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 .
In view of the Appeal Brief filed on 07 January 2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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 Appeal Brief filed 07 January 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 Rejections not reiterated from previous office actions are hereby withdrawn.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 Appeal Brief, filed 07 January 2026, it is noted that claim no claims have been amended as of 14 October 2025. No new matter has been added.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7-11 recite the phrase “including, but not limited to.” The phrase is ambiguous because it is not clear what agents are excluded or included within the scope of the claims. Therefore, the claims are indefinite because the metes and bounds cannot be determined.
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, 27 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.
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, 26, 27 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, and 27, McKay, 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, 27 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, and 27, McKay, 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 and Appeal Brief filed 07 January 2026 have been fully considered but they are not persuasive.
The teachings from McKay (US 9,623,222 B2) have been removed as prior art and the arguments against them will not be addressed.
The Applicant argues that nomismahealthcare.com does not cure the deficiencies of McKay with respect to the plurality of retention features as recited in independent claim 1 (Appeal Brief, pg. 7).
As stated above and in the previously issued office action, nomismahealthcare.com is used as evidentiary support to demonstrate that 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.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.A.K./Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613