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 1-15, and 23-25 are pending and are subject to this office action. Claim 1 has been amended, claim 16 is canceled, and claim 25 is new.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/29/2025 has been entered.
Response to Amendment
The Examiner acknowledges the Applicant’s response filed on 12/29/2025 containing amendments and remarks to the claims.
Response to Arguments
Applicant’s arguments, see pg. 6-7, filed 12/29/2025, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Applicant has amended to claim 1 to require the calcium salt is, “selected from the group consisting of calcium benzoate, calcium gluconate, calcium glycerol phosphate, calcium lactate, calcium lactate gluconate, and any combination thereof” which was previously presented in claim 16. Keller discloses the particulate filler components may include a calcium salt ([0092]) but does not explicitly disclose including at least one of the calcium salts recited in amended claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of a combination of previously applied art and newly found prior art.
On pg. 7-9, Applicant argues that the inclusion of the calcium salts recited in amended claim 1 provides unexpected results of enhanced nicotine release at an acidic pH. The Examiner disagrees.
Regarding Fig. 4, Applicant asserts that the inclusion of the calcium salts recited in amended claim 1 provides unexpected results of enhanced nicotine release at an acidic pH. However, claim 4 appears to show that nicotine release of powders excluding a calcium salt (powder A to C) reaches or exceeds 100%, whereas the maximum nicotine release of powders including calcium glycerol phosphate (powders D, E) is slightly lower. It has not been persuasively shown that Fig. 4 demonstrates unexpected results.
Further, the examples provided in Fig. 4 are not commensurate in scope with the claimed invention. Claim 1 requires a moisture content of at least 5%, whereas Fig. 4 and the associated disclosure in the specification are silent to the moisture content in the example compositions. Claim 1 requires an acidic pH (i.e. a pH less than 7.0), whereas Fig. 4 does not show the pH of each solution and the specification merely states the pH ranged from 3.92 to 7.92 which includes pH in the basic range of greater than 7.0. Claim 1 requires inclusion of a calcium salt selected from the group consisting of calcium benzoate, calcium gluconate, calcium glycerol phosphate, calcium lactate, calcium lactate gluconate, and any combination thereof. Fig. 4 provides data for a composition comprising calcium glycerol phosphate (powders D, E) but is silent to the remaining recited salts and combinations thereof. The examples lack sufficient comparison that would reasonably suggest to one of ordinary skill in the art that the results shown in the examples could be extrapolated to be representative of a superior result when using calcium salts other than calcium glycerol phosphate.
Regarding Fig. 5, the examples provided in Fig. 5 are not commensurate in scope with the claimed invention. Claim 1 requires inclusion of a calcium salt selected from the group consisting of calcium benzoate, calcium gluconate, calcium glycerol phosphate, calcium lactate, calcium lactate gluconate, and any combination thereof. Fig. 5 provides data for a composition comprising calcium glycerol phosphate (pouch AC, Table 8) or a combination of calcium lactate and calcium gluconate (pouch AD, Table 9) but is silent to the remaining recited salts and combinations thereof. The examples lack sufficient comparison that would reasonably suggest to one of ordinary skill in the art that the results shown in the example could be extrapolated to be representative of a superior result when using calcium salts other than calcium glycerol phosphate or a combination of calcium lactate and calcium gluconate.
The examples provided in Fig. 4 and Fig. 5 lack sufficient comparison to the closest prior art. The closest prior art relied upon in the prior rejection was Keller in view of Bruun, where Bruun discloses a composition comprising calcium benzoate. Fig. 4 provides data on compositions comprising calcium glycerol phosphate and Fig. 5 provides data on compositions comprising calcium glycerol phosphate or a combination of calcium lactate and calcium gluconate. The examples provided do provide a sufficient comparison to the closest prior art comprising calcium benzoate.
The prior art rejections below are maintained and modified below where necessitated by Applicant’s amendment.
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 1-10, 12, 15, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Keller (US 20210068447 A1) in view of Pederson (US 20120039981 A1) or alternatively in view of Bruun (US 20230210162 A1).
Regarding claim 1, Keller discloses a pouched product (100) for oral use (Fig. 9, [0162]), comprising:
A moisture permeable pouch (102) which contains a mixture (“composition”, Fig. 9, [0162]), and;
The mixture comprising at least 5% by weight water (“moisture content of about 5% or greater”, [0097]).
The mixture comprises a particulate filler, water, one or more organic acids, one or more active ingredients, and the mixture has a pH of less than 7.0 (“an acidic pH”, abstract, [0006, 0056, 0091, 0117])
The active ingredient is a nicotine component in the form of a resin complex of nicotine (“a nicotine polymer complex”, [0129, 0132])
The particulate filler components may include calcium carbonate, calcium phosphate, and combinations thereof (“at least one calcium salt”, [0092]).
Keller does not explicitly disclose the moisture content of the total product (i.e. pouch and mixture). However, it is evident that a mixture having a water content of at least 5% by weight would include pouched products with a moisture content that overlaps with the claimed range of about at least 5% and is therefore considered prima facie obvious.
Keller does not explicitly disclose the mixture comprises calcium salt selected from the group consisting of calcium benzoate, calcium gluconate, calcium glycerol phosphate, calcium lactate, calcium lactate gluconate, and any combination thereof.
However, Pederson, directed to oral nicotine products (abstract, [0073]), discloses:
A buccal sachet comprising one or more active ingredients including nicotine ([0025, 0047, 0073, 0086]),
The one or more active ingredients comprises nicotine, and calcium gluconate, calcium glycerophosphate or calcium lactate ([0167, 0186-0187]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Keller by including calcium gluconate, calcium glycerophosphate or calcium lactate in the nicotine containing composition as taught by Pederson because both Keller and Pederson are directed to oral nicotine products, Pederson discloses a pouch product comprising active ingredients including nicotine and calcium gluconate, calcium glycerophosphate or calcium lactate, and this involves applying a known active ingredient to a similar oral pouched product to yield predictable results.
Alternatively, Bruun, directed to an oral pouched nicotine product (abstract, [0195]), discloses:
The pouch composition comprises a preservative such as calcium benzoate ([0166-0167]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Keller, by including calcium benzoate in the mixture as taught by Bruun because both Keller and Bruun are directed to oral nicotine products, Bruun teaches the calcium benzoate can be used as a preservative, and this involves applying a known preservative in a similar oral nicotine product to yield predictable results.
Regarding claims 2 and 3, Keller discloses the mixture comprises at least 5% by weight water (“moisture content of about 5% or greater”, [0097]).
Keller does not explicitly disclose the moisture content of the total product (i.e. pouch and mixture). However, it is evident that a mixture having a water content of at least 5% by weight would include pouched products with a moisture content that overlaps with the claimed range of about at least 15% and about at least 25%.
Regarding claim 4, Keller discloses at least a portion of the nicotine is the form of a resin complex of nicotine ([0132]) which reasonably suggest an embodiment where the resin complex of nicotine is the only nicotine component.
Regarding claim 5, Keller discloses at least a portion of the nicotine is the form of a nicotine salt ([0131]) and at least a portion of the nicotine is in the form of a resin complex of nicotine ([0132]) which reasonably suggests an embodiment where the mixture comprises a portion of nicotine in the form of a resin complex and a portion of the nicotine is in the form of a nicotine salt.
Regarding claims 6 and 7, Keller discloses the resin complex of nicotine is nicotine polacrilex which is nicotine bound to polymethacrylic acid ([0132]) which is considered to meet the claim limitations of a polymeric cation exchange resin comprising a polyacrylic polymer.
Regarding claim 8, Keller discloses the resin complex of nicotine is nicotine polacrilex ([0132]).
Regarding claim 9, Keller discloses the overall product is in the form of particles ([0152]).
Regarding claim 10, Keller discloses the overall product is in the form of particles having a particle size of less than 1000µm ([0152-0156]) which overlaps with the claimed range and is therefore considered prima facie obvious.
Regarding claim 12, Keller does not explicitly disclose the particles are coated which reasonably suggests the particles are uncoated.
Regarding claim 15, Keller discloses the mixture comprises a pH adjuster including metal hydroxides such as sodium hydroxide and potassium hydroxide ([0127])
Regarding claim 24, Keller discloses the mixture has a pH of less than 7.0 ( abstract, [0006, 0056, 0117]), as discussed above. Keller further discloses that organic acid is added to bring the pH to a range of about 5.0-6.5 ([0117]).
Regarding claim 25, Pederson discloses an oral product comprising calcium gluconate, calcium glycerophosphate or calcium lactate ([0167, 0186-0187]).
Claims 11 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Keller (US 20210068447 A1) in view of Pederson (US 20120039981 A1) or alternatively in view of Bruun (US 20230210162 A1), as applied to claim 1 above, and further in view of Sahlén (US 20170280764 A1).
Regarding claim 11, Keller discloses the overall product is in the form of particles having a particle size of less than 1000µm ([0152-0156]).
Keller does not explicitly disclose that the particle size distribution is bimodal.
However, Sahlén, directed to an oral smokeless moist snuff product (abstract), discloses:
An oral smokeless moist snuff product comprising particles containing a flavorant ([0017, 0024])
The particles have a diameter of 100µm to 1mm ([0118]).
Different sized particles may be used to provide desired flavor release profile where a first flavor is released from a first set of particles and a second flavor is released later from a second set of particles ([0119]).
Sahlén does not explicitly disclose a bimodal particle size distribution comprising a first mode of 75 to 125 µm and a second mode of 500 to 1000 µm. However, Keller discloses the overall product is in the form of particles having a particle size of less than 1000µm ([0152-0156]) which overlaps with the claimed particle size ranges and Sahlén discloses using two different sized particles to provide a desired release profile. Therefore, a person having ordinary skill in the art could have reasonably arrived at an oral pouched product using two different sized particles having a bimodal particle size distribution comprising a first mode of 75 to 125 µm and a second mode of 500 to 1000 µm.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Keller, in view of Pederson or Bruun, by using two different sized particles as taught by Sahlén because both Keller and Sahlén are directed to oral nicotine products, Sahlén teaches that two different sized particles may be used to provide a desired release profile, and this involves applying particles of two different known sizes to a similar oral pouched product to yield predictable results.
Regarding claim 23, Keller discloses the overall product is in the form of particles having a particle size of less than 1000µm ([0152-0156]).
Keller does not explicitly disclose that the particle size distribution is bimodal.
However, Sahlén, directed to an oral smokeless moist snuff product (abstract), discloses:
An oral smokeless moist snuff product comprising particles containing a flavorant ([0017, 0024])
The particles have a diameter of 100µm to 1mm ([0118]).
Different sized particles may be used to provide desired flavor release profile where a first flavor is released from a first set of particles and a second flavor is released later from a second set of particles ([0119]).
Sahlén does not explicitly disclose a bimodal particle size distribution comprising a first mode of 80 to 110 µm and a second mode of 700 to 1000 µm. However, Keller discloses the overall product is in the form of particles having a particle size of less than 1000µm ([0152-0156]) which overlaps with the claimed particle size ranges and Sahlén discloses using two different sized particles to provide a desired release profile. Therefore, a person having ordinary skill in the art could have reasonably arrived at an oral pouched product using two different sized particles having a bimodal particle size distribution comprising a first mode of 80 to 100 µm and a second mode of 700 to 1000 µm.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Keller, in view of Pederson or Bruun, by using two different sized particles as taught by Sahlén because both Keller and Sahlén are directed to oral nicotine products, Sahlén teaches that two different sized particles may be used to provide a desired release profile, and this involves applying particles of two different known sizes to a similar oral pouched product to yield predictable results.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Keller (US 20210068447 A1) in view of Pederson (US 20120039981 A1) alternatively in view of Bruun (US 20230210162 A1), as applied to claim 9 above, and further in view of Hansson (US 20040191322 A1).
Regarding claim 13, Keller is silent to coated particles in the pouched product.
Keller does not explicitly disclose the nicotine polymer complex particles are coated with a filling component or pH adjuster.
However, Hansson, directed to a nicotine containing particulate material for oral administration (abstract, [0052]), discloses:
The particulate material may be coated to delay the release of nicotine ([0043])
The particle material is coated with a sugar (“a filling component”) such as mannitol ([0043]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Keller, in view of Pederson or Bruun, by coating the particles with sugar as taught by Hansson because both Keller and Hansson are directed to oral nicotine products, Hansson teaches that coating the particulate delays the release of nicotine, and this involves applying known coating to particles in a similar oral product to yield predictable results.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Keller (US 20210068447 A1) in view of Pederson (US 20120039981 A1) or alternatively in view of Bruun (US 20230210162 A1), and Hansson (US 20040191322 A1) as applied to claim 13 above, and further in view of Kindvall (US 20220248748 A1).
Regarding claim 14, Hansson discloses the particle material is coated with mannitol [0043]) and that sodium carbonate may be incorporated into the particulate material to serve as a buffer substance ([0045]).
Hansson does not explicitly disclose the sodium carbonate is applied as a coating on the particle material.
However, Kindvall, directed to an oral pouched nicotine product (abstract) discloses:
A filling material comprising coated particles (Fig. 1, [0042, 0058])
The coating comprises sodium carbonate as a pH adjusting agent ([0101, 0107])
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Keller, in view of Pederson or Bruun and Hansson, by including sodium carbonate in the particle coating as taught by Kindvall because both Keller and Kindvall are directed to oral nicotine products, Hansson teaches sodium carbonate can be incorporated into the particulate material but is silent to how the sodium carbonate is incorporated and Kindvall teaches applying sodium carbonate in the form of a coating to particulate materials, and this involves applying a known buffer substance to a particle coating in a similar oral nicotine product to yield predictable results.
Conclusion
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/M.F.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755