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 .
Status of Claims
Claims 1, 4-10, 24-26, 29-31, 34-38, and 71-73 are currently pending. Claim 73 is newly added. No new subject matter is added.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/05/2025 has been entered.
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.
6. 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 1, 5, 7-10, and 71-73 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 20180369462 A1), hereinafter referred to as “Anderson” in view of Collinson et al. (US 20140316359 A1), hereinafter referred to as “Collison”, and as evidence by (https://www.palmetto-industries.com/products/spunbond fabric/#:~:text=Medical%20and%20Hygiene,%2C%20dirt%2C%20and%20potential%20damage).
Regarding Claim 1, Anderson teaches a system to provide negative pressure to a wound site and a peri wound area surrounding the wound site (see Abstract)(see Figure 1) comprising:
a wound dressing (16) comprising: a top layer (cover layer (40)), a second intermediate layer (filler layer (38)), and a wound contact layer (contact layer (34)), wherein each of the layers comprises an upper surface and a lower surface (layers (40, 38, 34) have an upper and lower surface, see Figure 1); and wherein:
the top layer defines a perimeter configured to be positioned over the wound site and the peri wound area (cover layer (40) is adapted to extend laterally beyond the perimeter of the wound bed "w" so as to contact the healthy skin "s", see Paragraph [0082]) (see Figure 4), wherein the upper surface of the top layer comprises one or more placement guides (connective region (50)), and wherein the top layer comprises a first opening centered about the one or more placement guides (top layer (44) has a connective region (50) comprising perorations (58) with a central opening, see Figure 1) configured to transmit negative pressure to the wound site and the periwound area through the wound dressing and remove bodily fluids from the wound site and the peri wound area (the perforations located on connective region (50) allows for negative pressure to be communicated to wound dressing and wound site, see Paragraph [0083]) (see Paragraph [0076]-[0077]);
the second intermediate (38) layer is positioned between the top layer and the wound contact layer (see Figure 1), wherein the second intermediate layer comprises a smaller footprint than the top layer and the wound contact layer (see Figure 1); and
the wound contact layer is positioned below the first intermediate layer and is configured to contact the wound site and the peri wound area (wound contact layer (34) may be sufficiently conformable to be positioned in direct contact with an irregularly shaped surface of a wound bed “w, see Paragraph [0078]), wherein the wound contact layer comprises a plurality of apertures (the film layer (34) can have apertures or perforations, see Paragraph [0078]); and
a port (portal member (46)) configured to be secured to the upper surface of the top layer (connective region (50) receives reservoir surface (54), see Figure 1) (Paragraph [0083]) and to apply negative pressure through the first opening of the top layer for the application of topical negative pressure at the wound site and the peri wound area (the reservoir surface (54) is adapted to be positioned such that a primary aperture (64) therein may fluidly communicate with vacuum reservoir (14), through a perforation, see Paragraph [0076] and [0085]).
However, Anderson does not explicitly disclose a first intermediate layer, wherein the first intermediate layer is positioned between the top layer and the second intermediate layer, the second intermediate layer is positioned between the first intermediate layer and the wound contact layer, wherein the first intermediate layer comprises a smaller footprint than the top layer and the wound contact layer and a larger footprint than the second intermediate layer, wherein the first intermediate layer is configured to provide support to the wound dressing and protect the top layer from being pierced by the second intermediate layer, and wherein the first intermediate layer comprises a second opening aligned with the first opening and configured to transmit negative pressure to the wound site and the periwound area through the wound dressing and remove bodily fluids from the wound site and the periwound area;
Collinson teaches a negative pressure treatment system (see Abstract; Figures 3B) comprising: a wound dressing (2100) comprising: a top layer (2140), a first intermediate layer (masking layer 2107), a second intermediate layer (absorbent layer 2110), and a wound contact layer (2102); wherein the first intermediate layer is positioned between the top layer and the second intermediate layer (see Figure 3B), the second intermediate layer is positioned between the first intermediate layer and the wound contact layer (see Figure 3B), wherein the first intermediate layer comprises a smaller footprint than the top layer and the wound contact layer (the obscuring layer 2107 will be of a smaller area than the backing layer 2140, see Paragraph [0064]; two layers 2140, 2102 are preferably joined or sealed together so as to define an interior space or chamber, see Paragraph [0059]; therefore the obscuring layer 2107 is smaller than both the top layer and wound contact layer) and a larger footprint than the second intermediate layer (see Figure 3B), wherein the first intermediate layer is configured to provide support to the wound dressing and protect the top layer from being pierced by the second intermediate layer (the obscuring layer may comprise polypropylene spun bond material, see Paragraph [0084]; polypropylene spun bond material is tear resistance, as evidence by palmetto-industries.com), and wherein the first intermediate layer comprises a second opening (through hole 2146) aligned with the first opening (orifice 2145) and configured to transmit negative pressure to the wound site and the periwound area through the wound dressing and remove bodily fluids from the wound site and the periwound area (to allow a negative pressure to be applied to the dressing 2100, see Paragraph [0066])
Anderson and Collinson are analogous art because both teach a negative pressure wound dressing with multiple layers.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the dressing of Anderson and further include a first intermediate layer positioned between the top layer and the second intermediate layer, wherein the first intermediate layer has a second opening aligned with the first opening and configured to transmit negative pressure to the wound site, as taught by Collison. Collison teaches the first intermediate layer/obscuring layer is beneficial to help reduce the unsightly appearance of a dressing during use due to the absorption of wound exudate (see Paragraph [0084].
Regarding Claim 5, Anderson and Collinson teaches all of the limitations of claim 1, and Anderson further teaches wherein the one or more placement guides are provided on a sticker that is configured to be attached to the upper surface of the top layer (backing layer (44) may include a band of adhesive near the connective region (50) to form a seal with the portal member (46), see Paragraph [0084]).
Regarding Claim 7, Anderson and Collinson teaches all of the limitations of claim 1, and Anderson further teaches wherein the one or more placement guides comprises a circle with the first opening at a center of the circle (the connective region (50), is a circle with an opening in the center, see Figures 1-4).
Regarding Claim 8, Anderson and Collinson teaches all of the limitations of claim 1, and Anderson further teaches wherein the port (portal member (46)) comprises one or more alignment features (supplemental aperture (74) and primary aperture (64), see Figure 2) that are configured to interact with the one or more placement guides of the upper surface of the top layer (portal member (46) may be positioned over connective region (50) of backing layer (44) such that the primary and supplemental apertures (64, 74) are aligned with perforations (58), see Paragraph [0087]).
Regarding Claim 9, Anderson and Collinson teaches all of the limitations of claim 1, and Anderson further teaches wherein the second intermediate layer (38) comprises an acquisition distribution layer configured to communicate fluid through the wound dressing (an absorbent material such as non-woven gauze or reticulated foam may be used for filler 38 to trap any exudate that migrates through contact layer 34, see Paragraph [0079]).
Regarding Claim 10, Anderson teaches a method for treating a wound site (see Abstract) (see Figure 1), the method comprising:
positioning a wound dressing (16) over the wound site ("w") and a peri wound area surrounding the wound site (healthy skin "s", see Figure 1), the wound dressing comprising a wound contact layer (contact layer (34)) positioned in direct contact with the wound site and the peri wound area (in contact with wound "w" and healthy skin "s", see Figure 1) (see Paragraph [0082]), a first intermediate layer (filler (38)) positioned above the wound contact layer (positioned above contact layer (34), see Figure 1), and a top layer (cover layer (44)) positioned above the first intermediate layer (positioned above (filler (38), see Figure 1);
wherein the wound contact layer comprises a plurality of apertures (the film layer (34) can have apertures or perforations, see Paragraph [0078]);
wherein each of the layers comprise an upper surface and a lower surface (layers (40, 38, 34) have an upper and lower surface, see Figure 1);
wherein the top layer defines a perimeter configured to be positioned over the wound site and the peri wound area (the top layer (44) has a perimeter positioned over the wound site ("w") and adjacent healthy skin ("s"), see Figure 4) and wherein the top layer comprises a first opening configured to transmit negative pressure (top layer (44) has a connective region (50) comprising perorations (58) with a central opening, see Figure 1),
wherein the first intermediate layer has a smaller footprint than the top layer and the wound contact layer (see Figure 1);
positioning a port (portal member (46)) on the upper surface of the top layer about the first opening (connective region (50) receives reservoir surface (54) of portal member (46), see Figure 1) (Paragraph [0083]); and
applying negative pressure to the wound site and the peri wound area through the wound dressing via the first opening for a period of time (the reservoir surface (54) is adapted to be positioned such that a primary aperture (64) therein may fluidly communicate with vacuum reservoir (14), through a perforation, see Paragraph [0076] and [0085]);
wherein re-epithelialization and granulation tissue formation in the wound site after the period of time has passed is improved compared to re-epithelialization and granulation tissue formation that would have occurred when applying negative pressure to the wound site for the period of time without the wound dressing (the reduced pressure may be effective to promote blood flow to the area to stimulate the formation of granulation tissue and the migration of healthy tissue over the wound by the natural process, see Paragraph [0010]); and
wherein erythematous tissue formation in the peri wound area is increased compared to an amount of erythematous tissue formation that would have formed when applying negative pressure to the peri wound area for the period of time without the wound dressing (the reduced pressure may be effective to promote blood flow to the area to stimulate the formation of granulation tissue and the migration of healthy tissue over the wound by the natural process, see Paragraph [0010]) (reduce pressure also includes promoting erythematous tissue formation).
However, Anderson does not explicitly disclose a second intermediate layer positioned above the first intermediate layer and wherein the second intermediate layer has a smaller footprint than the top layer and the wound contact layer and a larger footprint than the first intermediate layer, wherein the second intermediate layer is configured to provide support to the wound dressing and protect the top layer from being pierced by the first intermediate layer, and wherein the second intermediate layer comprises a second opening aligned with the first opening and configured to transmit negative pressure.
Collinson teaches a negative pressure treatment system (see Abstract; Figures 3B) comprising: a wound dressing (2100) comprising: a top layer (2140), a first intermediate layer (absorbent layer 2110), a second intermediate layer (masking layer 2107), and a wound contact layer (2102); wherein the second intermediate layer positioned above the first intermediate layer (see Figure 3B) and wherein the second intermediate layer has a smaller footprint than the top layer and the wound contact layer (the obscuring layer 2107 will be of a smaller area than the backing layer 2140, see Paragraph [0064]; two layers 2140, 2102 are preferably joined or sealed together so as to define an interior space or chamber, see Paragraph [0059]; therefore the obscuring layer 2107 is smaller than both the top layer and wound contact layer) and a larger footprint than the first intermediate layer (see Figure 3B), wherein the second intermediate layer is configured to provide support to the wound dressing and protect the top layer from being pierced by the first intermediate layer (the obscuring layer may comprise polypropylene spun bond material, see Paragraph [0084]; polypropylene spun bond material is tear resistant, as evidence by palmetto-industries.com), and wherein the second intermediate layer comprises a second opening (through hole 2146) aligned with the first opening (orifice 2145) and configured to transmit negative pressure to allow a negative pressure to be applied to the dressing 2100, see Paragraph [0066]).
Anderson and Collinson are analogous art because both teach a negative pressure wound dressing with multiple layers.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the dressing of Anderson and further include a second intermediate layer positioned between the top layer and the first intermediate layer, wherein the second intermediate layer has a second opening aligned with the first opening and configured to transmit negative pressure to the wound site, as taught by Collison. Collison teaches the first intermediate layer/obscuring layer is beneficial to help reduce the unsightly appearance of a dressing during use due to the absorption of wound exudate (see Paragraph [0084].
Regarding Claim 71, Anderson and Collinson teaches all of the limitations of claim 1 and Collinson further teaches wherein the first intermediate is configured to mask the presence of wound exudate in the wound dressing (obscuring layer helps to reduce the unsightly appearance of a dressing during use due to the absorption of wound exudate, see Paragraph [0084]).
Regarding Claim 72, Anderson and Collinson teaches all of the limitations of claim 1 and Anderson further teaches wherein the second intermediate layer comprises multiple fibers (filler 38 may be made an absorbent material such as non-woven gauze having fibers, see Paragraph [0079]).
Regarding Claim 73, Anderson and Collinson teaches all of the limitations of claim 10 and Anderson further teaches wherein the first intermediate layer (38) comprises an acquisition distribution layer configured to communicate fluid through the wound dressing (an absorbent material such as non-woven gauze or reticulated foam may be used for filler 38 to trap any exudate that migrates through contact layer 34, see Paragraph [0079]).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson and Collinson, as applied to claim 1, and in further view of Edwards et al. (US 20210161725 A1), hereinafter referred to as “Edwards”.
Regarding claim 4, Anderson and Collinson teaches all of the limitations, as discussed above in claim 1. However, Anderson and Collinson do not explicitly disclose wherein the one or more placement guides are printed directly on the upper surface of the top layer.
Edwards teaches a fluid management bridge for providing a fluid communication between a wound interface dressing and a negative pressure source (see Abstract) (see Figures 1-4) comprising a dressing (424); wherein the first end of the fluid management bridge is configured to provide for central alignment of the first end with the port of the wound interface dressing (see Abstract); and wherein one or more placement guides (419) are printed directly on the upper surface of the top layer (the corresponding alignment features can be included on the adhesive layer by at least one of: applying a biocompatible ink, printing onto the adhesive layer of the base wound interface, embossing onto the base wound interface, or laminating on the base wound interface, see Paragraph [0013]).
Anderson, Collinson, and Edwards are analogous art because both deal with a negative pressure wound therapy system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the connective region of modified Anderson and replace it with the alignment features printed on the top layer, as taught by Edwards. Edwards teaches the alignment features disclosed herein provide an end user with the ability to place a dressing or a wound cover over a wound without having to manage the orientation of the bridge component. This allows the user to achieve a proper seal between the components of the wound management system (see Paragraph [0084]).
Regarding claim 6, Anderson and Collinson teaches all of the limitations, as discussed above in claim 1. However, Anderson and Collinson do not explicitly disclose wherein the one or more placement guides comprises two substantially perpendicular lines that intersect at the opening.
Edwards teaches a fluid management bridge for providing a fluid communication between a wound interface dressing and a negative pressure source (see Abstract) (see Figures 1-4) comprising a dressing (424); wherein the first end of the fluid management bridge is configured to provide for central alignment of the first end with the port of the wound interface dressing (see Abstract); and wherein the one or more placement guides comprises two substantially perpendicular lines that intersect at the opening (the one or more alignment features (419) on the fluid management bridge comprise one or more lines, wherein each line can be perpendicular to a central axis line of the first port, see Paragraph [0011]) (see Figure 4A).
Anderson, Collinson, and Edwards are analogous art because both deal with a negative pressure wound therapy system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the connective region of modified Anderson and replace it with the alignment features comprising two perpendicular lines, as taught by Edwards. Edwards teaches the alignment features disclosed herein provide an end user with the ability to place a dressing or a wound cover over a wound without having to manage the orientation of the bridge component. This allows the user to achieve a proper seal between the components of the wound management system (see Paragraph [0084]).
Claims 24-26, 29-31, and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Collison et al. (US 10076594 B2), hereinafter referred to as “Collison” and in view of Armstrong et al. (US 8801685 B2), hereinafter referred to as “Armstrong”.
Regarding claim 24, Collison teaches a system to provide negative pressure to a wound site and a periwound area surrounding the wound site (see Abstract; Figure 2B and 4A) comprising:
a wound dressing (100) comprising a drape portion (main portion of dressing 100) and a drape tail (a fluidic connector 110);
the drape portion comprising a top layer (220), a wound contact layer (222), an intermediate layer (absorbent layer 221) positioned between the top layer and the wound contact layer (222), and a transmission layer (226) positioned between the intermediate layer and the wound contact layer (see Figure 2B), wherein the drape portion is configured to be positioned over the wound site and the periwound area (see Col. 6 ln 60-62);
the drape tail extending away from the drape portion (Figure 2B), the drape tail comprising a distal end nearer to the drape portion (distal end 140) and a proximal end farther from the drape portion (proximal end 130), wherein the drape tail comprises an elongate transmission layer extending from the distal end to the proximal end of the drape tail (first fluid passage 212 comprising a porous material, such as a 3D knitted material, see Col. 12 ln 5-7);
wherein the top layer of the drape portion defines a perimeter configured to be positioned over the wound site and the periwound area (cover layer 220 having a perimeter and configured to be over a wound site, see Col. 7 ln 21-34);
wherein the intermediate layer of the drape portion has a larger footprint than the transmission layer of the drape portion (the absorbent layer 221 may be of a greater area than the transmission layer 226, see Col. 11 ln 1-2) and is configured to provide support to the wound dressing and protect the top layer from being pierced by the transmission layer (the absorbent layer overlaps the edges of the transmission layer 226, thereby ensuring that the transmission layer does not contact the backing layer 220, see Col. 11 ln 2-5);
wherein the wound contact layer is positioned below the top layer of the drape portion (see Figure 2) and is configured to contact the wound site and the periwound area (the wound contact layer over and/or in contact with the wound site 400, see Col. 14 ln 49-50), wherein the wound contact layer comprises a plurality of apertures (perforations 225 preferably comprise through holes in the wound contact layer 222 which enable fluid to flow through the layer, see Col. 7 ln 49-51); and
wherein the transmission layer of the drape portion is configured to define a continuous fluid pathway from the wound site to the elongate transmission layer of the drape tail (see Figure 2B).
However, Collinson does not explicitly disclose the elongate transmission layer of the drape tail being continuous with the transmission layer of the drape portion.
Armstrong teaches a negative a negative pressure treatment system (4801, see Figure 48A-D) comprising a transmission layer (a flexible suction adapter sheet 4803) capable of being packed into a wound space; and wherein the transmission layer (4803) preferably comprises a larger, planar section (4805) at its distal end, connected to a tail portion (4806) at its proximal end.
Collison and Armstrong are analogous art because both teach a negative pressure wound dressing have a drape and a drape tail.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the position of the drape tail of Collison and replace it with the drape tail with an elongate transmission layer of the drape tail being continuous with the transmission layer of the drape portion, as taught by Armstrong. Armstrong teaches the drape tail may offer a softer, kink-free fluidic connector for connecting a wound site to a source of negative pressure for treatment. Such a fluidic connector and/or suction adapter is faster to apply, requiring fewer steps compared to prior art connectors, and offers greater patient comfort and safety by being soft and conformable, thereby avoiding pressure ulcers and other complications caused by harder connectors (see Col. 1 ln 45-57).
Regarding claim 25, Collinson and Armstrong teach all of the limitations as discussed above in claim 24, and Collinson further teaches a port configured to be attached to the proximal end of the drape tail (coupling 160, see Figure 1B; embodiments can be used together, see Col. 29 ln 11-13) and to apply negative pressure through the elongate transmission layer of the drape tail for the application of topical negative pressure at the wound site and the periwound area (see Col. 6 ln 29-36).
Regarding claim 26, Collinson and Armstrong teaches all of the limitations of claim 24 and Armstrong further teaches wherein the drape tail further comprises an elongate black foam layer positioned alongside the elongate transmission layer (in some embodiments, a foam spacer may extend into the channel, and spacer comprising bosses may also be present on in an interior portion of the channel, see Col. 5 lines 14-17; many of the embodiments described above include similar components, and as such, these similar components can be interchanged in different embodiments, see Col. 50 ln 39-42).
Regarding claim 29, Collinson and Armstrong teaches all of the limitations of claim 24 and Collinson further teaches wherein the drape tail comprises a top layer extending over the elongate transmission layer from the distal end to the proximal end of the drape tail (flexible film layer 208 extending over layer 212, see Figure 2B).
Regarding claim 30, Collinson and Armstrong teaches all of the limitations of claim 24 and Armstrong further teaches wherein the top layer of the drape tail is continuous with the top layer of the drape portion (top layer of drape 4803 and tail 4806 having the same top layer, see Figure 48D).
Regarding claim 31, Collinson and Armstrong teaches all of the limitations of claim 24 and Collinson further teaches wherein the drape tail comprises a lower layer extending below the elongate transmission layer from the distal end to the proximal end of the drape tail (flexible film layer 210 below layer 212, see Figure 2B).
Regarding claim 35, Collinson and Armstrong teaches all of the limitations as discussed above in claim 24, and Collinson further teaches wherein the transmission layer is sized and configured to be positioned over the wound site and the peri wound area (the wound dressing 100 may be positioned and placed over the wound site 400, see Col. 14 ln 49-50).
Regarding claim 36, Collinson and Armstrong teaches all of the limitations of claim 24 and Armstrong further teaches a bridge (1502; similar to drape tail 4806) with at least one air leak (1524) in the drape portion and/or the drape tail (located at the proximal end of bridge (1502), see Figure 15B; many of the embodiments described above include similar components, and as such, these similar components can be interchanged in different embodiments, see Col. 50 ln 39-42).
Regarding claim 37, Collinson and Armstrong teach all of the limitations, as discussed above in claim 36 and Armstrong further teaches at least one air leak (1524) at the proximal end of the drape tail (located at the proximal end of bridge (1502), see Figure 15B).
Regarding claim 38, Collinson and Armstrong teach all of the limitations, as discussed in above claim 36. However, Collinson and Armstrong do not explicitly teach at least one air leak in the drape portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the air leak to be located on drape portion, since the claims to an air leak which read on the prior art expect with regard to the position of the aperture would not have modified the operation of the device (detecting blockages within the wound therapy system). The particular placement of the aperture would be obvious matter of design choice to one skilled in the art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.). See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Collinson and Armstrong, as applied in claim 24, and further in view of Collinson et al. (US 20140316359 A1), herein after referred to as “Collinson “359”.
Regarding claim 34, Collinson and Armstrong teach all of the limitations of claim 24. However, Collinson and Armstrong do not explicitly disclose wherein the drape portion further comprises an obscuring layer configured to obscure a presence of the wound exudate in the wound dressing.
Collinson “359 teaches a negative pressure treatment system (see Abstract; Figures 3B) comprising: a wound dressing (2100) comprising: a top layer (2140), a first intermediate layer (absorbent layer 2110), a wound contact layer (2102), and an obscuring layer (obscuring layer 2107) configured to obscure a presence of the wound exudate in the wound dressing (may be one of a variety of colors such as blue, orange, yellow, green, or any color suitable for masking the presence of wound exudate in the dressing, see Paragraph [0084]).
Collinson, Armstrong, and Collinson “359 are analogous art because both teach a negative pressure wound dressing.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the dressing of Modified Collinson and further include an obscuring layer, as taught by Collison “359. Collison “359 teaches the obscuring layer is beneficial to help reduce the unsightly appearance of a dressing during use due to the absorption of wound exudate (see Paragraph [0084]).
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive.
Specifically Applicant argues in claims 1 and 10 that there is no motivation to combine Anderson and Collinson. The applicant states that Anderson discloses a multi-part system that is applied to a wound in stages, with no motivation to add a layer, such as the obscuring layer 2107 of Collison and configure such layer to protect the top layer form being pierced by the filler given the material being a “tow”. Applicant also argues that the cover layer of Anderson is preferably transparent to permit a visual assessment of wound conditions without requiring removal of the cover layer.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Paragraph [0084] of Collison provides the motivation to include a first intermediate layer/obscuring layer to help reduce the unsightly appearance of a dressing during use due to the absorption of wound exudate. Paragraph [0086] of Collison also further teaches the obscuring layer to have viewing windows to allow for partial masking which enables a skilled clinician to perceive a different color caused by exudate, blood, by-products etc. in the dressing allowing for a visual assessment and monitoring of the extent of spread across the dressing. Therefore, Claim 1 and 10 would remain rejected over Simmons in view of Collinson.
Specifically Applicant argues in claims 9 that the filler layer (38) of Anderson does not teach “communicate fluid through the wound dressing”, but rather traps exudate within the layer.
The examiner respectfully disagrees with the applicant that filler layer (38) would fail to teach the filler layer (38) communicating fluid through the wound dressing. Paragraph [0078] discloses that the filler layer can be made from an absorbent material such as non-woven gauze or reticulated foam. By absorbing fluids within the layer fluid is communicated through the dressing and eventually to collection canister 28 (see Figure 1). Therefore, claim 9 would still be rejected in view of Anderson.
Applicant’s arguments with respect to claim 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/ERIC RASSAVONG/ (1/10/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781