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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/01/2025 has been entered.
Applicants' arguments, filed 12/01/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 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 layer consists of the first melt component.
Tiwari et al teach 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 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 of Kimata et al 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 first melt components recited in claim 1, the melt component layer consisting of a first melt component as made obvious above is polyethylene glycol 6000. As evidenced by the instant specification above, polyethylene glycol is synonymous with macrogol, thereby meeting the claimed limitation.
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 is polyethylene glycol 6000, and the second melt component is polyethylene glycol 4000, the second melt component is different from the first melt component, thereby appearing to meet the claimed limitation.
Purely arguendo, if the two different polyethylene glycols (macrogols) of different molecular weights somehow do not meet the limitation of being different, it would have been obvious to modify the second melt component by selecting from other suitable molten materials, such as cetyl alcohol, as taught by Kimata et al.
Regarding the polymers of claim 1, Examiner notes that the polymers are not required by the claim when the active ingredient containing layer comprises a second melt component, where the claim recites the active ingredient layer comprises a second melt component or a polymer, not both. (emphasis added) Accordingly, where the composition made obvious above comprises a first melt component consisting of polyethylene glycol 6000 (macrogol) and the active ingredient containing layer contains an active ingredient and a second melt component layer of polyethylene glycol 6000 (macrogol) or cetyl alcohol, the limitations are met.
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
First, Applicants assert that it would not have been obvious to modify the first melt component of Kimata et al by having the first melt component consisting of the first melt component. Applicants assert Tiwari et al discloses the barrier layer is typically a polymeric layer and that the preferred polymers are polyvinylpyrrolidone (PVP), vinylpyrrolidone-vinylacetate copolymer (PVP-VA) or a mixture thereof. Thus, Applicants assert if the preferred polymers of Tiwari et al are combined with the granules of Kimata et al, such granules would not meet the first melt component limitations as instant claimed. Likewise, Applicants assert the granules of Kimata et al combined with the polymeric layer of Tiwari et al could not meet the specific combination as instantly claimed. Second, Applicants disagree with the assertion in the prior Office Action that the polymers of claim 1 being a contingent limitation that are only required when the first melt component is stearic acid or lauromacrogol, and asserts that the present application clearly recites “the first melt component is selected from a group consisting of glycerin monostearate, macrogol, lauromacrogol and stearic acid” and “the polymer is selected from a group consisting aminoalkyl methacrylate copolymers, ammonioalkyl methacrylate copolymers, methacrylic acid copolymers, Hypromellose acetate succinates and polyvinylpyrrolidones when the first melt component is stearic acid or lauromacrogol.” Third, Applicants assert the object of minimizing or preventing contact of the active agent with the core, which may cause degradation of the drug and loss of potency of the pharmaceutical formulations is different from the objective of claim 1 of the present application which is to provide granules having a high content of the active ingredient and a high uniformity of particle size.
First, respectfully, this argument is not persuasive. Applicants appear to be asserting that it would not have been obvious to include the preferred polymers of Tiwari et al as a barrier layer on the granules of Kimata et al, but Tiwari et al was not cited for teaching the specific type of polymers. While the examiner recognizes that Tiwari et al lists preferred polymers, the reference more broadly teaches that it was known to include a first coating without an active agent on a core particle, where doing so was known to act as a barrier to minimize or prevent contact of the active agent with the core, which was known to cause degradation of the active agent and loss of potency of the pharmaceutical formulation. 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 a polymer were known to be coated onto granular particles as a barrier for the above mentioned benefits. Accordingly, it would have been obvious to modify the first melt component layer made of Kimata et al, by simply excluding the active agent in in the first melt component layer, in order to prevent degradation and loss of potency of the active agent, as taught by Tiwari et al.
Second, respectfully, this argument is not persuasive. Applicants appear to be asserting that the inclusion of the polymers as recited in claim 1 are not a contingent limitation and is required, however, as recited in claim 1, “the first active-ingredient containing layer contains and active ingredient and a second melt component or a polymer,” and “the polymer is selected from the group consisting of… when the first melt component is stearic acid or lauromacrogol.” (emphasis added) Here, the active ingredient layer comprises a second melt component or a polymer, not both. Where the combination made obvious above comprises the first melt component polyethylene glycol 6000 (macrogol) and the second melt component polyethylene glycol 4000 (macrogol) or cetyl alcohol, the listed polymers are not required to meet the claimed limitations. Additionally, even if the polymer were selected for the second active ingredient containing layer in lieu of the second melt component, this limitation is a contingent limitation that are only required when the first melt component is stearic acid or lauromacrogol. But as stearic acid or lauromacrogol are included in a list with other suitable melt components, the additional polymer limitations do not apply if stearic acid or lauromacrogol are not present as the first melt component in the formulation. Here, stearic acid and lauromacrogol are not present, therefore the limitations do not apply to the composition.
Third, respectfully, this argument is not persuasive. Applicants assert the motivation provided by Tiwari et al for including a first melt component consisting of those instantly claimed is different, however, the motivation for including the first melt component as instantly claimed can be different than Applicants’ desired motivation. While the motivation for including the first melt component as instantly claimed is for purposes of minimizing or preventing contact of the active agent with the core, which was known to cause degradation of the drug and loss of potency, as taught by Tiwari et al, upon modifying the granules of Kimata et al, the resulting granule appears to be the same regardless of the motivation used.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kimata et al (JP H06256169 A) 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 formulation the granules of Kimata et al, 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 are rejected under 35 U.S.C. 103 as being unpatentable over Kimata et al (JP H06256169 A), Tiwari et al (WO 2018065826 A1), and Nakano (JP 2017001999 A), 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, 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
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 5-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/942,333 (reference application), hereinafter referred to as ‘333, in view of Kimata et al (JP H06256169 A), Tiwari et al (WO 2018065826 A1), Nakano (JP 2017001999 A), and Felton et al (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 47, pp. 3–14). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘333 disclose a granule comprising an active ingredient, a melt component, and a polymer, wherein the active agent, the melt component, and the polymer are bound (claim 1). The melt component has a melting point of 100 deg C or lower (claim 2). The polymer is selected from aminoalkyl methacrylate copolymers, etc., when the melt component is stearic acid or lauromacrogol (claim 4). Also disclosed is a preparation comprising the granule according to claim 1 and one or more pharmaceutically acceptable additive agents, wherein the additive is a disintegrant (claims 8, 9).
The claims of ‘333 do not specifically disclose that there are two layers, wherein the nuclear material is spherical, specifically that the nuclear material has pores, nor the nuclear material being larger than the particle size of the active and melt component.
It would have been obvious to formulate the granules with a first and second layer, with the active in the second layer, where granules comprising this structure were known to have high drug concentrations, as taught by Kimata et al.
Regarding wherein the first layer consists of the melt component, 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 wherein the second melt component is different than the first melt component, where the claims of ’333 disclose multiple melt components are suitable, it would have been obvious to formulate the first and second melt component made obvious above with different melt components. Further support is provided by Kimata et al, where it was known to include two different melt components as the melt component layer and the active ingredient containing layer. As such, it would have been obvious to use different melt components for the different layers, which were known to be suitable for granules coated with active ingredient containing melt component layers.
It would have been obvious to use spherical core particles (i.e., nuclear material), for the same reasons discussed above by Tiwari et al or Nakano.
It would have been obvious to use known nuclear materials suitable for coated granules, such as magnesium aluminometasilicate, as taught by Nakano, which is evidenced above as having pores. Further motivation for the selection of a porous nuclear material is also provided by Felton et al, and is obvious for the same reasons discussed above.
It would have been obvious to use nuclear materials that are larger than the particle size of the active ingredient, as taught by Nakano. Further, it would have been obvious to use particle size of the second melt component that is smaller than the nuclear material, as taught by Kimata et al for the same reasons discussed above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants assert the Office has failed to show that ‘333 describes the newly amended limitations of claim 1 of the present application.
This argument is not persuasive. While the claims of ‘333 recite that the active ingredient, the melt component, and the polymer are bound, it would have been obvious for the skilled artisan to include an additional melt component layer between the core and the active ingredient containing layer, where this structure was known from Tiwari et al to provide the benefit of minimizing or preventing contact of the active agent with the core, in order to avoid degradation of the drug and loss of potency of the pharmaceutical formulation.
Conclusion
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