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 instant application was filed 02 October 2023 and claims priority to provisional application 63/412,678 filed 03 October 2022. The effective filing date of the instant application is 03 October 2022. Election/Restrictions Claims 38, 39, 42, 43, and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07 November 2025. Applicant's election with traverse of Group I (claims 1-4, 9-12, 15-17, 20, 24, 29, and 30) in the reply filed on 07 November 2025 is acknowledged. The traversal is on the ground(s) that there is no undue burden to examine all of the claims. This is not found persuasive because t he different inventions would require a completely different and new field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries) . The requirement is still deemed proper and is therefore made FINAL. 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 appl icant regards as his invention. Claim s 4 and 42 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 4 recites “a solubility less than about 2 mg/mL or less than about 1 mg/ mL. ” The claim does not recite a solvent, so it is unclear how to determine the metes and bounds of the claim. The Applicant should clarify what kind of solvent the pharmaceutical agent has a solubility of less than about 2 mg/mL or 1 mg/ mL. Claim 42 recites “K8.” It is unclear what kind of drug or compound K8 is and the Applicant is encouraged to draw the compound for clarity. Since it is unclear what K8 is referencing, the metes and bounds of the limitation 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) 1-4, 9-12, 15, 16, 20, 24, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (US 8871241 B2), as evidenced by lktlabs.com. Chou teaches an injectable cylindrical drug delivery device comprising a core that contains at least one drug and a polymer ( entire teaching; abs) , addressing claims 1 and 11 . The cylindrical shape encompassing the core is interpreted as extending longitudinally and circumferentially in clai ms 1 and 3 . The device may have one or two openings to expose the core (col. 7, lns . 50-51; col. 22, lns . 40-46) , addressing claims 1 and 2 . The membrane portion of the device may be permeable to a drug to diffuse through when in contact with a biological fluid, which is interpreted as aqueous based (col. 6, lns . 10-34) , interpreted as addressing the diffusion limitation in claim 1 . Active agents in the composition include antivirals, nucleoside antivirals (col. 9, lns . 28-29), or fluocinolone acetonide (claim 1), where fluocinolone acetonide has a solubility of less than 1 mg/mL in water . Since the Applicant did not specify a solvent in regards to the solubility, it is interpreted as addressing claim 4. The drugs may be in the form of a pellet (col. 8, lns . 37-39) or be in the form of particles (claim 1), addressing claims 9 and 10. In some embodiments, the amount of active agents to polymer, such as PVA, may be in a ratio of 90:10, which is interpreted as addressing claims 12 and 16. Other suitable polymers include PLA and PCL (col. 4, lns . 35-55), addressing claim 20. The polymer matrix does not significantly affect the release rate of the drug (col. 2, lns . 13-18), addressing claim 15. In one embodiment, the length of the tube portion of the drug delivery device may be 3 mm, which is interpreted as addressing claim 24. Chou describes an initial burst release phase followed by a slow-release phase of the active agent (col. 7, lns . 35-40), where it is interpreted that the initial burst has a much faster release rate, addressing claim 29. Chou describes a linear release of the drug for at least five months (col. 19, lns . 10-12) or a general release of at least 7 days (col. 12, lns . 17-29), addressing claim 30. Chou does not teach an exact combination of components described in claim 1. In regards to selecting the combination of an active agent, polymer, cylindrical body with apertures , “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious .” KSR v. Teleflex , 127 S.Ct . 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro , 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” ( Id .). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id . at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.” Chou teaches an injectable cylindrical drug delivery device comprising a core that contains at least one drug and a polymer , whereas the claimed invention is directed towards a drug delivery implant comprising a core, cylindrical implant body, and a longitudinal surface . Since Chou teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success. Claim(s) 1-4, 9-12, 15 -17 , 20, 24, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (US 8871241 B2) and Matthews et al. (Safety and pharmacokinetics of islatravir subdermal implant for HIV-1 pre-exposure prophylaxis: a randomized, placebo-controlled phase 1 trial, Nature Medicine, 2021) , as evidenced by lktlabs.com. In regards to claim(s) 1-4, 9-12, 15, 16, 20, 24, 29, and 30, Chou, as applied s upra , is herein applied in its entirety for its teachings of an injectable cylindrical drug delivery device comprising a core that contains at least one drug and a polymer. Chou does not specifically teach islatravir or K8 in claim 17. Matthews teaches an implant with islatravir , a highly potent HIV nucleoside reverse transcriptase translocation inhibitor (abs), which is advantageous over injectable formulations (entire teaching; pg. 1715), and prove n to be safe (abs) and well-tolerated (pg. 1715). Since Chou does not specifically teach islatravir in claim 17, one of ordinary skill in the art would have been motivated to use Matthews’ teaching of an islatravir implant to treat HIV with a reasonable expectation of success. A skilled artisan would have been led to use the teachings together since the islatravir implants proved to be safe and well-tolerated, as provided an advantage over using injection formulations. Furthermore, Chou teaches general antivirals and nucleoside antivirals as acceptable active agents in their composition. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Danielle Kim whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2035 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F: 9-5 p.m. PST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Brian-Yong Kwon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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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