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 .
Status of the Claims
Claims 1 – 9 were pending. Claim 10 has been newly added. Claims 1 – 10 are currently pending and are the subject of this Office Action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/13/2026 has been entered.
NEW REJECTIONS, NECESSITATED BY CLAIM AMENDMENTS
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly added claim 10 recites the method of treating CD according to claim 1, wherein the patient achieves steroid free remission. However, the specification as filed fails to support “wherein the patient achieves steroid free remission.”
The specification seems to describe a possible future study “[t]o evaluate the efficacy of treatment with mirikizumab compared to placebo in corticosteroid-free clinical remission” and lists criteria for such a study (Example 2: Clinical Study, pgs. 44 – 51). However, the results for such a study, especially results showing that a patent achieved steroid-free remission, do not appear to be included in the present specification. Thus, the limitations of claim 10 fails to find support in the present specification.
REJECTIONS MAINTAINED/MODIFIED
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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over D’HAENS (D’Haens, G.G.R. et al. OP38 Maintenance treatment with mirikizumab, a p19-directed IL-23 antibody: 52-week results in patients with moderately-to-severely active ulcerative colitis, Journal of Crohn's and Colitis, Volume 13, Issue Supplement_1, March 2019, Pages S026–S027; see PTO-892: Notice of References Cited of 12/18/2024) in view of NEURATH (Neurath, M F. IL-23 in inflammatory bowel diseases and colon cancer, Cytokine & Growth Factor Reviews, Volume 45, 2019, Pages 1-8; see PTO-892 of 12/18/2024).
The present application is directed to a method of treating moderately to severely active Crohn's Disease (CD) comprising administering mirikizumab to a patient in need thereof, said method comprising: a) administering three induction doses of mirikizumab to the patient by intravenous injection at about 4 week intervals, wherein each induction dose comprises about 900 mg of mirikizumab; and b) administering maintenance dose(s) of mirikizumab to the patient by subcutaneous injection at about 4 week or about 8 week intervals, wherein the first maintenance dose is administered about 4-8 weeks after the last induction dose is administered and wherein each maintenance dose comprises about 200 mg or about 300 mg of mirikizumab.
D’HAENS is directed to mirikizumab, a p19-directed IL-23 antibody, that demonstrated efficacy and was well-tolerated during 12 weeks of induction treatment in a Phase 2 randomised clinical trial (AMAC, NCT02589665) in the treatment of ulcerative colitis. Maintenance results through Week 52 from this trial are reported. See Abstract: Background. However, D’HAENS does not disclose the use of mirikizumab in the treatment of CD.
NEURATH is directed to the review of cytokine IL-23 in the pathogenesis of inflammatory bowel diseases (IBD: Crohn´s disease, ulcerative colitis) and colitis-associated colon cancer. Although D’HAENS’ method is directed to the treatment of ulcerative colitis, NEURATH discloses that the inflammatory bowel diseases Crohn’s and ulcerative colitis share a similar mechanism of pathogenesis, which is via IL-23 signaling and discloses that neutralizing antibodies against IL-23 p19 have been successfully used in clinical trials for therapy of Crohn´s disease. See Abstract .
Regarding claims 1 and 5, D’HAENS discloses a mirikizumab (miri) clinical trial for patients with moderately to severely active ulcerative colitis with induction treatment of intravenous (IV) placebo (N = 63), miri 50 mg (N = 63) or 200 mg (N = 62) with possibility of exposure-based (EB) dose increases, or fixed miri 600 mg (N = 61) every 4 weeks (Q4W), with efficacy assessment at Week 12. See title and Abstract: Methods. D’HAENS further teaches that patients who achieved a clinical response to miri at Week 12 went into a maintenance period where they received miri at 200 mg subcutaneously (SC) Q4W (N = 47) or every 12 weeks (Q12W; N = 46), and were treated through Week 52. See title and Abstract: Methods.
Regarding the administration of three induction doses of mirikizumab of about 900 mg each, because D’HAENS discloses an induction dose of up to 600 mg, it would have been obvious to one having ordinary skill in the art to optimize the treatment method by adding induction doses at different amounts such as 900 mg or increasing amounts of mirikizumab by the common practice of dose escalation. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”. See MPEP 2144.05 (I) and (II).
Because NEURATH discloses that both Crohn´s disease and ulcerative colitis are inflammatory bowel diseases (IBD) that involve IL-23, specifically the p19 subunit of IL-23 (which is what is targeted by mirikizumab) and both NEURATH and D’HAENS disclose that mirikizumab may be the future of ant-IL-23 therapy in IBD patients, it would have been obvious to come to a method of treating Crohn’s disease comprising administering mirikizumab according to the steps of present claim 1 by routine optimization. There would have been a reasonable expectation of success given that mirikizumab has been known to successfully treat inflammatory bowel diseases such as CD as evidenced by the applied prior art.
At the effective filing date of the present claims, it would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of D’HAENS and NEURATH. The artisan would have been motivated to use the method of claim 1 because D’HAENS teaches data demonstrating that a p19-directed IL-23 antibody mirikizumab may be an effective treatment as maintenance therapy in patients with moderately-to-severely active UC and NEURATH that like UC, Crohn’s disease involves IL-23p19 and antibodies against IL-23 p19 have been successfully used in clinical trials for therapy of Crohn´s disease. The artisan would have a reasonable expectation of success from the teachings of D’HAENS and NEURATH.
Regarding claim 6, D’HAENS teaches that patients who achieved a clinical response to miri at Week 12 were re-randomised 1:1 into a double-blind maintenance period to receive miri 200 mg subcutaneously (SC) every 4 weeks (Q4W). See Methods, first paragraph.
Regarding claim 7, D’HAENS teaches an induction period that included a fixed miri 600 mg (N = 61) every 4 weeks (Q4W). See Methods, first paragraph.
Regarding claim 8, D’HAENS discloses 12 weeks of induction treatment (see abstract) with administration every four weeks. See Methods, first paragraph.
Regarding claim 9, because D’HAENS did not teach that the patients were biologic-failed, the patients are assumed to not be biologic-failed.
Regarding claim 10, it is noted that a wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04. Alternatively, given that the method suggested by the prior art comprises the same method steps as claimed in the instant invention, the method suggested by the prior art will be a method wherein the patient achieves steroid free remission.
Response to Arguments
On p. 4, under “A. PRIOR ART QUALIFICATION - D'HAENS AND SANDBORN ARE NOT PRIOR ART UNDER 35 U.S.C. § 102(b)(1)(A)”of the reply of 03/25/2026, Applicant argues that D'HAENS and SANDBORN are not prior art because they fall within the exceptions set forth in 35 U.S.C. § 102(b)(1)(A). Although the D'HAENS reference names J. Tuttle and S. Friedrich as authors of in the reference, it also names G. Geert R. D’Haens, W. J. Sandborn, M. Ferrante, B. R. Bhandari, E. Berliba, T. Hibi, J. B. Canavan, M. Durante, V. Arora, B. Feagan as co-authors. Thus the D'HAENS reference has different authorship than the present application which names Stuart William Friedrich, Paul Frederick Pollack, and Jay Lawrence Tuttle as the inventive entity, and the exception under 35 U.S.C § 102(b) does not apply in this instant case.
However, "Applicant may establish that the AIA 35 U.S.C. 102(b)(1)(A) exception applies by way of an affidavit or declaration under 37 CFR 1.130(a). MPEP § 2155.01 discusses the use of affidavits or declarations to show that a disclosure was an inventor-originated disclosure made during the grace period." See MPEP 2153.01(a). Thus, the 103 rejections of the claims over D’HAENS in view of NEURATH or D’HAENS in view of NEURATH and BRODMERKEL and the double patenting rejections of claims 1 - 5 in view of D’HAENS and NEURATH are maintained.
Regarding the SANDBORN reference, it was not been applied in any outstanding rejection. SANDBORN was introduced by Applicant in the reply of 06/17/2025 to the Non-Final Office Action of 12/18/2024. References to SANDBORN in the Final Office Action of 09/25/2025 were only to address Applicant's remarks in the reply of 06/17/2025. SANDBORN has not been applied in a rejection of a pending claim in the present application.
On p. 8, last paragraph, of the reply, Applicant argues that "[a]lthough UC and CD are both inflammatory bowel diseases, the demonstrated reversal in mirikizumab dose- response behavior between these indications confirms they are pharmacologically distinct for purposes of the claimed dosing regimen - a distinction that is at least as material as the anatomical distinction between psoriasis and CD. The same principle applies here. This opposite dose-response profile across the UC and CD indications further supports the conclusion that disease indication is material to the ODP analysis, and that UC and CD are not interchangeable indications for purposes of the present claims."
Applicant's argument has been considered but not found persuasive because NEAURATH teaches that "studies on p19 blockade in both CD and UC patients are currently being conducted (e.g. with the p19 neutralizing antibodies risankizumab, brazikumab, mirikizumab, or guselkumab)" (see p. 6, right column, last sentence). Thus, at the effective filing date of the present application, it was obvious to use mirikizumab on CD patients. Furthermore, D'HAENS renders the claimed mirikizumab regimen obvious for the reasons of record and as discussed above.
Claims 2 – 4 are rejected under 35 U.S.C. 103 as being unpatentable over D’HAENS in view of NEURATH as applied to claims 1 and 5-10 above and further in view of (US 2019/0292265 A1, filed 08/17/2017; see PTO-892 of 12/18/2024).
The teachings of D’HAENS and NEURATH with regard to claim 1, from which claims 2 – 4 depend, are discussed above and are fully incorporated here. Although D’HAENS in view of NEURATH renders independent claim 1, from which claims 2 – 4 depend from, neither D’HAENS nor NEURATH expressly teaches the limitations of claims 2 – 4.
BRODMERKEL is directed to methods for treating Crohn's Disease with an antibody that binds NKG2D. See abstract. Although BRODMERKEL does not disclose the use of mirikizumab, BRODMERKEL discloses other conventional treatments for Crohn’s disease and discloses the treatment of Crohn’s with an antibody when other conventional treatments have failed. See abstract and ¶¶ 0228-0229.
According to the present specification, "conventional-failed" refers to patients who have an inadequate response to, loss of response to, or are intolerant to at least one of the following medications: 5-aminosalicylic (ASA) compounds; corticosteroids; AZA, 6-MP, or methotrexate (MTX) or CD-specific antibiotics (p. 16); "biologic experienced" refers to patients that have been administered a biologic for example, an anti-TNF-a antibody, for the treatment of CD, in particular, for the treatment of moderate to severe CD (p. 15); and "biologic-failed" refers to patients that have been administered a biologic, for example, an anti-TNF-a antibody, for the treatment of CD, in particular, for the treatment of moderate to severe CD (p. 15). Although D’HAENS and NEURATH discloses the treatment of Crohn’s disease with mirikizumab, they do not disclose much detail about other conventional treatments for Crohn’s disease. However, BRODMERKEL discloses these other treatments.
Regarding claims 2 – 4, BRODMERKEL discloses that “subjects in these studies must have previously failed or been intolerant to 1 or more approved biologic agents (i.e., TNFα-antagonists or vedolizumab, hereafter referred to as biologic intolerant or refractory subjects) or have demonstrated an inadequate response to or failed to tolerate corticosteroids or immunomodulators (i.e., 6-mercaptopurine [6-MP], azathioprine [AZA], and MTX) . . .”. See Example 5: Participants, paragraph [0296].
Because D’HAENS and NEURATH discloses mirikizumab for the treatment of Crohn’s disease and renders the method of claim 1, from which claims 2 – 4 depend, obvious as discussed above, and BRODMERKEL discloses the conventional treatments of Crohn’s disease and how an antibody treatment may be used in subjects that were intolerant to other conventional treatments, it would have been obvious to try mirikizumab in patients who are conventional-failed, biologic-experienced, or biologic-failed to arrive at the inventions of claims 2 – 4, respectively. There would have been a reasonable expectation of success given that some patients have been known to be intolerant to some of the conventional treatments for CD and given that mirikizumab has been known to successfully treat inflammatory bowel diseases such as CD, as evidenced by the applied prior art.
Response to Arguments
On page 7, last paragraph – p. 8, first paragraph, Applicant argues that “BRODMERKEL is directed to methods of treating CD with an antibody targeting NKG2D - an entirely different molecular target from IL-23p19 targeted by mirikizumab - and provides no teaching regarding mirikizumab dosing, IL-23 pathway biology, or the PK/PD considerations relevant to optimizing a mirikizumab dose regimen. Its sole contribution to the combination is the proposition that conventional-failed and biologic-experienced/-failed patient populations are known in CD treatment. That narrow teaching cannot cure the absence of any prior art basis for the claimed mirikizumab dosing regimen. Accordingly, the rejection of claims 2-4 should be withdrawn.”
Applicant’s arguments have been considered but not found persuasive because D’HAENS and NEURATH teaches the use of mirikizumab in treating CD, as discussed above, and BROMERKEL is cited to show that treating patients that are conventional-failed, biologic-experienced, and biologic-failed as recited in present claims 2 – 4, respectively, are known in the treatment of Crohn’s Disease. Thus, D’HAENS in view NEURATH and BRODMERKEL renders claims 2 – 4 obvious.
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 – 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 129 – 154 of copending Application No. 18/917,597 in view of D’HAENS and NEURATH.
Copending claim 129 recites a method of treating ulcerative colitis (UC) comprising administering to a patient in need thereof an anti-IL-23p 19 antibody, said method comprising: a) administering at least one induction dose of the anti-IL-23p 19 antibody to the patient, wherein the induction dose comprises 50 mg to 1200 mg of the antibody; and b) administering at least one maintenance dose(s) of the anti-IL-23p19 antibody to the patient after the last induction dose is administered, wherein the maintenance dose comprises 150 to 400 mg of the anti-IL-23p 19 antibody.
The main difference between present claims and the copending claims is that the present claim is directed to the treatment of Crohn’s disease while the copending claim is directed to the treatment of UC. However, NEURATH discloses that “[c]onsistently, neutralizing antibodies against IL-12/IL-23 p40 and IL-23 p19 have been successfully used in clinical trials for therapy of Crohn´s disease and pilot studies in ulcerative colitis are ongoing.”. See Abstract. The teachings of D’HAENS and NEURATH, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. 103 above. D’HAENS discloses the induction doses/intervals and maintenance dose as discussed above.
Because the copending claim discloses the treatment of UC with an anti-IL-23p 19 antibody, NEURATH discloses that UC and Crohn’s disease may both be treated with an anti-IL-23p 19 antibody, and D’HAENS discloses the treatment regimen and doses, it would have been obvious to use the anti-IL-23p 19 antibody of the copending claim to treat Crohn’s disease as claimed in the present application.
Regarding claim 10, it is noted that a wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04. Alternatively, given that the method suggested by the co-pending claims and D’HAENS and NEURATH comprises the same method steps as claimed in the instant invention, the method suggested by the co-pending claims and D’HAENS and NEURATH will be a method wherein the patient achieves steroid free remission.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
On page 8 of the reply, Applicant argues that ‘[t]he Office Action's Own Withdrawal of the Psoriasis ODP Further Supports Withdrawal Here: The Examiner withdrew the ODP rejection over copending Application No. 17/275,027 (psoriasis) because ‘Psoriasis is not closely related to CD.’ Office Action at 12. Although UC and CD are both inflammatory bowel diseases, the demonstrated reversal in mirikizumab dose- response behavior between these indications confirms they are pharmacologically distinct for purposes of the claimed dosing regimen - a distinction that is at least as material as the anatomical distinction between psoriasis and CD. The same principle applies here. This opposite dose-response profile across the UC and CD indications further supports the conclusion that disease indication is material to the ODP analysis, and that UC and CD are not interchangeable indications for purposes of the present claims. The ODP rejection therefore fails both because D'HAENS is disqualified and because the remaining evidence undermines the Office Action's rationale.”
Applicant’s argument is not persuasive because, although the cited references do not teach similarities between psoriasis and CD (thus the withdrawal of the double patenting rejection of copending application 17/275,027, which is directed to the treatment of psoriasis), NEURATH teaches the similarities of UC and CD and that “neutralizing antibodies against IL-12/IL-23 p40 and IL-23 p19 [such as mirikizumab] IL-23 p19 have been successfully used in clinical trials for therapy of Crohn´s disease and pilot studies in ulcerative colitis are ongoing.” See NEURATH at Abstract. Thus, the copending claims in view of D’HAENS and NEURATH render the present claims obvious.
Conclusion
Claims 1 – 10 are rejected.
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.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/PETER J REDDIG/Primary Examiner, Art Unit 1646
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