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 .
This Office Action is in reply to Applicants’ correspondence of 07/18/2026
Applicants’ remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicants’ amendments. Any rejections or objections not reiterated herein have been withdrawn in light of the amendments to the claims or as discussed in this Office Action.
This Action is made FINAL.
Please Note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
In the reply filed on 06/05/2025 Applicants elected, with traverse, the invention of Group 1 (claims directed to predicting age). The requirement was deemed proper and was made FINAL as set forth on page 2 of the Office Action of 07/10/2025.
Additionally, as set forth on pages 2-3 of the Office Action of 07/10/2025, the election as set forth in the reply of 04/24/2025 was extended to the combination of CpG sites provided in Table 1.
Withdrawn Claim Objections
The claim objection set forth on page 3 of the Office Action of 04/30/2026 is withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 112 - Indefiniteness
The rejections of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth on pages 3-4 of the Office Action of 04/30/2026, are withdrawn in light of the cancellation of the previous claims.
New Claim Rejections - 35 USC § 112 – Indefiniteness
Necessitated by Newly Presented Claims
Claims 63-82 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.
Claims 63-82 are unclear over a purpose of the claimed methods as “for determining that therapeutic or nutritional intervention is needed”, as recited in the preamble of claim 63, from which claims 64-82 depend. There is no process step of “determining that a therapeutic or nutritional intervention is needed”. The relevant steps of the claims are performed in step (d) which concludes with “determining that the epigenetic age of the subject or population to be tested is greater than a known chronological age of the subject or population to be tested” and ”feeding or administering a health-promoting substance or therapeutic agent”. But neither of these steps is a step of “determining that therapeutic or nutritional intervention is needed”.
Claims 63-82 are unclear over the recitation of the limitations set forth at the end of claim 63, from which claims 64-82 depend, as:
wherein, in step (b), the impact of genetic polymorphisms is eliminated by excluding CpG sites associated with single nucleotide polymorphisms; and
wherein, in step (b), the impact of sex-specific methylation differences on sex chromosomes is eliminated by excluding all CpG sites located on sex chromosomes.
The limitations are unclear because step (b) requires the determination of methylation at a specific closed set of recited CpG sites identified by chromosome number and position. The required CpG sites are, as set forth in the specification, not associated with any SNPs, and so it is unclear how the step of eliminating the impact of genetic polymorphisms is performed. And the required CpG sites are not on any chicken sex chromosome (i.e.: chromosome Z or W), and so it is unclear how the step of eliminating impact of sex-specific methylation differences on sex chromosomes is performed.
Claims 63-73 and 76-82 are unclear over the requirement that the “the methylation levels are normalized in a tissue-specific manner” as recited in step (b) of claim 63 form which claims 64-73 and 76-82 depend. The limitation is unclear because the claims generically encompass ant biological sample material (e.g.: as recited in claim 63), or are directed to biological samples that are not themselves any “tissue”. So it is unclear how the methylation in the sample is intended to be normalized. For example, where the claims are directed to a “body fluid” (e.g.: claims 64 and 72) sample, such a sample is not any tissue (e.g.: lymph, cerebrospinal fluid, saliva, uric acid paste, ascitic fluid) and so it is unclear how to methylation in the sample is “normalized in a tissue-specific manner”. Similarly, where the claims are directed to excrement or feces (e.g.: claims 64, 66, 67, 73, 81 and 82), sample, such a sample is not any tissue and so it is unclear how to methylation in the sample is “normalized in a tissue-specific manner”.
Withdrawn Claim Rejections - 35 USC § 112 – Failure to Limit
The rejection of claims under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as set forth on page 5 of the Office Action of 04/30/2026 is withdrawn in light of the amendments to the claims.
Maintained Claim Rejections - 35 USC § 101
Newly Applied to Newly Presented Claims
Claims 63-82 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception to patentability encompassing abstract ideas and a natural phenomenon without significantly more.
The claim(s) recite(s) a steps of normalizing determined methylation levels, and using a statistical prediction method to apply a trained regression function to process normalized levels relative to reference levels. These calculations (normalization; comparisons using a statistical method) fall under the mathematical calculation grouping of abstract ideas (see MPEP 2106.04(a)(2)(I)(C)). Furthermore, the claims are directed to determining that therapeutic or nutritional intervention is needed, and recite determining that an epigenetic age is greater than a chronological age; these elements of the claims are the evaluation of data or information to reach a conclusion and are also an abstract idea (see MPEP 2106.04(a)(2)(III)). Additionally, where the claims are directed to a correlation between methylation status, epigenetic age, chronological age, and a need for a treatment, the claims are directed to the natural association between age and methylation, and health and methylation, and thus are directed to a natural phenomenon (see MPEP 2106.04(b) I).
This judicial exception is not integrated into a practical application sufficient to create a methods that is significantly more than the judicial exceptions identified above. Here it is noted that while the claims recite, in step (d) of claim 63, “feeding or administering a health-promoting substance or therapeutic agent to the Gallus gallus subject or population”, such a recitation is not a requirement for any particular substance or agent to be administered. The administration of some generic substance or agent is essentially a broad instruction of the equivalent of “apply it” appended to the judicial exceptions of the claims (see MPEP 2106.05(f)). As provided in MPEP 2106.04(d)(2)(a), a relevant consideration for evaluation whether an additional element integrates a judicial exception into a practical application is the particularity or generality of the treatment. Here the claim limitations are similar to the unacceptable "administering a suitable medication to a patient", which is not particular, and is instead merely instructions to "apply" the exception in a generic way, and thus, does not integrate the judicial exception step into a practical application. In this regard it is noted that while some of the claims (e.g.: claims 76, 78-80) specify with some particularity the “health promoting substance” of the claims, such limitations do not address the generically encompassed “therapeutic agent” of the claims. The concept of administering some generic health promoting substance or therapeutic agent to a subject that is broadly determined to be in need therapeutic intervention is so general as to merely be and instruction to apply the judicial exception where epigenetic status is related to health (see MPEP 2106.04(d)(2)).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the data gathering steps of the claims (i.e.: obtaining genomic DNA and determining a methylation level of CpG sites) is activity that was well understood, routine, and conventional in the related art. The specification teaches detection of CpG methylation is performed using commercially available reagents and known techniques (e.g.: pages 14-15). Additionally, the prior art of Zhang et al (2017) (cited on the IDS of 10/26/2022) teaches the analysis of CpG methylation in samples from Gushi hens, including comparisons at different ages, using whole-genome bisulfite sequencing.
Thus the claims are properly rejected as being directed to a judicial exception to patentability without significantly more.
Response to Remarks
Applicants have traversed the rejection of claims under 35 USC 101 as being directed to a judicial exception to patentability without significantly more. Applicants’ arguments (p.9-12of the Remarks of 07/18/2026) are directed to the previous rejection applied to the previous claims, but in so far as the remarks are germane to the rejection as maintained above and applied to the newly presented claims, they are addressed here.
Applicants have asserted (p.9 of the Remarks) that claims recite a concrete laboratory-and-intervention methods form determining a need for intervention and providing the intervention. This argument is not persuasive. As set forth in the rejection the determination for a need for intervention is itself a judicial exception that is an abstract idea (e.g.: the mental correlation of data and information). And the steps recited as providing intervention are provided at the highest level of generality so as to be a mere instruction to apply the judicial exceptions of the claims.
Where Applicants point to the claims of Vanda as exemplary of practical application of a judicial exception akin to the requirements of the instantly claimed methods, the Examiner maintains that there is distinction between the claims of Vanda and the instant methods. In particular, the methods of Vanda require the administration of a specific dosage range of a particular therapeutic (e.g.: internally administering iloperidone to the patient in an amount of 12 mg/day or less) in response to a particular genotype. The instant claims have no requirements for such a specificity of applied treatments.
Where Applicants point to the limitations of claims 76, and 78-80 as requiring particular health-promoting substances, these limitations have been addressed in the rejection where it is noted that the particularity of the “health promoting substance” of the claims does not address the generically encompassed “therapeutic agent” of the claims.
Withdrawn Claim Rejections - 35 USC § 112 – Scope of Enablement
The rejection of claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as set forth on pages 8-10 of the Office Action of 04/30/2026, is withdrawn in light of the amendments to the claims.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
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