Detailed Office 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 .
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.
Election/Restrictions
Applicant’s election of Group 1 (Claims 1-19) in the reply filed on April 24, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 24, 2026.
Claim Objections
Claim 1 objected to because of the following informalities: ‘7,5’ from line 3, should be changed to ‘7.5’. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-7, 13-15, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holton (US20210169867A1).
In regards to claim 1, Holton teaches a nicotine pouch product container (outer container [0104],
a plurality of nicotine pouches for nicotine oral delivery having a pH ranging from 7,5 to 11 (The oral composition is positioned within a pouch [0035]. A high nicotine and a high moisture content product that displays a pH for the compositions to be in the range of about 7.5 to about 11 [0051]. The pouches can be provided as individual pouches, or a plurality of pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30 pouches) can be connected or linked together [0101].),
at least one oral product comprising a buffer component (the compositions or products to exhibit a defined pH, which may be achieved through the use of suitable buffers [0051]),
wherein the plurality of nicotine pouches has a pH distribution comprising a low pH side of the pH distribution and a high pH side of the pH distribution (A high nicotine and a high moisture content product that displays a pH for the compositions to be in the range of about 7.5 to about 11 [0051]. Holton teaches a range of pH’s that the composition can obtain. The pH 7.5 is on the lower pH side of the range and the pH 11 is on the high side of the range),
wherein the buffer component in the at least one oral product is in a quantity sufficient to reduce increased pH arising in an oral cavity of a user as a consequence of using a nicotine pouch selected from the plurality of nicotine pouches having a pH in the high pH side of the pH distribution ( it may be desirable in certain embodiments to provide a pH within a defined range, and the foregoing materials (pH adjusters or buffering agent) can be suitable for use in providing compositions and products having the desired pH range [0084].
In regards to claims 2 and 3, Holton teaches a nicotine pouch product container of claim 1, wherein the high pH side of the pH distribution of the plurality of nicotine pouches comprises nicotine pouches having a pH ranging from 9 to 11 (where a high nicotine, high moisture content product is desired, it may be useful to control the overall composition (include the addition or exclusion of any buffers) pH for such compositions may be in the range of about 7.5 to about 11 [0051]. Holton teaches a pH range from 7.5 to 11 and the pH range teach over the claimed range of nicotine pouches having a pH ranging from 9 to 11),
wherein the high pH side of the pH distribution of the plurality of nicotine pouches represent at most 35% of a total pH distribution of the plurality of nicotine pouches (Holton teaches the presence of nicotine composition that is used for nicotine pouches and having a pH range of 7.5-11 or about 8 to about 9.5 [0051]. The claimed range is ‘at most 35% represent the high pH side’, thus indicating that there can be an absence of the high pH side. Holton meets the limitation of the claim by having composition at about 8 to 9.5),
wherein the high pH side of the pH distribution of the plurality of nicotine pouches represent at most 5% of a total pH distribution of the plurality of nicotine pouches ((Holton teaches the presence of nicotine composition that is used for nicotine pouches and having a pH range of 7.5-11 or about 8 to about 9.5 [0051]. The claimed range is ‘at most 5% represent the high pH side’, thus indicating that there can be an absence of the high pH side. Holton meets the limitation of the claim by having composition at about 8 to 9.5).
In regards to claims 6-7, Holton teaches a nicotine pouch product container of claim 1, wherein the at least one oral product is in a solid form (The manner by which the various components of the present compositions are combined may vary. The components noted above, which may be in liquid or dry solid form [0094]),
wherein the oral product is a patch, a chewing-gum, a capsule, or a crash-ball (Products configured for oral use as described herein may take various forms, including gels, pastilles, gums, lozenges, powders, and pouches [0096]).
In regards to claim 13, Holton discloses a nicotine pouch product container of claim 1, wherein the at least one oral product comprising the buffer component is arranged in the plurality of nicotine pouches (where a high nicotine, high moisture content product is desired, it may be useful to control the overall composition (include the addition or exclusion of any buffers) to prove a pH for such compositions may be in the range of about 7.5 to about 11. [0051]. Holton is teaching that the buffer can be included in the nicotine composition and the nicotine composition is used to make the plurality of the final oral product that contains the nicotine composition).
In regards to claims 14, 15, 17 and 19, Holten discloses a nicotine pouch product container, wherein the buffer component consists of or comprises at least one of an acidic component, a mix of different acid components, or a mix of acid and basic components (the compositions and products may include a content of one or more organic acids. As used herein, the term “organic acid” refers to an organic (i.e., carbon-based) compound that is characterized by acidic properties. [0075]),
wherein the buffer component consists of or comprises an acidic component, and the acidic component is an organic acid (the compositions and products may include a content of one or more organic acids [0075]),
wherein the buffer component consists of or comprises an acidic component, and wherein the acidic component is in powder form and/or in liquid form (the one or more organic acids are added neat (i.e., in their free acid, native solid or liquid form [0075]),
wherein the at least one oral product comprising the buffer component comprises a flavoring agent (one or more flavoring agents may be retained on a portion of a carrier or filler, [0053]).
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.
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Holton (US20210169867A1), in view of Nilsson (US20150272878A1).
Holton is applied under 35 U.S.C. 102 (a)(1) , as above.
In regards to claim 4 and 5, Holton teaches a nicotine pouch product container comprising a plurality of nicotine pouches for nicotine oral delivery having a pH ranging from 7.5 to 11 ([0051]). Holton further teaches that the pH of the nicotine pouch composition is controlled through the inclusion or exclusion of buffering agents to provide a desired pH for the composition ([0051]).
Holton does not expressly disclose that the buffer agents in the oral product is present in an amount sufficient to reduce the increased pH of the oral cavity to a pH ranging from 6 to 8 or 6.5 to 7.5.
Nilsson teaches an oral nicotine product comprising a pH-adjusting agent. Nilsson further teaches that the pH adjusting agent adjusts the local pH in the oral environment and is present in an amount sufficient to adjust the pH to above 6, for example, about 7.5 to 9.5 ([0031 & 0048).
Holton and Nilsson are analogous prior art to the current invention because they are concerned with the same field of endeavor, namely oral delivery product containing nicotine. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nicotine pouch product container of Holton to utilize the pH adjusting teachings of Nilsson because Nilsson teaches selecting an amount of pH adjusting agent sufficient to achieve a desired pH in the oral environment. One of ordinary skill in the art would have had a reasonable expectation of success because Nilsson teaches that pH-adjusting agents effectively control oral pH and teaches pH values above 6, including about 7.5 to 9.5, which overlap the claimed ranges.
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Holton (US20210169867A1), in view of Kindvall (WO2021004928A1, English Translation: US20220248748A1).
In regards to claim 8 and 9, Holton teaches a nicotine pouch product container of claim 1, wherein the at least one oral product is arranged separately from the plurality of nicotine pouches and the at least one oral product comprising the buffer component substantially does not comprise nicotine.
Holton does not expressly teach the oral product being separated from the plurality of nicotine pouches nor does he teach at the oral product not having nicotine.
Kindvall supplements Holton by teaching a pH adjuster that may be included in the first coating, in the second coating and/or sorbed to nicotine free particles such as particles that are free from a coating comprising a nicotine source. By keeping a part or all of the pH adjusting agent separate from the nicotine source the storage stability of the nicotine source may improve since a high pH may have a negative effect on the stability of the nicotine source [0108]. Kindvall further teaches a filling material that comprises additives (a pH adjusting agent, a flavouring agent, a sweetener, a humectant and any mixture thereof) that does not comprise nicotine [0095].
Holton and Kindvall are analogous prior art to the current invention because they are concerned with the same field of endeavor, namely nicotine pouches and nicotine pouch containers.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nicotine pouch of Holten to include the teaches of the pH adjuster of Kindvall, because Kindvall discloses by keeping the pH adjusting agent separate from the nicotine to increase storage stability of the nicotine. By keeping the oral product buffer component separate from the nicotine pouch and letting the oral product buffer component not comprise of nicotine, the storage stability of the nicotine pouches will increase. [0108].
Claim(s) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Holton (US20210169867A1), in view of Kindvall (WO2021004928A1, English Translation: US20220248748A1), in further view of Reddick (US20140255452A1).
In regards to claim 10 and 11, Holton and Kindvall teaches a nicotine pouch product container of claim 8, wherein each of the plurality of nicotine pouches has an outer surface with a first indication and the at least one oral product comprising the buffer component has an outer surface with a second indication, wherein the first indication is different from the second indication,
wherein each of the first indication and the second indication comprises a color, a printed pattern, and/or an embossing pattern.
Holton and Kindvall does not expressly teach a way to distinguish he buffer component from the plurality of nicotine pouches by way of a color, a printed pattern, and/or an embossing pattern.
Reddick discloses a pouched product with the cavity of the pouch containing nicotine [0012]. Reddick teaches imprinting/embossing as a way of product identification on the outer surface of the pouch. The imprinted product identifying information serves not only a product identification function, but the imprinting also contributes to sealing of the pouch. The printed product embodiments describe, any combination of alphanumeric characters, designs, patterns, etc. can be imprinted onto a nicotine-containing pharmaceutical product. The finished product will have a three-dimensional (i.e., raised or indented) effect. [0033]
Holton, Kindvall, and Reddick are analogous prior art to the current invention because they are concerned with the same field of endeavor, namely nicotine pouch and nicotine pouch containers.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nicotine pouch of Holten and Kindvall to include the product identification function of Reddick to provide product identifying information and the imprinting also contributes to sealing of the pouch. This would allow the pattern of buffer components to have a different pattern from the plurality of buffers.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Holton (US20210169867A1), in view of Kindvall (WO2021004928A1, English Translation: US20220248748A1), in further view of Hession (US20220135293A1).
In regards to claim 12, Holton and Kindvall teaches a nicotine pouch product container of claim 8, wherein a first chamber and a second chamber, wherein the plurality of nicotine pouches is arranged in the first chamber and the at least one oral product comprising the buffer component is contained in the second chamber.
Holton and Kindvall does not expressly teach a container that comprises of multiple chambers (first and second chamber).
Hession discloses a container that provides housing for oral products that maybe a tobacco product (snus) or a non-tobacco product (nicotine, with or without tobacco) [0056]. Hession teaches a first compartment that may store the consumer product and a second compartment that can be the disposal or storage compartment [0080].
Holton, Kindvall, and Hession are analogous prior art to the current invention because they are concerned with the same field of endeavor, namely nicotine pouches and nicotine pouch container.
Therefore it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nicotine pouches of Holton and Kindvall with the container of Hession, to have the plurality of nicotine pouches in a separate chamber from the buffer component because Kindvall teaches by keeping a part or all of the pH adjusting agent separate from the nicotine source the storage stability of the nicotine source may improve since a high pH may have a negative effect on the stability of the nicotine source [0108].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Holton (US20210169867A1).
In regards to claim 16, Holton discloses a nicotine pouch product container of claim 1, wherein the buffer component consists of or comprises an acidic component, and wherein the at least one oral product comprises 2-10wt.% citric acid.
Holton does not expressly disclose the claimed range of 2-10 wt. % of citric acid, but teaches a broader range of 0-10 wt. % of organic acid and the organic acid is citric acid [0077 & 0078].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a citric acid wt. % within the disclosed range of 2-10 wt. % from the range disclosed by Holton because Holton teaches that wt. % throughout the disclosed range are suitable for the intended purpose. One of ordinary skill in the art would have had a reasonable expectation of success in selecting a wt.% of citric acid within the disclosed range.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Holton (US20210169867A1), in view of Chapman (US20160157515A1).
In regards to claim 18, Holten discloses a nicotine pouch product container of claim 17, wherein the acidic component is in liquid form and is comprised in a capsule or in a crash-ball.
Holton does not expressly teach the acidic component in a capsule or in a crash-ball.
Chapman discloses a pouched product adapted to release a releasable component (i.e. nicotine) from a fabric pouch. Chapman teaches a release modifying agent can be in an encapsulated form (i.e. capsule). The capsule is configured to disperse the release modifying agent sufficiently rapidly so as to modify the release of the releasable component from the composition in the water-permeable fabric pouch. Chapman further teaches the capsule can comprise a capsule wall that is formed of a material that is configured to allow for disperse of the release modifying agent and he capsule wall may comprise a material that is configured to dissolve or otherwise degrade under mouth conditions [0064].
Holton and Chapman are analogous prior art to the current invention because they are concerned with the same field of endeavor, namely nicotine pouches and nicotine pouch container.
Therefore it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nicotine pouches of Holton with the capsule of Chapman, to have release modifying agent (buffer component) stored in the capsule because the capsule wall, of the capsule, is made of comprise a material that is configured to dissolve or otherwise degrade under mouth conditions [0064].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNAH C NNABUGWU whose telephone number is (571)272-8791. The examiner can normally be reached Mon-Thurs. 8:30am-5:00pm.
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/H.C.N./Examiner, Art Unit 1747
/Christopher M Rodd/Primary Examiner, Art Unit 1766
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