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 .
Status of the Application
Claims 1-2, 13, 15, 18-21, 24-25, 27, 30, 32, 44, 49, 58, 72, and 75-85 in the claim set filed on 1/10/2024 are under examination.
Drawings
The drawings are objected to because Fig. 31 panel corresponding to [. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because of the following informalities: Figures .
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 does not further limit the limitations in claim 15. See MPEP 608.01(n)(III). Claim 18 adds a new type of chelators (DOTA, DOTAGA, and DOTASA) that are outside the scope of claim 15. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 1-2, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rylova, S. N.; et al. (Rylova, S. N.; Stoykow, C.; Del Pozzo, L.; Abiraj, K.; Tamma, M. L.; Kiefer, Y.; Fani, M.; Maecke, H. R. The somatostatin receptor 2 antagonist 64Cu-NODAGA-JR11 outperforms 64Cu-DOTA-TATE in a mouse xenograft model. PLoS ONE, 2018, 13, 4, 1-16) and Kelly, J. M.; et al. (Kelly, J. M.; Ponnala, S.; Amor-Coarasa, A.; Zia, N. A.; Nikolopoulou, A.; Williams, Jr., C.; Schlyer, D. j.; DiMagno, S. G.; Donnelly, P. S.; Babich, J. W. Preclinical Evaluation of a High-Affinity Sarcophagine-Containing PSMA Ligand for 64Cu/67Cu-Based Theranostics in Prostate Cancer. Mol. Pharmaceutics, 2020, 17, 1954-1962).
Rylova, S. N.; et al. (hereafter referred to as Rylova) is drawn to a comparison of in vitro and in vivo performance of a copper-based radiopharmaceutical with a chelator, linker, and targeting moiety (title; abstract). Rylova teaches 64Cu as the radionuclide, with a few chelators such as NODAGA and DOTA and that a variety of targeting moieties can be attached through linkers (title; abstract, lines 1-2, 13-15; pg 4, para 3, lines 1-3; pg 5, Fig 1) and synthesis with high specific activity and purity (pg 5, para 3, lines 1-2).
As to claim 1, Rylova teaches a composition comprising a radiotracer (pg 4, para 5, lines 1-2) comprising a chelating moiety, copper radionuclide chelated by the chelating moiety, and a targeting moiety covalently linked to the chelating moiety (pg 3, para 4, lines 1-2; pg 5, para 3, lines 1-3; pg 5, Fig 1). Rylova teaches that this composition is characterized by a specific activity of ≥ 3 MBq/nmol (pg 5, para 3, lines 1-3), radiochemical purity of ≥91% (pg 5, para 2-3; pg 14, para 2, line 1-4), and a radionuclidic purity of the radiotracer of ≥95% at the end of synthesis (pg 5, para 2-3).
Rylova does not expressly teach the activity concentration of ≥ 8 MBq/mL
Kelly, J. M.; et al. (hereafter referred to as Kelly) is drawn to preclinical evaluation of copper-based radiotherapeutics for prostate cancer (title; abstract) with a chelator for copper, linker, and PSMA-targeting moiety (abstract; pg 1955, Fig 1). And, Kelly is drawn tocompositions for administration with varying activity concentrations (pg 1957, col 1, para 4, lines 12-pg 1957, col 1, para 5, line 3).
Kelly teaches a composition with an activity concentration ≥ 8 MBq/mL (pg 1957, col 1, para 4, line 12 – pg 1957, col 1, para 5, line 3).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person having ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 2, Rylova teaches a composition wherein the chelator moiety where n is 1 is bound to a targeting moiety where p is 1 through a bond or a linker moiety where m is 1 (pg 3, para 3, lines 3-5; pg 5, Fig 1) and chelates a copper radionuclide 64Cu (pg 3, para 4, lines 1-2).
As to claim 13, Rylova teaches Formula II (pg 5, Fig 1) and X1, X2, and X3 are OH and where methylene next to X1, X2, and X3 has an oxo substituent (pg 5, Fig 1) and where the linker is attached to a methylene as shown in Formula II (pg 5, Fig 1).
Claim(s) 15 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rylova and Kelly as applied to claims 1-2, and 13 above, and further in view of Price, E. W.; et al. (Price, E. W.; Orvig, C. Matching chelators to radiometals for radiopharmaceuticals. Chem. Soc. Rev. 2014, 43, 260-290) and Sin, I.; et al. (Sin, I.; Kang, C. S.; Bandara, NN.; Sun, X.; Zhong, Y.; Rogers, B. E.; Chong, H-S. Novel hexadentate and pentadentate chelators for 64Cu-based targeted PET imaging. Bioorg. Med. Chem. 2014, 22, 2553-2562). The teachings of Rylova and Kelly as applied in the previous rejections are incorporated in this rejection.
Price, E. W.; et al. (hereafter referred to as Price) is drawn to a radiometals and chelators used as active radiopharmaceutical agents (abstract; pg 260, col 1, para 1) and discusses different radioisotopes (pg 262, Table 1), tetraamine chelators (pg 267, Table 2), and triamine chelators (pg 272, Table 6).
As to claim 15, Rylova teaches Formula IIi (pg 5, Fig 1).
Rylova does not explicity teaches Formula II’i, IIii, or IIiii.
Price teaches Formula II’i (pg 272, Table 6, structure p-SCN-Bn-NOTA(C-NOTA)), Formula IIiii (pg 272, Table 6, structure TACN-TM).
The prior art contained a product which differed from the claimed product by the substitution of some components (e.g. chelator) with other components (e.g. chelator). The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known component for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Price does not explicitly teach Formula IIii.
Sin, I.; et al. (hereafter referred to as Sin) is drawn to chelators useful for copper radiopharmaceuticals (title; abstract; pg 2554, Fig 1) and their synthesis (pg 2554-2556; pg 2558, Scheme 1 and Scheme 2; pg 2559, Scheme 3); and biodistribution in mice as determined by PET (pg 2560, col 2; pg 2561, Fig 4-5).
Sin teaches Formula IIii (pg 2554, Fig 1, Structure C).
The prior art contained a product which differed from the claimed product by the substitution of some components (e.g. chelator) with other components (e.g. chelator). The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known component for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
As to claim 18, Price teaches NOTA (pg 271, col 1, para 1-2; pg 272, Table 6, Structure NOTA); NODAGA (pg 272, Table 6, Structure NODAGA; pg 275, col 1, para 2, line 13-15); NODASA (pg 272, Table 6, Structure NODASA); DOTA (pg 266, col 2, para 2-3; pg 267, Table 2, Structure DOTA); DOTAGA (pg 266, col 2, para 3, lines 7-11; pg 267, Table 2, Structure DOTAGA); and DOTASA (pg 266, col 2, para 3, lines 7-11).
As to claim 19, Price teaches NOTA (pg 271, col 1, para 1-2; pg 272, Table 6, Structure NOTA); NODAGA (pg 272, Table 6, Structure NODAGA; pg 275, col 1, para 2, line 13-15); NODASA (pg 272, Table 6, Structure NODASA).
As to claim 20, Rylova teaches NODAGA (pg 5, Fig 1).
Claim(s) 21 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rylova, Kelly, Price, and Sin as applied to claims 1-2, 13, 15, and 18-20 above, and in further view of McInnes, L. E.; et al. (McInnes, L. E.; Harris, M. J.; Van Dam, E. M.; Biggin C. US 2025/0011362 A1). The teachings of Rylova, Kelly, Price, and Sin as applied in the previous rejections are incorporated in this rejection.
As to claim 21, Price teaches 61Cu (pg 262, Table 1)
Price does not teach 67Cu.
McInnes, L. E. (hereafter referred to as McInnes) is drawn to radiopharmaceutical compounds and compositions for treating cancer (title; abstract) and a includes a variety of chelators (pg 2, para [0014]) linked through a variety of linkers pg 3, para [0015]) to a targeting moiety (pg 4, para [0015]) which may be complexed with radionuclides (pg 6, para [0019]).
McInnes teaches the copper radionuclide may be 61Cu or 67Cu (pg 6, para [0019], line 2).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
As to claim 24, McInnes teaches PSMA I&T as the targeting moiety (pg 4, para [0015], formula Ia) which is recognized by a molecular target expressed in a tumor microenvironment (pg 1, para [0004], lines 3-6; pg 1, para [0008], lines 4-6).
Claim(s) 25, 27, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rylova, Kelly, Price, Sin, and McInnes as applied to claims 1-2, 13, 15, 18-21, and 24 above, and in further view of Satz, S. (US 2020/0085981 A1). The teachings of Rylova, Kelly, Price, Sin, and McInnes as applied in the previous rejection are included in this rejection.
As to claim 25, Rylova, Price, Sin, and McInnes teach the composition according to claim 24.
However, Rylova, Price, Sin, and McInnes do not explicitly and generally teach that the targeting moieties bind to tumor-associated antigens or tumor-specific antigens.
Satz, S. (hereafter referred to as Satz) is drawn to tumor targeted radionuclides for therapy and imaging of cancers (title; abstract) with a compound composed of a chelator (pg 5, para [0043], lines 23-25), radionuclide (pg 5, para [0043], lines 26-29), and a targeting moiety (pg 5, para [0043], lines 24-26).
Satz teaches a targeting moiety binds to tumor-associated antigen (pg 9, para [0083], lines 1-4).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 27, McInnes teaches the targeting moiety binds to PSMA (pg 1, para [0008], lines 4-6).
As to claim 30, Satz teaches somatostatin receptors (SSTR) (pg 5, para [0051], lines 10-14).
Claim(s) 32, 44, 49, 72, 75-83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rylova, Kelly, Price, Sin, McInnes, and Satz as applied to claims 1-2, 13, 15, 18-21, 24-25, 27, and 30 above, and in further view of and Osterkamp, F. (Osterkamp, F.; Haase, C.; Reineke, U.; Smerline, C.; Paschke, M.; Ungewill, J. US 2017/0119913 A1). The teachings of Rylova, Kelly, Price, Sin, McInnes, and Satz as applied in the previous rejection are included in this rejection.
As to claim 32, Rylova, Price, Sin, McInnes, and Satz teach the composition.
However, the teachings of Rylova, Price, Sin, McInnes, and Satz do not expressly teach FAP.
Osterkamp, F.; et al. (hereafter referred to as Osterkamp) is drawn to a conjugate of a targeting moiety with an adapter moiety (abstract; pg 163, claim 1) for diagnosing or treating a disease (pg 1, para [0001], lines 1-7).
Osterkamp teaches a targeting moiety binds to fibroblast activation protein (FAP) (pg 30, para [0144], col 2, line 37; pg 62, para [0349], col 1, line 28).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 44, Rylova teaches a method of generating an image through injection of the composition to the subject (pg 10, para 2), detecting the localization of the radiotracer at both an earlier and later time point (pg 10, para 2, lines 3-5) and monitoring or determining the effect of the cancer treatment by comparing the amount of localization at the later time point to the amount of localization at the earlier time point (pg 10, para 2, lines 1-10).
Rylova does not teach 61Cu.
McInnes teaches 61Cu (pg 6, para [0019], line 2; pg 29, claim 6).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
As to claim 49, Rylova demonstrates a method of tumor-containing organs vs non-tumor-containing organs (pg 10, para 2, lines 1-10).
Rylova does not teach 61Cu.
McInnes teaches 61Cu (pg 6, para [0019], line 2; pg 29, claim 6).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
As to claim 72, Rylova teaches a method of making a composition by combining a copper radionuclide and a compound containing a chelating moiety, a bond or linker moiety, and a targeting moiety (pg 5, para 2, lines 1-3; pg 5, para 3, lines 1-3).
As to claim 75, Rylova teaches the radiotracer where n is 1 and the chelating moiety comprises NODAGA (pg 5, Fig 1).
As to claim 76, McInnes teaches PSMA (pg 1, para [0008], lines 4-6).
As to claim 77, McInnes teaches *Cu is 61Cu (pg 6, para [0019], line 2; pg 29, claim 6).
As to claim 78, Rylova teaches a composition with a molar activity ≥ 8 MBq/nmol (pg 5, para 3, lines 1-2).
As to claim 79, Rylova teaches a composition with a molar activity ≥ 20 MBq/nmol (pg 5, para 3, lines 1-2).
As to claim 80, Rylova teaches a composition with a radiochemical purity of ≥ 95% (pg 5, para 3, line 1).
As to claim 81, Rylova teaches a composition with a radiochemical purity of ≥ 97% (pg 5, para 3, line 1).
As to claim 82, Kelly teaches a composition with an activity concentration ≥ 8 MBq/mL (pg 1957, col 1, para 4, line 12 – pg 1957, col 1, para 5, line 3).
As to claim 83, Kelly teaches a composition with an activity concentration of ≥ 15 MBq/mL ((pg 1957, col 1, para 4, line 12 – pg 1957, col 1, para 5, line 3).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rylova, Kelly, Price, Sin, McInnes, Satz, Osterkamp, and Kelly as applied to claims 1-2, 13, 15, 18-21, 24-25, 27, 30, 32, 44, 49, 72, and 75-83 above, and in further view of and Babich, J. W.; et al. (Babich, J. W.; Kelly, J. M.; Amor-Coarasa, A.; Ponnala, S.; Donnelly, P. WO 2021/225760 A1). The teachings of Rylova, Kelly, Price, Sin, McInnes, Satz, and Osterkamp as applied in the previous rejection are included in this rejection.
As to claim 58, Rylova teaches the administration of the radiopharmaceutical for imaging (pg 4, para 6, line 5 – pg 5, para 1, line 2).
However, Rylova does not teach administering the composition at an earlier time point where the copper is 61Cu and again at a later time point, imaging, and determining the effect of cancer by comparing the images from the earlier time point and the later time point.
Babich, J. W.; et al. (hereafter referred to as Babich) is drawn to radiopharmaceuticals for imaging and treating various cancers (title; abstract). Babich teaches methods of administering the radiopharmaceuticals in multiple dose intervals (pg 40, para [0108]; pg 51, para [0136], lines 8-10), the use of copper radioisotopes for imaging and therapy (pg 51, para [0136], lines 11-17). And Babich teaches methods of administering and imaging and treating to be used in isolation or in combination (pg 56-, para [0149], lines 1-2).
Babich teaches administering to a subject and then imaging (pg 65, para U) and then administering to a subject (pg 67, para AE) and then imaging (pg 65, para AJ). Babich teaches a copper radiopharmaceutical (pg 64, para O).
The person of ordinary skill int eh art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
Babich does not teach 61Cu.
McInnes teaches 61Cu (pg 6, para [0019], line 2; pg 29, claim 6).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rylova, Kelly, Price, Sin, McInnes, Satz, Osterkamp, and Babich as applied to claims 1-2, 13, 15, 18-21, 24-25, 27, 30, 32, 44, 49, 58, 72, and 75-83 above, and in further view of and Svedjehed, J.; et al. (Svedjehed, J.; Kutyreff, C. J.; Engle, J. W.; Gagnon, K. Automated, cassette-based isolation and formulation of high-purity [61Cu]CuCl2 from solid Ni targets, EJNMMI Radiopharmcy and Chemistry, 2020, 5, 21, 1-14). The teachings of Rylova, Kelly, Price, Sin, McInnes, Satz, Osterkamp, Kelly, and Babich as applied in the previous rejection are included in this rejection.
As to claim 84, Rylova teaches the composition.
However, Rylova does not teach a radionuclidic purity characterized by ≤ 0.1%
Svedjehed, J.; et al. (hereafter referred to as Svedjehed) is drawn to the production of copper radionuclides for radiopharmaceuticals (title; abstract). Svedjehed teaches removal of trace metals (pg 7, para 8, lines 2-4; pg 11, para 2, lines 3-6) and radionuclidic impurity limits (pg 10, para 5, lines 1-2).
Svedjehed teaches a radionuclidic impurity limit of 0.1% (pg 10, para 5, lines 1-2).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person having ordinary skill in the art would have recognized that the results of the combination were predictable.
As to claim 85, Svedjehed teaches a chemical purity with Fe, Co, Zn with levels below the detection limit (pg 11, para 2, lines 3-6).
Nonstatutory 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.
Copending Application No. 19/375,103
Claims 1-2, 13, 15, 18-21, 24-25, 27, 30, 32, 44, 49, 58, 72, and 75-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 82-83, 85, and 87 of copending Application No. 19/373,103 in view of Rylova, Price, Sin, McInnes, Satz, Osterkamp, Kelly, Babich, and Svedjehed.
This is a provisional nonstatutory double patenting rejection.
Instant claims require a composition comprising a chelating moiety, copper radionuclide, linker, and targeting moiety with a molar activity ≥ 3 MBq/nmol, radiochemical purity of ≥ 91%, activity concentration of ≥ 8 MBq/mL, and a radionuclidic purity of the radiotracer of ≥ 95% at the end of synthesis where the copper is 61Cu, 62Cu, 64Cu, or 67Cu, where the chelator is NODAGA, NOTA, NODASA, DOTA, DOTAGA, or DOTASA, and where the targeting moiety binds to PSMA, FAP, or SSTR, and a method of determining the effectiveness of the treatment after administration with low levels of trace metal impurities and chemical impurities.
Conflicting claims of copending application 19/375,103 (hereafter referred to as ‘103) teach a composition comprising a chelating moiety, copper radionuclide, linker, and targeting moiety, and method of determining the effectiveness of the treatment through imaging.
Conflicting claims ‘103 do not teach a molar activity ≥ 3 MBq/nmol.
Conflicting claims ‘103 do not teach a radiochemical purity ≥ 91%.
Conflicting claims ‘103 do not teach an activity concentration of ≥ 8 MBq/mL.
Conflicting claims of ‘103 do not teach radionuclidic purity of the radiotracer of ≥ 95 % at the end of synthesis.
Conflicting claims of ‘103 do not teach low levels of trace metal impurities and chemical impurities.
Rylova is drawn to a comparison of in vitro and in vivo performance of a copper-based radiopharmaceutical with a chelator, linker, and targeting moiety (title; abstract). Rylova teaches 64Cu as the radionuclide, with a few chelators such as NODAGA and DOTA and that a variety of targeting moieties can be attached through linkers (title; abstract, lines 1-2, 13-15; pg 4, para 3, lines 1-3; pg 5, Fig 1) and synthesis with high specific activity and purity (pg 5, para 3, lines 1-2).
Regarding molar activity with ≥ 3 MBq/nmol, Rylova teaches that this composition is characterized by a specific activity of ≥ 3 MBq/nmol (pg 5, para 3, lines 1-3).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding radiochemical purity with ≥91%, Rylova teaches a radiochemical purity with ≥91% (pg 5, para 2-3; pg 14, para 2, line 1-4).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding activity concentration of ≥ 8 MBq/mL, Kelly teaches activity concentration of ≥ 8 MBq/mL (pg 1957, col 1, para 4, line 12 – pg 1957, col 1, para 5, line 3).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding radionuclidic purity with ≥95%, Rylova teaches a radionuclidic purity of the radiotracer of ≥95% at the end of synthesis (pg 5, para 2-3).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Svedjehed is drawn to the production of copper radionuclides for radiopharmaceuticals (title; abstract). Svedjehed teaches removal of trace metals (pg 7, para 8, lines 2-4; pg 11, para 2, lines 3-6) and radionuclidic impurity limits (pg 10, para 5, lines 1-2).
Regarding low levels of trace metal impurities and chemical impurities, Svedjehed teaches a radionuclidic impurity limit of 0.1% (pg 10, para 5, lines 1-2) and a chemical purity with Fe, Co, Zn with levels below the detection limit (pg 11, para 2, lines 3-6).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Copending Application No. 19/452,054
Claims 1-2, 13, 15, 18-21, 24-25, 27, 30, 32, 44, 49, 58, 72, and 75-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 75-82, 85, 87-89, and 101-104 of copending Application No. 19/452,054 in view of Rylova, Kelly, Price, Sin, McInnes, Satz, Osterkamp, Babich, and Svedjehed.
This is a provisional nonstatutory double patenting rejection.
Instant claims require a composition comprising a chelating moiety, copper radionuclide, linker, and targeting moiety with a molar activity ≥ 3 MBq/nmol, radiochemical purity of ≥ 91%, activity concentration of ≥ 8 MBq/mL, and a radionuclidic purity of the radiotracer of ≥ 95% at the end of synthesis where the copper is 61Cu, 62Cu, 64Cu, or 67Cu, where the chelator is NODAGA, NOTA, NODASA, DOTA, DOTAGA, or DOTASA, and where the targeting moiety binds to PSMA, FAP, or SSTR, and a method of determining the effectiveness of the treatment after administration with low levels of trace metal impurities and chemical impurities.
Conflicting claims of copending application 19/452,054 (hereafter referred to as ‘054) teach a composition comprising a chelating moiety, copper radionuclide, linker, and targeting moiety with a radiochemical purity of ≥ 91%, activity concentration of ≥ 8 MBq/mL, and a radionuclidic purity of the radiotracer of ≥ 95% at the end of synthesis where the copper is 61Cu where the chelator is NODAGA, and where the targeting moiety binds to PSMA, and a method of determining the effectiveness of the treatment after administration with low levels of trace metal impurities and chemical impurities.
Conflicting claims of ‘054 do not teach a molar activity ≥ 3 MBq/nmol.
Rylova is drawn to a comparison of in vitro and in vivo performance of a copper-based radiopharmaceutical with a chelator, linker, and targeting moiety (title; abstract). Rylova teaches 64Cu as the radionuclide, with a few chelators such as NODAGA and DOTA and that a variety of targeting moieties can be attached through linkers (title; abstract, lines 1-2, 13-15; pg 4, para 3, lines 1-3; pg 5, Fig 1) and synthesis with high specific activity and purity (pg 5, para 3, lines 1-2).
Regarding molar activity with ≥ 3 MBq/nmol, Rylova teaches that this composition is characterized by a specific activity of ≥ 3 MBq/nmol (pg 5, para 3, lines 1-3).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
U.S. Patent No. 12,527,885
Claims 1-2, 13, 15, 18-21, 24-25, 27, 30, 32, 44, 49, 58, 72, and 75-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-8, 15, 17, and 64-69 of U.S. Patent No. 12,527,885 in view of Rylova, Kelly, Price, Sin, McInnes, Satz, Osterkamp, Babich, and Svedjehed.
Instant claims require a composition comprising a chelating moiety, copper radionuclide, linker, and targeting moiety with a molar activity ≥ 3 MBq/nmol, radiochemical purity of ≥ 91%, activity concentration of ≥ 8 MBq/mL, and a radionuclidic purity of the radiotracer of ≥ 95% at the end of synthesis where the copper is 61Cu, 62Cu, 64Cu, or 67Cu, where the chelator is NODAGA, NOTA, NODASA, DOTA, DOTAGA, or DOTASA, and where the targeting moiety binds to PSMA, FAP, or SSTR, and a method of determining the effectiveness of the treatment after administration with low levels of trace metal impurities and chemical impurities.
Conflicting claims of U.S. patent no. 12,527,885 (hereafter referred to as '885) teach a composition comprising a chelating moiety, copper radionuclide, linker, and targeting moiety, radiochemical purity of ≥ 91%, activity concentration of ≥ 8 MBq/mL, and a radionuclidic purity of the radiotracer of ≥ 95% at the end of synthesis where the copper is 61Cu, where the chelator is NODAGA, and the targeting moiety binds to PSMA; and a method of determining the effectiveness of the treatment after administration with low levels of trace metal impurities.
Conflicting claims of ‘885 do not teach a molar activity ≥ 3 MBq/nmol.
Conflicting claims of ‘885 do not teach low levels chemical impurities.
Rylova is drawn to a comparison of in vitro and in vivo performance of a copper-based radiopharmaceutical with a chelator, linker, and targeting moiety (title; abstract). Rylova teaches 64Cu as the radionuclide, with a few chelators such as NODAGA and DOTA and that a variety of targeting moieties can be attached through linkers (title; abstract, lines 1-2, 13-15; pg 4, para 3, lines 1-3; pg 5, Fig 1) and synthesis with high specific activity and purity (pg 5, para 3, lines 1-2).
Regarding molar activity with ≥ 3 MBq/nmol, Rylova teaches that this composition is characterized by a specific activity of ≥ 3 MBq/nmol (pg 5, para 3, lines 1-3).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Svedjehed is drawn to the production of copper radionuclides for radiopharmaceuticals (title; abstract). Svedjehed teaches removal of trace metals (pg 7, para 8, lines 2-4; pg 11, para 2, lines 3-6) and radionuclidic impurity limits (pg 10, para 5, lines 1-2).
Regarding low levels chemical impurities, Svedjehed teaches a chemical purity with Fe, Co, Zn with levels below the detection limit (pg 11, para 2, lines 3-6).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
U.S. Patent No. 12,447,217
Claims 1-2, 13, 15, 18-21, 24-25, 27, 30, 32, 44, 49, 58, 72, and 75-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 10-11, 16-33 of U.S. Patent No. 12,447,217 in view of Rylova, Kelly, Price, Sin, McInnes, Satz, Osterkamp, Babich, and Svedjehed.
Instant claims require a composition comprising a chelating moiety, copper radionuclide, linker, and targeting moiety with a molar activity ≥ 3 MBq/nmol, radiochemical purity of ≥ 91%, activity concentration of ≥ 8 MBq/mL, and a radionuclidic purity of the radiotracer of ≥ 95% at the end of synthesis where the copper is 61Cu, 62Cu, 64Cu, or 67Cu, where the chelator is NODAGA, NOTA, NODASA, DOTA, DOTAGA, or DOTASA, and where the targeting moiety binds to PSMA, FAP, or SSTR, and a method of determining the effectiveness of the treatment after administration with low levels of trace metal impurities and chemical impurities.
Conflicting claims of U.S. patent no. 12,447,217 (hereafter referred to as '217) teach a composition comprising a chelating moiety, copper radionuclide, linker, and targeting moiety, where the copper is 61Cu, 64Cu, and 67Cu where the chelator is NODAGA, NOTA, DOTA, DOTAGA, or DOTASA, and a method of determining the effectiveness of the treatment after administration with low levels of trace metal impurities.
Conflicting claims of ‘217 do not teach a molar activity ≥ 3 MBq/nmol,
Conflicting claims of ‘217 do not teach a radiochemical purity of ≥ 91%,
Conflicting claims of ‘217 do not teach an activity concentration of ≥ 8 MBq/mL,
Conflicting claims of ‘217 do not teach a radionuclidic purity of the radiotracer of ≥ 95% at the end of synthesis
Conflicting claims of ‘217 do not teach that the targeting moiety binds to PSMA, FAP, or SSTR
Conflicting claims of ‘217 do not teach low levels of trace metal impurities and chemical impurities.
Rylova is drawn to a comparison of in vitro and in vivo performance of a copper-based radiopharmaceutical with a chelator, linker, and targeting moiety (title; abstract). Rylova teaches 64Cu as the radionuclide, with a few chelators such as NODAGA and DOTA and that a variety of targeting moieties can be attached through linkers (title; abstract, lines 1-2, 13-15; pg 4, para 3, lines 1-3; pg 5, Fig 1) and synthesis with high specific activity and purity (pg 5, para 3, lines 1-2).
Regarding molar activity with ≥ 3 MBq/nmol, Rylova teaches that this composition is characterized by a specific activity of ≥ 3 MBq/nmol (pg 5, para 3, lines 1-3).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding radiochemical purity with ≥91%, Rylova teaches a radiochemical purity with ≥91% (pg 5, para 2-3; pg 14, para 2, line 1-4).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding activity concentration of ≥ 8 MBq/mL, Kelly teaches activity concentration of ≥ 8 MBq/mL (pg 1957, col 1, para 4, line 12 – pg 1957, col 1, para 5, line 3).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding radionuclidic purity with ≥95%, Rylova teaches a radionuclidic purity of the radiotracer of ≥95% at the end of synthesis (pg 5, para 2-3).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
McInnes, L. E. (hereafter referred to as McInnes) is drawn to radiopharmaceutical compounds and compositions for treating cancer (title; abstract) and a includes a variety of chelators (pg 2, para [0014]) linked through a variety of linkers pg 3, para [0015]) to a targeting moiety (pg 4, para [0015]) which may be complexed with radionuclides (pg 6, para [0019]).
Regarding targeting moiety binds to PSMA, FAP, or SSTR, McInnes teaches PSMA I&T as the targeting moiety (pg 4, para [0015], formula Ia) which is recognized by a molecular target expressed in a tumor microenvironment (pg 1, para [0004], lines 3-6; pg 1, para [0008], lines 4-6).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Svedjehed is drawn to the production of copper radionuclides for radiopharmaceuticals (title; abstract). Svedjehed teaches removal of trace metals (pg 7, para 8, lines 2-4; pg 11, para 2, lines 3-6) and radionuclidic impurity limits (pg 10, para 5, lines 1-2).
Regarding low levels of trace metal impurities and chemical impurities, Svedjehed teaches a radionuclidic impurity limit of 0.1% (pg 10, para 5, lines 1-2) and a chemical purity with Fe, Co, Zn with levels below the detection limit (pg 11, para 2, lines 3-6).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Conclusion
No claims allowed.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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