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 .
Applicant’s election without traverse of Group II claims 6 and 8-11 in the reply filed on 13 March 2026 is acknowledged. The election/restriction requirement is deemed proper and is therefore made FINAL. An Action on the merits of claims 6 and 8-11 is contained herein below. Group I Claims 1-5 and 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
This application claims the benefit of 63/412,802 filed 10/02/2022. The parent application 63/412,802 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 6, 8-9, and 10-11 of this application.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Weinrich et al (Chemistry A European Journal, 2018, 24, 6202-6207; cited in IDS filed 12/14/2023) in view of Nomura et al (Nucleic Acids Research, 1997, 25(14), 2784-2791; cited in IDS filed 12/14/2023).
Weinrich et al teaches compound # 7 (page 6203, Fig. 2):
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Compound 7 of Weinrich et al meets the structural limitations of the compounds of formula (I) and (II) in claim 6 for dimethoxytrityloxy protecting group at the 5’-position of the sugar ring, the protecting group at the 3’-position of the sugar ring (phosphoramidite), and the N-(O-methoxynitrobenzyl-TEMPO group as in claim 6, and the limitation of claim 8. Weinrich et al also teaches a spin-labeled oligonucleotide having the N-(O-methoxynitrobenzyl-TEMPO group (page 6204. Figs. 5-6; part of the limitations of claims 10-11):
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Weinrich et al does not teach a compound wherein X1 and X2 are each hydrogen, X3 is methoxy, fluoro, hydrogen and tert-butyldimethylsilyloxy, and the position of attachment of the N-(O-methoxynitrobenzyl-TEMPO group on the uracil ring as in claim 6, and does not teach the limitations of claim 9 and some of the limitations of claims 10-11.
Nomura et al, drawn to introduction of functional groups into phosphodiester oligodeoxynucleotides, teaches attaching substituents at the 5-position of the uracil moiety (page 2785, Scheme 2):
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The attachment is via a -C(=O)-NH- linkage as in claims 6, 10 and 11. Even though Nomura et al does not teach the attachment of the N-(O-methoxynitrobenzyl-TEMPO group on the uracil ring via the -C(=O)-NH- linkage, one of ordinary skill in the art will recognize that the sugar moiety in the compound of Weinrich can be substituted with the uracil moiety having the N-(O-methoxynitrobenzyl-TEMPO group attached via the -C(=O)-NH- linkage to arrive at the compounds with different substitutions as in claims 6, 8 and 9 and also make an oligonucleotide having the spin-labeled nucleotide as in claims 10 and 11 with a reasonable expectation of success. The reaction scheme of Nomura can be used to attach the N-(O-methoxynitrobenzyl-TEMPO group on the uracil ring via the -C(=O)-NH- linkage.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, structurally close cytidine phosphoramidite with protected a spin label are used extensively in the analysis of RNA structure and dynamics using electron spin resonance (ESR) spectroscopy. Nomura et al teaches attaching the spin label to the 5-position of the uracil ring via the claimed linkage.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. One of ordinary skill in the art would be motivated to make the compounds as in claims 6, 8 and 9 and the oligonucleotides as in claims 10-11 in order to look for structurally close compounds as alternatives for use in analysis of RNA structure and dynamics studies by ESR spectroscopy as taught by Weinrich et al.
Conclusion
1. Elected claims 6, and 8-11 (Group II) are rejected.
2. Group I Claims 1-5 and 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693
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