DETAILED ACTION
This Office action details a non-final action on the merits for the above referenced application No. Claims 1-30 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 May 2026 has been entered.
Response to Amendment
The amendments filed on 26 May 2026 have been entered.
The declarations under 37 CFR 1.132 filed 26 May 2026 are insufficient to overcome the rejection of claims as set forth below because of the reasons set for below.
Dr. Pipes declares that the claimed invention recites a particular molar ratio and at least 95% radiochemical purity for 72 h swapping out Lu for Cu would not allow for the level of certainty or precision. Dr. Pipes authoritatively states that you would not want to use significantly higher molar ratios in Cu-64 and DOTATATE than the currently claimed invention. Because Cu-64 ad Lu-177 have very different decay properties, extrapolating purity and stability from one to the other is not realistic in this case. The claimed invention reciting radiochemical purity of >95% for at least 72 h after production along with the claimed molar ratios genuinely appear unique and surprising over McCann and Weineisen. Unlike DOTA, the DOTAGA chelator used in PSMA I&T has 4 nitrogen and 4 carboxylic acid oxygens for binding to metal. McCann is inferior to the claimed invention which results in lower absorbed radiation to critical organs even when the same dose is administered. See ECLIPSE and SPLASH comparisons. McCann does not describe operating at ligand to 177Lu molar ratios in the range of 3:1 to 8:1, nor does it identify ligand reduction as a design objective. Extrapolating McCann to completely different reaction conditions would be erroneous. The labeling time of Cu-64 DOTATATE is simply nor relevant to 177Lu-PSMA I&T. Pipes does not provide any teachings regarding stability or RCP of Lu, not at least to 72 h at 95% RCP for any particular radioisotope. The Patent Office’s interpretation of my reference is highly unreasonable. The statement in Weineisen with 4.5 molar excess is not supported by the experimental data or supplemental materials and is therefore interpreted as a typographical error. The ligand to metal ratios used in the actual experiments are substantially higher than 4.5:1. A scientist reading Weineisen would understand that higher ligand to radionuclide ratios were required in practice. Weineisen fails to provide any description of RCP of 95% for at least 72 h as currently claimed in the ‘982 application. The Weineisen experiments were repeated at pg. 51 at McCann indicating a sharp drop off of RCP within 48 h, further confirming the Weineisen referenced could not achieve the RCP of 95% for at least 72 h. Trying to modify the 4.5 molar excess from the cellular studies of Weineisen to human dosages would result in lower radiochemical purity and lower stability. The molar ratio of targeting ligand to 177Lu was not recognized in the art as a simple result effective variable that could be optimized to lower values. Barbato does not identify ligand to radionuclide molar ratio as a parameter that can be reliably optimized towards lower values, nor does it suggest that reducing ligand excess improves stability or shelf-life as claimed. Barbato relies on stabilizer identity and concentration, not ligand reduction. Sartor does not provide technical guidance that could be used to predict how changes in ligand excess would affect chelation or stability of 177Lu-PSMA I&T formulations.
Dr. Denner declares that the claimed invention provides unexpected results. It is not possible to predict or extrapolate from the prior art which modifications would have potentially provided unexpected to surprising results. The experiments in Weineisen were repeated in McCann at pg. 51 and resulted in a rapid drop in radiochemical purity. At pg. 1171 of Weineisen, it cannot be 24.5 MBq and specific activity of 27 GBq/umol for a 4.5 molar excess. A person of ordinary skill in the art examining Weineisen would realize that pg. 1173 of states that anything more than 14.4 Gbq would exceed the safety limit of human kidneys. Regarding Pipes, the Patent Office has failed to account for numerous discrepancies between the isotope/ligand pairs that make this extrapolating tenuous. One of ordinary skill aware of numerous differences between 64Cu DOTATATE and 177Lu PSMA I&T would treat labeling time not as something similar between 64Cu DOTATATE and 177Lu PSMA I&T. There is no evidence that purification yield or specific activity is improved by reducing PSMA I&T concentration for 177Lu. The currently claimed invention would be separate and distinct because the molar ratio is completely outside of what Barbato states is necessary for a good safety margin.
The Dr. Pipes and Dr. Denner declarations filed 26 May 2026 have been fully considered but they are not persuasive. Weineisen is prior art under 35 USC 102 because Weineisen at supplemental information anticipates the claims. The Dr. Pipes and Dr. Denner declarations cannot be used to overcome a rejection of claims under 35 USC 102. At the supplemental information section, Weineisen provides for two preparations that form compositions comprising a solution for injection to patient in a single use vial wherein the solution comprises 177Lu PSMA I&T. The first preparation includes a specific activity of 177Lu-LuCl3 enabling a calculation of the molar ratio of PSMA I&T to 177Lu demonstrating a molar ratio of 4:5:1.0. The second labeling does not include a specific activity of 177Lu-LuCl3; however, it is understood that the preparation for clinical studies was carried following the preparation 1 where it was determined that a molar ratio of 4:5:1.0 provided quantitative complexation. Accordingly, Weineisen impliedly teaches a molar ratio of the PSMA I&T to 177Lu of 4.5:1.0 at the second preparation described for clinical studies. Regarding the recitation of a radiochemical purity of >95% for at least, a composition and its properties are inseparable. The compositions described Weineisen were quantitative and have a molar ratio of PSMA I&T to 177Lu as described in the specification as enabling a radiochemical purity of >95% for at least 72 h. The cited portions of McCann do not provide a molar ratio PSMA I&T to 177Lu. In McCann, the teaching that radiolabeling was performed using no carrier added 177LuCl3 following the radiolabeling described by Weineisen is not a teaching of a molar ratio of PSMA I&T to 177Lu of 4.5:1.0 was used in the experiments and did not result in the claimed radiochemical purity requirement. Regarding the claimed recitation of human patient, the first and second preparations in Weineisen are aqueous solutions at a pH suitable for human use. The Dr. Pipes and Dr. Denner declarations do not any evidence that the cited preparations of Weineisen are not suitable for human use. The above first preparation in Weineisen has a radioactivity amount suitable for fraction dosing and other dosing regimens. The teaching in Weineisen at pg. 1171 that for quantitative 177Lu complexation, 24.5 MBq of 177LuIII was reacted with a 4.5 molar excess of PSMA I&T, yielding 177Lu-PSMA I&T in specific activities of 27 GBq/µmol or more is not a contradiction since Weineisen at the above first preparation provides a specific activity of 120 GBq/µmol, which is more than 27 GBq/µmol. Instead, at the cited passage, Weineisen suggests that different molar ratios of PSMA I&T to 177Lu were used and a molar ratio of 4.5:1.0 was determined optimal by providing quantitative complexation. Regarding the arguments that the Pipes documents is not combinable with McCann and Weineisen, it is noted that the Pipes documents teaches 177Lu and radiopharmaceuticals and accordingly the Pipes document is in the same field of endeavor as Weineisen and McCann. The below rejection of claims does not rely of Pipes for 64Cu labeling conditions. At [0080], Pipes teaches different mole ratios of ligand to radionuclide but does not teach a particular ligand or radionuclide. At the cited table 7 and elsewhere the Pipes document experimented with different molar ratios. Weinesein is not deficient in disclosing both the claimed molar ratio of PSMA I&T to 177Lu and suitable labeling conditions for 177Lu PSMA I&T. The mole ratio of PSMA I&T to 177Lu is result effective variable that a person of ordinary skill in the art would have been motivated to optimize that the time of invention.
Response to Arguments
The rejection of claims 1-30 under 35 USC 103 as being unpatentable over McCann et al. (WO 2022/0136610 A2; published 20 Jan. 2022), in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Weiniesen et al. (J. Med. Chem.; published 2015), in further view of Barbato et al. (WO 2022/043556 A1; published 3 Mar. 2022) and Sartor et al. (N. Engl. J. Med.; published 2021) is withdrawn.
In view of the approved terminal disclaimer, the rejection of claims 1-30 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of US patent No. 12,324,846, in view of McCann et al. (WO 2022/013610 A2; published 20 Jan. 2022) and Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) 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) 1-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCann et al. (WO 2022/0136610A2; published 20 Jan. 2022), in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Weiniesen et al. (J. Med. Chem.; published 2015) for the reasons cited in the Office action filed on 24 Oct. 2025.
Applicants Arguments
Applicants assert that the attached declarations from Dr. Darcy Denner and Dr. Pipes make clear that the use of 4.5-fold PSMA I&T was recited by Weineisen is an obvious typographical error regardless was whether it is seen in view of the supplementary data section or on its own. The Dr. Denner declaration demonstrates that the recitation of 4.5-fold PSMA I&T in Weineisen in an obvious error due to its mathematical impossibility. The Pipes Declaration makes clear that the cited section of Weineisen does not even refer to any composition suitable for human administration as required by the claims but instead refers to incredibly small dosages (24.5 MBq) directed to cellular/animal studies. The Dr. Denner declaration makes clear that even if the 4.5-fold molar excess of PSMA I&T were to be used, the two stated properties simply cannot be met at such a molar ratio and certainly not for human administration. To Dr. Denner, the Weineisen reference is unreliable. Dr. Pipes approaches the problem from the perspective of the unpredictability of the cited passage being limited to cellular/animal studies and that scale up at that ratio is nowhere taught in Pipes and plainly contradicted elsewhere. Applicants reiterate the Dr. Pipes and Dr. Denner declarations. The teachings of McCann would lead the person of skill away from Weineisen. McCann shows that the teachings of Weineisen fail to result in the currently claimed RCP for at least 72 h. A person would not be motivated to combine the modified values of McCann and Pipes as they may exceed the safety limits that Weineisen teaches. The 177Lu and 64Cu radioisotopes do not radiolabel under the same conditions. McCann and Weineisen appear to provide dramatically different molar ratios and outcomes. Pipes does not provide motivation to optimize the molar ratio of PSMA I&T:177Lu as the Office proposes. Applicants refer to a comparison of ECLIPSE and SPLASH trials.
Applicant's arguments filed 1 Jun. 2026 have been fully considered but they are not persuasive. The Dr. Denner and Dr. Pipes declarations are ineffective for the reasons discussed above. Weineisen is not deficient since Weineisen anticipates the claimed molar ratio of PSMA I&T and 177Lu. Weineisen teaches and suggests a molar ratio of PSMA I&T to 177Lu of 4.5:1 is optimal after experimenting with different molar ratios. Applicants have failed to cite a section of McCann teaching that a molar ratio of 4.5:1 was used in the experiments therein. The reference to Weineisen at pg 51 is not a teaching that a molar ratio of PSMA I&T to 177Lu of 4.5:1 was used in the experiments but did not result claimed radiochemical purity requirement. McCann and Weineisen are not deficient as McCann and Weineisen teach and motivate all of the claimed limitations. At supplemental information, Weineisen provides for a composition comprising a solution for injection to a human patient in need thereof in a single vial, wherein the solution comprises a radiopharmaceutical composition comprising 177Lu-PSMA I&T wherein the molar ratio of PSMA I&T to 177Lu is 4.5:1 and the radiochemical purity is about 100%. At pg. 52, McCann provides for a composition comprising a solution for injection to a human patient in need thereof in a single vial, wherein the solution comprises a radiopharmaceutical composition comprising 177Lu-PSMA I&T that maintains >95% radiochemical purity over 6 d at room temperature in formulation. Accordingly, McCann and Weineisen teach and motivate all the claimed limitations.
Pipes is properly combinable with McCann and Weineisen for the reasons discussed above. At [0080], Pipes teaches different mole ratios of ligand to radionuclide but does not teach a particular ligand or radionuclide. At the cited table 7 and elsewhere the Pipes document experimented with different molar ratios of targeting ligand to radionuclide.
New Grounds of Rejection
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-5, 12-14, and 26-28 is/are rejected under 35 U.S.C. 102(a)1 as being anticipated by Weineisen et al. (J. Nucl. Med.; published 2015).
Regarding claims 1, 4-5, 12-14, and 26-28, at supplemental information, Weineisen et al. discloses compositions comprising a solution for injection to a human patient in need thereof a single use vial wherein the solution comprises a radiopharmaceutical composition comprising 177Lu-PSMA I&T wherein the compositions were derived from the following 177Lu labeling method.
Labeling 1:
0.91 nmol PSMA I&T was added to 24.5 MBq 177Lu-LuCl3 (120 GBq/µmol) in 0.05 HCl. The pH was adjusted to pH 5 by addition of NH4OAc.
Calculation for the mol amount of 177LuCl3
n
177
L
u
C
l
3
=
0.0245
G
B
q
×
1
µ
m
o
l
120
G
B
q
×
1,000
n
m
o
l
1
µ
m
o
l
=
0.2
n
m
o
l
Calculation of mol ratio (R) of PSMA I&T to 177Lu
R
=
1
0.9
n
m
o
l
0.2
n
m
o
l
=
1
4.5
Regarding the recitation that 177Lu-PSMA has a radiochemical purity of ≥95% for at least 72 h, a composition and its properties are inseparable. The composition described by Weineisen et al. has a mole ratio of PSMA I&T to 177Lu of 4.5:1 as describe in the instant specification as enable a radiochemical purity of >95% for at least 72 h after production. Regarding the recitation of intended use “for injection to human patient”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the composition described by Weineisen et al. is an aqueous solution a pH suitable for human use. The radioactivity amount is at least suitable for fractional and other dosing studies. Regarding labeling 2, 177Lu-PSMA I&T for clinical use, Weineisen et al. do not provide a specific activity of 177Lu-LuCl3; however, Weineisen impliedly teaches a molar ratio of PSMA I&T to 177Lu that is 4.5:1.0 since the labeling was understood to be performed after labeling 1 where the molar ratio of 4.5:1.0 was found to optimal for quantitative complexation.
Claim Rejections - 35 USC § 103
Claim(s) 1-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weineisen et al. (J. Nucl. Med.; published 2015), in view McCann et al. (WO 2022/013610 A2; published 20 Jan. 2022).
Weineisen et al. teach as discussed above. Weineisen et al. teach 68Ga- and 177Lu labeled PSMA I&T: optimization of the a PSMA targeted theranostic concept and first proof of concept human studies (see title). Weineisen et al. teach that PSMA I&T was developed and evaluated in detail both in vitro and in vivo (pg. 1170). For quantitative 177Lu complexation, 24.5 MBq of 177LuIII was reacted with 4.5-fold molar excess of PSMA I&T yielding 177Lu-PSMA I&T in specific activities of 27 GBq/µmol or more. For 177Lu PSMA I&T the radiochemical purity was 99.0%±1.0% as determined by HPLC and specific activities were achieved (pg. 1171). Weineisen et al. teach endoradiotherapy of patients using 177Lu-PSMA I&T. Both patients received 5.7 and 8 GBq of 177Lu PSMA I&T (pg. 1171). 177Lu-PSMA I&T shows high, specific and rapid uptake in all previously identified tumor lesions of the mCRPC patients (pg. 1175). Weineisen et al. teach incubation of 150-200 µg of PSMA I&T with 6-8 GBq of 177LuCl3 at 90oC for 30 min in NaOAc (0.4 M, 800 µL, pH 5.5. To this buffer, 5-10 mg of gentisic acid was added to prevent radiolysis (5 mg/supplemental information).
For the first and second 177Lu-labelings, Weineisen et al. do not expressly teach that the 177Lu-PSMA I&T has a radiochemical purity of >95% for at least 72 h after production. For the second 177Lu-labeling. Weineisen et al. are silent about a molar ratio of PSMA I&T to 177Lu that is from 3.0:1.0 to 8.0:1.0, 3.0:1.0 to 3.5:1.0, 3.5:1.0 to 4.0:1.0, 5.0:1.0 to 5.5:1.0 to 6.0:1.0, 6.0:1.0 to 6.5:1.0, 6.5:1.0 to 7.0:1.0, 7.0 :1.0 to 7.5:1.0, 7.5:1.0 to 8.0:1.0, 5.0:1.0 to 7.0:1.0, or 5.5:1.0 to 7.0:1.0. McCann et al. does not expressly teach the doses 7.4 GBq±0.3 GBq, 7.4 GBq±0.25 GBq, or 7.4 GBq±0.20 GBq. McCann et al. do not expressly teach the following concentrations of ethanol: 0.1% (v/v) to 10% (v/v), 1.0% (v/v) to 6.0% (v/v), 2.0% (v/v) to 5.0% (v/v) or 2.5% (v/v) to 4.5% (v/v). Weineisen et al. do not expressly teach an antioxidant that is ascorbic acid or an antioxidant amount that is 10 mg/mL to 90 mg/mL or 15 mg/mL to 35 mg/ mL. Weineisen et al. do not exemplify as solution comprising 15 to 20 mL.
McCann et al. teach radiopharmaceutical and methods (see title). McCann et al. teach an aqueous composition including 1) a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA and 2) one or more ascorbate compounds. The radiochemical purity of the composition is at least 99% where the composition is maintained at 30oC or less for 3 or more days following preparation (pg. 35). The 177Lu-PSMA I&T is provided as a sterile solution for intravenous use. A single dose vial will contain 6.8 ± 10% GBq 177Lu-PSMA I&T in 10-14 mL formulated with one or more radioprotectants and may include a buffer. The pH is from 5.0 to 7.0 (pg. 39). McCann et al. teach example 2 where radiolabeling was performed using no-carrier added 177LuCl3. The racemic 177Lu-PSMA-I&T or 177Lu-PSMA-I&T having optical excess of structure 2A was diluted using a reaction buffer and was added to a reaction vial (pgs 48-49). The preparation of 177Lu-PSMA-I&T following conditions described in condition 4 and condition 5, demonstrates for the first time a product that is >99% pure post incorporation reaction and maintains >95% radiochemical purity over 6 d at room temperature in the formulation composition. Condition 5 places 65 mg in the reaction composition and an admixture of 26 mg ascorbic acid and 66 mg gentisic acid in the formulation composition with 177Lu-PSMA-I&T (table 2). (Composition comprising a solution for injection into a human patient in need thereof in a single use vial wherein the solution comprises a radio-pharmaceutical composition comprising 177Lu-PSMA I&T and 177Lu-PSMA-I&T at a radiochemical purity of >95% for at least 72 h post production.) McCann et al. teaches a preferred preparation process (example 3). 177Lu-PSMA I&T having an optical excess of structure 2A in sterile aqueous solution is administered by intravenous injection. The dosing regimen may include four infusions of 6.8 ± 10% each, administered 8 wk apart (see pg. 55). A dose of 0.1 GBq to about 30 GBq may be administered (pg. 39). The one or more stabilizer compounds may include ethanol (pg. 37). McCann et al. teach ascorbate amounts ranging from 5 mg/mL to 90 mg/mL (pg. 15).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the compositions of Weineisen et al. (compositions comprising 177Lu-PSMA I&T wherein the molar ratio of PSMA I&T to 177Lu is asserted to be 4.5:1.0 so that the compositions have a radiochemical purity that is ≥95% for at least 72 h after production as taught by McCann et al. because it would have been expected to advantageously enable a composition comprising 177Lu PSMA I&T suitable for human and remains stable for several days following formulation. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Weineisen et al. so that the labeling at supplemental information describe as for clinical use has a molar ratio of PSMA I&T to 177Lu of 4.5:1 as taught by Weineisen et al. because that molar ratio would have been expected to enable quantitative 177Lu complexation.
The molar ratio is a result effective variable 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 in the art would have arrived at molar ratios of PSMA I&T and 177Lu within the following ranges in order to reduce PSMA I&T concentration, improve purification yield and optimize specific activity: 3.0:1.0 to 8.0:1.0, 3.0:1.0 to 3.5:1.0, 3.5:1.0 to 4.0:1.0, 5.0:1.0 to 5.5:1.0 to 6.0:1.0, 6.0:1.0 to 6.5:1.0, 6.5:1.0 to 7.0:1.0, 7.0 :1.0 to 7.5:1.0, 7.5:1.0 to 8.0:1.0, or 5.0:1.0 to 7.0:1.0, or 5.5:1.0 to 7.0:1.0.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify composition of Weineisen et al. so that the dose of the composition comprises 7.4 GBq±0.30 GBq, 7.4 GBq±0.25 GBq, or 7.4 GBq±0.30 GBq as taught by Weineisen et al. and McCann et al. because those doses would have been expected to enable an optimal therapeutically effective amount and because McCann et al. teaches doses in the range of 0.1 GBq to about 30 GBq are suitable doses for the radiotreatment of prostate cancer. MPEP 2144.05.II.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the composition of Weineisen et al. so that the composition contains an ethanol amount such as 2.8% (v/v) or 3.5% (v/v) as taught by McCann et al. because those ethanol amounts would have been expected to enable radioprotection against radiolysis and optimal solubility. MPEP 2144.05.II.
It would have been obvious to a person of ordinary skill in the art to modify the compositions of Weineisen et al. so that the compositions contain ascorbic acid at an amount between 15 mg/mL to 35 mg/mL as taught by Weineisen et al. and McCann et al. because the ascorbic acid in that amount would have been expected to advantageously enable radiolysis inhibition. The total volume solution is a result effective variable that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. A person of ordinary skill in the art would have arrived at a solution that comprises 15 to 20 mL in order to arrive at a solution that comprises one or more doses of 177Lu-PSMA I&T.
Conclusion
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/SEAN R. DONOHUE/
Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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