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 Claims 13-15, 17, 18, 21, 22, 23, 25, 27, 28, and 30, previously withdrawn from consideration as a result of a restriction requirement, do not require all the limitations of an allowable claim.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requirement between inventions I and II, as set forth in the Office action mailed on 2026 April 1, is hereby withdrawn and claims 13-15, 17, 18, 21, 22, 23, 25, 27, 28, and 30 are hereby rejoined and fully examined for patentability under 37 CFR 1.104.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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
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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.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699