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 . Claims 1-14 and 16-21 are pending; claims 1-13 and 17-20 are examined; claims 14 and 16 are withdrawn following Applicant’s election of 06 October 2025.
Applicant’s arguments, filed 06 March 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 4 is objected to because of the following informalities: “antipsasmodics” in line 6 should be recited as --- antispasmodics ---. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: at the end of the sentence there should be recited a period. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3-4 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitations (below, left), and the claim also recites the narrower statements of the ranges/limitations (below, right):
Broad recitation
Narrower statement
Cellulose derivatives
Hydroxypropyl cellulose
Natural gums
Agarose
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note: in clarification, the Examiner is referring to the broad recitation of “cellulose derivatives” and “natural gums” compared to narrower recitation of the numerous specific cellulose derivative species and natural gum species in the same claim, including: carboxymethyl cellulose, “hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl ethyl cellulose, sodium carboxymethyl cellulose, and ethyl or propyl cellulose”; and “alginates, pectin, pullulan, tragacanth, chitosan, alginic acid, agar, agarose,” and carrageenan, where the narrower statement listed is one instance of the numerous in the list, and not only referring to one specific cellulose derivative or natural gum species. To obviate this issue, it is suggested for the claim to recite such specific species instead of “cellulose derivatives” or “natural gums”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitations (below, left), and the claim also recites the narrower statements of the ranges/limitations (below, right).
Broad recitation
Narrower statement
Hormones
sexual hormones
Psychoneurotropic drugs
Analeptics
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note: in clarification, the Examiner is referring to the broad recitation of “hormones” and “psychoneurotropic drugs” compared to narrower recitation of the numerous specific hormone species and psychoneurotropic drugs in the same species in the same claim, including: thyroid hormones and “sexual hormones”; and antidepressants, “antiepileptics, analeptics” and “sedatives”, where the narrower statement gives one instance of the numerous in the list, and not only referring to one specific hormone or psychoneurotropic drug species. To obviate this issue, it is suggested for the claim to recite such specific species instead of “hormones” or “psychoneurotropic drugs”.
Response to Arguments
Applicant asserts the claims have been amended to address the alleged indefiniteness.
The Examiner has added explanation to the indefiniteness rejections remaining above for the purposes of clarification. The remaining indefiniteness have been withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6, 10-13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitz et al. (WO 2019/145524 A1, 08/01/2019) in view of Sebastian et al. (US 2015/0189910 A1, 07/09/2015).
Regarding claims 1-4 and 6, Schmitz discloses a multi-layer oral thin film, comprising at least two layers arranged one on top of the other, each comprising at least one water-soluble polymer, and the at least two layers being connected to one another by at least one sealing structure (abs). The water-soluble polymer includes polyvinyl alcohol and/or pullulan (p.3, ¶ 6 from bottom). The film may contain at least one of any pharmaceutically active agents suitable for oral administration, including antihistamines, dextromethorphan, ketoprofen, and/or nicotine (p.4, ¶¶ 5-8). Each layer of the multi-layer oral thin film may also comprise customary additives including antioxidants and dyes (p.4, ¶ 3-4 from bottom).
Schmitz differs from the instant claims insofar as not explicitly disclosing wherein the sealing structure is at least one stitched seam using at least one thread.
However, Sebastian discloses oral compositions having multi-layer structure comprising at least one edible film, wherein the multi-layer structure is reinforced by a sewing process using a biocompatible fiber/thread that may be laid around perimeter of a structure ([0008], [0049], [0084]-[0085]), to aid in ease of dispensing, use, and for an overall enjoyable form ([0004]). The biocompatible fiber/thread may be formed from a variety of materials including polyvinyl alcohol ([0071]). The thickness of the fiber/thread may vary depending on the desired taste level or feel within the user’s mouth ([0072]).
Schmitz discloses sealing but does not limit a type of seal. Accordingly, it would have been obvious to one of ordinary skill in the art to have sealed the multi-layer oral thin film of Schmitz by a sewing process using at least one thread formed from materials including polyvinyl alcohol to provide ease of dispensing and use as taught by Sebastian.
Regarding claims 10 and 11 reciting wherein the at least one thread comprises at least one water soluble polymer, or at least one claimed polymer, respectively, it would have been obvious to one of ordinary skill in the art to have included polyvinyl alcohol in the fiber/thread since it is a known and effective polymer suitable as a biocompatible fiber/thread as taught by Sebastian. As noted by p. 3 (¶ 6 from the bottom) of Schmitz, polyvinyl alcohol is a water soluble polymer. Thus the polyvinyl alcohol of Sebastian meets the limitation of a water soluble polymer as instantly claimed.
Regarding claims 12 and 20 reciting various thicknesses of the at least one thread, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed thickness (i.e. from 0.05 to 1mm, or from 0.1 to 0.5 mm, respectively) through routine experimentation based on the desired taste level or feel within the user’s mouth as taught by Sebastian. "[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." See MPEP § 2144.05(II)(A).
Regarding claim 13 reciting wherein the at least one thread has a color different from at least one of the at least two layers, as discussed above, Schmitz discloses wherein each layer of the multi-layer film may comprise dyes. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a dye into at least one layer of the multi-layer film, such that the color would be different from the fiber/thread.
Response to Arguments
Applicant mainly asserts on pp. 6-7 of the Remarks filed 06 March 2026 that Schmitz and Sebastian belong to different technical field with different design objectives; that there is no disclosure or suggestion in Sebastian to stitch together two dissolvable film layers, let alone layers with different pharmaceutical functions; and there is no reason as to why a skilled artisan would consider the fibrous structures of Sebastian as remotely relevant to the films of Schmitz. Applicant further asserts the present application explicitly demonstrates a technical effect that is neither disclosed nor suggested in the cited prior art. As shown in Example 2, stitching the layers together results in a reduction of migration of substances between the individual layers. This effect is specific to multilayer pharmaceutical films and addresses a problem that does not exist in Sebastian, where no controlled interlayer separation or migration issue are discussed. Sebastian therefore provides neither a motivation nor a reasonable expectation of success for the claimed solution.
The Examiner does not find the Applicant’s assertions to be persuasive.
In response to applicant's argument that Schmitz and Sebastian is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Schmitz is directed to a multi-layer oral thin film sealed by a structure that is not applied over the entire surface. Sebastian discloses oral compositions comprising at least one edible film, wherein the resulting multi-layer structure may be reinforced by a sewing process with a biocompatible fiber/thread that may be laid around perimeter of a structure (i.e. not over the entire surface). Thus both Schmitz and Sebastian are directed to oral films, and Applicant’s argument is unpersuasive.
In response to applicant's argument that there is no teaching or suggestion in Sebastian to stitch together two dissolving film layers, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it is not necessary for Sebastian to teach dissolving film layers; as this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejection above, Schmitz discloses multi-layer oral films sealed by a structure not applied over entire surface, and Sebastian provides a known and effective method of sealing (i.e. via biocompatible fiber/thread) that may be laid around the perimeter of a structure such as the multi-layer films. See MPEP 2141(III). Moreover in any case, Sebastian discloses at least one edible film layers comprising water-soluble polymers. Thus one of ordinary skill in the art would reasonably expect the edible film layers of Sebastian to be capable of dissolving in the mouth (i.e. aqueous environment).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a reduction of migration of substances between the individual layers and controlled interlayer separation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding allegations of unexpected results, Applicant has the burden of explaining the data in any declaration they proffer as evidence of non-obviousness. See MPEP § 716.02(b)(II). Applicant has explained that various statements referenced in the specification support their position, but these cannot take the place of evidence in the record. See MPEP § 716.01(c)(II).
Moreover, any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02. Applicant does not appear to have discussed same with respect to objective data.
Finally, assuming purely arguendo that the unexpectedness of the results has been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e., the claims must be “commensurate in scope” with the showing. MPEP § 716.02(d). See also MPEP § 2145. Example 2 of the instant Specification employs specific components in specific percentages, forming a specific solid dosage form, and even if Applicant were to show unexpected results, they would have been obtained, for example, not with the broad class of “layers”, “polymers”, or “thread” generally, but instead with specific species. Note for example, p. 13 et seq. of the instant specification uses two foamed layers with nitrogen as an aid for foaming, one layer comprising specifically S-ketamine, and the other contains a relatively high amount of tris buffer used to establish a mouth pH value that is advantageous for the absorption of the S-ketamine. These two specific layers were connected by sewing using a PVA filament 0.20mm according to p. 16 ¶ 2 of the Specification. Applicant would need to explain how these specific species are “reasonably representative” of the more broadly claimed subject matter of the claims.
Claims 5, 7-9, 17-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitz et al. (WO 2019/145524 A1, 08/01/2019) and Sebastian et al. (US 2015/0189910 A1, 07/09/2015), further in view of Müller et al. (WO 2018/224591 A1, 12/13/2018) (hereinafter Müller).
Regarding claim 5, the disclosure of Schmitz and Sebastian are discussed in detail above, and differ from the instant claims insofar as not explicitly disclosing wherein the pharmaceutically active agent includes ketamine, or wherein the one or more film layers is in the form of a solidified foam that has voids.
However, Müller discloses flat dosage forms that disintegrate or dissolve in an aqueous environment for releasing at least one active ingredient, which are formed from a polymer matrix in the form of a solidified foam having cavities, and at least one pharmaceutical active ingredient. Such dosage forms have a substantially improved mouthfeel in comparison to conventional film dosage forms (abs). The at least one pharmaceutical active ingredient includes N-methyl-D-aspartate (NMDA) receptor antagonists such as dextromethorphan or ketamine (p.4, ¶ 21) as to ensure rapid availability with transmucosal uptake (p.6, ¶ 20). The polymer matrix comprises water-soluble polymers (p.3, ¶ 12). The cavities may be isolated from each other in the polymer matrix, in the form of solidified bubbles, or the cavities may communicate with each other as a contiguous, matrix penetrating channel system. The cavities are filled with air or nitrogen gas, and have a volume fraction of 5-98% or 50-80% of the total volume to provide intended effect of influencing solution of the dosage form (p.3, last ¶ - p.4, ¶ 8).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included ketamine in the film of Schmitz since it is a pharmaceutically active agent suitable for transmucosal uptake to ensure rapid availability as taught by Müller.
Regarding claims 7-9 and 17-19, it would have been obvious to one of ordinary skill in the art to have included a layer in the form of a solidified foam having cavities (instant claim 7), either in the form of isolated bubbles filled with nitrogen (instant claims 8 and 17), or in the form of a contiguous, matrix penetrating channel system (instant claim 18), in 5-98%, or 50-80% by total volume of the layer (instant claims 9 and 19, respectively), in the oral film of Schmitz since it is a known and effective form providing improved mouthfeel in oral films as taught by Müller.
Regarding claim 21, Schmitz and Sebastian differ from the instant claim insofar as not explicitly disclosing wherein the water-soluble polymer includes carrageenan.
However, Müller further discloses wherein water-soluble polysaccharides include pullulan and carrageenan (p. 3, ¶ 8 from the bottom).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included carrageenan in the film of Schmitz since it is a known and effective water-soluble polymer suitable for oral films as taught by Müller. "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." See MPEP 2144.06(I). Similarly, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07.
Response to Arguments
Applicants do not present specific arguments with regards to Schmitz and Müller.
Since the Examiner has discussed Schmitz and Sebastian above, this rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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