Prosecution Insights
Last updated: April 19, 2026
Application No. 18/027,763

COMPOSITIONS AND METHODS FOR TREATING AND/OR PREVENTING AUTOIMMUNE DISORDERS

Final Rejection §112
Filed
Mar 22, 2023
Examiner
MILLER, DALE R
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Regents of the University of Michigan
OA Round
2 (Final)
62%
Grant Probability
Moderate
3-4
OA Rounds
2y 8m
To Grant
78%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
434 granted / 699 resolved
+2.1% vs TC avg
Strong +16% interview lift
Without
With
+16.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
40 currently pending
Career history
739
Total Applications
across all art units

Statute-Specific Performance

§101
4.2%
-35.8% vs TC avg
§103
39.3%
-0.7% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
23.3%
-16.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 699 resolved cases

Office Action

§112
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 . DETAILED ACTION This Office Action is in response to Applicants’ Amendment and Remarks filed on 1/28/2026 in which claims 3 and 22 are cancelled and claims 1, 7, 10, 11, 13 and 14 are amended. No claims are newly added. Claims 1, 2, 4-21 and 23 are pending in the instant application and are examined on the merits herein. Priority The application is a National Stage entry of PCT/US2021/051628 filed on 9/23/2021, which claims priority to provisional application 63/082236 filed on 9/23/2020. Withdrawn Rejections All rejection(s) of record for claim(s) 3 and 22 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot. Applicant’s amendment, filed on 1/28/2026, with respect to the rejection of claims 4, 7, 10, 11, 13 and 14-23 under 35 U.S.C. 112(b), has been fully considered and is persuasive. Applicant has amended the claims to 1) provide a clear description of which polymer is being modified by the degree of polymerization; 2) removed recitations of “such as”; 3) removed parenthetical statements; 4) removed unclear alphanumeric identifiers for compounds and 5) amended language to properly claim a Markush group. The rejection is hereby withdrawn. Applicant’s amendment, filed on 1/28/2026 with respect to the rejection of claims 1, 2, 5-9, 11 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Cooper et al. (US 5,476,844; 1995) and claims 1, 2, 5-9, 11-19 and 23 under 35 U.S.C. 102(a)(1) as being anticipated by Petrovsky et al. (WO 2011/032229A1), has been fully considered and is persuasive. Neither Cooper nor Petrovsky anticipate the limitation of an inulin gel with inulin having a DP from 20-47. The rejections are hereby withdrawn. Applicant’s amendment, filed on 1/28/2026, with respect to the rejection of claim 4 under 35 U.S.C. 103 as being unpatentable over Cooper et al. (US 5,476,844; 1995); claim 4 under 35 U.S.C. 103 as being unpatentable over Petrovsky et al. (WO 2011/032229A1) and claims 10, 20 and 21 under 35 U.S.C. 103 as being unpatentable over Petrovsky et al. (WO 2011/032229A1), in view of Singh et al. (US 2020/0246454A1, pub 8-2020), has been fully considered and is persuasive. Neither Cooper not Petrovsky teach or suggest an inulin gel lacking aluminum-based gel carriers or lacking crystalline inulin polymorph particles. Singh does not remedy the deficiency of Petrovsky. The rejections are hereby withdrawn. Rejections Necessitated by Amendment The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 1/28/2026, wherein instant independent claim 1 is amended to alter the breadth and scope of the claim, wherein the remaining pending claims depend from said independent claim. Therefore, new grounds of rejection have been made. New Grounds of Rejection Claim Rejections - 35 USC § 112(a) – Written Description The following is a quotation of 35 U.S.C. 112(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. Claims 1, 2, 4-21 and 23 are rejected under 35 U.S.C. 112(a) 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites the limitation that, “wherein the gel matrix is free of aluminum-based gel carriers and free of crystalline inulin polymorph particles dispersed within a non-inulin gel matrix”. There is insufficient support within the specification for this limitation. The limitation as recited above is intended to distinguish the claims from the prior art by excluding elements from the claims that are included in the disclosure of the prior art, which is proper provided the recited negative limitation has support within the specification. In the instant specification, there is no mention of either aluminum-based gel carriers or crystalline inulin polymorph particles. Thus, the negative limitations result in the addition of new mater to the claims. Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) , as failing to comply with the written description requirement. (MPEP § 2173.05(i)) Conclusion No claims are allowed. Applicant's amendment necessitated the new and/or modified 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 extension fee 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. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /DALE R MILLER/Primary Examiner, Art Unit 1693
Read full office action

Prosecution Timeline

Mar 22, 2023
Application Filed
Oct 24, 2025
Non-Final Rejection — §112
Jan 28, 2026
Response Filed
Feb 25, 2026
Final Rejection — §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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

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Prosecution Projections

3-4
Expected OA Rounds
62%
Grant Probability
78%
With Interview (+16.3%)
2y 8m
Median Time to Grant
Moderate
PTA Risk
Based on 699 resolved cases by this examiner. Grant probability derived from career allow rate.

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