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 .
Detailed Action
Previous Rejections
Applicants' arguments, filed 12/22/25, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18, 23-26 and 28-38 are rejected under 35 U.S.C. 103 as being unpatentable over Gilman (USP 5,018,515A) in view of Dillon et al. (US PG Pub. 2020/0323694A1)
Gilman discloses a transparent absorbent dressing comprising: a backing sheet 12 of an elastomer highly permeable to water vapor, the dressing 10 has a front sheet 14 of an elastomer film permeable to water vapor, the front sheet 14 (equivalent to a substrate) has a pressure-sensitive adhesive coating 16 on a front surface (equivalent to the first layer which is applied on one side of the substrate) thereof, such as an acrylic pressure-sensitive adhesive (equivalent to the first layer comprising a medically acceptable adhesive as claimed), the front surface of the adhesive coating 16 is releasably covered by a release sheet 18 which may be removed at the time of the use of the dressing 10 for application of the adhesive coating 16 over and around the wound of a patient; the front sheet 14 and adhesive coating 16 have a plurality of apertures 22 (equivalent to perforation holes as claimed) disposed throughout the width and length of the dressing extending through the adhesive coating 16 and front sheet 14 (equivalent to a perforated adhesive laminate); A 170 g/yd² needle punched fabric, 50% rayon, 50% polyester was used for the layer 20, with suitable openings being formed in the layer. An adhesive coated elastomer film highly permeable to water vapor was used for the front sheet 14. Apertures were punched in the adhesive coated front sheet 14 with a 1/8 inch circular punch, with the apertures being on a one inch square grid pattern (the diameter of the apertures punched by a 1/8 inch circular punch is 1/8 inch, and the corresponding apertures area is 7.92 mm² as claimed, (equivalent to method for the preparation of the perforated adhesive laminate).
Gilman further teaches that the front surface of the adhesive coating 16 is releasably covered by a release sheet 18 which may be removed at the time of the use of the dressing 10 for application of the adhesive coating 16 over and around the wound of a patient (equivalent to the first layer being the wound contact layer as claimed and a liner). Regarding claim 18, it may be selected and implemented by those skilled in the art according to actual needs to set the openings of the perforated holes to have an area between 1.75 mm² and 12.5 mm². Gilman discloses in Fig. 4 discloses that the perforation holes are arranged at equidistance from each other to form a square aligned to machine direction and cross direction.
Gilman does not teach wherein the perforation holes are provided, such that the strength of the first layer's average peel force in machine-direction and the strength of the first layer's average peel force in cross-direction differ no more than 5% and/or the amplitude between the maximum and minimum peaks of the peel force curve are no more than 25% of the average peel force.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have achieved the claimed peel force because based on the Gilman disclosing arranging patterned perforation holes on the adhesive laminate, the perforation holes designed so that the strength of the first layer's average peel force in machine-direction and the strength of the first layer's average peel force in cross-direction differ no more than 5% and/or the amplitude between the maximum and minimum peaks of the peel force curve are no more than 25% of the average peel force can be conceived of by those skilled in the art through limited experimentation according to actual needs.
Gilman also does not teach wherein the laminate (1) further comprising (c) optionally a second layer comprising a medically acceptable adhesive, and the optional second layer is applied on the opposite side of the substrate;
Dillon et al. teaches a wound dressing comprising a membrane with silicone gel adhesive coating [0029]. The membrane has a perforation patterns that can be squares aligned with or at 45° from the machine direction or as equilateral triangles (figs:2A-2D; [0030)).
Dillon et al. discloses a layered apertured wound dressing, and specifically discloses (see pages 3-6 of the description and Figs. 1-6): the dressing 60 comprises a semi-occlusive polymeric membrane layer 10 that is coated with a tacky silicone gel 20 on one side, and that on its other side is bonded to the silicone coated surface 40 of an apertured mesh layer 50. Fenestrations 70 are cut through the IPN/gel film but not through the apertured mesh, many variations of the fenestration or perforation patterns are possible. The drawings show perforation patterns with different arrangements. The above technical features provide technical hints for setting the perforation pattern of the adhesive laminate of the wound dressing to have different forms. On this basis, those skilled in the art are motivated to combine Dillon with the teachings of Gilman to design the perforation pattern therein differently.
As for designing that the perforation holes are arranged at equidistance from each other to form a square with a 45°angle from machine direction and cross direction, or that the perforation holes are arranged at equidistance from each other to form an equilateral triangle, wherein the aligned holes constitute an angle of between 10° and 20° from machine direction and cross direction, it may be selected and implemented by those skilled in the art according to actual needs.
It would have been also obvious to have selected and implemented by those skilled in the art according to actual needs that the sum of the areas of the openings of the perforated holes is between 10% and 50% of the total surface of the laminate.
Gilman discloses a pressure-sensitive adhesive coating 16, such as an acrylic pressure-sensitive adhesive; the dressing 10 has a front sheet 14 of an elastomer film permeable to water vapor. The silicone-based adhesive is a common wound adhesives in this field as taught by Dillon et al. as discussed above.
Gilman does not teach step (ii) die cutting the laminate provided by step (i), wherein die cutting is preferably performed such that the perforation holes are arranged at equidistance from each other to form an equilateral triangle, wherein the aligned holes constitute an angle of between 10° and 20° from machine direction and cross direction.
However, regarding the above distinguishing technical features based on the punching method disclosed in Gilman, die cutting is a common technique in this field. In addition, based on the different pattern arrangements of the perforation holes disclosed in Dillon et al., it may be selected and implemented by those skilled in the art according to actual needs that the perforation holes are arranged at equidistance from each other to form an equilateral triangle, and the aligned holes constitute an angle of between 10° and 20° from machine direction and cross direction.
Claims 18, 23-26 and 28-38 are rejected under 35 U.S.C. 103 as being unpatentable over Flach et al. (US PG Pub. 2017/0258957A1) in view of Lykke et al. (US PG Pub. 2008/0319368 A1), Carr et al. (US PG Pub. 2019/0134255A1) and Dillon et al. (US PG Pub. 2020/0323694 A1).
Flach et al. discloses medical dressing, see title. Flach et al. teaches a medical dressing comprising a medical dressing (30), comprising an adhesive layer (3) having a skin-facing surface (6) to adhere the medical dressing to a dermal surface, wherein said adhesive layer comprises a first chemical compound incorporated within said adhesive layer, and wherein at least a portion of said skin-facing surface comprises a coating (9) comprising a second chemical compound. Also disclosed is a method of manufacturing such a medical dressing, see abstract.
In an embodiment, the medical dressing may further comprise a substrate having a first surface facing the adhesive layer, wherein the skin-facing surface of the adhesive layer faces away from said first surface of said substrate, see [0020].
Flach et al. teaches that the medical dressing may further comprise a perforated film layer sandwiched between the first surface of the substrate and the adhesive layer, wherein the adhesive layer may be a coating on a non-perforated portion of the perforated film layer. For example, a top surface of a perforated film layer may be attached to first surface of the substrate, wherein the adhesive layer may be coated on a bottom surface of a portion of the perforated film, and wherein the top surface of the perforated film layer is opposite to, or faces away from, the bottom surface thereof. The perforated film layer may, for example, be a perforated polymeric film layer such as a perforated polyurethane film layer having a thickness of for example 10 to 150 μm, see [0022].
Flach et al. do not teach the peel force, the area of the perforation and the acrylate based layer.
Lykke et al. teaches skin plate adhesive product and method for its manufacture, see title. Lykke et al. teaches a skin plate product, which can be better tailored with respect to controlling the properties of the first and second surfaces. The invention provides this by inter alia laser cut holes in a first material and subsequently filling these holes with a second material. Being able to design the exact location, orientation, distribution and/or size of the second material opens the path for adhesive products where e.g. adhesion, absorption, and permeability are controlled and balanced, see [0006]. The reference teaches that when the holes have a conical or a pyramidal shape the materials in the holes can have a bigger effect on one side of the skin plate product compared to the other side of the product as the holes cover a different sized area on the surfaces. This could for example be used to control the peeling force of the skin plate products from the skin, and also to provide different peeling force in different directions for reducing the risk of unintended removal of the product during use and facilitating intended removal of the product, see [0025]. The skin-friendly adhesive may be of any kind, e.g. an acrylic adhesive, polyacrylate and silicone or mixtures thereof, see [0032] and [0035].
Carr et al. teaches an adhesive tape for use in wound dressings comprising a gel adhesive [0012]. The dressing is in the form of a tape (fig:1A,1B,1C). The peel strength of the tape is found to be dependent on the density of the perforation pattern [0013].
Dillon et al. teaches a wound dressing comprising a membrane with silicone gel adhesive coating [0029]. The membrane has a perforation patterns that can be squares aligned with or at 45° from the machine direction or as equilateral triangles (figs:2A-2D; [0030)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the acrylic adhesive, polyacrylate adhesive or silicone mixtures of adhesive layer into the medical dressing of Fach et al. as taught by Lykke et al. One of ordinary skill would have been motivated to do so because generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. It would have been further obvious to one of ordinary skill to have manipulated the perforation holes area and average peel force of the wound dressing because Lykke teaches that when the holes have a conical or a pyramidal shape the materials in the holes can have a bigger effect on one side of the skin plate product compared to the other side of the product as the holes cover a different sized area on the surfaces and this could for example be used to control the peeling force of the skin plate products from the skin, and also to provide different peeling force in different directions for reducing the risk of unintended removal of the product during use and facilitating intended removal of the product, see [0025] and Carr et al. teaches that the peel strength of the tape is found to be dependent on the density of the perforation pattern [0013] and Dillon teaches perforation patterns. Thus, manipulation of the pore area and peel strength would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Applicant’s arguments are moot in view of the new grounds of rejections made above.
Action is final
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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