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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/13/2025 has been entered.
Status of the Claims
Claims 1, 2, 6-18, 23-26, and 28-31 are pending and are subject to this office action. Claim 1 and 6 are amended. Claims 3-5 and 19-22 are cancelled. Claims 28-31 are new.
Response to Amendment
The Examiner acknowledges the Applicant’s response filed on 10/13/2025 containing amendments and remarks to the claims.
Response to Arguments
Applicant’s arguments, see pg. 5, filed 10/13/2025, 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, 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. 5-10, filed 10/13/2025, with respect to the rejections of claims 1, 2, 6-18, 23-26, and 28-31 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
On pg. 7, Applicant argues that there is no teaching, suggestion, or motivation to modify the pouch disclosed by Crawford with a nicotine component because Crawford discloses a “botanical focused” pouch without an active ingredient. The Examiner disagrees because Crawford discloses a pouch comprising a functional ingredient such as an energizing agent ([0031, 0033]). A functional ingredient is considered to be an active ingredient.
On pg. 7-8, 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. 8-9, Applicant argues that Goode and Fransén do not disclose the dimensions required by claim 1. Goode was relied upon for claim 6 for disclosing a seamless pouch which is no longer required by claim 6. 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. 9, Applicant argues that Crawford fails to disclose a triangular shaped pouch, as required by claim 28. The Examiner disagrees because Crawford discloses a polygonal pouch shape ([0017]) which includes a triangle.
On pg. 9-10, Applicant argues that Crawford does not disclose inclusion of a particulate filler and water in the claimed amounts, as required by claim 29. The Examiner disagrees that Crawford does not disclose a particulate filler. Crawford discloses the non-tobacco botanical component (18) may be 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). However, the Examiner agrees that Crawford does not disclose the pouch comprises a water content in the claimed range. However, newly found prior art reads on the claim and is presented in the rejection of claim 29 below.
On pg. 10, Applicant argues the references do not teach a pouch product having a total weight of 600 to 800 mg, as required by claim 30. The Examiner disagrees because Crawford discloses the pouch product (10) weighs 0.2 to 5.0g ([0015]). The claimed range of 600 to 800 mg overlaps with the range taught by the prior art and is therefore considered prima facie obvious.
On pg. 10, Applicant argues that Crawford does not disclose the pouch is 80 to 100% filled with the composition based on volume, as required by claim 31. The Examiner disagrees because Crawford discloses the inner filling material (16) may completely or partially fill the interior of the pouch wrapper (14). 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.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 recites “shorted edges” in line which should read “shorter edges.”
Appropriate correction is required.
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.
Claim 18 recites the limitation, “the long edge” in line 2. There is insufficient antecedent basis for this limitation in the claim because it the first mention of a long edge. The specification appears to disclose a five sided pouch (Fig. 4) have one primary edge that is longer (pg. 9-10) than the opposite edges. For the purposes of examination, the long edge will be interpreted as 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
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 a seal (12, “single seam”) around a periphery of the pouch wrapper (14, Fig. 2, [0022]).
Regarding claim 7 and 8, Crawford discloses 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 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 13-18, Crawford discloses 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 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 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 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). 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
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.
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/M.F.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/ Supervisory Patent Examiner, Art Unit 1755