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 .
Summary
Claims 24, 27-30, 32-33, 35-37, 40-46, and 49-50 are pending in this office action. Claim 34 is allowable subject-matter, but objected to due to its dependency on a rejected independent claim. Claims 1-23, 25-26, 31, 38-39, and 47-48 are cancelled. All pending claims are under examination in this application.
Priority
The current application filed on June 21, 2022 claims domestic priority to a provisional patent 63/212,854 filed on June 21, 2021.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 24, 27-30, 32-33, 35, 37, 40-44, and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Moldoveanu et al. (US2015/0068545A1) in view of Cantrell et al. (US2012/0138073A1) and Strickland et al. (US2014/0123986A1).
[The Examiner is going to introduce each reference and then combine them, as needed, in order to reject the instant claims.]
1. Moldoveanu et al.
Moldoveanu et al. is considered to be the prior art closest to the present application and teaches smokeless tobacco composition incorporating a botanical material (see title). In addition, Moldoveanu et al. disclose a smokeless tobacco product configured for insertion into the mouth of a user of the product is provided, the smokeless tobacco product including a dissolvable or meltable base composition admixed with a tobacco material and a botanical material, wherein the botanical material is present in an amount of at least about 0.1% of the total dry weight of the
smokeless tobacco product. The botanical material and the smokeless tobacco product can be characterized based on antioxidant content using the ORAC index or the FRAP
index. An exemplary product has an ORAC index value of at least about 20 (μmol TE)/g or a FRAP index value of at least about 50 (μmol/Fe2+)/g (see abstract).
2. Cantrell et al.
Cantrell et al. teaches smokeless tobacco pastille and injection molding process for forming smokeless tobacco products (see title). In addition, Cantrell et al. disclose a smokeless tobacco composition configured for insertion into the mouth of a user is provided. The smokeless tobacco composition includes a tobacco material and a polysaccharide filler component such as polydextrose. A process for preparing a smokeless tobacco composition pastille configured for insertion into the mouth of a user is also provided. The process includes mixing a tobacco material with a binder and a polysaccharide filler component to form a smokeless tobacco mixture, injection molding the smokeless tobacco mixture, and cooling the smokeless tobacco mixture to form a solidified smokeless tobacco composition pastille. The mixing step can include forming a dry blend of the tobacco, filler, and binder components, and combining the dry blend with a viscous liquid component. The injection-molded pastille can provide a dissolvable and lightly chewable product (see abstract).
3. Strickland et al.
Strickland et al. teach tobacco products (see title). Additionally, Strickland et al. disclose tobacco compositions and methods of their use and manufacture. Compositions of the invention may be based on a variety of technologies. Technologies
include films, tabs, shaped parts, gels, consumable units, insoluble matrices, and hollow shapes. In addition to tobacco, compositions may also contain flavors, colors, and other additives as described herein. Compositions may also be orally disintegrable. Exemplary compositions and methods of their manufacture are described herein (see abstract).
Combination of Moldoveanu et al., Cantrell et al., and Strickland et al.
Regarding instant claim 24, Moldoveanu et al., Cantrell et al., and Strickland et al. teach a product configured for oral use, the product comprising a plurality of granules. The necessary citations from Moldoveanu et al., Cantrell et al., and Strickland et al. which correspond to instant claim 24 are presented within Table I.
Table I
Instant Claim 24
Moldoveanu et al., Cantrell et al., and Strickland et al. Citations
a product configured for oral use, the product comprising a plurality of granules, the granules comprising:
Moldoveanu et al. disclose a base composition that could be in the form of a "pastille," which refers to a dissolvable oral product made by solidifying a liquid or gel composition, such as a composition that includes a gelling or binding agent, so that the final product is a hardened solid gel (see paragraph [0075] within Moldoveanu et al.). Furthermore, the tobacco material can be used in the smokeless tobacco compositions and products of the invention in a variety of forms. Exemplary forms include tobacco materials in shredded or particulate (e.g., a milled or ground product in a form characterized as granular or powder) form see paragraph [0049] within Moldoveanu et al.). However, as pointed out by the Applicant (see Remarks page 7 in the reply dated August 14, 2025), the granular tobacco material is not the same as a granular composition of the product.
The Strickland et al. reference meets this instant limitation. Strickland et al. disclose a dry mix comprising 25% tobacco powder, 32-34% sweetener, and 38-42% maltodextrin which is granulated with a binder solution comprising additional maltodextrin and gum arabic (see Examples 30-34 within Strickland et al.). Also, Strickland et al. disclose that compositions of the invention may also be fabricated as consumable units. These units may be packaged as edible or inedible materials. In one embodiment, the consumable unit includes tobacco (e.g., smokeless tobacco) or a tobacco composition, e.g., flakes, tabs, beads, granules, or other tobacco composition as described herein, and a wrapping, e.g., a pouch. The wrapping, in one embodiment may act as an adhesive to hold the composition together, e.g., to hold a plurality of tabs, beads, flakes, etc. together (see paragraph [0260] within Strickland et al.). Thus, implying a plurality of granules.
one or more fillers in an amount in a range from about 25% to about 40% by weight, based on the total dry weight of the granules, the one or more fillers comprising microcrystalline cellulose, a binder; at least one sugar alcohol in an amount in a range from about 5% to about 30% by weight, based on the total dry weight of the granules; a milled non-tobacco botanical material; from about 0.1% to about 10% nicotine by weight calculated as the free base and based on the total dry weight of the granules; and a flavorant; wherein the product is substantially free of tobacco material, excluding any nicotine component present.
Moldoveanu et al. disclose that the final product can contain microcrystalline cellulose (see paragraphs [0095], [0100], and [0160] within Moldoveanu et al.); binders (see claim 18 within Moldoveanu et al.).; a milled non-tobacco botanical material (see claim 19 and paragraph [0081] within Moldoveanu et al.); tobacco-derived nicotine (see claim 15 within Moldoveanu et al.) or pharmaceutical grade nicotine (see paragraph [0057] within Moldoveanu et al.), from 0.16-1.52 weight percent (see Examples 12, 15, 17, and 27 within Moldoveanu et al.); a flavorant (see claim 18 within Moldoveanu et al.).
Furthermore, Moldoveanu et al. disclose that the sugar alcohol can be about 20 wt% (see claim 33).
Additionally, Moldoveanu et al. does not disclose an upper limit of the botanical of “at least about 50% on a dry weight basis of the product.” (see paragraph [0075] within Moldoveanu et al.) indicating the product can be free of tobacco material. Moreover, the discussion within Cantrell et al. below for a replacement of a tobacco material with a botanical, supports the product being free of tobacco material.
Cantrell et al. disclose (see Example 10 within Cantrell et al.) a product configured for oral use comprising a plurality of granules including a sugar alcohol (maltitol; paragraph [0091] within Cantrell et al.), corn syrup, glycerin and a flavoring agent (liquid mixture), particulate tobacco (that can be seen as the claimed filler), gum and polysaccharides, e.g. maltodextrin (that can be seen as the claimed binder that in the presence of the liquid ingredients and mixed with them can be considered as liquid binder). The granulated composition can be compressed in a mold and yield a formed tobacco pellet; furthermore, Cantrell et al. disclose according to some aspects, the tobacco particulate component of the pastille composition may be replaced with other suitable botanical particulate components such as, for example, tea particulates, coffee particulates, herbal particulates,
spice particulates and/or combinations thereof. The
particulates may be typically provided in a powder form,
which may be extracted from an appropriate botanical source (see paragraph [0051] within Cantrell et al.). In addition, Cantrell et al. disclose that the smokeless tobacco compositions of the disclosure
may typically include at least one filler ingredient in
addition to the polysaccharide filler component. Such components of the composition often fulfill multiple functions, such as enhancing certain organoleptic properties such as texture and mouthfeel, enhancing cohesiveness or compressibility of the product, and the like. When present, a representative amount of additional filler, whether an organic and/or inorganic filler…the amount of additional filler within the composition will not exceed about 50 percent, and frequently will not exceed about 40 percent of the total dry weight of the composition. In one embodiment, a sugar alcohol such as sorbitol is provided as an additional filler (see paragraph [0040] within Cantrell et al.). Moreover, Cantrell et al. disclose disintegration or compressibility aids such as microcrystalline cellulose…(see paragraph [0033] within Cantrell et al.).
Strickland et al. disclose the use of the filler microcrystalline cellulose (see paragraph [0050]
Within Strickland et al.); exemplary ingredients within Table 41.1 illustrate 1-50% of a filler/disintegrant or a specific example with MCC at 30% (see Table 41.1 within Strickland et al.); also, Strickland et al. disclose (see Example 30 within Strickland et al.) a tobacco tab. Tobacco powder (containing nicotine and further active ingredients as well as flavor) was mixed with mannitol (sugar alcohol; see claim 38) as sweetener, maltodextrin (seen as the claimed filler) and emulsifier (see paragraph [0157]; Table 30.1 within Strickland et al.); a binding solution comprising water, maltodextrin, emulsifier, sucralose as sweetener, peppermint and spearmint flavors and Na2CO3 was prepared (see paragraph [0156]; Table 30.2 within Strickland et al.) and was applied to the dry ingredient blend to form a final granulation (see paragraphs [0158-0160] within Strickland et al.). The granulated material was sized and mixed with magnesium stearate used as lubricant (see paragraph [0161] within Strickland et al.). The granulated material plus lubricant was pressed to from the tab (see paragraph [0162] within Strickland et al.); additionally, Strickland et al. disclose generally that any composition can further include a coating, said coating comprising a flavor, sweetener, color, or flavor masking agent (see paragraph [0014] within Strickland et al.). In addition, the total amount of exemplary sugar components can be between 1-80% (see Table 23.1 within Strickland et al.).
[Within each of the following instant claims the combination of the Moldoveanu et al., Cantrell et al., and Strickland et al. references teach all the elements of instant claim 24.]
Regarding instant claim 27, Moldoveanu et al., Cantrell et al., and Strickland et al. teach a granulated particle in the range of 60 mm to 500 mm. Cantrell et al. disclose an average particle size of less than 100 microns (see paragraph [0004] within Cantrell et al.)
Regarding instant claim 28, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the granules further comprise calcium carbonate, maltodextrin, and rice starch. Strickland et al. disclose the use of such as starch, microcrystalline cellulose, wood pulp, disc refined wood pulp, insoluble fiber, soluble fiber, calcium carbonate, dicalcium phosphate, calcium sulfate, a clay, and the like or mixtures thereof (see paragraph [0009] within Strickland et al.). Furthermore, Strickland et al. disclose the use of maltodextrin (see paragraph [0151] within Strickland et al.). In addition, Strickland et al. does not disclose rice starch, but a skilled artisan (POSITA; person having ordinary skill in the art) could select rice starch under routine experimental conditions from the broad genus of “starch” disclosed within Strickland et al. (see above). Finally, Strickland et al. disclose the use of mixtures of all three components (see paragraph [0009] within Strickland et al.).
Regarding instant claims 29, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the use of a binder. The Markush Group presented within instant claim 29 is an alternative embodiment and the Examiner is focusing on one specific member (polyvinylpyrrolidone) to reject the claim. The Markush Group of instant claims 30 and 46 are rejected in a similar manner. Cantrell et al. disclose the use of the binder povidone, which is equivalent to polyvinylpyrrolidone (see paragraph [0033] within Cantrell et al.; also see PTO-892 NPL U).
Regarding instant claim 30, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the use of the sugar alcohols. Strickland et al. disclose the use of the sugar alcohol mannitol (see claim 38 within Strickland et al.).
Regarding instant claim 32, Moldoveanu et al., Cantrell et al., and Strickland et al. teach a milled non-tobacco botanical material particle size in the range of 0.05 mm to 1 mm. Moldoveanu et al. teach the milled non-tobacco botanical material particle size of less than about 50 micron (0.05 mm; see paragraph [0184] within Moldoveanu et al.).
Regarding instant claim 33, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the use of milled non-tobacco botanical materials. Strickland et al. disclose the use of peppermint (see paragraph [0004] within Strickland et al.). The use of peppermint within Strickland et al. is not as a substitute for a tobacco product, but as a flavoring agent. However, a skilled artisan (POSITA) could under routine experimental conditions substitute the botanical for the tobacco material using the teachings of Cantrell et al.
Regarding instant claim 35, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the use of the milled non-tobacco botanical comprising ginseng. Moldoveanu et al. disclose the use of the milled non-tobacco botanical ginseng (see paragraph [0027] within Moldoveanu et al.).
Regarding instant claim 37, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the use of the necessary binder and sugar alcohol. Cantrell et al. disclose the use of the binder povidone, which is equivalent to polyvinylpyrrolidone (see paragraph [0033] within Cantrell et al.; also see PTO-892 NPL U). Strickland et al. disclose the use of the sugar alcohol mannitol (see claim 38 within Strickland et al.).
Regarding instant claim 40, Moldoveanu et al., Cantrell et al., and Strickland et al. teach use of the additional components. Strickland et al. disclose the use of sweeteners (see claims 35-36 within Strickland et al.).
Regarding instant claim 41, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the use of a compressed pellet or tablet having an exterior surface and further comprising a coating on said exterior surface. Strickland et al. disclose the use of a compressed pellet (see paragraph [0148] within Strickland et al.), and a coating (see paragraph [0014] within Strickland et al.) for the exterior surface.
Regarding instant claim 42, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the use of cellulosic material for the coating. Strickland et al. disclose the use of cellulosic materials within a coating (see Table 68.1 within Strickland et al.)
Regarding instant claim 43, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the use of emetic-coatings. Strickland et al. disclose the use of shellac (see paragraph [0050] within Strickland et al.). and wax (see paragraph [0277] within Strickland et al.).
Regarding instant claim 44, Moldoveanu et al., Cantrell et al., and Strickland et al. teach the use of a flavorant within the coating. Strickland et al. disclose using a flavorant within the coating (see paragraph [0014] within Strickland et al.).
[The Examiner has interpreted instant claims 49 and 50 to encompass the ingredient being “encapsulated” by the composition.]
Regarding instant claim 49, Moldoveanu et al., Cantrell et al., and Strickland et al. teach wherein at least a portion of the nicotine is encapsulated in a dry, granular form. Moldoveanu et al. disclose that dry weight percent refers to weight of the basis of dry ingredients (see paragraph [0024] within Moldoveanu et al.). In addition, Moldoveanu et al. disclose that the tobacco material can be used in the smokeless tobacco compositions and products of the invention in a variety of forms. Exemplary forms include tobacco materials in shredded or particulate (e.g., a milled or ground product in a form characterized as granular or powder) form (see paragraph [0049] within Moldoveanu et al.). Reference to "tobacco extract" as explained above
encompasses extracts highly purified with respect to one or a few components thereof. For example, highly purified tobacco-derived nicotine (e.g., pharmaceutical grade nicotine having a purity of greater than 98% or greater than 99%) or a derivative thereof can be used in the present invention (see paragraph [0057] within Moldoveanu et al.).
Therefore, the dry nicotine product is mixed with the other additives to obtain the desired formulation (see Examples within Moldoveanu et al.) which is encapsulated within the composition. A skilled artisan (POSITA) would work with the dry ingredient, nicotine, in granular form.
Regarding instant claim 50, Moldoveanu et al., Cantrell et al., and Strickland et al. teach wherein at least a portion of the flavorant is encapsulated in a dry, granular form. Similar to instant claim 49, the flavorant is measured as a dry ingredient in granulated form (see paragraph [0094] within Moldoveanu et al.). Thus, upon mixing with the other additives the desired formulation will be obtained (see Examples within Moldoveanu et al.) encapsulated within the composition.
Analogous Art
The Moldoveanu et al., Cantrell et al., and Strickland et al. references are directed to the same field of endeavor as the instant claims, that is, a product configured for oral use comprising a filler, a sugar alcohol, a milled non-tobacco botanical material, and a flavorant.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the smokeless tobacco product disclosed by Moldoveanu et al., using the teachings of both Cantrell et al. and Strickland et al. to incorporate the necessary claim limitations. Starting with Moldoveanu et al., the skilled person only had to try the necessary claim limitations disclosed by both Cantrell et al. and Strickland et al. The combination of Moldoveanu et al., Cantrell et al., and Strickland et al. would allow one to arrive at the present application without employing inventive skill. This combination of the smokeless tobacco product taught by Moldoveanu et al. along with the use the necessary claim limitations taught by both Cantrell et al. and Strickland et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the smokeless tobacco product disclosed by Moldoveanu et al. with the use of the necessary claim limitations taught by both Cantrell et al. and Strickland et al. This combined modification would have led to an enhanced smokeless tobacco product that would be beneficial for consumers.
Claims 24 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Moldoveanu et al., Cantrell et al., and Strickland et al., as applied to claims 24, 27-30, 32-33, 35, 37, 40-44, and 49-50 above, and further in view of Farokhi et al. (WO2020/028991A1).
The teachings of the references are outlined above. They fail to teach the claim limitation where the milled non-tobacco botanical material is bleached.
However, Farokhi et al. teach this limitation.
Farokhi et al. teach cold extraction method for cannabinoids and terpenes from cannabis by polyunsaturated lipid-based solvents (see title). In addition, Farokhi et al. disclose methods for producing botanical extracts comprising cannabinoids and terpenes using cold extraction with highly polyunsaturated lipid solvents. These methods allow for the extraction of cannabinoids and terpenes while leaving behind impurities that are commonly found in organic solvent extraction methods (see abstract).
Combination of Moldoveanu et al., Cantrell et al., Strickland et al., and Farokhi et al.
Regarding instant claim 36, Moldoveanu et al., Cantrell et al., Strickland et al., and Farokhi et al. teach a milled non-tobacco botanical material that is bleached. Cantrell et al. and Strickland et al. teach all the elements of instant claim 24. Farokhi et al. teach a milled non-tobacco material that is bleached (see paragraph [00017] within Farokhi et al.).
Analogous Art
The Examiner concedes that the Farokhi et al. reference does not teach all the elements of instant claim 24. However, the Farokhi et al. reference does teach the use of a bleached non-tobacco botanical material. This makes the citation relevant to the present application.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the smokeless tobacco product disclosed by Moldoveanu et al., Cantrell et al., and Strickland et al. using the teachings of Farokhi et al. to incorporate the bleached non-tobacco botanical material. Starting with Moldoveanu et al., Cantrell et al., and Strickland et al. the skilled person only had to try the necessary claim limitation to incorporate the bleached non-tobacco botanical material disclosed by Farokhi et al. The combination of Moldoveanu et al., Cantrell et al., Strickland et al., and Farokhi et al. would allow one to arrive at the present application without employing inventive skill. This combination of the smokeless tobacco product taught by Moldoveanu et al., Cantrell et al., and Strickland et al. along with the use the necessary claim limitation to incorporate the bleached non-tobacco botanical material disclosed by Farokhi et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the smokeless tobacco product disclosed by Moldoveanu et al., Cantrell et al., and Strickland et al. with the use of the necessary claim limitation to incorporate the bleached non-tobacco botanical material disclosed by Farokhi et al. This combined modification would have led to an enhanced smokeless tobacco product that would be beneficial for consumers.
Claims 24, 41, 45 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Moldoveanu et al., Cantrell et al., and Strickland et al., as applied to claims 24, 27-30, 32-33, 35, 37, 40-44, and 49-50 above, and further in view of Chang et al. (WO2004/091483).
The teachings of the references are outlined above. They fail to teach the claim limitation where compressed pellet or tablet comprises a flow aid. Furthermore, they fail to teach specific flow aids.
However, Chang et al. teach these limitations.
Chang et al. once daily formulations of tetracyclines (see title). Furthermore, Chang et al. disclose once-daily formulations containing tetracyclines, especially doxycycline. Such formulations are useful, for instance, for the treatment of collagenase destructive enzyme-dependent diseases, such as periodontal disease and acne, and acute and chronic inflammatory disease states, such as rosacea and arthritis (see abstract).
Combination of Moldoveanu et al., Cantrell et al., Strickland et al., and Chang et al.
Regarding instant claim 45, Moldoveanu et al., Cantrell et al., Strickland et al., and Chang et al. teach a compressed pellet or tablet that comprises a flow aid. Cantrell et al. and Strickland et al. teach all the elements of instant claim 24. Chang et al. disclose the use of a flow aid (see paragraph [047] within Chang et al.).
Regarding instant claim 46, Moldoveanu et al., Cantrell et al., Strickland et al., and Chang et al. teach the use of silica as a flow aid (see paragraph [047] within Chang et al.). Cantrell et al. and Strickland et al. teach all the elements of instant claim 24.
Analogous Art
The Examiner concedes that the Chang et al. reference does not teach all the elements of instant claim 24. However, the Chang et al. reference does teach the use of a flow aid. This makes the citation relevant to the present application.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the smokeless tobacco product disclosed by Moldoveanu et al., Cantrell et al., and Strickland et al. using the teachings of Chang et al. to incorporate the flow aid. Starting with Moldoveanu et al., Cantrell et al., and Strickland et al. the skilled person only had to try the necessary claim limitation to incorporate the flow aid disclosed by Chang et al. The combination of Moldoveanu et al., Cantrell et al., Strickland et al., and Chang et al. would allow one to arrive at the present application without employing inventive skill. This combination of the smokeless tobacco product taught by Moldoveanu et al., Cantrell et al., and Strickland et al. along with the use the necessary flow aid disclosed by Chang et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the smokeless tobacco product disclosed by Moldoveanu et al., Cantrell et al., and Strickland et al. with the use of the necessary flow aid disclosed by Chang et al. This combined modification would have led to an enhanced smokeless tobacco product that would be beneficial for consumers.
Allowable Subject Matter
Claims 34 is 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.
Response to Arguments
Applicant's arguments filed August 14, 2025 have been fully considered but they are not persuasive.
The instant claim amendments did not necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that the Moldoveanu et al. reference is directed to pastille products (hardened, solid gel materials) and does not produce granular materials.
Examiner’s Rebuttal: The Examiner respectfully disagrees. Moldoveanu et al. disclose a base composition that could be in the form of a "pastille," which refers to a dissolvable oral product made by solidifying a liquid or gel composition, such as a composition that includes a gelling or binding agent, so that the final product is a hardened solid gel (see paragraph [0075] within Moldoveanu et al.). Furthermore, the tobacco material can be used in the smokeless tobacco compositions and products of the invention in a variety of forms. Exemplary forms include tobacco materials in shredded or particulate (e.g., a milled or ground product in a form characterized as granular or powder) form see paragraph [0049] within Moldoveanu et al.). However, as pointed out by the Applicant (see Remarks page 7 in the reply dated August 14, 2025), the granular tobacco material is not the same as a granular composition.
Since this is a 35 U.S.C. §103 rejection, combination with the Strickland et al. reference supports the particulate product form for the overall composition. Strickland et al. disclose a dry mix comprising 25% tobacco powder, 32-34% sweetener, and 38-42% maltodextrin which is granulated with a binder solution comprising additional maltodextrin and gum arabic (see Examples 30-34 within Strickland et al.). Also, Strickland et al. disclose that compositions of the invention may also be fabricated as consumable units. These units may be packaged as edible or inedible materials. In one embodiment, the consumable unit includes tobacco (e.g., smokeless tobacco) or a tobacco composition, e.g., flakes, tabs, beads, granules, or other tobacco composition as described herein, and a wrapping, e.g., a pouch. The wrapping, in one embodiment may act as an adhesive to hold the composition together, e.g., to hold a plurality of tabs, beads, flakes, etc. together (see paragraph [0260] within Strickland et al.). Thus, implying a plurality of granules.
Applicant Argument: The Applicant argues that the motivation to combine Moldoveanu et al., Cantrell et al., and Strickland et al. is not thoroughly described.
Examiner’s Rebuttal: The Moldoveanu et al., Cantrell et al., and Strickland et al. references are all directed toward oral smokeless tobacco products. Furthermore, there is a significant overlap with many of the instant claim 24 limitations (see Table I). Therefore, all three of these references are analogous art, and would be consulted by a skilled artisan (POSITA).
Applicant Argument: The Applicant argues that amended instant claim 24 is not taught by a combination of the Moldoveanu et al., Cantrell et al., and Strickland et al. references.
Examiner’s Rebuttal: The Examiner respectfully disagrees. Please see a full citation list within instant claim 24 (Table I) for all the relevant rejection text.
Applicant Argument: The Applicant argues that there is no clear motivation to modify the Moldoveanu et al., Cantrell et al., Strickland et al. references with Farokhi et al.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The Farokhi et al. reference discloses the bleaching of a milled non-tobacco botanical material that is not described in the other citations of record. The motivation to combine Moldoveanu et al., Cantrell et al., and Strickland et al. is established above. The Cantrell et al. reference links the replacement of a tobacco component with a botanical (see paragraph [0051] within Cantrell et al.). The Farohki et al. reference expands on the included botanicals to encompass a bleached product. Therefore, the Farokhi et al. reference is analogous art and a skilled artisan (POSITA) would be motivated to use the Farokhi et al. citation.
Applicant Argument: The Applicant argues that there is no clear motivation to modify the Moldoveanu et al., Cantrell et al., Strickland et al. references with Chang et al.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The Chang et al. reference discloses the use of flow aids in the oral product that is not described in the other citations of record. The motivation to combine Moldoveanu et al., Cantrell et al., and Strickland et al. is established above. The three references link together the oral smokeless tobacco element of the instant invention. Chang et al. expands on the oral delivery as disclosed by Moldoveanu et al., Cantrell et al., and Strickland et al. to include the use of flow aids. Therefore, the Chang et al. reference is analogous art and a skilled artisan (POSITA) would be motivated to use the Chang et al. citation.
Examiner’s Comment: It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Thus, the 35 U.S.C. § 103 rejection for instant claims 24, 27-30, 32-33, 35-37, 40-46, and 49-50 is maintained.
Conclusion
Claim 34 is objected to.
Claims 24, 27-30, 32-33, 35-37, 40-46, and 49-50 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN W LIPPERT III whose telephone number is (571)270-0862. The examiner can normally be reached Monday - Thursday 9:00 AM - 5:00 PM.
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, Robert A Wax can be reached on 571-272-0623. 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.
/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615