DETAILED ACTION
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 .
This Official Action considers the response filed 9/4/2025. Applicant argues that the references cited do not teach the limitation of “wherein the sense strand comprises 36 nucleotides with positions 1-36 from 5’ to 3’, wherein positions 8-11 comprise a 2’-fluoro modification; the antisense strand comprises 22 nucleotides with positions 1-22 from 5’ to 3’, and wherein positions 2, 3, 4, 5, 7, 10, and 14 comprise a 2’-fluoro modification; and the remaining nucleotides comprise a 2’-O-methyl modification”.
The examiner agrees and withdraws the rejection of claims 6, 9-21, and 26 under 35 U.S.C. 103 as being unpatentable over Naito et al (US20080113351) view of Abrams et al (US20190000870) and Brown et al (US20200283775). Claims 7 and 27-44 remain rejected.
Applicant asserts that the prior art does not teach 36nt sense strands. Brown et al discloses such at least at paragraphs 6, 75, 143, and claims 1, 6, and 28 which were cited in the rejection of record.
Election/Restrictions
Applicant’s election without traverse of Group I and SEQ ID NOS:787 and 874 in the reply filed on 3/06/2024 is acknowledged.
Claims 1-21 and 26-47 are pending.
Claims 1-5, 8, 46, and 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/06/2024.
Claims 6, 7, 9-21, and 26-45 are examined.
Claim Rejections - 35 USC § 103
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) 7 and 27-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naito et al (US20080113351) view of Abrams et al (US20190000870) and Brown et al (US20200283775).
Naito et al have taught SEQ ID NO:8248 which is taught to be a target sequence for siRNA inhibition of NR1H3. Naito et al have not specifically disclosed a dsRNA construct, but have taught a specific target region that corresponds with the elected SEQ ID NO:786. See paragraphs 119, 121, and 172, for example.
Abrams et al have taught all of the limitations of the claims were known at the time the application was effectively filed and provide teachings for the benefits of each of the limitations of the instant claims where all of the limitations are used for the same purpose as the prior art. One in the art would have been motivated to look to the prior art to find siRNA design choices that provide for more effective siRNA inhibitors especially since it was known that NR1H3 is expressed in the liver and associated with liver disease (see the instant specification at paragraphs 31 and 32, for example). While the entire reference is relied on and relevant applicant is directed to paragraphs 5, 11, 13, 15, 24, 71, 78, 89, 90, 118, 119, 123-136, 142-151.
Brown et al have also taught the limitations of the claims were known at the time the application was effectively filed and provide teachings for the benefits of each of the limitations of the instant claims where all of the limitations are used for the same purpose as the prior art. One in the art would have been motivated to look to the prior art to find siRNA design choices that provide for more effective siRNA inhibitors especially since it was known that LDHA is expressed in the liver and associated with liver disease (see the instant specification at paragraphs 31 and 32, for example). While the entire reference is relied on and relevant applicant is directed to paragraphs 4, 6, 10, 22, 54, 55, 66, 74, 75, 87, 93, 94, 143, 145, and claims 1-34, for example.
Sequence 8248, 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 FOR INHIBITING GENE EXPRESSION USING THE
TITLE OF INVENTION: SAME
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
NUMBER OF SEQ ID NOS: 817670
SEQ ID NO 8248
LENGTH: 19
TYPE: DNA
ORGANISM: Homo sapiens
FEATURE:
OTHER INFORMATION: siRNA target sequence for NR1H3 (NM_005693.1,980-998).
Query Match 50.0%; Score 18; Length 19;
Best Local Similarity 100.0%;
Matches 18; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CTCAAGGATTTCAGTTAT 18
||||||||||||||||||
Db 2 CTCAAGGATTTCAGTTAT 19
The invention as a whole would therefore have been prima facie obvious at the time the application was effectively filed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 6, 7, and 9-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11578329. Although the claims at issue are not identical, they are not patentably distinct from each other because both the application and the patent are drawn to the same dsRNAi for reducing NR1H3 expression. The patent claims and the application claims anticipate each other. See claim 1 of the patent and claims 6 and 7 of the application, for example.
Applicant has offered no arguments in regard to the double patenting rejection.
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 SEAN MCGARRY whose telephone number is (571)272-0761. The examiner can normally be reached M-Th/F 9:00-7:30.
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, Ram Shukla can be reached at 571 272 1600. 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.
/SEAN MCGARRY/Primary Examiner, Art Unit 1635