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 .
Priority
Instant application 17/904,139 filed on 08/12/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
The amendment filled on 09/30/2025 has been entered.
Claims 1-5, 7-21, 23-33 and 49-64 are pending
Election/Restrictions
Applicant’s election without traverse of:
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in the reply filed on 09/30/2025 is acknowledged.
Claims 26, 30, 31, 33 and 60-63 read on the combination of elected species.
However, regarding risk categories, it should be noted that treatments for High-Risk (HR) and treatments of Intermediate-Risk (IR) Non-Muscle-Invasive Bladder Cancer (NMIBC) overlap. As evidenced by Kamat (Kamat A. M. et al. Nat. Rev. Urol. 12, 225–235 (2015); published online 24 March 2015), BCG (Bacillus Calmette-Guérin) is the standard treatment for both.
It should be noted that Patients with NMIBC are usually placed into one of three risk categories (low, intermediate and high risk) for recurrence and progression base on the stage, grade, number and size of tumor and whether CIS is present (as evidenced by Cassell A, Yunusa B, Jalloh M, Mbodji MM, Diallo A, Ndoye M, Diallo Y, Labou I, Niang L, Gueye SM. Non-Muscle Invasive Bladder Cancer: A Review of the Current Trend in Africa. World J Oncol. 2019 Jun;10(3):123-131).
However, the risks categories often overlap.
As evidenced by Kamat (Kamat et. al., J Urol. 2014 August ; 192(2): 305–315. doi:10.1016/j.juro.2014.02.2573) “ while low- and high-risk disease have been well-classified, the intermediate-risk (IR) category has traditionally comprised a heterogeneous group of patients that do not fit into either of these categories. As a result, many urologists remain uncertain about the categorization of patients as ‘intermediate-risk’” (see abstract).
Given the status of prior art, the risk species election requirement is withdrawn.
Claims directed to High-Risk (HR) and claims directed to Intermediate-Risk (IR) Non-Muscle-Invasive Bladder Cancer (NMIBC) are under current considerations.
Claims 1-5, 12, 13, 17-24, 26, 30, 31, 33 and 59-63 are under current considerations.
Claims 7-11, 14-16, 25, 27-29, 32, 49-58 and 64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/30/2025.
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 1-5, 12, 13, 17-24, 26, 30, 31, 33 and 59-63 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.
The term high risk NMIBC has been defined in instant specification as: “poorly defined, low stage tumor” (see page 1, lines 9-14):
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However, the term “intermediate risk” has not been defined in the instant specification in a way that clearly distinguished the risk categories.
As evidenced by Kamat et. al., (J Urol. 2014 August ; 192(2): 305–315) “ while low- and high-risk disease have been well-classified, the intermediate-risk (IR) category has traditionally comprised a heterogeneous group of patients that do not fit into either of these categories. As a result, many urologists remain uncertain about the categorization of patients as ‘intermediate-risk’” (see abstract):
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Further, as evidenced by Cassell (Cassell A, Yunusa B, Jalloh M, Mbodji MM, Diallo A, Ndoye M, Diallo Y, Labou I, Niang L, Gueye SM. Non-Muscle Invasive Bladder Cancer: A Review of the Current Trend in Africa. World J Oncol. 2019 Jun;10(3):123-131) (see page 123, right column):
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However, there is possible alternative interpretation of the terms “intermediate risk”, and “high risk” based on risk factors such as smoking, exposures to carcinogens etc.
As evidenced by Cassell, smoking and occupational exposures to carcinogens are common risk factors of bladder cancer (see page 123, right column):
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Since the terms HR and IR has not been clearly defined in instant specification, the meats and bounds of instant claims are not clear.
Claim Rejections - 35 USC § 103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 12, 13, 17-24, 26, 30, 31, 33 and 59 are rejected under 35 U.S.C. 103 as being as being unpatentable over STUYCKENS (WO-2018-141921-A1) in view of Cassell (Cassell A, Yunusa B, Jalloh M, Mbodji MM, Diallo A, Ndoye M, Diallo Y, Labou I, Niang L, Gueye SM. Non-Muscle Invasive Bladder Cancer: A Review of the Current Trend in Africa. World J Oncol. 2019 Jun;10(3):123-131) (see page 123, right column) and in view of Kamat (Kamat et. al., J Urol. 2014 August ; 192(2): 305–315. doi:10.1016/j.juro.2014.02.2573).
STUYCKENS (WO-2018-141921-A1) teaches FGFR inhibitor erdafitinib (page 2):
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Further, STUYCKENS teaches and claims erdafitinib for treatment of bladder cancer (see claims 9 and 10):
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Furthermore, STUYCKENS teaches non-muscle-invasive bladder cancer (see page 33, lines 7-10).
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STUYCKENS teaches FGFR3 gene mutation – S249C (page 34, first paragraph):
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Regarding claims 17 and 33, STUYCKENS teaches erdafitinib is administered to the patient (see page 22, lines 11-20).
Regarding claims 21 and 59, STUYCKENS teaches erdafitinib is administered at a dosage of about 6 mg daily (see page 36, line 9).
Regarding claims 18 and 20, STUYCKENS teaches a continuous daily dosing schedule (see page 23, lines 6-18):
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Regarding claims 23 and 24, STUYCKENS teaches dosage form is a tablet (solid dose) (see page 22, lines 16):
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Regarding claim 19, it should be noted that the tablets are intended for orall administration.
STUYCKENS does not explicitly teaches NMIBC and STUYCKENS is silent about risks categories.
Cassell teaches:
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Since 70-75% of bladder cancer are NMIBC, a person of ordinary skill in the art would ‘at once envisage’ to use the method disclosed by STUYCKENS for NMIBC cancers.
MPEP 2131.02 stares “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.”
Regarding the risk categories, Kamat teaches “while low- and high-risk disease have been well-classified, the intermediate-risk (IR) category has traditionally comprised a heterogeneous group of patients that do not fit into either of these categories. As a result, many urologists remain uncertain about the categorization of patients as ‘intermediate-risk’” (see abstract):
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Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use FGFR inhibitor erdafitinib, disclosed by STUYCKENS for non-muscle invasive bladder cancer (NMIBC) including HR and IR. The skilled artisan would have been motivated to test the method disclosed by STUYCKENS for all bladder cancers.
Claims 1-5, 12, 13, 17-24, 26, 30, 31, 33 and 59-63 are rejected under 35 U.S.C. 103 as being unpatentable over STUYCKENS (WO-2018-141921-A1) in view of Steinberg (Steinberg RL, Thomas LJ, O'Donnell MA, Nepple KG. Sequential Intravesical Gemcitabine and Docetaxel for the Salvage Treatment of Non-Muscle Invasive Bladder Cancer. Bladder Cancer. 2015 Apr 30;1(1):65-72. doi: 10.3233/BLC-150008. PMID: 30561441; PMCID: PMC6218180).
This rejection applies to the methods wherein patient received BCG.
The teachings of STUYCKENS have been discuses above and those teachings are incorporated herein by reference.
STUYCKENS does not explicitly IR-NMIBC and HR-NMIBC.
Regarding instant claims 2-5 and 60-63, STUYCKENS does not teach the patient received BCG therapy.
Steinberg teaches “Bacillus Calmette-Guerin (BCG) is the most effective intravesical therapy for non-muscle invasive bladder cancer (NMIBC), but patients can fail, or supply shortages can develop. For BCG failures, radical cystectomy is recommended. However, in patients who desire bladder preservation or are poor surgical candidates, alternative salvage intravesical therapies should be explored” (see abstract).
Further, regarding BCG therapy, Steinberg teaches BCG therapy for intermediate-risk and high-risk NMIBC (see introduction):
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Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use FGFR inhibitor erdafitinib, disclosed by STUYCKENS, for patients who received BCG. The person of ordinary skill would have been motivated to test the method disclosed by STUYCKENS for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
Claims 1-5, 12, 13, 17-24, 26, 30, 31, 33 and 59-63 are rejected under 35 U.S.C. 103 as being unpatentable over STUYCKENS (WO-2018-141921-A1) in view of Hahn (Hahn NM, et al., A Phase II Trial of Dovitinib in BCG-Unresponsive Urothelial Carcinoma with FGFR3 Mutations or Overexpression: Hoosier Cancer Research Network Trial HCRN 12-157. Clin Cancer Res. 2017 Jun 15;23(12):3003-3011).
This rejection applies to the methods wherein patient received BCG.
The teachings of STUYCKENS have been discussed above and those teachings are incorporated herein by reference.
STUYCKENS does not explicitly teach that the cancer is IR-NMIBC and HR-NMIBC.
Regarding instant claims 2-5 and 60-63, STUYCKENS does not teach the patient received BCG therapy.
Hahn teaches FGFR inhibitor dovitinib in BCG-unresponsive urothelial carcinoma with FGFR3 Mutations (see title).
Hahn teaches non-muscle invasive bladder cancer (abstract):
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Hahn teaches (see page 3008, first paragraph):
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It should be noted that erdafitinib is also known as JNJ-42756493.
Applying KSR prong (A) and/or (B) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to test the method disclosed by STUYCKENS for all patients suffering from non-muscle invasive bladder cancer (NMIBC) and to use the method disclosed by STUYCKENS for NMIBC patients who received BCG therapy because BCG is a standard therapy for non-muscle invasive bladder cancer and Hahn discloses a FGFR3 inhibitors for treatment in BCG-unresponsive carcinoma.
Alternatively, starting from the Hahn’s disclosure, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute FGFR inhibitor dovitinib for FGFR inhibitor erdafitinib and use the method for the same purpose. The person of ordinary skill would have been motivated to test the method disclosed by STUYCKENS for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
Claims 1-5, 12, 13, 17-24, 26, 30, 31, 33 and 59-63 are rejected under 35 U.S.C. 103 as being unpatentable over STUYCKENS (WO-2018-141921-A1) in view of Clinical Trial 2019-002449-39 (A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) 2019).
This rejection applies to the methods wherein patient received BCG.
The teachings of STUYCKENS have been discussed above and those teachings are incorporated herein by reference.
STUYCKENS does not explicitly teach that the cancer is intermediate risk NMIBC and high risk NMIBC.
Regarding instant claims 2-5 and 60-63, STUYCKENS does not teach the patient received BCG therapy.
2019-002449-39 teaches “A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive BladderCancer (NMIBC) (see title).
Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use FGFR inhibitor erdafitinib, disclosed by STUYCKENS for patients who received BCG. Although 2019-002449-39 study does not disclosed results, a person of ordinary skill would have been motivated by the suggestions disclosed by 2019-002449-39 to test erdafitinib in patients who received Bacillus Calmette-Guérin (BCG). The skilled artisan would have been motivated to use the method disclosed by STUYCKENS for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
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 1-5, 12, 13, 17-24, 26, 30, 31, 33 and 59-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of US Patent 11,077,106 (application 16,483,579) in view of Hahn (Hahn NM, et al., A Phase II Trial of Dovitinib in BCG-Unresponsive Urothelial Carcinoma with FGFR3 Mutations or Overexpression: Hoosier Cancer Research Network Trial HCRN 12-157. Clin Cancer Res. 2017 Jun 15;23(12):3003-3011).
The claims of US Patent 11,077,106 recite a method for treating urothelial cancer comprising administering FGFR inhibitor, erdafitinib:
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The claims of US Patent 11,077,106 recite 6 mg dose on continuous daily basis (see claim 9):
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The claims of US Patent 11,077,106 recite S249C genomic alternation:
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The claims of US Patent 11,077,106 recite tablets (see claims 21-23):
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The claims of US Patent 11,077,106 do not recite that the urothelial cancer is high risk or intermediate risk NMIBC.
However, it should be noted that Non-Muscle Invasive Bladder Cancer (NMIBC), is a urothelium cancer (confined to the inner lining (urothelium) that hasn't invaded the muscle layer).
Regarding instant claims 2-5 and 60-63, the claims of US Patent 11,077,106 do not recite the patient received BCG therapy.
Hahn teaches FGFR inhibitor dovitinib in BCG-unresponsive urothelial carcinoma with FGFR3 mutations (see title).
Hahn teaches non-muscle invasive bladder cancer (abstract):
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Hahn teaches erdafitinib (also known as JNJ-42756493) (see page 3008, first paragraph):
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Applying KSR prong (B) and/or (A) - it would have been prima facie obvious to one of ordinary skill in the art to use the method recited in claims of US Patent 11,077,106 for NMIBC patients who received BCG therapy because Hahn discloses a FGFR3 inhibitor for treatment in BCG-unresponsive non-muscle-invasive urothelial carcinoma of the bladder.
Alternatively, it would have been prima facie obvious to one of ordinary skill in the art to substitute FGFR inhibitor dovitinib (disclosed by Hahn) for FGFR inhibitor erdafitinib (recited in claims of copending Application US Patent 11,077,106). The person of ordinary skill would have been motivated to test the method recited in claims of copending Application US Patent 11,077,106 for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
Claims 1-5, 12, 13, 17, 26, 30, 31, 33 and 60-63 are rejected over claims 1-25 of U.S. Patent No. 12037644 (application 16/131,201) in view of Hahn (Hahn NM, et al., A Phase II Trial of Dovitinib in BCG-Unresponsive Urothelial Carcinoma with FGFR3 Mutations or Overexpression: Hoosier Cancer Research Network Trial HCRN 12-157. Clin Cancer Res. 2017 Jun 15;23(12):3003-3011).
The claims of U.S. Patent No. 12037644 recite a method for treating blader cancer comprising administering FGFR inhibitor, erdafitinib:
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The claims of U.S. Patent No. 12037644 do not recite that the bladder cancer is HR or IR-NMIBC.
Regarding instant claims 2-5 and 60-63, the claims of U.S. Patent No. 12037644 do not recite the patient received BCG therapy.
Hahn teaches FGFR inhibitor, dovitinib in BCG-unresponsive urothelial carcinoma with FGFR3 mutations (see title).
Hahn teaches non-muscle invasive bladder cancer (abstract):
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Hahn teaches erdafitinib (also known as JNJ-42756493) (see page 3008, first paragraph):
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Applying KSR prong (B) and/or (A) - it would have been prima facie obvious to one of ordinary skill in the art to use the method recited in claims of U.S. Patent No. 12037644 for NMIBC patients who received BCG therapy because Hahn discloses a FGFR3 inhibitor for treatment in BCG-unresponsive non-muscle-invasive urothelial carcinoma of the bladder.
Alternatively, it would have been prima facie obvious to one of ordinary skill in the art to substitute FGFR inhibitor dovitinib for FGFR inhibitor erdafitinib recited in claims of U.S. Patent No. 12037644 . The person of ordinary skill would have been motivated to test the method recited in claims of U.S. Patent No. 12037644 for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
Claims 17-24 and 33-59 are rejected over claims 1-25 of U.S. Patent No. 12037644 (application 16/131,201) in view of Hahn (Hahn NM, et al., A Phase II Trial of Dovitinib in BCG-Unresponsive Urothelial Carcinoma with FGFR3 Mutations or Overexpression: Hoosier Cancer Research Network Trial HCRN 12-157. Clin Cancer Res. 2017 Jun 15;23(12):3003-3011) and further in view of STUYCKENS (WO-2018-141921-A1).
The recitations of claims U.S. Patent No. 12037644 and the teachings of Hahn have been discussed above and are incorporated herein by reference.
Regarding claims 18-24 and 59, the combination of claims U.S. Patent No. 12037644 and the teachings of Hahn is silent about the administration regime.
The deficiencies are cured by STUYCKENS.
Regarding claims 21 and 59, STUYCKENS teaches erdafitinib is administered at a dosage of about 6 mg daily (see page 36, line 9).
Regarding claims 18 and 20, STUYCKENS teaches a continuous daily dosing schedule (see page 23, lines 6-18):
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Regarding claims 23 and 24, STUYCKENS teaches dosage form is a tablet (solid dose) (see page 22, lines 16):
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Regarding claim 19, it should be noted that the tablets are intended for orall administration.
Applying KSR prong (B) and/or (A) - it would have been prima facie obvious to one of ordinary skill in the art to use the method recited in claims of U.S. Patent No. 12037644 for NMIBC patients who received BCG therapy because Hahn discloses a FGFR3 inhibitor for treatment in BCG-unresponsive non-muscle-invasive urothelial carcinoma of the bladder.
Alternatively, it would have been prima facie obvious to one of ordinary skill in the art to substitute FGFR inhibitor dovitinib for FGFR inhibitor erdafitinib recited in claims of U.S. Patent No. 12037644 . The person of ordinary skill would have been motivated to test the method recited in claims of U.S. Patent No. 12037644 for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
Furthermore, it would have been obvious to a skilled artisan to follow the administration regimen disclosed by STUYCKENS.
Claims 1-5, 12, 13, 17-20, 22-24, 26, 30, 31, 33 and 60-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2,3, 8, 9-18, 20-21, 23 and 32-34 of copending Application 17/599,729 (final rejection mailed 08/29/2025) in view of Hahn (Hahn NM, et al., A Phase II Trial of Dovitinib in BCG-Unresponsive Urothelial Carcinoma with FGFR3 Mutations or Overexpression: Hoosier Cancer Research Network Trial HCRN 12-157. Clin Cancer Res. 2017 Jun 15;23(12):3003-3011).
The claims of copending Application 17/599,729 recite:
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Further, the claims of copending Application 17/599,729 recite:
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Furthermore, the claims of copending Application 17/599,729 recite:
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The claims of copending Application 17/599,729 do not recite that the urothelial carcinoma is a urothelial carcinoma of the bladder.
Regarding instant claims 2-5 and 60-63, the claims of copending Application 17/599,729 do not recite the patient received BCG therapy.
Hahn teaches FGFR inhibitor, dovitinib in BCG-unresponsive urothelial carcinoma with FGFR3 mutations (see title).
Hahn teaches non-muscle invasive bladder cancer (abstract):
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Hahn teaches erdafitinib (also known as JNJ-42756493) (see page 3008, first paragraph):
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Applying KSR prong (B) and/or (A) - it would have been prima facie obvious to one of ordinary skill in the art to use the method recited in claims of copending Application 17/599,729 for NMIBC patients who received BCG therapy because Hahn discloses a FGFR3 inhibitor for treatment in BCG-unresponsive non-muscle-invasive urothelial carcinoma of the bladder.
Alternatively, it would have been prima facie obvious to one of ordinary skill in the art to substitute FGFR inhibitor dovitinib for FGFR inhibitor erdafitinib recited in claims of copending Application 17/599,729. The person of ordinary skill would have been motivated to test the method recited in claims of copending Application 17/599,729 for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
Claims 21 and 59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2,3, 8, 9-18, 20-21, 23 and 32-34 of copending Application 17/599,729 (final rejection mailed 08/29/2025) in view of Hahn (Hahn NM, et al., A Phase II Trial of Dovitinib in BCG-Unresponsive Urothelial Carcinoma with FGFR3 Mutations or Overexpression: Hoosier Cancer Research Network Trial HCRN 12-157. Clin Cancer Res. 2017 Jun 15;23(12):3003-3011) and further in view of STUYCKENS (WO-2018-141921-A1).
The recitations of claims of copending Application 17/599,729 and the teachings of Hahn have been discussed above and are incorporated herein by reference.
The combination of claims of copending Application 17/599,729 and the teachings of Hahn is silent about erdafitinib administered at the dose of about 6 mg.
The deficiency is cured by STUYCKENS.
The teachings of STUYCKENS have been discussed above and those teachings are incorporated herein by reference.
STUYCKENS teaches a continuous daily dosing schedule (see page 23, lines 6-18):
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Applying KSR prong (B) and/or (A) - it would have been prima facie obvious to one of ordinary skill in the art to use the method recited in claims of copending Application 17/599,729 for NMIBC patients who received BCG therapy because Hahn discloses a FGFR3 inhibitor for treatment in BCG-unresponsive non-muscle-invasive urothelial carcinoma of the bladder.
Alternatively, it would have been prima facie obvious to one of ordinary skill in the art to substitute FGFR inhibitor dovitinib for FGFR inhibitor erdafitinib recited in claims of copending Application 17/599,729. The person of ordinary skill would have been motivated to test the method recited in claims of copending Application 17/599,729 for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
Furthermore, it would have been obvious to a skilled artisan to administer erdafitinib at the dose of about 6 mg as disclosed by STUYCKENS.
Claims 1-5, 12, 13, 17, 26, 30, 31, 33 and 60-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 12, 16, -18, 36, 38, 40, 41, 42, 43, 44, 45-50, 57, 59, 64, 66-73 of copending Application 18/700,089 in view of Hahn (Hahn NM, et al., A Phase II Trial of Dovitinib in BCG-Unresponsive Urothelial Carcinoma with FGFR3 Mutations or Overexpression: Hoosier Cancer Research Network Trial HCRN 12-157. Clin Cancer Res. 2017 Jun 15;23(12):3003-3011).
The claims of copending Application 18/700,089 recite:
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The claims of copending Application 18/700,089 recite:
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The claims of copending Application 18/700,089 recite:
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The claims of copending Application 18/700,089 recite:
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The claims of copending Application 18/700,089 do not recite that the bladder cancer is HR or IR-NMIBC.
Regarding instant claims 2-5 and 60-63, the claims of copending Application 18/700,089 do not recite the patient received BCG therapy.
Hahn teaches FGFR inhibitor, dovitinib in BCG-unresponsive urothelial carcinoma with FGFR3 mutations (see title).
Hahn teaches non-muscle invasive bladder cancer (abstract):
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Hahn teaches erdafitinib (also known as JNJ-42756493) (see page 3008, first paragraph):
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Applying KSR prong (B) and/or (A) - it would have been prima facie obvious to one of ordinary skill in the art to use the method recited in claims of copending Application 18/700,089 for NMIBC patients who received BCG therapy because Hahn discloses a FGFR3 inhibitor for treatment in BCG-unresponsive non-muscle-invasive urothelial carcinoma of the bladder.
Alternatively, it would have been prima facie obvious to one of ordinary skill in the art to substitute FGFR inhibitor dovitinib for FGFR inhibitor erdafitinib recited in claims of copending Application 18/700,089. The person of ordinary skill would have been motivated to test the method recited in claims of copending Application 18/700,089 for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
Claims 17-24, 33 and 59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 12, 16, -18, 36, 38, 40, 41, 42, 43, 44, 45-50, 57, 59, 64, 66-73 of copending Application 18/700,089 in view of Hahn (Hahn NM, et al., A Phase II Trial of Dovitinib in BCG-Unresponsive Urothelial Carcinoma with FGFR3 Mutations or Overexpression: Hoosier Cancer Research Network Trial HCRN 12-157. Clin Cancer Res. 2017 Jun 15;23(12):3003-3011) and further in view STUYCKENS (WO-2018-141921-A1).
The recitations of claims of copending Application 18/700,089 and the teachings of Hahn have been discussed above and are incorporated herein by reference.
Regarding claims 18-24 and 59, the combination of claims of copending Application 18/700,089 and teachings of Hahn is silent about the administration regimen.
The deficiency is cured by STUYCKENS.
The teachings of STUYCKENS have been discussed above and those teachings are incorporated herein by reference.
Applying KSR prong (B) and/or (A) - it would have been prima facie obvious to one of ordinary skill in the art to use the method recited in claims of copending Application 18/700,089 for NMIBC patients who received BCG therapy because Hahn discloses a FGFR3 inhibitor for treatment in BCG-unresponsive non-muscle-invasive urothelial carcinoma of the bladder.
Alternatively, it would have been prima facie obvious to one of ordinary skill in the art to substitute FGFR inhibitor dovitinib for FGFR inhibitor erdafitinib recited in claims of copending Application 18/700,089. The person of ordinary skill would have been motivated to test the method recited in claims of copending Application 18/700,089 for all patients suffering from non-muscle invasive bladder cancer (NMIBC).
Furthermore, it would have been obvious to a skilled artisan to follow the administration regimen disclosed by STUYCKENS.
Conclusion
No claims are allowed.
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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621