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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Claim Status
Currently, claims 1-3 and 7-10 are pending in the instant application. Claim 4-6 have been canceled and claims 7-9 are withdrawn. This action is written in response to applicant' s correspondence submitted 12/30/2025. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is Non-Final.
Withdrawn Rejections
The rejection of claims 1-3 and 10 under 35 U.S.C. 103 as being unpatentable over Seeling (US20170233722) in view of Hashimshony (Genome Biology, 2016, 17:77, pp. 11-7) is withdrawn in view of the amendment to the claims.
New Grounds of Rejection, Necessitated by Amendment to the Claims
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 1-3, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Honda (bioRxiv, posted March 23,2020, pp. 1-43, cited on IDS)
Honda teaches caged ODNs with NPOM (see pg 19). Honda an oligonucleotide that comprises a T7 polymerase, adapter sequence and polyT region. Honda teaches the adapter sequence and poly T sequence comprises caged poly T (see fig 1). Honda teaches the caged ODN were examined for RNA-seq library preparation. The adapter sequence of Honda comprises additional sequence and comprises discrimination sequence (see pg 19).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claims 1, 3, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eberwine (US20170253876A1).
With regard to claim 1 and 3, Eberwine teaches a T7 promoter, index and capture region of a single stranded oligonucleotide. Eberwine teaches the capture region comprises a 3’ photoactivable dideoxynucleotide. Eberwine teaches the photoactivable dideoxynucleotide blocks strand synthesis until photoactivated (see para 418 and fig 39). The index sequence and capture sequence is additional sequence for detecting a nucleic acid sequence that comprises a discrimination sequence (index sequence). The photolabile nucleotide is located at the 3’ end and therefore is located at position close to the 3’ end than the promoter sequence (claim 3). Eberwine teaches the photoactivable deoxynucleotide is a TISA-tag (See para 84). Eberwine teaches a promoter sequence, spacer region and index region and a caged molecule. Eberwine teaches a plurality of TISA tags with unique index oligonucleotides and uncaging of TISA-tags (see 295). Eberwine teaches a photolabile ligand with a reactive moiety (see para 164).
With regard to claim 10, the recitation of kit is not defined in the specification and is given its broadest reasonable interpretation to include a plurality of articles grouped together. However the only components of claim 1 are an oligonucleotide of claim 1. As such the oligonucleotides disclosed by Eberwine comprise the claimed kit.
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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Eberwine (US20170253876A1) in view of Alexander (EP3126512B1).
Eberwine teaches a T7 promoter, index and capture region of a single stranded oligonucleotide. Eberwine teaches the capture region comprises a 3’ photoactivable dideoxynucleotide. Eberwine teaches the photoactivable dideoxynucleotide blocks strand synthesis until photoactivated (see para 418 and fig 39). Eberwine does not teach photocleavable dideoxynucleotide comprises NPOM.
Alexander teaches oligonucleotide probes. Alexander teaches probes that comprise a binding moiety and a cleavable moiety that includes light activated nucleotides. Alexander teaches light activated oligos contain photolabile nucleobase modifications including NPOM. Alexander teaches the oligonucleotides can comprise a caged thymidine at the 3’ end (see ex 9) and the probes comprise NPOM.
Therefore it would have been prima facie obvious to the ordinary artisan at the time the invention was made to include known caged photolabile nucleobase modifications including NPOM, as taught by Alexander, in the oligonucleotide taught by Eberwine. The skilled artisan would have been motivated with a reasonable expectation of success to replace the photocleavable dideoxynucleotide as taught by Eberwine with known photocleavable labeled nucleotides, including NPOM as taught by Alexander.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 10 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18273003 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3 and 10 would have been anticipated by claims 1-3 of 18273003. Specifically claim 1 of ‘003 includes a nucleic acid fragment with a polymerase binding sequence and a transposase sequence wherein the polymerase or transposase sequence contains a caged nucleotide reside. The transposase sequence comprises additional sequence that includes a discrimination sequence. The instant claim 1 requires an oligonucleotide that comprising additional sequence and a T7 promoter. Claim 1 of ‘003 falls entirely in the scope of instant claim 1-3. Instant claim 2 and 3 require NPOM and a photolabile protecting group which is encompassed by a caged nucleotide recited in claim 1 of ‘003.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
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