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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on 02/02/2026 has been entered.
Status of the Claims
Claims 1-45 are pending in a Response of 02/02/2026 and claims 36-45 have been withdrawn by way of applicant’s election of 08/05/2024. Thus, claims 1-35 are being examined.
Withdrawn objection/ rejections:
Applicant's amendments and arguments filed 02/02/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Claims 1-3, 6-11, 13-15, 17-21, 23-28 and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Sänd (WO2005/115180A1, IDS of 04/22/2024) in view of Lockwood (WO2010/114816A1, IDS of 01/29/2025) and Jonsson et al. (US2006/0147498A1) or further in view of Kleinsorgen et al., (US6165499A, IDS of 06/21/2024).
Applicant claims the below claims 1 and 31 filed on 02/20/2026:
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For examination purpose, the limitations of “the matrix is printed on the paper-based substrate” of claims 1 and 31, “the matrix is printed on the substrate via screen printing” of claim 23, and “the first liquid mixture and the second liquid mixtures are separately printed on the paper-based substrate” of instant claim 35 relate to how the printed matrix is made, and thus they are product-by-process limitations, which does not structurally limit the claimed system; and thus they are interpreted to recite “the matrix placed on the paper-based substrate” (claims 1, 23 and 31) and “the first liquid mixture and the second liquid mixture are separately placed on the paper-based substrate” (claim 35). Those limitations are not seen as structurally limiting the instant composition because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP 2113 reads “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”.
And the limitations of “the paper-based substrate, having the matrix placed thereon, fits on a user’s gum” (claim 1), “a user can easily tear off a portion providing an individual dose of the active ingredient component” of claim 26, “it fits on a user’s gums without forming a protrusion that is visible on the user’s face” of instant claim 28, and “the multiple connected segments are connected to allow a user to easily separate a segment of the multiple connected segments of the paper-based substrate having matrix printed thereon” of claim 31 are intended uses and/or properties. Particularly, an intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Thus, those intended use/properties limitations do not carry patentable weight, and it is seen that the claimed system would implicitly have those intended uses/properties.
Prior Art
Sänd teaches portion snuff (title) comprising nicotine which reads on the elected species of active ingredient, a mixture of ethyl acetate, alcohol and water, pH raising agent, and flavorings (page 4, first para.) which reads on the claimed carrier, and thus the said nicotine and carrier read on the claimed matrix wherein the nicotine would be dissolved or dispersed into the carrier; the portion snuff further contains fibres so that the portions are held together wherein tobacco is wetted in a solution, a controlled leaching of nicotine and other substances taking place that a mixture containing fibres is pressed into paper-like sheets (page 3, second para., page 5, second para., page 7, last second para., and claim 8 of prior art) which reads on the claimed matrix placed on the paper-based substrate and dissolved or dispersed into the carrier before being placed on the substrate, and the fibres are made of preferred cotton cellulose paper wherein the preferred cotton fibres contain high proportion of cellulose, up to approximately 98% which overlaps the instant range of about 50-about 60% of cellulose (page 5, second para. and page 6, third para.) in which the paper-like sheet made of cellulose fibres overcome the drawbacks of non-degradable plastic fibers (page 2, second para) and therefore the paper fibres read on the claimed paper-based substrate being not dissolvable but biodegradable and the nicotine and carrier are placed on the fiber paper; and the mixture containing nicotine, carrier and fibres is pressed into paper-like sheets, which can be divided into portion piece (abstract and claim 8 of prior art), and the sheet substrate has a length, a width, and a depth dimension such that the sheet-based substrate, having the nicotine/carrier thereon (Figs. 2-3 of prior art), and the tobacco matrix is then mixed with fibres of a length that substantially exceeds that of the tobacco particles (page 4, third para.); and the portion snuff may be taken in the mouth of a user (abstract) which means it would fit on a user’s gum (claim 1 of prior art) and consequently the portion snuff of prior art reads on the claimed active ingredient delivery system and further portion snuff sheet has divisions by cutting, punching and perforations and provided in separate units (Figs. 2 and 4 of prior art) and the sheets are divided up into portion pieces of a size that is suitable to be taken in the mouth of the user (page 6, second para.) which reads on the claimed multiple connected segments each having length, width, and depth (instant claim 1, 6, 9, 11, 13-15, 17-20, 23, 26-28 and 31-34); the portion snuff composition further comprises additives such as flavorings (page 4, first line), moisture retaining agent (page 5, 5th para.) such as propylene glycol and glycerol (=glycerin) (page 5, third para.) which should be food-grade because portion snuff is taken into the mouth of user, thus moisture retaining agent of prior art reads on the claimed softening agent (instant claims 2-3 and 21); and the obtained portion snuff containing nicotine has a moisture content of 40-70% (claim 5 of prior art) which overlaps the instant range of greater than about 20% or 35-75% (instant claims 24-25).
Sänd does not expressly teach the amounts of cellulose and cotton of instant claim 7, 8 and 10. However, this prior art teaches the fibres are made of preferred cotton cellulose paper wherein the preferred cotton fibres contain high proportion of cellulose, up to approximately 98% and therefore, the ordinary artisan would optimize the relative amounts of cotton and cellulose pulp depending on the intended purpose, type of nicotine-containing product, the amounts of nicotine and carrier, etc., in the absence of criticality of the ranges of instant claims 7, 8 and 10 (instant claims 7, 8 and 10).
Sänd does not expressly teach first/second liquid mixtures of instant claim 35. However, it would have been obvious to modify the teachings of Sänd with first/second liquid mixtures separately placed on the substrate of instant claim 35, and one of the ordinary artisan would have been motivated to do so because separating nicotine-containing liquid from flavoring/humectant-containing liquid without mixing together would prevent reduction of intended effects of respective nicotine and flavoring agent/sweetener (instant claim 35).
Sänd teaches small flat piece of snuff paper in a size that is suitable to be taken in the mouth of the user, and but does not expressly teach a numerical depth dimension of substrate as claimed. The deficiencies are cured by Lockwood/Jonsson.
Lockwood discloses nicotine dissolving film with or without menthol (title); the film substrate contains nicotine or its analog and menthol and is then packaged in a flat sealed container that can be unobtrusively placed into a pocket earned by the smoker, thereby making the container readily accessible to the smoker (abstract); the thickness of container can be as small as 1 to 3mm to accommodate the thickness of the film plus the thickness of the container walls on top of and below the strip in the container (e.g.,. [0033] and Fig. 1), and a container having a thickness only slightly greater than a thickness of the film (e.g., claim 9 of prior art), and therefore, since the container accommodating the film substrate has 1-3 mm thickness, the film substrate should be less than 1-3 mm (instant claims 1, 12 and 31 - substrate height dimension); Lockwood not only provides an effective and convenient way for a smoker to satisfy a temporary nicotine craving during periods when he cannot smoke, it also provides a convenient and inconspicuous way of facilitating the application of a nicotine boost by forming the nicotine-bearing strips so that they can be readily placed in the user's oral cavity while keeping the film ready for use at anytime and anywhere ([0022]); a plurality of containers accommodating plurality films are placed inside of the cartridge (Fig. 2); the film substrate is made of vegetable ingredients only (claim 4 of prior art); and the film contains sweeteners, flavoring agent, food coloring along with nicotine or its analog and menthol (e.g., [0031]).
Jonsson discloses composition material for transmucosal delivery (title); in particular, this prior art refers to the composition material is for a highly efficient transmucosal delivery in the mouth of biologically active substance(s), a pouch containing the composition material as well as an envelope for the composition material or the pouch ([0001]); the biologically active substance includes nicotine ([0036]); the composition material can be in the form of a sheet (e.g., [0070]) wherein the sheet can be made from cellulose ([0074]), and the sheet conforms to a shape in mouth, and the length can be 15-30mm and thickness can be less than 5 mm, such as between 0.5 and 3 mm ([0072]) which overlaps the claimed range of at least 1 mm to at most 3 mm (instant claims 1, 12 and 31 - substrate height dimension) MPEP 2144.05. MPEP 2144.05 states that [I]n 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).
It would have been obvious to modify the teachings of Sänd with small size of film substrate of Lockwood in order that the oral film or film substrate can be readily placed in the user’s oral cavity and that one cartridge can have multiple films having small size, as taught by Lockwood. Further, Jasson discloses overlapping thickness of sheet.
Thus, claims 1-3, 6-11, 13-15, 17-21, 23-28 and 31-35 are obvious over Sänd in view of Lockwood/Jonsson.
Alternatively,
Even if the said product-by-process “printing” limitations of instant claims 1, 17, 20, 23, 31 and 35 are considered, Kleinsorgen the printing method which cures the deficiency of Sänd in view of Lockwood.
Kleinsorgen discloses transdermal therapeutic system with small application -area thickness and great flexibility, and production process (title); the system comprises a substrate, a film layer comprising the active substance, a protective layer and by means of printing methods, such systems can be manufactured, and the printing method limiting the active -substance containing region to the application site reduces disposal problems (abstract), and the system manufacturing permits multi-dose unit production (col. 2, lines 15-40); wherein the substrate is a paper substrate (col.2, line 64 and col. 3, lines 20-21); the printing may be screen printing (col. 3, lines 49-51) and the active substance-containing film layer may be applied in one or several individual printing steps (col. 9, lines 27-30); and the active substance includes flavoring substance, nicotine, pharmaceuticals, etc. (col. 5, liens 23-col. 6, line 17).
It would have been obvious to modify the teachings of Sänd with printing the matrix containing active substance as taught by Kleinsorgen in order to reduce disposal problem and provide multi-dose system, as taught by Kleinsorgen. Further, it would have been obvious to modify the teachings of Sänd with printing the matrix containing active substance as taught by Kleinsorgen as a matter of choice or design because selection of such design would have been yielded no more than the predictable results of delivering active substance to the desired target area.
In light of the foregoing, instant claims 1-3, 6-11, 13-15, 17-21, 23-28 and 31-35 are obvious over Sänd in view of Lockwood and Jonsson or further in view of Kleinsorgen.
Response to Arguments
Applicant’s arguments have been considered, but are moot in view of new reference of Jonsson disclosing overlapping thickness of sheet. However, the examiner would like to address the followings:
Applicant argues that Lockwood fails to teach or suggest the claimed depth of at least 1.0mm to at most 3.0mm because Lockwood at [0033] disclose “the thickness of container is 1-3mm and accommodates the thickness of the film plus the thickness of the container walls on top of and below the strip in the container” and however, if the container is up to 3 mm in thickness, each container wall must be at least 1 mm thick allowing less than 1 mm for the thickness of the film, which is less than the thickness of the paper-based substrate of current claims 1 and 31, and further claim 9 of Lockwood reciting “the container has a thickness only slight greater than a thickness of the film” would be ambiguous and non-enabling language because Lockwood discloses the film is explicitly described as “thin (preferably in the range between about 1.5x3mils), and the actual teachings of the embodiment of Lockwood would have to be ignored and a film approximately 20 to 30 times the size of the one actually disclosed in [0033] would be required; and the selection of claimed depth size is significant as disclosed in [0040] of the instant specification.
The Examiner responds that the prior art is not limited to the problems to concern but to relevant for all they contain. See MPEP 2123 stating that “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)), and further see MPEP2123 II. NONPREFERRED AND ALTERNATIVE EMBODIMENTS CONSTITUTE PRIOR ART: Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.
In addition, as to non-enabling argument, please see MPEP2121 I – prior art is presumed to be operable/enabling: When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to provide facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. Here, Applicant did not provide prima-facie evidence of non-enablement. Further please see MPEP 2144.05 IV. CHANGES IN SIZE, SHAPE OR SEQUENCE OF ADDITIN OF INGREDIENTS: A. Changes in size/proportion stating since the case laws has been held that changing the size or range of an article is not ordinarily a matter of invention. Appropriate selection of size, weight, ratios, etc. is considered routine, and is typically a matter of design choice. See In re Rose 105 USPQ 237 (CCPA 1955) and also In re Yount (36 C.C.P.A. (Patents) 775, 171 F.2d 317, 80 USPQ 141. In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), “the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” That is, generally, a change in the size or dimension of a product is not considered an invention for patent purposes unless it results in a new or unexpected function or outcome, and accordingly, the reasoning is that selecting an appropriate size, weight, or ratio is typically a routine design choice that would be obvious to a person of ordinary skill in the art, and therefore, the claimed thickness range would be optimized or adjusted depending on the intended purpose, the used materials, type of snuff, etc. In case of overlapping ranges, a prima facie case of obviousness is established and the burden then shifts to the applicant to demonstrate that the claimed range is critical, for example by showing unexpected results within the claimed ranges. Lastly, [0040] of the specification is mere a statement without any evidentiary and/or experimental data. Here, the specification discloses “thickness ranges of at least 0.3 mm, more preferably at least 0.5 mm, more preferably at least 0.7 mm, more preferably at least 1.0 mm, more preferably at least 1.2 mm, and at most 3.0 mm, more preferably at most 2.7 mm, more preferably at most 2.3 mm, more preferably at most 2.1 mm, more preferably at most 2.0 mm, and more preferably at most 1.5 mm.” However, this statement cannot replace evidence. Please see MPEP 2145 states that “A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997). Therefore, unless criticality evidence of the claimed range is shown, the claimed depth dimension would be optimized and obvious over the teachings of applied art.
In light of the foregoing, applicant’s arguments are not persuasive.
Claims 12 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Sänd (WO2005/115180A1, IDS of 04/22/2024) in view of Lockwood et al. (WO2010/114816A1, IDS of 01/29/2025) and Jonsson et al. (US2006/0147498A1), or further in view of Kleinsorgen et al. (US6165499A, IDS of 06/21/2024), and further in view of Gee et al. US2011/0180087A1 (this reference corresponding to US9,027,567, IDS of 03/14/2024 patent #1).
However, Sänd in view of Lockwood/Jonsson or further in view of Kleinsorgen does not expressly teach various dimensions of substrate of instant claim 12 and sweetener of instant claim 29-30. The deficiencies are cured by Gee.
Gee teaches an oral pouch product 10 comprising a pouch wrapper 12 having an inner botanical filling material 22 and/or the coating 20 (Fig.3) on the inner 18 and/or outer web 16 contained within the pouch wrapper 12, and the inner web and/or the outer web can comprise paper ([0010]) and can be formed of a cellulose fiber ([0053]); and the filing material 22 comprise a tobacco component ([0036]-[0039]) and additives such as vitamins, flavorant, minerals, sweeteners, coloring agents, amino acids, etc., ([0039]-[0040] and [0042]) and the filling material can further include humectants (=softening agent) such as glycerol (=glycerin) or polypropylene glycol ([0038]) which reads on the claimed carrier/flavorant/sweeteners; and the coating on filling material comprises flavorant, other additives such as sweeteners and humectants, at least one polymer and/or water ([0012], [0023], [0024], [0039] and [0050]) and wherein the humectants can be added to the tobacco material 22, coating 20, inner web 18 and/or outer web 16 of the pouch wrapper 12 to help maintain the moisture levels in the oral pouch product 10 and the coating has a moisture content of about 5 to 8% (claim 8 of prior art) and additional humectants can provide a higher moisture feel to a drier tobacco component ([0038]); the pouch product 10 is an oral pouch product that is designed to be placed in the mouth, preferably between the cheek and gum, for oral enjoyment, it thus fits on a user's gums; the oral pouch product has the length up to about 5 cm, the width of up to about 5 cm, and the height of up to about 3cm ([0056]) which reads on the claimed length of about 10 to 50mm, width of about 3 to 15 mm, and a depth dimension of about 1.2 to about 2.7mm; in a preferred embodiment, the oral pouch product 10 is sized and configured to fit comfortably in a user's mouth, preferably between the cheek and gum ([0056]).
It would have been obvious to further define the sheet dimensions of Sänd with specific dimensions of Gee in order to provide a desired dimensions of substrate and thus such further definition would vary depending on the intended purpose, type of tobacco snuff, function of product, etc. And it would have been obvious to further add sweetener of Gee to the portion snuff composition of Sänd in order to give a predictable sweet taste to nicotine-containing composition of Sänd.
In light of the foregoing, instant claims 12 and 29-30 are obvious over Sänd in view of Lockwood/Jonsson, or further in view of Kleinsorgen and in view of Gee.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Gee is just stating its upper length, width and height dimensions and Gee teaches product 10 has a height from about 10 mm to about 3cm ([0056]) and oral pouch is comprised of multiple layers and filler of various materials, the ordinary artisan would not read the disclosure of “the height can be up to about 3cm”; and the significance of the substrate is stated in [0040] of instant specification.
The Examiner responds that again according to MPEP2123, the use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain, and even if the claimed thickness would not be intended in Gee, Lockwood/Jonsson do. Further please see MPEP 2144.05 IV. CHANGES IN SIZE, SHAPE OR SEQUENCE OF ADDITIN OF INGREDIENTS: A. Changes in size/proportion stating since the case laws has been held that changing the size or range of an article is not ordinarily a matter of invention. Appropriate selection of size, weight, ratios, etc. is considered routine, and is typically a matter of design choice. See In re Rose 105 USPQ 237 (CCPA 1955) and also In re Yount (36 C.C.P.A. (Patents) 775, 171 F.2d 317, 80 USPQ 141. In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), “the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” That is, generally, a change in the size or dimension of a product is not considered an invention for patent purposes unless it results in a new or unexpected function or outcome, and accordingly, the reasoning is that selecting an appropriate size, weight, or ratio is typically a routine design choice that would be obvious to a person of ordinary skill in the art, and the claimed thickness range would be optimized or adjusted depending on the intended purpose, the used materials, type of snuff, etc. Lastly, [0040] of the specification is mere a statement without any evidentiary/experimental data. The statement cannot replace evidence MPEP 2145 states that “A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997). Therefore, unless criticality evidence of the claimed range is shown, the claimed depth dimension would be optimized and obvious over the teachings of applied art.
Please note that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
In light of the foregoing, applicant’s arguments are not persuasive.
Claims 4, 5, 16 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sänd (WO2005/115180A1, IDS of 04/22/2024) in view of Lockwood (WO2010/114816A1, IDS of 01/29/2025) and Jonsson et al. (US2006/0147498A1), or further in view of Kleinsorgen et al. (US6165499A, IDS of 06/21/2024), and in view of Reddick et al. (US2014/0255452A1) and McAdam et al., “The composition of contemporary American and Swedish smokeless tobacco products”, BMC Chemistry, 2019 13:31, pp. 1-15.
However, Sänd in view of Lockwood/Jonsson, or further in view of Kleinsorgen does not expressly teach the amounts of glycerin of instant claims 4-5; and the amounts of nicotine and flavoring agent of instant claims 16 and 22. The deficiencies are cured by Reddick and McAdam.
Reddick teaches nicotine-containing pharmaceutical product comprising nicotine, excipients including flavorant (e.g., mint, cinnamon, cherry, or other fruit favors), humectant (e.g., glycerin), and sweetener ([0050]); and the selection and amount of each excipient can depend upon factors such as the ultimate form and function of product that is desired ([0049]), and the amount of nicotine active ingredient is at least about 0.5mg, generally, at least 1mg, at least 1.5mg, frequently at least about 2mg per day and but the amount of active ingredient within the overall composition can vary ([0057] and [0059]).
McAdam discloses nicotine-containing tobacco various commercial products wherein the products contain various amounts of humectants such as glycerol (Table 1: 0-3.43%) and polypropylene glycerol (Table 1: 0-3.02% of total sugar), sweeteners such as sugar (Table 1: 0-31.6%), nicotine (Table 1: 0.08-29.5mg/g), and moisture contents (Tables 4-5) that overlap the claimed ranges of 2-60% or 15-45% of glycerin, about 0.02-about 30% of nicotine.
It would have been obvious to optimize or adjust the prior art amounts of Sänd (moisture content), Reddick (nicotine and excipients) and MaAdam (glycerin and nicotine) with the claimed amounts because those applied references teach overlapping amounts of nicotine and glycerin and moisture contents, and Reddick further teaches amount of each excipient can depend upon factors such as the ultimate form and function of product that is desired. MPEP 2144.05 states that [I]n 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 light of the foregoing, instant claims 4, 5, 16 and 22 are obvious over Sänd/Lockwood/Jonsson, or in view of Kleinsorgen, and in view of Reddick and McAdam.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Reddick and McAdam also do not disclose the claimed thickness and McAdam is concerned with the composition of contemporary American and Swedish smokeless products and does not teach size of the product; and the claimed thickness is significant as disclosed in the specification at [0040].
The Examiner responds that Reddick and McAdams are not relied on for disclosing the claimed depth size, but rather for disclosing the amounts of additional ingredients. Lastly, please note that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
Accordingly, applicant’s arguments are not persuasive.
Conclusion
All the examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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