Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 285-304 have an effective filing date of 28 APR 2020. Information Disclosure Statement The information disclosure statements (IDS) submitted on 06/12/2023 and 07/14/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Status of Claims Claims 285-304 are currently pending and presented for examination on the merits. Claims 285-304 are new. Claims 1-284 are canceled. 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. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims FILLIN "Pluralize claim, if necessary, and then insert the claim number(s) which is/are under rejection." \d "[ 1 ]" 285-304 are rejected under 35 U.S.C. 103 as being unpatentable over FILLIN "Insert the prior art reference(s) relied upon for the obviousness rejection." \d "[ 2 ]" Cummings et al (WO2019018757 A1, IDS 6/12/2023) . In regards to claim 285, Cummings et al teaches method of treating cancer [Abstract]. Cummings et al further teaches lung cancer [Line 11, pg. 9]. Cummings et al further teaches non-small cell lung cancer (NSCLC) [Line 3, pg. 108]. Cummings et al further teaches treatments including an immune checkpoint inhibitor of PD-L1 [Abstract]. Cummings et al further teaches the anti-PD-L1 antibody atezolizumab [Line 30, pg. 9]. Cummings et al further teaches the OAK and POPLAR BEP (biomarker-evaluable population) that separate patients by EGFR and ALK mutations or without mutations [Lines 30-36, pg. 133]. Cummings et al further teaches identifying bTMB score from blood samples from patients [Lines 38-39, pg. 134]. Cummings et al further teaches treating patients with bTMB scores above and below a score of 16 [Fig. 5C]. Cummings et al further teaches the tumor expression level of PD-L1 is from 5% to less than 50% of the tumor cells [Lines 29-31, pg. 8]. Cummings et al further teaches the expression level of PD-L1 in tumor-infiltrating immune cells comprise 10% or more of the tumor sample [Lines 4-6, pg. 9]. One of ordinary skill, before the effective filing date, would have been motivated to combine Cumming’s methods for a method of treating metastatic NSCLC comprising administering atezolizumab, does not have sensitizing mutations in a g e ne encoding EGFR or ALK, wherein the bTMB score is >16, in a human from a sample with detectable PD-L1 expression levels of 50% or more and/or PD-L1 expression level of 10% or more in tumor-infiltrating immune cells. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to use Cumming’s teachings for a methods of treating metastatic NSCLC in a human that does not have sensitizing mutations in a gene encoding EGFR or ALK, wherein the bTMB score is >16, in a human from a sample with detectable PD-L1 expression levels of 50% or more and/or PD-L1 expression level of 10% or more in tumor-infiltrating immune cells, because Cummings teaches all aspects of the claim. In regards to claim 286, Cummings et al teaches the blood sample is whole blood, a plasma sample, a serum sample, or a combination thereof [Lines 7-9, pg. 9]. In regards to claim 287, Cummings et al teaches the bTMB score is somatic mutations counted over a defined number of sequenced bases [Lines 20-21, pg. 3]. Cummings et al further teaches the defined number of sequenced bases is from 100kb to 10Mb [Lines 20-21, pg. 3]. In regards to claim 288, Cummings et al teaches the number of somatic mutations is the number of single nucleotide variants (SNVs) counted or a sum of the number of SNVs and the number of indel mutations counted [Lines 35-37, pg. 3]. In regards to claim 289, Cummings et al teaches PFS extended compared to administration of platinum-based chemotherapy without atezolizumab [Line 6, pg. 64]. In regards to claim s 290 -291 , Cummings et al teaches treating metastatic NSCLC [Line 37, pg. 84]. Cummings et al further teaches the treatment comprising cisplati n or carboplatin + gemcitabine for squamous histology [Table 19, pg. 159]. In regards to claim s 29 2-293 , Cummings et al teaches the treatment comprising of cisplatin or carboplatin + pemetrexed for non-squamous histology [Table 19, pg. 159]. In regards to claim 294, Cummings et al teaches the subject receiving up to 6 doses of the anti-PD-L1 antibody [Line 39, pg. 90]. In regards to claim s 295 -296 , Cummings et al teaches administering the treatment q3w or once every 3 weeks [Line 18, pg. 91]. In regards to claim s 29 7 , 302, and 304 , Cummings et al teaches administering the treatment intravenously at 1200 mg q3w [Line 17, pg. 91]. In regards to claim 298, Cummings et al teaches administering the treatment as a monotherapy [Line 40, pg. 91]. In regards to claim 299, Cummings et al teaches the patient has not received prior treatment for cancer [Line 22, pg. 100]. In regards to claim 300, Cummings et al teaches measuring the expression level of PD-L1 using immunohistochemistry [Line 9, pg. 104]. In regards to claim 301, Cummings et al teaches method of treating cancer [Abstract]. Cummings et al further teaches lung cancer [Line 11, pg. 9]. Cummings et al further teaches non-small cell lung cancer (NSCLC) [Line 3, pg. 108]. Cummings et al further teaches treatments including an immune checkpoint inhibitor of PD-L1 [Abstract]. Cummings et al further teaches the anti-PD-L1 antibody atezolizumab [Line 30, pg. 9]. Cummings et al further teaches the OAK and POPLAR BEP (biomarker-evaluable population) that separate patients by EGFR and ALK mutations or without mutations [Lines 30-36, pg. 133]. Cummings et al further teaches identifying bTMB score from blood samples from patients [Lines 38-39, pg. 134]. Cummings et al further teaches treating patients with bTMB scores above and below a score of 16 [Fig. 5C]. Cummings et al further teaches the tumor expression level of PD-L1 is from 5% to less than 50% of the tumor cells [Lines 29-31, pg. 8]. Cummings et al further teaches the expression level of PD-L1 in tumor-infiltrating immune cells comprise 10% or more of the tumor sample [Lines 4-6, pg. 9]. Cummings et al further teaches the treatment comprising cisplatin or carboplatin + gemcitabine for squamous histology [Table 19, pg. 159]. In regards to claim 303, Cummings et al teaches method of treating cancer [Abstract]. Cummings et al further teaches lung cancer [Line 11, pg. 9]. Cummings et al further teaches non-small cell lung cancer (NSCLC) [Line 3, pg. 108]. Cummings et al further teaches treatments including an immune checkpoint inhibitor of PD-L1 [Abstract]. Cummings et al further teaches the anti-PD-L1 antibody atezolizumab [Line 30, pg. 9]. Cummings et al further teaches the OAK and POPLAR BEP (biomarker-evaluable population) that separate patients by EGFR and ALK mutations or without mutations [Lines 30-36, pg. 133]. Cummings et al further teaches identifying bTMB score from blood samples from patients [Lines 38-39, pg. 134]. Cummings et al further teaches treating patients with bTMB scores above and below a score of 16 [Fig. 5C]. Cummings et al further teaches the tumor expression level of PD-L1 is from 5% to less than 50% of the tumor cells [Lines 29-31, pg. 8]. Cummings et al further teaches the expression level of PD-L1 in tumor-infiltrating immune cells comprise 10% or more of the tumor sample [Lines 4-6, pg. 9]. Cummings et al teaches the treatment comprising of cisplatin or carboplatin + pemetrexed for non-squamous histology [Table 19, pg. 159]. 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 . Claim FILLIN "Pluralize \“Claim\” if necessary, insert \“is\” or \“are\” as appropriate, and insert the claim number(s) which are under rejection." s 285-304 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claim FILLIN "Pluralize \“Claim\” if necessary, and insert the claim number(s) of the U.S. Patent." s 1, 5, and 11-13 of U.S. Patent No. FILLIN "Insert the number of the primary reference patent." 11674962 ('962) in view of FILLIN "Insert the secondary reference." Cummings et al (WO2019018757 A1, IDS 6/12/2023) . The teachings of Cummings et al are discussed above. Claims 285, 287, 289 are directed to an invention not patentably distinct from claim 1 o f patent ‘962. Specifically, a method of treating metastatic NSCLC comprising administering atezolizumab in an individual with bTMB score is >16 and the number of somatic mutations counted over a defined number of sequenced bases of between about 100 kb to about 10 Mb , and there is an increase in PFS and/or OS. In regards to claim 286, Cummings et al teaches the blood sample is whole blood, a plasma sample, a serum sample, or a combination thereof [Lines 7-9, pg. 9]. In regards to claim 288, Cummings et al teaches the number of somatic mutations is the number of single nucleotide variants (SNVs) counted or a sum of the number of SNVs and the number of indel mutations counted [Lines 35-37, pg. 3]. In regards to claims 290-291, Cummings et al teaches treating metastatic NSCLC [Line 37, pg. 84]. Cummings et al further teaches the treatment comprising cisplatin or carboplatin + gemcitabine for squamous histology [Table 19, pg. 159]. In regards to claims 292-293, Cummings et al teaches the treatment comprising of cisplatin or carboplatin + pemetrexed for non-squamous histology [Table 19, pg. 159]. In regards to claim 294, Cummings et al teaches the subject receiving up to 6 doses of the anti-PD-L1 antibody [Line 39, pg. 90]. In regards to claims 295-296, Cummings et al teaches administering the treatment q3w or once every 3 weeks [Line 18, pg. 91]. In regards to claims 297, 302, and 304, Cummings et al teaches administering the treatment intravenously at 1200 mg q3w [Line 17, pg. 91]. In regards to claim 298, Cummings et al teaches administering the treatment as a monotherapy [Line 40, pg. 91]. In regards to claim 299, Cummings et al teaches the patient has not received prior treatment for cancer [Line 22, pg. 100]. In regards to claim 300, Cummings et al teaches measuring the expression level of PD-L1 using immunohistochemistry [Line 9, pg. 104]. In regards to claim 301, Cummings et al teaches method of treating cancer [Abstract]. Cummings et al further teaches lung cancer [Line 11, pg. 9]. Cummings et al further teaches non-small cell lung cancer (NSCLC) [Line 3, pg. 108]. Cummings et al further teaches treatments including an immune checkpoint inhibitor of PD-L1 [Abstract]. Cummings et al further teaches the anti-PD-L1 antibody atezolizumab [Line 30, pg. 9]. Cummings et al further teaches the OAK and POPLAR BEP (biomarker-evaluable population) that separate patients by EGFR and ALK mutations or without mutations [Lines 30-36, pg. 133]. Cummings et al further teaches identifying bTMB score from blood samples from patients [Lines 38-39, pg. 134]. Cummings et al further teaches treating patients with bTMB scores above and below a score of 16 [Fig. 5C]. Cummings et al further teaches the tumor expression level of PD-L1 is from 5% to less than 50% of the tumor cells [Lines 29-31, pg. 8]. Cummings et al further teaches the expression level of PD-L1 in tumor-infiltrating immune cells comprise 10% or more of the tumor sample [Lines 4-6, pg. 9]. Cummings et al further teaches the treatment comprising cisplatin or carboplatin + gemcitabine for squamous histology [Table 19, pg. 159]. In regards to claim 303, Cummings et al teaches method of treating cancer [Abstract]. Cummings et al further teaches lung cancer [Line 11, pg. 9]. Cummings et al further teaches non-small cell lung cancer (NSCLC) [Line 3, pg. 108]. Cummings et al further teaches treatments including an immune checkpoint inhibitor of PD-L1 [Abstract]. Cummings et al further teaches the anti-PD-L1 antibody atezolizumab [Line 30, pg. 9]. Cummings et al further teaches the OAK and POPLAR BEP (biomarker-evaluable population) that separate patients by EGFR and ALK mutations or without mutations [Lines 30-36, pg. 133]. Cummings et al further teaches identifying bTMB score from blood samples from patients [Lines 38-39, pg. 134]. Cummings et al further teaches treating patients with bTMB scores above and below a score of 16 [Fig. 5C]. Cummings et al further teaches the tumor expression level of PD-L1 is from 5% to less than 50% of the tumor cells [Lines 29-31, pg. 8]. Cummings et al further teaches the expression level of PD-L1 in tumor-infiltrating immune cells comprise 10% or more of the tumor sample [Lines 4-6, pg. 9]. Cummings et al teaches the treatment comprising of cisplatin or carboplatin + pemetrexed for non-squamous histology [Table 19, pg. 159] . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT DENNIS JOHN SULLIVAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0509 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon - Fri: 7:30AM - 4:30PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT Samira Jean-Louis can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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. /DENNIS J SULLIVAN/ Examiner, Art Unit 1642 /NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642