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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 Jun. 2026 has been entered.
Response to Amendment
The amendments filed on 12 Jun. 2026 have been entered.
The declarations under 37 CFR 1.132 filed 12 Jun. 2026 are insufficient to overcome the rejection of claims as set forth in the last Office action because of the reasons set forth below.
Dr. Pipes declares that reducing the ligand to metal ratio, especially in combination with a low ligand concentration would have been expected to result in incomplete complexation, increased amount of unbound or weakly bound 177Lu and reduced radiochemical purity and stability over time. The ‘200 application claims have achieved unexpected and surprising stability at the claimed molar ratios. The claimed composition embodied by the independent claims of the ‘200 patent application result in expected and superior performance. The use of the claimed composition for cancer treatment results in lower absorbed radiation by certain critical organs thus allowing for more cycles of treatment. The table shows that the claimed invention (shown by ECLIPSE) is clearly superior to McCann (shown as SPLASH) on a per GBq basis. There are surprising and unexpected results for the kidney, lacrimal glands, salivary glands and the liver. The ligand to metal ratio in radiopharmaceutical systems is not a simple result effective variable that can be predictably optimized across different systems but rather depends strongly on the specific radioisotope, ligand structure, chelator, and formulation conditions. Reducing the ligand ratio in combination with low ligand concentration would have been expected to decrease complexation efficiency and stability, not maintain high radiochemical purity over extended periods. In Pipes the preferred molar ratios in the examples are much higher and outside the currently claimed range. The cited references involve different radiometals, ligands, and chelators, including systems based on copper and other radionuclides as compared to the 177Lu-PSMA I&T system recited in the claims. A person of ordinary skill in the art would not have reasonably expected that teachings relating to copper systems, such as those described in Pipes, could be applied to a 177Lu-PSMA I&T system to arrive at the claimed combination of low ligand to metal molar ratio, low ligand concentration, and radiochemical purity of at least 95% for at least 72 h with a reasonable expectation of success. The factors governing labeling efficiency and those governing long term radiochemical stability in lutetium systems are distinct and not predictably optimized based on teachings from copper systems. The Patent Office’s position that the claimed molar ratio represents routine optimization of a result effective variable does not account for system specific differences. The claimed invention reciting radiochemical purity of > 95% for at least 72 h after production along with claimed concentration or claimed concentration and molar ratios genuinely appear unique and surprising over both McCann and Weineisen whether considered independently or with the other cited references. McCann dos not provide concentration of ≤6.0 µg/mL 177Lu-PSMA I&T not the molar ratio of the PSMA I&T to 177Lu that is from 3:1 to 8:1. McCann is also inferior to claimed invention which results in lower absorbed radiation to certain critical organs even when the same dosage is administered. Extrapolating McCann to completely different reaction conditions would be erroneous as reducing ligand would ordinarily be expected to decrease stability rather than preserve it. The Patent Office’s interpretation of my reference is highly unreasonable and there would not be motivation to modify or expectation of success in applying Pipes as argued by the Office. The Weineisen reference is unreliable for scale up and this is further evidenced by McCann. McCann indicates that Weineisen is unable to achieve the claimed RCP for at least 72 h. Once the experimental practice in McCann, Weineisen and Pipes are properly understood, the direction of optimization is consistently toward higher ligand to metal ratios, not lower ones. Hooijman does not disclose or suggest modifying ligand concentration, molar ratio, or formulation parameters to achieve reduced colloidal species, nor does it establish that such parameters can be predictably adjusted to simultaneously achieve low colloidal content, low ligand concentration, and extended radiochemical purity of ≥95% for at least 72 h. Okamoto does not disclose chelation conditions, concentration parameters, or stability optimization principles and does not describe how radiopharmaceutical compositions are formulated or prepared to achieve any particular radiochemical purity or stability.
Dr. Denner declares that the claimed composition provides lower absorbed radiation to key organs, there is the potential ability to provide additional cycles or rounds of cancer treatment, which is not available with compositions of the prior art that result in higher absorbed radiation to critical organs. The experiments of Weineisen were repeated by McCann at pg. 51 and resulted in a rapid drop in radiochemical purity. Modifying McCann toward the ratios/conditions of Weineisen would result in reduction in stability and radiochemical purity. Regarding the cited passage at pg. 1171 in Weineisen, the three numbers cannot be simultaneously correct for a 177Lu-PSMA preparation so there is a mathematical inconsistency. A person of ordinary skill in the at art examining Weineisen reference as a whole would realize that pg. 1173 of Weineisen states that anything more than 14.4 GBq would exceed the safety limit of human kidneys and certainly 24.5 GBq would exceed that safety. The most reasonable interpretation of Pipes is that it teaches away as it requires a much higher molar ratio in order to obtain a fast reaction time. The reaction time of one (Pipes) does not provide a rationale for combination for completely different reaction. There is no reasonable expectation of success in achieving comparable reaction times which is the stated reason for combination. Paragraph [0180] of Pipes would indicate a result effective variable would arrive at a molar ration of 10:1 and not the currently claimed range. There is no evidence in any of the cited references that purification yield or specific activity is improved by reducing PSMA I&T concentration for 177Lu.
The Dr. Pipes and Dr. Denner declarations filed 12 Jun. 2026 have been fully considered but they are not persuasive. The closest prior art is Weineisen who discloses a composition for injection to a human patient in need thereof wherein the solution comprises a radiopharmaceutical composition comprising 177Lu-PSMA I&T having 0.34 µg with concentrations ranging from 0.02 µg/mL to 0.034 µg/mL 177Lu-PSMA I&T and wherein the mole ratio of PSMA I&T to 177Lu is 4.5:1.0. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). A composition and its properties are inseparable. Regarding the limitation the composition has a radiochemical purity of ≥ 95% for at least 72 h, the composition of Weineisen has the molar ratio of 4.5:1.0 as described in the specification as enabling a radiochemical purity of ≥ 95% for at least 72 h. In addition, McCann cited below provides adequate teaching and motivation for a 177Lu-PSMA I&T composition having a radiochemical purity of >95% for 6 d following preparation. Neither the Dr. Pipes nor the Dr. Denner declaration describe any unexpected benefit relating to the 7.1 GBq to 7.6 GBq of 177Lu-PSMA I&T. At pg. 1171, Weineisen discloses administering 5.7 and 8.0 GBq of 177Lu-PSMA I&T to human patients in need thereof. McCann teaches compositions comprising 177Lu-PSMA I&T at a suitable range of up 30 GBq. A person of ordinary skill in the art would have had adequate reason and motivation to arrive at 7.1 GBq to 7.6 GBq of 177Lu-PSMA I&T in order to provide a therapeutically effective dose of 177Lu-PSMA I&T. At statement at pg. 1171 in Weineisen that 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 is not a contradiction as the exemplified 120 GBq/µmol is more that than 27 GBq/µmol. The statement in McCann that the radiolabeling was performed using no carrier added 177LuCl3 following the radolabeling conditions described by Weineisen is teaching that composition described therein comprise a molar ratio the PSMA I&T to 177Lu that is 4.5:1.0 but did not result in the claimed radiochemical purity of ≥95% for at least 72 h. The Dr. Pipes and Dr. Denner arguments regarding Pipes, Okamoto, Barbato, and Hooijman are moot since none of those references are being applied in any of the rejections below. Claims 16 and 29 do not require the molar ratio of PSMA I&T to 177Lu described in the declarations as enabling an unexpected beneficial dosimetry outcome.
Response to Arguments
The rejection of claims 1-29 under 35 USC 103 as being unpatentable over McCann et al. (WO 2022/013610 A1; published 20 Jan. 2022), in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Weineisen et al. (J. Nucl. Med.; published 2015) is withdrawn.
The rejection of claims 1-29 under 35 USC 103 as being unpatentable over McCann et al. (WO 2022/013610 A1; published 20 Jan. 2022), in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Barbato et al. (WO 2022/043556 A1; published 2 Mar. 2022), in further view of Hooijman et al. (EJNMMI Radiopharm. Chem.; published 2022) is withdrawn.
The rejection of claims 30 under 35 USC 103 as being unpatentable over McCann et al. (WO 2022/013610 A1; published 20 Jan. 2022), in view of Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) and Weineisen et al. (J. Nucl. Med.; published 2015), in further view of Okamoto et al. (J. Nucl. Med.; published 2017) is withdrawn.
New Grounds of Rejection
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 Weineisen et al. (J. Nucl. Med.; published 2015), in view McCann et al. (WO 2022/013610 A2; published 20 Jan. 2022; see IDS filed on 4 Jun. 2025).
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 that 0.9 nmol PSMA I&T was added to 24.5 MBq 177Lu-LuCl3 (120 GBq/µmole) in 0.05 M HCl. The pH was adjusted to pH 5 by the addition of NH4OAc (0.1 M, 150 µL). After 30 in at 95oC the labeling efficiency was examined by Radio-TKLC and Radio-HPLC (supplemental information). (Reads on a composition comprising a solution for injection in human patient in need thereof, wherein the solution comprises a radiopharmaceutical composition comprising 177Lu-PSMA I&T having from 0.02 µg/mL to 0.034 µg/mL of 177Lu-PSMA I&T wherein the molar ratio of the PSMA to 177Lu is 4.5:1.0 and wherein the solution comprises a pH of 5 and wherein the composition comprises two gamma emission lines at 113 keV and 208 keV and wherein colloidal 177Lu is 0% due to quantitative complexation).
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 (supplemental information). Weinesen et al. teach dose extrapolation to humans involving scaling of time integrated activity coefficients and the subsequent calculation of the absorbed dose from the animal biodistribution data (supplemental information, tables 1-3; pg. 1173, table 3). The administered mass of PSMA I&T was 142 and 200 µg and the administered activity was 5.7 and 8.0 GBq. In patient 2 the mediastinal lymph node metastases exhibited high uptake of 177Lu-PSMA I&T on posttherapy planar and SPECT/CT (Fig. 6). There was no adverse or clinically detectable pharmacologic effect. During early follow up, no side effects were observed, particularly no dry mouth caused by activity in salivary glands (pg. 1174). No side effects in either salivary glands or in kidneys or blood parameters were observed in either of the 2 treated patients and treatment was well tolerated (pg. 1175).
Weineisen et al. do not expressly teach that the compositions therein have a radiochemical purity of ≥ 95% for at least 72 h or that the compositions therein comprise 7.1 GBq to 7.6 GBq of 177Lu-PSMA I&T, optionally 7.4±10% GBq 177Lu-PSMA I&T. Weineisen et al. do not further teach that the solutions contain ascorbic acid as an antioxidant at 15 mg/mL to 35 mg/mL, 30 mg/mL to 50 mg/mL, less than 5 EU/mL of endotoxins or a composition further comprising 1.0% (v/v) to 6.0% (v/v) ethanol.
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). Batches were sampled for quality control testing and tested for stability for up to 6 d post day of manufacture (pg. 49).
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. so that the compositions have a radiochemical purity of ≥ 95% for at least 72 h and optionally include ascorbic acid at 15 mg/mL to 35 mg/mL or 30 mg/mL to 50 mg/mL as taught by Weineisen et al. and McCann et al. because the radiochemical purity of ≥ 95% for at least 72 h and optional ascorbic acid would have been expected to enable an optimal shelf-life for the 177Lu-PSMA I&T composition. MPEP 2144.05.II. A composition and its properties are inseparable. The compositions of Weineisen et al. comprising the PSMA I&T to 177Lu molar ratio that specification describes as enabling a radiochemical purity of > 95% for at least 72 h. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify the compositions of Weineisen et al. so the compositions comprise 7.1 GBq to 7.6 GBq or optionally 7.4±10% of 177Lu-PSMA I&T as taught by Weineisen et al. and McCann et al. because those doses would have been expected to provide an optimal therapeutic dose suitable for treating PSMA associated 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 further modify Weineisen et al. so that the compositions further comprise 1.0% (v/v) to 6 % (v/v) of ethanol as taught by McCann et al. because that amount of ethanol would have been expected to advantageously enable radiostabilization and solubility enhancement. Weineisen et al. teach a 177Lu-PSMA I&T composition and so the composition must comprise gamma emission lines at 113 keV and 208 keV. The amount of colloidal 177Lu in the composition is 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 colloidal 177Lu in an amount less than about 4.5% of radioactivity in order to ensure quantitative complexation of 177Lu. The endotoxins concentration in the composition 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 an endotoxin concentration that is less than 5 EU/mL in order to ensure passing quality control and to provide optimal subject safety.
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; see IDS filed on 4 Jun. 2025), in further view of Hooijman et al. (Pharmaceutics; published 2021; see attached 892).
Weineisen et al. teach as discussed above.
Weineisen et al. do not further teach that the solutions having less than 5 Eu/mL of endotoxins or a composition further comprising 1.0% (v/v) to 6.0% (v/v) ethanol.
McCann et al. teach as discussed above.
Hooijman et al. teach the development of [225Ac]Ac-PSMA I&T for targeted alpha therapy according to GMP guidelines for treatment of mCRPC (see title). Hooihman et al. teach [177Lu]-PSMA I&T (pg. 2). Hooijman et al. teach endotoxin levels of less than 5% (see abstract, pgs. 6, 9). Hooijman et al. teach ethanol in the injection solution (~6% of the final volume) (pg. 11).
It would have further been obvious to a person of ordinary skill in the art before the effective filing date to further modify the compositions of Weineisen et al. so that the compositions comprise ethanol at about 6% (v/v) as taught by McCann et al. and Hooijman et al. because that amount of ethanol would have been expected to provide enhanced solution and radioprotection. It would have been further obvious to a person of ordinary skill in the art before the effective filing date to further modify Weineisen et al. so that the compositions further comprise less than 5 EU/mL of endotoxins because it would have been expected to advantageously enable passing quality control and optimal subject safety.
Applicants Arguments
Applicants refer to the Dr. Pipes and Dr. Denner declarations. The Office concedes that McCann fails to teach or suggest a composition having a concentration of ≤ 6 µg/mL 177Lu-PSMA I&T as well as PSMA I&T:177Lu molar ratio in the range of 3:1 to 8:1. The passage cited by the Office in Weineisen does not correspond to the currently claimed dosage wherein the composition comprises 7.1 GBq to 7.6 GBq of 177Lu-PSMA I&T. Weineisen never teaches using the currently claimed ratios for administration to humans. The errors and inconsistencies in Weineisen make it an unsuitable reference for the purpose of obviousness. The expert declarations from Dr. Denner and Dr. Pipes make clear that the use of 4.5-fold PSMA I&T was recited in Weineisen is an obvious error of typographical or similar nature regardless of whether it is seen in view of the supplementary data or on its own. The Office’s calculations do not use the specific activity of 27 GBq/µmol to arrive at the 4.5:1 ratio and instead rely on the use of the specific activity of the stock reagent using in the radiolabeling (120 GBq/µmol). The Office is relying a passage in Weineisen that requires a dosage two orders of magnitude below the currently claimed invention. It is not possible for the composition to simultaneously have 24.5 MBq of 177Lu and a specific activity of 27 GBq/µmol at such a molar ratio. The Office’s calculations showing that Weineisen teaches a composition comprising 0.15-0.075 µg/mL 177Lu-PSMA I&T are either based on erroneous values or would correspond to a ligand to radioisotope ratio that is far greater than the claimed range. The experiments in Weineisen are repeated in McCann at pg. 51 and resulted in a rapid drop in radiochemical purity. McCann would lead the person of skill away from the cited Weineisen because McCann teaches that the compositions of Weineisen do not meet the requisite stability of the claims. The values that the Office relies upon in passage at pg. 1171 of Weineisen and the supplementary data are unsuitable for the treatment of a human patient. The 24.5 MBq dosage of the cellular/animal studies are nowhere close the dosage of the currently recited claims so further modification of Weineisen would be required with further uncertainties as to purity and stability. The Office fails to identify any reason as to why the person of skill would expect the conditions of Pipes to achieve the high stability and clinically beneficial performance of the claims with substituting 64Cu-DOTATATE for 177Lu-PSMA I&T. The labeling conditions would not be expected to be the same or optimized under similar conditions. The Pipes reference simply does not provide any reason to use or expect the same result from the use of the same DOTATATE:64Cu molar ratio for PSMA I&T:177Lu. Pipes himself has stated that he would have used substantially higher molar ratios that the claimed invention. And McCann and Weineisen appear to provide dramatically different molar ratios and outcomes. The present claimed invention results in significant and unexpected results in the form of substantially improved absorbed radiation burden for the kidneys, lacrimal glands, salivary glands and liver of the patient. The results were surprising and unexpected and would permit the claimed invention to be administered for more treatment cycles and at a higher radioactivity than would be permitted by the prior art. Hooijman only serves to increase uncertainty. Hooijman isn’t directed to formulation, radiolabeling or design of radiochemical species but rather is directed to analytical quality control techniques and species detection.
Applicant's arguments filed 12 Jun. 2026 have been fully considered but they are not persuasive. The Dr. Pipes and Dr. Denner declarations have been found ineffective for the reasons discussed above. Applicant’s arguments regarding Pipes, Okamoto, Barbato, and Hooijman are moot because none of those references are being used in a rejection herein. At supplemental information, Weineisen discloses all of a comprising a solution for injection to a human patient in need thereof wherein the solution comprises a radiopharmaceutical composition comprising 177Lu-PSMA I&T and 0.02 µg/mL to 0.034 µg/mL of 177Lu-PSMA I&T wherein the molar ratio of the PSMA to 177Lu is 4.5:1.0. Regarding the limitation that the composition comprising 177Lu-PSMA I&T has a radiochemical purity of ≥ 95% for at least 72 h, the composition of Weineisen has the molar ratio of PSMA to 177Lu that is 4.5:1.0 as described in the specification as enabling a radiochemical purity of ≥ 95% for at least 72 h. In addition, McCann provides reason and motivation to arrive at a composition comprising a solution for injection to a human patient in need thereof wherein the solution comprises 177Lu-PSMA I&T having a radiochemical purity of > 95% for at least 6 d following its preparation. Regarding the recitation of wherein the composition comprises 7.1 GBq to 7.6 GBq of 177Lu-PSMA I&T, Weineisen teaches administering 5.7 GBq and 8.0 GBq of 177Lu-PSMA I&T to human patients and McCann teaches compositions ranging up to 30 GBq. A person of ordinary skill in the art would have had reason and motivation to modify the compositions of Weineisen so that the compositions comprise from 7.1 GBq to 7.6 GBq of 177Lu-PSMA I&T in order to provide a optimal therapeutically effective dose to patients in need thereof.
Conclusion
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
Prosecution Insights