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 .
Status of the Claims
Claims 1 and 3-17 are pending and are subject to this Office Action. Claims 2 and 18-19 have been cancelled. Claims 1 and 3-14 have been amended. Claims 15-17 have been withdrawn.
Response to Amendment
The Examiner acknowledges Applicant’s response filed on 2/24/2026 containing
amendments and remarks to the claims.
Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/24/2026.
Response to Arguments
Applicant's arguments filed 2/24/2026 have been fully considered but they are not persuasive.
On pages 6-7, the Applicant argues that one of ordinary skill in the art would not combine Keller with the teaching of Brinkley because Brinkley only teaches tobacco products and does not disclose that a non-tobacco nicotine product should include any of the components disclosed in Brinkley. The Examiner does not find this to be persuasive. First, both Keller and Brinkley are directed to smokeless oral pouch products, and as such are considered to be analogous art. Further, Keller teaches that the products may include tobacco or tobacco-free alternatives ([0001]), and as such it would be obvious for one of ordinary skill in the art to look to the art for other smokeless oral pouch products that may contain tobacco or tobacco-free alternatives, such as the tobacco oral pouch product of Brinkley. Further, Brinkley teaches adding citric acid to the pouch enhances the flavor notes of the product and can reduce bitterness ([0086]). As the oral pouch products of Keller are intended to impart a taste when used orally ([0005]), one of ordinary skill in the art would recognize that the flavor enhancing benefit of citric acid to oral pouched products would be a benefit that is applicable to products comprising tobacco as well as products that that comprise tobacco-free alternatives.
On page 7, the Applicant argues that Brinkley teaches the addition of citric acid to the tobacco composition in the pouch, not to the pouch material itself. The Examiner does not find this to be persuasive. First, Brinkley recites in paragraph [0018] ”a tobacco formulation including a granular tobacco composition enclosed within a water-permeable pouch that has been treated with a substance selected from the group consisting of: an analgesic, a buffer, a coloring, an effervescent, or an organic acid”. The Applicant argues that this statement teaches the substances are treated to the tobacco composition, but the Examiner contends that this statement teaches the substances may be applied to both the tobacco product and the water permeable pouch. This is further evidenced through the disclosure of Brinkley, which teaches adding an analgesic directly to the fleece material ([0082]: incorporate an analgesic into the fleece material), adding a buffer directly to the fleece material ([0081]: the buffer solution is also added directly to the nonwoven pouch material), adding an effervescent directly to the fleece material ([0084]: Effervescent substances can also be added to the snus tobacco or directly to the fleece pouch), and adding a colorant directly to the fleece material ([0094]: adding colorants to the nonwoven pouch material). Further, paragraph [0086] of Brinkley describes adding citric acid to the pouch and furthermore, these materials can be added to the tobacco directly. The Applicant argues this shows Brinkley teaches the addition of citric acid to the composition in the pouch, not to the pouch material itself. However, the Examiner finds it quite evident through the explicit recitation of “add citric acid to the pouch” that Brinkley teaches adding citric acid to the packaging material as claimed. The further recitation in Brinkley of “furthermore, these materials can be added to the tobacco directly” makes it quite clear to one of ordinary skill in the art that this means the citric acid could also be added to the tobacco directly but does not mean it may only be added to the tobacco directly.
On pages 7-8, the Applicant further argues Brinkley discloses that tobacco itself can be aged or ground in a specific manner to remove bitterness, which the Applicant contends this means that Brinkley discloses tobacco causes bitterness which can be reduced by the addition of citric acid, and as such one of ordinary skill in the art would not modify a non-tobacco product of Keller to contain citric acid based on the disclosure of Brinkley. The Examiner does not find this to be persuasive. Tobacco is not the only substance that may cause bitterness, and further Brinkley also teaches adding citric acid to the pouch enhances the flavor notes of the product ([0086]). Keller teaches the oral pouch products are intended to impart a taste when used orally ([0005]), and as such one of ordinary skill in the art would recognize that the flavor enhancing benefit of citric acid would be advantageous to products comprising tobacco as well as products that that comprise tobacco-free alternatives.
On page 8, the Applicant argues the instant specification describes that it is well known that acids may protonate nicotine in an oral pouched nicotine product, thereby decreasing its uptake through the mucous membranes in the oral cavity and/or react with basic components such as basic pH adjusters in the filling material. The Applicant further contents thus, one of ordinary skill in the art would recognize that addition of one or more organic acids to the tobacco products of Brinkley or the oral products of Keller, would influence the release of nicotine from the product, regardless of the source of the nicotine, as well as negatively affect the uptake by mucous membranes. The Examiner does not find this to be persuasive. First, claim 1 requires the oral pouch product composing a nicotine source and an acid which may be citric acid, and so it is unclear why the claimed invention would require the addition of one or more acids to the pouched nicotine product if the Applicant contends this would negatively affect the product. Further, a judgment on obviousness only takes into account knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure. Therefore as Brinkley teaches adding citric acid to the pouch enhances the flavor notes of the product ([0086]), one of ordinary skill in the art would be motivated to modify the oral pouched product of Keller to add citric acid to the pouch for the benefit of enhancing the flavor notes.
The following is a modified rejection made based on the claim amendments.
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.
Claim(s) 1 and 3-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keller (US2021/0068447, cited in IDS dated 9/12/2023) in view of Brinkley (US2010/0018539) and/or Winterson (US2007/0012328).
Regarding claims 1, 9-10, and 12-14, Keller teaches:
An oral pouched non-tobacco nicotine product comprising a filling material (product for oral use that comprise a mixture and typically deliver nicotine to a user [0005] and may comprise tobacco-free alternative [0001]) and a saliva-permeable pouch of a packaging material enclosing the filling material (enclosing the mixture in a pouch [0026]).
The filling material comprising: a non-tobacco material (filler components [0006]), a nicotine source (a nicotine component [0014]), a flavouring agent (flavoring agent [0015]).
Moisture in an amount within the range of from about 5 wt. % to about 60 wt. % water based on the total weight amount of the filling material ([0012]). The range taught by the prior art overlaps the claim 1 range of 1 wt. % to 50 wt. %, claim 9 range of 1 wt. % to 20 wt. %, and the claim 10 range of 20 wt. % to 50 wt. %, and is therefore prima facie obvious.
A pH adjuster comprising one or more of the following: Na2CO3, K2C03, MgCO3,NaHCO3, KHCO3, NaOH, KOH (sodium carbonate [0127]).
wherein the oral pouched nicotine product is free from tobacco (In some embodiments, the products of the disclosure can be characterized as completely free or substantially free of tobacco material [0149]).
Keller is silent to the composition of the packaging material and therefore does not teach (I) the packaging material comprising an acid selected from the group consisting of citric acid, malic acid, lactic acid, ascorbic acid, tartaric acid and any combination thereof and (II) said acid being present in an amount within the range of from 5 wt. % to 20 wt. % based on the total dry weight of the packaging material.
In regard to (I), Brinkley, directed to smokeless tobacco products, teaches:
Packaging for smokeless tobacco products; the product includes a smokeless tobacco composition contained with a pouch [0013]-[0014].
Adding citric acid to the pouch to enhance the flavor notes of the product and can reduce bitterness [0086].
Furthermore, Winterson, directed to directed to a tobacco pouch product, teaches other flavors as acids that can be added to a tobacco pouch (A tobacco pouch that comprises souring agents such as citric acid and malic acid [0064]).
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 packaging material of Keller by incorporating citric acid and/or malic acid as taught by Brinkley and/or Winterson, because both Keller, Brinkley, and Winterson are directed to smokeless tobacco compositions that are contained within a pouch, Brinkley teaches adding citric acid to the pouch enhances the flavor noted and reduces bitterness, Winterson teaches other souring flavor acids such as malic acid and citric acid, and this merely involves incorporating a known smokeless tobacco product pouch element (i.e. flavoring acids) to a similar smokeless tobacco product pouch to yield predictable results. This further reads on the claim 13 limitation wherein the acid comprises or consists of citric acid and claim 14 wherein the acid comprises or consists of malic acid.
In regard to (II), Keller in view of Brinkley is silent to the wt. % of citric acid based on the total dry weight of the packaging material. However, Brinkley is reasonably considered to teach that the flavor notes of the product can be controlled by the amount of citric acid added to the packaging material. Therein, the weight percent of citric acid of the packaging material is considered a result effective variable with affects the flavor notes and bitterness of the product.
One of ordinary skill would recognize that the weight percent of citric acid would affect the amount of citric acid in the packaging material and thus affect the flavor notes and bitterness of the product. As such, it would be obvious for one having ordinary skill in the art to optimize the weight percent of citric acid in the packaging material since it has been held that, where 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. One of ordinary skill would be motivated to optimize the amount of citric acid in the packaging material by the desire to achieve reduced bitterness and enhanced flavor notes. The burden is shifted upon the Applicant to demonstrate that the claimed weight percent of citric acid is critical and has unexpected results.
This further reads on the claim 12 limitation wherein the acid is present in an amount within the range of 5 wt.% to 15 wt.% based on the total weight of the packaging material.
Regarding claim 3, Keller further teaches wherein the non-tobacco material is a particulate material or a combination of a particulate material and a fiber material (particulate, [0007]).
Regarding claims 4-5, Keller further teaches wherein the non-tobacco material comprises microcrystalline cellulose [0007].
Regarding claim 6, Keller further teaches wherein the nicotine source comprises one or more of the following: nicotine base, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, and nicotine salicylate [0131].
Regarding claim 7, Keller further teaches wherein the flavouring agent comprises one or more of the following: a synthetic flavour, a plant-based flavour [0118].
Regarding claim 8, Keller further teaches wherein the flavoring agent comprises one or more of lemon or lime [0118], and incorporated by reference is US Pat. App. Pub. No. 2005/0244521 to Strickland et al [0118] which teaches lemon oil and orange oil [0004].
Regarding claim 11, Keller is silent to the material of the packaging material.
However, Brinkley further teaches snus products have pouches that are typically a nonwoven fleece material [0005].
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 packaging material of Keller to a nonwoven fleece material as taught by Brinkley, because both Keller and Brinkley are directed to smokeless tobacco compositions that are contained within a pouch, and the selection of a known material based on its suitability for its intended use supports prima facie obviousness. See MPEP § 2144.07.
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 Nicole A Szumigalski whose telephone number is (703)756-1212. The examiner can normally be reached Monday - Friday: 8:00 - 4:30 EST.
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/N.A.S./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755