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 . 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.
Priority
The instant application is a 371 of PCT/US2022/048463 filed on 10/31/2022 and claims domestic benefit to US provisional application no. 63/274,874 filed on 11/02/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2024 and 05/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Claims
The preliminary claim amendment filed on 12/27/2024 is acknowledged. Claims 3-5, 11, 15, 19-21, 23-29, 41, 44, 46, 50, and 52 are amended. Claims 6-10, 12-14, 16-18, 22, 30-40, 42-43, 45, 47-48, 51, and 54-61 are cancelled.
Accordingly, claims 1-5, 11, 15, 19-21, 23-29, 41, 44, 46, 49-50, and 52-53 are pending and being examined on the merits herein.
Claim Objections
Claim 29 is objected to because of the following informalities:
The first six base structures and the last six base structures recited for BASE1 are duplicates.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 29 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 29 recites the BASE1 is a base structure in the recited list.
Claim 29 depends from claim 1, and claim 1 recites BASE1 is a base structure in the recited list.
However, claim 29 fails to further limit the subject matter of the claim upon which it depends because the recited list of base structures in BASE1 of claim 29 contains the same base structures recited in the BASE1 list of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(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) 1-4, 11, 15, 19-21, 24-27, 29, 41, 44, 46, and 50 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Meppen et al. (US20100022468A1 in PTO-892).
Meppen teaches several nucleoside cyclic phosphoramidate compounds having a structural formula (l) (Abstract). Meppen teaches pharmaceutical compositions comprising these compounds and a pharmaceutically acceptable carrier or excipient (claim 16 and paragraph 0082).
Meppen demonstrates in Example 1 (paragraph 0114) a specific species of their compound shown below:
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This compound anticipates the instant Formula II compound when R1 is butyl (C4 alkyl), R2a is methyl (C1 alkyl), R2b is OR7 (wherein R7 is H), R3 and R4 are H, R5a is methyl (C1 alkyl), R5b is H, BASE2 is
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, wherein R9 is H and R11 is NH2. Furthermore, the recited exclusion does not apply since R11 is NH2.
In regards to instant claims 24-26, even though these instant claims further limits the recited Y group, the instant compound can be either Formula I or II. The recited Y group only appears in instant Formula I and not in Formula II, and the Meppen compound above meets instant formula II. Therefore, the Meppen compound above also anticipates instant claims 24-26 since the Formulla II structure is still encompassed by the scope of instant claims 24-26.
In regards to instant claim 46, even though this instant claim further limits the recited R12 group, the recited R12 group only appears in certain BASE2, and the Meppen compound above meets a recited BASE2 structure that does not recite a R12 group. Therefore, the Meppen compound above also anticipates instant claim 46 since instant claim 46 does not limit the BASE2 structure.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 5, 23, 28, and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Meppen et al. (US20100022468A1 in PTO-892).
The teachings of Meppen are as described above and the compound above in Meppen anticipates the Formula II compound in instant claim 1 as discussed above.
Furthermore, Meppen teaches that their compounds can be used as inhibitors of HCV replication and/or treatment of hepatitis C infection, which is a chronic liver disease (Abstract and paragraph 0003) and includes pharmaceutical comprising an effective amount of these compounds useful for inhibiting HCV (paragraph 0084).
Meppen teaches their compound has a structural formula l (claim 1) shown below:
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Meppen teaches that R1 is hydrogen, methyl, or fluoromethyl, and R2 is fluoro or OR3, wherein R3 is hydrogen, methyl, C1-10 alkyloxycarbonyl, and others (claim 1). The C1-10 alkyloxycarbonyl meets the limitation of the recited R7 group in instant claim 28 when R7 is C(O)R8, wherein R8 is C1-C10 alkyl.
Meppen teaches that R4 and R5 can come together with the carbon atom to which they attached form a 3- to 6-membered aliphatic spirocyclic ring system (claim 1), which meets the limitation of the R5a and R5b group in instant claim 23.
Even though Meppen does not demonstrate a compound with a recited combination of R2a and R2b groups in instant claim 5 such as when R2a is methyl and R2b is fluoro, it would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the OH group in the Meppen compound shown above that is at the instant R2b position with a fluoro group as disclosed in Meppen to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Meppen provides guidance that this position in their compounds can be fluoro or OR3.
In regards to instant claim 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the Meppen compound shown above such that the R4 and R5 position, which corresponds to the instant R5a and R5b position, can come together with the carbon atom to which they are attached to form a 3- to 6-membered aliphatic spirocyclic ring system as disclosed in Meppen to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Meppen provides guidance that these positions in there compounds can come together to form 3 to 6 member ring, which overlaps with the instant recited five to ten membered ring at the same positions. See MPEP 2144.05 I.
In regards to instant claim 28, even though this instant claim further limits the recited R7 group, the recited R7 group only appears when R2a and/or R2b is OR7, and the Meppen compound described above meets the R2a and R2b groups when R2a is methyl (C1 alkyl) and R2b is fluoro. Therefore, instant claim 28 is also prima facie obvious because the R7 group is not required in the alternative R2a and/or R2b groups besides OR7, and the Meppen compound described above meets one of these alternative groups.
In regards to instant claims 52-53, even though Meppen does not demonstrate administering an effective amount of their compounds to treat a disease, disorder, or condition of the liver, it would have been prima facie obvious before the effective filing date of the claimed invention to have administered any of compounds disclosed in Meppen to treat hepatitis C infection as disclosed in Meppen with a reasonable expectation of success because Meppen discloses compositions comprising an effective amount of their compound that is useful for inhibiting HCV infection.
Claim(s) 49 is rejected under 35 U.S.C. 103 as being unpatentable over Meppen et al. (US20100022468A1 in PTO-892) in view of Dunn et al. (WO2017019581A1 in IDS filed 07/10/2024).
The teachings of Meppen are as described above. Meppen demonstrates in Example 15 (Table 1 page 18) a specific species of their compound shown below:
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R4 is methyl, and R6 is 2-Et-butyl. It is noted that the stereocenter of the carbon with the R4 group in the above compound has the same stereocenter (S) for the carbon at the same location in the compounds recited in instant claim 49.
This compound of Meppen is identical to the second compound listed in instant claim 49 except for the 2’ position on the sugar. The Meppen compound has a methyl and OH group at this position, whereas the instant compound has two H at this 2’ position.
Dunn teaches several phosphorus-containing nucleoside prodrug compounds having a structural Formula (lV) that are useful for inhibiting HCV replication and treatment of HCV infection (Abstract and lines 8-11 page 5).
The Formula (IV) structure is shown below:
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X can be O, N, S, or CH2, B can be a natural or non-natural purine or pyrimidine base, R1 and R2 can be H and other groups such as alkyls, R3 can be C1-6 alkyl and others, and R4 can be various alkyl groups.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the compound of Meppen above by substituting the methyl and OH groups at the 2’ position with H groups as disclosed in Dunn to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both Meppen and Dunn teach the same cyclic phosphoramidate compound structure that are useful for treating the same HCV infection.
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, 11, 15, 19-21, 23-29, 41, 44, 46, 49-50, and 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,427,550 in view of Meppen et al. (US20100022468A1 in PTO-892) and Dunn et al. (WO2017019581A1 in IDS filed 07/10/2024).
US’550 recites compound having the structure shown below:
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US’550 recites pharmaceutical compositions comprising these compounds and a pharmaceutically acceptable excipient (claim 20), and also recites a method of treating a disease, disorder, or condition of the liver by administering an effective amount of these compounds (claim 21).
While the general structure recited in US’550 meets the general structure in the instant claims, US’550 does not recite a compound in instant claim 49.
The independent teachings of Meppen and Dunn are as described above. Furthermore, the combined teachings of Meppen and Dunn teach the second compound listed in instant claim 49 as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the compounds recited in US’550 with the compound as disclosed by the combined teachings of Meppen and Dunn described above to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both US’550 and the combined teachings of Meppen and Dunn described above recite the same cyclic phosphoramidate compound structure that are useful for treating the same condition, disorder, or disease of the liver.
In regards to instant claim 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the compound as disclosed by the combined references described above such that the R4 and R5 position, which corresponds to the instant R5a and R5b position, can come together with the carbon atom to which they are attached to form a 3- to 6-membered aliphatic spirocyclic ring system as disclosed in Meppen to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Meppen provides guidance that these positions in this type of compound can come together to form 3 to 6 member ring, which overlaps with the instant recited five to ten membered ring at the same positions. See MPEP 2144.05 I.
In regards to instant claims 24-26, even though these instant claims further limits the recited Y group, the instant compound can be either Formula I or II. The recited Y group only appears in instant Formula I and not in Formula II, and the compound as disclosed by the combined references described above meets instant formula II. Therefore, instant claims 24-26 are also prima facie obvious since the Formulla II structure is still encompassed by the scope of instant claims 24-26.
In regards to instant claim 46, even though this instant claim further limits the recited R12 group, the recited R12 group only appears in certain BASE2, and the compound as disclosed by the combined references described above meets a recited BASE2 structure that does not recite a R12 group. Therefore, instant claim 46 is also prima facie obvious since instant claim 46 does not limit the BASE2 structure.
In regards to instant claim 28, even though this instant claim further limits the recited R7 group, the recited R7 group only appears when R2a and/or R2b is OR7, and the compound as disclosed by the combined references described above meets the R2a and R2b groups when R2a is methyl (C1 alkyl) and R2b is fluoro. Therefore, instant claim 28 is also prima facie obvious because the R7 group is not required in the alternative R2a and/or R2b groups besides OR7, and the compound as disclosed by the combined references described above meets one of these alternative groups.
Claims 1-5, 11, 15, 19-21, 23-29, 41, 44, 46, 49-50, and 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,110,311 in view of Meppen et al. (US20100022468A1 in PTO-892) and Dunn et al. (WO2017019581A1 in IDS filed 07/10/2024).
US’311 recites compounds having the structure shown below
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US’311 recites a pharmaceutical composition comprising this compound and a pharmaceutically acceptable excipient (claim 13), and also recites a method of treating a disease, disorder, or condition of the liver by administering an effective amount of this compound (claim 15)
While the general structure recited in US’311 is similar to the general structure in the instant claims, US’311 does not recite a compound in instant claim 49.
The independent teachings of Meppen and Dunn are as described above. Furthermore, the combined teachings of Meppen and Dunn teach the second compound listed in instant claim 49 as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the compounds recited in US’311 with the compound as disclosed by the combined teachings of Meppen and Dunn described above to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both US’311 and the combined teachings of Meppen and Dunn described above recite the same cyclic phosphoramidate compound structure that are useful for treating the same condition, disorder, or disease of the liver.
In regards to instant claim 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the compound as disclosed by the combined references described above such that the R4 and R5 position, which corresponds to the instant R5a and R5b position, can come together with the carbon atom to which they are attached to form a 3- to 6-membered aliphatic spirocyclic ring system as disclosed in Meppen to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Meppen provides guidance that these positions in this type of compound can come together to form 3 to 6 member ring, which overlaps with the instant recited five to ten membered ring at the same positions. See MPEP 2144.05 I.
In regards to instant claims 24-26, even though these instant claims further limits the recited Y group, the instant compound can be either Formula I or II. The recited Y group only appears in instant Formula I and not in Formula II, and the compound as disclosed by the combined references described above meets instant formula II. Therefore, instant claims 24-26 are also prima facie obvious since the Formulla II structure is still encompassed by the scope of instant claims 24-26.
In regards to instant claim 46, even though this instant claim further limits the recited R12 group, the recited R12 group only appears in certain BASE2, and the compound as disclosed by the combined references described above meets a recited BASE2 structure that does not recite a R12 group. Therefore, instant claim 46 is also prima facie obvious since instant claim 46 does not limit the BASE2 structure.
In regards to instant claim 28, even though this instant claim further limits the recited R7 group, the recited R7 group only appears when R2a and/or R2b is OR7, and the compound as disclosed by the combined references described above meets the R2a and R2b groups when R2a is methyl (C1 alkyl) and R2b is fluoro. Therefore, instant claim 28 is also prima facie obvious because the R7 group is not required in the alternative R2a and/or R2b groups besides OR7, and the compound as disclosed by the combined references described above meets one of these alternative groups.
Claims 1-5, 11, 15, 19-21, 23-29, 41, 44, 46, 49-50, and 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,566,041 in view of Meppen et al. (US20100022468A1 in PTO-892) and Dunn et al. (WO2017019581A1 in IDS filed 07/10/2024).
US’041 recites compounds having the structure shown below
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US’041 recites a method of treating viral infection by administering an effective amount of this compound (claim 14)
While the general structure recited in US’041 is similar to the general structure in the instant claims, US’041 does not recite a compound in instant claim 49.
The independent teachings of Meppen and Dunn are as described above. Furthermore, the combined teachings of Meppen and Dunn teach the second compound listed in instant claim 49 as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the compounds recited in US’041 with the compound as disclosed by the combined teachings of Meppen and Dunn described above to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both US’041 and the combined teachings of Meppen and Dunn described above recite the same cyclic phosphoramidate compound structure that are useful for treating a viral infection.
In regards to instant claim 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the compound as disclosed by the combined references described above such that the R4 and R5 position, which corresponds to the instant R5a and R5b position, can come together with the carbon atom to which they are attached to form a 3- to 6-membered aliphatic spirocyclic ring system as disclosed in Meppen to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Meppen provides guidance that these positions in this type of compound can come together to form 3 to 6 member ring, which overlaps with the instant recited five to ten membered ring at the same positions. See MPEP 2144.05 I.
In regards to instant claims 24-26, even though these instant claims further limits the recited Y group, the instant compound can be either Formula I or II. The recited Y group only appears in instant Formula I and not in Formula II, and the compound as disclosed by the combined references described above meets instant formula II. Therefore, instant claims 24-26 are also prima facie obvious since the Formulla II structure is still encompassed by the scope of instant claims 24-26.
In regards to instant claim 46, even though this instant claim further limits the recited R12 group, the recited R12 group only appears in certain BASE2, and the compound as disclosed by the combined references described above meets a recited BASE2 structure that does not recite a R12 group. Therefore, instant claim 46 is also prima facie obvious since instant claim 46 does not limit the BASE2 structure.
In regards to instant claim 28, even though this instant claim further limits the recited R7 group, the recited R7 group only appears when R2a and/or R2b is OR7, and the compound as disclosed by the combined references described above meets the R2a and R2b groups when R2a is methyl (C1 alkyl) and R2b is fluoro. Therefore, instant claim 28 is also prima facie obvious because the R7 group is not required in the alternative R2a and/or R2b groups besides OR7, and the compound as disclosed by the combined references described above meets one of these alternative groups.
Claims 1-5, 11, 15, 19-21, 23-29, 41, 44, 46, 49-50, and 52-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/032,783 (‘783) in view of Meppen et al. (US20100022468A1 in PTO-892) and Dunn et al. (WO2017019581A1 in IDS filed 07/10/2024).
‘783 recites compounds having a structure shown below
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‘783 recites a pharmaceutical composition comprising this compound (claim 12), and also recites a method of treating viral infection by administering an effective amount of this compound (claim 14)
While the general structure recited in ‘783 is similar to the general structure in the instant claims, ‘783 does not recite a compound in instant claim 49.
The independent teachings of Meppen and Dunn are as described above. Furthermore, the combined teachings of Meppen and Dunn teach the second compound listed in instant claim 49 as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the compounds recited in ‘783 with the compound as disclosed by the combined teachings of Meppen and Dunn described above to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both ‘783 and the combined teachings of Meppen and Dunn described above recite the same cyclic phosphoramidate compound structure that are useful for treating a viral infection.
In regards to instant claim 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the compound as disclosed by the combined references described above such that the R4 and R5 position, which corresponds to the instant R5a and R5b position, can come together with the carbon atom to which they are attached to form a 3- to 6-membered aliphatic spirocyclic ring system as disclosed in Meppen to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Meppen provides guidance that these positions in this type of compound can come together to form 3 to 6 member ring, which overlaps with the instant recited five to ten membered ring at the same positions. See MPEP 2144.05 I.
In regards to instant claims 24-26, even though these instant claims further limits the recited Y group, the instant compound can be either Formula I or II. The recited Y group only appears in instant Formula I and not in Formula II, and the compound as disclosed by the combined references described above meets instant formula II. Therefore, instant claims 24-26 are also prima facie obvious since the Formulla II structure is still encompassed by the scope of instant claims 24-26.
In regards to instant claim 46, even though this instant claim further limits the recited R12 group, the recited R12 group only appears in certain BASE2, and the compound as disclosed by the combined references described above meets a recited BASE2 structure that does not recite a R12 group. Therefore, instant claim 46 is also prima facie obvious since instant claim 46 does not limit the BASE2 structure.
In regards to instant claim 28, even though this instant claim further limits the recited R7 group, the recited R7 group only appears when R2a and/or R2b is OR7, and the compound as disclosed by the combined references described above meets the R2a and R2b groups when R2a is methyl (C1 alkyl) and R2b is fluoro. Therefore, instant claim 28 is also prima facie obvious because the R7 group is not required in the alternative R2a and/or R2b groups besides OR7, and the compound as disclosed by the combined references described above meets one of these alternative groups.
This is a provisional nonstatutory double patenting rejection. It is noted that an Notice of Allowance was mailed on 07/21/2026 for this co-pending application. Therefore, this rejection will convert to a nonstatutory double patenting rejection once the patent is published for this application.
Claims 1-5, 11, 15, 19-21, 23-29, 41, 44, 46, 49-50, and 52-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/604,681 (‘681) in view of Meppen et al. (US20100022468A1 in PTO-892) and Dunn et al. (WO2017019581A1 in IDS filed 07/10/2024).
‘681 recites compounds having a structure shown below
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‘681 recites a pharmaceutical composition comprising this compound and a pharmaceutically acceptable excipient (claim 52), and also recites a method of treating a disease, disorder, or condition by administering an effective amount of this compound (claim 56)
While the general structure recited in ‘681 is similar to the general structure in the instant claims, ‘681 does not recite a compound in instant claim 49.
The independent teachings of Meppen and Dunn are as described above. Furthermore, the combined teachings of Meppen and Dunn teach the second compound listed in instant claim 49 as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the compounds recited in ‘681 with the compound as disclosed by the combined teachings of Meppen and Dunn described above to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both ‘681 and the combined teachings of Meppen and Dunn described above recite the same cyclic phosphoramidate compound structure, and the combined teachings of Meppen and Dunn described above provide guidance that these types of compounds are useful for treating a viral infection of the liver such as HCV.
In regards to instant claim 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the compound as disclosed by the combined references described above such that the R4 and R5 position, which corresponds to the instant R5a and R5b position, can come together with the carbon atom to which they are attached to form a 3- to 6-membered aliphatic spirocyclic ring system as disclosed in Meppen to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Meppen provides guidance that these positions in this type of compound can come together to form 3 to 6 member ring, which overlaps with the instant recited five to ten membered ring at the same positions. See MPEP 2144.05 I.
In regards to instant claims 24-26, even though these instant claims further limits the recited Y group, the instant compound can be either Formula I or II. The recited Y group only appears in instant Formula I and not in Formula II, and the compound as disclosed by the combined references described above meets instant formula II. Therefore, instant claims 24-26 are also prima facie obvious since the Formulla II structure is still encompassed by the scope of instant claims 24-26.
In regards to instant claim 46, even though this instant claim further limits the recited R12 group, the recited R12 group only appears in certain BASE2, and the compound as disclosed by the combined references described above meets a recited BASE2 structure that does not recite a R12 group. Therefore, instant claim 46 is also prima facie obvious since instant claim 46 does not limit the BASE2 structure.
In regards to instant claim 28, even though this instant claim further limits the recited R7 group, the recited R7 group only appears when R2a and/or R2b is OR7, and the compound as disclosed by the combined references described above meets the R2a and R2b groups when R2a is methyl (C1 alkyl) and R2b is fluoro. Therefore, instant claim 28 is also prima facie obvious because the R7 group is not required in the alternative R2a and/or R2b groups besides OR7, and the compound as disclosed by the combined references described above meets one of these alternative groups.
In regards to instant claims 52-53, even though the combined references described above do not recite administering an effective amount of their compounds to treat a disease, disorder, or condition of the liver, it would have been prima facie obvious before the effective filing date of the claimed invention to have administered the compound as disclosed by the combined references described above to treat hepatitis C infection as disclosed in Meppen with a reasonable expectation of success because Meppen and Dunn described above provide guidance that these types of compounds are useful for treating a viral infection of the liver such as HCV.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5, 11, 15, 19-21, 23-29, 41, 44, 46, 49-50, and 52-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/561,681 in view of Meppen et al. (US20100022468A1 in PTO-892) and Dunn et al. (WO2017019581A1 in IDS filed 07/10/2024).
18/561,681 recites compounds having a structure shown below
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18/561,681 recites a pharmaceutical composition comprising this compound and a pharmaceutically acceptable excipient (claim 61), and also recites a method of treating a disease, disorder, or condition of the liver by administering an effective amount of this compound (claim 63)
While the general structure recited in 18/561,681 is similar to the general structure in the instant claims, 18/561,681 does not recite a compound in instant claim 49.
The independent teachings of Meppen and Dunn are as described above. Furthermore, the combined teachings of Meppen and Dunn teach the second compound listed in instant claim 49 as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the compounds recited in 18/561,681 with the compound as disclosed by the combined teachings of Meppen and Dunn described above to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both 18/561,681 and the combined teachings of Meppen and Dunn described above recite the same cyclic phosphoramidate compound structure that are useful for treating a disease, disorder, or condition of the liver.
In regards to instant claim 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the compound as disclosed by the combined references described above such that the R4 and R5 position, which corresponds to the instant R5a and R5b position, can come together with the carbon atom to which they are attached to form a 3- to 6-membered aliphatic spirocyclic ring system as disclosed in Meppen to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Meppen provides guidance that these positions in this type of compound can come together to form 3 to 6 member ring, which overlaps with the instant recited five to ten membered ring at the same positions. See MPEP 2144.05 I.
In regards to instant claims 24-26, even though these instant claims further limits the recited Y group, the instant compound can be either Formula I or II. The recited Y group only appears in instant Formula I and not in Formula II, and the compound as disclosed by the combined references described above meets instant formula II. Therefore, instant claims 24-26 are also prima facie obvious since the Formulla II structure is still encompassed by the scope of instant claims 24-26.
In regards to instant claim 46, even though this instant claim further limits the recited R12 group, the recited R12 group only appears in certain BASE2, and the compound as disclosed by the combined references described above meets a recited BASE2 structure that does not recite a R12 group. Therefore, instant claim 46 is also prima facie obvious since instant claim 46 does not limit the BASE2 structure.
In regards to instant claim 28, even though this instant claim further limits the recited R7 group, the recited R7 group only appears when R2a and/or R2b is OR7, and the compound as disclosed by the combined references described above meets the R2a and R2b groups when R2a is methyl (C1 alkyl) and R2b is fluoro. Therefore, instant claim 28 is also prima facie obvious because the R7 group is not required in the alternative R2a and/or R2b groups besides OR7, and the compound as disclosed by the combined references described above meets one of these alternative groups.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5, 11, 15, 19-21, 23-29, 41, 44, 46, 49-50, and 52-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/826,713 (‘713) in view of Meppen et al. (US20100022468A1 in PTO-892) and Dunn et al. (WO2017019581A1 in IDS filed 07/10/2024).
‘713 recites a method of treating cancer in the liver by administering an effective amount of a compound having a structure shown below
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While the general structure recited in ‘713 is similar to the general structure in the instant claims, ‘713 does not recite a compound in instant claim 49.
The independent teachings of Meppen and Dunn are as described above. Furthermore, the combined teachings of Meppen and Dunn teach the second compound listed in instant claim 49 as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the compounds recited in ‘713 with the compound as disclosed by the combined teachings of Meppen and Dunn described above to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both ‘713 and the combined teachings of Meppen and Dunn described above recite the same cyclic phosphoramidate compound structure that are useful for treating a disease, disorder, or condition of the liver.
In regards to instant claim 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the compound as disclosed by the combined references described above such that the R4 and R5 position, which corresponds to the instant R5a and R5b position, can come together with the carbon atom to which they are attached to form a 3- to 6-membered aliphatic spirocyclic ring system as disclosed in Meppen to arrive at the claimed invention.
One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Meppen provides guidance that these positions in this type of compound can come together to form 3 to 6 member ring, which overlaps with the instant recited five to ten membered ring at the same positions. See MPEP 2144.05 I.
In regards to instant claims 24-26, even though these instant claims further limits the recited Y group, the instant compound can be either Formula I or II. The recited Y group only appears in instant Formula I and not in Formula II, and the compound as disclosed by the combined references described above meets instant formula II. Therefore, instant claims 24-26 are also prima facie obvious since the Formulla II structure is still encompassed by the scope of instant claims 24-26.
In regards to instant claim 46, even though this instant claim further limits the recited R12 group, the recited R12 group only appears in certain BASE2, and the compound as disclosed by the combined references described above meets a recited BASE2 structure that does not recite a R12 group. Therefore, instant claim 46 is also prima facie obvious since instant claim 46 does not limit the BASE2 structure.
In regards to instant claim 28, even though this instant claim further limits the recited R7 group, the recited R7 group only appears when R2a and/or R2b is OR7, and the compound as disclosed by the combined references described above meets the R2a and R2b groups when R2a is methyl (C1 alkyl) and R2b is fluoro. Therefore, instant claim 28 is also prima facie obvious because the R7 group is not required in the alternative R2a and/or R2b groups besides OR7, and the compound as disclosed by the combined references described above meets one of these alternative groups.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
Prosecution Insights