Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
ELECTION
2. Applicant’s election without traverse of Group II in the reply filed on 03/05/26 is acknowledged.
3. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
NON-PRIOR ART REJECTION
4. 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 24 and 26 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. These claims are indefinite because ‘A and A’ sequences’ in claim 24, part c.ii., lacks proper antecedent basis. Correction is required.
PRIOR ART REJECTIONS
5. 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.
6. 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.
7. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. 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.
9. Claims 18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Welker et al. (US 2018/0346963).
Regarding independent claim 18, Welker discloses methods which utilize a first forked adapter complex and a second forked adapter complex, each comprising the required portions or sequences as recited in the claim. Regarding claim 24, the methods disclosed by Welker comprise all of the steps required in the claim. See Figs. 1-4 and 7-8, and paragraphs 0005-0031, 0040, 0128-0168.
Welker does not explicitly disclose an adapter composition or kit comprising the first and second forked adapters.
One of ordinary skill in the art would have been motivated to apply the disclosure of the methods of Welker utilizing the first and second forked adapter complexes to a composition or kit comprising said first and second forked adapters because such a composition or kit would have clearly been useful in carrying out the methods of Welker. Compositions and kits comprising reagents needed to perform various methods have long been conventional in the prior art and merely involve straightforward, logical scientific reasoning, which does not support unobviousness. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make the claimed composition or kit, and to use it to perform the claimed method.
10. Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Welker et al. (US 2018/0346963) in view of Drmanac et al. (US 2008/0318796).
The disclosure of Welker is discussed above.
Welker does not disclose compartmentalizing a sample comprising nucleic acid and performing a nucleic acid-based reaction in the compartments.
Drmanac discloses compartmentalizing a sample comprising nucleic acid and performing a nucleic acid-based reaction in the compartments. See paragraph 0013.
One of ordinary skill in the art would have been motivated to modify the method of Welker by compartmentalizing the sample and performing concatenation in the compartments because Drmanac disclosed the benefit of compartmentalizing nucleic acids and performing reactions within the compartments. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
11. Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Welker et al. (US 2018/0346963) in view of Drmanac et al. (US 2008/0318796), and further in view of Burgess et al. (US 2020/0032244).
The disclosure of Welker and Drmanac is discussed above.
These references do not disclose the use of a blocking oligonucleotide which hybridizes to an adapter.
Burgess discloses the benefit of using a blocking oligonucleotide which hybridizes to an adapter. See paragraphs 0163-0166.
One of ordinary skill in the art would have been motivated to modify the method of Welker by using a blocking oligonucleotide which hybridizes to an adapter because Burgess disclosed the benefit of using such a blocking oligonucleotide. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
12. Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Welker et al. (US 2018/0346963) in view of Drmanac et al. (US 2008/0318796), further in view of Burgess et al. (US 2020/0032244), and further in view of Drmanac et al. (US 2011/0033854).
The disclosure of Welker, Drmanac ‘796, and Burgess is discussed above.
These references do not disclose haplotype phasing.
Drmanac ‘854 discloses that haplotype phasing was a known or conventional form of genotype analysis. See paragraph 0297.
One of ordinary skill in the art would have been motivated to modify the method of Welker by carrying out haplotype phasing because Drmanac ‘854 disclosed that such haplotype phasing was a conventional form of genotype analysis. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
13. Claims 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Welker et al. (US 2018/0346963) in view of Lo et al. (US 2019/0241979).
The disclosure of Welker is discussed above.
Welker does not disclose identifying modified or methylated cytosines in a nucleic acid sequence.
Lo discloses that identifying modified cytosines in target nucleic acids, also known as determining a methylation profile, was a known or conventional form of genomic analysis. See paragraph 0073.
One of ordinary skill in the art would have been motivated to modify the method of Welker by carrying out cytosine methylation analysis because Lo disclosed that such analysis was a conventional form of genome analysis. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
CONCLUSION
14. No claims are free of the prior art.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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05/26/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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