DETAILED ACTION
This Office action details a first action on the merits for the above referenced application No. Claims 1-10, and 13-18 are pending in this application.
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 .
Priority
This application is a 35 USC 371 National Stage filing of international application No. PCT/EP2022/050081 filed on 4 Jan. 2022 and claims benefit under 36 USC 119(a)-(d) to foreign application No. EP 21150112.6 filed on 4 Jan. 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5 Jan. 2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for diagnosing and imaging neoangiogenesis and/or angiogenesis, does not reasonably provide enablement for preventing neoangiogenesis and/or angiogenesis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: The invention is directed to a method of preventing neoangiogenesis and/or angiogenesis comprising administering a compound of claim 1 to a subject.
The state of the prior art: Prevent is defined as to keep from happening. Backhaus et al. (Eur. J. Nucl. Med. Mol. Imaging; published 15 Jan. 2018; see attached 892) teach that PSMA is not a prerequisite for tumor associated neovascularization as it is not found consistently with it. Mechanistic insights into PSMA function do not yet allow to deduce its functional relevance relating to tumor aggressiveness and susceptibility to anti-angiogenic therapy regimens (pg. 886).
The relative skill of those in the art: The relative skill of those in the art is high requiring expert level knowledge and skill in medicine, radiochemistry and drug development.
The predictability or unpredictability of the art: The state of the art in medicine and (radio)pharmaceutical is generally unpredictable. That is, absent related experimental verification a person of ordinary skill in art would have been able to predict whether the claimed compounds can prevent neoangiogenesis or angiogenesis.
The Breadth of the claims: The claim is limited to a method of preventing neoangiogenesis and/or angiogenesis wherein the method includes administering the compound of claim 1 to a patient in need thereof; however, the claim is open ended and allows for other steps to be completed in addition the administering.
The amount of direction or guidance presented: The specification presents only a minimal amount of direction or guidance. Prevention is mentioned at [0022], [0038], and [0079]-[0080]. In each of these instances the specification only conclusory statements that the compounds and compositions of the invention may be used for prevention of neoangiogenesis. No other information or references are provided.
The presence or absence of working examples: The specification does not contain a working example of preventing neoangiogenesis or angiogenesis using a claimed compound
The quantity of experimentation necessary: The quantity of experimentation necessary to arrive at a method suitable for preventing neoangiogenesis or angiogenesis is undue and extensive. The experiments would have to include identifying a patient population expected to benefit from such preventive treatment and identifying doses and dosing schedule and identifying suitable metal cation.
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for a preventing neoangiogenesis and/or angiogenesis. The Examiner suggests removing “preventing” from the claim.
Claim Rejections - 35 USC § 102
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 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)(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.
Claim(s) 1-4, 6-8, 10, 13-14, and 16-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wurzer et al. (WO 2019/020831 A1; published 31 Jan. 2019; see IDS filed on 5 Jan. 2024).
Regarding claims 1-4, and 6-10, Wurzer et al. teach the PSMA ligand 10 that comprises the isomer
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(pgs. 39, 77). Wurzer et al. provides for 177Lu- natF-10 and 68Ga-natF-10 (pg. 58, Fig. 31,32 and 34) and their use in small animal imaging experiments in LNCaP (prostate cancer) tumor bearing SCID mice (pgs. 58, 82). These compounds comprise a compound of instant formula (1) wherein M3+ is a Lu3+ (177Lu3+) or a Ga3+ (68Ga3+). Regarding claims 13-14, and 16-17, the small animal experiments read on a methods of imaging, treating, and/or diagnosing (prostate) cancer comprising administering a compound of claim 1 to a patient in need thereof.
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) 1-10, and 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wurzer et al. (WO 2019/020831 A1; published 31 Jan. 2019; see IDS filed on 5 Jan. 2024).
Wurzer et al. teach as discussed above. Wurzer et al. teach dual mode radiotracer and therapeutics (see title). The invention provides for a ligand-SIFA conjugate comprising within a single molecule three separate moieties: (i) one or more ligands, (ii) a SIFA moiety, and (iii) one or more chelating groups optionally containing a chelated nonradioactive or radioactive cation (see abstract). The fluorine atom on the SIFA can be 19F or 18F (pg. 6). The hydrophilic chelator can be DOTAGA or DOTA (pgs. 7 and 13). Preferred cations include 68Ga, 225Ac, and 177Lu (pgs. 14, 48, and 89). Wurzer et al. teach 177Lu-natF-ligand 10 and log D of -3.59±0.05 and IC50 of 2.8±0.7 nM and an internalization of 184.1±116 (pgs. 78-82). Wurzer et al. teach biodistribution studies of 177Lu- natF-10 and 68Ga-natF-10 (pg. 58, Fig. 31,32 and 34). Wurzer et al. teach diagnosis, imaging or prevention of neoangiogenesis/angiogenesis (pgs.46, and 96). Wurzer et al. teach methods of imaging diagnosing or treating cancer wherein the cancer is prostate (pg. 96).
Wurzer et al. do not disclose a compound of claim 1 wherein M3+ is 225Ac3+ or the compound
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wherein the F is an 18F or exemplify a method of diagnosing, imaging, or prevention neoangiogenesis and/or angiogenesis comprising administering the claimed compound.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Wurzer et al. by substituting the chelated radioactive cation with 225Ac as taught by Wurzer et al. because the substituting would have been expected to provide an equivalent PSMA ligand-SIFA-DOTA complex advantageously capable of radiotherapy of prostate cancer. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Wurzer et al. by substituting the F with 18F to arrive at
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as taught by Wurzer et al. because that compound would have been expected to provide an equivalent PSMA ligand-SIFA-DOTA complex that advantageously enables PET imaging using cyclotron produced 18F. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Wurzer et al. by diagnosing, imaging, or preventing neoangiogenesis and/or angiogenesis comprising administering the compound of claim 1 or 10 to an patient in need thereof as taught by Wurzer et al. because it would have been expected to advantageously enable in vivo diagnosing, imaging, and/or preventing
Claim(s) 1-10, and 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over STN RN 2271115-11-6 (entered 19 Feb. 2019; see attached 892), in view of Wester et al. (WO 2019/115547 A1; published 20 Jun. 2019; see attached 892).
STN RN 2271115-11-6 disclose the compound
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.
STN RN 2271115-11-6 do not teach the compound
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or Lu (177Lu), Ga (68Ga), and Ac (225Ac) complexes thereof. STN RN 2271115-11-6 do not further teach the compound
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wherein the F is an 18F or exemplify a method of diagnosing, imaging, treating and/or preventing prostate cancer or neoangiogenesis and/or angiogenesis comprising administering the claimed compound.
Wester et al. teach PSMA ligands for imaging and endoradiotherapy (see title). Wester et al. teach compounds of formula (I)
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wherein the -X2-L1-X1- is preferably
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wherein R9A and R11A may be C1 to C10 alkanediyl substituted with -CO2H, and R10A may be a linear C2 to C10 alkanediyl, r may be 1, and Rm-X3- may be
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or
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(pg. 21). Preferred chelated cations include 177Lu, 68Ga, and 225Ac (see pg. 22). Wester et al. teach 18F (pg. 3) Wester et al. teach the compound
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(see pg. 81; psma-46). Wester et al. teach the EDS group wherein R6B is a substituent containing an electron lone pair at the atom attached to the Ph ring (see pgs. 7, 38, 93). An EDS group is an electron dense substituent (see pg. 13) that leads to unexpected advantages including high affinity and improved internalization (see pg. 8). Endotherapeutic approaches with [177Lu]PSMA I&T demonstrated efficacy, tolerability and high safety potential. Wester et al. teach diagnosing and/or treating cancer including prostate cancer and neoangiogenesis/angiogenesis (pg. 54). Wester et al. teach pharmaceutical composition comprising a pharmaceutically acceptable carrier (pgs. 33-34).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify STN RN 2271115-11-6 by substituting the DOTAGA chelator with a DOTA chelator and then form metal complex optionally wherein the metal is Lu (177Lu), Ga (68Ga), or Ac (225Ac) and optionally form a pharmaceutical composition with one of those compounds as taught by Wester et al. because the DOTA chelator would have expected to provide an equivalent chelator advantageously not comprising a stereocenter and because the Lu (177Lu), Ga (68Ga), or Ac (225Ac) complexes would have been expected to advantageously enable imaging and/or therapy. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify STN RN 2271115-11-6 by further substituting 19F with 18F to arrive at
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as taught by Wester et al. because substituting would have been expected to provide an equivalent PSMA ligand-SIFA-DOTA complex advantageously capable of PET imaging using cyclotron produced 18F. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify STN RN 2271115-11-6 by further administering one of the obvious PSMA ligand-SIFA-DOTA complexes to a subject for imaging, treating, or diagnosing prostate cancer or for diagnosing or imaging neoangiogenesis and/or angiogenesis as taught by Wester et al. because the administering would have been expected to advantageously enable in vivo diagnosing, imaging or treating.
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 1-10, and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,413,360 B2, in view of Wester et al. (WO 2019/115547 A1; published 20 Jun. 2019; see attached 892).
Claims 1-16 of U.S. Patent No. 11,413,360 B2 claim the compound
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or an individual isomer thereof optionally containing a chelated nonradioactive or radioactive metal cation and wherein the fluorine atom is 18F and wherein the chelated cation is selected from 68Ga, 177Lu, and 225Ac.
Claims 1-16 of U.S. Patent No. 11,413,360 B2 do claim a compound having the spatial arrangement of formula (1) or a Lu (177Lu), Ga (68Ga), or a Ac (225Ac) complex thereof or the compound
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wherein the F is an 18F or claim a method of diagnosing, imaging, treating and/or preventing prostate cancer or neoangiogenesis and/or angiogenesis comprising administering the claimed compound.
Wester et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the compound of claims 1-16 of U.S. Patent No. 11,413,360 B2 so that stereocenters on the linker portion of the compound have the (R) configuration and optionally form a (177Lu), a Ga (68Ga), or a Ac (225Ac) complex thereof as part of a pharmaceutical composition as taught by Wester et al. because the (R) configuration would have been expected to advantageously provide an chiral pure derivative and because the complexes would have been expected to enable imaging and/or therapy.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-16 of U.S. Patent No. 11,413,360 B2 by further substituting 19F with 18F to arrive at
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as taught by Wester et al. because substituting would have been expected to provide an equivalent PSMA ligand-SIFA-DOTA complex advantageously capable of PET imaging using cyclotron produced 18F. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-16 of U.S. Patent No. 11,413,360 B2 by further administering one of the obvious PSMA ligand-SIFA-DOTA complexes to a subject for imaging, treating, or diagnosing prostate cancer or for diagnosing or imaging neoangiogenesis and/or angiogenesis as taught by Wester et al. because the administering would have been expected to advantageously enable in vivo diagnosing, imaging or treating.
Claims 1-10, and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,390,540 B2, in view of Wester et al. (WO 2019/115547 A1; published 20 Jun. 2019; see attached 892).
Claims 1-16 of U.S. Patent No. 12,390,540 B2 claim the compound
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and a pharmaceutical or diagnostic composition and optionally wherein the chelator contains a chelated cation selected from 68Ga, 177Lu, and 225Ac and optionally wherein the SIFA fluorine atom is 18F.
Claims 1-16 of U.S. Patent No. 12,390,540 B2 do claim a compound having the spatial arrangement of formula (1) or a Lu (177Lu), Ga (68Ga), or a Ac (225Ac) complex thereof or the compound
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wherein the F is an 18F or claim a method of diagnosing, imaging, treating and/or preventing prostate cancer or neoangiogenesis and/or angiogenesis comprising administering the claimed compound.
Wester et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the compound of claims 1-16 of U.S. Patent No. 12,390,540 B2 so that stereocenters on the linker portion of the compound have the (R) configuration and optionally form a (177Lu), a Ga (68Ga), or a Ac (225Ac) complex thereof as part of a pharmaceutical composition as taught by Wester et al. because the (R) configuration would have been expected to advantageously provide an chiral pure derivative and because the complexes would have been expected to enable imaging and/or therapy.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-16 of U.S. Patent No. 12,390,540 B2 by further substituting 19F with 18F to arrive at
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as taught by Wester et al. because substituting would have been expected to provide an equivalent PSMA ligand-SIFA-DOTA complex advantageously capable of PET imaging using cyclotron produced 18F. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-16 of U.S. Patent No. 12,390,540 B2 by further administering one of the obvious PSMA ligand-SIFA-DOTA complexes to a subject for imaging, treating, or diagnosing prostate cancer or for diagnosing or imaging neoangiogenesis and/or angiogenesis as taught by Wester et al. because the administering would have been expected to advantageously enable in vivo diagnosing, imaging or treating.
Claims 1-10, and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,453,787 B2, in view of Wester et al. (WO 2019/115547 A1; published 20 Jun. 2019; see attached 892).
Claims `1-7 of U.S. Patent No. 12,453,787 B2 claim the compound
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optionally containing a chelated radioactive cation optionally wherein cation is 68Ga, 177Lu, or 225Ac.
Claims 1-7 of U.S. Patent No. 12,453,787 B2 do claim a compound having the spatial arrangement of formula (1) or a Lu (177Lu), Ga (68Ga), or a Ac (225Ac) complex thereof or the compound
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wherein the F is an 18F or claim a method of diagnosing, imaging, treating and/or preventing prostate cancer or neoangiogenesis and/or angiogenesis comprising administering the claimed compound.
Wester et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the compound of claims 1-7 of U.S. Patent No. 12,453,787 B2 so that stereocenters on the linker portion of the compound have the (R) configuration and optionally form a (177Lu), a Ga (68Ga), or a Ac (225Ac) complex thereof as part of a pharmaceutical composition as taught by Wester et al. because the (R) configuration would have been expected to advantageously provide an chiral pure derivative and because the complexes would have been expected to enable imaging and/or therapy.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-7 of U.S. Patent No. 12,453,787 B2 by further substituting 19F with 18F to arrive at
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as taught by Wester et al. because substituting would have been expected to provide an equivalent PSMA ligand-SIFA-DOTA complex advantageously capable of PET imaging using cyclotron produced 18F. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-7 of U.S. Patent No. 12,453,787 B2 by further administering one of the obvious PSMA ligand-SIFA-DOTA complexes to a subject for imaging, treating, or diagnosing prostate cancer or for diagnosing or imaging neoangiogenesis and/or angiogenesis as taught by Wester et al. because the administering would have been expected to advantageously enable in vivo diagnosing, imaging or treating.
Claims 1-10, and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,357,711 B2, in view of Wester et al. (WO 2019/115547 A1; published 20 Jun. 2019; see attached 892).
Claims 1-14 of U.S. Patent No. 12,357,711 B2 claim the compound
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and a pharmaceutical or diagnostic composition and optionally wherein the chelated cation is selected from Ga and Ac and optionally wherein F is 18F and claims methods of imaging and/or diagnosing or treating cancer including prostate cancer and a method of diagnosing, imaging, or preventing neoangiogenesis/angiogenesis.
Claims 1-14 of U.S. Patent No. 12,357,711 B2 do not claim a compound of instant formula (1) wherein DOTA replaces DOTAGA and Lu (177Lu), Ga (68Ga), or Ac (225Ac) complexes thereof or the compound
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wherein F is 18F.
Wester et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify claims 1-14 of U.S. Patent No. 12,357,711 B2 by substituting DOTAGA with DOTA and then form Lu (177Lu), Ga (68Ga), or Ac (225Ac) complexes thereof as taught by Wester et al. because the DOTA chelator would have expected to provide an equivalent chelator advantageously not comprising a stereocenter and because the Lu (177Lu), Ga (68Ga), or Ac (225Ac) complexes would have been expected to advantageously enable imaging and/or therapy. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-14 of U.S. Patent No. 12,357,711 B2 by further substituting 19F with 18F to arrive at
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as taught by Wester et al. because substituting would have been expected to provide an equivalent PSMA ligand-SIFA-DOTA complex advantageously capable of PET imaging using cyclotron produced 18F.
Claims 1-10, and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,377,176 B2, in view of Wester et al. (WO 2019/115547 A1; published 20 Jun. 2019; see attached 892).
Claims 1-6 of U.S. Patent No. 12,377,176 B2 claim a compound having the chemical structure
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and a pharmaceutical and diagnostic composition and methods of imaging and/or treating and/or diagnosing cancer including prostate cancer and a method of reducing angiogenesis.
Claims 1-6 of U.S. Patent No. 12,377,176 B2 do not claim a compound of instant formula (1) wherein DOTA replaces DOTAGA and Lu (177Lu), Ga (68Ga), or Ac (225Ac) complexes thereof or the compound
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wherein F is 18F or claim a method of diagnosing, imaging, treating and/or preventing prostate cancer or neoangiogenesis and/or angiogenesis comprising administering the claimed compound.
Wester et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify claims 1-6 of U.S. Patent No. 12,377,176 B2 by substituting DOTAGA with DOTA and then form Lu (177Lu), Ga (68Ga), or Ac (225Ac) complexes thereof as taught by Wester et al. because the DOTA chelator would have expected to provide an equivalent chelator advantageously not comprising a stereocenter and because the Lu (177Lu), Ga (68Ga), or Ac (225Ac) complexes would have been expected to advantageously enable imaging and/or therapy. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-6 of U.S. Patent No. 12,377,176 B2 by further substituting 19F with 18F to arrive at
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as taught by Wester et al. because substituting would have been expected to provide an equivalent PSMA ligand-SIFA-DOTA complex advantageously capable of PET imaging using cyclotron produced 18F. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-6 of U.S. Patent No. 12,377,176 B2 by further administering one of the obvious PSMA ligand-SIFA-DOTA complexes to a subject for imaging, treating, or diagnosing prostate cancer or for diagnosing or imaging neoangiogenesis and/or angiogenesis as taught by Wester et al. because the administering would have been expected to advantageously enable in vivo diagnosing, imaging or treating.
Conclusion
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618