DETAILED ACTION
This Action is in response to the communication filed on 02/18/2026.
Claims 1-15 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of the species: sense sequence SEQ ID NO: 14, and antisense sequence SEQ ID NO: 75, in the reply filed on 02/18/2026 is acknowledged.
The non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/18/2026.
Claims 1-15 are under consideration as they read on the elected subject matter.
Improper Markush Group
Claims 1-15 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of RNAi-inducing double stranded oligonucleotides that have a sense strand sequence selected from SEQ ID Nos: 1-61 in claim 1 and the Markush grouping of an antisense strand sequences selected from SEQ ID Nos: 62-122 (see claim 4) are improper (as are the group of antisense strand SEQ ID NOs: 62, 70, 75, 97, 90, 97, 122 and sense strands SEQ ID NOs: 1, 9, 14, 26, 29, 36, 61 as in claims 5, 12, 14) because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: although each sequence is part of RNAi-inducing double stranded molecule (as indicated in claim 1), they do not share a single structural similarity as each double stranded sequence is distinct from the others. Furthermore, since each double stranded sequence has different nucleotide sequences, no two double stranded sequences would have the exact same effect (i.e., each would have at least some difference in target gene inhibition). It is also noted that the specification indicates the some of the oligonucleotides are based on sequences conserved between SARS-CoV and SARS-CoV2, while other are based on conserved sequences between SARS-CoV-2 and a mutant thereof (see paragraph [0039] of the published application: U.S. 20230295633). Therefore, the Markush groups include sequences that are directed to different types of coronavirus sequences. All claims are included in the rejection as all claims encompass at least a portion of the indicated sequences.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 1-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/195307 (hereinafter “Akinc”).
Regarding claims 1, 4-5, 12, Akinc teaches a double stranded oligonucleotide comprising a sense strand having the sequence of SEQ ID NO: 14 and a complementary antisense strand wherein the antisense strand has the sequence of SEQ D NO: 75. For instance, see Duplex AD-1184011 on page 157, having sense strand SEQ ID NO: 93 which comprises a sequence 100% identical to SEQ ID NO: 14, and antisense strand SEQ ID NO: 448 which 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 11-15, 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;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GGAGUAUGCUGAUGUCUUU 19 (Instant SEQ ID NO: 14)
|||||||||||||||||||
Db 2 GGAGUAUGCUGAUGUCUUU 20 (Duplex AD-1184011, SEQ ID NO: 93 on page 157)
Query Match 100.0%; Score 19; Length 21;
Best Local Similarity 84.2%;
Matches 16; Conservative 3; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AAAGACAUCAGCAUACUCC 19 (Instant SEQ ID NO: 75)
|||||||:|||||:||:||
Db 20 AAAGACATCAGCATACTCC 2 (Duplex AD-1184011, SEQ ID NO: 448 page 157)
Conclusion
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).
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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.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637
Prosecution Insights