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 .
Applicant’s response (amendments and arguments) is acknowledged.
Claims 1-2, 6-7, 16, 17, 20, 22, 25, 27-28, 30, 53, 55 and new claims 56-61 are pending; claims 17 and 60-61 withdrawn as drawn to non-elected subject matter, and the remaining claims examined on the merits below.
The examiner remains open to interview to advance prosecution on the merits.
Election/Restrictions –
Species Maintained, Group Reinstated & Made Final Based on Amendments
Applicant’s election without traverse of Group I and 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 (adding non-elected Group subject matter back in as claims 60-61), the Group election has been reinstated and made Final. Claims 17 and 60-61 withdrawn as drawn to non-elected subject matter, and the remaining claims examined on the merits below.
Claim Rejections - 35 USC § 10 3- Obviousness - Maintained, Modified,
Necessitated by Amendment
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, 20, 22, 25, 27-28, 30, 53, 55 and new claims 56-59 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 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).
New claims 55-59 are simply drawn to standard routes of administration, merely a matter of simple selection depending on the desired target and intended outcomes.
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.
Response to Amendments and Arguments
Applicant’s amendments and arguments have been fully considered but are not yet found persuasive. There is no definition found in the specification as to what constitutes a “complex” as claimed. Such could merely be an “associative” “complex” in formulation. Further, there is no structural “complex” found described anywhere in the specification as to CER-001 with DXT. The only mention of a complex, with any structural identity even, is with something other than DXT (cyclosporine) with no ‘clear’ evidence of what/if type of complex was even formed with CER-001:
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Thus, based on the broadest reasonable interpretation of the claims, the combination of elected CER-001 and DXT for the treatment of uveitis into a third composition is still rendered prima facie obvious based on the references of record, as both are taught for treating the elected uveitis. The “complex” thereof could merely be “associative” in that third composition for treating uveitis. As such, and until “complex” is clearly defined and/or the claims further amended, applicant’s arguments are not commensurate in scope with that claimed. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. what ‘type’ of “complex” is intended) are not recited in the rejected claim(s) nor found defined in the specification. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Until further clarification and/or amendment, the claimed invention based on BRI remains prima facie obvious over the reference combination of record, for the reasons of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
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