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
The instant application is a 371 of PCT/CN2022/125101 filed on 10/13/2022 and claims benefit of foreign applications filed on 10/15/2021 and 10/09/2022. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
Acknowledgement is made of applicant’s filing of information disclosure statement (IDS) on 07/08/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I along with GSK126 and fenofibrate as the elected species in the reply filed on 06/26/2026 is acknowledged. Accordingly, claim 78 has been withdrawn further consideration pursuant to 37 CFR 1.142(b). Claims 11-14 read on the elected invention.
Claim Rejections - 35 USC § 112(b)
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 12 and 14 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.
Regarding claim 12, the claim recites the limitation "the mass ratio of the EZH2 inhibitor to the PPAR-α agonist" in independent claim 11. However, there is no antecedent basis for this limitation in the base claim. To overcome this rejection, Applicant is suggested to amend “the mass ratio” to “a mass ratio” in claim 12.
Regarding claim 14, the use of "e.g.," in line 4 of the claim is the abbreviation of "exempli gratia" and means "for the sake of example;" thus, the abbreviation "e.g.," is given the same meaning as the phrase "for example." The phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase, “astrocytoma, oligodendroglioma”, are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, claim 14 contains the limitation of “and preferably, the brain cancer…”. The phase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). To overcome this rejection, Applicant is suggested to amend “and preferably, the brain cancer is selected from meningioma, glioma (e.g., astrocytoma, oligodendroglioma), or medulloblastoma” to “and wherein the brain cancer is selected from meningioma, glioma, astrocytoma, oligodendroglioma or medulloblastoma.
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.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (cited in IDS filed 07/08/2025, hereinafter “Hu”) in view of Tan et al. (“PPAR-α Modulators as Current and Potential Cancer Treatments”, Frontiers in Oncology, March 2021, Vol. 11, pp. 1-15, hereinafter “Tan”), and further in view of Keilhack (US2019/0083504, hereinafter “Keilhack”) and Obukowicz (WO 2003/059294 A2, hereinafter “Obukowicz”).
Hu discloses that PPAR agonist such as bezafibrate can significantly improve the effects of GSK126 on proliferation inhibition and apoptosis promotion in vitro and the growth suppression of CDX tumors in vivo. The reference suggests that the combination of bezafibrate and GSK126 has synergistic effects on pancreatic cancer (PC), and the molecular mechanism thereof may be related to the enhanced inhibition of the Wnt/f3-catenin signaling pathway. In the study, the mice are randomly divided into the following groups: (1) control group, in which the mice are treated with vehicle daily; (2) bezafibrate treatment group, in which the mice are treated with bezafibrate, 150mg/kg/d, intraperitoneally; (3) GSK126 group, in which the mice are treated with GSK126, 150mg/kg/d, intraperitoneally; and (4) bezafibrate combination with GSK126 group (1:1 ratio), in which the mice are treated with the above-mentioned two drugs (see abstract; section 2.1 and section 2.8; Discussion).
Hu differs from the instant invention primarily in that Hu uses benzafibrate rather than fenofibrate
Tan is supplied as a supplement reference to demonstrate that both fenofibrate and bezafibrate are well known PPAR-α agonist and that fenofibreate is useful in the treatment various cancers, including breast, prostate, pancreatic cancer, lung cancer, colorectal cancer, liver cancer, esophageal cancer, glioblastomas, melanoma, angiosarcomas, etc… (abstract; pages 1-2; 5-11; Table 2).
Keilhack is introduced as a supplemental reference to demonstrate that GSK126 is a known EZHZ inhibitor useful in various cancer or tumor treatment, wherein GSK126 is prepared/delivered in various pharmaceutical dosage forms (entire documents: abstract; para. [0007], [0010]-[0018], [0100], [127]).
Obukowicz is introduced as a supplemental reference to demonstrate that fenofibrate is known PPAR-alpha agonist in treatment of various cancers or tumors as an adjunctive therapy agent wherein said agent is preapared/delivered in various pharmaceutical dosage forms (entire documents; abstract; para. [0023], [0025]. [0031]. [0124]-[0125], [0127]-[0130], [0154]).
It would have been obvious to one of ordinary skill in the art to substitute fenofibrate for bezafibrate in Hu’s composition because both compounds are known PPAR-α agonists and are recognized as members of the same class. The substitution would merely involve replacing one known PPAR-α agonist with another known PPAR-α agonist having a documented anticancer utility, with a reasonable expectation that fenofibrate would likewise enhance the anti-solid tumor effect of GSK126. The prior art thus provides both a motivation to make the substitution and a reasonable expectation of success.
As discussed above, Hu expressly teaches coadministration of the PPAR agonist and GSK126 in a 1:1 ratio. The claimed range of GSK126:fenofibrate = 1:1 to 1:10 overlaps and is adjacent to the ratio taught by Hu. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, thus addressing the specific mass ratio of GSK126 and fenofibrate “from 1:1 to 1:10”. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Where a claimed range overlaps or is close to a range disclosed in the prior art, the burden is on applicant to show that the claimed range is critical or yields unexpected results. No such criticality is apparent on the present record.
Moreover, once fenofibrate is substituted for bezafibrate as taught by Tan, selection of an appropriate mass ratio within the claimed range would have been a matter of routine optimization by one of ordinary skill in the art, especially cancer treatment art. The claimed ratio range merely reflects an expected dosage adjustment for the known combination of two known therapeutic agents and does not patentably distinguish over the teachings of the cited art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
Conclusion
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/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
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