Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The amendment filed 12/02/2025 has been entered. At entry, claims 23-50 are pending and under consideration.
Claim Objections
Claim 46 is objected to because of the following informalities:
Claim 46 line 2 recites “removing suction” which should read “removing a drain device”
Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “wherein the sheet is maintained on the skin graft donor site within the liquid impermeable boundary until complete epithelialization of the wound”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23-39 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 23 is amended and recites “wherein the sheet is maintained on the skin graft donor site within the liquid impermeable boundary until complete epithelialization of the wound” (emphasis added). A review of the originally filed specification discloses the following relevant portions:
[0004] “dressings changes or simple contact become extremely painful”
[0030] “Example advantages of some embodiments of the invention include: reduction of leakage of excess fluid; reduction of pain, reduction of requirement of dressing changes”
[0057] “If absorbent dressings are used, they become saturated quickly and require multiple changes. These dressing changes are very painful and require sterile technique and trained personnel.”
[0058] “If left open to air, the wound dries out, hampering re-epithelialization and being exposed to pathogens and shearing damage.”
[0059] “This novel concept reduces discomfort, nursing interventions, pain, frequency of dressing changes,”
[0079] “Once drainage flow from donor site 50 is sufficiently reduced, the bulb 424 and conduit 222 can be disconnected from the port 106, leaving the remainder of the device in place to aid in the healing process of the donor site:
The cited portions of the specification discloses and explain a motivation to reduce dressing changes during epithelialization, and, at most, disclose reducing the frequency of dressing changes (e.g., [0059]). However, it does not explicitly or inherently discloses that the sheet is maintained (i.e., without removal or replacement) until complete epithelialization of the wound as claimed. In the examiner’s view, the disclosure above does not preclude some changes (e.g., one replacement) during the process, as the specification emphasis on minimization of the dressing change rather than elimination of changes. Therefore, one of ordinary skill in the art would view the amendment as adding new matter not supported by the original disclosure.
Claims 24-39 are rejected for at least being dependent of claim 23.
Response to Arguments
With regard applicant’s argument, see pages 7-8, with respect 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 23, 24, 27, 29, 31, 32, 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Locke et al (US 20160325028 A1, hereinafter 'Locke'), Widgerow (US 20100280428 A1), and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS mailed on 03/01/2024).
Regarding claim 23, Ding substantially teaches applicant’s claimed invention, and specifically discloses a method as claimed (except for the limitations shown in italics and grayed-out), including:
a method for treating a skin graft donor site, the method comprising:
surgically removing a skin graft (pg 1548 “The skin graft was harvested from back, thigh, or chest with a hand knife”) from a site on a patient to form a skin graft donor site having a donor site wound area (wound area where skin graft is harvested) surrounded by a skin surface area wherein the skin graft is applied to a different wound site (pg 1548 “Split-thickness skin grafting procedures were performed on these patients for the management of full-thickness skin loss due to burns, trauma or surgery." the skin grafting procedures involves transplanting the harvested skin to a different site experiencing skin loss”);
adhesively coupling a sheet to the skin surface area (pg 1547 “dressings, such as vaseline gauze, alginates, Aquacel AG, hydrocolloids and biosynthetic skin substitutes” applying donor site dressings, such a vaseline gauze, alginates, Aquacel AG, hydrocolloids to the donor site) surrounding the skin graft donor site to form a liquid impermeable boundary wherein a port extends through the liquid impermeable boundary, the sheet having an absorbent layer (pg 1547 “Aquacel Ag is an absorbent wound dressing”) including a hydrogel (At least Acuacel AG dressing including hydrofiber, as evidenced by Convatec, that forms hydrogel when contact with fluid) contacting the donor site wound area for delivery of a wound healing medication (pg 1547, “Aquacel Ag is an absorbent wound dressing made from sodium carboxymethyl cellulose and impregnated with 1.2% silver. It is a moisture retentive topical dressing which can release silver within the dressing for up to 14 days” Acuacel AG delivers silver which is known for reducing inflammation. Reducing inflammation response effectively promotes re-epithelialization) that promotes re-epithelialization from the sheet to the donor site wound area and wherein the sheet further includes a transparent material to visualize the skin graft donor site and an adhesive surrounding the donor site wound area that is in liquid impermeable contact with the skin surface area wherein the sheet is maintained on the skin graft donor site within the liquid impermeable boundary until complete epithelialization of the wound; and
applying an intermittent suction force through the port that is configured to couple negative pressure to the absorbent layer over the donor site wound area of the skin graft donor site to drain fluid from the absorbent layer while retaining a moisture and medication level at the skin graft donor site during at least a portion of a period of re-epithelialization.
Ding does not teach adhesively coupling the sheet to the skin surface area to form a liquid impermeable boundary wherein a port extends through the liquid impermeable boundary, wherein the sheet further includes a transparent material to visualize the skin graft donor site and an adhesive surrounding the donor site wound area that is in liquid impermeable contact with the skin surface area
In the same field of endeavor, namely a method of treating wound, Locke teaches a method comprising treating a skin graft donor site ([0014] “The term “tissue site” may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue. For example, negative pressure may be used in certain tissue areas to grow additional tissue that may be harvested and transplanted to another tissue location.”) comprising adhesively coupling the sheet (figure 1 and [0035]-[0036] adhesively coupling drape 124 to skin 106 to form a fluid tight seal via adhesive 126. The adhesive extends a periphery portion of drape 124 thereby forming a flight tight seal) to the skin surface area to form a liquid impermeable boundary wherein a port (figure 1, negative-pressure interface 130 extend through the drape 124) extends through the liquid impermeable boundary, wherein the sheet further includes an adhesive (figure 1 and [[0030] adhesive 126 surrounding tissue site 102 is in liquid impermeable contact with skin 106) surrounding the donor site wound area that is in liquid impermeable contact with the skin surface area
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding to incorporate the teachings of Locke and provides the claimed method above, for the purpose of promoting healing in the skin graft donor sight by reducing evaporative losses and maintains the wound area sterile as taught by Locke ([0003] and [0035]).
Combination does not teach the sheet further includes a transparent material to visualize the skin graft donor site.
applying an intermittent suction force through the port that is configured to couple negative pressure to the absorbent layer over the donor site wound area of the skin graft donor site to drain fluid from the absorbent layer while retaining a moisture and medication level at the skin graft donor site during at least a portion of a period of re-epithelialization.
In the same field of endeavor, namely a method of medical device for treating wounds, Widgerow teaches the sheet (figure 5 and [0064] device 510 comprising transparent covering 501 to enable an observer to see the dressing beneath it) further includes a transparent material to visualize the skin graft donor site.
applying an intermittent suction force ([0005] applying intermittent suction to dressing) through the port ([0005] pipe couples the suction source to the dressing to drain secretion from the wound, the intermittent suction further retains moisture and medication level embedded within absorbent layer, i.e., maintaining silver embedded within Acuacel AG during wound healing) that is configured to couple negative pressure to the absorbent layer over the donor site wound area of the skin graft donor site to drain fluid from the absorbent layer while retaining a moisture and medication level at the skin graft donor site during at least a portion of a period of re-epithelialization.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Locke, to incorporate the teachings of Widgerow and provide the sheet and the intermittent suction source as claimed for the purpose of monitoring wound condition underneath the sheet and maintaining adequate negative pressure for wound healing as taught by Widgerow ([0005] and [0064]).
The combination is still silent as to wherein the sheet is maintained on the skin graft donor site within the liquid impermeable boundary until complete epithelialization of the wound.
In the same field of endeavor, namely an interface layer wound dressing, Rosenberg teaches wherein the sheet is maintained on the skin graft donor site within the liquid impermeable boundary until complete epithelialization of the wound ([0062] “the wound dressing is maintained over the wound bed until epithelialization is completed”)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Locke and Widgerow, to incorporate the teachings of Rosenberg and provide the claimed method for the purpose of controlling infection, pain, moisture content while allowing early mobilization and discharge without removing the dressing as taught by Rosenburg ([0031]) For instance, such a wound dressing would preserve the donor site under sterile conditions, thereby preventing bacterial contamination from the surrounding environment while sustaining an optimal moisture level to promote effective wound healing.
Regarding Claim 24, Ding, as modified by Locke, Widgerow and Rosenberg, teaches the method according to Claim 23.
The combination further teaches delivering a drug or molecule to the skin graft donor site, wherein at least a portion of the drug or molecule is embedded in the sheet (Ding; silver embedded in the sheet, pg 1547, “It is a moisture retentive topical dressing which can release silver within the dressing for up to 14 days”) or delivered through the port.
Regarding Claim 27, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination further teaches wherein the absorbent layer further comprises a bio- resorbable or biodegradable material over the skin graft donor site (Locke; [0034] "the manifold 122 may be constructed from bioresorbable materials").
Regarding Claim 29, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination does not teach capturing the fluid produced by the skin graft donor site in a reservoir in fluid communication with the port.
In the same field of endeavor, namely wound treating method, Locke teaches comprising capturing the fluid produced by the skin graft donor site in a reservoir (figure 1, container 120) in fluid communication with the port ([0024] "remove exudate and other fluid from the tissue site 102, which can be collected in the container 120").
Locke provide removing exudate and other fluid from the tissue site and collecting the fluid in the container in order to remove remaining effluent may be drawn out of dressing which enhances healing process ([0049]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ding, as modified by Locke and Widgerow, to incorporate the teachings of Locke and provide capturing the fluid produced by the skin graft donor site in a reservoir in order to enhance healing process.
Regarding Claim 34, Ding, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination does not expressly teach wherein the negative pressure is less than 100 mm Hg; though
Locke teaches the negative pressure ranges between -75 mm Hg and -300 mmHg (Locke; [0028]).
Therefore, 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 negative pressure ranges to be less than 100 mm Hg as applicant appears to have placed no criticality on the claimed range (see pp. [0062]) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 35, Ding, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination further teaches wherein adhesively coupling the sheet includes using an adhesive (Locke; figure 1, attachment device 126) on the sheet other than over a portion of the sheet expected to cover the skin graft donor site (Locke; [0036] “For example, an attachment device may be a medically-acceptable, pressure-sensitive adhesive that extends about a periphery, a portion, or the entire drape 124 “).
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Locke et al (US 20160325028 A1, hereinafter 'Locke'), Widgerow (US 20100280428 A1), and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS), and in further view of Askem et al (WO 2017153357 A1).
Regarding Claim 25, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination further teaches wherein the port (Locke; figure 1, port 130) is integrated with the sheet (Locke; figure 1, port 130 is integrated to drape 124).
The combination does not teach applying a suction force through the plurality of ports.
In the same field of endeavor, namely wound dressing, Askem teaches providing applying a suction force through the plurality of ports ([0072] “a full circumference port or multiple circumferential ports can be used. The circumference ports can be used at the perimeter of the wound dressing”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ding, as modified by Locke, Widgerow and Rosenburg, to incorporate the teachings of Askem and applying a suction force through the plurality of ports in order to draw the fluid from the wound dressing regardless of its position, and this would increase wound dressing absorbing capacity as taught by Askem ([0072]),
Regarding Claim 26, Ding, as modified by Locke, Widgerow, Rosenburg and Askem, teaches the method according to Claim 25.
The combination further teaches providing density of the plurality of ports in the sheet is higher toward a boundary than toward a center of the skin graft donor site (Askem; [0072 “The circumference ports can be used at the perimeter of the wound dressing”).
Regarding Claim 31, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination further teaches wherein the sheet includes a material selected from a group of materials consisting of: a polyurethane, an organic polymer (Locke; [0035] "the drape 124 may be a polymer drape, such as a polyurethane film").
Regarding Claim 32, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination does not teach further comprising positioning biomaterials coupled to the sheet with respect to the skin graft donor site, the biomaterial having integrated growth factors to enhance epidermal healing.
In the same field of endeavor, namely a wound treating method, Locke teaches biomaterials coupled to the sheet with respect to the skin graft donor site, the biomaterials having integrated growth factors to enhance epidermal healing (Locke; referring figure 1, the manifold 122 is coupled to drape 124 and [0034] the manifold comprises substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding as modified by Locke, Widgerow and Rosenburg, to incorporate the teachings of Locke and provide the sheet comprising positioning biomaterials coupled to the sheet with respect to the skin graft donor site, the biomaterial having integrated growth factors to enhance epidermal healing for the purpose of enhance and promotes the growth of cells or formation of tissue as taught by Locke ([0034]).
Claims 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Locke et al (US 20160325028 A1, hereinafter 'Locke'), Widgerow (US 20100280428 A1), and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS),and in further view of Mumby et al (US 20140249495 A1, hereinafter ‘Mumby’).
Regarding Claim 28, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination not teach the method comprising preventing clogging at the port using a sieve-like structure or membrane.
In the same field of endeavor, namely wound dressing, Mumby teaches preventing clogging ([0395] “prevents the lipids from blocking the hydrophobic filter) at the port (figure 15b, port 1250) using a sieve-like structure or membrane (figure 15b, filter element 2130).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ding, as modified by Locke and Widgerow, to incorporate the teachings of Mumby and provide the filter element at the port in order to prolong the life of dressing by avoiding blockage as taught by Mumby ([0057]).
Claims 30 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Locke et al (US 20160325028 A1, hereinafter 'Locke'), Widgerow (US 20100280428 A1), and Rosenberg (US 20110275972 A1), evidenced by Convatec (provided by IDS) and in further view of Locke et al (US 20110257613 A1, hereinafter ‘Locke’613’).
Regarding Claim 30, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 29.
The combination does not teach further comprising drawing fluid through filaments between the port and the reservoir.
In the same field of endeavor, namely a negative pressure wound therapy, Locke’613 teaches drawing fluid through filaments between the port and the reservoir (conduit comprising a silver impregnated mesh made of filaments [0063] “a body fluid in the form of a liquid from a tissue site is delivered through a reduced-pressure delivery conduit, e.g., the first reduced-pressure conduit 120” and [0040] “a silver impregnated mesh may be used as part of the fluid path, e.g., in the first reduced-pressure delivery conduit 120”)
Locke’613 provide the fluid path comprising a silver impregnated mesh in order to reduce the risk of contamination of the liquid exiting from the wound site ([0040] “silver impregnated mesh may be used as part of the fluid path, e.g., in the first reduced-pressure delivery conduit 120 or body fluid inlet 132, to kill bacteria and to address the aroma of the vapor exiting the container 104”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ding, as modified by Locke, Widgerow and Rosenburg, to incorporate the teachings of Lokcke’613 and provide the method drawing fluid through silver impregnated mesh made of filaments between the port and the reservoir for the purpose of reducing the risk of contamination as taught by Locke’613 ([0040])
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Locke et al (US 20160325028 A1, hereinafter 'Locke'), Widgerow (US 20100280428 A1), and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS) and in further view of Zuroveik (US 20140031735 A1).
Regarding Claim 33, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination further teaches applying the intermittent suction force through the port (Widgerow; [0005] “This suction can be intermittent or continuous.”).
The combination does not expressly teach drains up to 100 ml of fluid per day.
In the same field of endeavor, namely a negative pressure wound therapy, Zuroveik teaches drains up to 100 mL of fluid per day ([0025] “exudate removal rate (typically less than 100 mL/day).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, Ding, as modified by Locke, Widgerow and Rosenburg, to incorporate the teachings of Zuroveik and provide the method comprising drains up to 100 mL of fluid per day for the purpose of accommodating the prescribed therapy course to enhance wound healing as taught by Zuroveik ([0009])
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Locke et al (US 20160325028 A1, hereinafter 'Locke'), Widgerow (US 20100280428 A1), and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS) and in further view of Frederiksen et al (US 20090326430 A1, hereinafter 'Frederiksen').
Regarding Claim 36, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination does not teach adhesively coupling the sheet includes providing a backing sheet on an adhesive and releasing the adhesive from the backing sheet following contact of the adhesive to the skin surrounding the skin graft donor site.
In the same field of endeavor, namely would dressing, Frederiksen teaches adhesively coupling the sheet (figure 1, flexible film including adhesive surface layer 4) includes providing a backing sheet (figure 1, A removable release liner 5) on an adhesive and releasing the adhesive from the backing sheet following contact of the adhesive to the skin surrounding the skin graft donor site ([0053] “A removable release liner 5 covers the adhesive and thus protects the adhesive surface until the film dressing is to be used”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Locke and Widgerow, to incorporate the teachings of Frederiksen and provides the backing sheet in order to protect the adhesive against undesired sticking to other items before application as taught by Frederiksen ([0001])
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Locke et al (US 20160325028 A1, hereinafter 'Locke') and Widgerow (US 20100280428 A1), and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS) and in further view of Shuler et al (US 20170028113 A1, hereinafter ‘Shuler’)
Regarding Claim 37, Ding, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination does not teach visualizing the skin graft donor site without removal of the sheet through the transparent material in the sheet.
In the same field of endeavor, namely would dressing, Shuler teaches visualizing the skin graft donor site without removal of the sheet through a transparent material in the sheet ([0073] film barrier 124 may be composed of a transparent polymeric film and practitioner can visually monitor the superficial surface of the wound after the dressing has been applied and without disrupting the placement of the dressing).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Locke, Widgerow and Rosenburg, to incorporate the teachings of Shuler and provides the claimed method for the purpose of disrupting the placement of dressing as taught by Shuler ([0073])
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Locke et al (US 20160325028 A1, hereinafter 'Locke') and Widgerow (US 20100280428 A1), and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS) and in further view of Greener (US 20180361039 A1).
Regarding Claim 38, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination does not teach attaching a removable drain device in fluid communication with the port to drain fluid from the skin graft donor site, and further comprising disconnecting the removable drain device from the port while leaving the sheet over the skin graft donor site while maintaining the liquid impermeable boundary.
In the same field of endeavor, namely a vacuum assisted wound dressing, Greener teaches attaching a removable drain device (figure 1 and [0040], attaching apparatus 12 including a vacuum source 26, a connection tube 28 and a cup shaped member 30 in fluid communication with valve 22 of a wound covering element 18) in fluid communication with the port to drain fluid from the skin graft donor site, and further comprising disconnecting the removable drain device ([0039] [0050] disconnecting the apparatus 12 while the wound covering 18 maintaining the liquid impermeable boundary) from the port while leaving the sheet over the skin graft donor site while maintaining the liquid impermeable boundary.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Locke, Widgerow and Rosenburg, to incorporate the teachings of Greener and provides the removable drain device as claimed for the purpose of providing portable wound dressing system as taught by Greener ([0030]). For instance, the vacuum system incorporating a vacuum source, such as a pump, along with tubing connections, can become cumbersome during patient movement. Therefore, allowing the vacuum system to be removed while maintaining the sheet would facilitate wound healing without impeding mobility.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Locke et al (US 20160325028 A1, hereinafter 'Locke'), Widgerow (US 20100280428 A1) and Rosenberg (US 20110275972 A1), and evidenced by Convatec (provided by IDS) and in further view of Kasten (US 20010047177 A1)
Regarding Claim 39, Ding, as modified by Locke, Widgerow and Rosenburg, teaches the method according to Claim 23.
The combination further teaches the step of surgically removing the skin graft comprises using a blade to transect skin of the wound area (Ding; pg 1548 left column, paragraph 2, “the skin graft was harvested from back, thigh, or chest with a hand knife.”).
The combination does not teach transect skin of the wound area at a specified depth including at least a portion of epidermis and dermis of the skin.
In the same field of endeavor, namely method of skin graft preparation, Kasten teaches the surgical method comprising the step of surgically removing the skin graft comprises using a blade to transect skin of the wound area at a specified depth including at least a portion of epidermis and dermis of the skin ([0002] "Skin grafts of divergent thickness, which comprise all or only some tissue layers of the skin are used. Thus, one differentiates e. g. full-thickness skin grafts (FTSG), which comprise epidermis and complete dermis from split-thickness skin grafts (STSG)).
Kasten provides the surgical method comprising transecting skin of the wound area at a specified depth including epidermis and dermis because particular surgical procedure requires particular layers of skin ([0002] ” According to the medical indication and the recipient site, e. g. in the facial region for cosmetic purposes, skin grafts of divergent thickness, which comprise all or only some tissue layers of the skin are used”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ding, as modified by Locke, Widgerow and Rosenburg, to incorporate the teachings of Kasten and provide the method comprising transecting skin of the wound area at a specified depth including epidermis and dermis for the purpose harvesting the skin tissue suitable for specific surgical procedure.
Claims 40-43 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Kasten (US 20010047177 A1), Shuler et al (US 20170028113 A1) and Rosenberg (US 20110275972 A1), and evidenced by Convatec (provided by IDS).
Regarding Claim 40, Ding teaches a method for treating a skin graft donor site, the method comprising:
A method for treating a skin graft donor site, the method comprising:
removing a skin graft at a depth from within a dermis layer of a portion of skin with a blade to form a skin graft donor site wound area wherein the skin graft is applied to a different wound site (pg 1547, “the skin graft was harvested from back, thigh, or chest with a hand knife” “Split-thickness skin grafting procedures were performed on these patients for the management of full-thickness skin loss due to burns, trauma or surgery”, Procedure involving harvesting skin graft for transplanting the graft to a different site experiencing skin loose.);
adhesively coupling a flexible sheet (pg 1547 “dressings, such as vaseline gauze, alginates, Aquacel AG, hydrocolloids and biosynthetic skin substitutes” applying dressings to the donor site) to an area of skin surrounding the skin graft donor site wound area to form a liquid impermeable boundary wherein the sheet includes a hydrogel (At least Acuacel AG dressing including hydrofiber, as evidenced by Convatec, that forms hydrogel when contact with fluid) that contacts the skin graft donor site wound area and an adhesive that is configured to form a liquid impermeable contact with the skin surrounding the skin graft donor site, the flexible sheet including a transparent material to visualize the skin graft donor site and fluid retained within the flexible sheet;
delivering a wound healing medication with the sheet that promotes re-epithelialization to treat the skin graft donor site wound area (pg 1547, “release silver within the dressing for up to 14 days” Acuacel AG delivers silver, which is known for reducing inflammation, reducing inflammation response effectively promotes re-epithelialization); and
maintaining the sheet over the skin graft donor site wound area within the liquid impermeable boundary to retain moisture during re-epithelialization of the skin graft donor site wound area until complete epithelialization of the skin graft donor site wound area.
Ding does not teach the method comprising removing the skin at a depth from within a dermis layer;
In the same field of endeavor, namely method of skin graft preparation, Kasten provides a surgical method comprising transecting skin graft at a depth within a dermis layer of a portion of skin ([0002] "Skin grafts of divergent thickness, which comprise all or only some tissue layers of the skin are used. Thus, one differentiates e. g. full-thickness skin grafts (FTSG), which comprise epidermis and complete dermis from split-thickness skin grafts (STSG)).
Kasten provide the method harvesting epidermis and complete dermis from split-thickness skin graft because particular surgical procedure requires particular layers of skin ([0002] ”According to the medical indication and the recipient site, e. g. in the facial region for cosmetic purposes, skin grafts of divergent thickness, which comprise all or only some tissue layers of the skin are used”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ding to incorporate the teachings of Kasten, and provide the method comprising transecting skin of the wound area at a depth within a dermis layer of a portion of skin for the purpose harvesting the skin tissue suitable for specific surgical procedure.
The combination does not teach adhesively coupling the flexible sheet to form a liquid impermeable boundary and an adhesive that is configured to form a liquid impermeable contact with the skin surrounding the skin graft donor site, the flexible sheet including a transparent material to visualize the skin graft donor site and fluid retained within the flexible sheet;
In the same field of endeavor, namely a NPWT system, Shuler teaches adhesively coupling the flexible sheet to form a liquid impermeable boundary ([0033] figure 2, adhesively sealing layer 120 including a film barrier 124 and gel adhesive 128) and an adhesive that is configured to form a liquid impermeable contact with the skin surrounding the skin graft donor site ([0073] substantially liquid impermeable layer sealing layer with gel adhesive provide airtight seal), the flexible sheet including a transparent material ([0073] film barrier comprises a transparent polymeric film allows the wound to be visible) to visualize the skin graft donor site and fluid retained within the flexible sheet
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Kasten, to incorporate the teachings of Shuler and provide the claimed flexible sheet for the purpose of controlling wound bleeding while visually monitoring the wound after dressing has been applied without disrupting the placement of dressing as taught by Shuler ([0073])
The combination is still silent as to maintaining the sheet over the skin graft donor site wound area within the liquid impermeable boundary to retain moisture during re-epithelialization of the skin graft donor site wound area until complete epithelialization of the skin graft donor site wound area.
In the same field of endeavor, namely an interface layer wound dressing, Rosenberg teaches maintaining the sheet over the skin graft donor site wound area within the liquid impermeable boundary to retain moisture during re-epithelialization of the skin graft donor site wound area until complete epithelialization of the skin graft donor site wound area ([0062] “the wound dressing is maintained over the wound bed until epithelialization is completed”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Kasten, Locke and Widgerow, to incorporate the teachings of Rosenberg and provide the claimed method for the purpose of controlling infection, pain, moisture content and allows early mobilization and discharge without removing the dressing as taught by Rosenburg ([0031]) For instance, such a wound dressing would preserve the donor site under sterile conditions, thereby preventing bacterial contamination from the surrounding environment while sustaining an optimal moisture level to promote effective wound healing.
Regarding Claim 41, Ding, as modified by Kasten, Shuler and Rosenburg, teaches the method according to Claim 40.
The combination further teaches visualizing the at least one of the skin graft donor site wound area or a moisture retaining material ski graft donor site without removal of the sheet through the transparent material in the sheet (Shuler; [0073] film barrier 124 may be composed of a transparent polymeric film and practitioner can visually monitor the superficial surface of the wound after the dressing has been applied and without disrupting the placement of the dressing) extending over the skin graft donor site and the hydrogel (Shuler; see figure 1, sealing layer 120 including film barrier 124 extending over the wound site)
Regarding Claim 42, Ding, as modified by Kasten, Shuler and Rosenburg, teaches the method according to Claim 40.
The combination further teaches delivering a drug or molecule to the skin graft donor site, wherein the drug or molecule is embedded in the sheet (Ding; pg 1547 right column, “Aquacel Ag is an absorbent wound dressing made from sodium carboxymethyl cellulose and impregnated with 1.2% silver. It is a moisture retentive topical dressing which can release silver within the dressing for up to 14 days”) or delivered through the port.
Regarding Claim 43, Ding, as modified by Kasten, Shuler and Rosenburg, teaches the method according to Claim 40.
The combination further teaches wherein the sheet comprises a hybrid wound dressing including a polyurethane or an organic polymer (Shuler; [0033] barrier 124 is a polyurethane film).
Regarding Claim 45, Ding, as modified by Kasten, Shuler and Rosenburg, teaches the method according to Claim 40.
The combination further teaches wherein the flexible sheet further comprises a porous material, or a synthetic polymer (Shuler; [0033] "barrier 124 is a polyurethane film", polyurethane is synthetic polymer).
Claims 44 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Kasten (US 20010047177 A1), Shuler et al (US 20170028113 A1) and Rosenberg (US 20110275972 A1), and evidenced by Convatec (provided by IDS) and in further view of Johnson (US 6471685 B1)
Regarding Claim 44, Ding, as modified by Kasten, Shuler and Rosenburg, teaches the method according to Claim 40.
The combination does not teach the sheet is configured to conform to the shape of the skin graft donor site wound area on a leg of patient.
In the same field of endeavor, namely a medical dressing assembly, Johnson teaches the sheet is configured to conform to the shape of the skin graft donor site wound area on a leg of patient (col 4 lines 60-67 and figure 2g, dressing conforming an upper leg).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Kasten, Shuler and Rosenburg, to incorporate the teachings of Johnson and provide the sheet as claimed to conform to the shape of the wound area on a patient’s leg as taught by Johnson (col 4 lines 60-67) thereby establishing and maintaining the liquid-impermeable boundary surrounding the wound site in leg.
Claims 46 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Kasten (US 20010047177 A1), Shuler et al (US 20170028113 A1) and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS) in further view of Greener (US 20180361039 A1).
Regarding Claim 46, Ding, as modified by Kasten, Shuler and Rosenburg, teaches the method according to Claim 40.
The combination does not teach further comprising applying suction through the sheet with a port during re-epithelialization and removing a drain device and a suction conduit from the port prior to complete epithelialization
In the same field of endeavor, namely a vacuum assisted wound dressing, Greener teaches further comprising applying suction through the sheet with a port during re-epithelialization (figure 1, [0040] and [0049] providing a vacuum through a wound covering element) and removing a drain device and a suction conduit from the port prior to complete epithelialization ([0039] and [0050] disconnecting the apparatus 12 comprising a vacuum source 26 and vacuum connection tube 28 from a wound covering element 18 during wound therapy)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Kasten, Shuler and Rosenburg, to incorporate the teachings of Greener and provides the removable drain device as claimed for the purpose of providing portable wound dressing system as taught by Greener ([0030]). For instance, the vacuum system incorporating a vacuum source, such as a pump, along with tubing connections, can become cumbersome during patient movement. Therefore, allowing the vacuum system to be removed while maintaining the dressing on the wound site would facilitate wound healing without impeding mobility.
Claims 47-49 are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Kasten (US 20010047177 A1), Shuler et al (US 20170028113 A1) and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS), and in further view of Locke et al (US 20160325028 A1).
Regarding Claim 47, Ding, as modified by Kasten, Shuler and Rosenburg, teaches the method according to Claim 40.
The combination does not teach teaches the hydrogel comprises channels for passing fluid.
In the same field of endeavor, namely a method of treating wound, Locke teaches wherein the hydrogel comprises channels for passing fluid (Locke; [0031] and [0043], the manifold 122 made of hydrophilic polyurethanes, namely a hydrogel, includes plurality of pathways adapted to collect or distribute fluid across a tissue site).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ding, as modified by Kasten, Shuler and Rosenburg, to incorporate the teachings of Locke and provide the hydrogel comprises channels for passing fluid for the purpose of distributing negative pressure throughout the wound site evenly as taught by Locke ([0031])
Regarding Claim 48, Ding, as modified by Kasten, Shuler, Rosenburg and Locke, teaches the method according to Claim 47.
The combination further teaches the channels contact a surface of the skin graft donor site (Locke; see figure 1, manifold 122 comprising a plurality of pathway contact a surface of the skin graft donor site 102)
Regarding Claim 49, Ding, as modified by Kasten, Shuler, Rosenburg and Locke, teaches the method according to Claim 47.
The combination further teaches the hydrogel comprises a hydrophilic synthetic polymer (Locke; [0043] “the manifold 122 may be largely constructed from polymers that are hydrophilic”)
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (Ding, Xianchao et al. “A Randomized Comparison Study of Aquacel Ag and Alginate Silver as Skin Graft Donor Site Dressings.” Burns 39.8 (2013): 1547–1550. Web., provided by IDS dated 16 June 2020 and effectively published in 17 April 2013, hereinafter ‘Ding) in view of Kasten (US 20010047177 A1), Shuler et al (US 20170028113 A1) and Rosenberg (US 20110275972 A1) and evidenced by Convatec (provided by IDS) and in further view of Leung et al (US 20140276493 A1, hereinafter ‘Leung’)
Regarding Claim 50, Ding, as modified by Kasten, Shuler, Rosenburg and Locke, teaches the method according to Claim 40.
The combination does not teach the hydrogel comprises dl-lactic acid-co-glycolic acid (PLGA), though Locke teaches the manifold comprises a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA) (Locke; [0034]).
In the same field of endeavor, namely wound healing compositions, Leung teaches a carrier material as a hydrogel ([0033]) which including bioabsorbable or non-absorbable polymers comprising polylactide-co-glycolide (PLGA) ([0058] “including bioabsorbable or non-absorbable polymers, such as polylactic acid (PLA), polyglycolic acid (PGA), polylactide-co-glycolide (PLGA),”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the hydrogel material of Ding, as modified by Kasten and Locke, (PLA and PGA blend) with another (PLGA of Leung), since the modification would have been a simple substitution of one known material to another to obtain predictable result (diffusing pharmaceutical while maintaining desired moisture level for wound healing) see mpep 2143B
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the hydrogel made out of dl-lactic acid-co-glycolic acid (PLGA), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07
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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/S.H./Examiner, Art Unit 3781
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781