DETAILED ACTION
This Office action details a first action on the merits for the above referenced application No. Claims 1-2, 4-7, 11, 13, 16, 20, 23, 26-27, 30, 33-35, 44-45, and 52 are pending in this 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
This application is a 35 USC 35 USC 371 National Stage filing of international application No. PCT/US2022/076036 filed on 7 Sep. 2022 and claims benefit under 35 USC 119(e) to US provisional application No. 63/241,262 filed on 7 Sep. 2021.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 8 Apr. 2024, 2 Aug. 2024, 24 Dec. 2025, and 28 May 2025 have been considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-7, 11, 13, 16, 20, 23, 27, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cline (The University of Georgia-Dissertation; published 2019; see IDS filed on 8 Apr. 2024).
Regarding claims 1-2, 4, 11, 13, 27, and 30, Cline discloses potassium iodide (KI) nanoparticles and pharmaceutical composition thereof prepared by mixing potassium oleate and 1-octadecene and then oleylamine is added and mixed and iodine is added that the reaction is sealed and mixed overnight. The KI nanoparticles were coated with a PMAO coating using poly(maleic anhydride alt-1-ocadecene) and peg-bis-amine. (pg. 127). Regarding claims 16, 20, and 23, the nanoparticle comprises KI as a targeting moiety that targets the NIS symporter and as an active agent. Regarding claims 5-7, Cline discloses the radiosynthesis and coating of [131I]KI coated nanoparticles (pg. 143).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-2, 4-7, 11, 13, 16, 20, 23, 26-27, 30, 33-35, 44-45, and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cline (The University of Georgia-Dissertation; published 2019; see IDS filed on 8 Apr. 2024).
Cline teaches as discussed above.
Cline does not anticipate KI nanoparticles comprising a targeting moiety or active agent other than NaI, optionally wherein the active agent is incorporated into the coating. Cline does not anticipate the claimed method of sensitizing a subject to radiation therapy or treating a subject for cancer comprising sensitizing the subject to radiation therapy, optionally ionizing radiation therapy or a method of treating a subject using a nanoparticle comprising a radioactive isotope wherein the cells express NIS or anticipate the claimed method of imaging a subject in need thereof comprising administering a nanoparticle comprising a radioisotope and detecting the radioisotope.
However, Cline teaches that the KI nanoparticles based radiosensitizer utilize the Na+/I- symporter (NIS) for improved iodide retention and superior radiosensitization. Cline teaches that KI nanoparticles after injection are degraded to release iodide ions, which unlike conventional contrast agents can be taken up by breast cancer cells through NIS (pg. 120). Cline teaches in vitro KI nanoparticle radiosensitization lethality. Cline examined the particles efficacy as a radiosensitizer and characterized various type’s radicals likely in radiosensitization under 50 leV irradiation. Cline concludes that exploitation of the sodium iodide symporter adds an additional mechanism to radiosensitive lethality through lipid bilayer disruption, causing more rapid cellular death as well as conventional DNA damage (pg. 124-125). As iodine is the active component of radiosensitization and this two-delivery method improves retention as well as internalization the exact same therapy could be performed with 131I adding radiative decay in conjunction with external ionizing radiation to the therapeutic mechanism (pg. 127). Cline teaches that 124I is a positron emitting isotope that can be used for PET and 131I has potent therapeutic potential (pg. 140). 124I will later be used in conjunction with PET imaging to evaluate the fate of the radioiodide nanoparticles and radioisotopes in vivo (pg. 142). The surface coating is easily modifiable through amine functionalization and future studies will include active targeting ligands and other surface functionality could be achieved with ease (pg. 122). Cline teaches an estimated drug loading content of 33% (pg. 142). Pegylated castor oil has been used to successfully deliver hydrophobic drugs in the clinic such as Doxorubicin (pg. 152).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify the nanoparticles of Cline (([131I])KI nanoparticles optionally PMAO coated and pharmaceutical compositions thereof) by attaching a targeting moiety that targets the NIS or active agent into the coating optionally conjugated to a component of the coating as taught by Cline because the targeting agent/active agent would have been expected to enable improved delivery to the NIS and/or enhanced cancer cell cytotoxicity.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Cline by further sensitizing a subject to radiation therapy comprising administering to a subject in need thereof an effective amount of the pharmaceutical composition and optionally treating a subject cancer by further administering one or more doses of radiation therapy optionally including ionizing radiation as taught by Cline because the sensitizing and radiation therapy would have been expected to advantageously enable enhanced lethality causing more rapid cellular death as well as conventional DNA damage.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Cline by further imaging and/or treating a subject for cancer comprising administering to the subject a diagnostically and/or therapeutically effective amount of the KI nanoparticle pharmaceutical composition wherein the nanoparticle comprises 124I for PET and the subject is imaged by PET or 131I for treating and wherein cancer cells express NIS as taught by Cline because the imaging and/or treating would have been expected to advantageously enable non-invasive in vivo imaging and/or treating NIS associated cancers.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-7, 11, 13, 16, 20, 23, 26-27, 30, 33-35, 44-45, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 26, 35, 46, and 61-68 of copending Application No. 17/424,109, in view of Cline (The University of Georgia-Dissertation; published 2019; see IDS filed on 8 Apr. 2024). This is a provisional nonstatutory double patenting rejection.
Claims 1-14, 26, 35, 46, and 61-68 of copending Application No. 17/424,109 claim a pharmaceutical composition comprising a plurality of nanoparticles wherein each nanoparticle is a nanocrystal formed from an alkali meta or alkaline earth metal and a halide where each nanoparticle has a hydrophilic coating wherein the alkali metal is sodium or potassium and halide is iodide optionally wherein the nanoparticle comprises sodium iodide and claim a method of treating cancer comprising a pharmaceutical composition of the nanoparticles.
Claims 1-14, 26, 35, 46, and 61-68 of copending Application No. 17/424,109 do not expressly claim a nanoparticle formed from potassium and iodide ions optionally further comprising a radioisotope such as 124I or 131I and wherein the coating comprises poly(maleic anhydride alt1-acotadecene) optionally wherein the nanoparticle further comprises a targeting moiety that targets NIS or an active agent incorporated in the coating or a method of making potassium iodide nanoparticles comprising reacting potassium oleate with I2 in octadecene in the presence of oleyl amine or the claimed method of sensitizing a subject to radiation therapy or the claimed methods for treating a subject for cancer optionally wherein comprising ionizing radiation and wherein the cancer expresses NIS or the claimed method of imaging subject in need thereof.
Cline teaches as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-14, 26, 35, 46, and 61-68 of copending Application No. 17/424,109 so that the nanoparticles are formed from potassium and iodide by reacting potassium oleate with I2 in octadecene in the presence of oleylamine and optionally further comprises 124I or 131I and so that the coating comprises poly(maleic anhydride alt1-acotadecene as taught by Cline because those KI nanoparticles would have been expected to advantageously enable degradation to iodide ions and uptake by cancer cells expressing the NIS and optionally advantageous PET imaging and radiotherapy.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify the nanoparticles of claims 1-14, 26, 35, 46, and 61-68 of copending Application No. 17/424,109 by attaching a targeting moiety that targets the NIS or active agent into the coating optionally conjugated to a component of the coating as taught by Cline because the targeting agent/active agent would have been expected to enable improved delivery to the NIS and/or enhance cancer cell cytotoxicity.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify claims 1-14, 26, 35, 46, and 61-68 of copending Application No. 17/424,109 by further sensitizing a subject to radiation therapy comprising administering to a subject in need thereof an effective amount of the pharmaceutical composition and optionally treating a subject cancer by further administering one or more doses of radiation therapy optionally including ionizing radiation as taught by Cline because the sensitizing and radiation therapy would have been expected to advantageously enable enhanced lethality causing more rapid cellular death as well as conventional DNA damage.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-14, 26, 35, 46, and 61-68 of copending Application No. 17/424,109 by further imaging and/or treating a subject for cancer comprising administering to the subject a diagnostically and/or therapeutic effective amount of the KI nanoparticle pharmaceutical composition wherein the nanoparticle comprises 124I for PET and the subject is imaged by PET or 131I for treating and wherein cancer cells express NIS as taught by Cline because the imaging and/or treating would have been expected to advantageously enable non-invasive in vivo imaging and/or treating NIS associated cancers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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/SEAN R. DONOHUE/
Examiner, Art Unit 1618
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights