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 .
Status of the Claims
Claims 1-12 are pending and are subject to this Office Action. This is the first Office Action on the merits of the claims.
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, 3-4, 6, 8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sebastian et al. (US20160073689 A1).
Regarding claim 1, Sebastian directed to a pouched product adapted for oral use ([0008]), discloses a filler ([0039]) for an oral pouch comprising: an active material (nicotine, including free-base, salt and complex form); [0038] - [0039]); an excipient comprising cellulose ([0039]) and sugar alcohol (“e.g., xylitol, sorbitol”; [0039]); a binder ([0039]); a pH adjuster (pH control agents; [0039]); and a flavoring agent (flavors; [0039]), wherein the sugar alcohol comprises sorbitol ([0039]).
Sebastian doesn’t explicitly disclose a filler that comprises each of the claimed compounds but discloses them all as potential excipients and additional ingredients, and thus it would be obvious to one of ordinary skill to combine any number of these expressly disclosed ingredients into a filler as it merely involves combining known ingredients in the art with a reasonable expectation of success in forming a suitable filler for a pouch product.
Regarding claim 3, Sebastian discloses a pouched filler composition comprises a primary active material described as nicotinic compound. Nicotinic compound is disclosed in free-base form (i.e., natural nicotine), salt form or complex form (i.e., derivative) ([0037] – [0039]).
Regarding claim 4, Sebastian discloses that the cellulose comprises microcrystalline cellulose (MCC) ([0027]), and
the sugar alcohol comprises isomalt, mannitol, xylitol, mannitol, lactitol and sorbitol ([0039]).
While Sebastian doesn’t explicitly disclose blending two or more sugar alcohols to make a pouch composition, it would be obvious to one of ordinary skill in the art at the time of invention to formulate a pouch composition using a mixture of the sugar alcohols that are disclosed by Sebastian to achieve a reasonable success of making a suitable pouch product.
Regarding claim 6, Sebastian discloses that the binder comprises hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), acacia, sodium alginate, xanthan gum and gelatin ([0039]).
Regarding claim 8, Sebastian discloses that the pH adjuster comprises potassium carbonate, potassium bicarbonate, sodium carbonate, sodium bicarbonate, or mixtures thereof ([0039]).
Regarding claim 10, Sebastian discloses that the flavoring agent comprises of mint, cinnamon, cherry or other fruit flavors ([0039]).
Regarding claim 11, Sebastian discloses that the filler comprises one or more of a sweetener, a humectant, an antioxidant, and a preservative ([0039]).
Regarding claim 12, Sebastian discloses an oral pouch comprising: the filler for the oral pouch of claim 1; and a packaging material (an outer water-permeable container 20; [0028]) that wraps the filler ([0028]; FIG.1).
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sebastian as applied to claim 1 above, and alternatively in view of Bruun (US20220331306 A1 cited in the IDS dated 12/30/2024).
Regarding claim 2, Sebastian discloses various sugar alcohols described as natural or artificial sweeteners, such as sorbitol, used in pouch products suitable for oral use ([0039]).
While Sebastian doesn’t explicitly disclose the amount of sorbitol added to a pouch composition, a person of ordinary skill in the art would be motivated to select a single sugar alcohol from Sebastian’s disclosed list, and would arrive at a composition in which sorbitol constitutes the entirety (100%) of the sugar alcohol with a reasonable expectation of success in forming a suitable filler for a pouch product.
Alternatively, Bruun directed to an oral pouch containing a matrix composition including nicotine and a water-soluble composition (Abstract), discloses the composition includes sugar alcohol to be used either as carriers ([0012], [0043]) or as sweetener ([0037]). Bruun further discloses using a single type of sugar alcohol, or a mixture of two or more sugar alcohols in a composition ([0038]), such as sorbitol ([0039]; [0109]). Bruun further demonstrates that pouch number 101 has a composition with sorbitol as sole sugar alcohol included in an amount of 98 weight percent with respect to a total amount of sugar alcohol ([0168]; TABLE 1). The amount disclosed by the prior art overlaps the claimed range of sorbitol that is 50 wt% or more, and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian by making a composition with sorbitol amount of 50 wt% or more with respect to the total amount of sugar alcohol as taught by Bruun, because both Sebastian and Bruun are directed to a filler composition for an oral pouch, Bruun teaches it is known in the art to use a single or mixture of sugar alcohol for a filler composition and further teaches a specific amount of sorbitol is used to form an effective pouch composition, and this involves applying a known teaching to a similar product to yield predictable results.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sebastian as applied to claim 1 above, and further in view of Agren (US20230180817 A1 cited in the IDS dated 12/30/2024).
Regarding claim 5, Sebastian teaches the filler containing cellulose which comprises microcrystalline cellulose (MCC) ([0039]), but is silent regarding the specific content of nicotine and MCC.
Agren directed to nicotine oral delivery product (Abstract), discloses a filler comprising nicotine ([0016] – [0017]) and cellulose ([0021]), wherein the cellulose comprises MCC as a filler ([0041] – [0042]), and a content of the MCC is 1-30 wt% ([0047] – [0048]) with respect to a weight of total solid contents of the filler for the oral pouch ([0086]; TABLE 1]).
Agren further discloses the content of nicotine in the composition ranging between 1 to 15 wt%. The range disclosed by the prior art overlaps the claimed range of MCC content being 5 to 20 wt%, which is also 1 to 2 times the content of nicotine, and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian by making the amount of MCC in the filler to be 1 to 2 times the content of nicotine, that is about 5 to 20 wt% of MCC with respect to a weight of total solid contents of a filler oral pouch as taught by Agren, because one of ordinary skill in the art would look to a similar reference for a suitable amount of MCC in a similar pouch product, especially when the original reference is silent to one, Agren teaches a specific amount of MCC used as a filler for an oral nicotine pouch, and this merely involves applying a known MMC amount of a similar oral pouch product to yield predictable results.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sebastian as applied to claim 1 above, and further in view of Keller et al. (US20210177754 A1).
Regarding claim 7, Sebastian discloses that the binder comprises HPC ([0039]) but doesn’t disclose a content of the HPC is 5 to 8 wt% with respect to a content of the filler.
Keller directed to a nanoemulsion intended for human oral use (Abstract) discloses a composition enclosed within a pouch to form a pouched product intended for oral use ([0044]). Keller further discloses that the composition comprises an active ingredient and a binder ([0117]) among other standard filler ingredients ([0020], [0034], [0103], [0106]). Keller further discloses the binder comprises a cellulose derivative which is hydroxypropylcellulose (HPC) ([0119]). The composition comprises from about 1 to about 10% of HPC by weight, based on the total weight of the composition ([0119]). The amount of binder, HPC, utilized in the composition ranges from 5 to 10% by weight ([0118]). The range disclosed by the prior art overlaps the claimed range of HPC from 5 to 8 wt%, and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian by making the amount of HPC to be between 5 to 8 wt% with respect to a content of the filler as taught by Keller, because both Sebastian and Keller are directed to an oral pouch, Sebastian is silent to the amount of HPC with respect to a content of the pouch filler, one of ordinary skill in the art would be motivated to look to a similar reference for a suitable amount of HPC binder in a similar pouch product, Keller teaches a specific amount of HPC used to provide the desired physical attributes and physical integrity to a pouch composition, and this involves applying a known teaching to a similar product to yield predictable results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sebastian as applied to claim 1 and 8 above, and further in view of Nilsson (US20150272878 A1).
Regarding claim 9, Sebastian discloses that a filler comprises pH adjusters such as sodium carbonate and sodium bicarbonate ([0039]).
However, Sebastian doesn’t explicitly disclose the weight ratio of sodium bicarbonate and sodium carbonate being 7:3 to 6:4, and that a pH of the filler is 8.3 to 8.5.
Nilsson directed a product for oral delivery of nicotine (Abstract) discloses a composition of the oral delivery product containing a powder of free nicotine salt, at least one pH adjusting agent and at least one filler, and a water insoluble pouch ([0016]).
Nilsson further discloses a filler in a powder form pH adjusting agents in order to ensure that when the powder is dissolved in saliva, a sufficiently high local pH is obtained. Such a high local pH is important to ensure that the dissolved nicotine is unprotonated (free-base) and hence can be effectively absorbed through the oral mucosa ([0019]). Nilsson further discloses that an example of a suitable pH adjusting system is sodium bicarbonate and sodium carbonate, and mixtures thereof ([0045]). Nilsson further disclosed the pH adjusting agents adjust the pH to above 6 when the composition/powder is dissolved or dispersed in purified water. For example, it is desirable to obtain a pH of about 8.5 ([0048]).
Nilsson expressly discloses varied compositions containing a combination of pH adjusters sodium bicarbonate and sodium carbonate, in example 3, the amount in weight of sodium bicarbonate is 56g and of sodium carbonate is 35g ([0076]), which results at a weight ratio of 1.6:1 of sodium bicarbonate to sodium carbonate mix. Similarly, example 7 shows the amount in weight of sodium bicarbonate is 480g and of sodium carbonate is 300g ([0091]), which results at a weight ratio of 1.6:1 sodium bicarbonate to sodium carbonate mix. The range disclosed by the prior art overlaps the claimed range of bicarbonate and sodium carbonate weight ratio of 7:3 to 6:4, and is therefore considered prima facie obvious.
Nilsson further discloses pH levels of a filler ranging from 8.14 to 9.1 (example 9, [0102], TABLE 3). The range disclosed by the prior art overlaps the claimed range of a pH of the filler 8.3 to 8.5, and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Sebastian’s pH adjuster by blending sodium bicarbonate with sodium carbonate at a weight ratio of 7:3 to 6:4 so as to achieve a filler pH between 8.3 to 8.5 as taught by Nilsson, because both Sebastian and Nilsson are directed to a nicotine oral pouch, one of ordinary skill in the art would look to a similar reference for a suitable pH level of a filler comprising the same materials, especially when the original reference is silent to one, Nilsson teaches the importance of pH adjusters added to a filler composition with specific weight ratio, thereby adjusting the pH of a filler so that when in use, nicotine will be effectively absorbed through the oral mucosa of a user, and this involves applying a known pH adjuster blend and a known filler pH level of a similar oral pouch product to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELEN G GHEBRESELASSIE whose telephone number is (571)270-0196. The examiner can normally be reached 8am-5pm.
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/HELEN GHEBRESELASSIE/ Examiner, Art Unit 1755
/PHILIP Y LOUIE/ Supervisory Patent Examiner, Art Unit 1755
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