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
This application claims foreign priority to JP2023-186844, filed 10/31/2023 and to JP2023-196374, filed 11/20/2023.
Information Disclosure Statement
The IDS’s filed on 10/29/2024 and 9/15/2025 have been considered. See the attached PTO 1449 form.
Claim Status
Claims 1-9 are currently pending and under examination.
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.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Obara (European Journal of Pharmaceutics and Biopharmaceutics 47 (1999) 51-59) in view of Zhu et al. (US2019/0099378A1; Apr. 4, 2019) and Sauer (International Journal of Pharmaceutics 457 (2013) 488-502).
Obara teaches dry coating method of solid beads or tablets without any solvent, either organic solvent or water. Both beads and tablets were used as the solid dosage forms (i.e. solid pharmaceutical preparation). The coating materials include powdered hydroxypropylmethylcellulose acetate succinate (HPMCAS), liquid plasticizer triethyl citrate and liquid wetting agent acetylated monoglyceride. Obara discloses bead coating process wherein the coating process included quantitative feeding of the powder material (HPMCAS) (in spray form) and simultaneous spraying of the plasticizing fluid (triethyl citrate and acetylated monoglyceride, also a wetting agent), under heated air (reads on mixing step performed while heating), on to the beads and also continual spraying. The rates of powder feed and liquid spray were adjusted so that the two processes were started and ended simultaneously. After the powder feed, the beads were subjected to a curing process (which involved heating and reads on heating the mixture product), during which film formation proceeded. The beads were then dried with heated air until the outlet temperature reached 50°C. The particle size of HPMCAS is less than 10 micrometer. (see e.g. Title; Abstract; Introduction; Section 2. Experimental; Section 3. Results and discussion).
The teachings of Obara have been set forth above.
Obara does not teach the plasticizer and wetting agent being in the form of powder, the preliminary mixing of HPMCAS, a powdered plasticizer, and a powdered wetting agent in advance, to prepare a precursor mixture, and then mixing the precursor mixture and solid pharmaceutical preparation. Obara also does not teach the specific powdered plasticizer and wetting agent and the melting point and particle size of the powdered plasticizer and wetting agent, as recited in the claims. Zhu et al. and Sauer cure these deficiencies.
Zhu teaches a method of producing a dry powder coated pharmaceutical capsule comprising preparing a dry powder film forming polymer coating composition, comprised of particles, to be coated onto an outer surface of the capsules by spraying the dry powder film forming polymer coating composition. Further, spraying a suitable amount of plasticizer into a housing to comingle (mix) with the dry powder film forming polymer coating composition. The plasticizer is sprayed into the housing at the same time with spraying the dry powder film forming polymer coating composition. The plasticizer is any one or combination of a liquid pure plasticizer, a plasticizer in a solution, and a dry powder plasticizer. The dry powder film forming polymer includes hydroxypropyl methylcellulose acetate succinate. (see e.g. claims; abstract; entire document).
Sauer provides a review of dry powder coating of pharmaceuticals. Sauer teaches that in the process of dry powder coating, liquid or solid plasticizers can be added to the polymeric material via physical mixture, concurrent addition during production or by the preparation of a solid dispersion coating formulation containing plasticizers prior to the coating operation. A polymeric solution containing the plasticizer can be spray dried so that a fine pre-plasticized polymer powder can be obtained. Pre-plasticization of the polymer eliminates the need of the separate spray of a plasticizer solution. The addition of low-melting excipients including glycerol monostearate and polyethylene glycol 3350 was shown to improve coating powder adhesion, highlighting how plasticizing materials could be used to enhance performance. Glycerol monostearate, and polyethylene glycol 3350 increased the drug release rate from the powder coated tablets. PEG 3350 can be used as low-melting hydrophilic wetting agent to promote coating powder adhesion and can be used both as primer and component of the coating powder. In general, powders having a particle size below 100 micrometer have been demonstrated to be suitable for powder coating. (see e.g. Abstract; Page 489, Right Column; Page 490, Right Column; Table 1; Section 4.1 and 4.2; Entire document).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Obara, Zhu and Sauer and (1) have the plasticizer and wetting agent in the form of powder, incorporate the preliminary mixing of HPMCAS, a powdered plasticizer, and a powdered wetting agent in advance, to prepare a precursor mixture, and then mix the precursor mixture and solid pharmaceutical preparation, and (2) include the specifically claimed powdered plasticizer and wetting agent having the melting point and particle size of the powdered plasticizer and wetting agent, as recited in the claims. As discussed supra, both Zhu and Sauer teach dry powder coating of solid pharmaceutical preparation and both Zhu and Sauer teach the plasticizer used can be a liquid plasticizer or dry powder plasticizer. Thus, one skilled in the art would have readily envisioned using either liquid or dry powder plasticizer as both were known in the art to be used in the method of dry powder coating of pharmaceutical preparations. Further, as discussed supra, Sauer teaches that in the process of dry powder coating, liquid or solid plasticizers can be added to the polymeric material via physical mixture, concurrent addition during production or by the preparation of a solid dispersion coating formulation containing plasticizers prior to the coating operation. A polymeric solution containing the plasticizer can be spray dried so that a fine pre-plasticized polymer powder can be obtained. Pre-plasticization of the polymer eliminates the need of the separate spray of a plasticizer solution. Thus, it would have been obvious to one skilled in the art to incorporate the preliminary mixing of HPMCAS, a powdered plasticizer, and a powdered wetting agent in advance, to prepare a precursor mixture, and then mix the precursor mixture and solid pharmaceutical preparation, because Sauer teaches this method is known in the art and it eliminates the need of the separate spray of a plasticizer solution.
Further, it would have been prima facie obvious to one skilled in the art to (2) include the specifically claimed powdered plasticizer (e.g. polyethylene glycol) and wetting agent (e.g. glycerol fatty acid ester) having the melting point and particle size of the powdered plasticizer and wetting agent, as recited in the claims. One would have been motivated to do so because Sauer teaches the addition of low-melting excipients including glycerol monostearate and polyethylene glycol 3350 was shown to improve coating powder adhesion, highlighting how plasticizing materials could be used to enhance performance. Glycerol monostearate, and polyethylene glycol 3350 increased the drug release rate from the powder coated tablets. PEG 3350 can be used as low-melting hydrophilic wetting agent to promote coating powder adhesion and can be used both as primer and component of the coating powder. Sauer teaches powders having a particle size below 100 micrometer have been demonstrated to be suitable for powder coating, thus it would have been obvious to ensure powders having a particle size below 100 micrometer are used in the method of coating pharmaceutical preparation. Further, glycerol monostearate and polyethylene glycol 3350 are the same wetting and plasticizing agents recited in the instant claims and in Table 1. Glycerol monostearate is a glycerin fatty acid ester and glycerin fatty acid ester has melting point of 40.6 (Table 1 of instant specification). PEG 3350 has a melting point ranging from 54-58 C. Thus, including these plasticizer and wetting agents would read on the melting points recited in the claims.
Regarding the claimed limitation wherein the particle size is determined by dry laser diffractometry, it would have been obvious to one skilled in the art to use the method known in the art to determine the particle size and dry laser diffractometry method has been well known to determine the size of the particles.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616
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