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 .
DETAILED ACTION
Status of Claims
Claims 2, 4-5, and 13-27 are pending.
Election/Restrictions
Applicants’ election of analgesics as a species of active substances, in the reply filed on 11/25/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a))
Upon reconsideration, the requirement to elect species from a substrate free of an active substance and a substrate containing an active substance is hereby withdrawn.
Accordingly, claims 2, 4-5, and 13-27 are under examination in the instant office action.
Claim Objections
Claim 17 is objected to because of the following informalities: typographical errors.
It appears that the word, “one”, in line 3 is inadvertently not deleted.
Duplicate Claims, Warning
Applicant is advised that should claim 4 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Also, Applicant is advised that should claim 5 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Claim Rejections - 35 USC § 112(d)
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 2 and 4-5 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 2 and 4-5 are improperly dependent from succeeding claim 13 as claim 13 is not a claim that is previously set forth (see MPEP 608.01(n), iii. Test for proper dependency).
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 § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4-5, and 13-27 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 pre-AIA the applicant regards as the invention. All the dependent claims are included.
The preamble of claim 13 recites: “An active substance laminate produced by a method…”. However, the steps of the method only recite preparing an intermediate laminate but do not include a step of forming the active substance laminate from the intermediate laminate. Thus, it is unclear and confusing whether the intermediate laminate become an active substance laminate once it is dried, or an additional step of forming an active substance laminate from the intermediate laminate is required for producing an active substance laminate as claimed. Clarification is required.
The test for indefiniteness is “whether the claim delineates to a skilled artisan the bounds of the invention." SmithKline Beecham Corp. v. Apotex Corp., 74 USPQ2d 1398, 1404. Because of the ambiguities discussed above, once cannot be sure of the actual metes and bounds of the claimed method.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 4 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2003/0107149 (hereafter Yang).
Yang teaches rapidly dissolving films and methods of their preparation wherein the film with a substantially uniform distribution of components is prepared by the process comprising: combining a polymer component and water to form a uniformly distributed matrix, which further include active ingredients (active-substance containing mass), and is then formed into a film and fed onto the top side of a substrate surface having top and bottom sides (step a) by reverse roll coating technique and then heat is applied to the bottom side of the substrate surface in order to dry the film (drying the intermediate laminate, especially the active-substance containing layer) (abstract, [0015], [0042]-[0046], [0059], and claim 56). Yang further discloses: reverse roll coating provides excellent control and uniformity of the resulting films and in this procedure, master batch premix blended with a drug is prepared and the coating material (active substance containing mass) is measured onto the applicator roller by the precision setting of the gap between the upper metering roller (first roller) and the application roller (second roller) below it and the coating is transferred from the application roller to the substrate as it passes around the support roller (third roller) adjacent to the application roller wherein the active substance containing mass is applied on the top side of the substrate to form an active substance containing layer (steps b and c) and then transporting the wet film formed by the substrate and the active-substance-containing layer (intermediate laminate) to a drying device for drying it (steps d and e) ([0079], [0059], [0135] and Fig 6).
Yang further teaches a film having a uniformly dispersed composition including a polymer, a pharmaceutical and/or cosmetic active and a solvent, said film being formed by depositing a wet film of said composition onto a substrate surface and controllably drying the wet film from the side contacting the substrate to prevent self-aggregation and achieve compositional uniformity ([0060]). Yang specifically discloses that the liquid comprising an active substance was deposited into the 3-roll coater (reverse roll coater) and coated at 30 microns at a line speed of 1.3 m/min; the oven temperature was set at 90℃ to apply air and heat to the bottom only, with an air velocity set at 40 m/sec; and the dried film was 0.005 inch. thick (5 mil) and was cut into 1 in. x 0.75 in. pieces weighing 70 mg ± 0.7 mg, demonstrating the uniformity of the composition of the film ([0193]). Yang further teaches that the polymeric film has no more than a 10% variance of a pharmaceutical and/or cosmetic active per unit area ([0061]). Thus, the teachings reasonably read on the limitation, “the active-substance-containing layer arranged on the substrate has a constant areal density independently of the thickness and/or the areal density of the substrate” as recited in claim 13.
As to claims 4 and 14, the substrate of Yang does not contain active substance.
As to claim 15, Yang also discloses that the active substance includes analgesics ([0099]-[0101]).
As such, the instant claims are anticipated by Yang.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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 of this title, 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.
Claims 2, 4-5, 13-15, 17-18, and 21 and are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2006/0062830 (hereafter, Hayashi).
Hayashi teaches an orally administrable edible agent of laminate film form comprising an edible covering layer that forms an outermost layer, a drug layer that contains a base and an active ingredient of the administrable agent, and if required, a support layer laminated in succession ([0130]). The edible covering layer and the support layer are at least two active substance-free layers as claimed.
Hayashi disclose the following laminate film form comprising the drug layer on the upper side of the covering layer (substrate) and a resin (PET) film (carrier film) underside of the covering layer ([0153] and Fig. 17 (a)). The resin film is formed on the side of the substrate opposite the active-substance containing layer and releasably connected and the active-substance containing layer has a constant density (see Fig.17(a)).
Also, Hayashi teaches that the effective ingredient in the edible drug layer includes analgesic, alkaloid narcotics (opium alkaloid preparations, coca alkaloid preparations, or the like), and non-alkaloid narcotics (synthetic narcotics such as fentanyl citrate) ([0140]).
In addition, Hayashi disclose that the edible covering layer is prepared from an edible covering layer preparation solution comprising a polymer such as pulluran, d-sorbitol and water ([0147]).
While the reference does not specifically disclose all the specific steps (a)-(e) as recited in the instant claim 13, the prior art teaches the same laminate film form having the same layers as claimed, made by similar process (see [0024] and Fig. 16). “[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, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process, either 102 or 103 rejection can be properly made. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP §2113.
Thus, the claims are anticipated by or, in the alternative, obvious over Hayashi.
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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2, 4-5, 13-15, 17-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0107149 (hereafter, Yang) in view of DE202008017304.
The teachings of Yang as applied supra are herein applied for the same teachings in their entirety.
Yang does not specifically a carrier film recited in claim 2.
DE202008017304 teaches orally disintegrating films containing an active substance and wherein the film production takes place on a continuous coating plant, comprising an unwinding roll from which the carrier film is handled; a squeegee, over which the coating mass (active substance containing mass) is applied to the carrier film (substrate); an oven for drying, in which the intermediate laminate (formed film by applying coating mass to the carrier film) is dried; an optional laminating roller through which a second carrier foil (corresponding to claimed carrier film in claim 2) on the free side of the dried film from the coating mass is applied (formed on the side of the substrate opposite the active-substance-containing layer); and a take-up roller, on which the produced film (on the support or as a laminate) is wound up (rolling up) and the film is cut into pieces with dimensions of 2.5 to 10.0 cm2 (p4, Example 2). DE202008017304 further teaches that the second carrier foil advantageously improves the handling of the film during further processing, when cutting or punching, or during administration ([0035]). The carrier film (substrate) and the second carrier foil are at least two active-substance-free layers. DE202008017304 further teaches that the film is in the form of a single layer or the film comprises two or more layers (p2, lines 6-11). DE202008017304 teaches that preferred carrier films are films made of plastics such as PE, PP, or PETP (polymer) ([0035]).
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 further include a second carrier foil (corresponding to claimed carrier film) made from a polymer for the oral films with an active substance containing layer taught by Yang because such second carrier foil (film) is taught to advantageously improve the handling of the film during further processing, when cutting or punching, or during administration as evidenced by DE202008017304. The skilled artisan would have been motivated to do so on the reasonable expiation that the addition of such carrier film would improve the handling, processing and administration of the films with an active substance containing layer taught by Yang.
Claims 16, 19-20, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0107149 (hereafter, Yang) in view of DE202008017304 in further view of WO 2011/100423.
The teachings of Yang and DE202008017304 as applied supra are herein applied for the same teachings in their entirety.
Yang does not specifically teach a specific areal density of the active-substance containing layer and the substrate recited in claims 16, 19-20, and 22-26
The areal density is the mass or quantity of a substance per unit area, thus the areal density of the active-substance containing layer and the substrate depends on the size (length and width), and thickness of oral films. It was known in the art that oral films may be sized to a desired length and width and may be any desired thickness and size suitable for the intended use as evidenced by WO 2011/100423 (p4, lines 5-19). WO 2011/100423 further discloses that for example, a film may be sized such that it may be placed into the oral cavity of the user and other films may be sized for application to the skin of the user, i.e., a topical use (p4, lines 5-19). WO 2011/100423 further discloses that for example, some films may have a relatively thin thickness of from about 0.1 to about 10 mils, while others may have a somewhat thicker thickness of from about 10 to about 30 mils (p4, lines 5-19). Also, DE202008017304 teaches orally disintegrating films (abstract) and discloses that the active agent containing-film according to the invention has a weight of about 20-110, preferably 40-80 mg per 10 cm2 ([0033]), which discloses areal density being 20-110 g/m2 or 40-80 g/m2. In addition, DE202008017304 teaches that the coating width is variable, and is preferably between 50 to 200 mm and the film thickness is 0.2 to 0.8 mm (p4, Example 2).
Accordingly, the areal density is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. It would have been customary for an artisan of ordinary skill to determine the optimal size, thickness, and weight of the oral film suitable for intended use. Thus, absent some demonstration of unexpected results from the claimed parameters, such optimization would have been obvious at the time of applicant's invention. The skilled person would be able to identify proper areal density for obtaining desired film size and thickness by routine experimentation. In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[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 re Aller, 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.”)
Claims 2, 4-5, and 13-27 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0062830 (hereafter, Hayashi) in view of DE202008017304 and WO 2011/100423.
The teachings of Hayashi as applied supra are herein applied for the same teachings in their entirety.
Hayashi does not specifically teach a specific areal density of the active-substance containing layer and the substrate recited in claims 16, 19-20, and 22-26
The areal density is the mass or quantity of a substance per unit area, thus the areal density of the active-substance containing layer and the substrate depends on the size (length and width), and thickness of oral films. It was known in the art that oral films may be sized to a desired length and width and may be any desired thickness and size suitable for the intended use as evidenced by WO 2011/100423 (p4, lines 5-19). WO 2011/100423 further discloses that for example, a film may be sized such that it may be placed into the oral cavity of the user and other films may be sized for application to the skin of the user, i.e., a topical use (p4, lines 5-19). WO 2011/100423 further discloses that for example, some films may have a relatively thin thickness of from about 0.1 to about 10 mils, while others may have a somewhat thicker thickness of from about 10 to about 30 mils (p4, lines 5-19). Also, DE202008017304 teaches orally disintegrating films (abstract) and discloses that the active agent containing-film according to the invention has a weight of about 20-110, preferably 40-80 mg per 10 cm2 ([0033]), which discloses areal density being 20-110 g/m2 or 40-80 g/m2. In addition, DE202008017304 teaches that the coating width is variable, and is preferably between 50 to 200 mm and the film thickness is 0.2 to 0.8 mm (p4, Example 2).
Accordingly, the areal density is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. It would have been customary for an artisan of ordinary skill to determine the optimal size, thickness, and weight of the oral film suitable for intended use. Thus, absent some demonstration of unexpected results from the claimed parameters, such optimization would have been obvious at the time of applicant's invention. The skilled person would be able to identify proper areal density for obtaining desired film size and thickness by routine experimentation. In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[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 re Aller, 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.”)
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611