DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 107-120 are pending upon entry of amendment filed on 2/11/26.
Applicant’s election of group I, claims 107-119 without traverse in the reply filed on 2/11/26 has been acknowledged.
Accordingly, claim 120 is withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claims 107-119 are under consideration in the instant application.
The instant application comprises one independent claim and the claimed invention relates a composition comprising a plurality of Risankizumab species with N-glycosylation and less than 5.4 % of Risankizumab has a high mannose N-glycan.
3. Applicant’s IDS filed on 7/22/25 and 2/6/26 have been acknowledged.
4. The oath filed on 4/25/25 has been acknowledged.
5. 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 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.
6. 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 of this title, 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.
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.
7. Claims 107-119 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2013/165791 (IDS reference) in view of Higel et al (European Journal of Pharmaceutics and Biopharmaceuticals, vol. 100, p. 94-100, 2016).
The ‘791 publication teaches IL-23p19 formulation including Risankizumab (p. 12, 40, 85) in CHO cells. As evidenced in p. 98 and 160, the antibody is produced in CHO and modification includes glycosylation. Further, the ‘791 publication teaches N-glycosylation and the necessary post-translational modification improves processing as well as modification to improve stability and accessibility (p. 94-96).
IN addition, the ‘791 publication teaches subcutaneous administrations of antibody at 150mg (p.20) and various additional administrations for completion of treatment (p. 21). The subsequent administration can be later than 2weeks (example 7) and readable upon limitation of claim 108 between 15days and 85 days.
The disclosure of the ‘791 publication differs from the instant claimed invention in that it does not teach the use of less than 5.4% of N-glycosylation have high mannose N-glycan as in claim 107-119 of the instant application.
Higel at al teach the use of N-glycosylation in modification of monoclonal antibody. The reference teaches N-glycosylation influences monoclonal antibody effector function (p. 94) and the conventional high mannose in N-glycosylation is M5, M6 and M7 and the presence of such mannose improve clearance (p. 96). In addition, Fig 3 of the reference teaches mean percentage of glycan level is under 1% and meets the limitation of claim 107, 112 and 116 of the instant application. The glycation level contributes to ADCC and effector function and the individual glycan analysis and approaches influences PK level (p.98).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize glycation level or percentage taught by Higel publications into the IL-23p19 antibody formulation taught by the ‘791 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of glycosylation level influences ADCC and effector function and glycan attributes to PK level of the administration of antibody. Glycosylation may attribute effector and clearance of drug and is controllable by the glycosylation profile.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
8. No claims are allowable.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
February 17, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641