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 .
DETAILED ACTION
Status of the Claims
Claims 1-18 are pending. Claims 7-11 and 14 are withdrawn. Claims 1-6, 12-13 and 15-18 are rejected.
Election/Restrictions
Applicant's election of the species compound 43,
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, without traverse in the reply filed on 01/15/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-6, 12-13 and 15-18 read on Applicant’s species election of compound 43. Claims 7-8 and 10 do not appear to embrace the elected species since, per claim 7, R7 or R7’ must form a linker to another chelating moiety of Formula (III). Examination of the elected invention was conducted in accordance with the MPEP 803.02.
The elected species is allowable in view of the prior art; therefore, examination of the Markush-type claim has been extended to the scope of formula (II) of claim 5 wherein R2, R3, R2', R3' are H; R5 and R5' are OH or SH; R8 or R9 is substituted heteroalkyl and the other R8 or R9 is substituted alkyl; and R8 or R9 has a linker to a reactive amino group.
Since art was found on a nonelected species, subject matter not embraced by the above-identified non-elected species is therefore withdrawn from further consideration. Claims 7-11 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/US2021/056117 filed 10/21/2021, which claims priority under 35 U.S.C. 119(a-d) to PRO 63/094,752 filed 10/21/2020. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement(s) (IDS) dated 01/25/2024 and 09/11/2024 have been considered.
Claim Objections
Claims 5-6 and 17 are objected to because of the following informalities:
Claim 5 recites the limitation wherein R1’ and/or R2’ are -O(CH2)mC(O)NR10’R1’1 which should be corrected to -O(CH2)mC(O)NR10’R11’.
Claim 6 recites R5’ twice.
Claim 17 is a duplicate of claim 16.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 3, 5-6, 12 and 16-17 are rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 3 and 6 use the language "includes" which is an open-ended transition phrase. Per MPEP 2111.03 I, the use of such language "does not exclude additional, unrecited elements of method steps." Accordingly, the metes and bounds of the claims cannot be sufficiently interpreted by a person having ordinary skill in the art. Applicant may overcome the rejection by, for example, replacing the word "includes" with “has”.
Claim 5 recites limitations for an R1’ species, however neither formula (II) of the claim nor formula (I) of the parent claim include such a group. Applicant may have intended “R2’ and R3’” instead. For the sake of applying prior art, the Examiner assumed R1’ and R2’ were meant to be R2’ and R3’, respectively. Dependent claim 6 is rejected for the same reason as it does not appear to correct the indefiniteness of its parent claim.
Claim 12 is rejected because it recites formula (V) with variables R8, R9, R2’ and R3’ which are not defined in the claim, nor are they defined in parent claim 1. For the sake of identifying prior art, the definitions as provided in claim 5 were used. Applicant may correct the issue by amending the claim to define the aforementioned variable.
Claims 16 and 17 recite the limitation " wherein the metal ion bound thereto ". There is insufficient antecedent basis for this limitation in the claim since neither the claim itself nor the parent claim mentions a metal ion. Applicant may correct the issue by, for instance, amending the claim.
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.
Claim 16 is rejected under 35 U.S.C. 112(d) 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.
As written, claim 16 is an independent claim. As such, it is not clear to what chelating agent the claim is referring. To advance prosecution, however, the Examiner has interpreted the claim as being dependent upon claim 1. Applicant should cancel the claim or amend the claim so that it properly depends from a preceding claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(1 of 2) Claims 1-6 and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tatum et al. in WO 2018/045385.
Tatum et al. ‘385 disclose the compound 13 on page 52 which has the structure
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. Compound 13 is embraced by instant formula (I) of claim 1 wherein R2 and R3 are each H; R5 is OH; R1 and R4 are bonds.
Regarding instant claim 2, compound 43 is macrocyclic.
Regarding instant claim 3, compound 43 has four of the chelating moieties of claim 1.
Regarding instant claim 4, two of the chelating moieties are linked by a substituted heterocycloalkyl and a substituted alkyl.
The prior art compound is also embraced by instant formula (II) of claim 5,
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, wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R9 is the substituted heterocycloalkyl tetrahydrofuran; R8 is substituted heteroalkyl; and R8 has a linker to a reactive amino group, per instant claim 6.
Tatum et al. ‘385 also teach compound 9,
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(see page 48), wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R9 is the substituted heterocycloalkyl tetrahydrofuran; and R8 is substituted heteroalkyl.
Tatum et al. ‘385 also teach compound 13b,
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(see page 62), wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R9 is the substituted heterocycloalkyl tetrahydrofuran; R8 is substituted heteroalkyl; and R8 has a linker to a reactive amino group, per instant claim 6.
Tatum et al. ‘385 also teach compound 9b,
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(see page 65), wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R8 is substituted heteroalkyl; R9 is substituted heteroalkyl; and R9 has a linker to a reactive amino group, per instant claim 6.
Regarding claim 15, drawn to a pharmaceutical formulation comprising the chelating agent, Tatum et al. ‘385 on page 55, para. [00223] describe compound 13 being dissolved in methanol. Since methanol is a pharmaceutically acceptable carrier, the claim is anticipated by the prior art.
(2 of 2) Claims 1-6 and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tatum et al. in WO 2019/173639.
Tatum et al. ‘639 disclose the compound 43 on page 81 which has the structure
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. Compound 43 is embraced by instant formula (I) of claim 1 wherein R2 and R3 are each H; R5 is OH; R1 and R4 are bonds.
Regarding instant claim 2, compound 43 is macrocyclic.
Regarding instant claim 3, compound 43 has four of the chelating moieties of claim 1.
Regarding instant claim 4, two of the chelating moieties are linked by a substituted heterocycloalkyl and a substituted alkyl.
The prior art compound is also embraced by instant formula (II) of claim 5,
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, wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R8 is the substituted heterocycloalkyl tetrahydrofuran; R9 is substituted alkyl; and R9 has a linker to a reactive amino group, per instant claim 6.
Tatum et al. also teach compound 16,
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(see page 58), wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R8 is heteroalkyl; R9 is substituted heteroalkyl.
Tatum et al. also teach compound 29,
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(see page 70), wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R8 is substituted heteroalkyl tetrahydrofuran; R9 is substituted heteroalkyl; and R8 has a linker to a reactive amino group, per instant claim 6.
Tatum et al. also teach compound 33,
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(see page 74), wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R8 is substituted heteroalkyl tetrahydrofuran; R9 is substituted heteroalkyl; and R9 has a linker to a reactive amino group, per instant claim 6.
Tatum et al. also teach compound 40,
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(see page 76), wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R8 is substituted heteroalkyl tetrahydrofuran; R9 is substituted heteroalkyl.
Tatum et al. also teach compound 43,
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(see page 81), wherein R2, R3, R2', R3' are H; R5 and R5' are OH; R8 is substituted heteroalkyl tetrahydrofuran; R9 is substituted heteroalkyl; and R9 has a linker to a reactive amino group, per instant claim 6.
Regarding claim 15, drawn to a pharmaceutical formulation comprising the chelating agent, Tatum et al. ‘639 on page 83, para. [00264] describe compound 43 being dissolved in methanol. Since methanol is a pharmaceutically acceptable carrier, the claim is anticipated by the prior art.
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.
(1 of 2) Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tatum et al. in WO 2018/045385 as applied to claims 1-6 and 15 in the rejection under 35 U.S.C. 102 over WO 2018/045385 above.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Tatum et al. in ‘385 teach compound 13 as discussed in the 102 rejection above. Compound 13 is a metal chelator and the prior art discloses that the compound successfully binds with Eu(III) and Th(IV). See, for instance, page 55 para. [00220].
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Tatum et al. ‘385 does not disclose compound 13 binding with one of the instantly claimed metal ions of claim 18, nor another metal ion that a person having ordinary skill in the art would consider a “soft Lewis acid metal ion” per claims 16 and 17.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
Tatum et al. in ‘385 discloses a short, finite list of metal ions useful for radioimmunotherapy, including copper-64, gallium-67, gallium-68 and lead-212. See page 1, para. [0003]:
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. A person having ordinary skill in the art would be motivated to form complexes between compound 13 and the identified radiometals for the purpose of routine optimization of known radioimmunotherapeutics relying on chelating agents. The skilled artisan would have a reasonable expectation of success in doing so since the radiometals are already present in clinical trials and since Tatum et al. demonstrate the success of compound 13 with Europium and given the finite number of only 15 metals to try.
Thus, claims 16-18 are obvious in view of the prior art.
(2 of 2) Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tatum et al. in WO 2019/173639 as applied to claims 1-6 and 15 in the rejection under 35 U.S.C. 102 over WO 2019/173639 above.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Tatum et al. in ‘639 teach compound 13 as discussed in the 102 rejection above. Compound 43 is a metal chelator and the prior art discloses several examples wherein the compound successfully binds with various metal ions. See, for instance, page 84-85 para. [00278]-[00291].
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Tatum et al. ‘639 does not disclose compound 43 binding with one of the instantly claimed metal ions of claim 18, nor another metal ion that a person having ordinary skill in the art would consider a “soft Lewis acid metal ion” per claims 16 and 17.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
Tatum et al. in ‘639 discloses a short, finite list of metal ions useful for radioimmunotherapy, including copper-64, gallium-67, gallium-68 and lead-212. See page 1, para. [0004]:
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. A person having ordinary skill in the art would be motivated to form complexes between compound 43 and the identified radiometals for the purpose of routine optimization of known radioimmunotherapeutics relying on chelating agents. The skilled artisan would have a reasonable expectation of success in doing so since the radiometals are already present in clinical trials and since Tatum et al. demonstrate the success of compound 43 with the various metals listed above and given the finite number of only 15 metals to try.
Thus, claims 16-18 are obvious in view of the prior art.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(1 of 7) Claims 1-6 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,951,188, as evidenced by Bhattacharyya and Dixit “Metallic radionuclides in the development of diagnostic and therapeutic radiopharmaceuticals” Dalton Trans., 2011 40 pp.6112-6128. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims disclose, in part, compounds of formula
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, see claim 2 of patent ‘188. This formula is fully embraced by the instant formula (I) wherein R1 and R4 are bonds, R2 and R3 are hydrogen, and R5 is OH. See also instant formula (II) of claim 5 and instant formula (III) of claim 7 wherein R8 and R9 may have a linker to a reactive functional group or a targeting moiety, per instant claim 6.
Regarding instant claim 2, the reference formula is macrocyclic.
Regarding instant claim 3, the reference formula has two of the chelating moieties of claim 1.
Regarding instant claim 4, the chelating moieties are linked.
Regarding instant claims 16-18, patented claim 15 is drawn to a complex of a compound of the formula of claim 1 and a metal ion complexed therewith wherein the metal is a radionuclide. Bhattacharyya and Dixit teach that metallic radionuclides include gallium and copper (see Table 1, page 6114), which are found in present claim 18 and depends from claim 17.
Thus, the patented claims anticipate the present claims.
(2 of 7) Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,440,584. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims disclose compounds of formula
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, see claim 1 of patent ‘584. This formula is fully embraced by the instant formula (I) wherein R1 and R4 are bonds, R2 and R3 are hydrogen, and R5 is OH. See also instant formula (II) of claim 5 and instant formula (III) of claim 7 wherein R8 and R9 may have a linker to a reactive functional group or a targeting moiety, per instant claim 6.
Regarding instant claim 2, the reference formula is macrocyclic.
Regarding instant claim 3, the reference formula has two of the chelating moieties of claim 1.
Regarding instant claim 4, the chelating moieties are linked.
Thus, the patented claims anticipate the present claims.
(3 of 7) Claims 1-6 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,239,878, as evidenced by Bhattacharyya and Dixit “Metallic radionuclides in the development of diagnostic and therapeutic radiopharmaceuticals” Dalton Trans., 2011 40 pp.6112-6128. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims disclose, in part, compounds of formula
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, see claim 8 of patent ‘878. This formula is fully embraced by the instant formula (I) wherein R1 and R4 are bonds, R2 and R3 are hydrogen, and R5 is OH. See also instant formula (II) of claim 5 and instant formula (III) of claim 7 wherein R8 and R9 may have a linker to a reactive functional group or a targeting moiety, per instant claim 6.
Regarding instant claim 2, the reference formula is macrocyclic.
Regarding instant claim 3, the reference formula has two of the chelating moieties of claim 1.
Regarding instant claim 4, the chelating moieties are linked.
Regarding instant claims 16-18, patented claim 25 is drawn to a complex of a compound of the formula of claim 1 and a metal ion complexed therewith wherein the metal is a radionuclide. Bhattacharyya and Dixit teach that metallic radionuclides include gallium and copper (see Table 1, page 6114), which are found in present claim 18 and depends from claim 17.
Thus, the patented claims anticipate the present claims.
(4 of 7) Claims 1-6 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,603,371, as evidenced by Bhattacharyya and Dixit “Metallic radionuclides in the development of diagnostic and therapeutic radiopharmaceuticals” Dalton Trans., 2011 40 pp.6112-6128. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims disclose compounds of formula
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, see claim 1 of patent ‘371, and in particular claim 10 wherein Ap1 and Ap2 are each selected from
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. This subgenus is fully embraced by the instant formula (I) wherein R1 and R4 are bonds, R2 and R3 are hydrogen, and R5 is OH. See also instant formula (II) of claim 5 and instant formula (III) of claim 7 wherein R8 and R9 may have a linker to a reactive functional group or a targeting moiety, per instant claim 6.
Regarding instant claim 2, the reference formula is macrocyclic.
Regarding instant claim 3, the reference formula has two of the chelating moieties of claim 1.
Regarding instant claim 4, the chelating moieties are linked.
Regarding instant claims 16-18, patented claim 24 is drawn to a complex of a compound of the formula of claim 1 and a metal ion complexed therewith wherein the metal is a radionuclide. Bhattacharyya and Dixit teach that metallic radionuclides include gallium and copper (see Table 1, page 6114), which are found in present claim 18 and depends from claim 17.
Thus, the patented claims anticipate the present claims.
(5 of 7) Claims 1-6 and 15-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/834,195 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims disclose, in part, metal chelating agents of formula (V) and (VI):
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, see reference claim 8. This formula is fully embraced by the instant formula (I) wherein R1 and R4 are bonds, R2 and R3 are hydrogen, and R5 is OH. See also instant formula (II) of claim 5 and instant formula (III) of claim 7 wherein R8 and R9 may have a linker to a reactive functional group or a targeting moiety, per instant claim 6.
Regarding instant claim 2, the reference formula is macrocyclic.
Regarding instant claim 3, the reference formula has two of the chelating moieties of claim 1.
Regarding instant claim 4, the chelating moieties are linked.
Regarding instant claim 15, drawn to a pharmaceutical formulation comprising the chelating agent, reference application ‘195 recites in claim 15 “a pharmaceutical formulation comprising the metal chelate of claim 9 and a pharmaceutically acceptable carrier.”
Regarding instant claims 16-18, reference claims 13 and 14 are drawn to a metal chelate wherein the metal is selected from a short list that includes gallium and lead, which are found in present claim 18 and depends from claim 17.
Thus, the reference claims anticipate the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(6 of 7) Claims 1-6 and 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of copending Application No. 19/339,751 (reference application), as evidenced by Bhattacharyya and Dixit “Metallic radionuclides in the development of diagnostic and therapeutic radiopharmaceuticals” Dalton Trans., 2011 40 pp.6112-6128. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims disclose, in part, metal chelating agents of reference claim 31:
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. This formula is fully embraced by the instant formula (I) wherein R1 and R4 are bonds, R2 and R3 are hydrogen, and R5 is OH. See also instant formula (II) of claim 5 and instant formula (III) of claim 7 wherein R8 and R9 may have a linker to a reactive functional group or a targeting moiety, per instant claim 6.
Regarding instant claim 2, the reference formula is macrocyclic.
Regarding instant claim 3, the reference formula has two of the chelating moieties of claim 1.
Regarding instant claim 4, the chelating moieties are linked.
Regarding instant claims 16-18, reference claim 45 is drawn to a complex of a compound of the formula of and a metal ion complexed therewith wherein the metal is a radionuclide. Bhattacharyya and Dixit teach that metallic radionuclides include gallium and copper (see Table 1, page 6114), which are found in present claim 18 and depends from claim 17.
Thus, the patented claims anticipate the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(7 of 7) Claims 1-6 and 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of copending Application No. 19/676,454 (reference application), as evidenced by Bhattacharyya and Dixit “Metallic radionuclides in the development of diagnostic and therapeutic radiopharmaceuticals” Dalton Trans., 2011 40 pp.6112-6128. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims disclose, in part, metal chelating agents of reference claim 31:
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. This formula is fully embraced by the instant formula (I) wherein R1 and R4 are bonds, R2 and R3 are hydrogen, and R5 is OH. See also instant formula (II) of claim 5 and instant formula (III) of claim 7 wherein R8 and R9 may have a linker to a reactive functional group or a targeting moiety, per instant claim 6.
Regarding instant claim 2, the reference formula is macrocyclic.
Regarding instant claim 3, the reference formula has two of the chelating moieties of claim 1.
Regarding instant claim 4, the chelating moieties are linked.
Regarding instant claims 16-18, reference claim 45 is drawn to a complex of a compound of the formula of and a metal ion complexed therewith wherein the metal is a radionuclide. Bhattacharyya and Dixit teach that metallic radionuclides include gallium and copper (see Table 1, page 6114), which are found in present claim 18 and depends from claim 17.
Thus, the patented claims anticipate the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 12 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The compounds of claims 12 and 13 are both novel and nonobvious. The claimed compounds are not anticipated by the prior art compounds given the prior art does not disclose compounds of presently claimed formulas (V) and (VI). The prior art does disclose comparable compounds wherein the SH group of Formula (V) is instead a -OH group or -O, such as compound 13,
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, and others taught by Tatum et al. in WO 2018/045385 or compound 43,
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, and others taught in WO 2019/173639.
However, there is no suggestion or motivation that it would have been obvious to a skilled artisan to modify the referenced compounds such that the oxygen of the chelating moiety should be changed to a sulfur, for example, and expect the compounds to bind to a metal ion and be used successfully as a radionuclide therapeutic, making claims 12 and 13 nonobvious.
Contact Information
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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