DETAILED ACTION
This Office action details a first action on the merits for the above referenced application No. Claims 1-20 and 28-30 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/US2021/052271 filed on 28 Sep. 2021, and claims benefit under 35 USC 119(e) to US provisional application No. 63/086,216 filed on 1 Oct. 2020.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 30 Mar. 2023, 18 Apr. 2023, 18 Apr. 2023, 3 May 2023, and 26 Jul. 2024 have been considered by the examiner.
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 13 and 17 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 claim 13, it is not clear if the following recitations are merely examples, alternate names, abbreviations or required limitations: “(DTIC)” “(nitrogen mustard)”, “(BCNU)”, “(CCNU)”, “(ara-C)”, “(Adriamycin)”, or “(VP-16)”.
Claim 13 contains the trademark/trade names Adriamycin and VP-16. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe pharmaceutic preparations for the treatment of cancer and, accordingly, the identification/description is indefinite.
In claim 17, the recitation of “and other PSMA ligands/inhibitors/peptides” is indefinite because it is not clear what qualifies as PSMA ligands/inhibitors/peptides.
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)(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.
Claim(s) 30 is/are rejected under 35 U.S.C. 102(a)(1),(2) as being anticipated by Bander et al. (WO 2018/204477A1; published 8 Nov. 2018; see IDS filed on 30 Mar. 2023).
Regarding claim 30, Bander et al. disclose co-incubation of J591-177Lu and PSMA-617-177Lu leading to additive amount of radiolabel within cells wherein the amount of first and second therapeutic component internalized and retained inside the tumor is greater than the sum of the first and second therapeutic components internalized and retained in a tumor if each of the first and second therapeutic agents were administered individually (example 1). (Therapeutic composition comprising first agent (J591-177Lu) comprising a first targeting component (J591) coupled to a first therapeutic component (177Lu) and a second agent (PSMA-617-177Lu) blended with the first agent said second agent comprising a second targeting component (PSMA-617) coupled to a second therapeutic component (177Lu) wherein the first and second therapeutic components have different biodistributions and/or pharmacokinetics in a subject).
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) 1-20 and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bander et al. (WO 2018/204477A1; published 8 Nov. 2018; see IDS filed on 30 Mar. 2023).
Bander et al. teach as discussed above. Bander et a. teach methods and reagents for tumor targeting with greater efficacy and less toxicity (see title). Bander et al. teach combined treatment using radiolabeled anti-PSMA antibody J591-177Lu and radiolabeled PSMA-617-177Lu results in additive anti-tumor effect in vivo. Equal antitumor effect could be achieved at half the dose of J591-177Lu (75 µCi) by also adding a dose of PSMA-617-177Lu (200 µCi) ([0102]-[0103]). The data shows that co-administering 2 agents that bind different sites of a target molecule present on a population of cells results in additive binding of those agents. Where the target molecule/receptor is internalized, additive amounts of the 2 agents will therefore be internalized. If the 2 targeting agents have different properties such that their respective side effects differ, the 2 agents can be co-administered to result in additive binding/uptake by the targeted cells without causing any added toxicity ([0104]). When the two targeted agents are combined in a treatment strategy, the result is that both drugs converge simultaneously or sequentially at the target site providing a combined treatment effect ([0009]). Bander et al. teach maximum tolerable dose ([0023]). The first and second targeting components target the same molecular target ([0041]). In another embodiment, the first and second target components target different molecular targets on the same cell type ([0042]). The first and/or second targeting components may be the same or different ([0044]). The first and/or second therapeutic component is a chemotherapeutic agents independently selected from busulfan, etc ([0048]). The cancer is prostate cancer, neuroendocrine cancer, breast cancer, or non-Hodgkin’s lymphoma ([0026]). Bander et al. teach dosing in human patients where the two classes of agents differ greatly both in molecular size and plasma half-life (prophetic example 1).
Bander et al. do not expressly teach treating a subject for cancer by administering the first and second therapeutic agents no more than 8 h, 6 h, 4 h, or 2 h apart from each other or simultaneously.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Bander et al. (composition and method of treating e.g. prostate cancer in a human subject comprising the use of J591-177Lu and PSMA-617-177Lu to result in additive binding/uptake by targeted cells without causing any added toxicity) so that the J591-177Lu and PSMA-617-177Lu are co-administered 8 h, 6 h, 4 h, or 2 h or simultaneously as taught and suggested by Bander et al. because those co-administration times would have been expected to enable additive internalization and optimal efficacy resulting from simultaneous or sequential contact at the target site within the half-life of both agents.
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 molecular components target the same molecular target or so that the cancer is a neuroendocrine cancer as taught by Bander et al. because it would have been expected to provide an equivalent method of treating a cancer including a neuroendocrine cancer, the equivalent method advantageously enabling greater than additive internalization of the first and second therapeutic agent whereby improving therapeutic outcome.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26, 48, and 61 of copending Application No. 18/029,596, in view of Bander et al. (WO 2018/204477A1; published 8 Nov. 2018; see IDS filed on 30 Mar. 2023). This is a provisional nonstatutory double patenting rejection.
Claims 1-26, 48, and 61 of copending Application No. 18/029,596 claim a method for treating cancer, the method comprising: providing a first therapeutic agent comprising a first targeting component coupled to a cancer therapeutic component; providing a second agent comprising a second targeting component alone wherein second agent increases the uptake, internalization, and/or retention of the first target component coupled to a cancer therapeutic and administering to the subject having cancer, the first and second agents to treat cancer optionally wherein the first agent is PSMA-617-177Lu and the second agent is J581 optionally wherein the first and second targeting components target the same molecular target or different targets on the same cell optionally wherein the cancer therapeutic has a MTD and less than the MTD is given during the administering optionally wherein the cancer therapeutic component is a chemotherapeutic component selected from busulfan, etc, optionally wherein the subject is human and optionally wherein the cancer is a prostate cancer, neuroendocrine cancer, non-Hodgkin’s lymphoma, breast cancer and optionally wherein the first and second agents are different and optionally a combination therapeutic for treating cancer.
Claims 1-26, 48, and 61 of copending Application No. 18/029,596 do not claim a second agent where the second targeting component is coupled to a second cancer therapeutic component. Claims 1-26, 48, and 61 of copending Application No. 18/029,596 do not further claim administering the first and second agents no more than 8 h, 6 h, 4 h, or 2 h apart from each other or administered simultaneously.
Bander 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 claims 1-26, 48, and 61 of copending Application No. 18/029,596 so that the second targeting agent comprises a second targeting component coupled to a second cancer therapeutic component and so that the amount of first and second therapeutic components internalized and retained within a tumor is greater than the sum of the first and second therapeutic components internalized and retained in a tumor if each of the first and second agents were administered individually and so that the first and second agent are optionally blended as taught by Bander et al. because it would have been expected to advantageously enable greater than additive accumulation of two different therapeutic components in the cancer whereby enabling effective treatment of cancer. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-26, 48, and 61 of copending Application No. 18/029,596 so that the first and second agents are co-administered 8 h, 6 h, 4 h, or 2 h or simultaneously as taught and suggested by Bander et al. because those co-administration times would have been expected to enable additive internalization and optimal efficacy resulting from simultaneous or sequential contact at the target site within the half-life of both agents.
Claims 1-20 and 28-30 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 2018/204477A1; published 8 Nov. 2018; see IDS filed on 30 Mar. 2023).
Claims 1-19 of U.S. Patent No. 12,285,503 B2 claim a method for treating prostate cancer in a subject, 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 inhibitors is optionally PSMA 617-177Lu optionally wherein the agents are administering in separated composition or are co-administered simultaneously (within 8 h, 6 h, 4 h, and 2 h apart from each other) and optionally allow to be dosed at about 25% to 100% of their MTD. Claims 1-19 of U.S. Patent No. 12,285,503 B2 claim a combination therapeutic optionally wherein the first and second agents are in the same or separate compositions.
Claims 1-19 of U.S. Patent No. 12,285,503 B2 do not claim that the first and second targeting components target the same molecular target or different molecular targets on the same cell or claim cytotoxic agents selected from the group consisting of busulfan, etc or claim a human subject or claim treating a neuroendocrine cancer, etc.
Bander 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 1-19 of U.S. Patent No. 12,285,503 B2 so that the first and second agents target the same molecular target or different molecular targets on the same cell or so that the first and/or second therapeutic components are selected from busulfan, etc or so that the subject is human subject as taught by claims 1-19 of U.S. Patent No. 12,285,503 B2 because those modifications would have been expected to provide an equivalent method of treating cancer in a human subject wherein the first and second therapeutic components internalize and retain in a tumor greater than the sum if each of the first and second agents were administered individually. 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 by further treating a neuroendocrine cancer as taught by Bander et al. because it would have been expected to provide an equivalent method of treating a cancer including a neuroendocrine cancer, the equivalent method advantageously enabling additive internalization of the first and second therapeutic agent whereby improving therapeutic outcome.
Conclusion
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618