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 1-17 are pending in the present application file.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 11/28/2023 has been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
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.
Claim 2 is 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.
Claim 2 recites “crystalline modification H2” in line 7 of present claim 2. The phrase “crystalline modification H2” is not defined by the claim and one of ordinary skill in the art would not be reasonably appraised of the scope of the species encompassed by present claim 2.
Applicant can amend claim 2 to recite the specific structure or crystalline data that would define the intended species to overcome this rejection.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bladt (Bladt, Friedhelm, et al. "EMD 1214063 and EMD 1204831 constitute a new class of potent and highly selective c-Met inhibitors." Clinical Cancer Research 19.11 (2013): 2941-2951.), in view of US 9440914 B2 (Al-Abed et al.; Publication Date: 09/13/2016), US 2017/0182016 A1 (Caenepeel et al.; Publication Date: 06/29/2017) and WO 2021/102356 A1 (Narin et al.; Publication Date: 05/27/2021; International Filing Date: 11/20/2020).
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.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Bladt discloses method for treatment of glioblastoma comprising administering cMET inhibitor EMD 1214063 (or tepotinib) of present claim 1. See page 2948, right column, second paragraph.
Bladt also discloses wherein the cMET inhibitor is administered as monotherapy. See present claim 15. See page 2948, left column, penultimate paragraph.
Bladt discloses effective tumor growth inhibition and regression of established tumors by EMD 1214063 or EMD 1204831 were also observed in mice bearing ligand-independent Hs746T and HGF-dependent U87MG (human glioblastoma cell line) tumors (See supplementary Fig. S8A–S8D of Bladt).
Regarding present claim 5, Bladt does not disclose an extension in time to tumor progression. However, Bladt does disclose effective tumor growth inhibition and regression of established tumors by EMD 1214063. Tumor growth inhibition and regression would provide a reasonable expectation of success for one of ordinary skill in the art to achieve an extension of time to tumor progression. Further as the amount of time needed to meet the limitation of an extension of time is not defined, there is a reasonable expectation of success towards an extension of any amount of time in the progression of glioblastoma.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Bladt does not disclose wherein the treatment of glioblastoma is for at least 10 weeks, or the cMET inhibitor is administered for at least 11-52 weeks. See present claim 6.
Bladt does not disclose wherein a glioblastoma harboring IDH wild-type, MGMT-unmethylated or MET amplification at 7q31.2, or a combination thereof, is treated. See present claim 4.
Bladt does not disclose method of treatment further comprising radiotherapy. See present claims 7-8, 10, 13-14 and 17.
Bladt does not disclose administration of a cMET inhibitor as first or second line therapy. See present claims 9 and 11-12.
Bladt does not disclose where the treatment of glioblastoma achieves complete response. See present claim 16.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
Al-Abed discloses a method of treating an astrocytoma in a subject, wherein the astrocytoma is a glioblastoma, comprising administering to the subject an amount of a guanylhydrazone compound. See columns 5-8 for a description of the guanylhydrazone compounds as well as claims 1-2 of Al-Abed.
Al-Abed discloses where the method of treating a glioblastoma further comprises administering an anti-tumor therapy to the subject, wherein the anti-tumor therapy comprises brain tumor radiation therapy. See column 13 and claims 8-9 of Al-Abed. See present claim 7.
Al-Abed discloses where in an embodiment of the method of treating a glioblastoma, the dose of brain tumor radiation therapy is 1-60 Gy. Al-Abed also provides where the brain tumor radiation therapy can be administered before, during or after the administration of the guanylhydrazone compound. See col 13, lines 13-23. See present claims 10 and 13-14.
Caenepeel discloses a method of treating a patient diagnosed with cancer, including glioblastoma, where a sample of tumor cells obtained from the patient have the presence of focal amplification of the MET gene, the method comprising the step of administering to a patient diagnosed with cancer Compound M effective to provide a therapeutic benefit. See paragraphs [0008]-[0009], [0060], and claims 1 and 13. See present claim 3.
Caenepeel also discloses where the selective MET inhibitor is 6-{(1R)-1-[8-fluoro-6-(1-methyl-1H-pyrazol-4-yl)[1,2,4]triazolo[4,3-a]pyridin-3-yl]ethyl}-3-(2-methoxyethoxy)-1,6-naphthyridin-5(6H)-one (Compound M). See paragraph [0028]
Narin discloses methods of treating glioblastoma or gliosarcoma (IDH-wild type glioblastoma, see page 12, last paragraph) comprising administration of Coenzyme Q10 compound and radiation therapy. See pages 34-35. See present claim 4.
Narin discloses where the clinical benefit in the method of treatment of glioblastoma is complete response per RECIST 1.1 criteria. See claim 14 and page 13, last paragraph to page 15, first paragraph. See present claim 16.
Narin discloses where total radiation dose administered ranges from 1Gy to 200 Gy. See pages 48-49 of Narin. Narin provides in some embodiments, where the radiation therapy is administered to the subject for at least 2, 3, 4, 5, 6, 7 or 8 weeks. See page 48, lines 4-5. Narin also provides where the composition comprising the Coenzyme Q10 compound is administered in one or more cycles and where the cycle may encompass, for example, 8 consecutive weeks of administration followed by 4 weeks where the agent is not administered. See page 44, line 30 to page 45, line 2. Narin discloses where the composition comprising the chemotherapeutic agent is administered at least 24-144 hours before radiation therapy. See page 34, lines 9-25. See present claims 8, 11-12 and 17.
Narin discloses where the compositions and methods provided are for the treatment of glioma (e.g. glioblastoma) in a subject wherein the subject has previously failed at least one prior (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) cancer therapeutic regimen, e.g., radiation therapy or a chemotherapeutic regimen for the glioma. See page 58, lines 13-16. See present claim 9.
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).
Bladt discloses a method for the treatment of glioblastoma comprising administration of a chemotherapeutic agent, the cMET inhibitor of present claim 1. Al-Abed similarly provides a method for the treatment of a glioblastoma comprising administration of a chemotherapeutic agent and further comprising brain tumor radiation therapy. Caenepeel discloses a method for the treatment of MET amplified glioblastomas comprising administration of a selective MET inhibitor. Narin discloses methods for the treatment of glioblastoma, and further IDH-wild type glioblastoma, comprising administration of a chemotherapeutic agent and further comprising radiation therapy. Narin discloses where the therapy is administered in a cycle of up to 8 weeks and where the clinical benefit in the method of treatment of glioblastoma is complete response per RECIST 1.1 criteria. It would have been prima facie obvious for one of ordinary skill in the art to substitute the chemotherapeutic agent of Bladt with the chemotherapeutic agents of Al-Abed, Caenepeel and Narin, to provide a method of treating a glioblastoma comprising the cMET inhibitor of Bladt and further comprising radiation therapy. Bladt, Al-Abed and Narin all provide working examples and data demonstrating the efficacy of the methods of treatment, one of ordinary skill in the art would have been a reasonable expectation of success towards the treatment of glioblastoma comprising administration of the cMET inhibitor and further radiation therapy. Both Al-Abed and Narin teach radiation therapy as commonplace treatment for subjects with glioblastoma and Narin provides methods for the treatment of glioblastoma in patients who have previously received radiation therapy or a chemotherapeutic regimen for the glioblastoma.
Regarding the limitation of 10 weeks of treatment in present claim 1, and further limitation of 11-52 weeks of treatment in present claim 6, Narin provides in some embodiments, where the radiation therapy is administered to the subject for at least 2, 3, 4, 5, 6, 7 or 8 weeks. Narin also provides where the composition comprising the Coenzyme Q10 compound is administered in one or more cycles and where the cycle may encompass, for example, 8 consecutive weeks of administration followed by 4 weeks where the agent is not administered. See page 44, line 30 to page 45, line 2 and page 48, lines 4-5.
"[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05,II.A.
It would have been obvious for one of ordinary skill in the art to administer the treatment composition for the length of time necessary to achieve clinical benefit.
Therefore, the present claims are rejected.
Conclusion
Claims 1-17 are rejected.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626