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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on July 20, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements filed March 2, 2026 and May 20, 2026 fail to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v) and the cumulative number of references cited at the time of submission of these information disclosure statements required a size fee. They have been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claim 19 is objected to because of the following informalities: the abbreviations DOTA and DOTAGA are not accompanied by the complete name the first time they appear in the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 – 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of these claims recites a concentration with units of µg/mL, with milliliters being a volume measurement. Does this mean that the composition of claim 1, from which each of these claims depends, must a liquid? Or is the volume of a solid composition determined rather than using the mass of the solid composition such that a value with the appropriate units can be obtained to compare with the claimed values?
Please clarify.
Claims 14 – 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 14, from which claims 15 and 16 depend, recite that the composition “comprises a solution of hydrochloric acid (HCl) having a molarity of about 0.001 M to about 3 M” (emphasis added). This open language allows for the presence of other liquid components that would decrease the molar concentration of the HCl. It is not clear if claims 14 – 16 relate to the overall concentration of HCl in the claimed composition or if this is akin to a product-by-process limitation in which HCl is added to the composition such that the final concentration of HCl in the claimed composition falls within the claimed range.
The dependent claims fall therewith.
Please clarify.
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.
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 and 4 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pipes et al. (US 2022/0064015).
Pipes et al. discloses compositions comprising high levels of specific activity of copper-64 that comprise from about 2 Ci to about 15 Ci with specific activities up to about 3800 mCi copper-64 per microgram of copper (mCi 64Cu/µg Cu; whole document, e.g., abstract). In some embodiments the composition comprises a solution of HCl such that the 64Cu exists as [64Cu]CuCl2 (¶ [0010]). The HCl solution may comprise from 0.05 M to about 3.0 M HCl and a specific value of 0.05 M HCl is also disclosed (¶ [0026]). The radionuclide purity of the 64Cu compositions is generally greater than about 98.5% and can be greater than about 99.9%, referenced at 6 am the day after bombardment (¶ [0023]). In general, the disclosed compositions comprise low levels of metal contaminants such as cobalt, copper, iron, mercury, nickel and zinc (¶ [0025]). In some embodiments, at least one bifunctional chelating agent that can be a macrocyclic compound, a bridged macrocyclic compound, a bicyclic compound, or an acyclic compound such as DOTA (1,4,7,10-tetraazacyclododecane-N,N′,N″,N′″-tetraacetic acid) can be present in the composition (¶ [0027]). The bifunctional chelating agent may be linked to a cell targeting agent (¶ [0027]).
An explicit example of a composition with 15 – 110 Ci of copper-64 is not disclosed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare compositions with the claimed amount of radiopacity copper-64, either alone, in the presence of HCl that results in the formation of 64Cu(II) chloride or a bifunctional chelating agent that can be linked to a cell targeting agent. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close absent evidence of unexpected properties (see MPEP 2144.05). The range of Pipes et al. is broadened by the use of about, rendering obvious ranges that begin at 15 Ci as in claim 1 or 17 Ci as in claim 4. The range for the specific activity of the instant claims has substantial overlap with the range of up to 3,800 mCi 64Cu/µg Cu disclosed by Pipes et al. and such ranges are also obvious (see MPEP 2144.05). The amount of various ingredients in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results and there is no evidence of unexpected results. While the impurity amounts in the claims and prior art are not reported, high radiochemical purity as high as greater than about 99.9% is disclosed for metals such as those recited in the instant claims, motivating one of ordinary skill in the art to prepare compositions with very low level of other material such as elemental copper and other metal ions. There is no evidence of record as to the criticality of the claimed ranges for these materials in the claimed composition.
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 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of copending Application No. 18/745,925 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’925 recite compositions comprising a 64Cu composition of greater than 98.5% or 99.5% radionuclidic purity (claims 1 and 2). The compositions can comprise from 2 – 110 Ci copper-64 (claim 13) and have a specific activity of 50 – 3,850 mCi 64Cu/µg Cu (claim 14). Dependent claims recite various levels of impurities. HCl having a molarity of 0.001 – 3M and 64CuCl2 can also be present (claims 24 and 25). Bifunctional chelating agents such as DOTA can also be present (claims 26 and 27). These compositions render obvious those of the instant claims as a prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 4 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3 and 6 – 31 of copending Application No. 19/195,850 optionally in view of Pipes et al. (US 2022/0064015). The claims of US’850 recite a composition comprising a specific activity of 50 – 3,850 mCi 64Cu/µg Cu with purities suitable for positron emission tomography (PET; claim 1). The radionuclidic purty can be greater than 99.0% (claim 3). Dependent claims recite various levels of impurities. The composition can be isolated from compositions having 3 – 15 or 5 – 15 Ci 64Cu (claims 22 and 23), indicating that the initial composition contains at least those amounts of 64Cu. A chelator such as DOTATATE can be present (claims 25). A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of HCl, that will result in formation of copper (II) chloride, is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include HCl in the compositions of US’850. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pipes et al. discloses the high specific activity 64Cu compositions can contain HCl and given the high purity levels of the 64Cu, 64CuCl2 would be present. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 – 19 and 21 of copending Application No. 19/242,810 optionally in view of Pipes et al. (US 2022/0064015). The claims of US’810 recite a composition comprising 25 – 50 Ci 64Cu and a radiochemical purity of at least 95.0% (claim 1). Dependent claims recite various levels of impurities. The compositions can have a specific activity of 25 – 3860 mCi 64Cu/µg Cu (claims 6 – 14 and 21). A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of HCl, 64CuCl2 or a bifunctional chelator is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include HCl and/or a chelator in the compositions of US’810. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pipes et al. discloses the high specific activity 64Cu compositions can contain HCl and given the high purity levels of the 64Cu, 64CuCl2 would be present. A chelator can be used for attachment to a cell targeting agent as taught by Pipes et al. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 9, 11 – 16, 18 and 19 of copending Application No. 19/242,849 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’849 recite a composition comprising a specific activity of from 50 – 3,850 mCi 64Cu/µg Cu with purities suitable for positron emission tomography (PET; claim 1). That purity can be greater than 98.5% (claim 9). The composition can comprise more than 4, 10, 15, 20, 30, 40 or 50 Ci of copper-64 (claims 2 – 8). Dependent claims recite various levels of impurities. The compositions can contain about 0.001 – about 3 M or about 0.05 M HCl (claims 12 and 13) and can exist as [64Cu]CuCl2 (claim 16). Bifunctional chelating agents such as DOTA can also be present (claims 14 – 15). These compositions render obvious those of the instant claims as a prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 4 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of copending Application No. 19/377,844 in view of Pipes et al. (US 2022/0064015). The claims of US’844 recite a composition comprising about 35 to about 3,800 mCi 64Cu/µg Cu (claim 1). The radionuclidic purity can be greater than 98.5% (claim 7). Dependent claims recite various levels of impurities. Chelating agents such as DOTA or DOTAGA can be present in the composition (claims 9 and 10). Compositions comprising 2 – 15 Ci copper-64 are also claimed (claim 11). A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of HCl, that will result in formation of copper (II) chloride, is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include HCl in the compositions of US’844. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pipes et al. discloses the high specific activity 64Cu compositions can contain HCl and given the high purity levels of the 64Cu, 64CuCl2 would be present. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of copending Application No. 19/396,014 optionally in view of Pipes et al. (US 2022/0064015). The claims of US’014 recite a method of making copper-64 (e.g., claim 1) that can result in the formation of compositions that comprise about 2 to about 82 mCi 64Cu at the end of bombardment (claims 6 – 8). The eluate can be reconstituted with HCl at a concentration of 0.05 M (claim 19), which will result in the presence of 64CuCl2. The final product can have less than 5 ppm of trace metals as recited in claim 22. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of a chelating agent is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include a chelator such as DOTA in the compositions that result from the method of US’014. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because a chelator can be used for attachment to a cell targeting agent as taught by Pipes et al.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 13 and 18 - 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 and 23 - 28 of copending Application No. 19/725,847. The claims of US’847 recite a copper-64 composition with chelating agent coordinated to the 64Cu with a specific activity of about 350 to about 3,000 mCi 64Cu/µg Cu (claim 1). The composition can comprise various amounts of activity such as about 9 to about 15 Ci (claim 23) indicating that even broader amounts are encompassed by claims such as claim 1. The radionuclidic purity can be greater than about 98.5% (claim 27) and dependent claims recite various levels of impurities. These compositions render obvious those of the instant claims as a prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 21 of copending Application No. 19/748,302 optionally in view of Pipes et al. (US 2022/0064015). The claims of US’302 recite a method of preparing a copper-64 containing solution (claim 10). The product fraction can comprise about 2 to about 110 Ci copper-64 with a specific activity up to about 3,850 mCi 64Cu/µg Cu (claim 18). A total trace metal content of less than 5 ppm of those recited in claim 19 is also claimed. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of HCl, 64CuCl2 or a bifunctional chelator is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include HCl and/or a chelator in the compositions of US’302. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pipes et al. discloses the high specific activity 64Cu compositions can contain HCl and given the high purity levels of the 64Cu, 64CuCl2 would be present. A chelator can be used for attachment to a cell targeting agent as taught by Pipes et al. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 4 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 - 12 of U.S. Patent No. 11,521,762. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’762 recite compositions comprising 4 – 15 Ci copper-64 with a specific activity of about 35 to about 3,800 mCi 64Cu/µg Cu (claim 1). Claim 7 recites that less than 5 ppm of the recited trace elements are present. The composition can contain about 0.001 to about 3 M or 0.05 M HCl (claims 8 and 9). The 64Cu can be present as [64Cu]CuCl2 (claim 10). The composition can also comprise chelators (claims 11 and 12). These compositions render obvious those of the instant claims as a prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
Claims 1 and 4 – 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 7, 9, 10 and 23 - 28 of U.S. Patent No. 11,581,103. Although the claims at issue are not identical, they are not patentably distinct from each other because the compositions of US’103 comprises about 4 to 15 Ci copper-64 with a specific activity up to about 3,800 mCi 64Cu/µg Cu (claim 1). Dependent claims recite various levels of impurities. The composition can contain about 0.001 to about 3 M HCl (claim 26). The 64Cu can be present as [64Cu]CuCl2 (claim 26). The composition can also comprise chelators (claims 27 and 28). These compositions render obvious those of the instant claims as a prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
Claims 1 and 4 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of U.S. Patent No. 11,978,569. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’569 recite compositions of 2 – 15 Ci copper-64 and a specific activity of about 100 to about 3,800 mCi 64Cu/µg Cu (claim 1). Dependent claims recite various levels of impurities. The composition can contain about 0.001 to about 3 M HCl (claim 7). The 64Cu can be present as [64Cu]CuCl2 (claim 8). The composition can also comprise chelators such as DOTA (claims 9 and 10). These compositions render obvious those of the instant claims as a prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
Claims 1 – 20 are rejected on the ground of nonstatutory double patenting being unpatentable over claims 1 - 25 of U.S. Patent No. 12,148,542 optionally in view of Pipes et al. (US 2022/0064015). The claims of US’542 recite compositions comprising 38 – 51 Ci copper-64 with a specific activity from about 100 to about 3,800 mCi 64Cu/µg Cu (claim 1). Dependent claims recite various levels of impurities. The 64Cu can be present as [64Cu]CuCl2 (claim 17). The composition can also comprise chelators (claims 27 and 28). A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of HCl, 64CuCl2 or a bifunctional chelator is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include HCl and/or a chelator in the compositions of US’542. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pipes et al. discloses the high specific activity 64Cu compositions can contain HCl and given the high purity levels of the 64Cu, 64CuCl2 would be present. A chelator can be used for attachment to a cell targeting agent as taught by Pipes et al. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
Claims 1 and 4 – 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 29 of U.S. Patent No. 12,237,092. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’092 recite compositions that comprise 2 – 15 Ci copper-64, a radionuclidic purity of greater than 98.5% with less than about 6 ppm of the various metals recited in claim 1. The composition can contain about 0.001 to about 3 M HCl (claim 9). The 64Cu can be present as [64Cu]CuCl2 (claim 10). The composition can also comprise chelators such as DOTA (claims 11 and 12). These compositions render obvious those of the instant claims as a prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
Claims 1 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 28 of U.S. Patent No. 12,288,627 optionally in view of Pipes et al. (US 2022/0064015). The claims of US’627 recite compositions comprising 2 – 150 Ci copper-64 with a specific activity up to 3,850 mCi 64Cu/µg Cu and various levels of impurities as recited in claim 1 (see also claim 23). A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of HCl, 64CuCl2 or a bifunctional chelator is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include HCl and/or a chelator in the compositions of US’627. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pipes et al. discloses the high specific activity 64Cu compositions can contain HCl and given the high purity levels of the 64Cu, 64CuCl2 would be present. A chelator can be used for attachment to a cell targeting agent as taught by Pipes et al. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
Claims 1 and 4 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of U.S. Patent No. 12,315,649. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’649 recite compositions that comprise 2 – 15 Ci of copper-64 and a specific activity of about 50 to about 3,800 mCi 64Cu/µg Cu with purities suitable for PET (claim 1). Dependent claims recite various levels of impurities. The composition can contain about 0.001 to about 3 M HCl (claim 23). The 64Cu can be present as [64Cu]CuCl2 (claim 24). The composition can also comprise chelators (claims 25 and 26). These compositions render obvious those of the instant claims as a prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
Claims 1 and 4 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 – 9, 11 16 and 18 - 22 of U.S. Patent No. 12,603,190 optionally in view of Pipes et al. (US 2022/0064015). The claims of US’190 recite compositions comprising about 4 to about 15 Ci copper-64 with a radionuclidic purity greater than about 98.5% (claim 1) or even higher, such as greater than about 99.9% (claim 7). While the specific activity is not claimed, there is no evidence of record that compositions with the same amount of radioactivity and similar purity levels do not result in a specific activity falling within the range of the instant claims. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of HCl, 64CuCl2 or a bifunctional chelator is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include HCl and/or a chelator in the compositions of US’190. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pipes et al. discloses the high specific activity 64Cu compositions can contain HCl and given the high purity levels of the 64Cu, 64CuCl2 would be present. A chelator can be used for attachment to a cell targeting agent as taught by Pipes et al. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
Claims 1 and 4 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of U.S. Patent No. 12,462,943 optionally in view of Pipes et al. (US 2022/0064015). The claims of US’943 recite compositions comprising 2 – 15 Ci copper-64 and a specific activity of at least 25 mCi 64Cu/µg Cu with purities suitable for PET (claim 1). Dependent claims recite various levels of impurities. The composition can also comprise chelators such as DOTA or DOTAGA (claims 28 - 30). A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of HCl, that will result in formation of copper (II) chloride, is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include HCl in the compositions of US’943. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pipes et al. discloses the high specific activity 64Cu compositions can contain HCl and given the high purity levels of the 64Cu, 64CuCl2 would be present. A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
Claims 1 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1 - 30 of U.S. Patent No. 12,718,963 optionally in view of Pipes et al. (US 2022/0064015). The claims of US’963 recite compositions comprising 35 – 150 MBq of copper-64 with purities as defined in claims such as claim 1 that are suitable for PET (claim 1). These compositions can comprise 2 – 150 Ci of copper 64 (claim 7). The specific activity of the composition can range from 50 – 3,850 mCi 64Cu/µg Cu (claim 13). A prima facie case of obviousness exists where the claimed ranges overlap or the amounts do not overlap with the prior art but are merely close absent evidence of criticality (see MPEP 2144.05).
The presence of HCl, that will result in formation of copper (II) chloride, is not claimed.
Pipes et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to include HCl in the compositions of US’963. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pipes et al. discloses the high specific activity 64Cu compositions can contain HCl and given the high purity levels of the 64Cu, 64CuCl2 would be present.
Conclusion
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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