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 .
Receipt is acknowledged of Applicant’s Amendment filed on 07/23/2025; and IDS filed on 07/23/2025.
Claims 45-46 have been amended.
Claims 45-54 are pending in the instant application.
Claim 55 has been canceled.
Claims 51-54 have been previously withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 45-50, 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/568,234 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-applications recite A method of inducing an immune response to a tumor in a mammal, said method comprising: (i) administering to the mammal a radioimmunoconjugate, wherein the mammal has received or is receiving one or more checkpoint inhibitors; (ii) administering to the mammal one or more checkpoint inhibitors, wherein the mammal has received or is receiving a radioimmunoconjugate; or (iii) administering the mammal one or more checkpoint inhibitors at the same time as administering the mammal a radioimmunoconjugate, wherein: the radioimmnoconjugate has the structure of Formula I-b-1, or a pharmaceutically acceptable salt thereof: ##STR00007## wherein A is a metal complex of a chelating moiety, wherein said chelating moiety is selected from the group consisting of DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid), DOTMA (1R,4R,7R,10R)-α, α′, α′′ a‴-tetramethyl-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid, DOTAM (1,4,7,10-tetrakis(carbamoylmethyl)-1,4,7,10-tetraazacyclododecane), DO3AM-acetic acid (2-(4,7,10-tris(2-amino-2-oxoethyl)-l,4,7,10-tetraazacyclododecan-l-yl)acetic acid), DOTP (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetra(methylene phosphonic acid)), DOTA-4AMP (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetrakis(acetamido-methylenephosphonic acid), NOTA (1,4,7-triazacyclononane-1,4,7-triacetic acid), and HP-D03A (hydroxypropyltetraazacyclododecanetriacetic acid), wherein the metal of said metal complex is a radionuclide selected from the group consisting of .sup.47Sc, .sup.55Co, .sup.60Cu, .sup.61Cu, .sup.62Cu, .sup.64Cu, .sup.67Cu, .sup.66Ga, .sup.67Ga, .sup.68Ga, .sup.82Rb, .sup.86Y, .sup.87Y, .sup.89Zr, .sup.90Y, .sup.97Ru, .sup.99Tc, .sup.99mTc, .sup.105Rh, .sup.109Pd, .sup.111In, .sup.117mSn, .sup.149Pm, .sup.149Tb, .sup.153Sm, .sup.166Ho, .sup.177Lu.sub.,.sup.186Re, .sup.188Re, .sup.198Au, .sup.199Au, .sup.201Tl, .sup.203Pb, .sup.211At, .sup.212Pb, .sup.212Bi, .sup.213Bi, .sup.223Ra, .sup.225Ac, .sup.227Th, and .sup.229Th; L.sub.1 is optionally substituted C.sub.1-C.sub.6 alkyl or optionally substituted C.sub.1-C.sub.6 heteroalkyl; L.sup.2 has the structure of Formula II: ##STR00008## wherein X.sup.1 is C═.sub.O(NR.sup.1) or NR.sup.1, in which R.sup.1 is H or optionally substituted C.sub.1— C.sub.6alkylor optionally substituted C.sub.1-C.sub.6 heteroalkyl, optionally substituted aryl or heteroaryl; L.sup.3is optionally substituted C.sub.1-C.sub.50 alkyl or optionally substituted C.sub.1-C.sub.50 heteroakyl; and Z.sup.1 is CH.sub.2, C═O, C═S, OC═O,NR.sup.1C═O, or NR.sup.1, in which R.sup.1 is hydrogen, optionally substituted C.sub.1-C.sub.6 alkyl, or pyrrolide-2,5-dione, and B is a human or humanized IgG antibody or an antigen-binding fragment thereof (see 17/819,911 at claim 1, and claim 16), wherein the radionuclide is .sup.225Ac (see claim 15), wherein the one or more checkpoint inhibitors comprise a PD-1 inhibitor (see claim 17), wherein the patient has a cancer selected from the group consisting of breast cancer, non-small cell lung cancer, small cell lung cancer, pancreatic cancer, head and neck cancer, prostate cancer, colorectal cancer, cervical cancer, endometrial cancer, sarcoma, adrenocortical carcinoma, neuroendocrine cancer, Ewing’s Sarcoma, multiple myeloma, and acute myeloid leukemia (see claim 23).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 45-50, 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 10,093,741 in view of BAUES et al (Short Review of Potential Synergies of Immune Checkpoint Inhibition and Radiotherapy with a Focus on Hodgkin Lymphoma: Radio-Immunotherapy Opens New Doors. Immunotherapy, 9:5, (2017) pg. 423-433).
The patent recites a method of treating cancer, the method comprising administering to a subject in need thereof an effective amount of a composition comprising a compound of claim 1 in a pharmaceutically acceptable carrier (see claim 1), wherein the compound of claim 1, recites a compound comprising a structure:
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wherein B is an antibody and the antibody is AVE1642 (SEQ ID NO: 9) or a pharmaceutically acceptable salt thereof (see claim 1), wherein the radionuclide is .sup.225Ac (see claim 6), wherein the cancer is breast cancer, non-small cell lung cancer, small cell lung cancer, pancreatic cancer, head and neck cancer, prostate cancer, colorectal cancer, thyroid cancer, sarcoma, adrenocortical carcinoma, Ewing's Sarcoma, glioblastoma multiforme, liver cancer, neuroendocrine tumors, bladder cancer, gastric and gastroesophageal junction cancers, melanoma, multiple myeloma, or acute myeloid leukemia (see claim 9).
The patent does not recite administering a checkpoint inhibitor, such as pembrolizumab.
BAUES teaches a short review on a method of synergy (see title) combination approach of treating cancer comprised of: administering immune checkpoint inhibitor (see abstract), such as pembrolizumab – an antibody that target the PD-1 (see pg. 425, 2nd col) and administering a radiotherapy (see title and abstract). Additional disclosures include: optimal schedule and radiation dosing (see abstract; and pg. 426, under Radiotherapy & immunology in HL).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate administering a checkpoint inhibitor, such as pembrolizumab. The person of ordinary skill in the art would have been motivated to make those modifications, because the addition of a checkpoint inhibitor would have synergistic/additive effect on treating cancer, and reasonably would have expected success because both references dealt in the same filed of endeavor, such as treating cancer.
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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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/JAKE M VU/Primary Examiner, Art Unit 1618