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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 28, 2026 has been entered.
Status of the Application
2. Claims 74, 76-84 and 86-97 are pending under examination. Claims 1-73, 75 and 85 were canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive for the following reasons.
Claim Rejections - 35 USC § 103-withdrawn
3. The rejection of claims under 35 USC 103 as being obvious over Bjornson et al. in view of Mir has been withdrawn in view of the amendment.
Double Patenting-Withdrawn
4. The rejection of claims under obviousness type double patenting over the claims in the co-pending application 17/999,023 have been withdrawn in view of the amendment.
5. The rejection of claims under obviousness type double patenting over the claims in the patent US 10,768,173 have been withdrawn in view of the amendment.
6. The rejection of claims under obviousness type double patenting over the claims in the patent US 11,781,185 have been withdrawn in view of the amendment.
7. The rejection of claims under obviousness type double patenting over the claims in the patent US 12,139,727 have been withdrawn in view of the amendment. However, the rejection is restated to address the amendment.
Double Patenting
8. 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 74, 76-84 and 86-97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. US 12,139,727 in view of Iyidogan et al. (US 2018/0044715).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 74, 76-84 and 86-97 are entirely within the scope of the claims in the patent ‘727, specifically the method steps for nucleic acid sequencing in the claims 74, 76-84 and 86-97 comprising providing a first plurality of nucleotide conjugates, contacting primed nucleic acids with a first nucleotide of the plurality nucleotide conjugates, detecting signal of binding nucleotide conjugate with the nucleotides of a target nucleic acid, repeating the steps with a second nucleotide conjugate thereby detecting the identity of the nucleotide are within the scope of the claims in the patent ‘727, specifically claim 1, 13 and 24 of the patent ‘727. The claims 74, 76-84 and 86-97 recite ‘without performing primer extension’, which is obvious over the claim 1 of the patent ‘727 disclosing ‘inhibiting polymerase-catalyzed extension of the nucleic acid duplex’. However, the claims in the patent ‘727 do not disclose primer sequences comprise a blocked nucleotide.
Iyidogan et al. teach a nucleic acid sequencing and identifying first and second correct nucleotides respectively including bases complementary to the next two bases of a template strand in blocked primed template nucleic acid comprising providing a blocked primer comprising blocked nucleotide, contacting blocked primed template nucleic acid with polymerase and nucleotide analog comprising a detectable label, to form a ternary complex, without nucleotide incorporation (without primer extension) and detecting first labeled nucleotide analog that comprises the next correct nucleotide in said ternary complex and deblocking or removing blocked nucleotide and detect a second signal of the nucleotide in a template nucleic acid sequencing method (para 0009, 0011, 0018-0022, 0049, 0056-0059, 0064, 0226-0230).
It would have been prime facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of the claims in the patent ‘727 with a primer comprising blocked nucleotide as taught by Iyidogan et al. to develop a sensitive method for sequencing a nucleic acid. The ordinary person skilled in the art would have motivated to combine the method of the claims in the patent ‘727 with a blocking primer as taught by Iyidogan et al. and have a reasonable expectation of success that the combination would result in enhancing the sensitivity of the method because Iyidogan et al. explicitly taught a primer comprising a blocking nucleotide stabilizes a ternary complex formed by the blocked primed template with a polymerase and nucleotide analogs and provide efficient identification of correct nucleotide in a target nucleic acid sequencing and reduce processing time (para 0227-0230, 0018) and such a modification of the method is considered obvious over the cited prior art.
Conclusion
Claims 74, 76-84 and 86-97 are free of art.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681