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 .
Applicant’s amendments, filed 5/22/2026, is acknowledged.
Claims 3-5 and 7-14 are cancelled.
Claims 1, 2, 6, and 15 are currently pending.
In view of the amendments and remarks filed on 5/22/2026, the following rejections remain.
Applications 18/190,822, 17/818,298, 17/793,174, and 17/793,162 are abandoned. The nonstatutory double patenting rejections over these references have been withdrawn.
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, 2, 6, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (J Clin Oncol 27, 9023-9023(2009) doi: 10.1200/jco.2009.27.15_suppl.9023, in Office Action mailed 6/18/2025) in view of Tipton et al. (WO2018085555, on IDS filed on 8/25/2023, in Office Action mailed 6/18/2025) and Conejo-Garcia et al. (U.S. PGPub 20190201526, in Office Action mailed 6/18/2025), as evidenced by Schadendorf et al. (Lancet. 2018 Sep 15;392(10151):971-984. doi: 10.1016/S0140-6736(18)31559-9, in Office Action mailed 6/18/2025). This is a new grounds of rejection necessitated by Applicant’s amendments.
Applicant has amended claim 1 to include the limitations of instant claims 3-5. Therefore, these claims and newly added claim 15 (which recites the same cancers as claim 6 that was previously rejected) are rejected as obvious over Weber et al. Tipton et al., and Conejo-Garcia et al., as evidenced by Schadendorf et al. for the same reasons discussed in the Office Action mailed on 6/18/2025.
Briefly, Weber et al. teaches a method of treating stage IV melanoma comprising administration of ipilimumab every 8 weeks (i.e., “Q8W”; Abstract), Schadendorf et al. is used as an evidentiary reference to demonstrate that stage IV melanoma cancer is metastatic (Tables 1 and 2), Tipton et al. teaches activatable ipilimumab with heavy chain and light chain sequences that are 100% identical to instant SEQ ID NO: 11 and 24, respectively (Tipton et al. SEQ ID NO: 353 and 448), and Conejo-Garcia et al. teaches dosages of ipilimumab including 1600mg.
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the instant application, to have modified the combined teachings of Weber et al. in view of Tipton et al. and Conejo-Garcia et al., as evidenced by Schadendorf et al. to have used the activatable ipilimumab taught by Tipton et al. in the method taught by Weber et al. at the dosages taught by Conejo-Garcia et al. with a reasonable expectation of success, tried a dose of 1600mg for the activatable ipilimumab to treat metastatic melanoma in a patient though routine optimization. Conejo-Garcia et al. teaches doses of ipilimumab, including 1600mg, that one with ordinary skill in the art would be able to apply to the activatable ipilimumab taught by Tipton et al. to reduce side effects when treating cancer.
Applicant’s remarks, filed 5/22/2026, have been fully considered, but have been found to be not convincing.
Applicant has argued that the dosages taught by Conejo-Garcia et al. apply to ipilimumab and not activatable ipilimumab (Remarks pg. 3). Applicant further argues Conejo-Garcia et al. provides “no meaningful disclosure of any dosing” (Remarks pg. 3), as the ipilimumab dosages taught are only a “laundry list” of dosages (Remarks pg. 4).
This has been found to be not persuasive. In contrast to Applicant’s assertations, Conejo-Garcia et al. clearly teaches a list of dosages that can be applied to ipilimumab in ¶[0098], which specifically lists 1600mg of ipilimumab. One with ordinary skill in the art would use this teaching of dosages for ipilimumab for an activatable version of ipilimumab, at least as a starting point during the optimization of dosages.
Additionally, in response to Applicant’s assertations that Conejo-Garcia et al. only teaches a list of dosages to apply to ipilimumab, although picking and choosing is not permissible in the context of an anticipatory rejection – the instant rejection is based on the grounds of obviousness. As explained in Arkley, picking and choosing may be entirely proper in the making of a 103 obviousness rejection, where the applicant must be afforded an opportunity to rebut with objective evidence any inference of obviousness which may arise from the similarity of the subject matter which he claims to the prior art, but it has no place in the making of a 102, anticipation rejection.
In re Arkley, 455 F.2d 586, 587-588 (CCPA 1972). Although both Brandle and Herold disclose multiple compositions and multiple disease targets, as explained by the Examiner the list of compositions and disease targets is small. Specifically, the Examiner finds that Brandle teaches "just 3 diseases [that] are specifically recited in the claims, [and] 2 of the 3 being the diseases of the instant claims" (Final Act. 3).
Furthermore, in absence of evidence to the contrary, it is Examiner’s positions that the experimentation needed to arrive at the subject matter claimed was "nothing more than routine" application of a well-known problem-solving strategy, we must conclude it is not invention. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007).
An improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05IIA on this issue.
Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382.
See also In re Boesch, 617 F.2d 272, 276 (C.C.P.A. 1980): “[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.”; In re Esterhoy, 440 F.2d 1386, 1389 (C.C.P.A. 1971): “The conditions recited in the claims appear to us to be only optimum and easily ascertained by routine experimentation.”; In re Swentzel, 219 F.2d 216, 219 (C.C.P.A. 1955): “the determination of that desired size under the present circumstances involves nothing more than routine experimentation and exercise of the judgment of one skilled in the art.”; In re Swain, 156 F.2d 246, 247-48 (C.C.P.A. 1946): “In the absence of a proper showing of an unexpected and superior result over the disclosure of the prior art, no invention is involved in a result obtained by experimentation.” See also In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056.
As is stated in Iron Grip Barbell Co. v. USA Sports, Inc., 73 USPQ2d 1225, “[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness.” Note similar language in In re Cooper, 57 USPQ 117, 119-120 and Ormco Corp. v. Align Tech., Inc., 79 U.S.P.Q.2d 1931, 1940. To overcome this prima facie case of obviousness applicants must show “that the claimed range achieves unexpected results relative to the prior art range.” (Peterson). Moreover, this showing must be commensurate in scope with the claimed range or, in other words, an applicant must show that the unexpected result occurs throughout the entire claimed range. See In re Harris, 74 USPQ2d 1951 (“Harris needed to show results covering the scope of the claimed range”). The showing must also present enough data points within the prior art range, but outside the claimed range, to establish that the unexpected property does not occur outside the claimed range. In re Hill, 284 F.2d 955, 958-59 (CCPA 1960).
In the instant case, Conejo-Garcia et al. teaches a range of ipilimumab dosages that one with ordinary skill in the art would apply to methods of treating melanoma with activatable ipilimumab, and the claimed dosage of 1600mg not only falls within the range recited by Conejo-Garcia et al., it is a specific listed dosage. In absence of evidence to the contrary, such as demonstration of surprising results of the claimed dosage of activatable ipilimumab, arrival at the claimed dosage of 1600 mg would require experimentation needed that was "nothing more than routine".
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1, 2, 6, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-17 of U.S. Patent No. 9,320,811 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1-3)
Claims 1-10 of U.S. Patent No. 8,685,394 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1-3)
Claims 1-11 of U.S. Patent No. 8,119,129 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 2)
Claims 1-5 of U.S. Patent No. 8,449,886 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 1)
Claims 1-8 of U.S. Patent No. 8,475,790 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 7)
Claims 1-30 of U.S. Patent No. 10,377,824 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 13)
Claims 1-37 of U.S. Patent No. 10,266,591 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 28)
Claims 1-28 of U.S. Patent No. 10,072,082 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1, 20, and 21)
Claims 1-22 of U.S. Patent No. 9,856,320 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 3)
Claims 1-13 of U.S. Patent No. 10,688,180 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 1, SEQ ID NO: 19 and 20 are the ipilimumab variable regions)
Claims 1-29 of U.S. Patent No. 11,612,654 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 1)
Claims 1-29 of U.S. Patent No. 10,512,689 (in Office Action mailed on 5/22/2026; claims are drawn to pharmaceutical compositions comprising ipilimumab, see claim 1)
Claims 1-20 of U.S. Patent No. 10,174,113 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 13)
Claims 1-15 of U.S. Patent No. 12,152,075 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 13-15)
Claims 1-18 of U.S. Patent No. 11,078,278 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1, 5, and 6)
Claims 1-16 of U.S. Patent No. 10,983,128 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 1, SEQ ID NO: 1 and 2 are the ipilimumab variable regions)
Claims 1-18 of U.S. Patent No. 10,081,681 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1, 2, and 18)
Claims 1-20 of U.S. Patent No. 12,528,865 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 4)
Claims 1-11 of U.S. Patent No. 11,072,657 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 4)
Claims 1-11 of U.S. Patent No. 10,196,445 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1-3, SEQ ID NO: 9 and 10 are the ipilimumab variable regions)
Claims 1-11 of U.S. Patent No. 11,623,965 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 4)
Claims 1-11 of U.S. Patent No. 11,332,529 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 7)
Claims 1-15 of U.S. Patent No. 11,767,361 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 6)
Claims 1-14 of U.S. Patent No. 12,441,799 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of activatable ipilimumab, see claims 1 and 7)
Claims 1-20 of U.S. Patent No. 11,117,968 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of activatable ipilimumab, see claims 1, 5, and 18)
Claims 1-18 of U.S. Patent No. 11,400,094 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 10-13)
Claims 1-76 of U.S. Patent No. 12,077,584 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 60 and 75)
Claims 1-113 of U.S. Patent No. 11,274,150 (in Office Action mailed on 5/22/2026; claims are drawn to ipilimumab, see claim 15)
Claims 1-19 of U.S. Patent No. 12,466,888 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1, 2, and 18)
Claims 1-28 of U.S. Patent No. 11,572,405 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 28)
Claims 1-20 of U.S. Patent No. 12,479,917 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 3)
Claims 1-10 of U.S. Patent No. 12,478,674 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 3)
Claims 1-11 of U.S. Patent No. 12,590,153 (originally Application 17/523,702 in Office Action mailed on 5/22/2026; claims are drawn to methods of treating melanoma comprising administration of ipilimumab, see claim 1)
each in view of Weber et al. (J Clin Oncol 27, 9023-9023(2009) doi: 10.1200/jco.2009.27.15_suppl.9023, in Office Action mailed 6/18/2025, supra) in view of Tipton et al. (WO2018085555, on IDS filed on 8/25/2023, in Office Action mailed 6/18/2025, supra) and Conejo-Garcia et al. (U.S. PGPub 20190201526, in Office Action mailed 6/18/2025, supra), as evidenced by Schadendorf et al. (Lancet. 2018 Sep 15;392(10151):971-984. doi: 10.1016/S0140-6736(18)31559-9, in Office Action mailed 6/18/2025, supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new grounds of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention of each of the patents listed supra in view of Weber et al., Tipton et al., and Conejo-Garcia et al., as evidenced by Schadendorf et al., for the same reasons discussed in the 35 USC § 103 rejection supra.
Applicant’s arguments, filed 5/22/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons discussed for the 35 USC § 103 rejection supra, it would not have been obvious to combine the references. However, this has been found to be not persuasive for the reasons discussed in the 35 USC § 103 rejection supra.
Claims 1, 2, 6, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-4 of copending U.S. Application 19/030,567 (in Office Action mailed on 5/22/2026; claims are drawn to ipilimumab, see claims 1 and 2)
Claims 1, 2, 4-6, 8-11, 34-36, 38, 40, 41, 43, 44, 46, 47, and 49 of copending U.S. Application 19/172,371 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claims 1 and 8)
Claims 1, 2, 5, 8, 10, 11, 13-15, 21-23, 26, 27, 31, 34, 36, 37, 41, 44, and 48 of copending U.S. Application 18/778,430 (in Office Action mailed on 5/22/2026, claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 34)
Claims 1-3, 8, 11, 15, 16, 18, 22, 24, 26-31, 38, 43, 52, and 53 of copending U.S. Application 18/531,312 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 22)
Claims 1, 61, 62, 66, 67, 69-71, 73, 80, 85, 90, 91, 96, 97, 99-101, 103, 104 of copending U.S. Application 18/916,385 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 99)
Claims 1, 11-14, 16-21 of copending U.S. Application 19/025,586 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 11)
Claims 24-43 of copending U.S. Application 18/787,822 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 30)
Claims 1-20 of copending U.S. Application 18/450,219 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 8)
Claims 1-4, 6, 7, 9, 13, 16-27 of copending U.S. Application 19/025,613 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 9)
Claims 1-47 of copending U.S. Application 18/780,867 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 41)
Claims 1-23 of copending U.S. Application 18/468,097 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 22)
Claims 167-186 of copending U.S. Application 19/025,264 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 179)
Claims 1, 9, 11, 14-18, 24, 25, 27, 29, 33, 34, 41, 44, 52, 53, 67 of copending U.S. Application 19/199,098 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 41)
Claims 1, 15-17, 56, 57, 61, 64, 66, 72 of copending U.S. Application 17/599,433 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 64)
Claims 125, 126, 128-130, 132, 134-144 of copending U.S. Application 17/762,576 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 141)
Claims 21-29, 31-35, 37, 39, 41, 42, 44, 46-54 of copending U.S. Application 17/786,442 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 54)
Claims 93-111 of copending U.S. Application 18/841,061 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 111)
Claims 1-4, 8, 12, 18, 25, 28, 33, 39, 47, 48, 53, 68, 84, 88, 99, 103, 109, and 110 of copending U.S. Application 19/006,029 (in Office Action mailed on 5/22/2026; claims are drawn to methods of treatment comprising administration of ipilimumab, see claim 48(ii))
each in view of Weber et al. (supra) in view of Tipton et al. (supra) and Conejo-Garcia et al. (supra), as evidenced by Schadendorf et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new grounds of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention of each of the patents listed supra in view of Weber et al., Tipton et al., and Conejo-Garcia et al., as evidenced by Schadendorf et al., for the same reasons discussed in the 35 USC § 103 rejection supra.
Applicant’s arguments, filed 5/22/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons discussed for the 35 USC § 103 rejection supra, it would not have been obvious to combine the references. However, this has been found to be not persuasive for the reasons discussed in the 35 USC § 103 rejection supra. This is a provisional double patenting rejection.
Conclusion
No claim is allowed.
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 ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm EST.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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