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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/2026 has been entered.
Response to Amendment
The office action is in response to Applicant’s amendment filed on 04/28/2026.
Claim 1 is amended.
Claims 2 and 8 are cancelled.
Claims 13-21 are withdrawn for being directed to a non-elected group.
Claims 1, 3-7, and 9-22 are pending and are subject to this Office Action.
Response to Arguments
Applicant' s arguments, see pages 6-8, filed 04/28/2026, with respect to the rejection of claim 1 under 35 U.S.C. 103, have been fully considered and are persuasive. The Applicant introduced new limitations to the claims, specifically regarding the active ingredient is selected from “the group consisting of a stimulant, an amino acid, a vitamin, an antioxidant, a nicotine component, a nutraceutical, a cannabinoid, a cannabimimetic, rejection in view of Kobal has been withdrawn. However, a new grounds of rejection is made in view of Sebastian and Stahl, previously cited.
Applicant arguments, see pages 8-11, filed 04/28/2026, have been considered and are not persuasive.
On pages 8-9, the Applicant argues that it would not be obvious to combine Stahl to the primary reference because Stahl is directed to a single pouch membrane and Sebastian is a “unique layered design” and thus one of ordinary skill in the art would have no reasonable expectation of success in modifying a multilayered laminated fleece in the manner required to implement the principles of Stahl and introduce nicotine within the material. The Applicant further argues there would be significant hurdles to combine Stahl to modified Sebastian.
The Examiner respectfully disagrees.
First, as claimed the Examiner notes that the pouched product only requires nicotine to be within one of the layers and does not recite how the nicotine is applied to these layers. Since Sebastian teaches nicotine passes through the layers ([0030]) and into the users mouth, it would be obvious to one of ordinary skill in the art that Sebastian may read on this claim limitation.
Furthermore, Stahl discloses fleece materials for use in pouch membranes are an example of various types of pouch membrane materials that can be used ([0156] and [0161]) and even discloses “the pouch membrane may be of any suitable material e.g. woven or non-woven fabric (e.g. cotton, fleece etc.), heat sealable non-woven cellulose, such as long fiber paper, or other polymeric materials such as a synthetic, semi-synthetic or natural polymeric material” ([0156]). Therefore, Stahl does indeed teach a similar membrane material of Sebastian and even teaches “the pouch may for example be sealed by bonding two corresponding pieces of web or fabric to each other along their edges to form a cavity for the nicotine and the non-water-soluble composition.” ([0149]). Therefore, Stahl does indeed disclose a multi layered pouch comprising the same materials as Sebastian and it would indeed be obvious to apply nicotine to at least one of the layers of Sebastian since that is taught by Stahl, the materials in both references are the same, and there is proper motivation to do combine as described in the Final Rejection dated 01/28/2026.
Furthermore, as stated in the Final Rejection dated 01/28/2026, Sebastian discloses an active ingredient in the form of a flavorant/botanical can be used in the nonwoven layers ([0039]) and if desired, flavoring ingredients, disintegration aids, and other desired components, may be incorporated within, or applied to, the pouch material ([0031]). While Sebastian is considered to already make obvious the claim limitation, Sebastian additionally teaches motivation to apply a “desired component” to the fleece layers and is clearly not limited to the components listed in the disclosure. It would indeed be obvious to one of ordinary skill to apply additional nicotine to at least one of the fleece layers to greatly improve the release of nicotine, as taught by Stahl ([0015]).
On pages 10-11, the Applicant argues that claim 10 is not taught by the currently cited prior art, specifically arguing that there is no teaching of a first layer comprising an active ingredient as described in independent claim 1 and a second layer comprising a second active ingredient and/or flavorant different from the first active ingredient.
The Examiner respectfully disagrees.
First, the Examiner notes that an active ingredient is not required by the claim language in claim 10. The claim recites either an active ingredient or a flavorant or both in both of the layers. There is no requirement of the layers to comprise active ingredients and there is further no requirement that the active ingredients differ from one another. Therefore, as detailed in the Final Rejection dated 01/28/2026, Sebastian already teaches the claimed limitations because Sebastian teaches the layers can have different flavorants ([0061]). Sebastian explicitly discloses: “In certain embodiments, an outer hydrophilic layer can comprise a flavor component (such as any of the flavor components noted herein), which can be applied to the nonwoven layer in any conventional manner such as by coating, printing, and the like. In some embodiments, the flavor within an outer hydrophilic layer can differ from a flavor contained within the internal composition adapted for oral use. By having a hydrophobic layer between the inner composition and the outer hydrophilic layer, the different flavors can be prevented from blending because the hydrophobic layer can prevent moisture from leaving the inner composition until enough moisture from the mouth of the user overwhelms the hydrophobic layer and thereby allows moisture to enter and leave the inner area of the pouched product where the composition is housed. By the time this takes place, the flavor component of the outer hydrophilic layer can have dissipated. In this manner, the product can be designed to provide multiple, different sensory experiences, a first sensory experience where the flavor in the outer layer transitions into the mouth of the user and a second sensory experience, typically occurring later in time, where the flavor of the internal composition transitions into the mouth of the user.” ([0061]).
Furthermore, as explained above, it is indeed obvious to apply the nicotine of Stahl to at least one of the layers of Sebastian. It would be obvious to one of ordinary skill in the art to apply nicotine to one layer of Sebastian or multiple layers, depending on what is desired and further obvious that the inner layer, which is the membrane of Stahl would comprise nicotine which is different from the flavorant in the outer layer of Sebastian.
On pages 11-12, the Applicant argues that none of the current cited prior art teaches a second active ingredient as detailed in claim 1.
The Examiner finds the arguments persuasive, however newly found prior art is provided and applied below.
A modified rejection based on the amendments is provided below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 3-7, 9-11, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sebastian et. Al. (US 20160073689 A1, as cited in the IDS dated 05/17/2021) (Sebastian) and further in view of Advantage Converting (https://www.advantageconverting.com/converting-services/laminating/ and https://web.archive.org/web/20190720095125/https://www.advantageconverting.com/materials/), Acelli (https://web.archive.org/web/20200924214938/https://www.acelli.it/en/nonwovens-lamination) and Stahl et. Al. (US-20200383373-A1).
Regarding claim 1, Sebastian, directed to a pouched tobacco product adapted for oral use with varying degrees of porosity (i.e., porous pouch) ([0059]) discloses:
The pouch can retain a composition adapted for oral use that is enclosed within the pouch (i.e., define a cavity) ([0059]),
Wherein the porous pouch is formed from two layers, an outer water-permeable pouch comprising an outer hydrophilic layer 50 and an inner hydrophobic layer 55 and formed from a fleece fabric to form a nonwoven fleece pouch product ([0043], [0060], and [0062]),
Sebastian teaches the two layers can be attached together so that they are in direct contact with one another and that the layers may be formed by attaching the two layers together using any means known in the art ([0060]),
Sebastian further teaches in certain embodiments, the outer hydrophilic layer can comprise a flavor component (such as any of the flavor components noted herein), which can be applied to the nonwoven layer in any conventional manner such as by coating, printing, and the like ([0061]). Sebastian further discloses some of the flavor components include natural or artificial flavors such as, mint, cinnamon, cherry or other fruit flavors) (i.e., active ingredients like terpenes) ([0039]).,
And Sebastian further discloses embodiments of the disclosure that are tobacco free, such as nicotine treated non-tobacco material (i.e., product is free of tobacco) ([0009]).
Sebastian does not explicitly disclose the two or more layers are laminated via heat and pressure to one another (I) and the at least one of the two or more layers comprises an active ingredient, wherein the active ingredient is selected from the group consisting of a stimulant, an amino acid, a vitamin, an antioxidant, a nicotine component, a nutraceutical, a cannabinoid, a cannabimimetic, a pharmaceutical agent, and combinations thereof (II).
(I)
Sebastian discloses several methods of web bonding and that the web can be accomplished by any means known in the art, including thermal bonding which is a process that can use heat and/or pressure to bond the fibers of the non-woven web together ([0053]), but is silent on a specific method that involves laminating at least two layers via heat and pressure.
Advantage Converting discloses laminating is known for laminating parts in multi-sheet form (page 1) using materials such as non-woven fabrics (page 2, Fabrics & Mesh). Advantage Converting further discloses a thermal lamination, including heat-activated thermal bonds.
As evidenced by Acelli, “thermal lamination” includes pressure and heat. Acelli, directed to laminating multiple nonwoven layers, discloses that thermal lamination uses pressure and heat to adhere layers together (page 6).
Therefore, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify Sebastian by bonding the nonwoven layers together using thermal lamination, as taught by Advantage Converting, which involves pressure and heat as evidenced by Acelli, because Sebastian discloses the nonwoven layers can be bonded by any means known in the art, Advantage Converting discloses a known lamination method for nonwoven material, and this merely involves applying a known means for attaching two layers together with a reasonable expectation of success of bonding layers of nonwoven material.
(II)
Sebastian discloses an active ingredient in the form of a flavorant/botanical can be used in the nonwoven layers ([0039]) and if desired, flavoring ingredients, disintegration aids, and other desired components, may be incorporated within, or applied to, the pouch material, but does not explicitly disclose nicotine as an active ingredient in one of the layers ([0031]).
However, Sebastian discloses the nicotine and materials used in the pouch composition pass through the fleece layers ([0030] and [0061]) and therefore it would be obvious to one of ordinary skill in the art that at least at some point during use, the fleece layers do indeed comprise one of the active ingredients listed such as nicotine.
Additionally, Stahl, directed to a nicotine pouched product discloses the pouch having a composition and a pouch membrane enclosing the pouch composition (abstract).
Stahl further discloses the pouch membrane includes nicotine in an amount of at least 15% by weight of a total content of nicotine in the pouched product (i.e., one of the layers comprising nicotine) ([0007]).
Stahl further discloses fleece materials for use in pouch membranes are an example of various types of pouch membrane materials that can be used ([0156] and [0161]) and that adding nicotine to the pouch layer is advantageous because a relatively fast release of nicotine is facilitated due to the inclusion of said further nicotine in the pouch membrane and greatly improves nicotine release over pouches containing nicotine only in the pouch composition ([0015]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Modified Sebastian, by making one of the pouch layers further comprise nicotine, as taught by Stahl, because both are directed to oral pouched products, Stahl teaches the addition of nicotine allows for faster release of nicotine and greatly improves the nicotine release over pouches only comprising nicotine in the pouch composition ([0015]), and this merely involves applying a known technique of adding nicotine to a pouch layer, such as a fleece layer, of a similar product to yield predictable results to advantageously improve the release of nicotine in the pouched product of Sebastian.
Regarding claim 3, Sebastian teaches that the pouch may be a multilayer composite made of two or more nonwoven layers ([0060]). The claimed range of three or more layers overlaps the range taught by the prior art, and is therefore considered prima facie obvious.
Regarding claim 4, Sebastian teaches the pouch comprises at least two layers; a hydrophilic layer and a hydrophobic layer, with differing physical properties ([0060]).
Sebastian further teaches the inner hydrophobic layer is in contact with the composition adapted for oral use 60, and stores the composition ([0060]).
Regarding claim 5, Sebastian teaches the hydrophilic layer, comprising a flavorant, will dissipate before the hydrophilic inner layer (i.e., physical properties including dissolution properties) ([0061]).
Regarding claim 7, Sebastian teaches the outer hydrophilic layer can comprise a flavor component ([0053]).
Sebastian further teaches the outer layer can comprise a flavor component that differs from the inner layer ([0061]).
Regarding claim 10, Sebastian teaches the outer hydrophilic layer can comprise a flavor component ([0053]), and further teaches the outer layer can comprise a flavor component that differs from the inner layer ([0061]) (i.e., two different flavorants).
Modified Sebastian further teaches at least one of the layers can comprise an active ingredient (Stahl [0015]).
Regarding claim 11, Modified Sebastian teaches the non-woven fibers may be laminated together by needle punching which shapes the pouched product ([0053] and advantage converting (page 2, Fabrics & Mesh)).
Regarding claim 22, Modified Sebastian discloses the active ingredient is nicotine (Stahl [0015]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sebastian et. Al. (US 20160073689 A1, as cited in the IDS dated 05/17/2021) in view of Advantage Converting (https://www.advantageconverting.com/converting-services/laminating/ and https://web.archive.org/web/20190720095125/https://www.advantageconverting.com/materials/), Acelli (https://web.archive.org/web/20200924214938/https://www.acelli.it/en/nonwovens-lamination), and Stahl et. Al. (US-20200383373-A1), as applied to claim 1 above, and further in view of Strickland et. Al. (US 20060191548 A1) (Strickland).
Regarding claim 6, Sebastian teaches an outer layer and an inner layer, but does not explicitly teach the outer layer being softer than the inner layer.
Strickland, directed to tobacco compositions, teaches the outer layer can be softer than the inner layer. ([0035]; [0036]). Strickland teaches the inner layer contains tobacco and the outer layer may contain flavors such breath freshening agents ([0036]). The pouch composition disintegrates when placed in the mouth of a user ([0036]).
Strickland further teaches the tobacco pouch compositions are advantageous from the perspective of size, ease of use, and controlled rate of disintegration ([0028]; [0056]), (i.e., how the pouch is designed, size, shape, or softness, is advantageous and are picked based on their properties). Individual layers in multilayer films may also be formed or aerated to provide desirable physical properties or desirable dissolution or disintegration rates ([0056]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Modified Sebastian, making the outer layer softer than the inner layer of the pouch, as taught by Strickland, because all are directed to multi layered products are directed to tobacco compositions, modifying properties like softness in the composition can affect the rate of disintegration, size, and ease of use ([0028]), and this involves modifying a known composition of a similar pouch material to have a known softness to yield predictable results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sebastian et. Al. (US 20160073689 A1, as cited in the IDS dated 05/17/2021) in view of Advantage Converting (https://www.advantageconverting.com/converting-services/laminating/ and https://web.archive.org/web/20190720095125/https://www.advantageconverting.com/materials/), Acelli (https://web.archive.org/web/20200924214938/https://www.acelli.it/en/nonwovens-lamination), and Stahl et. Al. (US-20200383373-A1), as applied to claim 7 above, and further in view of Winterson et. Al. (US 9044049 B2) (Winterson).
Regarding claim 9, Sebastian teaches the outer layer can an active ingredient and a flavorant ([0039] and ([0061]) and further teaches the outer layer is configured for faster release of the flavorant ([0061]), but does not explicitly teach the inner layer configured for stain resistance.
Winterson, directed to tobacco pouch products, teaches an inner and outer liner (i.e., layer) within the pouch ([0044] - [0046]).
Winterson further teaches the layer(s) can reduce staining of the web ([0014]; [0022]; [0055]).
Winterson teaches the tobacco material may carry additives that stain or discolor the pouch ([0026]).
Winterson further teaches the inner layer of the web is configured for stain resistance by preventing the staining of the web from the tobacco component (claim 12).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Modified Sebastian, by making the inner layer stain resistant, as taught by Winterson, because all are directed to layers that can form a pouch, Winterson teaches the inner layer prevents the tobacco material from staining the pouch by using a stain resistant layer of web ([0026]; claim 12), and this merely involves modifying a similar inner layer with a known technique of making it stain resistant, to yield predictable results of a stain resistant inner layer of a pouch product.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Sebastian et. Al. (US 20160073689 A1, as cited in the IDS dated 05/17/2021) (Sebastian) in view of Advantage Converting (https://www.advantageconverting.com/converting-services/laminating/ and https://web.archive.org/web/20190720095125/https://www.advantageconverting.com/materials/), Acelli (https://web.archive.org/web/20200924214938/https://www.acelli.it/en/nonwovens-lamination) and Stahl et. Al. (US-20200383373-A1), as applied to claim 11 above, and further in view of Shikata et al. (US-20120298124-A1).
Regarding claim 12, Modified Sebastian teaches nicotine in the pouch layer (Stahl [0015]) and further discloses several botanical active ingredients, and that if desired, flavoring ingredients, disintegration aids, and other desired components, may be incorporated within, or applied to, the pouch material ([0031] and [0039]), but does not explicitly disclose a second active ingredient as defined in claim 1, applied to the pouch layer.
Shikata directed to a multi-layered pouch product ([0027]) discloses a first and second pouch layer, wherein the layers can optionally contain an additive such as an emulsifier, an antioxidant or a preservative. The pouch containing such an additive can be obtained by applying an additive-dissolving solution to the pouch ([0049]).
Shikata further discloses examples of the antioxidant or preservative include organic acids such as ascorbic acid, Vitamin E, acetic acid, citric acid, lactic acid, malic acid, sorbic acid and tartaric acid ([0050]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Modified Sebastian by applying an additional active ingredient such as a preservative or antioxidant, as taught by Shikata, because both are directed to pouched products comprising active ingredients, Shikata teaches preservatives and antioxidants are known active ingredients applied to pouch layers, and this merely involves applying an additional active ingredient known in the art of a similar product to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Keller et al. (US-20210068446-A1), oral product with cellulosic flavor stabilizer discloses a moisture-permeable container in the form of a pouch 102, which contains a material 104 comprising a mixture ([0159]).
Stahl et al. (US-20210329962-A1), directed to a nicotine pouched oral product, discloses nicotine in both the composition and the outer membrane layer ([0009]-[0015]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELEINE PAULINA DELACRUZ whose telephone number is (703)756-4544. The examiner can normally be reached Monday - Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at (571)270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MADELEINE P DELACRUZ/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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