DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 1-8, 10, 14-16, 19-20, 22, 24-26, 48, and 61 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 .
Status of Claims
Claims 1-2, 7, 14, 26, 48, and 61 are amended. Claims 9, 11-13, 17-18, 21, 23, 27-47, 49-60, and 62-73 are canceled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 22 Jul. 2026 has been considered by the examiner.
Response to Amendment
The amendments filed on 22 Jul. 2026 have been entered.
Response to Arguments
In view of Applicants amendments, the rejection of claims 9 and 13 under 35 USC 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn.
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) 1-8, 10, 14-16, 19-20, 22, 24-26, 48, and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bander et al. (WO 2018/204477 A1; published 8 Nov. 2018), in view of Bander et al. (WO 02/098897 A2; published 12 Dec. 2002; “Bander et al. II”) and Liu et al. (Cancer Res.; published 1998) for the reasons cited in the Office action filed on 22 Jan. 2026.
Bander et al. teach methods and reagents for tumor targeting with greater efficacy and less toxicity (see title). Bander et al. teach a method of treating cancer comprising a first agent couple to a first cancer therapeutic component and providing a second agent comprising a second targeting component coupled to a second therapeutic component (see abstract). The invention has devised a way to overcome the MTD of a targeted agent in order to achieve improved efficacy ([0009], [0023]). The cancer is prostate cancer, neuroendocrine cancer, breast cancer, or non-Hodgkin’s lymphoma ([0026]). Neuroendocrine tumors include carcinoid tumors, etc ([0072]). The first and second agent may target different molecular targets on the same cell or may bind to the same receptor (e.g., PSMA) expressed by the same cell type or HER1 and HER2 expressed on the same cell type ([0041]-[0042]). The first and second therapeutic component is a radionuclide selected from 177Lu, etc ([0045]-[0046]) or a chemotherapeutic agent selected from the group consisting of busulfan, etc ([0048]). Doses can range from 25% to about 100% of the MTD ([0051], [0053]). In one embodiment the first agent is J591-177Lu and the second agent is PSMA617-177Lu or PSMA I&T-177Lu ([0071]). In one embodiment the first and second component target the somatostatin receptor ([0073], [0076]) or the HER receptor family ([0078]) and the cancer is breast cancer ([0077]-[0078]). The cancer may be non-Hodgkin’s Lymphoma and the first and second component target CD20 ([0080]-[0081]). Bander et al. disclose a method of treating/imaging cancer in a subject comprising administering to the subject having cancer a composition comprising J591-177Lu (i.e. 75 µCi) and PSMA-617-177Lu (200 µCi) well below its MTD (example 2; Figs. 2, 3). (This reads on method and composition that administers to a subject having human prostate cancer cells a combination therapeutic for treating cancer comprising (i) a first targeting component coupled to a cancer therapeutic (PSMA-617-177Lu; small molecule), and (ii) a second agent comprising a second targeting component coupled to a second therapeutic component (J591-177Lu; antibody) wherein the second agent increases the uptake and internalization of the first or an targeting component wherein the first and second agents are different and target the same molecular target (PSMA) and target a cancer cell receptor.) Where the target molecule/receptor is internalized additive amounts of the 2 will therefore be internalized. If the 2 targeting agents have different properties and are non-overlapping, the 2 agents can be co-administered to result in additive binding/uptake by targeted cells without causing any added toxicity ([0104]). The tumor gets additive dosing while the non-target normal tissues do not receive additive doses ([0109]). Bander et al. teach human subjects (pg. 22).
Bander et al. do not disclose the instant methods of treating/imaging, combination therapeutic or imaging system wherein the second agent comprises a second targeting component alone such as J591. Bander et al. do not further exemplify a method optionally wherein the subject is human and optionally wherein the maximum tolerated dose of cancer therapeutic is given during the administering of the combination or a method wherein the cancer therapeutic is busulfan or wherein the subject is human. Bander et al. do not further exemplify a method wherein the cancer is a neuroendocrine cancer such as carcinoid tumors or wherein the first or second targeting components target the somatostatin receptor-2 isoform.
Bander et al. II teach modified antibodies to prostate-specific membrane antigen and uses thereof (see title). Bander et al. II teach J591 [0010], [0012]). Bander et al. II teach that the antibody can be administered alone in non-derivatized unconjugated form ([0059], [0061], [p0087) to thereby ablate or kill the PSMA-expressing cancer by e.g. antibody dependent cell killing mechanisms ([0070],[0076], [00118], [00254]). Combinations of the anti-PSMA antibody and a drug are in the scope of the invention ([0062], [0077], [0078], [00269]). Bander et al. teach internalization ([0014], [0267]).
Liu et al. teach constitutive and antibody induced internalization of prostate membrane antigen (see title). Liu et al. that in the presence of mAb J591 to PSMAext, the rate of internalization of PMSA increased up to 3-fold in a dose dependent manner reaching a maximum rate at an antibody concentration of 1-2 µg/mL (pg. 4058; Fig. 4,
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the combinations and method of Bander et al. (combinations and methods comprising J591-177Lu and PSMA-617-177Lu for the treatment of PSMA expressing cancers) so that the second agent antibody such as J591-177Lu is administering alone in unconjugated form as in J591 without a therapeutic component as taught and made obvious by Bander et al., Bander et al. II and Liu et al. because the J591 alone would have been expected to provide simplified compositions and methods (e.g. fewer (radio)synthesis steps) wherein the J591 alone in combination with PSMA-617-177Lu would have been expected to advantageously enable additive internalization of the PSMA-617-177Lu whereby improving PSMA-617-177Lu imaging and therapy and efficacy.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Bander et al. so that the first and second targeting agents target different targets on the same cell as taught by Bander et al. because it would have been expected to enable an equivalent method of treating cancer using a second agent that induces internalization of the first agent. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Bander et al. so that the subject is human and so that the maximum therapeutic dose of the cancer therapeutic is given during the administering as taught by Bander et al. because it would have been expected to advantageously enable maximal therapeutic efficacy optionally in human subjects. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Bander et al. so that the cancer therapeutic agent is a chemotherapeutic agent such as busulfan as taught by Bander et al. because it would have been expected to enable enhanced chemotherapeutic treatment of PSMA expressing cancer such as prostate cancer. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Bander et al. so that first and second therapeutic agent target somatostatin receptor-2 isoform and so that the cancer is a neuroendocrine cancer such as a carcinoid tumor or so that the first and second component target the HER receptor family and the cancer is breast cancer or so that the first and second component target is CD20 and cancer is non-Hodgkin’s lymphoma as taught by Bander et al. because it would have been expected to advantageously enable a simplified and equivalent combination treatments of carcinoid tumors, breast cancer, and non-Hodgkin’s lymphoma where the second agent improves internalization of the first agent.
Applicants Arguments
Applicants assert that the cited art does not teach or suggest each and every limitation and specifically a method of administering to a subject a combination of a first agent with a first targeting component coupled to a cancer therapeutic (a coupled first agent) and a second agent comprising a second targeting component alone (PMSA antibody or antigen binding portion) wherein the second agent increases uptake, internalization and/or retention of the first targeting component coupled to a cancer therapeutic. Bander II describes an unconjugated form of an antibody but also does not describe its combination with the first agent. Liu does not disclose the administration of two agents as claimed but instead simply discussed the internalization of a large endogenous transmembrane protein (PMSA) into the cell by the addition of one exogenous antibody. Liu alone or in combination with Bander I and Bander II does not teach or suggest each and every limitation of the claimed invention. The surprising and unexpected effect of the claimed invention is that administering a second agent without a cancer therapeutic has a profound effect on for example the uptake of the first therapeutic agent. See Example 4 of the specification where the uptake of PSMA-617-177Lu is increased 2-3 fold by adding another agent that also binds to the PSMA receptor (J591). The impact of unlabeled J591 anti-PSMA antibody on PSMA ligand (PSMA I&T-177Lu) internalization shows that tumors treated with PSMA I&T-177Lu plus unlabeled J591 had a mead of 36% or higher. In Liu, PSMA is not a first or second agent as claimed nor does the reference suggest the use of a second agent comprising a second targeting component alone wherein the second targeting component is a PSMA receptor antibody or antigen binding portion thereof and wherein the second agent increases the uptake, internalization and/or retention of the first targeting component coupled to a cancer therapeutic as claimed. Bander I and Bander II do not make up for the deficiencies of Liu.
Applicant's arguments filed 22 Jul. 2026 have been fully considered but they are not persuasive. At example 2, Bander provides for the combined treatment method using radiolabeled anti-PSMA antibody J591-177Lu and radiolabeled PSMA-617 wherein the method results in an additive tumor effect in vivo. According to Liu, an equal anti-tumor effect could be achieved at half the dose of J591-177Lu by adding a dose of PSMA-617-177Lu well below its MTD. When discussing the examples, Bander asserts that where the target molecular receptor is internalized, additive amounts of the 2 agents will be internalized. At the example 2, Bander teaches the amended claimed method of treating cancer (claim 1) in part wherein the method comprises providing a first agent comprising a targeting component coupled to a cancer therapeutic component (PSMA-617-177Lu); providing a second agent comprising a second targeting component coupled to a cancer therapeutic component (J591-177Lu) wherein the second agent increases the uptake, internalization, and retention of the first targeting component coupled to the cancer therapeutic and administering to a subject having cancer, the first and second agent to treat cancer, wherein the first targeting component is a PSMA receptor binding peptide and the second targeting component is a PSMA receptor antibody. That is, the example 2 of Bander differs from the claimed method only because in example 2 the J591 is attached to 177Lu whereas claim 1 requires the J591 to be alone. Both Bander II and Liu provide adequate teaching and suggestion that the J591 used at example 2 in Bander may just as well be administered alone without the 177Lu label that increases the complexity of the example 2 by at least requiring two different radiosyntheses. Regarding the use of PSMA-617-177Lu as a therapeutic agent, at [0069], Bander makes reference to a Lutje publication which teaches PSMA-617 as an exemplary ligand for radionuclide imaging and therapy. At Fig. 2, Bander demonstrates the PSMA-617-177Lu has an anticancer effect. Regarding the administration of J591 alone without the 177Lu, Liu teaches the administration of mAb J591 alone increased the internalization rate of PSMA up to three-fold. Bander II teaches the mAb J591 and teaches that the mAb J591 can be administered alone in non-derivatized unconjugated form. In view of Bander II ad Liu and a person of ordinary skill in the art would have understood that the mAb J591 without the 177Lu can be administered with PSMA-617-177Lu and still increase the uptake internalization, and retention of receptor bound PSMA-617-177Lu whereby enhancing PSMA-617-177Lu therapy and imaging at a lower dose.
See Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006) ("Indeed, we have repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves.")
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the example 2 of Bander with a reasonable expectation of success by substituting the J591-177Lu with J591 as taught by Bander II and Liu because the substituting would have been expected to advantageously enable enhanced PSMA-617-177Lu imaging and therapy of PSMA positive tumors at least at a reduced cost and complexity.
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 1-8, 10, 14-16, 19-20, 22, 24-26, 48, and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-59 of U.S. Patent No. 11,491,247 B2, in view of Bander et al. (WO 2018/204477 A1; published 8 Nov. 2018) and Bander et al. (WO 02/024477 A1; published 12 Dec. 2002) for the reasons cited in the Office action filed on 22 Jan. 2026.
Claims 1-59 of U.S. Patent No. 11,491,247 B2 claim a combination therapeutic and a method of treating prostate cancer the method comprising administering to the subject having prostate cancer the first agent coupled to a first therapeutic component and a second agent coupled to a second therapeutic component under conditions effective to treat prostate cancer optionally wherein the first and second targeting components target the same or different molecular targets on the same cell optionally wherein the MTD or less than the MTD of the first and second components are given, optionally wherein the first and second components are selected from 177Lu etc, optionally wherein the first agent is J591-177Lu and the second agent is PMSA-617-177Lu and optionally wherein the subject is human.
Claims 1-59 of U.S. Patent No. 11,491,247 B2 do not claim the instant methods of treating/imaging, combination therapeutic or imaging system wherein the second agent comprises a second targeting component alone such as J591. Claims 1-59 of U.S. Patent No. 11,491,247 B2 do not further claim the instant method wherein the cancer therapeutic is a chemotherapeutic selected from busulfan, etc. Claims 1-59 of U.S. Patent No. 11,491,247 B2 do not further claim the instant method the cancer is a neuroendocrine cancer such as carcinoid tumors and the first and second components target the somatostatin receptor-2 isoform or further claim a method wherein the cancer is non-Hodgkin’s lymphoma and the first and second components target CD20 or claim a method wherein the cancer is breast cancer and the first and second components target the HER receptor family.
Bander et al. teach as discussed above.
Bander et al. II 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 1-59 of U.S. Patent No. 11,491,247 B2 to arrive at the instant methods of imaging or treating or the combination therapeutic or imaging system so that the second agent comprising the second targeting component is alone without the therapeutic component such as in J591 as taught by Bander et al. and Bander et al. II because the second component alone such as J591 without the therapeutic component would have been expected to advantageously provide simplified methods and compositions (e.g. fewer (radio)synthesis steps) and enable improved imaging by therapy by providing additive internalization of the first agent whereby enhancing tumor uptake and retention.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-59 of U.S. Patent No. 11,491,247 B2 so that the cancer therapeutic component is a chemotherapeutic component such as busulfan as taught by Bander et al. because the chemotherapeutic component such as busulfan would have been expected to provide an equivalent therapeutic component capable of treating cancer.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-59 of U.S. Patent No. 11,491,247 B2 so that first and second therapeutic agent target somatostatin receptor-2 isoform and the cancer is a neuroendocrine cancer such as a carcinoid tumor or so that the first and second component target the HER receptor family and the cancer is breast cancer or so that the first and second component target CD20 and cancer is non-Hodgkin’s lymphoma as taught by Bander et al. because it would have been expected to advantageously enable a simplified and equivalent combination treatments of carcinoid tumors, breast cancer, and non-Hodgkin’s lymphoma where the second agent alone induces internalization of the first agent.
Claims 1-8, 10, 14-16, 19-20, 22, 24-26, 48, and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No.11,738,101 B2, in view of Bander et al. (WO 2018/204477 A1; published 8 Nov. 2018) and Bander et al. (WO 02/024477 A1; published 12 Dec. 2002) for the reasons cited in the Office action filed on 22 Jan. 2026.
Claims 1-21 of U.S. Patent No. 11,738,101 B2 claim a method for treating prostate cancer, the method comprising co-administering to a subject in need thereof, a therapeutically effective amount of J591-Ac225 and a therapeutically effective amount of a PSMA-Lu177 peptide, wherein the subject is human wherein the PSMA-Lu177 is administered at its MTD or less than its MTD.
Claims 1-21 of U.S. Patent No. 11,738,101 B2 do not claim the instant methods of treating/imaging, combination therapeutic or imaging system wherein the second agent comprises a second targeting component alone such as J591. Claims 1-21 of U.S. Patent No. 11,738,101 B2 do not further claim the instant method wherein the cancer therapeutic is a chemotherapeutic selected from busulfan, etc. Claims 1-21 of U.S. Patent No. 11,738,101 B2 do not further claim the instant method the cancer is a neuroendocrine cancer such as carcinoid tumors and the first and second components target the somatostatin receptor-2 isoform or further claim a method wherein the cancer is non-Hodgkin’s lymphoma and the first and second components target CD20 or claim a method wherein the cancer is breast cancer and the first and second components target the HER receptor family.
Bander et al. teach as discussed above.
Bander et al. II 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 1-21 of U.S. Patent No. 11,738,101 B2 to arrive at the instant methods of imaging or treating or the combination therapeutic or imaging system so that the second agent comprising the second targeting component is alone without the therapeutic component such as J591 as taught by Bander et al. and Bander et al. II because the second component alone such as J591 without the therapeutic component would have been expected to advantageously provide simplified methods and compositions (e.g. fewer (radio)synthesis steps) and enable improved imaging by therapy by providing additive internalization of the first agent whereby enhancing tumor uptake and retention.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-21 of U.S. Patent No. 11,738,101 B2 so that the cancer therapeutic component is a chemotherapeutic component such as busulfan as taught by Bander et al. because the chemotherapeutic component such as busulfan would have been expected to provide an equivalent therapeutic component capable of treating cancer.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-21 of U.S. Patent No. 11,738,101 B2 so that first and second therapeutic agent target somatostatin receptor-2 isoform and the cancer is a neuroendocrine cancer such as a carcinoid tumor or so that the first and second component target the HER receptor family and the cancer is breast cancer or so that the first and second component target CD20 and cancer is non-Hodgkin’s lymphoma as taught by Bander et al. because it would have been expected to advantageously enable a simplified and equivalent combination treatments of carcinoid tumors, breast cancer, and non-Hodgkin’s lymphoma.
Claims 1-8, 10, 14-16, 19-20, 22, 24-26, 48, and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,285,503 B2, in view of Bander et al. (WO 2018/204477 A1; published 8 Nov. 2018) and Bander et al. (WO 02/024477 A1; published 12 Dec. 2002) for the reasons cited in the Office action filed on 22 Jan. 2026.
Claims 1-19 of U.S. Patent No. 12,285,503 B2 claim a combination therapeutic and a method for treating prostate cancer, the method comprising co-administering to a subject in need thereof, a therapeutically effective amount of J591-Ac225 and a therapeutically effective amount of a PSMA ligand inhibitor wherein the PSMA ligand/inhibitor is PSMA-Lu177 optionally wherein the J591-Ac225 and PSMA ligand/inhibitor are co-administered allowing to be dosed at about 25% to 100% of their MTD.
Claims 1-19 of U.S. Patent No. 12,285,503 B2 do not claim the instant methods of treating/imaging, combination therapeutic or imaging system wherein the second agent comprises a second targeting component alone such as J591. Claims 1-19 of U.S. Patent No. 12,285,503 B2 do not further claim the instant method wherein the cancer therapeutic is a chemotherapeutic selected from busulfan, etc. Claims 1-19 of U.S. Patent No. 12,285,503 B2 do not further claim the instant method the cancer is a neuroendocrine cancer such as carcinoid tumors and the first and second components target the somatostatin receptor-2 isoform or further claim a method wherein the cancer is non-Hodgkin’s lymphoma and the first and second components target CD20 or claim a method wherein the cancer is breast cancer and the first and second components target the HER receptor family.
Bander et al. teach as discussed above.
Bander et al. II 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 1-19 of U.S. Patent No. 12,285,503 B2 to arrive at the instant methods of imaging or treating or the combination therapeutic or imaging system so that the second agent comprising the second targeting component is alone without the therapeutic component such as J591 as taught by Bander et al. and Bander et al. II because the second component alone such as J591 without the therapeutic component would have been expected to advantageously provide simplified methods and compositions (e.g. fewer (radio)synthesis steps) and enable improved imaging by therapy by providing additive internalization of the first agent whereby enhancing tumor uptake and retention.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-19 of U.S. Patent No. 12,285,503 B2 so that the cancer therapeutic component is a chemotherapeutic component such as busulfan as taught by Bander et al. because the chemotherapeutic component such as busulfan would have been expected to provide an equivalent therapeutic component capable of treating cancer.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-19 of U.S. Patent No. 12,285,503 B2 so that first and second therapeutic agent target somatostatin receptor-2 isoform and the cancer is a neuroendocrine cancer such as a carcinoid tumor or so that the first and second component target the HER receptor family and the cancer is breast cancer or so that the first and second component target CD20 and cancer is non-Hodgkin’s lymphoma as taught by Bander et al. because it would have been expected to advantageously enable a simplified and equivalent combination treatments of carcinoid tumors, breast cancer, and non-Hodgkin’s lymphoma.
Claims 1-8, 10, 14-16, 19-20, 22, 24-26, 48, and 61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 and 28-30 of copending Application No. 18/247,427, in view of Bander et al. (WO 2018/204477 A1; published 8 Nov. 2018) and Bander et al. (WO 02/024477 A1; published 12 Dec. 2002) for the reasons cited in the Office action filed on 22 Jan. 2026. This is a provisional nonstatutory double patenting rejection.
Claims 1-20, and 28-30 of copending Application No. 18/247,427 claim a therapeutic composition and a method of treating cancer comprising administering a first agent comprising a first targeting component coupled to a first cancer therapeutic component such as J591-Lu177 and second agent coupled comprising a second targeting component coupled to second cancer therapeutic such as PSMA 617-Lu177 optionally wherein the first and second targeting components target the same or different molecular targets on the same cell, optionally wherein the MTDs or less than the MTDS of the first and second therapeutic components are given, optionally wherein the first and/or second therapeutic component is cytotoxic agent such as busulfan, optionally wherein the subject is human, optionally wherein the cancer is a prostate cancer , neuroendocrine cancer, breast cancer, non-Hodgkin’s lymphoma and optionally wherein the first and second therapeutic components are different and target a cancer cell membrane molecule.
Claims 1-20, and 28-30 of copending Application No. 18/247,427 do not claim the instant methods of treating/imaging, combination therapeutic or imaging system wherein one of the targeting components is alone without a therapeutic component such as J591. Claims 1-20, and 28-30 of copending Application No. 18/247,427 do not claim the instant method wherein the first and second targeting components target the somatostatin receptor-2 isoform or the HER receptor family or CD20 or wherein the neuroendocrine cancer is selected from carcinoid tumors.
Bander et al. teach as discussed above.
Bander et al. II 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 1-20, and 28-30 of copending Application No. 18/247,427 to arrive at the instant methods of imaging or treating or the combination therapeutic or imaging system so that the antibody agent comprising the targeting component is alone without the therapeutic component such as J591 and increases internalization of the other agent comprising a therapeutic component as taught by Bander et al. and Bander et al. II because the antibody agent alone such as J591 without the therapeutic component would have been expected to advantageously provide simplified methods and compositions (e.g. fewer (radio)synthesis steps) and enable improved imaging and therapy by providing additive internalization of the agent comprising a therapeutic component whereby enhancing tumor uptake and retention.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-20, and 28-30 of copending Application No. 18/247,427 so the first and second targeting components target the somatostatin receptor-2 isoform or the HER receptor family or CD20 or wherein the neuroendocrine cancer is selected from carcinoid tumors as taught by Bander et al. those targeting components would have been expected to advantageously enable targeting neuroendocrine cancer, breast cancer, or non-Hodgkin’s lymphoma and because the carcinoid tumors would have been expected be neuroendocrine tumors comprising somatostatin receptors.
Applicants Arguments
Applicants defer addressing the present non-statutory double patenting rejections until there is allowable subject matter or all remaining rejections are withdrawn.
Applicant's arguments filed 22 Jul. 2026 have been fully considered but they are not persuasive. Allowable subject matter has not been identified for the reasons discussed above. The above NSDP rejections are being maintained for the reasons cited in the Office action filed on 22 Jan. 2026 and for the above reasons.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 16, 19-20, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In this case, claim 1 has been amended so that the first targeting component is a PSMA receptor binding peptide or PSMA receptor inhibitor and the second component is a PSMA receptor antibody or antigen binding portion thereof. Instant claim 4 depends to claim 1 and requires that the first and second targeting components target different molecular targets on the same cell. It is not clear if claim 4 further limits claim 1 since both targeting components in claim 1 are required to target PSMA. Claims 16 and 19 depend to claim 1 and require neuroendocrine cancers such as carcinoid tumors. It is not clear if claims 16 and 19 further limit claim 1 as amended since a neuroendocrine cancer is a subtype of tumor with distinct biology and often low or absent PSMA expression. Instant claims 20 and 22 depend to claim 1 and require the cancer to be breast cancer or non-Hodgkin’s Lymphoma (NHL). It is not clear if claims 20 and 22 further limit claim 1 since PSMA is generally not a target for breast cancer (rather HER-2 is a common target) and NHL and PSMA positive cancer are distinct concepts in oncology.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SEAN R. DONOHUE/
Examiner, Art Unit 1618
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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