DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 05/23/2025.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/23/2025 has been entered.
Status of Claims
Claim(s) 1-2, 5-6, 8-9, 11-12, 14, 17, 19, 21, 24-28, and 37 is/are pending in the application.
Claim(s) 1-2, 5-6, 8-9, 11-12, 14, 17, 19, 21, 24-28, and 37 is/are examined on the merits.
Information Disclosure Statement
The new information disclosure statements (IDS) submitted on 07/14/2025 in compliance with the provisions of 37 CFR 1.97. Accordingly, the new information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments filed on 05/23/2025 have been fully considered, but are moot because the independent claims have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Reference Riesinger (US PGPUB 20160262942) is applied to teach “a concave recess extending into an edge of the manifold at a first end to a maximum distance, a fold axis bisecting the concave recess and extending from the first end to a second end along a length of the manifold, a first conformable area extending orthogonal to the fold axis along a width of the manifold and toward a first side of the manifold, wherein the first conformable area includes a first flared portion, and a second conformable area extending orthogonal to the fold axis along the width of the manifold and toward a second side of the manifold opposite to the first side, wherein the second conformable area includes a second flared portion, wherein the first flared portion and the second flared portion are positioned closer to the second end of the manifold than the first end, and wherein the width of the manifold does not decrease from the maximum distance of the concave recess to the first flared portion and the second flared portion”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 28 recites the limitation “a fold axis bisecting the concave recess and extending from the first end to a second end along a length of the manifold to a maximum depth”; however, there is no embodiment within the disclosed invention wherein “a fold axis bisecting the concave recess and extending from the first end to a second end along a length of the manifold to a maximum depth”.
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(s) 28 is/are 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 28 recites the limitations “a concave recess extending into an edge of the manifold at a first end; … and wherein the width of the manifold does not decrease from the maximum distance of the concave recess to the first flared portion and the second flared portion” which is indefinite. There is not sufficient antecedent basis for “maximum distance” in the claim. In addition, it is unclear where the “maximum distance” is located on which part/portion of the concave recess. Claim has been examined below as if “a concave recess extending into an edge of the manifold at a first end to a maximum distance” (in view of Fig. 4 of Applicant’s published application); and “the width of the manifold does not decrease from the maximum distance of the concave recess to the first flared portion and the second flared portion”.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 5-6, 8, 11-12, 14, 17, 21, 24-25, 28, and 37 is/are rejected under 35 U.S.C 103 as being unpatentable over Randolph (US PGPUB 20140276288) in view of Hopman (US PGPUB 20120046582) and Riesinger (US PGPUB 20160262942).
Regarding claim 1, Randolph discloses a dressing (a dressing 602: ¶0066 and Fig. 6A) for treating an area around an extremity with reduced pressure (¶0066), comprising:
a manifold (a manifold layer 110/610: ¶0067 and Fig. 6A) configured to be in fluid communication with the area around the extremity (¶0047, 0067; Figs. 2A-B and 7A-C);
wherein the manifold includes a first surface (a top surface of the manifold 610: Fig. 6A) and an opposing second surface (a bottom surface of the manifold 610: Fig. 6A);
a cover (a sleeve layer 112/612: ¶0042, 0067 and Fig. 6A) configured to be disposed over the manifold (Fig. 6A).
Randolph further discloses a tissue contact layer (a comfort layer 620: ¶0067, 0069, and Fig. 6A) coupled to the second surface of the manifold (layer 620 is coupled to the bottom surface of the manifold 610: Fig. 6A) configured to be exposed to the area around the extremity (¶0069).
Randolph does not disclose an attachment device including a film layer and a treatment aperture; the attachment device is positioned on a portion of the tissue contact layer; the manifold is configured to be in fluid communication with the area around the extremity through the treatment aperture and at least a portion of the second surface of the manifold is configured to face the area around the extremity through the treatment aperture.
In an analogous art for being directed to solve the same problem, providing a suitable flexible sheet material which can occlude the wound, Hopman discloses a medical dressing 10 comprising a one-way valve assembly 14 mounted on an attachment device (a flexible base sheet or panel 12: ¶0057 and Fig. 2). Hopman further teaches the attachment device 12 comprising a film of polyurethane or polyethylene (¶0059) and a treatment aperture (an opening 12a: ¶0057 and Fig. 2) for the benefits of providing a suitable flexible sheet material for attaching to the wound and enhancing fluid communication through the opening (¶0015, 0057, and 0059). From these teachings, a person having ordinary skill in the art would have recognized/deduced that positioning/arranging the attachment device on a portion of the tissue contact layer yields the predictable result of providing a suitable flexible sheet material for attaching to the wound and enhancing fluid communication through the treatment aperture.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph in view of Hopman by incorporating an attachment device comprising a film layer and a treatment aperture and positioning/arranging the attachment device on a portion of the tissue contact layer, in order to provide a suitable flexible sheet material for attaching to the wound and enhance fluid communication through the treatment aperture, as suggested in ¶0015, 0057 and 0059 of Hopman. Since the tissue contact layer of Randolph in view of Hopman is configured to face the area around the extremity (¶0069), the attachment device positioned on a portion of the tissue contact layer of Randolph in view of Hopman is also capable of facing area around the extremity. Furthermore, since the tissue contact layer is coupled to the second surface of the manifold (see rejection above) and the attachment device of Randolph in view of Hopman is positioned on a portion of the tissue contact layer, the manifold of Randolph in view of Hopman is capable of being in fluid communication with the area around the extremity through the treatment aperture and at least a portion of the second surface of the manifold is capable of facing the area around the extremity through the treatment aperture.
Since the cover of Randolph in view of Hopman is configured to be disposed over the manifold (¶0070 of Randolph), the attachment device is positioned on a portion of the tissue contact layer, and the tissue contact layer is coupled to the second surface of the manifold (see rejection above and Figs. 6A-B), the cover of Randolph in view of Hopman is capable of coupling the attachment device around the manifold and the tissue contact layer.
Randolph further discloses/suggests size and shape of the manifold are adapted to the contours of the extremities; however, Randolph/Hopman does not disclose the manifold including a concave recess extending into an edge of the manifold at a first end to a maximum distance, a fold axis bisecting the concave recess and extending from the first end to a second end along a length of the manifold, a first conformable area extending orthogonal to the fold axis along a width of the manifold and toward a first side of the manifold, wherein the first conformable area includes a first flared portion, and a second conformable area extending orthogonal to the fold axis along the width of the manifold and toward a second side of the manifold opposite to the first side, wherein the second conformable area includes a second flared portion, wherein the first flared portion and the second flared portion are positioned closer to the second end of the manifold than the first end, and wherein the width of the manifold does not decrease from the maximum distance of the concave recess to the first flared portion and the second flared portion.
In the same field of endeavor, wound dressing, Riesinger discloses a flat wound care article having an essentially polygonal or ellipsoid base surface and at least one recess arranged on one side (Abstract). In the embodiment of Fig. 5, Riesinger further discloses a flat wound care article 50 comprising a concave recess extending into an edge of the article at a first end to a maximum distance (see annotated Fig. 5 below), a fold axis bisecting the concave recess and extending from the first end to a second end along a length of the article (see annotated Fig. 5 below), a first conformable area (an angled corner 51: ¶0014 and Fig. 5) extending orthogonal to the fold axis along a width of the article and toward a first side of the manifold (see annotated Fig. 5 below), wherein the first conformable area includes a first flared portion (see annotated Fig. 5 below), and a second conformable area (an angled corner 52: ¶0014 and Fig. 5) extending orthogonal to the fold axis along the width of the article and toward a second side of the article opposite to the first side (see annotated Fig. 5 below), wherein the second conformable area includes a second flared portion, wherein the first flared portion and the second flared portion are positioned closer to the second end of the article than the first end (see annotated Fig. 5 below), and wherein the width of the article does not decrease from the maximum distance of the concave recess to the first flared portion and the second flared portion (see annotated Fig. 5 below) for the benefit of providing a wound care article that can closely conform to the anatomical contours of different body regions of a patient (¶0005).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph/Hopman in view of Riesinger by changing a shape of the manifold as claimed, in order to provide a wound dressing can closely conform to the anatomical contours of different body regions of a patient, as suggested in ¶0005 of Riesinger and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. (See MPEP § 2144.04 (IV) (B)). Further, one would have been motivated to select the shape of the manifold as claimed for the purpose of providing a wound dressing that closely conforms to the anatomical contours of different body regions of a patient. Thus, Randolph/Hopman in view of Riesinger discloses the manifold including a concave recess extending into an edge of the manifold at a first end to a maximum distance, a fold axis bisecting the concave recess and extending from the first end to a second end along a length of the manifold, a first conformable area extending orthogonal to the fold axis along a width of the manifold and toward a first side of the manifold, wherein the first conformable area includes a first flared portion, and a second conformable area extending orthogonal to the fold axis along the width of the manifold and toward a second side of the manifold opposite to the first side, wherein the second conformable area includes a second flared portion, wherein the first flared portion and the second flared portion are positioned closer to the second end of the manifold than the first end, and wherein the width of the manifold does not decrease from the maximum distance of the concave recess to the first flared portion and the second flared portion.
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Regarding claim 2, Randolph/Hopman does not disclose the maximum distance the concave recess extends into the edge of the manifold is between 15 percent to 30 percent of the length of the manifold between the first end and the second end.
Riesinger further discloses to have at least one recess arranged on one side of the wound care article for the benefit of closely conforming to the anatomical contours of various body regions of humans (¶0005).
From these teachings, a person having ordinary skill in the art would have recognized/deduced that having the maximum distance of the concave recess extends into the edge of the manifold between 15 percent to 30 percent of the length of the manifold between the first end and the second end yields the predictable result of allowing the manifold to fit comfortably over the arch of the foot when the manifold is deformed and secured to the shin area and closely conform to the anatomical contours of the affected body regions.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the manifold of Randolph/Hopman/Riesinger in view of Riesinger by having the maximum distance that the concave recess extends into the edge of the manifold between 15 percent to 30 percent of the length of the manifold between the first end and the second end, in order to provide a wound dressing can closely conform to the anatomical contours of different body regions of a patient, ¶0005 of Riesinger and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)). Further, one would have been motivated to have the maximum distance that the concave recess extends into the edge of the manifold between 15 percent to 30 percent of the length of the manifold between the first end and the second end for the purpose of allowing the manifold to fit comfortably over the arch of the foot when the manifold is deformed and secured to the shin area. In addition, Applicant places no criticality on the dimension claimed, indicating simply that the concave recess 440 may extend into the edge 416 of the manifold 406 between about 15 percent to about 30 percent of a length 448 of the manifold 406 between the first end 446 and the second end 438 (¶0059 of Applicant’s published specification).
Regarding claim 5, Randolph/Hopman/Riesinger discloses the concave recess is a first concave recess (see rejection of claim 1 above).
Randolph/Hopman does not disclose the manifold further comprises a second concave recess extending into the edge of the manifold at the second end and the second concave recess is larger than the first concave recess.
In the embodiment of Fig. 8 of Riesinger, Riesinger further discloses the article comprising two recesses 82 and 83 that are each arranged on opposite side (¶0017).
In addition, a person having ordinary skill in the art would understand/recognize that making/having the first concave recess or the second concave recess larger or smaller would depend on the anatomical contours of the wound and a design choice.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph/Hopman/Riesinger in view of Riesinger by incorporating a second concave recess and making/having the second concave recess is larger than the first concave recess, in order to provide a wound dressing can closely conform to the anatomical contours of different body regions of a patient, as suggested in ¶0005 of Riesinger and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)).
Regarding claim 6, Randolph/Hopman/Riesinger further discloses the width of the manifold is greatest from the first flared portion to the second flared portion (see annotated Fig. 5 above).
Regarding claim 8, Randolph/Hopman/Riesinger further discloses the first flared portion is positioned at the edge of the manifold on the first side (see annotated Fig. 5 above) and the second flared portion is positioned at the edge of the manifold on the second side (see annotated Fig. 5 above).
Regarding claim 11, Randolph/Hopman/Riesinger further discloses further discloses the first conformable area is symmetrical to the second conformable area across the fold axis (see annotated Fig. 5 above).
Regarding claim 12, Randolph further discloses the manifold comprises porous foam (¶0039).
Randolph does not disclose the attachment device is configured to create a sealed space between the cover and the area around the extremity and the manifold and the tissue contact layer are configured to be positioned in the sealed space.
Hopman further teaches the attachment device 12 adhering to the patient’s skin around the wound by adhesive material 17 or 17a to form an air-tight seal (¶0075 and Fig. 3A).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph/Hopman/Riesinger in view Hopman by incorporating an adhesive material on the attachment device, in order to form an air-tight seal between the attachment device and patient’s skin around the wound, as suggested in ¶0075 of Hopman. Since the manifold and the tissue contact layer are coupled to the attachment device (see rejection of claim 1 above), the attachment device of Randolph/Hopman/Riesinger is capable of creating a sealed space between the cover and the area around the extremity via the adhesive material and the manifold and the tissue contact layer are configured to be positioned in the sealed space.
Regarding claim 14, Randolph/Riesinger does not disclose the attachment device comprises one or more of an adhesive, a hydrocolloid, and a gasket member.
Hopman further teaches the attachment device comprising a layer of an adhesive 17 (¶0060 and Fig. 2) for the benefit of enabling the attachment device to be adhered to the skin of a patient (¶0060).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph/Hopman/Riesinger in view of Hopman by incorporating an adhesive on the attachment device, in order to enable the attachment device to be adhered to the skin of a patient, as suggested in ¶0060 of Hopman.
Regarding claim 17, Randolph/Riesinger does not disclose the attachment device is positioned around the edge of the manifold and configured to surround the area around the extremity.
Hopman further teaches the attachment device 12 is configured to surround the wound area (¶0060) and is positioned around the edge of the one-way valve 14 (Fig. 2) for the benefit of providing air-tight seal in the dressing (¶0075). From these teachings, a person having ordinary skill in the art would have recognized/deduced that positioning/arranging the attachment device around the edge of the manifold and surround the area around the extremity yields the predictable result of providing air-tight seal in the dressing.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph/Hopman/Riesinger in view of Hopman by positioning the attachment device around the edge of the manifold and surround the area around the extremity, in order to provide air-tight seal in the dressing, as suggested in ¶0075 of Hopman and as it has been held that the use of known technique to yield predictable result is prima facie obvious. See MPEP § 2143 (I) (C & G).
Regarding claim 21, Randolph further discloses the tissue contact layer is configured to be positioned in direct contact with the area around the extremity (¶0069), and the tissue contact layer is selected from the group consisting of a woven material, a non-woven material, a polyester knit material, and a fenestrated film (the tissue contact layer 620 is a woven material or a polyester knit material: ¶0041).
Regarding claim 24, Randolph/Hopman/Riesinger discloses the dressing of claim 1 (see rejection of claim 1 above).
Randolph further discloses a reduced-pressure source (a vacuum source 106: ¶0025 and Fig. 1) fluidly coupled to the manifold (106 is fluidly coupled to the manifold 110/610 via a conduit 108: ¶0047 and Fig. 6A).
Since the dressing of Randolph in view of Hopman and Riesinger meets the structural limitations of the claimed dressing, it will inherently perform the method steps as claimed (See MPEP § 2112.02 (I)). Thus, Randolph in view of Hopman and Riesinger further discloses a method of treating an area around an extremity with reduced pressure, the method comprises:
applying the dressing of claim 1 so that the fold axis extends lengthwise along the extremity; wrapping the first conformable area circumferentially around the extremity in a first direction; wrapping the second conformable area circumferentially around the extremity in a second direction opposite to the first direction; fluidly coupling a reduced-pressure source to the manifold; and delivering reduced pressure from the reduced-pressure source to the manifold.
Regarding claim 25, Randolph further discloses the extremity is a leg (Fig. 1).
Since the dressing of Randolph in view of Hopman and Riesinger meets the structural limitations of the claimed dressing, it will inherently perform the method steps as claimed (See MPEP § 2112.02 (I)). Thus, Randolph in view of Hopman and Riesinger further discloses a method of treating an area around an extremity with reduced pressure, the method comprises: applying the dressing includes applying the fold axis lengthwise along a shin of the leg and positioning a dorsal portion of a foot on the leg in the concave recess.
Regarding claim 28, Randolph discloses a manifold (a manifold layer 110/610: ¶0067 and Fig. 6A) for treating an area around an extremity with reduced pressure (¶0047, 0066-0067; Figs. 2A-B and 7A-C):
Randolph further discloses a tissue contact layer (a comfort layer 620: ¶0067, 0069, and Fig. 6A) coupled to a surface of the manifold (layer 620 is coupled to the bottom surface of the manifold 610: Fig. 6A) configured to be positioned between the manifold and the area around the extremity (¶0069).
Randolph does not disclose an attachment device including a film layer configured to be positioned between a portion of the tissue contact layer and the area around the extremity.
In an analogous art for being directed to solve the same problem, providing a suitable flexible sheet material which can occlude the wound, Hopman discloses a medical dressing 10 comprising a one-way valve assembly 14 mounted on an attachment device (a flexible base sheet or panel 12: ¶0057 and Fig. 2). Hopman further teaches the attachment device 12 comprising a film of polyurethane or polyethylene (¶0059) and a treatment aperture (an opening 12a: ¶0057 and Fig. 2) for the benefits of providing a suitable flexible sheet material for attaching to the wound and enhancing fluid communication through the opening (¶0015, 0057, and 0059). From these teachings, a person having ordinary skill in the art would have recognized/deduced that positioning/arranging the attachment device on a portion of the tissue contact layer and the area around the extremity yields the predictable result of providing a suitable flexible sheet material for attaching to the wound and enhancing fluid communication through the treatment aperture.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph in view of Hopman by incorporating an attachment device comprising a film layer and positioning/arranging the attachment device on a portion of the tissue contact layer and the area around the extremity, in order to provide a suitable flexible sheet material for attaching to the wound and enhance fluid communication through the treatment aperture, as suggested in ¶0015, 0057, and 0059 of Hopman.
Randolph further discloses/suggests size and shape of the manifold are adapted to the contours of the extremities; however, Randolph/Hopman does not disclose the manifold including a concave recess extending into an edge of the manifold at a first end to a maximum distance, a fold axis bisecting the concave recess and extending from the first end to a second end along a length of the manifold to a maximum depth, a first conformable area extending orthogonal to the fold axis along a width of the manifold and toward a first side of the manifold, wherein the first conformable area includes a first flared portion, and a second conformable area extending orthogonal to the fold axis along the width of the manifold and toward a second side of the manifold opposite to the first side, wherein the second conformable area includes a second flared portion, wherein the first flared portion and the second flared portion are positioned closer to the second end of the manifold than the first end, and wherein the width of the manifold does not decrease from the maximum distance of the concave recess to the first flared portion and the second flared portion.
In the same field of endeavor, wound dressing, Riesinger discloses a flat wound care article having an essentially polygonal or ellipsoid base surface and at least one recess arranged on one side (Abstract). In the embodiment of Fig. 5, Riesinger further discloses a flat wound care article 50 comprising a concave recess extending into an edge of the article at a first end to a maximum distance (see annotated Fig. 5 below), a fold axis bisecting the concave recess and extending from the first end to a second end along a length of the article (see annotated Fig. 5 below), a first conformable area (an angled corner 51: ¶0014 and Fig. 5) extending orthogonal to the fold axis along a width of the article and toward a first side of the manifold (see annotated Fig. 5 below), wherein the first conformable area includes a first flared portion (see annotated Fig. 5 below), and a second conformable area (an angled corner 52: ¶0014 and Fig. 5) extending orthogonal to the fold axis along the width of the article and toward a second side of the article opposite to the first side (see annotated Fig. 5 below), wherein the second conformable area includes a second flared portion, wherein the first flared portion and the second flared portion are positioned closer to the second end of the article than the first end (see annotated Fig. 5 below), wherein the width of the article does not decrease from the maximum distance of the concave recess to the first flared portion and the second flared portion (see annotated Fig. 5 below), and wherein the first conformable area is symmetrical to the second conformable area across the fold axis (see annotated Fig. 5 below) for the benefit of providing a wound care article that can closely conform to the anatomical contours of different body regions of a patient (¶0005).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph/Hopman in view of Riesinger by changing a shape of the manifold as claimed, in order to provide a wound dressing can closely conform to the anatomical contours of different body regions of a patient, as suggested in ¶0005 of Riesinger and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. (See MPEP § 2144.04 (IV) (B)). Further, one would have been motivated to select the shape of the manifold as claimed for the purpose of providing a wound dressing that closely conforms to the anatomical contours of different body regions of a patient. Thus, Randolph/Hopman in view of Riesinger discloses the manifold including a concave recess extending into an edge of the manifold at a first end to a maximum distance, a fold axis bisecting the concave recess and extending from the first end to a second end along a length of the manifold to a maximum depth, a first conformable area extending orthogonal to the fold axis along a width of the manifold and toward a first side of the manifold, wherein the first conformable area includes a first flared portion, and a second conformable area extending orthogonal to the fold axis along the width of the manifold and toward a second side of the manifold opposite to the first side, wherein the second conformable area includes a second flared portion, wherein the first flared portion and the second flared portion are positioned closer to the second end of the manifold than the first end, and wherein the width of the manifold does not decrease from the maximum distance of the concave recess to the first flared portion and the second flared portion; and wherein the first conformable area is symmetrical to the second conformable area across the fold axis.
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Regarding claim 37, Randolph discloses a manifold (a manifold layer 110/610: ¶0067 and Fig. 6A) for use with a dressing (a dressing 602: ¶0066 and Fig. 6A) for treating an area around an extremity with reduced pressure (¶0066).
Randolph further discloses the manifold comprising a tissue contact layer (a comfort layer 620: ¶0067, 0069, and Fig. 6A) coupled to a surface of the manifold (layer 620 is coupled to the bottom surface of the manifold 610: Fig. 6A) and configured to be positioned between the manifold and the area around the extremity (¶0069 and Fig. 6A).
Randolph does not disclose an attachment device including a film layer positioned on a portion of the tissue contact layer configured to face the area around the extremity and the tissue contact layer is positioned between the manifold and the attachment device.
In an analogous art for being directed to solve the same problem, providing a suitable flexible sheet material which can occlude the wound, Hopman discloses a medical dressing 10 comprising a one-way valve assembly 14 mounted on an attachment device (a flexible base sheet or panel 12: ¶0057 and Fig. 2). Hopman further teaches the attachment device 12 comprising a film of polyurethane or polyethylene (¶0059) for the benefits of providing a suitable flexible sheet material for attaching to the wound (¶0015, 0057, and 0059). From these teachings, a person having ordinary skill in the art would have recognized/deduced that positioning/arranging the attachment device on a portion of the tissue contact layer yields the predictable result of providing a suitable flexible sheet material for attaching to the wound.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph in view of Hopman by incorporating an attachment device comprising a film layer and positioning/arranging the attachment device on a portion of the tissue contact layer, in order to provide a suitable flexible sheet material for attaching to the wound, as suggested in ¶0015, 0057 and 0059 of Hopman. Since the tissue contact layer of Randolph in view of Hopman is configured to face the area around the extremity (¶0069), the attachment device positioned on a portion of the tissue contact layer of Randolph in view of Hopman is also capable of facing area around the extremity. Furthermore, since the tissue contact layer is coupled to the bottom surface of the manifold (see rejection above) and the attachment device of Randolph in view of Hopman is positioned on a portion of the tissue contact layer, the manifold of Randolph in view of Hopman is positioned between the manifold and the attachment device.
Randolph further discloses/suggests size and shape of the manifold are adapted to the contours of the extremities; however, Randolph/Hopman does not disclose the manifold including a concave recess at a first end of the manifold, a fold axis bisecting the concave recess at a bisection point and extending from the first end to a second end of the manifold, a first portion extending orthogonal to the fold axis toward a first side of the manifold, a second portion extending orthogonal to the fold axis toward a second side of the manifold opposite to the first side, wherein a width of the manifold is greatest at a location along the fold axis between the first portion and the second portion that is closer to the second end of the manifold than to the first end, and wherein the width of the manifold does not decrease from the bisection point to the location along the fold axis where the width of the manifold is greatest.
In the same field of endeavor, wound dressing, Riesinger discloses a flat wound care article having an essentially polygonal or ellipsoid base surface and at least one recess arranged on one side (Abstract). In the embodiment of Fig. 5, Riesinger further discloses a flat wound care article 50 comprising a concave recess at a first end of the manifold (see annotated Fig. 5 below), a fold axis bisecting the concave recess at a bisection point and extending from the first end to a second end of the manifold (see annotated Fig. 5 below), a first portion extending orthogonal to the fold axis toward a first side of the manifold (see annotated Fig. 5 below), a second portion extending orthogonal to the fold axis toward a second side of the manifold opposite to the first side (see annotated Fig. 5 below), wherein a width of the manifold is greatest at a location along the fold axis between the first portion and the second portion that is closer to the second end of the manifold than to the first end (see annotated Fig. 5 below), wherein the width of the manifold does not decrease from the bisection point to the location along the fold axis where the width of the manifold is greatest (see annotated Fig. 5 below), and wherein the fold axis is configured to extend lengthwise (see annotated Fig. 5 below) for the benefit of providing a wound care article that can closely conform to the anatomical contours of different body regions of a patient (¶0005).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph/Hopman in view of Riesinger by changing a shape of the manifold as claimed, in order to provide a wound dressing can closely conform to the anatomical contours of different body regions of a patient, as suggested in ¶0005 of Riesinger and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. (See MPEP § 2144.04 (IV) (B)). Further, one would have been motivated to select the shape of the manifold as claimed for the purpose of providing a wound dressing that closely conforms to the anatomical contours of different body regions of a patient. Thus, Randolph/Hopman in view of Riesinger discloses the manifold including a concave recess at a first end of the manifold, a fold axis bisecting the concave recess at a bisection point and extending from the first end to a second end of the manifold, a first portion extending orthogonal to the fold axis toward a first side of the manifold, a second portion extending orthogonal to the fold axis toward a second side of the manifold opposite to the first side, wherein a width of the manifold is greatest at a location along the fold axis between the first portion and the second portion that is closer to the second end of the manifold than to the first end, wherein the width of the manifold does not decrease from the bisection point to the location along the fold axis where the width of the manifold is greatest, and wherein the fold axis is configured to extend lengthwise along the extremity.
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Claim(s) 9 is/are rejected under 35 U.S.C 103 as being unpatentable over Randolph in view of Hopman and Riesinger, as applied to claim 1 above, and further in view of Hayashi (US PAT 6056713).
Regarding claim 9, Randolph/Hopman/Riesinger does not disclose a first flap in the first conformable area partially defined by a first bisected portion of the concave recess, and a second flap in the second conformable area partially defined by a second bisected portion of the concave recess, wherein the concave recess is positioned between the first flap and the second flap, and wherein the first flap and the second flap are configured to be positioned on opposing sides of an ankle.
In an analogous art for being directed to solve the same problem, providing a design that fit comfortably over the arch of the foot, Hayashi discloses a conformable ankle brace constructed of a heat moldable thermoplastic material that can be formed in place around a patient's injured ankle (Abstract). Hayashi further teaches to provide the conformable ankle brace comprising a concave recess (concave section 52: Col. 5, lines 55-65 and Fig. 7) with a first flap (a medical extension 12) and a second flap (a lateral extension 14) for the benefits of permitting plantar flexion and dorsiflexion while stabilizing against ankle inversion and eversion, improving the strength of, and comfort of the ankle brace when the edge is rolled (Col. 5, lines 55-65).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Randolph/Hopman/Riesinger in view of Hayashi by providing/having the concave recess with a first flap and a second flap, in order to permit plantar flexion and dorsiflexion while stabilizing against ankle inversion and eversion and improve the strength of and comfort of the dressing when the edge is rolled, as suggested in Col. 5, lines 55-65 of Hayashi.
Claim(s) 19 is/are rejected under 35 U.S.C 103 as being unpatentable over Randolph in view of Hopman and Riesinger, as applied to claim 1, and further in view of Coulthard (US PGPUB 20100305490).
Regarding claim 19, Randolph/Hopman/Riesinger does not disclose the cover is configured to be coupled to a portion of the attachment device extending outward from the edge of the manifold.
In the same field of endeavor, wound dressing, Coulthard discloses a reduced pressure dressing comprising an attachment device (a seal layer 222 to seal the reduce pressure dressing 104 around the tissue site 108: ¶0046 and Fig. 3) and a manifold layer 224 (¶0046 and Fig. 3). Coulthard further teaches the cover 244 is configured to be coupled to a portion of the attachment device 222 extending outward from the edge of the manifold 224 (¶0078 and Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph/Hopman/Riesinger in view of Coulthard by coupling to a portion of the attachment device extending outward from the edge of the manifold, in order to provide seal around the tissue site, as suggested in ¶0078 of Coulthard.
Claim(s) 26 is/are rejected under 35 U.S.C 103 as being unpatentable over Randolph in view of Hopman and Riesinger, as applied to claim 24 above, and further in view of Hayashi (US PAT 6056713).
Regarding claim 26, Randolph/Hopman/Riesinger does not disclose a first flap and a second flap, and wherein the method further comprises positioning the first flap and the second flap on opposing sides of an ankle.
Hayashi further teaches to provide the conformable ankle brace comprising a concave recess (concave section 52: Col. 5, lines 55-65 and Fig. 7) with a first flap (a medical extension 12) and a second flap (a lateral extension 14) for the benefits of permitting plantar flexion and dorsiflexion while stabilizing against ankle inversion and eversion, improving the strength of, and comfort of the ankle brace when the edge is rolled (Col. 5, lines 55-65).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Randolph/Hopman/Riesinger in view of Hayashi by providing/having the concave recess with a first flap and a second flap, similar to that disclosed by, in order to permit plantar flexion and dorsiflexion while stabilizing against ankle inversion and eversion and improve the strength of and comfort of the dressing when the edge is rolled, as suggested in Col. 5, lines 55-65 of Hayashi.
Since the dressing of Randolph/Hopman/Riesinger in view of Hayashi meets the structural limitations of the claimed dressing, it will inherently perform the method steps as claimed (See MPEP § 2112.02 (I)). Thus, Randolph/Hopman/Riesinger in view of Hayashi further discloses the method comprises positioning the first flap and the second flap on opposing sides of an ankle.
Claim(s) 27 is/are rejected under 35 U.S.C 103 as being unpatentable over Randolph in view of Hopman and Riesinger, as applied to claim 24 above, and further in view of Simmons (US PGPUB 20150057624).
Regarding claim 27, Randolph further discloses an adhesive on a surface of the dressing configured to face the area around the extremity (the sleeve layer 612 comprises adhesive to seal over the manifold layer 610 and the slits 615 through the manifold 610 allow the adhesive to contact the intact skin thereby securing the dressing 602 to the limb intermittently: ¶0070; thus, Randolph discloses an adhesive on a surface of the dressing configured to face the area around the extremity).
Randolph/Hopman/Riesinger does not disclose a plurality of release liners covering the adhesive prior to applying the dressing and the method steps of removing one or more of the plurality of release liners covering the adhesive at the fold axis before applying the fold axis lengthwise along the extremity and before removing another of the release liners or wrapping the first conformable area or the second conformable area.
In the same field of endeavor, wound dressings, Simmons discloses a treatment system 200 comprising a dressing assembly 202 and a dressing bolster 204 (¶0046 and Fig. 5). Simmons further teaches to have a plurality of release liners (a bottom release member 256 and side release members 258: ¶0063) covering an adhesive prior to applying the dressing (covering a sealing device 254 and a sealing ring 248: ¶0063 and Fig. 5) for the benefits of covering and protecting the adhesive (¶0063). Furthermore, Simmons suggests to use/apply the bottom release liner 256 to cover a middle portion of the sealing device 254 and the sealing ring 248 positioned in the middle of the dressing 200 (¶0063 and Fig. 5) and use/apply the side release liners 258 to cover two sides of the sealing device 254 and to provide a grasping surface for user to facilitate deployment of the dressing assembly 202 (¶0063 and Fig. 5). From these teachings, a person having ordinary skill in the art would have recognized/deduced that incorporating a bottom release liner to cover the adhesive of the fold axis extending lengthwise along the extremity and incorporating side release liners to cover the adhesive on the first conformable area and the second conformable area yields the predictable result of covering and protecting the adhesive of the fold axis extending lengthwise along the extremity and the adhesive on the first conformable area and the second conformable area.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Randolph/Hopman/Riesinger in view Simmons by incorporating a bottom release liner to cover the adhesive of the fold axis extending lengthwise along the extremity and incorporating side release liners to cover the adhesive on the first conformable area and the second conformable area, in order to cover and protect the adhesive of the fold axis extending lengthwise along the extremity and the adhesive on the first conformable area and the second conformable area, as suggested in ¶0063 of Simmons.
Since Simmons further suggests to remove the bottom release liners 256 to expose the sealing device 254 on a second, inward-facing side 237 and expose a second, inward-facing surface 247 of the sealing ring 248 first (¶0064 and Figs. 4-5) and then remove the side release liners 258 after applying a second sealing member portion 228, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method steps of Randolph/Hopman/Riesinger in view Simmons by removing the bottom release liner covering the adhesive at the fold axis before applying the fold axis lengthwise along the extremity and before removing the side release liners or wrapping the first conformable area or the second conformable area, as suggested in ¶0064 of Simmons. Furthermore, a person having ordinary skill in the art would have understood/recognized that there is a finite number of ways to remove the plurality of release liners and to apply the adhesive to a patient’s extremity (i.e., removing all release liners at once and applying the adhesive to patient’s extremity or removing a middle release liner first, applying the middle release liner to the middle section of the patient’s extremity, removing a left side release liner first, applying the left side release liner to the left side of the patient’s extremity, removing a right side release liner, and then applying the right side release liner to the right side of the patient’s extremity). Thus, a person of ordinary skill would try to remove one release liner at a time and apply the adhesive to the patient’s skin after the one release liner removed in order to improve the ability for the adhesive to stick on the patient’s skin. “A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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/NHU Q. TRAN/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781