DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are currently pending in this Application.
Priority
CONTINUING DATA
This application is 371 of PCT/US2022/025378 04/19/2022
Information Disclosure Statement
Applicant’s Information Disclosure Statement, filed on September 18, 2025, has been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O' Shaughnessy et al., "Efficacy and safety of weekly paclitaxel with or without oral alisertib in patients with metastatic breast cancer: a randomized clinical trial," JAMA network open, April, 20, 2021.
The instant claims are directed to a method of treating cancer, comprising: administering to a patient in need thereof therapeutically effective amounts of a combination of alisertib and paclitaxel; wherein the cancer is estrogen receptor-positive and HER2-negative breast cancer and the patient has been treated with a CDK 4/6 inhibitor before being treated with the combination of alisertib and paclitaxel (see O' Shaughnessy et al. Page 2, last two paragraphs).
The prior art anticipates the instant claims as presented below:
Regarding Claim 1, O'Shaughnessy discloses a method of treating cancer comprising: administering to a patient in need thereof therapeutically effective amounts of a combination of alisertib and paclitaxel; wherein the cancer is estrogen receptor-positive and HER2-negative breast cancer and the patient has been treated with a CDK 4/6 inhibitor before being treated with the combination of alisertib and paclitaxel. (see O' Shaughnessy et al. Page 2, last two paragraphs).
Regarding Claim 2, O'Shaughnessy discloses the method of claim 1, further comprising identifying the patient as having an estrogen receptor-positive and ERBB2-negative breast cancer. (unresectable locally recurrent breast cancer that was histologically confirmed as ER-positive, ERBB2-negative invasive breast cancer, Page 3, paragraph 3)
Regarding Claim 3, O'Shaughnessy discloses the method of claim 2, wherein the identifying comprises: obtaining a biological sample containing cells from the patient (unresectable locally recurrent breast cancer that was histologically confirmed as ER-positive, ERBB2-negative invasive breast cancer, Page, 3, Paragraph 3); assaying the sample to determine whether the sample has estrogen receptor expression or over expression of HER2 protein; and based on a result of the assaying, determining that the patient has an estrogen receptor-positive and HER2-negative breast cancer.
Regarding Claim 4, O'Shaughnessy discloses the method of claim 1, wherein paclitaxel (paclitaxel, Page 3, Paragraph 4) is administered intravenously (Patients were randomized to receive paclitaxel 60 mg/m2 intravenously, Page 3, Paragraph 4).
Regarding Claim 5, O'Shaughnessy discloses the method of claim 4, wherein paclitaxel (paclitaxel, Page 3, Paragraph 4) is administered (Patients were randomized to receive paclitaxel, Page 3, Paragraph 4) at a dosage of 60 mg/m 2 on days 1, 8, and 15 of a 28-day cycle (60 mg/m2 intravenously (IV) on days 1, 8, and 15 plus alisertib 40 mg twice daily on days 1 to 3, 8 to 10, and 15 to 17 of a 28-day cycle, Page 3, Paragraph 4).
Regarding Claim 6, O'Shaughnessy discloses the method of claim 1, wherein alisertib (oral alisertib, Page 1, Paragraph 3) is administered orally (participants were randomized to intravenous (IV) paclitaxel plus oral alisertib, Page 1, Paragraph 3).
Regarding Claim 7, O'Shaughnessy discloses the method of claim 6, wherein alisertib (alisertib, Page 3, Paragraph 4) is administered (Patients were randomized to receive, Page 3, Fourth Paragraph) at a dosage of 40 mg twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle (40 mg twice daily on days 1 to 3, 8 to 10, and 15 to 17 of a 28-day cycle, Page 3, Paragraph 4).
Regarding Claim 8, O'Shaughnessy discloses the method of claim 1, wherein the CDK 4/6 inhibitor (palbociclib, Page 5, Paragraph 3; CDK 4/6 inhibitor-resistant, Page 8, Paragraph 4) is palbociclib (In 30 patients who had been previously treated with palbociclib for MBC, Page 5, Paragraph 3), ribociclib, or abemaciclib.
Regarding Claim 9, O'Shaughnessy discloses the method of claim 1, wherein the breast cancer (In 30 patients who had been previously treated with palbociclib for MBC, Page 5, Paragraph 3; 90 patients with ER-positive, ERBB2-negative MBC who had previously undergone endocrine therapy and CDK 4/6 inhibitor treatment, Page 8, Paragraph 4) is resistant to the treatment of a CDK 4/6 inhibitor (The CBR observed with paclitaxel plus alisertib in patients who had been pretreated with palbociclib was 61.5%, Page 5, Paragraph 3; The promising CBR in patients who were CDK 4/6 inhibitor-resistant and receiving alisertib alone corroborates the activity of alisertib seen in the patients who had been pretreated with CDK 4/6 inhibitor in this study, Page 8, Paragraph 4).
Regarding Claim 10, O'Shaughnessy discloses the method of claim 1, wherein the cancer (patients with ER-positive andERBB2-negative or triple-negative metastatic breast cancer (MBC), Page 1, Paragraph 2) is metastatic breast cancer (Patients With Metastatic Breast Cancer, Page 1, Title).
Regarding Claim 11, O'Shaughnessy discloses a method of treating cancer (The combination of paclitaxel with alisertib has also been investigated in a phase 1 study in patients with locally advanced or metastatic ovarian or breast cancer, Page 2, Paragraph 4; phase 2 study, Page 2, Paragraph 5; The primary objective of the study was to demonstrate the superiority of paclitaxel plus alisertib compared with paclitaxel alone in progression-free survival (PFS) in 2 MBC cohorts, Page 2, Fifth Paragraph), comprising: administering to a patient in need thereof (adding alisertib to weekly paclitaxel therapy in patients, Page 2, Paragraph 5; 169 patients received study treatment, Page 1, Paragraph 5) therapeutically effective amounts (assessed the effectiveness and safety, Page 2, Paragraph 5) of a combination of alisertib and paclitaxel (adding alisertib to weekly paclitaxel therapy in patients, Page 2, Paragraph 5); wherein the cancer is triple-negative breast cancer (patients with ER-positive, ERBB2-negative or TN MBC, Page 2, Paragraph 5).
Regarding Claim 12, O'Shaughnessy discloses the method of claim 11, further comprising identifying the patient as having a triple-negative breast cancer (Eligible patients were postmenopausal women aged 18 years or older with metastatic or unresectable locally recurrent breast cancer that was histologically confirmed as ER-positive, ERBB2- negative invasive breast cancer (any progesterone receptor status), with Ki-67 greater than 15% in primary or metastatic tissue, or grade 3 TN MBC, Page 3, Paragraph 3).
Regarding Claim 13, modified O'Shaughnessy discloses the method of claim 12, wherein the identifying comprises: obtaining a biological sample containing cells from the patient (unresectable locally recurrent breast cancer that was histologically confirmed as ER-positive, ERBB2-negative invasive breast cancer, Page, 3, Paragraph 3); assaying the sample to determine whether the sample has estrogen receptor expression, progesterone receptor expression, or over expression of HER2 protein; and based on a result of the assaying, determining that the patient has a triple-negative breast cancer (ERBB2-negative was defined as immunohistochemistry status of 0, 1 or more, or 2 or more. ER-negative and progesterone receptor-negative status was defined as ER and progesterone receptor less than 1% nuclei positive by immunohistochemistry, Page 3, Paragraph 3).
Regarding Claim 14, O'Shaughnessy discloses the method of claim 11, wherein paclitaxel (paclitaxel, Page 3, Paragraph 4) is administered intravenously (Patients were randomized to receive paclitaxel 60 mg/m2 intravenously, Page 3, Paragraph 4).
Regarding Claim 15, O'Shaughnessy discloses the method of claim 14, wherein paclitaxel (paclitaxel, Page 3, Paragraph 4) is administered (Patients were randomized to receive paclitaxel, Page 3, Paragraph 4) at a dosage of 60 mg/m 2 on days 1, 8, and 15 of a 28-day cycle (60 mg/m2 intravenously (IV) on days 1, 8, and 15 plus alisertib 40 mg twice daily on days 1 to 3, 8 to 10, and 15 to 17 of a 28-day cycle, Page 3, Paragraph 4).
Regarding Claim 16, O'Shaughnessy discloses the method of claim 15, wherein alisertib (oral alisertib, Page 1, Paragraph 3) is administered orally (participants were randomized to intravenous (IV) paclitaxel plus oral alisertib, Page 1, Paragraph 3).
Regarding Claim 17, O'Shaughnessy discloses the method of claim 16, wherein alisertib (alisertib, Page 3, Paragraph 4) is administered (Patients were randomized to receive, Page 3, Paragraph 4) at a dosage of 40 mg twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle (40 mg twice daily on days 1 to 3, 8 to 10, and 15 to 17 of a 28-day cycle, Page 3, Paragraph 4).
Regarding Claim 18, O'Shaughnessy discloses the method of claim 11, wherein the combination of alisertib and paclitaxel is an initial treatment to the patient (wherein the patient had not received prior chemotherapy or neo Taxane, Table 1; wherein Paclitaxel plus alisertib group includes 48 individuals (69.6% of the cohort) who had not received prior chemotherapy; and only 29 who also had prior neo or adjuvant taxane, thus wherein at least 19 members of the cohort had neither prior chemotherapy or neo or adjuvant taxane therapy).
Regarding Claim 19, O'Shaughnessy discloses the method of claim 11, wherein the patient (30 patients, Page 5, Paragraph 3) has been treated with a drug (In 30 patients who had been previously treated with palbociclib for MBC, Page 5, Paragraph 3) before being treated with the combination of alisertib and paclitaxel (The CBR observed with paclitaxel plus alisertib in patients who had been pretreated with palbociclib was 61.5% (95% Cl,31.6%-86.1%) vs 37.5% (95% CI, 15.2%-64.6%) in patients who had received paclitaxel alone, Page 5, Paragraph 3).
Regarding Claim 20, O'Shaughnessy discloses the method of claim 11, wherein the cancer (Metastatic Breast Cancer, Page 1, Title) is metastatic breast cancer (triple-negative metastatic breast cancer (MBC), Page 1, Paragraph 2).
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
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/Kamal A Saeed/
Primary Examiner, Art Unit 1626
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