DETAILED ACTION
Notice of Pre-AIA or AIA Status
This Office action details a first action on the merits for the above referenced application No. Claims 1 and 22-40 are pending and presented for examination. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/09/2023 was noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 03/09/2023. These drawings are acknowledged.
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.
Claim(s) 1 and 22-40 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen et al. (US 9,539,346) in view of Larsen (US 9,433,690 herein after ‘690) .
Larsen discloses pharmaceutical composition comprising one, more particles or a suspension of same or different particles comprising a degradable compound and an alpha emitting radionuclide and/or a radionuclide generating alpha emitting daughter (reads of progeny of alpha emitting radionuclide) beneficial for use in the treatment of cancer (abstract). The degradable compound (CC) selected from the group consisting of CaCO₃, PEG modified CaCO3, and/or inorganic crystal modified CaCO3. The size of the particle from 1 nm to 500 µm ( Col. 2 line 14-25). In one embodiment discloses the radionuclide selected from the group consisting of 224Ra, 212Bi, 212Pb, 223Ra, 225Ra, 225Ac, 213Bi, 211At, 227Th (Col. 2 line 13-15). In one embodiment, discloses the pharmaceutical composition prepared with an amount of radionuclide that is 1 kBq to 10 GBq or 50 MBq to 100 GBq suitable for multidose industrial scale production (Col. 2 line 35-41). Discloses a pharmaceutical composition comprising diluent, carrier, surfactant, and/or excipient and composition a particle suspension comprising monodisperse or polydisperse particles labeled with an alpha emitting radionuclide and/or a radionuclide generating alpha emitting daughter (Col. 2 line 43-46). In one embodiment, discloses a method for preparing a particle, the method comprising bringing an alpha emitting radionuclide and a biodegradable compound in contact with each other with or without using a carrier for the radionuclide. A solution comprising an alpha emitter, i.e. 224Ra solution with progeny 212Pb in mixture could be pretreated with chelate-antibody conjugate to complex 212Pb prior to particle labeling to produce a two-component therapeutic system containing a radioimmunoconjugate for 212Pb antigen-specific treatment and alpha emitter, e.g. 224Ra-particles for a general cavity treatment (Col. 8 line 55+). In one embodiment, discloses method of treating cancer in a human in need thereof, comprising administering to the human one or more therapeutic particles, wherein the one or more particles comprise: a degradable compound comprising CaCO3; and an alpha emitting 224Ra radionuclide; and daughter radionuclides of the alpha emitting ²²⁴Ra radionuclide, wherein the daughter radionuclides are 220Rn, 2¹⁶Po, and 2¹²Pb (Col. 8 line 51-55 and claim 8). The pharmaceutical composition is used in the treatment the cancer selected from the group consisting of intraperitoneal cancers, intracranial cancers, pleural cancers, bladder cancers, cardiac cancers, and cancers in the subarachnoid cavity, metastatic cancer, lung cancer, ovarian cancer, colorectal cancer, stomach cancer, pancreatic cancer, breast cancer, neoplastic meningitis, peritoneal cancer, pleural effusion, malignant mesothelioma, breast cancer, sarcomas, brain cancers like glioblastoma and astrocytoma, bladder cancer, and liver cancer (Col. 8 line 40-50 and claim 10). Additional disclosure includes the radionuclide can be conjugated to a targeting molecule by using bifunctional chelators such as DOTA.
Larsen fails to disclose phosphorus containing additive comprising EDTMP- ethylenediamine tetra(methylene phosphonic acid) and/or pamidronate.
Larsen ‘690 discloses a radiopharmaceutical solution comprising 224Ra and a complex capable of scavenging at least 212Pb. The complex comprises one or more compounds selected from the group consisting of acyclic chelators, cyclic chelators, or cyclic or noncyclic polyphosphonates. DOTMP, EDTMP, bisphosphonate, pamidronate conjugated to DOTA or TCMC. In another embodiment includes 212Pb and/or 212Bi is complexed by bone-seeking EDTMP (Col. 4 line 15-26). Yet another aspect discloses a radiopharmaceutical solution for use in treating skeletal disease, selected from the group consisting of skeletal metastases from cancers to the breast, prostate, kidneys, lung, bone, or multiple myeloma, or non-cancerous diseases causing undesired calcification including ankylosing spondylitis (Col. 4 line 50-58). In one embodiment the radioactivity of the solution 1 kBq to 1 GBq, such as 10 kBq to 100 MBq, such as 100 kBq to 100 MBq (Col.6 line 42-45). In one embodiment, 4-8 mg/ml of EDTMP was added to 224Ra solution thereby obtaining 224Ra solution with improved shelf life for use as a bone targeting radiopharmaceutical (Col.15, Example 5). Additional disclosure includes that the combination of phosphonates was not indicated for radionuclide complexation. The main purpose was to use pharmacologically active amounts of phosphonates as a secondary bone treatment to radium. Also, a non-complexing bisphosphonate, thus teaches away from using EDTMP or similar as additive to radium solutions for the complexation of daughter nuclides and have shown that when modest amounts of EDTMP is used, it is possible to complex 212Bi and 212Pb without significantly reducing the bone-seeking properties of 224Ra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate phosphorus containing additive consisting of EDTMP- ethylenediamine tetra(methylene phosphonic acid) and/or pamidronate into Larsen’s composition. The person of ordinary skill in the art would have been motivated to make those modifications because Larsen ‘690 teaches that by adding complexing agent such as EDTMP to a solution of radium the radioactive daughter can be made bone- or tumor-seeking and increase the therapeutic potential of the radium solution instead of being a health hazard (Col. 7 line 4-7) and reasonably would have expected success because both Larsen and Larsen ‘690 teaches radiopharmaceutical compositions that can be used in the same field of endeavor, such for treatment of cancer selected from the group consisting of skeletal metastases from cancers to the breast, prostate, kidneys, lung, bone, or multiple myeloma.
Conclusion
No claims are allowed at this time.
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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618