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 .
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.
Claims 1-4 and 7-15 are rejected under 35 U.S.C. 103 as being obvious over Baum ("177Lu-3BP-227 for Neurotensin Receptor 1-Targeted Therapy of Metastatic Pancreatic Adenocarcinoma: First Clinical Results; document already in record) in view of US 2018/0078556 A1 to Ipsen BioPharm Ltd. (hereinafter Ipsen) (document already in record). Baum teaches a combination (Pg. 811 After an initial intravenous application of 1.5 GBq of 177Lu-3BP-227 to assess tumor uptake and organ dosimetry, the patient first received 2 further cycles of FOLFOX and then started a series of 3 intraperitoneal administrations. The application of 177Lu-3BP-227 was tolerated without any side effects) comprising a neurotensin receptor binding compound (Pg. 809 Col 1 Para 1 Eligible patients were offered salvage radiopharmaceutical therapy with the novel NTR1 antagonist 177Lu-3BP-227. Six patients with confirmed ductal pancreatic adenocarcinoma who had exhausted all other treatment options received 177Lu-3BP-227 for evaluation of NTR1 expression in vivo) folinic acid, fluorouracil and oxaliplatin (Pg. 811 After an initial intravenous application of 1.5 GBq of 177Lu-3BP-227 to assess tumor uptake and organ dosimetry, the patient first received 2 further cycles of FOLFOX; Pg. 811 Col 2 Para 1 FolFOX is a folinic acid/fluorouracil/oxaliplatin) for use for the treatment of a neurotensin receptor overexpressing tumour in a subject (Pg. 809 Col 1 Para 1 Neurotensin receptor 1 (NTR1) is overexpressed in ductal pancreatic adenocarcinoma, which is still one of the deadliest cancers, with a very poor prognosis. Eligible patients were offered salvage radiopharmaceutical therapy with the novel NTR1 antagonist 177Lu-3BP-227 (pg. 809 col 1 para 1).Baum further teaches wherein the neurotensin receptor binding compound is radiolabeled with a therapeutic radionuclide (Pg. 809 Col 1 Para 1 Eligible patients were offered salvage radiopharmaceutical therapy with the novel NTR1 antagonist 177Lu-3BP-227. Six patients with confirmed ductal adenocarcinoma who had exhausted all other treatment options received 177Lu-3BP-227 for evaluation of NTR1 expression in vivo). Baum further teaches wherein the therapeutic radionuclide is selected from the group comprising 177Lu, 90Y, 67Cu, 1311, issRe, isaRe, 211At 212Pb, 213Bi, 225Ac, and 227Th (Pg. 809 Col 1 Para 1 Eligible patients were offered salvage radiopharmaceutical therapy with the novel NTR1 antagonist 177Lu- 3BP-227. Six patients with confirmed ductal pancreatic adenocarcinoma who had exhausted all other treatment options received 177Lu-3BP-227 for evaluation of NTR1 expression in vivo). Baum further teaches wherein the therapeutic radionuclide is 177Lu (Pg. 809 Col 1 Para 1 Eligible patients were offered salvage radiopharmaceutical therapy with the novel NTR1 antagonist 177Lu-3BP-227. Six patients with confirmed ductal pancreatic adenocarcinoma who had exhausted all other treatment options received 177Lu-3BP-227 for evaluation of NTR1 expression in vivo).
Baum fails to teach wherein the combination comprises liposomal innotecan.
Ipsen teaches a combination (Para [0002] This disclosure relates to novel therapies useful in the treatment of pancreatic cancer, including the use of liposomal irinotecan in combination with 5-fluorouracil and oxaliplatin) comprising liposomal irinotecan (Para [0006] Improved antineoplastic therapies for the treatment of pancreatic cancer provide the administration of liposomal irinotecan in combination) for the treatment of a tumor in a subject (Para [0008] liposomal irinotecan combined with 5-fluorouracil and oxaliplatin consistently improved tumor growth inhibition). It would have been obvious to one of ordinary skill in the art to combine these references to include liposomal irinotecan in the composition through routine experimentation to treat pancreatic cancer (Para [0006] treatment of pancreatic cancer provide the administration of liposomal irinotecan in combination with oxaliplatin and 5-fluorouracil to patients with previously untreated pancreatic cancer). Further regarding claim 15, it would have been obvious to treat a patient having metastatic PDAC that has not previously received a therapy for treating pancreatic cancer with the motivation to treat metastatic PDAC.
Claims 1-15 are rejected under 35 U.S.C. 103 as being obvious over Baum in view of Ipsen in further view of Solnes (Theranostics: Leveraging Molecular Imaging and Therapy to Impact Patient Management and Secure the Future of Nuclear Medicine, J Nucl Med 2020; 61:311–318). The relevant portions of Baum and Ipsen are given above.
Baum and Ipsen fail to teach “wherein the neurotensin receptor binding compound is a complex of formula (ii).
Solnes teaches a binding compound complex 3BP-277 chelator corresponding to formula (ii) provides effective imaging and treatment of cancer (abstract; conclusion).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the binding complex of Solnes. The motivation for this would be to provide effective imaging and treatment of cancer.
Double Patenting
Statutory
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-15 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-15 of prior U.S. Patent No. 18541584. Claims 1-15 of the present application and claims 1-15 of the copending application are identical. This is a statutory double patenting rejection.
Non-Statutory 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 obviousness-type 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
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 obviousness-type 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of copending Application No. 18541534 in view of Baum. Although the conflicting claims are not identical, they are not patentably distinct from each other because copending claims recite the present method of treating a neurotensin receptor overexpressing tumor, but fail to teach inclusion of Oxaliplatin in the components used to treat the tumor. However, Baum teaches incorporation of Oxaliplatin is an effective ingredient in compositions for treating neurotensin receptor overexpressing tumor (introduction; conclusion). It would have been obvious to incorporate Oxalplatin in the formulation of the copending claims to provide the advantages of Oxaplatin in treating cancer, including improved overall survival, stronger tumor-fighting power through drug combinations, and delayed disease progression.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
July 29, 2026
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