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 .
Claim Rejections - 35 USC § 103
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.
Claim 32-52 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/067372 (hereinafter referred to as “Kindvall et al”) in view of in view of Kobal et al (US. Pat. App. Pub. 2014/0261485) and WO 2012/134380 (hereinafter referred to as Nilsson”).
Regarding independent claim 32, and dependent claims 34-36, Kindvall et al discloses smokeless products for oral use, said products including a filling material and a pouch (see abstract and page 3, lines 10-15). While not appearing to be explicitly stated, it is noted that the pouch in which the mixture is contained must inherently be “porous” in order for the saliva to be able to pass through the pouch’s matrix (corresponding to the claimed “[a] pouched product for oral use, comprising a material within a porous pouch”).
Kindvall et al discloses that its oral smokeless product may be nicotine-containing (read: comprise one or more active ingredients) and further include a flavoring agent (see page 5, lines 10-15, see Examples and Tables) (corresponding to the claimed “wherein the material comprises…one or more flavoring agents and/or one or more active ingredients”; and the “wherein the one or more active ingredients are selected from the group consisting of a nicotine component…” recitation of claim 36).
Kindvall et al discloses that its pouched product may comprise water (see page 2, lines 35-30); however, it is silent regarding whether the material of its pouched product “further comprises one of more particulate fillers”; “wherein the one or more particulate fillers comprise a cellulose material”, and “wherein the cellulose material comprises microcrystalline cellulose”; however, the Nilsson reference discloses a pouched oral product, which may also be free from tobacco material, and which may further include “additional ingredients” like fillers, such as micro-crystalline cellulose (see page 5, lines 5-10). Hence, it would have been obvious to one of ordinary skill in the art to have chosen to add these further ingredients to the pouched product of Kindvall et al to further enhance the organoleptic experience of the user (corresponding to the claimed “wherein the material comprises one or more particulate fillers, water”; the “wherein the one or more particulate fillers comprise a cellulose material” recitation of claim 34; and the “wherein the cellulose material comprises microcrystalline cellulose” recitation of claim 35).
The modified Kindvall et al product appears to be silent regarding any preferred or required shape or thickness of its pouched oral products. However, like Kindvall et al, the Kobal et al reference discloses a non-smokable pouched product for placement in the mouth of a user. It also teaches that the pouch of this product may be formed into any shape selected from a group that includes polygons, and further discloses that the corners of pouch may preferably be rounded (see paras. [0033]-[0034]). Kobal et al also discloses that the thickness of its pouches can range from 3-6 mm (see para. [0034]). From this disclosure, it is clear that Kobal et al envisions shapes above and beyond those that are squares and rectangles for its pouched products, and the same would hold true for the modified Kindvall et al pouch. It would have been obvious to one of ordinary skill in the art to have considered any of these polygons for the shape of the modified Kindvall et al oral product (corresponding to the claimed “wherein the porous pouch shape is selected from the group consisting of triangular, rhombic, pentagonal, hexagonal, heptagonal, and octagonal and which has rounded edges, and wherein the porous pouch has a thickness of 2 to 8 mm”).
Regarding claim 33, as discussed above, Kindvall et al discloses that its oral smokeless tobacco product may include water. It further teaches that said water may be in an amount of from 25-55% w/w (page 8, lines 8-11). And while the modified Kindvall et al product may include filler, as stated above, it fails to indicate what amount of filler it envisions can be included. Nilsson discloses that its oral product compositions may include filler (a polyol, for example) in an amount that falls in the claimed range. In Table 1, Maltitol can be provided in an amount of 47.9% (see Composition L) which clearly lies within the claimed range. Hence, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to have provided such filler in the disclosed amount in the modified Kindvall et al product. Lastly, Kindvall et al discloses, in Examples, that each pouch had a weight of .65g and that the pouch comprised about 5.8% of that weight - which means that the material in the pouch is .612 g (or 612.3mg). Therefore, the modified Kindvall et al product meets all the claimed limitations (corresponding to the claimed “wherein the material comprises water in an amount of 25% to 55% by weight, and the one or more particulate fillers in an amount of 25% to 50% by weight, based on the total weight of the material, and wherein the total weight of the material within the porous pouch is 500 to 800 mg”).
Regarding claim 37, Kindvall et al discloses that its product may include additional salts such as sodium carbonate and calcium carbonate (see page 8, lines 14-18) (corresponding to the claimed “wherein the material further comprises one or more salts…”).
Regarding claim 38, Kindvall et al discloses that its products may be “non-tobacco” or “tobacco-free” products (see abstract) (corresponding to the claimed “wherein the pouched product is substantially free of tobacco material other than nicotine, where present”).
Regarding claims 39-40, Kobal et al discloses that its pouch may be about 20mm to about 35mm long and from about 10mm to about 20 mm wide (see para. [0034]) Note: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05. Hence, the disclosed ranges in Kindvall et al are obvious over those which are claimed (corresponding to the “wherein the pouch has a length and a width, the length being in the range of about 35mm to about 60mm and the width being in the range of about 8mm to about 16mm” recitation of claim 39; and the “wherein the pouch has a length and a width, the length being in the range of about 35mm to about 50mm and the width being in the range of about 10mm to about 16mm” recitation of claim 40).
Regarding independent claim 41, and dependent claims 43-44, Kindvall et al discloses smokeless products for oral use, said products including a filling material and a pouch (see abstract and page 3, lines 10-15). While not appearing to be explicitly stated, it is noted that the pouch in which the mixture is contained must inherently be “porous” in order for the saliva to be able to pass through the pouch’s matrix (corresponding to the claimed “[a] pouched product for oral use, comprising a material within a porous pouch”).
Kindvall et al discloses that its oral smokeless product may be nicotine-containing (read: comprise one or more active ingredients) and further include a flavoring agent (see page 5, lines 10-15, see Examples and Tables) (corresponding to the claimed “wherein the material comprises…one or more flavoring agents and/or one or more active ingredients”).
Kindvall et al discloses that its pouched product may comprise water (see page 2, lines 35-30); however, it is silent regarding whether the material of its pouched product “further comprises one of more particulate fillers”; “wherein the one or more particulate fillers comprise a cellulose material”, and “wherein the cellulose material comprises microcrystalline cellulose”; however, the Nilsson reference discloses a pouched oral product, which may also be free from tobacco material, and which may further include “additional ingredients” like fillers, such as micro-crystalline cellulose (see page 5, lines 5-10). Hence, it would have been obvious to one of ordinary skill in the art to have chosen to add these further ingredients to the pouched product of Kindvall et al to further enhance the organoleptic experience of the user (corresponding to the claimed “wherein the material comprises one or more particulate fillers, water”; the “wherein the one or more particulate fillers comprise a cellulose material” recitation of claim 43; and the “wherein the cellulose material comprises microcrystalline cellulose” recitation of claim 44).
The modified Kindvall et al product appears to be silent regarding any preferred or required shape or thickness of its pouched oral products. However, like Kindvall et al, the Kobal et al reference discloses a non-smokable pouched product for placement in the mouth of a user. It also teaches that the pouch of this product may be formed into any shape selected from a group that includes polygons, and further discloses that the corners of pouch may preferably be rounded (see paras. [0033]-[0034]). From this disclosure, it is clear that Kobal et al envisions shapes above and beyond those that are squares and rectangles for its pouched products, and the same would hold true for the modified Kindvall et al pouch. It would have been obvious to one of ordinary skill in the art to have considered any of these polygons for the shape of the modified Kindvall et al oral product (corresponding to the claimed “wherein the porous pouch shape is selected from the group consisting of triangular, rhombic, pentagonal, hexagonal, heptagonal, and octagonal and which has rounded edges”).
Lastly, Kindvall et al discloses, in Examples, that each pouch had a weight of .65g and that the pouch comprised about 5.8% of that weight - which means that the material in the pouch is .612 g (or 612.3mg) (corresponding to the “wherein the total weight of the material within the porous pouch is 500 to 800 mg”).
Regarding claim 42, as discussed above, Kindvall et al discloses that its oral smokeless tobacco product may include water. It further teaches that said water may be in an amount of from 25-55% w/w (page 8, lines 8-11). And while the modified Kindvall et al product may include filler, as stated above, it fails to indicate what amount of filler it envisions can be included. Nilsson discloses that its oral product compositions may include filler (a polyol, for example) in an amount that falls in the claimed range. In Table 1, Maltitol can be provided in an amount of 47.9% (see Composition L) which clearly lies within the claimed range. Hence, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to have provided such filler in the disclosed amount in the modified Kindvall et al product (corresponding to the claimed “wherein the material comprises water in an amount of 25% to 55% by weight, and the one or more particulate fillers in an amount of 25% to 50% by weight, based on the total weight of the material).
Regarding claim 45, Kindvall et al discloses that its products may be “non-tobacco” or “tobacco-free” products (see abstract) (corresponding to the claimed “wherein the pouched product is substantially free of tobacco material other than nicotine, where present”).
Regarding claims 46-47, Kobal et al discloses that its pouch may be about 20mm to about 35mm long and from about 10mm to about 20 mm wide (see para. [0034]) Note: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05. Hence, the disclosed ranges in Kindvall et al are obvious over those which are claimed (corresponding to the “wherein the pouch has a length and a width, the length being in the range of about 35mm to about 60mm and the width being in the range of about 8mm to about 16mm” recitation of claim 46; and the “wherein the pouch has a length and a width, the length being in the range of about 35mm to about 50mm and the width being in the range of about 10mm to about 16mm” recitation of claim 47).
Regarding claim 48, Kobal et al also discloses that the thickness of its pouches can range from 3-6 mm (see para. [0034]) (wherein the porous pouch has a thickness of 2 to 8 mm”).
Regarding independent claim 49, Kindvall et al discloses smokeless products for oral use, said products including a filling material and a pouch (see abstract and page 3, lines 10-15). While not appearing to be explicitly stated, it is noted that the pouch in which the mixture is contained must inherently be “porous” in order for the saliva to be able to pass through the pouch’s matrix (corresponding to the claimed “[a] pouched product for oral use, comprising a material within a porous pouch”).
Kindvall et al discloses that its oral smokeless product may be nicotine-containing (read: comprise one or more active ingredients) and further include a flavoring agent (see page 5, lines 10-15, see Examples and Tables) (corresponding to the claimed “wherein the material comprises…one or more flavoring agents and/or one or more active ingredients”).
Kindvall et al discloses that its pouched product may comprise water (see page 2, lines 35-30); however, it is silent regarding whether the material of its pouched product “further comprises one of more particulate fillers”; “wherein the one or more particulate fillers comprise a cellulose material”, and “wherein the cellulose material comprises microcrystalline cellulose”; however, the Nilsson reference discloses a pouched oral product, which may also be free from tobacco material, and which may further include “additional ingredients” like fillers, such as micro-crystalline cellulose (see page 5, lines 5-10). Hence, it would have been obvious to one of ordinary skill in the art to have chosen to add these further ingredients to the pouched product of Kindvall et al to further enhance the organoleptic experience of the user (corresponding to the claimed “wherein the material comprises one or more particulate fillers, water”).
The modified Kindvall et al product appears to be silent regarding any preferred or required shape or thickness of its pouched oral products. However, like Kindvall et al, the Kobal et al reference discloses a non-smokable pouched product for placement in the mouth of a user. It also teaches that the pouch of this product may be formed into any shape selected from a group that includes polygons, and further discloses that the corners of pouch may preferably be rounded (see paras. [0033]-[0034]). From this disclosure, it is clear that Kobal et al envisions shapes above and beyond those that are squares and rectangles for its pouched products, and the same would hold true for the modified Kindvall et al pouch. It would have been obvious to one of ordinary skill in the art to have considered any of these polygons for the shape of the modified Kindvall et al oral product (corresponding to the claimed “wherein the porous pouch shape is selected from the group consisting of triangular, rhombic, pentagonal, hexagonal, heptagonal, and octagonal and which has rounded edges”).
Lastly, Kobal et al discloses that, in one embodiment, its pouch may be about 20mm to about 35mm long and from about 10mm to about 20 mm wide (see para. [0034]) Note: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05. Hence, the disclosed ranges in Kindvall et al are obvious over those which are claimed (corresponding to the claimed “wherein the pouch has a length and a width, the length being in the range of about 35mm to about 60mm and the width being in the range of about 8mm to about 16mm”).
Regarding clam 50, Kobal et al also discloses that the thickness of its pouches can range from 3-6 mm (see para. [0034]) (wherein the porous pouch has a thickness of 2 to 8 mm”).
Regarding clam 51, Kindvall et al discloses that its products may be “non-tobacco” or “tobacco-free” products (see abstract) (corresponding to the claimed “wherein the pouched product is substantially free of tobacco material other than nicotine, where present”).
Regarding claim 52, Kobal et al discloses that, in another embodiment, its pouch may be about 20 mm to about 40 mm in length (see para. [0035]). Hence, the disclosed ranges in Kindvall et al are obvious over those which are claimed (corresponding to the claimed “wherein the length is in the range of about 40 mm to about 60 mm”).
Response to Arguments
Applicant's arguments filed on December 30, 2025 have been fully considered but they are not persuasive.
-Applicant argues that the broad reference in Kobal to “polygons” is insufficient to predictably guide one of ordinary skill in the art to the recited shapes in independent claims 32, 41 and 49, as Kobal states that its products are preferably provided with a generally rectangular or elliptical shape. As such, Applicant submits, one of ordinary skill in the art would not modify Kindvall as proposed by the Office and, for that reason, these claims, and those that depend therefrom, are patentable over the combination of Kindvall and Kobal. The Examiner disagrees. Applicant correctly notes that Kobal indicates that its products are preferably provided with a generally rectangular or elliptical shape. However, the word “preferably” is an indication of what is Applicant’s desired tobacco product shape, and in no way restricts its products to this particular form. In other words, a rectangular- or elliptical-shaped oral tobacco product is not what is required. Also note that, it has been well-established that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Therefore, non-preferred embodiments, like the polygon-shaped oral products of Kobal, are still appropriate for use in rejecting the instant claim recitation. Further, while Applicant states that Kobal does not mention triangles, or any polygon with more than four sides, the Examiner wishes to make Applicant aware of the fact that the very definition of a polygon is “a closed plane figure bounded by three or more straight sides…[s]pecific polygons are named according to the number of sides, such as triangle, pentagon, etc” (emphasis added, see https://www.dictionary.com/browse/polygon). Hence, by its actual definition, a polygon is at least a “triangle” so such shape is inferred merely by the use of the term “polygon” and, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to have considered this particular shape, or any other polygonal shape, as that of the form of the modified Kindvall et al oral product. NOTE: The Examiner has removed the “polygon-shaped articles ‘known in nearly every art’” statement that was problematic for Applicant in the previous Office Action, as that expression has been reconsidered and is not necessary for the validity of the instant rejection over the combination of references.
-Applicant further argues that the length values of the Kobal product would not be reasonably viewed as overlapping that of the claimed length as one of ordinary skill, Applicant submits, would not be motivated to prepare a pouch with a minimum length of about 35 mm based on the Kobal disclosure; however, the Examiner disagrees and states that the “about 35 mm” length overlaps the range as claimed, and - as the MPEP states - in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05. Hence, the disclosed ranges in Kindvall et al are obvious over those which are claimed.
-Applicant states that new claim 52 has been added that recites that the pouched product has a length even further outside the referenced range in Kobal but, as stated above, Kobal et al discloses, in another embodiment, that its pouch may be about 20 mm to about 40 mm in length (see para. [0035]). Hence, the disclosed ranges in Kindvall et al are obvious over those which are claimed.
For the above-mentioned reasons, the rejection over the current prior art will be maintained.
-NOTE: Due to the abandonment of US. Pat. App. 16/707,390 on November 24, 2025, the Double Patenting Rejected is hereby withdrawn.
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 DIONNE WALLS MAYES whose telephone number is (571)272-5836. The examiner can normally be reached Mondays and Thursdays, 8:00AM - 4:00PM (EST).
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/DIONNE W. MAYES/ Primary Examiner, Art Unit 1747