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 .
Request for Continued Examination (RCE)
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/18/26 has been entered.
Priority
This application is a CON of 16/937,225 (07/23/2020, now US11242522);
16/937,225 is a CON of 16/246,195 (01/11/2019, now US10731150);
16/246,195 is a DIV of 15/738,104 (12/19/2017 ABN);
15/738,104 is a 371 of PCT/GB2016/051883 (06/23/2016);
which claims foreign priority to UNITED KINGDOM 1511050.5 (06/23/2015).
Status
Claims 47-57 are pending. Claims 55-57 were newly presented.
Rejections not reiterated in this office action are withdrawn.
Claim Interpretation
The claims use the language “multimeric barcode molecule … wherein the multimeric barcode molecule comprises first, second, and third barcode regions” which is being interpreted broadly to be any sequence of nucleotides, including for example a three-mer NNN wherein each N is a “region”.
The claims also include the language “separate first, second, and third co-localized target nucleic acid molecules” which is being interpreted as being at least three nucleic acid molecules that may have the same or different sequence.
New Claim Rejections - 35 USC § 102
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.
Claims 47-52, and 54-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hindson et al. (US20150376609, EFD 2014-06-26).
Hindson teaches a method of analyzing one or more nucleic acids from cells by providing nucleic acids and a barcode into a partition to generate nucleic acid molecules comprising a sequence of the one or more nucleic acids and the barcode (claim 1), sequencing the resulting nucleic acid molecules to generate reads (claim 12; [0100]), followed by identifying through processing (claim 1, 11; [0028]-[0030]; [0076]-[0078]; [0100]). The barcode corresponds to the instant claim multimeric barcode at least under the claim interpretation, the barcoded polynucleotides correspond to the claims first, second, and third barcoded target molecules which comprises a sequence and the first, second, and third barcode regions. The identifying of the read corresponding to an individual cell corresponds to the claim’s identifying co-localized target nucleic acid molecules. Thus, claim 47 is anticipated.
Regarding claim 48, Hindson teaches the same barcode regions uniquely identify the nucleic acid molecules.
Regarding claims 49-52, Hindson teaches the barcode molecule comprises multiple nucleotides and regions from a library of at least 2 molecules ([0076]-[0081]).
Regarding claim 54, Hindson teaches the molecules are from the same cell (Abstract).
Regarding claims 55-57, Hindson teaches the nucleic acids are RNA fragments including from a single cell (claims 16-17, 41; [0010]; [0110]-[0111]).
New Claim Rejections - 35 USC § 103
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.
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.
Claims 53 are rejected under 35 U.S.C. 103 as being unpatentable over Hindson et al. (US20150376609, EFD 2014-06-26) in view of Anderson et al. (US20130005585).
Hindson anticipates and also renders obvious claims 47-52, and 54-57 as detailed above. Regarding claims 53, Hindson does not teach a FFPE sample.
Anderson is in the same field of endeavor of nucleic acid sequencing and teaches preparation of target nucleic acids from FFPE samples ([0073]; [0380]; claim 145) as well as from single cells ([0111]-[0116]; [00380]; Figs 19-24). One of ordinary skill in the art would have been aware of these well-known nucleic acid sample preparations routinely used in sequencing of target nucleic acids and combined the teaching with that of Hindson and arrive at the claimed invention with a reasonable expectation of success. Thus, the claims are prima facie obvious.
New Double Patenting Rejections
Claims 47-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11242522 in view of Hindson et al. (US20150376609, EFD 2014-06-26) and Anderson et al. (US20130005585). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method of generating a synthetic long read which comprises substantially the same steps as the instant claims. Thus, in view of the secondary references as detailed in the 35 USC 103 rejection supra and incorporated herein, one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the instantly claimed invention.
Claims 47-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10731150 in view of Hindson et al. (US20150376609, EFD 2014-06-26) and Anderson et al. (US20130005585). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method of generating a synthetic long read which comprises substantially the same steps as the instant claims. Thus, in view of the secondary references as detailed in the 35 USC 103 rejection supra and incorporated herein, one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the instantly claimed invention.
Response to Remarks
Applicant argues regarding rejections now withdrawn thereby rending the argument moot.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
