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 .
Receipt is acknowledged of Applicant’s Amendments and Arguments filed on 08/04/2026.
Claim 1 has been amended. Claims 31-34 has been newly added. Claims 2-5 and 11 has been canceled. Accordingly, claims 1, 6-10, and 12-34 are pending and presented for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/20/2026, 05/27/2026 and 06/23/2026 was noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Any previous rejections and/or objections not reiterated herein have been withdrawn in view of amendments filed on 08/04/2026. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
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, 6-10, 12-29 and 31-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by C. M. Jeffery et al., (AIP Conference Proceedings 1509, 84-90,2012).
Jeffrey discloses reliable production of copper-64 (64Cu) by irradiating enriched nickel-64 in an IBA 18/9 cyclotron. The specific activity of 64Cu was determined by ICP-MS and by titration with Diamsar to be 28.9 ± 13.0 GBq/µmol ( would read on 781.08 mCi/µg to 1132.43 mCi/µg). Radionuclidic purity of the 64Cu was 98.7 ± 1.6% at the end of separation (abstract). Targets were irradiated with 11.7 MeV protons for 2 hours and copper isotopes (60, 61, 62,64Cu), were separated from target nickel and cobalt isotopes (55,57,61Co) using a single ion exchange column. Additional disclosure includes that study includes fabrication of 64Ni solid targets, optimization of irradiation conditions, development of a single column simultaneous purification process for 64Cu and 64Ni target, and QC methods for characterizing the final product.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 6-10, and 12-34 are rejected under 35 U.S.C. 103 as being unpatentable over Welch et al. (US 6,011,825) in view of C. M. Jeffrey et al., (AIP Conference Proceedings, 1509, 84-90, 2012) and Miguel A. Avila-Rodriquez et al., (Applied Radiation and Iostopes, 65, 1115-1120, 2007).
Welch discloses production of radionuclides suitable for use in radiodiagnostic agents such as PET imaging agents and radiotherapeutic agents and/or compositions. In a preferred application, a biomedical cyclotron has been used to produce over 500 mCi of 6⁴Cu having a specific activity of over 300 mCi/mu of Cu (abstract). Welch discloses that the amount of ⁶⁴Cu required for imaging agents ranges from about 3 mCi to about 10 mCi when administered, and therefore, the amount of 64Cu produced for preparing the compositions is preferably ranges from at least about 10 mCi to at least about 30 mCi, (reads on composition suitable for one or more patient doses) (Col 13 line 10-15). In one
embodiment discloses that the radionuclidic purity of the accelerator produced 64Cu is dependent upon the isotopic composition of the target material and the energy of the charged-particle beam. The 64Cu after production runs and after separation of 6⁴Cu from nickel ranged from about 0.01% to about 0.04%. Traces (<10.sup.-4%) of other cobalt isotopes such as 56Co, 5⁷Co and 58Co were also observed (Col. 18 line 1-10). In one embodiment, a preferred radionuclide, 64Cu is produced by irradiating a 64Ni target
material with a proton beam to effect the reaction Ni(p,n) ⁶⁴Cu (Example 2). Additionally, compounds which can be radiolabeled with ⁶⁴Cu includes lipophilic copper chelates, monoclonal antibodies and antibody fragments and small peptides that can be used in both diagnosis and therapy. For example, discloses the preparation of 64Cu-labeled TETA-octreotide radiolabeled compounds using 64CuCl (Col. 27 and Table 7).
NOTE: With respect to composition has a total content of trace metals of less than about 3 parts per million (ppm), would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the purification step, such as the arrangement ion exchange column, and choice of eluting with varying concentration of solvent, to obtain an optimal process conditions for reducing metal contaminants without undue experimentation. Welch discloses that the level of carrier impurities in the target material is preferably low enough to allow production of the radionuclide at specific activities sufficient for clinical use in a radiopharmaceutical imaging composition or in a radiopharmaceutical therapeutic composition and the 64Cu after production runs and after separation of 6⁴Cu from nickel ranged from about 0.01% to about 0.04%. Traces (<10.sup.-4%) of other cobalt isotopes such as 56Co, 5⁷Co and 58Co were also observed (Col. 18 line 1-10). One of ordinary skill in the art would have a reasonable expectation of success because routine optimization of the prior art purification procedure is within the capability of one of ordinary skill in the art. See MPEP § 2144.05 which states: [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Welch fails to specifically disclose specific activity from 350 mCi/µg and radionuclidic purity of 64Cu greater than 99% in the composition.
Jeffrey discloses reliable production of copper-64 (64Cu) by irradiating enriched nickel-64 in an IBA 18/9 cyclotron. The specific activity of 64Cu was determined by ICP-MS and by titration with Diamsar to be 28.9 ± 13.0 GBq/µmol ( would read on 781.08 mCi/µg to 1132.43 mCi/µg). Radionuclidic purity of the 64Cu was 98.7 ± 1.6% at the end of separation (abstract). Targets were irradiated with 11.7 MeV protons for 2 hours and copper isotopes (60, 61, 62,64Cu), were separated from target nickel and cobalt isotopes (55,57,61Co) using a single ion exchange column. Additional disclosure includes that study includes fabrication of 64Ni solid targets, optimization of irradiation conditions, development of a single column simultaneous purification process for 64Cu and 64Ni target, and QC methods for characterizing the final product.
Avila-Rodriguez discloses production of high specific activity ⁶⁴Cu and ⁶¹Co by irradiation of enriched ⁶⁴Ni on a low energy proton-only cyclotron. Typical specific activity of ⁶⁴Cu were found to be 18.8±33.3 Ci/µmol (read on specific activity from 350 mCi to 3000 mCi) (abstract). Avila-Rodriguez discloses that among radioisotopes of copper, 64Cu has the potential to see a dual role in the development of molecular agents in positron emission tomography (PET) and radioimmunotherapy drugs in oncology (page 1115). In one embodiment, discloses that most of the ⁶⁰Cu and ⁶²Cu contamination decays during the processing time, ending with a radionuclidic purity >99% for ⁶⁴Cu and >98% for 61 Co at the time of their application, confirmed by y-ray spectroscopy and half-life measurement (page 1119). Additional disclosure includes that the production of ⁶⁴Cu radionuclide in a small biomedical cyclotron with 11.4 MeV protons has proven to be very efficient with an experimental thick target saturation yield of 159mCi/uA and specific activity as high as 25 Ci/µmol (page 1120).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the production method of Welch by single column ion exchange chromatography technique as taught by Jeffrey and Avila-Rodriguez to generate a composition comprising high specific activity and radionuclidic purity by routine experimentation. The person of ordinary skill in the art would have been motivated to make those modifications because Avila-Rodriguez teaches that most of the ⁶Cu and 62 Cu contamination decays during the processing time, ending with a radionuclidic purity >99% for ⁶⁴Cu and >98% for ⁶¹Co at the time of their application, confirmed by y-ray spectroscopy and half-life measurement (page 1119) and reasonably would have expected success because ⁶⁴Cu and 61 Co were separated from the Ni target material in a single step by using the well-known chromatography of the chloro-complexes on an anion-exchange resin column.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6-10 and 12-34 rejected on the ground of nonstatutory double patenting as being
unpatentable overclaims 1, and6 of U.S. Patent No. 11, 521,762, over claims 1-7 of U.S. Patent 11,581,103, over claims 1, and 11-18 of U.S. Patent 11,972,874, over claims 1, 11-17 of U.S. Patent 11,978,569, over claims 1-3 and 18-24 of U.S. Patent 12,148,542, over claims 1-5 and 13-26 of U.S. Patent 12,237,092, over claims 1 and 28-30 of U.S. Patent 12,315,649, over claims Although the claims at issue are not identical, they are not patentably distinct from each other because there is an overlap of the subject matter claimed in the patent and the instant claims comprising copper-64 (64Cu), specific
activity from about 50 mCi 64Cu/ugCu to about 3800 mCi 64 Cu/ugCu and the radionuclidic purity of the 64Cu is greater than 95%, wherein the composition suitable for positron emission tomography Thus, the claims are readily envisaged by the teaching of the prior art and the clams are properly cluded in the rejection. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined claim is either anticipated, or would have been obvious, over the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985).
The claims differ in that those of issued patents are directed to composition comprising from 2 Ci to 15Ci of copper-64, and having a specific activity of about 100 mCi upto about 3800 mCi 64Cu/ug, wherein the composition comprises chemical and radionuclidic purities suitable for position emission tomography. However, the skilled artisan would recognize that the production of 64Cu with optimized conditions in larger quantities, an easier reproducible operation mode can be achieved by automation method. Furthermore, the instant invention also contains claims wherein the composition is suitable for PET imaging. Hence, the skilled artisan would recognize that the inventions disclose overlapping subject matter.
Conclusion
No claims are allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
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, Hartley G Michael 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.R.S/Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
Prosecution Insights