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 .
As per papers filed 02/02/2026 a decision was made by supervisors of this Examiner to reopen the prosecution. Accordingly this rejection is a Non-Final Rejection.
Product claims 1, 4-19 and method claim 20 are examined together.
Note: References other than two NPL document and one WO document in this action are of record.
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 1, 4-19 and method claim 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001.
Bruun teach a pouch designed for administration of an active ingredient in the oral cavity; the pouch contains a matrix composition including a combination of nicotine and a water-soluble composition. Abstract.
Claim 1, releasable
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Claim 4, 7 in part, 8, non-sugar sweetener
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Claim 5,6, 7
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xylitol
Xylitol (as sugar alcohol) [0039] [0108] [0115] [0136] [0139] [0165] Table 1
(see below for more on how the above reads on ‘irritation’)
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Also according to Szel teaches xylitol has anti-irritant property.
claims 7-8 sweetener
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claims 9-12 flavor, double bond C=C, C=O
[0113] [0114] [0117]
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The flavoring agent, taught as pepper mint in the above mentioned Bruun Table corresponds to the flavoring agent of dependent claims (including the structural limitations of ‘double bond’: Peppermint component, for example, ‘limonene’ of claim 12, see page 121 Table 19th flavor component as per Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. To visualize the double bonds of claim 10 see cartoons on page 127.
Claims 13, 14, 15 particulate filler component (microcrystalline cellulose)
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(see below for more on how the above reads on ‘filler’)
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[0019]-[0022], [0073] , [0094],
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Example 3.1, 3.4
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Claim 16 no more than 10% tobacco.
T0obacco not excluded from the laundry list of active ingredients in the base claim 1; see Remarks filed 12/19/2025, page 1, last line. Further tobacco contains nicotine (about 5%).
The relevant limitations pertaining to the instant claims 1, 4-20, for example the inherent property of the various ingredients, are
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here in the obviousness analysis. What is good for applicant is good for examiner.
Specification page 1, line 15-23:
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taught in the applicant admitted to references in oral pouch products containing tobacco As set forth in the applicant admitted to references at page 1 Tobacco containing oral pouch products are well-known in the art as admitted to by the applicant at page 1
Claim 17 free flowing particulate form
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The powder obtained (Example 3.6 of Bruun) is usable in different particle size and is ‘sieved’.
Claim 18 salts, humectants
[0086] [0095] [0138] [0142] [0150] [0147] [0156] [0157]
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claim 19 mouth and throat,
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Claim 20 method
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The nicotine patch (and its contents) taught by Bruun fall(s) under the scope of the base claim, in the stipulated free-flowing particulate form. More specifically, the active ingredient, the irritation reducing agent xylitol, the filler (microcrystalline cellulose), three critical elements of base claim 1 are present in Bruun page 6-8, working Examples. On page 8, Table 1, specific combination (see Patch No.102) of nicotine, xylitol, flavoring material and sweeteners are prepared. Components other than the active ingredient nicotine are taught by Bruun in explicit manner, though, not always with the recited property. For example, the agent/compound xylitol is taught (as sugar alcohol which in turn is listed with the cellulose (filler)) as humectants by Bruun. It is noted that compound and its properties are inseparable. Further, though not taught by Bruun as such, the anti-irritant property of xylitol is not unknown in the art . See Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, teaches that xylitol has anti-irritant property. Likewise, the flavoring agent, taught as pepper mint in the above mentioned Bruun Table corresponds to the flavoring agent of dependent claims (including the structural limitations of ‘double bond’: Peppermint component, for example, ‘limonene’ of claim 12, see page 121 Table 19th flavor component as per Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. To visualize the double bonds of claim 10 see cartoons on page 127. Similarly, as to the ‘free-flowing’ limitations: The powder obtained (Example 3.6 of Bruun) is usable in different particle size and is ‘sieved’. The position taken is that such ‘sieved’ material would provide the property of free-flow. As to ‘mouth and throat’ limitation: The position taken is that it is one of commonsense to expect an oral composition, once released, is likely to leak into the throat in view of the proximal nature of mouth and throat:
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Various nicotine pouches are known to one of skill in the art. The global Nicotine Pouches market was valued at US$ 2.33 billion in 2020 and is expected to reach US$ 21.84 billion by the end of 2027, growing at a CAGR of 30.7% during 2021-2027. https://www.marketresearch.com/QYResearch-Group-v3531/Global-Nicotine-Pouches-Research-14261122/
With such motivation, one of skill in the art would make modifications to nicotine patches known in the prior art, to participate in the market. All the critical claimed elements of the claims are taught in the prior art of Bruun explicitly and or implicitly (by inherency) to make different forms of nicotine patches. Therefore with the teaching of the prior art one of skill in the art would have reasonable expectation of success in arriving at alternate versions of prior art composition As such there is nothing unobvious in the instant claim limitations, further because, data
with regards to
secondary considerations, or "objective indicia" of nonobviousness,, that is real-world facts—such as commercial success, long-felt need, failure of others, and industry praise—used to demonstrate that an invention was not obvious,
could not be found in the disclosure for
an oral composition comprising: an active ingredient that is releasable from the oral composition; a filler; and at least one irritation reducing agent effective to reduce irritation arising from the release of the active ingredient from the oral composition, wherein the active ingredient comprises one or more of: a vitamin selected from Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B7, Vitamin B9, Vitamin D, Vitamin E, Vitamin K; GABA lemon balm extract, citicoline, or sunflower lecithin; a stimulant selected from theacrine, theobromine and theophylline; a botanical selected from ashwagandha, Bacopa monniera, baobab, Centella asiatica, Chai- hu, chamomile, cherry blossom, chlorophyll, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, Galphimia glauca, Ginkgo biloba, Panax ginseng), green tea, Griffonia simplicifolia, hops, aempferia parviflora (Thai ginseng), kava, lemon balm, lemongrass, lutein, matcha, Nardostachys chinensis, oil-based extract of Viola odorata, quercetin, resveratrol, Rhizoma gastrodiae, Rhodiola, rose essential oil, Sceletium tortuosum, Schisandra, Skullcap, Spikenard, turmeric, Turnera aphrodisiaca, valerian, white mulberry, and Yerba mate; an amino acid selected from alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, methionine, proline, serine, threonine, and valine; an antioxidant selected from acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot, black pepper, blueberries, borage seed oil, bugleweed, cacao, calamus root, catnip, catuaba, cayenne pepper, chaga mushroom, chervil, dark chocolate, potato peel, grape seed, gingko biloba, Saint John's Wort, saw palmetto, green tea, black tea, black cohosh, cayenne, cranberry, dandelion, grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew, goldenseal, hawthorn, hibiscus flower, jiaogulan, kava, marjoram, milk thistle, oolong tea, beet root, orange, oregano, papaya, pennyroyal, red clover, rosehip, clary sage, savory, spirulina, slippery elm bark, sorghum bran hi-tannin, sorghum grain hi-tannin, sumac bran, comfrey leaf and root, goji berries, gutu kola, turmeric, uva ursi, valerian, wild yam root, wintergreen, yacon root, yellow dock, dock,yerba mate, yerba santa, bacopa monniera, withania somnifera, Lion's mane, silybum marianum, citric acid, a tocopherol, epicatechol, epigallocatechol, epigallocatechol gallate, erythorbic acid, sodium erythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B, theaflavin digallate, phenolic acids, glycosides, quercitrin, isoquercitrin, hyperoside, polyphenols, catechols, resveratrols, oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), a tertiary butylhydroquinone (TBHQ), and combinations thereof,a cannabinoid selected from cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A); anda cannabimimetic selected from yangonin, alpha-amyrin, beta amyrin, cyanidin,curcumin/turmeric, catechin, quercetin, salvinorin A, N-aceylethanolamines, and N-alkylamide lipids,wherein the active ingredient, the filler component, and the at least one irritation reducing agent are combined as a mixture that is enclosed in a pouch to form a pouched product.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of the base claims 1 and 20 and dependent claims is unclear. For example, with respect to the limitation for active ingredients, that is
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in addition to specific compounds (active ingredients), such as CBDL as
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the claims also include wide possibilities of chemicals that are present in botanicals such as
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.
According to Singh Afr J Tradit Complement Altern Med. (2011) 8(S):208-213,
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at page 1
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As such buried deep in the recited GABA extract, botanical, anti-oxidant, by implication are large number of possible of active ingredients in addition to these as such. While it is acknowledged that breadth is not indefinite, a meaningful comprehensive patent search cannot be done for the claims.
Further, the open-ended comprising language renders the base claims 1 and 20 and the dependent claims vague and indefinite. In addition to the laundry list of large number of active ingredients,
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the term comprising in the claims renders the scope of the claims with respect to the active ingredient unclear. For example, tobacco which is a major source of nicotine, not specifically mentioned in the plethora of possibilities listed is not excluded from the base claims. Tobacco itself contains over 7000 compounds including nicotine, exploited by tobacco companies advantageously by manipulating product design, see . https://cdn.who.int/media/docs/default-source/tobacco-hq/infosheet-marketing.pdf?sfvrsn=35121884_4
As per Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) "comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts. In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held. "The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended."
Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024]
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 1, 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bruun1 WO2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001.
Bruun1 teaches a pouch designed for administration of an active ingredient in the oral cavity is disclosed, the pouch containing an amount of one or more cannabinoids. Abstract.
Bruun1 teaches that the cannabinoid pouch contains, cellulose and xylitol. Bruun1 composition comprises at least one of carbohydrates, sugars, sugar alcohol, maltodextrin, sucralose, modified food starches, cornstarch, microcrystalline cellulose, THC distillate, MCT oil, baking soda, natural flavoring, botanical terpenes, vanilla extract, and salt. In some embodiments, the cannabinoid composition or cannabinoid infused wafer fragments composition do not comprise of microcrystalline cellulose. As used herein the term "humectant" is understood as a moistening agent used to attract moisture or water in the form of saliva. Humectants may typically include suitably hygroscopic compositions. In some cases, humectants may also be described as moistening agents, due to their role in attraction of moisture. Examples of humectants include cellulose, such as microcrystalline cellulose and other cellulose types disclosed herein, sugar alcohols, such as those disclosed herein, alginate, cellulose, such as microcrystalline cellulose, pectin, xanthan gum, etc.
Applicant is encouraged to use word search technique known to one of skill in the art by pressing Ctrl + F (or Cmd + F on Mac) to quickly find, search, or highlight specific words, phrases to claim limitations in Bruun1. The technique was used to locate these limitations in Bruun, which teaches nicotine replacement for cannabinoid in the Bruun1 pouch, as shown below:
Claim 1, releasable
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Claim 4, 7 in part, 8, non-sugar sweetener
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Claim 5,6, 7
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xylitol
Xylitol (as sugar alcohol) [0039] [0108] [0115] [0136] [0139] [0165] Table 1
(see below for more on how the above reads on ‘irritation’)
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Also according to Szel teaches xylitol has anti-irritant property.
claims 7-8 sweetener
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claims 9-12 flavor, double bond C=C, C=O
[0113] [0114] [0117]
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The flavoring agent, taught as pepper mint in the above mentioned Bruun Table corresponds to the flavoring agent of dependent claims (including the structural limitations of ‘double bond’: Peppermint component, for example, ‘limonene’ of claim 12, see page 121 Table 19th flavor component as per Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. To visualize the double bonds of claim 10 see cartoons on page 127.
Claims 13, 14, 15 particulate filler component (microcrystalline cellulose)
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(see below for more on how the above reads on ‘filler’)
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[0019]-[0022], [0073] , [0094],
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Example 3.1, 3.4
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Claim 16 no more than 10% tobacco.
T0obacco not excluded from the laundry list of active ingredients in the base claim 1; see Remarks filed 12/19/2025, page 1, last line. Further tobacco contains nicotine (about 5%).
The relevant limitations pertaining to the instant claims 1, 4-20, for example the inherent property of the various ingredients, are
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here in the obviousness analysis. What is good for applicant is good for examiner.
Specification page 1, line 15-23:
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taught in the applicant admitted to references in oral pouch products containing tobacco As set forth in the applicant admitted to references at page 1 Tobacco containing oral pouch products are well-known in the art as admitted to by the applicant at page 1
Claim 17 free flowing particulate form
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The powder obtained (Example 3.6 of Bruun) is usable in different particle size and is ‘sieved’.
Claim 18 salts, humectants
[0086] [0095] [0138] [0142] [0150] [0147] [0156] [0157]
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claim 19 mouth and throat,
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Claim 20 method
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All the claimed limitations are known in the prior art of Bruun1 and Bruun. Since the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition. Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024]
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https://cannadips.com/?srsltid=AfmBOoq2En5mt9eK_BFfVthF2Msd6Wcf1hKy8iOHw5_2UdkPo3RMsDTW
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11406630 further in view of Bruun1 2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Reddick US 20140255452, Nilsson US 2015/0272878, Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contains overlapping subject matter as explained below:
Claims of 11406630:
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The difference is in the scope of the base claims with respect to active ingredient. See Bruun1 and Bruun for the interchangeable use of nicotine and cannabinoids, for example, as active ingredients. The teachings if Reddick and Nilsson are invoked for the limitation of water-soluble limitation of claims of 11406630 as being within the purview of one of skill in the art.
On top of this obviousness analysis, Examination guidelines include the following:
Reliance on specification of a potentially conflicting patent or application is generally prohibited. However limited exceptions do exist. Exceptions to the General Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application include Dictionary for claim terminology, Portions of the disclosure which provide support for the claims in the potentially conflicting patent or application.
The MPEP refers to two exceptions to the general prohibition of using the disclosure of a potentially conflicting patent or application in an ODP-Obviousness analysis. The two exceptions are:
1. The disclosure can be used as a dictionary for claim terminology; and
2. “[T]hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent” (MPEP § 804).
The MPEP further notes:
The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 since only the disclosure of the invention claimed in the patent may be examined.”)
Brunn (for nicotine pouch)
Claim 1, releasable
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Claim 4, 7 in part, 8, non-sugar sweetener
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Claim 5,6, 7
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xylitol
Xylitol (as sugar alcohol) [0039] [0108] [0115] [0136] [0139] [0165] Table 1
(see below for more on how the above reads on ‘irritation’)
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Also according to Szel teaches xylitol has anti-irritant property.
claims 7-8 sweetener
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claims 9-12 flavor, double bond C=C, C=O
[0113] [0114] [0117]
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The flavoring agent, taught as pepper mint in the above mentioned Bruun Table corresponds to the flavoring agent of dependent claims (including the structural limitations of ‘double bond’: Peppermint component, for example, ‘limonene’ of claim 12, see page 121 Table 19th flavor component as per Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. To visualize the double bonds of claim 10 see cartoons on page 127.
Claims 13, 14, 15 particulate filler component (microcrystalline cellulose)
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(see below for more on how the above reads on ‘filler’)
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[0019]-[0022], [0073] , [0094],
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Example 3.1, 3.4
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Claim 16 no more than 10% tobacco.
Tobacco not excluded from the laundry list of active ingredients in the base claim 1; see Remarks filed 12/19/2025, page 1, last line. Further tobacco contains nicotine (about 5%).
The relevant limitations pertaining to the instant claims 1, 4-20, for example the inherent property of the various ingredients, are
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here in the obviousness analysis. What is good for applicant is good for examiner.
Specification page 1, line 15-23:
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taught in the applicant admitted to references in oral pouch products containing tobacco As set forth in the applicant admitted to references at page 1 Tobacco containing oral pouch products are well-known in the art as admitted to by the applicant at page 1
Claim 17 free flowing particulate form
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The powder obtained (Example 3.6 of Bruun) is usable in different particle size and is ‘sieved’.
Claim 18 salts, humectants
[0086] [0095] [0138] [0142] [0150] [0147] [0156] [0157]
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claim 19 mouth and throat,
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Claim 20 method
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Bruun1 (cannabis pouch):
Bruun1 teaches a pouch designed for administration of an active ingredient in the oral cavity is disclosed, the pouch containing an amount of one or more cannabinoids. Abstract
Bruun1 teaches that the cannabinoid pouch contains, cellulose and xylitol. Bruun1 composition comprises at least one of carbohydrates, sugars, sugar alcohol, maltodextrin, sucralose, modified food starches, cornstarch, microcrystalline cellulose, THC distillate, MCT oil, baking soda, natural flavoring, botanical terpenes, vanilla extract, and salt. In some embodiments, the cannabinoid composition or cannabinoid infused wafer fragments composition do not comprise of microcrystalline cellulose. As used herein the term "humectant" is understood as a moistening agent used to attract moisture or water in the form of saliva. Humectants may typically include suitably hygroscopic compositions. In some cases, humectants may also be described as moistening agents, due to their role in attraction of moisture. Examples of humectants include cellulose, such as microcrystalline cellulose and other cellulose types disclosed herein, sugar alcohols, such as those disclosed herein, alginate, cellulose, such as microcrystalline cellulose, pectin, xanthan gum, etc.
Applicant is encouraged to use word search technique known to one of skill in the art by pressing Ctrl + F (or Cmd + F on Mac) to quickly find, search, or highlight specific words, phrases to claim limitations in Bruun1.
Reddick teaches an oral pouch comprising a powder containing nicotine and pharmaceutical excipients including sweeteners such as mannitol (Abstract; [0001], [0011], [0012], [0041], [0042]-[0044] and [0047]-[0050]). Reddick teaches the active ingredient (nicotine) can be combined with pharmaceutical excipients to form granules for inclusion in a pouch ([0047] and [0056]). Reddick teaches the suitable nicotine form include nicotine polacrilex ([0052]).
Nilsson teaches a pouch for administering nicotine in the oral cavity, the pouch comprising powder containing nicotine a sweetener such as polyols including mannitol and maltitol ([0016], [0017], [0021], [0022], [0023], [0050]-[0064]; Examples 1-2 and 10; Tables 1 and 4; claims 1, 9-11, 13, 18 and 20). Nilsson teaches the nicotine and sweetener is mixed together then granulated ([0023], [0055], [0062], [0064]; Examples 1-2 and 10; claims 18 and 20). Nilsson teaches the resultant granules (powder) is filled in the pouch ([0055], [0057] and [0064]; Examples 1-2 and 10). Nilsson provided examples in which a powder mixture containing nicotine, maltitol or mannitol, sodium bicarbonate, and sodium carbonate and obtained powder is filled into a pouch (Example 1, Table 1, Compositions A and B). It is noted that the maltitol (or mannitol), sodium bicarbonate, and sodium carbonate that are part of the formed powder (or in other word, granules) are water soluble ingredients, thereby meets the claimed “water-soluble composition comprises sugar alcohol as a water soluble carrier for the nicotine.” Nilsson provided another example in which a powder mixture containing nicotine, mannitol, acesulfame K, sodium bicarbonate and sodium carbonate was granulated with a granulation solution containing polyvinylpyrrolidone, ethanol, lemon flavor, glycerol and menthol flavor to form granulate (or powder) that is then filled in the pouch (Example 2). It is noted the mannitol, acesulfame K, sodium bicarbonate, sodium carbonate, polyvinylpyrrolidone, ethanol, lemon flavor, menthol flavor and glycerol that are part of the formed granules (powder) are water-soluble ingredients, thereby also meeting the claimed “water-soluble composition comprises sugar alcohol as a water soluble carrier for the nicotine.” It is further noted the polyols such as mannitol and maltitol as taught by Nilsson make up the majority of the weight of formed granules (powder) (Nilsson: Compositions A and B of Table 1 in Example 1; Example 2; Example 10, Table 4), as well as, mannitol or maltitol meets the claimed structural component of “sugar alcohol.” Thus, mannitol or maltitol as taught in Compositions A and B in Table 1 of Example 1, Example 2 and Table 4 of Example 10 of Nilsson meets the claimed structure of “sugar alcohol as a carrier for nicotine.” This is because "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties (functions) applicant discloses and/or claims are necessarily present. As such, Compositions A and B in Table 1 of Example 1 of Nilsson teaches the claimed “granules consisting of a combination of nicotine and a water soluble composition” because the powders of Compositions A and B consist of nicotine and a water soluble composition comprising maltitol (or mannitol), sodium bicarbonate and sodium carbonate. Example 2 of Nilsson also teaches the claimed “granules consisting of a combination of nicotine and a water-soluble composition” because the granules (or powder) of Example 2 consist of nicotine and a water soluble composition comprising mannitol, acesulfame K, sodium bicarbonate, sodium carbonate, polyvinylpyrrolidone, ethanol, lemon flavor, menthol flavor and glycerol.
As such all the claimed elements are known in the secondary references and specification of the conflicting cases. Therefore there is extensive overlap in the conflicting claims.
Likewise (Likewise means for the same rationale in the obviousness analysis above and under section Claim Rejections - 35 USC § 103 in this action)
Claims 1, 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11793230 further in view of Bruun1 2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contains overlapping subject matter as explained below:
Claims of 11793230
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The implication that there is ionic bond between +vely charged active ingredient and the -vely charged carboxylate groups of cellulose is within the purview of one of skill in the art. It is known that saliva which is at pH 6.2-7.6 contains organic and inorganic substances in addition enzymes and proteins (which are all charged). The absorption of nicotine/active substance would be largely dependent on all these factors.
The suggestion that natural cannabinoids (see conflicting claim 2 +vely charged) is highly questionable. Further, Bruun teaches an oral product comprising: nicotine bitartrate [0131] (protonated nicotine active ingredient comprising a positively charged amine group, see [0055] of the published instant application); and sorbitol carrier (which comprises hydroxyl groups) [0108] (a filler comprising a negatively charged group – see [0043] of the published instant application); wherein the active ingredient is retained by the filler through chemical bonding [0079, 0092], i.e. bonding of the respective positively charged group and negatively charged group, wherein the active ingredient is configured for release when the product is present in an oral cavity and the active ingredient and the filler are combined as a mixture that is enclosed in a pouch to form a pouched product [0091].
Likewise (Likewise means for the same rationale in the obviousness analysis above and under section Claim Rejections - 35 USC § 103 in this action)
Claims 1, 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11883527 further in view of Bruun1 2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001, SENECI, WO 20101255516; Mori US 5292528 and BARNSCHEID CN 107308124; CERMAK WO 2015160842 for teaching that pH of nutritional supplements can be adjusted to about 2.5 to 6.5 and at specific pH values of 2.5, 3.0, 3.5, 4.0, 4.5, 5.0. 5.5, 6.0 and 6.5 with acidulant such as citric acid (page 35, first paragraph under definitions; last paragraph of page 41; first full paragraph of page 48); dosage forms are lozenges and pastilles, first full paragraph of page 55.
Seneci, Mori, Bransched and Cermark are of record in IDS.
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contains overlapping subject matter as explained below:
Claims of 11883527:
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SENCI discloses pharmaceutical, dietary and nutraceutical compositions containing
mixture of Lutein and Zeaxanthin in combination with physiologically acceptable excipient and the composition has an outer coating; the form of the composition is orobuccal and sublingual tablet, capsule, granule or pastille (see the whole document with emphasis on the title, abstract, page 4, lines 1-3, page 5, lines 3-11, Example 12, claim 13). The excipient includes surfactants (cationic, anionic or non-ionic), diluents, aggregates or binding agents, lubricants, glidants, disaggregants, solubilisers, emulsifiers, sweeteners, flavoring agents, pH regulators or their mixture with preferred excipients being silica gel, dispersed colloidal silica, soy lecithin, polysorbates, sodium lauryl sulfate, phospholipids, sodium carbonate, sodium bicarbonate, mineral bases (for example aluminum hydroxide, magnesium silicate aluminum, magnesium hydroxide carbonate, tribasic magnesium phosphate, magnesium silicate, magnesium peroxide),
cocoa paste, cocoa powder, cocoa butter or a mixture thereof (page 5, line 20 to page 6, line 5). Sweeteners such as fructose, maltitol, xylitol, mannitol, sucralose and sorbitol (lines 4 and 9-10 from the bottom of page 9). Maltitol, xylitol, and sorbitol are some of the sugar alcohols listed in claim 7. Seneci teaches pastille composition comprising citrus extract (see at least example 12) meeting the requirement for citrus. In the body of the disclosure, Seneci teaches that it’s composition can contain mint namely peppermint, spearmint and sweet mint (page 8, lines 2-3). Example 12 of SENECI is an orobuccal pastille (dragee) coated product comprising (i) mixture of Lutein and Zeaxanthin at 2.89% and citrus extract at 0.14% which meet the limitation
of nutraceutical/botanical active agent or claim 1 and the citrus meets the limitation of citrus botanical in the claim 1, (ii) maltitol, meeting the limitation of sugar alcohol of claims 1 and 7, (iii) silica gel. The product also contains sucralose, meeting limitation of sweetener. SENECI teaches that gelling insoluble fibers such as guar gum can also be used in the compositions (page 9, lines 7-8). It is known in the art, for example, CERMAK teaches using citric acid to adjust pH of nutritional supplements in the form of pastilles and lozenges to about 2.5 to about 6.5 and at specific pH values of 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 6.5 with acidulant such as citric acid (page 35, first paragraph under definitions; last paragraph of page 41; first full paragraph of page 48; first full paragraph of page 55).
Further, it is has been recognized in the art that guar gum, xanthan gum, tragacanth gum, gum Arabic, carrageenan, silica gel and bee gum are functionally equivalent as thickening agents (see column 5, line 68 to column 6, line 5 of Mori) in oral compositions. Also, SENECI clearly suggests using gelling agents such as guar gum in its composition (page 9, lines 7-8).
The pastille of SENECI has an outer coating of chocolate. SENECI differs from claims 1 and 33 by not using film-forming polymer as the outer coating. It is known that film-forming polymer coating improves stability and shelf live (page 28, 3rd full paragraph of the Eng. Trans. of BARNSCHEID (CN 107308124 A).
The amount of Lutein and Zeaxanthin at 2.89% and citrus extract at 0.14% is less than the 10 wt% required in claim 1. The composition of SENECI does not include nicotine or a nicotine-derived component and thus meets the proviso requirement that the composition of claim 1 does not include nicotine or a nicotine-derived component or tobacco.
CERMAK teaches using citric acid to adjust pH of nutritional supplements in the form of pastilles and lozenges to about 2.5 to about 6.5 and at specific pH values of 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 6.5 with acidulant such as citric acid (page 35, first paragraph under definitions; last paragraph of page 41; first full paragraph of page 48; first full paragraph of page 55). Thus, at the effective date of the invention, the artisan would reasonably expect that the presence of citric acid in the composition of SENECI would predictably adjust the pH to from about 2.5 to about 6.5 in accordance with the teachings of CERMAK.
Likewise (Likewise means for the same rationale in the obviousness analysis above and under section Claim Rejections - 35 USC § 103 in this action)
Claims 1, 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11166935 further in view of Bruun1 2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contains overlapping subject matter as explained below:
Claims of 11166935:
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The difference is the instant claims do not recite time for release of the active ingredient. !0 minutes (of 11166935) would be within commonsense expectation of any common man using the instant pouch for cannabinoid effect.
Xxxxxxxxxxxxxxxxxx
Likewise (Likewise means for the same rationale in the obviousness analysis above and under section Claim Rejections - 35 USC § 103 in this action)
Claims 1, 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12439949 further in view of Bruun1 2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001, SENECI, WO 20101255516; Mori US 5292528 and BARNSCHEID CN 107308124; CERMAK WO 2015160842 for teaching that pH of nutritional supplements can be adjusted to about 2.5 to 6.5 and at specific pH values of 2.5, 3.0, 3.5, 4.0, 4.5, 5.0. 5.5, 6.0 and 6.5 with acidulant such as citric acid (page 35, first paragraph under definitions; last paragraph of page 41; first full paragraph of page 48); dosage forms are lozenges and pastilles, first full paragraph of page 55.
Although the claims at issue are not identical, they are not patentably distinct from each other as explained above.
Claims of 12439949:
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The difference is ‘water activity’ absent in the instant claims. Water activity in tobacco products, for example, is known one of skill in the art: See page 7 of see Duran, Recommended Requirements for Stability Testing of Smokeless Tobacco Products, 2014, 1-21. With the comprising language in the instant claims water could be included or excluded in the instant composition.
Likewise (Likewise means for the same rationale in the obviousness analysis above and under section Claim Rejections - 35 USC § 103 in this action)
Claims 1, 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11617744 further in view of Bruun1 2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001, SENECI, WO 20101255516; Mori US 5292528 and BARNSCHEID CN 107308124; CERMAK WO 2015160842 for teaching that pH of nutritional supplements can be adjusted to about 2.5 to 6.5 and at specific pH values of 2.5, 3.0, 3.5, 4.0, 4.5, 5.0. 5.5, 6.0 and 6.5 with acidulant such as citric acid (page 35, first paragraph under definitions; last paragraph of page 41; first full paragraph of page 48); dosage forms are lozenges and pastilles, first full paragraph of page 55.
Although the claims at issue are not identical, they are not patentably distinct from each other as explained above.
Claims of 11617744:
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Likewise (Likewise means for the same rationale in the obviousness analysis above and under section Claim Rejections - 35 USC § 103 in this action)
Claims 1, 4-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25, 27-40 of copending Application No. 18143391 further in view of Bruun1 2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
The difference is that the claims of 18143391 exclude nicotine as one of the active ingredient. Interchangeable use of otherwise similar oral pouch products is the subject matter found in the combined teachings of Bruun1 (cannabinoid patch) and Bruun (nicotine patch):
Bruun1 teaches a pouch designed for administration of an active ingredient in the oral cavity is disclosed, the pouch containing an amount of one or more cannabinoids. Abstract
Bruun1 teaches that the cannabinoid pouch contains, cellulose and xylitol. Bruun1 composition comprises at least one of carbohydrates, sugars, sugar alcohol, maltodextrin, sucralose, modified food starches, cornstarch, microcrystalline cellulose, THC distillate, MCT oil, baking soda, natural flavoring, botanical terpenes, vanilla extract, and salt. In some embodiments, the cannabinoid composition or cannabinoid infused wafer fragments composition do not comprise of microcrystalline cellulose. As used herein the term "humectant" is understood as a moistening agent used to attract moisture or water in the form of saliva. Humectants may typically include suitably hygroscopic compositions. In some cases, humectants may also be described as moistening agents, due to their role in attraction of moisture. Examples of humectants include cellulose, such as microcrystalline cellulose and other cellulose types disclosed herein, sugar alcohols, such as those disclosed herein, alginate, cellulose, such as microcrystalline cellulose, pectin, xanthan gum, etc.
Applicant is encouraged to use word search technique known to one of skill in the art by pressing Ctrl + F (or Cmd + F on Mac) to quickly find, search, or highlight specific words, phrases to claim limitations in Bruun1. The technique was used to locate these limitations in Bruun, which teaches nicotine replacement in cannabinoid in the Bruun1 pouch, as shown below:
Claim 1, releasable
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Claim 4, 7 in part, 8, non-sugar sweetener
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Claim 5,6, 7
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xylitol
Xylitol (as sugar alcohol) [0039] [0108] [0115] [0136] [0139] [0165] Table 1
(see below for more on how the above reads on ‘irritation’)
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Also according to Szel teaches xylitol has anti-irritant property.
claims 7-8 sweetener
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claims 9-12 flavor, double bond C=C, C=O
[0113] [0114] [0117]
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The flavoring agent, taught as pepper mint in the above mentioned Bruun Table corresponds to the flavoring agent of dependent claims (including the structural limitations of ‘double bond’: Peppermint component, for example, ‘limonene’ of claim 12, see page 121 Table 19th flavor component as per Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. To visualize the double bonds of claim 10 see cartoons on page 127.
Claims 13, 14, 15 particulate filler component (microcrystalline cellulose)
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[0019]-[0022], [0073] , [0094],
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Example 3.1, 3.4
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Claim 16 no more than 10% tobacco.
T0obacco not excluded from the laundry list of active ingredients in the base claim 1; see Remarks filed 12/19/2025, page 1, last line. Further tobacco contains nicotine (about 5%).
The relevant limitations pertaining to the instant claims 1, 4-20, for example the inherent property of the various ingredients, are
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here in the obviousness analysis. What is good for applicant is good for examiner.
Specification page 1, line 15-23:
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taught in the applicant admitted to references in oral pouch products containing tobacco As set forth in the applicant admitted to references at page 1 Tobacco containing oral pouch products are well-known in the art as admitted to by the applicant at page 1
Claim 17 free flowing particulate form
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The powder obtained (Example 3.6 of Bruun) is usable in different particle size and is ‘sieved’.
Claim 18 salts, humectants
[0086] [0095] [0138] [0142] [0150] [0147] [0156] [0157]
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claim 19 mouth and throat,
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Claim 20 method
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All the claimed limitations are known in the prior art of Bruun1 and Bruun and in the conflicting claims. Since the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition. Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Likewise (Likewise means for the same rationale in the obviousness analysis above and under section Claim Rejections - 35 USC § 103 in this action):
Claims 1, 4-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, of copending Application No. 16707225
1-20 of U.S. Patent No. 12439949 further in view of Bruun1 2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001.
Although the claims at issue are not identical, they are not patentably distinct from each other as explained above.
Claim 1 of 16707225:
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The difference is ‘water activity’ absent in the instant claims. water activity in tobacco products, for example, is known one of skill in the art: See page 7 of see Duran, Recommended Requirements for Stability Testing of Smokeless Tobacco Products, 2014, 1-21.
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https://cannadips.com/?srsltid=AfmBOoq2En5mt9eK_BFfVthF2Msd6Wcf1hKy8iOHw5_2UdkPo3RMsDTW
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The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32
(2010) 324–330.
Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024]
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 1, 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schjölin US 11801219 (2020-09-21), Bruun1 2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001.
Schjölin teaches
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Bruun1 teaches a pouch designed for administration of an active ingredient in the oral cavity is disclosed, the pouch containing an amount of one or more cannabinoids. Abstract
Bruun1 teaches that the cannabinoid pouch contains, cellulose and xylitol. Bruun1 composition comprises at least one of carbohydrates, sugars, sugar alcohol, maltodextrin, sucralose, modified food starches, cornstarch, microcrystalline cellulose, THC distillate, MCT oil, baking soda, natural flavoring, botanical terpenes, vanilla extract, and salt. In some embodiments, the cannabinoid composition or cannabinoid infused wafer fragments composition do not comprise of microcrystalline cellulose. As used herein the term "humectant" is understood as a moistening agent used to attract moisture or water in the form of saliva. Humectants may typically include suitably hygroscopic compositions. In some cases, humectants may also be described as moistening agents, due to their role in attraction of moisture. Examples of humectants include cellulose, such as microcrystalline cellulose and other cellulose types disclosed herein, sugar alcohols, such as those disclosed herein, alginate, cellulose, such as microcrystalline cellulose, pectin, xanthan gum, etc.
Applicant is encouraged to use word search technique known to one of skill in the art by pressing Ctrl + F (or Cmd + F on Mac) to quickly find, search, or highlight specific words, phrases to claim limitations in Bruun1. The technique was used to locate these limitations in Bruun, which teaches nicotine replacement in cannabinoid in the Bruun1 pouch, as shown below:
Claim 1, releasable
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Claim 4, 7 in part, 8, non-sugar sweetener
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Claim 5,6, 7
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xylitol
Xylitol (as sugar alcohol) [0039] [0108] [0115] [0136] [0139] [0165] Table 1
(see below for more on how the above reads on ‘irritation’)
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Also according to Szel teaches xylitol has anti-irritant property.
claims 7-8 sweetener
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claims 9-12 flavor, double bond C=C, C=O
[0113] [0114] [0117]
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The flavoring agent, taught as pepper mint in the above mentioned Bruun Table corresponds to the flavoring agent of dependent claims (including the structural limitations of ‘double bond’: Peppermint component, for example, ‘limonene’ of claim 12, see page 121 Table 19th flavor component as per Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. To visualize the double bonds of claim 10 see cartoons on page 127.
Claims 13, 14, 15 particulate filler component (microcrystalline cellulose)
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(see below for more on how the above reads on ‘filler’)
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[0019]-[0022], [0073] , [0094],
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Example 3.1, 3.4
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Claim 16 no more than 10% tobacco.
T0obacco not excluded from the laundry list of active ingredients in the base claim 1; see Remarks filed 12/19/2025, page 1, last line. Further tobacco contains nicotine (about 5%).
The relevant limitations pertaining to the instant claims 1, 4-20, for example the inherent property of the various ingredients, are
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here in the obviousness analysis. What is good for applicant is good for examiner.
Specification page 1, line 15-23:
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taught in the applicant admitted to references in oral pouch products containing tobacco As set forth in the applicant admitted to references at page 1 Tobacco containing oral pouch products are well-known in the art as admitted to by the applicant at page 1
Claim 17 free flowing particulate form
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The powder obtained (Example 3.6 of Bruun) is usable in different particle size and is ‘sieved’.
Claim 18 salts, humectants
[0086] [0095] [0138] [0142] [0150] [0147] [0156] [0157]
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claim 19 mouth and throat,
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Claim 20 method
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All the claimed limitations are known in the prior art of Schjölin, Bruun1 and Bruun. Since the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition. Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
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https://cannadips.com/?srsltid=AfmBOoq2En5mt9eK_BFfVthF2Msd6Wcf1hKy8iOHw5_2UdkPo3RMsDTW
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Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024]
Copending Applications
Applicant is encouraged to check for additional copending applications and issued patents for overlapping subject matter in the claims and file terminal disclaimers.
As set forth by the court (not by this Examiner) in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972):
[W]e think that it is unfair to the busy examiner, no matter how diligent and well informed he may be, to assume that he retains details of every pending file in his mind when he is reviewing a particular application . . . [T]he applicant has the burden of presenting the examiner with a complete and accurate record to support the allowance of letters patent.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625