Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 26-27 and 29-33 are pending in the present application file.
AMENDMENTS
The amendment filed March 03, 2026 has been acknowledged and entered in the present application file.
Previous Claim Rejections - 35 USC § 103
Claims 1, 11-12, 15, and 19-28 were previously rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/174478 A1, in view of WO 2019/053595 A1 (international filing date - 9/11/2018; published -3/21/2019).
Applicant has amended the claims, submitted a declaration under 37 C.F.R. 1.132, and traversed the previous rejection on several grounds. Applicant has alleged there is no finding that the prior art taught an effective combination therapy comprising a PKC inhibitor and a c-MET inhibitor for the treatment of metastatic uveal melanoma, there is no finding that the prior art considered primary and metastatic uveal melanoma interchangeable (i.e., a person of skill in the art would not reasonably expect an effective treatment for primary uveal melanoma to provide the same response for treating metastatic uveal melanoma), with any reasonable expectation of success, and there is no finding that the prior art directs the skilled artisan to select IDE196 and crizotinib. Applicant provides in the declaration under 37 C.F.R. 1.132 where WO ‘478 only provides working examples for the treatment on non-metastatic uveal melanoma, the PKC compound of WO ‘478 has a completely different structural scaffold compared to the PKC inhibitor compound of the present claims and refers to unexpected results, including synergy for the combination and improved overall patient survival rates in Phase 1/2 clinical trials.
The Examiner has considered the amendment, declaration and traversal fully but must disagree for the following reasons.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant refers to the differences between the PKC inhibitors of WO ‘478 and the PKC inhibitor of the present claims; however, WO ‘595, which can be used in modifying the method of WO ‘478, discloses the same PKC inhibitor of the present claims. It is routine for one of ordinary skill in the art to substitute different members of the same class of compounds within a disclosed method of treatment and the disclosure of methods of treatment of a metastatic uveal melanoma comprising administration of various PKC inhibitors would provide the motivation for the skilled artisan to explore PKC inhibitors, including IDE196.
Conclusive proof of efficacy is not required to show a reasonable expectation of success. See MPEP 2143.02 (I). OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
The prior art need not provide a working example of the treatment of metastatic uveal melanoma to provide a reasonable expectation of success. Further the teaching or disclosure in the prior art of a composition comprising a PKC inhibitor and cMET inhibitor along with the disclosure of a method for the treatment of metastatic uveal melanoma comprising administration of the combination composition provides a reasonable expectation of success.
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP 2144 (IV). The court held "it is not necessary in order to establish a prima facie case of obviousness...that there be a suggestion or expectation from the prior art that the claimed [invention] will have the same or a similar utility as one newly discovered by applicant," and concluded that here a prima facie case was established because "[t]he art provided the motivation to make the claimed compositions in the expectation that they would have similar properties." In re Dillon, 919 F.2d at 693, 16 USPQ2d at 1901 (emphasis in original).
It is not necessary for the prior art the prior art to disclose where primary and metastatic uveal melanoma are interchangeable, as the prior art discloses a method for the treatment of metastatic uveal melanoma comprising administration of crizotinib and the PKC inhibitor. Further, the prior art need not disclose or suggest same the motivation to substitute the PKC inhibitor of WO ‘595 in the method of treatment of WO ‘478, however; as the references disclose PKC inhibitors for the same utility, the substitution is obvious.
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 also MPEP 2123.
The prior art discloses combinations comprising a PKC inhibitor and cMET inhibitor for the treatment of metastatic uveal melanoma. There is a reasonable suggestion in the prior art to one of ordinary skill in the art where the combination of a cMET inhibitor, including crizotinib, and a PKC inhibitor is suitable for the treatment of primary uveal melanoma and metastatic uveal melanoma.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., synergy between crizotinib and the PKC inhibitor of the present claims and clinical trial data) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 WO ‘478 and WO ‘595 both teach a composition suitable for the treatment of metastatic uveal melanoma, it would have been prima facie obvious to one of ordinary to skill to combine these compositions to form a third composition suitable for the same utility,. There would be a reasonable expectation of success for one of ordinary skill in the art based on the efficacy and utility disclosed in the prior art disclosures, particularly from WO ‘478 which discloses the combination of a cMET inhibitor and PKC inhibitor for the same purpose.
The previous rejection is maintained in an amended form necessitated by Applicant’s amendments.
Information Disclosure Statement
The Information Disclosure Statement filed 03/03/2026 has been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements has been considered by the Examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 26-27 and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/174478 A1, in view of WO 2019/053595 A1 (International Filing Date - 9/11/2018; Publication Date -3/21/2019).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
WO ‘478 discloses a method of treating metastatic uveal melanoma, or a tumor having a GNAQ or GNA11 mutation (“GNAQ/11 tumor”), in a patient, comprising administering a cMET inhibitor and a protein kinase C (PKC) inhibitor. See page 3, 56 and claims 14-16.
WO ‘478 discloses where the cMET inhibitors of the invention comprise crizotinib. See page 1, 15, and 39 of WO ‘478.
WO ‘478 discloses the simultaneous, separate or sequential administration of the PKC inhibitor and cMET inhibitor within the method of treating metastatic uveal melanoma (see present claims 30-32). See abstract, page 23 and 50, and claim 10.
WO ‘478 discloses where the combination of a cMET inhibitor and PKC inhibitor may be prepared in a manner suitable for oral administration (see present claim 33). See page 50.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
WO ‘478 does not disclose where the PKC inhibitor is represented by Formula II.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
WO ‘595 discloses a method of treating metastatic uveal melanoma, or a tumor having a GNAQ or GNA11 mutation (“GNAQ/11 tumor”), comprising administration of PKC inhibitor, where the PKC inhibitor has the structure of the compound of present claims 26-27 and 29. See pages 3 and 5-6 as well as claims 1 and 20.
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 WO ‘478 and WO ‘595 both teach a composition suitable for the treatment of metastatic uveal melanoma, it would have been prima facie obvious to one of ordinary to skill to combine these compositions to form a third composition suitable for the same utility. There would be a reasonable expectation of success for one of ordinary skill in the art based on the efficacy and utility disclosed in the prior art disclosures, particularly from WO ‘478 which discloses the combination of a cMET inhibitor, including crizotinib, and PKC inhibitor for the same purpose.
Conclusion
Claims 26-27 and 29-33 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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