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 .
Claims and Previous Objection/Rejections Status
Claims 75,76,78-80,82,83,85-88,91,92,94-121 are pending in the application.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
Response to Arguments
Applicant's arguments filed 7/28/26 have been fully considered but they are not persuasive.
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.
Claim(s) 75,76,78-80,82,83,85-88,91,92,94-121 is/are rejected under 35 U.S.C. 103 as being
unpatentable over Fani et al. (J. Nucl. Med. 2011, 52, 1110-1118) in view of Kim et al. (US 11,497,822B1),
and Mansour et al. (Nucl. Med. Biol. 2018, 56, 31-38) and in further view of Greifenstein, L.N, (2019) Synthesis, radiolabeling and in vitro and in vivo evaluation of different chelator systems with 44Sc, 64Cu, 68Ga and 177Lu (Doctoral dissertation, Dissertation, Mainz, Johannes Gutenberg-Universität, 2019) and Goldberg (US 6,306,393B1) and Svedjehed et al. (EJNMMI Radiopharm. Chem. 2020, 5, p1-14) as stated in the office action mailed 1/28/26.
Applicant asserts that the Office errs in its position that the present product claims require features of the process that prepared the claimed product in order to be “commensurate.” The Applicants are not claiming the process for making the high purity 61Cu. The Applicants have developed a novel and innovative process for preparing high purity 61Cu via the use of a niobium backing when bombarding nickel as the target material. The high purity 61Cu limitations (a) to (e) achievable only as a result of Applicants’ process for preparing the 61Cu. 61Cu via Applicants’ process was unexpected and led to superior 61Cu versus that prepared by Svedjehed or others, who use a silver backing when bombarding nickel. The pharmaceutical compositions with high purity 61Cu because the compositions are themselves new and nonobvious, not because they were derived from an innovative process that produced an unexpectedly pure 61Cu.
The instant claims are not drawn to a process for preparing high purity 61Cu via the use of a niobium backing when bombarding nickel as the target material.
The high purity 61Cu of radionuclide purity of ≥ 99.99% or ≥ 99.9999% of the instant claims does not require a nickel target material backed with niobium. The instant claims merely state the 61Cu is from a [61Cu]CuCl2 solution. The disclosure states that the routine purification of the 61Cu using FASTlab results in a 89.3% and 94% reduction in impurities for natNi or 61Ni on a niobium backing with respect to silver backing materials.
The instant claims further state that the radionuclide purity of the sum of radiocobalt is [Symbol font/0x3C]
0.05% or [Symbol font/0xA3] 0.01%.
The reference of Svedjehed et al. was used to teach of the process for preparing high purity
[61Cu]CuCl2 and its separation from irradiated solid Ni targets. The purification of the 61Cu was accomplished via an automated FASTlab chemistry module where sequential TBP and TK201 (Triskem) resins isolated [61Cu]CuCl2 and removed Ni, Co, and Fe. The majority of the 58Co impurity was [Symbol font/0x3C]0.0001% relative to 61Cu.
It would have been predictable to one of ordinary skill in the art that any minor 110mAg, 108mAg, 109Cd, 56Co, 57Co, 60Co, Pb, Al, Fe and Zn impurities will be present in an amount less than the amount of the major impurity 58Co, such as [Symbol font/0x3C]0.0001% relative to 61Cu as taught by Svedjehed et al. wherein the FASTlab advantageously resulted in a reduction of the major impurity 58Co to 61Cu ratio by more than a factor of 500 following purification.
The FASTlab of the disclosure uses TBP and TK201 (Triskem) resins that are identical to the TBP and TK201 (Triskem) resins of the FASTlab of Svedjehed et al. The resins have the same properties and are capable of the same functions, such as analogously removing the impurities from the irradiated Ni targets and providing the radiochemical purity for 61Cu of the instant claims.
Applicant asserts the Office must provide rationale or evidence for its position that Svedjehed’s teaching to use FAST lab purification method will inherently produce the high purity levels presently claimed. The 61Cu prepared by Svedjehed cannot achieve the presently claimed purity levels by mere purification using FASTlab. Rather it is the higher purity crude [61Cu]CuCl2 prepared by Applicants’ innovative process that results in the superior purity.
The instant claims merely state the 61Cu is from a [61Cu]CuCl2 solution. The disclosure states that 61Cu is purified via the routine purification method FASTlab with two ion exchange resins TBP and TK201 (Triskem).
The reference of Svedjehed et al. was used to teach of the process for preparing high purity
[61Cu]CuCl2 as well as that stated above.
It would have been predictable to one of ordinary skill in the art that any minor 110mAg, 108mAg, 109Cd, 56Co, 57Co, 60Co, Pb, Al, Fe and Zn impurities will be present in an amount less than the amount of the major impurity 58Co, such as [Symbol font/0x3C]0.0001% relative to 61Cu as taught by Svedjehed et al. wherein the FASTlab advantageously resulted in a reduction of the major impurity 58Co to 61Cu ratio by more than a factor of 500 following purification.
The FASTlab of the disclosure uses TBP and TK201 (Triskem) resins that are identical to the TBP and TK201 (Triskem) resins of the FASTlab of Svedjehed et al. The resins have the same properties and are capable of the same functions, such as analogously removing the impurities from the irradiated Ni targets and providing the radiochemical purity for 61Cu of the instant claims.
Conclusion
No claims are allowed at this time.
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 MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The
examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/MELISSA J PERREIRA/ Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618
