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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/27/2025 has been entered.
Applicant’s election of the species of ZFP36L1, DCXR and Chr4:90790001-90792000 in the reply filed on 6/08/2022 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
4. Claims 2, 5-6, 10, 12-13 are pending. Claim 1, 3-4, 7-9 and 11 has been cancelled. Claims 5-6 has been withdrawn as being drawn to nonelected species.
5. The following rejections for claims 2, 10, 12-13 are newly applied.
6. This action is NONFINAL.
Withdrawn Rejections
The 35 USC 103 rejection made in the previous office action is withdrawn based upon amendments to the claims.
Claim Rejections - 35 USC § 112
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 2,10,12-13 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.
After review of the claims the recitation of “FPKM value greater than or equal to 10” appears to not be described by the specification. It is noted that the recitation of “FPKM value greater than or equal to 10” was added to the claims on 11/08/2021 (claim 4). However, after review of the specification, the specificaoin teaches on pages 2-3 FPKM plots, however, does not describe dividing the sequence reads according to “FPKM value greater than or equal to 10”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 10, 12-13 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 2, 10, and 12-13 are indefinite over the phrase “consisting essentially of” in claim 2. The phrase is not clear as the phrase is an attempt to limit the steps to the recited “essential” steps. However it is not clear which steps would be considered essential. For example, the claims do not require isolated cfDNA from a sample. This would be an essential step to measuring cfDNA however it is not recited. Therefore the claims appear to omit essential steps for obtaining a hydromethylation profile. Further, for example, step e is optional and as such it is not clear if the step performed is essential.
Claim 10 is unclear over the phrase “at one or more reference target loci relative to the reference hydroxy methylome”. The reference target loci are not compared to the reference and as such it is not clear the metes and bounds of “reference”.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached on 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682