CTNF 18/857,946 CTNF 93442 DETAILED CORRESPONDENCE Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions Applicant’s election of invention and/or species, and corresponding claims (1-10, 12, 15-20) is acknowledged. The election has been made without traverse. Non-elected claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. 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, 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. 07-23-aia AIA The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. 07-21-aia AIA Claim 1-10, 12, 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cailleaux (NPL 2021 1 ) Summary: See Fig 4-6, table 1 and 3, and abstract In reference to claim 1 , Cailleaux discloses A method for preparing 3-D printed tablets, comprising the steps of: (“A promising solution to customize oral drug delivery has been found in the utilization of 3D Printing and in particular Fused Deposition Modeling (FDM). “ [abstract]) Providing a micro-extrusion printhead having a heatable reservoir, an extrusion means, a printing nozzle and optionally a heater; (Fig 5-6; Figure 6 is understood to show a Heating Zone: The area where the filament becomes a soften filament due to heat. Compression force (piston-like effect): The solid filament above acts like a piston, pushing the softened material through the nozzle. Nozzle: The final point where the molten material is extruded.) Loading a blend of one or more active pharmaceutical agents (APIs) and a polymer suitable for preparing tablets into said reservoir; (“A promising solution to customize oral drug delivery has been found in the utilization of 3D Printing and in particular Fused Deposition Modeling (FDM). “ [abstract] in view of Fig 5-6 and descriptions thereof). Applying heat such that said blend of polymer and API reaches a temperature that is suitable for extrusion through said nozzle; (Fig 5-6) Applying pressure on said extrusion means to result in extrusion of said heated blend of polymer and API. (Fig 5-6) As described above the compression zone of the extrusion means in Fig 5-6 is a plunger like, however, Cailleaux does not disclose that the extrusion means of Fig 5-6 is an actual plunger. Cailleaux provides a filament and extrudes the filament using a typical filament extrusion means (e.g,. traction of the filament into a hot end). However, in Fig 4, Cailleaux demonstrates the use of a plunger as an extrusion means for a similar purpose. Figure 4 shows a syringe: It is tilted diagonally downward, dispensing drops of liquid into a 3D-printed shell. It features a clear barrel, a plunger with a dark grey or black gasket, and a narrow tip. According to the diagram's label, it contains the active substance, which may be in the form of a solution, emulsion, or suspension. It acts as the delivery mechanism for the medication or material being printed. Therefore, it would have been obvious to one of ordinary skill in the art with a reasonable expectation of success before the effective filing date of the claimed invention to configure the printing such that the binder and API were extruded using a plunger as claimed. The rejection is made under 35 USC 103 because it combines different embodiments of the prior art. In reference to claim 2 , see “the active ingredient and excipients are added in the form of powder or pellets and are mixed either by a single or a twin screw conveyor to be co-extruded as an API-loaded filament” (bottom left of Pg. 824) In reference to claim 3 , see last entry of table 1 (250C is 30-60C above the Tm/Tg of PVA) and table 3 at 5% caffeine in PCL binder (150C is 30-60C above the Tm/Tg of PCL). In reference to claim 4 , see table 3 at PCL. In reference to claim 5-9 , Table 3 shows the same ingredients across the same ranges as claimed. Drug formulation of binder and drugs is a matter of optimization (see the titles of references [82]:“…quality by design to optimize drug release and extraction” and [97]:“Optimisation of novel polymeric compositions for sustained release theophylline caplets “ in the cited reference) In reference to claim 10 , Table 1 and 3 shows heating as claimed. In reference to claim 12 , Table 1 and 3 shows same drug as claimed. In reference to claim 15-20 , Table 1 and 3 shows same compositions as claimed and thus meets any limitations related to properties thereof. Conclusion Reference made to particular portions of the cited references are not intended to indicate that other portions of the cited reference is not applied. 07-96 Any prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20160256610 A1 teaches a method for using 3D printing technology produces personalized biomimetic drug-eluting coronary stent and the product thereof. The process of manufacturing stent, based on coronary angiography imaging data, measures the diameter of diseased coronary and conducts 3D reconstruction. A personalized stent for each patient according to diameter, length, and morphological characteristics of target vessel that suited to the lesion is produced. The coronary stent is formed from biodegradable poly-L-lactic acid (PLLA) or other materials. The stent is modeled by 3D printing and then coated with polymers carrying antiproliferative drug to reduce restenosis (the polymers is a mixture of antiproliferative drug and PDLLA at a ratio of 1:1). The biomimetic drug-eluting coronary stent produced by 3D printing technology is personalized stent for each patient according to different characteristics of diseased coronary, reduces the incidence of vascular injury, thrombosis, dissection and other complications caused by stent and vessel diameter mismatch. 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To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NICHOLAS KRASNOW/Examiner, Art Unit 1744 Application/Control Number: 18/857,946 Page 2 Art Unit: 1744 Application/Control Number: 18/857,946 Page 3 Art Unit: 1744 Application/Control Number: 18/857,946 Page 4 Art Unit: 1744 Application/Control Number: 18/857,946 Page 5 Art Unit: 1744 Application/Control Number: 18/857,946 Page 6 Art Unit: 1744 1 https://www.sciencedirect.com/science/article/pii/S0168365920306374
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