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 16-20, 24, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Strickland et al. (US 2014/0123986) in view of Epstein et al. (US 2022/0225754).
Claim 16. Strickland et al. discloses a smokeless tobacco, e.g., in shredded form, is mixed with pellets or granules of a low molecular weight polyethylene. The ratio of tobacco to polyethylene (or other insoluble format) may be 99:1 to 50:50, e.g., 95:5 to 90:10. The mixture (substrate layer) is heated to a temperature of about 90ºC and molded into a shape, e.g., a cylindrical shape with dimensions of 0.5-0.9 inches, e.g., approximately 0.75 inches, in diameter and 1-3 inches, e.g., approximately 2 inches, long. The shape typically has an opening for the insertion of a wooden handle (chewable wooden carrier element), which may be inserted while the mixture (substrate layer) is being heated. Heating continues until the moisture content of the mixture is reduced to about 3-30%, e.g., 5%. The mixture (substrate layer) is then allowed to cool and to adhere to the wooden handle. The user will insert the molded tobacco (containing nicotine) and polymer mixture (substrate layer) into the mouth using the handle (chewable wooden carrier element). After use, the product is discarded ([0276]). A larger composition or orally sized piece attached to a handle may also be partially inserted in the mouth, similar to a toothpick or cigarette, and the consumer may suck or chew on it ([0055]).
Strickland et al. does not explicitly disclose that the wooden handle (chewable wooden carrier element) is impregnated with one or more active compounds derived from Salvadora Persica.
Epstein et al. discloses a toothbrush made of any known materials, including plastics, wood, and the like. The bristles 16 can be natural, such as Miswak bristles, or synthetic, such as nylon. Miswak is a traditional chewing stick prepared from roots, twigs, and stem of the Salvadora persica plant. Chewing sticks of this nature have been used in many parts of the world for thousands of years. Miswak possesses antibacterial, anti-fungal, anti-viral, anti-carcinogenic, and anti-plaque properties. The present invention proposes using miswak fibers that are embedded into the head 14 of the toothbrush 10 and that serve as bristles 16. Alternatively, synthetic bristles, such as nylon, can be used, among other known types of materials. The bristles 16 can alternatively be Miswak extract infused nylon bristles ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date that the handle (chewable wooden carrier element) be infused with Miswak extract (wherein Miswak is prepared from the Salvadora persica plant) to impart antibacterial, anti-fungal, anti-viral, anti-carcinogenic, and anti-plaque properties as taught by Epstein et al.
Claim 17. Modified Strickland et al. discloses that the mixture (substrate layer) may include natural gums like xanthan gum, tragacantha, guar gum, acacia gum, arabic gum, water-dispersible polyacrylates like polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers (Strickland [0020]-[0021]).
Claims 18 and 19. Modified Strickland et al. discloses that the mixture (substrate layer) is heated to a temperature of about 90ºC and molded into a shape, e.g., a cylindrical shape. The shape typically has an opening for the insertion of a wooden handle (chewable wooden carrier element), which may be inserted while the mixture (substrate layer) is being heated. The mixture (substrate layer) is then allowed to cool and to adhere to the wooden handle (forming an outer layer) (Strickland [0055]).
Claim 20. Modified Strickland et al. discloses that the composition may further include a coating, e.g., matte or glossy. The coating preferably includes a color, flavor, sweetener, or flavor masking agent. The coating may also include a different flavor, color, or rate of disintegration from the format in the composition. The coating may also include tobacco (Strickland [0014]).
Claim 24. Modified Strickland et al. discloses mixture (substrate layer) is heated to a temperature of about 90.degree. C. and molded into a shape, e.g., a cylindrical shape with dimensions of 0.5-0.9 inches, e.g., approximately 0.75 inches, in diameter and 1-3 inches, e.g., approximately 2 inches, long (Strickland [0055]).
Claims 29 and 30. Modified Strickland et al. discloses that the mixture (substrate layer) may include flavor extracts including sweeteners such as xylitol (Strickland [0051]).
Claims 16-21 and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US 2018/0220696) in view of Epstein et al. (US 2022/0225754).
Claim 16. Gao et al. discloses an oral product 110 which can be molded into any desired shape ([0027]; Figures 2A-O). The body (chewable wooden carrier element) of the oral product includes a mouth-soluble polymer matrix, cellulosic fibers embedded in the mouth-soluble polymer matrix, and nicotine or a derivative thereof dispersed in the mouth-soluble polymer matrix (Abstract). Suitable sources for cellulosic fibers include wood pulp ([0063]). The oral product 110 can be wrapped or coated in an edible or dissolvable film (substrate layer). The coating can include nicotine to provide a user with an initial nicotine burst ([0030]).
Gao et al. does not explicitly disclose that the body (chewable wooden carrier element) of the oral product 110 comprises wood fibers or active compounds derived from Salvadora Persica.
Epstein et al. discloses a toothbrush made of any known materials, including plastics, wood, and the like. The bristles 16 can be natural, such as Miswak bristles, or synthetic, such as nylon. Miswak is a traditional chewing stick prepared from roots, twigs, and stem of the Salvadora persica plant. Chewing sticks of this nature have been used in many parts of the world for thousands of years. Miswak possesses antibacterial, anti-fungal, anti-viral, anti-carcinogenic, and anti-plaque properties. The present invention proposes using miswak fibers that are embedded into the head 14 of the toothbrush 10 and that serve as bristles 16. Alternatively, synthetic bristles, such as nylon, can be used, among other known types of materials. The bristles 16 can alternatively be Miswak extract infused nylon bristles ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date that the body (chewable wooden carrier element) of the oral product 110 of Gao et al. be infused with Miswak extract (wherein Miswak is prepared from the Salvadora persica plant) to impart antibacterial, anti-fungal, anti-viral, anti-carcinogenic, and anti-plaque properties as taught by Epstein et al.
Claim 17. Modified Gao et al. discloses that the suitable mouth-soluble polymers may include extracts (e.g., locust bean gum, guar gum, tara gum, gum tragacanth, pectin (e.g., low methoxy and amidated), … exudates (e.g., gum acacia (arabic) and shellac) (Gao [0021]).
Claims 18 and 19. Modified Gao et al. discloses that the oral product 110 can be wrapped or coated in an edible or dissolvable film (substrate layer) (Gao [0030]).
Claim 20. Modified Gao et al. discloses that the oral product 110 can be wrapped or coated in an edible or dissolvable film (substrate layer). The oral product 110 can be coated with a mouth-stable material. Exemplary coating materials include Beeswax, gelatin, acetylated monoglyceride, starch (e.g., native potato starch, high amylose starch, hydroxypropylated potato starch), Zein, Shellac, ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and combinations thereof. For example, a coating can include a combination of gelatin and methylcellulose. In some embodiments, a coating material can include a plasticizer. In some case, a coating can include a colorant, a flavorant, and/or a one or more of the additives discussed above. For example, a coating can include nicotine to provide a user with an initial nicotine burst. In some cases, the matrix of mouth-stable polymer 120 can have surfaces roughened to improve the adherence of a coating. In some cases, a coating can provide a glossy or semi-glossy appearance, a smooth surface, and/or an appealing visual aesthetic (e.g., a nice color). In some embodiments, the coating (e.g., a Beeswax, Zein, acetylated monoglyceride, and/or hydroxypropylated potato starch coating) can provide a soft mouth feel. In some embodiments, the coating (e.g., a methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, ethyl cellulose, and/or gelatin coating) can provide a hard outer coating (Gao [0030]).
Claim 21. Modified Gao et al. discloses that the oral product 110 can be embossed or stamped with a design (e.g., a logo, an image, or the like). For example, the oral product 110O can be embossed or stamped with any type of design 117 including, but not limited to, a trademark, a product name, or any type of image. The design 117 can be formed directly into the oral product, arranged along the exterior of the product 110O (thus creating a grooved surface on the exterior of the product) (Gao [0029]; Figures 2N and 2O). The oral product 110 or products 110A-O can be wrapped or coated in an edible or dissolvable film, which may be opaque, substantially transparent, or translucent (Gao [0030]).
Claims 25-28. Modified Gao et al. discloses that flavorants can be included on an exterior of the oral product 110 (Gao [0028]). A coating can include a colorant, a flavorant, and/or a one or more additives (Gao [0030]). A variety of synthetic and/or natural sweeteners can be used as additives in the oral product 110. Suitable natural sweeteners include sugars, for example, monosaccharides, disaccharides, and/or polysaccharide sugars, and/or mixtures of two or more sugars. According to some embodiments, the oral product 110 includes one or more of the following: sucrose or table sugar; honey or a mixture of low molecular weight sugars not including sucrose; glucose or grape sugar or corn sugar or dextrose; molasses; corn sweetener; corn syrup or glucose syrup; fructose or fruit sugar; lactose or milk sugar; maltose or malt sugar or maltobiose; sorghum syrup; mannitol or manna sugar; sorbitol or d-sorbite or d-sobitol; fruit juice concentrate; and/or mixtures or blends of one or more of these ingredients. The oral product 110 can also include non-nutritive sweeteners. Suitable non-nutritive sweeteners include: stevia, saccharin; Aspartame; sucralose; or acesulfame potassium (Gao [0056]).
Claim 29. Modified Gao et al. discloses that the mouth-soluble polymer matrix which makes up the body (chewable wooden carrier element) of the oral product includes one or more additives such as a plasticizer or sweetener (Gao [0008]), or minerals, vitamins, dietary supplements, nutraceuticals, energizing agents, soothing agents, amino acids, chemsthetic agents, antioxidants, botanicals, teeth whitening agents, therapeutic agents, or a combination thereof (Gao [0009]).
Allowable Subject Matter
Claims 22 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Strickland et al. in view of Epstein et al. and Gao et al. in view of Epstein et al. both disclose the chewable oral nicotine product of claim 16, but none of the references teach a layered structure having the substrate layer provided between opposed portions of the chewable wooden carrier element, or wherein the chewable wooden carrier element comprises one or more internal channels and wherein the substrate layer is provided within the one or more internal channels.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Wilson can be reached at (571)270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE A WILL/Primary Examiner, Art Unit 1747
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