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 .
Acknowledgement of Receipt
Applicant's response filed on 01/13/2026 to the Office Action mailed on 11/13/2025 is acknowledged.
Claim Status
Claims 14-26 are pending.
Claims 19-26 are withdrawn as being directed to a non-elected invention.
Claims 14-28 have been examined.
Claims 14-28 are rejected.
Priority
Priority to 371 PCT/EP21/85274 filed on 12/10/2021, which claims priority to application 63/125178 filed on 12/14/2020 is acknowledged.
Drawings
The drawings filed on 07/21/2023 are accepted.
Election/Restrictions
Applicant's election with traverse of Group I (claims 14-18) in the reply filed on 01/13/2026 is acknowledged. The traversal is on the ground(s) that the technical feature common to all the groups is a contribution over the prior art for not teaching or suggesting a solubilizer combined with the macrocyclic triene immunosuppressive compound of instant claim 14. This is not found persuasive because the 103 rejection below makes clear that the instant common technical feature does not contribute over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Objection to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See page 27). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubino et al. (International Application Published Under the PCT WO 2004/011000 A1, Published 02/05/2004) in view of Betts et al. (International Application Published Under the PCT WO 2013/182503 A1, Published 12/12/2013).
Rubino et al. teach a composition for intravenous administration comprising mixing rapamycin-42-ester with 3-hydrxoy-2-(hydroxymethyl)-2-methyl-propionic acid (CCI-779) with polysorbate 80, dehydrate ethanol, and polyethylene glycol 400; which is then further diluted with 0.9% sodium chloride injection (saline) (page 10, lines 12-20). CCI-779 has been shown to be effective in treatment in cancers (page 2, lines 1-19).
Rubino et al. lacks a teaching of the instantly claimed rapamycin derivative.
Betts et al. teach
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(page 2, lines 12-22 and page 3, lines 1-6).
The invention includes methods of treating cancer (page 3, lines 7-14 and page 21, lines 26-32). Other mTOR inhibitors include temsirolimus and everolimus for use in cancers (page 22, lines 1-7).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to add the 40-O-cyclic hydrocarbon ester compound and temsirolimus or everolimus of Betts et al and have a reasonable expectation of success. One would have been motivated to combine the teachings of Rubino et al. and Betts et al. since they are both directed to compositions for treating cancer. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Conclusion
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/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614