DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Herein, “the previous Office action” refers to the Final Rejection filed on 5/21/2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/16/2025 has been entered.
Priority
As detailed on the Filing Receipt filed 6/9/2020, the instant application claims priority to as early as 6/21/2013. At this point in prosecution, all claims are accorded the earliest claimed priority date.
Claim Status
Claims 1 and 3 are canceled.
Claims 2 and 4-24 are pending.
Claims 14-15 and 20 stand withdrawn pursuant to 37 CFR 1.142(b) as being directed to a nonelected invention, there being no currently allowable generic or linking claim. Election without traverse was made in the reply filed 6/19/2023.
Claims 2, 4-13, 16-19 and 21-24 are under examination.
Withdrawn Objections/Rejections
The rejection of claims 2, 4-13, 16-19 and 21-24 under 35 USC § 101, as being directed to non-statutory subject matter, is hereby withdrawn in view of Applicant’s amendment of the claims and persuasive argument that the amended claims integrate the recited judicial exceptions into a practical application in the same manner as the parent application was held to by the PTAB (Remarks filed 9/16/2025 at pg. 9, para. 2 – pg. 10, para. 2).
The rejection of claims 2, 4-13, 17-19 and 21-24 under 35 USC § 103, as being unpatentable over Srinivasan, is hereby withdrawn in view of Applicant’s amendment of the claims and persuasive argument that Srinivasan does not disclose a method relying on a polymorphism-independent parameter (Remarks filed 9/16/2025 at pg. 12, para. 3 – pg. 13, para. 1).
The rejection of claim 16 under 35 USC § 103, as being unpatentable over Srinivasan, in view of Zou, is hereby withdrawn in view of Applicant’s amendment of the claims and persuasive argument that Srinivasan does not disclose a method relying on a polymorphism-independent parameter (Remarks filed 9/16/2025 at pg. 12, para. 3 – pg. 13, para. 1).
The rejection of claims 2, 4-6, 9-13, 18-19 and 21 on the ground of nonstatutory double patenting as being unpatentable over claims of one or more of U.S. Patent Nos. 9,984,198; 10,497,461; 11,306,354; 11,492,659 in view of Srinivasan are hereby withdrawn in view of Applicant’s amendment of the claims and persuasive argument that the rejection is inapplicable to the claims as amended and in view of the previous arguments regarding Srinivasan (Remarks filed 9/16/2025 at pg. 13, para. 3 – pg. 14, para. 1).
The provisional rejection of claims 2, 5-6, 10-13 and 18-19 on the ground of nonstatutory double patenting as being unpatentable over claims of co-pending Application No. 18/080,620, in view of Srinivasan, is hereby withdrawn in view of Applicant’s amendment of the claims and persuasive argument that the rejection is inapplicable to the claims as amended and in view of the previous arguments regarding Srinivasan (Remarks filed 9/16/2025 at pg. 14, para. 2).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 USC § 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.
Claims 2, 4-13, 16-19 and 21-24 are rejected under 35 USC § 112(a) as failing to comply with the written description requirement. The claims 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, at the time the application was filed, had possession of the claimed invention.
With respect to claim 2 and dependents thereof, the recited limitation of “polymorphism-independent parameter comprising a quantification of the portion-specific minority fraction estimates” (e.g., claim 1, lines 22-23) lacks adequate support in the written description.
Genetic polymorphisms are types of genetic variation other than somatic mutations, including single nucleotide polymorphisms (SNPs), indels, short tandem repeats (STRs), restriction fragment length polymorphisms (RFLPs) and more. The specification does not provide a special definition to the term “polymorphism-independent parameter”, and the plain meaning of the term thus broadly excludes parameters based on heritable genetic variation.
The recited limitation requires that a parameter comprising a quantification of portion-specific minority fraction estimates, which are in turn based on counts of sequences mapped to particular genomic portions, is polymorphism-independent. It is uncertain how any parameter based on differential gene mapping could be polymorphism-independent, and the specification does not describe such a parameter.
For example, the instant claims require that analyzed genomic portions are chosen from a list of alternatives which includes “genomic bins having sequences of predetermined length” (claim 9). Differential binning of nucleic acid species based on predetermined sequence lengths is reliant on characteristic differences in location of restriction sites between the species (i.e., restriction fragment length polymorphisms). Indeed, the instant specification describes pre-enrichment of test samples via a “restriction endonuclease enhanced polymorphic sequence approach” involving selective cleavage of nucleic acid species at polymorphic sites to produce fragments of characteristic length, thus allowing for differential quantification of the species (pg. 23, line 29 – pg. 24, line 5). It is unclear how a differentiating parameter based on mapping of sequences to predetermined length bins as described could be polymorphism-independent.
Therefore, the recited limitation constitutes new matter and the claim lacks adequate written description support.
Conclusion
At this time in prosecution, no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore C. Striegel whose telephone number is (571)272-1860. The examiner can normally be reached Mon-Fri 12pm-8pm ET.
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, Olivia M. Wise can be reached at (571)272-2249. 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.
/T.C.S./Examiner, Art Unit 1685
/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 January 31, 2026
Prosecution Insights