DETAILED ACTION
This is a Final Rejection for Application 19/533,650 filed February 9, 2026. This application claims benefit to U.S. Prov. Pat. App. No. 63/758,031 filed on February 13, 2025. Claims 1-20 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 Arguments
Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive. Claims 1, 10, 11 and 20 have been amended to include limitations not previously presented. Particularly, claims 1 and 11 have been amended to add the limitations of claim 10, that the plurality of struts extend from the first surface to the second surface, and that the plurality of struts are separated by a portion of open cell matrix. Claims 10 and 20 have been amended to add the limitation that the plurality of struts are disposed at regular intervals. Both of these amendments change the scope of their respective claims, so new grounds of rejection are presented below in response. The same reference of US 2015/0150729 (Dagger et al.) is used to reject the amended claims because a different embodiment than the embodiment used in the previous Office action is disclosed in Dagger that teaches the added limitations. See the new grounds of rejection below.
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) 1-3, 8-13 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0111576 (Greene et al.) in view of US 2007/0275043 (Freeman) and US 2015/0150729 (Dagger et al.).
Regarding claim 1, Greene discloses a device for covering a wound in a dermal tissue ([0003] – “The present invention relates to wound dressings, and more particularly to multi-layer wound dressings having an element that is bioabsorbable.” See Figs. 1-8b.), the device comprising:
a bioabsorbable component comprising an open cell matrix including a plurality of pores having diameters of about 150 µm to about 500 µm ([0052] – “The scaffold material is porous, and has interconnecting pores having a pore size in the range of about 50-400 microns.” The scaffold is interpreted as an open cell matrix since the pores are interconnecting. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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 pore diameters to be about 150 µm to about 500 µm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.),
the bioabsorbable component having a first surface configured to contact the wound and a second surface opposing the first surface ([0079] – “FIG. 1 shows a first layer comprising a bioabsorbable scaffold material (10) disposed adjacent a wound site (65) in the tissue of a patient (60).” The scaffold 10 is interpreted as the bioabsorbable component with the first surface adjacent the wound site and the second surface on the opposing surface.); and
a backing component joined to the second surface and comprising a plurality of one or more of nanoparticles and salts configured to be released through the open cell matrix and into the wound ([0079] – “The first layer is covered by a second layer of an absorbent barrier material (20).” [0064] – “The absorbent barrier material can also serve as a platform for the regulated delivery of other therapeutic agents. Bioactive agents such as vitamins, proteins, peptides, growth factors, drugs, nutrients, antibiotics, and the like, can be included in the absorbent barrier material. […] The bioactive agents that are added to the absorbent barrier material can migrate to the wound bed over a period of time and thereby provide their beneficial activities for wound healing.” The barrier 20 is interpreted as the backing component joined to the second surface of the scaffold 10 and comprises a plurality of bioactive agents such as vitamins, proteins, peptides, growth factors, drugs, nutrients, antibiotics, and the like which are interpreted as nanoparticles that are configured to be released through the scaffold 10 into the wound.),
wherein the backing component is removable from the bioabsorbable component after the plurality of one or more of nanoparticles and salts are deposited into the wound ([0060] – “Thus, as the scaffold material is completely replaced by new tissue, the absorbent barrier material that can act as the second layer of the dressing can be easily removed from contact with the scaffold material with minimum force, thereby preventing trauma to the newly formed tissues.”).
Greene does not disclose a plurality of struts within the open cell matrix extending from the first surface to the second surface, each strut of the plurality of struts separated from an adjacent strut by a portion of the open cell matrix; and the nanoparticles having a diameter of about 1 nm to about 100 nm and the salts having a diameter of about 0.1 µm to about 100 µm.
However, Dagger discloses a wound filler 200 that is analogous to the scaffold of Greene and comprises a plurality of extending members 204; [0045]; Figs. 2A-2E. The extending members are a plurality of struts; [0047]. The plurality of extending members extend from the first surface to the second surface of the wound filer 200 and each strut is separated from an adjacent strut by a portion of the open cell matrix; Fig. 2D; [0050].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the scaffold layer of Greene to include a plurality of extending members as taught by Dagger. A skilled artisan would have been motivated to do so because Dagger teaches that the extending members allow for the wound filler 200 to contract in the horizontal plane while remaining rigid in the vertical plane ([0054]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to open cell wound fillers.
Greene in view of Dagger still does not disclose the nanoparticles having a diameter of about 1 nm to about 100 nm and the salts having a diameter of about 0.1 µm to about 100 µm.
However, Freeman discloses a wound dressing comprising a therapeutically effective amount of a particulate, water insoluble, inorganic silver salt (abstract). Freeman teaches the nanoparticles having a diameter of about 1 nm to about 100 nm and the salts having a diameter of about 0.1 µm to about 100 µm ([0022] – “Generally the silver salt will have a particle size less than 5 microns, more usually less than 2 microns”.).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the bioactive agents of Greene to include silver salt having a particle size 2 microns as taught by Freeman. A skilled artisan would have been motivated to do so because Freeman teaches [0002] – “It is well known that silver has antimicrobial properties and is useful for preventing or inhibiting colonisation of wounds by bacteria that would have a deleterious effect on the healing of the wound.” Additionally, [0034] – “These size limitations are to prevent breakage of the fibres due to incorporation therein of "large" particles.”. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn bioactive wound dressing agents.
Regarding claim 2, Greene in view of Freeman and Dagger discloses the device of claim 1, wherein the bioabsorbable component further comprises the one or more of nanoparticles and salts ([0053] – “The scaffold can also be impregnated with these and other bioactive agents such as drugs, vitamins, growth factors, therapeutic peptides, and the like.”).
Regarding claim 3, Greene in view of Freeman and Dagger discloses the device of claim 1, further comprising: an adhesive between the bioabsorbable component and the backing component ([0075] – “Alternatively, the first and second layers can be lightly bound together into a composite, multi-layer dressing prior to its application to the wound. Such binding may be accomplished by forming a second layer, such as for example, nonwoven fibers, directly onto one side of the first layer so that there will be points where the layers are bonded at the interface of the two layers. Thermal or ultrasonic pointbonding, as well as certain adhesives, may also be used to bond the two layers.”).
Regarding claim 8, Greene in view of Freeman and Dagger discloses the device of claim 1, wherein the bioabsorbable component comprises a thickness of about 0.5 mm to about 5 mm (Claim 12 – “where the first layer is from about 1 mm to about 10 mm in thickness.” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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 thickness of the scaffold to be about 0.5 mm to about 5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.).
Regarding claim 9, Greene in view of Freeman and Dagger discloses the device of claim 1, wherein the plurality of one or more of nanoparticles and salts comprise one or more of a metal cation and/or alloys thereof (As modified in claim 1, a silver salt is added which comprises a metal cation, silver.).
Regarding claim 10, Greene in view of Freeman and Dagger discloses the device of claim 1, wherein the plurality of struts are disposed within the open cell matrix at regular intervals such that they provide tensile support to the bioabsorbable component (The extending members 204 are parallel and spaced apart equally; Dagger [0048]. Due to their increased rigidity in comparison to the surrounding material, the extending members provide tensile support to the bioabsorbable component.).
Regarding claim 11, Greene discloses a method of treating a wound in a dermal tissue ([0003] – “The present invention relates to wound dressings, and more particularly to multi-layer wound dressings having an element that is bioabsorbable.” See Figs. 1-8b.), the method comprising:
placing a device in contact with the wound ([0079] – “FIG. 1 shows a first layer comprising a bioabsorbable scaffold material (10) disposed adjacent a wound site (65) in the tissue of a patient (60).”), the device comprising:
a bioabsorbable component comprising an open cell matrix including a plurality of pores having diameters of about 150 µm to about 500 µm ([0052] – “The scaffold material is porous, and has interconnecting pores having a pore size in the range of about 50-400 microns.” The scaffold is interpreted as an open cell matrix since the pores are interconnecting. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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 pore diameters to be about 150 µm to about 500 µm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.),
the bioabsorbable component having a first surface contacting the wound and a second surface opposing the first surface (The scaffold 10 is interpreted as the bioabsorbable component with the first surface adjacent the wound site and the second surface on the opposing surface.), and
a backing component joined to the second surface and impregnated with a plurality of one or more of nanoparticles and salts ([0079] – “The first layer is covered by a second layer of an absorbent barrier material (20).” [0064] – “The absorbent barrier material can also serve as a platform for the regulated delivery of other therapeutic agents. Bioactive agents such as vitamins, proteins, peptides, growth factors, drugs, nutrients, antibiotics, and the like, can be included in the absorbent barrier material. […] The bioactive agents that are added to the absorbent barrier material can migrate to the wound bed over a period of time and thereby provide their beneficial activities for wound healing.” The barrier 20 is interpreted as the backing component joined to the second surface of the scaffold 10 and comprises a plurality of bioactive agents such as vitamins, proteins, peptides, growth factors, drugs, nutrients, antibiotics, and the like which are interpreted as nanoparticles that are configured to be released through the scaffold 10 into the wound.),
retaining the device over the wound for a first time period ([0060] – “Thus, as the scaffold material is completely replaced by new tissue, the absorbent barrier material that can act as the second layer of the dressing can be easily removed from contact with the scaffold material with minimum force, thereby preventing trauma to the newly formed tissues.”),
wherein the one or more of nanoparticles and salts are configured to be released through the open cell matrix and into the wound during the first time period, thereby promoting healing of the wound ([0064] – “The absorbent barrier material can also serve as a platform for the regulated delivery of other therapeutic agents. Bioactive agents such as vitamins, proteins, peptides, growth factors, drugs, nutrients, antibiotics, and the like, can be included in the absorbent barrier material. […] The bioactive agents that are added to the absorbent barrier material can migrate to the wound bed over a period of time and thereby provide their beneficial activities for wound healing.”); and
removing the backing component from the bioabsorbable component after the first period and retaining the bioabsorbable component following the first time period, thereby promoting angiogenesis in the dermal tissue ([0060] – “Thus, as the scaffold material is completely replaced by new tissue, the absorbent barrier material that can act as the second layer of the dressing can be easily removed from contact with the scaffold material with minimum force, thereby preventing trauma to the newly formed tissues.”).
Greene does not disclose a plurality of struts within the open cell matrix extending from the first surface to the second surface, each strut of the plurality of struts separated from an adjacent strut by a portion of the open cell matrix; and the nanoparticles having a diameter of about 1 nm to about 100 nm and the salts having a diameter of about 0.1 µm to about 100 µm.
However, Dagger discloses a wound filler 200 that is analogous to the scaffold of Greene and comprises a plurality of extending members 204; [0045]; Figs. 2A-2E. The extending members are a plurality of struts; [0047]. The plurality of extending members extend from the first surface to the second surface of the wound filer 200 and each strut is separated from an adjacent strut by a portion of the open cell matrix; Fig. 2D; [0050].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the scaffold layer of Greene to include a plurality of extending members as taught by Dagger. A skilled artisan would have been motivated to do so because Dagger teaches that the extending members allow for the wound filler 200 to contract in the horizontal plane while remaining rigid in the vertical plane ([0054]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to open cell wound fillers.
Greene in view of Dagger still does not disclose the nanoparticles having a diameter of about 1 nm to about 100 nm and the salts having a diameter of about 0.1 µm to about 100 µm.
However, Freeman discloses a wound dressing comprising a therapeutically effective amount of a particulate, water insoluble, inorganic silver salt (abstract). Freeman teaches the nanoparticles having a diameter of about 1 nm to about 100 nm and the salts having a diameter of about 0.1 µm to about 100 µm ([0022] – “Generally the silver salt will have a particle size less than 5 microns, more usually less than 2 microns”.).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the bioactive agents of Greene to include silver salt having a particle size 2 microns as taught by Freeman. A skilled artisan would have been motivated to do so because Freeman teaches [0002] – “It is well known that silver has antimicrobial properties and is useful for preventing or inhibiting colonisation of wounds by bacteria that would have a deleterious effect on the healing of the wound.” Additionally, [0034] – “These size limitations are to prevent breakage of the fibres due to incorporation therein of "large" particles.”. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn bioactive wound dressing agents.
Regarding claim 12, Greene in view of Freeman and Dagger discloses the method of claim 11, wherein the bioabsorbable component further comprises the one or more of nanoparticles and salts ([0053] – “The scaffold can also be impregnated with these and other bioactive agents such as drugs, vitamins, growth factors, therapeutic peptides, and the like.”).
Regarding claim 13, Greene in view of Freeman and Dagger discloses the method of claim 11, wherein the device further comprises: an adhesive between the bioabsorbable component and the backing component ([0075] – “Alternatively, the first and second layers can be lightly bound together into a composite, multi-layer dressing prior to its application to the wound. Such binding may be accomplished by forming a second layer, such as for example, nonwoven fibers, directly onto one side of the first layer so that there will be points where the layers are bonded at the interface of the two layers. Thermal or ultrasonic pointbonding, as well as certain adhesives, may also be used to bond the two layers.”).
Regarding claim 18, Greene in view of Freeman and Dagger discloses the method of claim 11, wherein the bioabsorbable component comprises a thickness of about 0.5 mm to about 5 mm (Claim 12 – “where the first layer is from about 1 mm to about 10 mm in thickness.” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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 thickness of the scaffold to be about 0.5 mm to about 5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.).
Regarding claim 19, Greene in view of Freeman and Dagger discloses the method of claim 11, wherein the plurality of one or more of nanoparticles and salts comprise one or more of a metal cation and/or alloys thereof (As modified in claim 1, a silver salt is added which comprises a metal cation, silver.).
Regarding claim 20, Greene in view of Freeman and Dagger discloses the method of claim 11, wherein the plurality of struts are disposed within the open cell matrix at regular intervals such that they provide tensile support to the bioabsorbable component (The extending members 204 are parallel and spaced apart equally; Dagger [0048]. Due to their increased rigidity in comparison to the surrounding material, the extending members provide tensile support to the bioabsorbable component.).
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0111576 (Greene et al.) in view of US 2007/0275043 (Freeman) and US 2015/0150729 (Dagger et al.), and further in view of US 2005/0080157 (Wagener et al.).
Regarding claim 4, Greene in view of Freeman and Dagger discloses the device of claim 3.
Greene in view of Freeman and Dagger does not disclose wherein the adhesive comprises the one or more of nanoparticles and salts.
However, Wagener discloses an antimicrobial adhesive comprising cations in the form of salts ([0030]). Wagener teaches wherein the adhesive comprises the one or more of nanoparticles and salts ([0030] – “In a further embodiment the antimicrobial adhesive and coating material contains as further addition cations of at least one of the following metals: Au, Pt, Pd, Ir, Sn, Cu, Sb, Zn. […] It has shown to be useful that the cations are bound in ion exchangers, added in the form of a complex or as a salt. The cations can diffuse from the adhesive and coating material to their surface and develop their antimicrobial effectiveness there.”).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the adhesive of Greene to include the silver salt of Freeman as taught by Wagener. A skilled artisan would have been motivated to do so because Wagener teaches that a cation in the form of a salt can be added to an adhesive so that the cations can diffuse from the adhesive to its surface and develop its antimicrobial effectiveness there ([0030]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to adhesives used in medical devices.
Regarding claim 14, Greene in view of Freeman and Dagger discloses the method of claim 13.
Greene in view of Freeman and Dagger does not disclose wherein the adhesive comprises the one or more of nanoparticles and salts.
However, Wagener discloses an antimicrobial adhesive comprising cations in the form of salts ([0030]). Wagener teaches wherein the adhesive comprises the one or more of nanoparticles and salts ([0030] – “In a further embodiment the antimicrobial adhesive and coating material contains as further addition cations of at least one of the following metals: Au, Pt, Pd, Ir, Sn, Cu, Sb, Zn. […] It has shown to be useful that the cations are bound in ion exchangers, added in the form of a complex or as a salt. The cations can diffuse from the adhesive and coating material to their surface and develop their antimicrobial effectiveness there.”).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the adhesive of Greene to include the silver salt of Freeman as taught by Wagener. A skilled artisan would have been motivated to do so because Wagener teaches that a cation in the form of a salt can be added to an adhesive so that the cations can diffuse from the adhesive to its surface and develop its antimicrobial effectiveness there ([0030]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to adhesives used in medical devices.
Claim(s) 5, 7, 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0111576 (Greene et al.) in view of US 2007/0275043 (Freeman) and US 2015/0150729 (Dagger et al.), and further in view of US 2018/0296498 (Kochinke).
Regarding claim 5, Greene in view of Freeman and Dagger discloses the device of claim 1.
Greene in view of Freeman and Dagger does not disclose wherein the bioabsorbable component is formed from a polyester polyurethane or a derivative thereof.
However, Kochinke discloses a modular transdermal delivery system comprising a system 10. The system is analogous to the dressing of Greene. Kochinke teaches wherein the bioabsorbable component is formed from a polyester polyurethane or a derivative thereof ([0098] – “The transdermal system may contain additional layers, including additional drug reservoirs, which may or may not be of the matrix type; additional matrix layers and/or adhesive layers; fabric layers, and rate-controlling membranes. Any of these layers may be incorporated into the upper module, the lower module, or both.” [0099] – “Representative materials useful for forming rate-controlling membranes include […] polyester polyurethanes”.).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the material of the scaffold of Greene to be made of a polyester polyurethane as taught by Kochinke. A skilled artisan would have been motivated to do so because Kochinke teaches that polyester polyurethane is a suitable material to make a rate-controlling membrane that will regulate the rate at which agent are released from the membrane ([0099]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn wound dressings.
Regarding claim 7, Greene in view of Freeman and Dagger discloses the device of claim 1.
Greene in view of Freeman and Dagger does not disclose wherein the backing component comprises a laminate material.
However, Kochinke discloses a modular transdermal delivery system comprising a system 10. The system 10 comprises a backing layer 16 and porous drug reservoir layer 26. The backing layer 16 is analogous to the barrier 20 of Greene while the drug reservoir 26 is analogous to the scaffold 10 of Greene. Kochinke teaches wherein the backing component comprises a laminate material ([0080] – “Examples of materials useful for the backing layer are polyesters, polyethylene, polypropylene, polyurethanes, polyether amides, and ethylene-vinyl acetate copolymers (EVA). Backing layers may be obtained commercially, for instance under the Scotchpak™ and CoTran™ brands from 3M Corporation, including […] polyester film laminate backings (3M Scotchpak™ 1012, 9723, 9730, 9733, 9735, and 9738)”.).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the material of the barrier 20 of Greene to be a laminate material as taught by Kochinke. A skilled artisan would have been motivated to do so because Kochinke teaches that a polyester film laminate backing is useful to provide the device with physical characteristics such as flexibility, drape, and, if desired, occlusivity ([0079]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to multi-layered wound dressings.
Regarding claim 15, Greene in view of Freeman and Dagger discloses the method of claim 11.
Greene in view of Freeman and Dagger does not disclose wherein the bioabsorbable component is formed from a polyester polyurethane or a derivative thereof.
However, Kochinke discloses a modular transdermal delivery system comprising a system 10. The system is analogous to the dressing of Greene. Kochinke teaches wherein the bioabsorbable component is formed from a polyester polyurethane or a derivative thereof ([0098] – “The transdermal system may contain additional layers, including additional drug reservoirs, which may or may not be of the matrix type; additional matrix layers and/or adhesive layers; fabric layers, and rate-controlling membranes. Any of these layers may be incorporated into the upper module, the lower module, or both.” [0099] – “Representative materials useful for forming rate-controlling membranes include […] polyester polyurethanes”.).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the material of the scaffold of Greene to be made of a polyester polyurethane as taught by Kochinke. A skilled artisan would have been motivated to do so because Kochinke teaches that polyester polyurethane is a suitable material to make a rate-controlling membrane that will regulate the rate at which agent are released from the membrane ([0099]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn wound dressings.
Regarding claim 17, Greene in view of Freeman and Dagger discloses the method of claim 11.
Greene in view of Freeman and Dagger does not disclose wherein the backing component comprises a laminate material.
However, Kochinke discloses a modular transdermal delivery system comprising a system 10. The system 10 comprises a backing layer 16 and porous drug reservoir layer 26. The backing layer 16 is analogous to the barrier 20 of Greene while the drug reservoir 26 is analogous to the scaffold 10 of Greene. Kochinke teaches wherein the backing component comprises a laminate material ([0080] – “Examples of materials useful for the backing layer are polyesters, polyethylene, polypropylene, polyurethanes, polyether amides, and ethylene-vinyl acetate copolymers (EVA). Backing layers may be obtained commercially, for instance under the Scotchpak™ and CoTran™ brands from 3M Corporation, including […] polyester film laminate backings (3M Scotchpak™ 1012, 9723, 9730, 9733, 9735, and 9738)”.).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the material of the barrier 20 of Greene to be a laminate material as taught by Kochinke. A skilled artisan would have been motivated to do so because Kochinke teaches that a polyester film laminate backing is useful to provide the device with physical characteristics such as flexibility, drape, and, if desired, occlusivity ([0079]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to multi-layered wound dressings.
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0111576 (Greene et al.) in view of US 2007/0275043 (Freeman) and US 2015/0150729 (Dagger et al.), and further in view of US 2018/0256402 (Janis).
Regarding claim 6, Greene in view of Freeman and Dagger discloses the device of claim 1.
Greene in view of Freeman and Dagger does not disclose wherein the bioabsorbable component is formed as a bilayer of the open cell matrix.
However, Janis discloses a scaffold-based wound care delivery system comprising a body portion 20 made of first and second layers 32 and 34. The body portion 20 is analogous to the scaffold 10 of Greene. Janis teaches wherein the bioabsorbable component is formed as a bilayer of the open cell matrix ([0049] – “In particular embodiments, such as embodiments with a body portion that includes two layers, each layer may have a different porosity such that a side of the scaffold may be selected that has a porosity particularly suited for a specific wound etiology.”).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the scaffold layer of Greene to be a bilayer as taught by Janis. A skilled artisan would have been motivated to do so because Janis teaches that the bilayer has two different porosities such that a side of the scaffold may be selected that has a porosity particularly suited for a specific wound etiology ([0049]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn wound dressings comprising porous scaffolds.
Regarding claim 16, Greene in view of Freeman and Dagger discloses the method of claim 11.
Greene in view of Freeman and Dagger does not disclose wherein the bioabsorbable component is formed as a bilayer of the open cell matrix.
However, Janis discloses a scaffold-based wound care delivery system comprising a body portion 20 made of first and second layers 32 and 34. The body portion 20 is analogous to the scaffold 10 of Greene. Janis teaches wherein the bioabsorbable component is formed as a bilayer of the open cell matrix ([0049] – “In particular embodiments, such as embodiments with a body portion that includes two layers, each layer may have a different porosity such that a side of the scaffold may be selected that has a porosity particularly suited for a specific wound etiology.”).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the scaffold layer of Greene to be a bilayer as taught by Janis. A skilled artisan would have been motivated to do so because Janis teaches that the bilayer has two different porosities such that a side of the scaffold may be selected that has a porosity particularly suited for a specific wound etiology ([0049]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn wound dressings comprising porous scaffolds.
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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