DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the 1002
patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 5 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Mohanty et al. (US 2021/0322229).
With reference to claim 1, Mohanty et al. (hereinafter “Mohanty”) discloses a wound dressing (abstract) comprising:
skin substitute (included in water stable polymer layer 130 as discussed in [0050-0052]);
a polymeric contact layer (10) including an elastomeric layer (i.e., polyurethane) bonded to a hydrophobic membrane (90) as discussed in [0070] and as shown in figure 6; and
a release liner (30,120) arranged over and in contact with both the skin substitute and elastomeric layer as discussed in [0072] and as shown in figure 6;
wherein the skin substitute (130) is located between the polymeric contact layer (10, 90) and the release liner (120,30) as shown in figure 6.
The structure as disclosed by Mohanty is identical to that that recited. It is fully capable of being submersed for hydration, together with the polymeric contact layer and the release liner, in a saline solution. The structure, like most structures, has the capacity to be submersed.
As to claim 2, Mohanty discloses that the skin substitute is an acellular dermal matrix comprising decellularized fish skin as set forth in [0052] through the incorporation [0150] of Magnusson, et al., Military Medicine, 2017; 182, 3/4:383 (hereinafter “Magnusson”).
Magnusson discloses an acellular dermal matrix comprising decellularized fish skin as set forth on page 383 in the last paragraph which discloses the use of Kerecis Omega 3.
With reference to claim 5, Magnusson discloses a wound dressing wherein the skin substitute is in direct contact with the elastomeric layer of the polymeric contact layer as shown in figure 6 where outer edges of layer 130 are directly connected to outer edges of layer 10.
Claim Rejections – 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mohanty et al. (US 2021/0322229) and further in view of Sigurjonsson et al (US 2011/0244054).
With reference to claim 3, Mohanty teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Mohanty and claim 3 is the explicit recitation that
the skin substitute comprises lipids from a lipid layer of the decellularized fish skin.
Sigurjonsson et al. (hereinafter “Sigurjonsson teaches an analogous wound dressing that includes lipids from a lipid layer of the decellularized fish skin as set forth in the abstract.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the lipids as taught by Sigurjonsson within the article as taught by Mohanty in order to include properties that may facilitate the regeneration, repair and/or replacement of tissue (e.g., repair, regeneration, and/or growth of endogenous tissue) as taught by Sigurjonsson in [0029].
With reference to claim 4, Mohanty teaches the invention substantially as claimed as set forth in the rejection of claim 1.
Mohanty discloses the inclusion of mesh in [0038-0040 and 0045].
The difference between Mohanty and claim 4 is the explicit recitation that
the skin substitute comprises an extracellular matrix product (ECM) in a three-dimensional form of particles, or a sheet, or a mesh.
Sigurjonsson teaches an analogous wound dressing that includes an extracellular matrix product in a three-dimensional form of particles, or a sheet, or a mesh as set forth in [0039].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide ECM as taught by Sigurjonsson within the article as taught by Mohanty in order to include properties that may facilitate the regeneration, repair and/or replacement of tissue (e.g., repair, regeneration, and/or growth of endogenous tissue) as taught by Sigurjonsson in [0029].
Regarding claim 6, Mohanty teaches the invention substantially as claimed as set forth in the rejection of claim 1.
Mohanty discloses the inclusion of mesh in [0038-0040].
The difference between Mohanty and claim 6 is the explicit recitation that
the skin substitute includes at least one fenestration that extends through a thickness of the skin substitute.
Sigurjonsson teaches an analogous wound dressing wherein the skin substitute is a mesh material as set forth in [0039].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide ECM as taught by Sigurjonsson within the article as taught by Mohanty in order to include properties that may facilitate the regeneration, repair and/or replacement of tissue (e.g., repair, regeneration, and/or growth of endogenous tissue) as taught by Sigurjonsson in [0029].
As to claim 7, Mohanty modified teaches the invention substantially as claimed as set forth in the rejection of claims 1 and 6.
The difference between Mohanty and claim 7 is the provision that the fenestration has a specific shape.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the shape of the fenestration as desired since it has been held that the mere change in size and/or shape of an element previously set forth in the prior art is considered to be within the level of ordinary skill in the art.
Claims 8-17 are rejected under 35 U.S.C. 103 as being unpatentable over Mohanty et al. (US 2021/0322229) and further in view of Cotton (US 2023/0240900).
As to claims 8-11, Mohanty modified teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Mohanty and claim 8 is the explicit recitation that the elastomeric layer has sufficient tackiness to negate a need for an adhesive between the elastomeric layer and the skin substitute, a polyurethane material, and a distribution of apertures.
It is noted that claim 11 recites a distribution of apertures that is less than 25%. This recitation would include zero in which the apertures are not necessarily required to be present.
Cotton teaches an analogous wound dressing having an elastomeric layer having sufficient tackiness to negate a need for an adhesive as set forth in [0058] through the teaching of a silicone layer. The dressing also includes a polyurethane substrate and has apertures across its surface as set forth in [0064].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the dressing of Mohanty with the specific elements as taught by Cotton in order to ensure that the dressing can be removed from the skin substantially without harming the surface of the skin [0058] and with improved breathability as taught by Cotton in [0007].
With reference to claims 12-14, Mohanty discloses an integrated wound treatment comprising:
skin substitute (included in water stable polymer layer 130 as discussed in [0050-0052]) in direct contact with a polymeric contact layer (see figure 6 where outer edges of layer 130 are directly connected to outer edges of layer 10), the polymeric contact layer (10) including an elastomeric layer (i.e., polyurethane) bonded to a hydrophobic membrane (90) as discussed in [0070] and as shown in figure 6.
The integrated wound treatment is configured to (i.e., fully capable of) being applied to a wound such that the skin substitute is in contact with the wound and the polymeric contact layer overlays the skin substitute and further adheres to skin surrounding the wound (see figure 6) wherein the wound treatment is considered to be fully capable of performing the recited function (i.e., allowing for cellular ingrowth and tissue regeneration at the wound with the skin substitute) as the structure as disclosed by Mohanty is identical to that that recited. It is fully capable of performing the recited function.
Moharty also includes section (100) that is releasable (i.e., arranged to separate from the remaining structure) as set forth in [0078].
The difference between Mohanty and claims 12-14 is the explicit recitation that the elastomeric layer has sufficient tackiness to negate a need for an adhesive and that the layer has a predetermined porosity (cl. 13) and/or having fenestrations (cl. 14).
Cotton teaches an analogous wound dressing having an elastomeric layer having sufficient tackiness to negate a need for an adhesive as set forth in [0058] through the teaching of a silicone layer. The dressing also has apertures (i.e., fenestrations) across its surface as set forth in [0064].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the dressing of Mohanty with the specific elements as taught by Cotton in order to ensure that the dressing can be removed from the skin substantially without harming the surface of the skin [0058] and with improved breathability as taught by Cotton in [0007].
As to claims 15-16, Mohanty discloses that the skin substitute is an acellular dermal matrix comprising decellularized fish skin as set forth in [0052] through the incorporation [0150] of Magnusson, et al., Military Medicine, 2017; 182, 3/4:383 (hereinafter “Magnusson”).
With reference to claim 17, Moharty discloses an integrated wound treatment wherein the integrated wound treatment includes a release liner in contact with the skin substitute, the skin substitute being provided between the release liner and the polymeric contact layer as set forth in the rejection of claim 1.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Peyton (US 11,612,675) and further in view of Mohanty et al. (US 2021/0322229).
Regarding claim 18, Peyton discloses a method for producing an integrated wound treatment, the method comprising: harvesting a skin substitute as set forth in col. 14, lines 3-5.
The difference Peyton and claim 18 is the explicit recitation that the skin substitute is cut to size, integrated with a polymeric contact layer that includes a hydrophobic membrane coated with an elastomeric layer, wherein a release liner is arranged against the elastomeric layer of the polymeric contact layer and wherein the skin substitute is located between the release liner and the elastomeric layer.
Initially, it is noted that Peyton discusses determining the size of the wound and securing the edges of the fish skin and covering the biological bandage as shown in figure 4.
As such one of ordinary skill in the art would have been motivated to cut the skin substitute of Peyton to size in order to accommodate the wound that is being treated. Additionally, one of ordinary skill in the art would have been motivated to provide the skin substitute of Peyton with additional layers because Peyton discloses covering the skin substitute with additional layers as shown in Figure 4.
Additionally, Mohanty teaches an analogous wound dressing including an integrated wound treatment comprising skin substitute (included in water stable polymer layer 130 as discussed in [0050-0052]) in direct contact with a polymeric contact layer (see figure 6 where outer edges of layer 130 are directly connected to outer edges of layer 10), the polymeric contact layer (10) including an elastomeric layer (i.e., polyurethane) bonded to a hydrophobic membrane (90) as discussed in [0070] and as shown in figure 6.
The integrated wound treatment is configured to (i.e., fully capable of) being applied to a wound such that the skin substitute is in contact with the wound and the polymeric contact layer overlays the skin substitute and further adheres to skin surrounding the wound (see figure 6) wherein the wound treatment is considered to be fully capable of performing the recited function (i.e., allowing for cellular ingrowth and tissue regeneration at the wound with the skin substitute) as the structure as disclosed by Mohanty is identical to that that recited. It is fully capable of performing the recited function.
Moharty also provides a release liner (30,120) arranged over and in contact with both the skin substitute and elastomeric layer as discussed in [0072] and as shown in figure 6.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the bandage of Peyton with the specific structure as taught by Moharty in order to provide a structure that promotes healing of the wound as taught by Moharty in [0012].
As to claim 19, Peyton discloses a method wherein the skin substitute is a fish skin and comprises the following steps after harvesting the skin substitute (col. 14, lines 3-5);
decellularizing the fish skin (col. 17, lines 20-32); and
lyophilizing the decellularized fish skin as set forth in col. 15, lines 31-32.
With reference to claim 20, Peyton modified teaches the invention substantially as claimed as set forth in the rejection of claims 18-19.
Peyton also discloses sterilizing the integrated wound treatment as set forth in col. 16, lines 34-36.
The difference between Peyton modified and claim 20 is the provision that the sterilization uses ethylene oxide gas.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the type of sterilization used since it has been held that the mere substitution of one type of sterilization material for another is within the level of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kealey et al. (US 2020/0000612) teaches a spiral-based mesh for medical devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781
