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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/06/2025 has been entered.
Status of the Claims
Claims 1-3, 7-9, and 21-25 are pending and are subject to this office action. Claim 1 has been amended. Claims 4-6 and 10-20 are cancelled. Claims 21-25 are newly added.
Response to Amendment
The Examiner acknowledges the Applicant’s response filed on 11/06/2025 containing amendments and remarks to the claims.
Response to Arguments
Applicant’s arguments with respect to the rejection of claim 1 under 35 U.S.C. 103 (see pg. 2-3) have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments are directed to Crawford which was not relied upon in the rejection below.
A new ground of rejection is made below in view of newly found prior art.
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, 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 1-2, 8-9, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Ågren (US 20230180817 A1) in view of Kumamoto (US 20020119231 A1, as cited on IDS dated 05/17/2023).
Regarding claim 1, Ågren discloses an oral delivery pouched product ([0012]) comprising:
A saliva permeable pouch enclosing a composition (“outer water permeable pouch defining a cavity”, [0012])
The composition comprises a source of nicotine (i.e. a water soluble component and active ingredient) and cellulose or cellulose derivate ([0012])
The cellulose or cellulose derivative functions as a filler ([0032])
The oral delivery product is tobacco free ([0016], “substantially free of a tobacco material”) and delivers nicotine while having a pleasant taste and mouthfeel ([0004])
Ågren does not explicitly disclose the composition comprises vanillyl butyl ether in the amount of 10 to 800ppm.
However, Kumamoto, directed to an oral care preparation ([0001]), discloses:
An oral care preparation comprising a warming composition where the warming composition comprises a warming agent (C, [0003, 0010])
The warming agent is vanillyl butyl ether ([0002, 0037])
The warming composition causes less irritation and provides a long-lasting warming effect ([0004, 0007])
The content of the warming agent (C) in the final product can range from 0.000001 to 10% by weight and is subject to wide variation according to the kind of the product, the amount of the product to be applied, the mode of use or application of the product ([0042]). The claimed range of 10 to 800ppm lies within the range taught by the prior art and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Ågren by providing a warming composition comprising vanillyl butyl ether in the amount of 0.000001 to 10% by weight in the pouched product as taught by Kumamoto because both Ågren and Kumamoto are directed to oral products, Kumamoto teaches the warming composition provides a warming effect to the user, and this involves applying a known warming agent in a known amount to a similar oral product to yield predictable results.
Regarding claim 2, Kumamoto discloses providing the vanillyl butyl ether in the range of 0.000001 to 10% by weight. The claimed range of 100 to 500ppm lies within the range taught by the prior art and is therefore considered prima facie obvious.
Regarding claim 8, Ågren discloses the composition comprises one or more flavors including berry, orange, lemon, lime, peach, cherry, or combinations thereof ([0055]).
Regarding claim 9, Ågren discloses the composition comprises one or more flavors including vanilla ([0055]).
Regarding claims 21 and 22, Ågren discloses:
The cellulose or cellulose derivative functions as a filler ([0032])
The cellulose or cellulose derivative is present in any suitable amount, preferably 1 to 20 wt% of the total weight of the composition ([0033, 0084]).
The composition comprises additional cellulose or cellulose derivative, preferably in an amount of 1 to 30 wt% ([0035, 0048,0084])
A person having ordinary skill in the art would recognize that an oral pouch product having 1 to 20 wt% cellulose or cellulose derivative, and 1 to 30 wt% of additional cellulose or cellulose derivative would include an embodiment where the proportion of total cellulose and cellulose derivative is in a range that overlaps with the claimed ranges of at least 25% by weight or at least 35% by weight and is therefore considered prima facie obvious.
Regarding claim 23, Ågren discloses the oral pouch comprises additional cellulose or cellulose derivative in the form of microcrystalline cellulose ([0041]).
Regarding claim 24, Ågren discloses the cellulose derivative includes methylcellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, or carboxymethyl cellulose ([0022-0023])
Regarding claim 25, Ågren discloses:
The cellulose derivative functions as a filler ([0032])
The cellulose derivative is present in any suitable amount, preferably 1 to 20 wt% of the total weight of the composition ([0033, 0084]). The claimed range lies within the range taught by the prior art and is therefore considered prima facie obvious.
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ågren (US 20230180817 A1) in view of Kumamoto (US 20020119231 A1, as cited on IDS dated 05/17/2023), as applied to claim 1 above, further in view of Mishra (US 20110083680 A1, as cited on the IDS dated 05/30/2024).
Regarding claim 3, Ågren discloses the oral delivery product comprise granulated cellulose or cellulose derivative (“particulate non tobacco material”), a source of nicotine (“active ingredient”) and flavoring agent. ([0012, 0055])
Ågren does not explicitly disclose the cellulose or cellulose derivate is treated to contain an active ingredient or flavoring agent.
However, Mishra, directed to a tobacco free oral pouch product (50, Fig. 1, [0029]), discloses:
A tobacco free oral pouch product comprising flavor beads that provide immediate and long lasting flavor release ([0002, 0005])
The flavor beads are formed by extruding a mixture containing microcrystalline cellulose and flavoring, and forming the extrudate into beads ([0009-0010]) which is considered to be non-tobacco particulate treated to contain a flavoring agent.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Ågren, in view of Kumamoto, by treating the cellulose filler with flavoring as taught by Mishra because both Ågren and Mishra are directed to oral pouched products, Mishra teaches the flavor beads provide immediate and long lasting flavor release, and this involves applying a flavoring agent in a known manner to a similar oral pouched product to yield predictable results.
Regarding claim 7, Ågren discloses the composition comprises one or more flavors to influence the aroma or taste of the oral delivery product ([0055]).
Ågren does not explicitly disclose the flavors include cinnamon, ginger, or a combination thereof.
However, Mishra, directed to a tobacco free oral pouch product (50, Fig. 1, [0029]), discloses:
A tobacco free oral pouch product comprising flavors including cinnamon, ginger, and combinations thereof (Fig. 1, [0012, 0029]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Ågren, in view of Kumamoto, by providing the oral pouch with the flavors of cinnamon, ginger, or combinations thereof as taught by Mishra because both Ågren and Mishra are directed to oral pouched products, Ågren teaches the oral pouch product comprising comprises one or more flavors to influence the aroma or taste of the oral delivery product but is silent to including cinnamon or ginger, Mishra teaches a similar oral pouch product comprising flavors including cinnamon, ginger, or combinations thereof and this involves applying known flavors in an oral pouch product to a similar oral pouched product to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN FAITH DEZENDORF whose telephone number is (571)272-0155. The examiner can normally be reached M-F 8am-430pm EST.
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/M.F.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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