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 .
Applicants' arguments, filed 5/18/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-34 are rejected under 35 U.S.C. 103 as being unpatentable over Brundo et al (US2016/0220686).
Brundo et al teaches a refillable drug delivery system where the carrier is implanted within a subject and drug refills bind to a target recognition moiety on the device (abstract and ¶ 119), where in some embodiments the carrier is a polymer, such as an alginate hydrogel (¶¶ 12 and 24). Alginates may be formed in a scaffold formation (¶ 132). The drug can be related in a controlled manner form the drug delivery device by a covalent bond, such as an azide, alkyne, and dibenzocycooctyne complementary pairs (¶¶ 15 and 27). In such a way, the drug may be administered away from the treatment site, intravenously (¶ 57). The nanocarriers for the drugs include nanoparticles and liposomes (¶ 152). Among the disclosed drugs suitable for the refillable drug delivery system is daptomycin and vancomycin (¶ 285). The drug payload may be repeated with the same or different drug multiple times (¶ 215). Among the desired locations for administration include near implants or prosthetics (¶ 13). The target recognition moieties include lipids (¶ 117).
It would have been obvious to one of ordinary skill in the art to select from the disclosed carriers of Brundo et al to select alginate hydrogel in a scaffold as the implantable device, given it is the preferred embodiment. It would then have been obvious to select from the disclosed complementary functional groups for loading the active and to delivery any of the known and disclosed actives via a liposomes that is functionalized to attach to the implantable device.
Claims 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Brundo et al (US2016/0220686) in view of Zephati et al (US 9,107,931).
Brundo et al is discussed above and while teaching lipids maybe part of the functionalized groups, it does not teach DSPE per se.
Zephati et al teaches DSPE is a well-known lipid (¶ 63 and claim 18).
It would have been obvious to one of ordinary skill in the art to use any known lipid in the system made obvious by Brundo et al where lipids are taught generally.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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