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 7-8-26.
Claims 1, 12, 16, 18, 19, 30, 40, 51, 54, 57, 67, 71, 72, 74, 78, 80, 81, 94, 98 and 99 are pending in the instant application.
Election/Restrictions
Claims 74, 78, 80, 81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.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 7-8-26.
Applicant’s election without traverse of Group I, SEQ ID No. 175, claims 1, 12, 16, 18, 19, 30, 40, 51, 54, 57, 67, 71, 72, 94, 98 and 99 in the reply filed on 7-8-26 is acknowledged.
Claim Objections
Claim 54 is objected to because of the following informalities: In line 3 of claim 54, “or” appears to be a typographical error (e.g., perhaps replacing “or” with – of – would be remedial. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 71 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 71 recites a cell containing a dsRNA agent, which encompasses a human organism.
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, 12, 16, 18, 19, 30, 40, 51, 54, 57, 67, 71, 72, 94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freier et al (WO 2005/042552) and Freier et al (US 20050191653), the combination in view of Hasslet et al (Nucleic Acids Res., Vol. 46, No. 5, pages 2185-2196 (2018)) and Manoharan et al (CA 2708171).
The claims are drawn to kits, cells and pharmaceutical compositions comprising dsRNA between 17-25 nucleotides and comprising at least 15 contiguous nucleotides from SEQ ID No. 175, wherein all of the nucleotides on the sense and antisense strands comprise a nucleotide modification optionally comprising a sugar, base or internucleotide modification, and one of the strands is conjugated to one or more lipophilic moieties optionally comprising a saturated or unsaturated C6-C18 hydrocarbon chain, which nucleotide modifications optionally comprise sugar, base or internucleotide modifications optionally comprising 2’O-methyl, LNA, 2’-O-alkyl modifications, phosphate mimics, or non-natural base modifications, 3’-overhangs, and which lipophilic moieties are optionally conjugated to one or more internal positions selected from positions 4-8 and 13-18 on the sense strand, or positions 6-10 or 15-18 on the antisense strand.
Freier et al (WO 2005/042552) teach pharmaceutical compositions comprising antisense oligonucleotides between 17-25 nucleotides and comprising at least 15 contiguous nucleotides from SEQ ID No. 175, and further comprising sugar, base and/or internucleotide modifications, and terminal overhangs (see esp. Example 5 on pages 37-38). Freier also teaches lipophilic conjugates covalently attached to the oligonucleotides (see esp. pages 12, 20-25), or which oligonucleotide is fully modified (Table 57 on page 95). See the sequence alignment between instantly claimed SEQ ID No. 175 and Accession No. ADZ84789 of Freier as set forth below.
RESULT 22
ADZ84789
ID ADZ84789 standard; DNA; 20 BP.
XX
AC ADZ84789;
XX
DT 14-JUL-2005 (first entry)
XX
DE Murine sodium-glucose cotransporter 2 DNA antisense oligonucleotide #14.
XX
KW Diagnosis; screening; sodium-glucose cotransporter 2; SGLT2;
KW hyperproliferation; metabolic disorder; non-insulin dependent diabetes;
KW neoplasm; endocrine disease; gastrointestinal disease; antidiabetic;
KW cytostatic; metabolic; hypoglycemic; ss; antisense oligonucleotide;
KW phosphorothioate.
XX
OS Mus musculus.
XX
CC PN WO2005042552-A2.
XX
CC PD 12-MAY-2005.
XX
CC PF 03-NOV-2004; 2004WO-US036620.
XX
PR 03-NOV-2003; 2003US-0517334P.
PR 21-SEP-2004; 2004US-00946498.
XX
CC PA (ISIS-) ISIS PHARM INC.
XX
CC PI Freier SM, Wancewicz E, Monia BP, Siwkowski AM, Watts L;
CC PI Leedom TA;
XX
DR WPI; 2005-346847/35.
XX
CC PT New compound comprising 8 to 80 nucleobases targeted to a nucleic acid
CC PT molecule encoding sodium-glucose cotransporter 2 (SGLT2), useful in
CC PT preparing a composition for treating or preventing a SGLT2 associated
CC PT condition, e.g., diabetes.
XX
CC PS Example 16; SEQ ID NO 111; 181pp; English.
XX
CC The invention relates to a compound targeted to a nucleic acid molecule
CC encoding sodium-glucose cotransporter 2 (SGLT2). The compound is an
CC antisense oligonucleotide that specifically hybridizes with a nucleic
CC acid molecule encoding SGLT2 and inhibits expression of the polypeptide.
CC The antisense oligonucleotide comprises at least one modified
CC internucleoside linkage i.e. a phosphorothioate linkage, at least one
CC modified sugar moiety, preferably a 2'-O-methoxyethyl sugar moiety, or at
CC least one modified nucleobase comprising a 5-methylcytosine. The
CC antisense compounds are useful for screening for a modulator of SGLT2,
CC for inhibiting the expression of SGLT2 and for preventing or treating
CC hyperproliferative disorders and metabolic disorders (such as type 2
CC diabetes). This sequence represents an antisense oligonucleotide targeted
CC to murine SGLT2 cDNA of the invention.
XX
SQ Sequence 20 BP; 6 A; 7 C; 4 G; 3 T; 0 U; 0 Other;
Query Match 82.6%; Score 19; Length 20;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 CGAAGAGCGCATTCCACTC 20
|||||||||||||||||||
Db 2 CGAAGAGCGCATTCCACTC 20
The primary reference does not teach siRNA comprising terminal overhangs or conjugated hydrocarbon chains.
Hasslet et al (Nucleic Acids Res., Vol. 46, No. 5, pages 2185-2196 (2018)) teaches comparisons in targeting, stability and uptake of fully modified and partially modified siRNA. Hassler teaches conjugated mediated delivery of siRNA of fully modified siRNA comprising 2’-fluoro, 2’-O-methyl and phosphorothioate modifications (see esp. the text on page 2185, Figure 1 on page 2187, Figure 2 on page 2190, Figure 3 on page 2191).
Manoharan et al (CA 2708171) teaches siRNA molecules comprising overhangs and lipophilic conjugates optionally comprising C1-C18 hydrocarbon chains for enhancing stability and target cell uptake (see esp. pages 32, 59-71, claims 1-8).
It would have been obvious to design and optimize siRNA molecules comprising at least 15 contiguous nucleotides from SEQ ID No. 175 because antisense comprising this sequence and targeting sodium-glucose cotransporter-2 (SGLT2) were well known and routinely used in the prior art, as disclosed by Freier. Sugar, base and internucleotide modifications, as well as lipophilic conjugation were also routinely utilized for enhancing antisense and siRNA stability, targeting and cellular uptake, as taught previously by Manoharan, Freier and Hasslet.
For these reasons, the instant invention would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Allowable Subject Matter
Claims 98 and 99 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 and any intervening claims.
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.
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Jane Zara
8-11-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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