DETAILED ACTION
This Office action details a non-final action on the merits for the above referenced application No. Claims 1-7, and 13-30 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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.
Status of Claims
Claims 1-7, and 30 are amended. Claims 8-12 are cancelled.
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 organ dosimetry is an unpredictable field. Normal-organ uptake and retention of radioactivity are influenced by multiple interacting factors, including formulation conditions, complex stability, radiolysis behavior, biologic distribution, clearance characteristics and patient specific pharmacokinetics. The claimed dosimetry appears to be a substantial and surprising improvement over the field as a whole, including Fleshner, Okamoto, Pipes, and/or Weineisen. A person working the radiopharmaceutical formulation would not have expected that a 177Lu-PSMA I&T composition formulated within the claimed molar ratio range could maintain prolonged radiochemical stability while also achieving the organ dosimetry profile recited in the pending claims. The dosimetry values reported in the references such as Okamoto are much higher than the values recited in the pending claims particularly with respect to liver and salivary gland exposure. Fleshner generally describes therapeutic administration of 177Lu-PSMA I&T and discusses dosimetry evaluation but does not utilize the same molar ratios as the claimed invention and does not achieve the unexpected results of the currently claimed invention. The dosimetry values of the currently claimed invention are substantially lower than Okamoto. I would not have expected the specific dosimetry profiled recited in the pending claims based on the disclosures in Okamoto. As the lead inventor of the Pipes reference, the Patent Office’s position is not reasonable because 64Cu DOTATATE is optimized at very different conditions and higher molar ratios than the claimed invention. I would not have expected the combination of radiochemical stability and organ dosimetry properties recited in the pending claims based on the disclosures of the cited references. Once the experimental practices are understood, the direction of optimization is consistently toward higher ligand to metal ratios, nor lower ones. The currently claimed molar range combined with the radiochemical purity, stability and improved dosimetry would not have been a predictable outcome.
Dr. Darcy Denner declares that the claimed invention provides a surprisingly low mean absorbed dose per gram of tissue in the human patient’s salivary glands that is from about 0.01 Gy/GBq to about 0.2 Gy/GBq. At face value, the prior art does not teach this limitation. The Fleshner and Okamoto references are clearly outside the claimed range. Because the currently claimed invention results in low absorbed radiation to salivary glands, this is a significant improvement and unexpected/surprising result. The claims of the’267 patent application provide unexpected and surprising results over the prior art including superior dosimetry across multiple target organs including the salivary glands, liver and others. At the cited passage in Weineisen, there are directly conflicting requirements in the same sentence of Weineisen. Weineisen provide no teaching for how to use something mathematically impossible and apply it either to patients or otherwise. It is unclear how one of ordinary skill can combine a mathematical impossibility with another reference having specific activities several orders of magnitude different. A person of ordinary skill examining Weineisen 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 limit. Pipes is a completely different chemical reaction than either Weineisen or Fleshner. Pipes refers to 64Cu and DOTATATE not 177Lu and PSMA I&T. The reactions are completely different. Weineisen, Fleshner and Pipes cannot reasonably be relied on to arrive at the currently claimed invention. The currently claimed invention provides surprising and unexpected results for salivary glands and other critical organs that are drastically lower than the prior art and which directly helps patients avoid xerostomia.
Applicant's arguments filed 12 Jun. 2026 have been fully considered but they are not persuasive. The closest prior art is Weineisen who discloses a method comprising administering to a human patient in need thereof a radiopharmaceutical composition comprising 177Lu-PSMA I&T wherein the radiochemical purity at the time of administration was 99% as determined by reverse phase HPLC wherein the patients underwent therapy with 5.7 and 8.0 GBq of 177Lu-PSMA I&T. 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. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979).
Regarding the molar ratio of PSMA I&T to 177Lu, Weineisen provides for a composition comprising 177Lu-PSMA I&T prepared by adding 0.91 nmol PMSA I&T to 24.5 MBq 177Lu-LuCl3 (120 GBq/µmol) in 0.05 M HCl. The pH was adjusted to 5 by addition of NH4OAc resulting in a molar ratio of PSMA I&T to 177Lu of 4.5:1.0. Weineisen’s statement at pg. 1171 that for quantitative 177Lu complexation, 24.5 MBq of 177LuIII was reactive with a 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 120 GBq/µmol is more than 27 GBq/µmol. In addition, at supplemental information Weineisen provides for a second labeling of 177Lu-PSMA I&T prepared by incubation of 150-200 µg PSMA I&T with 6-8 GBq of 177LuCl3 at 90oC for 30 min in NaOAc. To this buffer 5-10 mg of gentisic acid was added to prevent radiolysis. In this case, Weineisen is impliedly teaching a molar ratio of PSMA I&T to 177LuIII that is 4.5:1.0 since it is understood that the second labeling was performed after the first where it was determined that the molar ratio of 4.5:1.0 provided quantitative complexation. Regarding the requirement that the composition comprises a radiochemical purity of ≥ 95% for at least 72 h after manufacture, the instant declarations do not provide any evidence that this requirement contributes to an unexpected lower dose in a patient’s salivary glands and other non-target organs including the liver. Weineisen teaches a solution of 177Lu-PSMA I&T that has a radiochemical purity of 99% at the time of administration. A composition and its properties are inseparable. The 177Lu-PSMA I&T compositions of Weineisen have a molar ratio of PSMA I&T to 177Lu of 4.5:1.0 that the instant specification describes as enabling a radiochemical purity of ≥95% for at least 72 h after manufacture. McCann cited herein provides a 177Lu-PSMA I&T product that is > 99% pure post incorporation reaction and maintains >95% radiochemical purity over 6 d at room temperature in the formulation composition. Regarding the requirement that the mean absorbed radiation dose per gram of tissue in the human patient’s salivary glands is from about 0.01 Gy/GBq to about 0.2 Gy/GBq, this amounts to a non-limiting intended result of a previously applied process step. In addition, at pg. 1174, Weineisen teaches that was no adverse or clinically detectable pharmacologic effect. During the follow-up, no side effects were observed, particularly no dry mouth cause by activity in salivary glands. Accordingly, Weineisen provides reason and motivation to optimize the mean absorbed dose per gram of tissue in the human patient’s salivary glands.
Response to Arguments
The rejection of claims 1-30 under 35 USC 103 as being unpatentable over Fleshner et al. (WO 2023/097329 A1; published 1 Jun. 2023), in view of Okamoto et al. (J. Nucl. Med; published 2017) and Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022) is withdrawn.
The rejection of claims 1-30 under 35 USC 103 as being unpatentable over Fleshner et al. (WO 2023/097329 A1; published 1 Jun. 2023), in view of Okamoto et al. (J. Nucl. Med.; published 2017) and Pipes et al. (US 2022/0080059 A1; published 17 Mar. 2022), in further view of Weineisen et al. (J. Nucl. Med.; published 2015) 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) 1-7, and 13-30 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). 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).
Although Weineisen et al. impliedly teaches a 4.5:1 mole ration of PSMA I&T to 177Lu, administered to human patient, Weineisen et al. do not expressly teach that the composition comprising 177Lu-PSMA I&T administered to human patient has a mole claimed mole ratio of 4.5:1 or that the composition comprises radiochemical purity of >95% for at least 72 h post manufacture or that mean absorbed dose to the patients salivary glands is from about 0.01 Gy/GBq to about 0.2 Gy/GBq or is about 0.2 Gy/GBq, 0.1 Gy/GBq, 0.01 Gy/GBq, 0.05 Gy/GB, ≤0.19 Gy/GBq, o ≤0.18 Gy/GBq, ≤0.2 Gy/GBq, ≤0.1 Gy/GBq. Weineisen et al. do not expressly teach a dose comprising 7.4±15% GBq, 7.4±10% GBq, or 7.4±5% GBq or about 7.4 GBq of PSMA I&T. Weineisen et al. do not further teach an absorbed radiation dose per gram in the human patients’ liver of about 0.04 Gy/GBq±0.02 Gy/GBq, 0.03 Gy/GBq±0.02 Gy/Gbq, or 0.02 Gy/GBq±0.02 Gy/GBq. Weineisen et al. do not expressly teach that the fraction of activity opf the 177Lu-PSMA OI&T in the liver of the human patient is ≤0.04, ≤0.03, ≤0.02, ≤0.01 or less within 24 h, 48 h, or 168 h.
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 method of Weineisen et al. (method comprising administering to a human patient in need thereof a radiopharmaceutical composition comprising 177Lu-PSMA I&T wherein the mole ratio of PSMA I&T to 177Lu is impliedly 4.5:1.0) so that the composition has a mole ratio of PSMA I&T to 177Lu of about 4.5:1.0 and so that the composition has a radiochemical purity of ≥ 95% for at least 72 h after manufacture as taught by Weineisen et al. and McCann et al. because a molar ratio of the PSMA I&T to 177Lu that is about 4.5:1.0 would have been expected to advantageously enable quantitative complexation and that radiochemical purity would have been expected to advantageously an optimal shelf life and suitable radiochemical purity for administration to human subjects. Regarding the claimed dosimetry limitations, an intended result of a process step positively recited is generally not given weight. See Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003). In addition, the claimed dosimetry limitations 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 in the art would have arrived at the following mean radiation absorbed dose per gram of the tissue in the patients salivary glands through routine experimentation into minimize potential side effects such as dry mouth: 0.01 Gy/GBq to about 0.2 Gy/GBq or is about 0.2 Gy/GBq, 0.1 Gy/GBq, 0.01 Gy/GBq, 0.05 Gy/GB, ≤0.19 Gy/GBq, o ≤0.18 Gy/GBq, ≤0.2 Gy/GBq, ≤0.1 Gy/GBq. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-30 of U.S. Patent No. 12,324,846 B2 so that the composition comprises 7.4±15% GBq, 7.4±10% GBq, or 7.4±5% GBq or about 7.4 GBq of 177Lu PSMA I&T as taught by Weineisen et al. and McCann et al. because those doses would have been expected to provide safe and effective tumor doses for the treatment of prostate cancer. 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 absorbed radiation dose is determined by SPECT imaging as taught by Weineisen et al. because it would have been expected to advantageously enable in vivo determination of absorbed radiation in human subjects.
The following radiation absorbed dose per gram of tissue in the human patient’s liver and fraction of radioactivity in the liver are result effective variables that a person of ordinary skill in the art would have been motivated to optimize in order to minimize hepatotoxicity: 0.04 Gy/GBq±0.02 Gy/GBq, 0.03 Gy/GBq±0.02 Gy/GBq, or 0.02 Gy/GBq±0.02 Gy/GBq and ≤0.04, ≤0.03, ≤0.02, ≤0.01 or less within 24 h, 48 h, or 168 h.
Applicants Arguments
Applicants assert that the Dr. Denner Declaration confirms as such noting Fleshner only discloses absorbed radiation doses to the salivary glands of greater than 0.34 Gy/GBq and that Okamoto only discloses absorbed radiation dose to the salivary glands of greater than 2-3 Gy/GBq. Xerostomia from salivary gland injury leads to persistent thirst, difficulty chewing and swallowing dry foods, disturbed sleep, dental caries, oral infections, and speech problems, all of which substantially reduce the quality of life in prostate cancer patients who otherwise may live many years. This was an unaddressed problem by the prior art. Because the claimed invention results in meaningful lower absorbed radiation to the salivary glands and liver, this is a significant improvement over the prior art and evidence of unexpected result/secondary considerations. Looking at the passage at pg. 1171 of Weineisen, it can be seen that 24.5 MBq of 177LuIII was reacted with a 4.5-fold molar excess of PSMA I&T which resulted in a 177Lu-PSMA I&T specific activity of 27 GBq/µmol. It is mathematically impossible for a 177Lu-PSMA I&T composition with a specific activity of 27 GBq/µmol to be prepared with 24.5 MBq of 177LuIII and a 4.5-fold molar excess of PSMA I&T. It is not possible for the composition to simultaneously have 24.5 MBq of 177Lu and a specific activity of 27 GBq/µmole at such a molar ratio. The experiments of Weineisen were repeated in McCann PCT and resulted in a rapid drop in radiochemical purity. One of ordinary skill would have no motivation to use the cited 4.5: 1 molar ratio and no expectation of success in achieving a radiochemical purity of ≥ 95% for at least 72 h using the molar ratios disclosed in Weineisen. It would be unreasonable for a person of skill in the art to use radiopharmaceuticals scaled for cellular and animal studies and expect that they would have a predictably similar radiochemical purity over time or absorbed radiation dosage for the salivary glands or the liver because the unpredictable nature of the art. A person of ordinary skill would still not be motivated to combine the scaled values with McCann and Pipes as they would exceed the human safety limits that Weineisen itself teaches. Lu and Cu are not optimized under the same conditions and in fact Lu requires more time and heat. The characteristics of 64Cu and 177Lu differ to such a vast degree that it would prevent one of skill in the art from ever consulting compositional data in order to arrive at a method of using 177Lu reacted with a ligand that isn’t even disclosed within Pipes. This inconsistency further demonstrate the contradictory and unpredictable nature of the prior art in the cited combination and why one of skill in the art would not have any expectation of success in achieving the claimed invention. The attached expert declarations establish there is too much unpredictability and too many modification required to make the asserted combination. Applicants assert unexpected results. The superior dosimetry was not only found for the salivary glands but also the liver and other critical organs for humans.
Applicant's arguments filed 12 Jun. 2026 have been fully considered but they are not persuasive. The Dr. Pipes and Dr. Denner declarations are ineffective for the reasons discussed above. Weineisen administers to human patients in need thereof a radiopharmaceutical composition comprising 177Lu-PSMA I&T at a doses of 5.7 and 8.0 GBq and there was no adverse or clinically detectable pharmacologic effect particularly caused by activity in the salivary glands. During early follow-up, no side effects were observed, particularly no dry mouth caused by activity in the salivary glands. Neither the Dr. Pipes nor the Dr. Denner declaration comprise a comparison with prior art at method of Weineisen to demonstrate an unexpected result over the closest prior art. Regarding the molar ratio of the PSMA I&T to 177Lu, at supplemental information, Weineisen provides for pharmaceutical compositions comprising 177Lu-PSMA I&T wherein the molar ratio of PSMA I&T to 177Lu is about 4.5:1.0. Regarding that the requirement that the composition comprises a radiochemical purity of ≥ 95% for at least 72 h, both Weineisen and McCann teach and motivated administering 177Lu-PSMA I&T at high radiochemical purity such as 99% radiochemical purity. The reference to Weineisen in McCann is not a teaching that the molar ratio of PSMA I&T to 177Lu that is 4.5:1.0 was used in the experiments of McCann and did not result in high radiochemical purity. McCann teaches and motivates a composition comprising 177Lu PSMA I&T wherein the composition comprises a radiochemical purity of >95% for at least 6 d after manufacture. Regarding the requirement that the mean absorbed radiation dose per gram of tissue in the human patient’s salivary glands is about 0.01 Gy/GBq to about 0.2 Gy/GBq, the requirement is a non-limiting intended result of a previously applied process step. In addition, Weiniesen provides some teaching and motivation for minimizing the absorbed dose per gram of tissue in a human patient’s salivary glands. MPEP 2144.05.II.
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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