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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 7/6/2026 is acknowledged. Regarding applicant’s argument that claim 7, as now amended, properly belongs to group I, the examiner agrees and the restriction between Groups I and II are withdrawn. Applicant traverses the restriction between Groups (I, II) and (III) on the basis that the method of Group III uses the product of Group (I, II). This is not found persuasive as a method using a product is not in and of itself evidence that the method and product are patentably indistinct groups. The method of Groups (I, II) are patentably distinct from the product of Group III for the reasons set forth in the restriction requirement. Claims 1-11 and 14 are under examination.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: thereby producing a 225 Ac solution.
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.
Claims 1-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019183724 to Harvey in view of WO2020260210A1 to Malmbeck. Harvey teaches a method for producing 225Ac solution comprising the producing and sequential separation of actinium (Ac) and radium (Ra) isotopes (Abstract; paragraphs 91-92), a step of passing a Ra-Ac solution (1) containing ions and 225Ac ions through a solid-phase extraction agent (a) that contains a compound represented by formula (A) below so as to cause the solid-phase extraction agent (a) to retain the 225 Ac ions, teaches feeding a solution containing radium and actinium isotopes through a extraction chromatography column packed with a solid-phase extraction agent (paragraph 91). Harvey teaches that under these acidic feed conditions, radium will pass through the column while actinium remains selectively retained on the resin (abstract; summary, claims). The solid-phase extraction agent utilizes diglycolamide-branched (TEHDGA) or diglycolamide-normal (TODGA) resins (paragraph 91). These DGA core structures directly correspond to the specialized diglycolamide coordinating compounds represented by the applicant's Formula A (abstract; summary, claims). Harvey teaches a step of eluting the 225Ac ions retained on the solid-phase extraction agent (a) from the solid-phase extraction agent (a) by using an acid-containing eluent (a), and passing a liquid containing an obtained eluate (2) through a solid-phase extraction agent (b) that contains a compound represented by formula (B) below so as to cause the solid-phase extraction agent (b) to retain the225Acions, washing the loaded DGA extraction resin column using an acid-containing eluent (nitric acid) to selectively strip off and recover the trapped actinium isotopes (paragraph 91). Harvey teaches routing this stripped solution sequentially through multiple tandem chromatographic extraction columns to continuously capture, re-isolate, and isolate specific actinium isotope products over successive decay intervals (paragraphs 91-92), and further a step of eluting the 225AC ions retained on the solid-phase extraction agent (b) from the solid-phase extraction agent (b) by using an acid-containing eluent (b) so as to obtain a 225 Ac solution having a higher 225Ac purity than the Ra-Ac solution, the final elution phase using concentrated acid (>10 M nitric acid) to cleanly flush the bound actinium product out of the secondary column matrices (. The resulting process yields an isolated, pure target product fraction suitable for medical radiopharmaceutical labeling, providing a significantly higher radiochemical purity than the crude mixed starting parent solutions (abstract; summary, paragraphs 33-73, 70-80, 100-104, Examples; claims).
Harvey fails to teach use of the present diglycolamide (DGA) ligand in the method.
Malmbeck teaches that a chelator that has the same structure as the presently claimed chelator is efficacious for producing 225 (abstract; paragraph 67).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to look to Malmbeck as it has the same goal as Harvey for producing AC225, and to incorporate the chelator taught by Malmbeck into he method of Harvey. The motivation for this would be to produce Ac225 solution, as desired by Harvey.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 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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/PAUL W DICKINSON/ Primary Examiner, Art Unit 1618
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