Prosecution Insights
Last updated: October 02, 2026
Application No. 18/692,541

DIROXIMEL FUMARATE PARTICLES HAVING IMPROVED FLOW PROPERTIES AND METHODS OF MAKING SAME

Non-Final OA §102
Filed
Mar 15, 2024
Priority
Sep 17, 2021 — provisional 63/245,476 +3 more
Examiner
JARRELL, NOBLE E
Art Unit
1699
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Biogen Ma Inc.
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
5m
Est. Remaining
91%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allowance Rate
851 granted / 1049 resolved
+21.1% vs TC avg
Moderate +10% lift
Without
With
+9.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
58 currently pending
Career history
1099
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
16.9%
-23.1% vs TC avg
§102
20.7%
-19.3% vs TC avg
§112
44.3%
+4.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1049 resolved cases

Office Action

§102
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 . Election/Restrictions Applicant’s election without traverse of group I, claims 1, 2, 4, 6, 8, and 10-12 in the reply filed on 2026 May 29 is acknowledged. Claims 1, 2, 4, 6, 8, and 10-12 are allowable. Claims 13-15, 17, 18, 21, 22, 23, 25, 27, 28, and 30, previously withdrawn from consideration as a result of a restriction requirement, do not require all the limitations of an allowable claim. Due to no prior art against elected group I, the claims of group II are rejoined for examination. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions I and II, as set forth in the Office action mailed on 2026 April 1, is hereby withdrawn and claims 13-15, 17, 18, 21, 22, 23, 25, 27, 28, and 30 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. Information Disclosure Statement The information disclosure statement (IDS) submitted on 2024 April 29 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SEN (WO 2021074842, published 2021 April 22, cited in IDS). Sen describes particle forms of diroxemil fumarate (examples 13-16, pages 24-25). Since claim 30 is a product by process claim, the method by which the particles are produced does not limit patentability. Please see MPEP 2113. PNG media_image1.png 290 706 media_image1.png Greyscale Conclusion Claims 1, 2, 4, 6, 8, 10-15, 17, 18, 21, 22, 23, 25, 27, and 28 are allowed. Claim 30 is not allowable. The following is a statement of reasons for the indication of allowable subject matter: SEN (WO 2021074842, published 2021 April 22, cited in IDS) does not describe neither the recited D10, D50, and D90 span properties of diroximel fumarate of claim 1 nor the milling process of claim 13 for preparing diroximel fumarate. None of the examples describe each D10, D50, and D90 span property that is encompassed by what is recited in the examined claims nor a reason that the prepared particles could have the claimed properties. In example 14, the D10 and D50 span properties are not encompassed by the examined claims. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM. 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, Fereydoun Sajjadi can be reached at 571-272-3311. 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. /NOBLE E JARRELL/Primary Examiner, Art Unit 1699
Read full office action

Prosecution Timeline

Mar 15, 2024
Application Filed
Aug 25, 2026
Non-Final Rejection mailed — §102 (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
81%
Grant Probability
91%
With Interview (+9.7%)
2y 11m (~5m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1049 resolved cases by this examiner. Grant probability derived from career allowance rate.

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