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 .
Election/Restrictions
Applicant’s election without traverse of Invention II in the reply filed on 3/17/2026 is acknowledged.
Claims 1-2, 15, 21-37 are pending. Claims 3-14, 16-20 have been cancelled.
Claims 1-2 and 15 are withdrawn as being drawn to a nonelected invention.
An action on the merits for claims 21-37 is set forth below.
Claim Objections
Claim 25 is objected to because of the following informalities: Claim 25 should end with a period. Appropriate correction is required.
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 21-37 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 21-37 are indefinite over the nexus of the claims steps and the preamble. The preamble recites “simultaneous DNA analysis” however the claims are drawn to generating a combined library. It is not clear which steps would be encompassed by the “simultaneous DNA analysis” as DNA is not analyzed in the claim steps.
Claim 26 is indefinite over the term “initial step” as it is not clear if the claim intends that the step would be performed prior to the steps of claim 21 or if the step can be performed afterwards.
Claim 27 m comprises numerous “or” statements. It is not clear which steps are required by the claim.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy et al. (US Patent Application 2019/0390253 December 26, 2019).
With regard to claim 21 and 34, Kennedy et al. teaches a first library with adapter tagged library that is used for MBD sampling (para 309-310 and 353-375) and a second library that is adaptor that has WGS for genetic analysis (para 309-310 and 386-387). Kennedy et al. suggests that libraries can be designed and pooled (para 25), therefore it would be prima facie obvious to the ordinary artisan at the time of the effective filing date modify the method of Kennedy to perform the suggestion of the libraries to be pooled together before screening with NGS.
With regard to claim 22, Kennedy et al. teaches that capture probes are used and amplifying is used (para 353-375 and 386-387).
With regard to claim 23, Kennedy et al. teaches WGS processing (para 386-387).
With regard to claim 24, Kennedy et al. teaches using capture probes to isolated particular targets and as such teaches a target capture library (para 353-375) and whole genome library (para 386-387).
With regard to claim 25, Kennedy et al. suggests methods wherein the different analysis can be recombined and pooled (para 25-26, 55).
With regard to claim 26, Kennedy teaches that the partitions of the adapter tagged libraries are splice from the same patient library (para 169).
With regard to claim 27, Kennedy teaches that the adapters from both libraries have tags at the 5’ ends and a gene of interest (para 121-122)
With regard to claim 28 and 30, Kennedy et al. teaches that adapters can comprise barcodes and as such these are unique ID regions which can be associated with a sample and a particular target (para 52).
With regard to claim 29, Kennedy et al. teaches a library that has an amplification region, a barcode (ID region) and a tag (anchor) ( para 51-52 and 126-130).
With regard to claim 31, Kennedy et al. teaches contacting the probes to hybridize to form probe adapters, wherein there is a binding site Kennedy teaches isolating complexes and enzymatically processing (p. 353-377).
With regard to claim 32-33, Kennedy et al. teaches a method wherein the whole genome library comprise a method of amplification using primers (para 169 and 309).
With regard to 35, Kennedy teaches a method withing the adaptors are ligated to the DNA fragment to provide adapter tagged parent libraries (para 125-126 and para 169).
With regard to claim 36, Kennedy et al. teaches samples can be blood or plasma (para 312, 314).
With regard to claim 37, Kennedy et al. teaches cfDNA or methylated DNA (para 63, 78).
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.
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, Wu Cheng (Winston) Shen can be reached at 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
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