DETAILED ACTION
In the preliminary amendment filed 3/15/24, Applicant has amended claims 1-7, 11-22 and 24; and amended the specification. Claims 8-10 and 23 have been cancelled. Currently, claims 1-7, 11-22 and 24 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 6, 12, 14, 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Holm et al (US 2016/0317358) in view of Jensen et al (EP 0768071 A1).
With respect to claim 1, Holm discloses a medical dressing (conformable wound dressing – para [0005]; wound dressing system 1000 which comprises dressing 10 in figs 1-3) for use in conjunction with a medical device (used in conjunction with wound vacuum device since the wound dressing is described as being configured to be applied to treatment sites and enable the application of vacuum to a wound – para [0005]), wherein said dressing comprises an outer layer (support layer 20 defining an outer surface as shown in fig 3); said outer layer comprising a line (gap 50 defines a visible line; figs 1 and 3; para [0052]) dividing said outer layer (20) into a first portion (20a; fig 3) and a second portion (20b; fig 3); said first (20a) and said second (20b) portion being symmetric about said folding line (as shown in fig 1; gap 50 substantially overlaps the longitudinal axis 16 and forms an axis of symmetry for the wound dressing system 1000 - para [0052]), wherein said dressing can be arranged in a first, flat configuration (shown in fig 1), wherein said first portion (20a) of said outer layer (20) comprises a first set of guiding lines (the dressing support layer may comprise a plurality of visible indicia 60 – para [0057]; several of the indicia 60 are shown on portion 20a in fig 1) indicating how to cut said dressing in said folded configuration into a first set of dressing pieces (visible indicia 60 function as guides for cleaving the wound dressing 10 into a plurality of cropped wound dressings – para [0057]), and wherein said second portion (20b) comprises a second set of guiding lines (the dressing support layer may comprise a plurality of visible indicia 60 – para [0057]; several of the indicia 60 are shown on portion 20b in fig 1) indicating how to cut said dressing in said folded configuration into a second set of dressing pieces (visible indicia 60 function as guides for cleaving the wound dressing 10 into a plurality of cropped wound dressings – para [0057).
Holm does not, however, explicitly disclose that the gap 50 which divides the outer layer into symmetric first and second portions is a folding line and that the dressing can be arranged in a second, folded configuration about said folding line.
Jensen, however, teaches a dressing which includes a depression 14 provided along the midline of the symmetrical dressing which defines a hinge line to facilitate folding of the dressing as shown in Figures 4 and 7-9 (col 5 lines 44-49). Jensen further teaches folding the dressing about the folding line (14) as shown in fig 4 in order to divide the dressing into two equal parts and, furthermore, to provide a configuration that is capable of application in narrow anatomic regions such as for use as a sacral dressing as shown in figs 7-9. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the gap 50 of Holm as a folding line, like the depression 14 on the dressing of Jensen, so that the dressing can be provided in a second, folded configuration about the folding line, as taught by Jensen, in order to divide the dressing into two equal parts and, furthermore, to provide a configuration that is capable of application in narrow anatomic regions if desired or necessary based on the treatment needs of a given user.
With respect to claim 2, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 1) and Holm further discloses that said first set of guiding lines is different from said second set of guiding lines (as shown in fig 1, each of the indicia 60 is at a different location, on a different support tab, and thus is interpreted as being “different” from the other indicia 60 on the dressing).
With respect to claim 3, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 1) and Holm also discloses that the dressing pieces of said first set of dressing pieces are adapted for a first medical device and wherein the dressing pieces of said second set of dressing pieces are adapted for a second medical device (the dressing is configured to enable the application and maintenance of vacuum to a wound (para [0005]) and thus is adapted for use on wound vacuum medical devices; also, the wound dressing system is adapted to be cleaved along predefined lines in order to yield a plurality of cropped wound dressing systems that have all of the necessary features to apply them to relatively-smaller, contoured wound sites (para [0005]) – thus, the dressing is interpreted as being divided into multiple individual dressings, each adapted for use on a wound vacuum device).
With respect to claim 6, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 1) and Holm also discloses that said first set of guiding lines and/or said second set of guiding lines (indicia 60) are formed by a print pattern, a weld pattern, a compressed pattern, an embossed pattern, a material deposition pattern, or combinations thereof (printed lines – para [0057]).
With respect to claim 12, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 1) and Holm also discloses that said outer layer is said backing layer and/or said release liner (the release liner 90 defines an outer layer of the dressing system 1000 as shown in fig 3) and wherein said outer layer comprises a polymeric film (the release liner 90 can comprise a polymeric film material - para [0134]).
With respect to claim 14, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 1) and Holm further discloses that said outer layer has a lateral (x) and a longitudinal (y) extension, wherein said folding line is a longitudinal (y) center line; said outer layer being defined by a first and a second longitudinal edge extending in parallel to each other in the lateral (x) direction, and a first and an a second lateral edge extending in parallel to each other in the longitudinal (y) direction (see annotated fig 1 of Holm).
ANNOTATED FIG 1 of Holm:
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With respect to claim 18, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 1) and Holm also discloses that said folding line is a guiding line indicating that said folding line is to be cut (the wound dressing system is adapted to be cleaved along predefined lines in order to yield a plurality of cropped wound dressing systems that have all of the necessary features to apply them to relatively-smaller, contoured wound sites - para [0005;0057]).
With respect to claim 21, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 1) and Holm also discloses that said dressing further comprises a fold marking indicating that the dressing should be folded prior to cutting (indicia 60 marks an area of weakness that is susceptible to folding and defines a portion of the dressing to be folded – para [0058]; indicia 60 also function as guides for cleaving the wound dressing into a plurality of cropped wound dressings – para [0057]).
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Holm et al (US 2016/0317358) in view of Jensen et al (EP 0768071 A1) and further in view of Cole (EP 0262786 A2).
With respect to claim 4, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 1) and Holm also discloses that said dressing comprises a backing layer (30; fig 3), an adhesive skin contact layer (40; fig 3) and a release liner (90; fig 3) configured to be detachably attached to said adhesive skin contact layer (para [0050]).
Holm does not, however, disclose that said outer layer comprising said first and said second sets of guiding lines is said backing layer and/or said release liner.
Cole, however, teaches an adhesive dressing which includes a release liner or backing bearing a logo, a decorative design, or instructions for use of the product (pg 6 lines 13-14). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Holm in view of Jensen by providing indicia 60 in the form of first and said second sets of guiding lines as taught by Holm on not just the support layer 20 but, also, on the release liner 90 or the backing 30, so that the release liner and/or backing includes instructions for use of the product, as taught by Cole, in order to assist with application and use of the dressing.
With respect to claim 5, Holm in view of Jensen and further in view of Cole discloses the invention substantially as claimed (see rejection of claim 4) and Holm also discloses that the surface area of said release liner (90) corresponds to the surface area of said adhesive skin contact layer (40) and said backing layer (30) (as shown in figure 3, the release liner 90 encompasses the entire surface area of layers 30 and 40 and thus has a surface area that corresponds to the surface area of each of these layers).
Holm does not, however, disclose that said outer layer comprising said first and said second sets of guiding lines is said release liner.
Cole, however, teaches an adhesive dressing which includes a release liner or backing bearing a logo, a decorative design, or instructions for use of the product (pg 6 lines 13-14). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Holm in view of Jensen by providing indicia 60 in the form of first and said second sets of guiding lines as taught by Holm on not just the support layer 20 but, also, on the release liner 90, so that the release liner includes instructions for use of the product, as taught by Cole, in order to assist with application and use of the dressing.
Claim(s) 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Holm et al (US 2016/0317358) in view of Jensen et al (EP 0768071 A1) and further in view of Levin (US 2002/0040202).
With respect to claims 7 and 11, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 1) and Holm further discloses that the guiding lines of said first and second sets of guiding lines (indicia 60) are printed guiding lines (printed lines – para [0057]) but does not disclose that the guiding lines are formed by a colored ink wherein said outer layer has a surface tension that is higher than the surface tension of said colored ink.
Levin, however, teaches an adhesive bandage that includes indicia or markings that may
be applied to the bandage in various ways such as by means of suitable inks, dyes, or pigments
which should optimally be relatively fast, water-insoluble and non-toxic (para [0012]) wherein the layer that the ink is applied to inherently must have a surface tension that is higher than the surface tension of said colored ink in order to provide optimal wetting and adhesion. Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date
of the invention, to have formed the printed guiding lines on the device of Holm in view of Jensen by a colored ink wherein said outer layer has a surface tension that is higher than the surface tension of said colored ink, as taught by Levin, in order to provide optimal wetting and adhesion of the graphic to the outer layer and, furthermore, to provide a graphic that is non-toxic for safety of the user but conveys information without potentially being washed off since it is water-insoluble.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Holm et al (US 2016/0317358) in view of Jensen et al (EP 0768071 A1) and further in view of Ostan et al (EP 3260099 A1).
With respect to claim 13, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 2) but does not disclose that said dressing comprises a pad arranged between said backing layer and said adhesive skin contact layer, wherein said pad comprises a pressure-relieving material.
Ostan teaches a dressing (1; fig 1-3) used for pressure ulcer prevention (abstract) comprising a backing layer (26; fig 3), an adhesive skin contact layer (adhesive body contact layer 20; fig 3) and a pad (3) arranged between said backing layer and said adhesive skin contact layer (para [0062]), wherein the pad comprises a material that provides for good pressure distribution (para [0033]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the dressing of Holm in view of Jensen to further include a pad arranged between said backing layer and said adhesive skin contact layer, wherein said pad comprises a pressure-relieving material, as taught by Ostan, in order to provide pressure ulcer prevention and treatment for a user.
Claim(s) 15-17, 20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Holm et al (US 2016/0317358) in view of Jensen et al (EP 0768071 A1) and further in view of Nordbo et al (US 20160206478).
With respect to claims 15-16, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 14) but does not disclose that said first set of guiding lines of said first portion comprises at least a first guiding line extending from a first point on said first longitudinal edge in a curved path to an opposing first point on said second longitudinal edge and a second guiding line extending from a second point on said first longitudinal edge to an opposing second point on said second longitudinal edge; said second guiding line being arranged at a distance from, and generally following the same curved path as said first guiding line.
Nordbo, however, teaches wound pads which include cut lines (14, 40 and 48 in fig 7b) which can be used to shape and size the wound pad and delineate sections that can be manually separated from one another (para [0018;0029]). Specifically, in figure 7b, the wound pad includes at least a first guiding line (cut line 40; fig 7b) extending from a first point on said first longitudinal edge in a curved path to an opposing first point on said second longitudinal edge (identified in annotated fig 7b) and a second guiding line (cut line 48 in fig 7b) extending from a second point on said first longitudinal edge to an opposing second point on said second longitudinal edge (identified in annotated fig 7b); said second guiding line (48) being arranged at a distance from, and generally following the same curved path as said first guiding line (40) (shown in annotated fig 7b). it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the first set of guiding lines on the device of Holm in view of Jensen to comprise at least a first guiding line extending from a first point on said first longitudinal edge in a curved path to an opposing first point on said second longitudinal edge and a second guiding line extending from a second point on said first longitudinal edge to an opposing second point on said second longitudinal edge; said second guiding line being arranged at a distance from, and generally following the same curved path as said first guiding line, as taught by Nordbo, in order to customize the size and shape of the wound pad to best meet the treatment needs of a given user (see Nordbo para [0005;0017]).
ANNOTATED FIG 7B of Nordbo:
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With respect to claim 17, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 14) but does not disclose that said first set of guiding lines of said first portion comprises a third guiding line extending from a first point on said first lateral edge in a curved path to a third point on said second longitudinal edge.
Nordbo, however, teaches wound pads which include cut lines (14, 40 and 48 in fig 7b) which can be used to shape and size the wound pad and delineate sections that can be manually separated from one another (para [0018;0029]). Specifically, in figure 7b, the wound pad includes a third guiding line (cut line 14 in fig 7b) extending from a first point on said first lateral edge (identified in annotated fig 7b) in a curved path (as shown in fig 7b) to a third point on said second longitudinal edge (identified in annotated fig 7b). it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the first set of guiding lines on the device of Holm in view of Jensen to comprise a third guiding line extending from a first point on said first lateral edge in a curved path to a third point on said second longitudinal edge, as taught by Nordbo, in order to customize the size and shape of the wound pad to best meet the treatment needs of a given user (see Nordbo para [0005;0017]).
With respect to claim 20, Holm in view of Jensen discloses the invention substantially as claimed (see rejection of claim 14) but does not disclose that said second set of guiding lines of said second portion comprises a third guiding line extending in a curved path from a first point on said folding line to a fourth point on said second longitudinal edge.
Nordbo, however, teaches wound pads which include cut lines (14, 40 and 48 in fig 7b) which can be used to shape and size the wound pad and delineate sections that can be manually separated from one another (para [0018;0029]). Specifically, in figure 7b, the wound pad includes a third guiding line(cut line 14 in fig 7b) extending in a curved path (as shown in fig 7b) from a first point on said folding line (identified in the 2nd annotated fig 7b) to a fourth point on said second longitudinal edge (identified in the 2nd annotated fig 7b). it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the second set of guiding lines on the device of Holm in view of Jensen to comprise a third guiding line extending in a curved path from a first point on said folding line to a fourth point on said second longitudinal edge, as taught by Nordbo, in order to customize the size and shape of the wound pad to best meet the treatment needs of a given user (see Nordbo para [0005;0017]).
2nd ANNOTATED FIG 7B of Nordbo:
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With respect to claim 24, Holm in view of Jensen discloses the medical dressing substantially as claimed (see rejection of claim 1) but does not disclose that the dressing is part of a kit that includes the dressing and at least one medical device.
Nordbo, however, teaches wound pads which include cut lines (14, 40 and 48 in fig 7b) which can be used to shape and size the wound pad and delineate sections that can be manually separated from one another (para [0018;0029]) and, additionally, teaches that the wound pad can be provided as part of a kit for negative pressure wound therapy, comprising the wound pad and at least one item selected from the group consisting of: a wound contact layer, a wound cover, and a wound interface device (para [0016]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have provided the dressing of Holm in view of Jensen as part of a kit with, additionally, at least one medical device, like the kit taught in Nordbo, in order to combine the necessary items for a procedure together in one convenient package for improved efficiency.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Holm et al (US 2016/0317358) in view of Jensen et al (EP 0768071 A1) and further in view of Gustin Bergstrom et al (EP 3373874 B1).
With respect to claim 22, Holm in view of Jensen discloses the medical dressing substantially as claimed (see rejection of claim 1) but does not disclose that said release liner is a first release liner, and wherein said dressing further comprises a second release liner arranged between said first release liner and said adhesive skin contact layer, wherein the surface area of said second release liner is smaller than the surface area of said first release liner.
Gustin Bergstrom, however, teaches a wound dressing in figure 1b which includes release liner 108 that comprises a first release liner (portion 110), and wherein said dressing further comprises a second release liner (portion 111) arranged between said first release liner and said adhesive skin contact layer (as shown in fig 1b, portion 111 of release liner 108 is provided between portion 110 of the liner and wound facing surface 106 of adhesive 105), wherein the surface area of said second release liner is smaller than the surface area of said first release liner (as shown in fig 1b). it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the release liner of Holm in view of Jensen so that said release liner is a first release liner, and wherein said dressing further comprises a second release liner arranged between said first release liner and said adhesive skin contact layer, wherein the surface area of said second release liner is smaller than the surface area of said first release liner, like the release liner 108 in Gustin Bergstrom, in order to provide a gripping region on a small part of the dressing to assist with handling the dressing while avoiding contact or contamination of the adhesive during application.
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of claim 19 could either not be found or was not suggested in the prior art of record. The subject matter not found was a medical dressing comprising an outer layer that includes a folding line that divides the outer layer into a first portion comprising a first set of guiding lines and a second portion comprising a second set of guiding lines, wherein said outer layer comprises first and second lateral edges extending in parallel to each other in the longitudinal (y) direction; wherein said second set of guiding lines of said second portion comprises at least a first guiding line extending from a first point on said second lateral edge, and a second guiding line extending from a second point on said second lateral edge; said first and said second guiding lines being connected at a connecting point in said second portion such that said first and said second guiding lines form the shape of a substantially curved triangle, in combination with the other elements in the claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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