action, any reference to the specification pertains to the clean copy of the substitute specification as originally filed on 06/12/2025.
Hyperlinks
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Non-limiting examples include [p. 73, par. 3]. Applicant will note that this is exemplary and other instances may exist. It is requested that all instances be corrected.
Appropriate correction for all objections to the specification is required.
Claim Interpretation
Claims 94-96 recite “A computer-implemented method”, however no specific computer or details on how each of the steps are to be implemented on a computer and can be interpreted that each do not necessarily require a computer.
Claim Rejections- 35 USC § 112
The outstanding rejections to the claims are withdrawn in view of the amendments submitted herein.
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 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. Any newly recited portions are necessitated by claim amendment.
For the following rejections, underlined text indicates newly recited portions necessitated by claim amendment.
MPEP 2106 organizes judicial exception analysis into Steps 1, 2A (Prongs One and Two) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1
With respect to Step 1: yes, the claims are directed to methods, i.e., a process, machine, or manufacture within the above 101 categories [Step 1: YES; See MPEP § 2106.03].
Step 2A, Prong One
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) are as follows:
Independent claim 94:
determining the age of an individual
determining the age of the individual based on its DNA methylation levels and the age indicator using the at least one coefficient per methylation probe ID.
Independent claim 96:
diagnosing the health state of an individual, said age indicator comprising (I) an ensemble of methylation probe IDs comprising at least 70 methylation probe IDs selected from the group consisting of:cg11330075, cg00831672, cg27320127, cg27173374, cg14681176, cg06161948, cg08224787, cg05396610, cg15609017, cg09805798, cg19215678, cg12333719, cg03741619, cg16677512, cg03230469, cg19851481, cg10543136, cg07291317, cg26430984, cg16950671, cg16867657, cg22077936, cg08044253, cg12548216, cg05211227, cg13759931, cg08686931, cg07955995, cg07529089, cg01520297, cg00087368, cg05087008, cg24724428, cg19112204, cg04525002, cg08856941, cg16465695, cg08097417, cg21628619, cg09460489, cg13460409, cg25642673, cg19702785, cg18506897, cg21165089, cg27540719, cg21807065, cg18815943, cg23677767, cg07802350, cg11176990, cg10321869, cg17343879, cg08662753, cg14911690, cg12804730, cg16322747, cg14231565, cg10501210, cg09275691, cg15008041, cg05812299, cg24319133, cg12658720, cg20576243, cg03473532, cg07381960, cg05106770, cg04320377, cg19432688, cg22519947, cg06831571, cg08194377, cg01636910, cg14305139, cg04028695, cg15743533, cg03680898, cg20088545, cg13333913, cg19301963, cg13973351, cg16781885, cg04287203,cg27394136, cg10240079, cg02536625, and cg23128025; and(II) at least one coefficient per methylation probe ID contained in the ensemble; and wherein said age indicator comprises less than 300 methylation probe IDs, wherein the health state relates to the state of at least one ageing- related disease such as Alzheimer's disease, Parkinson's disease, atherosclerosis, cardio- vascular disease, cancer, arthritis, cataracts, osteoporosis, type 2 diabetes, hypertension, Age-Related Macular Degeneration and/or Benign Prostatic Hyperplasia, at least one phenotype associated with said ageing-related disease(s), and/or cancer;
determining the age of the individual based on its DNA methylation levels and the age indicator using the at least one coefficient per methylation probe ID.
Dependent claims 95 recite further steps that limit the judicial exceptions in independent claim 94 and, as such, also are directed to those abstract ideas. For example, claim 95 further limits the determined age of claim 94.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation because the method only requires a user to determine and diagnosis. Without further detail as to the methodology involved in “determining the age” and “diagnosing the health state of an individual”, under the BRI, one may simply, for example, use pen and paper to manually determine the age or diagnosis the health state.
Therefore, claims 94 and 96 and those claims dependent therefrom recite an abstract idea [Step 2A, Prong 1: YES; See MPEP § 2106.04].
Step 2A, Prong Two
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two, provides that the claims must be examined further to determine whether they integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). 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).
Additional elements, Step 2A, Prong Two
With respect to the instant recitations, the claims recite the following additional elements:
Independent claim 94:
providing an age indicator comprising (I) an ensemble of methylation probe IDs comprising at least 70 methylation probe IDs selected from the group consisting of:cg11330075, cg00831672, cg27320127, cg27173374, cg14681176, cg06161948, cg08224787, cg05396610, cg15609017, cg09805798, cg19215678, cg12333719, cg03741619, cg16677512, cg03230469, cg19851481, cg10543136, cg07291317, cg26430984, cg16950671, cg16867657, cg22077936, cg08044253, cg12548216, cg05211227, cg13759931, cg08686931, cg07955995, cg07529089, cg01520297, cg00087368, cg05087008, cg24724428, cg19112204, cg04525002, cg08856941, cg16465695, cg08097417, cg21628619, cg09460489, cg13460409, cg25642673, cg19702785, cg18506897, cg21165089, cg27540719, cg21807065, cg18815943, cg23677767, cg07802350, cg11176990, cg10321869, cg17343879, cg08662753, cg14911690, cg12804730, cg16322747, cg14231565, cg10501210, cg09275691, cg15008041, cg05812299, cg24319133, cg12658720, cg20576243, cg03473532, cg07381960, cg05106770, cg04320377, cg19432688, cg22519947, cg06831571, cg08194377, cg01636910, cg14305139, cg04028695, cg15743533, cg03680898, cg20088545, cg13333913, cg19301963, cg13973351, cg16781885, cg04287203, cg27394136,cg10240079, cg02536625, and cg23128025; and (II) at least one coefficient per methylation probe ID contained in the ensemble, wherein said age indicator comprises less than 300 methylation probe IDs
providing the DNA methylation levels of the individual for whom the age is to be determined of the methylation probe IDs comprised in the age indicator to the age indicator,
Considerations under Step 2A, Prong Two
With respect to Step 2A, Prong Two, the additional elements of the claims do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to data gathering, such as “providing”, perform functions of collecting the data needed to carry out the judicial exceptions. Data gathering and outputting do not impose any meaningful limitation on the judicial exceptions, or on how the judicial exceptions are performed. Data gathering and outputting steps are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
Thus, none of the claims recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to one or more judicial exceptions [Step 2A, Prong 2: NO; See MPEP § 2106.04(d)].
Step 2B (MPEP 2106.05.A i-vi)
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the courts have found that receiving data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(II)(i)).
As such, the claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself [Step 2B: NO; See MPEP § 2106.05].
Therefore, the instant claims are not drawn to eligible subject matter as they are directed to one or more judicial exceptions without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
Response to Applicant Arguments
Applicant submits it was not well-understood, routine, or conventional to perform subject matter recited by claim 1, such as using methylation levels of the specifically recited CpG loci to determine age [p. 7, par. 6].
It is respectfully found not persuasive. The specification as published discloses determination of DNA methylation levels with Illumina™ DNA methylation array is well known, established and can be used in the present invention, although other methods will be described and might be preferred for reasons indicated [0069]. Thus, alternatively or in addition, methylation levels of CpGs can be quantified using other methods known in the art as well [0069]. Nonetheless, unless indicated otherwise, the CGs/CpGs identified in the present invention correspond to the Illumina ™ methylation probe IDs [0069]. The specification also discloses it should be noted that when defining a set of genomic DNA sequences having levels of methylation associable with an age of the individuum, the set being different from the entirety of genomic DNA sequences of a human being having levels of methylation associable with an age of the individuum, some or all of the CpG loci assumed to be known in the art to have levels of methylation associable with an age of the individuum known in the art, for example those listed in the WO 2012/162139 Al, could be included [0275]. The use of an age indicator is well known in the art as disclosed by the specification as published, data from a first larger group of 98 individuals was analysed 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. Also, the use of at least one coefficient per sequence is known in the art as disclosed by the specification as published [0010].
Claim Rejections - 35 USC § 102
The outstanding 102 rejection is withdrawn in view of Applicant’s persuasive argument that Wang does not teach selection of at least 70 out of these 88 methylation probes (p. 9, par. 2].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
For the following rejections, instantly claimed elements which are considered to be equivalent to the prior art teachings are described in bold for all claims, and underlined text indicates newly recited portions necessitated by claim amendment.
A. Claims 94-96 are rejected under 35 U.S.C. 103 as being unpatentable over Vilain et al. (WO 2012/162139 A1, published 11/29/2011, cited on IDS dated 04/20/2021).
Claim 94 is directed to is directed to a computer-implemented method for determining the age of an individual comprising the steps of (a) providing an age indicator comprising (1) an ensemble of methylation probe IDs comprising at least 70 methylation probe IDs selected from the group consisting of: cg11330075, cg00831672, cg27320127, cg27173374, cg14681176, cg06161948, cg08224787, cg05396610, cg 15609017, cg09805798, cg19215678, cg12333719, cg03741619, cg16677512, cg03230469, cg19851481, cg10543136, cg07291317, cg26430984, cg16950671, cg16867657, cg22077936, cg08044253, cg12548216, cg05211227, cg13759931, cg08686931, cg07955995, cg07529089, cg01520297, cg00087368, cg05087008, cg24724428, cg19112204, cg04525002, cg08856941, cg16465695, cg08097417, cg21628619, cg09460489, cg13460409, cg25642673, cg19702785, cg18506897, cg21165089, cg27540719, cg21807065, cg18815943, cg23677767, cg07802350, cg11176990, cg10321869, cg17343879, cg08662753, cg14911690, cg12804730, cg16322747, cg14231565, cg10501210, cg09275691, cg15008041, cg05812299, cg24319133, cg12658720, cg20576243, cg03473532, cg07381960, cg05106770, cg04320377, cg19432688, cg22519947, cg06831571, cg08194377, cg01636910, cg14305139, cg04028695, cg15743533, cg03680898, cg20088545, cg13333913, cg19301963, cg13973351, cg16781885, cg04287203, cg27394136, cg02536625, and cg23128025and cg10240079,
Vilain discloses method of obtaining information useful to predict an age of an individual by observing the methylation status of one or more specific loci in the genomic DNA [p. 3, par. 2]. Vilain further discloses observing cytosine methylation of one or more (and typically two, three, four or more) CG loci in the genomic DNA selected from the group consisting of 89 CG locus designation [p. 3, par. 2]. Vilain also discloses data obtained using Illumina HumanMethylation27 microarrays [p. 16, par. 3]. The specification discloses that the CpGs identified above are identified using Illumina™ methylation probe IDs [p. 39, par, 3], which contain the same CPGs as listed in claim 94.
(II) at least one coefficient per methylation probe IDs contained in the ensemble, wherein said age indicator comprises less than 300 methylation probe IDs,
Vilain discloses coefficient values in various models can also reflect the specific assay that is used to measure the methylation levels ( e.g. as the variance of the methylation levels of individual probes may affect the coefficient) [p. 21, par. 2]. Vilain further discloses for beta values measured on the Illumina methylation microarray platforms there can be one set of coefficients, while for other methylation measures ( e.g. using sequencing technology) there can be another set of coefficients [p. 21, par. 2]. Vilain also discloses certain embodiments of the invention, one can collect a reference data set ( e.g. of 100 individuals of varying ages) using specific technology platform(s) and tissue(s) and then design a specific multivariate linear model is fit to this reference data set to estimate the coefficients ( e.g. using least squares regression) [p. 21 par. 2]. Vilain further discloses observing cytosine methylation of one or more (and typically two, three, four or more) CG loci in the genomic DNA selected from the group consisting of 89 CG locus designation [p. 3, par. 2].
(b) providing the DNA methylation levels of the individual for whom the age is to be determined of the methylation probe IDs comprised in the age indicator to the age indicator, and (c) determining the age of the individual based on its DNA methylation levels and the age indicator using the at least one coefficient per methylation probe ID.
Vilain discloses specific age related methylation markers have been identified and validated using further assays and additional samples [p. 14, par. 2]. Vilain further discloses illustrative age prediction analyses models were also designed and tested, for example using a leave-one-out analysis, where one subject from the model is systematically removed and the model is used to predict the subject's age [p. 14, par. 2].
Villain differs from the instant claims as it uses a different selection of probe Id’s from the Illumina HumanMethylation27 microarrays which the specification discloses that the CpGs identified above are identified using Illumina™ methylation probe IDs [p. 39, par, 3], which contain the same CPGs as listed in claim 94. AS the probe Id’s in Vilain are not the same as the Probe Id’s in the instant claims it would be obvious that Probe Id’s that are used are determined by the desired outcome, data, and one would readily appreciate once you find multiple informative genes you would want to use as many as possible. Such a modification fails to patentably distinguish over Vilain.
Claim 95 is directed to the method for determining the age of an individual of claim 94, wherein the determined age is an indicator of the biological age of the individual which relates to the health state and/or fitness state of the individual.
Vilain discloses embodiments of the invention include methods of obtaining information useful to determine a level of risk of an age-related disease in an individual (e.g. Alzheimer's disease or Parkinson's disease) [p. 19, par. 3].
Claim 96 discloses the methods of claims 94 and 95 and therefore the same art and reasoning is applied as above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 94are rejected on the ground of provisional double patenting as being unpatentable over claims 1 and 33 of copending application number 17283775. Although the claims at issue are not identical, they are not patentably distinct from each other, as set forth in the following table:
Instant Application # 19/236435
Application No. 17/283775
Claim(s)
Limitation(s)
Claim(s)
Limitation(s)
94
A computer-implemented method for determining the age of an individual comprising the steps of (a) providing an age indicator comprising (I) an ensemble of genomic DNA sequences comprising at least 70 DNA sequences selected from the group consisting of: cgl 1330075, cg00831672, cg27320127, cg27173374, cg 14681176, cg06161948, cg08224787, cg05396610, cg 15609017, cg09805798, cg 19215678, cg12333719, cg03741619, cg 16677512, cg03230469, cg 19851481, cg 10543136, cg07291317, cg26430984, cg 16950671, cg16867657, cg22077936, cg08044253, cg 12548216, cg05211227, cg 13759931, cg08686931, cg07955995, cg07529089, cg01520297, cg00087368, cg05087008, cg24724428, cg 19112204, cg04525002, cg08856941, cg 16465695, cg08097417, cg21628619, cg09460489, cg 13460409, cg25642673, cg 19702785, cg 18506897, cg21165089, cg27540719, cg21807065, cg18815943, cg23677767, cg07802350, cg 11176990, cg 10321869, cg 17343879, cg08662753, cg 14911690, cg 12804730, cg16322747, cg14231565, cg 10501210, cg09275691, cg 15008041, cg05812299, cg24319133, cg 12658720, cg20576243, cg03473532, cg07381960, cg05106770, cg04320377, cg 19432688, cg22519947, cg06831571, cg08194377, cg01636910, cg 14305139, cg04028695, cg15743533, cg03680898, cg20088545, cg 13333913, cg 19301963, cg 13973351, cg 16781885, cg04287203, cg27394136, cg 10240079, cg02536625,andcg23128025;and (II) at least one coefficient per genomic DNA sequence contained in the ensemble, wherein said age indicator comp1ises less than 300 genomic DNA sequences, (b) providing the DNA methylation levels of the individual for whom the age is to be determined of the genomic DNA sequences comprised in the age indicator, and (c) determining the age of the individual based on its DNA methylation levels and the age indicator.
1
A method for determining an age indicator, the method comprising: (a) receiving a training data set of a plurality of individuals, the training data set comprising for each individual (i) the DNA methylation levels of a set of genomic DNA sequences for the individual, wherein the set of genomic DNA sequences comprises at least 850,000 genomic DNA sequences, and(ii) the chronological age of the individual, and(b) evaluating the training data set with a regression method comprising a Least Absolute Shrinkage and Selection Operator (LASSO), thereby determining the age indicator and a reduced training data set, wherein [[the]] independent variables of the LASSO are the DNA methylation levels of the genomic DNA sequences and wherein [[the]] a dependent variable is the chronological age, wherein the age indicator comprises (i) a subset of the set of genomic DNA sequences as an ensemble and (ii) at least one coefficient per genomic DNA sequence contained in the ensemble, and wherein the reduced training data set comprises at least some data of the training data set and does not include the DNA methylation levels of genomic DNA sequences which are eliminated by the LASSO.
94
(II) at least one coefficient per genomic DNA sequence contained in the ensemble, wherein said age indicator comprises less than 300 genomic DNA sequences,
33
The method of claim 1, wherein the age indicator comprises less than 300 or less than 150 or less than 110 or less than 100 or less than 90 genomic DNA sequences.
Claims 95-96 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 33 of copending Application No. 17283775 (reference application), in view of Vilain et al. (WO 2012/162139 A1, published 11/29/2011, cited on IDS dated 04/20/2021). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim method and devices for age determination.
Claim 95 discloses the method for determining the age of an individual of claim 94, wherein the determined age is an indicator of the biological age of the individual which relates to the health state and/or fitness state of the individual.
Application 17283775 is silent on to the health state and/or fitness state of the individual.
Vilain discloses embodiments of the invention include methods of obtaining information useful to determine a level of risk of an age-related disease in an individual (e.g. Alzheimer's disease or Parkinson's disease) [p. 19, par. 3].
Claim 96 discloses the methods of claims 94 and 95 and therefore the same art and reasoning is applied as above.
Regarding claims 95-96, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the reference application with Vilain as they both discloses methods for age determination. The motivation would have been to combine the results of the reference application with Vilain to accurately identify more thorough functions of aging, said practitioner would have readily predicted that the combination would successfully result in predicting the age of an individual with a high degree of accuracy as disclosed by Vilain (abstract).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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