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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7, 11, 13-15, in the reply filed on 07/31/2026 is acknowledged. Election of species of Formula 1 is acknowledged.
Claims 8-10, 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/31/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 11, 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites, in step b)(i), that "the initiator or the elongated fragment are elongated by incorporation of a 3'-O-amino nucleoside triphosphate to form 3'-O-amino elongated fragment" (emphasis provided). Since a pyrophosphate moiety would be released during such polymerase-based incorporation, it is unclear how a whole "3'-O-amino nucleoside triphosphate" could possibly be incorporated. Claims 2-7, 11, 13-15, each of which depends from claim 1, are also rejected for the same reason.
It is suggested that the recitation "incorporation of a 3'-O-amino nucleoside triphosphate" in step b)(i) be changed to "incorporation of a 3'-O-amino nucleotide" to overcome this rejection.
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.
Claim(s) 1-7, 11, 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutter et al (Nucleosides Nucleotides Nucleic Acids, 2010, 29(11), pages 1-18, cited from IDS) and in further view of Benner et al (US 8034923, October 2011, cited from IDS) and Sudo et al (US 2020/0061225, February 2020, cited from IDS).
Hutter teach methods of oligonucleotide elongation involving contacting initiator with a free 3’-hydroxyl with 3’-O-amino nucleoside triphosphate and polymerase so that initiator is elongated by incorporation of 3’-O-amino nucleotide and further deprotection of 3’-O-amino comprising fragment to form a free 3’-hydroxyl (see Figure 1). Such reaction is carried out in the presence of hydroxylamine, which is an aldehyde scavenger, to prevent formation of oximes (see second paragraph on page 5).
Hutter do not teach using template-independent polymerase such as terminal deoxynucleotidyltransferase (TdT) for use in the method, or using aldehyde scavenger of Formula (1) in specific concentrations.
Benner teach that template-independent polymerase TdT is capable of recognition of 3’-O-amino nucleoside triphosphates and therefore capable of using such modified triphosphates for oligonucleotide synthesis (see lines 45-50 in column 3).
Sudo teach a number of effective aldehyde scavengers including one identical to instant Formula (1) (see Table 1, Example 4 on page 8).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to carry out synthesis of an oligonucleotide using method of Hutter and TdT polymerase taught by Benner and aldehyde scavenger taught by Sudo, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so, because Hutter teach method of oligonucleotide synthesis using 3’-O-amino nucleoside triphosphates in the presence of aldehyde scavengers, Benner teach that TdT polymerase recognizes such modified triphosphates and can use them for oligonucleotide elongation and Sudo teach several effective aldehyde scavengers, which can be used in the method taught by Hutter. Further, it would be reasonable to deliver aldehyde scavenger together with 3’-O-amino nucleoside triphosphate, because such scavengers are used to protect amino group of 3’-O-amino nucleoside triphosphate. Lastly, it would be a matter of ordinary optimization to define specific concentration of aldehyde scavenger in such method of oligonucleotide synthesis.
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 1-7, 11, 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,428,668 in view of Hutter, Benner and Sudo, above. Claims of ‘668 teach methods of oligonucleotide synthesis using template-independent polymerase and 3’-O-blocked nucleoside triphosphates, same as in instant claims. Teachings of Hutter, Benner and Sudo are discussed above. It would have been obvious to use 3’-O-amino blocked nucleoside triphosphates taught by Hutter in the methods from ‘668 in combination with aldehyde scavengers taught by Sudo, arriving at instant invention.
Claims 1-7, 11, 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,606,856 in view of Hutter and Sudo, above. Claims of ‘856 teach methods of oligonucleotide synthesis using template-independent polymerase and 3’-O-amino nucleoside triphosphates, same as in instant claims. Teachings of Hutter and Sudo are discussed above. It would have been obvious to use 3’-O-amino blocked nucleoside triphosphates taught by Hutter in the methods from ‘856 in combination with aldehyde scavengers taught by Sudo, arriving at instant invention.
Claims 1-7, 11, 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11-28 of copending Application No. 17/629,322 in view of Hutter and Sudo, above. Claims from ‘322 recite methods of oligonucleotide synthesis comprising 3’-O-amino blocked nucleoside triphosphates and TdT, same as in instant claims. Teachings of Hutter and Sudo are discussed above. It would have been obvious to use aldehyde scavengers taught by Sudo in the methods of ‘322 based on teachings of Hutter and Sudo, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 11, 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 11-14, 18-22, 25-26, 30, 32-33, 42-43 of copending Application No. 18/014,993 in view of Sudo, above. Claims from ‘993 recite methods of oligonucleotide synthesis comprising 3’-O-amino blocked nucleoside triphosphates and TdT in the presence of aldehyde scavengers, same as in instant claims. Teachings of Sudo are discussed above. It would have been obvious to use aldehyde scavengers taught by Sudo in the methods of ‘993 based on teachings of Sudo, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 11, 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 12-17 of copending Application No. 18/285,014 in view of Hutter and Sudo, above. Claims from ‘014 recite methods of oligonucleotide synthesis comprising 3’-O-amino blocked nucleoside triphosphates and TdT, same as in instant claims. Teachings of Hutter and Sudo are discussed above. It would have been obvious to use aldehyde scavengers taught by Sudo in the methods of ‘014 based on teachings of Hutter and Sudo, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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