DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 41-43 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 1-40 and 44 are canceled. Claim 41 is amended.
Response to Amendment
The amendments filed on 9 Mar. 2026 have been entered.
Response to Arguments
In view of the Approved terminal disclaimer, the rejection of claims 1-11 of US patent No. 11,040120 B2, in view of Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2013) is withdrawn.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) 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2013), in view of Ciesielski et al. (J. Incl. Phenom. Macrocycl. Chem.; published 2011) and Müller et al. (US 2013/0310537 A1; published 21 Nov. 2013) for the reasons cited in the Office action filed on 18 Dec. 2025.
Applicants Arguments
Applicants assert that Müller discloses an old school method of eluting the gallium-68 from its generator through a cation exchange cartridge in order to avoid metal impurities. Müller discloses DTPA as a chelator for gallium-68. The skilled artisan would at most selected DTPA as a chelator to functionalize the targeting agent. Here, DTPA is used as an additional element in the radiolabeling reaction to compete with the actual chelator linked to the targeting molecule for metal impurities co-eluted from the gallium-generator. Fugazza and Müller disclose opposite technologies and the skilled artisan would never combine their mutual teachings. Fugazza uses a formate/formic acid buffering system. The difference in buffering system and need or not of heating is further evidence of the skilled person not being able to combine the teachings. Fugazza points away from using acetate buffers. Ciesielski discloses in a general manner that beta-cyclodextrin can chelate certain transition metal in a total different context of either Fugazza or Müller.
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 chelating functionalized targeting agent such as a DOTA peptide or NOTA peptide with 68Ga wherein the method and kit use a suitable amount of buffer suitable at least to balance an acidic pH eluate from a 68Ga generator to a pH value of 3.5-5 when the generator is eluted in the kit, and the chelate functionalized targeting agent able to chelate 68Ga in a radiolabeling reaction and a metal inhibitor such as 12-crown-4 capable of inactivating contaminant metals without interfering with the chelation between 68Ga and chelate functionalized targeting agent and wherein the method and kit allow for eluting a gallium-68 generator with an eluent comprising an acid directly in the kit and allow for radiolabeling at ambient temperature and at a pH of about 3.5 to 5. Fugazza does not prefer an acetate buffer and Fugazza is silent about a metal inhibitor that is DTPA or a monosaccharide. However, Fugazza teaches that buffers other than the formate buffer can be used. A suitable buffer is non-toxic and should be able to buffer in a pH range of 3.5 to 5. Fugazza only opines that an acetate buffer may no longer retain the required buffering capacity when elute acidity varies. Müller teaches a kit for 68Ga labeling wherein the kit preferably comprises sodium acetate buffer preferable for lyophilization. The kit is advantageous since it can be used by routine medical staff without expensive laboratory equipment. It would have been obvious to a person ordinary skill in the art before the effective filing date to modify Fugazza so that the buffer is an amount sodium acetate buffer suitable to ensure an adequate buffering capacity that maintains the desired pH with eluates having acidity that varies slightly.
Regarding the metal inhibitor, the instant claims do not require the DTPA chelator to be in reaction vessel with the chelator functionalized targeting agent at the same time prior addition of the 68Ga eluate. That is, the DTPA chelator can be added to a solution of the 68Ga and the chelate functionalized targeting agent to scavenge unreacted 68Ga and other metal ions. Fugazza teaches the use metal inhibitors such as chelators to scavenge metal ions. Müller teaches the DTPA chelator to chelate metals including 68Ga. 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 method of radiolabeling includes a metal inhibitor such as DTPA because the DTPA metal inhibitor would have been expected to advantageously enable scavenging unreacted 68Ga and other interfering metal ions.
At page 5, Fugazza teaches saccharides as suitable metal inhibitors. Ciesielski teaches saccharides including mono-saccharides as oxygen donor ligands able to O-ligate metal ions. Ciesielski teaches metal complexes of the glucose and fructose widely used in the pharmaceutical and food industries. 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 method of 68Ga radiolabeling uses a saccharide metal inhibitor that is a monosaccharide such as glucose or fructose because the monosaccharide metal inhibitor, such as glucose or fructose widely used in the food and pharmaceutical industries, would have been expected to scavenge metal impurities directly eluted from a 68Ga generator whereby enabling simpler and more efficient PET studies in human subjects.
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