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
This application, filed 02/06/2025 Claims Priority from Provisional Application 63550925, filed 02/07/2024.
Status of Claims
Claims 1-20 are currently pending.
Claims 1-20 were examined and are rejected.
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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nassar et. al., US 20200345712 A1, publ. 11/5/2020, in view of Lee et. al., JNCI J. Natl. Cancer Inst., vol. 107(7), pp. 1-4, publ. 2/24/2015, and Nathan et. al., Oncol. Ther., vol. 5, pp. 17-29, publ. 5/8/2017.
Nassar teaches the small molecule compound IODVA1 has inhibitory activity towards transformed cell lines, including Ph+ BCR-ABL1 B-ALL (leukemia) and colon adenocarcinomas (title & abstract; p. 36, claim 1):
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. Nassar further teaches treating cancer comprising administering IODVA1, optionally in a composition, to an individual in need thereof (para [0120]); in addition to B-ALL, other types of cancers to be treated include chemotherapy-resistant leukemia, immunotherapy-resistant leukemia, relapsed leukemia, breast cancer, prostate cancer, ovarian cancer, thyroid cancer, endometrial cancer, lung cancer, pancreatic cancer, and cervical cancer, along with other cancers that overexpress Vav3 (para [0123-0124]). Vav3 is an oncogene that activates the estrogen receptor (para [0384]). Oral, intravenous, intraperitoneal, subcutaneous, intralesion, topical, and intramuscular administration is taught (para [0126]). Nassar teaches the dose range of compound from 100 μg to 1000 mg/kg body weight, with oral doses taught to more particularly range from about 1-1000 mg/kg body weight (para [0151]). Nassar additionally teaches the IODVA1 compound and tautomers thereof can be combined with additional therapeutic agents in a kit comprising one or more containers for the agents, for serial or sequential administration (para [0154]). The compounds are taught to inhibit the proliferation of the ER and PR positive breast cancer cell line MCF7 (para [0175]). Treatment for a period of two weeks, as well as 28 days (four weeks) is exemplified (para [0014], [0027], [0199]). Notably, Nassar teaches IODVA1 treatment prolonged survival in a mouse model of TKI-resistant leukemia, and that this agent can be used to overcome TKI resistance in the clinic (para [0251]). Inhibition of phosphorylated Vav3 is also exemplified (para [0278-0279]).
Nassar doesn’t explicitly teach or suggest combination with a SERM or SERD as claimed; or treatment of an ER alpha expressing cancer.
Lee et. al. teaches the breast cancer cell line MCF-7 as one of the most studied breast cancer cell lines in the world, and further that this cell line expresses ER alpha (abstract; pp. 1-2, bridging para).
Since Nassar teaches IODVA1 inhibits the proliferation of MCF-7 cells, IODVA1 clearly has inhibitory activity towards the growth of not only Vav3 but also ER alpha expressing cancers.
Nathan teaches fulvestrant as a selective estrogen receptor degrader that binds, blocks, and degrades the ER, resulting in complete inhibition of estrogen signaling through this receptor (p. 17, abstract). Nathan teaches the estrogen receptor is expressed in about 80% of breast cancers, which is responsible for survival and proliferation (pp. 17-18, bridging para). Nathan teaches fulvestrant and tamoxifen to both function as anti-estrogens, however, tamoxifen is a selective estrogen modulator blocking E2-mediated activity of AF2 while exhibiting partial agonist activity (p. 18, 1st para under Mechanism of Action). Fulvestrant causes a reduction in cellular ER alpha levels (p. 18, 2nd para under Mechanism of Action). Nathan teaches previous studies had indicated similar benefits for patients with metastatic breast cancer treated with either fulvestrant or tamoxifen (pp. 18-19, bridging para). Nathan concludes that while fulvestrant is effective as a monotherapy, its use in combination treatment for ER+ breast cancer is preferred (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims, to have combined IODVA1 with the SERD, fulvestrant, and/or the SERM, tamoxifen in consideration of the combined teachings of Nassar and Nathan. Nassar teaches IODVA1 and tautomers thereof for treating Vav3 and ER alpha expressing cancers, including breast cancer, and that this agent can be combined with other active agents, for serial or sequential administration. Nathan teaches fulvestrant as a SERD and tamoxifen as a SERM for the treatment of ER+ breast cancer. As such, one of ordinary skill in the art would have been motivated to have combined IODVA1 with fulvestrant and/or tamoxifen, with the reasonable expectation that this combination would have had utility for treating cancer, particularly ER+ breast cancer. See MPEP 2144.06(I): "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). As Nassar teaches IODVA1 can be administered with an additional active agent serially or sequentially, it would have been prima facie obvious to have had IODVA1 and fulvestrant and/or tamoxifen in separate dosage forms, as recited by instant claim 20.
Regarding instant claims 12 and 16, Nassar teaches administration of IODVA1 for a period of two or four weeks. As Nassar teaches combination treatment as well, it would have been prima facie obvious to have administered the SERM and/or SERD for at least one, two, three, or four weeks following administration of IODVA1.
Regarding instant claim 17, Nassar teaches oral, intravenous, subcutaneous, intramuscular, and topical administration.
Regarding instant claim 18, Nassar teaches a dosage range of IODVA1 of 100 μg to 1000 mg/kg body weight, with oral doses taught to more particularly range from about 1-1000 mg/kg body weight, thereby overlapping with the range recited in this claim.
Claim Rejections-Nonstatutory 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 1-4, 9-11, 13-15, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-15, and 18-23 of U.S. Patent No. 11564913 B2 in view of McDonnell et. al., WO 2023059749 A1. Both sets of claims are drawn to compositions and methods of treating cancer comprising administering the compound IODVA1 or a tautomer thereof. Both sets of claims recite the treatment of leukemia, triple negative breast cancer, and NSCLC (see patented claims 9, 10, 18, and 21; instant claim 4). The patented claims differ from the instant claims as they don’t recite combination with a SERD or SERM, however, this combination would have been prima facie obvious in view of McDonnell. McDonnell teaches methods of treating cancer comprising administering at least one estrogen receptor (ER) modulating drug to a subject in need thereof (title & abstract; para [0003]). McDonnell teaches alternatively, the ER modulating drug can be administered in combination with at least one additional therapy (para [0007]). McDonnell teaches ER modulating drugs to include SERMs and SERDs, with tamoxifen, raloxifene, and toremifene taught as suitable SERMs, and fulvestrant including as a SERD (para [0009]). McDonnell teaches administering the ER modulating drug and additional therapy either simultaneously or sequentially (para [0009]). McDonnell teaches treatment of various types of cancers, including lung, breast, and colon (para [00032]), as well as various types of leukemias (para [00043]); McDonnell further teaches an embodiment wherein the cancer expresses ER alpha (p. 85, claim 34). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have combined the compounds in the compositions and methods claimed in the US patent with a SERM or SERD as claimed, since McDonnell teaches SERMs and SERDs for treating the cancers recited for treatment in the patented claims, as well as combination with additional chemotherapy agents, and have had a reasonable expectation of success.
Claims 1-4, 9-11, 13-15, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12268680 B2 in view of McDonnell et. al., WO 2023059749 A1. Both sets of claims are drawn to compositions and methods of treating cancer comprising administering the compound IODVA1 or a tautomer thereof. Both sets of claims recite the treatment of leukemia, triple negative breast cancer, and NSCLC (see patented claims 2, 5, and 6; instant claim 4). The patented claims differ from the instant claims as they don’t recite combination with a SERD or SERM, however, this combination would have been prima facie obvious in view of McDonnell. McDonnell teaches methods of treating cancer comprising administering at least one estrogen receptor (ER) modulating drug to a subject in need thereof (title & abstract; para [0003]). McDonnell teaches alternatively, the ER modulating drug can be administered in combination with at least one additional therapy (para [0007]). McDonnell teaches ER modulating drugs to include SERMs and SERDs, with tamoxifen, raloxifene, and toremifene taught as suitable SERMs, and fulvestrant including as a SERD (para [0009]). McDonnell teaches administering the ER modulating drug and additional therapy either simultaneously or sequentially (para [0009]). McDonnell teaches treatment of various types of cancers, including lung, breast, and colon (para [00032]), as well as various types of leukemias (para [00043]); McDonnell further teaches an embodiment wherein the cancer expresses ER alpha (p. 85, claim 34). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have combined the compounds in the compositions and methods claimed in the US patent with a SERM or SERD as claimed, since McDonnell teaches SERMs and SERDs for treating the cancers recited for treatment in the patented claims, as well as combination with additional chemotherapy agents, and have had a reasonable expectation of success.
Claims 1-7, 9-11, 13-15, 17, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12708627 B2 in view of McDonnell et. al., WO 2023059749 A1. Both sets of claims are drawn to compositions and methods of treating cancer comprising administering the compound IODVA1 or a tautomer thereof. Both sets of claims recite the treatment of leukemia, including TKI resistant B-ALL (see patented claim 5; instant claim 7), and oral or intravenous administration (see patented claim 3; instant claim 17). The patented claims differ from the instant claims as they don’t recite combination with a SERD or SERM, however, this combination would have been prima facie obvious in view of McDonnell. McDonnell teaches methods of treating cancer comprising administering at least one estrogen receptor (ER) modulating drug to a subject in need thereof (title & abstract; para [0003]). McDonnell teaches alternatively, the ER modulating drug can be administered in combination with at least one additional therapy (para [0007]). McDonnell teaches ER modulating drugs to include SERMs and SERDs, with tamoxifen, raloxifene, and toremifene taught as suitable SERMs, and fulvestrant including as a SERD (para [0009]). McDonnell teaches administering the ER modulating drug and additional therapy either simultaneously or sequentially (para [0009]). McDonnell teaches treatment of various types of cancers, including lung, breast, and colon (para [00032]), as well as various types of leukemias (para [00043]); McDonnell further teaches an embodiment wherein the cancer expresses ER alpha (p. 85, claim 34). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have combined the compounds in the compositions and methods claimed in the US patent with a SERM or SERD as claimed, since McDonnell teaches SERMs and SERDs for treating the cancers recited for treatment in the patented claims, as well as combination with additional chemotherapy agents, and have had a reasonable expectation of success.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
