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 .
Priority
The application was filed 27 August 2021 and claims domestic benefit to provisional application 62/894,113 filed 30 August 2019. Therefore, the effective filing date of the application is 30 August 2019.
Examiner’s Note
Applicant's arguments and amendments filed 12 June 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s remarks, filed 12 June 2026, it is noted that claim 1 has been amended, no claims have been canceled, and claim 28 has been newly added. Support for the amendment and new claim can be found in para. 75 of the instant specification. No new matter has been added.
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.
Claim(s) 1-7, 9-12, 21-24, 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKay (US 2007/0243225 A1), as evidenced by nomismahealthcare.com and Kassab (Recent advances in targeting COX-2 for cancer therapy: a review, RSC Medicinal Chemistry, 2025).
McKay teaches an implantable drug depot (abs; entire teaching) for retention in a synovial joint (para. 13) that may comprise PLGA together with a therapeutic agent (paras. 24, 114). The drug depot may comprise multiple barbs (para. 64, Figures 1, 2, 5) for better implantation and retention (para. 13), where the figures show the barbs surrounding the outside of the drug depot or around the implant circumferentially (para. 164), addressing claim 1 and the contour or edge in claim 24. The composition comprising PLGA is interpreted as having a molar ratio range from 0-100% lactide and 0-100% glycolide in claims 1 and 4. Therapeutic agents include COX-2 inhibitors (para. 99) and naproxen (para. 113), which addresses claim 7 and is interpreted as addressing claim 11 for an agent that is known in the art to treat cancer (evidenced by Kassab, section 3). Other therapeutic agents include fibroblast growth factors (para. 143), addressing claim 10. The viscosity of the polymer depends on the ratio of the monomers, where a 50:50 molar ratio of PLGA would have an inherent viscosity range of 0.08-1.8 dL/g, as evidenced by nomismahealthcare.com (pg. 1), addressing claim 12. In other embodiments, the device may further include a shell that can be made from a biodegradable material, such as PLGA (para. 165), addressing claims 21 and 22. The composition may include a modified release carrier (para. 28), addressing claim 23. The implant diameter may range from 0.5 mm to about 5 cm (para. 164), addressing claim 26. The shape of the implant may include a tapered portion (para. 74), addressing claim 27.
Regarding Applicant’s amendment in claim 1 for the limitations of “configured to release the therapeutic agent at a first release over an initial period following implantation of the bioresorbable drug delivery platform” and “configured to release the therapeutic agent at a second release rate after the initial period to provide sustained release of the therapeutic agent,” McKay teaches a protective coating comprising therapeutic agents in order to provide a controlled, sustained, or delayed release of the therapeutic agents (para. 122). The protective coating is interpreted as a “topcoat” and the coating on the depot is interpreted as including the backbone structure. The therapeutic agents released in a controlled, sustained, extended, or delayed manner in combination with McKay’s teaching of deposition of the drug at an intermittent rate (para. 94) and desire for delivering agents for an extended period of time (para. 12) are interpreted as the coating/depot capable of releasing a therapeutic agent from the coating first and release of a second agent from the depot over time.
Regarding new claim 28, the composition capable of controlled, sustained, or delayed release of therapeutic agents (para. 122) is interpreted as having a slower second release than the first release. As mentioned above, the therapeutic agents released in a controlled, sustained, or delayed manner in combination with McKay’s teaching of deposition of the drug at an intermittent rate (para. 94) is interpreted as a slower second release rate.
McKay does not specifically teach the mass % of claims 2, 3, 5, and 6.
McKay teaches that the amount of excipient may be between about 50-99.9% weight of the total composition (para. 126), where it is interpreted that the amounts of therapeutic agents may make up the rest and excipients include polymers, such as PLGA. That being said and in lieu of objective evidence of unexpected results, the amounts can be viewed as a variable that achieves the recognized result of successfully making the implantable drug depot, which a skilled artisan would have been easily motivated to modify and adjust. The optimum or workable range of weight % can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of polymer and therapeutic agents as nonobvious.
Claim(s) 1-12, 21-24-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKay (US 2007/0243225 A1) and Kimble (US 20100015196 A1), as evidenced by nomismahealthcare.com and Kassab (Recent advances in targeting COX-2 for cancer therapy: a review, RSC Medicinal Chemistry, 2025).
In regards to claim(s) 1-7, 9-12, 21-24, 26-28, McKay et al., as applied supra, is herein applied in its entirety for its teachings of an implantable drug depot comprising PLGA.
McKay does not teach antibiotics as a therapeutic agent in claim 8.
Kimble teaches a drug depot that is implantable in a synovial joint (abs; entire teaching) with hooks or grooves (para. 9) wherein the drug depot may comprise PLGA (para. 77) and amoxicillin as a therapeutic agent (para. 98).
Since McKay does not teach antibiotics as a therapeutic agent in claim 8, one of ordinary skill in the art would have been led to use Kimble’s teaching of amoxicillin as a therapeutic agent in their drug depot. A skilled artisan would have been easily led to use amoxicillin in McKay’s drug depot if the intended use of the composition was to treat bacterial infections. Furthermore, both implantable devices in McKay and Kimble are to deliver therapeutic agents to synovial joints.
Claim(s) 1-13, 21-24, 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKay (US 2007/0243225 A1), Kimble (US 2010/0015196 A1), and Lanao (Physicochemical Properties and Applications of Poly(lactic-co-glycoli acid) for Use in Bone Regeneration, Tissue Eng Part B Rev., 2013), as evidenced by nomismahealthcare.com and Kassab (Recent advances in targeting COX-2 for cancer therapy: a review, RSC Medicinal Chemistry, 2025).
In regards to claim(s) 1-12, 21-24, 26-28, McKay et al., as applied supra, is herein applied in its entirety for its teachings of an implantable drug depot comprising PLGA.
McKay does not teach acid or ester end capped polymer material in claim 13.
Lanao teaches that ester end capped PLGA used in drug delivery leads to slower degradation time (pg. 381 right column, pg. 382 left column).
Since McKay does not teach acid or ester end capped polymer material in claim 13, one of ordinary skill in the art would have been led to use Lanao’s teaching of using an ester end capped PLGA for slower degradation time in drug delivery compositions. A skilled artisan would have been easily led to ester end capped PLGA in McKay’s teaching, since McKay’s composition is for releasing therapeutic agents in a slow or sustained release manner (McKay, para. 24).
Response to Arguments
Applicant's arguments filed 12 June 2026 have been fully considered but they are not persuasive.
The Applicant argues that McKay does not disclose the limitations of amended claim 1 (Remarks, pgs. 7). The Applicant further argues that there is no teaching, suggestion, or motivation in McKay to provide an initial release at a first release rate (Remarks, pg. 8).
Applicant’s argument is not found persuasive. Regarding Applicant’s amendment in claim 1 for the limitations of “configured to release the therapeutic agent at a first release over an initial period following implantation of the bioresorbable drug delivery platform” and “configured to release the therapeutic agent at a second release rate after the initial period to provide sustained release of the therapeutic agent,” McKay teaches a protective coating comprising therapeutic agents in order to provide a controlled, sustained, or delayed release of the therapeutic agents (para. 122). The protective coating is interpreted as a “topcoat” and the coating on the depot is interpreted as including the backbone structure. The therapeutic agents released in a controlled, sustained, extended, or delayed manner in combination with McKay’s teaching of deposition of the drug at an intermittent rate (para. 94) and desire for delivering agents for an extended period of time (para. 12) are interpreted as the coating/depot capable of releasing a therapeutic agent from the coating first and release of a second agent from the depot over time.
The Applicant argues that new claim 28 is allowable (Remarks, pg. 9).
Applicant’s argument is not found persuasive. Regarding new claim 28, the composition capable of controlled, sustained, or delayed release of therapeutic agents (para. 122) is interpreted as having a slower second release than the first release. As mentioned above, the therapeutic agents released in a controlled, sustained, extended, or delayed manner in combination with McKay’s teaching of deposition of the drug at an intermittent rate (para. 94) and desire for delivering agents for an extended period of time (para. 12) are interpreted as the coating/depot capable of releasing a therapeutic agent from the coating first and release of a second agent from the depot over time.
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 Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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