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 .
Response to Amendment
The office action is in response to Applicant’s amendment filed on 11/17/2025.
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Claims 13-21 are withdrawn for being directed to a non-elected group.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 and 3-22 are pending and are subject to this Office Action.
Response to Arguments
Applicant' s arguments, see pages 6-11, filed 11/17/2025, with respect to the rejection of claims 1, 3-12, and 22 under 35 U.S.C. 103, have been fully considered and are not persuasive. The Applicant introduces 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, a terpene, a pharmaceutical agent, and combinations thereof, and wherein the oral pouched product is free of tobacco or comprises less than 1% by weight of tobacco other than a nicotine component, where present.
On page 8, the Applicant argues that Sebastian’s “flavor component” does not fall within the scope of the active ingredients claimed in amended claim 1, and that none of the cited references would predictably guide one of skill in the art to modify the cited references to incorporate a stimulant, an amino acid, a vitamin, an antioxidant, a nicotine component, a nutraceutical, a cannabinoid, a cannabimimetic, a terpene, a pharmaceutical agent, and combinations thereof.
The examiner respectfully does not find the arguments persuasive.
First, the flavoring agents of Sebastian are not limited to only being flavoring agents and therefore flavorings can in fact read on active ingredients. For example, Applicant’s instant specification lists flavoring agents include terpenes (page 4), and therefore it would be obvious that the flavorings of Sebastian would at the very least read on the active ingredient terpene as listed in claim 1.
Second, an additional reference that teaches flavoring agents include terpenes has been provided below in order to advance prosecution.
On pages 8-11, the Applicant argues that claim 22 which recites the active ingredient incorporated into at least one layer of the fleece material comprises nicotine now overcomes Strickland because of the amendments made to claim 1 regarding the tobacco content is less than 1% other than a nicotine component.
The Examiner finds the arguments persuasive and the previous rejection is withdrawn. However, a new rejection in view of newly found prior art 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, and 9-12 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 Kobal et al. (KR-20130009820-A, hereinafter referring to the English translation provided).
Regarding claim 1, Sebastian, directed to a pouched tobacco product adapted for oral use, teaches an outer water-permeable pouch comprising an outer hydrophilic layer 50 and an inner hydrophobic layer 55. Sebastian teaches the two layers can be attached together so that they are in direct contact with one another ([0060]).
Sebastian further teaches the layers are made from a fleece fabric ([0062]) and produce a nonwoven fleece pouch product ([0043]).
Sebastian further teaches the pouch, comprising the non-woven web, can have varying degrees of porosity (i.e., porous pouch) [0059].
Sebastian further teaches the pouched product can retain a composition adapted for oral use that is enclosed within the pouch (i.e., cavity) ([0059]).
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]).
Sebastian further teaches the layers of the pouch are bonded together and in direct contact with one another ([0011]; [0060]). The layers may be formed by attaching the two layers together using any means known in the art ([0060]).
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 additionally 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.
Sebastian discloses flavorings as active ingredients ([0061]), however Sebastian does not explicitly disclose an active ingredient claimed.
Kobal, directed to an oral tobacco product, discloses the oral tobacco product may include a pouch containing smokeless tobacco enclosed in a water-permeable packaging material ([0003]).
Kobal further discloses a coating of the pouched product may include flavoring additives, wherein the flavoring additives include terpenes ([0078]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify the flavoring agent of Sebastian to be the flavoring agent of Kobal, by making the flavoring agent comprise terpenes, as taught by Kobal, because both are directed to oral pouched products containing nicotine, Kobal teaches flavorings are known to comprise terpenes ([0078]), and this merely involves applying a known flavoring agent of a similar pouched product to yield predictable results. Further it would be obvious to one of ordinary skill in the art that the flavoring agents of Sebastian would include terpenes as an active ingredient because Kobal teaches flavoring agents comprise terpenes and it is therefore considered prima facie obvious that flavoring additives include active ingredients such as terpenes.
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).
Sebastian further teaches the outer layer can comprise an active ingredient ([0039]).
Regarding claim 11, Sebastian teaches the non-woven fibers may be laminated together by needle punching which shapes the pouched product ([0053]).
Regarding claim 12, Sebastian teaches nicotine, tobacco, and flavors can be incorporated in the layers of the pouch ([0009]).
Sebastian further teaches several manufacturing apparatuses and methods, including needle punching, to bond the non-woven web and seal the pouch [(0063]).
Sebastian further teaches sealing the pouch is the last step in the process (figure 4).
Since Sebastian 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]), it would be obvious to one of ordinary skill in the art that more than one active ingredient could be applied to the layers before manufacture and is therefore considered prima facie obvious that there could be two active ingredients.
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 Kobal et al. (KR-20130009820-A, hereinafter referring to the English translation provided), 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 Sebastian in view of Advantage Converting and Acelli, by 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 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 Kobal et al. (KR-20130009820-A, hereinafter referring to the English translation provided), 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 Sebastian in view of Advantage Converting and Acelli, 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.
Claim 22 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 Kobal et al. (KR-20130009820-A, hereinafter referring to the English translation provided), as applied to claim 1 above, and further in view of Stahl et. Al. (US-20200383373-A1).
Regarding claim 22, 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]).
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 further 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 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 the pouch layer 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 the pouch layers 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]).
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 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