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 Claims
Receipt of Remarks/Amendments filed on 12/15/2025 is acknowledged. Claims 1, 11, and 18 are amended and claims 12-13, 17, 22, and 32 are canceled. Claims 6-7, 20-21, and 23-31 remain withdrawn as being drawn to a non-elected invention and species. Claims 1-5, 8-11, 14-16, and 18-19 are currently examined on the merits herein.
Priority
The instant application filed 11/09/2022, is a 371 filing of PCT/EP2021/082091, filed 11/18/2021, which claims foreign priority to GB2018694.6, filed 11/27/2020.
Withdrawn Objections/Rejections
Claim 18 was objected to for informalities. Applicants’ amendments to claim 18 have overcome the objection and the objection is withdrawn.
Claims 11 and 12 were rejected under 35 U.S.C. 112(b). Applicants’ amendments to claim 11 and cancellation of claim 12 have overcome the rejection and the rejection is withdrawn.
Claims 1-2, 8-10, 14, 16, and 18-19 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Atchley. Applicants’ amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1-4, 8-11, and 14-19 were rejected under 35 U.S.C. 103 as being unpatentable over Atchley. Applicants’ amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1-4, 8-12, and 14-19 were rejected under 35 U.S.C. 103 as being unpatentable over Atchley and Persson. Applicants’ amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1-5, 8-12, and 14-19 were rejected under 35 U.S.C. 103 as being unpatentable over Atchley, Persson, and Franklin. Applicants’ amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1-5, 8-12, and 14-19 were provisionally rejected on the ground of nonstatutory double patenting as unpatentable over copending Application Nos. 17/921,150, 18/263,777, 18/263,839, and 18/940,422 in view of Atchley. Applicants’ amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
The following rejections are necessitated by amendment:
Claim Rejections - 35 USC § 103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8-11, 14-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Atchley, F., S., et al., (WO 2012/019025 A2, 02/09/2012, IDS dated 11/09/2022), hereinafter Atchley, in view of Tabor J, et al. (2019). The role of staple fiber length on the performance of carded, hydroentangled nonwovens produced with polypropylene fibers. Journal of Engineered Fibers and Fabrics (PTO-892), hereinafter Tabor, and Hernandez, G., et al. (US 20180014568 A1, 01/18/2018, PTO-892), hereinafter Hernandez.
Atchley teaches a smokeless tobacco product including smokeless tobacco and structural fibers. The structural fibers form a nonwoven network in which the smokeless tobacco is entangled (abstract; claims 1 and 3).
Regarding claim 1, A tobacco-entangled fabric (100) can include preformed structural fibers (either natural or synthetic) which are dry laid to provide an initial web of structural fibers (p. 12, lines 3-5). In a dry laid nonwoven system, smokeless tobacco can be mixed in with the structural fibers and entangled by a needling process (p. 12, lines 11-18). One dry laid method of forming a nonwoven web is carding (p. 12, lines 28-30). Thus, Atchley teaches nonwoven fabric substrates formed via dry-laid carding and needling, which have a matrix (i.e., web) of interleaved (i.e., entangled) fibers; and a substance (i.e., smokeless tobacco) held within the matrix, as defined in instant claim 1. A chewing action would necessarily release the tobacco substance from the matrix, as is typical in smokeless tobacco which includes chewing tobacco (p. 1, lines 13-16).
Regarding claim 2, Figures 1, 11, and 14 show the smokeless tobacco homogeneously distributed throughout the network of the structural fibers (item 100) (p. 9, lines 14-16).
Regarding claims 8-10, the structural fibers in the smokeless tobacco product of Atchley comprise viscose fibers (p. 32, lines 1-4; claim 8) and polypropylene fibers (p. 33, lines 1-4; claim 9). Figure 11 also teaches that the smokeless tobacco is needled between two layers (items 110a and 110b) of staple fibers to form a needled tobacco-entangled fabric (item 100) (p. 27, lines 24-26). Thus, Atchley teaches wherein the nonwoven fabric substrate comprises staple fibers of viscose, as recited in claim 8, and/or thermoplastic fibers such as polypropylene, as recited in claims 9-10.
Regarding claim 16, tablets, pills, and lozenges come in many shapes. Accordingly, any shape that fits in the oral cavity and may be comfortably held therein or swallowed is being interpreted by the examiner as a tablet, pill, or lozenge “shape”. Figures 1 and 14 shows shapes that are acceptable for the smokeless tobacco product. Specifically, the tobacco-entangled fabric (items 100A-K) can be formed in a shape that promotes improved oral positioning for the adult tobacco consumer, improved packaging characteristics, or both (p. 41, lines 2-4). As seen in Figures 1 and 14 the smokeless tobacco product is shaped as a tablet, pill, or lozenge.
Regarding claim 18 and 19, Figure 1 illustrates an exemplary packaging system containing the smokeless tobacco product wherein a plurality of pieces of tobacco-entangled fabric (item 100) are arranged in an interior space (item 51) of a container (item 52) that mates with a lid (item 54). The interior space is moisture tight (i.e., sealable) to prevent the tobacco-entangled fabric from drying out (p. 9, lines 1-7; claims 30-31).
Atchley teaches that after the smokeless tobacco and structural fibers are arranged during production, the web may need further mechanical, thermal, or chemical treatment in order to have the structural fibers form a network in which fibrous structures of the tobacco material are entangled (p. 24, lines 1-5). Examples of chemical bonding include coating the fibers with a binder, such as a latex emulsions or solutions polymers. Additionally, adhesive materials in the form of beads or small random shapes can be intermingled with the network of structural fibers and activated with heat and/or pressure to bond the network into the tobacco-entangled fabric. Chemical bonding can be used with any other technique of forming structural fibers and/or intermingling smokeless tobacco with the structural fibers (p. 32, lines 7-16). The binder/adhesive used for the chemical bonding process would necessarily be a food-grade substance since it is being incorporated into a smokeless tobacco product for use in a consumer’s mouth (p. 2, lines 9-12). The binder/adhesive of Atchley reads on the binder of claims 3-4 and carrier medium of claim 14.
Atchley teaches that melt-blown webs, for use in the invention, usually possess a basis weight of 1-350 g/m2 (p. 21, lines 22-25) and spun bond webs have a basis weight between 5 and 800 g/m2, typically 10-200 g/m2 (p. 22, lines 11-15). Such basis weights overlap with the weights of claim 11.
Atchley teaches that the products and methods described can be applied to other orally consumable plant materials in addition to smokeless tobacco. For example, some non-tobacco or "herbal" compositions have also been developed as an alternative to smokeless tobacco compositions. A non-tobacco smokeless product may include non-tobacco fibrous structures entangled with structural fibers and one or more tobacco extracts. The tobacco extracts can include nicotine (p. 4-5, lines 20-8), which reads on the pharmaceutical of claim 15.
The teaching of Atchley differ from that of the instantly claimed invention in that Atchley does not explicitly teach wherein the nonwoven fabric substrate has a thickness of 1-2 mm, as recited in claim 1, nor does Atchley explicitly teach the limitations of claims 3-4, 11, and 14-15, in a single embodiment.
Tabor teaches that carding is a common web-forming process used for stable fibers in the nonwovens industry. Tabor explores how polypropylene fibers of varying lengths can be carded and entangled to form fabrics characterized by their basis weight and thickness (abstract). The fibers of Tabor were carded and subsequently cross lapped, pre-needled, and hydroentangled. The resulting webs therefore read on a dry-laid carded needled nonwoven fabric as instantly claimed. During carding, samples were processed with similar settings to ideally achieve a basis weight of 125 g/m2. To achieve the desired basis weight, carded webs were folded twice (four layers) via crosslapping. Directly after crosslapping, the webs were pre-needled on the needle loom at a punch density of 50 needles/cm2. (Materials and methods, para. 3-5). For fabrics produced with the 6-denier PP fibers, the thickness is between 1 and 2 mm (Fig. 10), which reads on the thickness range of claim 1. For fabrics produced with the 6-denier PP fibers, the basis weight is between 100 and 200 gsm (Fig. 8), which reads on the weight range of claim 11.
Hernandez discloses a smokeless tobacco product for insertion into the mouth (abstract). The tobacco-containing fabric can be made using various techniques including air laying, wet laying, and/or carding methods to generate a nonwoven web of fibers with the desired thickness ([0008]). The thickness of the fibrous structures may vary, but will typically be of sufficient thickness to provide rigidity, strength, and support to the tobacco composition and to remain intact during oral use. The thickness of the fibrous structures can also depend on the desired taste level or feel within the user's mouth. The thickness of the fibrous structure can range from about 5 μm to about 5 mm ([0050]; claim 2). Hernandez specifically teaches a dry laid carding method ([0058]-[0063]; Ex. 2), which may be further treated with secondary methods such as needle punching ([0070-[0071]), which reads on a dry-laid carded needled nonwoven fabric as instantly claimed. Hernandez teaches an optional step of pressing which serves to conform the products to the final thickness and three dimensional shapes desired for the smokeless tobacco composites product ([0097]). Hernandez also teaches that the smokeless tobacco composite can incorporate additional ingredients or components in the form of a coating or in the form of a material imbedded in the fibrous material (e.g., impregnated). Such additional ingredients include binders and food binders ([0027]; [0051]; claim 33). A tobacco-containing fabric formed via carding methods can be modified by contacting the fabric with a second tobacco material and optionally other components such as a binder. The tobacco-containing fabric is then impregnated with the second tobacco material and any optional components (i.e., binder) and then bonded using bonding a process (e.g., a mechanical, chemical/adhesive, or thermal bonding) to generate a cohesive smokeless tobacco composite ([0056]). The binder of Hernandez reads on the binder of claims 3-4 and carrier medium of claim 14.
Regarding the thickness of claim 1, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide the nonwoven web of Atchley with the instantly claimed thickness since thicknesses within and overlapping this range are known and routine in the art. Tabor teaches that a thickness of 1-2 mm is achievable in nonwovens manufactured by a dry-laid carding and needling process, as instantly claimed. Hernandez teaches that a thickness of 5 μm to 5 mm is known and routine in tobacco containing nonwovens for oral use, which may also be produced by the dry-laid carding and needling method as instantly claimed. Hernandez also teaches that thickness is a results effective parameter which influences rigidity, strength, and support as well as desired taste level or feel within the user's mouth. Thus, one of ordinary skill in the art could have provided the nonwoven web of Atchley with any of the thicknesses taught by Tabor or Hernandez, as motivated by the improvement of structure, taste, and feel properties, according to the known method of dry-laid carding and needling, to predictably generate a nonwoven fabric with the desired thickness. Tabor teaches a thickness of 1-2 mm, which is identical to the instantly claimed range, and Hernandez teaches a thickness of 5 μm to 5 mm, which encompasses the instantly claimed range. 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.
Regarding claim 11, Atchley teaches that basis weights of 1-350 and 5-800 g/m2 are known and effective for nonwoven webs comprising tobacco for oral use. However, Atchley only teaches these weights for melt-blown and spun-bond webs as discussed above, Tabor teaches that basis weights between 100 and 200 gsm (g/m2) may be achieved in nonwoven webs manufactured via dry-laid carding and needling methods. Therefore, it would have been prima facie obvious to provide a nonwoven fabric substrate with the instantly claimed basis weight since Atchley teaches that basis weights including this range are known and effective in the art, while Tabor teaches that basis weights of 100-200 gsm are achievable by a dry-laid carding and needling method. One of ordinary skill in the art could have provided the nonwoven fabric substrate of Atchley with a basis weight taught by Tabor according to the known method of dry-laid carding and needling, to predictably generate a nonwoven fabric that may be used as an oral tobacco product. The basis weight range taught by Tabor (100-200 gsm) falls within the instantly claimed range.
One of ordinary skill in the art would have had a reasonable expectation of success in modifying the thickness and basis weight of Atchley since Tabor and Hernandez teach specific methods for achieving the desired thickness and basis weight in dry-laid carded needled nonwoven fabrics. Methods which influence thickness and basis weight (which are related properties) include crosslapping (i.e., folding), needle-punch density, staple fiber structure, and an optional pressing step.
Regarding claims 3 and 4, it would have been prima facie obvious to incorporate a food-grade chemical binder or adhesive into the nonwoven network of Atchley, since chemical binders are known and routine in the art as taught by Atchley and Hernandez. One of ordinary skill in the art could have combined the nonwoven network of Atchley with the binders of Atchley or Hernandez according to known methods to predictably yield a network in which the structural fibers and tobacco material are entangled by a food-grade binder. One of ordinary skill in the art would have been motivated to perform chemical bonding to strengthen the nonwoven network. There would have had a reasonable expectation of success since Atchley teaches that chemical bonding can be used with any other technique of forming structural fibers and/or intermingling smokeless tobacco with the structural fibers and Hernandez teaches a method of contacting a carded nonwoven with additional ingredients such as a binder to form a tobacco-containing fabric.
Regarding claim 14, the chemical binders taught by Atchley and Hernandez above in regards to claims 3-4, also read on a carrier medium. When a binder is incorporated into the final product, the final product comprises both binder and tobacco material, as “the substance held within the matrix”, wherein the binder reads on a “carrier medium” and the tobacco material reads on an “active agent”. The instant specification specifically defines wherein the binder and the carrier medium are the same (p. 6, lines 15-16).
Regarding claim 15, it would have been prima facie obvious to combine embodiments of Atchley by using a pharmaceutical such as nicotine to form the final smokeless product, since nicotine is a known and routine active to incorporate in the art as taught by Atchley. One of ordinary skill in the art would have been motivated to do so in order to avoid the harmful effects of tobacco while maintaining its pharmacological effect. One of ordinary skill in the art would have had a reasonable expectation of success in doing so since Atchley teaches means for incorporating such extracts.
Claim 1-5, 8-11, 14-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Atchley, Tabor, and Hernandez, as applied to claims 1-4, 8-11, 14-16, and 18-19 above, and further in view of Franklin Adhesives & Polymers. (2015). Duracet® 827 and 864 product data sheets, p. 203-204, (PTO-892), hereinafter Franklin.
The combined teachings of Atchley, Tabor, and Hernandez are discussed above.
As discussed above, Atchley teaches that after the smokeless tobacco and structural fibers are arranged during production, the web may need further mechanical, thermal, or chemical treatment in order to have the structural fibers form a network in which fibrous structures of the tobacco material are entangled (p. 24, lines 1-5). Examples of chemical bonding include coating the fibers with a binder, such as a latex emulsions or solutions polymers. Additionally, adhesive materials in the form of beads or small random shapes can be intermingled with the network of structural fibers and activated with heat and/or pressure to bond the network into the tobacco-entangled fabric. Chemical bonding can be used with any other technique of forming structural fibers and/or intermingling smokeless tobacco with the structural fibers (p. 32, lines 7-16).
Hernandez also teaches that the smokeless tobacco composite can incorporate additional ingredients or components in the form of a coating or in the form of a material imbedded in the fibrous material (e.g., impregnated). Such additional ingredients include binders and food binders ([0027]; [0051]; claim 33). A tobacco-containing fabric formed via carding methods can be modified by contacting the fabric with a second tobacco material and optionally other components such as a binder. The tobacco-containing fabric is then impregnated with the second tobacco material and any optional components (i.e., binder) and then bonded using bonding a process (e.g., a mechanical, chemical/adhesive, or thermal bonding) to generate a cohesive smokeless tobacco composite ([0056]).
The combined teachings of Atchley, Tabor, and Hernandez differ from that of the instantly claimed invention in that none explicitly teach the binder of claim 5.
Franklin teaches vinyl acrylic copolymers, Duracet ® 827 and 864, both designed for use as binders for nonwovens (first paragraphs of pages 203 and 204). Additionally, both vinyl acrylic copolymers conform to FDA regulations indicating their suitability as a “food-grade substance”.
It would have been prima facie obvious to one of ordinary skill in the art to use the vinyl acrylic copolymer of Franklin as the binder in the combined nonwoven product of Atchley, Tabor, and Hernandez since such a copolymer is a known and routine food-grade binder in the art of nonwovens. One of ordinary skill in the art could have incorporated the vinyl acrylic copolymers of Franklin as the binder in the combined nonwoven product according to known methods, taught by both Atchley and Hernandez, to predictably yield a chemically bonded nonwoven comprising a vinyl acrylic copolymer. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. One of ordinary skill in the art would have had a reasonable expectation of success in using the vinyl acrylic copolymers of Franklin in the combined nonwoven product since these chemicals are food-grade binders for nonwovens.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8-11, 14-16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-9 and 23 of copending Application No. 17/921,150 in view of Atchley and Tabor. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Atchley and Tabor.
Copending claims 8 and 9 of ‘150 recite a nonwoven fabric for forming an oral pouched product, the nonwoven fabric comprising: a nonwoven fabric substrate, which reads on the nonwoven fabric substate of instant claim 1. Claim 23 of ‘150 further recites wherein the nonwoven fabric substrate comprises a heat-sealable bonded web of viscose fibers and a binder, which reads on the fibers of instant claim 1. The copending claims differ from the instant claims in that they do not explicitly recite a “dry-laid carded needled” nonwoven wherein the nonwoven fabric substrate has a matrix of “interleaved” fibers and a “thickness of 1-2 mm” nor that a substance is releasable from the matrix by a chewing action as recited in instant claim 1. However, Atchley teaches smokeless tobacco product comprising a dry laid nonwoven system, wherein smokeless tobacco can be mixed in with the structural fibers and entangled (i.e., interleaved) by a needling process (p. 12, lines 11-18). One dry laid method of forming a nonwoven web is carding (p. 12, lines 28-30). Additionally, a chewing action would necessarily release the tobacco substance from the matrix, as is typical in smokeless tobacco which includes chewing tobacco as taught by Atchley. Tabor teaches dry-laid carding and entanglement methods for generating a nonwoven fabric with a thickness between 1 and 2 mm (Fig. 10). Thus, it would have been obvious to modify the nonwoven fabric substrate of ‘150 with the teachings of Atchley to entangle (i.e., interleave) a tobacco substance with the fibers of ‘150 via dry-laid, carded, needling methods to form a network (i.e., a matrix) that releases tobacco upon chewing. It would have been further obvious to provide such a network at the routine and known thickness of 1-2 mm as taught by Tabor. These combinations could have been performed using known methods in the art to predictably generate the instantly claimed chewable product.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5, 8-11, 14-16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 10, and 12 of copending Application No. 18/263,777 in view of Atchley and Tabor. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Atchley and Tabor.
Copending claim 1 of ‘777 recites a nonwoven fabric for forming an oral pouched product, the nonwoven fabric comprising a chemically bonded web of staple fibers and a binder while claim 10 recites an oral pouched product comprising a pouch formed from the a nonwoven fabric of any preceding claim, wherein the pouch encloses a substance comprising a carrier medium for nicotine, flavorings and cannabidiol (CBD), wherein the nonwoven fabric comprises a chemically bonded web of staple fibers and a binder. Copending claim 5 defines wherein the web is composed of a plurality of carded layers while copending claim 12 recites wherein the web is manufactured by dry loose fiber; and carding the loose fiber web. The nonwoven fabric of ‘777 therefore reads on the dry-laid carded nonwoven fabric substrate having a matrix of fibers as recited in instant claim 1. The substance of copending claim 10 further reads on the substance of instant claim 1. The copending claims differ from the instant claims in that they do not explicitly recite a “needled” nonwoven fabric substrate having a matrix of “interleaved” fibers and a “thickness of 1-2 mm” nor that a substance is releasable from the matrix by a chewing action as recited in instant claim 1. However, Atchley teaches smokeless tobacco product comprising a dry laid nonwoven system, wherein smokeless tobacco can be mixed in with the structural fibers and entangled (i.e., interleaved) by a needling process (p. 12, lines 11-18). Additionally, a chewing action would necessarily release the tobacco substance from the matrix, as is typical in smokeless tobacco which includes chewing tobacco as taught by Atchley. Tabor teaches dry-laid carding and entanglement methods for generating a nonwoven fabric with a thickness between 1 and 2 mm (Fig. 10). Thus, it would have been obvious to modify the nonwoven fabric substrate of ‘777 with the teachings of Atchley to entangle (i.e., interleave) a tobacco substance with the fibers of ‘777 via a needling method to form a network (i.e., a matrix) that releases tobacco upon chewing. It would have been further obvious to provide such a network at the routine and known thickness of 1-2 mm as taught by Tabor. These combinations could have been performed using known methods in the art to predictably generate the instantly claimed chewable product.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5, 8-11, 14-16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9, and 19 of copending Application No. 18/263,839 in view of Atchley and Tabor. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Atchley and Tabor.
Copending claim 1 of ‘839 recites a nonwoven fabric for forming a pouched product, the nonwoven fabric comprising a chemically bonded web of staple fibers. Copending claim 2 recites wherein the web is composed of a plurality of carded layers while copending claim 12 recites wherein the web is manufactured by dry loose fiber; and carding the loose fiber web. Copending claim 9 recites a pouched product comprising a pouch formed from a nonwoven fabric comprising a chemically bonded web of staple fibers and a non-fibrous binder; wherein the pouch encloses a substance. The nonwoven fabric and pouched product of ‘839, therefore reads on the dry-laid carded nonwoven fabric substrate having a matrix of fibers as recited in instant claim 1. The substance of copending claim 9 further reads on the substance of instant claim 1. The copending claims differ from the instant claims in that they do not explicitly recite a “needled” nonwoven fabric substrate having a matrix of “interleaved” fibers and a “thickness of 1-2 mm” nor that a substance is releasable from the matrix by a chewing action as recited in instant claim 1. However, Atchley teaches smokeless tobacco product comprising a dry laid nonwoven system, wherein smokeless tobacco can be mixed in with the structural fibers and entangled (i.e., interleaved) by a needling process (p. 12, lines 11-18). Additionally, a chewing action would necessarily release the tobacco substance from the matrix, as is typical in smokeless tobacco which includes chewing tobacco as taught by Atchley. Tabor teaches dry-laid carding and entanglement methods for generating a nonwoven fabric with a thickness between 1 and 2 mm (Fig. 10). Thus, it would have been obvious to modify the nonwoven fabric substrate of ‘839 with the teachings of Atchley to entangle (i.e., interleave) a tobacco substance with the fibers of ‘839 via a needling method to form a network (i.e., a matrix) that releases tobacco upon chewing. It would have been further obvious to provide such a network at the routine and known thickness of 1-2 mm as taught by Tabor. These combinations could have been performed using known methods in the art to predictably generate the instantly claimed chewable product.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5, 8-11, 14-16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 18/940,422 in view of Atchley and Tabor. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Atchley and Tabor.
Copending claim 1 of ‘422 recites a product for oral delivery of a substance, the product comprising: a layered structure comprising a plurality of nonwoven fabric layers that include an intermediate carrier layer and a pair of support layers; and a substance held by the intermediate carrier layer. Copending claim 8 recites wherein the pair of support layers comprise food-grade staple fibers that are entangled by needle punching. The nonwoven fabric layers of ‘422, therefore read on the needled nonwoven fabric substrate having a matrix of interleaved fibers as recited in instant claim 1. The substance of copending claim 1 further reads on the substance of instant claim 1. The copending claims differ from the instant claims in that they do not explicitly recite a “dry-laid carded” nonwoven fabric substrate having a “thickness of 1-2 mm” wherein the substance is releasable from the matrix by a chewing action as recited in instant claim 1. Atchley teaches smokeless tobacco product comprising a dry laid nonwoven system, wherein smokeless tobacco can be mixed in with the structural fibers and entangled (i.e., interleaved) by a needling process (p. 12, lines 11-18). One dry laid method of forming a nonwoven web is carding (p. 12, lines 28-30). Additionally, a chewing action would necessarily release the tobacco substance from the matrix, as is typical in smokeless tobacco which includes chewing tobacco as taught by Atchley. Tabor teaches dry-laid carding and entanglement methods for generating a nonwoven fabric with a thickness between 1 and 2 mm (Fig. 10). Thus, it would have been obvious to modify the nonwoven fabric substrate of ‘422 with the teachings of Atchley to form the fiber web ‘422 via a dry-laid, carded method to form a network (i.e., a matrix) that releases tobacco upon chewing. It would have been further obvious to provide such a network at the routine and known thickness of 1-2 mm as taught by Tabor. These combinations could have been performed using known methods in the art to predictably generate the instantly claimed chewable product.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments, filed 12/15/2025, with respect to the rejections of the claims under 102(a)(1) in view of Atchley, have been fully considered and are persuasive. Additionally, Applicant’s arguments with respect to the rejections of the claims under 103 in view of Atchley alone and in combination with Persson and Franklin, have been fully considered and are persuasive. Therefore, the rejections have also been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Atchley in combination with Tabor and Hernandez. Similarly, the double patenting rejections now rely on Atchley in combination with Tabor.
Conclusion
No claims are allowed.
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.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616