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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-6, 8-9, 11-14, 16-17, and 19-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite a water soluble pressure sensitive adhesive layer as a component of the multi-layer active-substance film that is recited and made by the claims. The disclosure does not mention the phrase “pressure sensitive adhesive”. The applicant notes a single statement that films were “pressed” during the process of the applicant assessing qualitative stickiness as support for this recitation. There is no evidence of record demonstrating that all pressure sensitive adhesives are sticky adhesives, such that the terms are synonymous. Thus it would not have been clear to the artisan of ordinary skill that the applicant was in possession of the invention as instantly claimed at the time of filing.
The is a new matter rejection.
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 1, 4-6, 8-9, 11-14, 16-17, and 19-23 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 1 recites the limitation “the at least one water-soluble sticky adhesive layer” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. There is no previous recitation of a sticky adhesive layer in the claim.
The scope of the term “adhesive” in the claims is unclear. While the specification at page 3 defines the term as in DIN EN 923:2016-03, the applicant does not abide by this definition in their example, where they entitle a layer composed of polyvinyl alcohol and idebenone as “non-adhesive”. According to DIN EN 923:2016-03, an adhesive is a non-metallic substance capable of joining materials by surface bonding (adhesion), where the bond possesses adequate internal strength (see page 5). The example in the instant specification makes a “non-adhesive” layer with polyvinyl alcohol 4-88 which is explicitly taught in the prior art as an adhesive component, where adhesivity can be water activated (see Clariant Mowiol® Polyvinyl Alcohol reference - previously cited - table B 1.0 sample 4-88 and page G5 second column second full paragraph; Baklouti et al. – previously cited - page 323 second column -page 324 first column). A dried film of polyvinyl alcohol is also known to be an adhesive, where heat induces tackiness and its adhesion to other materials (see US Patent No. 2,954,311 – previously cited - examples 6 and 18). Polyvinyl alcohol is also a claimed option for components in the “non-adhesive” layers. Thus the scope of components and proportions permissible in the instantly claimed “non-adhesive” layer is unclear, given that the applicant’s single example of such a layer does not meet their stated criteria and the presence of the adhesivity function can be altered depending on the conditions experienced by the layer. Thus it is possible for a single non-adhesive layer composition to be both inside and outside the claim scope, depending on its conditions when assessed.
For the sake of application of prior art, a film layer will be considered sufficient to meet the limitations of “non-adhesive” if it is not adhesive at the moment in time (e.g., without water or heat activation for situationally adhesive compositions) it is being considered.
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 1, 5-6, 8-9, 11-14, 16-17, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dadey et al. (previously cited) in view of Kabuto et al. (previously cited), Pinal et al. (US-PGPub No. 2014/0271783), and Biegajski et al. (previously cited).
Dadey et al. teach a layered drug containing oral film, where a different drug is included in each layer (see abstract and paragraphs 18 and 35-37). The films dissolve in the oral cavity (see paragraph 14). They detail desired component identity and proportion selections such that the film dissolves quickly in the mouth and such that it does not adhere (non-adhesive) to oral surfaces (see paragraph 73). Dadey et al. further detail preparing the multilayered structure by coating a second layer forming composition onto an already prepared first layer as well as by preparing the drug containing film layers separately and securing the two films into a multilayered structure via techniques such as laminating or bonding the layers together (see paragraph 37; instant claim 13). Particular water soluble (hydrophilic) polymers in the two exemplified layers include polyethylene oxide (PEO) as the most prevalent polymer and hydroxypropyl methyl cellulose (HPMC) (cellulose derivative) and does not recite polyvinylpyrrolidone as a component (see examples 1-4; instant claims 1 and 5). The examples also include drug at less than 75 wt% of the film layers (see instant claim 9). An example adheres the two layers with heat or a solution of the water soluble polymer (adhesive) polyvinyl pyrrolidone (PVP) (see paragraph 59 and examples 3 and 4; instant claim 13). They additionally teach the polymer compositions for the two layers to have different dissolution rates (see paragraph 37). Different water soluble polymers and/or polymer molecular weights are selected to achieve a slower dissolution rate in one drug containing layer as compared to another (see paragraphs 40-41). Other polymers envisioned in the layers include polyvinyl alcohol (PVA), pectin, hydroxypropyl cellulose, and alginate to adjust tear strength and dissolution times (see paragraph 76-77; instant claim 6). They additionally teach films made of PVA and PEO as PVA films without any added plasticizer, implying that neither ingredient is considered a plasticizer (see paragraph 77). Thus plasticizer is absent from the exemplified layers with PEO and HPMC (see instant claim 20). Dadey et al. teach the film thickness to be 0.1 to 10 mils in thickness (see paragraph 15). They additionally exemplify mass and dimensions for a film layer to be 28 to 32 mg and 22x10 mm that is made for later combination with another film layer (see example 1). Here the mass and area of the film correspond to an areal density of 127 to 145 g/m2 (see example 1, as calculated by the examiner; instant claim 11). A pressure sensitive adhesive with a plasticizer is not detailed as the connector between the layers.
Kabuto et al. teach an oral film dosage form that includes an adhesive layer (see abstract and paragraphs 102 and 110). The adhesive layer may function via a variety of the mechanisms (see paragraph 110-116). They note a desire to minimize the amount of heat exposure to which the drug is subjected by employing an adhesive that does not require heating for adhesion (see paragraph 123-124). The adhesive layer is employed to connect components in the film and is taught present at 10 to 30 g/m2 (see paragraph 120; instant claim 12 and 16). Kabuto et al. also teach the adhesive layer to include a plasticizer envisioned as polyethylene glycol and glycerol (paragraphs 65, 112, and 115-116).
Pinal et al. teach the preparation of a multilayered oral film dosage form that may be produced by pressing a desired stack of sheet layers into a singular unit (see abstract and paragraph 62). They detail a sheet adhesive between adjacent film sheets to adhere the adjacent film sheets to one another (see paragraph 70; instant claim 13). Arrangement of the various layers is envision to align all eth edges of each film layer (see paragraph 5 and figure 1; instant claim 13). Polymers for the adhesive sheet are envisioned to include polyvinylpyrrolidone, polyvinyl alcohol, and polyvinyl acetate (see paragraph 75). They further detail the sheets being prepared from sticky material (see paragraph 92).
Biegajski et al. teach water soluble pressure sensitive adhesives that adheres to various materials that compose a device and to the mucosal surfaces such as the mouth (see abstract and column 3 lines 34-44 lines 47-52). The devices are envisioned as delivering a drug or active via orally dissolvable dosage forms envisioned as films (see abstract, column 3 lines 53-56, and column 5 lines 20-33). The duration of dissolution may be selected based upon formulation choices (see column 5 lines 27-33). The adhesive is provided as a layer that is sticky/tacky due to the presence of a plasticizer in combination with a water soluble polymer (see abstract and column 7 lines 5-12). The water soluble polymer is envisioned as polyvinyl pyrrolidone (PVP) and hydroxypropyl cellulose (HPC) while the plasticizer is envisioned as glycerin and polyethylene glycol (see column 7 lines 21-35). Biegajski et al. further exemplify the adhesive to contain about 65 to 95 wt% PVP, up to about 50 wt% HPC, and about 5 to 35 wt% glycerin (see column 8 lines 47-51). A narrower envisioned range provides glycerin at 30 to 50 wt% of the layer (see claims 6-7). An exemplary adhesive layer they show to be tacky when both wet and dry has a weight ratio of 84 to 16 water soluble polymer to plasticizer (see example XVIII and figure 14; instant claim 1; instant claim 13). Another example provides a film layer with a desired active, a film layer of adhesive that are then pressed together and cut into a desired size and shape (see example XVII). An additional example that provides a film that dissolved within ten minutes in the mouth had an overall thickness of 10 mils and an adhesive layer thickness of 5 mils which employed an adhesive composed of PVP and glycerin at a weight ratio of 15.9 to 6 (61:39) (see column 14 line 55-column 15 line 13; instant claims 1, 13-14, 17, and 21). In addition to glycerol, tributyl citrate is also an envisioned plasticizer (see column 28 lines 46-50; instant claim 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the multilayered film dosage forms of Dadey et al. via with an adhesive layer as taught by Biegajski et al. to bond the two drug containing films. This modification would have been obvious in light of Pinal et al. and Kabuto et al. who teach the use of an adhesive layer to connect such film layers in oral dosage forms. In addition, the pressure sensitive adhesive layer of Biegajski et al. is predominantly composed of the same polymer Dadey et al. already envision to adhere two film layers to one another. The use of this adhesive also permits construction of the device while avoiding heat application, as Kabuto et al. teach is desirable, by employing adhesive components that do not require heat for adhesivity. The proportion of water soluble polymer/PVP and plasticizer in the adhesive meets or overlaps with that instantly claimed, thereby rendering the claimed range obvious (see instant claims 1 and 21). “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). It also would have been obvious to select polymers of different molecular weight or different varieties in the drug containing layers because Dadey et al. suggest to do so (see instant claim 6). The exchange of tributyl citrate for the glycerol also would have been obvious from the teachings of Biegajski et al. because they are taught as alternatives. The exchange is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The application of the adhesive layer at the density taught by Kabuto et al. would have been obvious as the application of the same technique to a similar product in order to yield the same improvement and the areal density range overlaps with that instantly claimed, thereby rendering the claimed range obvious (see MPEP 2144.05; instant claim 12). Applying the exemplified film areal density of Dadey et al. also would follow from their teachings. Therefore claims 1, 5-6, 8-9, 11-14, 16-17, and 20-22 are obvious over Dadey et al. in view of Kabuto et al., Pinal et al., and Biegajski et al.
Claims 1, 5-6, 8-9, 11-14, 16-17, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dadey et al. in view of Kabuto et al., Pinal et al., and Biegajski et al. as applied to claims 1, 5-6, 8-9, 11-14, 16-17, and 20-22 above, and further in view of Myers et al. (previously cited).
Dadey et al. in view of Kabuto et al., Pinal et al., and Biegajski et al. obvious the limitations of instant claims 1, 5-6, 9, 11-14, 16-17, and 20-22. While they suggest formulation choices to produce two non-adhesive drug containing outer layers, they do not exemplify a multilayer film whose outer drug layers are non-adhesive.
Myers et al. teach that adherence between film strips/surfaces of edible oral films due to tackiness is an issue in an otherwise desirable dosage form (see paragraphs 4-5 and 15-17). To address this issue, they teach the inclusion of anti-tacking agents in the film as well as the configuration of the film as a set of three layers of film formulations where the outer layers contain anti-tacking agent and the inner layer does not (see paragraphs 15, 17, 19, and 112). Myers et al. teach an example of drug containing tacky and non-tacky film layer formulations that differ in regard to the presence or absence of anti-tacking agents (see paragraph 161 and table 1). The result is a tacky film or a non-tacky film depending upon whether the anti-tacking agent is absent or present, respectively (see paragraph 166).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the anti-tacking agent(s) of Myers et al. to the drug containing layers Dadey et al. in view of Kabuto et al., Pinal et al., and Biegajski et al. in order to further attain non-adhesive layers as Dadey et al. desire. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 5-6, 8-9, 11-14, 16-17, and 20-22 are obvious over Dadey et al. in view of Kabuto et al., Pinal et al., and Biegajski et al., and Myers et al.
Claims 1, 5-6, 8-9, 11-14, 16-17, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dadey et al. in view of Kabuto et al., Pinal et al., and Biegajski et al. as applied to claims 1, 5-6, 8-9, 11-14, 16-17, and 20-22 above, and further in view of Gosselin et al. (US PGPub No. 2016/0206627) and David et al. (EP 2832723).
Dadey et al. in view of Kabuto et al., Pinal et al., and Biegajski et al. render obvious the limitations of instant claims 1, 5-6, 9, 11-14, 16-17, and 20-22. Biegajski et al. note that their adhesive composition is a water soluble pressure sensitive adhesive envisioned to include PVP (see abstract). A copolymer of polyvinyl caprolactam, vinyl acetate, and polyethylene glycol is not explicitly named as a component of this layer.
Gosselin et al. teach that PVP and a copolymer of polyvinyl caprolactam, vinyl acetate, and polyethylene glycol are alternatives for adhesive components in an oral drug delivery dosage form (see abstract and paragraph 41). These polymers are water soluble and known for formulating an oral drug (see Davis et al. paragraphs 2 and 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the device of Dadey et al. in view of Kabuto et al., Pinal et al., and Biegajski et al., where a copolymer of polyvinyl caprolactam, vinyl acetate, and polyethylene glycol is included with or instead of the PVP in the adhesive layer. This choice would have been obvious in light of Gosselin et al. and Davis et al. that teach the polymer’s suitability for the oral dosage forms and its water solubility. The selection is also obvious as the simple substitution of one known element for another. The combination with the PVP is obvious because the copolymer of polyvinyl caprolactam, vinyl acetate, and polyethylene glycol and PVP are employed for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06). Therefore claims 1, 5-6, 8-9, 11-14, 16-17, and 19-22 are obvious over Dadey et al. in view of Kabuto et al., Pinal et al., Biegajski et al., Gosselin et al., and Davis et al.
Claims 1, 5-6, 8-9, 12, 14, 16-17, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Daud et al. in view of Krumme, Pinal et al., Kabuto et al., Biegajski et al., and Singh et al. (previously cited).
Daud et al. teach rapidly dissolving non-sticky (non-adhesive) orally disintegrating film dosage forms (see page 10 lines 8-17; instant claim 1). The film comprises water soluble polymers (see page 11 lines 6-10). In addition, moisture resistant/hydrophobic additives are included that do not impede its dissolution characteristics, but impart the non-tacky/sticky characteristics that are desired (see page 13 lines 3-15). Daud et al. exemplify a film formulation that includes hydroxypropylmethyl cellulose (cellulose derivative) as the water soluble polymer, about 9-11 wt% drug, and is devoid of polyvinylpyrrolidone (page 18 lines 17-22 and examples 5 and 6; instant claims 5 and 9). Other polymers that are envisioned include hydroxy ethylcellulose, carboxy methyl cellulose, pullulan, polyvinyl alcohol, polyethylene glycol graft polymer, soluble cellulosic polymers, guar gum, xanthan gum, locust bean gum, and carrageenan (see page 18 lines 1-8). Multilayer embodiments are envisioned where a layer is cast and, prior to it fully drying, a second layer is cast on its surface (see page 12 lines 5-14). A layered embodiment with drug containing outer layers and an adhesive intervening layer is not detailed.
Krumme teaches a multilayered oral film that rapidly dissolves in water and delivers its active ingredients (see abstract and column 2 lines 29-45). The multiple layers are taught to facilitate the inclusion of more drug in the dosage form than can be held in a single layer and avoid formulation limitations of a single layer structure as well as permit the inclusion of different, potentially incompatible, drugs in the same dosage form (column 1 line 64-column 2 line 4 and 29-45 and column 4 lines 6-27; instant claim 1). They also detail the layers being composed of different polymers (see column 2 line 55-column 3 line 1).
Kabuto et al. teach an oral film dosage form that includes an adhesive layer (see abstract and paragraphs 102 and 110). The adhesive layer may be heat laminated to induce adhesion or the adhesive layer may provide adhesion due to the presence of a solvent that is later removed (see paragraph 110-116). They note a desire to minimize the amount of heat exposure to which the drug is subjected by employing an adhesive that does not require heating for adhesion (see paragraph 123-124). The adhesive layer is employed to connect components in the film and is taught present at 10 to 30 g/m2 (see paragraph 120; instant claim 12 and 16). Kabuto et al. also teach the adhesive layer to include a plasticizer envisioned as polyethylene glycol and glycerol (paragraphs 65, 112, and 115-116).
Pinal et al. teach the preparation of a multilayered oral film dosage form that may be produced by pressing a desired stack of sheet layers into a singular unit (see abstract and paragraph 62). They detail a sheet adhesive between adjacent film sheets to adhere the adjacent film sheets to one another (see paragraph 70). Polymers for the adhesive sheet are envisioned to include polyvinylpyrrolidone, polyvinyl alcohol, and polyvinyl acetate (see paragraph 75). They further detail the sheets being prepared from sticky material (see paragraph 92).
Biegajski et al. teach water soluble pressure sensitive adhesives that adheres to various materials that compose a device and to the mucosal surfaces such as the mouth (see abstract and column 3 lines 34-44 lines 47-52). The devices are envisioned as delivering a drug or active via orally dissolvable dosage forms envisioned as films (see abstract, column 3 lines 53-56, and column 5 lines 20-33). The duration of dissolution may be selected based upon formulation choices (see column 5 lines 27-33). The adhesive is provided as a layer that is sticky/tacky due to the presence of a plasticizer in combination with a water soluble polymer (see abstract and column 7 lines 5-12). The water soluble polymer is envisioned as polyvinyl pyrrolidone (PVP) and hydroxypropyl cellulose (HPC) while the plasticizer is envisioned as glycerin and polyethylene glycol (see column 7 lines 21-35). Biegajski et al. further exemplify the adhesive to contain about 65 to 95 wt% PVP, up to about 50 wt% HPC, and about 5 to 35 wt% glycerin (see column 8 lines 47-51). A narrower envisioned range provides glycerin at 30 to 50 wt% of the layer (see claims 6-7). An exemplary adhesive layer they show to be tacky when both wet and dry has a weight ratio of 84 to 16 water soluble polymer to plasticizer (see example XVIII and figure 14; instant claim 1; instant claim 13). Another example provides a film layer with a desired active, a film layer of adhesive that are then pressed together and cut into a desired size and shape (see example XVII). A 5 mil layer has a tack force of 472 g-f and 672 g-f when dry and wet, respectively (see figure 14 sample BFD). An additional example that provides a film that dissolved within ten minutes in the mouth had an overall thickness of 10 mils and an adhesive layer thickness of 5 mils which employed an adhesive composed of PVP and glycerin at a weight ratio of 15.9 to 6 (61:39) (see column 14 line 55-column 15 line 13; instant claims 1, 13-14, 17, and 21). In addition to glycerol, tributyl citrate is also an envisioned plasticizer (see column 28 lines 46-50; instant claim 8).
Singh et al. reach rapidly dissolving active releasing films (see abstract). They further teach rapid dissolution in a mucosal cavity, such as the mouth, to occur within 10 minutes (see paragraphs 11 and 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a multi-layered version of a non-tacky film of Daud et al., where two of their layers are bonded with the exemplified adhesive of Biegajski et al. such that the same or different drugs are included in the layers (see instant claims 1 and 23). The highlighted exemplary films or others with similar properties that are more generally taught would have been obvious to employ. This modification would have been obvious because Krumme teaches of the improvement gleaned from multilayered drug containing oral films for delivering added quantities of drug or multiple drugs from an easily administered oral film. Film layers of different polymer composition would also have been obvious in light of Krumme (see instant claim 6). The modification employing the pressure sensitive adhesive layer of Biegajski et al. would have been obvious in light of Pinal et al. and Kabuto et al. who teach the use of an adhesive layer to connect such film layers in oral dosage forms. Additionally, employing an adhesive to connect the film layers, as opposed to the casting detailed by Daud et al., is recognized as an alternative film layer connection mechanism, as noted and detailed by Pinal et al. In addition, the pressure sensitive adhesive layer of Biegajski et al. permits construction of the device while avoiding excess heat, as Kabuto et al. teach is desirable, by employing adhesive components that do not require heat for adhesivity. The proportion of water soluble polymer and plasticizer of Biegajski et al. meets or overlaps with that instantly claimed, thereby rendering the claimed range obvious (see MPEP 2144.05; instant claims 1 and 21). There would have been a reasonable expectation of success for the modification, given the dissolution time of composite films with the adhesive of Biegajski et al. in the oral cavity occurs within a duration considered to be rapid, in light of Singh et al. The exchange of tributyl citrate for the glycerol also would have been obvious from the teachings of Biegajski et al. because they are taught as alternatives. The exchange is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Further, the application of the adhesive layer at the density taught by Kabuto et al. would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 5-6, 8-9, 12, 14, 16-17, 21, and 23 are obvious over Daud et al. in view of Krumme, Kabuto et al., Pinal et al., and Biegajski et al., and Singh et al.
Claims 1, 4-6, 8-9, 12, 14, 16-17, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Daud et al. in view of Krumme, Kabuto et al., Pinal et al., and Biegajski et al., and Singh et al. as applied to claims 1, 5-6, 8-9, 12, 14, 16-17, 21, and 23 above, and further in view of Cortopassi (previously cited).
Daud et al. in view of Krumme, Kabuto et al., Pinal et al., and Biegajski et al., and Singh et al. render obvious the limitations of instant claims 1, 5-6, 8-9, 12, 14, 16-17, 21, and 23. Daud et al. teach that pharmaceutical agents without limitation may be included (see page 11 lines 19-20). Idebenone is not explicitly named as a drug to include.
Cortopassi teaches idebenone as a drug to treat diabetes related conditions as well as obesity (see abstract and paragraphs 3-4). They further envision oral administration as a route for delivery into a subject (see paragraph 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select idebenone as a pharmaceutical agent to include in the modified multilayered dosage form of Daud et al. in view of Krumme, Kabuto et al., Pinal et al., and Biegajski et al., and Singh et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., exchange of specific orally administrable drug for a generic orally administrable drug). Therefore claims 1, 4-6, 8-9, 12, 14, 16-17, 21, and 23 are obvious over Daud et al. in view of Krumme, Kabuto et al., Pinal et al., and Biegajski et al., Singh et al. and Cortopassi.
Response to Arguments
Applicant's arguments filed February 4, 2026 have been fully considered. In light of the amendment to the claims, the rejections under 35 USC 112(b) that were not restated in the rejections above and the rejections under 35 USC 103 are hereby withdrawn. New grounds of rejection are detailed to address the claim amendment. The arguments directed toward the remaining rejection under 35 USC 112(b) and the rejections under 35 USC 103 that are relevant to the new grounds of rejection are not persuasive.
Regarding rejections under 35 USC 112(b):
The applicant argues that the recitation of “pressure-sensitive adhesive” clarifies the issue concerning the meaning of the term “adhesive’; however, the same issue raised in the rejection remains. As the rejection notes, the applicant contradicts their own definition of “adhesive” when they categorize an exemplary film composition as non-adhesive in spite of it being made of an adhesive polymer whose adhesivity is water activated. Thus the meaning of the term is not sufficiently clear to permit the scope of a “non-adhesive” film to be clear in regard to which components are permitted.
Regarding rejections under 35 USC 103:
The applicant argues that Dadey et al. teach multilayers film produced by heat laminating water soluble films and that there is no reason to deviate from this connectivity approach. This characterization of Dadey et al. omits their other generally discussed and exemplified approaches for connecting the multiple layers in their film product. As the rejection notes, Dadey et al. discuss attaching the layers via lamination or bonding and explicitly exemplify a polymer solution that functions as an adhesive and bonds two films layers into a multilayered product. These teachings and example provide ample reason for the artisan to employ an approach other than heated lamination to connect the film layers of Dadey et al. In contrast to the applicant’s suggestion, the process of Dadey et al. does not need to employ excess heat in order to be improved by the use of a film adhesive that requires no heat application, as Kabuto et al. teach is beneficial for drug containing films. Kabuto et al. detail that the avoidance of heat application is generally beneficial to drug containing film dosage forms. The application of such benefits are not limited to processes that would otherwise apply an excessive amount of heat.
The applicant additionally argues that Daud et al. do not suggest the production of a higher drug content film by assembling more that one of their film layers into a composite. The absence of this suggestion in Daud et al. is noted in the rejection. Such a suggestion to make a multilayer film is not required to originate in Daud et al. in order for the assembly of two of their film layers into a composite to be obvious. The applicant appears to argue that the only viable path to the combination of teachings in a prima facia case of obviousness is a teaching, suggestion, or motivation (TSM) explicitly provided by one of the source references. MPEP 2141(I) details that a reliance solely upon a TSM rationale is overly rigid and does not serve as the only route to a case of obviousness. Here the rationale based upon applying a known technique to a known device (method, or product) ready for improvement to yield predictable results, was employed to support the prima facia case of obviousness. This line of reasoning is explicitly detailed as a viable path to building a prima facie case of obviousness (see MPEP 2141(III)).
The applicant also argues that the artisan would not cover the mucosal adhesive surface on the film of Biegajski et al. with another layer. The rejections do not suggest that such a modification be made. Instead the rejection that modifies Dadey et al. employs the adhesive composition of Biegajski et al. as the adhesive in the multilayered film of Dadey et al. who already teach an adhesive to attached their film layers composed of PVP which is also the main ingredient in the pressure sensitive adhesive of Biegajski et al. The rejection that modifies Daud et al. employs the pressure-sensitive adhesive of Biegajski et al. to generate a multi-layered form of its film to yield the benefits taught by Krumme. The fact that Biegajski et al. employs the adhesive to attach a film layer to a mucosal surface does not negate its utility to attach two film layers to each other since it clearly functions to adhere oral film layers to other surfaces. Thus the arguments are not relevant to the rejection as set forth.
The applicant’s arguments against Kabuto et al. are similarly divergent from the modification set forth in the rejections. Again, the films of Biegajski et al. are not modified by the rejections. Instead the adhesive of Biegajski et al. which is already known to adhere to orally applied layered drug dosage form components, is employed to adhere other oral film layers to each other. Thus, in contrast to the applicant’s argument, Kabuto et al. do not need to teach the claimed oral film layers adhered by an adhesive, given that these limitations are addressed by other references discussed in the rejection.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
No claim is 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 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.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615