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 .
Claims 1, 10, 12, 14, 16, 19, 23, 31, 33, 37, 39, 43, 53, 55, 59, 61, 67, 69, 74, and 77 are pending in the application. Preliminary amendment filed 04/19/2024.
Priority
This application is a 371 of PCT/CA2022/050536 filed 04/07/2022, which claims the benefit of 63171955 filed 04/07/2021.
The parent application 63171955 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1, 10, 12, 14, 16, 19, 23, 31, 33, 37, 39, 43, 53, 55, 59, 61, 67, 69, 74, and 77 of this application.
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.
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, 10 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al. (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al. (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Bi et al (Frontiers in Pharmacology, 2019, 10, 1-16) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a WEE1 inhibitor as in claims 1 and 10 and the use of compounds of formula (I) as in claim 77.
Bi et al teaches the anticancer activity of the WEE1 inhibitor AZD1775 (Abstract; page 4, right col., Results through page 7, left col.; page 12, left col. through page 14; limitation of claim 10).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and WEE1 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 12 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al. (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al. (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of He et al (DNA Repair, 2018, 63, 1-9) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a FEN1 inhibitor as in claims 1 and 12 and the use of compounds of formula (I) as in claim 77.
He et al teaches the anticancer activity of the FEN1 inhibitor SC13 (Abstract; page 7. Part 3.1; page 9, part 4; limitation of claim 12).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and FEN1 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 14 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al. (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al. (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Leonard et al (Anticancer Drugs, 2017, 28, 1086-1096) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a TOP1 inhibitor as in claims 1 and 14 and the use of compounds of formula (I) as in claim 77.
Leonard et al teaches the anticancer activity of the TOP1 inhibitor topotecan, nalIRI (Abstract; page 1087, left col, second full para; page 1089-Results; page 1095-Discussionlimitation of claim 14).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and TOP1 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 16 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al. (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al. (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Jordheim et al (Lancet Oncol, 2011, 12, 693-702) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering an RRM2 inhibitor as in claims 1 and 16 and the use of compounds of formula (I) as in claim 77.
Jordheim et al teaches the anticancer activity of the RRM1 inhibitor gemcitabine (page 693, right col. second full para; page 698-left col through right col; limitation of claim 16).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and RRM1 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 19 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al. (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al. (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Mukherjee et al (Dig Dis Sci, 2010, 55, 3304-3314) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering an AURKB inhibitor as in claims 1 and 19 and the use of compounds of formula (I) as in claim 77.
Mukherjee et al teaches the anticancer activity of AURKB inhibitors (page 3310, right col.; limitation of claim 19).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and AURKB inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 23 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Karnitz et al (Clin Cancer Res, 2015, 21(21), 4780-4785) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering an ATR inhibitor as in claims 1 and 23 and the use of compounds of formula (I) as in claim 77.
Karnitz et al teaches the anticancer activity of ATR inhibitors (Abstract; page 4780, right col. through page 4782, right col, first para; limitation of claim 23).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and ATR inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 23 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of He et al (Nature Chemical Biology, 2017, 13,1164-1171) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering an SAE1 inhibitor as in claims 1 and 31 and the use of compounds of formula (I) as in claim 77.
He et al teaches the anticancer activity of SAE1 inhibitor (Abstract; page 1164, right col., second para through page 1170; limitation of claim 31).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and SAE1 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 33 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Glasauer et al (The Journal of Clinical Investigation, 2014, 124(1), 117-128) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering an SOD1 inhibitor as in claims 1 and 33 and the use of compounds of formula (I) as in claim 77.
Glasauer et al teaches the anticancer activity of SOD1 inhibitor (Abstract; page 118, left col. through page 123 right col.; page 123-Discussion; limitation of claim 33).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and SOD1 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 37 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Seimeister et al (Clinical Cancer Research, 2019, 25(4), 1404-1414) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a BUB1 inhibitor as in claims 1 and 37 and the use of compounds of formula (I) as in claim 77.
Siemeister et al teaches the anticancer activity of BUB1 inhibitor (Abstract; page 1408, left col. under sub title: Characterization of Cell Activity through page 1413; limitation of claim 37).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and BUB1 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 39 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Iwai et al (Sci Adv, 2019, 5, 1-17) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a CDC7 inhibitor as in claims 1 and 39 and the use of compounds of formula (I) as in claim 77.
Iwai et al teaches the anticancer activity of CDC7 inhibitor (Abstract; Introduction; page 11-Discussion; limitation of claim 39).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and CDC7 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 43 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Zhao et al (Journal of Cancer Research and Clinical Oncology, 2019, 145, 2413-2422) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a PLK4 inhibitor as in claims 1 and 43 and the use of compounds of formula (I) as in claim 77.
Zhao et al teaches the anticancer activity of PLK4 inhibitor (Abstract; page 2417, left col., last para through 2419-Conclusion; limitation of claim 43).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and PLK4 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 53 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Katsha et al (Molecular Cancer, 2015, 14 (106), 1-13) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a AURKA inhibitor as in claims 1 and 53 and the use of compounds of formula (I) as in claim 77.
Katsha et al teaches the anticancer activity of AURKA inhibitor (Abstract; page 1, right col. last para through page 2 right col., lines 1-3 below Table; page 5 left col., last para through page 10; limitation of claim 53).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and AURKA inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 55 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Krivtsov et al (Cancer Cell, 2019, 36, 660-673) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a MEN1 inhibitor as in claims 1 and 55 and the use of compounds of formula (I) as in claim 77.
Krivtsove et al teaches the anticancer activity of MEN1 inhibitor (Abstract; page 661, left col., last para through page 611; limitation of claim 55).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and MEN1 inhibitors are known in the art for use as active agents in a method of treating the claimed cancers. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 59 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and further in view of Zhou et al (Blood, 2014, 124(21), 1-3) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a CREBBP inhibitor as in claims 1 and 59 and the use of compounds of formula (I) as in claim 77.
Zhou et al teaches the anticancer activity of CREBBP inhibitor C82 (Abstract; pages 1-3; limitation of claim 59).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and CREBBP inhibitors are known in the art for use as active agents in a method of treating cancer. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 61 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/20) and further in view of Zeng et al (Oncotarget, 2017, 8(2), 3396-3411) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a EZH2 inhibitor as in claims 1 and 61 and the use of compounds of formula (I) as in claim 77.
Zeng et al teaches the anticancer activity of EZH2 inhibitor GSK 126 (Abstract; page 3397, left col., first full par through page 3399, left col, third full para; page 3403, right col. first full para through page 3406, left col., second full para; limitation of claim 61).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and EZH2 inhibitors are known in the art for use as active agents in a method of treating cancer. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 67 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/20) and further in view of Zeng et al (Journal of Hematology & Oncology, 2020, 13(117), 1-15) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a METTL3 inhibitor as in claims 1 and 67 and the use of compounds of formula (I) as in claim 77.
Zeng et al teaches the anticancer activity of METTL3 inhibitor (Abstract; page 10, left col., first full para through page 15; limitation of claim 67).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and METTL3 inhibitors are known in the art for use as active agents in a method of treating cancer. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 69 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/20) and further in view of Guinan et al (Molecules, 2020, 25, 1-25) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering a nucleoside analog as in claims 1 and 69 and the use of compounds of formula (I) as in claim 77.
Guinan et al teaches that nucleoside analogs have proven to be highly successful chemotherapeutic agents in the treatment of a wide variety of cancers, and teaches several nucleoside analogs for this purpose (Abstract; page 2, third para through page 20; limitation of claim 69).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and nucleoside analogs are known in the art for use as active agents in a method of treating cancer. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
Claim(s) 1, 74 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/20) and further in view of Dasari et al (European Journal of Pharmacology, 2014, 740, 364-378) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020).
Lago discloses Myt1 kinase inhibitors of Formula (I) (title, abstract, page 2).
With respect to claim 1, Lago discloses a method of treating a disease or disorder selected from the group consisting of leukemias, solid tumor cancers and metastases, soft tissue cancers, brain cancer, esophageal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, bladder cancer, bone cancer, prostate cancer, ovarian cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, head cancer and neck cancer, which comprises administering to a subject in need thereof an effective amount of a compound according to Formula (I) (page 6, lines 8-12; page 13, claims 1-3 of Lago; part of the limitations of claim 1).
Nakayama and Wang are cited to show that, for example, ovarian cancer and prostate cancer have been previously identified as cancers overexpressing CCNE1.
Lago does not teach administering platinum-based DNA damaging agents as in claims 1 and 74 and the use of compounds of formula (I) as in claim 77.
Dasari et al teaches the use of Cisplatin and related platinum drugs for treating cancers (Abstract; page 365 part 2 through page 374; limitation of claim 74).
Szychowski et al teaches Myt1 inhibitor compounds of formula (I) for treating cancer in a subject having a cell overexpressing CCNE1 or having an inactivation mutation in the FBXW7 gene (page 18, line 25 through page 25, line 27; limitation of claim 77).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both Myt1 inhibitors and platinum-based agents are known in the art for use as active agents in a method of treating cancer. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 10, 12, 14, 16, 19, 23, 31, 33, 37, 39, 43, 53, 55, 59, 61, 67, 69, 74, and 77 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4, 11-16, 18, 20, 23, 27, 43, 48, 51, 54, 59 and 61 of copending Application No. 17/916,773 (‘773) in view of Lago (WO 2000033837 A2; cited in IDS filed 4/19/2024) as evidenced by Nakayama et al. (Cancer, 116(11), Jun. 2010, pp. 2621–34) and as evidenced by Wang et al. (Gene, vol. 744, March 2020, p. 144608; cited in IDS filed 4/19/2024) and Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020) and further in view of all the other secondary references cited in the rejections above for the other inhibitors. The secondary references cited in the rejections above for the other inhibitors is not cited here for the sake of brevity.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a method of treating cancer or inducing cell death of a cancer cell in a subject comprising administering a Myt1 inhibitor and a n inhibitor selected for a Markush group of 29 other inhibitors. Dependent claims 10, 12, 14, 16, 19, 23, 31, 33, 37, 39, 43, 53, 55, 59, 61, 67, 69, and 74 are drawn to a combination of the Myt1 inhibitor and the other individual inhibitors, and claim 77 is drawn to the use of the compounds of formula (I) as the Myt1 inhibitor.
Claim 1 of the ‘773 application is drawn to a method of treating or causing cell death of a cancer cell in a subject via administration of aMyt1 inhibitor of formula (I). Dependent claims recite limitations drawn to the type of cancers treated, compounds of formula (I) (claims 11-16, 18-20, 23, 27, 43, 48, 51, 54, 59). This overlaps with the compound of formula (I) in claim 77 of the instant application. Claim 61 is drawn to administration of the Myt1 inhibitor as a pharmaceutical composition.
The copending claims of ‘773 differ from the instant claims in that the instant claims are drawn to administration of other inhibitors with the Myt1 inhibitor whereas ‘733 administers only the Myt1 inhibitors of formula (I).
Although the claims of '773 teach administering compounds of formula (I) in the method of treating cancer, one of ordinary skill in the art would readily recognize that the method taught by '773 could be modified to arrive at the instant invention with a reasonable expectation of success in view of the secondary references
One of ordinary skill in the art would have reasonably expected that the Myt1 inhibitors in combination with the other inhibitors would have same or substantially similar beneficial therapeutic effects and usefulness in a method of treating cancer, since all the inhibitors are known in the art individually for treating cancer.
It has been held that 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 that is to be used for the very same purpose. The idea of combining them flows logically from their having been taught individually in the prior art. See In re Kerkhoven, 205 USPQ 1069, CCPA 1980. The combination of the two inhibitors would also enhance the anticancer activity.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Pending claims 1, 10, 12, 14, 16, 19, 23, 31, 33, 37, 39, 43, 53, 55, 59, 61, 67, 69, 74, and 77 are rejected.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693