DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 02/10/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 01/09/2026 (Response After Final Action), is acknowledged.
Claims 1-2, 4-19, 21-22 are pending in this action. Claims 3, 20 has been cancelled previously. Claims 1-2, 8, 21-22 have been amended. Claims 1-2, 4-19, 21-22 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a continuation of U.S. Patent Application No. 14/505,814, filed October 3, 2014, and now issued as U.S. Patent No. 11,771,127, which claims benefit of provisional U.S. Application No. 61/886,355, filed October 03, 2013.
Terminal Disclaimer
The terminal disclaimer, filed 10/08/2024, disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of the prior Patent No. 11,771,127, has been reviewed and are accepted. The terminal disclaimers have been recorded. The nonstatutory double patenting rejection over US 11,771,127 has been withdrawn.
Claim Objections
Claims 2, 5, 7-8, 11, 14-15, 17, 21 are objected to because of the following informalities:
Claim 2 recites the limitation ”in a range of greater than or equal to 20 wt% to less or equal to 70 wt%” that needs to be corrected to ”in the range of from 20 wt% to 70 wt%” for clarity. Similar is applied to claims 8, 11, 14-15, 17, 21.
In response to applicant’s argument that the claim 1 does not recited “a range”, it is noted that claim 2 recites/defines/refers to a specific range, identified by the set of values and indicates that values fall withing that range (i.e., from 20 wt% to 70 wt%). Therefore, the correction is required.
Claim 5 comprises the typographic error ”in an amount from” that needs to be corrected to ” in an amount of from”. Similar is applied to claim 7.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly amended claim 21 (dependent on independent claim 1) discloses the tablet comprising 30-40 wt% of water-soluble fibers, 30-40 wt% of sugar alcohol, 0.5-7 wt% of water, wherein the solid solution has a glass transition temperature of from -50 oC to 40oC, wherein independent claim 1 identifies said solid solution ONLY by the presence of water-soluble fibers, sugar alcohols and a nicotine.
The written description requirement for a claimed genus (here as chewable tablets comprising a solid solution) may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. MPEP §2163.
In the present case, the instant claims and/or specification do not teach or suggest how to control the tablet composition to provide said property of the solid solution included in said tablet. To this point, it is noted that one skilled in the art would understand that a glass transition temperature of a multicomponent multiphase mixture/system depends on compounds included in said mixture/system (see Read. Glass Transitions In Multicomponent Systems. M. Pineri and A. Eisenberg (eds.), Structure and Properties of Ionomers, 255-268. 1987 by D. Reidel Publishing Company). The instant specification provides no disclosure beyond the statement, that would have been amenable for use in the present invention, nor does it teach the specific structure, physical properties or a method of identification of compounds that can be included in claimed compositions for providing said claimed property. Furthermore, it has been held that a wish or plan for obtaining the chemical invention as claimed does not provide adequate written description of a chemical invention. Rather, a precise definition, such as by structure, formula, chemical name or physical properties, is required. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004).
While it is recognized that adequate written description of a limitation is not required to be stated in haec verba in the specification or claims as originally filed, adequate written support for claim limitations must arise from either an explicit or implicit suggestion by the disclosure to show that such a concept as claimed was actually in possession of applicant at the time of the invention. For the reasons provided supra, applicant has failed to provide the necessary teachings, by describing the claimed invention with all of its limitations using such descriptive means that fully set forth the claimed invention, in such a way as to reasonably convey to one skilled in the relevant art that applicant had possession of the entire genus of drugs.
In response to applicant’s argument regarding the recited references, it is noted that it is well known in the field that properties of multicomponent systems (i.e., compositions/tablets) depend on compounds included as well as on concentrations and distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. The examiner maintains the positions that claiming a result (i.e., a solid solution comprising oil domains) without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Furthermore, it is noted that “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Clarification is required.
Claim Rejections - 35 USC § 112(b)
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 1-2, 4-19, 21-22 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 pre-AIA the applicant regards as the invention.
Newly amended 1 recites the limitation “the plurality of oil domains contacting the solid solution such that the plurality of oil domains are exposed to the solid solution” that is unclear and indefinite. In the present case, it is noted that neither the claims nor the instant specification provides a definition for the terms “contacting”, “exposed”. To this point, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Therefore, the metes and bounds of the claim are not reasonably clear, and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
As stated previously, claim 4 recites the limitation “the water-soluble fibers include maltodextrin, …, cellulose, or any combination thereof” that is not reasonably clear. Does this limitation disclose the water-soluble fibers as a mixture of compounds (i.e., include/comprise), OR at least one of the recited compounds? Applicant is advised to use the proper Markush group language, i.e., “selected from the group consisting of A, B, … and C” to clarify the scope of the claim. Similar is applied to claims 6, 10, 12-14, 16, 18, 19. Clarification is required.
In response to the applicant’s argument that the term “or any combination thereof” clarifies the scope of the claim, as stated previously, said claim discloses fibers including/comprising recited compounds. Therefore, it is not clear if said claim discloses a mixture comprising claimed compounds (i.e., including/comprising), or at least one of them. Clarification is required.
As stated previously, the instant claims and/or the specification do not clearly define the structure of the claimed product (i.e., chewable dissolvable nicotine tablets). For instance, the same compounds, i.e., sorbitol, mannitol, are disclosed as sugar alcohols to be used in the claimed tablet in a solid solution (claim 6; Specification Para. 0012), and as fillers to be used in tablets (claims 15, 16; Specification Para. 0071), or as sweeteners (Para. 0064), and/or coatings (Para. 0042). Therefore, the examiner maintains the position that the structure of the claimed product is not clearly delineated. In the present case, it is unclear what compounds should be used as “sugar alcohols” in a solid solution, and/or as “a filler” in the claimed tablets. Similar is applied to claims 10 and 18 that disclose oil as “oil domains” (claim 10) and as a plasticizer (claim 18). Clarification is required.
Newly amended claim 8 (dependent on claim 1) recites the limitation “weight percent of the plurality of oil domains within the tablets” that is not reasonably clear. To this point, it is noted that independent claim 1 discloses tablets comprising a solid solution comprising a plurality of oil domains. The instant specification teaches that said tablets may also include oils as plasticizers (Para. 0018, 0076), and/or as flavorants (Para. 0017, 0066). In the present case, it is unclear if claim 8 discloses the amounts of the oil domains dispersed in the solid solution, OR the total amount of oils that are presented in the claimed tablets. Similar is applied to claim 5 regarding the limitation “the tablet includes sugar alcohols”. Clarification is required.
Claim 9 (dependent on claim 1) discloses a limitation “wherein an oil in the plurality of oil domains has a melting point of less than 37 oC” that is not reasonably clear. In the present case, it is unclear if recited plurality of oil domains consists of a single oil having recited melting point, OR it is a combination of oils and only one oil has said melting point. Clarification is required.
Newly amended claim 21 (dependent on claim 1) discloses tablets comprising “a sugar alcohol content” that is not reasonably clear. Does this limitation disclose the amount of the sugar alcohols in the solid solution, OR the amount of sugar alcohols that can be present in the claimed tablet (see above). Clarification is required.
Claims 2, 7, 11, 17 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Claim Rejections - 35 USC § 103-MAINTAINED
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 1-2, 4-19, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al., US 2013/0118512 (cited in IDS; hereinafter referred to as Jackson); in view of Duggins et al., US 2013/0206150 (cited in IDS; hereinafter referred to as Duggins), and Gao et al., US 2010/0291245 (cited in IDS; hereinafter referred to as Gao).
Jackson teaches dissolvable-chewable tobacco tablets (Para. 0009, 0067-0070) that include aqueous-soluble components interacting with moisture in the oral cavity and entering into solution, thereby causing gradual consumption of the product, wherein said tablets are capable of lasting in the user's mouth for a given period of time until they completely dissolve, e.g., 1-60 minutes, and/or can release the active component in less than 2 minutes, or even less than 20 sec (Para. 0068).
Jackson teaches that said tobacco products can exhibit a different texture, have a different mouth-feel, exhibit a different chew characteristic, or have a different dissolution quality in the mouth (Para. 0004; Examples). The preparation methods include combining tobacco material with carrier material (e.g., starch) and other additives for controlling the texture properties and dissolution rate (Para. 0007-0008, 0012). Jackson specifically teaches that said tobacco products can be in solid form/tablet (Para. 0009-0010, 0067; Examples 3-6 as applied to claim 1).
Jackson teaches that one can use various forms of tobacco as well as various types of tobaccos, as well as nicotine comprising species, e.g., Nicotiana species obtained by genetic-modification (Para. 0013-0023 as applied to claim 1). Jackson teaches that tobacco materials can be in form of particulate, i.e., shredded, ground, granulated, powdered, etc. (Para. 0020-0022), e.g., in form of particles having a size of 50 microns or less (Para. 0020), and further teaches that said dissolvable-chewable tobacco tablets may include:
(i) 0.5-50 wt% of soluble fibers (Para. 0038), e.g., comprising starch, maltodextrin, cellulose, etc. (Para. 0008, 0042; Table 1 as applied to claims 1-2, 4), i.e., water-soluble fibers (see instant claim 4);
(ii) 5-40 wt% of sweetener (Para. 0008, 0041), e.g., sugar alcohols such as mannitol, sorbitol, xylitol, erythritol, maltitol syrup, hydrogenated starch hydrolysates, and combinations thereof (Para. 0008, 0039-0041 as applied to claims 1, 5-6);
(iii) 10-60 wt% of tobacco material/nicotine comprising species (Para. 0024, 0026 as applied to claims 1, 7);
(iv) oils, e.g., 2-4% of partially hydrogenated soybean oil and/or olive oil, sesame oil, sunflower oil, mustard oil, etc. (Para. 0008, 0050 and references cited therein; Examples 3-5 as applied to claims 1, 8, 10);
(v) antioxidants (Para. 0050 as applied to claim 11);
(vi) polysaccharides (Para.0048 as applied to claim 13);
(vii) 0.5-10 wt% of flavoring ingredients, cocoa, licorice, coffee, vanilla, mint, cardamon, nutmeg, cinnamon, etc. (Para. 0019, 0044 as applied to claim 14);
(viii) 1-30 wt% of a filler, e.g., calcium carbonate, sorbitol, mannitol, etc. (Para. 0008, 0042-0043 as applied to claims 15, 16);
(ix) ≥0.5 wt% of a plasticizer/humectant, e.g., glycerin, propylene glycol (Para. 0019, 0046 as applied to claims 17, 18).
Jackson teaches that said tablets can be coated, e.g., with methylcellulose, hydroxypropyl methylcellulose, carboxy methylcellulose (Para. 0071 as applied to claim 19). Jackson also teaches that said tablets may have a moisture content of 5-20 wt% that may vary depending upon the specific form of the tobacco product (Para. 0065), and said tobacco products can be in any suitable predetermined shape or form (Para. 0070); may be a part of a sheet structure (Para. 0058) configured for subdivision into individual tablets (Para. 0061).
Jackson teaches a process of preparing said tobacco product comprising (i) providing a slurry comprising said components (including pre-melted oils/fats; Examples); and (ii) heating the slurry to give a mixture with desired solids content (Para. 0055-0056). Jackson teaches that said compositions should be held at the elevated temperature for a predetermined duration of time so as to allow said compositions to cure and solidify, while driving the moisture content of the compositions to a desired final moisture level; and further teaches that curing refers to the solidification process in which moisture loss occurs, the viscosity of the composition is raised, and chemical and physical changes begin to occur, e.g., crystallization, cross-linking, gelling, film forming, etc. (Para. 0060).
Though Jackson teaches the use of nicotine comprising species, Jackson does not specifically teach the use of nicotine and also does not teach tablets comprising oil domains comprising nicotine (claim 1).
Duggins teaches a smokeless tobacco product providing controlled release of active agents, e.g., nicotine (Abstract; Para. 0028, 0029, 0082) that is dissolvable and chewable (Claims 1-3; Para. 0005) and may include: (a) up to 20% of maltodextrin (Para. 0040); (b) up to 50% of mannitol and sorbitol (Para. 0061-0062); (c) 10-15% of soybean oil, palm oil, palm kernel oil, and/or mixture thereof (Para. 0071-0072); (d) propylene glycol (here as a humectant; Para. 0033); (e) antioxidants (Para. 0051); (f) a colorant, e.g., titanium dioxide (Para. 0051); and (g) nicotine as an active agent (Para. 0044, 0082). Duggins teaches the use of non-hydroscopic sugar alcohols capable of forming a glassy matrix (Para. 0069), and also teaches that said tobacco products can be provided in any suitable predetermined shape or form (Para. 0020, 0083, 0162); and the tablet may be a part of a sheet structure (Para. 0164, 0170).
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Gao teaches soft, chewable and orally dissolvable products (element 10 shown on the right) comprising biopolymer-sugar based matrix and optional additives (element 14), and flavor beads (elements 12; Figs 1-3; Abstract). To this point, Gao teaches that said products may include: (i) 1-35 wt % of such biopolymers as polysaccharides, cellulose, etc. and/or mixture thereof (Claim 12, 24; Para. 0011, 0012); (ii) 2-60 wt% of such sugar alcohols as sorbitol, xylitol, lactitol, maltitol, etc. and/or mixture thereof in sugar-based matrix (Claims 11, 24; Para. 0013-0015); (iii) 1-5 wt% of flavor beads that include encapsulated flavorants, e.g., olive oil, sesame oil, sunflower oil, bergamot oil, lemon oil, etc. and/or other additives or botanicals, and wherein said beads are randomly or uniformly distributed throughout the based matrix (Claims 18; Para. 0070-0080); (iv) tobacco powder (i.e., various forms of tobacco and/or various types of tobaccos) that can be encapsulated into flavor beads (Para. 0076) or dispersed through the matrix as powder particles having at list one liners dimension of less than 297 micron (Claims 1-4; Para. 0007, 0032-0034); (v) up to 10 wt% of other additives, e.g., antioxidants, colorants, etc. (Para. 0016); (vi) softener and/or plasticizer, such as glycerin can be used to add additional softness to the biopolymer-sugar based matrix (Para. 0009).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use nicotine dispersed through the matrix and/or encapsulated into flavor beads as taught by Duggins and Gao preparing compositions/tablets taught by Jackson, because it is prima facie obvious to combine compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a new composition to be used for the very same purpose. MPEP 2144.06. One would do so with expectation of beneficial results, because the cited prior art teaches the compounds (e.g., nicotine) that modifying a delivery profile during the use (Duggins; Para. 0004), and/or also teaches that using flavor beads allow controlling flavor delivery, providing additional texture and flavor to the chewable and orally dissolvable/disintegrable product.
Regarding the physical properties, i.e., “melting transition point”, “glass transition temperature” as instantly claimed (claims 9, 21, 22), it is noted that given that the cited prior art teaches the use of chemical constituents/compounds (i.e., maltodextrin fibers, sugar alcohols, oils) as instantly claimed, it is expected that said constituents/compounds have the physical properties as instantly claimed. Further, it is noted that the prior art teaches formulations/tablets that are substantially the same as the tablets recited by the instant claims. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties (e.g., stability, rate release, disintegration time, etc.) and effects would also be provided.
With regards to the concentrations as instantly claimed, it is noted that differences in experimental parameters, such as concentration of compounds in a formulation, will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. To this point, it is noted that cited prior art teaches that the relative amounts of various components within the product may vary so as to provide the desired sensory and performance characteristics to the tobacco/nicotine product, e.g., crisp/hard/soft/elastic chew tobacco product (e.g., Jackson - Para. 0010; 0052; Examples 1-6) identifying thereby said characteristics as result-effective variables. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 6,264,981 (cited in IDS) - teaches oral dosage forms comprising solid solution, wherein said dosage forms include nicotine; cellulose, starch and derivative thereof; lactitol, sorbitol, mannitol, xylitol, maltodextrin, propylene glycol; and other additives, e.g., colorants, sweetening agents, antioxidants, plasticizers.
US 2007/0196396 (cited in IDS) – teaches controlled release dosage forms/tablets that may include a solid solution of the active ingredient and solubilizer to increase the solubility of the active ingredient, wherein said dosage forms may include cellulose, starch and/or derivatives thereof, hydrogenated oils, sorbitol, propylene glycol, maltodextrin, and specifically teaches the use of cellulose fibers as swelling enhancer.
US 2005/0244521 (cited in IDS) – teaches orally disintegrable smokeless tobacco compositions/tabs that may contain flavors, colors, and other additives; and include oils, sorbitol and/or mannitol as a sweetener, propylene glycol as a plasticizer and soluble fibers/maltodextrin as a filler.
US 2005/0002996 (cited in IDS) – teaches dosage forms/tablets may include oils, sorbitol, mannitol, starch, cellulose and derivatives thereof, propylene glycol, antioxidants, etc., and specifically teaches the use of 50-99.9 wt% of cellulose fibers that can be hydrophilic or hydrophobic, have a median particle size of 3-30 micron to stabilize and release the active agent.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4-19, 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-6 of U.S. Patent No. 11,779,045; (2) claims 1-3, 5-13, 16 of U.S. Patent No. 12,274,276; (3) claims 1-2, 5-6 of U.S. Patent No. 11,771,127.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because:
The prior patent US 11,779,045 claims: A dissolvable-chewable tablets comprising: (i) soluble fibers; (ii) sugar alcohols; (iii) a plurality of oil domains dispersed through the tablet; and (iv) other additives, e.g., exhausted-tobacco, nicotine fibers, plasticizer, antioxidant. Further, the specification of the prior patent teaches that (i) said tablets may include a solid solution of soluble fiber and one or more sugar alcohols; (ii) pockets of oil, flavor, and nicotine; (iii) oil can be added to a molten mixture including sugar alcohol(s), soluble fibers, and nicotine. The specification of the prior patent also teaches that “soluble fiber dissolves in ambient water”. Further, the prior patent teaches that tablets can include nicotine within a solid solution of soluble fiber and one or more sugar alcohols, or, e.g., in a coating to provide a user with readily available nicotine. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patent.
The prior patent US 12,274,276 claims: Chewable dissolvable tablets comprising: solid solution comprising (i) soluble fibers; (ii) sugar alcohols, (iii) oils; and (iv) one or more additives within a solid solution of soluble fiber and one or more sugar alcohols and in a coating, e.g., therapeutic agents; antioxidants, flavorants, exhausted-tobacco fibers, filler. The specification of said prior patent also teaches that “soluble fiber dissolves in ambient water”. It would be obvious to try such additive as nicotine to be included in said tablets, because said prior patent teaches that said approach provides dissolvable-chewable tablets, wherein said additives can be released at a rate such that a majority of them is absorbed transbuccally, rather than swallowed. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patent.
The prior patent US 11,771,127 claims: A chewable dissolvable nicotine tablet receivable in an oral cavity of an adult consumer, wherein said tablet comprises a matrix including oral-soluble maltodextrin fibers; sugar alcohols; and a plurality of domains including an oil and dispersed in said matrix; and a nicotine; and wherein the tablet is free of tobacco plant tissue. In the present case, the instant claims are merely broader than prior patent claims that include additional limitation (i.e., specific oral soluble fibers, sugar alcohols, oils and concentrations thereof) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending application.
Claims 1-2, 4-19, 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/455,799.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in the referenced copending applications and would be covered by any patent granted on that copending application since the referenced copending applications and the instant application are claiming common subject matter, as follows: Chewable dissolvable tablets comprising (i) soluble fibers; (ii) sugar alcohols, (iii) oils; and (iv) other additive(s),i.e., nicotine; antioxidant, flavorants, exhausted-tobacco fibers, filler. The specifications of copending applications teach that said tablets can include a solid solution of soluble fiber and one or more sugar alcohols; soluble fiber dissolves in ambient water. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in the said copending applications. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant's arguments, filed 01/20/2026, have been considered, but they were not found to be persuasive for the reasons set forth above. New objections and/or rejections have been added to the record to address newly introduced amendments and to clarify the position of the examiner.
In response to applicant's argument regarding the obviousness rejection, the examiner maintains the positions that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Further, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
In the present case, all cited references are reasonably drawn to the same field of endeavor that is chewable and orally dissolvable products/tablets comprising an active agent (e.g., tobacco, nicotine, etc.). Jackson teaches dissolvable-chewable tobacco tablets comprising claimed compounds, wherein said tablets may include nicotine comprising species. Duggins and Gao teach dissolvable-chewable tobacco products that may include an active agent, e.g., nicotine (Duggins), and also teach that encapsulating an active agent into flavor beads or dispersing through the matrix can be used for controlling flavor delivery, providing additional texture and flavor to chewable and orally dissolvable/disintegrable product (Duggins, Gao).
Therefore, the examiner maintains the positions that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use nicotine dispersed through the matrix and/or encapsulated into flavor beads as taught by Duggins and Gao preparing compositions/tablets taught by Jackson, because the cited prior art teaches that said approach can be used for controlling flavor delivery, providing additional texture and flavor to chewable and orally dissolvable/disintegrable product.
To this point, it should be noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that:
the obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ.
the obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.
it is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed.
it is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton).
it is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.
Therefore, it is the examiner’s positions that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made/filed, because every element of the invention has been collectively taught by the combined teachings of the references. Applicant is advised to clarify the claim language, the scope of the claims, the structure of the claimed product/tablet, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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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.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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