DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 02/07/2024 has been entered. Claims 3, 15, and 20 are cancelled. Claims 1, 2, 4-14, 16-19, and 21 are pending in this application. Claims 1, 2, 4-14, and 21 are withdrawn. Claims 16-19 are currently under examination.
Priority
This application is a 371 of PCT/EP2022/072271 filed on 08/08/2022 and claims foreign priority of UNITED KINGDOM (GB) 2111456.6 filed on 08/09/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. GB2111456.6, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 16-19 recite “
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,
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, or
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… X is S”, “at the 3'-end, three successive copies of a monomer residue of formula”, and/or “
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;
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;
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”, which are not disclosed or supported by the prior-filed Application No. GB2111456.6. Thus, the priority of claims 16-19 is 08/08/2022.
Election/Restrictions
Applicant's election without traverse of Group III invention (claims 16-19) in the reply filed on 07/01/2026 is acknowledged. Claims 1, 2, 4-14, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 16-19 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 02/07/2024 has been considered.
Claim Objections
Claims 16, 17, and 19 are objected to because of the following informalities: In claim 16, insert the missing clause “; wavy lines denote points of attachment within the oligonucleotide chain or a terminus of the oligonucleotide chain” at the end of the claim to indicate the meaning of the wavy lines. In claim 17, change the incorrect recitation “claim 16 comprising, optionally at” (line 1) to “claim 16, wherein the oligonucleotide comprises, at” to become proper dependent claim. In claim 19, change the incorrect recitation “An oligonucleotide of claim 16 selected from” (line 1) to “The oligonucleotide of claim 16, wherein the oligonucleotide is selected from the group consisting of” to become proper dependent claim and to comply with Markush group format ending with conjunction “and’ before the last species; and replace the incorrect recitation “waved line indicates an oligonucleotide chain” (last line) with “waved ribbon indicates a 5’ end of the oligonucleotide chain” because the “line” is more accurately a ribbon and the “an oligonucleotide chain” encompasses the preceding “oligonucleotide” in the preamble. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Guan et al. (WO 2022/266316, December 22, 2022, filed on June 16, 2022 and benefitted by US PRO 63/212,519 filed on June 18, 2021, hereinafter referred to as Guan ‘316) in view of Khan et al. (WO 98/06732, February 19, 1998, hereinafter referred to as Khan ‘732).
With regard to structural limitations “an oligonucleotide comprising at least one monomer residue of formula: (A)
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, wherein X is S or O; wavy lines denote points of attachment within the oligonucleotide chain or a terminus of the oligonucleotide chain (or comprising at the 3 '-end, three successive copies of a monomer residue of formula (A); or the oligonucleotide is
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, wherein the waved ribbon indicates a 5’ end of the oligonucleotide chain)” (claims 16-19):
Guan ‘316 disclosed preparation of DMT-dlJ-EO-GaiNAc-Phosphoramidite/CGP:
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. GalNAc conjugated nucleosides in oligonucleotide synthesis. In some embodiments, the oligonucleotide comprises 1 to 100 base length, 5 to 50 base length, or 10 to 30 base lengths. In further embodiments, the reaction is conducted on a solid support. The solid support comprises an oligonucleotide, and the compound is incorporated into the oligonucleotide sequence, for example, to the terminal of the oligo sequence (either at the 5’ end or at the 3’ end). Fig. 6 illustrates a synthetic cycle of oligonucleotide using a nucleoside containing phosphoramidite moiety.
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(page 37/67, Example 4; [0119]; page 32/67, [0100-0102]; page 64/67, Fig. 6). A sequence was designed for trails: 5’-TTTTTTTTTT-Y-3’, where Y represents GalNAc-conjugated solid supports (page 51/67, [0157]).
Sharma ‘2004 did not explicitly disclose the limitation “
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”, required by claims 16-19.
Khan ‘732 disclosed a novel class of propargylethoxyamino nucleotides useful as chain-terminating dideoxynucleotides, and, as chain-extending deoxynucleotides. Synthesis of 5-[3-(2-(2-Phthalamidoethoxy)ethoxy)propyn-1-yl]-2’,3’-dideoxycytidine (17): 5-Iodo-2',3'-dideoxycytidine 6 (240 mg, 0.71 mmol)) was reacted with compound 16 (
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). Synthesis of 5-[3-{2-(2-Trifluoroacetamidoethoxy)ethoxy}propyn-1-y]-2’,3’-dideoxycytidine (18). Fig. 10:
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. The novel class of propargylethoxyamino nucleoside compounds useful as substrates for polymerase enzymes (page 5/55, lines 30-33; page 30/55, lines 10-31; page 31/55, lines 1-9; page 48/55, Fig. 10; page 8/55, lines 21-25).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the compound 1 (
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) as taught by Guan ‘316 with compound 16 (
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) or
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in view of Khan ‘732 to obtain an oligonucleotide that is synthesized chemically and also a substrate for polymerase enzyme-initiated synthesis, described above. Thus, one of skill in the art would have a reasonable expectation that by substituting the compound 1 (
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) as taught by Guan ‘316 with compound 16 (
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) or
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in view of Khan ‘732 to obtain an oligonucleotide that is synthesized chemically and also a substrate for polymerase enzyme-initiated synthesis, one would achieve Applicant’s claims 16-19. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I].
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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