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 claims 1-2, 7, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 with species election of “eeeeeeeeeeeeeeeeee”, “sssssssssoossssss”, and SCN1A in the reply filed on July 29, 2026 is acknowledged.
Status of Claims
Claims 1-2, 7, 25-26, 57, 62, 69, 72, 74, 78, 81-82, 87, 92-94, 97-98, and 101 are currently pending in the instant application. Claims 2, 7, 92-94, 97-98, and 101 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Accordingly, claims 1, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 are under examination on the merits in the instant application.
Specification
The disclosure is objected to because of the following informalities: page 42 of the specification discloses a Table without an associated Table number.
Appropriate correction is required.
Claim Rejections - Improper Markush Grouping
Claim 69 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination of process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP §706.03(y).
The Markush grouping of 26 different pre-mRNAs is improper because the alternatives defined by the Markush grouping do not share a nucleotide sequence similarity. Hence, the oligonucleotide sequences of the oligomeric compounds complementary to different pre-mRNAs do not share a common nucleotide sequence, nor do they all share a common use. For instance, an oligonucleotide sequence complementary to SMN2 pre-mRNA would modulate splicing of SMN2 pre-mRNA, whereas that complementary to SCN1A pre-mRNA would not modulate splicing of SMN2 pre-mRNA.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternatives within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 25 recites modified sugar motifs having “n” representing a 2’-NMA sugar moiety. It is noted that claim 1 specifically and expressly recites that the sugar-modified nucleoside is 2’-MOE, cEt, or 2’-OMe. As such, the 2’-NMA sugar moiety is not recited in claim 1, from which claim 25 depends. Accordingly, claim 25 fails to further limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 25-26, 57, 62, 72, 74, 78, and 81-82 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rigo et al. (US 2016/0032285 A1).
Rigo discloses chemically modified 18-mer antisense oligonucleotides fully modified with 2’-MOE (e.g., “eeeeeeeeeeeeeeeeee”) having the phosphodiester/phosphorothioate-mixed linkage modification pattern such as “SSOSOSOSOSOSOSOSS”, wherein the oligonucletoides target human Tau pre-mRNA. See for instance ISIS 678329 in Table 9.
Rigo teaches that the antisense oligonucleotide can comprise a conjugate group such as “lipids”. See paragraph 0366.
Accordingly, claims 1, 25-26, 57, 62, 72, 74, 78, and 81-82 are described by Rigo et al.
Claims 1, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhang et al. (WO 2019/075357 A1, applicant’s citation).
Zhang discloses an 18-mer antisense oligonucleotide complementary to a SMN2 pre-mRNA for modulating splicing of the SMN2 pre-mRNA, wherein the oligonucleotide consists of eighteen (fully) 2’-MOE-modfiied nucleotides having the backbone modification pattern of “SSSSSSSSOSSSSSSSS” (see “WV-6788”) or “SSSSSSSOOOSSSSSSS” (see “WV-6789”), wherein O is a phosphodiester linkage and S is a phosphorothioate linkage, wherein the oligonucleotide can be on conjugated with a conjugate group such as carbohydrate. Paragraphs 00593, 00631-00633, and 00648-00649; Table 1A.
Accordingly, claims 1, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 are described by Zhang et al.
Claims 1, 25-26, 57, 62, 72, 74, 78, and 81-82 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hinckley et al. (WO 2020/257631 A2).
Hinckley teaches making a 2’-MOE-modified antisense oligonucleotide of 18 nucleotides in length that is complementary to a “pre-mRNA sequence”, thereby “altering pre-mRNA splicing”, wherein “every nucleoside of the 5’ wing region or the 3’ wing region is a 2’-MOE nucleoside” and “every nucleoside of the central region is a 2’-MOE nucleoside”, wherein the oligonucleotide can comprise “a mixture of modified internucleoside linkages and naturally occurring phosphodiester linkages” such that the oligonucleotide comprises “8 phosphorothioate linkages and 9 phosphodiester linkages” or the mixture of the linkages has the modification pattern of “soosssssssssssoos”. See paragraphs 0015, 0026-0027, 00143-00144, 00174-00175, and 00186.
Hinckley teaches that “the oligonucleotide further comprises a conjugate moiety”, which is “a cholesterol conjugate” See paragraph 0032.
Accordingly, claims 1, 25-26, 57, 62, 72, 74, 78, and 81-82 are described by Hinckley et al.
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.
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 1, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Hinckley et al. (WO 2020/257631 A2) in view of Arnarez et al. (US 2018/0369275 A1).
Hinckley teaches making a 2’-MOE-modified antisense oligonucleotide of 18 nucleotides in length that is complementary to a “pre-mRNA sequence”, thereby “altering pre-mRNA splicing”, wherein “every nucleoside of the 5’ wing region or the 3’ wing region is a 2’-MOE nucleoside” and “every nucleoside of the central region is a 2’-MOE nucleoside”, wherein the oligonucleotide can comprise “a mixture of modified internucleoside linkages and naturally occurring phosphodiester linkages” such that the oligonucleotide comprises “8 phosphorothioate linkages and 9 phosphodiester linkages” or the mixture of the linkages has the modification pattern of “soosssssssssssoos”. See paragraphs 0015, 0026-0027, 00143-00144, 00174-00175, and 00186.
Hinckley teaches that “the oligonucleotide further comprises a conjugate moiety”, which is “a cholesterol conjugate” See paragraph 0032.
Hinckley does not teach that the “pre-mRNA sequence” targeted by the antisense oligonucleotide is SCN1A pre-mRNA.
Arnarez teaches that antisense oligonucleotides targeting SCN1A pre-mRNA are useful for potential treatment of SCN1A-associated conditions. See paragraph 0021.
It would have been obvious to one of ordinary skill in the art before the effective filing date to target SCN1A pre-mRNA as the target “pre-mRNA sequence” when making the 18-mer antisense oligonucleotide of Hinckley. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to make a composition that is potentially useful for treating SCN1A-associated conditions because making an antisense oligonucleotides targeting SCN1A pre-mRNA was an art-recognized goal for potential use in treating conditions associated with SCN1A pre-mRNA as taught by Arnarez.
Accordingly, claims 1, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 taken as a whole would have been prima facie obvious before the effective filing date.
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 72, 74, and 82 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,487,780 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘780 patent claims that require a fibronectin pre-mRNA-targeting modified antisense oligonucleotide targeting a region within nucleobase 55469-55790 of SEQ ID NO:1, wherein the broadly claimed oligonucleotide in the ‘780 patent claims is defined and disclosed to read on the appropriate oligonucleotides disclosed in Table 20, which discloses an 18-mer modified oligonucleotide targeting the region starting at 55470 of SEQ ID NO:1 having the modification pattern of “kkeekeekeekeekeeke”.
Claims 1, 25-26, 57, 62, 78, and 81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,487,780 B2 in view of Rigo et al. (US 2016/0032285 A1), Zhang et al. (WO 2019/075357 A1, applicant’s citation), Hinckley et al. (WO 2020/257631 A2), and Zhou et al. (Bioorganic & Medicinal Chemistry Letters, 1998, 8:3269-3274, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘780 patent claims that require a fibronectin pre-mRNA-targeting modified antisense oligonucleotide targeting a region within nucleobase 55469-55790 of SEQ ID NO:1, wherein the broadly claimed oligonucleotide in the ‘780 patent claims is defined and disclosed to read on the appropriate oligonucleotides disclosed in Table 20, which discloses an 18-mer modified oligonucleotide targeting the region starting at 55470 of SEQ ID NO:1 having the modification pattern of “kkeekeekeekeekeeke”. It would have been obvious to incorporate any of the art-recognized mixed backbone motif taught by Rigo, Zhang, or Hinckley into the oligonucleotide of the ‘780 patent claims because such mixed backbone motif was known to be useful when targeting a pre-mRNA as evidenced by Rigo, Zhang, and Hinckley, and further because oligonucleotides comprising a mixed backbone comprising phosphodiester and phosphorothioate linkages were known to have reduced toxicity while retaining serum stability as taught by Zhou (see pages 3271 and 3273; Table 1). It would also have been obvious to conjugate an art-recognized conjugate group to the oligonucleotide of the ‘780 patent claims because making a conjugate group-conjugated oligonucleotide targeting a pre-mRNA was an art-recognized design/goal as evidenced by Rigo, Zhang, and Hinckley.
Claims 1, 25-26, 62, 72, 74, and 82 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 9,644,207 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘207 patent claims drawn to and require a chemically modified antisense oligonucleotide targeting a region within nucleobases 121708-122044 or 121873-121898 of SEQ ID NO:1, which is defined to read on the fully 2’-MOE modified ISIS 678329 (SEQ ID NO:140) targeting human Tau pre-mRNA having the linkage modification motif of “SSOSOSOSOSOSOSOSS” as disclosed in Table 9.
Claims 57, 78, and 81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 9,644,207 B2 in view of Rigo et al. (US 2016/0032285 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘207 patent claims drawn to and require a chemically modified antisense oligonucleotide comprising SEQ ID NO:140, which is defined to read on the fully 2’-MOE modified ISIS 678329 (SEQ ID NO:140) targeting human Tau pre-mRNA having the linkage modification motif of “SSOSOSOSOSOSOSOSS” as disclosed in Table 9. It would have been obvious to conjugate a conjugate group such as lipids to the oligonucleotide of the ‘207 patent claims because making a conjugate group-conjugated oligonucleotide targeting a pre-mRNA was an art-recognized design/goal as evidenced by Rigo.
Claims 1, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,943,604 B2 in view of Zhang et al. (WO 2019/075357 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘604 patent claims drawn to and require a compound comprising a conjugate targeting group comprising N-acetylgalactosamine and a “therapeutic nucleoside”, which is defined to read on “an antisense compound” as disclosed in the ‘604 patent specification. It would have been obvious to use Zhang’s oligonucleotide that is 2’-MOE fully modified with mixed backbone modification motif targeting SMN2 pre-mRNA for the “therapeutic nucleoside” of the ‘604 patent claims because Zhang’s oligonucleotide was taught to be therapeutically useful in treating SMN2-related conditions such as SM and ALS (see abstract) thus one of ordinary skill in the art would have reasonably deemed Zhang’s oligonucleotide qualifies as the “therapeutic nucleoside” of the ‘604 patent claims.
Claims 72, 74, 82, and 87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,174,318 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘318 patent claims drawn to and require a chemically modified antisense oligonucleotide, which is defined to read on any including those disclosed in Table 1 containing “non-limiting examples of antisense compounds” including fully 2’-MOE modified ISIS 396443 targeting SMN pre-mRNA.
Claims 1, 25-26, 57, 62, 69, 78, and 81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,174,318 B2 in view of Zhang et al. (WO 2019/075357 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘318 patent claims drawn to and require a chemically modified antisense oligonucleotide, which is defined to read on any including those disclosed in Table 1 containing “non-limiting examples of antisense compounds” including fully 2’-MOE modified ISIS 396443 targeting SMN pre-mRNA. It would have been obvious to use Zhang’s oligonucleotide with mixed backbone modification motif targeting SMN2 pre-mRNA for the ‘318 patent claims’ oligonucleotide defined to encompass an SMN pre-mRNA-targeting oligonucleotide because Zhang’s oligonucleotide was taught to be therapeutically useful in treating SMN2-related conditions such as SM and ALS (see abstract) thus one of ordinary skill in the art would have reasonably deemed Zhang’s oligonucleotide qualifies as the oligonucleotide of the ‘318 patent claims.
Claims 1, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-18 of U.S. Patent No. 10,570,169 B2 in view of Zhang et al. (WO 2019/075357 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘169 patent claims drawn to and require a compound comprising a GalNac conjugate group and “an oligomer” comprising “at least one modified nucleoside” that is “complementary to an equal length portion of a target nucleic acid.” . It would have been obvious to use Zhang’s oligonucleotide that is 2’-MOE fully modified with mixed backbone modification motif targeting SMN2 pre-mRNA for the “oligomer” of the ‘169 patent claims because Zhang’s oligonucleotide was taught to be conjugated to a carbohydrate conjugate group.
Claims 1, 25-26, 62, 72, 74, and 82 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,155,815 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘815 patent claims drawn to and require a chemically modified antisense oligonucleotide comprising SEQ ID NO:140, which is defined to read on the fully 2’-MOE modified ISIS 678329 (SEQ ID NO:140) targeting human Tau pre-mRNA having the linkage modification motif of “SSOSOSOSOSOSOSOSS” as disclosed in Table 9.
Claims 57, 78, and 81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,155,815 B2 in view of Rigo et al. (US 2016/0032285 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘815 patent claims drawn to and require a chemically modified antisense oligonucleotide comprising SEQ ID NO:140, which is defined to read on the fully 2’-MOE modified ISIS 678329 (SEQ ID NO:140) targeting human Tau pre-mRNA having the linkage modification motif of “SSOSOSOSOSOSOSOSS” as disclosed in Table 9. It would have been obvious to conjugate a conjugate group such as lipids to the oligonucleotide of the ‘815 patent claims because making a conjugate group-containing anti-Tau pre-mRNA oligonucleotide was an art-recognized design/goal as evidenced by Rigo.
Claims 1, 25-26, 62, 69, 72, 74, 82, and 87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 12-37 of U.S. Patent No. 11,198,867 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘867 patent claims drawn to and require an SMN2 pre-mRNA-targeting, chemically modified 18-mer antisense oligonucleotide comprising SEQ ID NO:81, which is defined to read on the fully 2’-MOE modified ISIS 449323 having the linkage modification motif of “SOSOSOSOSOSOSOSOS” or ISIS 605918 having the motif of “SSSOSOSOSOSOSOSSS” as disclosed in Table 9.
Claims 57, 78, and 81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 12-37 of U.S. Patent No. 11,198,867 B2 in view of Zhang et al. (WO 2019/075357 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘867 patent claims drawn to and require an SMN2 pre-mRNA-targeting, chemically modified 18-mer antisense oligonucleotide comprising SEQ ID NO:81, which is defined to read on the fully 2’-MOE modified ISIS 449323 having the linkage modification motif of “SOSOSOSOSOSOSOSOS” or ISIS 605918 having the motif of “SSSOSOSOSOSOSOSSS” as disclosed in Table 9. It would have been obvious to conjugate a conjugate group such as a carbohydrate to the oligonucleotide of the ‘867 patent claims because making a conjugate group-containing anti-SMN2 pre-mRNA oligonucleotide was an art-recognized design/goal as evidenced by Zhang.
Claims 72, 74, 82, and 87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,236,330 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘330 patent claims that require a PM-K pre-mRNA-targeting antisense oligonucleotide of 16-18 nucleotides having the modification motif of “keekeekeekeek”.
Claims 1, 25-26, 57, 62, 69, 78, and 81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,236,330 B2 in view of in view of Rigo et al. (US 2016/0032285 A1), Zhang et al. (WO 2019/075357 A1, applicant’s citation), Hinckley et al. (WO 2020/257631 A2), and Zhou et al. (Bioorganic & Medicinal Chemistry Letters, 1998, 8:3269-3274, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘330 patent claims that require an antisense oligonucleotide having the modification motif of “keekeekeekeek”. It would have been obvious to incorporate any of the art-recognized mixed backbone motif taught by Rigo, Zhang, or Hinckley into the oligonucleotide of the ‘330 patent claims because such mixed backbone motif was known to be useful when targeting a pre-mRNA as evidenced by Rigo, Zhang, and Hinckley, and further because oligonucleotides comprising a mixed backbone comprising phosphodiester and phosphorothioate linkages were known to have reduced toxicity while retaining serum stability as taught by Zhou (see pages 3271 and 3273; Table 1). It would also have been obvious to conjugate an art-recognized conjugate group to the oligonucleotide of the ‘330 patent claims because making a conjugate group-conjugated oligonucleotide targeting a pre-mRNA was an art-recognized design/goal as evidenced by Rigo, Zhang, and Hinckley.
Claims 1, 25-26, 62, 72, 74, and 82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of copending Application No. 17/481,679.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘679 claims drawn to and require a chemically modified antisense oligonucleotide comprising SEQ ID NO:79, which is defined to read on the fully 2’-MOE modified ISIS 6938410 targeting human Tau pre-mRNA having the linkage modification motif of “SSOSOSOSOSOSOSOSS” as disclosed in Table 9.
Claims 57, 78, and 81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of copending Application No. 17/481,679 in view of Rigo et al. (US 2016/0032285 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘679 claims drawn to and require a chemically modified antisense oligonucleotide comprising SEQ ID NO:79, which is defined to read on the fully 2’-MOE modified ISIS 6938410 targeting human Tau pre-mRNA having the linkage modification motif of “SSOSOSOSOSOSOSOSS” as disclosed in Table 9. It would have been obvious to conjugate a conjugate group such as lipids to the oligonucleotide of the ‘679 claims because making a conjugate group-containing anti-Tau pre-mRNA oligonucleotide was an art-recognized design/goal as evidenced by Rigo.
Claims 1, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-29, 31, 34, 49-50, 53, 55, 57, 59, 61-62, 64, 66-68, and 73 of copending Application No. 17/802,324 (now allowed).
Note that this rejection will change to a non-provisional rejection once an issue fee is paid in the ‘324 application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘324 claims drawn to and require a fully 2’-MOE modified, SCN1A splicing-modulatory antisense oligonucleotide comprising a mixture of phosphodiester/phosphorothioate linkages such as the pattern of SOOSSSSSSSSSSSSSS and SSSSSSSSSOOSSSSSS, which is conjugated to a conjugate group.
Claims 1, 25-26, 57, 62, 69, 72, 74, 78, 81-82, and 87 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-7, 10-12, 14, 16, 18-19, 21, 23-24, 27-30, 34, 37-38, 45-46, and 50 of copending Application No. 18/685,362.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘362 claims drawn to and require an SCN1A pre-mRNA-targeting antisense oligonucleotide comprising a mixture of phosphodiester/phosphorothioate linkages such as the pattern of SOSOSSSSSSSSSSSSSS which is conjugated to a conjugate group, wherein the oligonucleotide comprises a full 2-MOE or a full 2’-NMA.
Claims 1, 25-26, 57, 72, 74, 78, and 81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-10, 17-18, 22-23, 25-29, 32, 35, 37, 39, 45, 47, 49, 65, 68, 70, 73, 76-77, 79, and 82-83 of copending Application No. 18/710,928.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘928 claims drawn to and require a fully 2’-MOE modified, GRN-targeting antisense oligonucleotide comprising a mixture of phosphodiester/phosphorothioate linkages such as the pattern of SOSSSSSSSOSSSSSSS, which is conjugated to a conjugate group.
Conclusion
No claim is allowed.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
