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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission dated 10/20/2025 has been entered pursuant to RCE filed on 12/12/2025.
Pursuant to the amendment dated 10/20/2025, claims 1-26 are cancelled and claim 27 was amended. Claims 27-29 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/US2020/060670 filed on 11/16/2020 and claims benefit to provision application 62/935,392 filed on 11/14/2019.
Withdrawn Rejections
Applicant’s amendment, filed on 10/20/2025, with respect to the rejection of claims 27-29 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement has been fully considered and is persuasive. Applicant has amended claim 27 to add the additional limitation of triciribine phosphate which is supported by the specification. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 10/20/2025, with respect to the rejection of claims 27-29 under 35 U.S.C. 103 as being unpatentable over Shinde et al. (WO 2018/236797 A1, published 12/27/2018, see PTO-892 dated 07/16/2025) has been fully considered and is persuasive. Applicant has amended independent claim 27 to add the additional limitation of administering triciribine phosphate which is not taught by Shinde. The rejection is hereby withdrawn.
New Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (WO 2015/160986 A2, published 10/22/2015, see PTO-892), Raimondi (WO 2018/102687 A2, published 06/07/2018, see PTO-892) and Hager et al. (US 20150258080 A1, published 09/17/2015, see PTO-892).
Stern is drawn to pharmaceutical compositions comprising a phosphatidylinositol 3-kinase (PI3K) inhibitor in combination with a second agent wherein the second agent is chosen from one or more of a CDK4/6 inhibitor, 2) an HDAC inhibitor, 3) a MEK inhibitor, 4) a mTOR inhibitor, 5) an AKT inhibitor, 6) a proteasome inhibitor, 7) an immunomodulator, 8) a glucocorticosteroid, 9) a BET inhibitor, 10) an epigenetic inhibitor, 11) a PBK alpha inhibitor, 12) a topoisomerase inhibitor, or 13) an ERK inhibitor. Stern teaches methods of treatment comprising administration of the compositions for treatment of cancer (abstract). The cancer may be hairy cell leukemia or myelogenous leukemia (paragraph 0705). Stern teaches that the additional combinations of three or more agents are encompassed by the methods and compositions (paragraph 0046). Stern teaches that the P13k inhibitor may be Compound 1 which is the structure of duvelisib (paragraph 0032, Figure 1). Stern teaches that the HDAC inhibitor may be CUDC-101 (paragraph 0075).
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Figure 1. Stern’s Compound 1 (paragraph 0032)
Stern does not teach that the Akt protein kinase inhibitor is triciribine phosphate. Stern does not teach that the checkpoint inhibitor is Rabusertib.
Raimondi is drawn to compositions comprising inhibitors of human histone
methyltransferase EZH2, the catalytic subunit of the PRC 2 complex which catalyzes the mono- through tri-methylation of lysine 27 on histone H3 (H3-K27), and one or more other therapeutic agents, particularly anticancer agents, and methods of combination therapy for treating cancer (paragraph 002). Raimondi teaches combination-therapy treatments for cancer have become more common, in part due to the perceived advantage of attacking the disease via multiple avenues (paragraph 003). Raimondi teaches that the one or more second agents may comprise a Checkpoint kinase 1 (CHK1) inhibitor (paragraph 057) and that the CHK1 inhibitor may be LY2603618 (rabusertib) (paragraph 0327). The one or more second agents may comprise a PI3K inhibitor (paragraph 060). The one or more second agents may comprise an HDAC inhibitor (paragraph 0052). Raimondi teaches that the cancer may be Hairy cell leukemia or myelogenous leukemia (paragraph 0426).
Hager teaches therapeutic combinations with estrogen receptor modulators for treating diseases or conditions that are mediated or dependent upon estrogen receptors (abstract).The condition may be cancer (paragraph 0009) and the cancers to be treated may be hairy cell leukemia or myelogenous leukemia (paragraph 0242).Hager teaches that combinations of anti-cancer pharmaceutical therapeutics administered simultaneously or sequentially in a dosing regimen are now common in cancer treatment. Successful combination therapy provides improved and even synergistic effect over mono-therapy, i.e. pharmaceutical treatment limited to one drug (paragraph 0007). Hager teaches a compound that may be used in combination with at least one additional therapeutic agent wherein the at least one additional therapeutic agent is an aromatase inhibitor, a phosphoinositide 3-kinase (PI3K)/mTOR pathway inhibitor, a CDK 4/6 inhibitor, a HER-2 inhibitor, an EGFR inhibitor, a PD-1 inhibitor, poly ADP-ribose polymerase (PARP) inhibitor, a histone deacetylase (HDAC) inhibitor, an HSP90 inhibitor, a VEGFR inhibitor, an AKT inhibitor, chemotherapy, or any combination thereof (paragraph 0028). Hager teaches that the AKT inhibitor may be triciribine phosphate (paragraph 0315). Hagar teaches that the HDAC inhibitor may be CUDC-101. It would have been prima facie obvious to combine Stern, Raimondi, and Hager before the effective filing date of the claimed invention by selecting the checkpoint inhibitor to be rabusertib as taught by Raimondi and selecting the AKT protein kinase inhibitor to be triciribine phosphate as taught by Hager in the composition comprising CUDC-101, duvelisib, an AKT protein kinase inhibitor, and a checkpoint inhibitor to treat hairy cell leukemia or myelogenous leukemia as taught by Stern to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select rabusertib, triciribine phosphate, CUDC-101 and duvelisib for the treatment of hairy cell leukemia or myelogenous leukemia because Stern teaches combining a PI3K inhibitor with one or more of a second agent and that those second agents could be an AKT protein kinase inhibitor, an HDAC inhibitor, and a checkpoint inhibitor wherein the HDAC inhibitor is CUDC-101 and the PI3K inhibitor is Duvelisib for the treatment of cancer that could be hairy cell leukemia or myelogenous leukemia. Further, Raimondi teaches combining rabusertib with additional PI3K inhibitors and HDAC inhibitors for the treatment of cancer that could be hairy cell leukemia or myelogenous leukemia, and Hager teaches combining triciribine phosphate with additional PI3K inhibitors and HDAC inhibitors for the treatment of cancer that could be hairy cell leukemia or myelogenous leukemia. One of ordinary skill in the art would have a reasonable expectation of success because Stern, Raimondi, and Hager teach a combination of agents that may be used to treat hairy cell leukemia or myelogenous leukemia wherein Stern teaches the combination may include a PI3K inhibitor with one or more of a second agent and that those second agents could be an AKT protein kinase inhibitor, an HDAC inhibitor, and a checkpoint inhibitor wherein the HDAC inhibitor is CUDC-101 and the PI3K inhibitor is Duvelisib, Raimondi teaches combining rabusertib with addition inhibitors, and Hager teaches combining triciribine phosphate with additional inhibitors.
Response to Arguments
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claims 27-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693