CTNF 18/799,503 CTNF 98757 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Status of the Claims Claims 1, 3, 7, 10, 14, 16, 17, 20 – 22, 24, 26, 30, 32, 35 – 37, 41 and 50 are currently pending and are examined on the merits. Information Disclosure Statement The information disclosure statement filed on 02/14/2025 does not fully comply with the requirements of 37 CFR 1.98(b) because the non-patent literature cite no. Q** on page 4 of 8 does not include a valid publication date. A valid publication date is the date the literature became available to the public, and a date of retrieval from a website is not a valid publication date. Applicant must indicate the date of publication of each reference. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-01 Claim 50 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. New claim 50, filed after the filing date, is new matter. In the remarks of 02/14/2025, Applicant argues that support can be found at page 112, lines 3-10 of the specification. The citation teaches the expression levels of CTLA4, BTLA, LAG3, HAVCR2, and PD1 represent potential biomarkers for response of UBC patients to treatment with PD-L1 axis binding antagonists, including the anti-PD-L1 antibody atezolizumab. However this does not provide support for the method of new claim 50 as broadly claimed. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 22, 24 and 26 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by HEGDE (WO 2016/196298 A1, published 12/08/2016, an IDS reference submitted 02/14/2025) . Independent claim 22 is directed to method for treating a patient suffering from a locally advanced or metastatic urothelial carcinoma who is not eligible for cisplatin-containing chemotherapy, the method comprising administering to the patient a therapeutically effective amount of an anti-cancer therapy comprising atezolizumab, wherein the patient is previously untreated for the urothelial carcinoma, wherein the patient has been identified as having a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise less than 5% of a tumor sample obtained from the patient, and wherein the treatment results in a durable response. HEGDE is directed to a method of treating a patient suffering from a urothelial bladder cancer by administering to the patient atezolizumab, wherein a tumor sample obtained from the patient has been determined to have a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise about 1 % or more of the tumor sample. See HEGDE ’s claims 1, 40 and 54. See also Example 2, p. 91 and p. 35, line 29 – p. 36, line 6. HEDGE teaches that durable responses were observed. See p. 100, lines 7 – 8. Thus, HEDGE anticipates claims 22 and 24. Regarding claim 26, HEDGE teaches that the median overall survival was 1 1 .4 months (95% CI , 9.0 to not estimable) for the IC2/3 group, 8.8 months (95% CI, 7.1 to 10.6) in the IC1 /2/3 group, and 7.9 months (95% CI, 6.6 to 9.3) for the entire cohort of patients. See p. 102, lines 7 – 9 . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1, 3, 7, 14, 16, 20, 22, 24, 26 30, 32, 35 – 37, 41 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over HEGDE (WO 2016/196298 A1, published 12/08/2016, an IDS reference submitted 02/14/2025) . Hedge teaches as set forth above with respect to claims 22, 24 and 26. HEGDE is directed to a method of treating a patient suffering from a urothelial bladder cancer by administering to the patient atezolizumab, wherein a tumor sample obtained from the patient has been determined to have a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise about 1 % or more of the tumor sample. See HEGDE ’s claims 1, 40 and 54. HEDGE teaches that a tumor sample obtained from the patient has been determined to have a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise about 1 % to about 65% or more (e.g., about 1 % to about 5%, about 5% to about 10%, about 10% to about 20%, about 20% to about 30%, about 30% to about 40%, about 40% to about 50%, or about 50% to about 65%) of the tumor sample. See p. 2, lines 1 – 4. HEDGE teaches that 20% of IC2/3 patients had a complete response (CR) (Figure 2). See p. 92, lines 4 – 7. Thus, HEDGE renders claims 1, 3, 7 and 16 obvious. Regarding claim 14, HEGDE teaches the median time to response was 2.1 months. See p. 98, 17 – 18. Regarding claim 20, HEDGE teaches that durable responses were observed. See p. 100, lines 7 – 8. Regarding claim 30, HEDGE teaches that Atezolizumab (MPDL3280A) is administered at 1200 mg intravenously every three weeks (q3w). See p. 61, lines 24 – 26. Regarding claim 32, HEDGE teaches that the dose may be administered as a single dose or as multiple doses (e.g., 2 or 3 doses), such as infusions. See p. 61, lines 26 – 27. Regarding claim 35, HEDGE teaches administering to the patient an effective amount of a second therapeutic agent. See HEDGE ’s claim 52 Regarding claim 36, HEDGE teaches that the second therapeutic agent is selected from the group consisting of a cytotoxic agent, a growth-inhibitory agent, a radiation therapy agent, an anti-angiogenic agent, and combinations thereof. See HEDGE ’s claim 53. Regarding claim 37, HEDGE teaches that tumor sample is a formalin-fixed and paraffin-embedded (FFPE) tumor sample, an archival tumor sample, a fresh tumor sample, or a frozen tumor sample. See HEDGE ’s claim 58. Regarding claim 41, HEDGE teaches that the protein expression level of PD-L1 is determined using a method selected from the group consisting of immunohistochemistry (IHC), immunofluorescence, flow cytometry, and Western blot. See HEDGE ’s claim 60. Regarding claim 50, HEGDE teaches that increased mRNA expression (as determined by a custom Nanostring assay) of the immunoblocker signature, as well as CTLA4, by T-cells by cycle 3, day 1 of treatment was associated with response to atezolizumab in UBC patients, and therefore, the expression levels of CTLA4, BTLA, LAG3, HA VCR2, and PD1 represent potential biomarkers for response of UBC patients to treatment with PD-L1 axis binding antagonists, including the anti-PD-L1 antibody atezolizumab. See example 3, p. 92 and Figure 6. Thus, it would have been obvious to determine patient response to the anti-cancer therapy based on an increase in expression levels of a gene signature comprising CTLA4, BTLA, LAG3, HAVCR2, and PD1 in a blood sample obtained from the patient at a time point following administration of an anti-cancer therapy comprising atezolizumab of present claim 50. It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed methods from the disclosures of HEGDE . The artisan would have been motivated to use the method of the claims because HEDGE teaches that atezolizumab has demonstrated promising clinical activity in a heavily pre-treated metastatic urothelial bladder cancer (UBC) cohort with encouraging survival and clinically meaningful responses and that PD-L1 expression in tumor infiltrating immune cells (ICs) appeared to be a predictive biomarker for response to PD-L1 axis binding antagonists such as the anti-PD-L1 antibody atezolizumab (MPDL3280A) (see p. 92, lines 34 – 27). Thus, the artisan would have a reasonable expectation of success with the methods taught by HEDGE . 07-21-aia AIA Claims 1, 3, 7, 10, 14, 16 – 17, 20 – 22, 24, 26, 30, 32, 37 and 41 are r ejected under 35 U.S.C. 103 as being unpatentable over B ALAR (Balar, Arjun V et al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial, The Lancet, Volume 389, Issue 10064, 2017, Pages 67-76; an IDS reference submitted 02/14/2025). P resent independent claim 1 is directed to a method for treating a patient suffering from a locally advanced or metastatic urothelial carcinoma who is not eligible for cisplatin-containing chemotherapy, the method comprising administering to the patient a therapeutically effective amount of an anti-cancer therapy comprising atezolizumab, wherein the patient is previously untreated for the urothelial carcinoma, and wherein the patient has been identified as likely to respond to the anti-cancer therapy with a likelihood of having a complete response (CR) of about 10% or higher based on a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise about 5% or more of a tumor sample obtained from the patient. BALAR is directed to first-line chemotherapy where humanised monoclonal anti-programmed death-ligand 1 antibody atezolizumab was assessed in patients with previously untreated, locally advanced or metastatic urothelial cancer who were ineligible for cisplatin-based chemotherapy. See Research in context: Added value of this study , p. 68, highlighted box. BALAR teaches that the patient has a detectible expression level of PD-L1 of about 5% or more (IC2/3) and wherein the treatment results in a complete response (CR) (see abstract and Methods: Procedures , p.68; and Table 2). BALAR teaches that 119 patients received one or more doses of atezolizumab and that at 17.2 months' median follow-up, the objective response rate was 23% (95% CI 16 to 31), the complete response rate (CR) was 9% (n=11), and 19 of 27 responses were ongoing. Considering the known use of atezolizumab to treat urothelial carcinoma and considering the physiological differences in individuals, the possibility of achieving a CR of 10% is likely with a different sample population and/or size. Regarding claims 1, 3 and 22, BALAR teaches the assessment of PD-L1 expression on tumour-infiltrating immune cells (IC) where the scoring criteria designated tumours as IC0 (PD-L1 expression on <1% of IC), IC1 (PD-L1 expression on ≥1% and <5% of IC), or IC2/3 (PD-L1 expression on ≥5% of IC). See p. 69, left column, top paragraph. Although BALAR does not expressly teach an IC of about 10% or more of the tumor sample, as recited in present claim 3, BALAR does teach an IC of greater than 5%, which could include 10%. It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed methods from the disclosures of BALAR . The artisan would have been motivated to use the methods of claims 1, 7 and 16 because BALAR teaches that the disclosed methods result in an overall survival that surpass historical rates (see R esearch in context: added value of this study , p. 68, highlighted box) and because BALAR teaches that patients that have a detectible expression level of PD-L1 of about 5% or more (IC2/3) the treatment results in a complete response (CR. Thus, the artisan would have a reasonable expectation of success with the methods taught by BALAR . Regarding claims 10 and 17, BALAR teaches a CR of about 9% at 17.2 months (see Findings, p.67; Table 2). Considering the known use of atezolizumab to treat urothelial carcinoma and physiological differences in individuals, the possibility of achieving a CR of 10% or higher at about 17, 29, 36 months, as recited in claims 10 and 17, is likely with a different sample population and/or size. Note that these claims do not require that the entire treated population have a certain CR rate, but that the individual patients have at least a certain percentage chance of having a CR at various recited time points. Given the data in Figure 2, at least some patients met the recited criteria. Regarding claim 14, BALAR teaches that the median time to onset of first response was 2.1 months (range 1.8–10.5) (see p.71, second paragraph), which is within four months. Regarding claim 20 – 22, BALAR teaches that objective responses by independent assessment according to Response Evaluation Criteria In Solid Tumors version 1.1 were durable, with 70% of patients continuing to respond after a median follow-up duration of almost 1.5 years and that overall survival also seemed to surpass historical rates. See Research in context: Added value of this study , p. 68, highlighted box. Regarding claims 22 and 24, BALAR teaches the assessment of PD-L1 expression on tumour-infiltrating immune cells (IC) and that IC1 (PD-L1 expression on ≥1% and <5% of IC) were assessed. See Methods, Procedures , p. 68 – 69. Regarding claim 26, BALAR teaches that objective responses by independent assessment according to Response Evaluation Criteria In Solid Tumors version 1.1 were durable, with 70% of patients continuing to respond after a median follow-up duration of almost 1·5 years (see Research in context: Added value of this study , p. 68, highlighted box) and that the median time to onset of first response was 2.1 months (range 1.8–10.5) (see p.71, second paragraph), which is within four months. Regarding claims 30 and 32, BALAR teaches that patients received 1200 mg intravenous atezolizumab and that the patients in the study were previously untreated and made no mention of additional treatments, suggesting that the atezolizumab was administered as a monotherapy. See Methods: Procedures , p.68. Regarding claims, 35 – 36, although BALAR teaches that atezolizumab was assessed in patients with previously untreated, locally advanced or metastatic urothelial cancer who were ineligible for cisplatin-based chemotherapy (see Research in context: Added value of this study, p. 68, highlighted box) and BALAR expected the study to attract patients who would not be candidates for combination chemotherapy, including those not eligible for any cytotoxic chemotherapy—reflective of the heterogeneous cisplatin-ineligible population (see p. 69, right column). However, BALAR teaches that further analyses in larger studies of metastatic urothelial cancer that incorporate multiple biomarkers could help patient selection for optimum efficacy and guide appropriate combination treatments in the future (see p. 75, sentence before the last paragraph on the left column). Thus, BALAR teaches combination treatments as the next step after the disclosed study, rendering the administration of an effective amount of a second therapeutic agent, such as cytotoxic chemotherapy, obvious. Regarding claim 37, BALAR teaches that the Glomerular filtration rate less than 60 mL/min and more than 30 mL/min. See Table 1, p. 70. Regarding claim 41, BALAR teaches that PD-L1 expression status defined according to IHC. See Supplementary Material p. 30 . Double Patenting 08-33 AIA 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. 08-36 AIA Claim s 1, 3, 7, 10, 14, 16, 17, 20 – 22, 24, 26, 30, 32, 35 – 37 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 – 33 of U.S. Patent No. 11,535,671 in view of BALAR . Patented claim 1 recites a method of treating a patient suffering from a bladder cancer, the method comprising administering to the patient a therapeutically effective amount of atezolizumab, wherein a tumor sample obtained from the patient has been determined to have a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise about 5% or more of the tumor sample. Patented claim 30 recites that the bladder cancer is an urothelial bladder cancer. Patented claim 31 recites that the urothelial bladder cancer is a muscle invasive urothelial bladder cancer. The main difference between the present claims and the patented claims is that the present claims recite that the patient is not eligible for cisplatin-containing chemotherapy and that the treatment results in a complete response (CR). However, BALAR teaches this difference. The teachings of BALAR , and how they relate to the claims, are set forth in the rejections under 35 USC 103 above. Because the patented claims recite a method of treating a patient suffering from a bladder cancer, the method comprising administering to the patient a therapeutically effective amount of atezolizumab, wherein a tumor sample obtained from the patient has been determined to have a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise about 5% or more of the tumor sample, and BALAR teaches that the patient is not eligible for cisplatin-containing chemotherapy and that the treatment results in a complete response (CR), it would have been obvious to one having ordinary skill in the art to use the patented claims ’ method in the methods of the present claims . 08-37 AIA Claim s 1, 3, 7, 10, 14, 16, 17, 20 – 22, 24, 26, 30, 32, 35 – 37 and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/352,717 in view of BALAR. Copending claim 1 recites a method of treating a patient suffering from a bladder cancer, the method comprising administering to the patient a therapeutically effective amount of a PD-L1 axis binding antagonist, wherein a tumor sample obtained from the patient has been determined to have a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise about 1% or more of the tumor sample. The main difference between the present claims and the copending claim is that the present claims recite that the patient is not eligible for cisplatin-containing chemotherapy and that the present claims recite that the patient is not eligible for cisplatin-containing chemotherapy and that the patient is previously untreated for the urothelial carcinoma and that the patient has been identified as likely to respond to the anti-cancer therapy with a likelihood of having a complete response (CR) of about 10% or higher based on a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise about 5% or more of a tumor sample obtained from the patient. Furthermore, the present claims recite additional limitations not recited in the copending claim. However, BALAR teaches these differences. The teachings of BALAR , and how they relate to the claims, are set forth in the rejections under 35 USC 103 above. Because the copending claim recites a method of treating a patient suffering from a bladder cancer, the method comprising administering to the patient a therapeutically effective amount of a PD-L1 axis binding antagonist and BALAR teaches that the patient is not eligible for cisplatin-containing chemotherapy and that the patient is previously untreated for the urothelial carcinoma and that the patient has been identified as likely to respond to the anti-cancer therapy with a likelihood of having a complete response (CR) of about 10% or higher based on a detectable expression level of PD-L1 in tumor-infiltrating immune cells that comprise about 5% or more of a tumor sample obtained from the patient, it would have been obvious to one having ordinary skill in the art to use the copending claims ’ method in the methods of the present claims . This is a provisional nonstatutory double patenting rejection. Conclusion No claims are allowed. 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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. /ESTELLA M. GUSTILO/Examiner, Art Unit 1646 /PETER J REDDIG/Primary Examiner, Art Unit 1646 Application/Control Number: 18/799,503 Page 2 Art Unit: 1646 Application/Control Number: 18/799,503 Page 3 Art Unit: 1646 Application/Control Number: 18/799,503 Page 4 Art Unit: 1646 Application/Control Number: 18/799,503 Page 5 Art Unit: 1646 Application/Control Number: 18/799,503 Page 6 Art Unit: 1646 Application/Control Number: 18/799,503 Page 7 Art Unit: 1646 Application/Control Number: 18/799,503 Page 8 Art Unit: 1646 Application/Control Number: 18/799,503 Page 9 Art Unit: 1646 Application/Control Number: 18/799,503 Page 10 Art Unit: 1646 Application/Control Number: 18/799,503 Page 11 Art Unit: 1646 Application/Control Number: 18/799,503 Page 12 Art Unit: 1646 Application/Control Number: 18/799,503 Page 13 Art Unit: 1646 Application/Control Number: 18/799,503 Page 14 Art Unit: 1646
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