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 1-14, 16-18 and 20 are pending in the instant application. Claims 14, 16-18 and 20 are rejected. Claims 1-13 are allowed.
Information Disclosure Statements
The information disclosure statements filed on January 4, 2024 and February 19, 2026 have been considered and signed copies of form 1449 are enclosed 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 (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.
Claims 14, 16-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/060147 A1.
WO 2019/060147 A1 discloses crystalline forms of Ponesimod designated as Form T1 and Form T2 (see claims and Figures 1 and 2) and pharmaceutical compositions (see claim 3), pharmaceutical formulations (see claim 5) and medicaments thereof (see claim 7). Also see [00077] and [000102]. A method of treating autoimmune diseases is also disclosed in the reference (see claim 9). Liquid pharmaceutical compositions are disclosed in the reference (see [00087]) wherein Ponesimod and any other solid excipients are dissolved or suspended in a liquid carrier such as water, vegetable oil, alcohol, polyethylene glycol, propylene glycol, or glycerin (see [00087]). Finally, it is stated that “Ponesimod is preferably formulated for administration to a mammal, preferably a human, by injection.” See [000101].
It is known in the art that when a crystalline compound is dissolved in a liquid excipient, the crystal lattice breaks apart and the compound is no longer in crystal form. Therefore, a liquid pharmaceutical composition, liquid pharmaceutical formulation, process for preparing a liquid pharmaceutical formulation, and liquid medicament as well as a method of treating an autoimmune disease comprising administering a liquid pharmaceutical composition of the claims is anticipated by the reference.
Allowable Subject Matter
Claims 1-13 are allowed. No prior art was found. The closest prior art is WO 2019/060147 A1 which discloses crystalline forms of Ponesimod (see above) that do not fit within the scope of those of the claims nor are they obvious variants.
Conclusion
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622