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, 6, 7, and 9-27 are pending and are subject to this Office Action. Claim 1 has been amended. Claim 28 has been cancelled.
Response to Arguments
Applicant' s arguments, pages 5-10, filed 01/13/2026, with respect to claims 1, 3, 6, 7 and 9-27 under 35 USC § 103 have been considered and are not persuasive.
Claim 1 has been amended to include the limitation: the pouched product is completely free of tobacco material.
Applicant argues, page 5, that one of skill in the art would recognize that inclusion of 15 to 25% by weight of humectant would not be compatible with fluid bed granulation and would make a bead too soft to process and to the desired product consistency in the product of Carrol.
The examiner respectfully disagrees. Carrol teaches that the composition of the of one or more tobacco-containing layers surrounding the core can include suitable sweeteners, fillers, and plasticizer. Carrol goes on to teach suitable plasticizers include propylene glycol, triacetin, and glycerin. [0006] Carrol teaches the inclusion of these materials can be used to create the desired characteristics in the layer material. Carrol further notes that a single material can act in multiple functional roles citing propylene glycol acting as both a plasticizer and a lubricant and sorbitol can acting as both a filler and a plasticizer. [0035] Carrol teaches the composition of the bead of an exemplary tobacco bead but does not disclose the needed amount of material would be required if the material has multiple functions. Carrol is modified by May to explicitly teach the inclusion of a material that is a humectant and a binder and that this amount can be in the range of 20 to 50 percent.
Applicant argues, pages 5-6, that one of skill in the art would not have been motivated to remove tobacco material from the tobacco product of Carrol at least because the beads of Carrol are intended to "provide an adult tobacco consumer with a satisfying tobacco experience." Carrol at paragraph [0004].
The Examiner respectfully disagrees. Carrol does teach that the tobacco beads of Carrol are designed to provide a “satisfying tobacco experience.”; however, that would not prevent the consideration of the removal of tobacco from a product as taught by May. May teaches that “the toxicity of tobacco products is generally well known throughout the world.” and “Due to the addictive nature of nicotine in tobacco products, cessation of use is extremely difficult and, even if possible for short periods of time, will cause negative physiological and psychological effects.” [0005] May teaches an oral composition that uses herbs, pueraria and kudzu, in the place of tobacco/ nicotine which provides the user with a “natural” tasting and feeling product that more resembles natural tobacco, although not suffering from the same harmful drawbacks as natural tobacco. [0010]
Applicant argues, pages 6-7, that Persson is used solely as purportedly teaching an orally dissolvable product comprising 40 to 90% sugar alcohol, and the suitability of isomalt as a possible sugar alcohol and that one of skill would not have been motivated to modify Carrol in the manner proposed by the Office (by including 15 to 25% humectant), nor to remove tobacco material. Even if one were to consider the purported teachings of Persson, which is not conceded, there is nothing in Persson to lead one to the quantity of humectant recited in claim 1 as Persson teaches 5 to 10% humectant (Persson at [0091]).
As discussed above, Carrol notes that a single material can serve several functional roles int eh composition of the bead material. Carrol further notes that the layers can include one or more flavorants, pH adjusters, sweeteners, fillers, plasticizers, emulsifiers, binders, pigments, surfactants, lipids, and/or disintegrators. The art then goes on to teach that this can include sugar alcohols and gives the examples of mannitol and sorbitol. [0006] Carrol does not explicitly teach that the sugar alcohol could be isomalt. Persson is used to modify Carrol to teach a broader list of sugar alcohols that are known for use in oral pouched non-tobacco products includes: maltitol, mannitol, sorbitol, xylitol, erythritol, arabitol, ribotol, isomalt, dulcitol, iditol, and lactitol. [0117] As such, a person having ordinary skill would consider the use of isomalt as a possible sugar alcohol.
The following is a modified rejection based on amendments made to the claims.
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.
Claims 1, 3, 7, 9-11, 19-20, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Carrol ( US20180235273A1) and further in view of May (US20070283974A1).
Regarding claim 1, Carrol teaches that pouched tobacco products for oral consumption are known in the art. [0003] Carrol goes on to teach that a plurality of tobacco bead that can be used in such a product a product. The plurality of the tobacco beads Carrol teaches can be packaged in a consumable package, e.g. an edible pouch. [0047] The bead having one or more tobacco-containing layers surrounding the core are adapted to dissolve within an adult tobacco consumer's mouth. ([0006], [0056]) Carrol teaches that the bead is designed to completely dissolve in a user’s mouth. The tobacco bead can contain sugar alcohols where the tobacco containing portion includes between 30 weight percent and 50 weight percent of one or more sugar alcohols. [0009] The claimed range overlaps the range disclosed by the prior art and is therefore considered prima facie obvious. See MPEP 2144.05
Carrol teaches that the tobacco containing material can contain flavoring. [0023]
Carrol teaches an exemplary composition for a tobacco bead. The bead for use as the oral product contains less than 1% water. (Table 2, [0062]) This range, as taught by Carrol, overlaps the range of the instant claim, and therefore the instant claim is prima facie obvious. See MPEPE 2144.05.
Carol does not expressly teach that the tobacco containing material is comprised of a humectant.
May, directed to the design of compositions of tobacco substitutes, teaches a tobacco substitute composition that is comprised of 20 to 50 percent by weight glycerin as a binder and humectant. [0014]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carrol by using the amount of humectant in the composition as taught by May because Carrol and May are directed to tobacco smokeless compositions, May teaches that by adding the humectant at this percentage you can maintain a desired moisture content [0015] and this involves using a known technique to improve similar products.
While Carol teaches that a layer can be tobacco free, the art is silent as to the composition of the entire article being tobacco and/or nicotine free.
May teaches a tobacco free and nicotine free orally dissolvable composition that is made by substituting the tobacco in traditional oral products with tobacco alternatives, such as the herbs pueraria and kudzu [0011], and is nicotine free. [0023]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carrol by using a tobacco substitute that is nicotine free as taught by May because Carrol and May are directed to tobacco smokeless compositions, May teaches this provides novel snuff and chew compositions that are nicotine-free and free of other toxic materials and still retain the characteristics of the commercially available tobacco products [0023] and this involves using a known technique to improve similar products.
Regarding claim 3, as discussed in claim 1, Carrol teaches that the tobacco bead is designed to be completely dissolvable in the user’s mouth. [0056]
Regarding claim 7, Carrol teaches the tobacco containing layers of the beads can contain a soluble fiber and gives the example of maltodextrin. ([0006], [0010], Claim 18)
Regarding claim 9, Carrol teaches that the tobacco bead has a tobacco layer and the layer composition can contain propylene glycol as a plasticizer [0006] Carrol goes on to explain that some components of the composition can perform multiple functions as expressly states that plasticizers can also be lubricants/humectants.
Regarding claim 10, Carrol teaches that the tobacco product may include sweeteners. Carrol teaches that the composition of the tobacco layers can include “suitable sweeteners” that are both natural and artificial and provides a list of possible sweeteners. ([0006-0007] [0016], [0029])
Regarding claim 11, Carrol teaches that tobacco bead are used to create a smokeless tobacco product. The pouched oral product may comprise a plurality of beads that are packaged together in either a porous wrapper or a pouch made of an edible film. [0047] The use of multiple beads of an oral tobacco product packaged together for use is considered to read on the limitation of one or more pellets.
Regarding claim 19, Carrol teaches an herbal cellulose replacement for tobacco can also be used. [0044] The use of herbal cellulose reads on botanical materials.
Regarding claim 20, Carrol teaches that the bead contain tobacco, which a person having ordinary skill would recognize contains nicotine. Carrol further teaches that when alternative herbal cellulose replacements are used which could include or not include tobacco-derived nicotine.[0044]
Regarding claim 28, Carrol teaches that the plasticizer that are used in the formation of the tobacco beads include propylene glycol and glycerin. [0006] Carrol also teaches that the components can be used as multiple functions; “propylene glycol can act as both a plasticizer and a lubricant and sorbitol can act as both a filler and a plasticizer.” [0035]
Carrol is silent with respect to the amount of glycerin, propylene glycol, or mixture that are used in the formulation of the beads.
May, directed to the design of compositions of tobacco substitutes, teaches a tobacco substitute composition that is comprised of 20 to 50 percent by weight glycerin as a binder and humectant. [0014]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carrol by using the amount of humectant in the composition as taught by May because Carrol and May are directed to tobacco smokeless compositions, May teaches that by adding the humectant at this percentage you can maintain a desired moisture content [0015] and this involves using a known technique to improve similar products.
Claims 6, 13-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Carrol ( US20180235273A1) and May (US20070283974A1), as applied to claim 1, and further in view of Persson (US20180257801A1).
Regarding claim 6, Carrol teaches the use of sugar alcohols but is silent with regards to the use of isomalt specifically.
Persson, directed to the formulation of oral snuff product, teaches that the sugar alcohol in a snuff formulation can be selected from a list of possible sugar alcohols including isomalt. [0117]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carrol and May by using isomalt as the sugar alcohol in the composition as taught by Persson because Carrol, May, and Persson are directed to tobacco smokeless compositions, Persson teaches that isomalt has a desired melting point temperature ([0120], Table 1) which aids in production and this involves using a known technique to improve similar products.
Regarding claim 13 and 14, As discussed in claim 1, Carrol, modified by May, teaches a tobacco substitute composition that is comprised of 20 to 50 percent by weight glycerin as a binder and humectant. [0014] The use of glycerin that is expressly stated as a humectant is considered to read on the limitation and as such the claimed range overlaps the range disclosed by the prior art and is therefore considered prima facie obvious. See MPEP 2144.05
However, Carol and May are silent with respect to the amount of sugar alcohol that is present in the composition.
Persson teaches that the orally dissolvable product can contain humectants such as propylene glycol or glycerol [0091] similar to May. Persson also teaches that the composition can be comprised of sugar alcohols in the range of from 40% to 90% by weight ([0130], [0148]) and teaches that the sugar alcohol can be selected from a list of possible sugar alcohols including isomalt. [0117]
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carrol and May by using isomalt as the sugar alcohol in the composition as taught by Persson because Carrol, May, and Persson are directed to tobacco smokeless compositions, Persson teaches that isomalt has a desired melting point temperature ([0120], Table 1) which aids in preventing melting during production of the pouches (specifically the ultrasonic welding portion) [0038] and this involves using a known technique to improve similar products.
Regarding claim 16, Carrol teaches that the tobacco bead can have an outer shell which can include binders, sweeteners, emulsifiers, plasticizers, sweeteners, and/or flavorants. Carrol goes on to teach that the binders can be selected from a group that includes methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and/or ethyl cellulose to create a hard shell. The shell can also have a binder selected from the group consisting of beeswax and/ or acetylated monoglyceride (a lipid). [0012], [0045-0046] The shell being formed of cellulose products and/or beeswax or known lipids is considered to read on the claim limitations.
Regarding claim 17, Carrol teaches tobacco beads in the product can be formulated to have different total dissolution times. [0054]
Claims 12 and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Carrol ( US20180235273A1) and May (US20070283974A1), as applied to claim 11, and further in view of Bruun, et al. (DK 201900698A1).
Regarding claim 12, Carrol teaches that the oral tobacco product can contain microcrystalline cellulose in the layers of material but fails to teach that the composition further comprises microcrystalline cellulose in an amount up to about 40%.
Bruun teaches wherein the composition further comprises microcrystalline cellulose in an amount up to about 40% by weight of the composition. Bruun teaches, “Examples of usable water-insoluble compositions may e.g. include water-insoluble fibers such as plant fibers, cellulose fibers, hereunder microcrystalline cellulose (MCC).” (p 8 ln 1-3) “In an advantageous embodiment of the invention, said amount of said water-insoluble composition is between 5 and 50 % by weight of the pouch composition” (p 12 ln 16-19) The range water-insoluble fibers of Bruun overlaps the range of the instant application.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carrol and May by using the amount of microcrystalline cellulose in the composition as taught by Bruun because Carrol, May, and Bruun are directed to tobacco smokeless compositions, Bruun teaches the combination of a nicotine containing substance and a water insoluble material can produce a sustained release product. (p7 ln 8-18) and this involves using a known technique to improve similar products.
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 Carrol and May by using a resin bound nicotine in the composition as taught by Bruun because Carrol, May, and Bruun are directed to tobacco 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 22, Carrol teaches the use of pH adjusters [0006] but fails to disclose what specific pH adjusters would be used.
Bruun teaches wherein the composition further comprises one or more organic acids, an alkali metal salt of the one or more organic acids, or both. “In an embodiment of the invention, said enhancers are selected from the group consisting of… malic acid and citric acid and alkali metal salts thereof, “(p 25 ln 15-16) Bruun teaches the use of organic acids.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carrol and May by using organic acids and metal salts in the composition as taught by Bruun because Carrol, May, and Bruun are directed to tobacco smokeless compositions, Bruun teaches that the acids are used as pH regulators to provide a product with a desirable mouthfeel (p 8 ln 25 -p 9 ln 6) and this involves using a known technique to improve similar products.
Regarding claim 23, 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 24, Bruun teaches wherein the one or more organic acids is citric acid, malic acid, tartaric acid, octanoic acid, benzoic acid, a toluic acid, salicylic acid, or a combination thereof. “In an embodiment of the invention, said enhancers are selected from the group consisting of… malic acid and citric acid and alkali metal salts thereof,, “(p 25 ln 15-16) Bruun provides an extensive list of enhancers on page 24 line 4 to page 25 line 28
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Carrol (US20180235273A1), May (US20070283974A1), and Persson (US20180257801A1), as applied to claim 13, and further in view of Bruun, et al (DK 201900698A1).
Regarding claim 15, Carrol teaches that the oral tobacco product can contain microcrystalline cellulose in the layers of material. However, Carrol does not disclose an amount of microcrystalline cellulose.
Bruun teaches wherein the composition further comprises microcrystalline cellulose in an amount of up to about 5% by weight of the composition. “In an advantageous embodiment of the invention, said amount of said water-insoluble composition is between 5 and 50 % by weight of the pouch composition, such as between 10 and 30% by weight of the pouch composition.” (p 12 ln 16-19) The range of Bruun overlaps the range of the instant application.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carrol and May by using organic acids and metal salts in the composition as taught by Bruun because Carrol, May, and Bruun are directed to tobacco smokeless compositions, Bruun teaches that water insoluble components, such as microcrystalline cellulose, can help create a sustained release product (p7 ln 8-18) and this involves using a known technique to improve similar products.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Carrol (US20180235273A1), May (US20070283974A1), and Persson (US20180257801A1), as applied to claim 13, and further in view of Zhuang (US 8,863,755 B2).
Carrol teaches that tobacco beads can be used alone or combined with other constituents to form part of a larger smokeless tobacco product [0047] but is silent with respect to the materials mixed with the tobacco beads.
Regarding claim 18, 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 Carrol, May, and Person by using microcrystalline cellulose as a filler material as taught by Zhuang because Carrol, May, Persson, 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 and 27 are rejected under 35 U.S.C. 103 as being unpatentable Carrol (US20180235273A1), May (US20070283974A1), and Persson (US20180257801A1), as applied to claim 13 and further in view of Virgalitto, et al (US20050089548A1).
Regarding claims 26 and 27, Carrol teaches that the tobacco beads can be packaged in a pouch or of a pair of edible film. [0047] Carrol references the teachings of Virgalitto and the teachings of an edible film. However Carrol does not specifically teach that the film would be dissolvable.
Virgalitto, directed to edible films, teaches that desirable to provide a film with the aforementioned attributes and which also disintegrates, disperses or dissolves rapidly to release its active agent on demand. [0008] The ability to dissolve when exposed to moisture would also lead a person having ordinary skill to recognize that the pouch would be biodegradable.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carrol, May, and Persson by using dissolvable pouch material as taught by Virgalitto because Carrol, May, Persson, and as Virgalitto are directed to tobacco smokeless compositions, Virgalitto teaches this provides the formulator with a greater latitude to design specific controlled release properties for the particular active agent to be delivered. [0011] and this involves using a known technique to improve similar products.
Conclusion
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phillip 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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/V.R.B./ Examiner, Art Unit 1755
/PHILIP Y LOUIE/ Supervisory Patent Examiner, Art Unit 1755