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. Election/Restrictions Claims 5-23 are pending in the instant application. Claims 1-4 were canceled by applicant’s amendment. Applicant’s election without traverse of Group II, Claims 5-21 in the reply filed on 12 January 2026 is acknowledged. Claims 22 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention , there being no allowable generic or linking claim. Claims 5-21 are being examined on the merits. Specification The use of the term “Tween®”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore , the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term . Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Objections Claims 5-21 are objected to for the following reasons: In Claim 5, at line 4, the phrase “agent, at least one” should instead read --agent, and at least one--. Claims 6-9, 11, 12, 19, and 20 are objected to because in each claim, the phrase “selected from the group of” should instead read --selected from the group consisting of--. Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 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 appl icant regards as his invention. Claim s 5-21 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. In Claim 5, the phrase “at least one disintegrating agent and as a rapid release” is indefinite because it is unclear what is a rapid release. Is the disintegrating agent a rapid release agent? Is a rapid release referring to a separate compound in the composition? Or is it referring to the composition as a whole being a rapid release oral film forming composition? Regarding Claims 10, 13, 16-18, and 21, the phrases "such as" and “optionally” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 10 is indefinite because it states that the composition further comprises a surfactant optionally in combination with a co-surfactant, however Claim 5 indicates that the composition comprises at least one hydrophilic surfactant and at least one co-surfactant. Since the composition already comprises a surfactant and a co-surfactant, it is unclear how the combination could therefore be optional. Claim 11 contains the trademark/trade name Tween®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a permeation enhancer of Claims 5 and 11 and, accordingly, the identification/description is indefinite. Claims 11 and 19 recite the limitation “further comprising” a permeation enhancer and a stabilizer, respectively. Since these compounds are listed as “at least one” in Claim 5, it is unclear whether the permeation enhancer and stabilizer are in addition to the “at least one” of Claim 5, or whether the permeation enhancer and stabilizer of Claim 5 are selected from the group consisting of the Markush groups of Claims 11 and 19, respectively. Claim 13 recites the limitation “polymers”. There is insufficient antecedent basis for this limitation in the claim and it is unclear whether the claims ratio is intended to comprise the film former polymer and the mucoadhesive polymer, one of them, or whether different polymers are being referred to. Claim 15 recites the limitation “ lipophilic surfactant ”. There is insufficient antecedent basis for this limitation in the claim. Claim 16 recites the limitation “ carrier solubilizer ”. There is insufficient antecedent basis for this limitation in the claim. Claim 18 recites the limitation “mucoadhesive agent”. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is necessary. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claims 5-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaur (US 2020/0222362 A1). The instant claims are as of record, drawn to an amorphous cannabinoid-loaded oral film formulation comprising at least one film former polymer, at least one mucoadhesive polymer, at least one solubilizer, at least one hydrophilic surfactant, at least one co-surfactant, at least one permeation enhancer, at least one stabilizer, at least one flavor agent, at least one sweetening agent, at least one disintegrating agent and as a rapid release, wherein over 80% of the cannabinoid is released in less than 10 min utes. Kaur , however, anticipates the claims by teach ing an oral disintegrating film comprising a cannabinoid ( cannabinoid-loaded oral film ; Kaur, Abstract ; as required for instant Claim 5 ). The oral film comprises : plasticizers which provide a stabilizing effect including medium-chain mono- di- or tri-glycerides and glyceryl monolinoleate (at least one solubilizer; Kaur, [0046]-[0048]; as required for instant Claims 5 and 6) film forming polymers including hydroxypropylmethyl cellulose (HPMC), polyethylene glycol (PEO; at least one film former polymer), and sodium alginate (at least one mucoadhesive polymer ; Kaur, [0045]; as required for instant Claims 5, 7, and 8) solubilizing agents including propylene glycol (Kaur, [0052] ), and PEG 300 (co-solubilizer; Kaur, [0066], Table 3; as required for instant Claim s 9 , 11, and 12 ) a single surfactant or a combination of lipophilic and hydrophilic surfactants (at least one hydrophilic surfactant; at least one co-surfactant; surfactant in combination with a co-surfactant; Kaur, [0053]; as required for instant Claims 5 and 10) surfactants or solubilizing agents with a capacity to emulsify the plasticizer component including polysorbate 20 and polysorbate 80 (at least one permeation enhancer; Kaur, [0053]; as required for instant Claims 5 and 11) plasticizers including glycerin (glycerol ; Kaur, [0050]; as required for instant Claims 9 and 12) excipients including ascorbic acid to increase solubility of the active ingredient and improve dissolution rate (at least one stabilizer; preservative; Kaur, [0058]; as required for instant Claims 5, 19, and 20) cosolvents including glycerol, ethanol , and propylene glycol (solubilizer; co-solubilizer; plasticizer; stabilizer; preservative; Kaur, [0055]; as required for instant Claims 5, 6, 9, 12, 19, and 20) other excipients including a flavorant (at least one flavor agent) and sweetening agents including maltitol, sorbitol, and lactose (at least one sweetening agent; at least one disintegrating agent, e.g., instant specification [0135]; Kaur, [0056]-[0057] , [0061] ; as required for instant Claim 5) The oral disintegrating film dissolves in less than 60 seconds in water at 23°C (e.g., the cannabinoid is release in less than 10 minutes; Kaur, page 9, Claim 16; as required for instant Claim 5) and release the medication (e.g., cannabinoid) into the mouth within a few seconds (Kaur, [0002]) . The oral disintegrating film provides increased solubility of the active ingredient (e.g., cannabinoid) and is produced via dissolving into a suitable volatile solvent and entrapping the active in solubilizer and plasticizers until a uniform dispersion is achieved (e.g., amorphous cannabinoid , see instant specification [0178] ; Kaur, [0064]; as required for instant Claim 5). Additionally, the oral disintegrating film comprises the following amounts of ingredients as described above, by weight of the total oral disintegrating film: cannabinoid, 0.25-50% (Kaur, [0043]) disintegrating agent, 0.5-5% (Kaur, [0061]) polymers and mucoadhesive polymers, 10-75% (Kaur, [0044]) surfactants, solubilizers, and permeability enhancers, 0.1-60% (Kaur, [0054]) The ratio s of cannabinoid to polymers (e.g., 10% cannabinoid and 50% polymers for a 1:5 ratio); mucoadhesive polymers (e.g., 50% cannabinoid and 25% mucoadhesive polymers for a 2:1 ratio); cannabinoid to hydrophilic surfactant (e.g., 5% cannabinoid and 5% hydrophilic surfactant for a ratio of 1:1); cannabinoid to lipophilic surfactant (e.g., 10% cannabinoid and 1% lipophilic surfactant for a ratio of 10:1); (as required for instant Claims 13-18 and 21); cannabinoid to solubilizer (e.g., 5% cannabinoid and 5% solubilizer for a 1:1 ratio); cannabinoid to permeation enhancer (e.g., 5% cannabinoid and 5% permeation enhancer for a 1:1 ratio); and cannabinoid to disintegrating agent (e.g., 4% cannabinoid and 1% disintegrating agent for a 4:1 ratio) are therefore all overlapping ratios (as required for instant Claims 13-18 and 21). Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JENNIFER L CAIN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-1318 . 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Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /J.L.C./ Examiner, Art Unit 1655 /AARON J KOSAR/ Primary Examiner, Art Unit 1655