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 .
Claim Status
Claims 1, 3-9, 12-13 and 15-31 are pending.
Claims 2, 10-11 and 14 have been canceled.
Claims 1, 3-9, 12-13, 15-30 are currently amended.
Claims 16-17 and 20-31 are withdrawn.
Claims 1, 3-9, 12-13, 15 and 18-19 are currently under consideration.
Claims 1, 3-9, 12-13, 15 and 18-19 are rejected.
Acknowledgement of Receipt
This Office Action is in response to the Applicants’ amendments and remarks filed 03/05/2026.
Withdrawn Objections/Rejections
The objections to claims 3 and 4 are withdrawn.
In light of the new amendments and/or upon further consideration, the rejection of claims 1-4, 8 and 10 under 35 U.S.C. § 102 as being anticipated by Catalent, evidenced by Seager are withdrawn.
Maintained Rejections
The following rejections are maintained from the previous Office Action dated 10/24/2025 since the art that was previously cited continues to read on the newly amended limitations.
Applicants Claim
The instant claims are directed to a lyophilized rapidly infusing composition, comprising: a pharmaceutically acceptable binder and/or excipient system comprising gelatin and a sugar alcohol, and a solid form of tetrahydrocannabinol (claim 1); which has a disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37° C± 2° C (claim 3); disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37° C ± 2° C (claim 4); wherein the gelatin is present in the rapidly infusing composition in an amount of 10 to 50 wt. %, based on a total weight of the rapidly infusing composition on a dry basis (claim 5); wherein the gelatin is a bovine gelatin (claim 6); wherein the sugar alcohol is present in the rapidly infusing composition in an amount of 5 to 45 wt. %, based on a total weight of the rapidly infusing composition on a dry basis (claim 7); wherein the sugar alcohol is mannitol (claim 8).
Applicants claim that the lyophilized rapidly infusing composition wherein the tetrahydrocannabinol is present in the rapidly infusing composition in an amount of 0.3 to 25 wt. %, based on a total weight of the rapidly infusing composition on a dry basis (claim 9); wherein the tetrahydrocannabinol is in the form of a solid that has been micronized to have a D50 diameter between 1 and 50 µm (claim 12); wherein the tetrahydrocannabinol has a purity between 95 and 99.99 wt. % (claim 13); wherein the rapidly infusing composition further comprises at least one selected from the group consisting of a sweetener, a flavorant, and a colorant (claim 15); wherein the rapidly infusing composition comprises the sweetener, and the sweetener comprises a mixture of sucralose and acesulfame-K (claim 18) further comprising melatonin (claim 19).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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. Applicants are 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, 3-9, 12-13, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ridall et al. (US 2015/0133504 A1, cited on IDS) in view of Schaneville (US 10,632,164 B2, pub. 04/28/2020), evidenced by Mohammed (Pharmaceutics 3, 440-457, pub. 07/20/2011) herein referenced Ridall Schaneville, and Mohammed.
Ridall discloses pharmaceutical compositions for direct systemic introduction (DSI) pharmaceutical compositions comprising bovine gelatin, mannitol, an optional surfactant, an optional flavorant, and an active pharmaceutical ingredient (abstract). The composition has a disintegration time of 5 seconds or less in deionized water maintained at 37.0° C. ± 0.5° C (abstract, [0012], [0026], claim 7) and comprises: 5-25 mass % bovine gelatin, about 5-25 mass % mannitol, about 0-1 mass % of a surfactant, about 0-0.5 mass % of a flavorant, and about 50-90 mass % of an active pharmaceutical ingredient ([0011], claim 1).
Ridall teaches combining one or more active pharmaceutical ingredient(s) with bovine gelatin and water to form a pre-formulation, freezing the pre-formulation, reducing the pressure surrounding the pre-formulation, and lyophilizing the pre-formulation to form a DSI composition ([0051]). In one embodiment, Ridall teaches combining one or more active pharmaceutical ingredients with bovine gelatin and water and adding at least one compound chosen from mannitol, sweetener, sucralose (ELECTED), a flavorant and a surfactant ([0051]).
Ridall does not teach tetrahydrocannabinol (THC).
Schaneville discloses mucosally dissolvable films containing a matrix and one or more active substances, such as those obtained from hemp and/or cannabis, which may include cannabinoids (CBD) or THC within the matrix and methods for preparing such a film for pharmaceutical and nutraceutical applications (abstract, col. 1, lines 17-21; col. 2, line 14).
Schaneville explicitly teaches that the extract of cannabis and/or hemp consists essentially of tetrahydrocannabinol (col. 3, line 15; col. 4, line 19; claims 3, 16, 30, 42). Schaneville teaches that the film includes an emulsion of an extract of cannabis, a binder, e.g., gelatin, and a flavorant and/or taste masking agent, e.g., mannitol, sucralose (col. 1, lines 17, 56; col. 2, lines 1; col. 10, line 36; claims 1, 14, 28, 40, 46). The mannitol may range from about 0.001% to 5% by weight of the film (col. 7, lines 5-8). Sucralose is also taught taste-masking agent within the matrix (col. 7, line 3; col. 13, line 10; col. 14, line 33; claims 12-13, 19, 26-27, 48). The films may be absorbed through the mucosal tissue within about 20 seconds (col. 21, line 21).
Regarding the solid form of tetrahydrocannabinol limitation, Schaneville teaches that the active substance may be in crystal, powder, isolate form (col. 4, line 59-60; col. 12, lines 50-51) and that CBD and/or THC may be in the form of particles, such as in the form of a powder (col. 6, line 14-18). Schaneville discloses that the particle sizes of the active agent can range from about 1-50 µm (col. 22, line 57). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Regarding the THC being present in an amount of 0.3 to 25 wt. % limitation, Schaneville teaches that the active substance, i.e., THC, may be present from less than 1% to greater than 60% by weight of the film (col. 5, line 34-37). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Regarding the THC micronized to have a D50 diameter between 1-50 µm, Ridall discloses an average particle diameter for the active is about 1 to about 10 µm ([0033]).
Regarding the purity limitation, Schaneville teaches that the extracted substance or active agent (e.g., CBD or THC) as the main constituent of the films, may be in a purified form such that the concentration of the CBD or THC is greater than 95%, greater than 98% or greater than or about 99% (col. 5, lines 1-8).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to utilize the THC taught by Schaneville in the composition of Ridall with expected results for several reasons. One would be motivated to do so with a reasonable expectation of success because Schaneville presents THC as an active therapeutic agent that can be used to treat many symptoms, ailments, and conditions (col. 23, lines 30-49) with a rapid delivery of active(s) while reducing the very bitter taste (of CBD and THC) (col. 2, lines 39-40). Schaneville provides an ultra-purified powdered THC that allows for accurate dosing of the agent in the emulsion and resulting film (col. 12, lines 55-63) with high load capabilities (col. 2, line 7; col. 22, line 60). This complements the focus of Ridall to enhance the systemic availability of the drug for its desired therapeutic effects ([0025]) while reducing the need for multiple dosing ([0055]). Specifically with respect to gelatin and mannitol in the context of lyophilization, as evidenced by Mohammed, gelatin and mannitol excel in the formulation of freeze-dried orally disintegrating tablets (ODTs) as gelatin provides structural strength, while mannitol provides crystallinity, hardness and elegance (pg. 441, para. 4).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ridall in view Schaneville evidenced by Mohammed as applied to claims 1, 3-9, 12-13, 15 and 18 above, further in view of MacPhail et al. (WO 2020/014776 A1, pub. 01/23/2020) herein referenced MacPhail.
The teachings of Ridall, Schaneville, and Mohammed above are incorporated herein.
Ridall, Schaneville, and Mohammed do not mention melatonin (ELECTED).
MacPhail discloses an oral dispersible film composition comprising at least one active ingredient and a film forming agent, wherein the active ingredient is dispersed within the film and has an average particle size of 1-20 microns (claim 1) and wherein the film forming agent is selected from the group consisting of gelatins (pg. 8, last para.; pg. 18, para. 1; claim 10). A plasticizer may be used in the oral dispersible film strip (pg. 16, para. 2). The plasticizer should be a food-grade or pharmaceutical-grade compound, for example one or more of the monosaccharides such as mannitol (pg. 16, para. 2). Sweetening agents may also be present in the oral dispersible film and could include natural sweeteners, for example, mannitol; and artificial sweeteners, for example, aspartame, sucralose (pg. 19, last para.).
The oral dispersible film composition can be utilized to administer various active ingredients, including cannabinoid compounds comprised of tetrahydrocannabinol (abstract, claim 6). The oral dispersible film composition comprises a cannabinoid, sucralose, wherein the cannabinoid ingredient is (THC) (claims 11-13, 29). MacPhail discloses that the formulation comprises a second active ingredient selected from the group consisting of melatonin (claims 8, 9, 15, 20, 31-32, 34, 43, 45). MacPhail teaches melatonin as a second active ingredient in the oral dispersible film composition (pg. 8, para. 5; pg. 9, para. 2) and provides an exemplary embodiment where the melatonin is in powdered form (pg. 29, para. 1, Example 5).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the melatonin taught by MacPhail in composition of Ridall in view of Schaneville with expected results. One would be motivated to do so with a high expectation of success because MacPhail teaches that specifically, an oral dispersible film strip comprising a cannabinoid (for example, cannabidiol) and melatonin can be used to treat and/or prevent sleep disorders and sleep disturbances such as sleep apnea and insomnia and suggests that oral dispersible film strips that contain more than one active ingredient may provide synergistic activity when treating and/or preventing the disease, disorder, or condition (pg. 21, para. 3). One would be motivated to apply the fast dissolving drug formulation for direct systemic introduction particularly when melatonin and THC are present, as Ridall provides a more accurate dosing, lowered dosing, an absence or diminishment of side-effects, and greater safety to both the patient and the administrator of the formulation ([0018],[0020], [0055]).
For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Response to Arguments
Applicants’ arguments have been fully considered but they are not persuasive.
Applicants argue that one of ordinary skill in the art would not have been motivated to replace the omeprazole of Ridall with the cannabinoids of Schaneville (e.g., THC/CBD) to arrive at the claimed subject matter, and would not have had a reasonable expectation of success (Remarks, pg. 10, para. 2).
The Examiner respectfully notes the comprising language of the base claim. Applicants’ instant disclosure describes that one of the goals of the invention is to provide methods to treat at least one condition selected from the group consisting of anorexia, cachexia, nausea, emesis, pain, spasticity, fibromyalgia, overactive bladder, sleep apnea, and glaucoma (see published spec., [0018-0019]). Omeprazole for gastric reflux, GERD, would address well known symptoms associated with gastrointestinal problems to include those mentioned above from the instant specification, e.g., cachexia, nausea, emesis. THC is also known to address these symptoms. As evidenced by Gotfried et al. (“Review: The Role of Cannabinoids on Esophageal Function – What We Know Thus Far” Cannabis and Cannabinoid Research Volume 2.1, 2017), the endocannabinoid system along the upper alimentary tract mitigates inflammation and mucosal damage in GERD and provides anti-inflammatory effects in esophageal reflux disease (see Table 1, pg. 253).
Applicants argue that Schaneville's express reliance on emulsions and film casting to handle hydrophobic cannabinoids teaches away from Ridall's solution-based lyophilization workflow as Schaneville's approach would render Ridall's process unsatisfactory for its intended purpose and change the principle of operation (aqueous dissolution at basic pH, solution dosing, freeze-drying into a porous tablet) (Remarks, bridging pgs. 10-11).
Shaneville is provided to teach THC. With respect to workflow and principles of operation, the rejected claims as written are product claims. Schaneville advantageously provides an ultra-purified powdered THC that allows for accurate dosing of the agent in the resulting film (col. 12, lines 55-63) with high load capabilities (col. 2, line 7; col. 22, line 60). This would resonate with Ridall’s pharmaceutical composition for direct system introduction wherein enhancement of efficacy ([0025]) and efficiency ([0055]) is the objective.
Applicants argue that the rejection does not supply a reasoned explanation why a POSITA would select "a solid form of tetrahydrocannabinol" for incorporation into Ridall's lyophilized gelatin/sugar-alcohol matrix, nor why success in achieving the same rapid disintegration and "rapid infusion" behavior would be reasonably expected. Schaneville's disclosures are film-specific and emulsion-based. Schaneville does not teach lyophilization with solid THC in a freeze-dried tablet. Mohammed's general excipient roles do not bridge this dosage-form and processing gap (Remarks, pg. 11, para.1).
Mohammed is brought in to provide evidence that gelatin and mannitol are excellent structural components (pg. 441, para. 4). It is well established in the art that bioavailability and solvability increases when you micronize something. As evidenced by Martín-Banderas et al. (“Cannabinoid derivate-loaded PLGA nanocarriers for oral administration: formulation, characterization, and cytotoxicity studies”, International Journal of Nanomedicine 2012:7 5793–5806). Martín-Banderas et al. provides CB13 (cannabinoid 1-Naphthalenyl [4-(pentyloxy)-1-naphthalenyl]methanone) release profiles in a study to show that there was an inverse relationship between release rate and NP size; further noting that this has been explained by other authors in which verified that large microspheres degrade more quickly than small microspheres, probably because of an increased accumulation of the acidic products of polymer hydrolysis in large microspheres (see pg. 5208, and Figure 8). Thus, a person of ordinary skill in the art would be motivated to select a solid form of THC.
Applicants argue that MacPhail teaches an oral dispersible film and is silent regarding "A lyophilized rapidly infusing composition, comprising: a pharmaceutically acceptable binder and/or excipient system comprising gelatin and a sugar alcohol, and a solid form of tetrahydrocannabinol," (Remarks, bridging pgs. 11-12).
Ridall teaches lyophilization. MacPhail teaches the active ingredient having an average particle size of 1-20 microns (pg. 7, see Summary). MacPhail teaches that cannabinoid (for example, cannabidiol) and melatonin may provide synergistic activity (pg. 21, para. 3).
For these reasons, Applicants’ arguments are found unpersuasive.
Conclusion
All claims under consideration remain rejected; no claims are allowed. 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 extension fee 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.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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