DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 58-73 and 75-82 are pending and represent all claims currently under consideration.
Response to Amendments
The amendment filed 05/29/2025 has been entered.
Claims 58-59, 64, 68, and 77-79 were amended. Claim 74 was canceled.
Applicant’s amendments have overcome the previous rejections under 35 U.S.C. 112(b) and the objections to the claims and specification.
The objection to the drawings has been modified to address the amendment and maintained.
The rejection of claim 74 under 35 U.S.C. 103 is moot, because the claim was canceled.
The rejections of claims 58-73 and 75-82 under 35 U.S.C. 103 has been modified and maintained.
Information Disclosure Statement
The information disclosure statements filed 03/12/2025, 05/30/2025, and 08/20/2025 have been considered.
New Claim Objections
Claim 68 is objected to because of the following informalities: a period needs to be added after “(g) water”. Appropriate correction is required.
Modified/Maintained Objection to the Drawings
The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d).
Drawings are present in the current specification, but are not included in a separate sheet as specified under 37 CFR 1.173. The Applicant corrected the unlabeled drawing on page 132 to be on a separate sheet, but did not correct figure 1 (page 107), figure 2, (page 109), figure 3 (page 111), and figure 4 (page 113).
Response to Arguments
Applicant's arguments with respect to the rejection of claims 58-61 and 68-82 under 35 U.S.C. 103 over Sapkal have been fully considered but they are not persuasive.
Applicant argues that Sapkal fails to teach or suggest an oral dissolvable film containing a minimum of three separate and distinct surfactants and the moisture content of the amended claim (Remarks, pages 11-12), and further argues that Sapkal explicitly discourages removing water from fluid microemulsions and therefore teaches away from lowering the moisture content (Sapkal, page 13). This argument is not persuasive, because Sapkal teaches three separate and distinct surfactants as listed in the modified rejection below and further teaches the moisture content is at least equal to the moisture bound in the emulsion component (Sapkal, claim 7) which ranges from a trace quantity to up to 49% (Sapkal, page 2, paragraph 0023), which encompasses the claimed range of 3-13%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Applicant argues that Begum, UMass Amherst, Janeway fail to teach or suggest an oral dissolvable film containing a minimum of three separate and distinct surfactants and the moisture content of the amended claim (Remarks, pages 11-12). This argument is not persuasive, because Begum, UMass Amherst, and Janeway are utilized only as evidentiary references to support the characterization of insulin as a hydrophobic active ingredient (Begum), oleic acid as a hydrophobic solvent (UMass Amherst), and an antibody as a hydrophilic active ingredient (Janeway).
Applicant’s arguments, see Remarks (pages 8-11), filed 05/29/2025, with respect to the rejections of claims 58-67, 69, 73, and 76-82 under 35 U.S.C. 103 over Schaneville, Koch Color, Paiement, and Kakumanu have been fully considered and are persuasive due to the amendment of the independent claim 58 to include a self-emulsifying lipophilic surfactant, a self-emulsifying hydrophilic surfactant, at least one co-surfactant (Remarks, page 8, 7th paragraph) and a moisture content (Remarks, page 9, 4th paragraph). Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Schaneville, Sapkal, Paiement, and Kakumanu as discussed below.
Applicant argues that the claim includes a specific order of combining the ingredients and states the claimed order is critical (Remarks, page 9). Applicant states that the order of the lipophilic surfactant, hydrophilic surfactant, and film-forming ingredient as described in figures 1-2 and paragraphs [0533]-[0539] increases the bioavailability of the active ingredient. This argument is not persuasive, because the specification/figures do not describe any new or unexpected results pertaining to the order of addition. While the ingredients are not added in the exact order claimed, selection of any order of mixing ingredients is prima facie obvious in the absence of new or unexpected results. See MPEP § 2144.04(IV). Further, the specification states that “by virtue of the active ingredient being lipophilic and having high solubility in organic solvents and low solubility in water, the active ingredient is proximal to L and distal to H in beaker” (page 105, paragraph 0495), which supports that the order of addition of the lipophilic and hydrophilic ingredients is not critical as the arrangement shown in figures 1-2 is inherent based on the chemical properties of the surfactants and active ingredient.
Applicant argues that Paiement fails to teach or suggest an oral dissolvable film containing a minimum of three separate and distinct surfactants and the moisture content of the amended claim (Remarks, page 10, 3rd paragraph). This argument is not persuasive, because Schaneville and Sapkal teach the oral dissolvable film containing a minimum of three separate and distinct surfactants and the moisture content of the amended claim as stated below.
Applicant argues that Kakumanu fails to teach or suggest an oral dissolvable film containing a minimum of three separate and distinct surfactants and the moisture content of the amended claim (Remarks, page 10, 4th paragraph). This argument is not persuasive, because Schaneville and Sapkal teach the oral dissolvable film containing a minimum of three separate and distinct surfactants and the moisture content of the amended claim as stated below.
Applicant argues that a skilled artisan would have had no motivation to modify the ingredients, order, or moisture content of Schaneville with Paiement or Kakumanu, because none of such ingredients or parameters are of any significance or importance to Schaneville (Remarks, page 11, 3rd paragraph). This argument is not persuasive, because all references are in the same field of manufacturing an oral dissolvable film and it would have been obvious to one of ordinary skill in the art to combine the teachings as discussed in the rejections below.
Maintained/Modified 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 58-61, 68-73, and 75-82 are rejected under 35 U.S.C. 103 as being unpatentable over Sapkal (US 20160317462 A1; IDS reference, 06/27/2024) as evidenced by Begum, UMass Amherst, Pharma Excipients, and Janeway.
Regarding claim 58, Sapkal teaches a process of making an orally dissolving thin film dosage form (Sapkal, page 3, paragraph 0053-0055) comprising mixing insulin (i.e., a hydrophobic active ingredient as evidenced by Begum (Begum, abstract), "step a"; Sapkal, page 4, paragraph 0044), oleic acid (i.e., a hydrophobic solvent as evidenced by UMass Amherst, "step a"; Sapkal, page 4, paragraph 0044), Span 80 (example 1 of the instant specification shows Span 80 to be a self-emulsifying lipophilic surfactant; "step b"; Sapkal, page 4, paragraph 0044) and labrasol (i.e., a surfactant as evidenced by Pharma Excipients; Sapkal, page 4, paragraph 0044) with a solution comprising Tween 80 ("step c"; the instant specification shows Tween 80 is a self-emulsifying hydrophilic surfactant (page 51, line 19); Sapkal, page 4, paragraph 0055), water (i.e., "step c"; Sapkal, page 4, paragraph 0055), and a film forming agent, HPMC (i.e., "step d"; Sapkal, page 4, paragraph 0055), then casting the resulting emulsion (i.e., slurry, "step e"; Sapkal, page 4, paragraph 0057). Sapkal teaches the moisture content ranges from a trace quantity to up to 49% (Sapkal, page 2, paragraph 0023), which encompasses the claimed range of 3-13%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). While the ingredients are not added in the exact order claimed, selection of any order of mixing ingredients is prima facie obvious in the absence of new or unexpected results. See MPEP § 2144.04(IV). Sapkal further teaches the film is casted on a support (i.e., substrate; Sapkal, page 5, paragraph 0065) and dried (i.e., cured; Sapkal, page 4, paragraph 0058). Sapkal is considered to be analogous to the claimed invention, because it is in the same field of oral dissolvable pharmaceutical films. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the teachings of Sapkal to arrive at the claimed invention.
Regarding claim 59, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal further teaches HPMC as a film forming agent and gelling agent (Sapkal, page 3, paragraph 0035).
Regarding claim 60, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal further teaches oleic acid as the oil phase (Sapkal, page 4, paragraph 0043).
Regarding claim 61, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal further teaches a solution in water (i.e., hydrophilic solvent, aqueous liquid; Sapkal, page 4, paragraph 0043).
Regarding claim 68, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal teaches an orally dissolving thin film dosage form (Sapkal, page 3, paragraph 0055) comprising a dispersion in water (i.e., water carrier; Sapkal, page 4, paragraph 0055), Tween 80 (the instant specification shows Tween 80 is a hydrophilic and self-emulsifying surfactant (page 51, line 19); Sapkal, page 4, paragraph 0053), Span 80 (example 1 of the instant specification shows Span 80 to be a self-emulsifying lipophilic surfactant; Sapkal, page 4, paragraph 0051), and water (Sapkal, page 4, paragraph 0051). Sapkal teaches the active pharmaceutical ingredient can be an antibody (i.e., a hydrophilic active ingredient as evidenced by Janeway (Janeway, paragraph 1); Sapkal, claim 9) and the microemulsion of the film dosage form is immobilized in a polymeric matrix (i.e., film matrix; Sapkal, claim 2).
Regarding claim 69, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal teaches the film dosage form to be fast dissolving and consumable orally (Sapkal, claim 18), resulting in an emulsion (Sapkal, page 4, paragraph 0052) in less than 30 seconds after dissolving in water (Sapkal, page 4, paragraph 0059), suggesting the same result would be reasonably expected in oral mucosa. The range less than 30 seconds overlaps the claimed time range of within 20 seconds. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Sapkal further teaches the emulsion contains Tween 80 (i.e., self-emulsifying surfactant; Sapkal, page 4, paragraph 0053).
Regarding claim 70, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal teaches the film dosage form to be fast dissolving and consumable orally (Sapkal, claim 18), resulting in an emulsion (Sapkal, page 4, paragraph 0052) in less than 30 seconds after dissolving in water (Sapkal, page 4, paragraph 0059), suggesting the same result would be reasonably expected in oral mucosa. The range less than 30 seconds overlaps the claimed time range of within 20 seconds. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Sapkal further teaches the emulsion is an oil-in-water emulsion (Sapkal, claims 7 and 23).
Regarding claim 71, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal teaches the film dosage form to be fast dissolving and consumable orally (Sapkal, claim 18), resulting in an emulsion (Sapkal, claim 7) and a particle size ranging from 250-1250 nm (i.e., 0.25-1.25 microns) in less than 30 seconds after dissolving in water (Sapkal, page 4, paragraph 0059), suggesting the same result would be reasonably expected in oral mucosa. The range of 0.25-1.25 microns overlaps the claimed particle size of 0.1-100 microns and less than 30 seconds overlaps the claimed time range of within 20 seconds 0.1-100 microns. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Sapkal further teaches the emulsion is an oil-in-water emulsion (Sapkal, claims 7 and 23).
Regarding claim 72, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal teaches the film dosage form to be fast dissolving and consumable orally (Sapkal, claim 18), resulting in an emulsion (Sapkal, claim 7) and a particle size ranging from 250-1250 nm (i.e., 0.25-1.25 microns) in less than 30 seconds after dissolving in water (Sapkal, page 4, paragraph 0059), suggesting the same result would be reasonably expected in oral mucosa. The range of 0.25-1.25 microns overlaps the claimed particle size distributions and less than 30 seconds overlaps the claimed time range of within 20 seconds. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Sapkal further teaches the emulsion is an oil-in-water emulsion (Sapkal, claims 7 and 23).
Regarding claim 73, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal teaches oral (Sapkal, claim 18), mucosal (Sapkal, claim 14), buccal (Sapkal, claim 15), and sublingual administration (Sapkal, claim 15).
Regarding claim 75, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal teaches the film dosage form to be fast dissolving (Sapkal, claim 18), teaches buccal administration (Sapkal, claim 15), and further teaches the film dissolves (i.e., disintegrates) in water in less than 30 seconds (Sapkal, page 4, paragraph 0050), which overlaps the claimed range of within 30 seconds. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 76, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal teaches the film dosage form to be fast dissolving and consumable orally (Sapkal, claim 18), and further teaches the film dissolves (i.e., disintegrates) in water in less than 30 seconds (Sapkal, page 4, paragraph 0050).
Regarding claim 77, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Sapkal teaches the film dosage form dissolves (i.e., disintegrates) in water (i.e., in vitro) in less than 30 seconds (Sapkal, page 4, paragraph 0050).
Regarding claim 78, Sapkal teaches all the elements of the claimed invention as applied to claim 58. The claimed pharmacokinetic parameters are an expected property of performing the claimed method to produce the claimed composition.
Regarding claim 79, Sapkal teaches all the elements of the claimed invention as applied to claim 58. The claimed pharmacokinetic parameters are an expected property of performing the claimed method to produce the claimed composition.
Regarding claim 80, Sapkal teaches all the elements of the claimed invention as applied to claim 58. An in vivo dissolution time of no more than 20 minutes is an expected property of performing the claimed method to produce the claimed composition. Sapkal further teaches the film dosage form to be consumable orally (i.e., in vivo; Sapkal, claim 18) and to dissolve within less than 30 seconds in water (Sapkal, page 4, paragraph 0059), suggesting the same result would be reasonably expected in vivo. The range of less than 30 seconds overlaps the claimed range of no more than 20 minutes. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 81, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Bioavailability of at least 15% is an expected property of performing the claimed method to produce the claimed composition.
Regarding claim 82, Sapkal teaches all the elements of the claimed invention as applied to claim 58. Stability of 96% after nine months as measured under 40 °C/75% RH accelerated conditions is an expected property of performing the claimed method to produce the claimed composition.
New Claim Rejections - 35 USC § 103
Claims 58-61, 69, 73, and 76-82 are rejected under 35 U.S.C. 103 as being unpatentable over Schaneville (US 20170290870 A1; IDS reference, 06/29/2022), further in view of Sapkal (US 20160317462 A1; IDS reference, 06/27/2024).
Regarding claim 58, Schaneville teaches a method of making a mucosally (i.e., orally) dissolvable film comprising dissolving an active agent (i.e., active pharmaceutical ingredient, “step a”) in a solvent mixture wherein the active agent is cannabinoids or THC (i.e., active pharmaceutical ingredient; Schaneville, claim 11), which is hydrophobic (Schaneville, page 2, paragraph 0028), and the carrier can be olive oil (i.e., hydrophobic solvent; Schaneville, page 11, paragraph 0099). Schaneville further teaches a polysorbate (Schaneville, page 8, table 1), which can be polyoxyethylene (20) sorbitan monolaurate (i.e., Tween 20 which is a self-emulsifying, hydrophilic or lipophobic surfactant as defined by the instant specification, page 51, paragraph 0154), water (“step c”, Schaneville, page 8, table 1), pullulan (Schaneville, page 8, table 1), which is a film forming agent (“step d”, Schaneville, page 4, paragraph 0039), to form an emulsion (i.e., slurry), and that the composition may further include oleoyl or lauroyl polyoxyglycerides (which the instant specification shows to be lipophilic, self-emulsifying surfactants, page 49, paragraphs 0145-0146; “step b”) and combinations thereof (i.e., a self-emulsifying, lipophilic surfactant and a co-surfactant; Schaneville, page 4, paragraph 0040) and teaches casting the emulsion into a film and drying (i.e., curing, “step e”; Schaneville, claim 11). Schaneville is considered to be analogous to the claimed invention, because it is in the same field of oral dissolvable pharmaceutical films. As discussed above, Schaneville teaches the first solvent system (i.e., “step a”), then addition of all other ingredients (i.e., “steps b-d”), then casting (i.e., “step e”). While the ingredients are not added in the exact order claimed, selection of any order of mixing ingredients is prima facie obvious in the absence of new or unexpected results. See MPEP § 2144.04(IV). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the teachings of Schaneville to arrive at the claimed invention. Schaneville does not specify a final moisture content. Sapkal, however, teaches an oral dissolvable film wherein the moisture content ranges from a trace quantity to up to 49% (Sapkal, page 2, paragraph 0023), which encompasses the claimed range of 3-13%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Schaneville and Sapkal are considered to be analogous to the claimed invention, because all are in the same field of oral dissolvable pharmaceutical films. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the final moisture content of Sapkal for the oral dissolvable film taught by Schaneville, because Schaneville does not specify a final moisture content, while Sapkal teaches such a moisture content to result in a film which is fast dissolving and consumable orally without a need for water (Sapkal, page 2, paragraph 0022).
Regarding claim 59, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches a plasticizer, filler, flavoring agent, coloring agent, solubilizing agent, emulsifying agent (Schaneville, page 4, paragraph 0038), sweetener (Schaneville, page 4, paragraph 0037), and binder (Schaneville, page 5, paragraph 0064).
Regarding claim 60, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches the carrier (i.e., hydrophobic solvent) can be olive oil (Schaneville, page 11, paragraph 0099).
Regarding claim 61, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches a solution in water (i.e., hydrophilic solvent or aqueous liquid; Schaneville, page 8, table 1).
Regarding claim 69, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches adding water to the film forms an emulsion (Schaneville, page 9, paragraph 0082) and the film is absorbed through the mucosal tissue within about 20 seconds (Schaneville, page 13, paragraph 0118), which overlaps the claimed range of within 30 seconds. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 73, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville teaches oral or mucosal administration (Schaneville, page 12, paragraph 0108).
Regarding claim 76, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches oral administration is a type of mucosal administration (Schaneville, page 12, paragraph 0108) and that the film is absorbed through the mucosal tissue within about 20 seconds (Schaneville, page 13, paragraph 0118), which overlaps the claimed range of within 30 seconds. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 77, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches the film is dissolvable when exposed to a wetting agent (i.e., in vitro disintegration) within about 30 seconds (Schaneville, page 13, paragraph 0118).
Regarding claim 78, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. The claimed pharmacokinetic parameters are an expected property of performing the claimed method to produce the claimed composition.
Regarding claim 79, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. The claimed pharmacokinetic parameters are an expected property of performing the claimed method to produce the claimed composition.
Regarding claim 80, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches the film is absorbed through the mucosal tissue (i.e., in vivo dissolution) within about 20 seconds (Schaneville, page 13, paragraph 0118), which overlaps the claimed range of no more than 20 minutes. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 81, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Bioavailability of at least 15% is an expected property of performing the claimed method to produce the claimed composition.
Regarding claim 82, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Stability of 96% after nine months as measured under 40 °C/75% RH accelerated conditions is an expected property of performing the claimed method to produce the claimed composition.
Claims 62-64 are rejected under 35 U.S.C. 103 as being unpatentable over Schaneville (US 20170290870 A1; IDS reference, 06/29/2022) and Sapkal (US 20160317462 A1; IDS reference, 06/27/2024) as applied to claims 58-61, 69, 73, and 76-82, further in view of Paiement (US 20160324773 A1).
Regarding claim 62, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches heating and curing (Schaneville, page 9, paragraph 0080) using an oven with convection air flow (i.e., hot air oven; Schaneville, page 10, paragraph 0090). Schaneville does not teach a specific air temperature, but does teach the speed and temperature settings should be sufficiently matched to result in an evenly dried film (Schaneville, page 10, paragraph 0090). Paiement, however, teaches drying of an oral film dosage form using an oven with a gradient temperature of 50-90 °C (Paiement, page 3, paragraph 0036), which lies within the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Schaneville and Paiement are considered to be analogous to the claimed invention, because all in the same field of oral dissolvable pharmaceutical films. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Schaneville to use the oven temperature taught by Paiement in order to achieve an evenly dried film, as taught by Schaneville (Schaneville, page 10, paragraph 0090).
Regarding claim 63, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches heating and curing (Schaneville, page 9, paragraph 0080) using an oven with convection air flow (i.e., hot air oven; Schaneville, page 10, paragraph 0090). Schaneville does not teach a specific air temperature, but does teach the speed and temperature settings should be sufficiently matched to result in an evenly dried film (Schaneville, page 10, paragraph 0090). Paiement, however, teaches drying of an oral film dosage form using an oven with a gradient temperature of 50-90 °C (Paiement, page 3, paragraph 0036), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Schaneville to use the oven temperature taught by Paiement in order to achieve an evenly dried film, as taught by Schaneville (Schaneville, page 10, paragraph 0090).
Regarding claim 64, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches heating and curing (Schaneville, page 9, paragraph 0080) using an oven with convection air flow (i.e., hot air oven; Schaneville, page 10, paragraph 0090). Schaneville does not teach a specific air temperature, but does teach the speed and temperature settings should be sufficiently matched to result in an evenly dried film (Schaneville, page 10, paragraph 0090). Paiement, however, teaches drying of an oral film dosage form using an oven with a gradient temperature of 50-90 °C (Paiement, page 3, paragraph 0036), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Schaneville to use the oven temperature taught by Paiement in order to achieve an evenly dried film, as taught by Schaneville (Schaneville, page 10, paragraph 0090).
Claims 65-67 are rejected under 35 U.S.C. 103 as being unpatentable over Schaneville (US 20170290870 A1; IDS reference, 06/29/2022) and Sapkal (US 20160317462 A1; IDS reference, 06/27/2024) as applied to claims 58-61, 69, 73, and 76-82, further in view of Kakumanu (US 20200000717 A1).
Regarding claim 65, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches heating and curing (Schaneville, page 9, paragraph 0080) using an oven with convection air flow (i.e., hot air oven; Schaneville, page 10, paragraph 0090). Schaneville does not teach a specific speed, but does teach the speed and temperature settings should be sufficiently matched to result in an evenly dried film (Schaneville, page 10, paragraph 0090). Kakumanu, however, teaches a dissolvable pharmaceutical film (Kakumanu, abstract) and drying (i.e., curing) with a forced hot air oven with a line speed between 0.25-5 meters/minute (i.e., 0.8-16 feet/min; Kakumanu, page 11, paragraph 0144), which overlaps the claimed range of 0.8-2.5 feet/min. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Schaneville and Kakumanu are considered to be analogous to the claimed invention, because all in the same field of oral dissolvable pharmaceutical films. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Schaneville to use the drying speed taught by Kakumanu in order to achieve an evenly dried film, as taught by Schaneville (Schaneville, page 10, paragraph 0090).
Regarding claim 66, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches heating and curing (Schaneville, page 9, paragraph 0080) using an oven with convection air flow (i.e., hot air oven; Schaneville, page 10, paragraph 0090). Schaneville does not teach a specific speed, but does teach the speed and temperature settings should be sufficiently matched to result in an evenly dried film (Schaneville, page 10, paragraph 0090). Kakumanu, however, teaches a dissolvable pharmaceutical film (Kakumanu, abstract) and drying (i.e., curing) with a forced hot air oven with a line speed between 0.25-5 meters/minute (i.e., 0.8-16 feet/min; Kakumanu, page 11, paragraph 0144), which overlaps the claimed range of 0.8-1.0 feet/min. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Schaneville to use the drying speed taught by Kakumanu in order to achieve an evenly dried film, as taught by Schaneville (Schaneville, page 10, paragraph 0090).
Regarding claim 67, Schaneville and Sapkal together teach all the elements of the claimed invention as applied to claim 58. Schaneville further teaches heating and curing (Schaneville, page 9, paragraph 0080) using an oven with convection air flow (i.e., hot air oven; Schaneville, page 10, paragraph 0090). Schaneville does not teach a specific speed, but does teach the speed and temperature settings should be sufficiently matched to result in an evenly dried film (Schaneville, page 10, paragraph 0090). Kakumanu, however, teaches a dissolvable pharmaceutical film (Kakumanu, abstract) and drying (i.e., curing) with a forced hot air oven with a line speed between 0.25-5 meters/minute (i.e., 0.8-16 feet/min; Kakumanu, page 11, paragraph 0144), which overlaps the claimed range of 2.0-2.5 feet/min. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Schaneville to use the drying speed taught by Kakumanu in order to achieve an evenly dried film, as taught by Schaneville (Schaneville, page 10, paragraph 0090).
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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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