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 .
Applicant’s arguments, filed 04/24/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. 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 Status
Claims 1 and 5-8 are pending an under examination.
Claim Rejections - 35 USC § 103
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, 7, and 8, are rejected under 35 U.S.C. 103 as being unpatentable over Kimata et al (JP H06256169 A), in view of Yoshimura (WO 2015152190 A1, cited on IDS dated 02/05/2024) and Tiwari et al (WO 2018065826 A1).
Kimata et al teach granules comprising a core material (i.e., nuclear material) (sugar granules or Cellphea for ex. 1 and 2, ¶¶ 29-31) coated with molten polyethylene glycol 6000 with a biological enzyme (i.e., melt component), and an additional coating of molten polyethylene glycol 4000 with a biological enzyme (i.e., active ingredient containing layer) (examples 1 and 2, ¶¶ 29-31). As evidenced by the instant specification, macrogol is synonymous with polyethylene glycol (see ¶ 24 of the instant specification). Each molten substance has a lower melting point than the previous molten substance (¶¶ 1, 10, 11). Suitable molten materials include polyethylene glycol, cetyl alcohol, oils, waxes, etc. (¶ 15). The melting point of the molten materials are 80 deg C or lower, and can vary depending on the melting material to be used later (¶ 16). The granules have a high drug concentration (¶ 1). A higher melting point substance can be layered on the low melting point substance to raise the melting point, hasten the hardening of the granules, and further has the effect of enhancing the coating (¶ 24).
Kimata et al do not teach wherein the first melt component is glycerin monostearate or stearic acid, nor wherein the first melt component layer consists of the first melt component
Yoshimura teaches granular solid formulations containing a core substance that is coated with a drug containing layer comprising a melt component (abs). The coatings can include two or more layers of a hot melt materials including macrogol 4000, macrogol 6000, stearic acid, fatty acid esters of glycerin, carnauba wax, hardened oil, palmitic acid, cetanol (i.e., cetyl alcohol), etc. (¶ 143). The reference teaches another layer may be formed between the core substance and the drug-containing layer (¶ 242).
Tiwari et al is cited for additional motivation for a first layer consisting of a first melt component, where the reference teaches multilayer beads for pharmaceutical use comprising a core particle, an optional barrier layer coated on the surface of the core particle, and a drug-in-polymer layer coated on the surface of the core or the barrier layer (abs). The purpose of the barrier layer is to separate the drug-in-polymer layer from the core particle and to minimize or prevent contact of the drug with the core, which may cause degradation of the drug and loss of potency of the pharmaceutical formulation (¶ 19). The multilayered beads may further comprise additives selected from pharmaceutically acceptable excipients as known in the art, including disintegrants (¶¶ 26, 33, claim 46).
Regarding the particular first melt component recited in claim 1, it would have been obvious to modify the first melt component layer of Kimata et al, by substituting other known melt component coating materials suitable for coating granular formulations, such as stearic acid, as taught by Yoshimura. Further, the skilled artisan would have a reasonable expectation of success in using stearic acid as the first coating layer, where Yoshimura teaches stearic acid was known to be suitable for coating layers between the granule and the drug containing layer.
Regarding wherein the first melt component consists of a first melt component of claim 1, it would have been obvious to modify the first melt component made obvious above by having the first melt component consisting of the first melt component, in order to create a barrier layer between the nuclear material and the active containing layers, in order to minimize or prevent contact of the active agent with the core, which may cause degradation of the drug and loss of potency of the pharmaceutical formulation, as taught by Tiwari et al.
Regarding the particular second melt components recited in claim 1, in the examples recited above, Kimata et al disclose the second melt component comprising an active ingredient is polyethylene glycol 4000. As evidenced by the instant specification above, polyethylene glycol is synonymous with macrogol, thereby meeting the claimed limitation.
Regarding wherein the second melt component is different from the first melt component of claim 1, where the first melt component in the composition made obvious above stearic acid, and the second melt component is polyethylene glycol 4000, the second melt component is different from the first melt component, thereby meeting the claimed limitation.
Regarding claims 7 and 8, it would have been obvious to include to include known excipients suitable for multi-layered coated granules, such as disintegrants, as taught by Tiwari et al.
Response to Arguments
Applicants argue that Tiwari et al do not teach or suggest a pharmaceutically acceptable polymer which performs the desired function of the barrier layer, other than PVP or PVP-VA. Applicants assert if the Office believes that lauromacrogol is the pharmaceutically acceptable polymer which performs the desired function of the barrier layer, the Office should show evidence.
Respectfully, this argument is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As discussed in the last Office Action, the polymers disclosed by Tiwari et al are simply preferred polymers and the reference further teaches that any pharmaceutically acceptable polymer which performs the desired function of the barrier layer may be used (see ¶ 19 of Tiwari). Nevertheless, the examiner notes that Tiwari et al were not cited for the inclusion of the preferred polymers as a barrier layer for the granules of Kimata et al, but rather simply that non-drug containing polymeric layers consisting of the layer component were known to be coated onto granular particles as a physical barrier separating the core from the drug containing layer for the above mentioned benefits. From this, and from the teachings of Yoshimura, the skilled artisan would reasonably expect that other suitable coating layers known for coating granular particles would create a layer that physically separates the core and drug containing layer, thereby minimizing or preventing contact of the core material with the drug containing layer. Thus, where Yoshimura teaches stearic acid was known to be a suitable melt component layer that can be coated between the granular core and the drug containing layer, it would have been reasonably expected that stearic acid would also provide the benefit of minimizing or preventing contact of the drug with the core, which may cause degradation of the drug and loss of potency of the pharmaceutical formulation, as taught by Taiwari et al.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kimata et al (JP H06256169 A), Yoshimura (WO 2015152190 A1, cited on IDS dated 02/05/2024), and Tiwari et al (WO 2018065826 A1) as applied to claims 1, 7, and 8 above, and further in view of Nakano (JP 2017001999 A, cited on IDS dated 09/12/2022), as evidenced by ECOLOGIX (Mesh to Micron Conversion Table, retrieved 2025).
Kimata et al is discussed above and further discloses the nuclear material in ex. 1 and 2 are 42-32 mesh (ex. 1, 2). As evidenced by ECOLOGIX, 30 mesh is equivalent to 595 microns and 45 mesh is 354 microns. The particle size of the melting substance can be from 10-100 microns, and a smaller particle size is preferable (¶ 24).
Tiwari et al are discussed above and further teach the core particle is typically spherical (¶ 17).
The references do not specifically teach wherein the particle size of the nuclear material is larger than a particle size of the active ingredient, nor wherein the nuclear material has pores with the first melt component arranged in the pores.
Nakano teaches core particles (i.e., nuclear material) with a coating layer comprising an active (abs), where various embodiments comprise spherical nuclear particles (ex 1, 2, 3, 10, 11, comparative ex 1). It was known to use active particles sizes in the coating that are smaller than the nuclear material (¶ 52). The core particles were selected from sugar, magnesium aluminometasilicate, magnesium carbonate, etc. (¶ 46). As evidenced by the instant specification, magnesium aluminometasilicate comprises pores (see ¶ 43).
Regarding claim 5, it would have been obvious to modify Kimata et al by using a spherical nuclear material, as taught by Tiwari et al or Nakano, where all are directed to coated nuclear materials containing active ingredients.
Regarding the particle size of the nuclear material, it would have been obvious when formulating the granules made obvious above, to use nuclear materials that are larger than the particle size of the active ingredient, which were known to be suitable for active ingredient coated nuclear materials, as taught by Nakano. Further, it would have been obvious to use particle size of the second melt component (i.e., the active containing layer) that is smaller than the nuclear material, as taught in the examples of Kimata et al discussed above.
Regarding claim 6, it would have been obvious to substitute the nuclear materials of Kimata et al, with other known nuclear materials suitable for coated granules comprising active ingredients, such as magnesium aluminometasilicate, as taught by Nakano.
Regarding the first melt component arranged in the pores, where the selection of magnesium aluminometasilicate is made obvious above, and comprises pores, a skilled artisan would reasonably expect that by coating a porous nuclear material with a melt material, that the melt material would also arrange within the pores of the nuclear material that is being coated.
Response to Arguments
Applicants assert the additional references do not cure the deficiencies with respect to claim 1 for the reasons discussed above.
Respectfully, this argument is not persuasive. Applicants have not provided arguments with respect to the teachings of Nakano. The claims stand rejected for the same reasons above and of record.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kimata et al (JP H06256169 A), Yoshimura (WO 2015152190 A1, cited on IDS dated 02/05/2024), Tiwari et al (WO 2018065826 A1), and Nakano (JP 2017001999 A, cited on IDS dated 09/12/2022), as applied to claims 5 and 6 above, and further in view of Felton et al (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 47, pp. 3–14).
Kimata et al, Yoshimura, Tiwari et al, and Nakano et al are discussed above, and further motivation for selecting a porous nuclear material is provided by Felton et al.
Felton et al teaches it was known that porosity has an influence on the adhesion of coating materials, where the coating penetrates the porous materials, increasing the interfacial contact between the polymer and the porous material, in this case tablets are discussed (3.1 last ¶). During coating, penetration of the coating solution into the outer layers of the porous substrate is inevitable (3.1 last ¶).
It would have been obvious to select from the porous materials, such as magnesium aluminometasilicate, as taught by Nakano, where it would be expected that the porous granules would have better adhesion to the coating materials, as taught by Felton et al. Further, it would be expected that the melt component would also arrange in the pores, where coating materials were known to penetrate porous substates, as taught by Felton et al.
Response to Arguments
Applicants assert the additional references do not cure the deficiencies with respect to claim 1 for the reasons discussed above.
Respectfully, this argument is not persuasive. Applicants have not provided arguments with respect to the teachings of Felton et al. The claims stand rejected for the same reasons above and of record.
Double Patenting - Withdrawn
The nonstatutory double patenting rejection over the claims of copending Application no. 17/942,333 has been obviated by the terminal disclaimed dated 04/24/2026. Accordingly, the nonstatutory double patenting rejection is withdrawn.
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 JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/
Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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