DETAILED ACTION 1. 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 election without traverse of Group I in the reply filed on 12/10/2025 is acknowledged. Claims 264-271 and 277 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025. INFORMATION DISCLOSURE STATEMENT 2. Information Disclosure Statements filed 8/21/2023 and 9/4/2024 are acknowledged. Claim Rejections- 35 USC § 112 3. 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 appl icant regards as his invention. Claims 264-271 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. Claim 264 recites biodegradable polymers 60LP2L20-D27, 10LP10L20-GLL40 and 20LP10L20-GLL-40. It is not clear what these polymers represent. Paragraph 0582 and 0583 discuss these polymers but it is not clear, for example what these such as D27 . Claim Rejections- 35 USC § 1 03 4. 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. Claims 264-265 and 267-271 are rejected under 35 U.S.C. 103 as being unpatentable over Berde et al. (US patent 6,238,702) , Gullapalli et al. “Polyethylene glycols in oral and parenteral formulations-A critical review” , Shenoy et al. (US 20010012844) and Haitjema et al. (US 20220332900) . Berde et al. (US patent 6,238,702) disclose sterile bupivacaine-polyester microspheres with high loading of anesthetic of a least 20 % (col, 2. Lines 51-60, col. 3, lines 60-62 , Example 1 an d 3 ). The formulation is to be injected into a patient and thus would be provided in an injector (syringe) . Polyethylene glycol is not disclosed. Gullapalli et al. “Polyethylene glycols in oral and parenteral formulations-A critical review” disclose that polyethylene glycols are frequently employed as vehicles in oral an parenteral dosage forms and have low toxicity, are miscible with aqueous fluids in all proportions (abstract). Compounds with poor aqueous solubility and resulting poor bioavailability and considerable individual variability in the adsorption were shown to provide exceptionally high bioavailability and reduced inter subject variability in plasma concentrations when dosed as solutions or suspensions in PEGs. Berde et al. does not disclose antioxidant however, Gullapali et al. disclose that the autooxidation reactions in PEG vehicles and the formation of reactive products resulting from these reactions can be minimized effectively by using an antioxidant. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include an antioxidant in the microsphere formulations. One would have been motivated to do so to minimize the formation of reactive products. Shenoy et al. (US 20010012844) (hereinafter Shenoy et al.) teach improving bioavailability of hydrophobic pharmaceutical agents. These formulations include PEG-400 from 0.01-10 g/mL (abstract and para 0064). Haitjema et al. (US 20220332900) (hereinafter Haitjema et al.) disclose multiblock copolymers for controlled/sustained release of drug that include 60LP2L20 -D27 (see para 0031 and abstract, Table 11, para 0236 and Table 13 and para 0041). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include the multiblock copolymers of Haitjema et al. in the compositions of Berde . One would have been motivated to do so in order to improve the bioavailability of the hydrophobic (bupivacaine) pharmaceutical agent which PEG copolymers have been shown to do in view of Shenoy et al. and to provide for sustained release of the biologically active compound as disclosed by Haitjema et al. While the shelf life is not disclosed, the combined teachings of the prior art arrive at the structural features of the claimed invention and thus the shelf life properties would necessarily follow. 5. Claims 264 and 266 are rejected under 35 U.S.C. 103 as being unpatentable over Berde et al. (US patent 6,238,702), Gullapalli et al. “Polyethylene glycols in oral and parenteral formulations-A critical review”, Shenoy et al. (US 20010012844) and Haitjema et al. (US 20220332900) as applied to clai ms 264-265 and 267-271 above, and further in view of Andhariya et al. “In vitro-in vivo correlation of parenteral PLGA microspheres: Effect of variable burst release” . Berde et al. has been discussed supra and does not disclose a diluent. Andhariya et al. “In vitro-in vivo correlation of parenteral PLGA microspheres: Effect of variable burst release” disclose that diluents are used for dispersion of commercial products prior to injection (section 2.5 In vivo release studies of risperidone and LA microspheres). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include a diluent for use in dispersing the microsphere formulation prior to injection. CORRESPONDENCE 6 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DANAH AL-AWADI/ Primary Examiner, Art Unit 1615