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 .
Election/Restrictions
Applicant’s election without traverse of Group IV in the reply filed on 12/19/2025 is acknowledged. Claims 1-3, 6-11, 15-17, 25, 29, 30, 32, 33, 64-66, 73, 74, 92, and 115 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I-III, and there being no allowable generic or linking claim.
Status of Claims
Withdrawn: 1-3, 6-11, 15-17, 25, 29, 30, 32, 33, 64-66, 73, 74, 92, and 115
Cancelled: 1-3, 6-11, 15-17, 25, 29, 30, 32, 33, 64-66, 73, 74, 79, 80, 92, and 115
New: 116-138
Examined Herein: 75, 116-138
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in PRO 63/409,684 on 9/23/2022 and PCT/US23/75064 on 9/25/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/31/2024, 7/24/2024, and 12/19/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 9/25/2023 and 1/18/2024 are accepted.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 138 rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 138 recites the limitation “an activity at end of synthesis (EoB + 2hrs).” It is unclear why “EOB +2 hrs” is parenthesis and how this limits the limitation, if it all. For example, it is unclear whether the limitation intends to define the end of synthesis as 2 hours after EOB. Further clarification is required.
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.
Claims 75, 116-126, and 138 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strangis (Production of 61cu by Deuteron Irradiation of Natural Ni, 2007, Cyclotrons and Their Applications, Eighteenth International Conference).
With respect to claim 75, Strangis discloses a high-purity radionuclide composition, comprising a radionuclide, 61Cu, having a radionuclidic purity at end of synthesis of ≥ 95.0% (≥ 99.9%), thus meeting the limitations of claim 75. [Page 247, Col. 1, Paragraph 3]
Claims 116-125 are drawn to a process for preparing the 61Cu radionuclide in the high-purity radionuclide composition. Thus, claims 116-125 recite product-by-process limitations. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, Strangis discloses a product (a composition comprising 61Cu having a radionuclidic purity at end of synthesis of > 95.0%) that is the same as the claimed product. Therefore, the limitations of claims 116-125 are unpatentable even if the product disclosed by Strangis was made by a different process. Accordingly, since the limitations of claim 75 are anticipated by Strangis, the limitations of claims 116-125 are also anticipated.
With respect to claim 126, Strangis discloses the composition has a radionuclidic purity at end of synthesis for the radionuclide of ≥ 97.0% (≥ 99.9%), thus meeting the limitations of claim 126. [Page 247, Col. 1, Paragraph 3]
With respect to claim 138, Strangis discloses the activity at end of synthesis is greater than 500 MBq (740 MBq), thus meeting the limitations of claim 138. [Page 247, Col. 1, Paragraph 3]
Claims 75 and 116-125 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asad (Cyclotron Production of 61Cu using Natural Zn & Enriched 64Zn Targets, 12/19/2012, AIP Conf. Proc. 1509, 91-95).
With respect to claim 75, Asad discloses a high-purity radionuclide composition comprising a radionuclide, 61Cu, and having a radionuclidic purity at end of synthesis of > 95.0%, thus meeting the limitations of claim 75. [Asad, Page 93, Paragraph 3 and Page 94, Paragraph 1]
Claims 116-125 are drawn to a process for preparing the 61Cu radionuclide in the high-purity radionuclide composition. Thus, claims 116-125 recite product-by-process limitations. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, Asad discloses a product (a composition comprising 61Cu having a radionuclidic purity at end of synthesis of > 95.0%) that is the same as the claimed product. Therefore, the limitations of claims 116-125 are unpatentable even if the product disclosed by Asad was made by a different process. Accordingly, since the limitations of claim 75 are anticipated by Asad, the limitations of claims 116-125 are also anticipated.
Claims 75, 116-129, and 133-137 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Svedjehedjehed (Automated, cassette-based isolation and formulation of high-purity [61Cu]CuCl2 from solid Ni targets 2020, EJNMMI Radiopharmacy and Chemistry, 5:21).
With respect to claim 75, Svedjehed discloses a high-purity radionuclide composition comprising a radionuclide, 61Cu, having a radionuclidic purity at end of synthesis of > 95.0% (~99.999%), thus meeting the limitations of claim 75. [Svedjehed, Page 12, Paragraph 4]
Claims 116-125 are drawn to a process for preparing the 61Cu radionuclide in the high-purity radionuclide composition. Thus, claims 116-125 recite product-by-process limitations. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, Svedjehed discloses a product (a composition comprising 61Cu having a radionuclidic purity at end of synthesis of > 95.0%) that is the same as the claimed product. Therefore, the limitations of claims 116-125 are unpatentable even if the product disclosed by Svedjehed was made by a different process. Accordingly, since the limitations of claim 75 are anticipated by Svedjehed, the limitations of claims 116-125 are also anticipated.
With respect to claim 126, Svedjehed discloses the composition has a radionuclidic purity at end of synthesis of ≥ 97.0% (~99.999%), thus meeting the limitations of claim 126. [Svedjehed, Page 12, Paragraph 4]
With respect to claim 127, Svedjehed discloses the composition is an aqueous solution (HCl solution) and comprises the radionuclide in the form of radionuclide cations (61Cu2+ of [61Cu]CuCl2), thus meeting the limitations of claim 127. [Svedjehed, Page 12, Paragraph 4]
With respect to claim 128, Svedjehed discloses the aqueous solution further comprises chloride anions (2Cl- of [61Cu]CuCl2), thus meeting the limitations of claim 128. [Svedjehed, Page 12, Paragraph 4]
With respect to claim 129, Svedjehed discloses the chloride anions are present in the composition in a molar excess of the radionuclide cations (2Cl- for every one Cu2+), thus meeting the limitations of claim 129. [Svedjehed, Page 12, Paragraph 4]
With respect to claim 133, Svedjehed discloses the composition has a chemical purity for the radionuclide of ≥ 99 molar %, thus meeting the limitations of claim 133. [Svedjehed, Page 12, Paragraph 4]
With respect to claim 134, Svedjehed discloses the composition is an aqueous solution (HCl solution) and comprises less than 2 mg/L (< 100 ppb = < 0.1 mg/L) of Zn, thus meeting the limitations of claim 134. [Svedjehed, Page 11, Paragraph 2 and Page 12, Paragraph 4]
With respect to claim 134 and 135, Svedjehed discloses the composition is an aqueous solution (HCl solution) and comprises less than 2 mg/L (< 500 ppb = <0.5 mg/L) of Fe, thus meeting the limitations of claim 134 and 135. [Svedjehed, Page 11, Paragraph 2 and Page 12, Paragraph 4]
With respect to claim 134 and 136, Svedjehed discloses the composition is an aqueous solution (HCl solution) and comprises less than 1 mg/L Cu (total and isotopic) (176 ± 37 ng/mL = 0.176 ± 0.037 mg/L). [Svedjehed, Page 11, Paragraph 2 and Page 12, Paragraph 4] Even under a conservative assumption that all of the measured copper is present as 69Cu and 65Cu, the concentration is still less than 1 mg/L, thus meeting the limitations of claim 134 and 136.
With respect to claim 134 and 137, Svedjehed further discloses the composition is an aqueous solution (HCl solution) and comprises less than 1 mg/L Ni (< 10 ppb = < 0.01 mg/L), thus meeting the limitations of claim 134 and 137. [Svedjehed, Page 7, Paragraph 4]
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.
Claims 75, 116-126, 131, 132, and 138 are rejected under 35 U.S.C. 103 as being unpatentable over Stangis, as applied to claim 75, 116-126, and 138 above, and further in view of the International Atomic Energy Agency (IAEA) (Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, 2014, General Safety Requirements, STI/PUB/1578, ISBN 978-92-0-135310-8).
With respect to claim 75, Strangis discloses the teachings above.
With respect to claim 131 and 132, Strangis discloses the composition comprises 0.11% Co-58 and 0.27% Co-56 impurities. [Strangis, Page 247, Col. 1, Paragraph 1]
Strangis does not disclose the composition comprises the activity concentration of 56Co is equal to or less than 1500 Bq/g or the activity concentration of 58Co is equal to or less than 15000 Bq/g.
However, with respect to claim 131 and 132, the IAEA, which is an international body that establishes radiation safety standards for member states, discloses that activities such as medical uses of radiation are subject to safety standards. [IAEA, Page 1, I.2-I.3 and Page 2, I.5] The IAEA further provides activity concentration guidelines for several radionuclides at moderate amounts that do not warrant regulatory control because the effective dose expected to be incurred by any individual (normally evaluated on the basis of a safety assessment) is of the order of 10 μSv or less in a year. [IAEA, Page 105, I.1. & I.2.] Particularly, the IAEA discloses that Co-56 and Co-58 having an activity concentration of up to 10 Bq/g do not pose a safety risk to individuals or warrant regulatory control. [IAEA, Page 111, Table I.1 and Page 11, 1.26]
Modifying the composition disclosed by Strangis so that the activity concentration of the Co-56 and Co-58 present in the composition is ≤ 10 Bq/g results in the composition of claim 131 and 132.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Strangis so that the activity concentration of Co-56 and Co-58 present in the composition is ≤ 10 Bq/g and have a reasonable expectation of success. Strangis discloses a composition comprising high-purity 61Cu, wherein the radionuclide has a radionuclidic purity at end of synthesis of ≥ 99.9%. Strangis discloses the composition further comprises 0.11% Co-58 and 0.27% Co-56 impurities. The IAEA discloses that Co-58 and Co-56, when present at an activity concentration of ≤ 10 Bq/g does not warrant regulatory control. Accordingly, the combined teachings of Strangis and the IAEA suggest that the Co-58 and Co-56 present in the composition disclosed by Strangis can reach an activity concentration of ≤ 10 Bq/g, in accordance with IAEA safety standards. Therefore, it is reasonable to expect the composition disclosed by Strangis may be modified so that the activity concentration of Co-58 and Co-56 present in the composition is ≤ 10 Bq/g. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, the IAEA discloses that Co-58 and Co-56, when present at a concentration of ≤ 10 Bq/g, do not warrant regulatory control because the effective dose expected to be incurred by any individual is of the order of 10 μSv or less in a year. [IAEA, Page 105, I.1. & I.2.] Therefore, one of ordinary skill in the art would have been motivated by the expectation that the modified composition poses a minimal risk to individuals and could be exempt from regulatory control.
Claims 75, 116-125, 130, and 132 are rejected under 35 U.S.C. 103 as being unpatentable over Asad, as applied to claim 75 and 116-125 above, and further in view of the International Atomic Energy Agency (IAEA).
With respect to claim 75, Asad discloses the teachings above.
With respect to claim 130 and 132, Asad discloses the composition further comprises Zn and Cu impurities and reports that Ga, Al, Ag, and Au impurities were not detected via ICP-MS. [Asad, Page 93, Paragraph 3 and Page 94, Paragraph 1]
Asad does not disclose the composition comprises 110mAg, 108mAg, or 109Cd at an activity concentration of ≤ 0.1 Bq/g.
However, with respect to claim 130 and 132, the IAEA, which is an international body that establishes radiation safety standards for member states, discloses that activities such as medical uses of radiation are subject to safety standards. [IAEA, Page 1, I.2-I.3 and Page 2, I.5] The IAEA further provides activity concentration guidelines for several radionuclides at moderate amounts that do not warrant regulatory control because the effective dose expected to be incurred by any individual (normally evaluated on the basis of a safety assessment) is of the order of 10 μSv or less in a year. [IAEA, Page 105, I.1. & I.2.] Particularly, the IAEA discloses that Ag-108m and Ag-110m present at an activity concentration of up to 1 Bq/g do not pose a safety risk to individuals or warrant regulatory control. [IAEA, Page 114, Table I.1 and Page 11, 1.26]
Modifying the composition disclosed by Asad so that the activity concentration of silver impurities, including Ag-108m and Ag-110m, present in the composition is ≤ 1 Bq/g results in the composition of claim 130 and 132.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Asad so that the activity concentration of silver impurities, including Ag-108m and Ag-110m, present in the composition is ≤ 1 Bq/g and have a reasonable expectation of success. Asad discloses a composition comprising high-purity 61Cu having a radionuclidic purity at end of synthesis of >95%. Asad discloses the composition further comprises Zn and Cu impurities and reports that Ag impurities were not detected via ICP-MS. Asad establishes that elemental Ag is a potential impurity in a high-purity 61Cu composition and indicates that elemental Ag, if present, is at an activity concentration below detectable limits. The IAEA discloses that Ag-108m and Ag-110m, when present at an activity concentration of ≤ 1 Bq/g does not warrant regulatory control. Accordingly, the combined teachings of Asad and the IAEA suggest that any Ag-108m and Ag-110m present in the composition disclosed by Asad can reach an activity concentration of ≤ 1 Bq/g, in accordance with IAEA safety standards. Therefore, it is reasonable to expect the composition disclosed by Asad may be modified so that that the activity concentration of silver impurities, including Ag-108m and Ag-110m, present in the composition is ≤ 1 Bq/g. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, the IAEA discloses that Ag-108m and Ag-110m, when present at a concentration of ≤ 1 Bq/g, do not warrant regulatory control because the effective dose expected to be incurred by any individual is of the order of 10 μSv or less in a year. [IAEA, Page 105, I.1. & I.2.] Therefore, one of ordinary skill in the art would have been motivated by the expectation that the modified composition poses a minimal risk to individuals and could be exempt from regulatory control.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618