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 .
Status of Claims
Claims 1-14, 18-20 and 22-23 are pending in the instant application.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 05/31/2023 was considered by the Examiner.
Priority
Acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) based upon an application filed in China on 12/01/2021. The claim for priority cannot be based on said application because the subsequent nonprovisional or international application designating the United States was filed more than twelve months thereafter and no petition under 37 CFR 1.55 or request under PCT Rule 26bis.3 to restore the right of priority has been granted.
Applicant may wish to file a petition under 37 CFR 1.55(c) to restore the right of priority if the subsequent application was filed within two months from the expiration of the twelve-month period and the delay was unintentional. A petition to restore the right of priority must include: (1) the priority claim under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) in an application data sheet, identifying the foreign application to which priority is claimed, by specifying the application number, country (or intellectual property authority), day, month, and year of its filing (unless previously submitted); (2) the petition fee set forth in 37 CFR 1.17(m)(3); and (3) a statement that the delay in filing the subsequent application within the twelve-month period was unintentional. The petition to restore the right of priority must be filed in the subsequent application, or in the earliest nonprovisional application claiming benefit under 35 U.S.C. 120, 121, 365(c), or 386(c) to the subsequent application, if such subsequent application is not a nonprovisional application. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 12/01/2021. It is noted, however, that applicant has not filed a certified copy of the PCT/CN2021/134798 application as required by 37 CFR 1.55.
Claim Objection
Claim 10 is objected to because of the following informalities:
It appears there is a type in line 2 of the claim. It is recommended that Applicant amend the claim to replace “choro” with “chloro”.
Claim 13 is objected to because of the following informalities:
It is recommended that Applicant amend the claim to recite “A compound selected from the group consisting of…” in lines 1-2 and end the claim with “or a stereoisomer, tautomeric form, pharmaceutically acceptable salt, N-oxide, or solvate thereof.”
Claim 8 is objected to as being dependent on a rejected base claim.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-12, 14, 18-20 and 22-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chunliang et al (US 2024/0279227 A1, which claims priority to PCT/CN2021/097848, filed 06/02/2021).
The applied reference has a common applicant and common inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Chunliang teaches the following compound (page 109, compound 16A, which finds support on page 15 of the priority document):
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This compound is embraced by Formula (I), wherein R1 is phenyl with 2 halo substituents, W is CHR4, wherein R4 is CONR6R7, wherein R6 is hydrogen and R7 is alkyl, X is CHR5, wherein R5 is hydrogen, R2 is C1 alkyl, Q is phenyl, R3 is OCHF2 and n is 1.
Regarding claim 2, the compound above is of Formula (IA), wherein R1a and R1b are halo, R1c is hydrogen, R2 is C1 alkyl, Q is phenyl, R3 is OCHF2 and n is 1.
Regarding claim 3, the compound above is of Formula (IB), wherein R1a and R1b are halo, R1c is hydrogen and R2 is C1 alkyl, R3 is OCHF2 and n is 1.
Regarding claim 4, the compound above is of Formula (IE).
Regarding claim 5, the compound above is of Formula (IC).
Regarding claim 6, the compound above is of Formula (ID).
Regarding claim 7, R4 is CONHC1alkyl and R5 is H.
Regarding claim 9-10, R1a and R1b are halo, R1c is hydrogen, wherein the halo is chloro.
Regarding claim 11, as seen above n is 1.
Regarding claim 12, as seen above, R3 is OCHF2.
Regarding claim 14, Chunliang teaches a pharmaceutical composition comprising the above compound and at least one pharmaceutically acceptable excipient (paragraph [0351], which finds support in claim 18 of the priority document)
Regarding claim 18, Chunliang teaches a method of treating an HBV infection or an HBV-induced disease in an individual in need thereof, comprising administering to the individual a therapeutically effective amount of the above compound ( claim 23, which finds support in claim 22 of the priority document).
Regarding claim 22, Chunliang teaches that the compound is for use in the treatment of chronic hepatitis B (paragraph [0354], which finds support in claim 21 of the priority document).
Regarding claim 23, Chunlaing teaches that the compound is administered in combination with another HBV inhibitor (paragraph [0358], which find support in claim 25 of the priority document).
Regarding claim 19, Chunliang teaches a product comprising a first compound and a second compound as a combined preparation for simultaneous, separate or sequential use in the prevention or treatment of an HBV infection or of an HBV-induced disease in a subject in need thereof, wherein said first compound is different from said second compound, wherein said first compound is the above compound 17 and wherein said second compound is another HBV inhibitor (paragraph [0356], which finds support in claim 23 of the priority document)
Regarding claim 20, Chunliang teaches that the second compound is another HBV inhibitor which is selected from the group consisting of: therapeutic agents selected from HBV combination drugs, HBV vaccines, HBV DNA polymerase inhibitors, immunomodulatory agents, toll-like receptor (TLR) modulators, interferon alpha receptor ligands, hyaluronidase inhibitors, hepatitis b surface antigen (HBsAg) inhibitors, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, cyclophilin inhibitors, HBV viral entry inhibitors, antisense oligonucleotide targeting viral mRNA, short interfering RNAs (siRNA) and ddRNAi endonuclease modulators, ribonucleotide reductase inhibitors, HBV E antigen inhibitors, covalently closed circular DNA (cceDNA) inhibitors, famesoid X receptor agonists, HBV antibodies, CCR2 chemokine antagonists, thymosin agonists, cytokines, nucleoprotein modulators, retinoic acid-inducible gene 1 simulators, NOD2 stimulators, phosphatidylinositol 3-kinase (PIЗK) inhibitors, indoleamine-2, 3-dioxygenase (IDO) pathway inhibitors, PD-1 inhibitors, PD-L1 inhibitors, recombinant thymosin alpha-1, bruton's tyrosine kinase (BTK) inhibitors, KDM inhibitors, HBV replication inhibitors, arginase inhibitors, and other HBV drugs (paragraph [0357], which finds support in claim 24 of the priority document).
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 1-7, 9-14 and 18-19 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19 and 23-24 of copending Application No. 18/565,664 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application claims the following compound (claim 17):
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This compound is embraced by Formula (I), wherein R1 is phenyl with 2 halo substituents, W is CHR4, wherein R4 is CONR6R7, wherein R6 is hydrogen and R7 is alkyl, X is CHR5, wherein R5 is hydrogen, R2 is C1 alkyl, Q is phenyl, R3 is OCHF2 and n is 1.
Regarding claim 2, the compound above is of Formula (IA), wherein R1a and R1b are halo, R1c is hydrogen, R2 is C1 alkyl, Q is phenyl, R3 is OCHF2 and n is 1.
Regarding claim 3, the compound above is of Formula (IB), wherein R1a and R1b are halo, R1c is hydrogen and R2 is C1 alkyl, R3 is OCHF2 and n is 1.
Regarding claim 4, the compound above is of Formula (IE).
Regarding claim 5, the compound above is of Formula (IC).
Regarding claim 6, the compound above is of Formula (ID).
Regarding claim 7, R4 is CONHC1alkyl and R5 is H.
Regarding claim 9, R1a and R1b are halo, R1c is hydrogen, wherein the halo is chloro.
Regarding claim 11, as seen above n is 1.
Regarding claim 12, as seen above, R3 is OCHF2.
Regarding claim 14, the copending application claims a pharmaceutical composition with the above compound and a pharmaceutically acceptable excipient (claim 19).
Regarding claim 18, the copending application claims a method of treating an HBV infection or an HBV-induced disease in an individual in need thereof with the above compound (claim 23).
Regarding claim 19, the copending application claims a product with the above compound and a second compound, wherein the second compound is another HBV inhibitor (claim 24).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 10-14 and 18-19 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19 and 23-24 of copending Application No. 18/565,725 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application claims the following compound (claim 17):
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This compound is embraced by formula (I), wherein R1 is phenyl, substituted with CN and halo, W is CHR4, wherein R4 is C1 alkyl, X is CHR5, wherein R5 is H, R2is C1 alkyl, Q is phenyl R3 is OCHF2 and n is 1.
Regarding claim 2, the compound above is of Formula (IA), wherein R1a and R1b are halo and cyano, R1c is hydrogen, R2 is C1 alkyl, Q is phenyl, R3 is OCHF2 and n is 1.
Regarding claim 3, the compound above is of Formula (IB), wherein R1a and R1b are halo, R1c is hydrogen and R2 is C1 alkyl, R3 is OCHF2 and n is 1.
Regarding claim 4, the compound above is of Formula (IE).
Regarding claim 5, the compound above is of Formula (IC).
Regarding claim 6, the compound above is of Formula (ID).
Regarding claim 7, R4 is CH3 and R5 is H.
Regarding claim 9, R1a and R1b are halo and cyano, R1c is hydrogen.
Regarding claim 11, as seen above n is 1.
Regarding claim 12, as seen above, R3 is OCHF2.
Regarding claim 18, the copending application claims a method of treating an HBV infection or an HBV-induced disease in an individual in need thereof with the above compound (claim 23).
Regarding claim 19, the copending application claims a product with the above compound and a second compound, wherein the second compound is another HBV inhibitor (claim 24).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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/A.G.K./Examiner, Art Unit 1626
/JOSEPH K MCKANE/Supervisory Patent Examiner, Art Unit 1626