DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 September 2025 has been entered.
This Office Action is in response to Applicant’s Remarks filed on 02 July 2025.
Claims 1-4, 6, 11, 13-17, 25, 33, 35-38, 41, 50-52 and 56-66 are pending in the current application. Claims 2-4, 6, 16, 17, 25, 41, 50, 56-60 and 63-66 remain withdrawn as being drawn to a non-elected invention. Claims 1, 11, 13-15, 33, 35-38, 51-52 and 61-62 are examined on the merits herein.
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 .
Maintained Rejections
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 13, 14, 33, 35, 36, 37, 38, 51, 52, 61 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Parsy et al. (US Patent No. 9,296,778, cited in previous Office Action).
Parsy et al. teach a compound of Formula (VIII):
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as a prodrug for treating Flaviviridae infections, including hepatitis C virus infections (HCV), (claim 1 and abstract). The base includes cytosine (elected base). Each Y is independently hydroxyl, or fluoro. And Z can be -L-Ar-C(O)O(L)pC(R)3, where L is independently alkylene, Ar is independently arylene, p is 0 or 1, R is alkyl: Z = alkyl-aryl-C(=O)OC(R)3. Parsy et al. teach a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier or diluent (claim 13). Parsy et al. also teach Z is generally alkyl-aryl-C(O)OC(R), where R is independently hydrogen, and alkyl, wherein the term alkyl includes propyl and i-propyl (col.5:6-13)
Parsy et al. exemplify compound 33 and diastereomers: 33a and 33b (col. 79):
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.
Compound 33 reads on present formula (Ib), where R3 and R4 is H, R2a is C1 alkyl, R5a is -COOR13, n is 0.
The difference between compound 33 and the present claims is the base (guanine vs claims towards uracil, deuterated uracil, cytosine); R2b (hydroxyl vs claimed halo); and 5a (COOR13, where R13 is an unsubstituted C1 alkyl vs claimed COOR13 and R13 is an unsubstituted C3-C10 alkyl (present claim 1; 35-37).
Parsy et al. exemplify compounds which reads on where R2b is F, a halo (compounds 3, 5-13, 15, 17, 20, 21, 24, 26, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65).
Parsy claim 1
Present Application Claim 1
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Formula (VIII)
Y is OH or F
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Formula (Ib)
R2b is H or halo
Parsy Compound 13
Present Claim 51
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Parsy Compound 33
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While the base of compound 33 is a guanine derivative, Parsy et al. teach cytosine is a suitable alternative nucleobase. Thus, it would have been obvious to substitute one nucleobase for another with a reasonable expectation of success since there are a limited number of nucleobases.
While compound 33 of Parsy et al. contains a 2’-hydroxyl group, 2b of present formula (Ib) contains a H, halo, CN, and an optionally substituted C1-C10 alkyl. R8 is independently selected from C(O)R7, C(O)OR7 and C(O)NHR7. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the C2’-position of compound 33 of Parsy et al. with a fluoro group because Parsy et al. expressly teach C2’ of the nucleoside can be modified with a fluoro or hydroxy, and because Parsy et al. expressly prepared derivatives having these functional groups at C2’, including numerous fluoro derivatives. The ordinary artisan would have had a reasonable expectation of success because cyclic phosphate compounds having C2’-fluoro were prepared for the treatment of HCV.
While Parsy et al. disclose Z is -CH2-Ph-C(O)O-CH3, Parsy et al. also teach Z is generally alkyl-aryl-C(O)OC(R), where R is independently hydrogen, and alkyl, wherein the term alkyl includes propyl and i-propyl. One having ordinary skill in the art would have been motivated to modify Z is -CH2-Ph-C(O)O-CH3 with Z is -CH2-Ph-C(O)O-CH2-CH2-CH--3 or Z is -CH2-Ph-C(O)O-CH-(CH3)2
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Parsy et al. as applied to claims 1, 13, 14, 33, 35, 36, 37, 38, 51, 52, 61 and 62 above, and further in view of Bennett et al. (US Patent Application Publication No. 2015/0299243, cited in previous Office Action).
Parsy et al. teach as discussed above.
Parsy et al. do not expressly disclose wherein R2a is OH (present claim 15).
Bennett et al. teach 2’-alkynyl substituted nucleoside phosphate derivatives of Formula (I) for treating HCV infection in a patient:
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, including compounds which reads on where R2a is OH:
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(claim 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the C2’-position such that R2a is OH because in the same field of endeavor of treating HCV infections with nucleoside phosphate derivatives, Bennett et al. teach administering derivatives wherein the C2’-position contains a hydroxy and alkyl in either stereoisomeric position. Thus, the ordinary artisan would have had a reasonable expectation of success in preparing a diastereomer of compound 33 of Pansy et al. for treating HCV.
The claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Parsy et al. as applied to claims 1, 2, 3, 13, 14, 33, 35, 36, 37, 38, 51, 52, 59, 61 and 62 above, and further in view of Beigelman et al. (US Patent No. 8,772,474, cited in previous Office Action).
Parsy et al. teach as discussed above.
Parsy et al. do not expressly disclose wherein at least one of R2a and R2b is H (present claim 11).
Beigelman et al. teach a compound of formula (I) for the treatment of HCV infections:
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(claims 1 and 21). The base B1 is any one of a pyrimidine or purine nucleobase:
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. Variable R6 can be hydrogen, hydroxy or alkoxy. Beigelman et al. exemplify a compound where at least one of the positions at C2’ of the cyclic phosphate nucleoside derivative is a hydrogen:
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(claim 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the C2’-position such that R2a or R2b is H because in the same field of endeavor of treating viral infections with cyclic phosphate nucleoside derivatives, Beigelman et al. teach nucleosides having a hydroxy and a hydrogen at the C2’-position.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Response to Arguments
Applicant's arguments filed 02 July 2025 have been fully considered but they are not persuasive.
Applicant cites the decision Takeda v. Alphapharm (Fed. Cir. 2007) in arguing that the Examiner has not shown that the compound of example 33 is a lead compound. However, the present case differs from Takeda v. Alphapharm. In Takeda v. Alphapharm, there was additional evidence to suggest that the closest prior art was not a lead compound. There is no evidence to the contrary in the instant case. And, there was evidence that the closest prior art in Takeda v. Alphapharm had negative properties. However, as will be discussed below, Parsy et al. further evaluated compounds having similar toxicity levels as compound 33. Thus, Parsy et al. do not regard the toxicity properties observed for compound 33 as negative.
The CAFC has addressed the “lead compound" analysis in Daiichi Sankyo Company, LTD. v. Matrix Laboratories, LTD. 96 USPQ2d 1526 (at page 1533):
While the lead compound analysis must, in keeping with KSR, not rigidly focus on the selection of a single, best lead compound, see Altana Pharma, 566 F.3d at 1008, the analysis still requires the challenger to demonstrate by clear and convincing evidence that one of ordinary skill in the art would have had a reason to select a proposed lead compound or compounds over other compounds in the prior art.
Accordingly, the “lead compound” analysis is not rigidly restricted to identifying the single best compound of the prior art, but rather identification of one or more compounds with promising properties.
Parsy et al. prepared 67 compounds and their diastereomers (denoted as ‘a’ and ‘b’). Parsy et al. evaluated their ability to inhibit HCV (EC50) and their cytotoxicity towards Huh-7 cells (CC50-), (Table 1). A select number of compounds were further evaluated for stability in different fluid environments (Table 2). A select number of compounds were also assayed for the amount of active triphosphate metabolite was released in hepatocytes (Table 3). And the pharmacokinetic behavior of a select number of compounds were measured (Table 4).
Turning to table 1, as noted by Applicant compound 33 was observed to have ‘++++’ EC50 activity towards HCV, and ‘++’ CC50 toxicity levels. However, numerous compounds having ‘++++’ EC50 activity and ‘++’ CC50 activity were selected for further evaluation including compounds 3, 4, 14, 16 and 24. Parsy et al. did not provide a reason for why compounds 3, 4, 14, 16 and 24 were further evaluated while compound 33 was not. However, since they had similar activity, as reported in Table 1, it is not reasonable to ignore compound 33 from Parsy et al. Rather, table 1 demonstrates that like compounds 3, 4, 14, 16 and 24, compound 33 has similar desirable anti-viral activity towards HCV. Furthermore, while it was more cytotoxic than other tested compounds, Parsy et al. do not teach away from using compounds this cytotoxic. Rather, as noted above, compounds 3, 4, 14, 16 and 24 also having these cytotoxic levels were further analyzed.
According to MPEP 2123: "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).”
Applicant also contends one of ordinary skill in the art would not have been motivated to select cytosine because the universe of bases that can be selected extends beyond those that are naturally occurring.
The above argument is not found persuasive. The skilled artisan would have been motivated to select and further modify compound 33 to include a cytosine base because Parsy et al. exemplify preparing cytosine derivatives (compounds 66 and 67).
With respect to substitution at 2b, Parsy et al. found compounds (compounds 5, 7, 9, 20, 24) having a 2-fluoro group (i.e. present 2b is fluoro) were particularly stable in simulated gastric fluids, as well as simulated intestinal fluids, whole blood cells, and the human liver microsome (table 2). Thus, Table 2 provides express teaching and motivation for one of ordinary skill in the art to have prepared compounds having a 2-fluoro group substitution.
With respect to the compound of formula (Ib) having a benzyl-substituted phosphate (and R5a substitution), Parsy et al. found compound 13, having a phenyl substituted phosphate group showed good stability in simulated intestinal fluid and human whole blood.
Additionally, table 3 shows compounds 3, 4, 13, 14, and 24 released high concentrations of the triphosphate metabolite in fresh human hepatocytes and mouse hepatocytes. Thus, table 3 shows compounds having the 2-fluoro substitution pattern and phenyl-substituted phosphate groups had desirable properties for treating/inhibiting HCV.
The skilled artisan would have been motivated to select and further modify compound 33 because phenyl substituted phosphate groups like compound 13 had good HCV inhibition activity, good toxicity levels and stability properties. The difference between R5a of compound 33 of Parsy and the elected species is 2 carbon atoms (methyl vs isopropyl). As noted in the Office Action, while Parsy et al. disclose Z is -CH2-Ph-C(O)O-CH3, Parsy et al. also teach Z is generally alkyl-aryl-C(O)OC(R), where R is independently hydrogen, and alkyl, wherein the term alkyl includes propyl and isopropyl.
Thus, the number of modifications needed to arrive at the present claims is small, wherein two of the modifications were exemplified (R2a is a halogen; and base is cytosine). The substitution at R5a and the present claims differ by methyl vs isopropyl. Thus, this third modification is two carbon atoms and encompassed by the overall teaching of Parsy et al.
Applicant’s arguments over Parsy in view of Bennett and separately Parsy in view of Beigelman are the same as above.
For the above stated reasons, said claims are properly rejected under 35 U.S.C. 103(a). Thus, the rejection is hereby maintained.
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, 11, 13, 14, 15, 33, 35, 36, 37, 38, 51, 52, 61 and 62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,566,041 in view of Beigelman et al. (US Patent No. 8,772,474, cited above).
Although the claims at issue are not identical, they are not patentably distinct from each other because the compound of formula I in the ‘041 Application reads on present formula (Ib), where base is a nucleobase derivative, R3 is H, R4 is CN, R2a is H, and R5a is -COOR13, and R13 is a C1-C10 alkyl including n-propyl and i-propyl. Claim 14 is directed towards administering the compounds to treat a viral infection.
The C2’-OH of the ‘041 Patent differs from R2b presently claimed.
Beigelman et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the C2’-position such that R2a or R2b is H because in the same field of endeavor of treating viral infections with cyclic phosphate nucleoside derivatives, Beigelman et al. teach nucleosides having a hydroxy and a hydrogen at the C2’-position. Furthermore, As noted above, Beigelman et al. teach the base is any one of a pyrimidine or purine nucleobase selected from
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. One having ordinary skill in the art would have been motivated to substitute the base of the ‘041 Patent for any of these bases with a reasonable expectation of success.
The claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claims 1, 11, 13, 14, 15, 33, 35, 36, 37, 38, 51, 52, 61 and 62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,427,550 in view of Bennett et al. (cited above) and Beigelman et al. (cited above).
Although the claims at issue are not identical, they are not patentably distinct from each other because the compound of Formula VI of the ‘550 Patent contains structures which overlap with present claim (Ib), when the repeating group for CR11R12 is equal to 1:
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,
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(claim 1). The compound of Formula VI of the ‘550 Patent reads on present formula Ib where R2a, R2b, R3 and R4 are H, R5a is -C-amido, R6 is halo, n is 1. The compounds can be used to treat a disease, disorder or condition of the liver (claim 21).
The claims of the ‘550 Patent do not expressly disclose the C2’-OH, or a cytosine nucleobase (elected species).
Bennett et al. teach as discussed above.
Beigelman et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the C2’-position such that R2a is OH because in the same field of endeavor of treating disorders/conditions of the liver with nucleoside phosphate derivatives, Bennett et al. teach administering derivatives wherein the C2’-position contains a hydroxy in either stereoisomeric position.
Furthermore, as noted above, Beigelman et al. teach the base is any one of a pyrimidine or purine nucleobase selected from
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. One having ordinary skill in the art would have been motivated to substitute the 5-fluorouracil base of the ‘041 Patent for a cytosine base, with a reasonable expectation of success, because in the same field of endeavor of treating disorders of the liver, Beigelman et al. teach a compound of formula (I) for the treatment of HCV infections, wherein the compound is a cyclic phosphate nucleoside:
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. Thus, one of ordinary skill in the art would have expected either base to result in a compound useful for treating disorders of the liver, including HCV.
The claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claims 1, 11, 13, 14, 15, 33, 35, 36, 37, 38, 51, 52, 61 and 62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,110,311 in view of Bennett et al. (cited above) and Beigelman et al. (cited above).
Claim 1 of the ‘311 Patent is directed to a compound of Formula (Ia):
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, which reads on present formula (Ib). When R4 of the ‘131 Patent is a C1-C10 alkyl it reads on present claim 1, where R5a is -COOR13 and R13 is an unsubstituted C3-C10 alkyl; and R2a, R2b are H, R3 and R4 are H. The compounds can be used to treat diseases, disorders, or condition of the liver.
The claims of the ‘311 Patent do not expressly disclose the C2’-OH (elected species). The fluoro-uracil nucleobase of ‘311 differs from the presently elected cytosine nucleobase.
Bennett et al. teach as discussed above.
Beigelman et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the C2’-position such that R2a is OH because in the same field of endeavor of treating disorders/conditions of the liver with nucleoside phosphate derivatives, Bennett et al. teach administering derivatives wherein the C2’-position contains a hydroxy in either stereoisomeric position.
Furthermore, as noted above, Beigelman et al. teach the base is any one of a pyrimidine or purine nucleobase selected from
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. One having ordinary skill in the art would have been motivated to substitute the 5-fluorouracil base of the ‘311 Patent for a cytosine base, with a reasonable expectation of success, because in the same field of endeavor of treating disorders of the liver, Beigelman et al. teach a compound of formula (I) for the treatment of HCV infections, wherein the compound is a cyclic phosphate nucleoside:
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. Thus, one of ordinary skill in the art would have expected either base to result in a compound useful for treating disorders of the liver, including HCV.
The claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claims 1, 11, 13, 14, 15, 33, 35, 36, 37, 38, 51, 52, 61 and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 10, 15, 20, 24, 28, 33, 34, 36, 37, 39, 42, 49, 51, 52, 57, 60, 61 and 63 of copending Application No. 18/561,681.
Claim 1 is directed towards a compound of formula (II):
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, which reads on present claim 1 where base is a natural nucleobase or a derivative thereof; R2a/R2b are selected from H, ORA, halo, -CN, and an optionally substituted C1-C10 alkyl, R3/R4 are H, R5a is -C(O)O-R7 and R7 is a C1-C10 alkyl, and n can be 0.
The compound of formula (II) anticipates present claim formula (Ib).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 11, 13, 14, 15, 33, 35, 36, 37, 38, 51, 52, 61 and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 11, 13-17 of copending Application No. 18/032,783.
Claim 1 is directed towards a compound of formula (I):
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, which reads on present claim 1, where base is a natural nucleobase or a derivative thereof; R3/R4 are H; R2a is H, R2b is OH, or O-acyl, C-carboxy, C-amido, R7 is CH3.
The compound of formula (II) anticipates present claim formula (Ib).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 02 July 2025, with respect to the non-statutory obviousness-type double patenting rejections have been fully considered but they are not persuasive.
With respect to the ‘041 Patent, Applicant argues the claims of the ‘041 Patent are directed towards different bases than the presently claimed compounds.
The rejection over the ‘041 Patent has been modified to address the obviousness regarding the bases.
Applicant contends the ‘550 Patent and ‘311 Patent are directed towards 5-fluorouracil bases.
The rejections have been modified to address the obviousness regarding bases.
The above rejections are hereby maintained.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699