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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2025 August 8 has been entered.
Claims 1-2, 4-12, and 14-19 are pending. Claims 7, 11-12, 14, and 16-17 remain withdrawn.
Claims 1-2, 4-6, 8-10, 15, and 18-19 are presently examined.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sjogren (US 20150075543 A1) as evidenced by “Vitacel BAF 200”.
Claim 1: Sjogren teaches a smokeless article ([43-44], smokeless tobacco product) for oral consumption comprising a pouch (pouch) enclosing a content (smokeless tobacco composition) comprising nicotine-dosed (nicotine) bamboo fibers (non-tobacco fibers; [66], a particularly preferred non-tobacco fiber is bamboo fiber), wherein the bamboo fibers are exemplified at a particle size of 350 µm ([66], exemplified BAF 200; [129] and Table 3, BAF 200 has an average length-to-width ratio greater than 3.5:1 which yields good density; “Vitacel BAF 200”, BAF 200 has an average fiber length of 350 µm).
Claim 5: Sjogren teaches the smokeless article according to claim 1, wherein the nicotine-dosed bamboo fibers comprise a nicotinic compound that is nicotine [43-44].
Claim 6: Sjogren teaches the smokeless article according to claim 5, wherein the nicotine is provided in a plant material ([67], second type of non-tobacco fiber).
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.
Claims 2, 4, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sjogren (US 20150075543 A1) as evidenced by “Vitacel BAF 200” and as applied to claim 1, as further evidenced by “Vitacel BAF 90” and “Vitacel BAF 400” and in view of Gao (US 20150075543 A1 cited on an IDS).
Claims 2 and 4: Sjogren teaches the smokeless article according to claim 1, wherein the bamboo fibers have a particle size exemplified at 350 µm ([129] and Table 3, BAF 200) in a preferred range (length-to-width ratio greater than or equal to 3.5:1 is preferred) between about 80 µm (BAF 90 has ratio 3.3:1, so BAF 90 roughly forms the bottom of the preferred range; “Vitacel BAF 90”, BAF 40 has an average fiber length of 80 µm) and 500 µm (BAF 400; “Vitacel BAF 400”, BAF 400 has an average fiber length of 500 µm).
Sjogren does not explicitly teach that the bamboo fibers have a particle size of 280-320 µm, or about 300 µm.
Gao teaches a smokeless article ([30], oral product) comprising a pouch (pouch) and a content comprising nicotine-dosed (nicotine is mixed with cellulosic fiber) bamboo fibers ([25], one such cellulosic fiber is bamboo),
wherein the fiber particle size is a result-effective variable that controls nicotine release [26].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to routinely optimize Sjogren’s fiber particle size to about 300 µm, because doing so would optimize nicotine release.
Claim 10: Sjogren teaches the smokeless article according to claim 1.
Sjogren does not explicitly teach that greater than 75 wt% of the total nicotine content of the smokeless article is released from the smokeless article after 20 minutes immersed in water.
As in the above rejection for claim 4, modified Sjogren teaches a pouch enclosing nicotine-dosed bamboo fibers of about 300 µm. Aspect A of the instant specification demonstrates (fig. 5 and [241-245]) that smokeless articles of record (Sample 1 and Sample 2) comprising nicotine-dosed bamboo fibers, at a particle size between 30-300 µm, yield the recited property of claim 10. Modified Sjogren teaches nicotine-dosed bamboo fibers at a particle size of about 300 µm, so one of ordinary skill would be motivated to make greater than 75 wt% of the total nicotine content of the smokeless article be released from the smokeless article after 20 minutes immersed in water.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to make greater than 75 wt% of the total nicotine content be released after 20 minutes immersed in water, because modified Sjogren’s smokeless article has the same essential composition as instant Aspect A which yields the recited property.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sjogren (US 20150075543 A1) as evidenced by “Vitacel BAF 200” and as applied to claim 1 in view of Hassler (WO 2018197454 A1 cited on an IDS) and Arnold (US 20170189388 A1).
Claim 8: Sjogren teaches the smokeless article according to claim 1.
Sjogren does not explicitly teach that the smokeless article is tobacco-free.
Hassler teaches a smokeless article (p. 8, lines 1-8, oral pouched nicotine product) for oral consumption comprising a pouch (pouch) enclosing a content (moist filling material), the content (moist filling material) comprising nicotine-dosed (nicotine source) bamboo fibers (particulate non-tobacco material; p. 10, lines 12-15, an exemplary particulate non-tobacco material is bamboo fiber), wherein the bamboo fibers have a particle size of 50-500 µm (p. 7, lines 1-4),
wherein the smokeless article can comprise equivalent alternatives of tobacco-derived nicotine and synthetic nicotine (p. 10, lines 25-29).
Arnold teaches that tobacco-derived nicotine is carcinogenic, while synthetic nicotine is not carcinogenic [79].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute Hassler’s synthetic nicotine for Sjogren’s tobacco-derived nicotine, because doing so would be a simple substitution of nicotine sources between smokeless articles and would reduce carcinogenicity as taught by Arnold.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sjogren (US 20150075543 A1) as evidenced by “Vitacel BAF 200” and as applied to claim 1 in view of Aspgren (US 20180271139 A1).
Claim 9: Sjogren teaches the smokeless article according to claim 1.
Sjogren does not explicitly teach that the total nicotine content is from 5 to 15 mg.
Aspgren teaches a smokeless article ([52-53], oral pouched product) comprising a pouch (pouch) enclosing a content comprising nicotine-dosed (snus) bamboo fibers (non-tobacco plant fibers; [55], an exemplary non-tobacco plant fiber is bamboo), wherein the smokeless article has a total nicotine content of 9 mg (p. 9, Table 3), such that a user perceives a high amount of delivered nicotine [163] without requiring excessive water to dissolve the nicotine [20].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use, as Sjogren Example 3’s generic total nicotine content, Aspgren’s specific total nicotine content of 9 mg, because doing so is exemplified by Aspgren as an effective total nicotine content that does not require excessive water to dissolve the nicotine.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sjogren (US 20150075543 A1) as evidenced by “Vitacel BAF 200” and as applied to claim 1 in view of Hassler (WO 2018197454 A1 cited on an IDS).
Claim 15: Sjogren teaches a kit comprising a plurality of contents ([76], smokeless tobacco compositions) according to claim 1, and a container (package known in the art).
Sjogren does not explicitly teach that the contents are pouched, i.e., that the kit comprises both a container and pouched contents.
Hassler teaches a kit (p. 7, lines 30-33, container and oral pouched nicotine products) comprising a plurality of smokeless articles (oral pouched nicotine products) and a container (container).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use, as Sjogren’s generic package known in the art, Hassler’s specific package comprising a plurality of smokeless articles and a container, because doing so would predictably package Sjogren’s contents for a user.
Claim 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Sjogren (US 20150075543 A1) as evidenced by “Vitacel BAF 200” and as applied to claim 1 in view of Hassler (WO 2018197454 A1 cited on an IDS) and Arnold (US 20170189388 A1) and Aspgren (US 20180271139 A1).
Claims 18-19: Sjogren teaches the smokeless article according to claim 1, wherein the nicotine-dosed bamboo fibers comprise a nicotinic compound that is nicotine [43-44].
Sjogren does not explicitly teach that the smokeless article is tobacco-free,
or that total nicotine content is from 5 to 15 mg, or about 10 mg.
Hassler teaches a smokeless article (p. 8, lines 1-8, oral pouched nicotine product) for oral consumption comprising a pouch (pouch) enclosing a content (moist filling material), the content (moist filling material) comprising nicotine-dosed (nicotine source) bamboo fibers (particulate non-tobacco material; p. 10, lines 12-15, an exemplary particulate non-tobacco material is bamboo fiber), wherein the bamboo fibers have a particle size of 50-500 µm (p. 7, lines 1-4),
wherein the smokeless article can comprise equivalent alternatives of tobacco-derived nicotine and synthetic nicotine (p. 10, lines 25-29).
Arnold teaches that tobacco-derived nicotine is carcinogenic, while synthetic nicotine is not carcinogenic [79].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute Hassler’s synthetic nicotine for Sjogren’s tobacco-derived nicotine, because doing so would reduce carcinogenicity as taught by Arnold.
Aspgren teaches a smokeless article ([52-53], oral pouched product) comprising a pouch (pouch) enclosing a content comprising nicotine-dosed (snus) bamboo fibers (non-tobacco plant fibers; [55], an exemplary non-tobacco plant fiber is bamboo), wherein the smokeless article has a total nicotine content of 9 mg (p. 9, Table 3), such that a user perceives a high amount of delivered nicotine [163] without requiring excessive water to dissolve the nicotine [20].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use, as Sjogren Example 3’s generic total nicotine content, Aspgren’s specific total nicotine content of 9 mg, because doing so is exemplified by Aspgren as an effective total nicotine content that does not require excessive water to dissolve the nicotine.
Claims 1-2, 4-5, 8, 10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hassler (WO 2018197454 A1 cited on an IDS) in view of Gao (US 20150020818 A1 cited on an IDS).
Claims 1-2 and 4: Hassler teaches a smokeless article (p. 8, lines 1-8, oral pouched nicotine product) for oral consumption comprising a pouch (pouch) enclosing a content (moist filling material), the content (moist filling material) comprising nicotine-dosed (nicotine source) bamboo fibers (particulate non-tobacco material; p. 10, lines 12-15, an exemplary particulate non-tobacco material is bamboo fiber), wherein the bamboo fibers have a particle size of 50-500 µm (p. 7, lines 1-4).
Hassler does not explicitly teach that the bamboo fibers have a particle size of 250-500 µm, 280-320 µm, or about 300 µm.
Gao teaches a smokeless article ([30], oral product) comprising a pouch (pouch) and a content comprising nicotine-dosed (nicotine is mixed with cellulosic fiber) bamboo fibers ([25], one such cellulosic fiber is bamboo),
wherein the fiber particle size is a result-effective variable that controls nicotine release [26].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to routinely optimize Hassler’s fiber particle size to about 300 µm, because doing so would optimize nicotine release.
Claim 5: modified Hassler teaches the smokeless article according to claim 1, wherein the nicotine-dosed bamboo fibers comprise a nicotinic compound that can be a nicotine salt (p. 10, lines 25-29).
Claim 8: modified Hassler teaches the smokeless article according to claim 1, wherein the smokeless article is tobacco-free (p. 8, lines 6-8).
Claim 10: modified Hassler teaches the smokeless article according to claim 1.
Modified Hassler does not explicitly teach that greater than 75 wt% of the total nicotine content of the smokeless article is released from the smokeless article after 20 minutes immersed in water.
As in the above rejection for claim 1, modified Hassler teaches a pouch enclosing nicotine-dosed bamboo fibers of about 300 µm. Aspect A of the instant specification demonstrates (fig. 5 and [241-245]) that smokeless articles of record (Sample 1 and Sample 2) comprising nicotine-dosed bamboo fibers, at a particle size between 30-300 µm, yield the recited property of claim 10. Modified Hassler teaches nicotine-dosed bamboo fibers at a particle size of about 300 µm, so one of ordinary skill would be motivated to make greater than 75 wt% of the total nicotine content of the smokeless article be released from the smokeless article after 20 minutes immersed in water.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to make greater than 75 wt% of the total nicotine content be released after 20 minutes immersed in water, because modified Hassler’s smokeless article has the same essential composition as instant Aspect A which yields the recited property.
Claim 15: modified Hassler teaches a kit (p. 7, lines 30-33, container and oral pouched nicotine products) comprising a plurality of smokeless articles (oral pouched nicotine products) according to claim 1 and a container (container).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hassler (WO 2018197454 A1 cited on an IDS) in view of Gao (US 20150020818 A1 cited on an IDS) as applied to claim 5 in further view of Rubenstein (WO 2019005889 A1).
Claim 6: modified Hassler teaches the smokeless article according to claim 5, wherein the nicotine salt can be provided in a plant material (p. 10, lines 16-21, cellulose).
In particular, Rubenstein teaches a nicotine salt (p. 36, [2]) mixed with a cellulose substrate, such that nicotine saturates in the mouth at a faster rate.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use Hassler’s embodiment comprising both fibers and cellulose, because doing so would make nicotine saturate in the mouth at a faster rate.
Claim 9 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hassler (WO 2018197454 A1 cited on an IDS) in view of Gao (US 20150020818 A1 cited on an IDS) as applied to claim 1 in further view of Aspgren (US 20180271139 A1).
Claims 9 and 18-19: modified Hassler teaches the smokeless article according to claim 1, wherein the nicotine-dosed bamboo fibers comprise a nicotinic compound that is a nicotine salt (p. 10, lines 25-29), wherein the smokeless article is tobacco-free (p. 8, lines 6-8), and wherein the total nicotine content is from 0.1 to 20 mg (p. 11, lines 9-13).
Modified Hassler does not explicitly teach that the total nicotine content is from 5 to 15 mg, or about 10 mg.
Aspgren teaches a smokeless article ([52-53], oral pouched product) comprising a pouch (pouch) enclosing a content comprising nicotine-dosed (snus) bamboo fibers (non-tobacco plant fibers; [55], an exemplary non-tobacco plant fiber is bamboo), wherein the smokeless article has a total nicotine content of 9 mg (p. 9, Table 3), such that a user perceives a high amount of delivered nicotine [163] without requiring excessive water to dissolve the nicotine [20].
Furthermore, Hassler’s 0.1-20mg range overlaps with the claimed 5-15mg range and the claimed about 10mg range. The courts have held that a prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The courts have held that prior art teaching carbon monoxide concentrations of “about 1-5%” renders obvious a claim reciting carbon monoxide concentrations of “more than 5%.” In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941). The courts have held that prior art renders obvious a claim reciting an overlapping endpoint, particularly when there is no showing of criticality of the claimed range.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use, within Hassler’s broad total nicotine content of 0.1-20 mg, Aspgren’s specific total nicotine content of 9 mg, because doing so is taught by overlapping ranges and in particular is exemplified by Aspgren as an effective total nicotine content without requiring excessive water to dissolve the nicotine.
Response to Arguments
Applicant’s arguments of 2025 August 8 have been carefully considered. Upon further search and consideration necessitated by applicant’s amendments, new grounds of rejection are made for claim 1 over Sjogren and Hassler in view of Gao ‘818.
Applicant’s arguments against Gao ‘818’s exemplified dimensions (p. 5-6) are rendered moot by the new grounds of rejection which do not rely on Gao ‘818’s exemplified dimensions.
Applicant’s arguments against Gao ‘573 (p. 6-9) are rendered moot by the new grounds of rejection which do not rely on Gao ‘573.
Conclusion
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/TOBEY C LE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747