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 .
Response to Arguments
Applicant's arguments filed 6/25/2026 have been fully considered but they are not persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The 101 rejection of claim 10 is withdrawn
The 112(b) rejection of claim 8 is withdrawn.
The 112(b) rejections of claims 1-7 and 9-11 are maintained.
The 103 of claims 1-11 are maintained.
112(b) rejection
Regarding the 112(b) rejections of claims 1 and 4 over the term “polyol-based”, Applicant’s arguments are not persuasive. Applicant cites the specification for guidance, however, the specification at [0050 – 0052] merely states species that the polyol based filling agents and/or polyol based hard coating “may be” based on. Furthermore, all of the listed species are polyols; no examples of polyol-based compounds are given. No objective definition or standard for measuring the scope of the term is provided. Examiner suggests amending “polyol-based” to “polyol” to obviate this rejection.
103 rejections of claims 1, 5-7, and 9-11
Applicant first asserts that Chau is not equivalent to the instantly claimed core, as it proposes to achieve biphasic release through coated nicotine particles dispersed in a gum base. This is not persuasive. Chau is relied on for teaching a fast-release nicotine powder comprising nicotine bitartrate and/or nicotine bitartrate dihydrate [0035] and the advantages conferred by the powder formulation [0031]. Chau teaches that the nicotine coated powder improves the rapid-release kinetics of the nicotine due to its coating on a water-soluble powder [0031]. A skilled artisan would appreciate Chau for teaching the advantages of the powder nicotine formulation that are associated with the properties of the powder itself, and are not reliant on being mixed into a gum base.
Applicant also argues that Carroll is not directed to nicotine gums, nor is it concerned with biphasic release of active ingredients from the gum, and that the unkneaded structure is not suggested to provide immediate release of ingredients contained therein. This is not persuasive as Carroll was not relied on for those teachings. Carroll was relied on for the physical structure of an outer gum shell surrounding a cavity containing a powdered center fill, wherein the powder centerfill is protected from environment moisture changes. Even though Carroll is directed to confectionary gums, the advantage resulting from gum structure of Carroll (protection from moisture) is reasonably pertinent to the instant invention and can be extrapolated and applied to the powder of Chau with a reasonable expectation of success.
Finally, Applicant argues that it would be contrary to the Thyresson teachings to move the fast release portion from the outside and instead it place it at the core of the gum. This is not persuasive. Thyresson was not relied on for teaching this proposition. Examiner relied on Thyresson for the teachings of placing nicotine polacrilex in the outer-most layer of gum [pg. 7, paragraph 1] (i.e. an extended-release portion in the outer layer). Rather, the inclusion of the fast-release portion in the gum core was made obvious over Chau in view of Carroll, wherein it would be obvious to place a fast-release powder core on the interior of the gum to protect it from moisture.
As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
103 rejections of claims 2-3
Applicant asserts that USDA is directed to confectionary gums and does not teach the claimed structure of the claimed gum, nor does it address biphasic release of active ingredients in the gum. This is not persuasive. USDA was not relied on for teachings those features of the claimed invention. USDA was relied on for its teachings of gum sizes that are known in the art. Applicant also argues that the cited references fail to disclose the weight limitations and ratio of core to coat weights, thus a skilled artisan would not recognize this as a relevant parameter to modify. This is not persuasive as Carroll explicitly teaches the relative weight amounts of the powder center fill and outer gum coat [col 1 line 36]. Carroll further teaches that the powder provides a unique mouthfeel [col. 6 line 43]. Thus, a skilled artisan would recognize that the powder to gum coat ratio would be a relevant parameter to optimize in order to accordingly tailor the mouthfeel provided by the gum.
103 rejections of claims 4-8
Applicant argues that Pedersen’s approach to controlled release is to load active ingredients on an inorganic mineral filler, which provides for controlled release but not bi-phasic release. This is not persuasive. Pedersen was not relied on for teaching the instantly claimed bi-phasic release nicotine gum. Instead, Pedersen was relied on for teaching a hard outer coating comprising a polyol.
Maintained 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.
Claim 1-7 and 9-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 4, the term “polyol-based” is a relative term which renders these claims indefinite. The term “polyol-based” is not defined by these claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far one can deviate from the parent compound of a polyol without being so far removed therefrom as to be considered a different type of coating.
Regarding claims 2-7, and 9-11, these claims depend from claim 1 and do not cure the deficiencies of claim 1. Therefore, claims 2-7, and 9-11 inherit the deficiencies of parent claim 1.
Maintained 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, 5-7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chau et al. (US 2008/0020050 A1), published 1/24/2008, further in view of Carroll et al. (US 4,513,012) (cited on the 11/15/2024 IDS), and Thyresson et al. (WO 2020/012009) (cited on the 4/15/2024 IDS).
Regarding claim 1, Chau teaches a rapid release [0020] medicinal delivery system comprising a medicinal compound-coated powder, a chewing gum base, and buffer [0014]. Chau teaches that the coated powder may be nicotine coated on a saliva- and water-soluble powder such as sorbitol (reads on polyol-based filling agent) [0031], which further comprises a bulk sweetener [0039]. The nicotine compound used to formulate the coated powder may be nicotine hydrogen tartrate (i.e. nicotine bitartrate) or nicotine bitartrate dihydrate, alone or in combination [0035].
Chau does not explicitly disclose a nicotine chewing gum comprising a nicotine powder core for immediate release of nicotine, and an outer gum coat comprising nicotine polacrilex for extended release of nicotine. Carroll teaches a chewing gum wherein an enclosed cavity contains a dry powder [Abstract, col. 1 line 7] comprising at a sweetener [col. 1 line 43]. Chau discloses that dissolution of the water-soluble nicotine powder can wash out the nicotine and buffer from the gum rapidly [0031]. While this is desirable during mastication, a skilled artisan would recognize the need to protect the nicotine-coated powder from environmental humidity to ensure product stability. It would be obvious to one having skill in the art, before the filing date of the claimed invention, to modify the teachings of Chau with that of Carroll, to formulate a nicotine chewing gum with the centerfill structure of Carroll, wherein the centerfill contains the nicotine-coated powder of Chau, to provide a rapid-release nicotine delivery system that is protected from environmental moisture-level changes [Carroll col. 1 line 28].
Chau as modified by Carroll does not explicitly disclose an outer gum coat (i.e. the body of the gum piece enclosing the powder filled cavity) comprising nicotine polacrilex for extended release of nicotine. Thyresson teaches a nicotine chewing gum wherein one portion comprises gum base and nicotine polacrilex to provide an extended release of nicotine [pg. 3 line 26] and at least one other portion comprises nicotine bitartrate or nicotine ditartrate dihydrate to provide an immediate release of nicotine [pg. 2 line 16], sugar alcohol (i.e. polyol) [pg. 3 line 12], and buffer [pg. 3 line 12]. The immediate-release portion of gum may further comprise a sweetener [pg. 8 line 28]. Thyresson further teaches that the at least one portion comprising the immediate-release portion is fused/adhered onto the outer coat of the extended-release portion [pg.7 line 1]. Thyresson also teaches that the instant-release portion may comprise of nicotine polacrilex [pg. 7 line 5]. Thus, Thyresson teaches that nicotine polacrilex may be used in the outer-most layer of the gum.
Furthermore, Carroll teaches that the outer gum layer (referred to in Carroll as an “outer shell”, see col. 1 line 30) enclosing the cavity may be formulated using various suitable, desired chewing gum types [col. 1 lines 52-66]. Chau teaches the need in the art for an improved nicotine delivery system that provides for both initial and extended release of nicotine to rapidly suppress nicotine withdrawal symptoms followed by sustained release to provide longer symptom relief [0012]. It would be obvious to one having skill in the art, before the effective filing date of the claimed invention, to formulate a nicotine gum with two distinct portions comprising an immediate-release and extended-release portions to provide the bi-phasic nicotine release discussed in Chau. A skilled artisan, with reasonable expectation of success, would be motivated to further modify the gum made obvious as discussed, and substitute the outer gum layer of Carroll with an extended-release nicotine gum comprising nicotine polacrilex (as taught by Thyresson, discussed above) as the outer gum layer enclosing the powder-filled cavity.
Thus, it would be obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Chau and Carroll, with that of Thyresson, to formulate a nicotine gum comprising an extended-release outer gum layer (i.e. gum coat) comprising nicotine polacrilex, surrounding an immediate-release nicotine-coated powder core comprising nicotine bitartrate and/or nicotine detartrate dihydrate, sweetener, buffer, and polyol-based filling agent. As previously discussed, the containment of the powder core within the external gum layer serves to shield the powder core from environmental humidity/moisture effects [Carroll col. 1 line 28] which accordingly ensures stability of the nicotine powder [Chau 0031], and substitution of the outer gum layer of Carroll with the extended-release layer of Thyresson serves to provide the bi-phasic release of nicotine contemplated by Chau [ 0012].
Regarding claim 5, claim 5 depends from claim 1 (said discussion above being incorporated herein in its entirety) and further recites the limitation wherein the sweetener is selected from the group consisting of a saccharin, sodium saccharin, aspartame, acesulfame K, neotame, thaumatin, glycyrrhizin, sucralose, cyclamate, dihydrochalcone, advantame, alitame, miraculin and monellin and mixtures thereof. Thyresson teaches that suitable sweeteners include saccharin, sodium saccharin, aspartame, acesulfame K, neotame, thaumatin, glycyrrhizin, sucralose, cyclamate, dihydrochalcone, alitame, miraculin and monellin and mixtures thereof [pg. 8 line 28]. It would be obvious to one having skill in the art, before the effective filing date of the claimed invention, to select a sweetener from sweeteners known in the art to be suitable for use in chewing gum.
Regarding claim 6, claim 6 depends from claim 1 (said discussion above being incorporated herein in its entirety) and further recites the limitation wherein the buffer is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, trometamol base (Tris base) or the corresponding conjugated acid of trometamol such as Trometamol hydrochloride (Tris HCl), trisodium phosphate, disodium hydrogenphosphate, sodium dihydrogen phosphate, tripotassium phosphate, dipotassium hydrogenphosphate, potassium dihydrogen phosphate, and mixtures thereof. Chau teaches that suitable buffering agents include sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, dipotassium, or mixtures thereof [0057]. It would be obvious to one having skill in the art, before the effective filing date of the claimed invention, to select a buffer from compounds known in the art to be suitable for use as buffering agents.
Regarding claim 7, claim 7 depends from claim 6 (said discussion above being incorporated herein in its entirety) and further recites the limitation wherein the buffer is sodium carbonate and/or sodium bicarbonate. As discussed, Chau teaches that suitable buffering agents include sodium carbonate and sodium bicarbonate [0057].
Regarding claim 9, claim 9 depends from claim 1 (said discussion above being incorporated herein in its entirety) and further recites the limitation wherein the powder core comprises nicotine bitartrate and/or nicotine ditartrate dihydrate in amount of from about 0.5 mg to about 5.0 mg per piece of gum (calculated as the free base), and the gum coat comprises nicotine polacrilex in an amount of from about 0.25 mg to about 6.0 mg (calculated as the free base). Thyresson teaches that the gum portion comprising nicotine polacrilex may contain nicotine in the amount of from about 1.0 mg to about 6.0 mg [claim 16]. Thyresson further teaches that the gum portion comprising nicotine bitartrate or nicotine ditartrate dihydrate may contain nicotine in the amount of from about 0.25 mg to about 1.5 mg [claim 16]. (The amounts denoted in Thyresson refer to the amount of nicotine as the free base [pg. 4 line 10].) 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). Thus, it would be obvious to one having skill in the art, before the effective filing date of the claimed invention, to formulate a nicotine gum comprising nicotine bitartrate or nicotine ditartrate dihydrate using amounts known in the art to be suitable for use in nicotine gum, and arrive at the invention of claim 9.
Regarding claim 10, claim 10 recites a method of a treating a human suffering from tobacco cravings and/or e-cigarette dependency, comprising administering the gum of claim 1. The gum of claim 1 has been made obvious above, said discussion will not be repeated herein. Chau contemplates the use of nicotine gum for treatment of a human being suffering from cravings from tobacco dependency [0006, 0018]. The administration of nicotine gum for treatment of tobacco-related nicotine cravings is well-known and would have been obvious to one having skill in the art before the filing date of the claimed invention.
Regarding claim 11, claim 11 depends from claim 1 and further recites the limitations of claims 5 and 6 (see above for discussion of claims 5 and 6) regarding sweeteners and buffers, respectively, and recites the additional limitation wherein the polyol-based filling agent is selected from the group consisting of xylitol, erythritol, lactitol, mannitol, maltitol, isomalt, arabitol and sorbitol or mixtures thereof. Chau teaches that the nicotine-coated powder may comprise a saliva-soluble powder such as sorbitol. [0031] It would be obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to select sorbitol for use in the powder composition, as taught by Chau, to improve the rapid-release of the nicotine and thereby improve performance of the drug delivery system [0031].
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Chau et al. (US 2008/0020050 A1), published 1/24/2008, further in view of Carroll et al. (US 4,513,012) (cited on the 11/15/2024 IDS), and Thyresson et al. (WO 2020/012009) (cited on the 4/15/2024 IDS) as applied to claim 1 above, and further in view of USDA (2018).
Regarding claim 2, claim 2 depends from claim 1 (said discussion above being incorporated herein in its entirety) and further recites the limitation wherein the powder core is present in an amount of up to 80 mg and the gum coat is present in an amount of about 950 mg. While the above cited references do not explicitly teach the weight amounts of the powder core and the gum coat, Carroll teaches that the powder core centerfill may be present in the range of about 10% to about 20% by weight of the gum piece [col. 1 line 36]. Accordingly, the outer gum coat would be present in the range of about 80% to about 90% by weight of the gum piece. In the instant application, the gum as claimed may comprise about 7.77% by weight of the nicotine gum ( 80/(80+950) x 100 = 7.767% ). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, such that one skilled in the art would have expected them to have similar properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, the USDA Commercial Item Description (CID) for chewing gum describes various parameters and sizes for chewing gums, such as “Size B” chewing gum that weighs between 1100 mg and 1600 mg [pg. 4, para. 6.2.1)]. Carroll also teaches that the powdered centerfill provides a unique mouthfeel and texture upon chewing [col. 6 line 43]. A skilled artisan would be motivated to adjust the amounts of powder centerfill and outer gum coat to achieve a final product with a desired mouthfeel and desired size. It would have been obvious to one of ordinary skill in the art to modify the teachings of modified Chau with that of USDA to optimize the weight amount of the powder core and the outer gum coat to arrive at a gum with about 7.77% by weight of nicotine powder core and about 92.23% by weight of the outer gum coat, to produce the claimed invention wherein the powder core is present in an amount up to 80 mg and the gum coat is present in an amount of about 950 mg. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight amounts of the powder core and the outer gum coat to arrive at the amounts of claim 2 would have been obvious before the effective filing date of the instant invention. See MPEP 2144.05.
Regarding claim 3, claim 3 depends from claim 1 (said discussion above being incorporated herein in its entirety) and further recites the limitation wherein the powder core is present in an amount of about 20 mg to about 60 mg. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight amounts of the powder core to arrive at the amounts of claim 3 would have been obvious before the effective filing date of the instant invention. See MPEP 2144.05.
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Chau et al. (US 2008/0020050 A1), published 1/24/2008, further in view of Carroll et al. (US 4,513,012) (cited on the 11/15/2024 IDS), and Thyresson et al. (WO 2020/012009) (cited on the 4/15/2024 IDS), as applied to claim 1 above, and further in view of Pedersen (US 2012/0039981 A1), published 2/16/2012.
Regarding claim 4, claim 4 depends from claim 1 (said discussion above being incorporated herein in its entirety) and further recites the limitation wherein the gum further comprises a polyol-based hard coating that coats an exterior of the gum coat. Chau teaches that the nicotine gum may be coated with a shell but does not explicitly disclose a polyol-based coating [0064]. Pedersen discloses a chewing gum containing a particulate core [0010] for controlled release of nicotine [0012]. Pedersen further teaches that the gum may comprise a hard outer coating comprising a sugarless coating agent, such as a polyol. [0141, 0143]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the gum made obvious as discussed, with the teachings of Pedersen to add a polyol-based hard coating to the nicotine gum of claim 1 to obtain a sweet, crunchy layer desirable to the consumer and to protect the gum center [Pedersen 0142].
Regarding claim 8, claim 8 depends from claim 4 (said discussion above being incorporated herein in its entirety) and further recites the limitation wherein the polyol-based filling agent and/or the polyol-based hard coating are selected from the group consisting of xylitol, erythritol, lactitol, mannitol, maltitol, isomalt, arabitol and sorbitol or mixtures thereof. Pedersen teaches that suitable polyols for the poly-based hard outer coating include xylitol, erythritol, sorbitol, lactitol, mannitol, maltitol, isomalt, and sorbitol [0143]. It would be obvious to one having skill in the art, before the effective filing date of the claimed invention, to select a polyol from polyols known in the art to be suitable for use in a hard coating for chewing gum.
Conclusion
No claims are allowed.
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 AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday from 9am-5pm ET.
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/AMANDA LYNN CHI/ Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
