DETAILED ACTION
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 .
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) 1-3,5-7,11,15-21,25,33 and 34 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Weineisen et al., The Journal of Nuclear Medicine, Vol 56, No 8, Aug 2015 and supplemental data, for the reasons set forth in the previous office action filed 9/8/2025.
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) 1-3,5-25 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCann (US 11,129,912), for the reasons set forth in the previous office action filed 9/8/2025.
Claim(s) 1-3,5-25 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCann (US 11,129,912) in view of Pipes et al. (US 2022/0080059), for the reasons set forth in the previous office action filed 9/8/2025.
Claim(s) 1-3,5-25 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCann (US 11,129,912) in view of Weineisen et al., cited above, for the reasons set forth in the previous office action filed 9/8/2025.
Claim(s) 1-3,5-25 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weineisen et al., cited above, in view of McCann (US 11,129,912), for the reasons set forth in the previous office action filed 9/8/2025.
Response to Arguments
Applicant's arguments filed in the arguments on 12/8/2025 have been fully considered but they are not persuasive.
Applicants assert Weineisen as evidenced by appendix a (declaration filed in 19/198,982) the amount of 4.5 molar excess of PSMA I&T to Lu is a clear miscalculation and a typographical error. Applicants insert stoichiometry calculations in appendix a for the amounts used in the administered mass of 142 and 200 µg with an activity of 5.7 and 8.0 GBq. From the stoichiometric calculations taken from page 1174 of the reference, applicants state the molar ratio administered is actually 12:1.
Applicants are not showing the example used by the examiner which is in the synthesis and radiolabeling section on page 1171 which clearly discloses a 4.5 molar excess was used with a specific activity of 27 GBq. The composition made in this section reads on the claims and simply because applicants can pick another section which is not within the scope of the claims does not discredit the clear disclosure on page 1171 rt. col 3rd ¶ on the use of a molar excess within the claimed scope. To be clear the examiner used the amounts disclosed on page 1171 rt. col 3rd ¶ and not the amounts on page 1174 under section 177Lu-PSMA I&T Therapy in Patients, used by applicants in appendix a for their calculation.
With regard to McCann applicants assert appendix B (declaration provided in US patent 12,324,846) shows a head-to-head comparison to McCann in that the compositions provide unexpected benefits in treating cancer while resulting in lower absorbed radiation doses in key organs.
The examiner notes that appendix B is a declaration filed in another application and in order to be prohibitive a new declaration should be filed for the current application. Further the declaration filed in appendix B compares to an unused reference Fleshner, thus no direct comparison to the reference relied upon, McCann is made. As the examiner has reiterated numerous times, applicants need to provide data which compares the claimed invention to the closest prior art. Where is the data that shows an unexpected result compared to the McCann reference? Opinion and argument are not a substitute for data. An allegation of unexpected results must compare data to the closest prior art. As noted in the previous action and above again, McCain is silent with respect to the specific molar ratio claimed. However, the reason sequestering agents such as DTPA were used was to remove excess Lu. One of ordinary skill could reason that by using an excess of PSMA I&T, as recited in the claims, free Lu could be reduced to trace amounts and doing so is within the level of skill of one of ordinary skill in the art.
Applicants assert the declarations provided for in the appendixes show that reducing the molar ratio below 11.1 would be expected to decrease instability, degrade purity and increase toxicity, see appendix B ¶ 9.
The argument is unpersuasive because outside of applicant’s opinion they have not shown that molar ratios below 11.1 would be expected to decrease instability, degrade purity and increase toxicity. Applicants only refer to their own opinion or finding, however there is no evidence that this problem was well known in the prior art before the time of the claimed invention. Therefore, one of ordinary skill would not be dissuaded from making 177Lu-PSMA I&T with a molar ratio of less than 11.1 since doing so was not discouraged in the prior art.
Applicants assert their invention has a clinical advantage over Mccann in that it allows administration of a higher activity dose while delivering a lower absorbed dose to critical organs. Applicants assert their invention can be administered in 6 cycles at 7.4 GBq per cycle while prior art formulations limit the does to four cycles of 6.8 GBq.
The relevance of this assertion is unclear. Once again applicants provide no data or other evidence to support their argument. An unsupported allegation cannot be considered persuasive. The examiner asks again where is the data that supports the conclusion on amounts in delivery cycles for the metal chelate? Regardless the relevance is unclear as the claims do not recite the argued feature in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants assert Pipes is too different to use the amounts within and substitute them within McCann.
As noted previously the references are at least related in their teachings radiochemicals for diagnostic imaging one of ordinary skill in the art would have a very high expectation of success in using the ratios of ligand to metal of Pipes in the McCann reference, at least as a starting point. It is within the skill set of one of ordinary skill to adjust amounts and measure the results.
Applicants assert that neither McCann or Weinesien teach a composition that maintains greater than 95% RCP over 72 hours.
With regard to Weinesien it follows that since the reference discloses the exact same molar ratio said to provide 95% RCP over 72 hours it will feature these same properties. As noted in the previous action filed 9/18/2024 McMann discloses high radiopurity of 99.9% which can be used up to 120 hours, meeting the recited functional property.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES W ROGERS/ Primary Examiner, Art Unit 1618