DETAILED ACTION
In Applicant’s Response filed 11/11/25, Applicant has amended claims 1-2, 4, 7, 9, 10, 12, 15-17, 19, 22 and 23; and added new claim 24. Claims 6, 8, 11, 13 and 21 have been cancelled. Currently, claims 1-5, 7, 9-10, 12, 14-20 and 22-24 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 Objections
Claims 1 and 7 are objected to because of the following informalities which require appropriate correction:
In claim 1 line 16: “illustrating of a step” should be “illustrating
In claim 1 line 17: “or b) said medical dressing” should be “or
In claim 7 line 5: “wherein each illustration of a step of the of applying” should be “and wherein each illustration of a step of the process of applying”.
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) 1-5, 7, 9-10, 12, 15 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ostan et al (EP 3260099 A1) in view of Cole (EP 0262786 A2) and further in view of Falconio-West et al (US 2014/0107546 A1).
With respect to claim 1, Ostan discloses a medical dressing (1; fig 1-3) for application onto a body part, preferably the heel (para [0055]), wherein the dressing has a longitudinal (y) extension (extension in direction along line P in fig 2) and a lateral (x) extension (extension in width direction along lines W1-W3, Wi and Ws in fig 2) and is symmetric about a longitudinal (y) center line (dressing 1 is symmetrical about line P as shown in fig 2; see also para [0058]) and asymmetric about a lateral (x) center line (interpreted as being a line that extends in the width direction at the center of dressing 1, approximately at line Wi in fig 2); said medical dressing (1) 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 said dressing (1) comprises a release liner assembly (release liners 30a-30e in fig 4a-4b) being co-extensive with said adhesive skin contact layer (para [0066]), wherein said release liner assembly comprises a centrally disposed first release liner (30a in fig 4a) covering from 50 to 90% of the surface area of said adhesive skin contact layer (liner 30a is illustrated as covering slightly more than 50% of the dressing in fig 4a), and a plurality of edge release liners (30b-e in fig 2); wherein said first release liner (30a) is configured to be removed prior to said plurality of edge release liners during use (as shown in fig 4a).
Ostan does not, however, disclose that said first release liner comprises a plurality of graphical icons each illustrating of a step in the process of applying said medical dressing onto said body part, or said medical dressing being applied correctly onto said body part.
Cole teaches an adhesive dressing which includes a release liner 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 first release liner of Ostan so that it includes instructions for use of the product, like the release liner in Cole, in order to assist with application and use of the dressing.
Cole does not, however, explicitly teach that the instructions on the release liner comprise a plurality of graphical icons each illustrating of a step in the process of applying said medical dressing onto said body part or said medical dressing being applied correctly onto said body part.
Falconio-West, however, teaches a medical device configured to be applied to a user’s leg (as shown in fig 8) which includes graphical indicia disposed on the outer face of the device such as diagrams and pictures that illustrate said medical dressing being applied correctly onto said body part (element 136 in fig 1; as shown in fig 1, the picture 136 shows the position/location where the device is to be applied on the body and illustrates how it should look when correctly applied) that can be included to provide a quick reference for a health care services provider that visually depicts how to use the device (para [0043]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the first release liner of the device of Ostan in view of Cole so that the instructions on the release liner comprise a plurality of graphical icons each illustrating of a step in the process of applying said medical dressing onto said body part, or said medical dressing being applied correctly onto said body part, like the indicia taught in Falconio-West, in order to provide a quick reference for a health care services provider and thereby assist in promoting proper use of the device.
With respect to claim 2, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) and Ostan further discloses that said backing layer (26) and said adhesive skin contact layer (20) extend beyond the periphery of said pad (3) to form a border portion (5) around said pad (3) (as shown in fig 1 and para [0062]).
With respect to claim 3, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) and Ostan further discloses that said medical dressing (1) comprises a plurality of protruding portions (tabs 15; shown in figs 1-2), and wherein said edge release liners (liners 30d and 30e; fig 4a-4b) are arranged to cover at least parts of said protruding portions (as shown in figures 4a-4b).
With respect to claim 4, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) and Ostan further discloses that said first release liner (30a) overlaps with said pad (as shown in figure 4a). Thus, when modified by Cole and Falconio-West to include a plurality of graphical icon (as described in the rejection of claim 1), the icons are expected to be disposed in an area of said first release liner that also overlaps with said pad.
With respect to claim 5, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) and Ostan further discloses that said first release liner (30a) is symmetric about said longitudinal (y) center line (as shown in fig 4a) and has a longitudinal extension (length direction) corresponding to the longitudinal extension of said adhesive skin contact layer in the area where the first release liner is arranged (both are interpreted as extending along line P in fig 1), and a maximum lateral (x) extension (maximum extension in the width direction) corresponding to from 50-90 % of the maximum lateral (x) extension of said adhesive skin contact layer (liner 30a is illustrated as covering slightly more than 50% of the width of the dressing in fig 4a).
With respect to claim 7, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) and Ostan further discloses that the dressing 1 is specifically configured for application to a user’s heel (see figs 4b-4g). Falconio-West further teaches that each illustration of a step of the process of applying said dressing is selected from: a correct removal and/or order of removal of said release liner assembly, a correct positioning of said medical dressing onto the heel, a correct application of said dressing onto the heel, and a medical dressing applied correctly onto the heel (diagrams and pictures 136 visually depict usage of the device – para [0043]; as shown in fig 1, the picture 136 shows the position/location where the device is to be applied on the body and illustrates how it should look when correctly applied). 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 graphical icons on the device of Ostan in view of Cole and further in view of Falconio-West so that each illustration of a step of the process of applying said dressing is selected from: a correct removal and/or order of removal of said release liner assembly, a correct positioning of said medical dressing onto the heel, a correct application of said dressing onto the heel, and a medical dressing applied correctly onto the heel, as taught by Falconio-West, in order to provide a quick reference for a health care services provider and thereby assist in promoting proper use of the device. Furthermore, when the teachings of Falconio-West are used to provide graphical icons on the first release liner of Ostan in view of Cole (as described in the rejection of claim 1) the resulting product is expected to comprise graphical icons that provide a pictorial representation of a step associated with the correct application of the dressing (of Ostan in view of Cole and further in view of Falconio-West) onto the heel (since the device of Ostan is specifically configured for use on the heel) wherein said step associated with the correct application of said medical dressing includes illustration of a correct positioning of said dressing onto the heel and illustration of a dressing applied correctly onto the heel.
With respect to claim 9, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 7) and Ostan further discloses that the dressing 1 is specifically configured for application to a user’s heel (see figs 4b-4g). Falconio-West further teaches that at least one graphical icon of said plurality of graphical icons comprises a pictorial representation indicating the correct positioning of said device on the body (diagrams and pictures 136 visually depict usage of the device – para [0043]; as shown in fig 1, the picture 136 shows the position/location where the device is to be applied on the body and illustrates how it should look when correctly applied) and wherein said pictorial representation comprises a guiding line indicating the correct positioning of the device onto the body (range indicator 117 is a guiding line that indicates correct positioning on the body – see para [0034]). 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 graphical icons on the device of Ostan in view of Cole and further in view of Falconio-West to provide at least one graphical icon of said plurality of graphical icons that comprises a pictorial representation indicating the correct positioning of said device onto the body, and wherein said pictorial representation comprises a guiding line indicating the correct positioning of the device onto the body, as taught by Falconio-West, in order to provide a quick reference for a health care services provider and thereby assist in promoting proper use of the device. Furthermore, when the teachings of Falconio-West are used to provide graphical icons on the first release liner of Ostan in view of Cole (as described in the rejection of claim 1) the resulting product is expected to comprise at least one graphical icon within said first set of graphical icons that comprises a pictorial representation indicating the correct positioning of said dressing (of Ostan in view of Cole and further in view of Falconio-West) onto the heel (since the device of Ostan is specifically configured for use on the heel), and wherein said pictorial representation comprises a guiding line indicating the correct positioning of the dressing onto the heel.
With respect to claim 10, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 7) and Falconio-West further teaches that said plurality of graphical icons comprises at least four graphical icons (shown in fig 1; i.e. indicia at 117-120 and 132-136), and wherein the graphical icons of said plurality of graphical icons are arranged in at least a first row (first row includes indicia 117-120 in fig 1) and a second row (second row includes indicia 132-136 in fig 1). 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 graphical icons on said first release liner of the device of Ostan in view of Cole and further in view of Falconio-West so that there are at least four graphical icons arranged in at least a first row and a second row, as taught by Falconio-West, in order to provide a quick reference for a health care services provider and thereby assist in promoting proper use of the device.
With respect to claim 12, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) and Falconio-West further teaches at least a printed texted word and/or graphical branding (indicia 132 and 135 in figure 1), wherein the orientation of said printed texted word and/or graphical branding indicates the orientation by which the device should be positioned onto said body part, (it is inherent that the direction of the text of the logos at indicia 132 and 135 in fig 1 indicates which side of the device is the top, which is the bottom, and how the device is to be oriented on the body so that the text is readable during use). 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 device of Ostan in view of Cole and further in view of Falconio-West such that said first release liner and/or said edge release liners further comprise(s) at least a printed texted word and/or graphical branding, wherein the orientation of said printed texted word and/or graphical branding indicates the orientation by which the device should be positioned onto said body part, as taught by Falconio-West, in order to provide a quick reference for a health care services provider and thereby assist in promoting proper use of the device.
With respect to claim 15, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 7) but does not disclose that said plurality of graphical icons are disposed on said first release liner such that at least 50% of the graphical icons of said first set of graphical icons overlap with said pad. It would have been obvious, however, to one having ordinary skill in the art, before the effective filing date of the invention, to have repositioned the graphical icons on the device of Ostan in view of Cole and further in view of Falconio-West so that the graphical icons on said first release liner of overlap with said pad since rearranging parts of an invention involves only routine skill in the art. Furthermore, it also would have been obvious to configure the device such that, specifically, at least 50% of the graphical icons on said first release liner overlap with said pad since discovering an optimum value of a result effective variable involves only routine skill in the art.
With respect to claim 24, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) and Ostan also discloses that the medical dressing (1; fig 1-3) is configured for application onto heel (para [0055]).
Claim(s) 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ostan et al (EP 3260099 A1) in view of Cole (EP 0262786 A2) and Falconio-West et al (US 2014/0107546 A1) and further in view of Atkinson et al (US 2015/0157509).
With respect to claim 14, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) but does not disclose that at least said first release liner of said release liner assembly is transparent or white.
Atkinson, however, teaches an adhesive device for attachment to a user’s skin which includes a release liner that is transparent (para [0010]). 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 release liner of the release liner assembly of Ostan in view of Cole and further in view of Falconio-West from a transparent material, like the release liner taught in Atkinson, in order to permit viewing through the liner to assist with placement of the dressing during application.
With respect to claim 16, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) but does not disclose that at least said first release liner of said release liner assembly comprises a polymeric film selected from a polyethylene film, a polypropylene film and a polyurethane film.
Atkinson, however, teaches an adhesive device for attachment to a user’s skin which includes a release liner that is made from polypropylene or polyethylene (para [0010]). 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 release liner of the release liner assembly of Ostan in view of Cole and further in view of Falconio-West from a material such as polypropylene or polyethylene, like the release liner taught in Atkinson, since 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.
Claim(s) 17, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ostan et al (EP 3260099 A1) in view of Cole (EP 0262786 A2) and Falconio-West et al (US 2014/0107546 A1) and further in view of Levin (US 2002/0040202).
With respect to claim 17, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 1) but does not disclose that said plurality of graphical icons are printed graphical icons formed by a 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]). 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 graphical icons on the release liner of Ostan in view of Cole and further in view of Falconio-West as printed graphical icons formed by a colored ink, like the indicia/markings on the bandage of Levin, in order 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.
With respect to claim 18, Ostan in view of Cole and Falconio-West and further in view of Levin discloses the dressing substantially as claimed (see rejection of claim 17) and also discloses that at least said first release liner of said release liner assembly has a surface tension that is higher than the surface tension of said colored ink (it is inherent that the ink must have a surface energy that is lower than the surface energy of the substrate that it is printed on in order to provide optimal wetting and adhesion).
With respect to claim 20, Ostan in view of Cole and Falconio-West and further in view of Levin discloses the dressing substantially as claimed (see rejection of claim 17) and also discloses that said colored ink reflects light (it is inherent that ink reflects light in order to provide a visible color to the viewer). Levin does not explicitly disclose that the ink reflects light in the range of from 430 to 500 nm, however, the visible light spectrum ranges from approximately 400nm (violet) to 700nm (red) with ink reflecting light between 430-500nm being expected to appear at a color ranging from violet to green. Thus, it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the invention, to have used an ink that reflects light in the range of 430-500nm for printing the graphical icon on the dressing of Ostan in view of Cole and Falconio-West and further in view of Levin in order for the icon to be visible to a user in a desired color ranging from violet to green.
Claim(s) 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ostan et al (EP 3260099 A1) in view of Cole (EP 0262786 A2) and Falconio-West et al (US 2014/0107546 A1) and further in view of Jansen et al (US 10335245).
With respect to claim 22, Ostan in view of Cole and further in view of Falconio-West discloses the dressing substantially as claimed (see rejection of claim 7) but does not disclose a sterile package that comprises a second set of graphical icons, wherein each graphical icon within said second set of graphical icons comprises a pictorial representation of a step associated with the correct application of said medical dressing, and wherein at least one graphical icon within said plurality of graphical icons of said first release liner corresponds to at least one graphical icon within said second set of graphical icons.
Jansen, however, teaches packaging for medical devices such as packaging 220 in figure 5 which includes markings thereon which identify the article that is contained within the packaging and illustrate steps for applying the article (col 12 line 55-col 13 line 7). Figure 5 shows that, specifically, at least one graphical icon indicates the correct application of the device (icon 6 shows the device correctly applied to the limb). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have stored the dressing of Ostan in view of Cole and further in view of Falconio-West in a sterile package that comprises a second set of graphical icons, wherein each graphical icon within said second set of graphical icons comprises a pictorial representation of a step associated with the correct application of said medical dressing, as taught by Jansen, and wherein at least one graphical icon within said plurality of graphical icons of said first release liner corresponds to at least one graphical icon within said second set of graphical icons (since both Falconio-West and Jansen illustrate correct application), so that there is no need for bags or instructions to accompany the packaging, and therefore there is a reduction in waste over known packaging (Jansen col 13 lines 1-4).
With respect to claim 23, Ostan in view of Cole and Falconio-West and further in view of Jansen discloses the package substantially as claimed (see rejection of claim 22) and Jansen further teaches a multi-pack comprising a plurality of the sterile packages (figures 7 and 8), wherein said multi-pack comprises a third set of graphical icons, wherein each graphical icon within said third set of graphical icons comprises a pictorial representation of a step associated with the correct application of said device wherein at least one of the graphical icons within said third set of graphical icons corresponds to at least one of the graphical icons within said plurality and said second sets of graphical icons (it is inherent that multiples of the same package will all include the same items and the same graphical icons on the packages). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have provided a plurality of the packaged dressings of Ostan in view of Cole and Falconio-West and further in view of Jansen as a multi-pack that comprises a third set of graphical icons, wherein each graphical icon within said third set of graphical icons comprises a pictorial representation of a step associated with the correct application of said device wherein at least one of the graphical icons within said third set of graphical icons corresponds to at least one of the graphical icons within said plurality and said second sets of graphical icons, as taught by Jansen, since mere duplication of the essential working parts of a device involves only routine skill in the art.
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.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 11/11/25 have been fully considered as follows:
Regarding the claim rejections under 35 USC 112, Applicant’s amendments and the arguments on pages 6-7 of the Response have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 7-9 of the Response have been fully considered but are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
Citation of Pertinent Prior Art
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure. BR 102016004991 A2, WO 2017127369; EP 3574875 A1 each teach dressings which include release liners that have instructions printed thereon.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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