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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: coating 5. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
The use of the term TRIGA® which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 6, “radionuclides,” should read “radionuclides, and”.
In line 9, “comprising” should read “comprising:”.
In line 12, “powder,” should read “powder, and”.
In line 14, “comprising” should read “comprising:”.
In line 18, “powder [[(2)]],” should read “powder [[(2)]], and”.
In line 21, “comprising” should read “comprising:”.
In line 23, “material [[(4)]],” should read “material [[(4)]], and”.
In line 25, “coating [[(5)]],” should read “coating [[(5)]], and”.
In line 30 (second page, line 3), “carriers [[(1)]],” should read “carriers [[(1)]], and”.
Appropriate correction is required.
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 A1; cited on PTO-892) in view of Sun et al. (US 2015 0320895 A1; cited on IDS filed July 17, 2023).
Rosa Grilo discloses a process for making a radionuclide-coated microsphere comprising a microsphere and radionuclide metrial (abstract; claim1). Rosa Grilo discloses that the radionuclide is milled to decrease agglomerations prior to being provided on the coating and the radionuclide material is powdered holmium oxide (claims 4 and 5), reads on the powder of instant claims 1, 6, and 7. Rosa Grilo discloses that the process used to mill the holmium oxide can be performed in isopropanol solvent (¶ 47), reads on the grinding step of instant claim 8. Rosa Grilo discloses that the powder is coated in a dispersion with a dipodal polysiloxane (¶ 10; claim 2), reads on the organofunctional material of instant claims 1-3. Rosa Grilo discloses that the milled holmium oxide can be in dispersion with the dipodal polysiloxane and the microsphere are then coated with the mixture (¶ 38; ¶ 45; ¶ 46), reads on the sub-steps of instant claims 1, 3, and 4. Rosa Grilo discloses that the microspheres are Class A or Class E glass microspheres (claims 7 and 8). Rosa Grilo also discloses that it will be understood by those skilled in the art that other classes of glass or other silica compounds including quartz can be used as the substrate material (¶ 30), reads on pure silica or glass without traces of CO2 and sodium of instant claims 5 and 12. Rosa Grilo discloses that epoxy-silane and amino-silane can be used to coat microsphere and holmium oxide (¶40), reads on the organofunctional material of instant claim 9 and 11. Rosa Grilo discloses that the radionuclide material can be irradiated in a nuclear reactor and the radioactivity can be analyzed (¶ 48; Table 1B), reads on the active carriers of instant claims 1 and 10.
Rosa Grilo does not disclose nanospheres.
Sun discloses a radioactive nanoparticle comprising a nanoparticle core and a radioisotope (abstract, claim 1). Sun discloses that the radioactive nanoparticle has a size of about 30 – 500 nm (claim 1) and can be used for brachytherapy (claim 16).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rosa Grilo to substitute microspheres with nanospheres to make active carriers comprising radionuclides. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Sun teaches nanoparticles can be used to make radioactive nanoparticles for therapeutic applications. Further, a person of ordinary skill in the art would have been motivated to use nanosphere as taught by Sun because relatively large particle size of microspheres limits penetration into tissues such as non-vascular tumors. Accordingly, applying the teaching of Sun to the method of Rosa Grilo constitutes no more than the predictable use of prior art elements according to their establishes functions and therefore renders instant claims obvious.
Conclusion
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