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 .
Priority
This application filed 10/06/2023 is a Continuation of 17831427, filed 06/02/2022, now U.S. Patent # 11781175. The claims are therefore examined as filed on 06/02/2022, the effective filing date. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further review of the priority application(s).
Claim Status
Claims 2-7 are pending.
Claim 1 is cancelled.
Claims 2-7 are examined.
Claims 2-7 are rejected.
Information Disclosure Statement
The Information Disclosure Statements are in compliance with the provisions of 37 CFR 1.97. Accordingly, all references have been considered.
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 2-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental processes and mathematical concepts, without significantly more.
The MPEP at MPEP 2106 sets forth steps for identifying eligible subject matter:
(1) Are the claims directed to a process, machine, manufacture or composition of matter?
(2A)(1) Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea?
(2A)(2) Do the claims recite additional elements that integrate the judicial exception into a practical application?
(2B) If the claims recite a judicial exception and do not integrate the judicial exception, do the claims recite additional elements that provide an inventive concept and amount to significantly more than the judicial exception?
With regard to step (1) (Are the claims directed to a process, machine, manufacture or composition of matter?): Yes. The claims are directed to one of the statutory classes. Claims 2-7 are directed to a process (a method).
With regard to step (2A)(1) (Do the claims recite a judicially recognized exception?): Yes. The claims recite the abstract ideas of processing data using mental steps and mathematical concepts, and observing the processed data. Claims that recite nothing more than abstract ideas, natural phenomena, or laws of nature are not eligible for patent protection (see MPEP 2106.04).
Abstract ideas include mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (See MPEP 2106.04(a)(2)). In particular, these abstract ideas include but are not limited to:
Training a model based on methylation profiles to predict an epigenetic age based on methylation values obtained from sequence data (mental process/mathematical process; the human mind is capable of applying data to a mathematical model, and doing so is equivalent to performing a calculation; claim 2)
Dependent claims 6-7 further limit the abstract ideas recited in the independent claims, and do not change their characterization as abstract ideas.
Therefore, the claims recite elements that constitute one or more judicial exceptions.
With regard to step (2A)(2) (Do the claims recite additional elements that integrate the judicial exception into a practical application?): No. Claim 2 recites the additional element of receiving a plurality of methylation profiles from a plurality of individuals based on sequence data corresponding to a degree of methylation at CpG sites. Claims 3-5 further describe the received data, with claim 5 describing that the sequence data is generated by amplifying loci.
While the claims recite the additional element of receiving data and generating data through amplification, such steps that only amount to necessary data gathering , without any technical details of how the data is obtained that integrate the judicial exception, are insignificant extrasolution activities that do not add a meaningful limitation to the claims (see MPEP 2106.05(g)). As a result, the judicial exception is not integrated into a practical application. Because the claims do not recite any additional elements that integrate the judicial exception into a practical application, the claims as a whole are directed to an abstract idea.
With regard to step (2B) (Do the claims recite additional elements that provide an inventive concept and amount to significantly more than the judicial exception?): No. The claims recite an abstract idea with additional elements; however, these additional elements are non-particular instructions to apply the abstract idea by linking it to a field of use or extrasolution activity (see MPEP 2106.05(f-h)). Non-particular instructions to gather or produce data do not provide an inventive concept. Non-particular instructions to gather data, by computer or through sequencing/amplification, are also considered well-understood, routine and conventional activities (see MPEP 2106.05(d), which indicates that limitations such as “Receiving or transmitting data over a network” from Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362, “Storing and retrieving information in memory” from Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, and “Amplifying and sequencing nucleic acid sequences”, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014) are recognized as conventional activities). The claims therefore do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As a result, the claims as a whole do not provide an inventive concept.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim Rejection
Claims 2 and 4-7 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by BORONI MARTINS 2020 “Methods For Detecting The Age Of Biological Samples Using Methylation Markers” (US 20200190568 A1, as cited on the IDS filed 10/06/2023).
Claim Interpretation and Scope and Contents of Prior Art
Claim 2 recites a method of generating an epigenetic clock predictor, the method comprising: receiving a plurality of methylation profiles from a plurality of individuals based on sequence data of the plurality of individuals, the sequence data corresponding to a degree of methylation at a plurality of CpG sites; and training a model based on the plurality of methylation profiles, the model being configured to predict an epigenetic age based on methylation values obtained from the sequence data.
With respect to this limitation, BORONI MARTINS teaches methods and systems for determining epigenetic age, comprising receiving methylation profiles of individuals corresponding to methylation status of CpG cites [0038, 0127, 0189] determined from sequence data [0036], and training a model based on the methylation profiles to predict epigenetic age [0012, 17-28].
Claim 4 recites the limitation wherein the plurality of CpG sites include 42 sites. With respect to this limitation, BORONI MARTINS teaches that the plurality of CpG sites can include 42 sites, or 10 to over 300 sites [0038].
Claim 5 recites the limitation wherein the sequence data is generated by amplifying a plurality of loci, the plurality of loci including the plurality of CpG sites. With respect to this limitation, BORONI MARTINS teaches that the sequence data is generated by amplifying the loci including the CpG sites [0122, 178, 182].
Claim 6 recites the limitation wherein training the model comprises training a linear regression model. With respect to this limitation, BORONI MARTINS teaches that the model can comprise a linear regression model [0010, 13, 15, 17].
Claim 7 recites the limitation wherein training the model comprises training a random forest model. With respect to this limitation, BORONI MARTINS teaches that the model can comprise a random forest model [0294, 0405].
Claims Without an Art Rejection
No art rejection is applied to claim 3. The cited prior art, while teaching several other markers, does not teach that the sequence data corresponds to the degree of methylation at the plurality of CpG sites identified by markers cg27330757, cg04777312, and cg13740515 specifically, and no combinable art before the effective filing date could be found to render the claims as obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY C LEVERETT whose telephone number is (571)272-5494. The examiner can normally be reached 8:00am - 5:00pm M-Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz R. Skowronek can be reached at (571) 272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARY C LEVERETT/ Examiner, Art Unit 1687
Prosecution Insights