DETAILED ACTION
This Action is in response to the communication filed on 11/14/2025.
Claims 1-14 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 dsRNA species having SEQ ID NO: 17 and SEQ ID NO: 18 in the reply filed on 11/14/2025 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The non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b), there being no allowable generic or linking claim.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 11/14/2025.
Claims 1-14 are under consideration as they read on the elected subject matter.
Claim Objections
Claims 1-2 are objected to because of the following informalities: claim 1 recites “a nucleobase sequence of nucleotide” (emphasis added). This appears to be a simple typographical error where “nucleotide” should be “nucleotides” (i.e., “nucleotide” is missing an “s”) which renders the phrase grammatically incorrect.
Claim 3 is objected to because of the following informalities: each of (a)-(ee) recites “a nucleobase sequence of a nucleotide represented by SEQ ID NO…” (emphasis added). The recitation “nucleotide” appears to be grammatically incorrect and should be “nucleotide sequence” or possible “polynucleotide) as each SEQ ID is a nucleotide sequence or polynucleotide (i.e., not a single nucleotide).
Appropriate correction is required.
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)(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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 20080113351 (hereafter “Naito”).
Claim 1 is drawn to a dsRNA that inhibits production of a HBV protein, wherein the sense strands includes a nucleobase sequence of nucleotide[s] represented by SEQ ID NO: 17 (the elected species). It is noted that “inhibits production of a HBV protein” is considered an functional limitation for the claimed dsRNA. Any dsRNA that meets the structural limitations of the claim would necessarily have the same functions as the claimed dsRNA, including the ability to inhibit production of an HBV protein.
Naito teaches double-stranded RNA polynucleotides, including siRNA polynucleotides (e.g., see paragraph [0004]), and explicitly teaches siRNA polynucleotides comprising a sequence of any of SEQ ID NOs: 47 to 817081 (e.g., see paragraph [0356]). It is noted that instant SEQ ID NO: 17 is identical to Naito’s SEQ ID NO: 325128 (see sequence alignment information below).
Accordingly, Naito anticipates claim 1.
Regarding claims 2-3, claim 2 is drawn to the dsRNA of claim 1 wherein the antisense strand is SEQ ID NO: 18 (the elected species), and claim 3 is drawn to the dsRNA of claim 1 wherein (e) (the elected species) the dsRNA includes SEQ ID NO: 17 and SEQ ID NO: 18.
It is noted that the nucleotides sequence of SEQ ID: 18 is perfectly (100%) complementary to the nucleotides sequence of SEQ ID: 17 (see sequence alignment information below). Therefore, since Naito teaches a siRNA having SEQ ID NO: 17 as indicated above, the siRNA having SEQ ID NO: 17 would necessarily have a complementary strand having SEQ ID NO: 18.
Regarding claim 4, Naito teaches that the dsRNA can comprise modified nucleotides (see [0106]).
Regarding claim 5, drawn to the dsRNA of claim 1 wherein the HBV protein is an HBsAG protein, it is noted that since Naito teaches a dsRNA which meets the structural limitations of claim 1, as indicated above, it would necessarily have all of the same functions of the dsRNA of claim 1 including the ability to inhibit production of a HBV protein, including HBsAg.
Regarding claim 6, drawn to the dsRNA of claim 1 wherein the dsRNA reduces an expression level of an HBV DNA, it is noted that “wherein the dsRNA reduces an expression level of an HBV DNA” is functional language which does not impart any further structural limitations to the dsRNA of claim 1. Therefore, since Naito teaches a dsRNA of claim 1, as indicated above, the dsRNA would necessarily have all of the same functions of the dsRNA of claim 1 including the ability to reduce an expression level of an HBV DNA.
Regarding claim 7, drawn to the dsRNA of claim 1 wherein the dsRNA reduces expression of a cccDNA. it is noted that “reduces expression of a cccDNA” is functional language which does not impart any further structural limitations to the dsRNA of claim 1. Therefore, since Naito teaches a dsRNA of claim 1, as indicated above, the dsRNA would necessarily have all of the same functions of the dsRNA of claim 1 including the ability to reduces expression of a cccDNA.
Regarding claim 8, Natio teaches that siRNA polynucleotides are dsRNA which are RNA interfering agents (e.g., see [0003], [0004], [0057], etc.), thus Naito teaches the limitations of claim 8.
Regarding claim 9, Naito teaches that the dsRNA can be formulated into pharmaceutical compositions (e.g., see [0006]).
Regarding claim 10, Naito teaches that the dsRNA can be included in an expression vector (e.g., see [0113], [0126]).
Regarding claim 11, 13-14, Naito teaches that the dsRNA can be incorporated into a viral recombinant vector including a retrovirus or adenovirus vector (e.g., see [0276]).
SEQUENCE ALIGNMENTS
US-11-598-052B-325128
Sequence 325128, US/11598052B
Publication No. US20080113351A1
GENERAL INFORMATION
APPLICANT: RNAi Co., Ltd.
APPLICANT: NAITO, Yuki
APPLICANT: FUJINO, Masato
APPLICANT: OGUCHI, Shinobu
APPLICANT: NATORI, Yukikazu
TITLE OF INVENTION: POLYNUCLEOTIDES FOR CAUSING RNA INTERFERENCE AND METHOD
FILE REFERENCE: 0230-0243PUS1
CURRENT APPLICATION NUMBER: US/11/598,052B
CURRENT FILING DATE: 2006-11-13
PRIOR APPLICATION NUMBER: PCT/IB2005/00164
PRIOR FILING DATE: 2005-05-11
PRIOR APPLICATION NUMBER: JP 2004-232811
PRIOR FILING DATE: 2004-05-11
SEQ ID NO 325128
LENGTH: 19
TYPE: DNA
ORGANISM: Homo sapiens
FEATURE:
OTHER INFORMATION: siRNA target sequence for YT521 (NM_133370.1,1515-1533).
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 GGGTTTGCAAGACTTTCTT 19 (SEQ ID NO: 17)
|||||||||||||||||||
Db 1 GGGTTTGCAAGACTTTCTT 19
US-11-598-052B-325128/c
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 325128, US/11598052B
Publication No. US20080113351A1
GENERAL INFORMATION
APPLICANT: RNAi Co., Ltd.
APPLICANT: NAITO, Yuki
APPLICANT: FUJINO, Masato
APPLICANT: OGUCHI, Shinobu
APPLICANT: NATORI, Yukikazu
TITLE OF INVENTION: POLYNUCLEOTIDES FOR CAUSING RNA INTERFERENCE AND METHOD
CURRENT APPLICATION NUMBER: US/11/598,052B
CURRENT FILING DATE: 2006-11-13
PRIOR APPLICATION NUMBER: PCT/IB2005/00164
PRIOR FILING DATE: 2005-05-11
PRIOR APPLICATION NUMBER: JP 2004-232811
PRIOR FILING DATE: 2004-05-11
NUMBER OF SEQ ID NOS: 817670
SEQ ID NO 325128
LENGTH: 19
TYPE: DNA
ORGANISM: Homo sapiens
FEATURE:
OTHER INFORMATION: siRNA target sequence for YT521 (NM_133370.1,1515-1533).
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 AAGAAAGTCTTGCAAACCC 19 (SEQ ID NO: 18)
|||||||||||||||||||
Db 19 AAGAAAGTCTTGCAAACCC 1
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 20080113351 (hereafter “Naito”), as applied in the rejection above, in view of U.S. 10,125,092 (hereafter “Beckwith”).
Naito teaches a pharmaceutical composition comprising the dsRNA of claim 1, as indicated above.
Naito does not teach that the pharmaceutical composition further comprises a lipid nanoparticle (LNP).
However, LNPs were well known in the prior art as agents which can be used in pharmaceutical composition for delivering siRNA molecules. For instance, Beckwith teaches, “Another embodiment of the present invention provides for a lipid nanoparticle comprising a compound of formula (I) a helper lipid, for example cholesterol, a neutral lipid, for example DSPC, and a stealth lipid, for example S010, S024, S027, S031, or S033, and a biologically active agent, for example a mRNA, siRNA or DNA” (See column 32, lines 27-35 ); and, “The lipid nanoparticles (LNPs) were formed by mixing equal volumes of lipids dissolved in alcohol with siRNA…” (See 121:45-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, prior to the day the claimed invention was filed to combine Naito and Beckwith to arrive at the composition comprising an LNP of Beckwith and the dsRNA of Naito, with a reasonable expectation of success. The motivation to combine would be based on Beckwith’s indication that the LNP can be used as a delivery agent for dsRNAs.
Improper Markush Group
Claims 1-3 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 dsRNA sequence SEQ ID Nos in claims 1-3 is improper 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 a dsRNA molecule that targets and inhibits expression of an HBV gene, they do not share a single structural similarity as each dsRNA sequence is distinct from the others. Furthermore, since each dsRNA has different nucleotide sequences, no two dsRNAs would have the exact same effect (i.e., each would have at least some difference in target gene inhibition).
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.
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