DETAILED ACTION
This Action is in response to the communication filed on 06/30/2026.
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 .
Status of the Claims
Upon entry of the amendment, claims 1-3. 6-11, 13, 15 are pending and are under consideration.
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)(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 1-3. 6-11, 13, 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/195307 (hereinafter “Akinc”).
Regarding claims 1, Akinc teaches a double stranded oligonucleotide comprising a sense strand having the sequence of SEQ ID NO: 14 and a complementary antisense strand having the sequence of SEQ D NO: 75. For instance, see Duplex AD-1184011 on page 157, wherein the sense strand comprises a sequence 100% identical to SEQ ID NO: 14, and antisense strand comprises a sequence 100% identical to SEQ ID NO: 75 (see sequence alignment information below). Akinc teaches that the double stranded oligonucleotide is an RNAi-inducing agent (e.g., see abstract, page 25 lines 35-38).
Regarding claim 2, Akinc teaches that the double-stranded oligonucleotide is an siRNA molecule (e.g., see Figures 3-5 and description thereof on pages 19-20).
Regarding claim 3, Akinc teaches that the strands independently consist of 19 to 31 nucleotides (e.g., Duplex AD-1184011 on page 157, has sense strand SEQ ID NO: 93, and antisense strand SEQ ID NO: 448, both which are 21 nucleotides in length).
Regarding claims 6-7, Akinc teaches that at least one of the strands has one or more chemical modifications, wherein the chemical modification can be a substitution of -OH with OCH3 (methoxy) (e.g., see page 4 lines 15-17 and 20-21; it is noted “methoxy” is also known a O-methyl).
Regarding claims 8-9, Akinc teaches that the double-stranded oligonucleotide comprises a ligand that is polyethylene glycol (PEG) and the ligand can be bound to at least one end of sense or antisense strand (e.g., see page 83 line 30 through page 84 line7 and line 20; page 60 lines 21-22, etc.).
Regarding claim 10, Akinc teaches that the double-stranded oligonucleotide can be used to treat SARS-CoV or SARS-CoV-2 (e.g., see page 2 lines 17-25)
Regarding claims 11, 13 and 15, Akinc teaches a composition including a pharmaceutical composition comprising the double stranded oligonucleotide which would be useful for treating coronavirus disease including COVID-19 (e.g., see page 2 lines 17-25; claim 83; page 9 lines 13-15).
Therefore, Akinc anticipates the instant claims.
SEQUENCE ALIGNMENTS:
DE SARS-CoV-2 DNA targeted siRNA sense strand, SEQ ID 93.
XX
KW coronavirus infection; gene silencing; respiratory-gen.;
KW rna interference; short interfering RNA; siRNA; ss; therapeutic;
KW virucide; virus inactivation.
XX
OS Severe acute respiratory syndrome coronavirus 2.
XX
CC PN WO2021195307-A1.
XX
CC PD 30-SEP-2021.
XX
CC PF 25-MAR-2021; 2021WO-US024038.
XX
PR 26-MAR-2020; 2020US-0994907P.
PR 30-MAR-2020; 2020US-0001580P.
PR 04-MAY-2020; 2020US-0019481P.
PR 14-DEC-2020; 2020US-0124910P.
XX
CC PA (ALNY ) ALNYLAM PHARM INC.
CC PA (VIRB-) VIR BIOTECHNOLOGY INC.
XX
CC PI Akinc A, Mcininch JD, Anglero-Rodriguez Y, Schlegel MK, Hebner CM;
CC PI Lempp FA;
XX
DR WPI; 2021-B26007/086.
XX
CC PT Double stranded ribonucleic acid agent for inhibiting expression of
CC PT coronavirus genome in cell, comprises sense strand and antisense strand
CC PT forming double stranded region, where sense strand comprises nucleotide
CC PT sequence.
XX
CC PS Claim 5; SEQ ID NO 93; 264pp; English.
XX
CC The present invention relates to a double stranded ribonucleic acid
CC (dsRNA) agent for inhibiting expression of coronavirus genome in a cell.
CC The dsRNA comprises a sense strand and an antisense strand forming double
CC stranded region. The invention also includes: (1) a double stranded RNA
CC interference (RNAi) agent for inhibiting expression of a coronavirus
CC genome in a cell; (2) a cell comprising the dsRNA agent; (3) a
CC pharmaceutical composition for inhibiting expression of a coronavirus
CC genome, comprising the dsRNA agent; (4) a pharmaceutical composition
CC comprising the dsRNA agent and a lipid formulation; (5) a composition
CC comprising two or more double stranded RNAi agents for inhibiting
CC expression of coronavirus genome in a cell; (6) a cell comprising the
CC composition; (7) a method for inhibiting expression of a coronavirus
CC genome in a cell; (8) a method for inhibiting replication of a
CC coronavirus in a cell; and (9) a method for treating a subject having a
CC coronavirus infection.
XX
SQ Sequence 21 BP; 4 A; 3 C; 6 G; 0 T; 8 U; 0 Other;
Query Match 100.0%; Score 19; Length 21;
Qy 1 GGAGUAUGCUGAUGUCUUU 19 (Instant SEQ ID NO: 14)
|||||||||||||||||||
Db 2 GGAGUAUGCUGAUGUCUUU 20 (Duplex AD-1184011, SS SEQ ID NO: 93 on page 157)
Query Match 100.0%; Score 19; Length 21;
Qy 1 AAAGACAUCAGCAUACUCC 19 (Instant SEQ ID NO: 75)
|||||||:|||||:||:||
Db 2 AAAGACATCAGCATACTCC 20 (Duplex AD-1184011, AS SEQ ID NO: 448 page 157)
Response to Arguments
Regarding the improper Markush group rejection, Applicant’s arguments, have been fully considered and in view of the amendment to the claims, are persuasive. The rejection has been withdrawn.
Regarding the rejection of claims under 35 USC 102, Applicant's arguments filed have been fully considered but they are not persuasive. Applicant argues that there are multiple potential combinations of sense and antisense strand duplexes possible in Akinc, specifically 126,025 possible combinations, and asserts that there is no example of the selection of SEQ ID NO: 93 and SEQ ID NO: 448 in combination disclosed. Applicant further asserts that the Examiner’s assertion that the claimed RNAi-inducing double-stranded oligonucleotide of the present invention is identical to that disclosed in Akinc is clearly erroneous, contending that the the antisense strand is not complementary to the sense strand.
This is not persuasive as Akinc clearly teaches Duplex AD-1184011 on page 157 which comprises the sense strand sequence GGAGUAUGCUGAUGUCUUU (identified as SEQ ID NO: 93 in Akinc) which is identical to instant SEQ ID NO: 14, paired with the complementary antisense strand comprising the sequence AAAGACAUCAGCAUACUCC (identified as SEQ ID NO: 448 in Akinc) which is identical to instant SEQ ID NO: 75, as indicated above. To be clear, the sense strand (Akinc’s SEQ ID NO: 93) and antisense strand (Akinc’s SEQ ID NO: 448 are complementary as indicated below:
(SEQ ID NO: 75) 5’- AAAGACAUCAGCAUACUCC -3’ (Akinc SEQ ID NO: 448 AS)
| | | | | | | | | | | | | | | | | | |
(SEQ ID NO: 14) 3’- UUUCUGUAGUCGUAUGAGG -5’ (Akinc SEQ ID NO: 93 SS)
Furthermore, Akinc explicitly teaches the sense strand SEQ ID NO: 93 (which comprises instant SEQ ID NO: 14) paired with the complementary antisense strand SEQ ID NO: 448 (which comprises instant SEQ ID NO: 75) on page 157 identified as duplex AD-1184011 (See Table 2 on page 157). Since duplex AD-1184011 teaches a double stranded oligonucleotide that meets the structural limitations of the claims, it would necessarily have the same function, including being a coronavirus-specific RNAi-inducing double-stranded oligonucleotide, which is also taught by Akinc, the title of which is “Coronavirus iRNA Composition and Methods of Use Thereof” (also see abstract, page 2 beginning at line 17, etc.).
Therefore, Applicant’s arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637
