DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/20/2025 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1,3-9, 11, 19-20, 24-26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Strickland et al. (U.S 20050244521) in view of Stenberg WO2007073346A1) and further in view of Gedevanishvili et al. (U.S Pub. No. 20090022917) and Essen et al. (U.S Pub. No. 20090065013).
Regarding claim 1, Strickland discloses a plant fiber product for oral use, said product comprising:
a pouch [0014] [0253];
plant fibers arranged within the pouch ([0246] [0195] [0008] [0253]); and
at least one added substance (part of other ingredients), wherein the substance is releasable from the product when said product is placed in a mouth of a user ([0246][0195] [0010]), wherein the product contains a composition homogeneously distributed with the plant fibers in the product ([0245-0246] [0195]), the composition comprising a uniform mixture of at least water, and other ingredients, wherein the plant fiber product has a water content [0195] overlapping with the claimed range of 40-60%; in case of overlapping ranges, it would have been obvious to one of ordinary skill in the art at the time the invention was made to pick the claimed range.
Strickland further discloses the plant fiber product can be produced by a process comprising: homogeneously mixing plant fibers with the aqueous solution and the other ingredients to obtain the plant fiber product ([248] [0195]).
Strickland discloses alginates is suitable for use in the compositions of Strickland [0028], therefore it would have been obvious to one of ordinary skill in the art at the time the invention was made to have other ingredients including alginates.
Strickland also discloses flavors can be included in any composition [0004] and the composition can provide satisfaction in the chemical and physical environment that exits in the user’s mouth for 30 minutes [0010] [0015] [0032] within the claimed range. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to pick the claimed range of time for the flavor dissolve in a user’s mouth and provide satisfaction for 30 minutes.
Strickland discloses providing satisfaction for 30 minutes but does not expressly disclose the alginate being formed so as to gradually release for about 30 minutes. Stenberg also discloses alginates are linear block copolymers of a-L-guluronate (G) and b-D-mannuronate and the mixtures of alginates are selected for their desired viscosities (Abstract and page 1, line 13 through page 2, line 9). Stenberg also discloses the higher the viscosity, the lower the resulting release rate in alginate matrix systems; therefore one of ordinary skill in the art at the time the invention was made to use the alginate matrix disclosed by Stenberg and the perform routine experimentation to arrive to a desired mixture of alginates with Strickland desired releasing rate of about 30 minutes.
Strickland discloses the product is adapted to deliver a flavor (such as coffee extract [0004] [0051]) (corresponding to the claimed active substance) to a user’s mouth and provide satisfaction. It would have been obvious to one of ordinary skill in the art at the time the invention was made that the coffee extract is capable of being absorbed through the mucous membranes in the mouth when the product is used.
Strickland does not express disclose a non-tobacco pouched plant fiber product for oral use. Gedevanishvili discloses oral delivery pouch product can have tobacco, tobacco substitutes and/or non-tobacco botanical components ([0010], [0015] and [0019]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the tobacco plant fiber and use a non-tobacco plant fiber as taught by Gedevanishvili. Essen discloses plant fiber product wherein the size distribution of the plant fibers range from 0.1mm to .25mm (table 1) overlapping with the claimed range. In case of overlapping ranges, it would have been obvious to one of ordinary skill in the art at the time the invention was made to pick the claimed range.
Regarding the plan fiber product is produced by a process. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113). In this case the product of the combination of Strickland and Stenberg discloses the alginate composition containing tobacco (powder, granules, shreds) ([0008] of Strickland) is the same as or obvious from the product of the prior art.
Regarding claims 3-4, as discusses above, since Strickland discloses the product is adapted to deliver a flavor (such as coffee [0004] [0051]) (corresponding to the claimed active substance) to a user’s mouth and provide satisfaction. It would have been obvious to one of ordinary skill in the art at the time the invention was made that the flavor is capable of being absorbed through the mucous membranes in the mouth when the product is used.
Regarding claims 5 and 19-20, Strickland discloses the product further comprising an added substance can be a flavor (different from coffee extract [0004] [0051]) (corresponding to the claimed a taste substance).
Regarding claims 6-7, Strickland discloses sodium alginate [0226] for a desired format (corresponding to the claimed an alginate salt of monovalent cations and is soluble in cold water).
Regarding claim 9, Strickland discloses the plant fibers can be tobacco [0008].
Regarding claim 11, Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113). In this case the product of the combination of Strickland and Stenberg discloses the alginate composition containing tobacco (powder, granules, shreds) ([0008] of Strickland) is the same as or obvious from the product of the prior art which are plant fibers that are treated with steam. It is also noted that tobacco filler is known for being treated with steam.
Regarding claim 25, Strickland discloses the product can be in the form of loose plant fiber [0014].
Regarding claim 26, Strickland discloses the product is in the form of a portion-sized pressed form of plant fiber [0195].
Regarding claims 8 and 24, Stenberg also discloses alginates are linear block copolymers of a-L-guluronate (G) and b-D-mannuronate and the mixtures of alginates are selected for their desired viscosities (Abstract and page 1, line 13 through page 2, line 9).
Response to Amendment
The affidavit under 37 CFR 1.132 filed 10/10/2025 is insufficient to overcome the rejection of claims 1,3-9, 11, 19-20, 24-26 under pre-AIA 35 U.S.C. 103(a) based upon Strickland et al. (U.S 20050244521) in view of Stenberg WO2007073346A1) and further in view of Gedevanishvili et al. (U.S Pub. No. 20090022917) and Essen et al. (U.S Pub. No. 20090065013) as set forth in the last Office action because:
I. Comparison of Water Content, Strickland discloses the plant fiber product has a water content [0195] overlapping with the claimed range of 40-60%.
II. Comparison of Plant fiber size, the affidavit only show that plant fibers sizes outside the claimed range (Product A with 0.09 mm) reaches a plateau and drastically reduces after about 10 minutes wherein Product B which includes a larger fiber size has a more gradual and more consistent release. It is noted that the combination of Strickland et al. (U.S 20050244521) in view of Stenberg WO2007073346A1), Gedevanishvili et al. (U.S Pub. No. 20090022917) and Essen et al. (U.S Pub. No. 20090065013) teaches/suggests plant fibers sizes overlapping with the claimed ranges. Essen discloses plant fiber product wherein the size distribution of the plant fibers range from 0.1mm to .25mm (table 1) overlapping with the claimed range. In case of overlapping ranges, it would have been obvious to one of ordinary skill in the art at the time the invention was made to pick the claimed range.
III. Comparison of Alginate Inclusion, the affidavit shoes that Product D has a more consistent and gradual rate of release compared to Product C which does not include the alginate. It is noted that the combination of Strickland et al. (U.S 20050244521) in view of Stenberg WO2007073346A1), Gedevanishvili et al. (U.S Pub. No. 20090022917) and Essen et al. (U.S Pub. No. 20090065013) teaches/suggests the inclusion of alginate. Stenberg also discloses alginates are linear block copolymers of a-L-guluronate (G) and b-D-mannuronate and the mixtures of alginates are selected for their desired viscosities (Abstract and page 1, line 13 through page 2, line 9). Stenberg also discloses the higher the viscosity, the lower the resulting release rate in alginate matrix systems; therefore one of ordinary skill in the art at the time the invention was made to use the alginate matrix disclosed by Stenberg and the perform routine experimentation to arrive to a desired mixture of alginates with Strickland desired releasing rate of about 30 minutes.
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Regarding claim 1, Strickland discloses a plant fiber product for oral use, said product comprising:
a pouch [0014] [0253];
plant fibers arranged within the pouch ([0246] [0195] [0008] [0253]); and
at least one added substance (part of other ingredients), wherein the substance is releasable from the product when said product is placed in a mouth of a user ([0246][0195] [0010]), wherein the product contains a composition homogeneously distributed with the plant fibers in the product ([0245-0246] [0195]), the composition comprising a uniform mixture of at least water, and other ingredients, wherein the plant fiber product has a water content [0195] overlapping with the claimed range of 40-60%; in case of overlapping ranges, it would have been obvious to one of ordinary skill in the art at the time the invention was made to pick the claimed range.
Strickland further discloses the plant fiber product can be produced by a process comprising: homogeneously mixing plant fibers with the aqueous solution and the other ingredients to obtain the plant fiber product ([248] [0195]).
Strickland discloses alginates is suitable for use in the compositions of Strickland [0028], therefore it would have been obvious to one of ordinary skill in the art at the time the invention was made to have other ingredients including alginates.
Strickland also discloses flavors can be included in any composition [0004] and the composition can provide satisfaction in the chemical and physical environment that exits in the user’s mouth for 30 minutes [0010] [0015] [0032] within the claimed range. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to pick the claimed range of time for the flavor dissolve in a user’s mouth and provide satisfaction for 30 minutes.
Strickland discloses providing satisfaction for 30 minutes but does not expressly disclose the alginate being formed so as to gradually release for about 30 minutes. Stenberg also discloses alginates are linear block copolymers of a-L-guluronate (G) and b-D-mannuronate and the mixtures of alginates are selected for their desired viscosities (Abstract and page 1, line 13 through page 2, line 9). Stenberg also discloses the higher the viscosity, the lower the resulting release rate in alginate matrix systems; therefore one of ordinary skill in the art at the time the invention was made to use the alginate matrix disclosed by Stenberg and the perform routine experimentation to arrive to a desired mixture of alginates with Strickland desired releasing rate of about 30 minutes.
Strickland discloses the product is adapted to deliver a flavor (such as coffee extract [0004] [0051]) (corresponding to the claimed active substance) to a user’s mouth and provide satisfaction. It would have been obvious to one of ordinary skill in the art at the time the invention was made that the coffee extract is capable of being absorbed through the mucous membranes in the mouth when the product is used.
Strickland does not express disclose a non-tobacco pouched plant fiber product for oral use. Gedevanishvili discloses oral delivery pouch product can have tobacco, tobacco substitutes and/or non-tobacco botanical components ([0010], [0015] and [0019]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the tobacco plant fiber and use a non-tobacco plant fiber as taught by Gedevanishvili. Essen discloses plant fiber product wherein the size distribution of the plant fibers range from 0.1mm to .25mm (table 1) overlapping with the claimed range. In case of overlapping ranges, it would have been obvious to one of ordinary skill in the art at the time the invention was made to pick the claimed range.
Regarding the plan fiber product is produced by a process. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113). In this case the product of the combination of Strickland and Stenberg discloses the alginate composition containing tobacco (powder, granules, shreds) ([0008] of Strickland) is the same as or obvious from the product of the prior art.
As explained above, The affidavit under 37 CFR 1.132 filed 10/10/2025 is insufficient to overcome the rejection of claims 1,3-9, 11, 19-20, 24-26 under pre-AIA 35 U.S.C. 103(a) based upon Strickland et al. (U.S 20050244521) in view of Stenberg WO2007073346A1) and further in view of Gedevanishvili et al. (U.S Pub. No. 20090022917) and Essen et al. (U.S Pub. No. 20090065013) as set forth in the last Office action.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/PHU H NGUYEN/Examiner, Art Unit 1747
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