DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-16 are pending in the instant application.
Priority
This application was filed on December 27, 2023, which claims the benefit of and priority to U.S. Provisional Patent Application No. 63/435,883, filed December 29, 2022.
Information Disclosure Statements
Applicants’ Information Disclosure Statements, filed on 01/17/2025 and 11/13/2025, have been considered. Please refer to Applicant’s copies of the PTO-1449 submitted herewith.
Status of the Claims
Claims 1-16 are under examination on the merits.
Specification
The specification is objected to for containing a phrase “the elution of mobilized radium species” at line 1 of paragraph [0013], wherein the term “mobilized” seems to be miss-spelled. The term seems to be “immobilized”, or Applicant is advised to confirm the term “mobilized” is properly used.
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 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.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McAlister et al., Applied Radiation and Isotopes, (2018), v.140, p.18-23.
Applicants’ claim 1 is drawn to a method for producing Actinium-225 via a radium generator, the method comprising: dissolving a thorium target into a thorium solution, evaporating the thorium solution thereby resulting in a dried thorium salt, reconstituting the dried thorium salt in sulfuric acid for formation of neutral thorium species, passing neutral thorium species through a cation exchange chromatography column for bulk thorium removal, and conducting extraction chromatography in a mixed resin bed thereby eluting radium.
McAlister et al. discloses a method for producing Actinium-225, the method comprising: dissolving a thorium target into a thorium solution, reconstituting the dried thorium salt in sulfuric acid for formation of neutral thorium species, passing neutral thorium species through a cation exchange chromatography column for bulk thorium removal, and conducting extraction chromatography in a mixed resin bed thereby eluting radium (see section 2.3.-2.6, p.19-20). In terms of the limitation “evaporating the thorium solution thereby resulting in a dried thorium salt” of claim 1, McAlister et al. discloses “Thorium sulfate solutions were prepared by dissolving anhydrous Th(SO4)2 in aqueous solutions of ammonium sulfate and sulfuric acid or by adjustment of thorium metal dissolved in H2SO4/HF” (see section 2.4. Dry weight distribution ratio measurments, p.19). Because a clear solution of thorium sulfate was produced in the method of section 2.3. Thorium metal dissolution, p.19, the step of “evaporating the thorium solution thereby resulting in a dried thorium salt” of claim 1 is clearly indicated in order to obtain anhydrous Th(SO4)2 from a clear solution of thorium sulfate, as being disclosed by McAlister et al. Therefore, McAlister et al. anticipates claim 1.
In terms of claim 4 wherein the radium generator is stored to allow for ingrowth of Ac-225 from decay of Ra-225, McAlister et al. teaches radium passes through both resins and is collected for future production of 225Ac from 225Ra (see section 2.6. Extraction chromatography separations, p.20)., and the radium fraction can be further processed following ingrowth of 225Ac from 225Ra to produce additional 225Ac free from any potential 227Ac impurity (see ABSTRACT, p.18).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 2-3, and 5-16 are rejected under 35 U.S.C. 103 as being unpatentable over McAlister et al. in view of Melville et al., Applied Radiation and Isotopes, (2007), v.65, p.1014-1022, U.S. Patent No. 5,809,394 (“the `394 patent”) to Bray et al. and/or US2015/0292061 (“the `061 publication”) to Fassbender et al.
Determination of the scope and content of the prior art (MPEP §2141.01)
McAlister et al. discloses a method for producing Actinium-225, the method comprising: dissolving a thorium target into a thorium solution, reconstituting the dried thorium salt in sulfuric acid for formation of neutral thorium species, passing neutral thorium species through a cation exchange chromatography column for bulk thorium removal, and conducting extraction chromatography in a mixed resin bed thereby eluting radium (see section 2.3.-2.6, p.19-20). In terms of the limitation “evaporating the thorium solution thereby resulting in a dried thorium salt” of claim 1, McAlister et al. discloses “Thorium sulfate solutions were prepared by dissolving anhydrous Th(SO4)2 in aqueous solutions of ammonium sulfate and sulfuric acid or by adjustment of thorium metal dissolved in H2SO4/HF” (see section 2.4. Dry weight distribution ratio measurments, p.19). Because a clear solution of thorium sulfate was produced in the method (see section 2.3. Thorium metal dissolution, p.19), the step of “evaporating the thorium solution thereby resulting in a dried thorium salt” of claim 1 is clearly indicated in order to obtain anhydrous Th(SO4)2 from a clear solution of thorium sulfate, as being disclosed by McAlister et al.
Melville et al. discloses a method for producing Actinium-225 for cancer therapy by photon-induced transmutation of Ra-226 by bombard a Ra-226 target. A linac dose of 2800 Gy produced about 64 µCi of Ra-225, which decays to Ac-225 illustrated by the following nuclear reactions:
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(1); and
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(2),
see Abstract, and p.1014-1015.
Ascertainment of the difference between the prior art and the claims (MPEP §2141.02)
The difference between the instantly claimed method of claims 2-3 and the method of McAlister et al. is that the prior art does not teach the radium generator contains multiple radium isotopes selected from the group consisting of radium-223, radium-224, radium-226, radium-227, radium-228, and a combination thereof. Instead, McAlister et al. teaches the radium generator contains radium-225.
Finding of prima facie obviousness--rational and motivation (MPEP §2142-2413)
The instantly claimed method would have been obvious over the method disclosed by McAlister et al. because the difference is further taught and/or suggested by Melville et al. Melville et al. discloses a method for producing Actinium-225 for cancer therapy from multiple radium isotopes radium-225 and radium-226. Specifically, Melville et al. discloses producing Actinium-225 for cancer therapy by photon-induced transmutation of Ra-226 by bombard a Ra-226 target, and a linac dose of 2800 Gy produced about 64 µCi of Ra-225, which decays to Ac-225. Therefore, Melville et al. teaches Ac-225 can be produced via a radium generator contains multiple radium isotopes of radium-225 and radium-226. Therefore, McAlister et al. in view of Melville et al. would have rendered claims 2-3 obvious.
In terms of claims 5-16, McAlister et al. does not teach the steps “evaporating the radium containing eluent, reconstituting dried radium, and conducting extraction chromatography to elute a purified radium fraction thereby constructing a radium generator”. However, these steps are common processes for preparing a radium generator for producing Ac-225 from decay of Ra-225. This separation process is further disclosed by the `394 patent and the `061 publication. The `394 patent teaches a method of obtaining a radionuclide product selected from the group consisting of 223Ra and 225Ac from a radionuclide "cow" of 227Ac or 229Th respectively; and the `061 publication teaches separation and recovery of protactinium, actinium, radium, radiolanthanides and other radionuclide fission products from a proton-irradiated thorium target through extraction chromatography, evaporation, and elution of a purified radium fraction. It would have been obvious to a person skilled in the art to arrive the matter defined in claims 2-3 and 5-16 by combining the teachings of McAlister et al. in view of Melville et al., the `394 patent and/or the `061 publication with general knowledge.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Applicant’s claims 1-16 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of co-pending U.S. Patent Application No. 19/002,194 (“the `194 application”), published as US20250218616.
Applicants claims 1-16 are drawn to a method for producing Actinium-225 via a radium generator, the method comprising: dissolving a thorium target into a thorium solution, evaporating the thorium solution thereby resulting in a dried thorium salt, reconstituting the dried thorium salt in sulfuric acid for formation of neutral thorium species, passing neutral thorium species through a cation exchange chromatography column for bulk thorium removal, and conducting extraction chromatography in a mixed resin bed thereby eluting radium according to claim 1.
Claims 1-13 of the `194 application are drawn to a method for manufacturing a radium generator, the method comprising: dissolving a target comprising thorium metal to form a target solution; evaporating of the target solution thereby generating isolated dried Thorium salt; reconstituting the isolated dried thorium salt; conducting cation exchange chromatography for bulk Thorium removal; conducting extraction chromatography; conducting eluent evaporation; conducting in-process radium reconstitution; and conducting cation exchange chromatography for barium removal, the method thereby forming the radium generator according to claim 1.
Even though present claims 1-16 are not identical as claims 1-13 of the `194 application, the two applicants contain overlapped steps of a method for manufacturing a radium generator. Since radium-225 (225Ra) can be further decayed ingrowth to 225Ac, the present claims drawn to a method for producing Actinium-225 via a radium generator would have been obvious over claims 1-13 of the `194 application drawn to a method for manufacturing a radium generator with the same process. Therefore, claims 1-16 would have been obvious over claims 1-13 of the `194 application.
Conclusions
Claims 1-16 are rejected.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong L. Chu, whose telephone number is (571)272-5759. The examiner can normally be reached on M-F 8:30am-5:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amber R. Orlando can be reached on 571-270-3149. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/YONG L CHU/Primary Examiner, Art Unit 1731
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