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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08 July 2026 has been entered.
Status of the Claims
Claims 1, 3, 6-7, 9-12, and 15-27 are pending and subject to this Office Action. Claims 13 and 14 have been cancelled.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 6, 7, and 9-27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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.
Claims 1, 3, 6-7, 9-12, 15-17, 19-20, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Lampe, et al (US20150230515A1) and further in view of Gee, et al (US20100300464A1).
Regarding claim 1, Lampe teaches a smokeless tobacco gel product that is comprised of sugar alcohols, a humectant, and water (Abstract) where the gel is orally dissolvable [0004] and describes the complete dissolution of the product(claim 23, [0009])
Lampe teaches the gel composition can include the following constituents:
Sugar alcohols which make up 50 to 90 weight percent based on the total weight of the gel. [0044]
Humectants which make up less than 20% of the weight of the composition. Lampe teaches that the amount of water in the composition can affect the consistency of the composition. [0047]
Water can make up 10% to 45% [0047]
Lampe teaches the gel composition can incorporate nicotine (active) [0035] and one or more optional flavorants [0051] Lampe teaches that the nicotine can be either tobacco derived nicotine or synthetic nicotine. The use of a synthetic nicotine would create a gel composition that was completely free of tobacco.
Lampe teaches the gel component can be in the shape of a sphere and can be an extruded to form the product. The prior art further teaches that the gel is a mixed (homogenized) ([0062], [0065]) compound before extrusion into desired shapes. [0066] The prior art is silent with respect to how the extrusion would form a spherical extruded product
Gee, directed to oral botanical pouch products, teaches a method of making an oral pouched product containing moist botanical materials. [0013] Gee teaches the MST fibers and other non-tobacco botanical fibers can be mixed using a mixer to form a dough-like mixture. Gee teaches that beads of moist material can be formed by extrusion and spheronization [0025-0026] [0032] Gee teaches that the mixture is mixed for a suitable time (e.g. 10 minutes) at a suitable rotation speed (e.g. 1200 RPM) before the extrusion and spheronization. [0026] The mixing taught by Gee would create a homogenized material that is then extruded and spheronized. Gee teaches this allows for easy packaging using typical high speed horizontal and vertical pouching machines. [0030]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Lampe by using the extrusion and spherization as taught by Gee because both Lampe and Gee are directed to oral products, Gee teaches this allows for easy packaging using typical high speed horizontal and vertical pouching machines. [0030], and this involves using a known technique to improve similar products.
Lampe teaches the gel can be deposited and stored in an air-impermeable pouch or straw [0014] and further discusses the possible use of an edible pouch [0067]; however, the prior art is silent as to the outer pouch being water permeable.
Gee teaches that an oral pouched product includes a pouch comprising a porous outer web and an inner filling material comprising solid moist botanical beads. [0002] The prior art teaches the porous outer web can be selected to have desired properties including water permeability. [0050]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Lampe by using a water permeable pouch as taught by Gee because both Lampe and Gee are directed to oral products, the pouch of gee is taught to be suitable as an oral pouch and this involves using a known pouch in a similar product to yield predictable results.
Regarding claim 3, Lampe teaches that the composition is a dissolvable smokeless tobacco product [0004] that dissolves with the moisture in the oral cavity. [0020]
Regarding claim 6, teaches that the sugar alcohol can be selected from a variety of sugar alcohols including isomalt. [0006]
Regarding claim 7, the prior art teaches that the smokeless tobacco product can include maltodextrin. [0049]
Regarding claim 9, Lampe teaches the humectant can be glycerin ([0007], [0059]) or propylene glycol. [0045]
Regarding claim 10, Lampe teaches the composition can include other ingredients such as sweeteners. ([0009-0010], [0049], [0052])
Regarding claim 11, Lampe teaches the gel product can have various shapes can have the form of a bead or tablet. [0060]
Regarding claim 12 and 15, Lampe teaches the use microcrystalline cellulose in the composition as a disintegration or compressibility aid.[0049] A person having ordinary skill in the art would recognize that microcrystalline cellulose is a known binder. The prior art further teaches the use of a binder material that may make up at least 5 percent of the total weight of the composition and in certain embodiments will be present in the amount of at least 40 weight percent. [0055]
Regarding claim 16, Lampe teaches the composition can be coated to facilitate portability, reduce exposure to air, and improve the packing process. [0067-0068] The prior art teaches the coating for the bead composition may include binders. [0069]
Regarding claim 17, Lampe teaches the extrusion process can provide two different compositions featuring different dissolution rates. [0074]
Regarding claim 19, Lampe teaches the gel compound can include non-tobacco botanicals. [0037-0038]
Regarding claim 20, as discussed in claim 1, Lampe teaches the active ingredient is nicotine. [0035]
Regarding claim 22, Lampe teaches the additional components of the gel composition can include alkali metal hydroxides and pH adjusters such as citric acid [0058]
Regarding claim 24, Lampe teaches a composition that is comprised of citric acid. [0080]
Claims 21, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lampe, et al (US20150230515A1) and Gee, et al (US20100300464A1) as applied to claims 1, 11, 20, and 22 above, and further in view of Bruun, et al (DK201900698A1) .
Regarding claim 21, Bruun teaches wherein the nicotine component comprises resin-bound nicotine. “In an embodiment of the invention, the pouch composition comprises free-base nicotine mixed with ion exchange resin combined with nicotine as a complex with an ion exchange resin, such as polacrilex resin.” (p 15 ln 28-30)
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Lampe and Gee by using a resin bound nicotine in the composition as taught by Bruun because Lampe, Gee and Bruun are directed to oral smokeless compositions, Bruun teaches by using a nicotine-ion exchange resin complex, a relatively sustained release may be obtained. (p4 ln 11-12; p15 ln 1-4) and this involves using a known technique to improve similar products.
Regarding claim 23, Lampe teaches the use of pH adjusters ([0049], [0058]) but fails to disclose the specific amount of pH adjusters that would be used.
Bruun teaches wherein the one or more organic acids or alkali metal salt thereof is present in the composition in an amount by weight of from about 0.1 to about 10%, or from about 0.1 to about 0.5%, based on the total weight of the composition. “In an advantageous embodiment of the invention, the pouch composition further comprises a preservative in an amount of 0.05 to 0.5% by weight of the pouch composition, such as 0.1 to 0.2% by weight of the pouch composition. Non-limiting examples of usable preservatives within the scope of the invention includes sorbic acid (E200) and salts thereof (e.g. sodium sorbate (E201), potassium sorbate (E202), calcium sorbate (E203)), benzoic acid (E210) and salts thereof (e.g. sodium benzoate (E21 l), potassium benzoate (E212), calcium benzoate (E213)).” (p 16 ln 14-21) Bruun teaches the use of organic acids and the salts of the organic acids as a preservative. The range taught by Bruun overlaps the claimed range of the instant application.
Regarding claim 25, Bruun teaches wherein at least a portion of the organic acid, the alkali metal salt of the organic acid, or both are associated with at least a portion of the nicotine component in the form of an ion pair. “In an embodiment of the invention, the pouch composition comprises free-base nicotine mixed with ion exchange resin combined with nicotine as a complex with an ion exchange resin, such as polacrilex resin.” (p 15 ln 28-30)
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lampe, et al (US20150230515A1) and Gee, et al (US20100300464A1) as applied to claim 1 above, and further in view of Zhuang (US 8,863,755 B2).
Regarding claim 18, Neither Lampe nor Gee teach the beads of material being mixed with other materials in the pouch.
Zhuang, directed to the design of pouched tobacco products, teaches “The filling material includes tobacco material capable of releasing tobacco flavor components and at least one hydrocolloid interspersed with the tobacco material in an amount sufficient to at least partially slow and/or retard the release of at least one tobacco flavor component from the tobacco material during use.” (cl 1 ln 9-14) and “Preferably, the at least one hydrocolloid is selected from the group consisting of high-methylated pectin, low-methylated pectin, amidated pectin, hydroxyl methyl propyl cellulose, methyl cellulose, hydroxyl propyl cellulose, Xanthan gum, agar, carrageenan, guar gum, alginate, carboxyl methyl cellulose, microcrystalline cellulose, starch, dextrin, maltodextrin.” (cl 1 ln 36-41) Zhuang teaches the use of microcrystalline cellulose as a filler alongside a tobacco produce in an oral pouch product.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Lampe and Gee by using microcrystalline cellulose as a filler material as taught by Zhuang because Lampe, Gee, and as Zhuang are directed to tobacco smokeless compositions, Zhuang teaches that hydrocolloid (microcrystalline cellulose) interspersed with the tobacco material in a sufficient amount can at least partially slow and/or retard the release of at least one tobacco flavor component from the tobacco material during use.(cl 1 ln 11-14) and this involves using a known technique to improve similar products.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Lampe, et al (US20150230515A1) and Gee, et al (US20100300464A1) as applied to claim 1 above, and further in view of Engstrom, et al (US20080302682A1) .
Regarding claim 26, Neither Lampe nor Gee explicitly teach the pouch for the product would be biodegradable.
Engstrom, directed to smokeless pouched tobacco products, teaches a smokeless tobacco product that includes a permeable pouch for oral use of the product. (Abstract) Engstrom teaches the pouch is made from a degradable polymer that is configured to degrade in nature after disposal. (Abstract) The prior art notes that the pouch pore size should be such that the tobacco material is retained in the pouch but should allow for the free exchange of water soluble substances and that pores that are too small may inhibit the free water flow. [0022] Thus the prior art acknowledges that the pouch material itself is water permeable.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Lampe and Gee by using a biodegradable material for the pouch material as taught by Engstrom because Lampe, Gee, and as Engstrom are directed to tobacco smokeless compositions, Engstrom teaches the ability of the pouch holding tobacco material to degrade obviates or reduces the environmental impacts of disposed used materials. [0004-0005], and this involves combining prior art elements according to known methods to yield predictable results.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Lampe, et al (US20150230515A1) and Gee, et al (US20100300464A1) as applied to claim 1 above, and further in view of Mua, et al (US20160100625A1).
Regarding claim 27, Gee teaches an inner web of the pouch can be formed of a dissolvable material that provides additional moisture and/or flavors to the user upon dissolution thereof. [0055] However, the prior art is silent to the outer pouch being dissolvable.
Mua, teaches the outer pouch may be manufactured from a dissolvable or dispersible material. ([0020], [0136])
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Lampe and Gee by using a dissolvable pouch material as taught by Mua because Lampe, Gee, and as Mua are directed to tobacco smokeless compositions, Mua teaches a dissolvable pouch allows for the residual components of the outer shell to be dispersed within the users mouth and allow for ingestion. [0020] and combining prior art elements according to known methods to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIRGINIA R BIEGER whose telephone number is (703)756-1014. The examiner can normally be reached M-Th: 7:30-4:30.
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/V.R.B./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
