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 .
Claims 1-20 are pending in the instant application. Preliminary amendment filed 13 October 2022.
Priority
This application is a 371 of PCT/JP2021/014017 filed 03/31/2021. This application claims foreign priority to JAPAN JP2020-072234 filed 04/14/2020, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
Claim Objections
Claims 2, 3 and 13 are objected to because of the following informalities: In claims 2 and 3 the recitation ‘X represents any groups’ should be replaced by the recitation ‘X represents a group’. In claim 13 the recitation ‘of the formula (1)’ at lines 5 and 6 should replaced by the recitation ‘of formula (1)’. Appropriate correction is required.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Krotz et al (WO 03/005822 A1; cited in IDS filed 01/13/2023).
Krotz et al teaches a formulation comprising a nucleic acid oligomer having a phosphorothioate linkage (page 3, lines 9-14; page 14, lines 6-7; part of the limitations of claim 1 nucleic acid oligomer having a phosphorothioate bond). The composition can contain a-lipoic acid as an additive (page 3, lines 23-27; see also examples 4 and 5 at pages 46-47; additive of formula 3 as in claim 1, and claims 6, 7 and 14). The composition includes base addition salts with alkali metals and ammonium ions (page 25, lines 6-16; ammonium salt as in claim 1 and limitation for G in claim 1). This renders obvious the use of the ammonium salts as in claims 8 and 15. A suitable carrier is water and alcohol (page 26, lines 18-22; water and water-soluble organic solvent as in claim 1 and alcoholic water-soluble solvent as in claims 9, 16 and 19). The oligonucleotides used in the composition comprise from about 8 to about 30 nucleotides. More preferable is from about 10 to about 25 nucleotides (page 13, lines 1-3; limitation of claim 1 for 15 ≤ n). The bases can be any one of the unmodified or natural nucleobases (page 15, line 31 through page 16, line 24; limitation Bc in claim 1). The sugar modification includes oligonucleotides having substitutions at the 2’-position which can be OH, F, O-alkyl. Several other modifications are also taught including modifications at other positions of the ribose (page 17, line 3 through page 19, line 7; limitation R and Q in claim 1 and limitation for R in claims 10-11, 17-18 and 20). The invention encompasses RNA and DNA (page 8, lines 8-21; meets formula (1) and limitation of X and Y as in claim 1).
According to Krotz substances like glutathione and a-lipoic acid inhibited desulfurization of the oligonucleotide comprising phosphorothioate linkages. In addition, Krotz also teaches that even though certain antioxidants are exemplified, the use of any such antioxidant is within the scope of its invention (page 3, lines 23-31). Since both glutathione and a-lipoic acid have sulfur /sulfide linkages in them and they stabilize the oligonucleotide comprising phosphorothioate linkages one of ordinary skill in the art would substitute the glutathione and a-lipoic acid with the other additives of formula 3 and 4 as in claims 1-5 and 14 in order to look for oligonucleotide compositions that are stable since these are used for treating many disorders (page 1, line 15 through page 2, line 5).
Regarding claim 12, Krotz teaches precipitation of oligonucleotide using ethanol (C1 alcohol; Example 4 at page 46). In view of this teaching one of ordinary skill in the art will find it obvious to prepare a nucleic acid oligomer as in claim 12.
Krotz teaches preparation of oligonucleotides including the ones with phosphorothioate linkages (page 23). Regarding purification, Krotz teaches that after deblocking in concentrated ammonium hydroxide, the oligonucleotides were purified by precipitation with NaCl and ethanol and further purified by reverse phase high pressure liquid chromatography (page 41, part B). In view of this teaching one of ordinary skill in the art can carry out the process of preparing the composition as in claim 13 by mixing the components recited and subjecting it to reverse phase chromatography. This is well within the skill level of the artisan to conceive and perform in view of the teaching of Krotz.
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, compositions comprising the claimed components are known in the art as stable compositions for use in treating many disorders. Preparation and purification steps as claimed are also taught in the prior art. Thus, it is obvious to arrive at the claimed invention in view of the teachings of the prior art.
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. Product improvement is the motivation. The composition having the claimed components is also suggested by the prior art to be stable and useful in treating many disorders. Hence the artisan would look for such stable compositions comprising the nucleic acid oligomers of formula (1) comprising the phosphorothioate bond and the other components.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 of copending Application No. 17/970,138 (‘138). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant Claims are drawn to a composition comprising a nucleic acid oligomer of formula (1) having a phosphorothioate bond and wherein there is 2’ position modification which includes 2’-OMe.
The copending claim 1 of ‘138 is drawn to a modified nucleic acid oligomer having a purity of at least 70% and a strand length of at least 90 nucleotides and having a 2’-OMe modification. Claims 2 and 3 of ‘138 recite limitations drawn to the nucleotide length being from 90 to 200 and the purity level is at least 90%.
The copending claims of ‘138 differ from the instant claims in that the instant claims do not recite the purity level and do not recite a nucleotide length of at least 90 nucleotides or from 90-200 nucleotides.
The instant specification, at page 32, para 0072, teaches nucleic acid oligomers of strand lengths of n ≥ 100, and also n ≤ 200. 94.2% purity level is also taught page 37, para 0082. Therefore, the claimed product is an obvious variant of the product made in the claims of ‘138.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Pending claims 1-20 are rejected
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693