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 .
DETAILED ACTION
Status of the Application
This is a TRACK1 application. Claims 69-82 are pending and currently under examination.
Compliance with Sequence Rules
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the following reason(s). Applicant’s attention is directed to the final rule making notice published at 55 FR 18230 (May 1, 1990), and 1114 OG 29 (May 15, 1990). If the effective filing date is on or after July 1, 1998, see the final rulemaking notice published at 63 FR 29620 (June 1, 1998) and 1211 OG 82 (June 23, 1998).
Figures 1A, 4A, 17 and 25 comprise nucleic acid sequences of greater than 9 nucleotides in length that are not identified by a SEQ ID NO in either the figure or the brief description thereof in the specification.
If these sequences are listed in the current Sequence Listing, then the Figures should be amended to include the appropriate SEQ ID NOS, or the specification should be amended to include the appropriate SEQ ID NOS in the brief description of each drawing. If these sequences are not in the current Sequence Listing, then in addition to amending the disclosure to include appropriate SEQ ID NOS, Applicant must also provide:
A substitute computer readable form (CRF) copy of the “Sequence Listing”.
A substitute paper copy of the “Sequence Listing”, as well as an amendment directing its entry into the specification.
A statement that the content of the paper and computer readable copies are the same and, where applicable, include no new matter, as required by 37 C.F.R. 1.821(e) or 1.821(f) or 1.821(g) or 1.825(b) or 1.825(d).
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A complete response to this office action must correct the defects cited above regarding compliance with the sequence rules and a response to the action on the merits which follows.
The aforementioned instance of failure to comply is not intended as an exhaustive list of all such potential failures to comply in the instant application. Applicants are encouraged to thoroughly review the application to ensure that the entire application is in full compliance with all sequence rules. This requirement will not be held in abeyance.
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 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.
Claim(s) 69, 79 and 80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beigelman et al. (US 20210277403).
Regarding claims 69, 79 and 80 Beigelman et al. teach a siRNA having a sense strand and an antisense strand having 15 to 40 nucleotides in length wherein the antisense strand is complementary a target sequence of SEQ ID No. 5 (see alignment below). SEQ ID No. 99 has 19 nucleotides complementary to SEQ ID No. 5. Beigelman et al. teach SEQ ID No. 99 is an antisense strand of a siRNA that targets CD274. The antisense strand has 19 would have a complementary sense strand to form a siRNA). Beigelman et al. teach the siRNA can have a lipid moiety conjugated to either the 5’ or 3’ end wherein the lipid moiety is fatty acid (0006). Beigelman et al. teach the siRNA reduces expression of CD274 and teach pharmaceutical compositions (see 0100-0102).
Publication No. US20210277403A1
GENERAL INFORMATION
APPLICANT: Aligos Therapeutics, Inc.
TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TARGETING
TITLE OF INVENTION: PD-L1
FILE REFERENCE: ALIG.036A
CURRENT APPLICATION NUMBER: US/17/249,337A
CURRENT FILING DATE: 2021-02-26
PRIOR APPLICATION NUMBER: 62/983114
PRIOR FILING DATE: 2020-02-28
NUMBER OF SEQ ID NOS: 380
SEQ ID NO 99
LENGTH: 19
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: 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 GGATATTTGCTGTCTTTAT 19 Qy = SEQ ID No. 5
Db 19 GGATATTTGCTGTCTTTAT 1 Db = SEQ ID No. 99
Thus, Beigelman et al. anticipates the instant claims.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 72-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beigelman et al. (cited above), Ren et al. (US 20110256088) and Roberts et al. ("Synthetic SiRNA delivery: progress and prospects." SiRNA delivery methods: Methods and protocols (2016): 291-310).
Regarding claims 72-74, Beigelman et al. teach the siRNA can have a lipid moiety conjugated to either the 5’ or 3’ end wherein the lipid moiety is fatty acid (0006). Beigelman et al. teach do not teach the fatty acid is a C8 to C30 in length.
Ren et al. teach targeted delivery of siRNA to increase efficacy (0003) and teach the siRNA can comprise saturated fatty acids having C12-C18 carbon atoms (0120). It would have been obvious to one of ordinary skill in the art to use saturated fatty acids having anyone of C12-C18 carbon atoms to conjugate to a strand of a siRNA to increase efficacy by improving the targeting ability. Roberts et al. teach it was well known that an siRNA strand can be efficiently modified at the 2’ end of the carbon atom and it would have obvious to attach a lipid moiety such as taught by Yin et al. (see pages 294-295).
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
Allowable subject matter
Claims 70, 71, 75, 76, 77, 78, 81 and 82 are 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.
The closest prior art is Beigelman et al. who teach siRNA targeted to the CD274 transcript (NCBI accession number NM_014143.4). Beigelman et al. teach the siRNA can be from 15-35 nucleotides in length and teach siRNA targeted to the CD274 transcript as in the 102 rejection above. Beigelman et al. do not teach asymmetric siRNA, do not teach the full sequence of SEQ ID Nos. 487 and 728 and do not teach the modified siRNA having SEQ ID Nos. 1050 and 1005 with the modification patterns as below.
(SEQ ID NO: 1050), 5’[ademGsC18][mG][mA][mU][mA][mU][mU][fU][fG][fC][fU][mG][mU][mC][mU][mU][mU][mA][mU][mA][mG][mC][mA][mG][mC][mC][mG][mA][mA][mA][mG][mG][mC][mU][mG][mC]-3′
(SEQ ID NO: 1005),
5′ [MePhosphonate-4OmUs][fAs][fUs][fA][fA][mA][fG][mA][mC][fA][mG][mC][mA][fA][mA][mU][mA][mU][mC][mCs][mGs][mG]3′
wherein mC, mA, mG, mU=2′-OMe ribonucleosides; fA, fC, fG, fU=2′F ribonucleosides; s=phosphorothioate, and wherein ademA-GalNAc=GalNAc modified adenine nucleotide.
While the CD274 transcript having NM_014143.4 is known (Beigelman et al.), the prior art does not teach or make obvious the asymmetric siRNA comprising SEQ ID No. 728 of 22 nucleotides in length or SEQ ID No. 487 of 36 nucleotides in length. The prior art does not teach or make obvious the siRNA with the modification patterns of SEQ ID Nos. 1050 and 1005. One of skill would not have been motivated to make these specific siRNA and there is not a design need or market demand given Beigelman et al. teach efficient siRNA having 19 and 21 nucleotides in length that target and reduce expression of CD274.
Conclusion
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If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636
Prosecution Insights