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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/07/2026 has been entered.
Status of the Claims
Claims 1-79, 82 and 94 had been cancelled in a previous communication.
Claims 80-81, 83-93, and 95-96 are pending and currently under examination.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 80-81, 83-91, 93, and 95-96 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 80 recites “wherein the device and the pre-formulation comprised in the device are both water-free, and wherein the pre-formulation spontaneously for a nano particulate oil-in-water emulsion when dispersed in aqueous media”. This language renders the claim indefinite because Applicants are claiming that the pre-formulation is water-free but then also claiming that pre-formulation spontaneously forms a nano particulate oil-in-water emulsion when dispersed in aqueous media, therefore it is not clear whether water is required or not as an emulsion is formed.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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 80-81, 83-93, and 95-96 are rejected under 35 U.S.C. 103 as being unpatentable over Schaneville (US20170290870A1, Published 10/12/2017) as evidenced by Salawi (Drug Delivery, 2022 Dec; 29(1): 1811-1823).
Applicant’s Invention
Applicant’s claims are drawn to a solvent-free device for controlled delivery of at least one poorly water-soluble or lipophilic active through at least one tissue of the oral cavity of a subject, the device being a solid fast dissolving device comprising at least one water-soluble polymer and at least one edible alcohol and a solid or semi-solid pre-formulation composed of: at least one atomized poorly water-soluble or lipophilic active, at least one dispersant, at least one lipid component, and at least one amphiphilic material, wherein the device and the pre-formulation comprised in the device are both water-free, and wherein the pre-formulation spontaneously forms a nano particulate oil-in-water emulsion when dispersed in aqueous media.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 80, Schaneville teaches a thin mucosally dissolvable film containing a high loading dose of purified active ingredient from cannabis (i.e., poorly water-soluble or lipophilic active) which is easily penetrable through mucosal tissue (paragraph [0005]). Schaneville also teaches the films may also have particular applicability as ingestible films, which are dissolved in the mouth of the user, either rapidly or over a controlled period of time. They may also be used for systemic administration of agents by applying the films to oral or vaginal mucosal surfaces (paragraph [0073]). Schaneville further teaches the thin film include polycarboxylic acids (i.e., water-soluble polymer)(paragraph [0007]); wherein the film composition also comprise monoglycerides and polyethylene glycol (i.e., edible alcohol) (paragraph [0040]). Schaneville also teaches the film may also include polysorbates, sorbitan esters, and poloxamers (i.e., dispersants) (paragraph [00045]) ; triglycerides (i.e., lipid component) (paragraph [0040]); glycerol and propylene glycol (i.e., amphiphilic solvent) (paragraph [0099]). Schaneville further teaches the method of preparing an emulsion composition may also include providing an aqueous-based emulsion and converting the aqueous-based emulsion into a non-aqueous dry emulsion (paragraph [0082]). Schaneville also teaches that the method of preparing a film for delivery of an active further includes drying the film by a process whereby the active become dispersed within the film (i.e., solid device) (paragraph [0083]). Schaneville continues to teach that the film may include self-emulsifying system agents (paragraph [0038]), such as poloxamers, Cremophor, polysorbates, Lutrol (e.g., polyethylene glycol) (paragraph [0053]). As evidenced by the definition of Salawi, SEDDS (Self Emulsifying Drug Delivery System) and isotropic mixtures, are composed of oils, surfactants, and occasionally cosolvents. The ability of these formulations and methods to produce microemulsions or fine oil-in-water (o/w) emulsions after moderate stirring and dilution by water phase along the GI tract might be a promising technique for lipophilic agents with dissolution rate-limited absorption (abstract); wherein by adding co-surfactant, the higher amounts of surfactant (approximately 30%) can be simulated. The contact enlargement at this moment results in the creation of finely scattered droplets. It will absorb more surfactant or a higher surfactant/co-surfactant ratio until the film is depleted enough to restore positive interfacial tension. Spontaneous emulsion is formed as a result of this (Section 4.1.3., Surfactant and co-surfactant). Therefore, self-emulsifying formulation means the same as a spontaneous formation.
Regarding claim 81, Schaneville teaches the “films” or “wafers” or “sheets” can be any type of film that can be administered to a subject to provide the substance or mixture of substances from hemp or cannabis or other biologically active agents such as a medicament or a pharmaceutical or a nutraceutical. The films may be sublingual or orally dissolving films or mucosally dissolving films, that are edible and pharmaceutically acceptable. A “mucosally dissolvable film” refers to any thin film that allows an active agent to seep or absorb through the mucosal membrane of any mammalian subject (paragraph [0026]). Schaneville also teaches the films may also have particular applicability as ingestible films, which are dissolved in the mouth of the user, either rapidly or over a controlled period of time (paragraph [0073]).
Regarding claim 83, Schaneville teaches the film may contain anti-inflammatory substances (paragraph [0010]) THC in the films can be used to provide analgesia (i.e., analgesic) and CBD in the films can be used to treat inflammation (i.e., anti-inflammatory) (paragraph [0127]).
Regarding claim 84, Schaneville teaches the film may also include dietary supplements such as proteins (paragraph [0063]).
Regarding claim 85, Schaneville teaches the films may contain vitamins and nutraceuticals (paragraph [0010]).
Regarding claims 86-88, Schaneville teaches mucosally dissolvable film having an active agent. The “active agent” may include one or more substances, such as cannabinoids or cannabidiol (CBD) or tetrahydrocannabinol (THC) obtained from hemp and/or cannabis (paragraph [0025]).
Regarding claims 89-90, Schaneville teaches the active agent being an extracted substance from cannabis or hemp, may include cannabinoids (CBD) or tetrahydrocannabinol (THC) (paragraph [0006]).
Regarding claim 91, The active agent or drug may be used as fine particles, wherein the particles can be microspheres, liposomes, micelles, or other agglomeration of molecules and the active agent can be in a nanoparticle size or single molecule, such as less than about 500 nm (paragraph [0033]).
Regarding claim 92, Schaneville teaches a thin mucosally dissolvable film containing a high loading dose of purified active ingredient from cannabis (i.e., poorly water-soluble or lipophilic active) which is easily penetrable through mucosal tissue (paragraph [0005]). Schaneville also teaches the films may also have particular applicability as ingestible films, which are dissolved in the mouth of the user, either rapidly or over a controlled period of time. They may also be used for systemic administration of agents by applying the films to oral or vaginal mucosal surfaces (paragraph [0073]). Schaneville further teaches the thin film include polycarboxylic acids (i.e., water-soluble polymer)(paragraph [0007]); wherein the film composition also comprise monoglycerides and polyethylene glycol (i.e., edible alcohol) (paragraph [0040]). Schaneville also teaches the film may also include polysorbates, sorbitan esters, and poloxamers (i.e., dispersants) (paragraph [00045]) ; triglycerides (i.e., lipid component) (paragraph [0040]); glycerol and propylene glycol (i.e., amphiphilic solvent) (paragraph [0099]). Schaneville further teaches drying the film by a process whereby the active become dispersed within the film (i.e., solid and solvent free) (paragraph [0083]). Schaneville also teaches the films may also have particular applicability as ingestible films, which are dissolved in the mouth of the user, either rapidly or over a controlled period of time (paragraph [0073]), therefore the dosage form inherently has a preferential solubility in the oral cavity because the film is being released and delivered in the mouth (i.e., oral cavity). As evidenced by the definition of Salawi, SEDDS (Self Emulsifying Drug Delivery System) and isotropic mixtures, are composed of oils, surfactants, and occasionally cosolvents. The ability of these formulations and methods to produce microemulsions or fine oil-in-water (o/w) emulsions after moderate stirring and dilution by water phase along the GI tract might be a promising technique for lipophilic agents with dissolution rate-limited absorption (abstract); wherein by adding co-surfactant, the higher amounts of surfactant (approximately 30%) can be simulated. The contact enlargement at this moment results in the creation of finely scattered droplets. It will absorb more surfactant or a higher surfactant/co-surfactant ratio until the film is depleted enough to restore positive interfacial tension. Spontaneous emulsion is formed as a result of this (Section 4.1.3., Surfactant and co-surfactant). Therefore, self-emulsifying formulation means the same as a spontaneous formation.
Regarding claims 93 and 96, Schaneville teaches the film strips described herein having the CBD and/or THC can be used for treatments known in the art. CBD could be used for treating symptoms of rheumatoid arthritis and other autoimmune diseases, diabetes, nausea, bowel disorders, inflammation, provide neuroprotective effects, and provide anti-cancer effects, and reduce many other hard-to-control side effects of other medications. THC can be used to treat aches, pains, backache, muscle stiffness, joint pain, inflammation, and reduce many other hard-to-control side effects of other medications or anticancer treatments (paragraph 0127]).
Regarding claim 95, Schaneville teaches The films may also have particular applicability as ingestible films, which are dissolved in the mouth of the user, either rapidly or over a controlled period of time (i.e., prolonged and/or sustained delivery) (paragraph [0073]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Schaneville does not disclose a single embodiment or example where every limitation recited in the instant claims is taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art at the time of filing because Schaneville teaches all of the claimed elements. It would have been prima facie obvious to one of ordinary skill at the time of filing to make a solvent-free device for controlled delivery of at least one poorly water-soluble or lipophilic active through at least one tissue of the oral cavity of a subject, the device being a solid fast dissolving device comprising at least one water-soluble polymer and at least one edible alcohol; and at least one atomized poorly water-soluble or lipophilic active comprised in a solid pre-formulation with at least one dispersant, at least one lipid component and at least one amphiphilic material because Schaneville teaches and contemplates all the elements required to make the device for controlled delivery.
With regards to claims 80 and 92, wherein the solid or semi-solid pre-formulation spontaneously forms a nano-dispersion in aqueous media, Schaneville’s thin mucosally dissolvable film comprises cannabis (i.e., poorly water-soluble or lipophilic active); polysorbates, sorbitan esters, and poloxamers (i.e., dispersants) (paragraph [00045]) ; triglycerides (i.e., lipid component) (paragraph [0040]); glycerol and propylene glycol (i.e., amphiphilic solvent) (paragraph [0099]), which are the same chemical components as claimed in instant claim 80, therefore, inherently it would be expected by one of ordinary skill in the art for Schaneville’s thin mucosally dissolvable films to have the same property as the instantly claimed formulation, which would spontaneously form a nano-dispersion. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Response to Arguments
Applicant's arguments filed 01/07/2026 have been fully considered but they are not persuasive.
On page 11 of Applicants remarks, Applicants argue that Salawi is not available as reference because of its date, as Salawi was published in 2022. Applicants also argue that according to the examiner, Schaneville could be further improved by the incorporation of SEDDS of Salawi.
These are arguments are not persuasive. The Examiner is not relying on any teachings from Salawi to address any limitations other than to define the fact that formulations taught in Schaneville are inherently and necessarily capable of self-emulsifying. The Examiner also points out that the arguments directed to Salawi are moot because Salawi is not used as prior art but rather for evidentiary purposes to define the formulation.
On pages 12-13 of Applicants remarks, Applicants argue that Schaneville teaches that the polysorbate is used as a surfactant and creates a suspension when added to water and provides a suspension of CBD, and nowhere does Schaneville teaches water-free compositions or films but rather it teaches “drying the film”, therefore Schaneville is teaching away from the water-free device and the dosage form of the claims.
This argument is not persuasive. The Examiner points out that Applicants are arguing a product by process limitation, in that the method by which Applicants make the device is water free, however the claims are directed to a solid device wherein the solid device would need to be water free. The drying step of Schaneville removes water from the device making the final product a water free solid device. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614