NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/US2022/013676, filed Jan. 25, 2022, which claims benefit of priority to Provisional Applications 63/144,788, filed Feb. 2, 2021 and 63/232,996, filed Aug. 13, 2021.
Claims 1-3, 5, 7, 10, 13, 14, 16, 17, 19, 20, 23, 24, 27, 32, 35, 36, and 39, as amended, are pending.
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 .
Priority
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Sep. 30, 2023 (2) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II, drawn to methods of treating cancer; dexrazoxane as the species of iron chelator; 5-fluorouracil as the species of anti-cancer agent; and colorectal cancer as the species of cancer to be treated, in the reply filed on Nov. 10, 2025 is acknowledged.
Claims 5, 7, 10, 16, 17, 23, 24, 27, 32, 35, 36, and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Nov. 10, 2025.
Claims 1-3, 13, 14, 19, and 20 are currently pending and under consideration.
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.
Claims 1-3, 13, 14, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kong (CN 1957922A, with English translation, cited on PTO-892).
Kong discloses that 5-fluorouracil has been widely used to treat various tumors, such as colorectal cancer (para. [0009]).
Kong discloses that certain drugs, when used in combination with 5-FU, can enhance each other's anticancer effects, referred to as 5-FU synergists (para. [0010]). In addition to inhibiting tumor growth, 5-FU synergists can also increase the sensitivity of tumor cells to anticancer drugs (para. [0011]).
In particular, Kong discloses and claims sustained-release formulations, microspheres, injections, and/or implants comprising 5-fluorouracil (5-FU) and a 5-fluorouracil synergist (para. [0015]).
The effective anti-cancer components are 5-FU and 5-FU enhancers, with the 5-FU enhancers selected from antimetabolites (paras. [0025]-[0026]). In a preferred embodiment, the antimetabolite is, e.g., dexrazoxane (paras. [0027], [0035]; claims 1-2).
The synergistic combinations of Kong are disclosed and claimed in methods of treating solid tumors including, e.g., colon cancer and rectal cancer (claim 10).
Thus, Kong discloses methods of treating cancer comprising administering the elected iron chelator, dexrazoxane, as recited by claims 1-3, in combination with the elected anticancer agent, 5-fluorouracil, as recited by claims 13-14, in methods of treating colon cancer or rectal cancer in a patient in need thereof, as recited by claims 19-20.
For the foregoing reasons, Kong anticipates claims 1-3, 13, 14, 19, and 20.
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 1-3, 13, 14, 19, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-9 of U.S. Patent No. 11,878,018 in view of Kong (CN 1957922A, with English translation, cited on PTO-892).
Specifically, the reference claims are drawn to methods of therapeutically treating cancer in a patient in need thereof comprising administering to said patient an effective amount of a TBK-1 inhibitor and an inhibitor of Syntaxin 17 phosphorylation to said patient, which are co-administered with at least one additional agent for treating cancer (claims 1-3),
wherein said additional agent for treating cancer is, e.g., 5-fluorouracil, dexrazoxane, or a mixture thereof (claims 6-8),
wherein said cancer is a carcinoma, a leukemia, a lymphoma, melanoma, a myeloproliferative disease, a sarcoma, a tumor of the central nervous system, a germ-line tumor, a mixed type of neoplasia or a tumor of mixed origin (claim 9).
It would have been predictable to one of ordinary skill in the art to employ the combination of 5-fluorouracil and dexrazoxane in the treatment of these cancers because Kong teaches that this combination has a significant synergistic effect (para. [0136]).
Thus, the reference claims are drawn to methods of treating cancer comprising administering to a patient in need thereof the elected iron chelator, dexrazoxane, as recited by examined claims 1-3, in combination with the elected anticancer agent, 5-fluorouracil, as recited by examined claims 13-14, in methods of treating, e.g., melanoma, a skin cancer, as recited by examined claims 19-20.
Claims 1-3, 13, 14, 19, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, and 11 of U.S. Patent No. 11,672,779 in view of Kong (CN 1957922A, with English translation, cited on PTO-892).
Specifically, the reference claims are drawn to methods of treating cancer comprising administering to a patient in need thereof an anti-cancer effective amount of a composition comprising R-ketorolac or a pharmaceutically acceptable salt thereof in combination with an angiogenesis inhibitor and a pharmaceutically acceptable carrier, additive or excipient (claim 1),
wherein the cancer is selected from, e.g., colon cancer (claim 4),
wherein said composition is co-administered with an additional anti-cancer agent (claim 8), wherein the additional anti-cancer agent is selected from the group consisting of, e.g., 5-fluorouracil, dexrazoxane, and mixtures thereof (claim 11).
It would have been predictable to one of ordinary skill in the art to employ the combination of 5-fluorouracil and dexrazoxane in the treatment of, e.g., colon cancer, because Kong teaches that this combination has a significant synergistic effect (para. [0136]).
Thus, the reference claims are drawn to methods of treating cancer comprising administering to a patient in need thereof the elected iron chelator, dexrazoxane, as recited by examined claims 1-3, in combination with the elected anticancer agent, 5-fluorouracil, as recited by examined claims 13-14, in methods of treating colon cancer or rectal cancer, as recited by examined claims 19-20.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629