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.
Examiner’s Note
The Applicant's amendments and arguments filed 20 March 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not reiterated from previous office actions are hereby withdrawn.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 response, filed 20 March 2026, it is noted that claims 1, 3, 4, 10, 15-17 have been amended and no new claims have been added. Support for the amendments can be found on pg. 4 of the 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) 1-4, 9, 10, 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 claim 1. The core material comprising the drug and polymer is interpreted as a “matrix” in claims 1 and 3. The cylindrical shape encompassing the core is interpreted as extending longitudinally and circumferentially in claims 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, 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 amounts of active agents to polymer, such as PVA, may be in a ratio of 90:10 (col. 22, lns. 35-37), which addresses claim 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. Chou does not specifically teach the % weight limitations in claims 1, 3, and 12.
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.
In regards to the % weight limitations in claims 1, 3, and 12, Chou teaches that the amounts of active agents to polymer, such as PVA, may be in a ratio of 90:10 (col. 22, lns. 35-37). That being said and in lieu of objective evidence of unexpected results, the % weight can be viewed as a variable that achieves the recognized result of successfully making the drug delivery device, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Chou. The optimum or workable range of amounts 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 as nonobvious.
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 supra, 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 proven 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.
Response to Arguments
Applicant's arguments filed 20 March 2026 have been fully considered but they are not persuasive.
The Applicant argues that Chou teaches higher amounts of polymer (Remarks, pg. 7).
Applicant’s argument is not found persuasive. The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, it would be obvious to adjust the amount of polymer to maintain a stable or favorable composition for the intended purpose, e.g. for drug delivery to a subject, consumption or as a dietary supplement, food ingredient or additive, a medical food or a nutraceutical.
The Applicant argues that unexpected results regarding the amount of polymeric material in the core of the implant (Remarks, pgs. 7-8).
Applicant’s argument is not found persuasive. The Applicant argues that implants having 5% or less polymeric material in the core have beneficial drug release properties and cites Example 3 and Figures 4 and 8. Example 3 demonstrates a composition comprising islatravir with 4% of PVA. It is unclear that the results are surprising or unexpected without any substantial comparative data, such as data comparing different amounts of PVA. Without clear comparative data, it is not obvious that a polymeric amount of 5% or less yields significantly superior results than a composition comprising a polymeric amount of greater than 5%.
Furthermore, any evidence of better drug release properties does not have a causal relationship with the merits and scope of the claimed invention, which is, broadly, a drug delivery implant comprising any pharmaceutical agent and any polymeric material. As such, the data are not commensurate in scope with the claims.
“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp., 463 F.3d at 1312 (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
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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