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 amendment filed on 9/02/2026 is acknowledged and has been entered. Claims 1-4, 8-16, 21-22 and 24-26 are currently pending and under consideration.
Rejections Withdrawn:
The rejection of Claims 8-9, 24 and 30-31 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicants arguments.
The rejection of Claim(s) 1-5, 14-16, 21-23, 25-27 and 36-38 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 (Oncogene 2017; 36: 2910-2918, IDS) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 8-9, 11-13, 24, 30-31 and 33-35 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 (Cells 2019; 8: 321) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 6-7, 23 and 28-29 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 (US Patent 12,371,425, 2025-07-29) is withdrawn in view of Applicants statement of common ownership exception.
The rejection of Claim(s) 9-10, 24 and 31-32 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 (US Patent 11,220,494B2, 2022-01-11) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1-10, 14-16, 21-24, 26-32 and 36-38 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 (US Patent 11,220,494B2, 2022-01-11) is withdrawn in view of Applicants statement of common ownership exception.
The rejection of Claim(s) 1, 3-9, 11-13, 16, 21-24, 26-31, 33-35 and 38 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) is withdrawn in view of Applicants statement of common ownership exception.
The rejection of Claim(s) 1-5, 9-10, 14-16, 21-24, 25-27, 31-32 and 36-38 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) is withdrawn in view of Applicants amendments.
Rejections Maintained, but amended in view of Applicants amendments:
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) 1-4, 14-16, 21-22 and 25-26 remain 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).
In response to this rejection, Applicants contend that the office action point to the teachings of Voss, paragraphs [0116] and [0118], as teaching the combination of its MOZ inhibitors with additional anti-cancer agents, including antiestrogens, but Voss’ complete disclosure of additional agents is in paragraphs [0117]-[0125]. Applicants contend that this teaching represents a laundry list of dozens of categories of anti-cancer agents and absent impermissible hindsight, one of ordinary skill would not have been motivated specifically to identify antiestrogens from amongst the numerous options. Regarding the teachings of Vu et al., Applicants contend that while Yumay provide information about the mechanism by which MYST3 inhibitors treat breast cancer, this information add nothing to claims 1-4 of Bozikis. Moreover, Applicants contend that the final sentence of Yu speculating that “dual targeting of ERalpha and MYST3 may achieve a better therapeutic effect in MYST3-high ER+/HER2- breast tumors,” would not have been sufficient to provide one of ordinary skill with a reasonable expectation of success in achieving the methods of independent claims 1 and 2.
These arguments have been carefully considered, but are not found persuasive.
In response to Applicants arguments, the Examiner acknowledges and the complete listing of additional agents of Voss is pretty expansive. However, these do appear to be known anti-cancer agents. Moreover, it appears that the majority of Applicants arguments are at the references individually. However, the Examiner recognizes that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As noted above, while Voss discloses numerous additional agents, Voss specifically teaches antiestrogens such as tamoxifen or fulvestrant. Yu teaches 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. Thus, Yu provides a suggestion to specifically select antiestrogen therapy from Voss for combination with MYST3. Applicants are reminded that “Obviousness does not require absolute predictability, but at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976)” See MPEP 2143.02 (II).
8-16, 21-22 and 24-26
Claim 8-9, 11-13, 24 remain 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 1-4, 14-16, 21-22 and 25-26 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).
In response to this rejection, Applicants contend that claim 1 is amended to incorporate the subject matter of dependent claim 7, which was not subject to the rejection.
These arguments have been carefully considered, but are not found persuasive.
In response to Applicants arguments, previous claim 7 was included in this rejection and therefore, the rejection is maintained.
Claim(s) 1, 4, 8-10, 14-16, 21-22, 24 and 26 remain 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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, 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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.
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 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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, 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).
In response to this rejection, Applicants contend that while Chen is cited by the office action as claiming a method of treating cancer, including ER+/HER2- breast cancer, comprising administering a CDK4 inhibitor, including a specific CDK4 inhibitor, the office action also cites Chen as administration of additional anti-cancer agents which represents a laundry list of additional anti-cancer agents including antiestrogens. Thus, Applicants assert that absent impermissible hindsight, one of ordinary skill would not have been motivated to combine with a CDK4 inhibitor any particular anticancer agent from amongst these numerous options, let alone an inhibitor of KAT6/MOZ/MYST3, which is not even mentioned in Chen.
These arguments have been carefully considered, but are not found persuasive.
As noted above, US Patent No. 12,371,425 claims a method of treating breast cancer comprising administering a compound
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, wherein the cancer is ER+ HER2-breast cancer. Chen teaches 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. Thus, both compounds have been taught to be useful for treating ER+/HER2- breast cancer. "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).
In addition to the arguments set forth above, Applicants also note that the Office action notes that “similar analysis can be made using US Patent 11,220,494 as the conflicting patent”, but the office action contains no rejection over the ‘494 patent claims. Moreover, Applicants contend that Chen does not claim administration of a CDK4 inhibitor in combination with an inhibitor of KAT6/MOZ/MYST3.
These arguments have been carefully considered, but are not found persuasive.
As noted above, each US patent claims “a” compound taught to be useful for treating ER+/HER2- breast cancer. "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). Thus, while the Examiner has not specifically rejected the above claims on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of Chen et al. (US Patent 11,220,494B2, 2022-01-11) in view of U.S. Patent No. 12,371,425, the rationale is the same, e.g. combining 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....
Conclusion
Therefore, No claim is allowed.
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 BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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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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