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 .
Response to Arguments
Applicant's arguments and the Declaration, both filed 1/12/2026, have been fully considered (and addressed together below) but they are not persuasive. All rejections are hereby maintained.
103 Rejection over Anastassov in view of Etsey, Renwick, and Bondu
Applicant argues, citing Dr. Neergard’s explanation, that the kneading method disclosed in Anastassov cannot result in the present claimed invention because the kneading process results in the formation of a “complex” wherein the components are integrated with each other on a molecular level and are therefore not adsorbed to the surface. This is not persuasive as Dr. Neergard has merely provided his opinion without citing to any factual evidence or data, thus amounting to conclusory statements. Furthermore, the formation of a complex wherein the components are integrated on a molecular level is not incompatible with the adsorption of sugar alcohol particles to the cannabinoid. As evidenced by Atif et al. (2022), there are different types of adsorption processes including surface adsorption (surface physisorption) through intermolecular/van der Waals forces [3.1] and chemisorption wherein a chemical bond is formed between a molecule and a surface [3.2]. Thus, the integration of the components on an intermolecular level can still be a type of adsorption. Atif also discusses a specific type of physisorption wherein complex formation occurs, further evidencing that the formation of a complex can still read on adsorption [3.1.] Furthermore, Anastassov teaches that its method results in a homogenous mixture. Thus, some of the cannabinoid would necessarily be in contact with the surface of the sugar alcohol, thus reading on surface adsorption (i.e. physisorption via van der Waals forces, which exist between all molecules).
Regarding the arguments about “reversible association”, the interaction between a surface and an adsorbent through van der Waals forces is considered a type of surface adsorption, as discussed above [Atif 3.1]. Thus, “reversibly associated” can still be interpreted to read on “adsorbed to the surface”. The instant specification does not define or narrow “surface adsorption” to any specific type of intermolecular interaction, thus “surface adsorption” as taught in the prior art and broadly interpreted is not inconsistent with the instant claims.
Applicant also argues that the prior art does not teach the instantly claimed first and second portion of sugar alcohol particles. This is not persuasive as the instant claim language does not exclude the possibility that the “first” portion comprises cannabinoids as well. Therefore, the first and second portion may be compositionally identical. Since this embodiment still reads on the claim language, the distinction between the first portion and the second portion/premixture essentially amounts to an expression of the steps required to form the claimed invention. However, the patentability of a product does not depend on its method of production but rather the product itself. Thus, the composition of Anastassov reads on the instant claims, consistent with an interpretation wherein the first and second portion both comprise of cannabinoids and sugar alcohol. It is immaterial that Anastassov does not teach a method wherein a separate first portion of sugar alcohol without cannabinoid is being added to a premixture, since the selection of any order of performing process steps and mixing ingredients is immaterial in the absence of new or unexpected results. See MPEP 2144.04. Additionally, the argument that Anastassov does not teach sugar alcohol particles is not found persuasive since it teaches that sugar alcohols are solid [0012] with sugar-like physical properties [0013] (i.e. particles). Anastassov also teaches that the cannabinoid and sugar alcohol complex may be in powder form [0036].
In response to applicant's argument that the teachings relied upon from the cited references are incompatible, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Finally, as for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Nonstatutory Double Patenting Rejections
Regarding the non-statutory double patenting rejections, as applicant has not addressed the merits of the rejections, the double patenting rejections are maintained for reasons of record.
Maintained Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-17 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160220593 to Anastassov et al (Anastassov), WO 2017223309 to Etsey et al (Etsey), US 20180221332 to Renwick et al (Renwick) and US 20120276199 to Bondu et al (Bondu).
Instant claim 1 is are directed to: A single-layered compressed cannabinoid tablet, the tablet comprising a tablet formulation including: a first portion of one or more sugar alcohol particles in an amount of 50 to 90% by weight of the tablet, one or more disintegrants in an amount of 0.5 to 25% by weight of the tablet operable to disintegrate the tablet within a period of 2 minutes or less than 2 minutes in contact with oral saliva, and a second portion of a premixture comprising one or more cannabinoids adsorbed to the surface of one or more sugar alcohol particles, wherein cannabinoids are not adsorbed to silica in the tablet formulation.
Anastassov teaches a composition comprising multiple granules each granule comprising a complex of at least one sugar alcohol and at least one cannabinoid wherein the composition is in the form of a tablet (0051-0053). For the claimed cannabinoids (clams 14-17), see paragraph [0005-0011]. For the sugar alcohol, Anastassov teaches isomalt, mannitol, sorbitol and xylitol [0012-0016]. Anastassov teaches that the cannabinoid and at least sugar alcohol is at 1:5 to 1:30 [0042] and in a powder form [0036], which falls within the range of claim 11.
Anastassov teaches that the complex may be produced by several methods such as just kneading cannabinoid [0047]. Thus, a process of kneading reads on “adsorption” of cannabinoid on sugar alcohol and can be interpreted that cannabinoid is adsorbed on the surface of sugar alcohol in Anastassov, particularly, in light of the higher amount of sugar alcohol than cannabinoid, as explained above. Moreover, instant specification defines “premixture” (p 15-16) to be intended to mean that the one or more cannabinoids have been mixed with the one or more solid particles, such as solid sugar alcohol particles, prior to being applied in the tablet formulation together with the sugar alcohol formulation.
With respect to the limitation “one or more cannabinoids adsorbed to the surface of one or more sugar alcohol particles”, Applicants refer to the [0065-0070] of the instant specification. A review of the instant disclosure at [0065-0070] provides that the premix allows reversible association of cannabinoids with sugar alcohols with cannabinoids distributed properly. The process of reversible association (of the instant disclosure) does not appear to differ from kneading step of Anastassov. And hence meets the claimed arrangement of cannabinoids adsorbed on the surface of sugar alcohol particles.
[0047] of the reference does not teach any solvent and hence meet claim 13.
Anastassov teaches emulsifying agents can be included in the tablet ([0049]). The tablet composition of does not comprise silica and therefore meet the instant limitation “wherein cannabinoids are not adsorbed to silica in the tablet formulation”. Thus, the teachings of Anastassov meet the instant second portion of the claimed tablet. Anastassov teaches a tablet composition which can be construed as a single layer because the reference does not state or describe layered tablet.
Anastassov does not teach the instant claimed disintegrants and a portion containing the same in combination with sugar alcohols.
Etsey teaches oral, chewable and fast or slow dissolvable composition comprising cannabinoid. For the claimed cannabinoids, Etsey teaches cannabinoids, cannabidiol etc [p, 6-7 and page 10, l 4-7). Etsey teaches compositions in the form of chewing gum (page 10, l 23-31), tablet (p 13, l 31), and lozenges (page 12, l 30-31) that disintegrate in 1 minute or more in the mouth of a subject. Etsy particularly teaches employing sugar alcohols in an amount of about 10% to about 80% by weight of the composition, and includes instant claimed sorbitol, isomalt, xylitol, maltitol, erythritol or combinations thereof (p 11, l 18-20) , and additionally include flavoring agents (p 12, l 1-15). The composition includes a sugar alcohol in an amount of 55% to 70% by weight (p 13, l 15-17), which includes xylitol, mannitol, erythritol etc (p 11, l 28-31). Table 1 of Etsy describes 62.37% sorbitol, 20-79% microcrystalline cellulose (MCC) and 2.49% cannabinoid. Table 1 teaches microcrystalline cellulose, which meets the disintegrant of instant claims. Table 1 further includes the claimed amounts disintegrant. Etsy teaches that the composition of table 1 dissolves in less than 1 minute in oral or sublingual cavity, with an increase or decrease in the amounts of MCC and bamboo fiber concentration. Because table 1 of Etsy meets the claimed components and their amounts, and hence the properties of instant claims are inherent to the composition of Etsy.
Hence, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the composition of Anastassov comprising cannabinoid and sugar alcohol prepared by kneading [0047], and further modify by including disintegrants such as MCC, and optimize the amounts of MCC and sugar alcohols, so as to arrive at the instant claimed composition comprising not only sugar alcohol particles with cannabinoids adsorbed on the surface but also include a fast disintegrating portion comprising disintegrants and sugar alcohol particles separately. One of an ordinary skill in the art would have been motivated to do so because Etsey suggests tablets comprising disintegrants in the sugar alcohol and cannabinoid composition provides rapid or fast disintegration of the composition of the said tablet or lozenge. Accordingly, one of an ordinary skill in the art would have expected that the modification results in a fast-disintegrating cannabinoid composition as claimed.
Anastassov and Etsey does not teach the instant compressed tablet formulations.
Renwick teaches flash-melt cannabinoid formulations in the form of compressed tablets, wherein the composition comprises cannabinoid, microcrystalline cellulose, mannitol and flavoring are mixed in a blender [0079-0082]. Further, Renwick teaches all of the instant disintegrants selected from croscarmellose sodium, crospovidone (same as cross-linked polyvinyl pyrrolidone), sodium starch glycolate, sodium carboxymethyl cellulose, hydroxypropyl cellulose, alginic acid, alginates, polacrilin potassium or combination thereof ([0072]). Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the cannabinoid composition of Anastassov and include any of the instant disintegrants (taught by Etsey), along with cannabinoid and sugar alcohol, and further prepare compressed tablets because Renwick reference, analogous to the teachings of Anastassov and Etsey, teaches fast disintegrating cannabinoid tablets by employing sugar alcohols super disintegrants formulated in to compressed tablets and provide flash-melting and rapid disintegration.
While instant tablet recites a first portion of one or more sugar alcohol particles in an amount of 50 to 90% by weight of the tablet and one or more disintegrants in an amount of 0.5 to 25% by weight, and a second portion comprising a premixture comprising one or more cannabinoids adsorbed to one or more sugar alcohol particles, the term “comprising” allows for the presence of a cannabinoid in the first portion and disintegrants in the second portion. Accordingly, the present claims allow for both the first and second portions to be of the same composition for enhanced release of cannabinoid and in this regard, Anastassov teaches multiple granules and each comprising cannabinoid and sugar alcohol and in the form of a tablet. Therefore, it can be interpreted that each of the granule read on a portion claimed.
In any event, the teachings of Bondu have been relied upon for the separate portions of a tablet comprising different compositions and including sugar alcohol and disintegrants as claimed.
Bondu teaches taste masked pharmaceutical formulations for rapid disintegration [0102] and comprising an intragranular portion and an extragranular portion (0021). Bondu teaches that both the intragranular and the extragranular portions comprises sugar alcohols (claims 18 and 25-26). Bondu teaches that the composition is compressible [0105]. Examples 1-4 of Bondu teaches different amounts of mannitol in the intragranular and extragranular component at 319.8 mg per 620 mg of tablet (which is about 51.6 % by weight of the tablet) (example 4A). Further, the different portions of the tablets (intra and extragranular) include disintegrants.
Hence, it would have been obvious to one of ordinary skill in the art before the effective filing to have modified the teachings of Anastassov (modified by Etsey and Renwick) and further include two portions (also construed as intra and extragranular components) each comprising sugar alcohols, and incorporate disintegrants and/or the claimed cannabinoids, with an expectation to not only provide fast disintegration (Anastassov, Renwick and Etsey) but also mask the taste of cannabinoids. One of an ordinary skill in the art would be motivated because Bondu teaches taste masked pharmaceutical formulations with the use of sugar alcohols in both intra and extragranular components. In this regard, Anastassov also recognizes sugar alcohols as providing sweet taste. One of an ordinary skill in the art would have further been motivated to employ the optimum amounts of the first and second portions in the final tablet of Anastassov (modified by Etsey, Renwick and Bondu) without affecting the taste as well as fast disintegration property of said tablets.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160220593 to Anastassov et al (Anastassov), WO 2017223309 to Etsey et al (Etsey), US 20180221332 to Renwick et al (Renwick) and US 20120276199 to Bondu et al (Bondu), as applied to claims 1-17 and 21-24, and further in view of US 10028919 to Kaufman.
Anastassov, Etsey, Renwick and Bondu, discussed above, fails to teach the instant emulsifiers and lipid carriers.
Kaufman teaches lipid nanoparticle compositions and methods as carriers of cannabinoids, wherein the cannabinoids are formed from phospholipids and simpler lipids, provides increased bioavailability (abstract,). Kaufmann teaches phytocannabinoids such as cannabidiol and THC (col. 2, l 23-62 and Summary of the invention). Kaufman teaches lipid nanospheres (see col. 5, l 12-55) for encapsulating the active agent and cannabinoids such as those of the instant claims (col. 5, l 56-col. 6, l 6). Kaufman teaches that the surfactant provides less surface tension (col. 7, 10-17). Kaufman teaches compositions comprising cannabinoids, phospholipids, polysorbate, surfactant and other excipients (examples) including sweeteners such as sugar alcohol, for oral administration and in the form of tablet, lozenge, pellets etc.
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the cannabinoid composition of Anastassov (modified by Etsey, Renwick and Bondu) by further including lipid carriers and surfactants so as to arrive at the instant composition of instant claims 18 and 19. One of an ordinary skill in the art would have been motivated to do so because Kaufman further teaches that the composition increases cannabinoid transport across hydrophobic mucosa, increase its bioavailability and further reduce the amount of cannabinoid needed to administer i.e., 2-fold to 8-fold, thus reduce the adverse effects of cannabinoids and improve the efficacy of cannabinoids (col. 12, l 35-46).
Double Patenting
Claims 1-17 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No.11529329 in view of US 20160220593 to Anastassov et al (Anastassov), WO 2017223309 to Etsey et al (Etsey), US 20180221332 to Renwick et al (Renwick) and US 20120276199 to Bondu et al (Bondu).
The patented claims of US patent No 11529329 are directed to compressed tablet comprising one or more cannabinoids, a bulk portion comprising bulk sweeteners in an amount of 30-70% by weight, and a gum base.
Patented claim compositions do not include the instant claimed sugar alcohols and disintegrants.
However, the teachings of Anastassov, Etsey, Renwick and Bondu, discussed above and incorporated herewith in full, teaches and suggests the instant claimed tablet comprising cannabinoid, sugar alcohol and disintegrants, the claimed amounts of the same, and further suggests the claimed compressed tablet. Anastassov further suggests the kneading of sugar alcohol and cannabinoid to form solid particles, which meets the instant premix comprising cannabinoid adsorbed on sugar alcohol.
Anastassov teaches that the complex may be produced by several methods such as just kneading cannabinoid and sugar alcohol [0047]. Thus, a process of kneading reads on “adsorption” of cannabinoid on sugar alcohol and can be interpreted that cannabinoid is adsorbed on the surface of sugar alcohol in Anastassov, particularly, in light of the higher amount of sugar alcohol than cannabinoid, as explained above. Moreover, instant specification defines “premixture” (p 15-16) to be intended to mean that the one or more cannabinoids have been mixed with the one or more solid particles, such as solid sugar alcohol particles, prior to being applied in the tablet formulation together with the sugar alcohol formulation.
With respect to the limitation “one or more cannabinoids adsorbed to the surface of one or more sugar alcohol particles”, Applicants refer to the [0065-0070] of the instant specification. A review of the instant disclosure at [0065-0070] provides that the premix allows reversible association of cannabinoids with sugar alcohols with cannabinoids distributed properly. The process of reversible association (of the instant disclosure) does not appear to differ from kneading step of Anastassov. And hence meets the claimed arrangement of cannabinoids adsorbed on the surface of sugar alcohol particles.
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the cannabinoid composition of the patented claims by further modifying to include the instant claimed amounts of sugar alcohols and disintegrants and prepare compressed tablet composition with an expectation to provide fast disintegration of the cannabinoid tablet within 2 minutes. One of an ordinary skill in the art would have employed the method of preparing the claimed mix of cannabinoid and sugar alcohol, in the claimed amounts, because Anastassov teaches kneading the two components and further Etsey (cannabinoid) and Renwick teaches sugar alcohols for providing fast disintegration of tablets. Moreover, one of an ordinary skill in the art would have been motivated to prepare the composition of patented claims with two different portions (instant portions construed as intra and extragranular components) each comprising sugar alcohol along with active agent (cannabinoid), disintegrants etc., so as to not only provide the desired disintegration speed of the tablet but also provide taste masking suggested by Bondu. Patented claims do not recite adsorption of cannabinoids on colloidal silica and hence meet instant claims.
Claims 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 1-21 of U.S. Patent No.11529329 in view of US 20160220593 to Anastassov et al (Anastassov), WO 2017223309 to Etsey et al (Etsey), US 20180221332 to Renwick et al (Renwick) and US 20120276199 to Bondu et al (Bondu), as applied to claims 1-17 and 20-24 in view of US 10028919 to Kaufman.
The above patented claims, Anastassov, Etsey, Renwick and Bondu fail to teach the instant emulsifiers and lipid carriers.
Kaufman teaches lipid nanoparticle compositions and methods as carriers of cannabinoids, wherein the cannabinoids are formed from phospholipids and simpler lipids, provides increased bioavailability (abstract,). Kaufmann teaches phytocannabinoids such as cannabidiol and THC (col. 2, l 23-62 and Summary of the invention). Kaufman teaches lipid nanospheres (see col. 5, l 12-55) for encapsulating the active agent and cannabinoids such as those of the instant claims (col. 5, l 56-col. 6, l 6). Kaufman teaches that the surfactant provides less surface tension (col. 7, 10-17). Kaufman teaches compositions comprising cannabinoids, phospholipids, polysorbate, surfactant and other excipients (examples) including sweeteners such as sugar alcohol, for oral administration and in the form of tablet, lozenge, pellets etc.
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the cannabinoid composition of the patent claims (modified by Anastassov, Etsey, Renwick and Bondu) as a compressed tablet, and further include lipid carriers and surfactants so as to arrive at the instant composition of instant claims 18 and 19. One of an ordinary skill in the art would have been motivated to do so because Kaufman further teaches that the composition increases cannabinoid transport across hydrophobic mucosa, increase its bioavailability and further reduce the amount of cannabinoid needed to administer i.e., 2-fold to 8-fold, thus reduce the adverse effects of cannabinoids and improve the efficacy of cannabinoids (col. 12, l 35-46).
Claims 1-18 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US Patents No.11633351 in view of US 20160220593 to Anastassov et al (Anastassov), US 20180221332 to Renwick et al (Renwick) and US 20120276199 to Bondu et al (Bondu).
The patented claims of US patent No 11633351 are directed to a composition comprising a two-tablet module including a fast-disintegrating tablet and a lozenge tablet each comprising one or more cannabinoids, sugar alcohols, and further in the claimed amounts. The patented claims recite the same ratio of cannabinoid and sugar alcohol, and further suggests emulsifying agent of instant claim 18. Both claim sets recite a fast-disintegrating tablet that disintegrates within 2 minutes. Patented claims do not recite adsorption of cannabinoids on colloidal silica and hence meet instant claims. Patented claims do not recite a compressed tablet.
The teachings of Anastassov, Renwick and Bondu, discussed above and incorporated herewith in full, teaches and suggests the instant claimed tablet comprising cannabinoid, sugar alcohol and disintegrants, the claimed amounts of the same. Anastassov further suggests the kneading of sugar alcohol and cannabinoid to form solid particles, which meets the instant premix comprising cannabinoid adsorbed on sugar alcohol. Furthermore, Renwick teaches cannabinoid claimed compressed tablet.
Anastassov teaches that the complex may be produced by several methods such as just kneading cannabinoid. Thus, a process of kneading reads on “adsorption” of cannabinoid on sugar alcohol and can be interpreted that cannabinoid is adsorbed on the surface of sugar alcohol in Anastassov, particularly, in light of the higher amount of sugar alcohol than cannabinoid, as explained above. Moreover, instant specification defines “premixture” (p 15-16) to be intended to mean that the one or more cannabinoids have been mixed with the one or more solid particles, such as solid sugar alcohol particles, prior to being applied in the tablet formulation together with the sugar alcohol formulation.
With respect to the limitation “one or more cannabinoids adsorbed to the surface of one or more sugar alcohol particles”, Applicants refer to the [0065-0070] of the instant specification. A review of the instant disclosure at [0065-0070] provides that the premix allows reversible association of cannabinoids with sugar alcohols with cannabinoids distributed properly. The process of reversible association (of the instant disclosure) does not appear to differ from kneading step of Anastassov. And hence meets the claimed arrangement of cannabinoids adsorbed on the surface of sugar alcohol particles.
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the cannabinoid composition of the patented claims by further modifying with the teachings of Anastassov so as to prepare sugar alcohol and cannabinoid particles by kneading because Anastassov teaches complex enhances the release of cannabinoid. Further, one of an ordinary skill in the art would have been able to prepare the composition of patented claims as a compressed tablet composition with an expectation to provide fast disintegration of the cannabinoid tablet within 2 minutes. One of an ordinary skill in the art would have been motivated to do so because Renwick teaches sugar alcohols for providing fast disintegration of tablets and suggests preparing compression tablets. Moreover, Bondu provides the motivation to prepare the composition (of Anastassov) with two different portions (instant portions construed as intra and extragranular components) each comprising sugar alcohol along with active agent (cannabinoid), disintegrants etc. Therefore, one of an ordinary skill in the art would have been able to modify so as to provide the desired disintegration speed of the tablet. Patented claims do not recite adsorption of cannabinoids on colloidal silica and hence meet instant claims.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No.11633351 in view of US 20160220593 to Anastassov et al (Anastassov), US 20180221332 to Renwick et al (Renwick) and US 20120276199 to Bondu et al (Bondu), as applied to claims 1-18 and 21-24, and further in view of US 10028919 to Kaufman.
The above patented claims, Anastassov, Etsey, Renwick and Bondu references fail to teach the instant lipid carriers.
Kaufman teaches lipid nanoparticle compositions and methods as carriers of cannabinoids, wherein the cannabinoids are formed from phospholipids and simpler lipids, provides increased bioavailability (abstract,). Kaufmann teaches phytocannabinoids such as cannabidiol and THC (col. 2, l 23-62 and Summary of the invention). Kaufman teaches lipid nanospheres (see col. 5, l 12-55) for encapsulating the active agent and cannabinoids such as those of the instant claims (col. 5, l 56-col. 6, l 6). Kaufman teaches that the surfactant provides less surface tension (col. 7, 10-17). Kaufman teaches compositions comprising cannabinoids, phospholipids, polysorbate, surfactant and other excipients (examples) including sweeteners such as sugar alcohol, for oral administration and in the form of tablet, lozenge, pellets etc.
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the cannabinoid composition of the patent claims (modified by Anastassov, Etsey, Renwick and Bondu) as a compressed tablet, and further include lipid carriers and surfactants so as to arrive at the instant composition of instant claim. One of an ordinary skill in the art would have been motivated to do so because Kaufman further teaches that the composition increases cannabinoid transport across hydrophobic mucosa, increase its bioavailability and further reduce the amount of cannabinoid needed to administer i.e., 2-fold to 8-fold, thus reduce the adverse effects of cannabinoids and improve the efficacy of cannabinoids (col. 12, l 35-46).
Claims 1-19 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US Patents No.10925853 in view of US 20160220593 to Anastassov et al (Anastassov), WO 2017223309 to Etsey et al (Etsey), US 20180221332 to Renwick et al (Renwick) and US 20120276199 to Bondu et al (Bondu).
The claims of US patent No 10925853 are directed to a composition comprising chewable tablet comprising one or more cannabinoids, claimed sugar alcohols, emulsifying agents and oil carriers. The patented claims recite the same ratio of cannabinoid and sugar alcohol and fast-disintegrating tablet that disintegrates within 2 minutes. Patented claims further recite a compressible tablet. Patented claims do not recite adsorption of cannabinoids on colloidal silica and hence meet claim 1. Patented claims further recite the instant claimed ratio of cannabinoids and sugar alcohols. The above patented claims do not teach the instant claimed disintegrants, binders and the natural extracts and isolated cannabinoids. Patented claims lack the specific teaching of adsorption of cannabinoid on sugar alcohol, instant first and second portions and compressed tablet.
However, the teachings of Anastassov, Etsey, Renwick and Bondu, discussed above and incorporated herewith in full, teaches and suggests the instant claimed tablet comprising cannabinoid, sugar alcohol and disintegrants, the claimed amounts of the same, and further suggests the claimed compressed tablet. Anastassov further suggests the kneading of sugar alcohol and cannabinoid to form solid particles, which meets the instant premix comprising cannabinoid adsorbed on sugar alcohol.
Anastassov teaches that the complex may be produced by several methods such as just kneading cannabinoid [0047]. Thus, a process of kneading reads on “adsorption” of cannabinoid on sugar alcohol and can be interpreted that cannabinoid is adsorbed on the surface of sugar alcohol in Anastassov, particularly, in light of the higher amount of sugar alcohol than cannabinoid, as explained above. Moreover, instant specification defines “premixture” (p 15-16) to be intended to mean that the one or more cannabinoids have been mixed with the one or more solid particles, such as solid sugar alcohol particles, prior to being applied in the tablet formulation together with the sugar alcohol formulation. With respect to the limitation “one or more cannabinoids adsorbed to the surface of one or more sugar alcohol particles”, Applicants refer to the [0065-0070] of the instant specification. A review of the instant disclosure at [0065-0070] provides that the premix allows reversible association of cannabinoids with sugar alcohols with cannabinoids distributed properly. The process of reversible association (of the instant disclosure) does not appear to differ from kneading step of Anastassov. And hence meets the claimed arrangement of cannabinoids adsorbed on the surface of sugar alcohol particles.
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the cannabinoid composition of the patented claims by further modifying to include the instant claimed amounts of sugar alcohols and disintegrants, and prepare compressed tablet composition with an expectation to provide fast disintegration of the cannabinoid tablet within 2 minutes. One of an ordinary skill in the art would have employed the method of preparing the claimed mix of cannabinoid and sugar alcohol, in the claimed amounts, because Anastassov teaches kneading the two components and further Etsey (cannabinoid), and Renwick teaches sugar alcohols for providing fast disintegration of tablets. Moreover, one of an ordinary skill in the art would have been motivated to prepare the composition of patented claims with two different portions (instant portions construed as intra and extragranular components) each comprising sugar alcohol along with active agent (cannabinoid), disintegrants etc., so as to not only provide the desired disintegration speed of the tablet but also provide taste masking suggested by Bondu.
Claims 1-19 and 21-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 138, 140-144, 146-156, 158, 160-161, 163 and 165 of copending Application No. 16/852168 (20200330425) in view of US 20160220593 to Anastassov et al (Anastassov), WO 2017223309 to Etsey et al (Etsey), US 20180221332 to Renwick et al (Renwick) and US 20120276199 to Bondu et al (Bondu).
The copending application claims are directed to a tablet for improved delivery of cannabinoids to mucosal surfaces comprising: i) a mucosal delivery enhancing component comprising: one or more cannabinoids; an agent with hydrophobic interacting properties; and a plurality of water-soluble solid particles present in the mucosal delivery enhancing component, the agent with hydrophobic interacting properties forming an encapsulation of the one or more cannabinoids in the mucosal delivery enhancing component, and the encapsulation being reversibly associated with the plurality of water-soluble solid particles present in the mucosal delivery enhancing component by adsorption; and ii) an extragranular component blended with the mucosal delivery enhancing component comprising one or more extragranular sugar alcohols present as sugar alcohol particles, wherein the lozenge tablet is compressed and disintegrates upon sucking or licking in minutes. Copending claims recite the same water-soluble solid particles i.e., sugar alcohols (claim 158 of the copending claim) and in amount that falls within the instant claims and further recites the same self-emulsifiers (claim 143 of copending claim). While instant claims recite first and second portion, copending claims recite a mucosal delivery enhancing component and an extragranular component. The above pending claims do not recite the instant disintegrant, its amount, compressed tablet, the claimed premix.
The teachings of Anastassov, Renwick and Bondu, discussed above and incorporated herewith in full, teaches and suggests the instant claimed tablet comprising cannabinoid, sugar alcohol and disintegrants, the claimed amounts of the same. Anastassov further suggests the kneading of sugar alcohol and cannabinoid to form solid particles, which meets the instant premix comprising cannabinoid adsorbed on sugar alcohol. Furthermore, Renwick teaches cannabinoid claimed compressed tablet.
Anastassov teaches that the complex may be produced by several methods such as just kneading cannabinoid and sugar alcohol. Thus, a process of kneading reads on “adsorption” of cannabinoid on sugar alcohol and can be interpreted that cannabinoid is adsorbed on the surface of sugar alcohol in Anastassov, particularly, in light of the higher amount of sugar alcohol than cannabinoid, as explained above. Moreover, instant specification defines “premixture” (p 15-16) to be intended to mean that the one or more cannabinoids have been mixed with the one or more solid particles, such as solid sugar alcohol particles, prior to being applied in the tablet formulation together with the sugar alcohol formulation.
With respect to the limitation “one or more cannabinoids adsorbed to the surface of one or more sugar alcohol particles”, Applicants refer to the [0065-0070] of the instant specification. A review of the instant disclosure at [0065-0070] provides that the premix allows reversible association of cannabinoids with sugar alcohols with cannabinoids distributed properly. The process of reversible association (of the instant disclosure) does not appear to differ from kneading step of Anastassov. And hence meets the claimed arrangement of cannabinoids adsorbed on the surface of sugar alcohol particles.
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the cannabinoid composition of the copending claims by further modifying with the teachings of Anastassov so as to prepare sugar alcohol and cannabinoid particles by kneading because Anastassov teaches complex enhances the release of cannabinoid. Further, one of an ordinary skill in the art would have been able to prepare the composition of copending claims as a compressed tablet composition with an expectation to provide fast disintegration of the cannabinoid tablet within 2 minutes. One of an ordinary skill in the art would have been motivated to do so because Renwick teaches sugar alcohols for providing fast disintegration of tablets and suggests preparing compression tablets. Moreover, Bondu provides the motivation to prepare the composition (of Anastassov) with two different portions (instant portions construed as intra and extragranular components) each comprising sugar alcohol along with active agent (cannabinoid), disintegrants etc. Therefore, one of an ordinary skill in the art would have been able modify so as to provide the desired disintegration speed of the tablet. Copending claims do not recite adsorption of cannabinoids on colloidal silica and hence meet instant claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
/AMANDA LYNN CHI/ Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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