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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/26/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 01/26/2026 regarding the rejection over Gao and Strickland are moot. Applicant amended the claims to include the new limitation that the granulate mixture does not contain medium-chain triglycerides (MCT) oil, thereby changing the scope of the claimed invention. Accordingly, the rejection over Gao and Strickland is withdrawn.
A new ground of rejection is set forth below over Holton in view of Wan, which addresses the amended claim scope, including the separate gelatin capsule comprising MCT oil and the nicotine-containing granulate mixture that does not contain MCT oil.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 6–9, 11, 12, 15–19, and 21 are rejected under 35 U.S.C. § 103 as being unpatentable over Holton et al. (US 2007/0186941 A1) in view of Wan et al. (US 2019/0174820 A1).
Regarding claims 1 and 11, Holton teaches an oral tobacco product comprising:
a pouch comprising fiber paper (a pouch manufactured from a mesh-like form of rice paper or perforated rice paper) (Holton, ¶ [0044]);
a granulate mixture comprising nicotine disposed within the pouch (a loose, free-flowing granular tobacco formulation within a sealed pouch) (Holton, ¶ [0065]);
a single gelatin capsule disposed within the pouch (one spherical capsule incorporated within the pouch) (Holton, ¶ [0065]), wherein the capsule has an outer shell that may comprise gelatin and an inner payload region comprising at least a flavoring ingredient and a triglyceride liquid (Holton, ¶ [0053]); and
wherein the gelatin capsule is operable to release its contents when broken (the capsule is breached by pinching or biting the pouch to release its contents into the tobacco formulation) (Holton, ¶ [0066]).
Holton teaches a breakable gelatin capsule having an inner payload region comprising a flavoring ingredient and a triglyceride liquid, but does not teach that the triglyceride liquid comprises medium-chain triglycerides (MCT) oil.
Wan teaches a breakable capsule for a tobacco-industry product having a core-shell structure (Wan, ¶ [0007]). Wan further teaches that the capsule core may comprise a solvent, wherein the solvent may comprise MCT oil, including caprylic triglycerides and capric triglycerides (Wan, ¶¶ [0040]–[0042]).
Wan is in the same field of endeavor as Holton because Wan is directed to tobacco-industry capsules and recognizes tobacco products in the form of a pouch placed in a user’s mouth (Wan, ¶ [0005]). Holton teaches that the flavoring ingredient may comprise menthol (Holton, ¶ [0023]), and Wan teaches MCT as a suitable solvent for dissolving menthol in a capsule core (Wan, ¶¶ [0040]–[0041]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holton’s triglyceride-liquid capsule payload in view of Wan to comprise MCT oil. One would have been motivated to make the modification because MCT would provide Holton’s menthol-containing capsule payload with a known solvent suitable for dissolving menthol.
The modified Holton product retains Holton’s granular tobacco formulation and locates Wan’s MCT oil in the separately recited capsule payload before the capsule is breached. Accordingly, the granulate mixture does not contain MCT oil before release of the capsule contents, and the gelatin capsule is operable to release MCT oil when broken (Holton, ¶ [0066]).
Regarding claim 1, the recitation that breaking the gelatin capsule produces an anti-sting result by providing MCT oil to reduce oral absorption of the granulate mixture states an intended result of using the recited product and does not impose an additional structural limitation on the claimed product. Holton as modified by Wan renders obvious the recited pouch, nicotine-containing granulate mixture, and separate gelatin capsule comprising MCT oil. Claim 1 does not positively recite an additional structural feature required to achieve the stated anti-sting result. Accordingly, the stated result does not distinguish the claimed product from the product rendered obvious by Holton as modified by Wan.
Regarding claim 11, the recitations that the capsule partially dissolves in saliva, that the pouch releases the granulate mixture and MCT oil over time, and that release produces an anti-sting result state functional performance or intended results of using the recited product. Claim 11 does not positively recite an additional structural feature of the pouch, granulate mixture, or gelatin capsule required to achieve those results. Accordingly, such language does not distinguish the claimed product from the product rendered obvious by Holton as modified by Wan.
Regarding claims 2 and 12, Applicant’s specification teaches that an oral pouch having a capsule delivering MCT oil may function as a non-stick oil pouch, wherein released MCT oil prevents the pouch paper from sticking during oral use (Spec., ¶ [0024]). Holton as modified by Wan renders obvious an oral pouch having a nicotine-containing granulate mixture and a separate gelatin capsule comprising MCT oil. Holton further teaches release of capsule contents into the tobacco formulation after capsule breach (Holton, ¶ [0066]). Thus, modified Holton is capable of providing the claimed anti-stick function.
Regarding claim 6, Holton teaches that the capsule payload comprises a flavoring ingredient (Holton, ¶ [0053]). Wan teaches sucralose as a possible flavoring additive (Wan, ¶ [0084]). Accordingly, modified Holton teaches that the gelatin capsule further comprises sucralose because Wan’s sucralose flavoring additive would have been included with Holton’s capsule flavoring ingredient.
Regarding claims 7 and 17, modified Holton teaches that the gelatin capsule is spherical and has a diameter of 5 mm (Holton, ¶ [0048]).
Regarding claims 8 and 18, modified Holton teaches that the gelatin capsule further comprises flavoring agents (an inner payload region comprising at least a flavoring ingredient) (Holton, ¶ [0053]).
Regarding claims 9 and 19, the recitation that MCT oil reduces an unpleasant taste associated with the nicotine states an intended result of using the recited product and does not impose an additional structural limitation on the claimed product. Holton as modified by Wan renders obvious the recited pouch, nicotine-containing granulate mixture, and separate gelatin capsule comprising MCT oil. Claims 9 and 19 do not positively recite an additional structural feature required to achieve the stated taste-reduction result. Accordingly, the stated result does not distinguish the claimed product from the product rendered obvious by Holton as modified by Wan.
Regarding claim 15, modified Holton teaches nicotine derived from tobacco (Holton, ¶ [0019]).
Regarding claim 16, the recitation that the nicotine is synthetically derived states a source of nicotine and does not impose an additional structural limitation on the claimed product. Holton as modified by Wan renders obvious the recited pouch, nicotine-containing granulate mixture, and separate gelatin capsule comprising MCT oil. Claim 16 does not positively recite a structural distinction between synthetically derived nicotine and the nicotine in Holton’s tobacco formulation. Accordingly, the stated source of nicotine does not distinguish the claimed product from the product rendered obvious by Holton as modified by Wan.
Regarding claim 21, modified Holton teaches a gelatin capsule having an inner payload region comprising a triglyceride liquid (Holton, ¶ [0053]). Wan teaches that the capsule core may comprise MCT oil (Wan, ¶ [0041]). Thus, modified Holton teaches a gelatin capsule having an interior comprising MCT oil.
The phrase “consists essentially of MCT oil” does not exclude additional ancillary ingredients that do not materially affect the MCT-oil character of the capsule interior. Applicant’s specification describes an MCT-oil gelatin capsule that may further include sorbitol, glycerin, sucralose, or coloring agents (Spec., ¶ [0028]). Accordingly, the phrase “consists essentially of MCT oil” does not exclude the additional flavoring ingredients in the capsule interior taught by modified Holton.
Claims 3 and 13 are rejected under 35 U.S.C. § 103 as being unpatentable over Holton et al. (US 2007/0186941 A1) in view of Wan et al. (US 2019/0174820 A1), as evidenced by Herbal Topical.
Regarding claims 3 and 13, modified Holton teaches a capsule payload comprising a flavoring ingredient (Holton, ¶ [0053]), wherein flavoring ingredients may comprise clove or lavender (Holton, ¶ [0023]). Herbal Topical evidences that clove and lavender oil have natural anesthetic and analgesic properties. Accordingly, modified Holton teaches a gelatin capsule further comprising a natural anesthetic, as evidenced by Herbal Topical.
Claims 4 and 14 are rejected under 35 U.S.C. § 103 as being unpatentable over Holton et al. (US 2007/0186941 A1) in view of Wan et al. (US 2019/0174820 A1), as evidenced by Essential Oils Directory.
Regarding claims 4 and 14, modified Holton teaches a capsule payload comprising a flavoring ingredient (Holton, ¶ [0053]). Wan teaches orange oil as a flavoring material (Wan, ¶ [0084]), as evidenced by Essential Oils Directory (pp. 5 and 7). Accordingly, modified Holton teaches that the gelatin capsule further comprises an essential oil.
Claim 5 is rejected under 35 U.S.C. § 103 as being unpatentable over Holton et al. (US 2007/0186941 A1) in view of Wan et al. (US 2019/0174820 A1), and further in view of Gao et al. (US 2022/0312816 A1).
Regarding claim 5, modified Holton teaches a nicotine-containing granulate mixture, but does not teach that the granulate mixture comprises from 4 mg to 20 mg nicotine.
Gao teaches an oral nicotine pouch product comprising nicotine and triglyceride, wherein the oral nicotine pouch product may include nicotine in an amount from about 4 mg to about 14 mg (Gao, ¶ [0215]). Gao is in the same field of endeavor as modified Holton because Gao is likewise directed to oral nicotine pouch products.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nicotine-containing granulate mixture of modified Holton in view of Gao to use Gao’s disclosed nicotine amount. One would have been motivated to make the modification because combining Gao’s known nicotine amount with modified Holton’s known nicotine-containing granulate mixture would have been a combination of prior-art elements according to known methods to yield predictable results. (See MPEP § 2143(I)(A)).
Claim 10 is rejected under 35 U.S.C. § 103 as being unpatentable over Holton et al. (US 2007/0186941 A1) in view of Wan et al. (US 2019/0174820 A1), and further in view of Gerardi et al. (US 2021/0177044 A1).
Regarding claim 10, modified Holton teaches an oral pouch product comprising a pouch, but does not teach that the pouch comprises rayon chemically bonded with polyester with an acrylic binder.
Gerardi teaches an oral pouch material comprising rayon/viscose fibers and polyester fibers (Gerardi, ¶ [0162]) and further teaches that the pouch material comprises an acrylic binder in combination with the rayon/viscose and polyester fibers (Gerardi, ¶ [0163]).
Gerardi teaches an oral pouch product comprising a saliva-permeable pouch through which the composition readily diffuses into the user’s mouth (Gerardi, ¶ [0164]). Gerardi is in the same field of endeavor as modified Holton because Gerardi is likewise directed to oral pouch products having saliva-permeable pouch materials.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pouch material of Holton in view of Gerardi to comprise rayon chemically bonded with polyester with an acrylic binder. One would have been motivated to make the modification because Gerardi teaches that its rayon/polyester/acrylic-binder pouch material provides a saliva-permeable pouch through which the composition readily diffuses into the user’s mouth (Gerardi, ¶ [0164]), thereby providing modified Holton with a known pouch material suitable for oral release of the pouch contents.
The recitation that the rayon is chemically bonded with the polyester describes the manner in which the recited pouch materials are bonded and does not positively recite a structural distinction of the resulting pouch material from Gerardi’s pouch material comprising rayon/viscose fibers, polyester fibers, and an acrylic binder.
Claim 20 is rejected under 35 U.S.C. § 103 as being unpatentable over Holton et al. (US 2007/0186941 A1) in view of Wan et al. (US 2019/0174820 A1), further in view of Gerardi et al. (US 2021/0177044 A1), and further in view of Chapman et al. (US 2016/0157515 A1), as evidenced by Herbal Topical and Essential Oils Directory.
Regarding claim 20, claim 20 combines the limitations addressed for claims 1, 3, 4, 10, and 11, including the oral pouch product, the separate gelatin capsule comprising MCT oil, the natural anesthetic, the essential oil, and the rayon/polyester/acrylic-binder pouch material.
Modified Holton teaches that the granulate mixture comprises nicotine (Holton, ¶ [0065]), microcrystalline cellulose (Holton, ¶ [0019]), and maltodextrin (Holton, ¶ [0022]). However, modified Holton does not teach that the granulate mixture further comprises β-cyclodextrin.
Chapman teaches that an oral pouch composition may comprise β-cyclodextrin (Chapman, ¶ [0090]). Chapman is in the same field of endeavor as modified Holton because Chapman is likewise directed to smokeless tobacco pouch products.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nicotine-containing granulate mixture of modified Holton in view of Chapman to further comprise β-cyclodextrin. One would have been motivated to make the modification because Chapman teaches β-cyclodextrin as a known component for oral pouch compositions (Chapman, ¶ [0090]). Incorporating β-cyclodextrin into modified Holton’s nicotine-containing granulate would have been the use of a known oral-pouch ingredient for its established purpose, with the predictable result of a granulate comprising β-cyclodextrin. (See MPEP § 2143(I)(A)).
Conclusion
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/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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