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 .
DETAILED ACTION
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 02, 2026 has been entered.
Status of the Application
2. Claims 6-9, 11-15, 17-19, 21-25 are pending under examination. Claims 1-5, 10, 16, 20 and 26 were canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive for the following reasons.
Priority
3. This application filed on March 20, 2023 is a CON of 16/588,405 filed on September 30, 2019, now US patent 11,639,517 which claims priority to US 62/739,795 filed on October, 01, 2018. This application discloses and claims only subject matter disclosed in prior application no. 16/588,405 filed September 30, 2019, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a division. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq.
Claim Rejections - 35 USC § 103-Withdrawn
4. The rejection of claims under 35 USC 103 as being obvious over Chang et al. in view of Withey et al. has been withdrawn in view of the amendment.
Double Patenting-Withdrawn
5. The rejection of claims under obviousness type of double patenting over the claims in US patent 11,946,095 in view of Withey et al. and Chang et al. has been withdrawn in view of the amendment.
6. The rejection of claims under obviousness type of double patenting over the claims in co-pending application 17/163,177 in view of Withey et al. and Chang et al.; The rejection of claims under obviousness type of double patenting over the claims in US 11,365,409 in view of Withey et al. and Chang et al.; and the rejection of claims under obviousness type of double patenting over the claims in US 11,773,436 in view of Withey et al. and Chang et al. have been withdrawn in view of the terminal disclaimer.
Double Patenting
7. 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.
A. Claims 6-9, 11-15, 17-19 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,084,712 (the ‘712) in view of Linnarson (US 2012/0010091) and Withey et al. (WO 2017 /079593).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 6-9, 11-15, 17-19 and 21-25 are obvious over claims 1-26 in the patent ‘712. Specifically, the kit comprising plurality of oligonucleotide barcodes, each comprising a molecular label and a target-binding region and wherein at least 10 of the plurality of barcodes comprises different molecular label sequences of claim 6 and the limitations of the dependent claims 7-9, 11-15, 17-19 and 21-25 are within the scope of the claims 1-26 of the patent ‘712 specifically claims 1, 2, 15 and 22-26 of the patent ‘712, disclosing plurality of indexing oligonucleotides, wherein plurality comprises at least 10 different indexing oligonucleotide sequences.
However, the claims in the patent ‘712 did not specifically disclose template switch
oligonucleotide comprising one or more 3’ ribonucleotides and oligo d(T) sequence of at least 5 nucleotides.
Linnarson teaches cDNA synthesis, wherein the cDNA synthesis composition comprises template switch oligonucleotide (TSO), wherein the 3’ portion of TSO includes one or more ribonucleotides, wherein the ribonucleotides are guanines (para 0057, 0063, 0080, 0090). Linnarson also teach that the TSO comprises an amplification primer sequence and a tag (barcode) sequence comprising at least 4-20 nucleotides (para 0015-0016, 0065) and choride salt (STRT buffer comprising TRis-Hcl, Kcl and MgCl2) (para 0129).
Withey et al. teach a method for barcoding and detection of target nucleic acid wherein the reaction composition comprises plurality of barcode oligonucleotides, reverse transcription with and a reverse transcriptase in the presence of a template switch oligonucleotide (TSO) comprising a barcode sequence, wherein the barcode sequence comprises poly-T of at least 5 nucleotides (para 0113-0133).
It would have been prima facie obvious to an ordinary person skilled in the art before the effective filling date of the invention to modify the method of the claims in the patent ‘712 with the template switch oligonucleotide comprising one or more ribonucleotides as taught by Linnarson and oligo-dT of at 5 nucleotides as taught by Withey et al. to improve the kit composition for reverse transcription amplification. The ordinary person skilled in the art would have motivated to combine the kit components of the claims in the patent ‘712 with a template switch oligonucleotide as taught by Linnarson and Withey et al. and have a reasonable expectation of success that the combination would improve the kit composition for detecting and quantifying target nucleic acids because Linnarson explicitly taught TSO comprising one or more ribonucleotides to improve reverse transcription (para0050-0057) and Withey et al. explicitly taught use of template switch oligonucleotide having target binding region comprising barcode sequence wherein the barcode comprises oligo d(T), allowing identification of origin of the target nucleic acid (para 0113-0124, 0128-0133) and such a modification is considered obvious over the cited prior art.
B. Claims 6-9, 11-15, 17-19 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11, 639,517 (the ‘517) in view of Chang et al. (WO 2017/048993) and Withey et al. (WO 2017 /079593).
Note: the following rejection is made in view of the priority benefit claimed as a continuation application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 6-9, 11-15, 17-19 and 21-25 are obvious over claims 1-21 in the patent ‘517. Specifically, the kit comprising plurality of oligonucleotide barcodes, each comprising a molecular label and a target-binding region and wherein at least 10 of the plurality of barcodes comprising different molecular label sequences, template switch oligonucleotide comprising target binding region that is a poly (dT) sequence of claim 6 and the limitations of the dependent claims 7-9, 11-15, 17-19 and 21-25 specifically 1, 6, 11, 13 disclosing plurality of different oligonucleotide barcodes and a template switch oligonucleotide comprising three guanines (ribonucleotides) are within the scope of the claims of the patent ‘517.
However, the claims in the patent ‘517 did not specifically disclose at least 10 barcode oligonucleotides and template switch oligonucleotide comprising oligo d(T) sequence of at least 5 nucleotides.
Chang et al. teach that the kit comprising plurality of oligonucleotides comprising barcodes, wherein plurality of barcodes comprises at least 10, template switch oligonucleotides and one or more of ethylene glycol, PEG, DMSO, glycerol or 1, 2-propanediol; (page 9, line 19-33, page 10, line 1-6).
Withey et al. teach a method for barcoding and detection of target nucleic acid wherein the reaction composition comprises plurality of barcode oligonucleotides, reverse transcription with and a reverse transcriptase in the presence of a template switch oligonucleotide (TSO) comprising a barcode sequence, wherein the barcode sequence comprises poly-T of at least 5 nucleotides (para 0113-0133).
It would have been prima facie obvious to an ordinary person skilled in the art before the effective filling date of the invention to modify the method of the claims in the patent ‘517 with at least 10 barcode oligonucleotides as taught by Chang et al. and the template switch oligonucleotide comprising oligo-dT of at 5 nucleotides as taught by Withey et al. to improve the kit composition for reverse transcription amplification. The ordinary person skilled in the art would have motivated to combine the kit components of the claims in the patent ‘517 with at least 10 barcode oligonucleotides and a template switch oligonucleotides comprising oligo d(T) of at least 5 nucleotides as taught by Chang et al. and Withey et al. and have a reasonable expectation of success that the combination would improve the kit composition for detecting and quantifying target nucleic acids because Chang et al. explicitly taught at least 10 barcode oligonucleotides (page 9, line 19-33, page 10, line 1-6) and Withey et al. explicitly taught use of template switch oligonucleotide having target binding region comprising barcode sequence wherein the barcode comprises oligo d(T), allowing identification of origin of the target
nucleic acid (para 0113-0124, 0128-0133) and such a modification is considered obvious over the cited prior art. Further, it would be obvious to modify the kit with the inclusion of one or more of ethylene glycol, PEG, DMSO, glycerol or 1,2-propanediol as taught by Chang et al. to improve the kit composition because Chang et al. explicitly taught use of 1,2-propanediol to facilitate amplification of GC rich sequences in the target nucleic acid (page 9, line 19-33, page 10, line 1-6) and such a modification is obvious over the cited prior art.
Conclusion
Claims 6-9, 11-15, 17-19, 21-25 are free of prior art.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681