DETAILED ACTION
1. This action is written in response to applicant’s correspondence filed 1/22/2026. Applicant has amended claims 13-20. Claims 13-20 are currently pending for examination. All the amendments and arguments have been thoroughly reviewed but are found insufficient to place the instantly examined claims in condition for allowance. In view of applicant’s amendment to claim 13, all the rejections from the previous Office action have been withdrawn. However, new grounds of rejection under 35 USC 102 are presented as set forth below.
Claim Rejections - 35 USC § 102
2. 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 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.
3. 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.
4. Claims 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zamft et al. (PLoS ONE 2012, 7(8):e43876).
Zamft et al. disclose a synthetic DNA polynucleotide (see the synthetic DNA polynucleotide formed by a barcoded primer hybridizing to a DNA template as shown in Figure 1C prior to “Error-Prone Primer Extension”, wherein the DNA template is template strand N1.0.6 (5’-AAAATCATAACTAAGTCAGTCAGTACGTCAGTAGCTCAGTCGATGGATGCAATGAATGAATGAATGAAAATAAAAATACAACAGCTATGACCAT-ddC-3’) and the barcoded primer is any one of the 96 barcoded primers N1.1.1.x (5’-ACACTCTTTCCCTACACGACGCTCTTCCGATCTNNNNNGATGGTCATAGCTGTTGTA-3’, x = 1 to 96), as listed under “Primer Extension Assay” at page 8, column 1) comprising: (1) a first DNA polynucleotide strand (e.g., template strand N1.0.6) comprising: a first 5’ region (e.g., 5’-AAAATCATAACTAAGTCAGTCAGTA or any portion of said 5’-segment), a common sequence (e.g., “GAAAATAAAAA” which is immediately next to the sequence segment hybridizing to the barcoded primer) 3’ to the first 5’ region that is complementary to an amplification primer (Note that any given sequence is complementary to an amplification primer that has the corresponding complementary sequence to said given sequence), and a first 3’ region (e.g., TACAACAGCTATGACCAT-ddC-3’ or any portion of said 3’-segment) 3’ to the common sequence; and (2) a second DNA polynucleotide strand (e.g., the barcoded primer) in the opposite 5’-to-3’ orientation as the first DNA polynucleotide strand, the second DNA polynucleotide strand comprising: a second 3’ region (e.g., GATGGTCATAGCTGTTGTA-3’ or any portion of said 3’-segment) hybridized to the first 3’ region, a barcode (e.g., “NNNNN” or “TNNNNN”, which is immediately next to the sequence segment hybridizing to the template strand. Note that any sequence can serve as a barcode.) 5’ to the second 3’ region, and a second 5’ region (e.g., 5’-ACACTCTTTCCCTACACGACGCTCTTCCGATC or any portion of said 5’-segment) 5’ to the barcode; wherein the first 5’ region (e.g., 5’-AAAATCATAACTAAGTCAGTCAGTA or any portion of said 5’-segment) comprises from five to 25 nucleotides, wherein the common sequence (e.g., “GAAAATAAAAA” which is immediately next to the sequence segment hybridizing to the barcoded primer) comprises from six to 50 nucleotides, wherein the first 3’ region (e.g., TACAACAGCTATGACCAT-ddC-3’ or any portion of said 3’-segment) comprises from one to 10 nucleotides (Although TACAACAGCTATGACCAT-ddC-3’ has a length of 19 nucleotides, portion of said 3’-segment can have a length of from one to 10 nucleotides. Furthermore, since the term “comprises” is open-ended, this wherein clause does allow the first 3’ region to be longer than 10 nucleotides.), wherein the second 3’ region (e.g., GATGGTCATAGCTGTTGTA-3’ or any portion of said 3’-segment) comprises from five to 25 nucleotides, wherein the barcode (e.g., “TNNNNN”) comprises from six to 50 nucleotides, and wherein the second 5’ region (e.g., 5’-ACACTCTTTCCCTACACGACGCTCTTCCGATC or any portion of said 5’-segment) comprises from one to 10 nucleotides (Although 5’-ACACTCTTTCCCTACACGACGCTCTTCCGATC has a length of 32 nucleotides, portion of said 5’-segment can have a length of from one to 10 nucleotides. Furthermore, since the term “comprises” is open-ended, this wherein clause does allow the second 5’ region to be longer than 10 nucleotides.).
5. Claims 13-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Nelissen et al. (Nucleic Acids Res. 2009, 37(17):e114).
Nelissen et al. disclose a synthetic DNA polynucleotide (e.g., the DNA-splinted ligation complex formed by the 19-nt Junction 6 wt-p1, 20-nt Junction 6 wt-p2, and 28-nt DNA splint. See page 3, column 2, paragraphs 2-3; Table 1) comprising: (1) a first DNA polynucleotide strand (e.g., 19-nt Junction 6 wt-p1 (5’-GCGGAGCAGCACCTTGGTG-3’)) comprising: a first 5’ region (e.g., 5’-GCGGA), a common sequence (e.g., the 8-nt sequence “GCAGCACC” that is immediately 3’ to the first 5’ region) 3’ to the first 5’ region that is complementary to an amplification primer (Note that any given sequence is complementary to an amplification primer that has the corresponding complementary sequence to said given sequence), and a first 3’ region (e.g., TTGGTG-3’) 3’ to the common sequence; (2) a second DNA polynucleotide strand (e.g., 28-nt DNA splint (5’-CAGCCCAAGGGCAGCACCAAGGTGCTGC-3’)) in the opposite 5’-to-3’ orientation as the first DNA polynucleotide strand, the second DNA polynucleotide strand comprising: a second 3’ region (e.g., CACCAAGGTGCTGC-3’ or any portion of said 3’-segment) hybridized to the first 3’ region, a barcode (e.g., the 6-nt sequence “GGGCAG” that is immediately 5’ to the second 3’ region. Note that any sequence can serve as a barcode.) 5’ to the second 3’ region, and a second 5’ region (e.g., 5’-CAGCCCAA) 5’ to the barcode; and (3) a third DNA polynucleotide strand (e.g., 20-nt Junction 6 wt-p2 (5’-CTGCCCTTGGGCTGCTCCGC-3’)) comprising: a 5’ region (e.g., 5’-CTGCCCTTGGGCTG or any portion of said 5’-segment) hybridized to the 5’ region of the second strand, and a second barcode (e.g., CTCCGC-3’. Note that any sequence can serve as a barcode.); wherein the first 5’ region (e.g., 5’-GCGGA) comprises from five to 25 nucleotides, wherein the common sequence (e.g., the 8-nt sequence “GCAGCACC” that is immediately 3’ to the first 5’ region) comprises from six to 50 nucleotides, wherein the first 3’ region (e.g., TTGGTG-3’) comprises from one to 10 nucleotides, wherein the second 3’ region (e.g., CACCAAGGTGCTGC-3’ or any portion of said 3’-segment) comprises from five to 25 nucleotides, wherein the barcode (e.g., the 6-nt sequence “GGGCAG” that is immediately 5’ to the second 3’ region) comprises from six to 50 nucleotides, and wherein the second 5’ region (e.g., 5’-CAGCCCAA) comprises from one to 10 nucleotides.
Response to Arguments
6. Applicant’s arguments have been considered but are moot because the arguments do not apply to the new grounds of rejection presented in the current Office action.
Conclusion
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
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