DETAILED ACTION
In the Response filed 5/28/26, claims 17-18 remain cancelled and claims 1-16 and 19-22 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 .
Election/Restrictions
Applicant’s election without traverse of species A, directed to claims 1-9, 15, 19-20 and 22, in the reply filed on 5/28/26 is acknowledged.
Claims 10-14, 16 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/28/26.
Specification
The abstract of the disclosure is objected to because in lines 3-4, the phrase “the described a medical dressing” should be revised to recite “the described medical dressing”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 9-10 and 19-20 are objected to because of the following informalities which require appropriate correction:
In claim 9 line 1: “claim,” should be amended to recite “claim 1,”.
Claim 10 is objected to because the claim has been provided with an incorrect status identifier because the claim recites that it is “previously presented” but it has been withdrawn. Thus, the status identifier should have been “withdrawn”. It has been assumed for purposes of examination that Applicant intended for claim 10 to be treated as being “withdrawn” (based on the arguments provided in the Response filed 5/28/26). However, correction of the status identifier in future communications is necessary in order to clarify of the status of the claims.
In claim 19 line 2: “the surface tension” should be “a surface tension”.
In claim 20 line 2: “has lateral (x)” should be “has a lateral (x)”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gustin Bergstrom (EP 3373874 B1).
With respect to claim 1, Gustin Bergstrom discloses a medical dressing (wound dressing in fig 1b) comprising a backing layer (backing layer 101), an adhesive skin contact layer (adhesive layer 105 having a wound facing surface 106; para [0074-0077]) and a first release liner detachably attached to said adhesive skin contact layer (first removable portion 110 of release liner 108; para [0081-0085]); said dressing further comprising a second release liner (second removable portion 111; para [0110]) arranged between said adhesive skin contact layer and said first release liner (shown in fig 1b), 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, portion 111 extends from the edge of the dressing only to the dividing line 109 where it is folded to form tab 114 that extends partly along tab 113, but portion 110 is much larger and extends from dividing line 109 all the way along the dressing to the opposite end) characterized in that said first release liner (110) is co-extensive with said backing layer (101) and said adhesive skin contact layer (105) (as shown in fig 1b; see also para [0110]) and in that said first release liner (110) comprises at least one marking (score line 116b; fig 1b; para [0110-0111]).
With respect to claim 2, Gustin Bergstrom discloses the dressing as claimed (see rejection of claim 1) and also discloses that said at least one marking (score line 116b) indicates how to cut, fold, use or apply said dressing (score line 116b indicates how to use and apply the dressing because when a user is peeling away part of portion 110 and the peeling reaches the score line 116b, the user will perceive a change in retention force, which serves as an indication that the peeling may temporarily be stopped and the user may, thereafter, apply the dressing very precisely at the end of the incision site – para [0111]).
With respect to claim 9, Gustin Bergstrom discloses the dressing as claimed (see rejection of claim 1) and Gustin Bergstrom also discloses that said dressing comprises a pad (wound pad 102; fig 1b) arranged between said backing layer and said adhesive skin contact layer (para [0062]).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gustin Bergstrom (EP 3373874 B1) in view of Jensen (EP 0750892 A2).
With respect to claim 3, Gustin Bergstrom discloses the dressing as claimed (see rejection of claim 1) and Gustin Bergstrom also discloses that said first release liner (110) is defined by a central portion (area of portion 110 that covers pad 102 at the center of the dressing in fig 1b) and an edge portion surrounding said central portion (peripheral portion of portion 110 which covers the part of backing layer 101 which forms a frame around pad 102 in fig 1b), wherein said at least one marking is arranged in at least said edge portion of said first release liner (as shown in fig 1b, the score line 116b extends across not only the center, but also across the parts of portion 110 at the peripheral edges in the area that covers the part of backing layer 101 outside of edges 103 of pad 102 defining part of the frame around pad 102 in fig 1b). Gustin Bergstrom does not, however, explicitly disclose that said central portion constitutes from 70 to 95 % of the surface area of said first release liner.
Jensen, however, teaches a wound dressing in fig 5 comprising a first release liner (section 11a’ of release sheet 11’) and a second release liner (section 11b’ of release sheet 11’) wherein the surface area of said second release liner is smaller than the surface area of said first release liner (as shown in fig 1) and wherein the first release liner (11a’) has a central portion (center of portion 11a’ in fig 1) that constitutes from 70 to 95 % of the surface area of said first release liner (the larger section 11a' has a surface area at least 70%, preferably 80% or more, of the total area of release sheet 11' – col 7 lines 37-47). 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 release liner of Gustin Bergstrom to have a central portion that constitutes from 70 to 95 % of the surface area of said first release liner, as taught by Jensen, in order to first expose a large area for application to a wound site while providing a smaller area that remains covered as a gripping surface for handling the dressing and permitting application of the exposed area without contacting or contaminating the skin contacting surface (Jensen col 7 lines 37-47).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gustin Bergstrom (EP 3373874 B1) in view of Holm et al (US 2016/0317358).
With respect to claim 4, Gustin Bergstrom discloses the dressing as claimed (see rejection of claim 1) but does not disclose that said at least one marking is formed by a print pattern, a weld pattern, a compressed pattern, an embossed pattern, a material deposition pattern, or combinations thereof.
Holm, however, teaches a medical dressing (conformable wound dressing – para [0005]; wound dressing system 1000 which comprises dressing 10 in figs 1-3) wherein said dressing comprises an outer layer (support layer 20 defining an outer surface as shown in fig 3); that comprises at least one marking (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 (visible indicia 60 function as guides for cleaving the wound dressing 10 into a plurality of cropped wound dressings – para [0057]) wherein the at least one marking (indicia 60) is formed by an embossed pattern (embossed area – para [0058]). 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 at least one marking on the dressing of Gustin Bergstrom by an embossed pattern as taught by Holm to provide an area of weakness that is configured to cause the layer to be more susceptible to bending or folding along a line defined by the marking to facilitate conforming the dressing to a contoured surface on the body (Holm para [0058]).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gustin Bergstrom (EP 3373874 B1) in view of Joelsson (EP 3574875 A1).
With respect to claim 5, Gustin Bergstrom discloses the dressing as claimed (see rejection of claim 1) but does not disclose that said first release liner and said second release liner are formed from different materials.
Joelsson, however, teaches a wound dressing comprising a release liner that is divided into two or more separate portions wherein the two or more separate portions may be of the same material or may be of different materials (para [0030]). 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 and second release liners of Gustin Bergstrom to be formed from different materials as taught by Joelsson in order to provide different properties and/or material characteristics in different areas of the dressing and, furthermore, because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
With respect to claim 6, Gustin Bergstrom discloses the dressing as claimed (see rejection of claim 1) and Gustin Bergstrom also discloses that the first and second release liners (portions 110 and 111 of release liner 108) comprise a polymeric film (para [0084]). Gustin Bergstrom does not, however, specifically disclose that said first release liner comprises a first polymeric film, and wherein said second release liner comprises a second polymeric film, wherein said first polymeric film is different from said second polymeric film.
Joelsson, however, teaches a wound dressing comprising a release liner that is divided into two or more separate portions wherein the two or more separate portions may be of the same material or may be of different materials (para [0030]) and, more specifically, comprise polyurethane, polyethylene or polypropylene, or any combination thereof (para [0044]). 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 and second release liners of Gustin Bergstrom so that said first release liner comprises a first polymeric film, and said second release liner comprises a second polymeric film, wherein said first polymeric film is different from said second polymeric film, as taught by Joelsson, in order to provide different properties and/or material characteristics in different areas of the dressing and, furthermore, because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
With respect to claim 7, Gustin Bergstrom in view of Joelsson discloses the dressing substantially as claimed (see rejection of claim 6) and Gustin Bergstrom also discloses that said first and said second polymeric film is selected from a polyethylene film or a polypropylene film (para [0084]).
With respect to claim 8, Gustin Bergstrom in view of Joelsson discloses the dressing substantially as claimed (see rejection of claim 6). Gustin Bergstrom also discloses that said first and said second polymeric film is selected from a polyethylene film or a polypropylene film (para [0084]) and Joelsson teaches that the two or more separate release liner portions may be of the same material or may be of different materials (para [0030]) and, more specifically, comprise polyurethane, polyethylene or polypropylene, or any combination thereof (para [0044]). Neither reference, however, specifically teaches the exact combination where said first polymeric film is a polyethylene film and said second polymeric film is a polypropylene film. It would have been obvious, however, to one having ordinary skill in the art, before the effective filing date of the invention, to try this specific combination of materials because choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, is within the level of ordinary skill in the art.
Claims 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gustin Bergstrom (EP 3373874 B1) in view of Levin (US 2002/0040202).
With respect to claims 15 and 19, Gustin Bergstrom discloses the dressing as claimed (see rejection of claim 1) but does not disclose that the at least one marking is a printed marking formed by a colored ink wherein said first release liner 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]; application of ink is interpreted as involving “printing” the indicia/markings with the ink) 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 at least one marking on the device of Gustin Bergstrom by printing the marking with a colored ink wherein said first release liner (which includes the marking) 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 liner 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 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gustin Bergstrom (EP 3373874 B1).
With respect to claim 20, Gustin Bergstrom discloses the dressing as claimed (see rejection of claim 1) and Gustin Bergstrom also discloses that said first release liner (110) has lateral (x) extension (“x” direction identified in fig 1b) defining the width of the first release liner (as shown in fig 1b), and a longitudinal (y) extension (“y” direction identified in fig 1b) defining the length of the first release liner (as shown in fig 1b), wherein the width of said second release liner (measurement of portion 111 across “x” dimension in fig 1b) corresponds to the width of said first release liner (as shown in fig 1b, portions 110 and 111 have the same size/measurement along the “x” dimension). Gustin Bergstrom also discloses that the length of said second release liner (measurement of portion 111 along “y” dimension in fig 1b) is less than 60% of the length of said first release liner (as shown in fig 1b, the length of portion 111 along the “y” dimension is less than 50% of the length of portion 110). However, Gustin Bergstrom does not explicitly disclose that the length of said second release liner corresponds to, specifically, from 20 to 60 % of the length of said first release liner. It would have been obvious, however, to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the length of portion 111 of the release liner of Gustin Bergstrom to correspond to 20-60% of the length of portion 110 of the release liner in order to provide a sufficiently sized gripping area for holding the dressing without contacting the adhesive during application and, furthermore, because such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art and where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gustin Bergstrom (EP 3373874 B1) in view of Nordbo et al (US 20160206478).
With respect to claim 22, Gustin Bergstrom discloses the dressing 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 Gustin Bergstrom 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.
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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