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 .
Response to Amendment
The amendment filed November 25, 2025 has been entered. Claims 1-3, 5-7, 9-18, 37, and 65 remain pending in the application. Claims 4, 8, 19-36, 38-64, and 66-88 were previously cancelled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5, 7, 10-15, 18, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Beisang, III et al. (USPN 5395344) in view of Thomas (USPN 3677250) in further view of Ward et al. (USPN 4941882).
Regarding claim 1, Beisang discloses a medical dressing (skin attachment patch 40), comprising:
a body (body of patch 40) comprising:
a first major surface (upper surface of patch 40; Figure 6A);
a second major surface (lower surface of patch 40 having adhesive material 44; shown Figure 6B) opposite the first major surface (Figures 6A and 6B);
a perimeter (outer edges of patch 40; Figure 6A);
a central region (center of patch 40; Figure 6A);
a first flap (cutout flap segment/tongue/tab 46) defined by a first distal end formed by a first part of the perimeter (see annotated Figure 6A below),
a first area of weakness defined by a first indent (left side of tab 46; see annotated Figure 6A below) having a first end proximate the central region (see annotated Figure 6A below), a second area of weakness defined by a second indent (right side of tab 46; see annotated Figure 6A below) having a second end proximate the central region (see annotated Figure 6A below), and a first hinge region (see annotated Figure 6A below) extending between the first end and the second end (Figure 6A), wherein the first flap has a maximum length and a maximum width (Figure 6A), and wherein a ratio of the maximum width to the maximum length is less than 4 to 1 (Figure 6A);
a first lateral extension (see annotated Figure 6A below) extending in a first direction away from the first flap (Figure 6A); and
a second lateral extension (see annotated Figure 6A below) extending in a second direction away from the first flap (Figure 6A);
wherein the first direction away from the first flap is substantially opposite the second direction away from the first flap (Figure 6A); and
an adhesive (skin adhesive material 44 including “The removable adhesive layer of the flap segment 46” [Col 6, lines 51-52]) disposed on at least a portion of the second major surface (“the body anchoring or skin patch 40 has a skin anchoring reverse side including a layer of release paper 42 and a skin adhesive material 44” [Col 6, lines 43-46]), wherein the portion of the second major surface on which the adhesive is disposed includes a part of each of the first flap, the first lateral extension, and the second lateral extension (“the body anchoring or skin patch 40 has a skin anchoring reverse side including a layer of release paper 42 and a skin adhesive material 44” [Col 6, lines 43-46]).
Beisang fails to explicitly teach the body is a transparent body; the first indent comprising a plurality of perforations, the second indent comprising a plurality of perforations; a second flap defined by a second distal end formed by a second part of the perimeter, a third area of weakness defined by a third indent comprising a plurality of perforations having a third end proximate the central region, a fourth area of weakness defined by a fourth indent comprising a plurality of perforations having a fourth end proximate the central region; a third lateral extension extending in a third direction away from the second flap; a fourth lateral extension extending in a fourth direction away from the second flap wherein the third direction away from the second flap is substantially opposite the fourth direction away from the second flap, wherein the first lateral extension and the third lateral extension are conjoined and the second lateral extension and the fourth lateral extension are conjoined.
Thomas teaches a medical dressing (tape 40; Figure 7), comprising: a body (body of tape 40; Figure 7) comprising: a first major surface (upper surface of tape 40; Figure 7); a second major surface (lower surface of tape 40 having adhesive 20) opposite the first major surface (Figure 7); a perimeter (outer edges of tape 40; Figure 7); a central region (central portion 45); a first flap (strap portion 43); a second flap (strap portion 44) defined by a second distal end (at enlarged portions 44A) formed by a first part of the perimeter (Figure 7), a third area of weakness defined by a third indent (at slot 48 left of strap portion 44; “the side edges 47 of strap portions 43, 44 being laterally spaced from edges 50 of said tab portions, to define slots 48 which terminate at their inner ends in enlarged portions 49.” [Col 3, lines 35-38]) having a third end proximate the central region (Figure 7), a fourth area of weakness defined by a fourth indent (at slot 48 right of strap portion 44) having a fourth end proximate the central region (Figure 7); a first lateral extension (tab portion 41 below central portion 45) extending in a first direction away from the first flap (Figure 7); and a second lateral extension (tab portion 42 below central portion 45) extending in a second direction away from the first flap (Figure 7), wherein the first direction is substantially opposite the second direction (Figure 7); a third lateral extension (tab portion 41 above central portion 45) extending in a third direction away from the second flap (Figure 7); and a fourth lateral extension (tab portion 42 above central portion 45) extending in a fourth direction away from the second flap (Figure 7); wherein the third direction away from the second flap is substantially opposite the fourth direction away from the second flap (Figure 7), wherein the first lateral extension and the third lateral extension are conjoined and the second lateral extension and the fourth lateral extension are conjoined (Figure 7).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the medical dressing utilized in the method of Beisang to include a second flap similar to the first flap that is defined by a second distal end, a third indent, and a fourth indent; and third and fourth lateral extensions, wherein the first lateral extension and the third lateral extension are conjoined and the second lateral extension and the fourth lateral extension are conjoined based on the teachings of Thomas to allow for the tubiform components of the medical device to be secured in numerous configurations, such as allow for multiple tubiform components to be held parallel to each other or to secure a single tubiform component against both longitudinal and transverse movement (Thomas [Col 3, lines 41-55] and Figures 7-10).
Modified Beisang fails to explicitly teach the body is a transparent body; and the first indent comprising a plurality of perforations, the second indent comprising a plurality of perforations, the third indent comprising a plurality of perforations, and the fourth indent comprising a plurality of perforations.
Ward teaches a medical dressing (Figure 1) comprising a transparent body (backing film 1 and handle 2; “Suitable backing films include polymeric films, papers, woven and nonwoven fabrics, but preferably the backing film comprises a flexible polymeric film…it is most convenient to employ a transparent material.” [Col 2, lines 14-21]) and an area of weakness defined by an indent (perforated dividing line 3) comprising a plurality of perforations (“A dividing line may include for example cuts and lines of perforations. Preferably the dividing line is a line of perforations.” [Col 22, lines 7-9]).
Before the effective filing date, it would have been obvious to one having ordinary skill in the art to modify the body of the medical dressing of Beisang to be transparent based on the teachings of Ward to provide a flexible medical dressing that allows for visualization of the skin surface when the medical dressing is secured to the skin (Ward [Col 2, lines 14-21] and Figure 3) and to modify the first, second, third, and fourth indents of the first and second flaps of modified Beisang to each comprise a plurality of perforations based on the teachings of Ward to provide both versatility and flexibility during placement of the medical dressing by allowing each of the flaps and lateral extensions to be moved independently of each prior to their adhesive surface being exposed (Ward [Col 7, line 57 – Col 8, line 8]).
Regarding claim 5, modified Beisang teaches the medical dressing of claim 1, wherein the body (tape 40) comprises sheet material selected from the group consisting of a translucent polymeric film, an opaque polymeric film, a woven fabric, a nonwoven fabric, a foam, and a combination thereof (“The material of construction comprising the plastic underlayer of the device 16 (FIG. 3), as described above, is preferably formed from either a woven or non-woven polymeric material having a pattern of fibers or the like orientated therein so as to exhibit a preferred or easy direction of stretch identified by the arrow 17 in FIGS. 1 and 2.” [Col 5, lines 25-32]; “the materials of the skin patch or skin engaging portion of the anchoring device of the alternate embodiments is preferably one having the same physical properties or attributes as that of the first-described embodiment, including asymmetric stretchability and a modulus which is patterned after that of the skin itself.” [Col 8, lines 17-24]).
Regarding claim 7, modified Beisang teaches the medical dressing of claim 5, wherein at least a portion of the body comprises a first layer (skin patch 40) overlaying and bonded to a second layer (skin adhesive material 44 and release paper 42; Figures 6A-B; “The body anchoring or skin patch 40 has a skin anchoring reverse side including a layer of release paper 42 and a skin adhesive material 44 similar to the adhesive layer 15 in the embodiment of FIG. 2.” [Col 6, lines 43-47]).
Regarding claim 10, modified Beisang teaches the medical dressing of claim 7, wherein the first layer (skin patch 40) defines a first area (Figure 6A), wherein the second layer (skin adhesive material 44 and release paper 42) defines a second area (Figure 6B), wherein the first area is at least 50% of the second area (Figures 6A-B showing patch 40 having the same area as adhesive material 44 and release paper 42, and therefore the first area is at least 50% of the second area).
Regarding claim 11, modified Beisang teaches the medical dressing of claim 10, wherein the first area is at least 90% of the second area (Figures 6A-B showing patch 40 having the same area as adhesive material 44 and release paper 42, and therefore the first area is at least 90% of the second area).
Regarding claim 12, modified Beisang teaches the medical dressing of claim 7, wherein the first layer (skin patch 40) defines a first area (Figure 6A), wherein the second layer (adhesive material 44 and release paper 42) defines a second area (Figure 6B), wherein the second area is at least 50% of the first area (Figures 6A-B showing patch 40 having the same area as adhesive material 44 and release paper 42, and therefore the second area is at least 50% of the first area).
Regarding claim 13, modified Beisang teaches the medical dressing of claim 7, wherein the first layer (skin patch 40) defines a first area (Figure 6A), wherein the second layer (adhesive material 44 and release paper 42) defines a second area (Figure 6B), wherein the second area is at least 90% of the first area (Figures 6A-B showing patch 40 having the same area as adhesive material 44 and release paper 42, and therefore the second area is at least 90% of the first area).
Regarding claim 14, modified Beisang teaches the medical dressing of claim 1, wherein the first indent (left side of tab 46) comprises a first slit portion (Figure 6A).
Regarding claim 15, modified Beisang teaches the medical dressing of claim 1, wherein the second indent (right side of tab 46) comprises a second slit portion (Figure 6A).
Regarding claim 18, modified Beisang teaches the medical dressing of claim 1.
Modified Beisang fails to explicitly teach wherein the first part of the perimeter is located on the perimeter opposite the second part of the perimeter; wherein the portion of the second major surface on which the adhesive is disposed includes a part of the second flap, the third lateral extension, and the fourth lateral extension.
Thomas teaches a medical dressing (tape 40; Figure 7), comprising: a body (body of tape 40; Figure 7) comprising: a first flap (strap portion 43) defined by a first distal end formed by a first part of the perimeter (Figure 7); a second flap (strap portion 44) defined by a second distal end (at enlarged portions 44A) formed by a part of the perimeter (Figure 7), wherein the first part of the perimeter is located on the perimeter opposite the second part of the perimeter (Figure 7); and wherein the portion of the second major surface on which the adhesive is disposed (lower surface of tape 40 having adhesive 20) includes a part of each of the first flap, the second flap, the first lateral extension, the second lateral extension, the third lateral extension, and the fourth lateral extension (Figures 7 and 9 showing the adhesive 20 on the lateral extensions 41, 42 and flaps 43, 44; “a single tubing T is anchored in place by the oppositely extending strap portions 43, 44 adhesively secured to said tubing T which overlies said strap portions.” [Col 3, lines 45-47]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the medical dressing utilized in the method of Beisang to include the first part of the perimeter is located on the perimeter opposite the second part of the perimeter and wherein the portion of the second major surface on which the adhesive is disposed includes a part of the second flap, the third lateral extension, and the fourth lateral extension based on the teachings of Thomas to allow for the tubiform components of the medical device to be secured in numerous configurations, such as allow for multiple tubiform components to be held parallel to each other or to secure a single tubiform component against both longitudinal and transverse movement (Thomas [Col 3, lines 41-55] and Figures 7-10).
Regarding claim 65, Beisang discloses a method of securing a medical device comprising a tubiform component (catheter tube 38) to a receiving surface (“The removable adhesive layer of the flap segment 46 is designed to wrap about the outer surface 36 of the tube tab 30 as shown in FIG. 6C, thereby firmly attaching the tube 38 to the skin.” [Col 6, lines 51-54]; Figures 5A-6C), the method comprising:
contacting an adhesive (skin adhesive material 44 including “The removable adhesive layer of the flap segment 46” [Col 6, lines 51-52]) disposed on a second major surface (“skin anchoring reverse side” [Col 6, line 44]; shown Figure 6B) of a first flap (cutout flap segment/tongue/tab 46) of a medical dressing (skin attaching patch 40) with a first part (tab 30) of an outer surface of the tubiform (catheter tube 38; Figure 5B) component of the medical device (“the release paper may be removed from the skin attaching patch 40 and the tongue or tab 46 opened away from the skin such that when the adhesive surface 44 of the patch 40 is placed on the skin, the tongue 46 is available to be wrapped about the surface 36 of the tube tab 30, thereby securing the tube tab 30 and the tube 38 in place.” [Col 6, lines 59-65]), wherein the medical dressing comprises:
a body (body of patch 40) comprising:
a first major surface (upper surface of patch 40; Figure 6A);
the second major surface (lower surface of patch 40 having adhesive material 44; shown Figure 6B) opposite the first major surface (Figures 6A and 6B);
a perimeter (outer edges of patch 40; Figure 6A);
a central region (center of patch 40; Figure 6A);
the first flap (cutout flap segment/tongue/tab 46) defined by a first distal end formed by a first part of the perimeter (see annotated Figure 6A above), a first indent (left side of tab 46; see annotated Figure 6A above) having a first end proximate the central region (see annotated Figure 6A above), a second indent (right side of tab 46; see annotated Figure 6A above) having a second end proximate the central region (see annotated Figure 6A above), and a first hinge region (see annotated Figure 6A below) extending between the first end and the second end (Figure 6A);
a first lateral extension (see annotated Figure 6A above) extending in a first direction away from the first flap (Figure 6A); and
a second lateral extension (see annotated Figure 6A above) extending in a second direction away from the first flap (Figure 6A);
wherein the first direction is substantially opposite the second direction (Figure 6A); and
the adhesive (skin adhesive material 44 including “The removable adhesive layer of the flap segment 46” [Col 6, lines 51-52]) disposed on at least a portion of the second major surface (“the body anchoring or skin patch 40 has a skin anchoring reverse side including a layer of release paper 42 and a skin adhesive material 44” [Col 6, lines 43-46]);
wherein the portion of the second major surface on which the adhesive is disposed includes a part of each of the first flap, the first lateral extension, and the second lateral extension (“the body anchoring or skin patch 40 has a skin anchoring reverse side including a layer of release paper 42 and a skin adhesive material 44” [Col 6, lines 43-46]);
contacting the adhesive disposed on the second major surface of the first lateral extension of the medical dressing with a first part of the receiving surface; and contacting the adhesive disposed on the second major surface of the second lateral extension of the medical dressing with a second part of the receiving surface (“the release paper may be removed from the skin attaching patch 40 and the tongue or tab 46 opened away from the skin such that when the adhesive surface 44 of the patch 40 is placed on the skin, the tongue 46 is available to be wrapped about the surface 36 of the tube tab 30, thereby securing the tube tab 30 and the tube 38 in place.” [Col 6, lines 59-65]; wherein the first and second lateral extensions contact a first and second part of the skin, respectively).
Beisang fails to explicitly teach the first indent comprising a plurality of perforations, the second indent comprising a plurality of perforations; a second flap defined by a second distal end formed by a part of the perimeter, a third indent comprising a plurality of perforations having a third end proximate the central region, a fourth indent comprising a plurality of perforations having a fourth end proximate the central region, and a second hinge region extending between the third end and the fourth end; and a third lateral extension extending in a third direction away from the second flap; a fourth lateral extension extending in a fourth direction away from the second flap wherein the third direction away from the second flap is substantially opposite the fourth direction away from the second flap, wherein the first lateral extension and the third lateral extension are conjoined and the second lateral extension and the fourth lateral extension are conjoined; and wherein the portion of the second major surface on which the adhesive is disposed includes a part of each of the first flap, the second flap, the first lateral extension, the second lateral extension, the third lateral extension, and the fourth lateral extension.
Thomas teaches a medical dressing (tape 40; Figure 7), comprising: a body (body of tape 40; Figure 7) comprising: a first major surface (upper surface of tape 40; Figure 7); a second major surface (lower surface of tape 40 having adhesive 20) opposite the first major surface (Figure 7); a perimeter (outer edges of tape 40; Figure 7); a central region (central portion 45); a first flap (strap portion 43); a second flap (strap portion 44) defined by a second distal end (at enlarged portions 44A) formed by a part of the perimeter (Figure 7), a third indent (at slot 48 left of strap portion 44; “the side edges 47 of strap portions 43, 44 being laterally spaced from edges 50 of said tab portions, to define slots 48 which terminate at their inner ends in enlarged portions 49.” [Col 3, lines 35-38]) having a third end proximate the central region (Figure 7), a fourth indent (at slot 48 right of strap portion 44) having a fourth end proximate the central region (Figure 7), and a second hinge region (junction 46) extending between the third end and the fourth end (Figure 7); a first lateral extension (tab portion 41 below central portion 45) extending in a first direction away from the first flap (Figure 7); and a second lateral extension (tab portion 42 below central portion 45) extending in a second direction away from the first flap (Figure 7), wherein the first direction is substantially opposite the second direction (Figure 7); a third lateral extension (tab portion 41 above central portion 45) extending in a third direction away from the second flap (Figure 7); and a fourth lateral extension (tab portion 42 above central portion 45) extending in a fourth direction away from the second flap (Figure 7); wherein the first direction is substantially opposite the second direction and the third direction away from the second flap is substantially opposite the fourth direction away from the second flap (Figure 7), wherein the first lateral extension and the third lateral extension are conjoined and the second lateral extension and the fourth lateral extension are conjoined (Figure 7); and wherein the portion of the second major surface on which the adhesive is disposed (lower surface of tape 40 having adhesive 20) includes a part of each of the first flap, the second flap, the first lateral extension, the second lateral extension, the third lateral extension, and the fourth lateral extension (Figures 7 and 9 showing the adhesive 20 on the lateral extensions 41, 42 and flaps 43, 44; “a single tubing T is anchored in place by the oppositely extending strap portions 43, 44 adhesively secured to said tubing T which overlies said strap portions.” [Col 3, lines 45-47]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the medical dressing utilized in the method of Beisang to include a second flap similar to the first flap that is defined by a second distal end, a third indent, a fourth indent, and a second hinge; third and fourth lateral extensions, wherein the first lateral extension and the third lateral extension are conjoined and the second lateral extension and the fourth lateral extension are conjoined; and wherein the portion of the second major surface on which the adhesive is disposed includes a part of each of the first flap, the second flap, the first lateral extension, the second lateral extension, the third lateral extension, and the fourth lateral extension based on the teachings of Thomas to allow for the tubiform components of the medical device to be secured in numerous configurations, such as allow for multiple tubiform components to be held parallel to each other or to secure a single tubiform component against both longitudinal and transverse movement (Thomas [Col 3, lines 41-55] and Figures 7-10).
Modified Beisang fails to explicitly teach the first indent comprising a plurality of perforations, the second indent comprising a plurality of perforations, the third indent comprising a plurality of perforations, and the fourth indent comprising a plurality of perforations.
Ward teaches a medical dressing (Figure 1) comprising a body (handle 2) and an indent (perforated dividing line 3) comprising a plurality of perforations (“A dividing line may include for example cuts and lines of perforations. Preferably the dividing line is a line of perforations.” [Col 22, lines 7-9]).
Before the effective filing date, it would have been obvious to one having ordinary skill in the art to modify the first, second, third, and fourth indents of the first and second flap of modified Beisang to each comprise a plurality of perforations based on the teachings of Ward to provide both versatility and flexibility during placement of the medical dressing by allowing each of the flaps and lateral extensions to be moved independently of each prior to their adhesive surface being exposed (Ward [Col 7, line 57 – Col 8, line 8]).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Beisang, III et al. (USPN 5395344) in view of Thomas (USPN 3677250) in further view of Ward et al. (USPN 4941882) as applied in claim 1 above, and further in view of Schmidt et al. (US 20120004615).
Regarding claim 2, modified Beisang discloses the medical dressing of claim 1, wherein the first flap (tab 46) defines a first flap axis extending from the perimeter through the first hinge region (Figure 6A).
Modified Beisang fails to explicitly disclose wherein, proximate the first end, the first indent comprises a portion that extends in a direction away from the first flap axis.
Schmidt discloses a medical dressing (slitted compress 1) comprising a first flap axis (aligned along slit 5) extending from a perimeter to central region (Figure 1 and 5), and wherein proximate an end, an indent comprises a portion that extends in a direction away from the first flap axis (slit 6a).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the first indent of Beisang to include a portion that extends in a direction away from the first flap axis based on the teachings of Schmidt to allow the first flap to bend either away or towards a medical device and therefore lie closely against the medical device to secure it in place (Schmidt [0039], [0042]).
Regarding claim 3, modified Beisang discloses the medical dressing of claim 1, wherein the first flap (tab 46) defines a first flap axis extending from the perimeter through the first hinge region (Figure 6A).
Modified Beisang fails to explicitly disclose wherein, proximate the second end, the second indent comprises a portion that extends in a direction away from the first flap axis.
Schmidt discloses a medical dressing (slitted compress 1) comprising a first flap axis (aligned along slit 5) extending from a perimeter to central region (Figure 1 and 5), and wherein proximate an end, an indent comprises a portion that extends in a direction away from the first flap axis (slit 6a).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the second indent of Beisang to include a portion that extends in a direction away from the first flap axis based on the teachings of Schmidt to allow the first flap to bend either away or towards a medical device and therefore lie closely against the medical device to secure it in place (Schmidt [0039], [0042]).
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Beisang, III et al. (USPN 5395344) in view of Thomas (USPN 3677250) in further view of Ward et al. (USPN 4941882) as applied in claims 5 and 7 above, and further in view of Heinecke et al. (US 20160015570).
Regarding claim 6, modified Beisang teaches the medical dressing of claim 5.
Modified Beisang fails to explicitly teach the sheet material is self-supporting.
Heinecke teaches a medical dressing (medical dressing 100) comprising a body (Figures 1 and 2) comprising a sheet material (backing layer 300 and support material 400) selected from the group consisting of a transparent polymeric film, a translucent polymeric film, an opaque polymeric film, a woven fabric, a nonwoven fabric, a foam, and a combination of any two or more of the foregoing sheet materials (“Representative barriers may include non-woven and woven fibrous webs, knits, films, foams polymeric films and other familiar backing materials.” [0045]; “The support material…may be a…another film, woven, knitted, or nonwoven fabric.” [0050]), wherein the sheet material is self-supporting (“The support material…may be a self-supporting substrate such as another film, woven, knitted, or nonwoven fabric.” [0050]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the sheet material of the body of Beisang to be self-supporting based on the teachings of Heinecke to provide strength and stiffness to the medical dressing (Heinecke [0050]).
Regarding claim 9, modified Beisang teaches the medical dressing of claim 7.
Modified Beisang fails to explicitly teach the portion of the body forms a frame structure that forms a border around a portion of the first layer and provides a transparent or translucent window in the dressing that permits observation of at least a portion of the central region.
Heinecke teaches a medical dressing (medical dressing 100) comprising a body (Figures 1 and 2) comprising a sheet material (backing layer 300 and support material 400) of a transparent polymeric film, a translucent polymeric film, an opaque polymeric film, a woven fabric, a nonwoven fabric, a foam, and a combination of any two or more of the foregoing sheet materials (“Representative barriers may include non-woven and woven fibrous webs, knits, films, foams polymeric films and other familiar backing materials. In some embodiments, a transparent substrate is desirable to allow for viewing of the underlying skin or medical device.” [0045]; “The support material…may be a…another film, woven, knitted, or nonwoven fabric.” [0050]), wherein at least a portion of the body comprises a first layer (backing layer 300) overlaying and bonded to a second layer (support material 400; “The support material 400 is secured to the backing layer 300, through adhesive, thermal bonding, lamination, or other commonly used securement techniques.” [0030]); and wherein the portion of the body forms a frame structure (support material 400]) that forms a border around a portion of the first layer (“the support material 400 extends adjacent the entire perimeter 140, but is not continuous across the entire dressing area 140.” [0022]; Figure 2) and provides a transparent or translucent window (central window 150) in the dressing that permits observation of at least a portion of the central region (“As best seen in FIGS. 1 and 2, the support material 400 is not located in a central window 150 of the medical dressing 100, while allows for a transparent window to view the inserted catheter.” [0022]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the sheet material of the body of Beisang such that the portion of the body forms a frame structure that forms a border around a portion of the first layer and provides a transparent or translucent window in the dressing based on the teachings of Heinecke to provide strength and stiffness to the medical dressing while also allowing the user to view a secured tubiform component (Heinecke [0022], [0050]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Beisang, III et al. (USPN 5395344) in view of Thomas (USPN 3677250) in further view of Ward et al. (USPN 4941882) as applied in claim 1 above, and further in view of Propp (US 20070060892).
Regarding claim 16, modified Beisang teaches the medical dressing of claim 1.
Modified Beisang fails to explicitly teach the body further comprises a fifth indent extending from the perimeter into or adjacent the first lateral extension.
Propp teaches a medical dressing (dressing assembly 10) comprising a body (fabric layer 12) comprising a first lateral extension (first portion 46), and a second lateral extension (second portion 48), wherein the body further comprises a fifth indent (perforation line 40 with notch 42) extending from a perimeter (edge 14) into or adjacent the first lateral extension (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the body of the medical dressing of Beisang to include a fifth indent extending from the perimeter into or adjacent the first lateral extension based on the teachings of Propp to increase the flexibility of the medical dressing and allow the medical dressing to be secured to curved surfaces of the patient’s body (Propp [0029]).
Regarding claim 17, modified Beisang teaches the medical dressing of claim 1.
Modified Beisang fails to explicitly teach the body further comprises a sixth indent extending from the perimeter into or adjacent the second lateral extension.
Propp teaches a medical dressing (dressing assembly 10) comprising a body (fabric layer 12) comprising a first lateral extension (first portion 46), and a second lateral extension (second portion 48), wherein the body further comprises a sixth indent (perforation line 40 with notch 42) extending from a perimeter (edge 14) into or adjacent the second lateral extension (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the body of the medical dressing of Beisang to include a sixth indent extending from the perimeter into or adjacent the second lateral extension based on the teachings of Propp to increase the flexibility of the medical dressing and allow the medical dressing to be secured to curved surfaces of the patient’s body (Propp [0029]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Beisang, III et al. (USPN 5395344) in view of Thomas (USPN 3677250) in further view of Ward et al. (USPN 4941882) in further view of DeBusk et al. (USPN 5344415).
Regarding claim 37, Beisang discloses a medical tape (skin attachment patch 40), comprising:
a body (body of patch 40) comprising:
a first major surface (upper surface of patch 40; Figure 6A);
a second major surface (lower surface of patch 40 having adhesive material 44; shown Figure 6B) opposite the first major surface (Figures 6A and 6B);
a first primary edge (lower edge of patch 40; Figure 6A);
a second primary edge (upper edge of patch 40; Figure 6A);
a longitudinal axis (Figure 6A); and
a first flap (cutout flap segment/tongue/tab 46) defined by a first distal end formed by a part of the first primary edge (see annotated Figure 6A above), a first indent (left side of tab 46; see annotated Figure 6A above) having a first end proximate the longitudinal axis (see annotated Figure 6A above), a second indent (right side of tab 46; see annotated Figure 6A above) having a second end proximate the longitudinal axis (see annotated Figure 6A above), and a first hinge region (see annotated Figure 6A above) extending between the first end and the second end (Figure 6A);
a first lateral extension (see annotated Figure 6A above) extending in a first direction away from the first flap (Figure 6A); and
a second lateral extension (see annotated Figure 6A above) extending in a second direction away from the first flap (Figure 6A);
wherein the first direction is substantially opposite the second direction (Figure 6A); and
an adhesive (skin adhesive material 44 including “The removable adhesive layer of the flap segment 46” [Col 6, lines 51-52]) disposed on at least a portion of the second major surface (“the body anchoring or skin patch 40 has a skin anchoring reverse side including a layer of release paper 42 and a skin adhesive material 44” [Col 6, lines 43-46]), wherein the portion of the second major surface on which the adhesive is disposed includes a part of each of the first flap, the first lateral extension, and the second lateral extension (“the body anchoring or skin patch 40 has a skin anchoring reverse side including a layer of release paper 42 and a skin adhesive material 44” [Col 6, lines 43-46]).
Beisang fails to explicitly teach the medical tape comprising a plurality of body units; the first indent comprising a plurality of perforations, the second indent comprising a plurality of perforations; a second flap defined by a second distal end formed by a part of the second primary edge, a third indent comprising a plurality of perforations having a third end proximate the longitudinal axis, a fourth indent comprising a plurality of perforations having a fourth end proximate the longitudinal axis, and a second hinge region extending between the third end and the fourth end; and a third lateral extension extending in a third direction away from the second flap; a fourth lateral extension extending in a fourth direction away from the second flap wherein the third direction away from the second flap is substantially opposite the fourth direction away from the second flap, wherein the first lateral extension and the third lateral extension are conjoined and the second lateral extension and the fourth lateral extension are conjoined; wherein each of the body units is disposed on a unitary carrier, the unitary carrier is joined to at least one adjacent unitary carrier at an area of weakness that extends substantially orthogonal to the longitudinal axis; and wherein the portion of the second major surface on which the adhesive is disposed includes a part of each of the first flap, the second flap, the first lateral extension, the second lateral extension, the third lateral extension, and the fourth lateral extension.
Thomas teaches a medical tape (tape 40; Figure 7), comprising: a body (body of tape 40; Figure 7) comprising: a first major surface (upper surface of tape 40; Figure 7); a second major surface (lower surface of tape 40 having adhesive 20) opposite the first major surface (Figure 7); first and second primary edges (top and bottom outer edges of tape 40; Figure 7); a longitudinal axis (through central portion 45); a first flap (strap portion 43); a second flap (strap portion 44) defined by a second distal end (at enlarged portions 44A) formed by a part of the second primary edge (Figure 7), a third indent (at slot 48 left of strap portion 44; “the side edges 47 of strap portions 43, 44 being laterally spaced from edges 50 of said tab portions, to define slots 48 which terminate at their inner ends in enlarged portions 49.” [Col 3, lines 35-38]) having a third end proximate the longitudinal axis (Figure 7), a fourth indent (at slot 48 right of strap portion 44) having a fourth end proximate the longitudinal axis (Figure 7), and a second hinge region (junction 46) extending between the third end and the fourth end (Figure 7); a first lateral extension (tab portion 41 below central portion 45) extending in a first direction away from the first flap (Figure 7); and a second lateral extension (tab portion 42 below central portion 45) extending in a second direction away from the first flap (Figure 7), wherein the first direction is substantially opposite the second direction (Figure 7); a third lateral extension (tab portion 41 above central portion 45) extending in a third direction away from the second flap (Figure 7); and a fourth lateral extension (tab portion 42 above central portion 45) extending in a fourth direction away from the second flap (Figure 7); wherein the first direction is substantially opposite the second direction and the third direction away from the second flap is substantially opposite the fourth direction away from the second flap (Figure 7), wherein the first lateral extension and the third lateral extension are conjoined and the second lateral extension and the fourth lateral extension are conjoined (Figure 7); and wherein the portion of the second major surface on which the adhesive is disposed (lower surface of tape 40 having adhesive 20) includes a part of each of the first flap, the second flap, the first lateral extension, the second lateral extension, the third lateral extension, and the fourth lateral extension (Figures 7 and 9 showing the adhesive 20 on the lateral extensions 41, 42 and flaps 43, 44; “a single tubing T is anchored in place by the oppositely extending strap portions 43, 44 adhesively secured to said tubing T which overlies said strap portions.” [Col 3, lines 45-47]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the medical tape of Beisang to include a second flap similar to the first flap that is defined by a second distal end, a third indent, a fourth indent, and a second hinge; third and fourth lateral extensions, wherein the first lateral extension and the third lateral extension are conjoined and the second lateral extension and the fourth lateral extension are conjoined; and wherein the portion of the second major surface on which the adhesive is disposed includes a part of each of the first flap, the second flap, the first lateral extension, the second lateral extension, the third lateral extension, and the fourth lateral extension based on the teachings of Thomas to allow for the tubiform components of the medical device to be secured in numerous configurations, such as allow for multiple tubiform components to be held parallel to each other or to secure a single tubiform component against both longitudinal and transverse movement (Thomas [Col 3, lines 41-55] and Figures 7-10).
Modified Beisang fails to explicitly teach the medical tape comprising a plurality of body units, the first indent comprising a plurality of perforations, the second indent comprising a plurality of perforations, the third indent comprising a plurality of perforations, and the fourth indent comprising a plurality of perforations; and wherein each of the body units is disposed on a unitary carrier, the unitary carrier is joined to at least one adjacent unitary carrier at an area of weakness that extends substantially orthogonal to the longitudinal axis.
Ward teaches a medical tape (Figure 1) comprising a body (handle 2) and an indent (perforated dividing line 3) comprising a plurality of perforations (“A dividing line may include for example cuts and lines of perforations. Preferably the dividing line is a line of perforations.” [Col 22, lines 7-9]).
Before the effective filing date, it would have been obvious to one having ordinary skill in the art to modify the first, second, third, and fourth indents of the first and second flap of modified Beisang to each comprise a plurality of perforations based on the teachings of Ward to provide both versatility and flexibility during placement of the medical dressing by allowing each of the flaps and lateral extensions to be moved independently of each prior to their adhesive surface being exposed (Ward [Col 7, line 57 – Col 8, line 8]).
Modified Beisang fails to explicitly teach the medical tape comprising a plurality of body units, and wherein each of the body units is disposed on a unitary carrier, the unitary carrier is joined to at least one adjacent unitary carrier at an area of weakness that extends substantially orthogonal to the longitudinal axis.
DeBusk teaches a medical tape (Figure 6) comprising a body (roll 102) comprising a first major surface (forming web 62’ of strips 16’); a second major surface (forming peel-back strips 74’ of strips 16’); a first primary edge (lower edge of strips 16’ having V-shaped cutouts 76’); a second primary edge (upper edge of strips 16’); a longitudinal axis (horizontal axis through adjoining strips 16’); and plurality of body units (strips 16’; “the strip 16 of the system 10 may be supplied from a series of individual strips 16' connected end-to-end and wound on a plastic or paper tubular core 100 of a roll 102.” [Col 8, lines 42-45]; Figure 6); wherein each of the body units is disposed on a unitary carrier (one of cover strips 72’, 74’), the unitary carrier is joined to at least one adjacent unitary carrier at an area of weakness (score lines 104) that extends substantially orthogonal to the longitudinal axis (“Score lines 104 demark the location of the separation between adjacent strips 16 and provide easy separation of strips from the roll.” [Page 8, lines 46-48], Figure 6 showing the score lines 104 orthogonal to the horizontal axis through the adjoining strips 16’).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the medical tape of Beisang to include that the medical tape comprising a plurality of body units; wherein each of the body units is disposed on a unitary carrier, the unitary carrier is joined to at least one adjacent unitary carrier at an area of weakness that extends substantially orthogonal to the longitudinal axis based on the teachings of DeBusk to allow for simple dispensing and placement of the body unit on site (DeBusk [Col 8; lines 49-56]).
Response to Arguments
Applicant's arguments filed 11/25/25 have been fully considered but they are not persuasive.
Regarding the argument that “the Examiner has not provided an articulated reasoning with rational underpinning to combine Beisang, Thomas and Ward” (Remarks, page 9), the examiner respectfully disagrees. 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, the motivation and reasoning for the combination of Beisang, Thomas, and Ward was found in the references themselves, as detailed in the rejections above.
Regarding the argument that “the Examiner has not provided an articulated reasoning with rational underpinning to modify the medical dressing of Beisang to include a second flap” and “the Examiner’s reasoning to include a second flap on the dressing of Beisang is a mere conclusory statement” (Remarks, page 10), the examiner respectfully disagrees. As detailed above, Beisang discloses a medical dressing (40) having a first flap (46) as claimed, but fails to explicitly disclose a second flap. Thomas discloses a medical dressing (40; Figure 7) having a first flap (43) and a second flap (44) such that “separate tubings T, T' may be anchored against longitudinal or transverse movement by the respective strap portions 43, 44 which are wrapped around and adhered to said tubings T, T'”, “a single tubing T is anchored in place by the oppositely extending strap portions 43, 44 adhesively secured to said tubing T which overlies said strap portions” and/or “a pair of tubings T, T' in side by side relation are held together by strap portions 43, 44 extending toward each other with their enlarged portions 43A, 44A in overlapped, adhesively secured relation, allowing only limited lateral movement while permitting longitudinal movement since the uncoated surface of said strap portions are in contact with the tubings” (Thomas [Col 3, lines 41-55]). Therefore, one having ordinary skill in the art would have recognized that it would have been obvious to modify the medical dressing of Beisang to have both a first flap and a second flap based on this disclosure of Thomas to allow for the tubiform components of the medical device to be secured in numerous configurations, such as allow for multiple tubiform components to be held parallel to each other or to secure a single tubiform component against both longitudinal and transverse movement (Thomas [Col 3, lines 41-55] and Figures 7-10). Though Beisang does not explicitly disclose the use of multiple tubes, one having ordinary skill in the art would recognize that a patient may require the use of multiple tubes during a surgical procedure, such as disclosed by Thomas (“Many surgical procedures require the use of tubings, as for example naso-gastric tubes, oxygen therapy tubing, drainage tubes, various catheters, intravenous administration, and the like. Inasmuch as such tubings or tubes extend between the patient and a supply means or drainage vessel, it is important that the tubings or tubes be restrained against undesirable movement thereof, to insure proper surgical procedures as well as comfort of the patient.” [Col 1, lines 4-13]).
Regarding the argument that “if a second flap was to be added, it is unclear whether the dressing would adequately adhere to the patient’s skin in order to hold a catheter in place” (Remarks, page 10), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Additionally, Beisang discloses numerous embodiments of medical dressings, each with a differing surfaces areas of adhesive that are adequate to adhere to a patient’s skin (see Beisang Figures 1, 6, and 7).
Regarding the argument that “DeBusk does not teach that such body units are supplied on a unitary carrier” as required by amended claim 37 (Remarks, page 13), the examiner respectfully disagrees. As detailed above with respect to the rejection of claim 37, DeBusk discloses a medical tape (Figure 6) comprising a body (102) comprising a longitudinal axis (horizontal axis through adjoining strips 16’); and plurality of body units (strips 16’; [Col 8, lines 42-45]); wherein each of the body units is disposed on a unitary carrier (one of cover strips 72’, 74’), the unitary carrier is joined to at least one adjacent unitary carrier at an area of weakness (104) that extends substantially orthogonal to the longitudinal axis (“Score lines 104 demark the location of the separation between adjacent strips 16 and provide easy separation of strips from the roll.” [Page 8, lines 46-48], Figure 6 showing the score lines 104 orthogonal to the horizontal axis through the adjoining strips 16’). It is therefore maintained that it would have been obvious to one having ordinary skill in the art to modify the medical tape of Beisang to include that the medical tape comprising a plurality of body units; wherein each of the body units is disposed on a unitary carrier, the unitary carrier is joined to at least one adjacent unitary carrier at an area of weakness that extends substantially orthogonal to the longitudinal axis based on the teachings of DeBusk to allow for simple dispensing and placement of the body unit on site (DeBusk [Col 8; lines 49-56]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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