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 .
Response to Arguments
Applicant's arguments, filed July 22, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Drawings
Applicants amended the drawings filed July 22, 2026, the issues identified in the January 22, 2026 Office Action have been fully resolved. Therefore, the drawings received on July 22, 2026 are acceptable.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rosa Grilo et al. (US 2022 0370652) in view of Sun et al. (US 2015 0320895; cited on IDS filed July 17, 2023).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed January 22, 2026 and those set forth herein.
Applicant argues that Rosa Grilo does not teach at least the defined sequence and the distinct nanospheres. Applicant argues that Sun does not remedy Rosa Gilo’s deficiencies because Sun does not teach coating a nanoparticle with an inactive powder and subsequently activating it. Applicant argues that Sun’s metallic core-shell chemical synthesis using pre-existing radioisotopes cannot be obviously combined with Rosa Grilo’s matrix. Applicant argues that the claimed invention solves the problem of delivering radionuclides at the nanoscale by adapting a specific inorganic/organofunctional powder-coating process and subsequent activation sequence.
This argument is unpersuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. As discussed in the Office Action mailed January 22, 2026, Rosa Grilo teaches radionuclide powder (powdered holmium oxide), organofunctional material (dipodal polysiloxane), dispersing agent (isopropanol), grinding step, dispersion step, coating step, and activation step which read on claimed materials and steps. While Rosa Grilo utilizes micro-scale carriers, it explicitly teaches the step of irradiating a radionuclide in a nuclear reactor. It is also obvious to a POSITA to delay radioactivation until after carrier formation to minimize radiation exposure to personnel and reduce handling hazards. The rejection does not rely on combining the entirety of Sun’s process with Rosa Grilo’s matrix formulation. Rather, Sun is cited as a secondary reference for its explicit teaching that a nanosphere-sized particle is advantageous for radiation therapy. A POSITA seeking to improve tissue penetration and cellular uptake would have been motivated to modify Rosa Grilo’s method by substituting its microspheres with nanospheres. Such a modification represents a straightforward optimization of a known physical parameter (particle size) in order to apply a known element to a known method to achieve a predictable result. The functional mechanics of Rosa Grilo’s method remain identical regardless of whether the substrate is micro-scale or nano-scale. Applying the exact process of Rosa Gilo to a nanosphere substrate instead of a microsphere substrate does not alter the fundamental mechanism of the process, nor does it represent a patentable distinction. Further, Applicant has not provided comparative test data or objective evidence demonstrating any unexpected results or critical technical synergy resulting from applying Rosa Grilo’s method specifically to nanosphere-scale carriers compared to micro-scale carriers. Delaying radioactivation until after carrier formation is obvious to a POSITA to minimize radiation exposure to personnel and reduce handling hazards, as post-synthesis activation is a well-known technical strategy in the art. The challenge of handling short-lived or hazardous radioactive materials during multi-step chemical synthesis is a routine, known problem in radio-pharmaceutical manufacturing. The problem of managing particle size, coating efficiency, and delayed activation during chemical synthesis is an inherent challenge in the field of radio-pharmaceutical manufacturing rather than a novel issue identified solely by Applicant. It is also known that a radionuclide can be milled to decrease agglomeration prior to being provided in the coating as taught by Rosa Grilo. Therefore, addressing this standard technical problem using known prior art techniques yields expected results and does not impart patentable distinction.
Conclusion
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 JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley 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.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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