DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to applicant’s amendments and remarks filed February 27, 2026. Claim 1 has been amended. Claims 6-10 have been canceled. Claims 28-34 were previously withdrawn as the result of a restriction. Claims 35-36 are new. Claims 1-5, 11-14. 16-27, and 35-36 stand rejected.
Restriction/Election
Applicant’s election of Group I in the reply filed on August 30, 2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 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 1-3, 11-14, 16-27, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 2021/0068446 A1, hereinafter ‘Keller’) in view of Gao et al. (US 2015/0096573 A1, hereinafter ‘Gao’) and US 2015/0344456 A1 (hereinafter ‘Dull’).
Regarding claim 1, Keller teaches a coated chewing gum product comprising:
at least one sugar substitute in the form of isomalt (¶0119) in an amount ranging from at least 0.1% to about 20% by weight percent (¶0119);
a gum in the form of gum arabic (¶0121);
a basic amine in the form of nicotine (¶0011, ¶0020); and
a combination of an organic acid and an alkali metal salt thereof (¶115-¶116). Keller explicitly teaches in ¶115 that, “In some embodiments, the organic acid or a portion thereof may be added in the form of a salt with an alkali metal such as sodium, potassium, and the like.” This is a combination of the organic acid and the alkali metal salt.
wherein organic acid has a logP value from about 1.0 to about 12.0. Keller discloses the use of benzoic acid (¶12, ¶20, ¶46) which is identical to the use of benzoic acid of the instant application (page 16). The instant application discloses the logP value for benzoic acid, a suitable acid for use, is 1.9 (Instant application, Table 1, pg. 16). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In this case, benzoic acid has the property of a logP value of 1.9.
wherein the nicotine may be in the form of a salt of nicotine (¶0115); and
wherein the product is in the form of a pastille (¶0156).
wherein the organic acid is benzoic acid (¶12, ¶20, ¶46). Keller explicitly discloses the use of benzoic acid.
wherein the basic amine is nicotine (¶0011, ¶0020)
Keller does not disclose the claimed range of 15% to 45% by weight of sugar substitute. Keller teaches a range from 0.1% to 20% which overlaps the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Keller further teaches wherein the oral product comprises from about 0.001% to about 10% by weight of nicotine (¶0011) and no more than about 7.5% of an alkali metal salt and about 0.1 to 0.5% by weight of an organic acid like octanoic or benzoic acid (¶0012).
Keller teaches wherein the organic acid comprises from 2 to 10 molar equivalents relative to nicotine. Keller teaches weights of the organic acid in relation to nicotine (¶12, ¶90, ¶116, ¶118, ¶123, Claim 26).
It is known that the molecular weight of benzoic acid is 122.12 g/mol and the molecular weight of nicotine is 162.24 g/mol. Keller teaches that the weight percent for nicotine is 0.001 to 10 wt% nicotine (or 10 parts / 100 total) and 0.1 to 0.5 wt% benzoic acid. A person of ordinary skill in the art can readily calculate the weight percentages to molar equivalents for the ranges taught in Keller. For example, 0.25 g benzoic acid is 0.25/122.12 = 0.00204 mol benzoic acid. For nicotine, the range is 0.001 g to 10 g. Therefore, 0.000006 mol (0.001 g) to 0.0616 mol (10 g).
0.00204/0.000006 = 341
0.00204 / 0.0616 = 0.033
Therefore, the above analysis demonstrates how one of ordinary skill in the art is reasonably suggested that the weight percents of Keller set up a range of 0.033 to 341 molar ratio of acid to nicotine which overlaps the range claimed by claim 1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Keller does not disclose including gum in an amount from about 20% to about 55% by weight of the total product.
Gao teaches oral nicotine products of several forms of oral nicotine products, including a dissolvable oral product (¶0002, ¶0007, ¶0019, ¶0039) similar to the pastille of Keller. Gao’s dissolvable oral product comprises soluble fiber in the form of natural gum (¶0049-¶0051), sugar alcohols as sugar substitutes (¶0052-¶0054), and optionally nicotine (¶0055, ¶0057-¶0059) at the most basic level. Gao uses soluble fiber to provide a satisfying tactical and flavor experience rather than merely as an additive (¶0049). Gao teaches that gum arabic is one of many suitable soluble fibers for use in such a product (¶0050). Gao provides that a product may contain anywhere from 20% to 70% of the total weight of soluble fiber (¶0051).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Keller’s oral product composition to include a higher amount of gum shown to create a viable oral product as taught by Gao, as Keller and Gao are both directed to the oral tobacco product field of art. Gao provides that the higher level of soluble fiber provides a satisfying tactile experience and/or flavor experience (¶0049) as well as helping provide solubility so that the product can dissolve when placed in a user’s mouth (¶0010). One of ordinary skill in the art would have been motivated before the effective filing date of the present application to modify the amount of gum/soluble fiber included in the oral product of Keller with the teaching that increasing the gum content can provide a satisfying tactile experience for the user while still providing a dissolvable oral product.
Neither Keller nor Gao disclose the association in the form an ion pair between the basic amine and a conjugate base of the organic acid, or both.
Dull teaches nicotine salts and methods of preparation and characterization of the salts for use in tobacco products (abstract). Dull teaches that the salts, co-crystals, and salt cocrystals are formed using isolation and purification of nicotine from tobacco in the presence of water or organic solvents (¶51). Dull teaches that advantageously coformers including acids are used in combination with nicotine to form salts (¶58). The resulting salt is characterized by the transfer of one or more protons from the donor (acid) to the nicotine acceptor (¶45, ¶48). This is a description of chemical principles of acid/base chemistry wherein ions are forming ion pairs to achieve equilibrium. This is inherent when acids and bases are combined as taught in Dull (and in Keller and Gao) and would be immediately appreciated by anyone of ordinary skill in the art. Dull teaches that the nicotine salts can be incorporated within a smokeless tobacco product (¶125). Dull teaches that the various other substances can be added to the smokeless tobacco compositions (¶131). Dull teaches that pH adjusters may be added (¶131). Dull discloses that the nicotine salt itself, found in the smokeless tobacco, is characterized by the interaction between nicotine in ionic form and a conformer in ionic form (e.g. an acid), “The structure of nicotine is such that it comprises two nitrogen atoms that are capable of accepting protons from a conformer and, accordingly, it can be present in non-protonated, mono-protonated, and/or di-protonated form in a given sample.” (¶45). This is a disclosure to the basic amine (nicotine) associated with the acid.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Keller’s oral product composition to include the association in the form an ion pair between the basic amine and a conjugate base of the organic acid, or both as taught by Dull. A person of ordinary skill in the art would immediately recognize that combining acids and bases leads to ion pairing as detailed in Dull. A person would use this inherent chemical reaction to produce a tobacco product for human consumption that has been adjusted for pH (Dull ¶131).
Regarding claims 2 and 3, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches product comprising octanoic acid (¶0012, ¶0020, ¶0114, ¶0115) which is an organic acid with a logP value of 3.05 according to the instant application (Table 1). As explained above, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claims 11 and 12 modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches an embodiment wherein the oral product comprises a portion of the organic acid in the form of an organic acid salt made from an alkali metal like sodium or potassium (¶0115).
Regarding claim 13, modified Keller teaches the oral product of claim 12 as discussed above. Keller further teaches wherein the oral product has no more than about 7.5% of total weight of an alkali salt and from about 0.1 to 0.5% of total weight of one or more organic acids (¶0012). Keller provides that sodium may be used as the alkali metal to form alkali salts with the organic acid of the product (¶0115).
While Keller does not explicitly teach the ratio range of 0.1 to about 10 of organic acid to the sodium alkali salt as claimed, based on the disclosed weight percentages, one of ordinary skill would reasonably conclude that the prior art discloses a ratio of organic acid to the sodium alkali salt that overlaps the claimed ranges of 0.1 to 10 of an organic acid to the sodium alkali salt thereof. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 14, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches wherein the oral product may comprise an organic acid, a portion of which is in an alkali salt form formed from an alkaline component, like sodium, and such a salt may be benzoate (¶0115, ¶0126-¶0127). Therefore, Keller teaches an embodiment wherein the oral product may comprise benzoic acid and sodium benzoate.
Regarding claim 16, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches wherein the nicotine is present in an amount of from about 0.001 to about 10% by weight of the oral product, based on the total weight of the oral product (¶0011). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 17, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches wherein the oral product comprises from about 1% to about 60% by weight of water based on the total weight of the oral product (¶0090).
While Keller does not teach the claimed range of 5% to 20% by weight of water as claimed, Keller discloses a range from 1% to 60% which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 18, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches wherein the oral product further comprises an active ingredients in the form of cannabinoids (¶0011, ¶0125).
Regarding claim 19, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches wherein the composition may be substantially free of tobacco material (¶0001, ¶0145).
Regarding claims 20-21, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches Keller further teaches wherein the at least one sugar substitute is in the form of isomalt (¶0119). Due to the recitation of “or” in claims 20-21, only one of the listed limitations need be listed in the prior art to read upon the claim.
Regarding claim 22, modified Keller teaches the oral product of claim 20 as discussed above. Keller teaches that the mixture for the oral product may comprise one or more sweeteners including isomalt, maltitol and erythritol in a combined amount of about 0.1% to about 20% of the mixture by weight.
Keller does not explicitly disclose the mixture comprising isomalt in an amount from about 15 to 35% by weight, maltitol in an amount from about 1 to 10% by weight, and erythritol in an amount from about 0.1 to about 2% by weight, based on the total weight of the oral product.
However, Keller teaches that all three sweeteners may be used in combination with one another and it would therefore be obvious to one of ordinary skill in the art to conclude that the three sweeteners could be used in any relative amounts with a reasonable expectation of success and predictability so long as the total amount is within the disclosed range of Keller. As such the claimed amounts are considered to be obvious in view of the teachings of Keller and the rationale that the sweeteners could be used in any relative amounts. If the Applicant can show criticality and unexpected results based on the claimed amounts, the rejection may be overcome.
Regarding claims 23-24, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches wherein the gum is gum arabic (¶0121).
Regarding claim 25, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches wherein the product further comprises an additive in the form of an emulsifier or a disintegration aid (¶0146).
Regarding claim 26, modified Keller teaches the oral product of claim 1 as discussed above. Keller further teaches wherein the product further comprises a buffering agent (¶0123) in an amount sufficient with the organic acid to adjust the pH to be in the range of about 5.0 to 7.0 (¶0117).
Regarding claim 27, modified Keller teaches the oral product of claim 1 as discussed above. Keller does not disclose wherein the product has an outer coating
Gao teaches that the dissolvable nicotine tablet can be coated in an edible or dissolvable film (¶0042). Gao teaches that the film can readily dissipate in the oral cavity (¶0042). Gao further teaches that the coating can include other additives such as sugar, colorant, flavorant (¶0042). Gao teaches that the coating can include nicotine to provide the user with readily available nicotine (¶0042). Gao teaches that the coating can provide an appealing visual aesthetic (¶0042).
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 have further modified Keller to provide the product has an outer coating as taught in Gao. A person of ordinary skill in the art would obviously provide an outer coating. Doing so would provide additional flavor or nicotine to the user and improve the aesthetic of the product (Gao (¶0042)).
Regarding claim 35, modified Keller teaches the oral product of claim 1 as discussed above. Keller further discloses wherein the organic acid is benzoic acid (¶12).
Regarding claim 36, modified Keller teaches the oral product of claim 1 as discussed above. Keller further discloses wherein the alkali metal salt is sodium benzoate (¶115).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Keller, Gao, and Dull as applied to claim 1 above, and further in view of Kobal et al. (US 2014/0271946 A1, hereinafter ‘Kobal’).
Regarding claims 4 and 5, modified Keller teaches the oral product of claim 1 as discussed above. Keller does not disclose wherein the product comprises an organic acid with a logP value between 4.5 to 8.0 and comprises a solubility enhancer in the form of propylene glycol or glycerol.
Kobal, directed to smokeless oral tobacco products, teaches one embodiment of a chewable nicotine containing lozenge like that of Keller (¶0057). This chewable lozenge may comprise additives like an active ingredient, notably stearic acid (Identified as an organic acid with a logP value of 7.6 according to Table 1 of the instant application), to provide sensory relief by inhibiting nicotinic acetylcholine receptors (¶0021). Kobal additionally teaches that the chewable lozenge embodiment may comprise propylene glycol to serve multiple functions as a plasticizer and a lubricant for the composition (¶0063). While Kobal does not teach using propylene glycol as a solubility enhancer, the propylene glycol of Kobal has the same physical characteristics and properties of the propylene glycol of the instant application. When the composition is physically the same, it must have the same properties. See MPEP 2112.01 II. Therefore, Kobal teaches an oral product composition that comprises stearic acid and propylene glycol.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of the Keller and Gao by further including stearic acid and propylene glycol as additives as taught by Kobal, as Keller, Gao, and Kobal are all directed to oral smokeless tobacco products. Kobal provides that stearic acid is known to provide sensory relief for users and propylene glycol can provide a dual purpose as a plasticizer and lubricant for chewable oral nicotine products, and this merely involves supplementing a known composition with known additives to create a similar product to yield predictable results.
Response to Arguments
Applicant’s amendment and arguments, filed February 27, 2026, with respect to the Keller have been fully considered but are not sufficient to move the application to allowance. The rejection of record based on Keller has been modified to account for the newly presented ratio limitation. This modification has been necessitated by Applicant’s amendment.
Applicant argues, Keller teaches acid and nicotine in terms of weight percent and this cannot read over a limitation in mols (or molar ratios). However, this argument is not persuasive. Weight and molar amounts are interconnected via the molecular weight of the compound in question. There is no requirement the prior teaches Applicant’s claim limitation in Applicant’s terminology to read. The rejection of record has been updated to reflect how one of ordinary skill in the art is taught a range of molar equivalents that overlaps the claimed range. Further, Applicant has presented no arguments how the wt% of Keller cannot achieve the recited ratios even when converted to molar amounts.
Applicant argues the recited molar ratio provides for unexpected results. This argument is not persuasive.
If Applicant intends to argue there is criticality which gives an unexpected result to the compositions in light of the teachings of the prior art, Applicant is reminded such arguments to unexpected results can only be properly considered when all the factors in MPEP §716.02 are properly taken into account. Overcoming a §103 rejection based on unexpected results requires the combination of three different elements: the results must fairly compare with the prior art, the claims must be commensurate in scope and the results must truly be unexpected. (See MPEP §716.02) Applicant’s showing of allegedly unexpected results must satisfy ALL of these requirements. Additionally, MPEP §716.01(b) states a “nexus” between the claimed invention and the evidence of secondary considerations, such as unexpected results, must be present. The burden rests with Applicant to establish results are unexpected and significant. (MPEP §716.02(b)).
Applicant presents no discussion of their proffered data on the ratio nor does there appear to be any comparative examples to support Applicant’s assertation the claimed composition is unexpectedly better for some reason. Applicant has not argued why the proffered data is commensurate in scope with the showing to establish the required nexus between the claims and the demonstration of allegedly unexpected results. Applicants have the burden of explaining the proffered data. (MPEP §716.02(b) Section II).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 STEPHANIE L MOORE whose telephone number is (313)446-6537. The examiner can normally be reached Mon - Thurs 9 am to 5 pm.
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/STEPHANIE LYNN MOORE/Examiner, Art Unit 1747
/Christopher M Rodd/Primary Examiner, Art Unit 1766