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 . The amendment filed on 11/06/2025 has been entered. Claim 17 is cancelled. Claims 1-16 and 18-20 are pending in this application and are currently under examination.
Priority
This application is a 371 of PCT/CN2021/099405 filed on 06/10/2021 and claims foreign priority of CHINA 202010522407.6 filed on 06/10/2020 and CHINA 202011524307.3 filed on 12/21/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. CHINA 202010522407.6, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 10 and 11 recite “
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”, “
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”, and/or “
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”, which are not explicitly disclosed or supported by the prior-filed Application No. CHINA 202010522407.6. Thus, the priority date of claims 10 and 11 is 12/21/2020.
Withdrawn Claim Objections/Rejections
The objection of claims 2, 3, 8, 11, and 16 because of improper recitation, as set forth on page 4 of the Non-Final Rejection mailed on 08/06/2025, is withdrawn in view of amended claims.
The objection of claims 2 and 11 because reference characters are not enclosed within parentheses, as set forth on page 4 of the Non-Final Rejection mailed on 08/06/2025, is withdrawn in view of amended claims.
The rejection of claims 1-16 and 18-20 under 35 U.S.C. 103 as being unpatentable over Prakash et al. in view of Budzik et al. and Xiao et al. as set forth on page 4 of the Non-Final Rejection mailed on 08/06/2025, is withdrawn in view of Applicant’s Remarks and Declaration filed on 11/06/2025. Applicant argued “Declaration provides KD values of an exempalry claimed compound, D-01-M (
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) and a comparative compound L96 (
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), which is structurally similar to the compounds disclosed in Prakash, for binding to ASGAR ¶¶ 3-4. As shown in Table 1 (
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) in the Declaration, the claimed D-01-M Compound showed superior binding affinity to ASGAR relative to Compound L96 ¶ 5 (p. 14, para. 4). In response, these arguments are persuasive because the above superior ASGAR binding of the claimed structure is unexpected.
New (necessitated by amendment) Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 11 depends from claim 10.
Claim 10 recites “inclusive” (last line). It is not clear what the recitation refers to. The term “inclusive” was also not found in the Specification. Applicant is advised to delete the recitation.
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 1-16 and 18-20 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 25, 32, 33, 35, and 37 of copending Application No. 18/001,244 (An et al., the claim set of 12/08/2022). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘244 claims “A double-stranded siRNA analogue, a conjugate thereof or a salt thereof, comprising: a sense strand and an antisense strand, wherein the antisense strand comprises a sequence obtained by replacing one or more nucleotide residues in a sequence set forth in SEQ ID NO: 2 (or optionally comprises an overhang at the 5' end and/or 3' end)… wherein each of nucleotides and r m the siRNA analogue is independently modified or unmodified (or wherein the double-stranded siRNA analogue is linked to a pharmaceutically acceptable conjugate group, and the pharmaceutically acceptable conjugate group comprises a GalNAc group; or the pharmaceutically acceptable conjugate group comprises a compound group D:
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; or wherein a phosphorothioate moiety of the double-stranded siRNA analogue or the conjugate thereof comprises (R)- and (S)-enantiomers, diastereoisomers, and/or racemic mixtures thereof” (claims 1, 25, 32, 33, and 35), and “A method for treating hepatitis B in a subject, comprising administering to the subject the double-stranded siRNA analogue, the conjugate thereof or the salt thereof according to claim 1 or the pharmaceutical composition thereof” (claim 37), reading on claims 1-16 and 18-20 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Arguments/Remarks filed on 11/06/2025 have been fully considered. Applicant argued “this rejection be held in abeyance until allowable subject matter is identified in the instant application… the above double patenting rejection will be reevaluated in view of the allowable claims in relation to the then pending claims of co-pending Application No. 18/001,244.
In response, this provisional double patenting is thus maintained in view of Applicant’s arguments above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 pm EST.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691