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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed May 10th, 2026, have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
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.
Claims 1 – 2, 4, and 6 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2017198221 A1 to Chen et. al. (herein after Chen’221; cited on the ISR form 237; English translation used).
Regarding claims 1 – 2, 4, and 6 – 10, Chen’221 teach compounds of formula (I) of structure
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(Chen’221 original document page 1)and (II) of structure
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(Chen’221 original document page 1) as a new class of pyrimidine derivatives (Chen’221 translation page 6 paragraph 1). More specifically, Chen’221 teach compound 5 of structure
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(Chen’221 original document page 4 Table row 5). Furthermore, Chen’221 teach that the compounds of the disclosures, which include compound 5 can be formulated to form pharmaceutically usable salts using a suitable acid, which includes ethanesulfonic acid and methanesulfonic acid (Chen’221 translation page 42 paragraph 1).
Moreover, Chen’221 teach that in recent years, increasing evidence has shown that FGFR1, FGFR2, FGFR3, and FGFR4 gene amplification (claim 7) mutations exist in many types of cancers (Chen’221 translation page 4 paragraph 1). Furthermore, Chen’221 teach that FGFR4 has mutations and overexpression in lung cancer, ovarian cancer, prostate cancer, liver cancer, and bile duct cancer, and is also overexpressed in thyroid cancer and ovarian cancer (Chen’221 translation page 4 paragraph 1). Additionally, Chen’221 teach that compounds of this disclosure can be used in methods for treating disease with FGFR4 overexpression (claim 6) (Chen’221 translation page 21 paragraph 2) and FGF19 amplification (Chen’221 translation page 21 paragraph 3).
Also, Chen’221 teach that compounds of the disclosure as useful in methods for treating cancer, comprising administering to a patient in need of treatment an effective dose of a compound of general formula (I) or (II) or a stereoisomer, tautomer, or pharmaceutically acceptable salt thereof, or a pharmaceutical composition thereof, wherein the cancer (claim 8) is selected from non-small cell lung cancer, gastric cancer, multiple myeloma, liver cancer, and cholangiocarcinoma, preferably liver cancer and cholangiocarcinoma (claims 9 – 10) (Chen’221 translation page 22 paragraph 2). Additionally, Chen’221 teach a pharmaceutical composition comprising an effective dose of a compound of general formula (I) or (II) or a stereoisomer, tautomer or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, excipient or combination thereof (claim 4) (Chen’221 translation page 20 paragraph 1).
Regarding claim 7, recitation for a method of treating a disease resulting from FGFR4 amplification, as taught above by, Chen’221 FGFR1, FGFR2, FGFR3, and FGFR4 gene amplification mutations exist in many types of cancers including lung cancer, ovarian cancer, prostate cancer, liver cancer, and bile duct cancer, and is also overexpressed in thyroid cancer and ovarian cancer (Chen’221 translation page 4 paragraph 1). Therefore, by administering the mesylate or ethanesulfonate salt of compound 5 for the treatment of lung cancer, ovarian cancer, prostate cancer, liver cancer, and bile duct cancer would treat patients wherein the cancer results of FGFR4 amplification.
Regarding claim 1, while Chen’221 does not explicitly teach compound 5 as either an mesylate salt or an ethanesulfonate salt; Chen’221 does teach that the compounds of the disclosures, which include compound 5 can be formulated to form pharmaceutically usable salts using a suitable acid, which includes ethanesulfonic acid and methanesulfonic acid (Chen’221 translation page 42 paragraph 1). Therefore, it would have been obvious before the effective filing date of the insta application and within the purview of one of ordinary skill in the art to have modified compound 5 into the mesylate salt or ethanesulfonate salt.
Response to Arguments
Applicant's arguments filed May 10th, 2026 have been fully considered but they are not persuasive.
Applicant argues that none of the prior art including Chen, teaches or motivates the selection of the mesylate or ethanesulfonate salts for the compound in Example 5 of Chen. See applicants remarks page 6 paragraph 4. Moreover, Applicant argues that Chen provides a significant deviation of teachings from the present invention by teaching particularly preferred salt embodiments of hydrochloric acid, hydrobromic acid, phosphoric acid, and sulfuric acid, with hydrochloride salts being the most preferred." See applicants remarks page 7 paragraph 1.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Chen’221 teach that the compounds of the disclosures, which include compound 5 can be formulated to form pharmaceutically usable salts using a suitable acid, which includes ethanesulfonic acid and methanesulfonic acid (Chen’221 translation page 42 paragraph 1). Therefore, given the finite options for acid salts and given that the skill of one of ordinary skill in the art is relatively high as a pharmaceutical scientist or medicinal chemist. It would have been within the purview of such skilled artisan, in an attempt to find an appropriate pharmaceutical salt, to choose from the finite list provided by Chen’221 to make the mesylate salt or ethanesulfonate salt of prior art compound 5 as taught by Chen’221 with a reasonable expectation of success. Moreover, the examiner contends that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998)( See MPEP 2123). Furthermore, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023)(See MPEP 2145 (X)D. 1.)
Moreover, applicant argues the present application also confirms that the mesylate and ethanesulfonate salts of the present invention have achieved unexpected and surprising technical effects. See applicants remarks page 7 paragraph 2. Furthermore, applicant argues that in example 1 and 2 of the instant specification the in vivo pharmacokinetic experiments in rats and mice respectively, confirmed that the pharmacokinetic properties of the ethanesulfonate salt of mesylate are significantly superior to other salt forms, mainly reflected in the AUC0-t and Cmax parameters. See applicants remarks page 7 paragraph 2.
While the mesylate and ethansulfonate salt demonstrated higher maximum serum concentrations (Cmax) and higher exposure/clearance rate in the body (AUC0-t) these values where not shown to be statistically different. See instant specifically page 9 paragraph 0036 Table 3 page 12 paragraph 0043 Table 6. Moreover, when all salt forma were used in a method of treating cancer as shown in the Figure 1 and Figure 2 of the specification all salts of the compound performed statistically similar in terms of reducing tumor volume grown (Figure 1) and maintaining the body weight of BALB/c nude mice in the Hep3B model (Figure 2). Therefore, there is no showing that the results are unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02(b)(I)
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, and 6 – 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 16 of U.S. Patent No. 10654836 B2 to Chen et. al. (herein after Chen’836) in view of International Publication Number WO 2017198221 A1 to Chen et. al. (herein after Chen’221; cited on the ISR form 237; English translation used) and Engel et. al. ((2000), Salt form selection and characterization of LY333531 mesylate monohydrate, International Journal of Pharmaceutics, 198, 239 – 247).
Chen’836 recite a compound represented by formula (I) or a stereoisomer, tautomer thereof or a pharmaceutically acceptable salt thereof:
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(reference claim 1) wherein R1 is selected from halogen or alkoxy (reference claim 3); wherein R2 is –NHC(O)CH=CH2 (reference claim 4); wherein R3 is a monospiroheterocyclyl, wherein the monospiroheterocyclyl is further substituted by an alkyl (reference claim 5); wherein R3 is 3-memenered/6-memebered (reference claims 6 and 7). Furthermore, Chen’836 recite the compound or the stereoisomer, tautomer thereof or the pharmaceutically acceptable salt thereof according to (reference) claim 1, which is a compound of formula (II) or a stereoisomer, tautomer thereof or a pharmaceutically acceptable salt thereof:
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(reference claim 2). Specifically, Chen’836 recite the compound or the stereoisomer, tautomer thereof or the pharmaceutically acceptable salt thereof according to (reference) claim 1, wherein the compound is selected from:
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(reference claim 8; instant claim 1); pharmaceutical composition comprising an effective amount of the compound or the stereoisomer, tautomer thereof or the pharmaceutically acceptable salt thereof according to (reference) claim 1, and a pharmaceutically acceptable carrier, excipient or a combination thereof (reference claim 9; instant claim 4); a method for inhibiting FGFR4 (instant claims 6 – 7), which comprises contacting the receptor with the compound or the stereoisomer, tautomer thereof or the pharmaceutically acceptable salt thereof according to (reference) claim 1 (reference claim 10); and a method for inhibiting FGFR4, which comprises contacting the receptor with the pharmaceutical composition according to (reference) claim 9.
However, Chen’836 fails to recite the formation of the mesylate salt or the ethanesulfonate salt of the compound (instant claims 1). Moreover, Chen’836 fails to recite a method for preparing the salt according to instant claim 1 (instant claim 3). Furthermore, Chen’836 fails to recite a method of treating cancer (instant claims 8 – 10).
The teachings of Chen’221 and Engel et. al. as they relate to the prior art rejections of instant claims 1 – 2, 4, and 6 – 10, are given previously in this office action and are fully incorporated here.
Therefore it would have been obvious before the effective filing date of the instant application to modify the invention of Chen’836 in view of Chen’221 that is to make the mesylate or ethanesulfonate salt in further view of Engel et. al. that is to dissolve the free base said compound in a mixture of acetone/water at 10/1 v/v and the respective acid. One of ordinary skill in the art would have been motivated to make this modification and have a reasonable expectation of success to avoid some of the potential issues of HCl salt as well as avoid the formation of methyl methanesulfonate.
Claims 1 – 2, 4, and 6 – 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 9 of U.S. Patent No. 11001572 B2 to Chen et. al. (herein after Chen’572) in view of International Publication Number WO 2017198221 A1 to Chen et. al. (herein after Chen’221; cited on the ISR form 237; English translation used) and Engel et. al. ((2000), Salt form selection and characterization of LY333531 mesylate monohydrate, International Journal of Pharmaceutics, 198, 239 – 247).
Chen’572 recite a method of treating cancer (instant claim 8) comprising administering to a patient in need of treatment an effective amount of a compound represented by formula (I) or a stereoisomer, tautomer thereof or a pharmaceutically acceptable salt thereof:
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(reference claim 1) wherein R1 is selected from halogen or alkoxy (reference claim 3); wherein R2 is –NHC(O)CH=CH2 (reference claim 4); wherein R3 is a monospiroheterocyclyl, wherein the monospiroheterocyclyl is further substituted by an alkyl (reference claim 5); wherein R3 is 3-memenered/6-memebered (reference claims 6 and 7). Furthermore, Chen’572 recite the method of (reference) claim 1, wherein the compound is a compound of formula (II):
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(reference claim 2). Specifically, Chen’572 recite the method of (reference) claim 1, wherein the compound is selected from:
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(reference claim 8; instant claim 1); pharmaceutical composition comprising an effective amount of the compound or the stereoisomer, tautomer thereof or the pharmaceutically acceptable salt thereof according to (reference) claim 1, and a pharmaceutically acceptable carrier, excipient or a combination thereof (reference claim 9; instant claim 4); the method of (reference) claim 1, wherein the cancer (instant claim 8) is selected from the group consisting of a hepatocellular carcinoma and cholangiocarcinoma (reference claim 9; instant claims 9 – 10).
However, Chen’572 fails to recite the formation of the mesylate salt or the ethanesulfonate salt of the compound (instant claims 1). Moreover, Chen’572 fails to recite a method for preparing the salt according to instant claim 1 (instant claim 3). Furthermore, Chen’572 fails to recite a method of treating a disease with FGFR4 overexpression (instant claim 6) or FGFR4 amplification (instant claim 7).
The teachings of Chen’221 and Engel et. al. as they relate to the prior art rejections of instant claims 1 – 2, 4, and 6 – 10, are given previously in this office action and are fully incorporated here.
Therefore it would have been obvious before the effective filing date of the instant application to modify the invention of Chen’572 in view of Chen’221 that is to make the mesylate or ethanesulfonate salt in further view of Engel et. al. that is to dissolve the free base said compound in a mixture of acetone/water at 10/1 v/v and the respective acid. One of ordinary skill in the art would have been motivated to make this modification and have a reasonable expectation of success to avoid some of the potential issues of HCl salt as well as avoid the formation of methyl methanesulfonate.
Claims 1 – 2, 4, and 6 – 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 8 of U.S. Patent No. 11827625 B2 to Chen et. al. (herein after Chen’625) in view of International Publication Number WO 2017198221 A1 to Chen et. al. (herein after Chen’221; cited on the ISR form 237; English translation used) and Engel et. al. ((2000), Salt form selection and characterization of LY333531 mesylate monohydrate, International Journal of Pharmaceutics, 198, 239 – 247).
Chen’625 recite a method for treating diseases of FGFR4 over-expression comprising administering to a patient in need of treatment an effective amount of a compound represented by formula (I) or a stereoisomer, tautomer thereof or a pharmaceutically acceptable salt thereof:
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(reference claim 1) wherein R1 is selected from halogen or alkoxy (reference claim 3); wherein R2 is –NHC(O)CH=CH2 (reference claim 4); wherein R3 is a monospiroheterocyclyl, wherein the monospiroheterocyclyl is further substituted by an alkyl (reference claim 5); wherein R3 is 3-memenered/6-memebered (reference claims 6 and 7). Furthermore, Chen’625 recite the method of (reference) claim 1, wherein the compound is a compound of formula (II):
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(reference claim 2). Specifically, Chen’625 recite the method of (reference) claim 1, wherein the compound is selected from:
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(reference claim 8; instant claim 1).
However, Chen’625 fails to recite the formation of the mesylate salt or the ethanesulfonate salt of the compound (instant claims 1). Moreover, Chen’625 fails to recite a method for preparing the salt according to instant claim 1 (instant claim 3). Furthermore, Chen’625 fails to recite a method of treating a disease with FGFR4 amplification (instant claim 7). Additionally, Chen’625 fails to recite a method of treating cancer (instant claims 8 – 10).
The teachings of Chen’221 and Engel et. al. as they relate to the prior art rejections of instant claims 1 – 2, 4, and 6 – 10, are given previously in this office action and are fully incorporated here.
Therefore it would have been obvious before the effective filing date of the instant application to modify the invention of Chen’625 in view of Chen’221 that is to make the mesylate or ethanesulfonate salt in further view of Engel et. al. that is to dissolve the free base said compound in a mixture of acetone/water at 10/1 v/v and the respective acid. One of ordinary skill in the art would have been motivated to make this modification and have a reasonable expectation of success to avoid some of the potential issues of HCl salt as well as avoid the formation of methyl methanesulfonate.
Claims 1 – 2, 4, and 6 – 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 9 of U.S. Patent No. 12358898 B2 to Chen et. al. (herein after Chen’898) in view of International Publication Number WO 2017198221 A1 to Chen et. al. (herein after Chen’221; cited on the ISR form 237; English translation used) and Engel et. al. ((2000), Salt form selection and characterization of LY333531 mesylate monohydrate, International Journal of Pharmaceutics, 198, 239 – 247).
Chen’898 recite a method for treating diseases of FGF19 amplification comprising administering to a patient in need of treatment an effective amount of a compound represented by formula (I) or a stereoisomer, tautomer thereof or a pharmaceutically acceptable salt thereof:
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(reference claim 1) wherein R1 is selected from halogen or alkoxy (reference claim 3); wherein R2 is –NHC(O)CH=CH2 (reference claim 4); wherein R3 is a monospiroheterocyclyl, wherein the monospiroheterocyclyl is further substituted by an alkyl (reference claim 5); wherein R3 is 3-memenered/6-memebered (reference claims 6 and 7). Furthermore, Chen’898 recite the method of (reference) claim 1, wherein the compound is a compound of formula (II):
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(reference claim 2). Specifically, Chen’898 recite the method of (reference) claim 1, wherein the compound is selected from:
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(reference claim 8; instant claim 1).
However, Chen’898 fails to recite the formation of the mesylate salt or the ethanesulfonate salt of the compound (instant claims 1). Moreover, Chen’898 fails to recite a method for preparing the salt according to instant claim 1 (instant claim 3). Furthermore, Chen’898 fails to recite a method of treating a disease with FGFR4 overexpression (instant claim 6) or FGFR4 amplification (instant claim 7). Additionally, Chen’898 fails to recite a method of treating cancer (instant claims 8 – 10).
The teachings of Chen’221 and Engel et. al. as they relate to the prior art rejections of instant claims 1 – 2, 4, and 6 – 10, are given previously in this office action and are fully incorporated here.
Therefore it would have been obvious before the effective filing date of the instant application to modify the invention of Chen’898 in view of Chen’221 that is to make the mesylate or ethanesulfonate salt in further view of Engel et. al. that is to dissolve the free base said compound in a mixture of acetone/water at 10/1 v/v and the respective acid. One of ordinary skill in the art would have been motivated to make this modification and have a reasonable expectation of success to avoid some of the potential issues of HCl salt as well as avoid the formation of methyl methanesulfonate.
Response to Arguments
Applicant's arguments filed May 10th, 2026 have been fully considered but they are not persuasive.
Applicant arguments against the NSDP rejections are identical to the arguments provided against the prior art rejections above. See applicants remarks page 8 paragraph 4 and page 9 paragraphs 1 – 5.
The examiner’s response to applicants arguments against the NSDP rejection are given above in the response to applicants prior art arguments.
Conclusion
Claims 1 – 2, 4, and 6 – 10 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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