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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 14 and 15 recite the limitation "the pharmacological composition" in the first lines. There is insufficient antecedent basis for this limitation in the claims.
For the purpose of examination it will be considered that claims 14 and 15 should recite “the method” instead of "the pharmacological composition", but appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 6-9, 12-16, 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lundberg et al (WO 2018/002886, January 2018, cited from IDS).
Concerning claims 1-4, 6-9, 21-22 Lundberg et al disclose a single-stranded oligonucleotide of SEQ ID NO: 29793, 20 nucleotides long, first 18 of which are identical to instant SEQ ID NO: 239 (see paragraphs [00060, 000117-000118], sequence listing). Such oligonucleotide can be 2’-OMe phosphorothioate modified and can include 5-methylcytosine (see paragraphs [000156, 000164-000165, 000171]).
Concerning claim 12 Lundberg et al disclose pharmaceutical compositions comprising the oligonucleotide of the invention and pharmaceutically acceptable carrier (see paragraph [000315]).
Concerning claims 13-16, 19-20 Lundberg et al teach methods of treatment of spinocerebellar ataxia type 3 by administering oligonucleotides and compositions of the invention (see paragraph [0007]).
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.
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) 1-16, 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rigo et al (WO 2017/053781, March 2017, cited from IDS) and in further view of Seth et al (WO 2011/156202, December 2011, cited from IDS).
Rigo et al teach methods of treating, preventing and ameliorating neurodegenerative diseases such as spinocerebellar ataxia type 3 (see lines 10-15 on page 1) by administering modified oligonucleotides to an individual in need thereof (see bridging paragraph between pages 2 and 3). One of such oligonucleotides of SEQ ID NO: 4 (see Table 1) is single-stranded, 22 nucleotides long, and is fully complementary to instant SEQ ID NO: 1. Such oligonucleotide can comprise 2’-O-methoxyethyl group (see lines 2-3 on page 3), LNAs (see lines 8-11 on page 18), 5-methylcytosines (see lines 19-21 on page 4) and phosphorothioate linkages (see lines 10-11 on page 4). Rigo et al teach pharmaceutical compositions comprising oligonucleotides of the invention and pharmaceutically acceptable carrier (see lines 5-7 on page 7). Further Rigo et al teach designing antisense oligonucleotides targeting ataxin 3 by complementarity of such oligonucleotide to the target mRNA, synthesizing and testing the oligonucleotides (see lines 30-34 on page 31, Example 1).
Rigo et al do not teach specific oligonucleotides of instant SEQ ID NOs: 239-263, or gapmer oligonucleotide modification as in instant claim 10, or the presence of specific modifications such as ALNA[mU].
Seth et al teach antisense oligonucleotides (see lines 14-17 on page 3) comprising bicyclic nucleosides such as LNAs (see lines 22-28 on page 47), some of such nucleosides are the same as instantly claimed ALNA[mU] (see structures of Formula IVa on pages 28-29). Further Seth et al teach that antisense oligonucleotides can have wing-gap-wing motifs with wings comprising modified sugars (see lines 12-25 on page 35). Seth et al teach that such modifications enhance antisense oligonucleotides properties (see Abstract).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to identify new antisense oligonucleotides targeting ataxin 3 based on teachings on Rigo et al and further improve them by including modifications taught by Seth et al arriving at instant invention with a reasonable expectation of success. One of the ordinary skill in the art would be motivated to do so, because Rigo et al provides basic framework for designing and testing of antisense oligonucleotides for spinocerebellar ataxia type 3 treatment, motivating one of the art to create new, more effective, antisense oligonucleotides. Seth et al teach further modifications improving properties of antisense oligonucleotides, motivating one of the art to include such modifications into new antisense oligonucleotides designed based on teachings of Rigo et al.
Claim(s) 1-9, 11-16, 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rigo et al (WO 2017/053781, March 2017, cited from IDS) and in further view of Sawamoto et al (WO 2020/100826 from IDS, claiming priority to JP 2018-212424, cited from machine translation of JP 2018-212424).
Teachings of Rigo et al are discussed above.
Rigo et al do not teach specific oligonucleotides of instant SEQ ID NOs: 239-263, or the presence of specific modifications such as ALNA[mU].
Sawamoto et al teach further improvement of antisense oligonucleotides by inclusion of modified nucleotides (see paragraphs [0002-0004]) identical to instantly claimed ALNA[mS], ALNA[mU], ALNA[ipU], ALNA[Oxz], ALNA[Trz] (see paragraph [0147]).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to identify new antisense oligonucleotides targeting ataxin 3 based on teachings on Rigo et al and further improve them by including modifications taught by Sawamoto et al arriving at instant invention with a reasonable expectation of success. One of the ordinary skill in the art would be motivated to do so, because Rigo et al provides basic framework for designing and testing of antisense oligonucleotides for spinocerebellar ataxia type 3 treatment, motivating one of the art to create new, more effective, antisense oligonucleotides. Sawamoto et al teach further modifications improving properties of antisense oligonucleotides, motivating one of the art to include such modifications into new antisense oligonucleotides designed based on teachings of Rigo et al.
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 1-16, 19-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 12,338,265 in view of Rigo et al and Seth et al. Claims from ‘265 recite modified nucleotides identical to instantly claimed ALNA[mS], ALNA[mU], ALNA[ipU], ALNA[Oxz], ALNA[Trz]. Teachings of Rigo et al and Seth et al are discussed above. It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to identify new antisense oligonucleotides targeting ataxin 3 based on teachings on Rigo et al and further improve them by including modifications taught by ‘265 and Seth et al arriving at instant invention with a reasonable expectation of success. One of the ordinary skill in the art would be motivated to do so, because Rigo et al provides basic framework for designing and testing of antisense oligonucleotides for spinocerebellar ataxia type 3 treatment, motivating one of the art to create new, more effective, antisense oligonucleotides. ‘265 and Seth et al teach further modifications improving properties of antisense oligonucleotides, motivating one of the art to include such modifications into new antisense oligonucleotides designed based on teachings of Rigo et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637