DETAILED ACTION
This is a Final Rejection for Application 18/866,607 filed 18 November 2024. This application is a U.S. National Phase application under 35 U.S.C. § 371 of International Application No. PCT/EP2023/057955, filed on March 28, 2023, and claims benefit to German Patent Application No. DE 10 2022 112 586.6, filed on May 19, 2022. Claims 1-15 and 17-22 are currently pending.
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 .
Response to Amendment
The examiner acknowledges the amended claims filed July 23, 2026.
The 35 USC § 112(d) rejection indicated in the Office action filed April 24, 2026 is overcome by amendment and hereby withdrawn.
The amendment to claim 1 is acknowledged. The 35 USC § 103 rejection below is amended in response.
Response to Arguments
Applicant's arguments filed July 23, 2026 have been fully considered but they are not persuasive.
Applicant argues that Heagle fails to disclose "a fabric that is formed by the bonding of a fibrous web" as presently claimed, and as conforms to definitions of a nonwoven as would be understood to persons having ordinary skill in the art.
This argument is unpersuasive as the previous Office action states [0078] – “fibers 102 may be entangled by various processes to form a gathering feature 114 (FIG. 2G)”. The entanglement of the fibers 102 bonds the fibers, thereby creating a web of fibers which is a nonwoven. US 2013/0122770 (Wahal et al.) provides evidence that a nonwoven material may be formed from entangled tow bands; Wahal [0014]. Therefore, Heagle does disclose a nonwoven. Additionally, the recitation “formed by the bonding of a fibrous web by needle-punching” is considered a product-by-process limitation. 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. See MPEP 2113(I).
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.
Claim(s) 1-5, 7, 14-15 and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0036334 (Heagle et al.) in view of US 2014/0058310 (Pernot et al.) and US 6,648,926 (Immediato).
Regarding claim 1, Heagle discloses a wound dressing comprising a needle-punched nonwoven ([0069] – “the wound dressing 100 may be formed from an assembly of fibers each of which fibers having a length of at least 2 inches”; [0078] – “fibers 102 may be entangled by various processes to form a gathering feature 114 (FIG. 2G)”; [0078] – “Another entangling process involves needles used in a manner similar to needle punching to entangle fibers 102.” Heagle discloses a wound dressing 100 comprising fibers 102 that are entangled in a process that involves needles used in a manner similar to needle punching.) that comprises:
self-crimped fibers ([0079] – “Referring to FIGS. 3A through 3G, two or more distinct polymers may be co-extruded to generate a fiber with specialized characteristics”; [0079] – “A fiber 126 exhibiting an eccentric sheath-core arrangement is depicted in FIG. 3B including an off-center core polymer 128 and corresponding sheath polymer 130. This arrangement may be used to provide a self-crimping fiber 126 when the core polymer 128 and sheath polymer 130 are provided with differing shrinkage characteristics when subject to a temperature change. When heated, the fibers 126 may curl into a helix that is retained when the fiber is cooled, thus developing a crimp or bulk in an otherwise flat fiber 126. Such a self-crimping procedure may be further facilitated by using a side-by-side arrangement as depicted in FIG. 3C.” The fibers 102 are self-crimped fibers of either the sheath-core type or a side-by-side type.),
wherein the needle-punched nonwoven is a fabric that is formed by the bonding of a fibrous web by needle-punching (The recitation “formed by the bonding of a fibrous web by needle-punching” is considered a product-by-process limitation. 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. See MPEP 2113(I). Since the fibers 102 are entangled to form a gathering feature 114, they form a nonwoven.), and
wherein the needle-punched nonwoven is thermally treated ([0079] – “When heated, the fibers 126 may curl into a helix that is retained when the fiber is cooled, thus developing a crimp or bulk in an otherwise flat fiber 126.” Claim 6 of Heagle requires the fibers of the wound dressing to be crimped which requires thermal treatment when the fibers are self-crimped fibers.).
Heagle does not disclose wherein the needle-punched nonwoven is 30% to 80% by weight, based on a total weight of the needle-punched nonwoven, superabsorbent fibers, and 70% to 20% by weight, based on the total weight of the needle-punched nonwoven, the self-crimped fibers, and wherein the thermal treatment is at a temperature of 160°C to 200°C.
However, Pernot discloses an absorbent nonwoven compress formed from a mixture: of bicomponent thermal bonding non-absorbent fibers; of bicomponent superabsorbent fibers; and of a net fabric made from a hydrocolloid elastomer (abstract). The bicomponent thermal bonding non-absorbent fibers are analogous to the fibers 102 of Heagle. Pernot also discloses that the absorbent nonwoven compress needle-punched ([0047]). Pernot teaches a needle-punched nonwoven that is: 30% to 80% by weight, based on a total weight of the needle-punched nonwoven, superabsorbent fibers, and 70% to 20% by weight, based on the total weight of the needle-punched nonwoven, the bicomponent thermal bonding non-absorbent fibers (The preparation of the nonwoven as described in Example 1 includes 70% by weight of LANSEAL® F superabsorbent fibers. See [0169]. The mixture is preferably between 60% and 80% the super absorbent fibers. See [0045]. The preparation of the nonwoven as described in Example 1 includes 30% by weight of biocomponent thermal bonding fibers. See [0169].).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add 70% by weight of LANSEAL® F superabsorbent fibers to the self-crimped fibers of Heagle as taught by Pernot. A skilled artisan would have been motivated to do so because Pernot teaches that superabsorbent fibers allow for a very high capacity for absorbing liquids ([0032]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings.
Heagle in view of Pernot does not disclose wherein the thermal treatment is at a temperature of 160°C to 200°C.
However, Immediato discloses a process for improving the properties of fabrics comprising a plurality of self-crimping biocomponent fibers. In Immediato, the bicomponent fibers comprise poly(ethylene terephthalate) (PET) and poly(trimethylene terephthalate) (PTT) (Col. 2, Lns. 21-26). The PET/PTT bicomponent fiber is analogous to the bicomponent self-crimping fibers of Heagle. The PET/PTT bicomponent fiber is self-crimping and the crimping is performed at a temperature of 160-177°C. See Claim 1 of Immediato. Immediato teaches a thermal treatment of self-crimped fibers at a temperature of 160°C to 200°C (The PET/PTT bicomponent fiber is crimped at a temperature of 160-177°C.).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to use bicomponent fibers comprising poly(ethylene terephthalate) (PET) and poly(trimethylene terephthalate) (PTT) as the material in the bicomponent fibers of Heagle and to treated the PET/PTT fibers at a temperature of 160°C to 200°C as taught by Immediato. A skilled artisan would have been motivated to do so because Immediato teaches that PET/PTT fibers treated at a temperature of 160°C to 177°C have a highly desirable combination of high recovery from stretching ("unload power"), excellent dye washfastness, and a smooth surface appearance and hand (Col. 2, Lns. 12-19). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn self-crimping bicomponent fibers.
Regarding claim 2, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1.
Heagle in view of Pernot and Immediato does not directly disclose wherein a plastic portion of the deformation ε(pl) of the wound dressing and/or the needle-punched nonwoven is longitudinally and/or transversely less than 12%.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the wound dressing of Heagle in view of Pernot and Immediato to have a plastic portion of the deformation ε(pl) longitudinally less than 12%, since it has been held that where 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. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The nonwoven of Heagle in view of Pernot and Immediato in one embodiment comprises 60% of a super absorbent fiber, which is preferably LANSEAL® F, and 40% of self-crimping fibers. Since the combination of Heagle in view of Pernot and Immediato in response to claim 1 is similar in composition to example 4 disclosed in Applicant’s Specification [0095], and since Immediato desires a high recovery from stretching, the modification is expected to be successful. Modifying the plastic portion of the deformation ε(pl) of the wound dressing can be done by changing the ratios of the component and/or increasing the crimp density of the self-crimped fibers. See MPEP 2112(V).
Regarding claim 3, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1, wherein the self-crimped fibers comprise fiber materials which are selected from the group of polyamides, polyesters, polyolefins, and mixtures or copolymers thereof (PET and PTT are polyesters.).
Regarding claim 4, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1, wherein the self-crimped fibers are produced from self-crimping fibers which have at least two components, wherein one component of the at least two components has a different shrinkage behavior under thermal treatment than the other component of the at least two components, and wherein an arrangement of the at least two components is configured to induce a three-dimensional deformation of the self-crimped fibers under thermal treatment and/or wherein the self-crimped fibers are manufactured from self-crimping fibers in which there is a different shrinkage behavior under thermal treatment of at least one fiber component with respect to at least one other fiber component ([0079] – “Referring to FIGS. 3A through 3G, two or more distinct polymers may be co-extruded to generate a fiber with specialized characteristics”; [0079] – “A fiber 126 exhibiting an eccentric sheath-core arrangement is depicted in FIG. 3B including an off-center core polymer 128 and corresponding sheath polymer 130. This arrangement may be used to provide a self-crimping fiber 126 when the core polymer 128 and sheath polymer 130 are provided with differing shrinkage characteristics when subject to a temperature change. When heated, the fibers 126 may curl into a helix that is retained when the fiber is cooled, thus developing a crimp or bulk in an otherwise flat fiber 126. Such a self-crimping procedure may be further facilitated by using a side-by-side arrangement as depicted in FIG. 3C.” The fibers 102 are self-crimped fibers of either the sheath-core type or a side-by-side type.).
Regarding claim 5, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 4, wherein the self-crimped fibers and/or the self-crimping fibers used as starting material are present as bicomponent fibers ([0079] – “A fiber 126 exhibiting an eccentric sheath-core arrangement is depicted in FIG. 3B including an off-center core polymer 128 and corresponding sheath polymer 130. This arrangement may be used to provide a self-crimping fiber 126 when the core polymer 128 and sheath polymer 130 are provided with differing shrinkage characteristics when subject to a temperature change. When heated, the fibers 126 may curl into a helix that is retained when the fiber is cooled, thus developing a crimp or bulk in an otherwise flat fiber 126. Such a self-crimping procedure may be further facilitated by using a side-by-side arrangement as depicted in FIG. 3C.”).
Regarding claim 7, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1, wherein the superabsorbent fibers contain polymers selected from the group consisting of polymers of unsaturated carboxylic acids, graft copolymers of unsaturated carboxylic acids, modified cellulose, gel-forming polysaccharides other than modified cellulose, and mixtures thereof (LANSEAL® F is made from a shell of an acrylic acid and a core of polyacrylonitrile. Acrylic acids are a simple form of unsaturated carboxylic acids.).
Regarding claim 14, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1, wherein the wound dressing and/or the needle-punched nonwoven has a shrinkage from contact with air humidity after 24 hours of 0% to 10% and/or the needle-punched nonwoven has an absorption capacity for 0.9% aqueous sodium chloride solution from 1000% to 5000% and/or the capillary height of 0.9% by weight NaCl solution of the wound dressing and/or the needle-punched nonwoven is less than 30 mm, longitudinally and/or transversely (The nonwoven of Heagle in view of Pernot and Immediato in one embodiment comprises 60% of a super absorbent fiber, which is preferably LANSEAL® F, and 40% of self-crimping fibers. The needle-punched nonwoven of Heagle in view of Pernot and Immediato would have a capillary height of 0.9% by weight NaCl solution of less than 30 mm longitudinally and transversely. While this is not explicitly disclosed in Heagle as Heagle is silent with regards to the capillary height, the capillary height is a property of the material and since the materials used in Heagle in view of Pernot and Immediato are the same as is described in Example 4 of Applicant’s specification, then the capillary height of the nonwoven of Heagle is expected to have similar results to the Example 4 of Applicant which are significantly below a capillary height of 30 mm. See [0098]-[0100] and the accompanying tables. See MPEP 2112(V).).
Regarding claim 15, Heagle discloses a method of manufacturing a wound dressing ([0069] – “the wound dressing 100 may be formed from an assembly of fibers each of which fibers having a length of at least 2 inches”; [0078] – “fibers 102 may be entangled by various processes to form a gathering feature 114 (FIG. 2G)”; [0078] – “Another entangling process involves needles used in a manner similar to needle punching to entangle fibers 102.” Heagle discloses a wound dressing 100 comprising fibers 102 that are entangled in a process that involves needles used in a manner similar to needle punching.), the method comprising:
1) manufacturing and/or providing a fibrous web, including self-crimping fibers ([0079] – “Referring to FIGS. 3A through 3G, two or more distinct polymers may be co-extruded to generate a fiber with specialized characteristics”; [0079] – “A fiber 126 exhibiting an eccentric sheath-core arrangement is depicted in FIG. 3B including an off-center core polymer 128 and corresponding sheath polymer 130. This arrangement may be used to provide a self-crimping fiber 126 when the core polymer 128 and sheath polymer 130 are provided with differing shrinkage characteristics when subject to a temperature change. When heated, the fibers 126 may curl into a helix that is retained when the fiber is cooled, thus developing a crimp or bulk in an otherwise flat fiber 126. Such a self-crimping procedure may be further facilitated by using a side-by-side arrangement as depicted in FIG. 3C.” The fibers 102 are self-crimped fibers of either the sheath-core type or a side-by-side type.);
2) bonding the fibrous web obtained in step 1) (Heagle discloses a wound dressing 100 comprising fibers 102 that are entangled in a process that involves needles used in a manner similar to needle punching.);
3) triggering self-crimping of the self-crimping fibers of the bonded fibrous web obtained in step 2) ([0079] – “When heated, the fibers 126 may curl into a helix that is retained when the fiber is cooled, thus developing a crimp or bulk in an otherwise flat fiber 126.” Claim 6 of Heagle requires the fibers of the wound dressing to be crimped which requires thermal treatment when the fibers are self-crimped fibers.),
wherein a wound dressing is obtained, wherein triggering self-crimping of the self-crimping fibers comprises raising the temperature of the self-crimping fibers ([0079] – “When heated, the fibers 126 may curl into a helix that is retained when the fiber is cooled, thus developing a crimp or bulk in an otherwise flat fiber 126.” Claim 6 of Heagle requires the fibers of the wound dressing to be crimped which requires thermal treatment when the fibers are self-crimped fibers.).
Heagle does not disclose the web containing 30% to 80% by weight, based on a total weight of the fibrous web, superabsorbent fibers and 70% to 20% by weight, based on the total weight of the fibrous web, the self-crimping fibers; bonding the fibrous web obtained in step 1) into a needle-punched nonwoven by needle-punching; and raising the temperature of the self-crimping fibers to at least 160°C and at most 200°C.
However, Pernot discloses an absorbent nonwoven compress formed from a mixture: of bicomponent thermal bonding non-absorbent fibers; of bicomponent superabsorbent fibers; and of a net fabric made from a hydrocolloid elastomer (abstract). The bicomponent thermal bonding non-absorbent fibers are analogous to the fibers 102 of Heagle. Pernot also discloses that the absorbent nonwoven compress needle-punched ([0047]). Pernot teaches the web containing 30% to 80% by weight, based on a total weight of the fibrous web, superabsorbent fibers and 70% to 20% by weight, based on the total weight of the fibrous web, the self-crimping fibers; and bonding the fibrous web obtained in step 1) into a needle-punched nonwoven by needle-punching (The preparation of the nonwoven as described in Example 1 includes 70% by weight of LANSEAL® F superabsorbent fibers. See [0169]. The mixture is preferably between 60% and 80% the super absorbent fibers. See [0045]. The preparation of the nonwoven as described in Example 1 includes 30% by weight of biocomponent thermal bonding fibers. See [0169]. Pernot also discloses that the absorbent nonwoven compress needle-punched ([0047])).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to bond 70% by weight of LANSEAL® F superabsorbent fibers to the self-crimped fibers of Heagle by needle-punching as taught by Pernot. A skilled artisan would have been motivated to do so because Pernot teaches that superabsorbent fibers allow for a very high capacity for absorbing liquids ([0032]) and that the needle punching operation makes it possible in particular to orientate the superabsorbent fibers in a substantially vertical direction relative to the plane of the nonwoven. This orientation of the fibers makes it possible to reduce the transverse propagation of exudates absorbed by the dressing containing this nonwoven and therefore makes it possible to reduce the risks of maceration and consequently of deterioration of the perilesional skin ([0048]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings.
Heagle in view of Pernot does not disclose raising the temperature of the self-crimping fibers to at least 160°C and at most 200°C.
However, Immediato discloses a process for improving the properties of fabrics comprising a plurality of self-crimping biocomponent fibers. In Immediato, the bicomponent fibers comprise poly(ethylene terephthalate) (PET) and poly(trimethylene terephthalate) (PTT) (Col. 2, Lns. 21-26). The PET/PTT bicomponent fiber is analogous to the bicomponent self-crimping fibers of Heagle. The PET/PTT bicomponent fiber is self-crimping and the crimping is performed at a temperature of 160-177°C. See Claim 1 of Immediato. Immediato teaches raising the temperature of the self-crimping fibers to at least 160°C and at most 200°C (The PET/PTT bicomponent fiber is crimped at a temperature of 160-177°C.).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to use bicomponent fibers comprising poly(ethylene terephthalate) (PET) and poly(trimethylene terephthalate) (PTT) as the material in the bicomponent fibers of Heagle and to treated the PET/PTT fibers at a temperature of 160°C to 200°C as taught by Immediato. A skilled artisan would have been motivated to do so because Immediato teaches that PET/PTT fibers treated at a temperature of 160°C to 177°C have a highly desirable combination of high recovery from stretching ("unload power"), excellent dye washfastness, and a smooth surface appearance and hand (Col. 2, Lns. 12-19). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn self-crimping bicomponent fibers.
Regarding claim 17, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1, wherein the self-crimped fibers are bicomponent fibers in side-by-side arrangement with an overall round cross-section ([0079 – “Such a self-crimping procedure may be further facilitated by using a side-by-side arrangement as depicted in FIG. 3C.” Fig. 3C also shows the overall round cross-section of the fibers.).
Regarding claim 18, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1, wherein the self-crimped fibers are bicomponent fibers in eccentric core-sheath arrangement with an overall round cross-section (0079] – “A fiber 126 exhibiting an eccentric sheath-core arrangement is depicted in FIG. 3B including an off-center core polymer 128 and corresponding sheath polymer 130. Fig. 3B also shows the overall round cross-section of the fibers.).
Regarding claim 19, Heagle in view of Pernot and Immediato discloses the method of manufacturing a wound dressing of claim 15, wherein the self-crimped fibers are bicomponent fibers in side-by-side arrangement with an overall round cross-section ([0079 – “Such a self-crimping procedure may be further facilitated by using a side-by-side arrangement as depicted in FIG. 3C.” Fig. 3C also shows the overall round cross-section of the fibers.).
Regarding claim 20, Heagle in view of Pernot and Immediato discloses the method of manufacturing a wound dressing of claim 15, wherein the self-crimped fibers are bicomponent fibers in eccentric core-sheath arrangement with an overall round cross-section (0079] – “A fiber 126 exhibiting an eccentric sheath-core arrangement is depicted in FIG. 3B including an off-center core polymer 128 and corresponding sheath polymer 130. Fig. 3B also shows the overall round cross-section of the fibers.).
Regarding claim 21, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1, wherein the needle-punched nonwoven is thermally treated at a temperature of 180°C to 190°C (Immediato further discloses heat setting the PET/PTT bicomponent fiber at 182°C yields a product with fair quality in washfastness. While the quality of the washfastness may be reduced from excellent at 182°C, the product still benefits from thermal treatment at this temperature in its high recovery from stretching ("unload power") and smooth surface appearance and hand (Col. 2, Lns. 12-19).).
Regarding claim 22, Heagle in view of Pernot and Immediato discloses the method of manufacturing a wound dressing of claim 15, wherein triggering self-crimping of the self-crimping fibers comprises raising the temperature of the self-crimping fibers to at least 180°C and at most 190°C (Immediato further discloses heat setting the PET/PTT bicomponent fiber at 182°C yields a product with fair quality in washfastness. While the quality of the washfastness may be reduced from excellent at 182°C, the product still benefits from thermal treatment at this temperature in its high recovery from stretching ("unload power") and smooth surface appearance and hand (Col. 2, Lns. 12-19).).
Claim(s) 6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0036334 (Heagle et al.) in view of US 2014/0058310 (Pernot et al.) and US 6,648,926 (Immediato), and further in view of US 2009/0156974 (Truelsen et al.).
Regarding claim 6, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1, wherein the self-crimped fibers are staple fibers, wherein a staple fiber length of the self-crimped fibers and/or the superabsorbent fibers independently of each other is between 32 and 80 mm and/or the titer of the self- crimped fibers and/or the superabsorbent fibers independently of each other is between 1.7 and 20 dtex ([0064] – “It is advantageous to utilize as the wound dressing a plurality of fibers with each fiber having a length of at least two (2) inches”; The self-crimped fibers have a discrete length, making them staple fibers, with a length of 2 inches (50.8 mm).).
Heagle in view of Pernot and Immediato does not disclose wherein the superabsorbent fibers are staple fibers.
However, Truelsen discloses an absorbent wound care device that is found in analogous art to the wound dressing of Heagle. The absorbent wound care device of Truelsen comprises LANSEAL® fibers which are disclosed as exemplary staple fibers. See [0044]-[0045]. Truelsen teaches superabsorbent fibers that are staple fibers (LANSEAL® fibers are disclosed as exemplary staple fibers in [0044]-[0045].).
It would have been obvious to an artisan of ordinary skill before the effective filing date for the LANSEAL® F superabsorbent fibers of Heagle in view of Pernot to be staple fibers as taught by Truelsen. A skilled artisan would have been motivated to do so because Truelsen teaches that staple fibers provide a high absorption of liquid and still show sufficient coherency to be removed without leaving remnants or sticking to the wound or skin around the wound ([0044]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings comprising nonwoven fibers that are needle-punched.
Regarding claim 11, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1.
Heagle in view of Pernot and Immediato does not disclose wherein the needle-punched nonwoven has a needle density of 50 to 150 punctures/cm2.
However, Truelsen discloses an absorbent wound care device that is found in analogous art to the wound dressing of Heagle. Truelsen teaches wherein the needle-punched nonwoven has a needle density of 50 to 150 punctures/cm2 (The absorbent wound care device of Truelsen is needle-punched and has a needle-density of 85 to 275 punctures/cm2. See [0040].).
It would have been obvious to an artisan of ordinary skill before the effective filing date for the needle-punched nonwoven of Heagle to have a needle-punch density of 85 punctures/cm2 in view of Truelsen. A skilled artisan would have been motivated to do so because Truelsen teaches that 85 punctures/cm2 allows only moderate expansion when wetted and also ensures sufficient space between the swollen fibres for exudates to pass into the material and slough to be removed from the wound bed ([0039]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings comprising nonwoven fibers that are needle-punched.
Claim(s) 8-10 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0036334 (Heagle et al.) in view of US 2014/0058310 (Pernot et al.) and US 6,648,926 (Immediato), and further in view of US 2015/0017225 (Hubbell et al.).
Regarding claim 8, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1.
Heagle in view of Pernot and Immediato does not disclose wherein the needle-punched nonwoven also comprise further fibers selected from fibers including one or more of the following fiber raw materials: polyolefins, cellulose, regenerated cellulose, polyamides, polyacrylonitriles, elastanes, polyvinyl chlorides, polylactides, polyglycolides, polyesteramides, polycaprolactones, polyhexamethylene terephthalates, polyhydroxybutyrates, polyhydroxyvalerates, animal and/or vegetable natural fibers and/or polyesters.
However, Hubbell discloses a hemostatic pad that is found in analogous art to the wound dressing of Heagle. The hemostatic pad of Hubbell discloses a scaffold 30 comprising a knitted oxidized regenerated cellulose (ORC) backing layer under a layer of Polyglactin 910 (PG910) non-woven fibers. See [0045]. The PG910 fibers are needle-punched to the ORC backing to produce the scaffold. The ORC is provided in amounts from 5-30 mg/cm2 and the PG910 is provided in amount from 5-30 mg/cm2. See [0046]. Therefore, by using 5 mg/cm2 of ORC and 30 mg/cm2 of PG910, ORC comprises 14.2% of the scaffold. Hubbell teaches wherein the needle-punched nonwoven also comprise further fibers selected from fibers including one or more of the following fiber raw materials: polyolefins, cellulose, regenerated cellulose, polyamides, polyacrylonitriles, elastanes, polyvinyl chlorides, polylactides, polyglycolides, polyesteramides, polycaprolactones, polyhexamethylene terephthalates, polyhydroxybutyrates, polyhydroxyvalerates, animal and/or vegetable natural fibers and/or polyesters (Scaffold 30 comprising a knitted oxidized regenerated cellulose (ORC) backing layer.).
It would have been obvious to an artisan of ordinary skill before the effective filing date to add the knitted oxidized regenerated cellulose backing layer of Hubbell to the nonwoven of Heagle by needle-punching such that the combined total weight of the nonwoven and the knitted oxidized regenerated cellulose backing layer comprises 15% by weight of the knitted oxidized regenerated cellulose backing layer. This results in the LANSEAL® F comprising 59.5% of the total weight and the biocomponent fibers comprising 25.5% of the total weight, which still meets the claimed limitations in claim 1. A skilled artisan would have been motivated to do so because Hubbell teaches that the knitted oxidized regenerated cellulose backing layer acts as a reinforcement and handling layer ([0013]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings comprising nonwoven fibers that are needle-punched.
Regarding claim 9, Heagle in view of Pernot, Immediato and Hubbell discloses the wound dressing according to claim 8, wherein the further fibers are hydrophilic fibers including one or more fiber raw materials selected from cellulose and regenerated cellulose (The nonwoven of Heagle includes the knitted oxidized regenerated cellulose (ORC) backing layer of Hubbell, which is interpreted as the further fibers.).
Regarding claim 10, Heagle in view of Pernot, Immediato and Hubbell discloses the wound dressing according to claim 8, wherein the further fibers are present in a proportion of 5% to 30% by weight based on the total weight of the needle-punched nonwoven (The nonwoven of Heagle includes the knitted oxidized regenerated cellulose (ORC) backing layer of Hubbell, which is interpreted as the further fibers, and comprises 15% by weight based on the total weight of the needle-punched nonwoven.).
Regarding claim 12, Heagle in view of Pernot and Immediato discloses the wound dressing according to claim 1.
Heagle in view of Pernot and Immediato does not disclose wherein the wound dressing has at least one further fiber layer which is arranged on at least one side of the needle-punched nonwoven, and wherein the at least one further fiber layer is connected to the needle-punched nonwoven by needle-punching.
However, Hubbell discloses a hemostatic pad that is found in analogous art to the wound dressing of Heagle. The hemostatic pad of Hubbell discloses a scaffold 30 comprising a knitted oxidized regenerated cellulose (ORC) backing layer under a layer of Polyglactin 910 (PG910) non-woven fibers. See [0045]. The PG910 fibers are needle-punched to the ORC backing to produce the scaffold. The ORC is provided in amounts from 5-30 mg/cm2 and the PG910 is provided in amount from 5-30 mg/cm2. See [0046]. Therefore, by using 5 mg/cm2 of ORC and 30 mg/cm2 of PG910, ORC comprises 14.2% of the scaffold.
It would have been obvious to an artisan of ordinary skill before the effective filing date to add the knitted oxidized regenerated cellulose backing layer of Hubbell to the nonwoven of Heagle by needle-punching such that the combined total weight of the nonwoven and the knitted oxidized regenerated cellulose backing layer comprises 15% by weight of the knitted oxidized regenerated cellulose backing layer. This results in the LANSEAL® F comprising 59.5% of the total weight and the biocomponent fibers comprising 25.5% of the total weight, which still meets the claimed limitations in claim 1. A skilled artisan would have been motivated to do so because Hubbell teaches that the knitted oxidized regenerated cellulose backing layer acts as a reinforcement and handling layer ([0013]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings comprising nonwoven fibers that are needle-punched.
Regarding claim 13, Heagle in view of Pernot, Immediato and Hubbell discloses the dressing according to claim 12, wherein the at least one further fiber layer is hydrophilic (The knitted oxidized regenerated cellulose (ORC) backing layer of Hubbell is hydrophilic as ORC is a hydrophilic material.).
Conclusion
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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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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