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 .
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 06/30/2025, claims 17, 21, 30, 38, 48, and 50 are amended, and claims 51-52 are newly added. Per Applicant’s amendment to the claims, submitted on 07/27/2025, claims 17 and 38 have been further amended. Currently, claims 17, 21, 24-27, 29-30, 38-42, 44-45, 48, and 50-52 are pending in the instant application.
Claim Objections – Withdrawn
Objections to claims 17 and 30:
In light of Applicant’s amendment to the claims, the objections are hereby withdrawn.
Claim Objections – Necessitated by Amendment
Claim 51 is objected to because of the following informalities: Claim appears to have been amended, but has incorrect status indicator. Claim 51 was newly added in the amendment submitted on 06/30/2025, and recites the following:
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However, in the amendment submitted on 07/27/2025, claim 51 is provided as “(previously presented)” and now recites the following:
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Applicant must clarify if this was an intentional amendment, and provide the necessary status indicator, or revert the claim to its previous form. Appropriate correction is required.
Claim 23 appears to be missing from the listing of claims. The last claim set submitted wherein claim 23 was dated 05/03/2024. If claim 23 was intended by Applicant to have been canceled, the claim must be listed along with the appropriate status indicator.
Claim Rejections - 35 USC § 112 Second Paragraph – Withdrawn
Rejections of claims 17, 21, 38, 48, and 50:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn. Previously indicated indefinite recitations from each of the claims have been removed.
Claim Rejections - 35 USC § 112 First Paragraph – Withdrawn
Rejections of claims 17, 21, 38, 48, and 50:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn. The claims have been amended such that the written description requirement has been met.
Claim Rejections - 35 USC § 102 – Withdrawn
Rejections of claims 17, 21, 24-27, and 29-30:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn. The previously indicated compound of Vandyck (previously referenced) no longer anticipates a compound of claim 1. Claim 1 has been amended such that R1’ group no longer allows for a C1 alkyl moiety.
Double Patenting - Maintained
Claims 17, 21, 24-27, and 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-42 of copending Application No. 18/453,887 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 17, 21, 24-27, and 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10752584 (herein the ‘584 patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Rejections of claims 17, 21, 24-27, and 29-30:
Applicant has chosen to defer response to the outstanding double patenting rejections, as stated in Remarks (06/30/2025). Accordingly, the rejections of the claims are maintained. As iterated in the previous Office Action, the scope of the claims of the instant application remain in overlap with the scope of the claims of Application 18/453,887, and patent 10752584.
For purpose of clarity and record, the outstanding rejections will be reiterated herein.
Reiterated Rejections:
Claims 17, 21, 24-27, 29-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-42 of copending Application No. 18/453,887 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 17 of the instant application appears to encompass the compounds of claims 7 and 20 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 17 of the instant application recites a compound of the following formulas 9 and 10:
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Claim 7 of the reference application recites a compound of the following structure:
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Claim 20 of the reference application recites a compound of the following structure:
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The compounds of claims 7 and 20 of the reference application appear to be embraced by the structural genus presented in claim 17 of the instant application. Formulas 9 and 10 of the instant application recite limitations for rings B, C, D, and E encompass the corresponding ring structures of the compounds of the reference application (i.e., substituted pyrrole and substituted phenyl). Furthermore, variable W of Formulas 9 and 10 are equivalent to the corresponding structure in the claims of the reference application. Furthermore, both the instant application (claims 24-27, 29, 39-42, 44) and the reference application (claims 33-34, 38-39) recite compositions comprising said compounds and methods of use in treating HBV. Given the significant structural overlap and shared method of use in treating the same condition, the claims at hand cannot be considered as patentably distinct from one another.
Claims 17, 21, 24-27, 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10752584 (herein the ‘584 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘584 patent lays claim to compounds which anticipate compounds of the instant application.
Claim 17 of the instant application recites a compound of the following formulas 9 and 10:
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Claim 2 of the ‘584 patent claims various compound species. Of particular note is the following compound:
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The above exemplary compound of claim 2 of the ‘584 patent anticipates a compound Formula 9 of claim 17 of the instant application wherein:
R1 is C1 alkyl
R1’ is halogen (F)
u is 3
v is 2
Ring C is phenyl
Ring B is a 5 membered heteroaromatic ring containing one heteroatom (N)
W is
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R12 is H
R13 is C3 alkynyl
The same compound anticipates a compound of Formula 10 of the same claim wherein:
R1 is C1 alkyl
R1’ is halogen (F)
u is 3
v is 2
Ring E is phenyl
Ring D is a 5 membered heteroaromatic ring containing one heteroatom (N)
W is
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R12 is H
R13 is C3 alkynyl
As the claims of the reference application recite subject matter which anticipates claims of the instant application, the claims at hand cannot be considered as patentably distinct from one another.
Double Patenting – Necessitated by Amendment
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 51-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-42 of copending Application No. 18/453,887 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
As iterated in the previous Office Action, claims 17, 21, 24-27, and 29-30 were rejected as being unpatentable over claims 7-42 of copending Application No. 18/453,887. Instant claims 51 and 52 depend upon claim 17, and even with the narrowed limitations, appear to still fall within the scope of at least claim 7 of the copending application. Accordingly, the instant claims are rejected for the same reasons as claims 17, 21, 24-27, and 29-30 in view of application 18/453,887.
Claims 51 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10752584 (herein the ‘584 patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
As iterated in the previous Office Action, claims 17, 21, 24-27, and 29-30 were rejected as being unpatentable over claims 1-20 of the ‘584 patent. Instant claims 51 and 52 depend upon claim 17, and even with the narrowed limitations, appear to still fall within the scope of at least claim 1 of the copending application. Accordingly, the instant claims are rejected for the same reasons as claims 17, 21, 24-27, and 29-30 in view of application 18/453,887.
Allowable Subject Matter
The prior art does not appear to teach or reasonably suggest the compounds of the instant claims, methods of use of said compounds, or compositions comprising said compounds. The closest prior art remain Vandyck (previously referenced) and Schinazi (previously referenced), which each teach compounds as HBV inhibitors having similar basic structure to compounds of the instant claims. As discussed in the previous Office Action Vandyck and Schinazi teach the following generic structures for their HBV inhibitors, respectively:
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While the above generic structures and various species taught by both have analogous structures to the compounds of the instant claims, they do not teach or suggest any compound species which anticipate or obviate the compounds of the instant claims.
Conclusion
Claims 17, 21, 24-27, 29-30, and 51-52 are rejected.
Claims 38-42, 44-45, 48, and 50 are in condition for allowance.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629