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 .
Response to Arguments
Applicant's arguments filed 5/29/2026 have been fully considered but they are not persuasive.
The applicant arguments concerning the declaration are addressed in the response section below.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 5/29/2026 has been considered but is insufficient to overcome the rejection of claim 1, 4, 5, 15-19, 24, 25, 27, 28-31, and 39 based upon Aspgren (US 2018/0271139) as set forth in the last Office action because: The declarant’s opinion that the prior art did not apply to non-tobacco products is not supported by the text of the prior art.
The prior art explicitly discloses that tobacco snus, non-tobacco nicotine snus, and non-tobacco non-nicotine pouched products are all within the scope of the invention [0038-0054]. However, the declarant states that, “As stated in Aspgren, the components recited in paragraphs [0057]-[0061] specifically relate to oral tobacco containing products, not oral non-tobacco containing products.”
This interpretation is not supported by the prior art document because the prior art explicitly states that the tobacco material is but one option and other options are non-tobacco with nicotine or without nicotine. There is no indication that the crux of the invention, the preservative effect of salt is restricted to only tobacco products [0059]. In addition, the declaration makes several statements that do not have evidence to support them. The declaration states that salts are added to tobacco products to prevent microbial growth and for taste, but that, “…the taste profile of non-tobacco products does not require salt and there are no microbes.”
The declarant argues states that one of ordinary skill would have understood that maltitol and mannitol are not used in oral tobacco products at the time of Aspgren. This is not supported by other prior art. Holton Jr. et al. (US 20070062549) disclose a pouched tobacco product containing tobacco and mannitol (claim 22). In addition, the indication that non-tobacco snus would include additional ingredients does not indicate that salts and pH modifiers would not be used. One of ordinary skill would expect salt and pH adjustment to be necessary for nicotine delivery (as a freebase or a salt). Furthermore, limiting the disclosure of Aspgren to tobacco snus would be effectively narrowing the disclosure to the examples and not the teaching of the disclosure as a whole. The rejections are maintained.
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Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 5, 15-19, 24, 25, 27, 28-31, and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aspgren (US 2018/0271139).
Regarding claims 1 and 18, Aspgren discloses an oral pouched nicotine product comprising a filling material and a saliva-permeable pouch [0023] of a packaging material enclosing the filling material, the filling material comprising: a particulate non-tobacco material [0053, 0054], a nicotine source [0056], water in an amount within the range of from 1 wt% to 50 wt% based on the total weight of the filling material [0156], and a pH adjusting agent comprising: (i) Na2CO3, K2CO3 [0057] and (ii) a salt of Formula (I): M2+(An-)m or a hydrate of said salt, wherein M2+ is selected from the group consisting of Ca2+ and Mg2+ [0059], An- is an anion selected from the group consisting of chloride [0059], and said salt being present in an amount within the range of from 0.05 wt% to 5 wt%, based on the total weight of the filling material [0059]. As is known in the art, the magnesium chloride and calcium chloride have water solubility values of 560g/L and 745 g/L (i.e., >1g/L), respectively, at room temperature.
Aspgren further teaches that the oral pouched nicotine product does not comprise a tobacco material (i.e., tobacco-free filling material) [0042, 0055, 0056].
Aspgren teaches the inclusion of carbonates as a pH adjuster and to affect the aroma profile at [0057, 0060], and Aspgren also teaches the inclusion of salts, e.g., MgCl2 and CaCl2, for effects on taste as well as improving the shelf life of the compositions [0059]. Further, the amounts of the pH adjusting agent taught by Aspgren falls within the claimed range [0060] and indicate that the pH of the product is about 7.5 to 8.5. Similarly, the amount of the salt as taught by Aspgren encompasses the claimed ranges [0057].
Aspgren does not expressly disclose that the combination of (i) and (ii) causes the pH of said filing material not to exceed a pH of 9.5 and/or the pH changes by no more than +/- 0.5 pH units upon storage with the storage is 15 weeks at relative humidity of 60-75% and temperature 22-30C.
First, the results claimed are inherent because the composition of the prior art is the same as that of the instant claims. Aspgren indicates that the product contains a (1) tobacco or non-tobacco material, (2) water, (3) salt, and (4) pH adjuster [0056-0057]. Other ingredients are optional. In particular, the chemicals involved in pH adjustment and buffering (i.e. salt) are the same as instantly claimed and because the claims are written in closed language, no other pH adjusting agents are present than those which are expressly claimed. Therefore, because the prior art has the same ingredients, especially pH adjusting agents, the pH adjustments in the product during the same storage conditions would be inherent.
Second, the storage of the product is intended use of the product. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, no structural difference is present and the prior art is capable of being stored under the same conditions.
Regarding claims 4-5 and 15-17, Aspgren discloses the salts [0059] (i.e., magnesium chloride and calcium chloride) have water solubility equal to or above 2 g/L (i.e., 560g/L and 745 g/L), wherein chloride is chosen as the anion for the salts, and the filling material does not comprise a tobacco material [0053, 0054, 0042]. Furthermore, Aspgren discloses the oral pouched nicotine product comprises an amount of water within the range of 20 wt% to 50 wt% based on the total weight of the filling material [0156], wherein the salt of Formula (I), or hydrate of said salt, is present in an amount within the range of from 0.05 wt% to 5 wt% based on the total weight of the filling material [0059].
Regarding claims 19, 24, 25, and 27, Aspgren discloses wherein M2+ is selected from the group consisting of Ca2+ and Mg2+ (i.e., magnesium chloride and calcium chloride) [0059]. Furthermore, Aspgren teaches the oral pouched nicotine product where the salt of Formula (I) consists of CaCl2 [0059], wherein the filling material further comprises NaCl [0059] and MgCO3 [0057]. In addition, Aspgren does not explicitly state that the oral product includes more than one pH adjuster or salt. Therefore, it is evident that the composition of Aspgren includes only one pH adjuster and either MgCl2 or CaCl2 as a salt.
Regarding claims 28-31, Aspgren discloses the filling material of oral pouched nicotine product has a pH from 7 to 10 when it is dispersed in purified water [0060], wherein at least part of the filling material (i.e., microcrystalline cellulose) is water-insoluble [0056]. Aspgren further teaches the oral pouched nicotine product comprises microcrystalline cellulose [0056]; wherein the filling material comprises one or more water- insoluble fibers selected from the group consisting of maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buck wheat fibers, wheat fibers, pea fibers, potato fibers, apple fibers, cocoa fibers, bamboo fibers, and citrus fibers [0063]. As is known in the art, microcrystalline cellulose is a gum that is the nonfibrous form of cellulose, and it is dispersible in water but not soluble.
Regarding claim 39, Aspgren discloses sodium carbonate as a pH adjuster [0057] and discloses that prior art GothiaTek uses sodium chloride and sodium carbonate together [0112].
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Aspgren (US 2018/0271139) as applied to claim 1 above, and further in view of Hodin et al. (US 2017/0318858).
Regarding claim 14, Aspgren discloses an oral pouched nicotine product as set forth above. However, Aspgren does not explicitly teach the amount of water is within the range of from 0.5 wt% to 12 wt%, based on the total weight of the filling material.
Hodin discloses a smokeless tobacco product for oral use comprising an amount of water ranging from about 2% to about 55% by weight, based on the total weight of the oral product ([0063]). Hodin is considered to be analogous art because it is reasonably pertinent to the oral nicotine products.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the oral pouched nicotine product of Aspgren to incorporate the teachings of Hodin by including an amount of water within the range of from about 2% to about 12% by weight. Doing so would add water to the oral product, maintaining its moisture content, as recognized by Hodin.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Aspgren (US 2018/0271139), as applied to claim 1 above, and further in view of Winterson et al. (US 2014/0158145).
Regarding claim 21, Aspgren discloses an oral pouched nicotine product as set forth above. However, Aspgren does not explicitly teach the M2+ is selected from the group consisting of Mn2+, Zn2+, and Fe2+.
Winterson discloses a non-tobacco pouch product with filling agents, including zinc oxide (ZnO; i.e., Zn2+) [0064]. Winterson is considered to be analogous art because it is reasonably pertinent to the oral products.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the oral pouched nicotine product of Aspgren to incorporate the teachings of Winterson by including zinc oxide as a salt for the oral nicotine product. Doing so would contribute to enhancing the stability of the pH-adjusting agent.
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Aspgren (US 2018/0271139) as applied to claim 1 above, and further in view of Persson et al. (US 2018/0257801).
Regarding claims 32-33, Aspgren discloses an oral pouched nicotine product as set forth above. However, Aspgren does not explicitly teach the nicotine source is one or more of the following: nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate, nicotine salicylate, nicotine polacrilex.
Persson discloses an oral pouched nicotine-containing snuff product comprising nicotine bitartrate as the nicotine source ([0102]). Persson is considered to be analogous to the claimed invention.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the oral pouched nicotine product of modified Aspgren to incorporate the teachings of Persson by including nicotine bitartrate. Doing so would add nicotine into the oral product, and thereby arriving at the presently claimed invention.
persuasive as set forth above in the Response to Amendment section.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL J FELTON whose telephone number is (571)272-4805. The examiner can normally be reached Monday, Thursday-Friday 7:00-4:30, Wednesday 7:00-1:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at 571-270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael J Felton/Primary Examiner, Art Unit 1747
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