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 .
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.
Claims 1-16 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 claims 1-2 and 7, the phrase "derivative thereof” renders the claim indefinite because it is unclear, the term “derivative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claims refer to derivates of 5-ALA. The claims of 3-6 and 8-20 are dependent on claims 1-2 and 7 and does not specify or clarify the nature of the derivate of 5-ALA. The specification does not provide what is included by the term derivate of being structural or functional making the claims unclear. Ultimately, the metes and bounds of the claims are unclear.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al. (US Patent No. 20160361418 A1) in view of Takahashi et al. ATX-S10(Na)-photodynamic therapy inhibits cytokine secretion and proliferation of lymphocytes, Dermatological science, February 2008, Pages 174-177, Xu et al. Hypericin-photodynamic therapy inhibits the growth of adult T-cell leukemia cells through induction of apoptosis and suppression of viral transcription, Retrovirology, February 2019, Pages 1-13, Chio-Srichan et al. Toxicity and phototoxicity of Hypocrellin A on malignant human cell lines, evidence of a synergistic action of photodynamic therapy with Imatinib mesylate, Photochemistry, May 2010, Pages 100-104, Cempezo (JP 2017513952).
Regarding claims 1-16, Ishikawa teaches preventive or therapeutic composition for a therapy-resistant cancer having therapy-resistant cancer cells used in photodynamic therapy (PDT) (abstract) comprising 5-aminolevulinic acids (para. 0004) and anticancer therapeutic imatinib (relevant to claim 7) (para. 0138) or tyrosine kinase inhibitors of stem cell factor receptor (KIT) or Bcr-Abl (para. 0023). Ishikawa additionally teaches the compound tested on tumor tissues and cancer cells (ex vivo) (relevant to claims 8 and 11-13) (para. 0009) and wherein the therapy-resistant cancer includes lymphoma (para. 0079).
Ishikawa fails to teach the composition for treating drug-resistant hematological cancer wherein the cancer is resistant to lenalidomide, mogamulizumab, tretinoin or imatinib.
Takahashi teaches photodynamic therapy (PDT) used for the treatment of adult T cell leukemia, acute lymphoblastic leukemia, and acute lymphoblastic leukemia, in particular HUT102 cell lines (lymphoma) (abstract, fig.2).
Xu teaches treatment for Adult T-cell leukemia (ATL), an aggressive neoplasm, which carries a poor prognosis due to chemotherapy resistance, by administration of a photodynamic therapy (relevant to claims 2-3) (abstract).
Chio-Srichan teaches the synergistic combination of a photodynamic therapy and imatinib for the treatment of epidermoid lung carcinoma and leukemic K562 cells that are resistant to Imatinib mesylate (relevant to claims 1, 6, 9-10 and 14-16) (abstract).
Cempezo teaches the treatment of Lymphoma, preferably T-cell lymphoma, most preferably cutaneous T-cell lymphoma or erythrodermic skin T-cell lymphoma; and / or-Hematological cancer or lymphocyte leukemia by the administration of an ALA compound which is 5-aminolevulinic acid (5-ALA) or an ester thereof (Pg. 2, 5th para).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have administered the 5-ALA compound taught by Ishikawa to treat drug-resistant hematological cancer wherein the cancer is resistant to lenalidomide, mogamulizumab, tretinoin and imatinib. One would have been motivated to do so as Cempezo teaches the compound 5-ALA is used to treat hematological cancers in combination with the teachings of Chio-Srichan of a photodynamic therapy to treat leukemic K562 cells that are resistant to Imatinib. It is also known in the art that hematological cancers are resistant to lenalidomide, mogamulizumab, tretinoin and imatinib. Thus, on would use the compound and combination treatment taught by Ishikawa in treating drug-resistant hematological cancers wherein the resistant to lenalidomide, mogamulizumab, tretinoin and imatinib.
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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