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 .
Response to Arguments
Applicant's arguments filed 06/04/2026 have been fully considered but they are not persuasive. Applicants’ argument with respect to the 103 rejection of claim 1 over Jou et al. (US 20120129869 A1) is rendered moot on the basis of Jou teaches the ALK inhibitor of Crizotinib. From the previous office action, the teachings of Jou were highlighted which included Crizotinib but was mistakenly not used to reject claims 26 and 30.
Applicant has canceled claims 16, 24, 26, 28, 30 and added claim 33. Claims 1, 4-6, 10-11, 14-15, 20-22 and 31-33 is now evaluated on its merits
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.
Claims 1, 4-6, 10-11, 14-15, 20-22 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Jou et al. (US 20120129869 A1) in view of Guo et al. EML4-ALK induces epithelial-mesenchymal transition consistent with cancer stem cell properties in H1299 non-small cell lung cancer cells, Biochem and Biophysicial Research comm, February 2015, Pages 389-404, Mondal et al. Matrix metalloproteinase-9 (MMP-9) and its inhibitors in cancer: A minireview, Euro Journal Med Chem, March 2020, Pages 1-7 and Muller et al. Anaplastic lymphoma kinase inhibition in metastatic non-small cell lung cancer: clinical impact of alectinib, Onco Targets Ther; September 2017, Pages 4535-4541.
Regarding claims 1, 4-6, 10-11, 14-15, 20-22 and 31-33, Jou teaches a method of diagnosing and treating lung cancer comprising steps of detecting ALK mutations from lung adenocarcinoma patients (relevant to claims 10 and 20) and detecting the tumorigenic activities and treating the ALK mutation lung adenocarcinoma by administration of an ALK inhibitor (relevant to claim 33) (claim 16). Jou teaches the ALK mutations from lung adenocarcinoma patients are expressed in H1299 cells lines which are EML4-ALK NSCLC cell lines (relevant to claims 21-22) (Fig. 4) are treated with an ALK inhibitors selected from WHI-P154, TAE684 and Crizotinib (relevant to claim 6).
In reference to claims 4-5 and 14-15, applicant’s specification page 11 paragraph 00058, EML4-ALK is known in the art with the absence of an inhibitor to be “of oncogenic RTK fusion protein in the tumor cells dramatically suppress signaling through the transmembrane RTKs by sequestration of downstream effectors for the transmembrane RTKs”. Thus, the teaching of Jou on treating cancer tumor cells associated ALK fusion protein which comprises inhibiting EML4-ALK read to the limitations of claims 4-5 and 14-15 and will inherently “ sequester GRB2 or SOS from the above EML4-ALK downstream effector for the transmembrane RTKs as per MPEP 2112.01 (II): "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Jou fails to teach the treatment in combination with a MMP inhibitor and the ALK inhibitor of alectinib.
Gou teaches the properties of EML4-ALK H1299 non-small lung cancer cells, in which MMP-2 and MMP-9, two crucial proteins involved in cancer cell metastasis, were significantly increased in cells of EML4-ALK expression compared with control cells. Additionally, EML4-ALK in H1299 cells attributed to increased expression of MMP2 and MMP9, modulating invasive migration during EMT (abstract, Page 400 2nd column 1st para.)
Mondal teaches MMP-9 is an important therapeutic approach for combating various diseases including lung cancer (abstract, fig. 5). Inhibitors of MMP-9 can be used as anticancer agents and inhibitors of MMP-9 includes Batimastat, Marimastat, Tanomastat, Rebimastat, Priomastat and Doxycycline (relevant to claim 1).
Muller teaches that in non-small cell lung cancer (NSCLC) tumors, 5% harbors an anaplastic lymphoma kinase (ALK) translocation that drives tumorigenesis. The first line of defense crizotinib specifically inhibits ALK and improves progression-free survival (PFS) in treated and untreated patients by 4 months compared to standard chemotherapy. Some patients have reported to have relapsed after crizotinib treatment due to resistance mutations in ALK. Thus, the second-generation ALK inhibitor alectinib has been approved for ALK-rearranged NSCLC after patients progressed on crizotinib. Alectinib is able to inhibit several crizotinib and ceritinib-resistant ALK mutations in vitro. Muller additionally teaches alectinib is a more potent tyrosine kinase inhibitor and considered safer than crizotinib (abstract).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have developed a method for treating EML4-ALK NSCLC by administrating a pharmaceutical composition comprising a ALK inhibitor of EML4-ALK NSCLC cell lines of crizotinib and MMP inhibitor of Marimastat. One would have been motivated to do so from the teaching of Gou on the properties of EML4-ALK NSCLC increasing the expression of MMP-9 and the teachings of Mondal on the known inhibitor of MMP-9 of Marimastat, in combination with the teaching of Jou on the treatment of EML4-ALK NSCLC by crizotinib. There is a reasonable expectation of treating EML4-ALK NSCLC as well as increasing the efficacy of the therapeutic by administration of the ALK inhibitor crizotinib taught by Jou in combination with the MMP-9 inhibitors taught by Mondal.
It would additionally have been obvious to someone of ordinary skill in the art to interchange ALK inhibitors of crizotinib and alectinib as Muller teaches both inhibitors are approved to treat EML4-ALK NSCLC and alectinib is considered to be more potent and safer. There is a reasonable expectation of interchanging crizotinib and alectinib to treat EML4-ALK NSCLC.
In regards to claims 11 and 33, It would also have been obvious to incorporate a pharmaceutical acceptable carrier for it is known in the art and routine experimentation to include pharmaceutical excipients for delivery of therapeutics to a patient.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627 /SARAH PIHONAK/Primary Examiner, Art Unit 1627
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