CTNF 18/036,664 CTNF 86829 DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 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 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. Information Disclosure Statement The information disclosure statement (IDS) submitted on 05/12/2023 has been considered by the examiner. Status of the Claims The response filed 12/23/2025 is acknowledged. The claims filed 05/12/2023 are under consideration. Claims 1-17 and 19-26 are pending. 08-25-02 Applicant’s election of Group I, claims 1-8 , in the reply filed on 12/23/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The requirement is still deemed proper and is therefore made FINAL. 08-06 AIA Claim s 9-17 and 19-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/2025 . Claims 1-8 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application . Claim Rejections - 35 USC § 103 07-20-aia AIA 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 of this title, 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kangas, US 20150250772 and Codina, WO 2016015874 A1 . Kangas teaches suspension compositions comprising microparticulate crystalline limus drug, which suspension may be applied to medical devices as a coating, and wherein the coating formulation contains microcrystalline drug in a suspension (Kangas, e.g., 0051-0057, e.g.,0052 and claims 1-12). Selecting excipients in which the drug is substantially undissolved enables the drug to be applied while remaining in the crystalline form (Kangas, e.g., 0043). Applying the drug in microcrystalline form in a suspension may be done to form coatings on the device with drug in crystalline form (Kangas, e.g., 0050-0055). The suspension enables seeding the surface of the medical device with desired microcrystalline morphology, which in turn improves drug crystal adherence to the device surface and optimal particle size to reduce risk of dislodging the drug from the surface (Kangas, e.g., 0070). This technique is particularly useful for optimizing drug release from the coating, e.g., ratio of microcrystalline to other drug polymorphs is useful for tailoring drug release from the coating (Kangas, e.g., 0072). Kangas teaches various limus drugs consistent with claim 2. See Kangas, e.g., 0035-0037 and claims 1-5. Microcrystalline everolimus suspensions are exemplified (Kangas, e.g., Example 1-4, 0079-0097). The suspensions are formulated for coating medical devices, e.g., stent (Kangas, e.g., 0096), and balloons, catheters, catheter ballons (Kangas, e.g., 0046-0048). Kangas teaches non-polymeric excipients, such as oils (triglycerides) may be included in the coating suspension to facilitate adhesion of the drug to the device (Kangas, e.g., 0040-0043). Kangas does not expressly teach wherein the triglyceride is selected from the group consisting of trioctanoylglycerol, trinonanoylglycerol, tridecanoylglycerol, and triundecanoylglycerol as claimed. However, triglycerides within the scope of the claimed invention were known and used for coating compositions containing similar drugs, which compositions are useful to coat the same devices reported by Kangas, e.g., stents, catheters, etc. Codina teaches a composition for coating a medical device comprising paclitaxel and a lipophilic excipient, e.g., caprylic acid triglyceride, i.e., trioctanoylglycerol (Codina, e.g., claim 6). Codina teaches the composition further comprising a solvent (Codina, e.g., claim 15). Codina teaches the form of the drug may be crystalline and the form of the drug may be controlled by selection of the solvent used in the preparation of the formulation for coating (Codina, e.g., 0024). Like Kangas, Codina teaches crystalline form of the drug is desirable for sustained dosing and longer effect to achieve better therapeutic results with less probable restenosis (Codina, e.g., 0026). Codina teaches the drug having a small crystal size, e.g., in the range of nanometers (Codina, e.g., 0026). Codina teaches the triglyceride excipient, e.g., caprylic acid triglyceride, i.e., trioctanoylglycerol (Codina, e.g., claim 6) is effective to retain crystalline drug on the device while also promoting drug transfer to tissue at the treatment site (Codina, e.g., 0030-0035). Codina teaches excipients having formula 1 (Codina, e.g., claim 1) such as trioctanoylglycerol, aka, tricaprylin (Codina, e.g., 0053) offer uniform coatings of crystalline drug on devices (Codina, e.g., 0027) with excellent adhesion such that losses during navigation are very low (Codina, e.g., 0042). It would have been obvious before the effective filing date of the presently claimed invention to modify coating suspensions containing microcrystalline limus drugs understood from Kangs by including a triglyceride excipient such as those of formula 1, e.g., trioctanoylglycerol known from Codina to improve the device coating formed using the suspension in the same way. The skilled artisan would have been motivated to make this modification for improved microcrystalline drug retention and improved drug to tissue transfer in the same way reported by Codina. The skilled artisan would have considered this modification the use of a known technique to improve similar coating compositions in the same way. The skilled artisan would have had a reasonable expectation of success since Kangas teaches the coating compositions may further comprise excipients such as triglycerides and since Codina teaches particular triglycerides which offer improved drug retention and improved drug tissue transfer. Applicable to claim 3: Codina teaches a coating formulation having mass ratio of 20 tricaprylin to 80 drug (Codina, e.g., 0053). This is an example in the claimed ranges. The skilled artisan would have been motivated to start optimization using these amounts since Codina exemplifies these amounts as effective to achieve the reported improvements. Applicable to claims 4-5: Kangas teaches micron sized drug crystals (Kangas, e.g., 0051-0052), e.g., having a size in the claimed ranges, e.g., preferably having a mean particle size of less than 20 microns, e.g., less than about 10 microns (Kangas, e.g., 0053-0055). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Further particle size may vary and the size of the particle is a result effective parameter the skilled artisan would have optimized to retain the particles on the device surface (Kangas, e.g., 0070 too large size makes it easy to dislodge). Applicable to claim 6: Kangas teaches wherein the drug has a crystallinity in the claimed range, e.g., about 100% (Kangas, e.g., 0073 and 0077). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Applicable to claim 7: Kangas clearly names heptane as a non-solvent for so that the drug is substantially undissolved (Kangas, e.g., 0056-0057). Heptane has properties consistent with those claimed as evidenced by the specification, e.g., pp. 44-45 table 2. This clear teaching in Kangas would have prompted the skilled artisan to use heptane as a non-solvent vehicle to modify coating formulations suggested by Codina as a suspension for the benefits reported in Kangas. As evidenced by the specification, trioctanoylglycerol is soluble in heptane (Spec, e.g., pg. 42:15-19). Claim 8 is included in this rejection as further limiting an optional solvent mixture limitation of claim 1. Further, Kangas teaches vehicle which may be effective to induce crystallization of the limus drug includes similar mixed solvents such as heptane/ethyl acetate (Kangas, e.g., 0065). Accordingly, the subject matter of claims 1-8 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT. 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. /WILLIAM CRAIGO/Examiner, Art Unit 1615 Application/Control Number: 18/036,664 Page 2 Art Unit: 1615 Application/Control Number: 18/036,664 Page 3 Art Unit: 1615 Application/Control Number: 18/036,664 Page 4 Art Unit: 1615 Application/Control Number: 18/036,664 Page 5 Art Unit: 1615 Application/Control Number: 18/036,664 Page 6 Art Unit: 1615 Application/Control Number: 18/036,664 Page 7 Art Unit: 1615 Application/Control Number: 18/036,664 Page 8 Art Unit: 1615