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 .
Status of Claims
Cancelled: 1-74, 76-115
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.
Withdrawn Rejections
The rejection of claim 138 under 35 U.S.C. 112(b) is hereby withdrawn in view of Applicant’s amendment to claim 138, which removes the limitation “(EoB + 2hrs),” thereby rendering the rejection moot.
The rejection of claims 75, 116-126, and 138 under 35 U.S.C. 102(a)(1) over Strangis is hereby withdrawn in view of Applicant’s substantive amendments to claim 75.
The rejection of claims 75 and 116-125 under 35 U.S.C. 102(a)(1) over Asad is hereby withdrawn in view of Applicant’s substantive amendments to claim 75.
The rejection of claims 75, 116-129, and 133-137 under 35 U.S.C. 102(a)(1) over Svedjehed is hereby withdrawn in view of Applicant’s substantive amendments to claim 75.
The rejection of claims 75, 116-126, 131, 132, and 138 under 35 U.S.C. 103 over Stangis and the International Atomic Energy Agency (IAEA) is hereby withdrawn in view of Applicant’s substantive amendments to claim 75.
The rejection of claims 75, 116-125, 130, and 132 under 35 U.S.C. 103 as being unpatentable over Asad and the International Atomic Energy Agency (IAEA) is hereby withdrawn in view of Applicant’s substantive amendments to claim 75.
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 and 116-129 are rejected under 35 U.S.C. 103 as being unpatentable over Jalilian (Synthesis and Preclinical Studies of [61Cu]-N-(2-hydroxyacetophenone)glycinate as a Possible PET Radiopharmaceutical, Sci. Pharm., 9/16/2008, 76(4), 637-652), in view of Arnsdorf (US 2010/0178244 A1, Published 7/15/2010).
With respect to claim 75, Jalilian discloses a high-purity radionuclide composition, [61Cu]NHAG, comprising a radionuclide and having a radionuclidic purity at end of synthesis of >99%;
wherein:
the radionuclide is copper-61, and
the composition is characterized at end of synthesis by radiochemical purity of ≥ 95% (i.e., 99.9%). [Abstract; Page 638, Paragraph 5; Page 641, Figure 4]
Also, with respect to claim 75, Jalilian discloses a high-purity radionuclide composition, the composition, [61Cu]CuCl2, comprising a radionuclide and having a radionuclidic purity at end of synthesis of >99%;
wherein:
the radionuclide is copper-61, and
the composition is characterized at end of synthesis by radiochemical purity of ≥ 95% (i.e., 99.9%). [Page 638, Paragraph 5; Page 641, Figure 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 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, Jalilian discloses a product (a high-purity radionuclide composition) that is obvious from the claimed product (as explained below). Therefore, the limitations of claims 116-125 are unpatentable even if the product disclosed by Jalilian was made by a different process. Accordingly, since the limitations of claim 75 are obvious over Jalilian, the limitations of claims 116-125 are also obvious.
With respect to claim 126, Jalilian discloses that the composition has a radionuclidic purity at the end of synthesis of >99% for the radionuclide. [Page 638, Paragraph 5]
With respect to claim 127, Jalilian discloses that the composition is an aqueous solution, saline. [Page 642, Paragraph 3] Moreover, the composition necessarily comprises copper in the form of radionuclide cations, Cu2+.
With respect to claim 128, Jalilian discloses that the composition is [61Cu]CuCl2. [Page 642, Paragraph 3] [61Cu]CuCl2 necessarily comprises chloride anions, (2) Cl-.
With respect to claim 129, Jalilian further discloses that the composition is [61Cu]CuCl2. [Page 642, Paragraph 3] The chloride anions in [61Cu]CuCl2 are necessarily present in a molar excess of the copper cations.
Jalilian does not disclose that the composition has a radionuclidic purity at end of synthesis for the radionuclide of ≥ 99.99% or 99.999%. (Claim 75 and 126)
However, with respect to claim 75 and 126, a prima facie case of obviousness exists where the claimed ranges overlap with ranges disclosed by the prior art. MPEP 2144.05(I). In the present case, the claimed ranges, ≥ 99.99% and 99.999%, overlap with the range, >99%, disclosed by Jalilian. Jalilian expresses the radionuclidic purity via 2 significant figures while the claimed range expresses the radionuclidic purity via 5-6 significant figures. However, this difference reflects a difference in precision, not necessarily a difference in the underlying purity value.
Additionally, the mere purity of a product, by itself, does not render the product nonobvious where the claimed chemical compound or composition has the same utility as the prior art, and where the prior art suggests the particular form or structure of the claimed material. MPEP 2144.04(VII). In the present case, Jalilian discloses that the copper-61 radionuclide and composition have the same utility (i.e., for use in high-purity radionuclide compositions) and form (i.e., aqueous) as the claimed copper-61 radionuclide and composition. Accordingly, a mere difference in purity between the claimed copper-61 radionuclide and composition and the copper-61 radionuclide and composition disclosed by Jalilian does not render the claimed radionuclidic purity of copper-61 nonobvious.
Moreover, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where 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. MPEP 2144.05(II)(A). In the present case, Jalilian discloses the general conditions of the instant claim (as explained above). Therefore, it is not inventive to discover the optimum or workable radionuclidic purity of copper-61 by routine experimentation.
It would have been routine optimization to arrive at the claimed invention because radionuclidic purity is a result-effective variable. Arnsdorf discloses that radionuclides are used to destroy cells. So, one must be very sure that localization of these nuclides in target tissue is optimal. If the radionuclides used to label the radiopharmaceuticals do not have a very high purity, then contaminating radionuclides can significantly increase the radiation dose to the target and surrounding tissues and, possibly, to areas of the body remote from the site of interest. If radiochemical purity is not high, then the radioisotope is in the wrong radiochemical form. In this case, it might localize in an undesirable place instead of in the desired target organ. The potential for a resulting catastrophic illness resulting from this poor biological distribution is quite significant. [Arnsdorf, 0067] Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide and composition free from radioactive contaminants to avoid the adverse effect of poor biological distribution that they cause.
A person of ordinary skill in the art would have had a reasonable expectation of success in formulating the claimed range because Arnsdorf discloses that poor biological distribution is attributed to the presence of contaminants. Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide composition free from radioactive impurities, including a radionuclidic purity of as close to 100% as possible (e.g., >99.99% and 99.999%).
Claims 75, 116-129, and 133 are rejected under 35 U.S.C. 103 as being unpatentable over Jalilian and Arnsdorf, as applied to claim 75 and 116-129 above, and further in view of Zhernosekov (US 2010/0202915 A1, Published 8/12/2010).
With respect to claim 75, Jalilian and Arnsdorf disclose the teachings above.
Jalilian and Arnsdorf do not disclose that the composition has a chemical purity for the radionuclide of ≥ 99 molar %. (Claim 133)
However, with respect to claim 133, the mere purity of a product, by itself, does not render the product nonobvious where the claimed chemical compound or composition has the same utility as the prior art, and where the prior art suggests the particular form or structure of the claimed material. MPEP 2144.04(VII). In the present case, Jalilian discloses that the copper-61 radionuclide and composition have the same utility (i.e., for use in high-purity radionuclide compositions) and form (i.e., aqueous) as the claimed copper-61 radionuclide and composition. Accordingly, a mere difference in purity between the claimed copper-61 radionuclide and composition and the copper-61 radionuclide and composition disclosed by Jalilian does not render the claimed chemical purity of copper-61 nonobvious.
Moreover, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where 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. MPEP 2144.05(II)(A). In the present case, Jalilian discloses the general conditions of the instant claim (as explained above). Therefore, it is not inventive to discover the optimum or workable chemical purity of copper-61 by routine experimentation.
It would have been routine optimization to arrive at the claimed invention because chemical purity is a result-effective variable. Zhernosekov discloses that radionuclides used to label radiopharmaceuticals have to meet high quality standards by having a high degree of purity. That is, radionuclides must be free from metallic impurities since these may, owing to competing reactions, adversely affect the labelling of the radiopharmaceuticals and reduce the technically achievable yield. [Zhernosekov, 0007] Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide and composition free from metallic contaminants to avoid the adverse effect on the labelling and yield of radiopharmaceuticals that they cause.
A person of ordinary skill in the art would have had a reasonable expectation of success in formulating the claimed range because Zhernosekov discloses that to achieve a high degree of purity, a radionuclide must be free from metallic impurities. Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide composition free from radioactive and metallic impurities, including a chemical purity as close to 100 molar % as possible (e.g., ≥ 99 molar %).
Claims 75, 116-126, and 138 are rejected under 35 U.S.C. 103 as being unpatentable over Fonseca (Production of GMP-Compliant Clinical Amounts of Copper-61 Radiopharmaceuticals from Liquid Targets, Pharmaceuticals, 6/7/2022, 15, 723), in view of Arnsdorf.
With respect to claim 75, Fonseca discloses a high-purity radionuclide composition, [61Cu]Cu-DOTA-TATE, comprising a radionuclide and having a radionuclidic purity at end of synthesis of about 99.97%; [Page 5, Paragraph 3; Page 6, Table 3 & Figure 2]
wherein:
the radionuclide is copper-61,
the composition is characterized at end of synthesis by radiochemical purity of ≥ 95% (i.e., 99.90%), and
the composition is characterized at end of synthesis +12 hours by radiochemical purity of > 97%. [Page 6, Table 3 & Figure 2; Page 7, Figure 3(C)]
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 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, Fonseca discloses a product (a high-purity radionuclide composition) that is obvious from the claimed product (as explained below). Therefore, the limitations of claims 116-125 are unpatentable even if the product disclosed by Fonseca was made by a different process. Accordingly, since the limitations of claim 75 are obvious over Fonseca, the limitations of claims 116-125 are also obvious.
With respect to claim 126, Fonseca discloses the composition has a radionuclidic purity at end of synthesis for the radionuclide of about 99.97%. [Page 5, Paragraph 3; Page 6, Table 3]
With respect to claim 138, Fonseca discloses the composition is characterized at end of synthesis by an activity of > 500 MBq (i.e., 2.06 GBq = 2060 MBq). [Page 5, Paragraph 3; Page 6, Table 3]
Fonseca does not disclose that the composition has a radionuclidic purity at end of synthesis for the radionuclide of ≥ 99.99% or 99.999%. (Claim 75 and 126)
However, with respect to claims 75 and 126, a prima facie case of obviousness exists where the claimed ranges overlap with ranges disclosed by the prior art. MPEP 2144.05(I). In the present case, the claimed radionuclidic purity, ≥ 99.99% and 99.999%, overlaps with the range, >99.97%, disclosed by Fonseca.
Additionally, the mere purity of a product, by itself, does not render the product nonobvious where the claimed chemical compound or composition has the same utility as the prior art, and where the prior art suggests the particular form or structure of the claimed material. MPEP 2144.04(VII). In the present case, Fonseca discloses that the copper-61 radionuclide and composition has the same utility (i.e., for use in high-purity radionuclide compositions) and form (i.e., aqueous) as the claimed radionuclide and composition. Accordingly, the mere difference in purity between the claimed copper-61 radionuclide and solution and the copper-61 radionuclide and solution disclosed by Fonsesca does not render the claimed radionuclidic purity nonobvious.
Moreover, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where 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. MPEP 2144.05(II)(A). In the present case, Fonseca discloses the general conditions of the instant claim (as explained above). Therefore, it is not inventive to discover the optimum or workable radionuclidic purity of copper-61 by routine experimentation.
It would have been routine optimization to arrive at the claimed invention because radionuclidic purity is a result-effective variable. Arnsdorf discloses that radionuclides are used to destroy cells. So, one must be very sure that localization of these nuclides in target tissue is optimal. If the radionuclides used to label the radiopharmaceuticals do not have a very high purity, then contaminating radionuclides can significantly increase the radiation dose to the target and surrounding tissues and, possibly, to areas of the body remote from the site of interest. If the radiochemical purity is not high, then the radioisotope is in the wrong radiochemical form. In this case, it might localize in an undesirable place instead of in the desired target organ. The potential for a resulting catastrophic illness resulting from this poor biological distribution is quite significant. [Arnsdorf, 0067] Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide and composition free from radioactive contaminants to avoid the adverse effect of poor biological distribution that they cause.
A person of ordinary skill in the art would have had a reasonable expectation of success in formulating the claimed range because Arnsdorf discloses that poor biological distribution is attributed to the presence of contaminants. Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide composition free from radioactive impurities, including a radionuclidic purity of as close to 100% as possible (e.g., >99.99% and 99.999%).
Claims 75, 116-126, 133, and 138 are rejected under 35 U.S.C. 103 as being unpatentable over Fonseca and Arnsdorf, as applied to claim 75, 116-126, and 138 above, and further in view of Zhernosekov.
With respect to claim 75, Fonseca and Arnsdorf disclose the teachings above.
Fonseca and Arnsodorf do not disclose that the composition has a chemical purity for the radionuclide of ≥ 99 molar %. (Claim 133)
However, with respect to claim 133, the mere purity of a product, by itself, does not render the product nonobvious where the claimed chemical compound or composition has the same utility as the prior art, and where the prior art suggests the particular form or structure of the claimed material. MPEP 2144.04(VII). In the present case, Fonseca discloses that the copper-61 radionuclide and composition have the same utility (i.e., for use in high-purity radionuclide compositions) and form (i.e., aqueous) as the claimed copper-61 radionuclide and composition. Accordingly, a mere difference in purity between the claimed copper-61 radionuclide and composition and the copper-61 radionuclide and composition disclosed by Fonseca does not render the claimed chemical purity of copper-61 nonobvious.
Moreover, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where 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. MPEP 2144.05(II)(A). In the present case, Fonseca discloses the general conditions of the instant claim (as explained above). Therefore, it is not inventive to discover the optimum or workable chemical purity of copper-61 by routine experimentation.
It would have been routine optimization to arrive at the claimed invention because chemical purity is a result-effective variable. Zhernosekov discloses that radionuclides used for labelling the radio-pharmaceuticals have to meet high quality standards by having a high degree of purity. That is, radionuclides must be free from metallic impurities since these may, owing to competing reactions, adversely affect the labelling of the radiopharmaceuticals and reduce the technically achievable yield. [Zhernosekov, 0007] Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide and composition free from metallic contaminants to avoid the adverse effect on the labelling and yield of radiopharmaceuticals that they cause.
A person of ordinary skill in the art would have had a reasonable expectation of success in formulating the claimed range because Zhernosekov discloses that to achieve a high degree of purity, a radionuclide must be free from metallic impurities. Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide composition free from radioactive and metallic impurities, including a chemical purity as close to 100 molar % as possible (e.g., ≥ 99 molar %).
Claims 75, 116-126, and 133-138 are rejected under 35 U.S.C. 103 as being unpatentable over Alves (GMP-Automated Purification of Copper-61 Produced in Cyclotron Liquid Targets: Methodological Aspects, Current Radiopharmaceuticals, 11/12/2021, Vol. 14, No. 4, 421-428), in view of Arnsdorf.
With respect to claim 75, Alves discloses a high-purity radionuclide composition, the composition, [61Cu]CuCl2, comprising a radionuclide and having a radionuclidic purity at end of synthesis (a.k.a. “end of production”) of about 98.4%;
wherein:
the radionuclide is copper-61,
the composition is characterized at end of synthesis by radiochemical purity of ≥ 95% (i.e., >99.9%). [Page 426, Table 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 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, Alves discloses a product (a high-purity radionuclide composition) that is obvious from the claimed product (as explained below). Therefore, the limitations of claims 116-125 are unpatentable even if the product disclosed by Alves was made by a different process. Accordingly, since the limitations of claim 75 are obvious over Fonseca, the limitations of claims 116-125 are also obvious.
With respect to claim 126, Alves discloses the composition has a radionuclidic purity at end of synthesis for the radionuclide of about 98.4%. [Page 426, Table 1]
With respect to claim 134 and 135, Alves discloses the composition is an aqueous solution and comprises Fe ≤ 2 mg/L (i.e., < 2 ug/5 mL = < 0.4 mg/L). [Page 425, Figure 4]
With respect to claim 134 and 136, Alves discloses the composition is an aqueous solution and comprises total Cu ≤ 1 mg/L (i.e., < 1 ug/5 mL = < 0.2 mg/L). [Page 425, Figure 4] Accordingly, since the amount of total copper is ≤ 1 mg/L, the amount of 69Cu and 65Cu must also be ≤ 1 mg/L.
With respect to claim 134 and 137, Alves discloses the composition is an aqueous solution and comprises Ni ≤ 1 mg/L (i.e., < 1 ug/5 mL = 0.2 mg/L). [Page 425, Figure 4]
Also, with respect to claim 134, Alves discloses the composition is in an aqueous solution and comprises:
Zn ≤ 2 mg/L (i.e., < 5 ug/5 mL = < 1 mg/L)
Al ≤ 2 mg/L (i.e., < 2 ug/5 mL = < 0.4 mg/L)
Co ≤ 0.1 mg/L (i.e., < 0.5 ug/5 mL = < 0.1 mg/L). [Page 425, Figure 4]
With respect to claim 138, Alves discloses the composition is characterized at end of synthesis by an activity of > 500 MBq (i.e., 1 GBq = 1000 MBq). [Page 426, Col. 1, Paragraph 3]
Alves does not disclose that the composition has a radionuclidic purity at end of synthesis for the radionuclide of ≥ 99.99% or 99.999%. (Claim 75 and 126) Alves does not disclose that the composition has a chemical purity for the radionuclide of ≥ 99 molar%. (Claim 133)
However, with respect to claims 75, 126, and 133, the mere purity of a product, by itself, does not render the product nonobvious where the claimed chemical compound or composition has the same utility as the prior art, and where the prior art suggests the particular form or structure of the claimed material. MPEP 2144.04(VII). In the present case, Alves discloses that the copper-61 radionuclide and composition have the same utility (i.e., for use in high-purity radionuclide compositions) and form (i.e., aqueous) as the claimed radionuclide and composition. Accordingly, the mere difference in purity between the claimed copper-61 radionuclide and solution and the radionuclide and composition disclosed by Alves does not render the claimed radionuclidic purity or chemical purity of copper-61 nonobvious.
Moreover, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where 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. MPEP 2144.05(II)(A). In the present case, Alves discloses the general conditions of the instant claim (as explained above). Therefore, it is not inventive to discover the optimum or workable radionuclidic purity or chemical purity by routine experimentation.
It would have been routine optimization to arrive at the claimed invention because radionuclidic purity and chemical purity are result-effective variables. Arnsdorf discloses that radionuclides are used to destroy cells. So, one must be very sure that localization of these nuclides in target tissue is optimal. If radionuclides used to label the radiopharmaceuticals do not have a very high purity, then contaminating radionuclides can significantly increase the radiation dose to the target and surrounding tissues and, possibly, to areas of the body remote from the site of interest. If the radiochemical purity is not high, then the radioisotope is in the wrong radiochemical form. In this case, it might localize in an undesirable place instead of in the desired target organ. The potential for a resulting catastrophic illness resulting from this poor biological distribution is quite significant. [Arnsdorf, 0067] Alves discloses that decreasing the concentration of metal contaminants (e.g., zinc) from the composition enables both an increase in the purity of the final solution and an optimal yield. [Alves, Page 424, Col. 2, Paragraph 3] Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide and copper-61 composition free from radioactive and non-radioactive contaminants to avoid the effect of poor biological distribution that they cause and to achieve a composition having increased purity and optimal yield.
A person of ordinary skill in the art would have had a reasonable expectation of success in formulating the claimed radionuclidic purity and chemical purity because Arnsdorf discloses that poor biological distribution is attributed to the presence of contaminants and Alves discloses that purity and yield are inversely attributed to the presence of trace metal contaminants. Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide and composition free from radioactive and metal contaminants, including a radionuclidic purity as close to 100% as possible (e.g., >99.99% and 99.999%) and a chemical purity as close to 100 molar % as possible (e.g., ≥ 99 molar %).
Claims 75, 116-126, and 130-138 are rejected under 35 U.S.C. 103 as being unpatentable over Alves and Arnsdorf, as applied to claim 75, 116-126, and 133-138 above, and further in view of Rowshanfarzad (An overview of copper radionuclides and production of 61Cu by proton irradiation of natZn at a medical cyclotron, Applied Radiation and Isotopes, 2006, 64(12), 1563–1573).
With respect to claim 75, Alves and Arnsdorf disclose the teachings above.
Alves does not explicitly disclose that the composition comprises ≤ 0.1 Bq/g 110mAg, 108mAg, or 109Cd, ≤ 100 Bq/g 57Co, or ≤ 15 Bq/g 60Co.
However, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where 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. MPEP 2144.05(II)(A). In the present case, Alves discloses the general conditions of the instant claim. (as explained above). Therefore, it is not inventive to discover the optimum or workable radionuclidic purity by routine experimentation.
It would have been routine optimization to arrive at a composition comprising a very high radionuclidic purity, and by extension, minimal or no contaminants, because radionuclidic purity is a result-effective variable. Arnsdorf discloses that radionuclides are used to destroy cells. So, one must be very sure that localization of these nuclides in target tissue is optimal. If radionuclides used for labelling the radiopharmaceuticals do not have a very high purity, then contaminating radionuclides can significantly increase the radiation dose to the target and surrounding tissues and, possibly, to areas of the body remote from the site of interest. Therefore, one of ordinary skill in the art would have been motivated to produce a copper-61 radionuclide free from radioactive contaminants, including 110mAg, 108mAg, 109Cd, 57Co, and/or 60Co, to avoid the effect of poor biological distribution that they cause.
A person of ordinary skill in the art would have had a reasonable expectation of success in formulating a composition free from 110mAg, 108mAg, 109Cd, 57Co, and/or 60Co contaminants because Alves discloses that the copper-61 composition was produced by the natZn(p,x)61Cu reaction. [Alves, Page 422, Col. 2, Paragraph 1] Furthermore, Alves discloses that the radionuclidic impurities present in the composition include 66Ga, 67Ga, and 64Cu. [Alves, Page 423, Col.2, Paragraph 1] Rowshanfarzad discloses the ALICE code for natZn(p,x)60–69Cu reactions. [Rowshanfarzad, Page 1567, Figure 1] The expected radionuclidic impurities produced by this reaction include 60-69Cu. Moreover, the proton bombardment of a natZn target leads to the production of several zinc and gallium isotopes with a mixture of short and long half-lives. [Rowshanfarzad, Page 1568, Col. 1, Paragraph 2] Accordingly, The combined teachings of Alves and Rowshanfarzad suggest that 57Co, 60Co, 110mAg, 108mAg, and 109Cd are not impurities that are expected to be produced by the natZn(p,x)61Cu reaction disclosed by Alves. Therefore, it is reasonable to expect that a copper-61 composition, wherein 57Co, 60Co, 110mAg, 108mAg, and 109Cd are not present, may be produced.
Response to Arguments
Applicant’s arguments with respect to the claim Rejections under 35 U.S.C. § 102 over Strangis, Svedjehed, and Asad have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to the claim Rejections under 35 U.S.C. § 103 over Strangis and IAEA, Svedjehed, and Asad have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant asserts “In contrast, in the present application, Applicant has demonstrated that 61Cu compositions obtained by Applicant's improved methods using a high purity niobium substrate/coin result in 61Cu compositions with lower levels of impurities than those prepared from targets of Ni electroplated onto a silver substrate/coin (i.e., Svedjehed), as shown in Table 14 of the present specification, reproduced below.” [Remarks 6/29/2026, Page 9 (last paragraph); Page 10, Paragraph 1-2]
As explained above and in the CTNF of 3/7/2026, the method of producing the claimed composition (using a high purity niobium substrate/coin) cannot support patentability. The instant claims are drawn to a product (composition), not a method; and the determination of patentability is based on the product itself. The Applicant bears the burden of establishing a nonobvious difference between the claimed product and the prior art product. To the extent that Applicant relies on Table 14 to establish that using a high purity niobium substrate/coin to produce the claimed composition improves the purity of the composition compared to a composition produced by a different method in the prior art, the question is whether the claimed composition’s purity is non-obvious, not whether the claimed composition achieved greater purity as a result of its method of production. However, in view of the prima facie case of obviousness raised in the rejections above based on MPEP 2144.05(I), MPEP 2144.05(II), and 2144.04(VII), the data provided by the Applicant, without more, fails to establish non-obviousness.
Applicant asserts “Table 14 reports that 61Cu compositions prepared from Applicant's innovative method using Ni on a niobium substrate/coin have significantly lower impurities (e.g., ten-fold less highly toxic 56Co and 58Co) compared to 61Cu compositions prepared from Ni on a silver substrate/coin (the method taught by Svedjehed).” [Remarks 6/29/2026, Page 10, Paragraph 1-2]
Table 14 does not support the conclusion that compositions produced using Ni on a niobium substrate/coin are “ten-fold less highly toxic 56Co and 58Co.” Impurities are not synonymous with toxicity. The fact that a composition produced from another method has higher impurities does not support a conclusion that said composition is more toxic as a result. Applicant is asked to provide evidence that compositions produced according to the prior art method are, in fact, more toxic than the composition of the claimed invention (which requires a comparison between the two compositions to establish unexpected properties).
Applicant asserts “Applicant respectfully submits that the Office has not provided support for this conclusion. The Office does not explain where Strangis and IAEA, either alone or in combination, disclose how one of skill in the art could accomplish such modifications for compositions of 61Cu. Without some teaching in the prior art on how to modify the compositions of Strangis, there is no reasonable expectation of success in the Office's proposed modification to arrive at the claimed compositions.” [Remarks 6/29/2026, Page 12 (last paragraph); See also Page 13 (last paragraph)]
To the extent Applicant equates the reasonable expectation of success requirement with a requirement that the Office demonstrate success in carrying out the proposed modification or combination by relying on enabling methodology that teaches doing so, this standard incorrect.
The Office does not bear the burden of providing an express, enabling methodology for performing the proposed modification. The reasonable expectation of success requirement refers to "the likelihood of success" in combining or modifying the prior art disclosures to meet the limitations of the claimed invention. Moreover, conclusive proof of efficacy is not required to show a reasonable expectation of success. The expectation of success need only be reasonable, not absolute.
A reasonable expectation can be established by several means. It can be shown implicitly through prior art teachings or as part of the obviousness analysis. Even if, arguendo, the prior art does not provide some teaching on how to modify the compositions of Strangis, that does not mean there is no reasonable expectation of success in the Office's proposed modification, especially if the Office supports that showing with other valid teachings. While, some enabling methodology in the prior art that describes how to perform the modification could suffice to meet the requirement, this is certainly not the rigid rule for providing such a showing as set forth in the MPEP.
Conclusion
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.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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