DETAILED ACTION
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 .
Receipt is acknowledged of Applicant’s Amendments and Arguments filed on 05/18/2026.
Claim 1 has been amended. Claims 2-22 and 24 has been canceled.
Claims 1, 23 and 25-40 are pending and presented for examination.
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.
Claim(s) 1, 23 and 25-40 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) are maintained for reasons of record in the previous office action filed on 02/19/2026.
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 nvention 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.
Applicant’s arguments filed on 05/18/2026 have been fully considered but they are not persuasive. Applicant argues the Larsen does not teach or suggest the use of the specifically recited phosphorus-containing additives, sodium hexametaphosphate (SHMP), EDTMP, or pamidronate, for stabilizing CaCO3 particles, inhibiting recrystallization, or maintaining particle size and radiolabel retention during suspension, storage, or sterilization including under autoclaving conditions. Nor does Larsen suggest any chemical strategy for stabilizing such particles while preserving retention of the radionuclide and its progeny.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., phosphorus-containing additives, sodium hexametaphosphate (SHMP), EDTMP, or pamidronate, for stabilizing CaCO3 particles, inhibiting recrystallization, or maintaining particle size and radiolabel retention during suspension, storage, or sterilization including under autoclaving conditions and chemical strategy for stabilizing such particles while preserving retention of the radionuclide and its progeny) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claims are allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Hartley G Michael can be reached at 571 272 0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights