DETAILED ACTION
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 7-11, 18, 20, and 26) and the species of steroid (for the anti-inflammatory agent) in the reply filed on 18 August 2026 is acknowledged. Claims 1-6, 12-16, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Warning
Applicant is advised that should claim 10 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
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.
Claims 7-8, 10, 18, 20, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Olf et al. (US Patent Application Publication 2021/0246271).
Olf et al. discloses implantable delivery devices for the long-term release of therapeutic agents (abstract). The devices include a nanoporous membrane which allows for the long-term release (id.). The devices are more specifically a capsule which includes a reservoir in which the therapeutic agent is disposed (claim 1). And the nanoporous membrane has a plurality of pores (id.).
Olf et al. further suggests that two therapeutic agents can be present (paragraph [272]), and these include dexamethasone (paragraph [278]). Dexamethasone is an anti-inflammatory agent and a steroid (as stated by the instant specification at paragraph [102]). Instant claim 7 further recites that the anti-inflammatory agent improves the AUC of the therapeutic agent. Olf et al. is silent as to such an effect. However, dexamethasone would provide such an effect, as demonstrated by the instant specification (paragraph [102]).
Olf et al. thus discloses devices comprising the individual elements of the instantly claimed combination (two therapeutic agents, one of which being dexamethasone) and together these would provide a device as instantly claimed. However, Olf et al. is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been prima facie obvious, however, to make the combination since each component is taught as being useful in making the compositions of the prior art. Since this modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions a prima facie case of obviousness exists. See MPEP 2141.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Olf et al. (US Patent Application Publication 2021/0246271) as applied to claim 7 above, and further in view of Bridges et al. (J. Diabetes Sci. Tech., 2008, 2(6), pages 984-994).
Olf et al. discloses most of the limitations recited by instant claim 9, but does not suggests the coating of the device with dexamethasone.
Bridges et al. discusses implantable devices, and states that these can elicit a strong inflammatory host response which limits their performance (abstract). To address this problem, Bridges et al. suggests coatings based on anti-inflammatory agents (section starting at page 985) such as dexamethasone (table 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used the surface coating of dexamethasone suggested by Bridges et al. This would address the known problem of implantable devices discussed by Bridges et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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