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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-4, 8, 9, 11, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sebastian et al. (WO 2012/061192) in view of Hodin et al. (US 2017/0318858).
Claims 1-3. Sebastian et al. discloses a tobacco product comprising a water-permeable pouch containing a tobacco formulation that includes a granular tobacco composition (Abstract). The tobacco formulation can be contained within a container, such as a pouch or bag, such as is the type commonly used for the manufacture of snus types of products (e.g., a sealed, moisture permeable pouch) ([00012]). Preferred pouch materials are designed and manufactured such that under conditions of normal use, a significant amount of the tobacco formulation contents (composition comprising a water-soluble component) permeate through the pouch material prior to the time that the pouch undergoes loss of its physical integrity ([00031]). A representative liquid-permeable pouch can be composed of a "fleece" type of material (nonwoven) ([00012]). In one embodiment, a traditional fleece fabric (e.g., made from viscose/ regenerated cellulose or other polymer) (nonwoven) or other pouch material may be coated with a food-grade low-melting biodegradable polymer such as, for example, polycaprolactone. Polycaprolactone polymer has a 60°C melting temperature. The lower-melting characteristic of this and other polymers (e.g., as compared to rayon and/or other cellulose material) is desirable because it provides for thermal bonding and pouch sealing without the use of acrylic. Specifically, the biodegradable fibers and/or coatings/sheaths preferably will include lower melting behavior than bi-component fiber cores and/or other fibers used in a fleece such that application of heat may be performed in a temperature range above the melting point of that material, but below the melting point of said other fibers (e.g., rayon) and/or bi- component core material(s). In this manner, the lower-melting material may provide for thermal bonding of pouch fleece to itself for forming and/or sealing a pouch ([00035)). Aqueous dispersions of polycaprolactone (PCL), polylactic acid (PLA), or polyhydroxyalkanoates (PHAs) (liquid coating of a heat sealable binder) are used to coat the pouch ([00040)).
Sebastian et al. does not explicitly disclose an embodiment wherein the composition is substantially free of a tobacco material.
Hodin et al. discloses an oral smokeless tobacco or a nicotine-containing non-tobacco product comprising a composition enclosed by a wrapping material ([0016]). The composition of a nicotine-containing non-tobacco product may consist of or comprise non-tobacco plant fibers, microcrystalline cellulose and/or other filler materials, and nicotine or derivatives of nicotine, and water ([0050]).
Hodin et al. teaches that nicotine-containing non-tobacco snuff products and nicotine-free non-tobacco snuff products are available alternatives to smokeless tobacco products ([0009]). It would have been obvious to one of ordinary skill in the art before the effective filing date that a nicotine-containing non-tobacco snuff or nicotine-free non-tobacco snuff, such as that disclosed by Hodin et al., replace the tobacco composition of Sebastian et al. as an alternative to smokeless tobacco products ([0009]).
Claim 4. Modified Sebastian et al. discloses that at least one biodegradable polymer such as, for example, polyhydroxyalkanoate and/or polylactic acid may be used to form fleece fabrics ([00036]). Polyhydroxyalkanoat.es (PHAs)(e.g., polyhydroxypropionate, polyhydroxyvalaerate, polyhydroxybutyrate, and polyhydroxyoctanoate) are known to be degradable by both aerobic and anaerobic microorganisms, which will allow them to biodegrade in a broad variety of environments (Sebastian [00038]).
Claim 8. Modified Sebastian et al. discloses that the fleece fabric comprises regenerated cellulose (Sebastian [00033]).
Claims 9, 11, and 14. Modified Sebastian et al. discloses that the water-permeable pouch contains a tobacco formulation wherein the tobacco used for the manufacture of the tobacco product preferably is provided in a shredded, ground, granulated, fine particulate or powder form. The tobacco composition can incorporate salts, sweeteners, binders, colorants, pH adjusters or buffers, fillers, flavoring agents, disintegration aids, antioxidants, humectants, and preservatives (Sebastian [00077]).
Claim 12. Modified Sebastian et al. discloses that the water-permeable pouch contains a tobacco formulation (nicotine component) wherein the type of tobacco used typically has a 1 % or less than 1% nicotine content (Sebastian [00076]).
Claims 5-7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sebastian et al. (WO 2012/061192) in view of Hodin et al. (US 2017/0318858) and further in view of Sebastian et al. (US 2016/0073689).
Claims 5-7. Modified Sebastian et al. discloses the pouched product of claim 1 but does not explicitly disclose that the nonwoven web comprises staple fibers having a size of about 1.5 dpf to about 2.0 dpf, a fiber length of about 35 mm to about 60 mm, or about 4-10 crimps per cm.
Sebastian et al. ‘689 discloses a similar pouched product configured for insertion into the mouth of a user. The pouched product can comprise an outer water-permeable pouch and a composition situated within the outer water-permeable pouch. The outer water-permeable pouch of the present invention utilizes a fibrous nonwoven web that includes a plurality of heat sealing binder fibers comprising a thermoplastic polymer capable of providing the function of heat sealing of the pouch. In a preferred embodiment, the binder fibers are staple fibers. The heat sealing binder fibers are typically mixed or blended with other dissimilar fiber types, such as conventional fibers used to form nonwoven “fleece” pouches. For example, the heat sealing binder fibers can be blended with cellulosic fibers (e.g., regenerated cellulose known as rayon or viscose fibers) ([0043]). In some embodiments, all or a portion of the nonwoven web can comprise heat sealable binder fibers in the form of multicomponent fibers wherein the thermoplastic polymer adapted for use as the heat sealing binder is combined with a second polymer material. The fibers used in the nonwoven web can have varying size (e.g., length, dpf) and crimp characteristics ([0044]). In some embodiments, fibers used in the nonwoven web can be nano fibers, sub-micron fibers, and/or micron-sized fibers. In certain embodiments, fibers useful herein can measure about 1.5 dpf to about 2.0 dpf, or about 1.6 dpf to about 1.90 dpf. In a preferred embodiment, each fiber can be a staple fiber. Each fiber length can measure about 35 mm to about 60 mm, or about 38 mm to about 55 mm. Each fiber can measure about 4-10 crimps per cm, or about 5-8 crimps per cm ([0052]).
Sebastian et al. ‘689 teaches that the use of multicomponent fibers can be useful to reduce cost by reducing the total amount of heat sealable binder utilized in the nonwoven web ([0044]). It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate multicomponent fibers such as those disclosed by Sebastian et al. ‘689 in the pouched product of Sebastian et al. ‘192 in order to reduce the total amount of heat sealable binder used as taught by Sebastian et al. ‘689 ([0044]).
Claim 13. Modified Sebastian et al. discloses the pouched product of claim 1 but does not explicitly disclose that the composition is substantially free of a nicotine component.
Sebastian et al. ‘689 discloses the composition positioned within the pouch can be any composition containing a water-soluble component capable of being released through the water-permeable pouch, such as tea or coffee materials (e.g., in the context of a beverage pouch adapted for brewing or steeping) (composition substantially free of a tobacco material) (Sebastian et al. ‘689 [0027]).
It would be have been obvious to one of ordinary skill in the art before the effective filing date that the tobacco formulation disclosed by Sebastian et al. ‘192 be replaced with a tea or coffee materials (e.g., in the context of a beverage pouch adapted for brewing or steeping) (composition substantially free of a tobacco material) (Sebastian et al. ‘689 [0027]), as is contemplated by Sebastian et al. ‘192 at [0073] (“A snus pouch could also be used to create a tea-type drink. For example, a snus pouch such as those described above could be soaked in an 8 ounce glass of hot or cold water.”).
Response to Arguments
Applicant’s arguments, filed 6/17/25, concern claim amendments that are addressed in the rejections above.
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 Katherine A Will whose telephone number is (571)270-0516. The examiner can normally be reached Monday-Friday 10:00AM-6:00PM(EST).
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/KATHERINE A WILL/Primary Examiner, Art Unit 1747
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