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 .
Application Status
The preliminary amendment filed on 1/13/2023 is acknowledged. Claims 1-16 and 21-38 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 1/13/2023 is acknowledged and has been entered.
Claim Objections
Claims 27-38 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 5-16. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Interpretation
Claims 22-25 recite kit claims. It is noted that the claims only require pharmaceutical compositions comprising each of the active agents, but does not include any other structural features. As such, it appears that all is required are pharmaceutical compositions comprising the two agents which appears to be met by the prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-9, 24 and 30-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 8-9, 24 and 30-31, claims 8-9, 24 and 30-31 recite the phrase “CDK4 selective inhibitor”. However, neither the claims, nor the specification define the meets and bounds of what is encompassed by “selective”. For example, it is unclear of whether selective means only inhibits CDK4 vs. for example, CDK6 or it inhibits CDK4 more than CDK6. Abemaciclib is taught by the specification to be a CDK4/6 inhibitor, but is known to be 5 times more potent against CDK4 than CDK6 (see for example, Braal et al. (Drugs 2020; 81(3): 317-331), specifically page 321, 1st column, line 2). Thus, for prior art purposes, a selective CDK4 inhibitor will be interpreted as inhibiting CDK4 more than the other CDK’s and encompass palbociclib, ribociclib and abemaciclib.
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) 1-5, 14-16, 21-23, 25-27 and 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al. (US20180222857A1, 2018-08-09) in view of Yu et al. (Oncogene 2017; 36: 2910-2918, IDS).
Voss et al. teach aryl sulfonohydrazides which inhibit the activity of MOZ and are useful in treating conditions ameliorated by the inhibition of the activity of MOZ (paragraph 0010). With regards to MOZ, Voss et al. teach that MOZ is also referred to as KAT6a (paragraph 0009). With regards to conditions ameliorated by the inhibition of the activity of MOZ, Voss et al. teach that since MOZ is required for stem cell self-renewal, several cancers associated with self-renewing population of cancer stem cells such as breast cancer, lung cancer or brain cancer are contemplated for treatment with the aryl sulfonohydrazides (paragraphs 0098 and 0101). Accordingly, Voss et al. teach a method of treating cancer comprising administering to a subject in need thereof a therapeutically effective amount of an aryl sulfonohydrazide or a pharmaceutical composition comprising said compound and a pharmaceutically acceptable excipient (paragraph 0115). In addition to the aryl sulfonohydrazide as the sole therapy, Voss et al. teach that the aryl sulfonohydrazide is combined with an additional anti-cancer agent including, but not limited to, antiestrogens such as tamoxifen or fulvestrant (paragraphs 0116 and 0118).
While Voss et al. suggest treatment of breast cancer and the combination with an antiestrogen, Voss et al. does not specifically select said breast cancer or antiestrogen therapy.
Yu et al. identified MYSTR3, also known as KAT6A and MOZ, as a novel epigenetic activator of ERalpha frequently amplified in breast cancer (Title). Specifically, Yu et al. teach our animal studies showed that targeting MYST3 attenuates breast tumor growth, wherein MYST3 depletion results in an inhibitory effect only in MYST3-high cells (page 2917, 1st column, 1st full paragraph). Moreover, Yu et al. teach that while targeting ER with endocrine therapy is an effective treatment of ER+ breast cancer, resistance to endocrine therapy is a major challenge with a significant portion of ER+ breast cancer treated with endocrine therapies relapse (page 2917, 1st full paragraph). Regarding MYST3-high cells, Yu et al. teach that high levels of MYST3 also predicted worse survival outcomes for ER+/HER2- patients treated with endocrine therapy, wherein targeting MYST3 may be an alternative strategy to treating MYST3-high ER+/HER2- breast cancers in addition to endocrine therapy (page 2917, 1st column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating cancer taught by Voss et al to specific select breast cancer and combine with an antiestrogen therapy in view of the teachings of Yu et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Yu et al. teach that overall, compared with hormone therapy targeting ERalpha alone, dual targeting of ERalpha and MYST3 may achieve a better therapeutic effect in MYST3-high ER+/HER2- breast tumors (page 2917, 1st column, 1st full paragraph, last sentence).
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Claim(s) 8-9, 11-13, 24, 30-31 and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al. (US20180222857A1, 2018-08-09) in view of Yu et al. (Oncogene 2017; 36: 2910-2918, IDS), as applied to claims 1-5, 14-16, 21-23, 25-27 and 36-38 above, in further view of Sobhani et al. (Cells 2019; 8: 321).
The combination of Voss et al. and Yu et al. has been discussed above and incorporated herein. In short, the combination of Voss et al. and Yu et al. teach a method of treating ER+/HER2- breast tumors comprising administering a combination of a MOZ inhibitor in combination with an antiestrogen. In addition to the antiestrogens, Voss et al. teach that cyclin dependent inhibitors such as CDK2 and/or CDK4 can be combined with the aryl sulfonohydrazides (paragraph 0121).
The combination of Voss et al. and Yu et al do not specifically select a CDK4/6 inhibitor either in combination with the aryl sulfonohydrazides or in addition to the combination of aryl sulfonohydrazides and antiestrogen for the treatment of ER+/HER2- breast tumors.
Sobhani et al. provide an update on the CDK4/6 inhibitory strategy and combination in breast cancer (Title). Specifically, Sobhani et al. teach that in the past four years, the CDK4/6 inhibitors, palbociclib, ribociclib and abemaciclib, received their first FDA approval for the treatment of hormone receptor (HR)-positive and Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer after significant improvements in progression-free survival in several randomized clinical trials (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating cancer taught by the combination of Voss et al and Yu et al. either substitute the antiestrogen therapy for a CDK4/6 inhibitor or add a CDK4/6 inhibitor to the aryl sulfonohydrazides specific in view of the teachings of Sobhani et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Sobhani et al. teach that in the past four years, the CDK4/6 inhibitors, palbociclib, ribociclib and abemaciclib, received their first FDA approval for the treatment of hormone receptor (HR)-positive and Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer after significant improvements in progression-free survival in several randomized clinical trials.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Claim(s) 6-7, 23 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al. (US20180222857A1, 2018-08-09) in view of Yu et al. (Oncogene 2017; 36: 2910-2918, IDS), as applied to claims 1-5, 14-16, 21-23, 25-27 and 36-38 above, in further view of Bozikis et al. (US Patent 12,371,425, 2025-07-29).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The combination of Voss et al. and Yu et al. has been discussed above and incorporated herein. In short, the combination of Voss et al. and Yu et al. teach a method of treating ER+/HER2- breast tumors comprising administering a MOZ inhibitor in combination with an antiestrogen.
The Combination of Voss et al. and Yu et al. do not specifically teach that the MOZ inhibitor is a compound having the formula:
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or
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Bozikis et al. claim a method of treating cancer in a patient comprising administering to the patient an amount of a compound
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, wherein the cancer is ER+ HER2-breast cancer (Claims 1-4). In addition to the compound described above, Bozikis et al. teach a structurally similar compound having KAT6 inhibitory activity referred to as compound 98 having the structure
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(column 151 and Column 21, Table 21).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the MOZ inhibitor (e.g. KAT6 inhibitor) of the combination of Voss et al and Yu et al. for the compounds taught by Bozikis et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
- Bozikis et al teach two compounds having MOZ inhibitory activity which are useful for treating ER+ HER2-breast cancer.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Claim(s) 9-10, 24 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al. (US20180222857A1, 2018-08-09) in view of Yu et al. (Oncogene 2017; 36: 2910-2918, IDS), as applied to claims 1-5, 14-16, 21-23, 25-27 and 36-38 above, in further view of Chen et al. (US Patent 11,220,494B2, 2022-01-11).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The combination of Voss et al. and Yu et al. has been discussed above and incorporated herein. In short, the combination of Voss et al. and Yu et al. teach a method of treating ER+/HER2- breast tumors comprising administering a MOZ inhibitor in combination with an antiestrogen. In addition to the antiestrogens, Voss et al. teach that cyclin dependent inhibitors such as CDK2 and/or CDK4 can be combined with the aryl sulfonohydrazides (paragraph 0121).
The combination of Voss et al. and Yu et al do not specifically select a CDK4 inhibitor either in combination with the aryl sulfonohydrazides or in addition to the combination of aryl sulfonohydrazides and antiestrogen for the treatment of ER+/HER2- breast tumors. The combination of Voss et al. and Yu et al do not specifically teach that the CDK4 inhibitor has the structure
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Chen et al. claims a method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound having the formula
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, wherein the cancer is ER+/HER2- breast cancer (claims 7-10). Moreover, Chen et al. further claim that the method further comprises administering to the subject an additional anti-cancer agent such as an endocrine agent (claims 11-13). Regarding the compound, Chen et al. teach that the compound is a selective inhibitor of CDK4 (see column 317, compound A67).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating cancer taught by the combination of Voss et al and Yu et al. either substitute the antiestrogen therapy for a CDK4 inhibitor or add a CDK4 inhibitor to the aryl sulfonohydrazides in view of the teachings of Chen et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Chen et al. teach a method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound having the formula
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, wherein the cancer is ER+/HER2- breast cancer (claims 7-10); and
-Chen et al. further claim that the method further comprises administering to the subject an additional anti-cancer agent such as an endocrine agent (claims 11-13).
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Claim(s) 1-10, 14-16, 21-24, 26-32 and 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bozikis et al. (US Patent 12,371,425, 2025-07-29) in view of Chen et al. (US Patent 11,220,494B2, 2022-01-11).
Note: While Bozikis et al. is used as the primary reference here the order can be easily substituted so that Chen et al. is the primary reference.
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Bozikis et al. claim a method of treating cancer in a patient comprising administering to the patient an amount of a compound
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, wherein the cancer is ER+ HER2-breast cancer (Claims 1-4). In addition to the compound described above, Bozikis et al. teach a structurally similar compound having KAT6 inhibitory activity referred to as compound 98 having the structure
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(column 151 and Column 21, Table 21).
Bozikis et al. do not teach the addition of another anticancer agent such as an antiestrogen or CDK4 inhibitor, wherein the CDK4 inhibitor has the structure
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Chen et al. claims a method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound having the formula
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, wherein the cancer is ER+/HER2- breast cancer (claims 7-10). Moreover, Chen et al. further claim that the method further comprises administering to the subject an additional anti-cancer agent including, but not limited to, endocrine agents such as letrozole or fulvestrant (claims 11-13). Regarding the compound, Chen et al. teach that the compound is a selective inhibitor of CDK4 (see column 317, compound A67).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating cancer taught Bozikis et al. to include an additional therapeutic treatment of either an antiestrogen therapy or CDK4 inhibitor or both in view of the teachings of Chen et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Chen et al. teach a method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound having the formula
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, wherein the cancer is ER+/HER2- breast cancer (claims 7-10); and
-Chen et al. further claim that the method further comprises administering to the subject an additional anti-cancer agent such as an endocrine agent (claims 11-13).
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Claim(s) 1, 3-9, 11-13, 16, 21-24, 26-31, 33-35 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bozikis et al. (US Patent 12,371,425, 2025-07-29) in view of Sobhani et al. (Cells 2019; 8: 321).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Bozikis et al. claim a method of treating cancer in a patient comprising administering to the patient an amount of a compound
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, wherein the cancer is ER+ HER2-breast cancer (Claims 1-4). In addition to the compound described above, Bozikis et al. teach a structurally similar compound having KAT6 inhibitory activity referred to as compound 98 having the structure
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(column 151 and Column 21, Table 21).
Bozikis et al. do not teach the addition of another anticancer agent such as a CDK4/6 inhibitor for the treatment of ER+/HER2- breast tumors.
Sobhani et al. provide an update on the CDK4/6 inhibitory strategy and combination in breast cancer (Title). Specifically, Sobhani et al. teach that in the past four years, the CDK4/6 inhibitors, palbociclib, ribociclib and abemaciclib, received their first FDA approval for the treatment of hormone receptor (HR)-positive and Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer after significant improvements in progression-free survival in several randomized clinical trials (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating cancer taught by Bozikis et al. to add another anticancer agent such as a CDK4/6 inhibitor in view of the teachings of Sobhani et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Sobhani et al. teach that in the past four years, the CDK4/6 inhibitors, palbociclib, ribociclib and abemaciclib, received their first FDA approval for the treatment of hormone receptor (HR)-positive and Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer after significant improvements in progression-free survival in several randomized clinical trials.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-5, 7, 14-16, 21-23, 25-27, 29 and 36-38 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,371,425 in view of Voss et al. (US20180222857A1, 2018-08-09) and Yu et al. (Oncogene 2017; 36: 2910-2918, IDS).
The US Patent claims a method of treating cancer in a patient comprising administering to the patient an amount of a compound
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, wherein the cancer is ER+ HER2-breast cancer (Claims 1-4).
The US Patent does not claim the cancer cell as acquired resistance to endocrine therapy or that the compound is combined with antiestrogens.
Voss et al. teach aryl sulfonohydrazides which inhibit the activity of MOZ and are useful in treating conditions ameliorated by the inhibition of the activity of MOZ (paragraph 0010). With regards to MOZ, Voss et al. teach that MOZ is also referred to as KAT6a (paragraph 0009). With regards to conditions ameliorated by the inhibition of the activity of MOZ, Voss et al. teach that since MOZ is required for stem cell self-renewal, several cancers associated with self-renewing population of cancer stem cells such as breast cancer, lung cancer or brain cancer are contemplated for treatment with the aryl sulfonohydrazides (paragraphs 0098 and 0101). Accordingly, Voss et al. teach a method of treating cancer comprising administering to a subject in need thereof a therapeutically effective amount of an aryl sulfonohydrazide or a pharmaceutical composition comprising said compound and a pharmaceutically acceptable excipient (paragraph 0115). In addition to the aryl sulfonohydrazide as the sole therapy, Voss et al. teach that the aryl sulfonohydrazide is combined with an additional anti-cancer agent including, but not limited to, antiestrogens such as tamoxifen or fulvestrant (paragraphs 0116 and 0118).
Yu et al. identified MYSTR3, also known as KAT6A and MOZ, as a novel epigenetic activator of ERalpha frequently amplified in breast cancer (Title). Specifically, Yu et al. teach our animal studies showed that targeting MYST3 attenuates breast tumor growth, wherein MYST3 depletion results in an inhibitory effect only in MYST3-high cells (page 2917, 1st column, 1st full paragraph). Moreover, Yu et al. teach that while targeting ER with endocrine therapy is an effective treatment of ER+ breast cancer, resistance to endocrine therapy is a major challenge with a significant portion of ER+ breast cancer treated with endocrine therapies relapse (page 2917, 1st full paragraph). Regarding MYST3-high cells, Yu et al. teach that high levels of MYST3 also predicted worse survival outcomes for ER+/HER2- patients treated with endocrine therapy, wherein targeting MYST3 may be an alternative strategy to treating MYST3-high ER+/HER2- breast cancers in addition to endocrine therapy (page 2917, 1st column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating cancer claimed by the US Patent by combining the compound with an antiestrogen therapy and/or treat breast cancer that has acquired resistance to endocrine therapy in view of the teachings of Voss et al. and Yu et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Voss et al. teach MYST3 inhibitors can be combined with antiestrogens;
-Yu et al. teach that overall, compared with hormone therapy targeting ERalpha alone, dual targeting of ERalpha and MYST3 may achieve a better therapeutic effect in MYST3-high ER+/HER2- breast tumors (page 2917, 1st column, 1st full paragraph, last sentence),
- Moreover, Yu et al. teach that while targeting ER with endocrine therapy is an effective treatment of ER+ breast cancer, resistance to endocrine therapy is a major challenge with a significant portion of ER+ breast cancer treated with endocrine therapies relapse.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Claim 8-9, 11-13, 24, 30-31 and 33-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,371,425 in view of Voss et al. (US20180222857A1, 2018-08-09) and Yu et al. (Oncogene 2017; 36: 2910-2918, IDS), as applied to claims 1-5, 7, 14-16, 21-23, 25-27, 29 and 36-38 above, in further view of Sobhani et al. (Cells 2019; 8: 321).
The combination of the US Patent, Voss et al and Yu et al. have been discussed above and incorporated herein.
The combination does not claim the addition of another anticancer agent such as a CDK4/6 inhibitor for the treatment of ER+/HER2- breast tumors.
Sobhani et al. provide an update on the CDK4/6 inhibitory strategy and combination in breast cancer (Title). Specifically, Sobhani et al. teach that in the past four years, the CDK4/6 inhibitors, palbociclib, ribociclib and abemaciclib, received their first FDA approval for the treatment of hormone receptor (HR)-positive and Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer after significant improvements in progression-free survival in several randomized clinical trials (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating cancer claimed by the combination to add another anticancer agent such as a CDK4/6 inhibitor in view of the teachings of Sobhani et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Sobhani et al. teach that in the past four years, the CDK4/6 inhibitors, palbociclib, ribociclib and abemaciclib, received their first FDA approval for the treatment of hormone receptor (HR)-positive and Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer after significant improvements in progression-free survival in several randomized clinical trials.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Claim(s) 1, 3-5, 7-10, 14-16, 21-24, 26-27, 29-32 and 36-38 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,371,425 in view of Chen et al. (US Patent 11,220,494B2, 2022-01-11).
NOTE: Similar analysis can be made using US Patent 11,220,494B2 as the conflicting patent.
The US Patent claims a method of treating cancer in a patient comprising administering to the patient an amount of a compound
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160
301
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, wherein the cancer is ER+ HER2-breast cancer (Claims 1-4).
The US Patent does not claim the addition of another anticancer agent such as an antiestrogen or CDK4 inhibitor, wherein the CDK4 inhibitor has the structure
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179
259
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.
Chen et al. claims a method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound having the formula
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179
259
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, wherein the cancer is ER+/HER2- breast cancer (claims 7-10). Moreover, Chen et al. further claim that the method further comprises administering to the subject an additional anti-cancer agent including, but not limited to, endocrine agents such as letrozole or fulvestrant (claims 11-13). Regarding the compound, Chen et al. teach that the compound is a selective inhibitor of CDK4 (see column 317, compound A67).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating cancer claimed by the US Patent to include an additional therapeutic treatment of either an antiestrogen therapy or CDK4 inhibitor or both in view of the teachings of Chen et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Chen et al. teach a method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound having the formula
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179
259
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, wherein the cancer is ER+/HER2- breast cancer (claims 7-10); and
-Chen et al. further claim that the method further comprises administering to the subject an additional anti-cancer agent such as an endocrine agent (claims 11-13).
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Claim(s) 1-5, 9-10, 14-16, 21-24, 25-27, 31-32 and 36-38 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 7-13 of U.S. Patent No. 11,220,494B2 in view of Voss et al. (US20180222857A1, 2018-08-09) and Yu et al. (Oncogene 2017; 36: 2910-2918, IDS).
The US Patent claims a method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound having the formula
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179
259
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, wherein the cancer is ER+/HER2- breast cancer (claims 7-10). Moreover, the US Patent further claim that the method further comprises administering to the subject an additional anti-cancer agent such as an endocrine agent (claims 11-13). Regarding the compound, The US Patent teach that the compound is a selective inhibitor of CDK4 (see column 317, compound A67).
The US Patent does not claim the addition of a KAT6 inhibitor or that the cancer cells are resistant to endocrine therapy.
Voss et al. teach aryl sulfonohydrazides which inhibit the activity of MOZ and are useful in treating conditions ameliorated by the inhibition of the activity of MOZ (paragraph 0010). With regards to MOZ, Voss et al. teach that MOZ is also referred to as KAT6a (paragraph 0009). With regards to conditions ameliorated by the inhibition of the activity of MOZ, Voss et al. teach that since MOZ is required for stem cell self-renewal, several cancers associated with self-renewing population of cancer stem cells such as breast cancer, lung cancer or brain cancer are contemplated for treatment with the aryl sulfonohydrazides (paragraphs 0098 and 0101). Accordingly, Voss et al. teach a method of treating cancer comprising administering to a subject in need thereof a therapeutically effective amount of an aryl sulfonohydrazide or a pharmaceutical composition comprising said compound and a pharmaceutically acceptable excipient (paragraph 0115). In addition to the aryl sulfonohydrazide as the sole therapy, Voss et al. teach that the aryl sulfonohydrazide is combined with an additional anti-cancer agent including, but not limited to, antiestrogens such as tamoxifen or fulvestrant (paragraphs 0116 and 0118).
Yu et al. identified MYSTR3, also known as KAT6A and MOZ, as a novel epigenetic activator of ERalpha frequently amplified in breast cancer (Title). Specifically, Yu et al. teach our animal studies showed that targeting MYST3 attenuates breast tumor growth, wherein MYST3 depletion results in an inhibitory effect only in MYST3-high cells (page 2917, 1st column, 1st full paragraph). Moreover, Yu et al. teach that while targeting ER with endocrine therapy is an effective treatment of ER+ breast cancer, resistance to endocrine therapy is a major challenge with a significant portion of ER+ breast cancer treated with endocrine therapies relapse (page 2917, 1st full paragraph). Regarding MYST3-high cells, Yu et al. teach that high levels of MYST3 also predicted worse survival outcomes for ER+/HER2- patients treated with endocrine therapy, wherein targeting MYST3 may be an alternative strategy to treating MYST3-high ER+/HER2- breast cancers in addition to endocrine therapy (page 2917, 1st column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating cancer claimed by the US Patent by adding a MYST3 (KAT6) inhibitor and to treat breast cancer that has acquired resistance to endocrine therapy in view of the teachings of Voss et al. and Yu et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Voss et al. teach MYST3 inhibitors can be combined with antiestrogens;
-Yu et al. teach that overall, compared with hormone therapy targeting ERalpha alone, dual targeting of ERalpha and MYST3 may achieve a better therapeutic effect in MYST3-high ER+/HER2- breast tumors (page 2917, 1st column, 1st full paragraph, last sentence),
- Moreover, Yu et al. teach that while targeting ER with endocrine therapy is an effective treatment of ER+ breast cancer, resistance to endocrine therapy is a major challenge with a significant portion of ER+ breast cancer treated with endocrine therapies relapse.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06).
Conclusion
Therefore, No claim is allowed.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626
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