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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 filed on 8/28/26 has been entered.
Claims 1, 2, 13, 14, 19, 41, 43, 45, 56, 61, 71, 72, 88, and 91-97 are pending.
Claim 1 has been amended by Applicant.
Claims 1, 2, 13, 14, 19, 41, 43, 45, 56, 61, 71, 72, 88, and 91-97 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The following Office Action contains NEW GROUNDS of rejections Necessitated by Amendments.
Rejections Withdrawn
All previous rejections are withdrawn.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 103
Claims 1, 13, 14, 19, 41, 43, 45, 56, 61, 91, and 93-97 are rejected under 35 U.S.C. 103(a) as being unpatentable over Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331) in view of Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), and Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054).
Creelan et al teaches a method of therapeutically treating subjects with NSCLC that have received anti-PD-1 antibody (nivolumab) therapy followed by treatment comprising lymphodepletion with the chemotherapeutics cyclophosphamide and fludarabine (Cy/Flu) and adoptive transfer of a population of tumor infiltrating lymphocytes (TILs) (Background, Method, and Figure, in particular). Creelan et al gives no indication the TILs have been modified to express any CAR. Creelan et al does not indicate the subjects are indicated for treatment by the inhibitors of instant claim 13. Subjects of Creelan et al include those with low or no expression of PD-L1, including those having a PD-L1 TPS of less than 1% (Figure, in particular). Subjects of Creelan et al include those that are refractory to nivolumab administered prior to TILs (Figure, in particular). Subjects of Creelan et al include those with NSCLC that have been analyzed for the presence or absence of driver mutations (including those of P53), where the driver mutations are absent (Figure).
Creelan et al does not specifically describe anti-PD-1 antibody therapy as systemic. Further, Creelan et al does not describe the lymphodepleting chemotherapeutics as being systemically administered or being administered before the TILs. Further, Creelan et al does not describe the subjects with NSCLC as having adenocarcinoma, wherein the subjects have been treated with and/or are refractory or resistant to a chemotherapeutic agent such as a platinum-based doublet chemotherapy or that the subjects have been treated with and/or is resistant to a VEGF-A inhibitor such as bevacizumab. Further, Creelan et al does not describe the subjects as having “bulky disease”. Further, Creelan et al does not describe achieving a partial response or complete response “per RECIST v1.1”. However, these deficiencies are made up in the teachings of Sepesi et al, Rizvi et al, Zhang et al, and Samejima et al.
Sepesi et al teaches lymphodepleting subjects by administering cyclophosphamide and fludarabine (Cy/Flu) decreases regulatory T cells and myeloid-derived suppressor cells and provides homeostatic growth stimulus to adoptively transferred TILs prior to administering the TILs to enables dramatic increase and persistence of transferred cells in vivo, along with enhanced TIL antitumor activity (page 562, in particular).
Rizvi et al teaches therapeutically treating NSCLC patients (including adenocarcinoma and squamous cell NSCLC patients) by systemically administering a checkpoint inhibitor (anti- PD-1 nivolumab) and the platinum-based doublet chemotherapy (Abstract and page 2970, in particular). Rizvi et al further teaches 48% of the NSCLC patients have less than 1% tumor PD-L1 expression (right column on page 2974 and Table S12, in particular). Rizvi et al further teaches bevacizumab (VEGF-A inhibitor) and maintenance chemotherapies have shown to provide therapeutic benefit to subjects with NSCLC; however, progression and resistance to chemotherapeutic agents invariably develops (left column on page 2970, in particular). Zhang et al teaches chemotherapy as “the main treatment modality” for NSCLC patients and that chemotherapy with a platinum-based doublet is the standard of care for patients with advanced NSCLC (page 1417, in particular). Zhang et al further teaches NSCLC patients can be refractory to chemotherapy (left column on page 1421, in particular). Zhang et al further teaches the VEGF-A inhibitor bevacizumab has been approved for advanced NSCLC, but clinical benefits are modest and all patients eventually develop resistance (Abstract, in particular).
Samejima et al teaches NSCLC patients can have "bulky" or "non-bulky" disease, wherein bulky disease is determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method comprising treating just any subjects with NSCLC (including those that have NSCLC adenocarcinoma or NSCLC squamous cell carcinoma of Rizvi et al with characteristics of Creelan et al and/or characteristics of Rizvi et al and/or Zhang et al that have been treated with chemotherapy, such as platinum-based doublet chemotherapy, and/or bevacizumab and eventually become refractory or resistant to the chemotherapy and/or bevacizumab; including those with “bulky” disease of Samejima et al) by administering to the subjects the treatment of Creelan et al wherein the subjects are systemically administered both the nivolumab and the lymphocyte-depleting chemotherapeutics prior to administering the TILs because (I) Rizvi et al teaches nivolumab is systemically administered to subjects with NSCLC and (ii) administration of the lymphocyte-depleting chemotherapeutics is taught by Sepesi et al to decrease regulatory T cells and myeloid-derived suppressor cells and provide homeostatic growth stimulus to adoptively transferred TILs prior to administering the TILs in an effort to enable dramatic increase and persistence of transferred cells in vivo, along with enhanced TIL antitumor activity (page 562, in particular) and systemic administration of the lymphocyte-depleting chemotherapeutics would have the benefit of decreasing regulatory T cells and myeloid-derived suppressor cells throughout the bodies of the subjects prior to administering the TILs of Creelan et al. This is an example of 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. See MPEP 2143.
Further, said combined method would result in a partial response or complete response per RECIST v1.1 (as recited by instant claim 1) with a reasonable predictability of success because the combined method provides therapeutic benefit and administers reagents encompassed by the instant claims to patients recited by instant claims and responses of NSCLC patients to therapies are determined by RECIST v1.1 (Abstract of Rizvi et al, in particular).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1, 2, 13, 14, 19, 41, 43, 45, 56, 61, 71, 72, 88, and 91-97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331) in view of Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), and Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054) as applied to claims 1, 13, 14, 19, 41, 43, 45, 56, 61, 91, and 93-97 above, and further in view of Wardell et al (US 2018/0207201 A1; 7/26/2018).
Teachings of Creelan et al, Sepesi et al, Rizvi et al, Zhang et al, and Samejima et al are discussed above.
Creelan et al, Sepesi et al, Rizvi et al, Zhang et al, and Samejima et al do not specifically teach administered TILs are processed as recited by instant claims. However, these deficiencies are made up in the teachings of Wardell et al.
Wardell et al teaches an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs comprising performing a method comprising obtaining a first population of TILs from a tumor resected from a patient by processing a tumor sample from the patient into multiple tumor fragments, adding the first population of TILs to a closed container/system, performing a first expansion (same as “priming first expansion”) by culturing the first population of in a cell culture medium comprising IL-2 (including 6000 IU/mL IL-2 – see [0332] and [0334]) for 3-14 days and providing a first gas-permeable surface area to produce a second population of TILs in the closed container/system wherein the second population is at least 50-fold greater in number than the first population of TILs, performing a second expansion (same as “rapid expansion”) by supplementing the cell culture medium of the second population of TILs with additional IL-2, OKT-3 (20 ng/ml – see [0354]) and optionally IL-15 and/or IL-21 (see [0023]), and APCs, for about 7-14 days and providing a second gas-permeable surface area to produce a therapeutic third population of TILs in the closed container/system, harvesting the therapeutic third population of TILs without opening the system/container, transferring the harvested TILs to an infusion bag in the closed container/system ([0005]-[0012], in particular). Wardell et al further teaches said method wherein the infusion bag is cryopreserved ([0013], in particular). Wardell et al further teaches said method wherein the steps from obtaining to cryopreserving is performing 10 to 22 days ([0031]-[0032], in particular). Wardell et al further teaches said method wherein the patient has cancer and the patient is treated by administering a therapeutically effective dosage of the therapeutic third population of TILs from the infusion bag to the patient ([0062], in particular). Wardell et al further teaches said method wherein the cancer is NSCLC ([0076], in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said combined method wherein, prior to administration of the TILs, the TILs are expanded by the method of Wardell et al into a therapeutic population of TILs because the method of Wardell et al is taught to be an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs ([0005], in particular), and is taught to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). This is an example of 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. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Double Patenting
Claims 1, 2, 13, 14, 19, 41, 43, 45, 56, 61, 71, 72, 88, and 91-97 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-14 of U.S. Patent No. 10166257 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-14 and 18-22 of U.S. Patent No. 10272113 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-14, 18, 20, and 21 of U.S. Patent No. 10463697 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-14 and 18-22 of U.S. Patent No. 10646517 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-21, 25, and 27-29 of U.S. Patent No. 11007225 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-29 of U.S. Patent No. 11939596 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-14, 18, and 20-24 of U.S. Patent No. 11013770 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-20 of U.S. Patent No. 11083752 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-16 and 18-20 of U.S. Patent No. 11202804 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-16 and 18-20 of U.S. Patent No. 11241456 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-15 and 17-19 of U.S. Patent No. 11273181 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-22 of U.S. Patent No. 11529372 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-21, 23, and 24 of U.S. Patent No. 11541077 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-17 and 19-23 of U.S. Patent No. 11998568 B2 view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-35 of U.S. Patent No. 12121541 B2 view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-20 of U.S. Patent No. 11266694 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-20 of U.S. Patent No. 11311578 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-20 of U.S. Patent No. 11344581 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-20 of U.S. Patent No. 11351199 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-25 of U.S. Patent No. 11364266 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-25 of U.S. Patent No. 11369637 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-30 of U.S. Patent No. 12570959 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Allowed claims 1,2, 8, 9, 12-14, 16, 24, 32, 34, 36-38, 41-45, and 52 of Application No. 16/969362 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018); and
Claims 1-27 of U.S. Patent No. 12642268 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims of the patents and the instant claims are both drawn to methods of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of the expanded TILs to the NSCLC patient. The instant claims differ from the claims of the patents in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims.
However, of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method comprising treating just any subjects with NSCLC (including those that have NSCLC adenocarcinoma or NSCLC squamous cell carcinoma of Rizvi et al with characteristics of Creelan et al and/or characteristics of Rizvi et al and/or Zhang et al that have been treated with chemotherapy, such as platinum-based doublet chemotherapy, and/or bevacizumab and eventually become refractory or resistant to the chemotherapy and/or bevacizumab; including those with “bulky” disease of Samejima et al) by administering to the subjects the treatment of Creelan et al comprising TILs of the patent claims wherein the subjects are systemically administered both the nivolumab and the lymphocyte-depleting chemotherapeutics prior to administering the TILs because (I) Rizvi et al teaches nivolumab is systemically administered to subjects with NSCLC and (ii) administration of the lymphocyte-depleting chemotherapeutics is taught by Sepesi et al to decrease regulatory T cells and myeloid-derived suppressor cells and provide homeostatic growth stimulus to adoptively transferred TILs prior to administering the TILs in an effort to enable dramatic increase and persistence of transferred cells in vivo, along with enhanced TIL antitumor activity (page 562, in particular) and systemic administration of the lymphocyte-depleting chemotherapeutics would have the benefit of decreasing regulatory T cells and myeloid-derived suppressor cells throughout the bodies of the subjects prior to administering the TILs of Creelan et al.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said combined method wherein, prior to administration of the TILs, the TILs are expanded by the method of Wardell et al into a therapeutic population of TILs because the method of Wardell et al is taught to be an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs ([0005], in particular), and is taught to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). This
Further, said combined method would result in a partial response or complete response per RECIST v1.1 (as recited by instant claim 1) with a reasonable predictability of success because the combined method provides therapeutic benefit and administers reagents encompassed by the instant claims to patients recited by instant claims and responses of NSCLC patients to therapies are determined by RECIST v1.1 (Abstract of Rizvi et al, in particular).
Double Patenting
Claims 1, 2, 13, 14, 19, 41, 43, 45, 56, 61, 71, 72, 88, and 91-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 14-16 and 19-31 of copending Application No. 18/886988 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 14-16 of copending Application No. 18/661510 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1, 2, 7, 13, 14, 19, 20, 27-29, 30, 38, 46, 48, 50, 57, 84, 94, 106, and 112 of copending Application No. 18/858710 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-18 of copending Application No. 18/707719 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-5, 8, 9, 13, 15, 16, 46, 59, 69, 112-116, 119, 120, and 141 of copending Application No. 18/291536 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 162-178 of copending Application No. 18/256421 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1, 7-15, 17, and 19-22 of copending Application No. 17/829087 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims 1-20, 22, and 24 of copending Application No. 19/011427 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018); and
Claims 1, 2, 4, 13, 15, 16, 18-21, 23, 34-45, 56, 61, and 91 of of copending Application No. 18/247877 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13 (10 supplement): S330-S331), Sepesi et al (Surg Oncol Clin N Am, 2020, 555-569), Rizvi et al (J Clin Oncol, 2016, 34: 2969-2979), Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426), Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054), and Wardell et al (US 2018/0207201 A1; 7/26/2018);
Claims of copending applications and the instant claims are both drawn to methods of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of the expanded TILs to the NSCLC patient. The instant claims differ from the claims of the copending applications in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims.
However, of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method comprising treating just any subjects with NSCLC (including those that have NSCLC adenocarcinoma or NSCLC squamous cell carcinoma of Rizvi et al with characteristics of Creelan et al and/or characteristics of Rizvi et al and/or Zhang et al that have been treated with chemotherapy, such as platinum-based doublet chemotherapy, and/or bevacizumab and eventually become refractory or resistant to the chemotherapy and/or bevacizumab; including those with “bulky” disease of Samejima et al) by administering to the subjects the treatment of Creelan et al comprising TILs of the copending claims wherein the subjects are systemically administered both the nivolumab and the lymphocyte-depleting chemotherapeutics prior to administering the TILs because (I) Rizvi et al teaches nivolumab is systemically administered to subjects with NSCLC and (ii) administration of the lymphocyte-depleting chemotherapeutics is taught by Sepesi et al to decrease regulatory T cells and myeloid-derived suppressor cells and provide homeostatic growth stimulus to adoptively transferred TILs prior to administering the TILs in an effort to enable dramatic increase and persistence of transferred cells in vivo, along with enhanced TIL antitumor activity (page 562, in particular) and systemic administration of the lymphocyte-depleting chemotherapeutics would have the benefit of decreasing regulatory T cells and myeloid-derived suppressor cells throughout the bodies of the subjects prior to administering the TILs of Creelan et al.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said combined method wherein, prior to administration of the TILs, the TILs are expanded by the method of Wardell et al into a therapeutic population of TILs because the method of Wardell et al is taught to be an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs ([0005], in particular), and is taught to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). This
Further, said combined method would result in a partial response or complete response per RECIST v1.1 (as recited by instant claim 1) with a reasonable predictability of success because the combined method provides therapeutic benefit and administers reagents encompassed by the instant claims to patients recited by instant claims and responses of NSCLC patients to therapies are determined by RECIST v1.1 (Abstract of Rizvi et al, in particular).
This is a provisional nonstatutory double patenting rejection.
Conclusion
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