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 .
In view of the amendment, previous 112(a) rejection on claims 1-11, previous 112(b) rejection on claims 1-11, previous 112(b) rejection on claim 2 and previous 112(b) rejection on claims 3-7 are hereby withdrawn.
In view of the amendment, previous 102(a)(1)/102(a)(2) and 103 rejections over Garabagi et al’870 are hereby withdrawn. Thus, applicant’s argument with respect to these rejections are now moot.
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.
Claim Objections
Claim 1 is objected to because of the following informalities: on line 1, applicant need to change “spray” to --- solid --- (see [0060] of present specification). Appropriate correction is required.
Claim 7 is objected to because of the following informalities: on line 2, applicant need to change “sodium stearyl” to --- sodium stearyl fumarate --- (as there is no compound called “sodium stearyl”). Appropriate correction is required.
Claim 9 is objected to because of the following informalities: (i) on line 3, applicant need to change “the composition of claim 1” to --- the formulation of claim 3 ---; and (ii) on line 4, applicant need to change “a disorder” to --- the disorder ---. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: on the last line, applicant need to change “and” to --- or ---. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: in [0007] of present specification, applicant need to change “sodium stearyl” to --- sodium stearyl fumarate ---.
Appropriate correction is required.
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.
Claim(s) 1-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over XU et al (WO 2023/055648 A1) (with Dangoor et al (WO 2023/126934 A1) and Zettl (US 2021/0236458 A1), which are being cited here merely to support the Examiner’s assertion that CBD and THC act synergistically to relieve symptoms, such as inflammation and pain).
Xu teaches (see claim 1, abstract and [0009]) a solid dispersion matrix formulation (having an enhanced dissolution for an increased oral bioavailability for CBD in a pharmaceutically acceptable dosage form) comprising CBD and a polymer selected from PVP, poly(vinylpyrrolidone-vinyl acetate) copolymer or mixtures thereof, wherein CBD is non-crystalline and uniformly dispersed in the matrix. Xu teaches ([0011], [0037] and [0059]) that in certain aspects, the solid dispersion matrix is an amorphous solid and that KollidonTR VA 64 (a copolymer of vinylpyrrolidone and vinyl acetate in a ratio of 6:4 by mass) is useful as a matrix former for CBD amorphous solid dispersions. Xu further teaches ([0036]) the equivalence of CBD and a combination of CBD and THC both as active ingredients that are suitably used in its formulation. Thus, based on Xu’s teaching, it would be obvious to one skilled in the art to form in Xu an amorphous solid dispersion matrix formulation comprising a combination of CBD and THC (instant at least two active agents selected from a cannabinoid and/or a terpene, wherein at least one of the active agents is selected from CBD, CBG, CBDA, THC, caryophyllene, limonene, linalool, alpha pinene, myrcene or humulene) and KollidonTR VA 64 (as the matrix for the amorphous solid dispersion) with a reasonable expectation of achieving enhanced dissolution for an increased oral bioavailability for CBD and THC in a pharmaceutically acceptable dosage form. Although Xu does not explicitly teach that its formulation is useful for alleviating a disorder of the gastrointestinal tract such as those listed in instant claim 8, since Xu teaches instant composition comprising instant at least two active agents (CBD and THC) in the form of an amorphous solid dispersion, it is the Examiner’s position that Xu’s amorphous solid dispersion matrix formulation containing the combination of CBD and THC and KollidonTR VA 64 would inherently be capable of being used for alleviating a disorder of the gastrointestinal tract (such as those listed in instant claim 8).
Thus, Xu renders obvious instant claims 1 and 8.
With respect to instant claim 2, as discussed above, Xu teaches using the combination of CBD and THC as its active ingredient. As evidenced by Dangoor et al (claim 1, [0011], [0038] and [00263]) or Zettl ([0010]), it is already known in the art that CBD and THC act synergistically to relieve symptoms, such as inflammation and pain, as compared to administering THC or CBD separately. Thus, Xu renders obvious instant claim 2.
With respect to instant claims 3-4, Xu teaches that (claim 6) its solid dispersion matrix (amorphous solid dispersion matrix) can be in a form of tablet. Thus, Xu renders obvious instant claims 3-4.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over XU et al (WO 2023/055648 A1) in view of Morrison (US 2002/0147159 A1).
Xu teaches ([0008]) that its CBD formulation can be provided in a sustained-release tablet form and teaches ([0077]) that its solid dispersion matrix provides a near complete dissolution (no less than 80%) and release of the CBD within 24 hours and that this slow and prolonged dissolution is preferred for a dosage form that is intended to provide a sustained action (i.e., a sustained release) of CBD. Even though Xu does not explicitly teach that its sustained-release tablet is coated, as evidenced by Morrison ([0014]), it is well known in the art that a sustained release can be achieved by two common methods: (i) by providing a sustained release coating upon tablets wherein slow release of the active ingredient occurs via gradual breakdown of this coating; or (ii) by providing a sustained release matrix, such as a polymeric material intermixed with the active ingredient in the tablet itself. It would be obvious to one skilled in the art to further provide a sustained release coating on Xu’s sustained-release tablet (which is obtained by providing a sustained release matrix) so as to ensure the sustained release of CBD and THC in Xu. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art,” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). Thus, Xu in view of Morrison renders obvious instant claim 5.
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over XU et al (WO 2023/055648 A1) in view of GARABAGI et al (US 2021/0186870 A1).
In Xu’s Example 2 ([0097]-[0098]), its solid dispersion matrix was co-milled to fine powder, and that the solid dispersion matrix powder was mixed with microcrystalline cellulose, starch and magnesium stearate, and the mixed powder was compressed into tablets. Xu does not teach the use of instant croscarmellose sodium, colloidal silicon dioxide, mannitol or sodium stearyl of claims 6-7. Xu teaches (claim 13) that its formulation can comprise one or more excipients including fillers, disintegrants and lubricants. As evidenced by Garabagi (see abstract and [0185]), mannitol (filler), croscarmellose sodium (disintegrant), colloidal silicon dioxide (lubricant) and sodium stearyl fumarate (lubricant) are well known among commonly used excipients in cannabinoid formulations for oral administration. It would have been obvious to one skilled in the art to further use excipients including mannitol, croscarmellose sodium, colloidal silicon dioxide and sodium stearyl fumarate in Xu’s tablet formulation with a reasonable expectation of success. Thus, Xu in view of Garabagi renders obvious instant claims 6 and 7.
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over XU et al (WO 2023/055648 A1) in view of Rudnic et al (US 2023/0338399 A1).
Xu does not teach instant method of claim 9 for alleviating a gastrointestinal tract disorder. However, as evidenced by Rudnic ([0073], claims 12, 14, 36 and 41), it is already known in the art that oral formulations containing cannabinoid, such as CBD and THC, can be used in treating inflammatory gastrointestinal disorders, such as inflammatory bowel disease (IBD), GERD, Crohn’s disease, ulcerative colitis and irritable bowel syndrome (IBS). It would have been obvious to one skilled in the art to use Xu’s tablet formed of its amorphous solid dispersion matrix formulation containing CBD and THC in treating gastrointestinal disorders, such as IBD, GERD, Crohn’s disease, ulcerative colitis and IBS, with a reasonable expectation of success. Thus, Xu in view of Rudnic renders obvious instant claims 9-11.
Claim(s) 1-6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Rudnic et al (US 2023/0338399 A1) in view of Makriyannis et al (US 2025/0387335 A1) and Xu et al (WO 2023/055648 A1).
Rudnic teaches (abstract) oral cannabinoid pharmaceutical compositions used for treating inflammatory gastrointestinal disorders. Rudnic teaches ([0073]) that a pharmaceutical composition of its invention can include two or more cannabinoids and that the cannabinoid may be CBG, CBD, THC or any combinations thereof. Rudnic further teaches ([0110]) that in some embodiments, its oral dosage form may comprise CBG and CBD and teaches ([0152]) that its oral cannabinoid formulation may be in a solid dosage form, such as tablet or capsule. Based on Rudnic’s teaching, it would have been obvious to one skilled in the art to prepare an oral tablet formulation containing CBG and CBD with a reasonable expectation of treating inflammatory gastrointestinal disorders. In Table 1 of present specification, applicant list formulations containing CBD and CBG (i.e., Formulas 1 and 6) among “synergistic” combinations of formulations. Rudnic also teaches (claims 36 and 41) a method of treating an inflammatory gastrointestinal disorder (such as inflammatory bowel disease (IBD), Crohn’s disease, ulcerative colitis and GERD) comprising orally administering a therapeutically effective amount of its oral dosage form to a subject. Rudnic further teaches ([0133]) that its cannabinoid formulation for a delayed release may include a coating layer of one or more pH-dependent polymers.
With respect to the newly added limitation as to the composition being in the form of an amorphous solid dispersion (ASD), Rudnic does not explicitly teach such limitation. However, as evidenced by Makriyannis ([0002]), it is known in the art that in order to improve a drug’s kinetic solubility, formulators commonly use amorphous solid dispersions (ASD), wherein amorphous API is combined with a polymer (and optionally other excipients including surfactants). Techniques to convert a crystalline API to amorphous form include mixing with polymers, surfactants and other pharmaceutically acceptable carriers, excipients and/or solvents and apply these formulations towards spray dried dispersion and hot melt extrusion technologies and further towards pharmaceutically acceptable human dosage forms. The polymers in ASDs disarrange the crystalline lattice of the API and produce a higher energy amorphous state which exhibits higher dissolution rate, solubility and bioavailability. The polymers also prevent the recrystallization of the drug, maintain drug supersaturation and provide improved physical stability of API in accelerated temperature and humidity conditions which increases the overall shelf-life of the drug product. Furthermore, Xu teaches ([0009], [0011], [0037] and [0059]) an amorphous solid dispersion matrix formulation containing CBD (or CBD and THC) and KollidonTR VA 64 (this polymer is also mentioned in Makriyannis – see [0715]), which provides enhanced dissolution for an increased oral bioavailability for CBD in a pharmaceutically acceptable dosage form. Thus, based on the teachings of Makriyannis and Xu, it would have been obvious to one skilled in the art to have Rudnic’s tablet formulation containing CBG and CBD to be formed from an amorphous solid dispersion matrix formulation containing CBG and CBD and a polymer (such as KollidonTR VA 64) with a reasonable expectation of achieving higher dissolution rate, solubility and bioavailability for CBG and CBD.
Thus, Rudnic in view of Makriyannis and Xu renders obvious instant claims 1-5 and 8-11.
With respect to instant claim 6, Rudnic teaches ([0125] and [0131]]) that its cannabinoid formulations (both immediate release and delayed release formulations) may comprise one or more pharmaceutically acceptable excipients. Among examples of such excipients, Rudnic teaches ([0125], [0136], [0139], [0141], [0143]) a binder (such as microcrystalline cellulose and mannitol), a disintegrant (such as croscarmellose sodium), a lubricant (such as magnesium stearate), a flow aid (such as colloidal silicon dioxide) (see also Examples 1-3, 6, 10, 11 and 16, which use microcrystalline cellulose and croscarmellose sodium; see also compositions shown in Tables 8 and 20, which use colloidal silicone dioxide and magnesium stearate). It would have been obvious to one skilled in the art to add excipients, such as microcrystalline cellulose and mannitol (as a binder),croscarmellose sodium (as a disintegrant), magnesium stearate (as a lubricant), colloidal silicon dioxide (as a flow aid) and magnesium stearate (as a lubricant), in Rudnic’s oral tablet or capsule formulation containing CBG and CBD with a reasonable expectation of success. Thus, Rudnic in view of Makriyannis and Xu renders obvious instant claim 6.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rudnic et al (US 2023/0338399 A1) in view of Makriyannis et al (US 2025/0387335 A1) and Xu et al (WO 2023/055648 A1), as applied to claim 6 above, and further in view of LEVY (US 2019/0183850 A1).
As already discussed above, Rudnic teaches the use of mannitol (as a binder) and magnesium stearate (as a lubricant) in its oral tablet cannabinoid (CBG and CBD) formulation. Although Rudnic does not teach the use of sodium stearyl, as evidenced by Levy ([0215]), sodium stearyl fumarate is well-known in the art as a tablet lubricant. Because both magnesium stearate and sodium stearyl fumarate are being individually taught to be useful for the same purpose (i.e., useful as lubricants), it would have been obvious to one skilled in the art to use a combination of magnesium stearate and sodium stearyl fumarate (as lubricants) in Rudnic’s tablet cannabinoid formulation with a reasonable expectation of further enhancing the advantageous effect of using a lubricant. MPEP 2144.06 states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, Rudnic in view of Makriyannis and Xu, and further in view of Levy renders obvious instant claim 7.
Response to Arguments
With respect to the previous 103 rejection over Rudnic and previous 103 rejection over Rudnic in view of Levy, applicant argue that the amended claims now specify the amorphous solid dispersion nature of the composition and that this property is absent from the cited prior arts and thus provides meaningfully different properties to the composition that are not suggested in the prior arts. Applicant thus argue that none of the previous rejections in the Office Action constitutes a prima facie case of obviousness of the amended claims. The Examiner believes that applicant’s such argument is already answered above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
June 9, 2026
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