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 .
Status of Claims
Receipt of Remarks/Amendments filed on 2/25/2026 is acknowledged. Claims 1-27, 29-33, 35 and 38-40, 42-48 are pending in this application. Claims 1-14 and 42-44 are drawn to a non-elected group and are withdrawn. Claims 15-27, 29-33, 35, 38-40, 45-48 are currently under examination and the subject matter of the present Office Action.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Information Disclosure Statement
The IDS filed on 2/25/2026 has been considered. See the attached PTO 1449 form.
Withdrawn Objections/Rejections
Applicant’s remarks/amendments, filed 2/25/2026, with respect to the previous 112(b) rejections have been fully considered and are persuasive. The previous 112(b) rejection has been withdrawn due to claim amendments.
New/Maintained Claim Objection(s) / Rejection(s)
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 46 and 47 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.
Claims 46 and 47 recite “at least higher than 1:1”. This recitation makes it unclear whether weight ratio is at least 1:1 or higher than 1:1. The examiner suggests amending the claim to recite either “at least 1:1” or “higher than 1:1”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 26 and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 26 recites “from 15 to 45 wt% of coenzyme Q10” and claims 27 recites “between 15 wt% and 45 wt% of the dry weight of the film of coenzyme Q10”. Both of claims 26 and 27 depend from claim 15, which recites poorly water soluble bioactive material is present in an amount of at least 20 wt%. 15 wt% of coenzyme Q10 falls outside the concentration of at least 20 wt% bioactive material recited in claim 15. As such, claims 26 and 27 improperly broaden the scope of claim 15 and fail to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 15-24, 26-27, 30-31, 35, 39-40, 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over JP2018203618A as evidenced by Nukui (BioFactors, Volume 32, issue 1-4, pp. 2019-219, April 2009), and further in view of KR20140014073.
Determination of the scope and content of the prior art
(MPEP 2141.01)
‘618 teaches oral films/films which can be adhesive/mucoadhesive (adhered and delivered through the skin/mucous membranes) which comprise CoQ10 as at least one poorly water soluble bioactive material and wherein the oral film comprises alginate as major film forming polymer, and an emulsifier and wherein the weight ratio between said bioactive material and said alginate can be higher than 1:2.5, specifically wherein the alginate is present in amounts of 10 to 94% by mass and wherein the CoQ10 is present in the film in amounts of up to 72% by mass, but is preferably from about 10 to about 60% by mass which can be optimized to yield the claimed ratios by one of ordinary skill in the art, and emulsifiers wherein the emulsifiers are the claimed monoglyceride/glycerol fatty acid ester, and/or lecithin (which are nonionic emulsifiers) and teaches wherein these emulsifiers are present in amounts which are not particularly limited, but are typically 10 to 70% by mass (see entire document; paragraphs beginning: The film preparation is a preparation in the form of a thin film, and can be taken in the mouth…; As the coenzyme Q10 used in the present invention, those obtained by known…; The present invention includes the following aspects:…through (8); The water-soluble polymer used in the present invention has the above-mentioned molecular weight…; The blending amount of coenzyme Q10 and water-soluble polymer or emulsifier….; claims; 5: Appropriately sticky to bending and does not crack…(stickiness helps it adhere, e.g. mucoadhesive). As evidenced by Nukui, CoQ10 is known to be highly hydrophobic and is insoluble in water (Abstract). Thus, CoQ10 reads on wherein poorly water-soluble bioactive material has an aqueous solubility below 10 mg/L. ‘618 also teaches wherein the thickness of their film(s) can be appropriately set depending on use…the film thickness is about 30 to about 500 microns (See paragraph: The film thickness of the film agent of the present invention can be appropriately set depending on the use mode of the film agent, but it is not too hard and not too soft, and from the viewpoint of ease of handling, the film thickness is about 30 to 500 μm. Is preferred.).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
‘618 does not specifically teach wherein the weight ratio between said bioactive material and said alginate is at least 1:2.5 or is specifically in a range of from 1:2.5 to 2.5:1, or from 1:1 to 2.5:1. However, ‘618 does teach wherein the amounts of coenzyme Q10 and the alginate overlap those instantly disclosed and claimed and it would have been obvious to one of ordinary skill in the art to optimize the weight ratios of the CoQ10 and the alginate in order to form the most effective film that delivers effective amounts of CoQ10 to users in need thereof with a single film, etc. as necessary by offering a higher loading of CoQ10 in the films. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In 6ealer, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”). ‘618 also does not expressly teach wherein their film is formed as a uniform film as defined by the instant claims. However, ‘618 does teach wherein their films are homogeneous wherein the CoQ10 is mixed with the other components using a high pressure homogenizer, alginate is added and the composition is mixed well/well mixed and/or mixed uniformly, and heated while rolling/hammering to produce a film. Therefore, the composition obviously would have little to no weight standard deviation throughout the film and the composition obviously would not contain powder aggregates/clumps of the poorly water soluble bioactive material as clumps/aggregates would not be a uniform mixture because clumps are not a uniform mixture. (See sections/paragraphs cited above, also see: paragraph beginning: The coenzyme Q10 emulsion is prepared by mixing the above components…or may be used as it is in the next film forming step; paragraph beginning: In producing the film agent of the present invention, the film formation itself after the production of the coenzyme Q10 emulsion can be performed by a known method…). This deficiency in ‘618 is also addressed by ‘073.
‘073 teaches that it was known to form films of drugs wherein the films are uniform and have the active agents/drugs dispersed throughout the film (i.e. does not contain powder aggregates as aggregates would not provide a uniform film/uniform dispersion for forming the film) and that the amount of drug is preferably substantially uniform throughout the film, e.g. the standard deviation is preferably about 90% uniform in content from one region to another or higher, specifically as high as greater than 99% uniform in content (The paragraph beginning: The agent may be dispersed throughout the film or may be deposited on one or more surfaces of the film. In either manner, the amount of drug per unit area is preferably substantially uniform throughout the film…), which read on the claimed wherein said weight standard deviation is lower than 20%, specifically wherein it is lower than 10% as claimed in instant claims.
‘618 does not specifically teach wherein the concentration of the emulsifier is lower than 1/5 of the concentration of the bioactive material in said film or wherein the concentration of the emulsifier is between 1/20 and 1/60 of the concentration of the bioactive in the film. However, ‘618 does teach using the same emulsifiers in alginate films comprising the same active agents which are instantly claimed and wherein the amounts of the active agent/CoQ10 and the amounts of alginate overlap with those instantly claimed and as such it would be obvious to one of ordinary skill in the art to optimize the amount of the emulsifier to be the claimed concentrations because ‘618 teaches forming the same oral films with the same alginate and the same CoQ10 in the same/overlapping amounts and it would have been obvious to optimize the amount of the claimed emulsifiers which are also taught by ‘618 to be effective in their alginate/CoQ10 films in order to form highly effective CoQ10 films containing the claimed amounts of active agents because it is known, Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In 8ealer, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
‘618 does not teach wherein the alginate is homogenized with the poorly water soluble, CoQ10, and emulsifier to form the mass that is suitable for casting or specifically wherein the ratio of bioactive to alginate is higher than 1:2.5 or the specific mixers are used. However, these are product-by-process claims and it is known: “[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). In the instant case, applicants have not demonstrated that their films are structurally and/or materially different from the films taught by ‘618 which can comprise up to 72% by mass of the bioactive agent and from 10 to 94% by mass of the alginate and as such it would be obvious to one of ordinary skill in the art to optimize the amounts of the CoQ10/bioactive agent to fall within the claimed weight ratios/ratios because it was known in the art to optimize the loadings of active agents in dosage forms in order to provide the highest loadings possible so that multiple unit dosage forms do not need to be taken in order for a patient/user to achieve the effective dose every time dosing is needed, e.g. patients would rather take 1 film strip or 1 tablet or 1 spoonful of an oral liquid drug formulation instead of multiple film strips and multiple tablets, and multiple spoonfuls of oral liquid drugs each time they need to take an effective dose of their medicine/vitamin, etc. Especially since applicants have not disclosed any criticality of their claimed amounts and/or wherein their films are structurally distinct/materially different from the films taught by ‘618.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have formed the claimed mucoadhesive films because ‘618 teaches forming oral films which are obviously mucoadhesive because they comprise the same alginate and the same active agent CoQ10 in the same/overlapping amounts and further comprise the claimed emulsifiers and as such it would be obvious to optimize the weight ratios of the alginate and the CoQ10 to fall within the claimed weight ratios and to optimize the amounts of the CoQ10 and the alginate to fall within the claimed ranges for the reasons discussed above, and it also would have been obvious to optimize the amounts of the emulsifiers especially since ‘618 teaches using the same emulsifiers and that the amounts of the emulsifiers is not particularly limited and as such can be optimized by one of ordinary skill in the art as desired to form the most effective mucoadhesive oral films for delivering CoQ10. Especially since the courts have previously determined, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In 9ealer, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It also would have been obvious to one of ordinary skill in the art to form the claimed uniform film free of powder aggregates of the poorly water soluble bioactive, specifically wherein the uniformity is as defined and claimed, e.g. weight standard deviation of said film and said bioactive material per unit area of the film, wherein said weight standard deviation is lower than 20%, specifically lower than 10% because it was known to form oral films with this standard deviation because you do not want films to have all of the active agent and weight of film in one area, e.g. square centimeter of the film, and very little or no weight of drug and other ingredients elsewhere in the film, so that dosing of the bioactive agent is repeatable and reliable throughout the film thus the importance of ensuring no aggregates/clumps, etc. and as taught by ‘618 having a uniform mixture prior to spreading out the formulation which when dry becomes the film having uniform dispersion of the ingredients comprised in the film. Thus, one of ordinary skill in the art would want the composition prior to spreading as a film to be as homogenous as possible to ensure little to no standard deviation of the active agent throughout the film as is taught by ‘073 when forming the ‘618 in order to form films which provide effective and repeatable and reliable dosings of the same/same within a std. deviation of the actives/bioactives to the patients/users of the films. Further, one of ordinary skill in the art would want to make sure there was effective uniform mixing of the components in the film so as to prevent any clumping/aggregates of the poorly water soluble actives as this would lead to non-uniformity in the dosing of the active agent from the film which is undesirable for forming effective oral films for delivering active agents.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 22-23, 25 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over JP2018203618A as evidenced by Nukui (BioFactors, Volume 32, issue 1-4, pp. 2019-219, April 2009), and in view of KR20140014073 as applied to claims 15-24, 26-27, 30-31, 35, 39-40, 45-47 above and further in view of Schaneville (US20170290870).
Determination of the scope and content of the prior art
(MPEP 2141.01)
The combined references together teach the orally administrable film of claims 15-24, 26-27, 30-31, 35, 39-40, 45-47 as discussed above and incorporated herein.
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
The combined references do not teach wherein the bioactive materials are specifically hemp oil, which reads on natural oil of claim 22-23. This deficiency in the combined references is addressed by Schaneville.
Schaneville teaches oral films which may be mucoadhesive ([0026]; claims; [0010, contain bioadhesive agent]; [0038]; [0047-0048]) and which comprise as the active agent hemp oil containing cannabinoids ([0032]; [0006]; [0028-0029]; [0031]; [0076]) and wherein the emulsifier can be lecithin, monoglycerides, ethoxylated sorbitan esters, etc. ([0097-0098]) the hemp oil is used in amounts/concentrations of 1 to 70% by weight of the film, typically up to about 50% by weight of the sheet/film ([0006]; [0034]) and the matrix film agent can be alginate/sodium alginate ([0009]) and can further contain the claimed emulsifiers.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have formed the claimed film with the claimed amounts of hemp oil, lecithin and/or monoglycerides, etc. and film forming polymers, specifically alginate because Schaneville teaches that mucoadhesive films can be formed from the claimed ingredients and wherein the hemp oil is used in overlapping amounts to form these films. Thus, it would be obvious to substitute the CoQ10 of ‘618 and the combined references for the hemp oil in Schaneville and in order to form additional orally mucoadhesive films for delivering active agents effectively to users. One of ordinary skill in the art would be motivated to form the claimed film by optimizing the amounts of the claimed emulsifiers and alginate to use with the hemp oil in order to provide the most effective films because each of the claimed agents was already known in the art to be useful for forming oral mucoadhesive films for delivering the claimed active agents especially since it is known, Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 32-33, 38 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over JP2018203618A as evidenced by Nukui (BioFactors, Volume 32, issue 1-4, pp. 2019-219, April 2009), and in view of KR20140014073 as applied to claims 15-24, 26-27, 30-31, 35, 39-40, 45-47 above and further in view of Manegold et al. (US20050186257) and FR2999086.
Determination of the scope and content of the prior art
(MPEP 2141.01)
The combined references together teach the orally administrable film of claims 15-24, 26-27, 30-31, 35, 39-40, 45-47 as discussed above and incorporated herein. As discussed supra, ‘618 also teaches wherein the thickness of their film(s) can be appropriately set depending on use…the film thickness is about 30 to about 500 microns which reads on the claimed 150 to 350 microns (See paragraph: The film thickness of the film agent of the present invention can be appropriately set depending on the use mode of the film agent, but it is not too hard and not too soft, and from the viewpoint of ease of handling, the film thickness is about 30 to 500 μm. Is preferred.).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
The combined references do not teach wherein the wherein the film strip has an area of between 6 to 12 cm2 and wherein the dosage is between 40 to 160 mg, more specifically 60 to 100 mg and wherein the bioactive in the film is between 5 and 20 mg per cm. sq. However, this deficiency the combined references is addressed by Manegold and FR2999086.
Manegold teaches that it was known to form orally administrable film strips which are of various thicknesses and generally are about 1 inch wide (2.54 cm) and about 1.25 (3.175 cm) inches in length leading to a surface area of 2.54*3.175=8.06 cm2 ([0050]).
FR2999086 teaches that it was known to form unit dosage forms as films which comprise up to 100 mg of poorly water soluble active agent (claims; see sentence: According to a particular embodiment, the invention relates to an oral pharmaceutical form in the form of a unitary thin film suitable for oral administration comprising from about 0.1 mg to about 100 mg of the active ingredient per unit film; see sentences: The active ingredients used in the compositions described in the present invention are active ingredients poorly soluble in water and fluids of the gastrointestinal tract., and Preferably, the active ingredients used in the composition according to the invention are pharmaceutically active ingredients which are poorly soluble in water or fluids of the gastrointestinal tract and are included in the composition in an amount of approximately 0.01% to 80%, preferably 1% to 50% (w / w of the composition)).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have formed the film strip instantly claimed having the claimed area and the claimed dosing of mg because it was known in the art that this is a common surface area size for unit film strip dosage forms and it was known to formulate poorly water soluble active agents into film strip dosage forms in dosage loadings of up to 100 mg which reads on the claimed dosage ranges. One of ordinary skill in the art would be motivated to have the claimed high dosages by optimizing the amounts of CoQ10 in ‘618 because ‘618 already teaches wherein their films comprise up to 72% by mass as is discussed above and as such it would be obvious to optimize the bioactive/CoQ10 loading to be from 60 to 100mg, 5 to 20 mg per cm. sq., etc. as claimed because it was known to optimize dosage forms to provide the highest loading of drugs possible in the dosage forms so that patients/users do not need to take many dosage forms at once in order to achieve the necessary effective doses of active agent/drug/CoQ10, etc.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments/Remarks
Applicant argued the claimed film must be free of powder aggregates of the poorly water soluble bioactive material. This limitation is critical to achieving the claimed <20% weight standard deviation, as powder aggregates would create localized regions of high bioactive concentration that violate the uniformity requirement. It was argued that neither Myers (KR20140014073) nor JP2018203618A (‘618) teaches achieving films free of such aggregates. It was also argued that ‘618 describes uniform emulsion before drying provides only qualitative observation after drying where an almost smooth film was obtained. The reference provide zero quantitative uniformity measurement.
In response, ‘618 teach wherein their films are homogeneous wherein the CoQ10 is mixed with the other components using a high pressure homogenizer, alginate is added and the composition is mixed well/well mixed and/or mixed uniformly, and heated while rolling/hammering to produce a film. Therefore, the composition obviously would have little to no weight standard deviation throughout the film and the composition obviously would not contain powder aggregates/clumps of the poorly water soluble bioactive material as clumps/aggregates would not be a uniform mixture because clumps are not a uniform mixture. Myers (‘073) teaches that it was known to form films of drugs wherein the films are uniform and have the active agents/drugs dispersed throughout the film (i.e. does not contain powder aggregates as aggregates would not provide a uniform film/uniform dispersion for forming the film) and that the amount of drug is preferably substantially uniform throughout the film. It would have been obvious to one of ordinary skill in the art to form the claimed uniform film free of powder aggregates of the poorly water soluble bioactive, specifically wherein the uniformity is as defined and claimed, e.g. weight standard deviation of said film and said bioactive material per unit area of the film, wherein said weight standard deviation is lower than 20%, specifically lower than 10% because it was known to form oral films with this standard deviation because you do not want films to have all of the active agent and weight of film in one area, e.g. square centimeter of the film, and very little or no weight of drug and other ingredients elsewhere in the film, so that dosing of the bioactive agent is repeatable and reliable throughout the film thus the importance of ensuring no aggregates/clumps, etc. and as taught by ‘618 having a uniform mixture prior to spreading out the formulation which when dry becomes the film having uniform dispersion of the ingredients comprised in the film. The examiner further argues that applicant need to provide evidence of why the formed film of the prior art would lack uniformity after drying and/or explain/demonstrate why the prior art does not achieve a uniform film as applicant argue. Applicant have not provided persuasive evidence that the prior art of record does not achieve a uniform film upon drying when the art teaches a uniform mixture before drying.
Applicant argued agglomeration problems related to oral films loaded with cannabidiol (CBD) at high loading are described in WO2019219773 (‘773), describing the problems of emulsion instability due to the drying process, observing oil released during the drying process, the presence of crystals in the dry alginate film.
In response, the examiner argues that the presence of crystals in the dry alginate film after drying CBD emulsion does not necessarily mean that any other bioactive material would also behave the same way. Coenzyme Q10 and CBD are two very different bioactive agents and presence of crystals in the CBD film does not translate to such behavior also occurring with another bioactive such as Coenzyme Q10. Further, ‘618 does not disclose any presence of crystals after drying and teaches an almost smooth film was obtained. Also, it does not appear that ‘773 provides a uniform emulsion/mixture before drying whereas ‘618 provides a uniform emulsion/mixture before drying. Moreover, ‘773 teaches that with addition of salt, no partial oil release was observed with CBD formulation contain NaCl. Thus, one skilled in the art can add salt to prevent partial oil release even in the case when CBD is used as the bioactive.
Applicant again argued that '283 (as cited in their response) states if the content of the hardly soluble component exceeds 20% by mass the hardly soluble component is not uniformly dispersed in the film preparation (for example, partially agglomerated)..." and point to [0021] in this reference. However, applicants have not demonstrated how/why these teachings from a completely different document, their cited '283, relate to the prior art cited in the examiner's office action, nor have they demonstrated and/or clearly explained how the prior art cited in the office action ('618) which is a homogeneous composition/formulation prior to casting/forming the film, does not lead to a homogeneous film upon drying.
Applicant argued Nukui disclosure is not related directly to oral mucoadhesive films of the invention.
In response, Nukui is utilized only as an evidentiary reference for teaching that CoQ10 is known to be highly hydrophobic and is insoluble in water (Abstract). Thus, CoQ10 reads on wherein poorly water-soluble bioactive material has an aqueous solubility below 10 mg/L.
Applicant argued that ‘618 teaches it is required to emulsify CoQ10 before mixing the alginate in order to provide the desired CoQ10 dry film. ‘773 also follows the practice of mixing the alginate with previously prepared mixture comprising emulsifiers and API. It was found by ‘618 that performing homogenization process with alginate cause the dried films to possess undesired property of unevenness thickness. Example 1 and comparative example 1a in instant specification were performed to evaluate the effect of the process on the properties of the films and the process follow in ‘618 results in uneven films. Comparative example 1a provided film possessing non-uniform orange color, due to aggregation of the CoQ10.
In response, firstly the examiner argues that the data provided in the examples, specifically example 1 and comparative example 1a, is not commensurate in scope with the claims because the independent claims broadly recite the film comprising a poorly water soluble bioactive material, an emulsifier and alginate as film forming polymer. Example 1 and comparative example 1a comprise a specific bioactive (CoQ10), specific emulsifiers (e.g. lecithin) and sodium alginate. The examples also include number of other ingredients such as xylitol, stevia, flavors, etc. Thus, it cannot be concluded that a similar effect would occur over any bioactive, emulsifier and alginate used to form the film and it is unclear of what role other ingredients (e.g. xylitol, stevia, flavors) play in the film formation in the examples of the specification. Thus, the claims in the current form and the data provided in the specification does not appear to show that applicant’s method of making the film provided unexpected uniformity of the film. Also, the comparative example 1a includes flavor agent in the formulation to make the film whereas the example 1 does not include a flavor agent. Thus, the comparison is not a single variable comparison and it is unclear if the flavor agent plays a role in producing non-uniform film. For example, in ‘773, it is disclosed that xylitol causes partial oil release in the film in the drying process and xylitol is crystalline in nature. Thus, it is unclear what flavor agent is used and what effect the flavor agent may have in the causing non-uniformity in the film. Also, example 1 and comparative example 1a of instant specification use ingredient (e.g. xylitol, flavors, stevia, tocopherol, etc.) that are not used in the film making process of ‘618 and as such, one cannot ascertain that the film of ‘618 will be non-uniform after drying because it is non-uniform in the comparative example 1a. Applicant have not demonstrated with direct comparison of ‘618 to the claimed films that '618's homogeneous/uniform compositions prior to casting/drying into films are not uniform once dried into film form. Thus, applicant’s argument that emulsifying CoQ10 before mixing the alginate in ‘618 would produce non-uniform film because similar process used in comparative example 1a also produced non-uniform film is not found persuasive at this time.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALI SAEED whose telephone number is (571)272-2371. The examiner can normally be reached M-F 8-5 EST.
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/A.S/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616
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