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, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, 71, 72, and 85-90 are pending and currently under consideration.
Claim Objections
Claim 19 is objected to because of an apparent typographical issue. The word “or” appears to be missing before “v.” Proper correction is required.
Claim 45 is objected to because of apparent typographical issues. At step “v.,” instance of “CTLA -4” should be replaced with “CTLA-4.” Proper correction is required.
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 56, 61, 71, 72, and 85-87 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 claim 56, the phrase "including for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 61 recites instance of “the first cell culture medium,” “the second cell culture medium,” “the initial expansion,” “the rapid expansion,” and “the third population of TILs.” There is insufficient antecedent basis for “the first cell culture medium,” “the second cell culture medium,” “the initial expansion,” “the rapid expansion,” and “the third population of TILs” in the claim.
Claim 71 recites “the first cell culture medium.” There is insufficient antecedent basis for “the first cell culture medium” in the claim.
Claim 72 recites “the OKT-3 antibody” and “the second cell culture medium.” There is insufficient antecedent basis for “the OKT-3 antibody” and “the second cell culture medium” in the claim.
Claims 85 is rejected because claim 85 recites “The method of any one of claim 7,….” Claim 7 is cancelled. The metes and bounds off claim 85 are unclear because (i) it is unclear what is meant by a method of “any one of” a single claim and (ii) it is unclear which method claim 85 is further limiting.
Claims 86-87 are rejected for reciting “The method of claim 7, wherein…” Claim 7 is cancelled. The metes-and-bounds of claims 86-87 are unclear because it is unclear which method claims 86-87 are further limiting.
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.
Claim(s) 1, 13, 14, and 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331).
Creelan et al teaches a method of therapeutically treating NSCLC by administering a population of tumor infiltrating lymphocytes (TILs) to subjects that have previously been treated with anti-PD1 antibody nivolumab, wherein the subjects have a median tumor proportion score (TPS) of 0% (see Result and Pts 02, 03, 05, 06, 08, and 12 “PD-L1 TPS” of Figure, in particular), resulting in a reduction in target lesions. Several of the subjects have a TPS score of between 1 and 49% (see Pts 07, 09, and 10 “PD-L1 TPS” of Figure), and several subjects lack driver oncogenes (see “Wild-type” TP53 status of Pts 01, 02, 03, 05, and 09 of Figure). Creelan et al does not indicate NSCLCs of the subjects are indicated for treatment by all the inhibitors of instant claim 13. Regarding instant claim 45, Pts 01, 02, 04, 05, 07, 10, 11, and 12 of Creelan could be described as refractory or resistant to treatment with nivolumab (Figure).
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 1, 2, 4, 13, 14, 45, and 88-90 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wardell et al (US 2018/0207201 A1; 7/26/2018) in view of by Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331).
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 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, 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).
Wardell et al does not specifically teach recited characteristics of patients with NSCLC. However, these deficiencies are made up in the teachings of Creelan et al.
Creelan et al teaches a method of therapeutically treating NSCLC by administering a population of tumor infiltrating lymphocytes (TILs) to subjects that have previously been treated with anti-PD1 antibody nivolumab, wherein the subjects have a median tumor proportion score (TPS) of 0% (see Result and Pts 02, 03, 05, 06, 08, and 12 “PD-L1 TPS” of Figure, in particular), resulting in a reduction in target lesions. Several of the subjects have a TPS score of between 1 and 49% (see Pts 07, 09, and 10 “PD-L1 TPS” of Figure), and several subjects lack driver oncogenes (see “Wild-type” TP53 status of Pts 01, 02, 03, 05, and 09 of Figure). Creelan et al does not indicate NSCLCs of the subjects are indicated for treatment by all the inhibitors of instant claim 13. Pt 02 of Creelan has a TPS score of 0% and lacks a TP53 driver oncogene (Figure). A patient lacking driver oncogenes is equivalent to a patient that has “a predetermined absence of one of more driver mutations.” Pts 01, 02, 04, 05, 07, 10, 11, and 12 of Creelan could be described as refractory or resistant to treatment with nivolumab (Figure). Patients of Creelan et al are administered the NSCLC therapeutic pembrolizumab (see Method and Figure 1, 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 the method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient of Wardell et al into a therapeutic population of TILs and treat the NSCLC patient by administering a therapeutically effective dose of the expanded TILs to the patient, as taught by Wardell et al, wherein the patient with NSCLC is any patient with NSCLC 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 taught to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. 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, 4, 13, 14, 19, 43, 45, 56, 61, and 88-90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wardell et al (US 2018/0207201 A1; 7/26/2018) and Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331) as applied to claims 1, 2, 4, 13, 14, 45, and 88-90 above, and further in view of Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426).
Teachings of Wardell et al and Creelan et al are discussed above.
Wardell et al and Creelan et al do not specifically teach NSCLC patients treated with and/or resistant or refractory to VEGF-A inhibitors and/or chemotherapeutics. However, these deficiencies are made up in the teachings of Zhang et al.
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 from advanced NSCLC, but clinical benefits are modest and all patients eventually develop resistance (Abstract, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of Wardell et al and Creelan et al comprising the method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient of Wardell et al and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient 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 taught to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. 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, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 88-90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), and Zhang et al (Expert Opinion on Investigational Drugs, 2012, 21(9): 1417-1426) as applied to claims 1, 2, 4, 13, 14, 19, 43, 45, 56, 61, and 88-90 above, and further in view of Samejima et al (Japanese Journal of Clinical Oncology, 2015, 45(11): 1050-1054).
Teachings of Wardell et al, Creelan et al, and Zhang et al are discussed above.
Wardell et al, Creelan et al, and Zhang et al do not specifically comment on the NSCLC patients as having “bulky disease” at baseline. However, these deficiencies are made up in the teachings of Samejima et al.
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 the combined method of Wardell et al, Creelan et al, and Zhang et al comprising the method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient of Wardell et al and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient 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 taught to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima 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.
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.
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 18 of U.S. Patent No. 10166257 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-11 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 10-12 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 24-26 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 21-23 of column 5 and line 15 of column 6, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 19-23 of U.S. Patent No. 11998568 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 12121541 B2 in view of Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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), 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). The patent claims 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 patent claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the patent claims. However, one would have been motivated to perform the patented method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the patent method is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see lines 8-10 at column 2 of the patent, in particular) and taught to provide therapeutic benefit to patients with NSCLC (lines 7-9 and 67 of column 5, in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-16 and 19-30 of copending Application No. 18/886988 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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. While copending claims are directed to species of some instant claims, some instant claims differ from the copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-16 and 19-30 of copending Application No. 18/661510 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite the steps of expanding TILs are performed in a “closed” system/container and the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the expansion is performed, as described by Wardell et al, in a “closed” system/container and the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al in a closed system/container as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 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 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/707719 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 9, 13, 15, 16, 46, 59, 69, 112-116, 119, 120, and 141 of copending Application No. 18/291536 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 and 28-30 of copending Application No. 17/823454 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 162-168 of copending Application No. 18/256421 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7, 13, 15, 16, 18-21, 23, 34-45, 56, and 61 of copending Application No. 18/247877 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because pending claims are directed to species of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-15, 17, and 19-22 of copending Application No. 17/829087 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28, 31-41, 125, 126, and 128-131 of copending Application No. 17/271601 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 65, 68-76, and 82-98 of copending Application No. 17/050552 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,2, 8, 9, 12-14, 16, 24, 32, 34, 36-38, 41-45, and 52 of copending Application No. 16/969362 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, and 89-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 19/011427 (reference application) in view of Wardell et al (US 2018/0207201 A1; 7/26/2018), Creelan et al (Journal of Thoracic Oncology, 2018, 13(10 supplement): S330-S331), 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). The copending claims 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 copending claims in that the instant claims recite various characteristics of the NSCLC patient not recited by the copending claims. However, one would have been motivated to perform the copending method of expanding tumor infiltrating lymphocytes (TILs) from an NSCLC patient and administering a therapeutically effective dose of expanded TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient because the copending method is of expanding TIL is taught by Wardell et al as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs (see [0005]) and administering said TILs is taught by Wardell et al to provide therapeutic benefit to patients with NSCLC ([0062] and [0076], in particular). Such NSCLC patients include those Creelan et al teaches treating with TILs and just any NSCLC patient whose TPS was determined at any time and just any NSCLC patient who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those NSCLC patients administered treatments of Creelan et al and/or treatments comprising VEGF-A inhibitor bevacizumab and/or platinum-based doublet of Zhang et al at any time point and NSCLC patients of Zhang et al refractory or resistant to such treatments. Pembrolizumab of Creelan et al, bevacizumab of Zhang et al, and platinum-based doublet therapy of Zhang et al are all systemic treatment courses. Such NSCLC patients include those NSCLC patients with “bulky” disease at any time point, as determined as swollen lymph nodes with short-axis diameter ≥20 mm (Abstract of Samejima et al, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E AEDER whose telephone number is (571)272-8787. The examiner can normally be reached M-F 9am-6pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN E AEDER/Primary Examiner, Art Unit 1642