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 .
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0044], “0,.25 mg to about 6,.0 mg” should read “0.25 mg to about 6.0 mg”.
Appropriate correction is required.
The use of the terms Nicorette and Quickmist, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware of in the specification.
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 1-11 is 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 claim 1, the recitation “at least one of nicotine bitartrate and nicotine ditartrate dihydrate, a sweetener, a buffer and a polyol-based filling agent” is indefinite. It is unclear whether “at least one” refers to all the listed elements or if it only refers to nicotine bitartrate and nicotine ditartrate dihydrate. Thus, it is unclear if all of the listed elements are essential to the invention.
For the purpose of compact prosecution, the limitation is being interpreted as “a powder core comprising nicotine bitartrate and/or nicotine ditartrate dihydrate, a sweetener, a buffer, and a polyol-based filling agent.”
Regarding claims 2-11, these claims depend from claim 1 and do not cure the deficiencies of claim 1. Therefore, claims 2-11 inherit the deficiencies of parent claim 1.
Regarding claims 6 and 11, these claims recite the exemplary claim language “such as.” Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In the instant claims, the phrase “such as” renders the claims indefinite because it is unclear whether the recitation of “Trometamol hydrochloride (Tris HCl)” following the phrase are part of the claimed invention. See MPEP 2173.05(d).
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 claim 9, the parenthetical recitation of “(calculated as the free base)” renders the claim indefinite because it is unclear whether the recitation in parentheses is part of the claimed invention. See MPEP 2173.05(d).
Regarding claim 9, there is insufficient antecedent basis for the limitation “per piece” in the claim.
Regarding claim 10, this claim attempts to claim a process without setting forth any steps. Attempts to claim a process without setting forth any steps involved in the process generally raise an issue of indefiniteness under 35 U.S.C. 112(b). For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Regarding claim 10, the claim does not fall within at least one of the four categories of patent eligible subject matter because it recites a use but fails to recite steps. Claim 10 therefore does not purpose to claim a process, machine, manufacture, or composition of matter. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ( "one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").
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 nonobviousness.
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.
Claim(s) 1, 5-7, and 9-11 is/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 attempts to recite a use of the gum of claim 1 (said discussion above being incorporated herein in its entirety) (see the above 112(b) and 101 rejections) for the treatment of a human being suffering from cravings from tobacco and/or e-cigarette dependency. Chau contemplates the use of nicotine gum for treatment of a human being suffering from cravings from tobacco dependency [0006, 0018]. The use of nicotine gum for treatment of tobacco-related nicotine cravings is well-known and would be 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].
Claim(s) 2-3 is/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.
Claim(s) 4 and 8 is/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 allowable.
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 9 am-5pm ET.
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/AMANDA LYNN CHI/ Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613