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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 2026 has been entered.
Status
Applicant’s response dated 11 February 2026 to the previous Office action dated 12 November 2025 is acknowledged. Pursuant to amendments therein, claims 1, 3-4, 21, 23, 26, 29-31, and 33-37 are pending in the application.
A new rejection under 35 U.S.C. 112 is made herein in view of applicant’s claim amendments.
The rejections under 35 U.S.C. 103 made in the previous Office action are withdrawn in view of applicant’s claim amendments, but new (modified) rejections under 35 U.S.C. 103 are made herein in view of applicant’s claim amendments.
Election/Restrictions
Applicant’s election without traverse of species fleece material as carrier material in the reply filed on 17 November 2023 is acknowledged.
Applicant’s election without traverse of species nicotine as releasable material in the reply filed on 17 November 2023 is acknowledged.
Claims 1, 3-4, 21, 23, 26, 29-31, and 33-37 are under current consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 35-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 35-37 recite the limitation "the first and second flavoring agents" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, such limitation is interpreted herein as “the first and second flavorants”.
Claim 37 depends upon claim 32, which has been canceled, and thus claim 37 is incomplete and therefore indefinite. See MPEP 608.01(n)(V). For purposes of compact prosecution, claim 37 is interpreted herein as depending upon claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-4, 21, 23, 26, 29-30, and 33-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 2017/0157106 A1; published 08 June 2017; of record) in view of Hassler et al. (US 2020/0128870 A1; published 30 April 2020; filed 24 April 2018; of record).
Rogers et al. discloses a pouch/fleece as a solid carrier that is a moisture-permeable fabric and that carries a suspension and that has a further material such as a tobacco substitute included within the pouch that may also carry the suspension (paragraph [0087]) wherein the fabric comprises a nonwoven web and the pouch is placed in the mouth of a human subject/user (paragraph [0088]) wherein the solid carrier can be fibers (paragraphs [0104], [0107]) wherein the suspension or active ingredient may be absorbed or adsorbed on the solid carrier (paragraph [0075]) wherein the suspension may comprise an internal phase material of nicotine and an external phase (paragraph [0052]; claim 1) wherein release of the internal phase material can be configured to be a sustained release meaning a continuous release for at least 1, 2, 6, 12, or 24 hours after delivery of the suspension (paragraph [0066]) wherein the internal phase material may also comprise flavorants and humectants (paragraph [0008]) wherein flavorants can include sweeteners such as xylitol (paragraph [0059]) wherein humectants can include sugar alcohols such as xylitol (paragraph [0061]) wherein a tobacco substitute can include microcrystalline cellulose (paragraph [0086]) wherein the product can be essentially free of components of tobacco other than nicotine (paragraph [0054]) wherein the external phase may include hydroxypropyl cellulose (paragraph [0067]).
Rogers et al. does not disclose that the tobacco substitute further material including microcrystalline cellulose comprises 30-50% by weight microcrystalline cellulose and 30-60% by weight water, as claimed.
Hassler et al. discloses an oral pouched nicotine product (title) wherein a saliva-permeable pouch encloses a filling material comprising microcrystalline cellulose (abstract) wherein an example filling material composition comprises 39 wt% microcrystalline cellulose and 51 wt% water (Table 1 Sample 1 paragraph [0113]) wherein such pouch products are often nonwoven fibers that can be heat/melt-sealed/welded (paragraphs [0004], [0127]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rogers et al. and Hassler et al. by including in the tobacco substitute of Rogers et al. as discussed above further material of the pouch product of Rogers et al. as discussed above with components as discussed above, 30-50% by weight microcrystalline cellulose and 30-60% by weight water as suggested by Hassler et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because Rogers et al. suggest including microcrystalline cellulose therein and Hassler et al. teaches that 30-50% by weight is a suitable concentration of microcrystalline cellulose within oral pouched nicotine product filler material and Hassler et al. further teaches that 30-60% by weight water is also a suitable component in oral pouched nicotine product filler material, and moreover the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination per MPEP 2144.07.
It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Rogers et al. as discussed above and to include in the pouch of Rogers et al. in view of Hassler et al. as discussed above flavorant in the internal phase material in the suspension absorbed or adsorbed on the pouch/fleece solid carrier as well as another flavorant in the suspension in the tobacco substitute included within the pouch, wherein the flavorants are cinnamon (i.e., comprises cinnamaldehyde, has a carbon-carbon double bond, aldehyde), lemon (i.e., comprises limonene, has a carbon-carbon double bond, a terpene), and/or orange (i.e., comprises limonene, has a carbon-carbon double bond, a terpene), with a reasonable expectation of success. Although Rogers et al. discloses absorption/adsorption of the suspension specifically in association with a film solid carrier rather than a fleece solid carrier in paragraph [0075], it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to use fleece solid carrier with suspension absorbed/adsorbed thereon on the pouch of Rogers et al. in view of Hassler et al. as discussed above, with a reasonable expectation of success, given that Rogers et al. discloses both fleece and film as solid carriers in the pouch, and given that substitution of equivalents known for the same purpose is prima facie obvious per MPEP 2144.06(II).
It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Rogers et al. as discussed above and to include in the pouch of Rogers et al. in view of Hassler et al. as discussed above flavorant such as xylitol sweetener and/or xylitol sugar alcohol humectant in the internal phase material in the suspension in the further material / tobacco substitute, with a reasonable expectation of success.
Further regarding claim 33, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize sweetness and/or moisture in the pouch of Rogers et al. in view of Hassler et al. as discussed above by varying the amount of xylitol sweetener and/or xylitol humectant in the further material / tobacco substitute therein through routine experimentation per MPEP 2144.05(II), such as increasing the amount of xylitol to increase sweetness or moisture therein or decreasing the amount of xylitol to decrease sweetness or moisture therein, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to achieve a desired sweetness and/or moisture therein, given that Rogers et al. teaches that xylitol is a sweetener and humectant that can be used therein.
Claim(s) 1, 3-4, 21, 23, 26, 29-31, and 33-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. in view of Hassler et al. as applied to claims 1, 3-4, 21, 23, 26, 29-30, and 33-37 above, and further in view of Winterson et al. (US 2007/0261707 A1; published 15 November 2007; of record).
Rogers et al. and Hassler et al. are relied upon as discussed above.
Rogers et al. and Hassler et al. do not disclose benzoic acid as in claim 31.
Winterson et al. discloses tobacco pouch products (title) that include benzoic acid as a preservative therein (paragraph [0068]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rogers et al. and Hassler et al. and Winterson et al. by including benzoic acid as in Winterson et al. in the pouch product of Rogers et al. in view of Hassler et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to include therein a preservative to preserve/prevent microbial growth in the product as suggested by Winterson et al.
Response to Arguments
Applicant's arguments filed 11 February 2026 have been fully considered but they are not persuasive.
Applicant argues that Rogers et al. does not disclose a suspension/active/releasable material absorbed/adsorbed on fleece material (remarks page 6). In response, Rogers et al. explicitly discloses a solid carrier can include fabric in the form of a pouch and that “a suspension as described herein may be carried by the fabric and/or carried by a further material (e.g., a tobacco material and/or a tobacco substitute) included within the pouch form of the fabric” (paragraph [0087]). Thus, the suspension may be carried by the fabric of the pouch as well as by the tobacco substitute material included within the pouch. Moreover, Rogers et al. discloses that a solid carrier can have the suspension absorbed/adsorbed thereon (paragraph [0075]).
Applicant argues that Rogers et al. teaches absorption/adsorption on film rather than fleece (remarks page 6). In response, although Rogers et al. discloses absorption/adsorption of the suspension specifically in association with a film solid carrier rather than a fleece solid carrier in paragraph [0075], it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to use fleece solid carrier with suspension absorbed/adsorbed thereon on the pouch of Rogers et al. in view of Hassler et al. as discussed above, with a reasonable expectation of success, given that Rogers et al. discloses both fleece and film as solid carriers in the pouch, and given that substitution of equivalents known for the same purpose is prima facie obvious per MPEP 2144.06(II).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617