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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28 April 2026 has been entered.
Status of the Claims
Claims 1-54 are pending and examined herein.
No claims are canceled.
Priority
As detailed on the date filing receipt, the application claims priority as early as 20 June 2019. At this point in examination, all claims have been interpreted as being accorded this priority date as the effective filing date.
Withdrawn Objections & Rejections
The objection regarding claim 4 is withdrawn in view of the amendment.
The rejection under 35 USC 103 is withdrawn in view of amendment and persuasive argument regarding creation of synthetic data using a generative neural network based on chronological ages of individuals and omic data to determine omic data at points in a subject’s life differing from the subject’s actual chronological age. Previously cited art, such as Aliper (US 2019/0034581 A1; previously cited on the 13 April 2023 IDS form) and Fabris (Biogerontology 18: 171-188, 2017; previously cited on the 03 February 2026 PTO-892 form) teach omic changes with aging using a generative neural network, do not teach the required elements of specific expectations in a subject’s omic value or comparison to their instant chronological age. These steps are not considered to be taught or fairly suggested by the prior art and thus are considered free of the prior art. The non-statutory double patenting rejections are withdrawn on similar grounds.
The following objections and/or rejections are maintained and/or newly applied, and constitute the complete set of objections and/or rejections for the instant claims.
Drawings
The drawings are objected to because Figures 6A and 6B have legends which are uninformative without color. While reference to color is partially removed from paragraphs [29-30]), this does not render the drawing informative. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
It is noted that a petition for color drawings has been filed 29 April 2026 but color drawings are not examined until the petition has been approved.
Specification
The specification discloses color images (pg. 5-6, paragraphs [29-30]) as “saturation color” in the legend. Because the drawings are not yet allowed to be in color, this paragraph must be amended. A petition may be filed to request color in the drawings. The petition was filed 29 April 2026 and is not approved yet.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 31-54 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 31, by extension of referencing claim 1, recites obtaining a real biological sample and measuring omic data based on the sample to obtain a signature in a non-transitory, computer readable medium coupled to a processor executing code. The specification does not disclose support for a computer program coupled to memory and a processor performing a step of obtaining a real sample from a subject and performing omic analysis on said sample. Therefore, claim 31 is considered to introduce new matter and both claim 31 and claims dependent on claim 31 are rejected.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11, 13, and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 was amended to recite obtaining a biological signature based on a sample from the subject, and so claim 11 does not further limit claim 1.
Claim 1 was amended to recite conditioning latent codes and is not further limited by claim 13.
Claim 1 was amended to recite simulations increasing and decreasing subject age and thus claim 15 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-54 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). The claims as a whole, considering all claim elements individually and in combination, are directed to a judicial exception at Step 2A, Prong 2, and the additional elements of the claims, considered individually and in combination, do not provide significantly more at Step 2B than the abstract idea of creating synthetic biological data.
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
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 (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The claims are directed to a method (claims 1-30) and a non-transitory computer-readable medium (claims 31-54), each of which falls within one of the categories of statutory subject matter. [Step 1: Yes]
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 (MPEP 2106.04(a-c))?
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Claims 1 and 31 recite creating input vectors based on the data signature. Creating a vector is interpreted as generating a string of numerical values. Generating a string of number is therefore a mathematical concept. Additionally, creating a string of numbers can be practically performed by the human mind.
Claims 1 and 31 recite generating a predicted biological data signature and the machine learning platform includes a model trained on data from whole blood. Generating a predicted signature is a data analysis step performed using a neural network, which is discussed below.
Claims 1 and 31 recite applying the synthetic data to an age simulation of increasing or decreasing age, which is a mathematical concept wherein the analysis is completed with a different age or mental observation for trends in a graph over time related to, for instance, expression levels (Figs. 4-5).
Dependent claims 2 and 32 recite performing one or more of the steps of the independent claims again, and the independent claim recites judicial exceptions.
Dependent claims 3 and 33 recite “comparing” signatures, “determining a difference,” and “preparing a report,” where comparing and determining a difference and preparing to report on such a difference are practically performed by the human mind as data evaluation. Preparing a report does not require a physical component and is interpreted as a mental step.
Dependent claims 4-5 and 34-35 recites “identifying at least biological target,” where the human mind is practically equipped to perform such a selection.
Dependent claims 7 and 37 recite correlating data, where, under a broadest reasonable interpretation, a correlation may be a mathematical concept or mental process, as the human mind can form an opinion or evaluate the relationship between data.
Dependent claims 8 and 38 recite “performing feature importance analysis for ranking” and “identifying a subset biomarkers.” Feature importance analysis can be interpreted as a mental process of ranking, as the human mind can evaluate or form an opinion in which the items are ordered, or a mathematical concept generating values for ranking numerically. Identification of a set of biomarkers is interpreted as a mental process as the human mind can make a selection.
Dependent claims 9 and 39 recite “identifying at least one biological target,” where the human mind is practically equipped to perform identification.
Dependent claims 10 and 40 recite “correlating the predicted biological data signature with a predicted biological age,” where, under a broadest reasonable interpretation, a correlation may be a mathematical concept or mental process, as the human mind can form an opinion or evaluate the relationship between data.
Dependent claims 12 and 42 recite additional information about the signature in that it is a simulation, where the simulation is disclosed as increasing biological age (pg. 13, paragraph [49]), which is a mathematical concept.
Dependent claims 13 and 43 recite “conditioning latent codes of the input vectors” and is interpreted as applying a probability function and thus a mathematical concept.
Dependent claims 14 and 44 recite additional information about the data.
Dependent claims 15 and 45 recite additional information about the data being a simulation, where the simulation is disclosed as increasing biological age (pg. 13, paragraph [49]), which is a mathematical concept.
Dependent claims 16 and 46 recite identification in difference in a biomarker, and the human mind is practically equipped to evaluate or judge such a difference.
Dependent claims 17 and 47 recite identification of a biological target, and the human mind is practically equipped to perform such an identification.
Dependent claims 18 and 48 recite performing previously discussed steps, a comparison of outputs interpreted as a mental process, and determining a change in the data, which is interpreted as a mental process.
Dependent claims 19-20 and 49-50 recite identification of a difference, which is interpreted as a mental process because the human mind is practically equipped to determine a difference.
Dependent claims 21 and 51 recite determining a rate and tracking change, which can be interpreted as a mental process or mathematical concept as the human mind is practically equipped to determine rate change or rate of change may be interpreted as a mathematical change.
Dependent claim 22 recites repeating steps, comparing reports, determining a change and the nature of the change, and determining whether to continue, change, or stop the regimen, which are abstract ideas in the form of mental processes, where steps like comparing data, determining change in the data, and determining a course of action are mental steps.
Dependent claim 23 recites additional information about the predicted signature, which is an abstract idea as the predicted signature is the output of a mathematical concept or mental process.
Dependent claim 24 recites data comparison, which is an abstract idea in the form of a mental process where the human mind is practically equipped to compare data.
Dependent claim 25 recites a data prediction, which is a mental process because a prediction is something the human mind is equipped to do.
Dependent claims 26-27 and 52-53 recite performing “biological signal activation analysis” which, under a broadest reasonable interpretation, includes abstract ideas, and determining a health status is interpreted as a mental process.
Dependent claims 28 and 54 recite tracking aging rate, which is interpreted as a mental process as the human mind is equipped to observe data change.
Dependent claim 29 recites a prediction, which is a mental process, where the human mind can perform a prediction as a form of data evaluation.
Dependent claim 30 identifying a therapeutic protocol, which is a mental process as the human mind can identify or select data.
Hence, the claims explicitly recite numerous elements that, individually and in combination,
constitute abstract ideas. The claims must therefore be examined further to determine whether they
integrate that abstract idea into a practical application (MPEP 2106.04(d)). [Step 2A: Yes]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Claim 1 recites obtaining a real sample from the subject, obtaining a real data signature by measuring omic data, inputting the vectors into a generative neural network machine learning platform, where said generative neural network includes an encoder and decoder. Claim 31 recites these limitations as well as a non-transitory computer readable medium. Dependent claim 6 recites additional information about the biological signature. Dependent claim 11 recites “obtaining the biological sample from the subject” and “obtaining the real biological data signature by performing a measurement,” which are also recited in the independent claims. Claim 22 recites performing a therapeutic regimen.
Claims 1, 6, 11, and 31 recite data collection and inputting for the abstract idea of generating the predicted biological data signature. Therefore, these are interpreted as insignificant extra solution activities and thus do not integrate the abstract idea into a practical application (MPEP 2106.05(g)). Claim 6 recites additional information about the collected data, which does not change the data gathering step. Similarly, providing the report is a mere data outputting, which is data output and thus also insignificant extra-solution activity (MPEP 2106.05(g)).
The recited use of a generative neural network is considered a field of use limitation, where the abstract idea is confined to a particular technological environment (neural networks) and thus fails to add an inventive concept. MPEP 2106.05(h) pertains.
Claim 22 recites performing a therapeutic regimen. The therapeutic regimen is not particularly stated. Furthermore, it is interpreted as necessary data collection to perform the comparing and determining steps, which are abstract idea, and thus is also insignificant extra solution activity (MPEP 2106.05(g)).
Claim 31 recites a computer program performing the steps of the method. The claims are interpreted as stating a generic computer performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
Thus, the judicial exceptions are not integrated into a practical application by the additional elements. [Step 2A Prong Two: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
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 of 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
Claim 1 recites obtaining a real sample from the subject, obtaining a real data signature by measuring omic data, inputting the vectors into a generative neural network machine learning platform, where said generative neural network includes an encoder and decoder. Claim 31 recites these limitations as well as a non-transitory computer readable medium. Dependent claim 6 recites additional information about the biological signature. Dependent claim 11 recites “obtaining the biological sample from the subject” and “obtaining the real biological data signature by performing a measurement,” which are also recited in the independent claims. Claim 22 recites performing a therapeutic regimen.
Receiving and inputting data is interpreted as receiving or transmitting data over a network (Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362). A review by Khan (Aging Cell 16(4): 624-633, 2017; previously cited on the 07 August 2025 PTO-892 form) teaches signatures of senescence (pg. 625, col. 2, last paragraph) or hallmarks of aging (pg. 625, col. 1, first paragraph) in young or old tissues (pg. 626, col. 2, first paragraph) based at last on methylation (pg. 625, col. 2, second paragraph) and proteomic signatures (pg. 626, col. 2, last paragraph), which are input into a mathematical model (pg. 626, Fig. 2 caption) and therapies to restore decline and homeostenosis (pg. 625, col. 1, first paragraph), and outputting an age score based on a patient (Fig. 2).
While Khan does not teach a generative neural network, Yousoff (International Journal of Innovative Computing 6(1): 9-15, 2016; newly cited) teaches application of generative neural networks to omic data (pg. 10, Section B), where at least autoencoders are taught but encoders, decoders, and latent space are inherent properties of a neural network. The additional element of applying the generative neural network is at best mere instructions to “apply” the abstract ideas, which cannot provide an inventive concept. See MPEP 2106.05(f).
Therefore, the recited additional elements, alone or in combination with the judicial exceptions, do not appear to provide an inventive concept. [Step 2B: No]
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole,
are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not
constitute significantly more than the abstract idea, so the claims are rejected under 35 USC § 101 as
being directed to non-statutory subject matter.
Response to the 28 April 2026 Applicant Remarks
Applicant remarks state, regarding Step 2A Prong One, that the claims are not directed to an abstract idea (pg. 18, last paragraph). At Step 2A Prong One, it is determined whether the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c)). At least creating vectors is interpreted as an abstract idea, as are the data analysis steps of generating a synthetic signature, and so analysis continues to Step 2A Prong Two.
Applicant remarks state, regarding Step 2A Prong Two, that the claims produce a tangible result (pg. 19, third paragraph) provided by a specific neural network architecture in the form a generative neural network (pg. 19, last paragraph), which is trained on omic and age data and able to simulate increased or decreased age (pg. 20, last paragraph). The neural network is further explained to achieve an improvement in eliminating batch effects (pg. 21, first paragraph). It is unclear what the tangible result is, as the result is interpreted as data in the form of a predicted signature given an age different from the chronological age of the subject. Given the age of the subject is not input into the machine learning model, the simulation is interpreted as judging on a plot, such as those found in Figs. 4-5, a differences in the trends over time on the x-axis. Furthermore, it is not clear that the generative neural network is improved but rather the data processing procedure. Using machine learning steps to improve simulations of biomarker changes is distinct from improvement to machine learning itself, such as that found in Ex Parte Desjardins.
Applicant remarks state, regarding Step 2B, that the claims recite an unconventional arrangement of additional elements, namely the specific combination of: obtaining a biological sample from the subject; performing an omic measurement to obtain the real biological data signature; processing through a generative neural network with encoder-decoder architecture and latent space conditioning; using a model trained on real gene expression profiles from a plurality of subjects linked to chronological age; and then applying the output to an age simulation protocol that modifies the predicted biological data
signature to correspond to an increased or decreased biological age (pg. 21-22). At Step 2B, it is determined whether the elements in addition to the abstract ideas amount to significantly more than the judicial exception(s) either alone or in combination (MPEP 2106). Khan teaches the elements besides the generative neural network, which is taught by Yousoff in general terms and taught as applicable to omic data. Applying a trained neural network is interpreted as applying the abstract ideas, which cannot provide an inventive concept (MPEP 2106.05(f)). Furthermore, the step of modifying the predicted signature to observe the profile at different ages does not appear to be anything more than an abstract step, such as tracking changes on the graphs in Figs. 4-5.
Therefore, the rejection under 35 USC 101 is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert J Kallal whose telephone number is (571)272-6252. The examiner can normally be reached Monday through Friday 8 AM - 4 PM EST.
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/Robert J. Kallal/Examiner, Art Unit 1685
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