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 .
The amendment filed 07 August 2026 has been received, entered and considered. The following information has been made of record in the instant amendment:
1. Claims 2-9, 11, 13, 15, 17-18, 20-22, 24-30, 32, 34-36, 38, 40-42, 44-52, 54, 56-58, 60, 62-66, 68, 70-73 and 75-128 have been canceled.
2. No new Claims have been added.
3. Claim 1 has been amended.
4. Remarks drawn to rejections under 35 USC 103 and double patenting.
The rejections of claims under 35 USC 103 of record in the previous Action have been withdrawn in view of the amendment to claim 1 which now requires administration of a Myt1 inhibitor of formula (I) in combination with other inhibitors. The rejection of claim 77 has been rendered moot by cancelation. The following rejections are made of record in view of the amendment.
The rejection of Claims 1, 10, 12, 14, 16, 19, 23, 31, 33, 37, 39, 43, 53, 55, 59, 61, 67, 69, 74 provisionally 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A1, priority to 63/003,745 filed 01 April 2020) and further in view of all the other secondary references, has been withdrawn. A request for Express Abandonment was filed in the ‘773 application on July 10, 2026.
Claims 1, 10, 12, 14, 16, 19, 23, 31, 33, 37, 39, 43, 53, 55, 59, 61, 67, 69, and 74 are pending in the case.
The following rejections are necessitated by Applicant's amendment filed 07 August 2026 wherein the limitation in pending claim 1 has been amended. The limitation of claim 77 has been incorporated into claim 1.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 74 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment).
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 51, line 39; page 64, line 22 through page 65, line 8; part of the limitation of 1 regarding compound of formula (I), the method, mutation in FBXW7 and overexpressing CCNE1). The compound of formula (I) may be administered to a subject in combination with a platinum-based DNA damaging agent like carboplatin, cisplatin and oxaliplatin (page 72, line 11; as in claim 1 and as in claim 74; carboplatin, cisplatin and oxaliplatin are defined as DNA damaging agents in the specification at page 92, lines 28-29).
Therefore, Szychowski anticipates claims 1 and 74.
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.
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Bi et al (Frontiers in Pharmacology, 2019, 10, 1-16; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski does not expressly teach the step of administration of a WEE1 inhibitor as in claim 10.
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 claims 1 and 10).
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 of formula (I) and WEE1 inhibitors are known in the art for use as active agents in a method of treating cancer or inducing cell death of a cancer cell in a subject. 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 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of He et al (DNA Repair, 2018, 63, 1-9; of record and necessitated amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach the administration of a FEN1 inhibitor as in claims 1 and 12.
He et al teaches the anticancer activity of the FEN1 inhibitor SC13 (Abstract; page 7. Part 3.1; page 9, part 4; limitation of claims 1 and 12).
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 cancer or inducing cell death of a cancer cell in a subject. 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 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Leonard et al (Anticancer Drugs, 2017, 28, 1086-1096; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach the administration of TOP1 or the TOP2A inhibitor as in claims 1 and 14.
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-Discussion; limitation of claims 1 and 14).
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 cancers or inducing cell death of a cancer cell in a subject. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art. The artisan would find it obvious to administer the related TOPA2A inhibitor also in the claimed method in view of Leonard.
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 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Jordheim et al (Lancet Oncol, 2011, 12, 693-702; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach the administration of RRM1 or the RRM2 inhibitor as in claims 1 and 16.
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 claims 1 and 16).
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 cancer or inducing cell death of a cancer cell in a subject. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art. The artisan would find it obvious to administer the related RRM2 inhibitor also in the method in view of Jordheim.
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 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Mukherjee et al (Dig Dis Sci, 2010, 55, 3304-3314; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach the administration of the AURKB inhibitor as in claims 1 and 19.
Mukherjee et al teaches the anticancer activity of AURKB inhibitors (page 3310, right col.; limitation of claims 1 and 19).
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 cancer or inducing cell death of a cancer cell in a subject. 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 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Karnitz et al (Clin Cancer Res, 2015, 21(21), 4780-478; of record and necessitated by amendment5).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach the administration of the ATR inhibitor as in claims 1 and 23.
Karnitz et al teaches the anticancer activity of ATR inhibitors (Abstract; page 4780, right col. through page 4782, right col, first para; limitation of claims 1 and 23).
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 cancer or inducing cell death of a cancer cell in a subject. 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 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of He et al (Nature Chemical Biology, 2017, 13,1164-1171; or record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. In addition. Szychowski teaches the use of a cell checkpoint kinase inhibitor and several other inhibitors in combination with its compounds of formula (I) for treating cancer (page 73). Szychowski et al does not expressly teach the administration of the SAE1 inhibitor as in claims 1 and 31.
He et al teaches the anticancer activity of SAE1 inhibitor (Abstract; page 1164, right col., second para through page 1170; limitation of claims 1 and 31).
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 cancer or inducing cell death of a cancer cell in a subject. The teaching of Szychowski regarding the use of a cell checkpoint kinase inhibitor and several inhibitors renders obvious the use of the CHECK 1 inhibitor and all the other inhibitors as in claims 1 and 31. 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 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Glasauer et al (The Journal of Clinical Investigation, 2014, 124(1), 117-128; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach the administration of SOD1 or the SOD2 inhibitor as in claims 1 and 33.
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 claims 1 and 33).
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 cancer or inducing cell death of a cancer cell in a subject. Thus, it is obvious to arrive at the claimed method of treatment in view of the combined teachings of the prior art. The artisan would find it obvious to also administer SOD2 inhibitor in the claimed method.
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 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Seimeister et al (Clinical Cancer Research, 2019, 25(4), 1404-1414; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach administering a BUB1 inhibitor as in claims 1 and 37.
Siemeister et al teaches the anticancer activity of BUB1 inhibitor (Abstract; page 1408, left col. under subtitle: Characterization of Cell Activity through page 1413; limitation of claims 1 and 37).
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 cancer or inducing cell death of a cancer cell in a subject. 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 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Iwai et al (Sci Adv, 2019, 5, 1-17; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach administering a CDC7 inhibitor as in claims 1 and 39.
Iwai et al teaches the anticancer activity of CDC7 inhibitor (Abstract; Introduction; page 11-Discussion; limitation of claims 1 and 39).
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 cancer or inducing cell death of a cancer cell in a subject. 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 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Zhao et al (Journal of Cancer Research and Clinical Oncology, 2019, 145, 2413-2422; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach administering a PLK4 inhibitor as in claims 1 and 43.
Zhao et al teaches the anticancer activity of PLK4 inhibitor (Abstract; page 2417, left col., last para through 2419-Conclusion; limitation of claims 1 and 43).
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 cancer or inducing cell death of a cancer cell in a subject. 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 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Katsha et al (Molecular Cancer, 2015, 14 (106), 1-13; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach administering a AURKA inhibitor as in claims 1 and 53.
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 claims 1 and 53).
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 cancer or inducing cell death of a cancer cell in a subject. 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 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Krivtsov et al (Cancer Cell, 2019, 36, 660-673; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach administering a MEN1 inhibitor as in claims 1 and 55.
Krivtsov et al teaches the anticancer activity of MEN1 inhibitor (Abstract; page 661, left col., last para through page 611; limitation of claims 1 and 55).
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 cancer or inducing cell death of a cancer cell in a subject. 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 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Zhou et al (Blood, 2014, 124(21), 1-3; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach administering a CREBBP inhibitor as in claims 1 and 59.
Zhou et al teaches the anticancer activity of CREBBP inhibitor C82 (Abstract; pages 1-3; limitation of claims 1 and 59).
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 or inducing cell death of a cancer cell in a subject. 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 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Zeng et al (Oncotarget, 2017, 8(2), 3396-3411; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach administering a EZH2 inhibitor as in claims 1 and 61.
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 claims 1 and 61).
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 or inducing cell death of a cancer cell in a subject. 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 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Zeng et al (Journal of Hematology & Oncology, 2020, 13(117), 1-15; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach administering a METTL3 inhibitor as in claims 1 and 67.
Zeng et al teaches the anticancer activity of METTL3 inhibitor (Abstract; page 10, left col., first full para through page 15; limitation of claims 1 and 67).
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 or inducing cell death of a cancer cell in a subject. 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 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Szychowski et al (WO 2021/195781 A1, priority to 63/003,745 filed 01 April 2020; of record and necessitated by amendment) in view of Guinan et al (Molecules, 2020, 25, 1-25; of record and necessitated by amendment).
Szychowski et al’s teachings are set forth above. Szychowski et al does not teach administering a nucleoside analog as in claims 1 and 69.
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 claims 1 and 69).
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 or inducing cell death of a cancer cell in a subject. 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.
Response to Applicants’ Remarks
Regarding the rejection of claims under 35 USC 103, applicant has traversed arguing that the application discloses the surprising discovery that the combination of a Myt1 inhibitor of formula (I) in combination with certain cell-cycle or chromosome-integrity related secondary agents consistent with claim 1 provide synergistic results (Figs 8A-8G). The Office Action fails to explain why a skilled person would reasonably expect to obtain such results. Thus, the amended claims are non-obvious over the cited references. Accordingly, reconsideration and withdrawal of this rejection is requested (Remarks-pages 10-13).
In view of the amendment to claim 1 the obviousness rejections above are made of record.
Regarding synergism, applicant has disclosed a combination experiment performed using a representative HCC1569 high breast cancer cell lines, wherein the cells were dosed with either Myt1 inhibitor, compound 182 (structural formula disclosed in the Table at page 41), gemcitabine, irinotecan, or ATR inhibitor (compound A121) alone or in combination. Efficacy of compound 182 either alone or in combination with the three active agents was also assessed in the OVCAR3 ovarian cancer xenograft model in mice. The synergistic effect of only one Myt1 inhibitor in combination with gemcitabine, irinotecan, and ATR inhibitor is disclosed at page 169 in specification. The concentration of the active agents used is not disclosed. These two examples are not sufficient for asserting synergism. The Myt1 inhibitor of formula (I) used in the claimed method of treating cancer includes several compounds with vastly differing substitutions. These are used in combination with 27 different additional inhibitors, which gives rise to myriad combinations of active agents. One of ordinary skill in the art will not extrapolate the synergism asserted in the disclosed examples to all the combinations as claimed.
Synergism is not only dependent on the agonist pair; it also depends on the ratio of the drug doses (see Tallarida, Genes & Cancer, 2011, 2(11), 1003-1008). Not all ratios are synergistic (page 1007, left col., last para through page 1008). The instant claims are drawn to administration of the Myt1 inhibitors of formula (I) in combination with several other inhibitors. From the claim recitation any concentration of the combination can be used in the method. Not all concentrations/ratios of the combinations of the claimed combinations of active agents will produce a synergistic effect as suggested by Tallarida. Therefore, applicant cannot assert synergism to overcome the rejection when the examples disclosed in the specification are insufficient for such an assertion.
Conclusion
1. Pending claims 1, 10, 12, 14, 16, 19, 23, 31, 33, 37, 39, 43, 53, 55, 59, 61, 67, 69, and 74 are rejected.
2. Claims 2-9, 11, 13, 15, 17-18, 20-22, 24-30, 32, 34-36, 38, 40-42, 44-52, 54, 56-58, 60, 62-66, 68, 70-73 and 75-128 have been canceled.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
