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 1-26-26.
Claims 1-14, 17-19, 23, 24, 27-29 are pending in the instant application.
Election/Restrictions
Claims 13, 14, 18, 19, 23, 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.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 1-26-26.
Applicant’s election without traverse of Group I, SEQ ID No. 1, SEQ ID No. 416 (position 434-454 in SEQ ID No. 1), claims 1-12, 17, 27-29, in the reply filed on 1-26-26 is acknowledged.
The restriction requirement set forth on 11-25-25 between Groups II-IV, has been withdrawn as to Groups II-IV, claims 13, 14, 18, 19, 23, 24. These Groups have been rejoined as Group II, drawn to methods of modulation, inhibition and treatment.
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 1-5, 7-12, 17, 27-29 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.
It is unclear in claim 1 and claim 4 whether the wing regions comprise fully modified or singly modified nucleic acids.
Appropriate clarification is required.
It is unclear in claims 9-11 what is meant by the phrases “following a base located at one of position 8 to position 10…”
Appropriate clarification is required.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12, 17, 28, 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The breadth of the claims:
The claims are drawn to compositions comprising single stranded antisense oligonucleotides comprising a sequence identity of 90-100% identity with SEQ ID No. 1.
Teachings in the specification:
The specification teaches the in vitro screening of antisense having 100% homology to the target gene for target gene inhibition (See, e.g., pages 60-81, 86-98, 113, 114 of the specification). The specification fails to provide the broad genus comprising any antisense sharing 90% homology to the target gene, and further whereby target gene inhibition is provided.
. The specification, prior art and claims do not adequately describe the genus of modulatory agents claimed, and/or fail to provide a representative number of species, and do not indicate what distinguishing attributes are concisely shared by the members of this genus, and further whereby inhibition has been provided.
For the reasons stated above, the instant rejection for lacking adequate written description is proper.
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) 1-11, 17, 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khvorova et al (USPN 8,090,542) in view of Kauppinen et al (WO 2017/211999).
The claims are drawn to pharmaceutical compositions comprising single stranded antisense comprising 12-30 nucleotides that share 90-100% identity with SEQ ID No. 1, and which further comprises a gap region and a 5’ and 3’ wing region, which wing regions comprise 1-5 nucleotides that are modified optionally comprising 2’MOE and/or LNA modifications.
Khvorova et al (USPN 8,090,542) teach siRNA specifically targeting SEQ ID No. 1 (See SEQ ID Nos. 443079, 443065, 443082, 443092, and the alignments below).
RESULT 57
US-10-714-333C-443079
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 443079, US/10714333C
Patent No. 8090542
GENERAL INFORMATION
APPLICANT: Dharmacon, Inc.
APPLICANT: Khvorova, Anastasia
APPLICANT: Reynolds, Angela
APPLICANT: Leake, Devin
APPLICANT: Marshall, William
APPLICANT: Scaringe, Stephen
TITLE OF INVENTION: Functional and Hyperfunctional siRNA
FILE REFERENCE: 13499US
CURRENT APPLICATION NUMBER: US/10/714,333C
CURRENT FILING DATE: 2003-11-14
PRIOR APPLICATION NUMBER: 60/502,050
PRIOR FILING DATE: 2003-09-10
PRIOR APPLICATION NUMBER: 60/426,137
PRIOR FILING DATE: 2002-11-14
NUMBER OF SEQ ID NOS: 1591911
SEQ ID NO 443079
LENGTH: 19
TYPE: DNA
ORGANISM: Homo sapiens
Query Match 3.9%; Score 19; Length 19;
Score over Length 100.0%;
Best Local Similarity 73.7%;
Matches 14; Conservative 5; Mismatches 0; Indels 0; Gaps 0;
Qy 224 TGATAAACTCTGTAAGGAA 242
:||:||||:|:|:||||||
Db 1 UGAUAAACUCUGUAAGGAA 19
RESULT 58
US-10-714-333C-443065
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 443065, US/10714333C
Patent No. 8090542
GENERAL INFORMATION
APPLICANT: Dharmacon, Inc.
APPLICANT: Khvorova, Anastasia
APPLICANT: Reynolds, Angela
APPLICANT: Leake, Devin
APPLICANT: Marshall, William
APPLICANT: Scaringe, Stephen
TITLE OF INVENTION: Functional and Hyperfunctional siRNA
FILE REFERENCE: 13499US
CURRENT APPLICATION NUMBER: US/10/714,333C
CURRENT FILING DATE: 2003-11-14
PRIOR APPLICATION NUMBER: 60/502,050
PRIOR FILING DATE: 2003-09-10
PRIOR APPLICATION NUMBER: 60/426,137
PRIOR FILING DATE: 2002-11-14
NUMBER OF SEQ ID NOS: 1591911
SEQ ID NO 443065
LENGTH: 19
TYPE: DNA
ORGANISM: Homo sapiens
Query Match 3.9%; Score 19; Length 19;
Score over Length 100.0%;
Best Local Similarity 78.9%;
Matches 15; Conservative 4; Mismatches 0; Indels 0; Gaps 0;
Qy 211 ACAAAGCTACCTATGATAA 229
|||||||:|||:|:||:||
Db 1 ACAAAGCUACCUAUGAUAA 19
RESULT 59
US-10-714-333C-443082
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 443082, US/10714333C
Patent No. 8090542
GENERAL INFORMATION
APPLICANT: Dharmacon, Inc.
APPLICANT: Khvorova, Anastasia
APPLICANT: Reynolds, Angela
APPLICANT: Leake, Devin
APPLICANT: Marshall, William
APPLICANT: Scaringe, Stephen
TITLE OF INVENTION: Functional and Hyperfunctional siRNA
FILE REFERENCE: 13499US
CURRENT APPLICATION NUMBER: US/10/714,333C
CURRENT FILING DATE: 2003-11-14
PRIOR APPLICATION NUMBER: 60/502,050
PRIOR FILING DATE: 2003-09-10
PRIOR APPLICATION NUMBER: 60/426,137
PRIOR FILING DATE: 2002-11-14
NUMBER OF SEQ ID NOS: 1591911
SEQ ID NO 443082
LENGTH: 19
TYPE: DNA
ORGANISM: Homo sapiens
Query Match 3.9%; Score 19; Length 19;
Score over Length 100.0%;
Best Local Similarity 84.2%;
Matches 16; Conservative 3; Mismatches 0; Indels 0; Gaps 0;
Qy 172 GCAAAGTTCGGGACAAGCT 190
||||||::||||||||||:
Db 1 GCAAAGUUCGGGACAAGCU 19
RESULT 60
US-10-714-333C-443092
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 443092, US/10714333C
Patent No. 8090542
GENERAL INFORMATION
APPLICANT: Dharmacon, Inc.
APPLICANT: Khvorova, Anastasia
APPLICANT: Reynolds, Angela
APPLICANT: Leake, Devin
APPLICANT: Marshall, William
APPLICANT: Scaringe, Stephen
TITLE OF INVENTION: Functional and Hyperfunctional siRNA
FILE REFERENCE: 13499US
CURRENT APPLICATION NUMBER: US/10/714,333C
CURRENT FILING DATE: 2003-11-14
PRIOR APPLICATION NUMBER: 60/502,050
PRIOR FILING DATE: 2003-09-10
PRIOR APPLICATION NUMBER: 60/426,137
PRIOR FILING DATE: 2002-11-14
NUMBER OF SEQ ID NOS: 1591911
SEQ ID NO 443092
LENGTH: 19
TYPE: DNA
ORGANISM: Homo sapiens
Query Match 3.9%; Score 19; Length 19;
Score over Length 100.0%;
Best Local Similarity 84.2%;
Matches 16; Conservative 3; Mismatches 0; Indels 0; Gaps 0;
Qy 432 GCATGAATAGGTCCAACCA 450
|||:|||:|||:|||||||
Db 1 GCAUGAAUAGGUCCAACCA 19
Kauppinen et al (WO 2017/211999) teach antisense oligonucleotides comprising gapmers with a central region of 6-16 consecutive DNA nucleotides flanked in each end by wings each comprising 1-5 nucleotide linkages optionally comprising 2’-MOE and/or LNA modified residues, and which antisense optionally comprises phosphorothioate linkages, which wings comprise modified nucleic acids (See esp. pages 5-6, page 19, second paragraph, text on pages 35-37).
It would have been obvious to design antisense oligonucleotides comprising gapmers and wings, which antisense specifically target SEQ ID No. 1 because the design and optimization of antisense comprising gapmers and wings were routinely performed, as illustrated in the teachings of Kauppinen. The antisense targeting SEQ ID No. were also well known in the art, as disclosed by Khvorova. One of ordinary skill in the art would have reasonably expected that antisense comprising wings and gapmers, and further comprising modifications including 2’-MOE and LNA, provide enhanced stability and target binding.
For these and the aforementioned reasons, the instant invention would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention.
Allowable Subject Matter
SEQ ID No. 416 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
3-6-26
/JANE J ZARA/Primary Examiner, Art Unit 1637