DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 12 May 2026 in which claim 67 was newly added.
Claims 1-4, 6, 11, 13-17, 25, 33, 35-38, 41, 50-52, 56-67 are pending in the current application. Claims 3, 4, 6, 16, 17, 25, 41, 57-60 and 63 remain withdrawn as being drawn to a non-elected species. Claims 2 and 50 are hereby rejoined. Claims 1, 2, 11, 13, 14, 15, 33, 35, 36, 37, 38, 50-52, 61, 62 and 67 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 .
Withdrawn Rejections
Applicant’s arguments, filed 12 May 2026, with respect to the rejection of claims 1, 13, 14, 33, 35, 36, 37, 38, 51, 52, 61 and 63 under 35 U.S.C. § 103 as being unpatentable over Parsy et al. over the compound of formula (Ib), where base is a guanine derivative, R2a is an unsubstituted C1-C10 alkyl (claim 13), R2a is methyl, R2b is fluoro (claim 14), R13 is n-propyl (claim 37), have been fully considered and is persuasive.
Applicant has pointed to data presented in Table 3 of Parsy et al., where levels of metabolite (nucleoside triphosphate) in the liver were measured in humans and mice (see page 11 of the Remarks). A compound having a natural guanine had no detectable levels of metabolite in mouse hepatocytes. A compound drawn to the 6-ethyl guanine derivative had substantially more metabolite detected.
Applicant also compared data where the compounds differed by a single methylene repeating unit (see p.12 of the Remarks). One of these compounds had no detectable levels of metabolite, while the other had significantly higher levels of metabolite.
And Applicant has compared data between two compounds where they differed at the 2’-position of the ribose moiety (F vs OH), and showed significant differences in metabolite levels in human hepatocytes (p.13 of the Remarks).
Applicant has argued each one of these modifications alone, results in different amounts of metabolite in the liver. Thus, Applicant argues modifying the claimed compounds as argued in the Office Action is not predictable, and could result in loss of activity.
The arguments are found persuasive. The rejections are hereby withdrawn.
Applicant’s arguments, filed 12 May 2026, with respect to the rejection of claim 15 under 35 U.S.C. § 103 as being unpatentable over Parsy et al. in view of Bennet, are the same as discussed above.
The above arguments are found persuasive. The rejection is hereby withdrawn.
Applicant’s arguments, filed 12 May 2026, with respect to the rejection of claim 11 under 35 U.S.C. § 103 as being unpatentable over Parsy et al. in view of Beigelman, are the same as discussed above.
The above arguments are found persuasive. The rejection is hereby withdrawn.
Applicant’s arguments, filed 12 May 2026, with respect to the rejection of claims 1, 11, 13-15, 33, 35-38, 51, 52, 61 and 62 as being unpatentable over 1-17 of US Patent No. 11,566,041 in view of Beigelman, are the same as discussed above.
The above arguments are found persuasive. The rejection is hereby withdrawn.
Election/Restrictions
Applicant elected the species of compound 109 in the response submitted 19 September 2024. The species was also expanded to include derivatives of formula (Ib), where base is a guanine derivative, R2a is an unsubstituted C1-C10 alkyl, where R2a is methyl, R2b is fluoro, R13 is n-propyl.
The rejections over this compound have been withdrawn (see above), and is found allowable.
MPEP 803.02 states that if the examiner determines that the elected species is allowable, the examination of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the Markush-type claim with respect to the nonelected species, the Markush-type claim shall be rejected and claims to the nonelected species held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
A second action on the rejected claims can be made final unless the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). See MPEP § 706.07(a).
The following new rejection was based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p).
New Rejections
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 18 May 2026 prompted the new ground(s) of rejection presented in this Office action.
Therefore, rejections from the previous Office Action, dated 02 April 2025, have been modified and are listed below.
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.
(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, 2, 50 and 52 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Parsy et al. (US Patent Application Publication No. 2013/0315867, hereinafter the ‘867 Publication, cited in IDS submitted 18 May 2026).
The ‘867 Publication discloses compound 32, 32a and 32b:
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(col. 39). Compound 32 reads on claimed formula (Ia), where base is a derivative of a natural nucleobase, R2a is a C1 alkyl, R2b is OR8, R8 is C(O)R7 where R7 is a C1 alkyl, R5b is -C(O)OR7 where R7 is a C3 alkyl.
The compound anticipates claim 2 (fourth nucleobase listed), where R11 is C1 alkyloxy.
Thus, the disclosure of the ‘867 Publication anticipates claims 1, 2 and 50 of the present application.
Maintained Rejection
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, 2, 11, 50 and 52 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 discloses
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and
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, which read on formula (Ia), where R5b is an unsubstituted C5-C10 alkyl, R2a/R2b are both H, the base is 5-fluorouracil (see claim 19).
Thus, the claims of the ‘550 Patent anticipate claims 1, 2, 11, 50 and 52 of the present application.
Claims 1, 2, 11, 50 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 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 compounds of formula (II) read on present formula (Ia/Id). For example, the compound:
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(claim 12) anticipates the present compound of formula (Ia), where R5b is an unsubstituted C5-10 alkyl, R2a/R2b are both H, the base is 5-fluorouracil.
Thus, the disclosure of the ‘311 Patent anticipates the present claims.
Claims 1, 11, 13, 14, 15, 33, 35, 36, 37, 38, 51, 52, 61, 62 and 67 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, 62 and 67 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 (soon to be issued).
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 12 May 2026 have been fully considered but they are not persuasive.
With respect to the ‘550 Patent, Applicant contends the claims of the ‘550 Patent are directed towards compounds having a 5-fluorouracil base.
The argument is not found persuasive, because the present claims do not exclude a 5-fluorouracil base when the compound is a compound of formula (Ia).
With respect to the ‘311 Patent, Applicant contends the claims of the ‘311 Patent are directed towards compounds having a 5-fluorouracil base.
The argument is not found persuasive, because the present claims do not exclude a 5-fluorouracil base when the compound is a compound of formula (Ia).
Applicant has requested that the provisional rejections be held in abeyance until patentable subject matter is identified.
The obviousness double patenting rejections are hereby maintained.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 18 May 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 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
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