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 .
Response to Arguments
Applicant's arguments, filed June 22, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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, 4-9, 40-47, 50, 52, 54, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Seth et al. (WO 2019 027973) in view of Rudensky et al. (US 2019 0092875).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 28, 2026 and those set forth herein.
Regarding new claim 50, Seth discloses that the method can be uses to treat tumors epithelium in colorectal adenocarcinoma (¶ 9) and that the monoclonal antibody can be labeled with 225Ac (claim 1). Regarding new claim 52, Seth discloses that the subject can be a mammal such as a human (¶ 47). Regarding new claims 54 and 55, Seth discloses that the monoclonal antibody can be first conjugated with a p-SCN-Bn-DOTA (para-isothiocyanatobenzyl-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) chelating agent, followed by chelation of 225Ac by the p-SCN-Bn-DOTA on the conjugated antibody to form the radiolabeled antibody (¶ 86).
Applicant argues that the radiolabel is supplied only by hindsight because Rudensky neither discloses nor suggests radiolabeling an anti-CCR8 (chemokine C-C motif receptor 8) antibody and that element is drawn solely from Seth’s anti-CD38 (cluster of differentiation 38) platform. Applicant argues that Seth's lone mention of anti-CTLA-4 (cytotoxic T-lymphocyte associated protein 4) lists it among generic additional immunosuppressive and/or immunomodulatory agents, untethered to any CCR8-directed therapy, and supplies no motivation to assemble the specific claimed combination.
This argument is unpersuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. As discussed in the Office Action mailed April 28, 2026, it would have been obvious to a person of ordinary skill in the art (POSITA) before the effective filing date of the claimed invention to modify the cancer treating method of Seth by substituting its CD38 targeting agent with the CCR8 targeting agent of Rudensky for radioimmunotherapy directed to CCR8. A POSITA would have been motivated to make these modifications and reasonably would have expected success because Rudensky teaches that an effective amount of the CCR8 targeting agent can be used to selectively deplete tumor-infiltrating regulatory T cells (Tregs) and to enhance antitumor immunity. Further, a POSITA would have been motivated to use a radiolabeled CCR8 targeting agent in order to improve therapeutic efficacy and expand the scope of radioimmunotherapy applications. Substituting one target-specific antibody for another known antibody in the art (replacing CD38-targeting with CCR8-targeting) represents a simple substitution of known elements to achieve predictable results. Because both CD38 and CCR8 targeting agents operate within the same technical field, immunotherapy and targeted radionuclide therapy, a POSITA seeking to enhance target specificity and therapeutic efficacy would routinely combined or substitute known target antibody. Regarding Applicant’s argument of Seth’s lone mention of anti-CTLA-4, Seth discloses that an inhibitor of a negative T cell regulator such as an antibody against CTLA 4 can be used as an additional immunosuppressive and/or immunomodulatory agent (¶ 113) as discussed in the Office Action mailed April 28, 2026. The fact that it would have been equally obvious to use other immunosuppressive and/or immunomodulatory agents from Seth does not make the use of anti-CTLA-4 any less obvious. Furthermore, the administration of immune checkpoint inhibitors such as anti-CTLA-4 antibodies was already known in the art as a standard strategy to enhance T-cell-mediated antitumor activity. A POSITA seeking additional ways to enhance antitumor immune responses would have been motivated to combine this immunomodulatory approach using CTLA-4 antibody with the CCR8-directed therapy, as both target Tregs to overcome tumor immunosuppression. Because both references address the same biological pathway and therapeutic goal, combining these teachings represents nothing more than the predictable application of known immunomodulatory strategies.
Applicant argues that there was no reasonable expectation of success in substituting CCR8 for CD38 because these are differ in kind between the two targets, and that the art gave no reasonable expectation that Seth’s CD38 results would translate to CCR8 target in solid tumors.
This argument is unpersuasive. Obviousness does not require absolute expectation of success, but merely a reasonable expectation of success. Because both CD38 and CCR8 are known surface markers expressed on Tregs within solid tumor microenvironments, a POSITA would have had a reasonable expectation that targeting CCR8 with a radiolabeled agent would successfully deplete tumor-infiltrating Tregs and enhance antitumor immunity, just as taught for CD38 in Seth and for CCR8 in Rudensky. Accordingly, the modification yields predictable therapeutic utility, and Applicant’s argument fails to establish non-obviousness.
Applicant argues that objective evidence of unexpected synergy rebuts the alleged prima facie case. Applicant argues that Frank (publication after Applicant’s filing) demonstrates the combined radioimmunotherapy shows greater-than-additive efficacy, confirming an advantageous property flowing from the combination therapy the application discloses.
This argument is unpersuasive. Applicant 225AC-anti-CD38 radioimmunotherapy combined with anti-CTLA-4). Anti-CTLA-4 immunotherapy alone is not the closet prior art. The evidence of unexpected results must involve a direct, side-by-side comparison between the claimed invention and the closest prior art. Without a direct comparison showing that the actual performance of the claimed compound is significantly better that what would be predicted from a simple additive effect of Seth and Rudensky. Further, the results are not commensurate in scope with the claims. To effectively rebut a rejection of obviousness, the disclosure or evidence of unexpected results must be commensurate in scope with the claims to which the evidence is applied. Broad claims 1 and 42 encompass a wide genus of solid cancers, mammalian subjects, and radiolabels. However, Applicant’s arguments rely on narrow, specific examples such as 225Ac-labeled CCR8 antibody in murine colorectal adenocarcinoma cell lines. The limited experimental data does not establish that the entire claimed genus would exhibit the same allegedly unexpected properties. Accordingly, because the combination of teachings to substitute one known element for another would have been obvious to a POSITA, and because the Applicant has not provided sufficient objective evidence to demonstrate unexpected results, the rejection is maintained.
Claims 3, 48, 49, 51, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Seth and Rudensky as applied to claims 1, 2, 4-9, 40-47, 50, 52, 54, and 55 above, and further in view of Derer et al. (Frontiers in Immunology, 2015).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 28, 2026 and those set forth herein.
Regarding new claims 51 and 53, Derer discloses that Ipilimumab can be used as a checkpoint inhibitor antibody against CTLA-4 (page 7, Table 1).
Applicant argues that these claims depend from or are parallel to the claims shown nonobvious over Seth and Rudensky, and Seth and Rudensky fail for the same reasons set forth above while Derer fails to cure deficiencies of Seth and Rudensky. Applicant argues that Derer is silent as to CCR8, Treg-directed radioimmunotherapy, and antibody radioconjugates, and does not provide missing motivation or a reasonable expectation of success. Applicant argues that none of Seth, Rudensky, or Derer teaches CCR8+ Treg depletion that is not mediated by ADCC.
This argument is unpersuasive. Applicants traverse this rejection on the grounds that Derer does not cure the deficiencies of Seth and Rudensky. As discussed in greater detail above, Seth and Rudensky are not deficient as alleged by Applicant so Derer is not required to cure those deficiencies. Regarding Applicant’s assertion that no reference explicitly teaches non-ADCC mediated depletion, Derer discloses that radiotherapy can locally destroy tumors by inducing non-immunological DNA damage in tumor cells, which reads on the depletion or ablation of Treg cells via a mechanism not mediated by ADCC, as discussed in the Office Action mailed December 5, 2025. Further, Applicant’s attempt to patent a specific biological pathway (non-ADCC mechanism) does not impart patentability to an otherwise obvious structural combination (radioconjugate targeting CCR8 and an immune checkpoint therapy comprising an antibody against CTLA-4), as a functional limitation or mechanism-of-action designation cannot patentably distinguish an obvious chemical structure or physical process. Accordingly, the combination of Seth, Rudensky, and Derer renders the claimed subject matter obvious and Applicant’s arguments fail to overcome the rejection.
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.
Applicant argues that each of the six provisional rejections reaches the pending claims only by combining the reference application's claims with the same Seth, Rudensky, and Derer art addressed above. Applicant argues that every instance the CCR8 limitation is imported wholesale from those references. Applicant argues that the same analysis establishes that the pending claims are patentably distinct from each set of reference can be applied.
This argument is unpersuasive. As discussed above, Seth, Rudensky, and Derer renders instant claims obvious. As discussed in in the Office Action mailed April 28, 2026, claims of copending applications reads on several instant claims, and claims of copending applications in combination with the prior art render remaining instant claims obvious.
Claims 1-9 and 40-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 16/627,872 in view of Seth et al. (WO 2019 027973), Rudensky et al. (US 2019 0092875), and Derer et al. (Frontiers in Immunology, 2015).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 28, 2026 and those set forth herein.
Regarding new claims 50-55, the claims of the ‘872 do not recite colorectal cancer, human subject, p-SCN-Bn-DOTA, and Ipilimumab.
As discussed in in the Office Action mailed April 28, 2026, Seth discloses that the subject can be a mammal such as a human (¶ 47). Seth discloses that the method can be used to treat tumors epithelium in colorectal adenocarcinoma (¶ 9). Seth discloses that the monoclonal antibody can be first conjugated with a p-SCN-Bn-DOTA chelating agent, followed by chelation of 225Ac by the p-SCN-Bn-DOTA on the conjugated antibody to form the radiolabeled antibody (¶ 86). Derer discloses that Ipilimumab can be used as a checkpoint inhibitor antibody against CTLA-4 (page 7, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘872 as taught by Seth and Derer to arrive at the instantly claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Seth teach that such modifications can be applied to improve radioimmunotherapy. Accordingly, applying the teachings of Seth to the method of the ‘872 constitutes no more than the predictable use of prior art elements according to their established functions.
Claims 1-9 and 40-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 17/293,663 in view of Seth et al. (WO 2019 027973), Rudensky et al. (US 2019 0092875), and Derer et al. (Frontiers in Immunology, 2015).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 28, 2026 and those set forth herein.
Regarding new claims 50-55, the claims of the ‘663 do not recite colorectal cancer, human subject, p-SCN-Bn-DOTA, and Ipilimumab.
As discussed in in the Office Action mailed April 28, 2026, Seth discloses that the subject can be a mammal such as a human (¶ 47). Seth discloses that the method can be uses to treat tumors epithelium in colorectal adenocarcinoma (¶ 9). Seth discloses that the monoclonal antibody can be first conjugated with a p-SCN-Bn-DOTA chelating agent, followed by chelation of 225Ac by the p-SCN-Bn-DOTA on the conjugated antibody to form the radiolabeled antibody (¶ 86). Derer discloses that Ipilimumab can be used as a checkpoint inhibitor antibody against CTLA-4 (page 7, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘663 as taught by Seth and Derer to arrive at the instantly claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Seth teach that such modifications can be applied to improve radioimmunotherapy. Accordingly, applying the teachings of Seth to the method of the ‘663 constitutes no more than the predictable use of prior art elements according to their established functions.
Claims 1-9 and 40-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 17/532,919 in view of Seth et al. (WO 2019 027973), Rudensky et al. (US 2019 0092875), and Derer et al. (Frontiers in Immunology, 2015).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 28, 2026 and those set forth herein.
Regarding new claim 50, claim 9 of the ‘919 recites that the solid cancer can be a colorectal cancer, and claim 2 of the ‘919 recites that the radionuclide can be 225Ac.
Regarding new claims 51-55, the claims of the ‘919 do not recite human subject, p-SCN-Bn-DOTA, and Ipilimumab.
As discussed in in the Office Action mailed April 28, 2026, Seth discloses that the subject can be a mammal such as a human (¶ 47). Seth discloses that the monoclonal antibody can be first conjugated with a p-SCN-Bn-DOTA chelating agent, followed by chelation of 225Ac by the p-SCN-Bn-DOTA on the conjugated antibody to form the radiolabeled antibody (¶ 86). Derer discloses that Ipilimumab can be used as a checkpoint inhibitor antibody against CTLA-4 (page 7, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘919 as taught by Seth and Derer to arrive at the instantly claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Seth teach that such modifications can be applied to improve radioimmunotherapy. Accordingly, applying the teachings of Seth to the method of the ‘919 constitutes no more than the predictable use of prior art elements according to their established functions.
Claims 1-9 and 40-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/012,740 in view of Seth et al. (WO 2019 027973), Rudensky et al. (US 2019 0092875), and Derer et al. (Frontiers in Immunology, 2015).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 28, 2026 and those set forth herein.
Regarding new claim 52, claim 15 of the ‘740 recites that the subject can be human.
Regarding new claims 51, 51 and 53-55, the claims of the ‘740 do not recite colorectal cancer, p-SCN-Bn-DOTA, and Ipilimumab.
As discussed in in the Office Action mailed April 28, 2026, Seth discloses that the method can be uses to treat tumors epithelium in colorectal adenocarcinoma (¶ 9). Seth discloses that the monoclonal antibody can be first conjugated with a p-SCN-Bn-DOTA chelating agent, followed by chelation of 225Ac by the p-SCN-Bn-DOTA on the conjugated antibody to form the radiolabeled antibody (¶ 86). Derer discloses that Ipilimumab can be used as a checkpoint inhibitor antibody against CTLA-4 (page 7, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘740 as taught by Seth and Derer to arrive at the instantly claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Seth teach that such modifications can be applied to improve radioimmunotherapy. Accordingly, applying the teachings of Seth to the method of the ‘740 constitutes no more than the predictable use of prior art elements according to their established functions.
Claims 1-9 and 40-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/392,556 in view of Seth et al. (WO 2019 027973), Rudensky et al. (US 2019 0092875), and Derer et al. (Frontiers in Immunology, 2015).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 28, 2026 and those set forth herein.
Regarding new claim 50, claim 5 of the ‘556 recites that the solid cancer can be colorectal carcinoma, and claim 2 of the ‘556 recites that the radionuclide can be 225Ac.
Regarding new claim 52, claim 3 of the ‘556 recites that the subject can be human.
Regarding new claims 51 and 53-55, the claims of the ‘556 do not recite p-SCN-Bn-DOTA and Ipilimumab.
As discussed in in the Office Action mailed April 28, 2026, Seth discloses that the monoclonal antibody can be first conjugated with a p-SCN-Bn-DOTA chelating agent, followed by chelation of 225Ac by the p-SCN-Bn-DOTA on the conjugated antibody to form the radiolabeled antibody (¶ 86). Derer discloses that Ipilimumab can be used as a checkpoint inhibitor antibody against CTLA-4 (page 7, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘556 as taught by Seth and Derer to arrive at the instantly claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Seth teach that such modifications can be applied to improve radioimmunotherapy. Accordingly, applying the teachings of Seth to the method of the ‘556 constitutes no more than the predictable use of prior art elements according to their established functions.
Claims 1-9 and 40-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/685,667 in view of Seth et al. (WO 2019 027973), Rudensky et al. (US 2019 0092875), and Derer et al. (Frontiers in Immunology, 2015).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 28, 2026 and those set forth herein.
Regarding new claim 50, claim 5 of the ‘667 recites that the cancer can be colorectal cancer, and claim 1 of the ‘667 recites that the radionuclide can be 225Ac.
Regarding new claim 52, claim 22 of the ‘667 recites that the subject can be human.
Regarding new claims 54 and 55, claim 30 of the ‘667 recites that the radiolabeled phosphatidylserine targeting agent can comprise a conjugate of the antibody with p-SCN-Bn-DOTA
Regarding new claims 51 and 53, the claims of the ‘667 do not recite Ipilimumab.
As discussed in in the Office Action mailed April 28, 2026, Derer discloses that Ipilimumab can be used as a checkpoint inhibitor antibody against CTLA-4 (page 7, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘667 as taught by Derer to arrive at the instantly claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Seth teach that such modifications can be applied to improve radioimmunotherapy. Accordingly, applying the teachings of Seth to the method of the ‘667 constitutes no more than the predictable use of prior art elements according to their established functions.
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 JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 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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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Nissa M Westerberg/Primary Examiner, Art Unit 1618
Prosecution Insights