DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 44-50 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 1-43 are canceled. Claims 44-50 are previously presented.
Response to Amendment
The amendments filed on 10 Mar. 2026 have been entered.
Response to Arguments
In view of the approved terminal disclaimer, the rejection of claims 44-50 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US patent No. 11,045,563 B2, in view of Müller et al. (US 2013/0310537 A1; published 21 Nov. 2013), in view of Eder et al. (Pharmaceuticals; published 30 Jun. 2014) and Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2013) is withdrawn.
In view of the approved terminal disclaimer, the rejection of claims 44-50 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US patent No. 11,040,120 B2, in view of Müller et al. (US 2013/0310537 A1; published 21 Nov. 2013), Eder et al. (Pharmaceuticals; published 30 Jun. 2014) and Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2013) is withdrawn.
In view of the approved terminal disclaimer, the rejection of claims 44-50 on the ground of nonstatutory double patenting as being unpatentable over claims 41-43 of Copending Application No. 17/324,243, in view of Müller et al. (US 2013/0310537 A1; published 21 Nov. 2013), Eder et al. (Pharmaceuticals; published 30 Jun. 2014) and Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2013) is withdrawn.
In view of the approved terminal disclaimer, the rejection of claims 44-50 on the ground of nonstatutory double patenting as being unpatentable over claims 40-42 and 44-51 of Copending Application No. 17325,258, in view of Müller et al. (US 2013/0310537 A1; published 21 Nov. 2013), Eder et al. (Pharmaceuticals; published 30 Jun. 2014) and 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 (WO 2013/024013 A2; published 21 Feb. 2013) is withdrawn.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) 44-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Müller et al. (US 2013/0310537 A1; published 21 Nov. 2013), in view of Eder et al. (Pharmaceuticals; published 30 Jun. 2014) and Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2013) for the reasons cited in the Office action filed on 8 Jan. 2026.
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. This is not a direct elution step. Eder uses different radiolabeling conditions. Eder uses a cation exchange column to avoid breakthrough and impurities co-eluted from the gallium-68 generator like Müller does. Eder does not mention the use of acetate buffers during radiolabeling but in fact uses HEPES buffers again in contrast to what Fugazza does. A skilled artisan would not combine the teachings of Fugazza and Müller since they actually disclose the opposite. Fugazza points away from acetate buffers and uses formate/formic acid buffers and sequestering agent. The difference in buffering system, the need or no of heating, and the use of cation exchange columns vs sequestering agents is further evidence of the skilled person not being able to combine these teachings and even when doing so would not automatically and up with the claimed methods.
Applicant's arguments filed 10 Mar. 2026 have been fully considered but they are not persuasive. Müller provides a kit for radiolabeling a chelator functionalized targeting agent with 68Ga wherein the kit comprises preferably sodium acetate in an amount sufficient to balance an acidic pH from a 68Ga generator when the generator is eluted in the kit and a chelator functionalized targeting agent that chelates 68Ga in radiolabeling conditions wherein preferable sodium acetate buffer salt and the chelator functionalized targeting agent are co-lyopilized in the reaction vial and wherein the kit allows the chelator functionalized targeting agent to be labeled with 68Ga in radiolabeling conditions at an ambient temperature for a time from about 5 min to 15 min. Müller is silent about an HBED chelator. However, Eder teaches the HBED-CC as a highly effective chelator that allows for 68Ga fast labeling at ambient temperature to form a Ga-HBED-CC having high kinetic stability. At Fig. 1, Eder teaches near quantitative 68Ga-labeling of the HBED-CC-c(RGDyK) model peptide in less than 1 min at room temperature. At pgs. 783-784, Eder teaches a kit for 68Ga labeling of PSMA-HBED-CC where the 68Ga labeling uses a 1.5 M acetate buffer pH 4.5. 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 kit of Müller so that the chelator functionalized peptide is an HBED functionalized peptide such as HBED-CC-c(RGDyK) or PSMA-HBED-CC as taught by Eder because the HBED chelator would have been expected to advantageously enable near quantitative 68Ga labeling in about 2 min at an ambient temperature.
Müller provides a kit that requires a cation exchange cartridge to remove contaminant metals from a 68Ge/68Ga generator eluate. Fugazza provides a kit for 68Ga-labeling that replaces a cation exchange cartridge with a metal sequestering agent that allows for direct elution of 68Ga from a generator with an eluent comprising HCl.
“We have repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the … combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient.” See Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006).
In this case, modification of Müller simply requires the addition of a metal sequestering agent to the reaction vial of the kit. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the kit of Müller so that the kit of Müller allows for direct elution of 68Ga from a generator with an eluent comprising HCl as taught by Fugazza because it would have been expected to advantageously enable a simpler and more efficient kit capable of allowing for direct elution of 68Ga in a HCl solution from a 68Ga generator.
Müller prefers a sodium acetate buffer for a lyophilized kit that and Eder used an acetate buffer for kit labeling with 68Ga. Fugazza does not teach a lyophilized kit or an HBED chelator. While Fugazza prefers sodium formate buffer, Fugazza teaches that other buffers can be used. Fugazza only opines that acetate buffers may no longer retain buffering capacity when the eluate acidify varies. A person of ordinary skill in the art when contemplating a lyophilized kit for 68Ga labeling would have used that acetate buffer that Müller teaches as preferred for the lyophilized kit therein and adjusted the amount of acetate to ensure adequate buffering capacity.
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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/SEAN R. DONOHUE/
Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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