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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/01/2025 has been entered.
Response to Arguments
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the claim(s) rejection in the prior office action have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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
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/Michael J Felton/Primary Examiner, Art Unit 1747