DETAILED ACTION
This is a Non-Final Rejection for Application 19/044,832 filed February 4, 2025. This application is a continuation of U.S. Patent Application No. 16/148,780, filed on October 1, 2018, which application claims priority to U.S. Provisional Patent Application No. 62/566,890, filed on October 2, 2017. Claims 1-20 are currently pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities: the recitation “the top surface of the primary layer” in line 12 should be amended to recite the upper surface to remain consistent with terminology throughout the claims.
Claim 9 is objected to because of the following informalities: the recitation “the top surface of the support structure” in lines 2-3 should be amended to recite the upper surface to remain consistent with terminology throughout the claims.
Claim 13 is objected to because of the following informalities: the recitation “the top surface of the primary layer” in line 12 should be amended to recite the upper surface to remain consistent with terminology throughout the claims.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the junction" in line 1. There is insufficient antecedent basis for this limitation in the claim. A junction is not previously recited so it is unclear what structure is being limited. This rejection may be overcome with language such as “a junction”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8,212,101 (Propp) in view of US 6,884,920 (Worthley) and US 9,168,180 (Ha et al.).
Regarding claim 1, Propp discloses a window dressing (Abstract, Figure 1-dressing 110) comprising:
a primary layer (Figures 1 & 2- fabric layer 112) having a lower, skin-facing surface (Figure 3- adhesive side 118) and an upper surface (Figure 3- non-adhesive top side 120), the primary layer having a first stiffness ([Col 4, lines 1-2]- “The fabric layer 112 may be a woven or non-woven material”, the woven or non-woven material of the fabric layer 112 would inherently have some properties of stiffness to define a first stiffness; see MPEP 2112 for reference regarding inherency) and comprising a window portion (Figures 3- insertion site viewing portion 114) having a window formed therein (Figure 1- opening 122) and a securement portion (Figures 1 & 3- anchor member portion 116);
a primary adhesive layer (Figure 3- adhesive side 118 of fabric layer 112) covering at least a portion of the lower, skin-facing surface of the primary layer ([Col 4, lines 2-7]- “The fabric layer 112 has an adhesive side 118 and an opposite non-adhesive top side 120. The "top" side refers to an upper (or outer) side when the dressing is disposed on a patient's skin (for example, see FIG. 4). The adhesive side 118 may be coated with any suitable medical grade adhesive”);
a support structure (Figure 2- reinforcing structure 130) attached to the upper surface of the primary layer (Figures 2 & 3- reinforcing structure 130 is attached on top of the fabric layer 112), the support structure comprising:
a structural layer (Figures 1 & 2- reinforcing structure 130 itself is a structural layer) having a lower surface (Figure 3- adhesive side 132) and an upper surface (Figure 3- opposite non-adhesive side 134), and
an adhesive layer (Figure 3- adhesive side 132) covering at least a portion of the lower surface of the structural layer (Figure 3- adhesive side 132 is a lower surface of reinforcing structure 130 which also is understood to be an adhesive layer) and adhering the structural layer to the top surface of the primary layer ([Col 4, lines 18-21]- “The reinforcing structure adhesive side 132 is adhered to the fabric layer non-adhesive side 120 such that the reinforcing structure is on top of the fabric layer 112”);
a central region covering a catheter tube over a tube covering distance when the window dressing is applied to a patient (Fig. 1 - The reinforcing structure 130 comprises a central body 136 that is configured to cover a catheter tube over a tube covering distance when the dressing is applied to a patient.); and
a plurality of arms, each arm extending from the central region in both lateral and longitudinal directions ([Col. 4, Lines 35-37] – “The reinforcing structure 130 may be any shape that has multiple axes such as an X-shape, another similar hub-and-spoke shape, or a backbone and rib shape.” In the embodiment shown in the figures, the reinforcing structure 130 is a backbone and rib shape; the ribs are interpreted as a plurality of arms and each of them extends from the central region in both lateral and longitudinal directions.); and
a transparent layer (Figure 2- transparent film layer 124) and covering at least a portion of the primary layer window ([Col 4, lines 8-12]- “A transparent film layer 124 having an adhesive skin-adhering side 126 and an opposite non-adhesive side 128 is adhered by its non-adhesive side to the fabric layer adhesive side 118. The transparent film layer 124 closes the opening 122 in the fabric layer 112”, Figure 1.), the transparent layer comprising:
a transparent film ([Col 4, line 13]- “transparent film layer 124 may be a polyurethane film”) having a lower surface (Figure 3- adhesive skin-adhering side 126) and an upper surface (Figure 3- opposite non-adhesive side 128), and
an adhesive layer covering at least a portion of the lower surface of the transparent film ([Col 4, lines 12-14]- “The transparent film layer 124 may be a polyurethane film coated on one side with any suitable medical grade adhesive”).
Propp does not disclose the structural layer having a second stiffness that is greater than the first stiffness; wherein the tube covering distance is greater than a thickness of each arm; the transparent layer attached to the upper surface of the primary layer; and adhering a first portion of the transparent layer to the upper surface of the primary layer and a second portion of the transparent layer to the upper surface of the structural layer.
However, Propp discloses [Col. 4, Lines 35-37] – “The reinforcing structure 130 may be any shape that has multiple axes such as an X-shape, another similar hub-and-spoke shape, or a backbone and rib shape.” This recitation provides support for the reinforcing structure to be an X-shape and an X-shape has a plurality of arms extending longitudinally and laterally from a central region. The central region of the X-shape would be along the centerline of the dressing since it is desired for the reinforcing structure 130 to be symmetrical. The central region, at which the arms of an X-shape cross, is inherently longer than the thickness of each arm in a regular X-shape because the length of the central region is measured diagonally across an arm which is longer than the thickness, which is measured perpendicularly across an arm.
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Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the shape of the reinforcing portion of Propp to that of an X-shape. A skilled artisan would have been motivated to do so because Propp teaches that the reinforcing structure 130 may be any shape including an X-shape ([Col. 4, Lines 35-37]). A skilled artisan would have a reasonable expectation of success given that Propp discloses this modification. As a result, Propp discloses wherein the tube covering distance is greater than a thickness of each arm (The tube covering distance, which lies under the central region, covers a greater distance than a thickness of each arm since the central region of an X-shape reinforcing portion, which is symmetric about the longitudinal axis, would inherently have a longer central region than a thickness of the arms in a normal X-shape.).
Additionally, Worthley teaches an analogous window dressing (Abstract, Figure 1- dressing 2) comprising a transparent layer (Figure 1- semi-permeable film 12 that is transparent) attached to an upper surface of a primary layer (Figure 1- semi-permeable film 12 that is transparent is attached by its bottom side 14 to contact the top surface 16 of the semi-permeable tape border 18) and an adhesive layer (Figure 2- adhesive 13) adheres to a portion of the transparent layer (Figure 2- bottom side 14 of semi-permeable film 12 has an adhesive coat 13, [Col 4, lines 18-26]- discusses that the semi-permeable film 12 has a bottom side 14 that has an adhesive 13 coated on) to the upper surface of the primary layer (Figure 1- shows the bottom side 14 with the adhesive 13 coat of the semi-permeable film 12 attached to the top surface 16 of the semi-permeable tape border 18). A person of ordinary skill would have recognized that the transparent film layer 124 of Propp may be rearranged in a similar manner as taught by Worthley such that the transparent film layer 124 is now positioned as a top-most layer and adhered to a top portion of the primary layer 112. A person of ordinary skill would also recognize that in order to accomplish the attachment of to the upper surface of the primary layer, the transparent film layer 124 of Propp is modified to have a lower adhesive surface and an upper non-adhesive surface as also specifically taught by Worthley. Modification of the transparent layer of Propp to be a top-most layer and having the adhesive layer being at a bottom surface of the transparent layer as taught by Worthley still allows the transparent film layer to form a window for viewing the insertion site of a catheter when the dressing is applied (Propp- [Col 5, lines 16-26] & Worthley [Col 4, lines 32-40])- thus the functionality of the transparent layer being unhindered when rearranged to be the top-most layer of the dressing. Propp and Worthley are analogous because they both teach a window dressing comprised of multiple layers.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the position of the transparent layer as taught by Propp to be rearranged such that the transparent layer is the top-most layer of the window dressing having a lower adhesive surface as taught by Worthley, which would adhere to portions of both the primary layer and the support structure of the dressing. A skilled artisan would have been motivated to utilize a transparent film layer positioned as the top-most layer on a window dressing because Worthley teaches having a transparent film at the top-most layer protects the wound from the insertion of a catheter from exposure to harmful environmental conditions while also keeping the area visible (Worthley- [Col 1, lines 9-17] & [Col 1, lines 53-57]). A skilled artisan would also have a reasonable expectation to manufacture the window dressing with a transparent layer as taught by Propp wherein the transparent layer is positioned to be the top-most layer of the window dressing because Worthley suggests that this positioning of the transparent layer is conventional in window dressings comprised of multiple layers that are analogous to Propp. As a result, Propp in view of Worthley teaches the transparent layer attached to the upper surface of the primary layer (The transparent layer of Propp is positioned as the top-most layer with an adhesive layer attaching it to the upper surface of the fabric layer 112); and
adhering a first portion of the transparent layer to the upper surface of the primary layer and a second portion of the transparent layer to the upper surface of the structural layer (The transparent layer of Propp is positioned as the top-most layer with an adhesive layer attaching it to the upper surface of the fabric layer 112 at one portion which would also attach the transparent layer to the reinforcing structure at a second portion.).
Additionally, Ha teaches an analogous dressing (Abstract, Figure 2- dressing 10) wherein a support layer (Figure 2- support-substrate 12) comprising a structural layer (Figure 2- support-substrate 12 is understood to be formed of an inherent structural layer of material) and wherein the structural layer (Figure 2- support-substrate 12) has a second stiffness greater than a first stiffness ([Col 15, lines 15-16]- “The material used to form the self-supporting substrate is generally substantially more rigid than the backing layer.”) of an analogous primary layer (Figure 2- backing layer 14, [Col 13, lines 36-46]- discusses materials of the backing layer). A person of ordinary skill would recognize that the materials of the structural layer of the support layer and primary layer of Propp in view of Worthley may be the specific materials as taught by Ha such that the second stiffness would be greater than the first. Thus, the claimed limitations are met as discussed. Propp in view of Worthley and Ha are analogous because the combination and Ha both teach transparent wound dressings comprised of multiple layers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the materials of the structural and primary layers of the dressing of Propp in view of Worthley wherein the second stiffness is greater than the first stiffness as taught by Ha. A skilled artisan would have been motivated to utilize the specific materials of primary layer and support layer because Ha suggests that the less stiff materials of the primary layer are more conformable for attachment to a patient’s skin and materials of the structural layer are understood to provide greater support as this material holds the shape of the layer once formed and further facilitates handling of the dressing (Ha- [Col 2, lines 65-67], [Col 13, lines 30-43] & [Col 15, lines 9-25]). A skilled artisan would also have a reasonable expectation to manufacture the structural layer of the dressing of Propp in view of Worthley to be comprised of a polyester film and have a stiffness greater than a first stiffness of the primary layer because Ha suggests that the use of these differing materials in conventional in wound dressings of multiple layers that are analogous to Propp in view of Worthley. As a result, Propp in view of Worthley and Ha teaches the structural layer having a second stiffness that is greater than the first stiffness (The reinforcing structure 130 is modified to be made of a material that is stiffer than the fabric layer 112, specifically a polyester film.).
Regarding claim 2, Propp in view of Worthley and Ha discloses the window dressing of claim 1, wherein the plurality of arms comprises four arms (A normal X-shape has 4 arms and the reinforcing portion 130 of Propp is modified to be X-shaped.).
Regarding claim 3, Propp in view of Worthley and Ha discloses the window dressing of claim 2, wherein the four arms form an X-shape extending from the central region (The reinforcing portion 130 of Propp is modified to be X-shaped).
Regarding claim 4, Propp in view of Worthley and Ha discloses the window dressing of claim 3.
Propp in view of Worthley and Ha does not directly disclose wherein the junction between each arm and an adjacent arm is rounded to form a smooth transition between each arm and the adjacent arm.
However, Propp does show that transitions between the arms 138 and the central body 136 are rounded as can be seen in Fig. 1. It would therefore be reasonable to expect the transitions between the central body and arms in an X-shape to also be rounded. Additionally, it would have been an obvious matter of design choice for the junctions between each arm and an adjacent arm to be rounded, since such a modification would have involved a mere change in shape of a component. A change in shape that is absent of persuasive evidence that the particular configuration of the claimed component is significant is recognized as being within the level of ordinary skill in the art before the filing date of the claimed invention. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the junctions between adjacent arms of the X-shape of Propp to be rounded. A skilled artisan would have been motivated to do so because a rounded junction prevents sharp edges from being formed which may damage the dressing, the catheter, or the patient. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to dressings. As a result, Propp in view of Worthley and Ha discloses wherein the junction between each arm and an adjacent arm is rounded to form a smooth transition between each arm and the adjacent arm (The X-shape reinforcing portion 130 of Propp is modified to have rounded junctions between adjacent arms.).
Regarding claim 5, Propp in view of Worthley and Ha discloses the window dressing of claim 3, wherein each arm comprises a corner at an extremity of the arm (An X-shape reinforcing portion 130 inherently has a corner at an extremity of the arm as that is a part of the X-shape.).
Propp in view of Worthley and Ha does not directly disclose that the corner is rounded.
However, Propp does show that corners of the arms 138 are rounded as can be seen in Fig. 1. It would therefore be reasonable to expect the corners of the arms in an X-shape to also be rounded. Additionally, it would have been an obvious matter of design choice for the corners to be rounded, since such a modification would have involved a mere change in shape of a component. A change in shape that is absent of persuasive evidence that the particular configuration of the claimed component is significant is recognized as being within the level of ordinary skill in the art before the filing date of the claimed invention. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the corners of the arms of the X-shape of Propp to be rounded. A skilled artisan would have been motivated to do so because a rounded corner prevents sharp edges from being formed which may damage the dressing, the catheter, or the patient. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to dressings. As a result, Propp in view of Worthley and Ha discloses the corner is rounded (The X-shape reinforcing portion 130 of Propp is modified to have rounded corners.).
Regarding claim 6, Propp in view of Worthley and Ha discloses the window dressing of claim 1, wherein the transparent layer covers the entire primary layer window (The transparent layer of Propp is positioned as the top-most layer with an adhesive layer attaching it to the upper surface of the fabric layer 112 at one portion which would also attach the transparent layer to the reinforcing structure at a second portion. This results in the transparent layer covering the entire opening 122.).
Regarding claim 7, Propp in view of Worthley and Ha discloses the window dressing of claim 6 wherein the support structure is attached to the upper surface of the primary layer within the securement portion (The reinforcing portion 130 is attached to the upper surface of the fabric layer 122 within the securement portion, which is the portion opposite the opening 122 on the fabric layer.).
Regarding claim 8, Propp in view of Worthley and Ha discloses the window dressing of claim 7, wherein the transparent layer covers the entire support structure and comprises an adhesive attachment to the primary layer around an entire periphery of the support structure (Propp Figures 1-3- transparent film layer 124 extends to the outer edge of the fabric layer 112 as shown wherein it would also encompass the entirety of the reinforcing structure 130; see claim 1 discussion- transparent layer 124 of Propp is modified by Worthley to be a top-most layer, wherein as a result the reinforcing structure 130 would be positioned between the top-most transparent layer 124 and fabric layer 112 of Propp. Transparent layer 124 of Propp is modified by Worthley to be a top-most layer having an adhesive bottom layer as specifically taught by Worthley to be able to adhere to an upper surface of the primary/fabric layer and around an entire periphery of the reinforcing structure 130 of Propp.).
Regarding claim 9, Propp in view of Worthley and Ha discloses the window dressing of claim 8, wherein the adhesive layer of the transparent layer adheres the transparent film of the transparent layer to the top surface of the support structure (The transparent film layer 124 of Propp is modified to be a top-most layer having an adhesive surface at its lower surface as taught by Worthley, such that the lower adhesive surface of the top-most transparent layer 124 of Propp is capable of being adhered to an upper surface of reinforcing structure 130 which is positioned between transparent layer 124 and fabric layer 112).
Regarding claim 10, Propp in view of Worthley and Ha discloses the window dressing of claim 1, wherein the structural layer of the support structure comprises a polyester film (The reinforcing structure 130 is modified to be made of a material that is stiffer than the fabric layer 112, specifically a polyester film.).
Regarding claim 11, Propp in view of Worthley and Ha discloses the window dressing of claim 10.
As modified, Propp in view of Worthley and Ha does not explicitly teach wherein the polyester film has a thickness between 0.005 inches and 0.030 inches.
However, Ha teaches an analogous dressing (Abstract, Figure 2- dressing 10) comprising a structural layer of a support structure (Figure 1- support-substrate 12) comprised of polyester film ([Col 15, lines 15-25]- discusses that the material of the self-supporting substrate may include “polyester films”) wherein the polyester film has a thickness between 0.005 inches and 0.030 inches ([Col 15, lines 16-19]- discusses that the thickness of the material is preferably greater than 1 mil and less than 6 mil, wherein a mil= 0.001 inch, thus the recited range being from 0.001-0.006 inches). A person of ordinary skill in the art would recognize that Ha teaches an overlapping range of thickness that overlaps with the instantly claimed range, wherein the recited overlapping range may be optimized to have a value that falls within the claimed range (see MPEP 2144.05 for reference regarding ranges), thus meeting the claimed limitations as discussed. Propp in view of Worthley and Ha are analogous because the combination and Ha both teach a transparent wound dressings comprised of multiple layers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the polyester film of the structural layer as taught by Propp in view of Worthley and Ha to have a thickness of the structural layer comprised of a polyester film as specifically taught by Ha, wherein the overlapping range of thickness may be optimized to fall within the instantly claimed film thickness. A skilled artisan would have been motivated to utilize the polyester film with the instant range of thickness because Ha suggests that the layers of the dressing be relatively thin to improve conformability to an anatomical surface and wherein the specific thickness range affects the rigidity of a support layer relative additional backing layers such that the support layer has greater support (Ha- [Col 14, lines 53-54] & [Col 15, lines 16-20]). A skilled artisan would also have a reasonable expectation to manufacture the structural layer comprised of a polyester film as taught by Propp in view of Worthley and Ha to have a thickness of the polyester film that it optimized to be the instant range of thickness because Ha specifically suggests that small thickness of the polyester film for a structural layer is conventional in window dressing comprised of multiple layers that are analogous to Propp in view of Worthley and Ha. As a result, Propp in view of Worthley and Ha teaches wherein the polyester film has a thickness between 0.005 inches and 0.030 inches (The thickness of the polyester film is between 0.005 and 0.030 inches as taught by Ha.).
Regarding claim 12, Propp in view of Worthley and Ha discloses the window dressing of claim 1, further comprising a pad attached to the skin-facing surface of the primary layer (Figure 2- pad member 144; pad member 144 is attached to the bottom side 118 of fabric layer 112 when the transparent layer is moved to the top-most layer as modified in response to claim 1.).
Regarding claim 13, Propp discloses a window dressing (Abstract, Figure 1-dressing 110) comprising:
a primary layer (Figures 1 & 2- fabric layer 112) having a lower, skin-facing surface (Figure 3- adhesive side 118) and an upper surface (Figure 3- non-adhesive top side 120), the primary layer having a first stiffness ([Col 4, lines 1-2]- “The fabric layer 112 may be a woven or non-woven material”, the woven or non-woven material of the fabric layer 112 would inherently have some properties of stiffness to define a first stiffness; see MPEP 2112 for reference regarding inherency) and comprising a window portion (Figures 3- insertion site viewing portion 114) having a window formed therein (Figure 1- opening 122) and a securement portion (Figures 1 & 3- anchor member portion 116);
a primary adhesive layer covering at least a portion of the lower, skin-facing surface of the primary layer ([Col 4, lines 2-7]- “The fabric layer 112 has an adhesive side 118 and an opposite non-adhesive top side 120. The "top" side refers to an upper (or outer) side when the dressing is disposed on a patient's skin (for example, see FIG. 4). The adhesive side 118 may be coated with any suitable medical grade adhesive”);
a support structure attached to the upper surface of the primary layer, the support structure (Figures 2 & 3- reinforcing structure 130 is attached on top of the fabric layer 112) comprising:
a structural layer (Figures 1 & 2- reinforcing structure 130 itself is a structural layer) having a lower surface (Figure 3- adhesive side 132) and an upper surface (Figure 3- opposite non-adhesive side 134), and
an adhesive layer (Figure 3- adhesive side 132) covering at least a portion of the lower surface of the structural layer (Figure 3- adhesive side 132 is a lower surface of reinforcing structure 130 which also is understood to be an adhesive layer) and adhering the structural layer to the top surface of the primary layer ([Col 4, lines 18-21]- “The reinforcing structure adhesive side 132 is adhered to the fabric layer non-adhesive side 120 such that the reinforcing structure is on top of the fabric layer 112”);
a central region covering a catheter tube over a tube covering distance when the window dressing is applied to a patient (Fig. 1 - The reinforcing structure 130 comprises a central body 136 that is configured to cover a catheter tube over a tube covering distance when the dressing is applied to a patient.); and
a first arm and a second arm, each arm extending from the central region in both lateral and longitudinal directions ([Col. 4, Lines 35-37] – “The reinforcing structure 130 may be any shape that has multiple axes such as an X-shape, another similar hub-and-spoke shape, or a backbone and rib shape.” In the embodiment shown in the figures, the reinforcing structure 130 is a backbone and rib shape; two of the ribs are interpreted as a first arm and a second arm and each of them extends from the central region in both lateral and longitudinal directions.),
wherein the arms converge at a point that aligns with a centerline of the dressing ([Col. 4, Lines 44-45] – “The reinforcing structure 130 may be generally symmetric about one of its axes”; See Fig. 1.); and
a transparent layer (Figure 2- transparent film layer 124) covering at least a portion of the primary layer window ([Col 4, lines 8-12]- “A transparent film layer 124 having an adhesive skin-adhering side 126 and an opposite non-adhesive side 128 is adhered by its non-adhesive side to the fabric layer adhesive side 118. The transparent film layer 124 closes the opening 122 in the fabric layer 112”, Figure 1.), the transparent layer comprising:
a transparent film ([Col 4, line 13]- “transparent film layer 124 may be a polyurethane film”) having a lower surface (Figure 3- adhesive skin-adhering side 126) and an upper surface (Figure 3- opposite non-adhesive side 128), and
an adhesive layer (Figure 3- adhesive side 132) covering at least a portion of the lower surface of the transparent film ([Col 4, lines 12-14]- “The transparent film layer 124 may be a polyurethane film coated on one side with any suitable medical grade adhesive”).
Propp does not disclose the structural layer having a second stiffness that is greater than the first stiffness; the transparent layer attached to the upper surface of the primary layer; and adhering a first portion of the transparent layer to the upper surface of the primary layer and a second portion of the transparent layer to the upper surface of the structural layer.
However, Worthley teaches an analogous window dressing (Abstract, Figure 1- dressing 2) comprising a transparent layer (Figure 1- semi-permeable film 12 that is transparent) attached to an upper surface of a primary layer (Figure 1- semi-permeable film 12 that is transparent is attached by its bottom side 14 to contact the top surface 16 of the semi-permeable tape border 18) and an adhesive layer (Figure 2- adhesive 13) adheres to a portion of the transparent layer (Figure 2- bottom side 14 of semi-permeable film 12 has an adhesive coat 13, [Col 4, lines 18-26]- discusses that the semi-permeable film 12 has a bottom side 14 that has an adhesive 13 coated on) to the upper surface of the primary layer (Figure 1- shows the bottom side 14 with the adhesive 13 coat of the semi-permeable film 12 attached to the top surface 16 of the semi-permeable tape border 18). A person of ordinary skill would have recognized that the transparent film layer 124 of Propp may be rearranged in a similar manner as taught by Worthley such that the transparent film layer 124 is now positioned as a top-most layer and adhered to a top portion of the primary layer 112. A person of ordinary skill would also recognize that in order to accomplish the attachment of to the upper surface of the primary layer, the transparent film layer 124 of Propp is modified to have a lower adhesive surface and an upper non-adhesive surface as also specifically taught by Worthley. Modification of the transparent layer of Propp to be a top-most layer and having the adhesive layer being at a bottom surface of the transparent layer as taught by Worthley still allows the transparent film layer to form a window for viewing the insertion site of a catheter when the dressing is applied (Propp- [Col 5, lines 16-26] & Worthley [Col 4, lines 32-40])- thus the functionality of the transparent layer being unhindered when rearranged to be the top-most layer of the dressing. Propp and Worthley are analogous because they both teach a window dressing comprised of multiple layers.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the position of the transparent layer as taught by Propp to be rearranged such that the transparent layer is the top-most layer of the window dressing having a lower adhesive surface as taught by Worthley, which would adhere to portions of both the primary layer and the support structure of the dressing. A skilled artisan would have been motivated to utilize a transparent film layer positioned as the top-most layer on a window dressing because Worthley teaches having a transparent film at the top-most layer protects the wound from the insertion of a catheter from exposure to harmful environmental conditions while also keeping the area visible (Worthley- [Col 1, lines 9-17] & [Col 1, lines 53-57]). A skilled artisan would also have a reasonable expectation to manufacture the window dressing with a transparent layer as taught by Propp wherein the transparent layer is positioned to be the top-most layer of the window dressing because Worthley suggests that this positioning of the transparent layer is conventional in window dressings comprised of multiple layers that are analogous to Propp. As a result, Propp in view of Worthley teaches the transparent layer attached to the upper surface of the primary layer (The transparent layer of Propp is positioned as the top-most layer with an adhesive layer attaching it to the upper surface of the fabric layer 112); and
adhering a first portion of the transparent layer to the upper surface of the primary layer and a second portion of the transparent layer to the upper surface of the structural layer (The transparent layer of Propp is positioned as the top-most layer with an adhesive layer attaching it to the upper surface of the fabric layer 112 at one portion which would also attach the transparent layer to the reinforcing structure at a second portion.).
Additionally, Ha teaches an analogous dressing (Abstract, Figure 2- dressing 10) wherein a support layer (Figure 2- support-substrate 12) comprising a structural layer (Figure 2- support-substrate 12 is understood to be formed of an inherent structural layer of material) and wherein the structural layer (Figure 2- support-substrate 12) has a second stiffness greater than a first stiffness ([Col 15, lines 15-16]- “The material used to form the self-supporting substrate is generally substantially more rigid than the backing layer.”) of an analogous primary layer (Figure 2- backing layer 14, [Col 13, lines 36-46]- discusses materials of the backing layer). A person of ordinary skill would recognize that the materials of the structural layer of the support layer and primary layer of Propp in view of Worthley may be the specific materials as taught by Ha such that the second stiffness would be greater than the first. Thus, the claimed limitations are met as discussed. Propp in view of Worthley and Ha are analogous because the combination and Ha both teach transparent wound dressings comprised of multiple layers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the materials of the structural and primary layers of the dressing of Propp in view of Worthley wherein the second stiffness is greater than the first stiffness as taught by Ha. A skilled artisan would have been motivated to utilize the specific materials of primary layer and support layer because Ha suggests that the less stiff materials of the primary layer are more conformable for attachment to a patient’s skin and materials of the structural layer are understood to provide greater support as this material holds the shape of the layer once formed and further facilitates handling of the dressing (Ha- [Col 2, lines 65-67], [Col 13, lines 30-43] & [Col 15, lines 9-25]). A skilled artisan would also have a reasonable expectation to manufacture the structural layer of the dressing of Propp in view of Worthley to be comprised of a polyester film and have a stiffness greater than a first stiffness of the primary layer because Ha suggests that the use of these differing materials in conventional in wound dressings of multiple layers that are analogous to Propp in view of Worthley. As a result, Propp in view of Worthley and Ha teaches the structural layer having a second stiffness that is greater than the first stiffness (The reinforcing structure 130 is modified to be made of a material that is stiffer than the fabric layer 112, specifically a polyester film.).
Regarding claim 14, Propp in view of Worthley and Ha discloses the window dressing of claim 13.
Propp in view of Worthley and Ha does not directly disclose wherein the first arm and second arm of the support structure form a V-shape.
However, Propp discloses [Col. 4, Lines 35-37] – “The reinforcing structure 130 may be any shape that has multiple axes such as an X-shape, another similar hub-and-spoke shape, or a backbone and rib shape.” A V-shape is a shape that has multiple axes and Propp states that the reinforcing structure may be any shape that has multiple axes. Additionally, a change in shape that is absent of persuasive evidence that the particular configuration of the claimed component is significant is recognized as being within the level of ordinary skill in the art before the filing date of the claimed invention. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the reinforcing structure 130 of Propp to be V-shaped. A skilled artisan would have been motivated to do so because the V-shape has multiple axes, which is desired in Propp. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to dressings. As a result, Propp in view of Worthley and Ha teaches wherein the first arm and second arm of the support structure form a V-shape (The reinforcing structure 130 of Propp has been modified to be V-shaped.).
Regarding claim 15, Propp in view of Worthley and Ha discloses the window dressing of claim 14, wherein the point at which the support structure first arm and second arm converge is a lower point of the V-shape (Since the reinforcing structure 130 of Propp has been modified to be a V-shape, a V-shape inherently has two arms which converge at a lower point of the V-shape.).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8,212,101 (Propp) in view of US 6,884,920 (Worthley) and US 9,168,180 (Ha et al.) and further in view of US 2010/0121282 (Propp2).
Regarding claim 16, Propp in view of Worthley and Ha discloses the window dressing of claim 14,
Propp in view of Worthley and Ha does not directly disclose wherein the support structure further comprises an extension extending into an open portion of the V-shape.
However, Propp2 discloses an anchor member 120 that is generally U-shaped and has an extension along a centerline of the device and forming tines within the generally U-Shaped structure. See [0033] and Fig. 1. Propp2 states that the innermost tines form a keyhole-like effect to prevent the catheter hub from sliding out of the dressing. While the anchor member 120 is not disposed over the catheter hub, the shape of the anchor member may still provide benefits on devices that do cover the catheter hub such as Propp.
Additionally, Propp discloses [Col. 4, Lines 35-37] – “The reinforcing structure 130 may be any shape that has multiple axes such as an X-shape, another similar hub-and-spoke shape, or a backbone and rib shape.” A change in shape that is absent of persuasive evidence that the particular configuration of the claimed component is significant is recognized as being within the level of ordinary skill in the art before the filing date of the claimed invention. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the reinforcing structure 130 of Propp to comprise V-shaped arms with an extension along the centerline of the V-shape forming tines as taught by Propp2. A skilled artisan would have been motivated to do so because the V-shape has multiple axes, which is desired in Propp, and the extension forms two tines that form a keyhole-like effect to prevent the catheter hub from sliding out of the dressing. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to dressings. As a result, Propp in view of Worthley, Ha and Propp2 teaches wherein the support structure further comprises an extension extending into an open portion of the V-shape (The reinforcing structure 130 of Propp has been modified to be V-shaped and to have an extension formed of tines.).
Regarding claim 17, Propp in view of Worthley, Ha and Propp2 discloses the window dressing of claim 16, wherein the extension increases the tube covering distance (The tines increase the tube covering distance as it is desired for the reinforcing structure 130 to be symmetric about the longitudinal axis of the dressing, which results in tines being disposed along this axis and is also where the tube is covered.).
Regarding claim 18, Propp in view of Worthley, Ha and Propp2 discloses the window dressing of claim 17, wherein the extension comprises a point that aligns with the centerline of the dressing (It is desired for the tines of the reinforcing structure 130 to be symmetric about the centerline of the dressing. [Col. 4, Lines 44-45] – “The reinforcing structure 130 may be generally symmetric about one of its axes”).
Regarding claim 19, Propp in view of Worthley, Ha and Propp2 discloses the window dressing of claim 17.
Propp in view of Worthley, Ha and Propp2 does not directly disclose wherein the extension extends in a longitudinal direction for a length such that the tube covering distance is less than a longitudinal extension of the first and second arms.
However, it would have been an obvious matter of design choice to modify the length of the longitudinal extension of the first and second arms of the V-shaped reinforcing structure 130 of Propp, since such a modification would have involved a mere change in shape of a component. A change in shape that is absent of persuasive evidence that the particular configuration of the claimed component is significant is recognized as being within the level of ordinary skill in the art before the filing date of the claimed invention. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). As a result, Propp in view of Worthley, Ha and Propp2 teaches wherein the extension extends in a longitudinal direction for a length such that the tube covering distance is less than a longitudinal extension of the first and second arms (The first and second arms of the V-shaped reinforcing structure 130 of Propp are modified to be longer than the tines in the longitudinal direction.).
Regarding claim 20, Propp in view of Worthley, Ha and Propp2 discloses the window dressing of claim 17.
Propp in view of Worthley, Ha and Propp2 does not directly disclose wherein the extension extends in a longitudinal direction for a length such that the tube covering distance is greater than a longitudinal extension of the first and second arms.
However, it would have been an obvious matter of design choice to modify the length of the longitudinal extension of the first and second arms of the V-shaped reinforcing structure 130 of Propp, since such a modification would have involved a mere change in shape of a component. A change in shape that is absent of persuasive evidence that the particular configuration of the claimed component is significant is recognized as being within the level of ordinary skill in the art before the filing date of the claimed invention. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). As a result, Propp in view of Worthley, Ha and Propp2 teaches wherein the extension extends in a longitudinal direction for a length such that the tube covering distance is greater than a longitudinal extension of the first and second arms (The first and second arms of the V-shaped reinforcing structure 130 of Propp are modified to be shorter than the tines in the longitudinal direction.).
Conclusion
The following prior art made of record and not relied upon are considered pertinent to applicant's disclosure.
US 2014/0005607 (Elsamahy et al.)
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786