DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 3-2-26.
Claims 1, 4, 9, 10, 13, 17, 21, 27, 28, 36, 40, 42, 44, 46, 48, 53, 56, 65-67, 83, 92, 98, 99, 101 are pending in the instant application.
Election/Restrictions
Claims 83, 99 and 101 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3-2-26
Applicant’s election without traverse of Group I, claims 1, 4, 9, 10, 13, 17, 21, 27, 28, 36, 40, 42, 44, 46, 48, 53, 56, 65-67, 83, 92, 98, SEQ ID No. 1846 as the sense strand, sequence, SEQ ID No. 1551 as the target sequence, and SEQ ID No. 1586 as the antisense strand, in the reply filed on 3-2-26 is acknowledged.
Claim Objections
Claims 44 is objected to because of the following informalities:
In lines 4-5 of claim 44, “between positions” is recited twice in a row and is redundant. Appropriate correction is required.
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.
In claim 67 (o), the claim recites SEQ ID Nos. 1551 and 1586 as being a complementary pair, but these two sequences are not complementary. SEQ ID Nos. 1846 and 1586 appear to be complementary.
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.
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, 9, 10, 17, 21, 27, 28, 40, 42, 44, 46, 48, 53, 56, 65, 98 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bennett et al ((USPN 9,663,783 and US 2014/0005252),Tan, P. (US 2009/0176729) and Bentwich, I. (USPN 7,687,616), the combination further in view of Keating et al (WO 2021/207167) and Saxena, U. (US 2021/0380984).
SEQ ID NO: 1586 identifies SEQ ID NO: 1551 as being complementary. Nucleotides 1-20 of SEQ ID NO: 1586 are complementary to nucleotides 20-1 of SEQ ID NO: 1551.
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The claims are drawn to RNAi oligonucleotides comprising a sense strand between 15-50 nucleotides in length, and an antisense strand of 15-30 nucleotides in length, which antisense strand comprises a region of complementarity to SEQ ID No. 1846, which RNAi oligonucleotide optionally comprise a stem loop at the 3’ end, which oligonucleotides optionally comprise a 3’ blunt end of the sense strand, or a 3’ overhang of one or more nucleotides, and which oligonucleotide optionally further comprises a 2’-O modification, a phosphorothioate internucleotide linkage, or a vinyl phosphonate at the 4’ carbon, and which RNAi oligonucleotide is optionally conjugated to a GalNAc targeting ligand, which sense strand optionally comprises SEQ ID No. 1551, and which antisense strand optionally comprises SEQ ID No. 1586, and optionally comprising a tetraloop comprising GAAA and a 3’ overhang comprising AA, GG, AG or GA..
Bennett et al (US 2014/0005252) teach inhibitory oligonucleotides comprising SEQ ID No.1846 for targeting alpha synuclein optionally comprising modified sugar, internucleotide linkages, and nucleobases (para 0054-0058, 0071, 0076, 0185-0252). Bennett teaches SEQ ID No. 1846 for targeting alpha synuclein and optionally comprising modified sugars, internucleotide linkages, and nucleobases. (see the alignment below of Bennett SEQ ID No. 40 with instantly claimed SEQ ID No. 1846).
Align w seq id no. 1846
RESULT 5
US-61-414-848-40/c
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 40, US/61414848
USPN 9,663,783
GENERAL INFORMATION
APPLICANT: C. Frank Bennett
APPLICANT: Susan M. Freier
APPLICANT: Jyothi Mallajosyula
TITLE OF INVENTION: MODULATION OF ALPHA SYNUCLEIN EXPRESSION
FILE REFERENCE: BIOL0139US.L
CURRENT APPLICATION NUMBER: US/61/414,848
CURRENT FILING DATE: 2010-11-17
NUMBER OF SEQ ID NOS: 136
SEQ ID NO 40
LENGTH: 20
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic Oligonucleotide
Query Match 100.0%; Score 19; Length 20;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CAGTCATGACATTTCTCAA 19
|||||||||||||||||||
Db 19 CAGTCATGACATTTCTCAA 1
RESULT 5
US-13-988-296-40/c
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 40, US/13988296
Publication No. US20140005252A1
GENERAL INFORMATION
APPLICANT: C. Frank Bennett
APPLICANT: Susan M. Freier
APPLICANT: Jyothi Mallajosyula
TITLE OF INVENTION: MODULATION OF ALPHA SYNUCLEIN EXPRESSION
FILE REFERENCE: BIOL0139USA
CURRENT APPLICATION NUMBER: US/13/988,296
CURRENT FILING DATE: 2013-05-17
PRIOR APPLICATION NUMBER: 61/414,848
PRIOR FILING DATE: 2010-11-17
PRIOR APPLICATION NUMBER: PCT/US2011/061245
PRIOR FILING DATE: 2011-11-17
NUMBER OF SEQ ID NOS: 143
SEQ ID NO 40
LENGTH: 20
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic Oligonucleotide
Query Match 100.0%; Score 19; Length 20;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CAGTCATGACATTTCTCAA 19
|||||||||||||||||||
Db 19 CAGTCATGACATTTCTCAA 1
SEQ ID NO: 1586 identifies SEQ ID NO: 1551 as being complementary. Nucleotides 1-20 of SEQ ID NO: 1586 are complementary to nucleotides 20-1 of SEQ ID NO: 1551.
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The claims are drawn to RNAi oligonucleotides comprising a sense strand between 15-50 nucleotides in length, and an antisense strand of 15-30 nucleotides in length, which antisense strand comprises a region of complementarity to SEQ ID No. 1846, which RNAi oligonucleotide optionally comprise a stem loop at the 3’ end, which oligonucleotides optionally comprise a 3’ blunt end of the sense strand, or a 3’ overhang of one or more nucleotides, and which oligonucleotide Tan, P. (US 2009/0176729) teaches SEQ ID No. 1846 for targeting ALPHA SYNUCLEIN optionally comprising modified sugars, internucleotide linkages, and nucleobases. Tan teaches inhibitory oligonucleotides comprising phosphorothioate linkages, 2’- O-methyl and 2’-fluoro modified sugars, linkers, and stem loops (see esp. para 0007-0008, 0014, 0084, 0085, 0106-0116, 0226, Table 8, see the alignment below of Tan SEQ ID Nos. 440 and 439 with instantly claimed SEQ ID No. 1846).
Align w seq id no. 1846
RESULT 3
US-12-334-080-440/c
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 440, US/12334080
Publication No. US20090176729A1
GENERAL INFORMATION
APPLICANT: TAN, PAMELA
TITLE OF INVENTION: METHOD OF TREATING NEURODEGENERATIVE DISEASE
FILE REFERENCE: A2038-709410
CURRENT APPLICATION NUMBER: US/12/334,080
CURRENT FILING DATE: 2009-03-05
PRIOR APPLICATION NUMBER: 61/058,468
PRIOR FILING DATE: 2008-06-03
PRIOR APPLICATION NUMBER: 61/013,759
PRIOR FILING DATE: 2007-12-14
NUMBER OF SEQ ID NOS: 854
SEQ ID NO 440
LENGTH: 19
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
oligonucleotide
Query Match 100.0%; Score 19; Length 19;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CAGTCATGACATTTCTCAA 19
|||||||||||||||||||
Db 19 CAGTCATGACATTTCTCAA 1
RESULT 4
US-12-334-080-439
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 439, US/12334080
Publication No. US20090176729A1
GENERAL INFORMATION
APPLICANT: TAN, PAMELA
TITLE OF INVENTION: METHOD OF TREATING NEURODEGENERATIVE DISEASE
FILE REFERENCE: A2038-709410
CURRENT APPLICATION NUMBER: US/12/334,080
CURRENT FILING DATE: 2009-03-05
PRIOR APPLICATION NUMBER: 61/058,468
PRIOR FILING DATE: 2008-06-03
PRIOR APPLICATION NUMBER: 61/013,759
PRIOR FILING DATE: 2007-12-14
NUMBER OF SEQ ID NOS: 854
SEQ ID NO 439
LENGTH: 19
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
oligonucleotide
Query Match 100.0%; Score 19; Length 19;
Best Local Similarity 68.4%;
Matches 13; Conservative 6; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CAGTCATGACATTTCTCAA 19
|||:||:||||:::|:|||
Db 1 CAGUCAUGACAUUUCUCAA 19
Bentwich, I. (USPN 7,687,616) teaches inhibitory oligonucleotides comprising SEQ ID No. 1586 (see alignments below between Bentwich’s SEQ ID Nos. 1936746 and SEQ ID NO 372232 and instantly claimed SEQ ID No. 1586).
Align w seq id no 1586
RESULT 4
USPN 7,687,616
US-10-709-577B-1936746/c
(NOTE: this sequence has 7 duplicates in the database searched.
See complete list at the end of this report)
Sequence 1936746, US/10709577B
GENERAL INFORMATION
APPLICANT: ROSETTA GENOMICS LTD
APPLICANT: Bentwich, Itzhak
APPLICANT: Daniel, Kfar
TITLE OF INVENTION: SMALL MOLECULES MODULATING ACTIVITY OF MICRO RNA
TITLE OF INVENTION: OLIGONULEOTIDES AND MICRO RNA TARGETS AND USES THEREOF
FILE REFERENCE: 06087.0202.CPUS02
CURRENT APPLICATION NUMBER: US/10/709,577B
CURRENT FILING DATE: 2004-05-14
NUMBER OF SEQ ID NOS: 10068177
SEQ ID NO 1936746
LENGTH: 23
TYPE: DNA
ORGANISM: Homo sapiens
Query Match 100.0%; Score 22; Length 23;
Best Local Similarity 100.0%;
Matches 22; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TTTGAGAAATGTCATGACTGGG 22
||||||||||||||||||||||
Db 23 TTTGAGAAATGTCATGACTGGG 2
RESULT 1
US-10-310-914B-372232
Sequence 372232, US/10310914B
Patent No. 7250496
GENERAL INFORMATION
APPLICANT: Bentwich, Isaac
APPLICANT: Shiler, Kvuzat
TITLE OF INVENTION: Bioinformatically detectable group of novel regulatory genes and
TITLE OF INVENTION: uses thereof
FILE REFERENCE: 06087.0200.CPUS01
CURRENT APPLICATION NUMBER: US/10/310,914B
CURRENT FILING DATE: 2002-12-06
NUMBER OF SEQ ID NOS: 1388411
SEQ ID NO 372232
LENGTH: 24
TYPE: DNA
ORGANISM: Human
Query Match 100.0%; Score 22; Length 24;
Best Local Similarity 68.2%;
Matches 15; Conservative 7; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TTTGAGAAATGTCATGACTGGG 22
:::||||||:|:||:|||:|||
Db 3 UUUGAGAAAUGUCAUGACUGGG 24
The primary references do not teach siRNA comprising vinyl phosphonate modifications, GalNAc ligands, loops comprising GAAA, or siRNA comprising terminal GG overhangs.
Keating et al (WO 2021/207167) teach siRNA comprising phosphorothioate internucleotide linkages, 2’O-methyl sugar modifications, vinyl phosphonate modifications, overhangs, blunt ends, hydrocarbon chains, and stem loops (see e.g., pages 6-12, 19, 24, 26, 27, 37-39, 41-42).
Saxena, U. (US 2021/0380984) teach siRNA comprising terminal overhangs comprising GG, and loops comprising GAAA (see para 0009, 0059, 0063).
It would have been obvious to design the modified siRNA instantly claimed because the prior art of Bennett, Tan, and Bentwich had taught the sense and antisense sequences comprising SEQ ID Nos. 1551 and 1586, and the modifications instantly claimed were all well-known and routinely used in the prior art, as taught previously Keating and Saxena. One of ordinary skill in the art would have reasonably expected that the instantly claimed siRNA duplexes, and the modifications, loops, and overhangs claimed would provide enhanced targeting and inhibition of the target gene encoding alpha synuclein.
For these reasons, the instant invention would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
Claim 92 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 115 of copending Application No. 19/383,234 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to RNAi oligonucleotides for reducing SNCA comprising SEQ ID No. 1621 and SEQ ID No. 1656, and the structure:
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 36 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
SEQ ID No. 1680 appears free of the prior art searched and of record.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Jane Zara
5-4-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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