DETAILED ACTION
This Office action details a non-final action on the merits for the above referenced application No. Claims 21, 26, and 32-46 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 Apr. 2026 has been entered.
Status of Claims
Claims 1-20, 22-25, and 27-31 are cancelled. Claims 21, and 32 are amended. Claims 43-46 are new.
Response to Amendment
The amendments filed on 17 Apr. 2026 have been entered.
Response to Arguments
In view of Applicants amendments, the rejection claims 27-31 under 35 USC 103 as being unpatentable over Mariani et al. (WO 2021/001360 A1; published 2021), in view of Luna-Gutiérrez et al. (J. Radioanal. Nucl. Chem.; published 2017) is withdrawn.
In view of Applicants amendments, the rejection of claims 21-42 under 35 USC 103 as being unpatentable over Mariani et al. (WO 2021/001360 A1; published 2021), in view of Luna-Gutiérrez et al. (J. Radioanal. Nucl. Chem.; published 2017), in further view of Fugazza et al. (WO 2013/024013 A2; published 2013) is withdrawn.
In view of Applicants amendments, the rejection of claims 21-42 under 35 USC 103 as being unpatentable over Ray et al. (WO 2017/165473 A1; published 2017), in view of Luna-Gutiérrez et al. (J. Radioanal. Nucl. Chem.; published 2017), in further view of Fugazza et al. (WO 2013/024013 A2; published 2013) is withdrawn.
Claim Objections
Claim 21 is objected to because of the following informalities: “radioactive isotope 64Cu” should be “radioactive isotope is 64Cu”. Appropriate correction is required.
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) 21, 26, and 32-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mariani et al. (WO 2021/001360 A1; published 2021), in view of Luna-Gutiérrez et al. (J. Radioanal. Nucl. Chem.; published 2017) and Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2013).
Mariani et al. teach prostate specific membrane antigen (PSMA) ligands and uses thereof (see title). Mariani et al. teach PSMA-R2
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(pg. 9) and 68Ga-PSMA-R2 (pg. 11-). The results show that the after 1 h, the kidney uptake and the salivary gland uptake are lower for 68Ga-PSMA-R2. Moreover, the high tumor to kidney ratio after 1 h suggest a better visualization of the tumor in the case of 68Ga-PSMA-R2 (pg. 22). Mariani et al. teach 64Cu and 67Ga (pg. 9). Mariani et al. teach pharmaceutical compositions comprising a pharmaceutical carrier (pg. 13). The preferred methods of the invention are vacuum-drying and freeze-drying techniques which yield a powder of the active ingredient plus any additional desired ingredient from a previously sterile filtered solution (pg. 13).
Mariani et al. do not teach the claimed kit comprising i) a first vial of consisting of the following components in dried form a) a PSMA ligand of formula (II) in an amount between 10 and 100 mg, and b) a bulking agent mannitol in an amount between 5 and 50 mg, and ii) a second vial consisting of a buffering agent comprising formic acid and sodium hydroxide in dried form, optionally wherein formula (II) is present in an amount between 10 and 100 mg, 15 and 60 mg, or 30 mg and optionally wherein mannitol is present in an amount between 5 and 50 mg, 10 and 30 mg, or about 20 mg and formic acid and sodium hydroxide buffering agents for maintaining a pH between 2.5 and 4.0, 2.8 and 4.0, 3.0 and 4.0, or 3.2 and 3.8 and optionally wherein the kit does not contain an antioxidant such as gentisic acid. Mariani et al. do not further teach the claimed limiting method to obtain a radiolabeled PSMA-binding ligand with a high radiochemical purity, the method comprising the steps of i) providing a first vial consisting of said PSMA binding ligand and the bulking agent mannitol, in dried form; ii) adding a solution of the radioactive isotope into the first vial, and iii) mixing the solution obtained in ii) with a buffering agent comprising formic acid and sodium hydroxide and incubating for a sufficient period of time an elevated temperature for obtaining the PSMA ligand labeled with the radioactive isotope, and iv) adjusting the pH of the solution wherein the radioactive isotope is 68Ga or 67Ga, the high radiochemical purity of the radiolabeled PSMA-binding ligand is at least 92% and the incubating step is performed at a temperature comprised between 80oC and 95oC and a period of time comprised between 5 and 7 min or wherein if the radioactive isotope is 64Cu, the high radiochemical purity of the radiolabeled PSMA binding ligand is at least 92% and the incubating step is performed at a temperature comprised between 7 and 15 min, and wherein the radiolabeling method is carried out in absence of an antioxidant such as gentisic acid and optionally wherein the radiochemical purity is determined by HPLC and optionally after radiolabeling free 68Ga3+, 67Ga3+ or 64Cu3+ is in a percentage of 2% or less as determined by HPLC.
Luna-Gutiérrez et al. teach freeze-dried multi-dose kits for the fast preparation of 177Lu-Tyr3-octreotide and 177Lu-PSMA(inhibitor) under GMP conditions. From only lyophilized kit of DOTA-iPSMA it was possible to obtain from 5 to 10 doses suitable for patients. It is possible to obtain GMP-compliant 177Lu-peptides from sterile freeze-dried formulation without the need of using commercially available radiochemical synthesizers (abstract). It is possible to design freeze dried sterile formulations to obtain a lyophilized powder with the sterile solution of LuCl3 followed by heating in a vial for complete 177Lu-conjugate formation under sterile conditions (pg. 2182). Different amounts of 177Lu-iPSMA were used to evaluate the effect of the variations on the 177Lu-peptide radiochemical purity (pg. 2182). Luna-Gutiérrez et al. teach the manufacturing of freeze-dried kits. The peptide and mannitol/ascorbic acid solutions are mixed and then lyophilized for 19 h. After freeze-drying the formulation, the kit was stored at 2-8oC (pg. 2182). Luna-Gutiérrez et al. teach that radiochemical purity (reversed phase HPLC with a C18 column was evaluated in accordance with Mexican Pharmacopeia (pg. 2183). Luna-Gutiérrez et al. teach radiosynthesis. The total volume of 177LuCl3 and acetate buffer pH 5.0 was withdrawn using a sterile syringe and afterward employed for the reconstitution of the DOTA-iPSMA lyophilized kit. The reconstituted vial was heated in the dry bath at 95oC for 30 min (pg. 2183). The selected kit composition was: (1) one lyophilized vial containing 0.6 mg (DOTA-iPSMA) of the peptide, 100 mg of ascorbic acid and 50 mg of mannitol as a diluent, and (2) a second vial containing acetate buffer (pg. 2184). The lyophilized formulations were stable since the three validation batches consistently produced 177Lu-radiopharmaceuticals with radiochemical purities in agreement with established specifications (>97%) (pg. 2185).
Fugazza et al. teach a process for the preparation of complexes of 68Ga (see title). Fugazza et al. teach that the buffer should be non-toxic and able to buffer in the pH range of 3.5-5.0 (pg. 1). Depending on the selected chelator functionalized molecule heating at 75-90oC can be necessary (pg. 1). The formic acid/format buffer allows to establish the right pH and tolerate the eluate volume/acidity variation (pg. 3). Sequestering agents include polysaccharides (pg. 6). Preferably the complexation reaction is carried out at a pH of 3 to 4.5 (pg. 6). The reaction vial is heated for a short time; the product solution is collected and checked by reversed phase HPLC and ITLC (pg. 6). The invention relates to a kit comprising ultrapure formic acid/formate buffer. The kit comprising: - a siliconized vial containing the chelator functionalized molecule and a siliconized vial containing a suitable ultrapure formic acid/formate mixture. The invention relates to a single vial containing the chelator functionalized molecule and suitable ultrapure formic acid/sodium formate (pg. 7). Fugazza et al. teach reducing the amount of not complexed Ga-68 (pg. 7). Fugazza et al. teach 68GaDOTApeptide labeling using ultrapure buffer formation and NaOH (carried out in the absence of gentisic acid; pg. 8) wherein formate and NaOH are added to vial containing the 68Ga and DOTA peptide. The product was checked by reversed phase HPLC and ITLC (pg. 8).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the composition of Mariani et al. (composition comprising PSMA-R2 (instant formula (II)) so that the composition is provided as a kit consisting of a first vial consisting of the following components in dried form a) PSMA-R2, and b) bulking agent mannitol and second vial consisting of buffering agent comprising formic acid and sodium hydroxide as taught by Luna-Gutiérrez et al. and Fugazza et al. because that kit would have been expected to advantageously enable a simple and convenient GMP compliant preparation of 64Cu- or 68Ga- PSMA-R2 optionally multiple doses without the need for a commercially available synthesizer. The amounts of PSMA-R2 and mannitol are result effective variables that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. MPEP 2144.05.I. A person of ordinary skill would have arrived at an amount of PSMA-R2 that is between 10 and 100 mg, 15 and 16 mg or 30 mg through routine experimentation in order to arrive at an optimal amount of PSMA-R2 that provided high RCY, RCP and stability. A person of ordinary skill in the art would have at an amount of mannitol that is between 5 and 50 mg, 10 and 30 mg or 20 mg in order to arrive at an optimal amount of bulking agent for the dried powder. A person of ordinary skill in art would have arranged the buffering agents to maintain a pH between 2.8 and 4.0, 3.0 and 4.0, 3.2 and 3.87 as taught by Fugazza et al. because those pH values would have been expected to enable optimal complexation conditions and yields. It is prima facie to omit an ingredient if the ingredient is not required. See Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989). It would have been obvious to a person of ordinary skill in the art to omit a radiostabilizer such as ascorbic acid/gentisic acid in the case PSMA-R2 is not sensitive to radiolytic degradation.
It would have been obvious to a person of ordinary skill in the art before the art before the effective filing date to further modify Mariani et al. so that the obvious kit is used in a method for labeling PSMA-R2 comprising the steps of i) providing a first vial consisting of PSMA-R2 and mannitol bulking material in dried form, ii) adding a solution of the radioisotope (68Ga, 67Ga, or 64Cu) into the first vial to obtain a solution of the PSMA-R2 with the radioisotope, iii) mixing the solution in ii) with a formic acid and NaOH buffering agent and incubating for a sufficient period of time at an elevated temperature for obtain the radiolabeled PSMA-R2, and iv) adjusting the pH wherein the radiolabeling method is carried out in the absence antioxidants as taught by taught by Mariani et al., Luna-Gutiérrez et al., and Fugazza et al. because that labeling method would have been expected to advantageously enable a simple and convenient GMP compliant production radiolabeled PSMA-R2 under optimized conditions and suitable for administration to mammalian subjects. Regarding the contingent limitations starting with “wherein if the radioisotope is 68Ga or 67Ga” and “wherein if the radioactive isotope 64Cu”, Fugazza et al. teaches and makes obvious an incubated step performed at a temperature between 80 and 95oC or 70oC and 95oC and a periods of time between 5 and 7 min or 7 and 15 min. The radiochemical purity is both a result of obvious method steps and result effective variable that a person of ordinary skill in the art would have been motivated to optimize at the time of invention in order to obtain a GMP compliant production meeting quality control standards. Regarding the limitations requiring that after labeling, the free 68Ga3+, 67Ga3+ or 64Cu2+ is present in a percentage of less than 2% and asdetermined by HPLC, the limitations are both results obtained by the obvious method steps and result effective variables that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. Luna-Gutiérrez et al., and Fugazza et al. teach and make obvious quality control determination by HPLC. Fugazza et al. teach and suggest minimized free radiometal content. A person of ordinary skill in the art would have arrived at an amount of free 68Ga3+, 67Ga3+ or 64Cu2+ that is 2% or less through routine experimentation in order to arrive an minimal amount of contaminant radiometals.
Claims 21, 26, and 32-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mariani et al. (WO 2021/001360 A1; published 2021), in view of Luna-Gutiérrez et al. (J. Radioanal. Nucl. Chem.; published 2017) and Fugazza et al. (WO 2013/024013 A2; published 21 Feb. 2013), in further view of Müller et al. (US 2013/0310537 A1; published 21 Nov. 2013; see attached 892).
Mariani et al. teach as discussed above.
Mariani et al. do not teach the claimed kit comprising i) a first vial of consisting of the following components in dried form a) a PSMA ligand of formula (II) in an amount between 10 and 100 mg, and b) a bulking agent mannitol in an amount between 5 and 50 mg, and ii) a second vial consisting of a buffering agent comprising formic acid and sodium hydroxide in dried form, optionally wherein formula (II) is present in an amount between 10 and 100 mg, 15 and 60 mg, or 30 mg and optionally wherein mannitol is present in an amount between 5 and 50 mg, 10 and 30 mg, or about 20 mg and formic acid and sodium hydroxide buffering agents for maintaining a pH between 2.5 and 4.0, 2.8 and 4.0, 3.0 and 4.0, or 3.2 and 3.8 and optionally wherein the kit does not contain an antioxidant such as gentisic acid. Mariani et al. do not further teach the claimed limiting method to obtain a radiolabeled PSMA-binding ligand with a high radiochemical purity, the method comprising the steps of i) providing a first vial consisting of said PSMA binding ligand and the bulking agent mannitol, in dried form; ii) adding a solution of the radioactive isotope into the first vial, and iii) mixing the solution obtained in ii) with a buffering agent comprising formic acid and sodium hydroxide and incubating for a sufficient period of time an elevated temperature for obtaining the PSMA ligand labeled with the radioactive isotope, and iv) adjusting the pH of the solution wherein the radioactive isotope is 68Ga or 67Ga, the high radiochemical purity of the radiolabeled PSMA-binding ligand is at least 92% and the incubating step is performed at a temperature comprised between 80oC and 95oC and a period of time comprised between 5 and 7 min or wherein if the radioactive isotope is 64Cu, the high radiochemical purity of the radiolabeled PSMA binding ligand is at least 92% and the incubating step is performed at a temperature comprised between 7 and 15 min, and wherein the radiolabeling method is carried out in absence of an antioxidant such as gentisic acid and optionally wherein the radiochemical purity is determined by HPLC and optionally after radiolabeling free 68Ga3+, 67Ga3+ or 64Cu3+ is in a percentage of 2% or less as determined by HPLC.
Luna-Gutiérrez et al. teach as discussed above.
Fugazza et al. teach as discussed above.
Müller et al. teach method and kit for preparing a radiopharmaceutical (see title). Müller et al. teach a kit for preparing a radiopharmaceutical comprising a cation exchange cartridge, a reaction vial with labeling precursor. The buffer salt may be comprised in the reaction vial or the solvent vial ([0030]-[0038]). Müller et al. teach kit application where the lyophilized mixture in the reaction vial by the solvent of the solvent vial and the SCX cartridge is eluted into the reaction vial. The resulting reaction solution in the reaction vial may optionally be heated to a temperature of 90oC to 100oC for a period of 5 min to 15 min. The concentration of free gallium is preferably lower than 5% The tracer may be neutralized by adding a sterile phosphate buffer ([0047]-[0048]; [0126]-[0127]). The product can be obtained with high purity and high yield of about 80% to 95% ([0052]). Müller et al. teach a pH between 3 and 4.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the composition of Mariani et al. (composition comprising PSMA-R2 (instant formula (II)) so that the composition is provided as kit consisting of a first vial consisting of the following components in dried form a) PSMA-R2, and b) bulking agent mannitol and second vial consisting of buffering agent comprising formic acid and sodium hydroxide as taught by Luna-Gutiérrez et al., Fugazza et al., and Müller et al. because that kit would have been expected to advantageously enable a simple and convenient GMP compliant preparation of 64Cu- or 68Ga- PSMA-R2 optionally multiple doses by routine medical staff without the need for a commercially available synthesizer. The amounts of PSMA-R2 and mannitol are result effective variables that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. MPEP 2144.05.II. A person of ordinary skill would have arrived at an amount of PSMA-R2 that is between 10 and 100 mg, 15 and 16 mg or 30 mg through routine experimentation in order to arrive at an optimal amount of PSMA-R2 that provided high RCY, RCP and stability. A person of ordinary skill in the art would have at an amount of mannitol that is between 5 and 50 mg, 10 and 30 mg or 20 mg in order to arrive at an optimal amount of bulking agent for the dried powder. A person of ordinary skill in art would have arranged the buffering agents to maintain a pH between 2.8 and 4.0, 3.0 and 4.0, 3.2 and 3.87 as taught by Fugazza et al. and Müller et al. because those pH values would have been expected to complexation conditions and yields. It is prima facie to omit an ingredient if the ingredient is not required. See Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989). It would have been obvious to a person of ordinary skill in the art to omit a radiostabilizer such as ascorbic acid/gentisic acid in the case PSMA-R2 is not sensitive to radiolytic degradation,
It would have been obvious to a person of ordinary skill in the art before the art before the effective filing date to further modify Mariani et al. so that the obvious kit is used in a method for labeling PSMA-R2 comprising the steps of i) providing a first vial consisting of PSMA-R2 and mannitol bulking material in dried form, ii) adding a solution of the radioisotope (68Ga, 67Ga, or 64Cu) into the first vial to obtain a solution of the PSMA-R2 with the radioisotope, iii) mixing the solution in ii) with a formic acid and NaOH buffering agent and incubating for a sufficient period of time at an elevated temperature for obtain the radiolabeled PSMA-R2, and iv) adjusting the pH wherein the radiolabeling method is carried out in the absence antioxidants as taught by taught by Mariani et al., Luna-Gutiérrez et al., Fugazza et al., and Müller et al. because that labeling method would have been expected to advantageously enable a simple and convenient GMP compliant production radiolabeled PSMA-R2 under optimized conditions and suitable for administration to mammalian subjects. Regarding the contingent limitations starting with “wherein if the radioisotope is 68Ga or 67Ga” and “wherein if the radioactive isotope 64Cu”, Fugazza et al. teaches and makes obvious an incubated step performed at a temperature between 80 and 95oC or 70oC and 95oC and a period of time between 5 and 7 min or 7 and 15 min. The radiochemical purity is both a result of obvious applied method steps and result effective variable that a person of ordinary skill in the art would have been motivated to optimize at the time of invention in order to obtain a GMP compliant production meeting quality control standards. Regarding the limitations requiring that after labeling, the free 68Ga3+, 67Ga3+ or 64Cu2+ is present in a percentage of less than 2% and determined by HPLC, the limitations are both results obtained by the obvious applied method steps and result effective variables that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. Luna-Gutiérrez et al., and Fugazza et al. teach and make obvious quality control determination by HPLC. Fugazza et al. and Müller et al. teach and motivate minimizing free radiometal content. A person of ordinary skill in the art would have arrived at an amount of free 68Ga3+, 67Ga3+ or 64Cu2+ that is 2% or less through routine experimentation in order to arrive a minimal amount of contaminant radiometals.
Applicants Arguments
Applicants assert that as shown in the examples in the specification, reaction temperatures and durations are crucial to obtain high radiochemical purity. Mariani is not itself concerned with how to radiolabel a PSMA ligand with a radiometal. About radiolabeling Mariani references Fugazza which comprises the use of a formic acid/formate buffer and a sequestering agent. Luna-Gutiérrez reports experiments showing that the presence of ascorbic acid is crucial to stability. Applicants submits that Luna-Gutiérrez describes a radiolabeling method wherein the presence of ascorbic acid is required. Neither Mariani nor Luna-Gutiérrez teach or even suggest a method for radiolabeling a PSMA binding ligand with 68Ga, 67Ga or 64Cu with high radiochemical purity (>92%), wherein the radiolabeling takes place in the presence of the PSMA binding ligand, the radioactive isotope, mannitol, and a buffer formic acid/NaOH. Neither Mariani nor Luna-Gutiérrez teach a method for radiolabeling a PSMA binding ligand with 68Ga, 67Ga, or 64Cu in the absence of sequestering agent and in the absence of an antioxidant.
Fugazza does not cure the deficiencies of Mariani and Luna-Gutiérrez. Mariani does not teach a kit having a second vial and Fugazza describe only two possible kits. None of Mariani, Luna-Gutiérrez, and Fuggazza teach or suggest a kit for carrying out a radiolabeling method of the invention.
Applicant's arguments filed 17 Apr. 2026 have been fully considered but they are not persuasive. Mariani provides for the PSMA-R2 that reads on instant formula (II) and for PSMA-R2 complexing 68Ga, 67Ga, or 64Cu. Mariani teaches freeze dried compositions. At pg. 19, Mariani directly referenced Fugazza who teaches and motivates kit preparation. At pg. 3 Fugazza teaches that the presence of competing metallic ions is usually reduced by pre-purification of the eluate before labeling. In addition, at pg. 6 Fugazza teaches that sequestering agents include polysaccharides. A person of ordinary skill in the art would have understood mannitol to have the same metal complexing functionalities. Fugazza teaches and motivates comprising formic acid/NaOH since the buffer not only allows to establish the right pH but also to tolerate the eluate volume/acidity variation. At examples, Fugazza teaches 68Ga labeling in the absence of antioxidant wherein the antioxidant is gentisic acid. Mariani and Fugazza differ from kit claim 32 mainly because they do not teach or suggest a first vial further consisting of the bulking agent mannitol wherein the contents of the first vial are in dried form. At pg. 2184, Luna-Gutiérrez teaches and motivates kits for GMP production where the kit composition was (1) one lyophilized vial containing DOTA-iPSMA peptide and 50 mg of mannitol as diluent and ascorbic acid and (2) a second vial containing acetate buffer. The omission of an element is prima facie obvious if the function of the element is not desired. A person of ordinary skill in the art would have had reason and motivation to omit ascorbic acid since neither Mariani nor Fugazza teach that ascorbic acid is desired. A person of ordinary skill in the art would have had reason and motivation omit an addition sequestering agent because Fugazza and Muller teach and suggest pre-purification 68Ga eluate as common step for 68Ga labeling.
A recognized advantage is strongest reason to combine. It would have been obvious to a person ordinary skill in the art before the effective filing date to modify Mariani and Fugazza to arrive at the claimed kit and method where (1) one lyophilized vial contained PSMA-R2 and mannitol and (2) a second vial contains formic acid and sodium hydroxide because that kit would have been expected to advantageously enable GMP compliant production of for example 68Ga-PSMA-R2 by routine medical.
Conclusion
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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