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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/26/2029 has been entered.
Status of the Applications, Amendments and/or Claims
This action is written in response to applicant's correspondence(s) submitted on 05/26/2026 and 05/29/2026. In the paper of 05/26/2026, Applicant amended claims 1, 13 and 16 and newly canceled claims 21-24 and filed a terminal disclaimer over the claims of U.S. Patent No. 11,566,283.
The terminal disclaimer over the claims of U.S. Patent No. 11,566,283 was approved on 05/29/2026. Accordingly, claims 1, 7-10 and 12-20 are pending and under review. Claims 2-6, 11 and 21-80 are canceled.
Response to Arguments
Moot and/or Withdrawn Rejection(s)
The rejection of claim 23 under 35 U.S.C. 102(a)(1) as being anticipated by Kawano et al. (2010, Biotechniques 49(4):751-755: previously cited) as evidenced by Warshawsky et al. (2011, Journal of clinical pathology, 64(10), pp.905-910: previously cited) is moot based on the cancellation of this claim.
The rejections of claims 21-22 and 24 under 35 U.S.C. 103 as being unpatentable over Kawano et al. (2010, Biotechniques 49(4):751-755: previously cited) in view of Warshawsky et al. (2011, Journal of clinical pathology, 64(10), pp.905-910: previously cited) and Behlke et al (US 2011/0117559: previously cited) are moot based on the cancellation of these claims.
The rejection of claims 21-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,566,283 is moot based on the cancellation of these claims.
The rejection of claims 1, 7-10, 12-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,566,283 is withdrawn based on the filing of a terminal disclaimer on 05/26/2026.The terminal disclaimer was approved on 05/29/2026.
The rejection of claims 1, 7-10, 12-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,266,889 is withdrawn based on the filing of a terminal disclaimer on 05/26/2026.The terminal disclaimer was approved on 05/29/2026.
The rejections of claims 21-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,266,889 are moot based on the cancellation of these claims.
The rejection of claims 16-17 under 35 U.S.C. 102(a)(1) as being anticipated by Kawano et al. (2010, Biotechniques 49(4):751-755: previously cited) as evidenced by Warshawsky et al. (2011, Journal of clinical pathology, 64(10), pp.905-910: previously cited) is withdrawn based on claim amendments.A new rejection was necessitated by the amendments.
Maintained Rejection(s)
The rejection of claims 1, 7-10, 12-15, 18-20 under 35 U.S.C. 102(a)(1) as being anticipated by Kawano et al. (2010, Biotechniques 49(4):751-755: previously cited) as evidenced by Warshawsky et al. (2011, Journal of clinical pathology, 64(10), pp.905-910: previously cited) is maintained.
Claim Rejections - 35 USC § 102
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 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 1, 7-10, 12-15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawano et al. (2010, Biotechniques 49(4):751-755: previously cited) as evidenced by Warshawsky et al. (2011, Journal of clinical pathology, 64(10), pp.905-910: previously cited).
Kawano et al. (2010): claims 1,7-9, 18-19
Regarding claim 1 and 12-15, Kawano et al. teach the instant oligonucleotide which is a locked nucleic acid oligonucleotide (22 nucleotides in length) called “dimer eliminator-22”,
(5′-TACGAGATTTNNGATCGTCGGA-3′) (LNA nucleotides are underlined and also shown in italics, while NN shows random DNA) (see also in Fig. 1B, further reproduced below from pg 753, Fig. 1B). The one or more LNA nucleotides at the 3’ terminal end of the dimer eliminator-22 prevent polymerase directed synthesis from the oligonucleotide.
Fig. 1B (from pg 753 of Kawano et al., 2010)
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The LNA “dimer-eliminator” oligonucleotide has at least one locked nucleotide (LNA) and is configured to be a complement sequence of an adapter-dimer ligation product and capable of partial hybridization to a terminal adapter sequence of a desired template of a population of templates.
Regarding claims 1 and 12, as shown in Fig. 1B as reproduced above, the LNA “dimer-eliminator” oligonucleotide of Kawano et al. is a blocker oligonucleotide, preventing the binding and extension of a RT primer to an adapter-dimer ligation product.
The LNA “dimer-eliminator” oligonucleotide of Kawano et al. provides a significant improvement to methods for construction of small RNA libraries for high through put sequencing as it reduces generation of libraries of adaptor-dimers that are devoid of inserts thereby meeting the limitation of claims 18-19 (see pg 751, abstract and pg 751, all text of the right col).
Regarding claims 1 and 7-10, the LNA “dimer eliminator-22” oligonucleotide of Kawano et al. meets the instant limitation of claim 1 as it is a “bait”/capture oligonucleotide for “adapter dimers” and is an oligonucleotide that comprises a plurality of locked nucleic acid group(s) i.e. the instant Tm-enhancing group(s).
Regarding claim 10, the locked nucleotides of the LNA “dimer eliminator-22” oligonucleotide of Kawano et al. provide a rise in the melting temperature of that oligonucleotide from about 1.4 ⁰C to about 25 ⁰C relative to an oligonucleotide having the same nucleotide sequence but no locked nucleotide(s) as Warshawsky et al. teach LNA is a nucleic acid analogue that contains a 2′-O,4′-C-methylene bridge in the ribose moiety and that where LNA bases are incorporated into any DNA oligonucleotide, each LNA base increases by 3-8°C the thermal stability with complementary DNA (Warshawsky et al., pg 1, 1st para of left col., below Conclusions).
Regarding claims 12-15, Kawano et al. teach a blocker-barcode domain comprising “about” 5 nucleotides arranged substantially contiguously i.e. the nucleotide sequence (5’-AGNNTTTA’-3).
Regarding claim 20, Kawano et al. teach a 3’ terminal modification (i.e. various LNAs/ locked nucleotides at 3’ terminus of the dimer-eliminator 22).
Accordingly, the instant claims 1, 7-10, 12-15 and 18-20 are anticipated by Kawano et al. (2010).
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.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kawano et al. (2010, Biotechniques 49(4):751-755: previously cited) in view of Warshawsky et al. (2011, Journal of clinical pathology, 64(10), pp.905-910: previously cited) and Behlke et al (US 2011/0117559: previously cited).
The teachings of Kawano et al. as it relates to claims 1 and 14 are provided above.
Kawano et al. (2010, Biotechniques): claims 16-17
Regarding claims 16-17, Kawano et al. do NOT teach a locked nucleic acid oligonucleotide having a 3’ terminal modification selected from 3'-deoxynucleotide, 2',3'-dideoxynucleotide or a 3'-spacer C3 group), wherein the 3’ terminal modification prevents polymerase directed synthesis.
Regarding claims 16-17, Behlke et al. teach an oligonucleotide having a 3’ terminal modification that is a blocking moiety for preventing polymerase directed synthesis from the oligonucleotide (e.g. the terminal modification being 3’-deoxynucleotide, 2’,3’-dideoxynucleotide or a 3’-spacer C3 group: see SEQ ID NOS: 1 and 3, wherein SEQ ID NO: 1 of Behlke consists GGCTGGAGTGTAGCAGCAcGxxA, where x =C3 spacer and RNA base is lowercase; SEQ ID NO: 3 of Behlke consists ATTACGGGATACGGTGGATCGcCxxT, where x =C3 spacer and RNA base is lowercase).
Behlke disclosed (paragraph [0092]): "Alternatively abasic residues such as a C3 spacer may be incorporated in these locations to block primer extension."
Alternatively, Warshawsky et al. taught it already a matter of routine practice in the art to incorporate a 3’ C3 spacer as a 3’ terminal modification into LNA containing oligonucleotide useful for target sequence capture (see pg 2, left col., section entitled “NPM1 mutation detection” wherein Warshawsky et al. discloses a NPM1 LNA bait/capture oligonucleotide 5’- A*A*+G+ATCT+CT+G+GCA+GT+GG/3SpC3/–3′; where *, + and /3spC3/ refer to phosphorothioate, LNA and C3 spacer).
It would have been prima facie obvious to one of ordinary skill in the art to use a C3 spacer as a blocking group in the oligonucleotide suggested by the combined teachings of Warshawsky et al., since this was a known structure used to prevent primer extension, and thus represents nothing more than selecting an art recognized material for its intended purpose; see MPEP 2144.07.
Conclusion
No claims are currently allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
./GARY BENZION/ Supervisory Patent Examiner, Art Unit 1681
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