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 1-2, 6-7, 16, 18-20, 22, 25, 27-28, 30 and 50-55 are pending and examined on the merits below.
See Also – Interview Summary (Attached).
Election/Restrictions – Species Maintained, Group Withdrawn Based On Amendments
Applicant’s election without traverse of the species dexamethasone palmitate (DXT) and CER-001 for the treatment of the elected eye disorder species uveitis, in the reply filed on 9/26/25 is acknowledged. Based on the amendments, the Group election is withdrawn.
Claim Rejections - 35 USC § 103 - Obviousness
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 6-7, 16, 18-20, 22, 25, 27-28, 30 and 50-55, as drawn to the elected species combination of dexamethasone palmitate (DXT) and CER-001 for the treatment of the elected eye disorder species uveitis, is/are rejected under 35 U.S.C. 103 as being unpatentable over Santen (CA2653902; 12/6/2007) – directed to using dexamethasone palmitate (DXT) for the treatment of the elected eye disorder species uveitis – in view of the prior art of record applied by the International Authority in the related PCT written opinion – the entirety of which is incorporated by reference here, including the following relied upon references and passages –
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- directed to prior art using CER-001 for the treatment of the elected eye disorder species uveitis.
Santen (claims 61, 65, 82, and 86) teach dexamethasone palmitate (DXT) for the treatment of the elected eye disorder species uveitis. But not in combination with CER-001.
Macregen and Roizman (cited in the related PCT above, see passages in each above) teach CER-001 for for the treatment of the elected eye disorder species uveitis. But not in combination with CER-001.
As a matter of law, "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 (here 3 known cancer agents), in order to form a third composition which is to be used for the very same purpose." In re Susi, 169 USPQ 423, 426 (CCPA 1971); In re Kerkhoven, 205 USPQ 1069 (CCPA 1980). As a result, it would have necessarily been prima facie obvious to one of ordinary skill in the art to combine the compositions taught in the prior art to arrive at the instantly claimed invention.
The choice of concentrations, forms, and any further additives therein would have merely been a matter of routine optimization by one of ordinary skill in the art (MPEP 2144.03).
Thus, the claims and claimed invention as drawn to the elected species, would have been prima facie obvious to combine Santen with either Macregen or Roizman into a third composition for the same purpose of treating uveitis with both DXT and CER-001.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654