Prosecution Insights
Last updated: April 18, 2026
Application No. 18/306,958

MULTISPECIFIC ANTIBODIES TARGETING IL-13 AND IL-18

Non-Final OA §103§DP
Filed
Apr 25, 2023
Examiner
O'BRIEN, LEA S
Art Unit
1646
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Novartis AG
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
3y 0m
To Grant
58%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allow Rate
16 granted / 32 resolved
-10.0% vs TC avg
Moderate +8% lift
Without
With
+8.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
17 currently pending
Career history
49
Total Applications
across all art units

Statute-Specific Performance

§101
6.5%
-33.5% vs TC avg
§103
29.9%
-10.1% vs TC avg
§102
10.6%
-29.4% vs TC avg
§112
26.2%
-13.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 32 resolved cases

Office Action

§103 §DP
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. Restrictions/Elections Applicant’s election of Group I (Claims 1-24 and 46) without traverse filed March 06 , 202 6 is acknowledged. Status of the Claims Claims 1 , 4- 24 , and 46 are currently pending and are the subject of this Office Action and are under consideration. This is the first Office Action on the merits of the claims. IDS The references cited on the information disclosure statement(s) were considered and have been made of record. Priority T he effective filing date of the claims is deemed the filing date of the provisional application (i.e., 63334964 ), namely April 26 , 20 22. 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 , 4- 24 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Terada , Bardroff 2014 , and in further view of Bardroff 2018 and Dall'Acqua Wu discloses bispecific antibod ies directed to IL-13 and IL-17 comprising the anti-IL 13 antibody designated lebrikizumab , which comprises heavy and light chain variable region sequences that share 100% id. with instant SEQ ID Nos: 55 and 27 (see Wu ; compare id. of disclose d SEQ ID N O s: 11 and 12 with instant SEQ ID N O s: 55 and 27 respectively; reads on the anti-IL-13 CDR and variable regions sequences set forth in instant claim s 1 .b., 6.a., 7.a., 7.b., 8) . Said bispecific antibody constructs are used in treatment of inflammation (e.g. asthma). Wu further discloses the following: wherein the first light chain is of lambda type, and the second light chain is of kappa type (see Wu, e.g., claims 9, 31 ; see also at para [00132], [00 144 ]; reads on instant claim 4 ) ; wherein the bispecific antibody further comprises IgG1 heavy chains with the hetero-dimerization modifications set forth in instant claim 10 (see Wu, e.g., at para [0040] , [0085] to [0088] ; reads on instant claim 10) ; a pharmaceutical formulation comprising the antibody and a pharmaceutically acceptable carrier (see Wu, e.g., at claim 60 and para. [00390]; reads on instant claim 17) ; the pharmaceutical formulation further comprising one or more additional active agents (see Wu, e.g., at para. [00424]; reads on instant claim 1 8 ) ; an isolated nucleic acid molecule encoding the antibody as well as cloning vectors, host cells, methods of producing, kits, and conjugates comprising said antibody (see Wu, e.g., at claims 32-57; see also para. [00145], [ 00380] to [00385], [00432] ; reads on instant claim s 1 9-24 and 46 ) ; The prior art of Wu differs from the instantly claimed invention as follows: Wu does not expressly disclose the IL-18 antibody sequences and all Fc region mutations . Terada teaches the involvement of both IL-18 and IL-13 are in the development of atopic dermatitis, that IL-18 induces production of IL-13 by Th1 cells, and that b lockade of IL-18 prevented AD development, whereas blockade of IL-3 partially prevented AD development (see Terada , e.g., at abstract and discussion ). Bardroff 2014 discloses the anti-IL 18 antibody designated , MOR9464 , which comprises heavy and light chain variable regions that share 100% id. with instant SEQ ID Nos: 41 and 13 used in the present application (see Bardroff 2014; compare id. of disclosed SEQ ID Nos: 14 and 16 to instant SEQ ID Nos: 41 and 13, respectively). Said antibody is used in the treatment of inflammatory diseases, e.g. asthma ( see Bardroff 2014, e.g., at claims 50-51; see also p. 100 I ine 9 to p . 103 I ine . 4). Furthermore, bispecific antibodies are described ( see Bardroff 2014, e.g., at p. 66 I ine 8 to p . 69 I ine 2). ( R eads on the anti-IL-18 CDR and variable regions sequences set forth in instant claim s 1 .a., 6.b., 7.c., 7.d. ) . Bardroff 2018 discloses anti-IL 18/IL - 1b bispecific antibody constructs comprising the anti- I L-18 antibody , designated MOR9464 , used in the treatment of inflammasome-related disorders (see Bardroff 2018, e.g., at p. 8 Iines 16-33) , wherein the antibody comprise s F c modifications that increa se half-life ( see, e.g., p. 31 I ines 9-15) and increasing heterodimerization ( see, e.g., p. 34 I ine 13 to p . 40 I ine 28) , and wherein the first variable light chain is of lambda 1 type, and the second variable light chain is of kappa 4 type ( see, e.g., claim 1; see also at p. 10 to 12 ) . ( Reads on instant claims 4-5 and 8 -1 6 ). Dall'Acqua discloses introducing the YTE mutation to improve half-life ( see, e.g., abstract, claim 1 ) . (Reads on instant claim 12 -16 ). Obviousness Analysis: Regarding claims 1, 4-7, 17-24 and 46 , it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than: the s imple substitution of one known element for another (e.g., the anti-IL-18 antibody of Bordoff 2014 for the anti-IL-17 antibody of Wu ) to obtain predictable result s (e.g., to develop a bispecific antibody directed to IL-13 and IL-18, as both cytokines are involved in the development and pathogenesis of atopic dermatitis) ( s ee MPEP 2143(I)( B ), (G)) ; and c ombining the prior art elements of the cited references , as the teachings of Terada suggest the implications of cytokines, IL-18 and IL-13, in the development and pathogenesis of atopic dermatitis ( see MPEP 2143(I) (A) , (G )). Furthermore, i t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose (e.g., combining anti-IL-13 antibody sequences with those of an anti-IL-18 antibody to develop a bispecific antibody that targets both cytokines, as the blockade of cytokines IL-13 and IL-18 is known in the art to prevent the development and pathogenesis of atopic dermatitis) . [T]he idea of combining them flows logically from there having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) . See MPEP 2144.05 (II). Regarding claims 8-16 , it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than: u se of known technique (e.g., Fc region mutations known in the art to improve half-life and heterodimerization) to improve similar products (the bispecific antibody directed to IL-13 and IL-18, rendered obvious by the prior art above) in the same way ( see MPEP 2143(I) (A), ( C ), (G) ) . Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the composition of the present invention , as the prior art references cited above provides support and motivation for doing so, as discussed above . Accordingly, claims 1 , 4- 24 and 46 are rejected. Claim Rejections - 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. Copending Application No. 18/859,970 ( unpublished application ) Claims 1, 4-24, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No. 18/859,970 (reference application ) . Although the claims at issue are not identical, they are not patentably distinct from each other as described below. This is a provisional nonstatutory double patenting rejection. Claim interpretation: The applicable claim interpretation has been set forth in a preceding Office Action, s ection , and/or rejection above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below. Legal Analysis: MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an anticipation analysis . Anticipation analysis: Regarding instant claim s 1, 4-24, and 46 , the reference application explicitly claims a multispecific antibody directed to IL-18 and IL-13, comprising the same sequences of the present application, as well as the same Fc region mutations, method of making, and compositions of the present application ( see reference claim s 1-43 ; compare id. with instant claim s 1, 4-24, and 46; also compare SEQ ID NOs claimed in both applications, i.e., compare id. of reference SEQ ID NOs: 32-40 with instant SEQ ID NOs: 32-40, etc. ). Accordingly, the instant claims are not patentably distinct relative to the reference claims. Conclusion Claims 1-24 and 46 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Enter examiner's name" \* MERGEFORMAT LEA S O'BRIEN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4793 . The examiner can normally be reached FILLIN "Work schedule?" \* MERGEFORMAT Monday - Thursday 9:00 AM to 6:00 PM PT . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached on (571) 272-8149 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LEA S O'BRIEN/ Examiner, Art Unit 1646 /MARK HALVORSON/ Primary Examiner, Art Unit 1646
Read full office action

Prosecution Timeline

Apr 25, 2023
Application Filed
Feb 24, 2025
Response after Non-Final Action
Mar 31, 2026
Non-Final Rejection — §103, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
50%
Grant Probability
58%
With Interview (+8.3%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 32 resolved cases by this examiner. Grant probability derived from career allow rate.

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