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, 2, 6-18, 23-26, and 28-31 are pending and are subject to this office action. Claim 18 is amended.
Response to Amendment
The Examiner acknowledges the Applicant’s response filed on 04/21/2026 containing amendments and remarks to the claims.
Applicant has amended claim 18 to properly recite, “the shorter edges” instead of “the shorted edges”. The objection to claim 18 is withdrawn.
Response to Arguments
Applicant’s arguments, see pg. 5, filed 04/21/2026, with respect to the rejections of claim 18 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Applicant has amended claim 18 to replace the limitation, “the long edge” with “the primary edge” which corrects the antecedent basis issue. However, upon further consideration, claim 18 is rejected under 35 U.S.C. 112(b) for relative terms, “longer edges” and “shorter edges”, as detailed below.
Applicant’s arguments, see pg. 5-6, filed 04/21/2026, with respect to the rejections of claims 23-25 under 35 U.S.C. 112(b) have been fully considered but they are not persuasive.
On pg. 5-6, Applicant argues that the recited comparisons in claims 23-25 are intended to be against a standard conventional pouched product that would be readily appreciated by one of ordinary skill in the art. The Examiner disagrees because pouched products have varying packing densities and release profiles, and what is considered conventional may change over time. A person having ordinary skill in the art would not be able to ascertain the packing density or the degree of an extended release or delayed release of a conventional pouched product in order determine the scope of the claimed invention. Therefore, the rejection of claims 23-25 under 35 U.S.C. 112(b) is maintained.
Applicant’s arguments, see pg. 6-9, filed 04/21/2026, with respect to the rejections of claims 1, 2, 6-8, 12-18, 23-26, 28, and 30-31 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
On pg. 8, Applicant argues that one of ordinary skill in the art would not modify Crawford with the nicotinic component disclosed by Johnson because a nicotinic component is not a reasonable substitution for the functional ingredient disclosed by Crawford. The Examiner disagrees. Crawford discloses the pouch comprising a functional ingredient that may include an effervescent, vitamin, soothing ingredient, energizing ingredient, or chemesthesis agent but does not limit the functional ingredients that can be included or explicitly exclude providing a nicotine component in the pouch. Further, Crawford discloses an energizing agent may be included and nicotine is a stimulant that can be considered an energizing agent.
On pg. 8-9, Applicant argues that the combination of Crawford and Johnson does not disclose a method of modulating release of water soluble component by modifying the shape of the pouch. The Examiner disagrees. Crawford discloses modifying the pouch (10) to be shaped like a boomerang shape that covers more area than other shapes which allows the flavors and functional ingredients to disperse over a larger area of the mouth and provides a longer lasting flavor (Fig. 4, [0018]). Modulating release of water soluble components is interpreted as controlling the amount of component released, the rate of release, the timing of release (e.g. delayed or extended), or the location of the component released within the mouth. Therefore, allowing the functional ingredients to be dispersed over a larger area or providing longer lasting flavor is considering to be modulating release of water soluble components.
On pg. 9, Applicant argues that Crawford discloses broad ranges for the length, width, and thickness of the pouch compared to the claimed ranges and therefore a person having ordinary skill in the art would not be reasonably and predictably led to the claimed ranges. The Examiner disagrees because claimed length, width, and thickness ranges lie within the ranges taught by Crawford and are therefore considered prima facie obvious. The ranges of pouch dimensions taught by Crawford being broader than the claimed ranges does not preclude a person having ordinary skill in the art from arriving at a pouch with the claimed dimensions, absent evidence to the contrary. The Examiner notes that the Applicant has not provided any evidence that the claimed range is critical and has unexpected results which would rebut the prima facie case of obviousness.
On pg. 10, Applicant argues that Fransén do not disclose the dimensions required by claim 1. However, Fransén was not relied upon for disclosed the pouch dimensions. Instead, Fransén was relied upon for claims 9-11 for disclosing a pouch having multiple compartments. Crawford was relied upon for disclosing the claimed pouch dimensions, as discussed above.
On pg. 11, Applicant argues that Crawford does not disclose a fill percentage of 80-100%, as required by claim 31. The Examiner disagrees. Crawford discloses the inner filling material (16) may completely or partially fill the interior of the pouch wrapper (14, [0022]). While Crawford does not disclose a range of exact fill percentages by volume, a disclosure of a completely filled pouch is considered to be a pouch filled to the maximum capacity of 100% by volume. A completely filled/100% filled pouch lies within the claimed range and is therefore considered prima facie obvious. The Examiner notes that the Applicant has not provided any evidence that the claimed range is critical and has unexpected results which would rebut the prima facie case of obviousness.
The rejections below are maintained and modified based on Applicant’s amendment.
Claim Rejections - 35 USC § 112
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.
Claims 18, and 23-25 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.
The terms, “the two longer edges” and “the opposite edges are the shorter edges” in claim 18 are relative terms which renders the claim indefinite. The terms “the two longer edges” and “the opposite edges are the shorter edges” are not defined by the claim, 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. The claim recites “two longer edges” but does not define what component they are longer than. Similarly, the claim recites, “the opposite edges are the shorter edges” but does not define what component they are shorter than. The claimed relative dimensions between the two opposite edges, two shorter edges, and primary edge cannot be ascertained from the claim as written and therefore the claim is indefinite. The specification discloses a pouched product comprising 5 sides, where one side is longer and the other four sides are similar in length (Fig. 4, pg. 9 lines 30-31 to pg. 10 lines 1-2). For the purposes of examination, claim 18 will be interpreted as the method of claim 1, wherein the shape comprises a 5 sided surface having a primary edge that is the longest edge and the two opposite edges and two shorter edges are shorter than the primary edge.
Claim 23 recites the limitation, “the packing density is greater than in a corresponding conventional pouched product”, Claim 24 recites the limitation, “the release is extended as compared to the corresponding conventional pouched product”, and claim 25 recites the limitation, “the release is delayed as compared to the corresponding conventional pouched product.” The specification does not define the packing density or release profile of a conventional pouched product and therefore one of ordinary skill in the art could not determine the scope of the invention. For the purposes of examination, a packing density greater than a conventional pouch product will be interpreted as any pouched product with a packing density, an extended release compared to a conventional pouch product will be interpreted as any pouched product with extended release, and a delayed release compared to a conventional pouch product will be interpreted as any pouch product with a delayed release.
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.
Claims 1, 2, 6-8, 12-18, 23-26, 28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Crawford (US 20090025741 A1) in view of Johnson (US 20210169791 A1).
Regarding claim 1, Crawford discloses a method comprising:
Providing a tobacco free (“substantially free of tobacco”) oral flavor delivery pouched product (10, Fig. 2, [0002-0003, 0010]) comprising an inner filling material (16, “a composition”) enclosed in a porous pouch wrapper (14) which is designed to be inserted in the mouth (Fig. 2, [0010, 0013 0022]).
Providing a pouch wrapper made of a porous pouch outer material that allows the flavors and functional ingredients to diffuse out of the pouch wrapper and into the user's mouth (“an outer water permeable pouch”, [0022]).
Providing an inner filling material (16) that includes a non-tobacco botanical component (18), a functional ingredient, and a solid flavor component (22, [0023, 0029]).
Modifying the pouch (10) to be shaped like a boomerang having rounded edges with long arms that can extend around the gum line (Fig. 4, [0018]). Modifying the pouch to have a boomerang shape covers more area than other shapes which allows the flavors and functional ingredients to disperse over a larger area of the mouth and provides a longer lasting flavor (Fig. 4, [0018]) which is considered to meet the limitation of modulating release of water soluble components by modifying a shape of the outer water permeable pouch.
Providing the pouch (10) that fits comfortably in a user’s mouth, having a width, length, and thickness of 0.1 to 2 inch ([0015-0016]). The claimed ranges lie within the ranges taught by the prior art and are therefore considered prima facie obvious.
Crawford discloses the pouch comprises a functional ingredient which may include an energizing agent ([0030-0031, 0033]).
Crawford does not explicitly disclose the functional ingredient includes a nicotinic component in the form of nicotine, nicotine salt, or a resin complex of nicotine.
However, Johnson, directed to an oral pouched product (100, Fig. 1, [0061-0062]), discloses:
A pouched product (100) which contains a material (104, “composition”, Fig. 1, [0062])
The composition comprises one or more active ingredients including botanical ingredients and nicotine components ([0089, 0091])
The nicotine component may be in the form of nicotine free base, nicotine salt, or a resin complex of nicotine ([0109-0111])
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Crawford by providing nicotine free base, nicotine salt, or a resin complex of nicotine as a functional ingredient as taught by Johnson because both Crawford and Johnson are directed to oral pouched products, Crawford teaches an oral pouch product that comprises a botanical component and a functional ingredient but is silent to including nicotine, Johnson discloses an oral pouched product comprising active ingredients including botanicals and nicotine, and this involves applying a known functional ingredient to a similar oral pouched product to yield predictable results.
Regarding claim 2, Crawford discloses that the inner filling material comprises a botanical component such as coffee extracts (“flavorant”, [0023, 0029]).
Regarding claim 6, Crawford discloses providing a seal (12, “single seam”) around a periphery of the pouch wrapper (14, Fig. 2, [0022]).
Regarding claim 7 and 8, Crawford discloses providing a boomerang shaped pouch (10) that is placed between the cheek and gum of the user and extends around the gum line (Fig. 4, [0018]).
Regarding claim 12, Crawford discloses providing an oral flavor delivery pouch product (10) comprising a pouch wrapper (14) that has a seal (12, “grooves or ridges”) around the edges (Fig. 2, Fig. 4, [0013, 0019]).
Regarding claim 13-17, Crawford discloses providing a polygonal pouch shape that does not have sharp edges ([0017]) which reasonably suggests shapes with rounded edges. A polygonal pouch shape includes a four-sided surface (claim 13), a square or rectangle surface (claim 14), a parallelogram surface comprising equal sides (claims 15-16), and a pentagon (claims 17-18).
Regarding claim 18, Crawford discloses providing a polygonal pouch shape ([0017]) which includes a 5 sided surface and Crawford discloses providing a pouch (10) that fits comfortably in a user’s mouth, having a width of 0.1 to 2 inch and length of 0.1 to 2 inch ([0015-0016]). Therefore, a person having ordinary skill in the art, in view of the disclosed pouch shapes and dimensions, could have reasonably arrived at a 5 sided pouched product having a primary edge that is the longest edge, absent evidence to the contrary.
Regarding claim 23, Crawford discloses the filing material (16) may partially or completely fill the interior of the pouch wrapper (14, Fig. 2, [0022]). The packing density is interpreted as the weight of the filling material relative to the volume of the pouch. Therefore, the oral flavor delivery pouch product (10) is considered to have a variable packing density.
Regarding claim 24, Crawford discloses providing a boomerang shaped pouch (10) with long arms that can extend around the gum line and cover more area which allows the flavors and functional ingredients to disperse over a larger area of the mouth and provides a longer lasting flavor (“extended release”, Fig. 4, [0018]).
Regarding claim 25, Crawford discloses that the inner filling material (16) can include beads or capsules that contain liquid, semi-liquid, and/or gel additives that are released through mechanical action (i.e. the user biting down), allowing the user to delay the release of additives ([0030]).
Regarding claim 26, Crawford discloses providing an oral flavor delivery pouch product with a length of 0.1in to 2.0in and width of 0.1in to 2.0in ([0015]). The claimed range of greater than 30mm in one-dimension overlaps with the range taught by the prior art and is therefore considered prima facie obvious.
Regarding claim 28, Crawford discloses a polygonal pouch shape ([0017]) which includes a triangular shape. Crawford also discloses the pouch shapes do not have sharp edges ([0017]) which reasonably suggests shapes with rounded edges.
Regarding claim 30, Crawford discloses the pouch product (10) weighs 0.2 to 5.0g ([0015]). The claimed total weight overlaps with the range taught by the prior art and is therefore considered prima facie obvious.
Regarding claim 31, Crawford discloses the inner filling material (16) may completely or partially fill the interior of the pouch wrapper (14, [0022]). Completely filling the interior of the pouch wrapper is considered to be 100% filled based on volume. A completely filled/100% filled pouch lies within the claimed range and is therefore considered prima facie obvious.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Crawford (US-20090025741-A1) in view of Johnson (US 20210169791 A1), as applied to claim 1 above, and further in view of Fransén (US-20210235752-A1).
Regarding claim 9, Crawford discloses a single compartment oral flavor delivery pouch (Fig. 4, [0018]).
Crawford does explicitly disclose a shape comprising 2 or more compartments.
However, Fransén, directed to an outer water-permeable pouch containing an active ingredient-containing composition (abstract), discloses:
An active ingredient-containing product (100) comprising at least two pouches (101) having dimensions suitable for insertion into a user’s mouth (Fig. 1, Fig. 3, [0032, 0103,0104, 0110])
The multi-compartment design allows stable placement of multiple pouches underneath the lip compared to using multiple pouches in the mouth that are difficult to keep in place ([0005]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Crawford, in view of Johnson, by including two or more compartments in the boomerang shaped oral flavor delivery pouch because both Crawford and Fransén are directed to oral pouched products, Fransén teaches that the multi-compartment design allows stable placement of multiple pouches underneath the lip and this involves applying a known multi-compartment design to a similar pouch to yield predictable results.
Regarding claims 10 and 11, Fransén discloses an active ingredient-containing product (100) comprising at least two pouches (101, Fig. 1, Fig. 3, [0032, 0103, 0110]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Crawford (US-20090025741-A1) in view of Johnson (US 20210169791 A1), as applied to claim 1 above, and further in view of Abrahamian (US 20250194662 A1).
Regarding claim 29, Crawford discloses the non-tobacco botanical component (18) is a mixture of granulated tea and citrus fiber (“at least one particulate filler”), where the inner filling material (16) includes 25-90 wt% black tea and 8 to 25 wt% citrus fiber ([0023], claim 20). Therefore, a person having ordinary skill in the art would have reasonably arrived at an oral pouch product with a particulate filler (i.e. total weight percentage of both black tea and citrus fiber) in a range that overlaps with the claimed range.
Crawford does not explicitly disclose a water content of the composition.
However, Abrahamian, directed to a composition for an oral pouch product (abstract), discloses:
The water content of the composition is at least 40 wt% which results in greater palatability and greater softness for the user ([0089]). The claimed range overlaps with the range taught by the prior art and therefore is 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 Crawford, in view of Johnson, by providing a filling with a water content of at least 40 wt% as taught by Abrahamian because both Crawford and Abrahamian are directed to oral pouch products, Abrahamian teaches the higher water content results in greater palatability and greater softness for the user, and this involves applying a known water content to a similar oral pouched product to yield predictable results.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MORGAN FAITH DEZENDORF whose telephone number is (571)272-0155. The examiner can normally be reached M-F 8am-430pm EST.
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, Philip Louie can be reached at (571) 270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.F.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
Prosecution Insights