DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/24/26 has been entered.
Claims 1, 2, 4, 13, 15, 16, 18-21, 23, 34-61, and 91 are pending.
Claims 1, 2, 4, 13, 15, and 16 have been amended by Applicant.
Claims 1, 2, 4, 13, 15, 16, 18-21, 23, 34-61, and 91 are currently under consideration.
This Office Action contains New Rejections.
Rejections Withdrawn
All previous rejections are withdrawn, except for (1) the provisional rejection of claims on the ground of nonstatutory double patenting as being unpatentable over claims 14-16 and 19-30 of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); and (2) the provisional rejection of claims on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, 71, 72, and 85-90 of copending Application No. 18/247878 (reference application).
Rejections Maintained
Double Patenting
Claim 1, 2, 4, 13, 15, 16, 18-21, 23, 34-45, 56, 61, and 91 remain 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 with an absence of a recited driver mutation 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 encompassed by the copending claims 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 any NSCLC patient encompassed by the patent claims whose TPS was determined at any time and just any NSCLC patient encompassed by the patent claims 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. Regarding “systemic treatment courses” of claim 45: 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.
Response to Arguments
In the Reply of 3/24/26, Applicant argues the claims are not drawn to obvious variants of overlapping subject matter. Applicant further argues the rejection should be withdrawn because the instant application has an earliest effective filing date and no other rejection remains.
The amendments to the claims and the arguments found in the Reply of 3/24/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the claims are not drawn to obvious variants of overlapping subject matter, the examiner disagrees for the reasons stated above. In regards to the argument the rejection should be withdrawn because the instant application has an earliest effective filing date and no other rejection remains, the examiner disagrees because other rejections remain.
Claims 1, 2, 4, 13, 15, 16, 18-21, 23, 34-45, 56, 61, and 91 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, 71, 72, and 85-90 of copending Application No. 18/247878 (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.
Request
In the Reply of 3/24/26, Applicant requests this rejection be held in abeyance. The request is denied because the Office does not hold rejections in abeyance. Claims remain provisionally rejected.
New Rejections
Double Patenting
Claims 1, 2, 4, 13, 15, 16, 18-21, 23, 34-45, 56, 61, and 91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-10, 12, 14, 17, 31, 33, and 37-39 of copending Application No. 18/555513 (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 (the copending claims have the additional limitation of the administered TILs expressing a CCR).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4, 13, 15, 16, 18-21, 23, 34-45, 56, 61, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12553029 B2 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 patent claims and instant claims are both drawn to methods of administering a therapeutically effective dose of TILs to the same NSCLC patients with an EGFR driver mutation. The patent claims differ from the instant claims in that the instant claims further recite, prior to administration, the TILs are expanded using a method of Wardell et al.
However, one would have been motivated to perform the patented method of administering a therapeutically effective dose of TILs to the NSCLC patient wherein the NSCLC patient is any NSCLC patient encompassed by the patent claims and wherein the administered TILs have been expanded using the method of Wardell et al because the TIL expansion method of Wardell et al is disclosed as an “improved and/or shortened” method of expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs ([0005]-[0012], in particular) and taught to provide therapeutic benefit to patients with NSCLC ([0076], in particular). Such NSCLC patients include any NSCLC patient encompassed by the patent claims whose TPS was determined at any time and just any NSCLC patient encompassed by the patent claims who was administered pembrolizumab of Creelan et al to treat NSCLC at any time. Such NSCLC patients include those 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. Regarding “systemic treatment courses” of claim 45: 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).
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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