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 Amendment
Applicant’s response of 01/07/2026 has been received and entered into the application file. Claims 1-15 and 21-25 are pending in this application. New claims 21-25 are added.
Applicant’s amendments to the Specification and claims have overcome objection previously set forth in the Non-Final Office Action mailed 10/07/2025.
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.
Claims 1-15 and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Obeid et al. (US 2018/0360736, Published 12/20/2018) and Liu et al (CN 109172547 A, Translated).
Obeid discloses orally disintegrating film capable of delivering an agent to a patient over an extended period of time while reducing discomfort (Abstract). Controlled release of an active agent for local action in the buccal cavity is achieved by providing a dosage form in which mucoadhesive particles containing active agent, are dispersed in a disintegrating film. Upon administration, the film disintegrates (e.g., within an acceptable period of time) and releases the mucoadhesive particles, some of which will contact the oral mucosa and immediately become bound to the mucosa. The active agent can be released from the mucoadhesive particles over a prolonged period of time as the mucoadhesive material slowly dissolves ([0006]). The mucoadhesive particles are insoluble polymers such as polyacrylic acid or polymethacrylates-based polymers or poly(D,L-lactide-co-glycolide) ([0007-0008]). The active agent can be a hydrophobic active agent such as cannabinoid ([0096]). Water soluble polymers can be employed in the films including hydroxypropyl methylcellulose, cellulose derivatives, hydroxyethyl cellulose, hydroxypropyl cellulose, polyethylene oxide ([0030]). The mucoadhesive particles or insoluble polymer matrix have residence time lasting from about 5 min to a few days, depending on the size of the mucoadhesion particles and materials used. The erosion time and thus the residence time is related to the molecular weight and other physical and/or chemical properties of the mucoadhesive material ([0073]).
Obeid does not explicitly disclose maropitant as active ingredient.
Liu discloses an orally dissolving film preparations used for pets (Abstract). The active ingredient is selected from an antiemetic drug such as maropitant (pg 2, 4th paragraph). Film-forming material can be methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol (pg 2, 6th paragraph). A pet oral film formulation comprises plasticizers, disintegrating agents, thickening agents, flavoring agents (pg 2, 3rd paragraph).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have used maropitant as a possible active agent within an oral film formulation taught by Obeid. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 2, Obeid discloses that emulsifiers can include polyvinyl alcohol, polysorbates, or sodium lauryl sulfate ([0083]). Liu discloses that emulsifiers routinely used for oral film formulations include polysorbates, glycerol, polyethylene glycol esters (pg 2, 5th paragraph).
Regarding claim 3, Obeid discloses the use of poloxamer during emulsification procedure ([0102]). Other surfactants include polyoxy-ethylene sorbitan fatty acid esters ([0031]). Obeid discloses that sodium lauryl sulfate and polysorbates can also be used as penetration enhancers ([0032]).
Regarding claim 4, cannabinoid is disclosed above.
Regarding claim 5, Obeid discloses that surfactants, polyalcohols, and or plasticizers may be incorporated into the disintegrating film to facilitate or enhance wettability and disintegration of the film ([0029]). Obeid discloses that the non-mucoadhesive and low-mucoadhesive films can comprise at least 60% by weight of water-soluble polymers ([0023]). Furthermore, one of ordinary skill in the art would routinely experiment with different ratios of water-soluble, water-insoluble polymers within an oral film formulation to test for dissolution rates and disintegration times. It would have been obvious to alter the concentration of polymeric matrix within such a formulation.
Regarding claims 6 and 8, polymeric matrix comprising insoluble polymers is disclosed above.
Regarding claim 7, polymeric matrix comprising soluble polymers is disclosed above.
Regarding claim 9, Obeid discloses that the active cannabinoid agent is added to the oil phase containing an oil base, one or more surfactants, and an antioxidant ([0096]); antioxidant includes butylated hydroxytoluene ([0103]), tocopherol ([0102]).
Regarding claim 10, The oral film can comprise sweetener, flavor and a pore former. A pore former is an agent such as maltodextrin that quickly dissolves on the surface of the film, creating holes which allows water to enter the film and thus promote film dissolution and/or disintegration ([0090]); pore formers include polyalcohols such as maltitol ([0029], [0031]).
Regarding claim 11, Obeid discloses that the residence time in the oral cavity of the mucoadhesive particles will be modulated by various parameters such as size of the mucoadhesive particles, the materials used in the mucoadhesive particles, and pH of the medium ([0074]). One of ordinary skill in the art would immediately envisage that pH plays an important role in controlling disintegration, dissolution, and erosion of an oral film formulation. Additionally, maropitant, polymeric matrix, surfactant/emulsifier, plasticizer are all taught by Obeid and Liu as discussed above.
Regarding claims 12-13, a pore former is discussed above.
Regarding claim 14, animal oral film is taught by Liu,
Regarding claim 15, Liu discloses that animals routinely use maropitant as an antiemetic agent (pg 2).
Regarding claim 21, Obeid teaches that the film is administered to the patient in a way that promotes film disintegration ([0049]). One of ordinary skill in the art would immediately envisage that an oral film would in fact have a disintegration phase.
Regarding claim 22, one of ordinary skill in the art would experiment with various concentration of an active ingredient within an oral film formulation.
Regarding claim 23, Obeid discloses lecithin as an emulsifier ([0102]).
Regarding claim 24, Liu discloses that the oral film after ingestion disintegrates in a very short time (pg 2). one of ordinary skill in the art would routinely experiment with a dosage form as an immediate-release or an extended-release form
Regarding claim 25, Liu discloses Maropitant as an anti-emetic drug. One of ordinary skill in the art would recognize that an anti-emetic drug would treat emesis when absorbed.
Response to Arguments
Applicant’s arguments filed 01/07/2026 have been fully considered but they are not persuasive.
On pages 7-8 of remarks, applicant argues that the importance of their invention is how the polymeric film matrix itself controls the rate of drug release. The drug is dispersed directly within the polymeric matrix using an “all-in-one blend” manufacturing approach. No coating step is required and no pre-formed coated particles are embedded within the film. Applicant further argues that Obeid teaches a fundamentally different structure. In Obeid, the film matrix plays no role in controlling release. However, per MPEP 2145 (D) (1), the nature of the teaching is highly relevant and must be weighed in substance.” The present invention credits a blend of polymeric matrix to impart the characteristic of “rate-controlling”; specifically, insoluble polymers such as ethyl cellulose, polymethacrylate and soluble polymers such as HPMC, polyethylene glycol, and HPC are mentioned. Obeid clearly discloses that the oral film formulation comprises polymer matrix including HPMC and HPC ([0030]), and polyethylene glycol listed as mucoadhesive particle (claim 20) as well as polymethacrylates ([0041]). All of which can be blended or dispersed within the polymeric matrix as Obeid teaches that the dosage form comprises a disintegrable matrix, and mucoadhesive dispersed in the matrix ([0018]). In fact, Obeid discloses the production of film oral dosage form – the mucoadhesive particles are combined in water and stirred until a homogeneous dispersion (wet-blend) is obtained. PEO is then added and mixed until completely dissolved. Later, the wet-blend including the active ingredient is poured into a cast and allowed to air dry thus creating the oral film formulation ([0090-0094]). One of ordinary skill in the art would immediately envisage that an oral film formulation can be created from a homogeneous mixture of soluble, insoluble polymers, and mucoadhesive agents. No coated particles or pellets would be required. This blend of polymer matrix is nothing new within the art and per MPEP 2145 (II), Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.
On page 9 of remarks, applicant argues that a person of ordinary skill in the art would have no motivation to combine Obeid and Liu. However, Liu teaches that pet oral films can comprise maropitant. One of ordinary skill in the art would certainly experiment with any and all anti-emetic drugs within an oral film formulation.
On page 10 of remarks, applicant argues that Obeid teaches away from the claimed subject matter. As discussed above, Obeid discloses a homogeneous blend of polymers and mucoadhesive agents. Per MPEP 2145 (D) (1), the nature of the teaching is highly relevant and must be weighed in substance.”
On page 11 of remarks, applicant argues that pH range is critical in determining whether maropitant films disintegrate or dissolve. However, figure 5 illustrates that the acidic pH of the film is the main driving condition for disintegration of Maropitant film; pH level of 8 is compared to pH level of 4.91 (Tables 7-9). The examiner cannot determine the criticality of pH range from about 7.5 to about 8.5 as claimed in claim 11. Obeid teaches a range of about 6.7 to about 7.4 ([0028]).
In conclusion, the examiner cannot determine the criticality of pH ranges nor the unexpected rate-controlling element for the polymeric matrix blend. Is this quality imparted only by a specific blend of soluble and insoluble polymers? At specific concentrations of each polymer? How the oral film is produced? The claim as currently written does not distinguish over the teachings of the prior art of record. And therefore, claims remain rejected.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615