DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted on 08/24/2023 and 07/31/2024 were considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 and 19 of U.S. Patent No. 9,77,487. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the Patent are drawn to a method of treating a metastatic pancreatic adenocarcinoma or ductal pancreatic adenocarcinoma in a patient comprising administering to the patient (i) an antibody having the ability of binding to claudin 18 splice variant 2 (CLDN18.2), wherein the antibody comprises a heavy chain variable region (VH) having a CDR1 of positions 45-52 of SEQ ID NO: 17, a CDR2 of positions 70-77 of SEQ ID NO: 17, and a CDR3 of positions 116-126 of SEQ ID NO: 17, and a light chain variable region (VL) having a CDR1 of positions 47-58 of SEQ ID NO: 24, a CDR2 of positions 76-78 of SEQ ID NO: 24, and a CDR3 of positions 115-123 of SEQ ID NO: 24 and wherein the antibody mediates killing of cells expressing CLDN18.2 and (ii) gemcitabine or a prodrug thereof.
Thus, the Patent claims are anticipating the instant claim 40.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 10,314,890. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the Patent is drawn to a method of treating a metastatic pancreatic cancer characterized by pancreas cells expressing claudin 18 splice variant 2 (CLDN18.2), the method comprising the steps of: increasing susceptibility of the pancreas cells to killing by an anti-CLDN18.2 antibody by administering to a patient gemcitabine or a prodrug thereof, wherein the administration of gemcitabine or a prodrug thereof provides an increase in the number of CLDN18.2 proteins on the surface of the pancreas cells; and administering to the patient an anti-CLDN18.2 antibody, wherein the antibody comprises a heavy chain variable region (VH) having a CDR1 of positions 45-52 of SEQ ID NO: 17, a CDR2 of positions 70-77 of SEQ ID NO: 17, and a CDR3 of positions 116-126 of SEQ ID NO: 17, and a light chain variable region (VL) having a CDR1 of positions 47-58 of SEQ ID NO: 24, a CDR2 of positions 76-78 of SEQ ID NO: 24, and a CDR3 of positions 115-123 of SEQ ID NO: 24, and wherein the antibody has the ability of binding to CLDN18.2 and mediates killing of cells expressing CLDN18.2; wherein the patient has cancerous or precancerous pancreas tissue comprising cells expressing CLDN18.2.
Thus, the Patent claim is anticipating the instant claim 40.
Claims 40-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim12, 14 and 20 of U.S. Patent No. 10, 946,069. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the Patent are drawn to a method of treating metastatic pancreatic cancer in a patient in need thereof, wherein the pancreatic cancer is characterized by cells expressing claudin 18 splice variant 2 (CLDN18.2), the method comprising: administering an anti-CLDN18.2 antibody to the patient, wherein the antibody comprises a heavy chain variable region (VH) having an amino acid sequence represented by SEQ ID NO: 32 and a light chain variable region (VL) having an amino acid sequence represented by SEQ ID NO: 39 (which comprise SEQ ID NO: 17 and 24, respectively), and wherein the antibody has the ability of binding to CLDN18.2 and mediates killing of cells expressing CLDN18.2; administering gemcitabine to the patient to increase susceptibility of the cells to killing by the anti-CLDN18.2 antibody; and administering a taxane to the patient. The taxane is albumin-bound paclitaxel; the combination is administered repeatedly according to a combination dosing regimen, wherein the combination dosing regimen comprises once weekly administration for 3 of 4 weeks, at an initial dose of up to 1000 mg/m2 followed by repeated doses of 300 to 600 mg/m2. The antibody is a chimeric antibody comprising a human kappa light chain constant region and a human IgG1 heavy chain constant region. The human kappa light chain constant region is allotype Km(3) and the human IgG1 heavy chain constant region is allotype G1m(3). The anti-CLDN18.2 antibody comprises a heavy chain having an amino acid sequence represented by SEQ ID NO: 17 and a light chain having an amino acid represented by SEQ ID NO: 24.
Thus, the Patent claim are anticipating the instant claims 40-45.
Claims 40-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,826,402. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the Patent are drawn to a method for treating metastatic pancreatic adenocarcinoma in a patient in need thereof, wherein the metastatic pancreatic adenocarcinoma is characterized by cells expressing claudin 18 splice variant 2 (CLDN18.2), the method comprising: administering an anti-CLDN18.2 antibody to the patient, wherein the antibody comprises a heavy chain variable region (VH) having an amino acid sequence represented by SEQ ID NO: 32 and a light chain variable region (VL) having an amino acid sequence represented by SEQ ID NO: 39 (which comprise SEQ ID NO: 17 and 24, respectively), and wherein the antibody has the ability of binding to CLDN18.2 and mediates killing of cells expressing CLDN18.2, wherein the method further comprises administering a chemotherapy to the patient, wherein the chemotherapy comprises gemcitabine and/or a taxane, wherein the taxane is albumin-bound paclitaxel. The chemotherapy comprises a combination of gemcitabine and albumin-bound paclitaxel. The combination is administered repeatedly according to a combination dosing regimen, wherein the combination dosing regimen comprises once weekly administration for 3 of 4 weeks. The antibody is administered repeatedly according to antibody dosing regimen, wherein the antibody dosing regimen comprises an initial dose of up to 1000 mg/m2 followed by repeated doses of 300 to 600 mg/m2. The antibody is a chimeric antibody comprising a human kappa light chain constant region and a human IgG1 heavy chain constant region. The human kappa light chain constant region is allotype Km(3) and the human IgG1 heavy chain constant region is allotype G1m(3). The anti-CLDN18.2 antibody comprises a heavy chain having an amino acid sequence represented by SEQ ID NO: 17 and a light chain having an amino acid represented by SEQ ID NO: 24.
Thus, the Patent claim are anticipating the instant claims 40-45.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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