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 .
CONTINUING DATA
This application is a 371 of PCT/US2022/028490 05/10/2022
PCT/US2022/028490 has PRO 63/256,419 10/15/2021
PCT/US2022/028490 has PRO 63/189,402 05/17/2021
This office action is in response to Applicant’s amendment submitted June 12, 2026. Claims 1, 5, 10, 15, 20, 24,28, 33-34, 36-37, 39, 42, 49, 51-52, 57, 60-61, and 63 are pending.
The rejection of Claim 63 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of Applicant’s amendment.
The rejection of Claim 57 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendment to provide definitions for R9 and R10.
Priority
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 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 applications, Application No. 63256419 and 63189402, fail 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. The ‘419 application does not provide support for formulae (V)-(VII). The ‘402 application does not provide support for formula (III)-(VII). Neither of the applications provides support for at least one compound in claim 60, such as the second to last compound on page 10. The filing date of the claims is May 10, 2022.
The following rejections of record are maintained and modified where necessary to account for the new limitation “of the liver” in claim 63.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
It is noted that a very large number of prior art references were found. The examiner has included rejections over a reasonable number of prior art references. Rejections have not been made over all possible prior art references, even possibly some references which are used in double patenting rejections, to avoid unnecessary duplication of rejections.
It is also noted that formulae are listed in the alternative in claim 1, and many of the dependent claims limit variables which are only present in some of the claimed formulae. These dependent claims do not require that the recited variable is present in the prior art compound, only that if that variable is present, it must be as recited in the dependent claim.
Claim(s) 1, 10, 15, 24, 28, 33-34, 36, 42, 51, 52, 61, and 63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suresh (Arch. Pharm. Chem. Life Sci. 2016, 349, 442-455).
Suresh teaches the following compounds in Scheme 1, page 453.
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Compound 9 is a compound of claimed Formula (I). R5a, R5b, R6a, and R6b are all H. BASE is a nucleoside base. R4 is Cl and n is 1. R3a and R3b are H or ethyl. Y is H. R1 is H. The compounds were used for treating NDV (page 454, In vivo studies). NDV targets the liver.
Claim(s) 1, 5, 10, 15, 20, 24, 28, 33-34, 36-37, 39, 42, 51, 52, 61, and 63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parsy (US 20130315867 A1, 2013).
Parsy teaches the following compound on page 40:
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This is a compound which is a stereoisomer of Formula (II). R6a and R6b are OH or methyl. BASE is a nucleoside base derivative. R7 is methyl and n is 0. The compound is used for treating hepatitis C (claim 39).
Claim(s) 1, 5, 10, 15, 20, 24, 33-34, 36-37, 39, 42, 51, and 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gohil (Nucleic Acids Research Volume 1 number 12 December 1974).
Gohil teaches the following compounds on page 1692:
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This is a stereoisomer of Formula (VI). R6a and R6b are H or OH. BASE is a nucleoside base. R8 is a C1-C3 alkyl.
Claim(s) 1, 5, 10, 15, 20, 24, 33-34, 36-37, 39, 42, 49, 52, 57, 61 and 63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhi (US 9,676,809 B2, 2017).
Zhi teaches compounds in claim 6 such as:
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This is a stereoisomer of claimed Formula (VII) where R4 is chloro and n is 1. R6a and R6b are fluoro or methyl. R5a and R5b are H and the second moiety shown in current claim 39. BASE is as shown in current claim 57 where R9 and R10 are H. A pharmaceutical composition and method of treating a viral infection are claimed (claims 12-13). The viral infection is hepatitis C (see title).
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.
Claim(s) 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhi (WO 2020/219464 A1, October 29, 2020). The filing date of all the claims was deemed to be May 10, 2022, as set forth above.
Zhi teaches the following compound in claim 51:
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This compound differs from the first compound shown in current claim 60 because the compound of the current claim contains a fluorine substituent which the Zhi compound lacks. Zhi also teaches that the broader formula (Ia) on page 6:
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Zhi teaches that R2a and R2b can be H or F. Paragraph [0039].
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare a fluorinated analog of Zhi’s compound at either R2a or R2b, which would have resulted in a stereoisomer of the first compound shown on page 10 of the current claims. The skilled artisan would have prepared the compound because Zhi teaches a finite number of possibilities for position R2a or R2b, specifically including fluorine. Simple substitution of F for H in Zhi’s compound would have resulted in the claimed compound, and the results would have been predictable because Zhi teaches that fluorine is suitable for the position R2a or R2b.
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, 5, 10, 15, 20, 24, 28, 33-34, 36-37, 39, 42, 51-52, 61, and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 9,326,991. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘991 patent claims compounds of Formula I, which are stereoisomers of the claimed compounds:
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In Formula I, R3 and R4 is H or acyl, and R1 is an optionally substituted phenyl. Claim 12 recites a first compound wherein R1 is 3-chlorophenyl and R3 and R4 are both H. This corresponds to current formula (VII) where R5a and R5b are H and OH, R61 and R6b are H and OH, R4 is chloro, and n is 1. Claim 12 recites a sixth compound wherein R3 and R4 are acetyloxy, which meets the limitations of current claim 39. The ‘991 patent also claims a pharmaceutical composition and treatment of a viral infection. Claims 14-15. The viral infection is an infection of the liver (claim 17).
Claims 1, 5, 10, 15, 20, 24, 28, 33-34, 36-37, 39, 42, 49, 52, 57, 61, and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,676,809. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘809 patent claims compounds in claim 6 such as:
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This is a stereoisomer of claimed Formula (VII) where R4 is chloro and n is 1. R6a and R6b are fluoro or methyl. R5a and R5b are H and the second moiety shown in current claim 39. BASE is as shown in current claim 57 where R9 and R10 are H. A pharmaceutical composition and method of treating a viral infection are claimed (claims 12-13). The viral infection is HCV (claim 15).
Claims 1, 5, 10, 15, 20, 24, 28, 33-34, 36, 39, 42, 52, 57, 61, and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,435,429. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘429 patent claims compounds in claim 14 such as:
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This is a stereoisomer of claimed Formula (VII) where R4 is chloro and n is 1. R6a and R6b are each hydrogen. R5a and R5b are H and the second moiety shown in current claim 39. BASE is as shown in current claim 57 where R9 and R10 are H. A pharmaceutical composition and method of treating a hepatocellular carcinoma are claimed (claims 16-17).
Claims 1, 5, 10, 15, 20, 24, 28, 33-34, 36-37, 39, 42, 49, 51-52, 57, and 61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 11, 13-17, 25, 32-33, 35-38, 41, 50-52, and 56-67 of copending Application No. 17/604,681 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims compounds such as the following in claim 51.
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These compounds are stereoisomers of Formula (II) wherein R7 is alkyl and n is 0. R6a and R6b are both H, are both F, or one is OH and the other is H, or one is F and the other is methyl. BASE is as shown in current claim 57. A pharmaceutical composition and method of treating disease are claimed (claims 52 and 56). The illustrated compounds anticipate current claims 1, 5, 10, 15, 20, 24, 28, 33-34, 36-37, 39, 42, 49, 51-52, 57, 61, and 63.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5, 10, 15, 20, 24, 28, 33-34, 36-37, 39, 42, 51, 52, 57, 61, and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,427,550. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘550 patent claims compounds, pharmaceutical compositions, and methods of treating a disease or disorder (claims 19-20). The disease is a condition of the liver (claim 21). Claimed compounds include:
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This is a stereoisomer of claimed Formula (VI) where BASE is as shown in current claim 57. R6a and R6b are both H and R8 is C8 alkyl. In the following compound, R8 is phenyl.
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Claims 1, 5, 10, 15, 20, 33-345, 36-37, 39, 42, 51, 52, 61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12, and 14-16 of copending Application No. 18/032,783 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims compounds such as the following in claim 10:
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This is a compound of claimed Formula (II) where R6a and R6b are each H and R7 is ethyl and n is 0. This is also a compound of claimed formula (VI) where R8 is a substituted aryl. Pharmaceutical compositions and methods of treatment are claimed (claims 12 and 14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5, 10, 15, 20, 24, 28, 33-34, 36-37, 39, 42, 51-52, 57, 61, and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,110,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘311 patent claims compounds, pharmaceutical compositions, and methods of treatment for a disease of the liver. Claims 12-15. Compounds in claim 12 include:
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This is a stereoisomer of Formula (VI) where R6a and R6b are each H and R8 is C6 alkyl. BASE is as shown in current claim 57 where R9 is F and R10 is H. In the following compound, R8 is phenylethyl.
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Claims 1, 5, 10, 15, 20, 24, 28, 34, 36-37, 39, 41, 51, 52, 57, 61, and 63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11, 15, 19-29, 41, 44, 46, 49-50, 52-53 of copending Application No. 18/706,719 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the’719 application claims compounds, pharmaceutical compositions, and methods of treatment of a disease of the liver (claims 49-50 and 52-53). Compounds in claim 49 include:
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This is a stereoisomer of Formula (III) where R6a and R6b are each H. One of R3a and R3b is H and the other is methyl. R7 is a C6 alkyl group.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5, 10, 15, 20, 24, 28, 33-34, 36-37, 39, 42, 51-52, 57, 61, 63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/826,713 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the’713 application claims a method of treatment using compounds in claim 12. The disease is a cancer of the liver (claim 14). The first compound in claim 12 is:
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This is a compound of Formula (VI). BASE is a nucleoside base analog. R6a and R6b are both H. R8 is a C6 alkyl. Another compound in claim 12 is as follows, wherein R8 is fluorophenyl.
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Response to Arguments
For each of the above rejections, Applicant argues that the claimed compounds are of a different configuration than the compounds recited in the prior art references or patents or patent applications. This argument is not persuasive because the claims are drawn to recited compounds or a stereoisomer thereof. The compounds presented in the above rejections are stereoisomers of the claimed compounds.
Applicant argues that the office action does not explain why it would be obvious to prepare the unnatural configuration compounds with a reasonable expectation of success. This argument is not persuasive because the rejections do not rely on preparing an unnatural configuration of the prior art (or patent/application) compounds. The prior art/patent/application compounds are stereoisomers of the claimed compounds, and the claims encompass stereoisomers.
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 LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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