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 .
This application is the national stage entry of PCT/US2023/062847, filed 17 Feb 2023; claims benefit of provisional application 63/353,482, filed 17 June 2022; and claims benefit of provisional application 63/312,387, filed 21 Feb 2022.
Claims 1-3, 5-9, 11, 14, 16-17, 23-26, 33-35, 38, and 42 are pending in the current application and are examined on the merits herein.
However, the parent provisional application 63/312,387 upon which priority is claimed fails to provide adequate support under 35 U.S.C. 112 for the subject matter of claims 5, 7-8, 14, 33-35, 38, and 42 of this application since the parent application is not seen to disclose the particular values for the amount of ivaltinostat in claims 5 and 7-8, all of the particular ranges for the amount of capecitabine in claim 14, or the criteria for discontinuing or reducing the administration of ivaltinostat in claims 33-35, 38, and 42. Written description for certain values for the amount of ivaltinostat and capecitabine may be found in 63/312,387, for example ivaltinostat in a range of about 10 mg/m2 to about 500 mg/m2 or about 50 mg/m2 to about 300 mg/m2, and capecitabine from about 200 mg/m2 to about 2000 mg/m2 or about 1000 mg/m2 at page 2, paragraph 7 , however no support is found for ivaltinostat in a range of about 25 mg/m2 to about 500 mg/m2, or capecitabine from about 500 mg/m2 to about 1500 mg/m2 or from about 750 mg/m2 to about 1250 mg/m2 . Further, 63/312,387 does not disclose criteria for discontinuing or reducing the administration of ivaltinostat.
Based on this analysis, the filing date of claims 5, 7-8, 14, 33-35, 38, and 42 of the examined application is deemed to be the filing date of provisional application 63/353,482, filed 17 June 2022. If applicant disagrees, applicant should present a detailed analysis as to why the claimed subject matter has clear support in the earlier priority applications. Applicant is reminded that such priority for the instant limitations requires written description and enablement under 35 U.S.C. § 112, first paragraph.
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.
Claims 5, 7, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walker et al. (Presentation at 2022 ASCO Annual Meeting held June 3-7, 2022, meeting abstract and poster provided by Applicant in IDS filed 23 July 2025) with evidence provided by Reagan-Shaw et al. (FASEB Journal, 2007, 22, p659-661, cited in PTO-892).
Walker et al. was disclosed 1 year or less before the effective filing date of the invention of claims 5, 7-8, 14, 33-35, 38, and 42, which are deemed to have an effective filing date of the provisional application 63/353,482, filed 17 June 2022. Walker et al. names authors other than the joint inventors of the claimed invention, and the record is not clear whether the disclosure was made by the joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the joint inventor or whether any exception under 35 U.S.C. 102(b)(1) applies. Therefore Walker et al. is considered to qualify as prior art under 35 U.S.C. 102(a)(1).
Walker et al. discloses ivaltinostat plus capecitabine in the maintenance setting in patients with metastatic pancreatic adenocarcinoma (PDAC). The patients treated were on first-line FOLFIRINOX chemotherapy (a fluoropyrimidine-based chemotherapy including 5-fluorouracil) and whose disease had not progressed. Patients were treated with ivaltinostat (60, 125, or 250 mg/m2 iv weekly on days 1 and 8) in combination with capecitabine (1000 mg/m2 po BID on days 1-14) of a 21-day cycle, meeting limitations of claims 5 and 14.
Regarding claims 7, Reagan-Shaw et al. provides evidence that the body surface area (BSA) of an adult human is 1.6 m2 based on FDA Draft Guidelines (page 660, table 1 at top of right column). Therefore the ivaltinostat dose of 60, 125, or 250 mg/m2 would have been expected to translate to an amount of 37.5 mg, 78.125 mg, and 156.25 mg, meeting limitations of claims 7.
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (Presentation at 2022 ASCO Annual Meeting held June 3-7, 2022, meeting abstract and poster provided by Applicant in IDS filed 23 July 2025) with evidence provided by Reagan-Shaw et al. (FASEB Journal, 2007, 22, p659-661, cited in PTO-892).
Walker et al. with evidence provided by Reagan-Shaw et al. discloses as above. Walker et al. further teaches an initial dose escalation phase 1b study evaluating 3 dose levels of ivaltinostat.
Walker et al. does not specifically disclose the effective amount of ivaltinostat is in about 50 mg/day, about 100 mg/day, about 200 mg/day, or about 300 mg/day (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 teachings of Walker et al. to determine the optimal dose of the ivaltinostat through routine experimentation. One of ordinary skill in the art would have been motivated to modify Walker et al. with a reasonable expectation of success because Walker et al. teaches a dose escalation study, suggesting it would have been obvious to determine the optimal dose of the ivaltinostat through routine experimentation, and provide guidance of starting points for this experimentation in the disclosed dose levels of 60, 125, or 250 mg/m2 which would have been expected to translate to an amount of 37.5 mg, 78.125 mg, and 156.25 mg.
Claims 33-35, 38, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (Presentation at 2022 ASCO Annual Meeting held June 3-7, 2022, meeting abstract and poster provided by Applicant in IDS filed 23 July 2025) in view of Jo et al. (Int. J. Cancer., 2022, 151, p1565–1577, first published 03 June 2022, provided by Applicant in IDS filed 08 Nov 2024).
Jo et al. was disclosed 1 year or less before the effective filing date of the invention of claims 5, 7-8, 14, 33-35, 38, and 42, which are deemed to have an effective filing date of the provisional application 63/353,482, filed 17 June 2022. Jo et al. names authors other than the joint inventors of the claimed invention, and the record is not clear whether the disclosure was made by the joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the joint inventor or whether any exception under 35 U.S.C. 102(b)(1) applies. Therefore Jo et al. is considered to qualify as prior art under 35 U.S.C. 102(a)(1).
Walker et al. discloses and teaches as above regarding claims 5, 7-8, 14.
Walker et al. does not specifically teach the method including the criteria for discontinuing or reducing the administration of ivaltinostat (claims 33-35, 38, and 42).
Jo et al. teaches a phase I/II study to evaluate the safety and efficacy of a new histone deacetylase (HDAC) inhibitor, ivaltinostat, in combination with gemcitabine and erlotinib for advanced pancreatic ductal adenocarcinoma (PDAC) (page 1565, abstract). Eligibility criteria for the patients in the study included adequate hematologic function (absolute neutrophil count 1500/mm3, hemoglobin 9.0 g/dL, platelets ≥100 000/mm3) (page 1566, right column, paragraph 3). Twenty-four patients received at least one dose of ivaltinostat and were included in the safety analysis. Doses of ivaltinostat and gemcitabine were reduced in 3 of 24 patients (12.5%, respectively) due to occurrence of adverse events (AEs) (page 1572, paragraph spanning left and right columns). The most frequently reported adverse drug reactions (ADRs) included decreased platelet count (page 1572, right column, paragraph 2). The most frequently reported treatment-related grade 3 or 4 AEs were neutropenia, thrombocytopenia, and anemia (paragraph spanning pages 1572-1573; table 2 at page 1572).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Walker et al. in view of Jo et al. in order to select the criteria for discontinuing or reducing the administration of ivaltinostat. One of ordinary skill in the art would have been motivated to combine Walker et al. in view of Jo et al. with a reasonable expectation of success because both Walker et al. and Jo et al. are drawn to study of the treatment of pancreatic adenocarcinoma with ivaltinostat in combination with another agent, and Jo et al. suggests it would have been obvious to modify the treatment such as reduction of dose in response to AEs such as grade 3 or 4 neutropenia or thrombocytopenia, and further teaches treatment based on measures of hematologic function such as platelet count and that reported ADRs included decreased platelet count. Regarding the specific amount of the reduced dose, it would have been routine experimentation by one of ordinary skill in the art to find the workable reduced dose in response to the AEs.
Claims 1-3, 5-8, 11, 14, 16-17, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Satomi et al. (WO 2019/043176, published 07 March 2019, provided by Applicant in IDS filed 08 Nov 2024) in view of Lee et al. (Sci. Rep., 2017, 7(1), 41615, 9 pages, provided by Applicant in IDS filed 08 Nov 2024).
Satomi et al. teaches methods for the treatment of cancer comprising administration of an HDAC inhibitor in combination with an antimetabolic agent (abstract). Satomi et al. teaches cancers that are metastatic may be responsive to treatment with the combination (page 5, line 20). In embodiments the HDAC inhibitor is selected from the group including CG-200745 (page 28, lines 30-35). In embodiments the antimetabolic agent is a fluoropyrimidine derivative. (page 8, lines 5-10). More particularly, the fluoropyrimidine derivative is selected from the group including capecitabine (page 9, line 5). The cancer treated is particularly selected from the group comprising biliary tract cancer and pancreatic cancer (page 9, line 30 to page 10, line 10). In embodiments the patient having the cancer has received prior systemic treatment against the cancer, such as 5-FU/leucovorin in combination with irinotecan and oxaliplatin (page 16, lines 20-25), where this combination is also known as FOLFIRINOX chemotherapy, addressing limitations of claims 24. Satomi et al. teaches the embodiment wherein the HDAC inhibitor is resminostat and the dose may be 100-400 mg/day (page 29, lines 10). Satomi et al. teaches the embodiment wherein the antimetabolic agent is the combination S-1, an orally available anticancer agent consisting of Tegafur, a prodrug of 5-Fluorouracil; 5-Chloro-2,4-Dihydroxypyridine (CDHP) and Potassium Oxonate, and the selection of the dose as a function of patient body surface area (page 2, lines 20-30; page 29, lines 10-15). The daily doses may be administered in two half-portions, twice daily (page 30, lines 5-10). In specific embodiments of the present invention, the antimetabolite agent is administered on days 1-14 in a 21 days treatment cycle and the HDAC inhibitor is administered on days 1-5 and 8-12 in a 21 days treatment cycle (page 30, lines 10-15). Satomi et al. teaches the working example of a clinical phase I study of resminostat/S-1 combination in patients with pre-treated biliary tract or pancreatic cancer, in which the patients have a history of receiving one or more regimen of systemic chemotherapy for biliary tract or pancreatic cancer and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 (page 38, lines 15-40), suggesting selection of patients wherein the subject has stability of the chemotherapy or whose disease has not progressed.
Satomi et al. does not specifically disclose the embodiment of the method comprising administering an effective amount of ivaltinostat in combination with capecitabine (claim 1).
Lee et al. teaches evaluation of the HDAC inhibitor, CG200745, combined with gemcitabine/erlotinib on pancreatic cancer cells. CG200745 induced the expression of apoptotic proteins (PARP and caspase-3) and increased the levels of acetylated histone H3 (page 1, abstract). The compound CG200745 is (E)-N(1)-(3-(dimethylamino)propyl)-N(8)-hydroxy-2-((naphthalene-1-loxy)methyl) oct-2-enediamide, and is an intravenous hydroxamate-based pan-HDAC inhibitor (page 2, paragraph 1), where this chemical name is also known as ivaltinostat. Lee et al. teaches determination of the anti-proliferative and pro-apoptotic activities of CG200745 against pancreatic cancer cells (page 2, paragraph 3 and figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Satomi et al. in view of Lee et al. in order to select the method comprising administering an effective amount of the HDAC inhibitor ivaltinostat in combination with capecitabine, and to select the dosage of the agents through routine experimentation. One of ordinary skill in the art would have been motivated to combine Satomi et al. in view of Lee et al. with a reasonable expectation of success because Satomi et al. and Lee et al. are drawn to combination chemotherapy comprising an HDAC inhibitor such as ivaltinostat for use in treatment of pancreatic cancer, and Lee et al. teaching CG200745 has activity against pancreatic cancer cells provides guidance for selecting the HDAC inhibitor to be CG200745 (also known as ivaltinostat) from within the scope of the method taught by Satomi et al. Regarding the dosage of the ivaltinostat and the antimetabolic agent such as capecitabine, Satomi et al. suggests that it would have been routine experimentation to select the optimum or workable dosage of the agents selected, and Lee et al. teaches CG200745 dose-dependently decreased pancreatic cancer cell viability, suggesting a reasonable expectation of success to select the dose through routine experimentation.
Claims 5-9, 33-35, 38, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Satomi et al. (WO 2019/043176, published 07 March 2019, provided by Applicant in IDS filed 08 Nov 2024) in view of Lee et al. (Sci. Rep., 2017, 7(1), 41615, 9 pages, provided by Applicant in IDS filed 08 Nov 2024) as applied to claims 1-3, 5-8, 11, 14, 16-17, and 23-26 above, and further in view of Kim et al. (Invest. New Drugs, 2015, 33, p1048–1057, provided by Applicant in IDS filed 08 Nov 2024).
Satomi et al. in view of Lee et al. teaches as above. Satomi et al. further teaches the eligibility criteria for inclusion into the clinical study includes a neutrophil count: ≥ 1500/mm3 and a platelet count: ≥ 100,000/mm3 (page 39, lines 5-10).
Satomi et al. in view of Lee et al. does not specifically teach the ivaltinostat administered by intravenous infusion over about 30 minutes to about 120 minutes (claim 9). Satomi et al. in view of Lee et al. does not specifically teach the method including the criteria for discontinuing or reducing the administration of ivaltinostat (claims 33-35, 38, and 42).
Kim et al. teaches a study of the safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and efficacy of single and multiple doses of intravenous CG200745, a novel histone deacetylase (HDAC) inhibitor, in patients with advanced solid malignancies. In all, 28 patients were treated at 13 dose levels (1.8–250 mg/m2) and received a total of 71 cycles of CG200745. Hematologic toxicities included grade 3/4 neutropenia (22.2 %). Additional phase II trials are recommended at 250 mg/m2 (page 1048, abstract). The CG200745 was administered by intravenous infusion over 1 hour (page 1051, right column, paragraph 2; page 1053, right column). Kim et al. teaches Grade 3/4 neutropenia was seen in four patients, all of whom were in the 200 and 250 mg/m2 cohorts. Although neutropenia was seen in subsequent exposure to CG200745 in these patients, it did not last more than 7 days; the dose of CG200745 was not modified on repeated treatment. In a total of 74 administered cycles, no treatment omission or delay was implemented (page 1051, paragraph spanning left and right columns).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Satomi et al. in view of Lee et al. further in view of Kim et al. in order to select the administration regimen of the compound CG200745. One of ordinary skill in the art would have been motivated to combine Satomi et al. in view of Lee et al. further in view of Kim et al. with a reasonable expectation of success because all of Satomi et al., Lee et al., and Kim et al. are drawn to methods of treatment of cancer with an HDAC inhibitor such as CG200745, Lee et al. teaches CG200745 is administered by an intravenous route, and Kim et al. teaches the CG200745 administered by intravenous infusion over 1 hour. Regarding the criteria for discontinuing or reducing the administration of ivaltinostat, Satomi et al. teaches guidance for selection criteria for which patients to treat such as hematologic parameters, and Kim et al. suggests it would have been obvious to modify or omit doses based on hematologic toxicities such as grade 3/4 neutropenia, and teaches the higher dose cohorts experienced such adverse events, suggesting the modification would be to reduce the dose. See also MPEP 2144.05 at II.A. providing ““[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” In this case Kim et al. teaches dose levels from 1.8–250 mg/m2 and suggests it would have been obvious to reduce the dose in response to adverse events. Further, regarding the effective dose of the ivaltinostat administered, Kim et al. provides additional guidance for selecting the effective amount of ivaltinostat to administer to a patient, such as the at 250 mg/m2 dose level.
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, 5-8, 11, 14, 16-17, 23, and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 18-21, and 24-30 of U.S. Patent No. 12,553,903 (reference patent) in view of Reagan-Shaw et al. (FASEB Journal, 2007, 22, p659-661, cited in PTO-892).
Reference claims 1-11 18-21, and 24-30 of the reference patent are drawn to a method of treating pancreatic cancer in a subject in need thereof, comprising: administering an effective amount of ivaltinostat in combination with one or more additional anti-cancer agents to the subject. Reference claim 24 recites the subject is administered about 60 to 250 mg/m2 ivaltinostat by intravenous infusion on day 1 and day 8 of each 21-day (3 week) cycle, in combination with 1000 mg/m2 capecitabine orally twice daily on days 1 to 14 of each 21-day cycle, addressing limitations of claims 1, 5-6, 14, 16-17. Reference claim 29 recites the subject's pancreatic cancer has not progressed on a first line fluoropyrimidine-based chemotherapy, addressing limitations of claims 1-3, and 25-26. Reference claims 7-8 recite the ivaltinostat is administered by intravenous infusion, such as over about 30 minutes to about 120 minutes, addressing limitations of claim 9. Reference claim 9 recites the ivaltinostat is administered orally, addressing limitations of claim 11. Reference claim 28 recites the pancreatic adenocarcinoma is metastatic, addressing limitations of claims 23 and 25-26.
Reference claims 1-11 18-21, and 24-30 do not specifically recite the dosage of the ivaltinostat administered in terms of mg/day (claims 7-8).
Reagan-Shaw et al. provides evidence that the body surface area (BSA) of an adult human is 1.6 m2 based on FDA Draft Guidelines (page 660, table 1 at top of right column). Therefore the ivaltinostat dose of 60, 125, or 250 mg/m2 would have been expected to translate to an amount of 37.5 mg, 78.125 mg, and 156.25 mg.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Reference claims in view of Reagan-Shaw et al. and select the optimum dosage through routine experimentation. One of ordinary skill in the art would have been motivated to combine the Reference claims in view of Reagan-Shaw et al. with a reasonable expectation of success because the Reference claims suggest it would have been obvious to select the effective dosage such as from within the range of 60 to 250 mg/m2 ivaltinostat, and Reagan-Shaw et al. teaches one of ordinary skill in the art would have the relationship between the dosage value in terms of mg/m2 and mg for a known patient would have been predictable.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 18-21, and 24-30 of U.S. Patent No. 12,553,903 (reference patent) in view of Satomi et al. (WO 2019/043176, published 07 March 2019, provided by Applicant in IDS filed 08 Nov 2024) and Lee et al. (Sci. Rep., 2017, 7(1), 41615, 9 pages, provided by Applicant in IDS filed 08 Nov 2024).
Reference claims 1-11 18-21, and 24-30 teach as above.
The Reference claims do not specifically recite the first line fluoropyrimidine-based chemotherapy is FOLFIRINOX chemotherapy (claim 24).
Satomi et al. teaches as above. Satomi et al. teaches treatment wherein the patient having the cancer has received prior systemic treatment against the cancer, such as 5-FU/leucovorin in combination with irinotecan and oxaliplatin (page 16, lines 20-25), where this combination is also known as FOLFIRINOX chemotherapy.
Lee et al. teaches as above. Lee et al. teaches the compound CG200745 is (E)-N(1)-(3-(dimethylamino)propyl)-N(8)-hydroxy-2-((naphthalene-1-loxy)methyl) oct-2-enediamide (page 2, paragraph 1), where this chemical name is also known as ivaltinostat.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Reference claims in view of Satomi et al. and Lee et al. in order to select the first line fluoropyrimidine-based chemotherapy to be FOLFIRINOX chemotherapy. One of ordinary skill in the art would have been motivated to combine Reference claims in view of Satomi et al. and Lee et al. with a reasonable expectation of success because all of the Reference claims, Satomi et al. and Lee et al. are drawn to treatment of pancreatic cancer with an HDAC inhibitor such as ivaltinostat, Reference claim 29 recites the subject's pancreatic cancer has not progressed on a first line fluoropyrimidine-based chemotherapy, and Satomi et al. teach treatment of a patient having received prior systemic treatment against the cancer, such as 5-FU/leucovorin in combination with irinotecan and oxaliplatin, also known as FOLFIRINOX chemotherapy, suggesting it would have been obvious to select the patient having undergone this first-line therapy.
Claims 33-35, 38, and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 18-21, and 24-30 of U.S. Patent No. 12,553,903 (reference patent) in view of Satomi et al. (WO 2019/043176, published 07 March 2019, provided by Applicant in IDS filed 08 Nov 2024) and Lee et al. (Sci. Rep., 2017, 7(1), 41615, 9 pages, provided by Applicant in IDS filed 08 Nov 2024), further in view of Kim et al. (Invest. New Drugs, 2015, 33, p1048–1057, provided by Applicant in IDS filed 08 Nov 2024).
The Reference claims in view of Satomi et al. and Lee et al. teach as above. Reference claim 30 further recites the method comprising adjusting pancreatic cancer treatment based on the subject's response to the treatment.
The Reference claims do not specifically recite the method including the criteria for discontinuing or reducing the administration of ivaltinostat (claims 33-35, 38, and 42).
Kim et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Reference claims in view of Satomi et al. and Lee et al. and further in view of Kim et al. in order to select the criteria for discontinuing or reducing the administration of ivaltinostat. One of ordinary skill in the art would have been motivated to combine the Reference claims in view of Satomi et al. and Lee et al. and further in view of Kim et al. with a reasonable expectation of success because Reference claim 30 further recites the method comprising adjusting pancreatic cancer treatment based on the subject's response to the treatment, Kim et al. suggests it would have been obvious to modify or omit doses based on the subject's response to the treatment for the reasoning detailed above, and Satomi et al. further teaches selecting patients for treatment based on hematologic parameters such as platelet or neutrophil count.
Conclusion
No claim is found to be allowable.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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