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 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 11/13/2025 has been entered.
Response to Amendment
This office action is in response to Applicant’s amendment filed 11/13/2025.
Claims 1 and 17 are amended.
Claims 2, 4-5, 14, and 18 are cancelled.
Claims 1, 3, 6-13, 15-17, and 19-21 are pending.
Response to Arguments
Applicant’s arguments, see page 9, filed 11/13/2025, with respect to the rejection of claims 1, 3-13, 15-16, and 20 as being provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending application 17/836564 and the rejection of claims 17, 19, and 21 as being provisionally rejection on the ground of nonstatutory double patenting as being unpatentable over copending application 17/836564 over Wiesmuller have been fully considered and are persuasive. Particularly, Applicant has amended the copending application to recite “alpha alumina has a particle size of about 0.5 µm to about 500 µm and comprises micropores with an average pore size of greater than 500 nm.” The rejection of 11/3/2023 has been withdrawn.
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Applicant argues that nothing in the cited references of Chapman, Canham, Weismuller, Corkery, and Kumar would predictably lead one of ordinary skill in the art to a product configured for oral use comprising a mixture that comprises a particulate filler comprising porous alumina in the form of agglomerates (p. 7). Applicant argues that Kumar mentions alumina only as a possible additional filler used to control the texture and/or weight of the disclosed tobacco products, but does not provide the additional filler, much less specifically alumina, in agglomerated form (p. 7).
The Examiner respectfully disagrees. As mentioned by Applicant, the instant specification defines the term “agglomerate” as “a combination of particles that are held together by a variety of physical/chemical forces” (p. 9, last paragraph). However, Kumar teaches that exemplary fillers include aluminum oxide ([0071]) and that tobacco particles may include one or more binders, which agglomerate smaller particles of tobacco together, and which may also hold fillers…which adhere to the tobacco particles ([0048]). In other words, Kumar teaches that the alumina filler is “in the form of agglomerates” because alumina particles are adhered to tobacco particles by the binder.
The Examiner suggests amending the claim in a way that specifies that the alumina particles are agglomerated to other alumina particles (e.g., “an agglomerate of porous alumina;” see p. 9, last paragraph) to overcome the current rejection.
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.
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.
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, 6-13, 15-17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Chapman (US 2016/0157515; of record) in view of Canham et al. (WO 2010/139987; of record), Wiesmuller (US 2007/0082101; of record), Corkery et al. (US 2011/0223297; of record), and Kumar et al. (US 2009/0293889; of record) as evidenced by Niesz et al. (“Sol-gel synthesis of ordered mesoporous alumina”; of record).
Regarding claim 1, Chapman discloses a pouched product adapted for the release of a releasable component therefrom (abstract; “product configured for oral use”) comprising an admixed composition (para. 62; “mixture”) comprising:
a composition (315) including one or more releaseable components (para. 35) and particulate tobacco material ([0026]);
a release modifying agent (325; para. 62), such as alumina (para. 80), adapted to react with the at least one or more releaseable components in the composition and thereby modify the release thereof (para. 9);
at least a particulate non-tobacco material (such as microcrystalline cellulose) (Paragraph 35; “one or more other particulate filler”); and
a water permeable fabric (320; “pouch”) to form a pouched product (300; para. 62).
However, Chapman is silent as to wherein the alumina is porous such that at least a portion of the releasable material is retained by porous alumina.
Canham teaches a mesoporous material for modifying the flavor and/or texture of an oral composition (abstract) comprising: a mesoporous material including a mesoporous alumina (Page 5, line 13; “particulate filler comprising a porous alumina”) having pores in the range of 5-50 nm (Page 5, ll. 17-18; “first average pore size”); and a loaded ingredient that is entrapped in the pores (Page 10, line 30-35; Page 11, lines 14-29; “releasable material retain by the porous alumina”), the loaded ingredient is released on contact or shortly after contact with the human tongue, pharynx, or soft palate (Page 3, line 25-27). Canham further teaches that the loaded ingredient can be herbal extracts, stimulants, and essential oils (page 11, line 10-12) or may be a flavor (Page 11, line 9; page 17, line 8-9) including ethyl vanillin and citral (Page 17, line 30-31). Lastly, Canham teaches wherein mesoporous alumina may be made as described in Chem. Commun. 1986-1987 (2005) (Canham; Page 10, line 7-8; equivalent to Niesz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nicotine and/or flavoring agents of Chapman to be located within a mesoporous alumina as in Canham because adding the ingredient into a mesoporous material can increase or mask the potency of the ingredient (Canham; Page 3, line 21-10).
As evidenced by Niesz, the mesoporous alumina used in Canham has a distribution of different pore diameters (see Fig. 2-3). Therefore, Canham’s mesoporous alumina with a distribution of different pore diameters has at least two different average particle sizes (see Fig. 3B of Niesz).
Moreover, modified Chapman does not explicitly teach the mesoporous alumina being gamma-alumina. Specifically, modified Chapman does not disclose the form of the mesoporous alumina.
Wiesmuller teaches a particulate carrier material loaded with flavoring agents having a large specific surface (abstract) wherein it is known that alumina oxide (alumina) is subdivided into three classes including the gamma form (paragraph 16), wherein the gamma-alumina oxide has a specific surface between 0.1 and 1000 m2/g (Paragraph 28) and a pore size between 0.3 and 5000 nm (Paragraph 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tried using gamma-alumina as the mesoporous material because (a) it is known in the art that there are a 3 of identified forms of alumina including gamma-alumina (Wiesmuller; Paragraph 16), and (b) Wiesmuller teaches that that the gamma-alumina is proven to be suitable for being loaded with a flavor and stably releasing the flavors over long period of time (Paragraph 12).
Furthermore, modified Chapman is silent as to the mesoporous alumina including pores with at least two different average pore sizes that are non-overlapping, including pores with a second average pore size of about 100 nm to about 500 nm.
Corkery teaches the use of a porous particle to control the release of a flavor in a food product which are loaded into the porous particle (abstract), the porous particle being silica (Paragraph 14) the particles having a first fraction of pores having a substantially uniform first pore diameter (Paragraph 14) and a second fraction of pores having a substantially uniform second pore diameter (Paragraph 14). Corkery further teaches that it has been determined that for pore sizes smaller than 500 nanometers controlling the pore diameter will generally provide the practitioner of the present invention with some control over the flavor profile (Paragraph 33). For example, particles with the largest pores exhibit the highest maximum flavor intensity (Paragraph 33; Fig. 2). Decreasing pore sizes also reduces the maximum intensity experienced (Paragraph 33; Fig. 2). Lastly, Corkery teaches that the first pore diameter is larger than the second pore diameter (claim 9; “two different average pore sizes that are non-overlapping”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chapman’s porous alumina having a smaller pore size of 5-50 nm to include a larger pore size which is larger than the 5-50 nm but smaller than 500 nanometers as suggested by Corkery because (a) modified Chapman suggests that the mesoporous particle can include a plurality of ingredients (Canham; page 11, lines 1-12), and (b) the modification is beneficial because it gives the practitioner more control over the flavor profile of the particle including a plurality of ingredients (Corkery; Paragraph 33).
Lastly, modified Chapman is silent as to wherein the particulate filler is in an amount of 30 to 75 percent by weight based on the weight of the mixture, wherein the porous alumina and one or more other particulate fillers are present in a ratio of 0.5 to 5, and wherein the porous alumina is in the form of agglomerates.
Kumar teaches a consumable tobacco product (abstract) comprising at least one tobacco component, at least one flavorant, at least on sweetener, at least one filler-binder, at least one lubricant, at least one desiccant, and at least one glidant (para. 43) , the filler-binder may comprise micro-crystalline cellulose (para. 51) and be present in an amount of 3-35% by weight of the tobacco product (para. 75) to achieve a target performance of increasing disintegration time, maintaining integrity of the compressed tobacco product and/or achieve appropriate hardness and friability characteristics (para. 51), and an additional filler can be used to control the tobacco product’s physical properties e.g., texture, weight) including aluminum oxide (i.e. “alumina”) wherein the additional filler can be used in an amount of 0.1 to about 2.0% (para. 71). Moreover, Kumar teaches that tobacco particles that may also include one or more binders, which agglomerate smaller particles of tobacco together, and which may also hold fillers, flavorants, lipids and other additives, which adhere to the tobacco particles, wherein binders suitable for agglomerating tobacco particles together include those described herein as suitable for use in forming the compressed tobacco product ([0048]).
Therefore, Kumar teaches the total amount of filler-binder and additional filler is in the range of 3.1-37% (overlapping the claimed range of “the particulate filler is in an amount of 30 to 75 percent by weight based on the weight of the mixture”). Moreover, Kumar teaches the additional filler:filler-binder ratio is 0.0029 to 0.67 (overlapping the claimed range of “the porous alumina and one or more other particulate fillers are present in a ratio of 0.5 to 5”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified composition of Chapman to include 3-35% micro-crystalline cellulose in order to achieve the predictable result of controlling the tobacco product’s disintegration time, maintaining integrity of the tobacco product, and/or achieving an appropriate hardness and friability at a desirable level (Chapman; para. 51) and include the 0.1-2% aluminum oxide as in Kumar to control the compressed tobacco product’s texture and weight (Kumar; para. 71). Moreover, such a modification would involve routine optimization within prior art conditions and/or through routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2144.05(II)(A).
As a result, one of skill in the art would appreciate that Chapman’s mixture of particulate tobacco, microcrystalline cellulose, and modified alumina would be agglomerated together via the binding properties in the microcrystalline cellulose (see Kumar; [0048]).
Regarding claim 17, Chapman discloses a method for processing tobacco products (see para. 4) comprising:
admixing (para. 62; “mixing”) a particulate release modifying agent (325; para. 62) with a composition (315) thereby forming a mixture (see para. 62), the composition (315) including one or more releaseable components (para. 35), the release modifying agent may be alumina (para. 80), adapted to react with the at least one or more releaseable components in the composition and thereby modify the release thereof (para. 9);
wherein the composition further comprises at least a particulate non-tobacco material (such as microcrystalline cellulose) (Paragraph 35; “one or more other particulate filler”) and particulate tobacco ([0026]); and
containing the composition within a water permeable fabric (320; “pouch”) to form a pouched product (300; para. 62).
However, Chapman is silent as to wherein the alumina is porous such that at least a portion of the releasable material is retained by porous alumina.
Canham teaches a mesoporous material for modifying the flavor and/or texture of an oral composition (abstract) comprising: a mesoporous material including a mesoporous alumina (Page 5, line 13; “particulate filler comprising a porous alumina”) having pores in the range of 5-50 nm (Page 5, ll. 17-18; “first average pore size”); and a loaded ingredient that is entrapped in the pores (Page 10, line 30-35; Page 11, lines 14-29; “releasable material retain by the porous alumina”), the loaded ingredient is released on contact or shortly after contact with the human tongue, pharynx, or soft palate (Page 3, line 25-27). Canham further teaches that the loaded ingredient can be herbal extracts, stimulants, and essential oils (page 11, line 10-12) or may be a flavor (Page 11, line 9; page 17, line 8-9) including ethyl vanillin and citral (Page 17, line 30-31). Lastly, Canham teaches wherein mesoporous alumina may be made as described in Chem. Commun. 1986-1987 (2005) (Canham; Page 10, line 7-8; equivalent to Niesz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nicotine and/or flavoring agents of Chapman to be located within a mesoporous alumina as in Canham because adding the ingredient into a mesoporous material can increase or mask the potency of the ingredient (Canham; Page 3, line 21-10).
As evidenced by Niesz, the mesoporous alumina used in Canham has a distribution of different pore diameters (see Fig. 2-3). Therefore, Canham’s mesoporous alumina with a distribution of different pore diameters has at least two different average particle sizes (see Fig. 3B of Niesz).
Moreover, modified Chapman does not explicitly teach the mesoporous alumina being gamma-alumina. Specifically, modified Chapman does not disclose the form of the mesoporous alumina.
Wiesmuller teaches a particulate carrier material loaded with flavoring agents having a large specific surface (abstract) wherein it is known that alumina oxide (alumina) is subdivided into three classes including the gamma form (paragraph 16), wherein the gamma-alumina oxide has a specific surface between 0.1 and 1000 m2/g (Paragraph 28) and a pore size between 0.3 and 5000 nm (Paragraph 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tried using gamma-alumina as the mesoporous material because (a) it is known in the art that there are a 3 of identified forms of alumina including gamma-alumina (Wiesmuller; Paragraph 16), and (b) Wiesmuller teaches that that the gamma-alumina is proven to be suitable for being loaded with a flavor and stably releasing the flavors over long period of time (Paragraph 12).
Furthermore, modified Chapman is silent as to the mesoporous alumina including pores with at least two different average pore sizes that are non-overlapping, including pores with a second average pore size of about 100 nm to about 500 nm.
Corkery teaches the use of a porous particle to control the release of a flavor in a food product which are loaded into the porous particle (abstract), the porous particle being silica (Paragraph 14) the particles having a first fraction of pores having a substantially uniform first pore diameter (Paragraph 14) and a second fraction of pores having a substantially uniform second pore diameter (Paragraph 14). Corkery further teaches that it has been determined that for pore sizes smaller than 500 nanometers controlling the pore diameter will generally provide the practitioner of the present invention with some control over the flavor profile (Paragraph 33). For example, particles with the largest pores exhibit the highest maximum flavor intensity (Paragraph 33; Fig. 2). Decreasing pore sizes also reduces the maximum intensity experienced (Paragraph 33; Fig. 2). Lastly, Corkery teaches that the first pore diameter is larger than the second pore diameter (claim 9; “two different average pore sizes that are non-overlapping”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chapman’s porous alumina having a smaller pore size of 5-50 nm to include a larger pore size which is larger than the 5-50 nm but smaller than 500 nanometers as suggested by Corkery because (a) modified Chapman suggests that the mesoporous particle can include a plurality of ingredients (Canham; page 11, lines 1-12), and (b) the modification is beneficial because it gives the practitioner more control over the flavor profile of the particle including a plurality of ingredients (Corkery; Paragraph 33).
Lastly, modified Chapman is silent as to wherein the particulate filler is in an amount of 30 to 75 percent by weight based on the weight of the mixture, wherein the porous alumina and one or more other particulate fillers are present in a ratio of 0.5 to 5.
Kumar teaches a consumable tobacco product (abstract) comprising at least one tobacco component, at least one flavorant, at least on sweetener, at least one filler-binder, at least one lubricant, at least one desiccant, and at least one glidant (para. 43) , the filler-binder may comprise micro-crystalline cellulose (para. 51) and be present in an amount of 3-35% by weight of the tobacco product (para. 75) to achieve a target performance of increasing disintegration time, maintaining integrity of the compressed tobacco product and/or achieve appropriate hardness and friability characteristics (para. 51), and an additional filler can be used to control the tobacco product’s physical properties e.g., texture, weight) including aluminum oxide (i.e. “alumina”) wherein the additional filler can be used in an amount of 0.1 to about 2.0% (para. 71). Therefore, the total amount of filler-binder and additional filler is in the range of 3.1-37% (overlapping the claimed range of “the particulate filler is in an amount of 30 to 75 percent by weight based on the weight of the mixture”). Moreover, the additional filler:filler-binder ratio is 0.0029 to 0.67 (overlapping the claimed range of “the porous alumina and one or more other particulate fillers are present in a ratio of 0.5 to 5”). Moreover, Kumar teaches that tobacco particles that may also include one or more binders, which agglomerate smaller particles of tobacco together, and which may also hold fillers, flavorants, lipids and other additives, which adhere to the tobacco particles, wherein binders suitable for agglomerating tobacco particles together include those described herein as suitable for use in forming the compressed tobacco product ([0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified composition of Chapman to include 3-35% micro-crystalline cellulose in order to achieve the predictable result of controlling the tobacco product’s disintegration time, maintaining integrity of the tobacco product, and/or achieving an appropriate hardness and friability at a desirable level (Chapman; para. 51) and include the 0.1-2% aluminum oxide as in Kumar to control the compressed tobacco product’s texture and weight (Kumar; para. 71). Moreover, such a modification would involve routine optimization within prior art conditions and/or through routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2144.05(II)(A).
As a result, one of skill in the art would appreciate that Chapman’s mixture of particulate tobacco, microcrystalline cellulose, and modified alumina would be agglomerated together via the binding properties in the microcrystalline cellulose (see Kumar; [0048]).
Regarding claim 3, modified Chapman discloses the mesoporous material has pores including the smaller pore size of 5-50 nm to include the larger pore size which is larger than the 5-50 nm but smaller than 500 nanometers (see rejection above). Therefore, the average pore size will be in between 5-500 nm. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 6 and 19, modified Chapman discloses particles with the largest pores exhibit the highest maximum flavor intensity and decreasing pore sizes also reduces the maximum intensity experienced (Corkery; Paragraph 33; Fig. 2; pore sizes have different release rates).
Regarding claims 7-8, modified Chapman discloses the releaseable material may be nicotine (para. 35; “one or more active ingredients”).
Regarding claim 9, modified Chapman discloses the releaseable material may be flavoring agents (para. 35).
Regarding claim 10-12, modified Chapman discloses the loaded one or more ingredients may be a flavor including ethyl vanillin and citral (Canham; Page 17, line 30-31). One of ordinary skill in the art would appreciate that ethyl vanillin includes a carbon-oxygen double bond and includes an aldehyde.
Regarding claim 13, modified Chapman discloses that the composition may include particulate non-tobacco material treated with nicotine (claim 17).
Regarding claim 15, modified Chapman discloses the composition may include particulate non-tobacco material (such as microcrystalline cellulose) (Paragraph 35).
Regarding claim 16, modified Chapman discloses the composition may include both particulate tobacco material and flavoring agents (para. 35).
Regarding claims 20-21, modified Chapman discloses the microparticles are particles of about 1 to 1000 μm in diameter (p. 6, ll. 5-12). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Conclusion
The art made of record and not relied upon is considered pertinent to applicant's disclosure:
Finnie (US 2009/0252808) teaches an aggregate of primary particles between 5 and 500 nm made of alumina, having pores between 1 and 50 nm for use in the context of releasing a biological entity, the size of which determines the pore dimension thus enabling tailoring of gel porosity and controls the release of biological entities.
Engqvist (US 2025/0280866) teaches a pouch that contains a composition, wherein a finer part of the powders are agglomerated in order to prevent the powder form traversing through the pores in the pouch membrane, wherein alumina can be used as a filler. However, Engqvist is not considered prior art.
Luan (US 2006/0130861) teaches the use of mesoporous sieve materials in which a carrier can be formed into an agglomerate using binders, the carrier including alumina (see [0064]) used in the context of smoking filters.
Garner-Gray (US 5336665) teaches the use of aggregates of two or more particles to form particles having diameters having 1000 microns in the context of perfume particles.
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/SONNY V NGUYEN/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755