DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending and examined on the merits.
Claim Objections
Claim 15 is objected to because of the following informalities: the word processing error of 47Sc rather than 47Sc-NM600. Appropriate correction is required.
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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-13, 16-22 of U.S. Patent No.11,633,506. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 and 16-22 anticipate the instant claims.
Claims 1--22 anticipate the instant claims to the extent that the claims of the patent read on the structure of the formula in claim 1 wherein R1 comprises a chelating agent and a chelated metal atom which is the metal isotopes of claim 6(1) of the patent. Claim 13 of the patent teaches that the radioactive phospholipid ether metal chelate is NM600 chelated to a metal atom which meet the same limitations in instant claims 8, 9, wherein Z3 is methyl and claims 12-14. Claims 8 and 9 of the patent also meet the limitations of instant claims 8 and 9. Claims 7, 10 and 11 meet the limitations of instant claims 7, 10 and 11. Claims 12 and 13 of ‘506 meet the limitation of instant claim 12 and 13 to the extent that claim 13 of the patent is drawn to NM600. Claim 6(1) of the patent teaches the metal isotopes encompassed by claim 1 of the patent include 177Lu which anticipates that portion of instant claim 14. Claims 2-25 of the patent meet the limitations of instant claims 2-5. Claims 16-18 of the patent meet the limitations of instant claims 16-18. Claims 2-5 of the patent meet the limitations of instant claims 2-5 and 19. Claims 19 and 20 of ‘506 also meets the limitations of claim 19. Claim 21 of he patent meets the limitations of instant claim 20.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.11,730,834. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 anticipate or the instant claims..
Claim 1 of the ‘834 patent discloses, in part, a method of treating a metastatic cancer in a subject wherein the metastatic cancer comprises a primary malignant solid tumor and one or more metastatic tumors capable of causing concomitant immune tolerance comprising administering an immunomodulatory dose of a radioactive phospholipid metal chelate compound that is differentially take up by and retained without the malignant solid tumor tissue. Claims 6 and 11-16 of the patent discloses the phospholipid structure of instant claim 1 . Claims 8-10 meet the limitations of instant claims 7, 10 and 11. The first structure in claim 10 of the ‘834 patent meets the limitation of NM600 in instant claim 6, 13 and 14, and the structural requirements of instant claim 12. Claim 3 of the patent discloses that the immunomodulatory dose of the phospholipid metal chelate is from 2 Gy to 8 Gy to the metastatic tumors. Which meets the imitation of instant claim 20 Claim 7 of the patent discloses the metal isotopes of required in instant claim 1 and 14. Thus, claim 1 of the ‘834 patent encompasses the instant formula of claim 1, the metal isotopes, the immunomodulatory dosage of 2 Gy to 8 Gy of instant claim 20.
Claim 1(b) of the patent requires that an in situ vaccination is carried out by contacting the primary tumor with one or more agents capable of stimulating specific immune cells within the tumor microenvironment. Claim 4 discloses that the one or more treatments capable of stimulating specific immune cells within the tumor environment is a immunostimulatory antibody. Claim 5 of the patent discloses that the immunostimulatory antibody is an anti-CTLA4 antibody, an anti-CD137 antibody, an anti-CD134 antibody, and an anti-PD-1 antibody, an anti-KIR antibody, an anti-PD-L1 antibody, an anti-LAG3 antibody and an anti-CD40 antibody which meet the limitations of instant claims 2-5. Anti-PD-L1 in claim 5 also meets the limitations of instant claim 19 because anti-PD-L1 is expressed by tumors and is a checkpoint molecule. As such the method of claim 19 require no administration of an antibody to a tumor antigen that is not a checkpoint molecule.
Claims 17-20 of the patent anticipate instant claims 16-19.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of copending Application No. 18/345,385 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are anticipated by the ‘385 claims. Claim 1 discloses a method of treating a metastatic cancer comprising determination and administration of an immunomodulatory dose of a radioactive phospholipid metal chelate., wherein the metal chelate comprises alpha, beta, auger and/or gamma emitting isotopes Claim 2 discloses the structure of the phospholipid, which meets the same limitations for the structure as in instant claim 1(a). Claim 13 discloses that the alpha, beta, auger and/or gamma emitting isotopes are the same as those required in instant claim 1(a) and the 177Lu in claim 14. Claims 3-5 disclose the compounds used for the metal chelated and the metal chelates obtained therefore which anticipate instant claims 7, 10 and 11. The first structure of claim 5 anticipates instant claim 6, 12 and 13, and the NM600 of claim 14. Claims 10 and 11 of ‘385 anticipate instant claims 8 and 9.
Claim 16 of the ‘385 application anticipates instant claim 1(b) wherein an agent capable of stimulating immune cells is administered. Claims 19 of ‘385 anticipates instant claims 2-5 and 19. Claims 20-22 of ‘385 anticipate instant claims 16-18. Claim 15 of ‘385 anticipates the radiation dose of instant claim 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15, 17, 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 9, 11, 13-18 of copending Application No. 19053,084(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the application anticipate the instant claims.
Claim 1 of ‘084 discloses a method comprising administering a phospholipid metal chelate compound to a subject with cancer having the indicated structure in part c, wherein the radioactive metal chelate is chelated to a metal isotope. The structure of claim 1(C) of ‘084 meets the limitations of DO3A in claim 7, claims 8 and 9 wherein each Z is methyl, the first structure in claims 10 and 11, NM600 in claims 6, 12-14. Claims 8 and 9 of ‘084 disclose the metal isotopes of 177Lu and 225Ac which meet the same limitations in claims 1(a), 14 and 15. Claim 5 of ‘085 disclose that the cancer is metastatic disease which meets that limitation in instant claim 1. Claim 11 regarding the dosage of the radiation meets the limitations of instant claim 22.
Claim 1 (c) of ‘084 requiring administration of an immunostimulatory agent meets the same limitation in instant claim 1(b). Claims 13-17 of ‘084 meet the limitations in instant claims 2-5 and 19.
Regarding claims 17 and 18
Thee specification defines “subject” s including human subjects:
In some embodiments, the subject is a human.
and defines cancers treatable by the instant methods to include:
melanoma, neuroblastoma, lung cancer, adrenal cancer, colon cancer, colorectal cancer, ovarian cancer, prostate cancer, liver cancer, subcutaneous cancer, squamous cell cancer of the skin or head and neck, intestinal cancer, retinoblastoma, cervical cancer, glioma, breast cancer, pancreatic cancer, soft tissue sarcomas, Ewings sarcoma, rhabdomyosarcoma, osteosarcoma, retinoblastoma, Wilms’ tumor, or pediatric brain tumors.
Thu, instant claims 17 and 18 are obvious over the ‘084 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
All claims are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Weichert et al (WO2017/079535, reference of the IDS filed 3/13/2023) teach the phospholipid ether metal chelates of the instant invention wherein the chelated atom is gadolinium (abstract). Weichert et al teach that the gadolinium metal chelates are effective MRI contrast agents that demonstrate signal enhancing uptake and retention in multiple cancer types including metastases(paragraph [00161]) Weichert et al suggest that due to the high neutron capture cross section of gadolinium, the agents may have applications in targeted neutron capture therapy of cancer(paragraph [00161]). Weichert et al do not teach an immunomodulatory dose of the phospholipid ether metal chelates wherein the metal atom is an alpha, beta or Auger emitting metal isotope for delivery of the immunomodulatory dose of radiation.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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