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 .
In the amendment filed 9/11/2025: claim 28 was canceled and claims 30, 37, 53 and 56 were amended. In the amendment filed 11/12/2025, claims 58-63 were added. Claims 25-27 and 29-63 are pending and under consideration.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant’s cancelation of claim 28 has restored benefit of claims 30, 37-42, 46-51, 53, 56 and 57 to 1/14/2020.
The rejection of claims 25-27, 29, 31, 32, 43, 45, 52, 54 and 55 under 35 U.S.C. 103 as being unpatentable over Garcia et al (WO2019/104092, reference of the IDS filed 6/6/2022) in view of Yaghoubi et al (Biomedicine & Pharmacotherapy, 2019, Vol. 110, pp. 312-318), Rozkova et al (Clinical Immunology, 2009, Vol. 131, pp. 1-10), Schneider et al (Journal of Thoracic Oncology, 2011, Vol. 6, pp. 432-438) and the abstract of Eikawa et al (Cancer Research, 2010, Vol. 70, No. 8., suppl., abstract no. 1915) is withdrawn in light of applicant’s arguemtns that SEQ ID NO: 22 of Garcia et al, represented as REK in figure 9C, did not decrease Treg relative to vehicle control.
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 25-27, 29-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 11-18 of U.S. Patent No.11,491,205. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claim 15 of the ‘205 patent teaches that the polypeptide of claim 1 is identical to the instant SEQ ID NO: 8.
The claims of the ‘205 patent do not teach that the cancer is a solid cancer.
Section 804 IIb of the M.P.E.P. states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).
In the instant case, the neoplastic diseases of the ‘205 patent are defined as both solid cancer and hematopoietic cancers:
(52) In some embodiments, the neoplastic disease disorder or condition is selected from the group consisting of: adenomas, fibromas, hemangiomas, hyperplasia, atypia, metaplasia, dysplasia, carcinomas, leukemias, breast cancers, sarcomas, leukemias, lymphomas, genitourinary cancers, ovarian cancers, urethral cancers, bladder cancers, prostate cancers, gastrointestinal cancers, colon cancers, esophageal cancers, stomach cancers, lung cancers; myelomas; pancreatic cancers; liver cancers; kidney cancers; endocrine cancers; skin cancers; gliomas, neuroblastomas, astrocytomas, myelodysplastic disorders; cervical carcinoma-in-situ; intestinal polyposes; oral leukoplakias; histiocytoses, hyperprofroliferative scars including keloid scars, respiratory system carcinomas, gastrointestinal system carcinomas, genitourinary system carcinomas, testicular carcinomas, breast carcinomas, prostatic carcinomas, endocrine system carcinomas, melanomas, adenocarcinomas, myeloproliferative neoplasms, myeloid and lymphoid disorders with eosinophilia, myeloproliferative/myelodysplastic neoplasms, myelodysplastic syndromes, acute myeloid leukemia and related precursor neoplasms, and acute leukemia of ambiguous lineage, promyeloid leukemia (APML), acute myelogenous leukemia (AML) and chronic myelogenous leukemia (CIVIL), precursor lymphoid neoplasms, mature B-cell neoplasms, mature T-cell neoplasms, Hodgkin's Lymphoma, and immunodeficiency-associated lymphoproliferative disorders, lymphoblastic leukemia (ALL) which includes B-lineage ALL and T-lineage ALL, chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), hairy cell leukemia (HLL) and Waldenstrom's macroglobulinemia (WM). erythroblastic leukemia and acute megakaryoblastic leukemia, malignant lymphomas including, but are not limited to, non-Hodgkins lymphoma and variants thereof, peripheral T cell lymphomas, adult T-cell leukemia/lymphoma (ATL), cutaneous T cell lymphoma (CTCL), large granular lymphocytic leukemia (LGF), Hodgkin's disease and Reed-Stemberg disease.
Thus, the method of treating a human subject suffering from a neoplastic disease in the claims of the ‘205 patent does not exclude solid cancers, and specifically includes prostate cancer, ovarian cancer, lung cancer and colon cancers, thus rendering obvious claims 43-51.
It is noted that the specification fails to provide a description of specific “symptoms associated with the cancer” which are to be ameliorated. The method of the claims of the ‘205 patent would inherently ameliorate one or more symptoms associated with the cancer because it is a method directed to the treatment of cancer.
Claim 4 and 5 of the patent meet the limitations of instant claims 26 and 27. Claims 11 and 12 of the patent meet the limitations of instant claims 31, 32, 37 and 38. Claims 13, 14 and 17 of ‘205 meets the limitations of instant claims 33-36, 39-42.
Regarding claims 29 and 30, the ‘205 specification defines the terms “administration” to include subcutaneous administration:
The terms “administration” and “administer” are used interchangeably herein to refer the act of contacting a subject, including contacting a cell, tissue, organ, or biological fluid in vitro, in vivo and/or ex vivo of a subject with an agent (e.g. an hIL2 mutein, a vector encoding a hIL2 mutein, an engineered cell expressing an hIL2 mutein, a chemotherapeutic agent, an antibody, or a pharmaceutical formulation comprising one or more of the foregoing). Administration of an agent may be achieved through any of a variety of art recognized methods including but not limited to the topical administration, intravascular injection (including intravenous or intraarterial infusion), intradermal injection, subcutaneous injection, intramuscular injection, intraperitoneal injection, intracranial injection, intratumoral injection, transdermal, transmucosal, iontophoretic delivery, intralymphatic injection, intragastric infusion, intraprostatic injection, intravesical infusion (e.g., bladder), inhalation (e.g., respiratory inhalers including dry-powder inhalers), intraocular injection, intraabdominal injection, intralesional injection, intraovarian injection, intracerebral infusion or injection, intracerebroventricular injection (ICVI), and the like.
Thus, instant claims 29 and 30 are obvious variants of the method of treating a human subject of claims 1-5 and 11-18 of the ‘205 patent.
Claims 25-27, 31-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11-18 of U.S. Patent No. 11,491,205 in view of Garcia et al (WO2019/104092) and Yaghoubi et al (Biomedicine & Pharmacotherapy, 2019, Vol. 110, pp. 312-318).
Claim 1 of the patent teaches that the polypeptide exhibits diminished binding to CD132 relative to wt-human Il2. One of skill in the art would reasonably conclude that the polypeptide of claim 1 of the patent was a partial agonist Il-2 mutein.
Garcia et al teach a “therapeutically effective amount” of a subject partial agonist IL-2 mutein ranges from approximately 0.001 to 0.1 mg/kg of patient body weight (paragraph [00163]) which meets the limitations of claims 52 and 53 and that the dosage may be administered one time per week (paragraph [00163]) which meets the limitations of claims 54 and 56.
Regarding claims 55 and 57, Yaghoubi et al teach a clinical trial in which intravenous pembrolizumab was administered to patients with colon and rectal solid tumors, and that the results of the trial suggest that pembrolizumab at 2 mg/kg every three weeks to 10 mg/kg every two weeks is safe and effective.
Thus, it would be prima facie obvious to administer a partial agonist mutein Il-2 which included SEQID NO: 8 of claim 15 of the ‘205 patent at a weekly dose from 0.001 to 0.1 mg/kg of patient body weight with the pembrolizumab every two to three weeks because both of these agents are active against cancer cells, including solid cancers and the claims of the patent teach the combination of the polypeptide with the pembrolizumab in a method of treating cancer.
Claims 25-27, 31-34, 37-40, 59 and 61-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11-18 of U.S. Patent No. 11,491,205 in view of Koopmans et al (Oncoimmunology, 2018, Vol. 7, e1466016, 11 pages).
Claim 13 of the patent teaches that the supplemental agent of claim 12 is an immune checkpoint modulator. Claim 14 of the patent further teaches that the immune checkpint modulator is an anti-PD-L1 antibody.
The claims of the patent do not teach that the immune checkpoint modulator is a bispecific antibody.
Koopmans et al teach that the efficacy of current PD-L1 blocking antibodies is potentially reduced by ‘on-target-off tumor” binding to PD-L1widely expressed on normal cells (abstract, first paragraph). Koopmans et al teach that to reduce the ‘on-target-off tumor” binding a bispecific antibody that binds to EGFR and PD-L1 and thus directs the PD-L1 blockade to EGFR+ cancer cells was constructed (abstract, paragraph 2). Kopmans et al teach that the PD-L1 X EGFR bispecific antibody blocked the PD-1/PD-L1 immune checkpoint in an EGFR-directed manner thereby promoting selective reactivation of anti-cancer T cells (abstract, paragraph 2).
Thus, it would be prima facie obvious to administer SEQID NO: 8 of claim 15 of the ‘205 in combination with PD-L1 X EGFR because both of these agents are active against cancer cells, including solid cancers that express EGFR and the claims13 and 14 of the patent teach the combination of the polypeptide with supplemental agent which is an immune checkpoint inhibitor in a method of treating cancer.
Claims 25-27, 31, 32, 37, 38, 52, 53, 54, 56, 58, 60 and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11-18 of U.S. Patent No. 11,491,205 in view of Garcia et al (WO2019/104092) and Au et al (The Oncologist, ePub November 14, 2019, Vol. 25, e709-e715).
Claim 1 of the patent teaches that the polypeptide exhibits diminished binding to CD132 relative to wt-human Il2. One of skill in the art would reasonably conclude that the polypeptide of claim 1 of the patent was a partial agonist Il-2 mutein. The claims of the ‘205 patent do not teach that the cancer is a hematopoietic cancer, such as B-cell ALL.
Section 804 IIb of the M.P.E.P. states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).
In the instant case, the neoplastic diseases of the ‘205 patent are defined as both solid cancer and hematopoietic cancers:
(52) In some embodiments, the neoplastic disease disorder or condition is selected from the group consisting of: adenomas, fibromas, hemangiomas, hyperplasia, atypia, metaplasia, dysplasia, carcinomas, leukemias, breast cancers, sarcomas, leukemias, lymphomas, genitourinary cancers, ovarian cancers, urethral cancers, bladder cancers, prostate cancers, gastrointestinal cancers, colon cancers, esophageal cancers, stomach cancers, lung cancers; myelomas; pancreatic cancers; liver cancers; kidney cancers; endocrine cancers; skin cancers; gliomas, neuroblastomas, astrocytomas, myelodysplastic disorders; cervical carcinoma-in-situ; intestinal polyposes; oral leukoplakias; histiocytoses, hyperprofroliferative scars including keloid scars, respiratory system carcinomas, gastrointestinal system carcinomas, genitourinary system carcinomas, testicular carcinomas, breast carcinomas, prostatic carcinomas, endocrine system carcinomas, melanomas, adenocarcinomas, myeloproliferative neoplasms, myeloid and lymphoid disorders with eosinophilia, myeloproliferative/myelodysplastic neoplasms, myelodysplastic syndromes, acute myeloid leukemia and related precursor neoplasms, and acute leukemia of ambiguous lineage, promyeloid leukemia (APML), acute myelogenous leukemia (AML) and chronic myelogenous leukemia (CIVIL), precursor lymphoid neoplasms, mature B-cell neoplasms, mature T-cell neoplasms, Hodgkin's Lymphoma, and immunodeficiency-associated lymphoproliferative disorders, lymphoblastic leukemia (ALL) which includes B-lineage ALL and T-lineage ALL, chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), hairy cell leukemia (HLL) and Waldenstrom's macroglobulinemia (WM). erythroblastic leukemia and acute megakaryoblastic leukemia, malignant lymphomas including, but are not limited to, non-Hodgkins lymphoma and variants thereof, peripheral T cell lymphomas, adult T-cell leukemia/lymphoma (ATL), cutaneous T cell lymphoma (CTCL), large granular lymphocytic leukemia (LGF), Hodgkin's disease and Reed-Stemberg disease.
Thus, the method of treating a human subject suffering from a neoplastic disease in the claims of the ‘205 patent does not exclude hematopoietic cancers, and specifically includes B-cell precursor ALL.
Au et al teach the administration of Blinatumomab for the treatment of B-lineage ALL (page e710, first column, 4th full paragraph).
It is noted that the specification fails to provide a description of specific “symptoms associated with the cancer” which are to be ameliorated. The method of the claims of the ‘205 patent would inherently ameliorate one or more symptoms associated with the cancer because it is a method directed to the treatment of cancer.
Claim 4 and 5 of the patent meet the limitations of instant claims 26 and 27. Claims 11 and 12 of the patent meet the limitations of instant claims 31, 32, 37 and 38.
Garcia et al teach a “therapeutically effective amount” of a subject partial agonist IL-2 mutein ranges from approximately 0.001 to 0.1 mg/kg of patient body weight (paragraph [00163]) which meets the limitations of claims 52 and 53 and that the dosage may be administered one time per week (paragraph [00163]) which meets the limitations of claims 54 and 56.
Thus, it would be prima facie obvious to administer a partial agonist mutein Il-2 of SEQ ID NO:8 of claim 15 of the ‘205 patent at a weekly dose from 0.001 to 0.1 mg/kg of patient body weight with blinatumomab every two to three weeks because both of these agents are active against cancer cells, including B-cell lineage ALL, and the claims of the patent teach the combination of the polypeptide with the supplementary agents which include antibodies in a method of treating cancer.
.
All claims are rejected.
All other rejections and/or objections as set forth in the previous Office action are withdrawn
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643