DETAILED ACTION
This Office action details a non-final action on the merits for the above referenced application No. Claims 40-42, and 44-51 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 .
Status of Claims
Claims 1-39 and 43 are canceled. Claims 40 is amended.
Response to Amendment
The amendments filed on 5 May 2025 have been entered.
Response to Arguments
In view of applicants’ amendments, the rejection of claims 41-42, 44-45 and 51 under 35 USC 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn.
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) 40-42, 44-49, and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2023), in view of Ciesielski et al. (J. Incl. Phenom. Macrocycl. Chem.; published 2011) for the reasons cited in the Office action filed on 19 Dec. 2025.
Claim(s) 40-42 and 44-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2023), in view of Ciesielski et al. (J. Incl. Phenom. Macrocycl. Chem.; published 2011), in further view of Müller et al. (US 2013/0310537 A1; published 21 Nov. 2013) for the reasons cited in the Office action filed on 19 Dec. 2025.
Applicants Arguments
Applicants assert that Ciesielski does not even deal with radiolabeling methods and kits and merely provides a review of potential chelating effects of e.g. beta-cyclodextrin and other O-ligand metal ions (such as mono- and di-saccharides). Müller is disclosing an old school method of eluting the gallium-68 from its generator through a cation exchange cartridge in order to avoid the need for cation exchange column prior to adding the eluate to the reaction mixture that the present invention adds a metal inhibitor at the start of the radiolabeling reaction. Fugazza and Müller actually disclose opposite technologies and the skilled artisan would never combine their mutual teachings. The skilled art would not simply assume that the radiolabeling conditions of Müller could be simply swapped with those of Fugazza or vice-versa. Fugazza teaches a formate buffering system and requires heating. Müller uses a sodium or ammonium acetate buffering system or HEPES either with or without heating. Fugazza actually points away from acetate buffers.
Applicant's arguments filed 9 Mar. 2026 have been fully considered but they are not persuasive. Fugazza provides a method and kit for radiolabeling a chelate functionalized targeting agent for use in in vivo PET imaging with a metal radionuclide wherein the method and kit provide a chelate functionalized targeting agent such as a DOTApeptide or NOTApeptide able to chelate a metal radionuclide in a radiolabeling reaction and adding a metal inhibitor such as a saccharide not chemically linked to the chelate functionalized targeting agent wherein the metal inhibitor is capable of inactivating metals other than metal radionuclides without interfering with the chelation between the metal radionuclide and the chelate-functionalized targeting agent under conditions of the radiolabeling reaction and wherein the methods adds a 68Ga to the mixture of chelate functionalized targeting agent and metal inhibitor by directly eluting the 68Ga from its generator in the mixture. Fugazza is silent about a saccharide metal inhibitor that is a cyclodextrin, disaccharide or monosaccharide. Ciesielski teaches pharmaceutical applications and the use of saccharides including polysaccharides, mono- and di-saccharides to form metal complexes with different metal ions. A person of ordinary skill in the art would have reasonably considered Ciesielski in combination with Fugazza who teaches pharmaceutical methods and the use of saccharides to chelate different metal ions. Ciesielski teaches the mono- and di-saccharides as oxygen donor ligands. Polysaccharides are able to O-ligate metal ions. Ciesielski teaches metal complexes of the β-cyclodextrin, glucose, and fructose widely used in the food and pharmaceutical industeries. A recognized advantage is the strongest reason to combine. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Fugazza so that the saccharide metal inhibitor used in the method or kit is a β-cyclodextrin, glucose, fructose or di-saccharide would because those metal inhibitors would have been expected to advantageously provide sequestering agents widely used in the food and pharmaceutical industries and capable of complexing a wide range of metal impurities.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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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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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618