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 .
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 18/835,547 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of ‘547 would anticipate the methods claimed herein. For example, claim 5 of ‘547 would anticipate the present claims as both claims are drawn to methods of making oligonucleotides comprising the same steps wherein the binding step os to be practiced at lower temperatures of overlapping ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. (Tetrahedron, vol. 69, 2013, pp 3615-3637) in view of US 7,339,052.
The claims of the present application are drawn to methods of making an oligonucleotide comprising (a) removing a 3’- or 5’-hydroxy, thiol, or amino protecting group from a protected nucleoside attached to a support; (b) binding a nucleoside phosphoramidite to the deprotected 3’- or 5’-group in the presence of an activator; (c) sulfurizing or oxidizing the bond formed in (b); and (d) capping the unbonded 3’- or 5’-hydroxy, thiol, or amino group; wherein the temperature of a solution is 5-19°C. Dependent claims provide the amount of phosphoramidite used in step (b) is 1-2 equivalents of the nucleoside on the support in step (a); limits the temperature to 5-15°C; and limits the activators to various such as 4,5-dicyanoimidazole or 5-benzylthio-1H-tetrazole.
Wei discloses methods of making oligonucleotides via the phosphoramidite approach which comprises a cycle of steps consisting of deblocking, coupling, capping/sulfurization, and capping reactions (see page 3618, top paragraph and scheme 2). The deblocking step is shown to release the free 5’OH group; the coupling/binding step is performed with activators such as 5-benzylthio-1H-tetrazole (see 2.2.4 on page 3623; see also scheme 14); the sulfurization/capping step is then performed as it is taught that a small percentage of the unreacted 5’-hydroxyl groups remain active after completion of the coupling step and in order to prevent these sites from reacting with the later phosphoramidites, the unbound active 5’-hydroxyl groups are capped. Wei also teaches that the (P(III)) linkage formed in the coupling/binding step (b) is unstable and has to be transferred to the phosphate triester P(V)) linkage by treating the chain with oxidation agents (or sulfurizing) – see page 3618 steps 1-4. What is not disclosed is the actual temperature used being a lower temperature within the range of 5-19°C.
US ‘7,339,052 disclose methods of making oligonucleotides via the phosphoramidite method wherein an activator solution comprising BTT (benzylthiotetrazole) used in the coupling reaction wherein the temperature is maintained above 4°C (see column 6, lines 16-24).
As such, it would be obvious to modify the process of Wei such as by modifying the temperature with these references before them. On page 3623, Wei note that one method to improve the efficiency of activation is to provide an activator solution with a higher concentration which allows the activators to stay in solution even at a very low temperature. ‘052 teaches that this solution should be maintained above 4°C, thus arriving at a temperature of 5-19°C would be prima facia obvious. A skilled artisan would have had a reasonable expectation of success since the process steps and conditions claimed herein were disclosed and suggested in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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