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 .
Claims 16-45 are canceled. Therefore, claims 1-15 are currently pending in this Application.
Priority
CONTINUING DATA
This application is a 371 of PCT/EP2023/053304 02/10/2023
This application has PRO 63/309,250 02/11/2022
Information Disclosure Statement
Applicant’s Information Disclosure Statements, filed on April 02, 2026 have been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2021/1176070.
Claims 1-15, are directed to a method of slowing an increase in brain ventricular volume in a patient comprising administering ponesimod,
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wherein the patient has multiple sclerosis (MS).
In regards to claims 1-7, WO 2021/1176070 teach ponesimod for use in slowing brain volume loss in a patient in need thereof, in particular in a patient with multiple sclerosis (see, claims 1-7; . The dosage regimen in WO 2021/1176070 corresponds exactly to that of the instant claims (see claims 7-8 and specification page 8, paragraphs 44-46).
In regards to claims 7-12, WO 2021/1176070 teach wherein the patient has a base line EDSS score of less than or equal to 3.5 (see paragraph 068). The prior art further teach wherein the standard care treatment comprises teriflunomide (see paragraph 0120).
In regards to claims 12-15, WO 2021/1176070 teach wherein the patient has a base line EDSS score of less than or equal to 3.5 (see paragraph 068). The prior art further teach wherein the standard care treatment comprises teriflunomide (see paragraph 0120).
In regards, to claims 13-15, the description of the instant application and the prior art both describe that slowing down an increase in brain ventricular volume and reducing the rate of brain volume loss are a clinical outcome in the treatment of multiple sclerosis. Therefore, since the same products and doses are used in the treatment, the slowing of the increase of the ventricular volume is inherently covered by the prior art. Therefore, claims 1-15 are anticipated by the prior art.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kamal A Saeed/
Primary Examiner, Art Unit 1626
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