DETAILED ACTION
Claims 1-2 are pending in the instant application.
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 claims priority to 371 of PCT/TR2023/050333 filed 04/10/2023 which claims priority to turkiye 2022/007524 filed 05/09/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Tapsin (Mechanism of Boron Derivatives For Treatment of Renal Cell Carcinoma, Thesis, 2014), Bendel (Biomedical applications of 10B and 11B NMR, NMR IN BIOMEDICINE, 2005) and Dynamic Science Corp (WO 2019/181018A1).
Tapsin discloses that in recent years, boron derivatives have been used as a targeted drug for cancer cells (pg v). Tapsin discloses that low dietary of boron is associated with lung cancer. Studies showed that boron compounds have antioxidant and anti-inflammatory effects (pg 18, 2nd paragraph). In this study, the mechanism of three boron derivatives as sodium pentaborate pentahydrate (NaB), boric acid (BA) and a type of boronic acid called bortezomib (B) has been investigated on ACHN and A498 renal carcinoma cell lines and human primary renal proximal tubule epithelial cells (RPTEC) (pg 57). Results suggest that NaB and BA have anti-carcinogenic effects for A498 and ACHN cancer cells while non-toxic effect for RPTEC normal renal cells (pg 58). This study showed for the first time that, different boron derivatives might be an effective carcinogenic treatment for renal cancer. Moreover, our results were the first findings and evidences about the mechanism of boron derivatives on cell proliferation, cell migration and cell death for ACHN, A.498 and RPTEC cell lines. NaB and BA were effective as much as Boron but less toxic (pg 66).
Tapsin does not disclose boron isotopes.
Bendel discloses investigation of molecules used for boron neutron capture therapy (BNCT) by 10B and 11B NMR. Boron-containing molecules (also called BNCT agents) enriched in the 10B isotope are targeted to the tumor and irradiated with thermal and epithermal neutrons (Abstract). Briefly, BNCT can be classified as a binary cancer treatment, wherein two components, each administered at sub-toxic levels, are combined (ideally within cancer cells) to produce the desired cell-killing effect. The two components of the binary system are 10B nuclei and low-energy (thermal or epithermal) neutrons (pg 74, BNCT Section).
Dynamic Science Corp discloses that in the present invention, a drug for boron neutron capture therapy (BNCT) that is highly accumulated in cancer cells using amino acids, amino sugars, and oligopeptides is chemically bonded to stable nanosilica, and a drug delivery system. BNCT is a boron isotope compound. BNCT can kill cancer cells and malignant tumor cells without affecting normal cells if boron isotope compounds can be selectively accumulated in cancer cells (pg 1).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to create a sodium pentaborate pentahydrate enriched with boron isotope for killing cancer cells. These compounds are known to exhibit anticancer properties. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 2, NaB is effective for eliminating renal carcinoma cells as discussed above.
Conclusion
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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