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 .
Status of Claims
Claims 63-69 and 72-73 are pending in the instant application. Claims 64-68 are amended and claims 1-62 and 70-71 are cancelled via the amendment filed January 1st, 2026.
Withdrawn Rejections
Applicant’s arguments and amendments, filed January 1st, 2026, with respect to the 112(b) rejection of claims 1-5, 11-12, 35-41 and 64-68 have been fully considered and are persuasive. The 112(b) rejection of claims 1-5, 11-12, 35-41 and 64-68 has been withdrawn.
Applicant has overcome this rejection by cancelling claims 1-5, 11-12, 35-41 and amending claims 64-68 to remove “about”.
Applicant’s arguments and amendments, filed January 1st, 2026, with respect to the rejection under 35 USC 103 of claims 1-5 and 11-12 over NCT04892017 in view of Chowdhury have been fully considered and are persuasive. The 35 USC 103 rejection of claims 1-5 and 11-12 has been withdrawn.
Applicant has overcome this rejection by cancelling claims 1-5 and 11-12.
Applicant’s arguments and amendments, filed January 1st, 2026, with respect to the rejection under 35 USC 103 of claims 1-3, 11-12 and 35-41 over NCT04892017 in view of Chowdhury have been fully considered and are persuasive. The 35 USC 103 rejection of claims 1-3, 11-12 and 35-41 has been withdrawn.
Applicant has overcome this rejection by cancelling claims 1-3, 11-12 and 35-41.
Applicant's arguments filed January 1st, 2026, with regard to the 35 USC 103 rejection of claims 63-69 and 72-73 over Flynn, in view of Dhillon and Chowdhury have been fully considered but they are not persuasive.
See response to remarks below.
Response to Remarks
In the response filed on January 16th, 2026, Applicant has traversed the rejection of claims 63-69 and 72-73 under 35 USC 103.
Applicant has traversed the rejection on the grounds that there is no teaching, suggestion or motivation to combine a compound of formula (I) and ripretinib with any reasonable expectation of synergistic success, see page 5 of the remarks. Applicant further traverses the rejection on the grounds that only through the present disclosure is there a demonstration of a synergistic result. Applicant provides Example 5 and Figures 11A-11D of the present application as a demonstration of unexpected synergism, by way of treating a GIST-T1 cancer model.
The Examiner has considered the traversal fully but must disagree for the following reasons.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02 (d) and MPEP 716.02 (e).
An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closes prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979).
Applicant refers to alleged efficacious activity against GISTs with a combination of a compound of formula (I) and ripretinib; however, even if the results were considered unexpected, the results would not be commensurate in cope with the scope of the claims. Further, the results provided do not occur over the entire claimed range (a therapeutically effective amount of a compound of formula (I) and a therapeutically effective amount of ripretinib) of present claim 63. In Example 5, as seen in Figures 11A-11D, 1μ M and 50mg/kg of a compound of formula (I) and 50nM and 25mg/kg of ripretinib was tested, however, the present claims do not require a specific dosage amount.
Regardless, Applicant has not compared the unexpected results provided to the prior art to effectively rebut the prima facie case of obviousness previously set forth.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
As Flynn teaches a compound of instant formula (I) is used to treat gastrointestinal stromal tumors and Dhillon teaches that ripretinib treats gastrointestinal stromal tumors, it would have been prima facie obvious to one of ordinary skill to combine them to form a third composition suitable for the same utility.
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, as explained above, the motivation to combine arises from it being prima facie obvious to one of ordinary skill in the art to combine two compositions known in the art for being useful in the treatment of the same disease/disorder to form a third composition the two for the same utility.
Therefore, the rejection below is maintained.
Maintained 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.
Claim(s) 63-69 and 72-73 stand rejected under 35 U.S.C. 103 as being unpatentable over Flynn et al (US 2020/0354352 A1) in view of Dhillon et al (Drugs (2020) 80:1133–1138) and Chowdhury et al (US 2025/0064804, which claim priority to 63/265,240, filed 12/10/2021).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Flynn teaches a method of treating cancer, wherein the cancer is gastrointestinal stromal tumors, comprising administering to the patient a therapeutically effective amount of the following compound (claims 77 and 90-91):
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This compound is embraced by instant Formula (I).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not explicitly teach that DCC-3116 is administered to the patient in a dosage range from about 20 mg to 600 mg and in combination with repretinib.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Further, Dhillon teaches that ripretinib treats gastrointestinal stromal tumor (abstract).
As Flynn teaches that the compound of instant formula (I) treats gastrointestinal stromal tumor and Dhillon teaches that ripretinib treats gastrointestinal stromal tumor, one of ordinary skill in the art would have been motivated to combine to two for the same purpose, treating gastrointestinal stromal tumor.
See MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Further, Chowdhury teaches a method of treating cancer in a subject in need thereof with a combination therapy, which includes the administration of DCC-3116 (claim 27, which finds support in claim 26 of the priority document). Chowdury further teaches that the DCC-3116 is administered at a dose of 10 mg to 2000 mg, once daily (claim 31, which finds support in claim 31 of the priority document).
As such, one looking to optimize the teaching of Flynn would have been motivated to administer the compound of formula (I) in a dosage range of 10 mg to 2000 mg and would have a r4easonable expectation of success as Chowdhury teaches a method of treating cancer with a combination including DCC-3116 at a dose of 10 mg to 2000 mg.
As such, instant claims 63-66 and 65-66 has been rendered obvious.
Regarding claims 64 and 67, Dhillon teaches that the recommended dosage of ripretinib is 150 mg orally once daily (page 1134, left column, paragraph 3).
Regarding claim 68, Dhillon teaches that in a dose escalation phase, patients received ripretinib at a dose of 100 mg once daily (page 1137, left column, paragraph 1).
Regarding claim 69, Dhillon teaches that ripretinib treats KIT drive or PDGFRA driven gastrointestinal stromal tumor (abstract).
Regarding claims 72-73, Dhillon teaches that patients with gastrointestinal stromal tumors that benefit from ripretinib are those that develop resistance to imatinib and sunitib (page 1133, right column, paragraph 2).
Conclusion
No claim is allowed.
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.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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