DETAILED ACTION
This is a Non-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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 12, 2026 has been entered.
Response to Amendment
The examiner acknowledges the amendments to claims 1, 15, 21 and 22. These amendments change the scope of the claims. As indicated in the Advisory action filed on March 2, 2026, the amendments overcome the previous 35 USC § 103 rejections which are hereby withdrawn. Therefore, new grounds of rejection are presented below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed February 13, 2026 with respect to claim(s) 21 and 22 have been fully considered but they are not persuasive. Applicant argues that Immediato does not teach or suggest a temperature range of 180°C to 190°C.
This argument is unpersuasive as Immediato discloses that heat setting at 182°C yields fair results with regards to the product’s washfastness. The term “fair” does not indicate that the product heat set at 182°C is unusable or destroyed. Conversely, it indicates that the product is functional after being heat set at 182°C.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 requires that the needle-punched nonwoven be thermally treated however, this limitation is already required in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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, 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.).
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 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%, 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
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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