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 1-3, 7-9, and 21-31 are pending and are subject to this office action. Claim 1 has been amended. Claims 4-6 and 10-20 are cancelled. Claims 26-31 are newly added.
Response to Amendment
The Examiner acknowledges the Applicant’s response filed on 02/25/2026 containing amendments and remarks to the claims.
Response to Arguments
Applicant’s arguments, see pg. 5-7, filed 02/05/2026 with respect to the rejection of claim 1 under 35 U.S.C. 103 over Ågren in view of Kumamoto have been fully considered and are persuasive. Applicant has amended claim 1 to require that the product has a moisture content of 30-50 wt%, which was not previously presented. Ågren discloses that the composition has a moisture content of 7-12 wt% ([0068]). Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of newly found prior art.
On pg. 6, Applicant argues that a person having ordinary skill in the art would not apply the warming composition of Kumamoto to the pouched product disclosed by Ågren because Kumamoto applies the warming composition to products that are designed to enter and exit the oral cavity rather quickly. The Examiner disagrees. Kumamoto discloses the warming composition may be used in products like mouthwash ([0043, 0059]), but does not limit warming composition to applications where the product is only in the oral cavity for a short time. For example, Kumamoto also discloses the warming composition may also be used in candy ([0053]), chewing gum ([0056]), and medicinal drops ([0043]). Ågren and Kumamoto are both directed to oral products and therefore the disclosure of Kumamoto is applicable to the oral pouched product disclosed by Ågren.
The rejections below are maintained and modified based on Applicant’s amendment.
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 1-3, 8-9, 21-24, and 26-31are rejected under 35 U.S.C. 103 as being unpatentable over Kindvall (US 20220248748 A1) in view of Kumamoto (US 20020119231 A1, as cited on IDS dated 05/17/2023).
Regarding claim 1, Kindvall discloses an oral pouched product ([0052]), comprising:
A saliva permeable pouch (“an outer water permeable pouch”) enclosing (i.e. defines a cavity) a filling material (“a composition”) for oral use ([0052]), where the filling material comprises:
Cellulose particles (“a filler comprising cellulose”) coated with nicotine (i.e. a water soluble component and an active ingredient, [0052-0056, 0080, 0083]), and;
Water in an amount of 1 to 50 wt% ([0125]).
The oral pouched product may be free from tobacco ([0063]).
Kindvall does not explicitly disclose the moisture content of the overall product (i.e. combined moisture content of the pouch and fill). However, Kindvall discloses a water content of the filling material which overlaps with the claimed range and the pouch disclosed by Kindvall does not require additional liquid ingredients that would substantially contribute to the total moisture content. Therefore, the overall product is considered to have a moisture content in a range that overlaps with the claimed range and is therefore considered prima facie obvious.
Kindvall 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, 0054-0055])
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 Kindvall by providing a warming agent comprising vanillyl butyl ether in the amount of 0.000001 to 10% by weight in the pouched product as taught by Kumamoto because both Kindvall and Kumamoto are directed to oral products, Kumamoto teaches the warming agent 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 3, Kindvall discloses the composition comprises cellulose particles (“particulate non-tobacco material”) coated with nicotine (“an active ingredient”) and flavorings ([0052-0056, 0080, 0083, 0112-0113]),
Regarding claim 8, Kindvall discloses the composition may include flavors including berry, orange, lemon, lime, peach, cherry, or combinations thereof ([0111]).
Regarding claim 9, Kindvall discloses the composition may include flavors including vanilla, licorice, or combinations thereof ([0111]).
Regarding claims 21 and 22, Kindvall discloses the cellulose particles may be present in an amount of 50-100 wt% of the filling material ([0057, 0066]). The claimed ranges overlap with the range taught by the prior art and are therefore considered prima facie obvious.
Regarding claim 23, Kindvall discloses the cellulose particles may be in the form of microcrystalline cellulose ([0080]).
Regarding claim 24, Kindvall discloses the cellulose particles may be coated, and the coating comprises a binder such as hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), or methyl cellulose (MC, [0083]).
Regarding claim 26, Kindvall discloses the composition may comprises a flavor ([0109]) but does not require that a flavor be included. Kumamoto discloses including vanillyl butyl ether to provide a warming effect to the user ([0002-0004, 0007, 0037, 0054-0055]). Therefore, Kindvall, in view of Kumamoto, is considered to disclose an embodiment where the only flavoring is VBE.
Regarding claims 27 and 28, Kindvall discloses the composition may include flavors including berry, orange, lemon, lime, peach, cherry, or combinations thereof ([0109, 0111]). Kumamoto discloses including vanillyl butyl ether to provide a warming effect to the user ([0002-0004, 0007, 0037, 0054-0055]). Therefore, Kindvall, in view of Kumamoto, is considered to disclose an embodiment where the only flavoring is VBE and a fruit flavoring selected from the claimed fruit flavorings.
Regarding claim 29 and 30, Kindvall discloses the composition may include flavors including vanilla, licorice, or combinations thereof ([0111]). Kumamoto discloses including vanillyl butyl ether to provide a warming effect to the user ([0002-0004, 0007, 0037, 0054-0055]). Therefore, Kindvall, in view of Kumamoto, is considered to disclose an embodiment where the only flavoring is VBE and a herbal, floral, or spiced flavoring selected from the claimed flavors.
Regarding claim 31, Kumamoto discloses an embodiment comprising VBE as a warming agent and no cooling agent (i.e. no CA-10 or TPG-1 included, Table 1 Comparative Example 4, [0054-0055]).
Claims 7 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Kindvall (US 20220248748 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 7, Kindvall discloses the composition comprises one or more flavors ([0109]).
Kindvall 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 Kindvall, in view of Kumamoto, by providing the oral pouch with the flavors of cinnamon, ginger, or combinations thereof as taught by Mishra because both Kindvall and Mishra are directed to oral pouched products, Kindvall teaches the oral pouch product comprising comprises one or more flavors 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.
Regarding claim 25, Kindvall discloses the core material of the particles comprises cellulose ([0080]) and flavoring may be incorporated into the particles ([0113]).
Kindvall does not explicitly disclose the particles comprise cellulose derivate in an amount of 1-5 wt% of the composition.
However, Mishra, directed to a tobacco free oral pouch product (50, Fig. 1, [0029]), discloses:
Flavor beads formed of microcrystalline cellulose and an additional polymer such as hydroxypropyl methyl cellulose in an amount of 2-6 wt% of the total flavor bead weight([0009-0011, 0113-0114]).
The hydroxypropyl methyl cellulose is include because it has a higher solubility in saliva and releases the flavors more quickly, controlling the flavor release from the beads ([0009-0011, 0113-0114]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Kindvall, in view of Kumamoto, by providing 2-6 wt% of hydroxypropyl methyl cellulose in the cellulose particles of as taught by Mishra because both Kindvall and Mishra are directed to oral products, Kindvall teaches providing hydroxypropyl methyl cellulose in a cellulose flavor bead helps control the release of flavors, and this involves applying a known cellulose derivative to a similar cellulose particle in a similar oral product to yield predictable results.
Kindvall, in view of Kumamoto and Mishra, does not explicitly disclose the weight percentage of cellulose derivative based on the total weight of the composition. However, Kindvall discloses the cellulose particles comprise 50-100 wt% of the filling material ([0057, 0066]) and Mishra discloses including a cellulose derivative in an amount of 2-6 wt% of the particles ([0013]). Therefore, a person having ordinary skill in the art could having reasonably arrived at an oral pouched product where the amount of cellulose derivative is in a range that overlaps with the claimed range and is therefore considered prima facie obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Berta (US 20220370334 A1) discloses an oral care composition comprising a flavor in the form of a warming sensate in an amount of 0.001% to about 2%, where the warming sensate is vanillyl butyl ether, and where the oral care composition may be provided in a pouch ([0049, 0051, 0055, 0119-0120]).
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 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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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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/M.F.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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