DETAILED ACTION
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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract comprises legal phraseology such as “comprises”, and “configured to” often used in patent claims. 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-15, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Locke et al. (US 2018/0353337 A1) (hereinafter Locke).
In regards to claim 1, Locke discloses a dressing (104; see [0025]; see figure 2) configured to be positioned adjacent to a tissue site (see [0034]), comprising:
a first film layer (215; see [0043]; see figure 2) comprising a treatment region (230; see [0058]; see figure 7) and a sealing region (225; see [0058]; see figure 7) around the treatment region (see figure 7), a first plurality of perforations (235 of 230; see [0058]; see figure 7) formed through the treatment region (see figure 7), a second plurality of perforations (235 of 225; see [0058]; see figure 7) formed through the sealing region that are larger than the first plurality of perforations (see [0061]), and a sealing adhesive covering the sealing region on a first side of the first film layer (patient facing side of 215) configured to face the tissue site (215 may be coated with a soft silicone (see [0056]); 215 must be tacky to hold 104 in position (see [0080]; thus, the silicone coating is a sealing adhesive positioned on the patient facing side as claimed);
a manifold (205; see [0043]; see figure 2) disposed adjacent a second side of the first film layer (205 is disposed on the non-patient facing side of 215; see figure 2), the second side opposite the first side; and
a cover layer (116; see [0025]; see figure 2) comprising a second film layer (116 is a second film layer; see [0035]) and a cover adhesive (255; see [0064]; see figure 2), the cover layer disposed over the manifold and coupled to the second side of the first film layer around the manifold (see figure 2), the cover adhesive disposed adjacent to the second plurality of perforations (255 is disposed adjacent 235 of 225 and is exposed therethrough; see [0075]).
In regards to claim 4, Locke discloses the invention as discussed above.
Locke further discloses wherein the manifold comprises an open-cell foam (see [0046]) having a thickness of between about 5 millimeters and about 10 millimeters (see [0047]).
In regards to claim 5, Locke discloses the invention as discussed above.
Locke further discloses wherein the second film layer (116) comprises a polyurethane film (see [0036]) having a thickness of between about 20 microns and about 35 microns (the cover 116 may comprise… a thickness of about 30 microns; see [0036]).
In regards to claim 6, Locke discloses the invention as discussed above.
Locke further discloses wherein the cover adhesive (255) comprises an acrylic adhesive having a coating weight of between about 25 grams per square meter and about 65 grams per square meter (see [0037]).
In regards to claim 7, Locke discloses the invention as discussed above.
Locke further discloses wherein the cover adhesive (255) is configured to extend through the second plurality of perforations from the second side of the first film layer to the first side of the first film layer (see [0082]).
In regards to claim 8, Locke discloses the invention as discussed above.
Locke further discloses wherein the treatment region (230) is configured to contact the tissue site and the sealing region (225) is configured to contact epidermis around the tissue site (see [0080]).
In regards to claim 9, Locke discloses the invention as discussed above.
Locke further discloses wherein the treatment region (230) is free of adhesive such that the first side of the first film layer in the treatment region is configured to be positioned in direct contact with the tissue site (230 is positioned to cover a tissue site (see [0080]); 255 extends through 235 about 225 of 215 (See [0081]) thus, 230 is free from adhesive to allow for the removal or repositioning of 104 without trauma to the tissue site (See [0080])).
In regards to claim 10, Locke discloses the invention as discussed above.
Locke further discloses wherein the first plurality of perforations (235 of 230) comprises slits (235 may be slits; see [0059]) arranged in a pattern (see figure 7).
In regards to claim 11, Locke discloses the invention as discussed above.
Locke further discloses wherein the second plurality of perforations (235 of 225) comprises circular openings arranged in a pattern (see figure 7).
In regards to claim 12, Locke discloses the invention as discussed above.
Locke further discloses wherein each of the first plurality of perforations comprises a first open area and each of the second plurality of perforations comprises a second open area (see figure 7 that both sets of 235 have open areas) that is larger than the first open area (the size and thus, the open area of 235 in 230 is smaller than the size/open area of 235 in 225; see [0061]).
In regards to claim 13, Locke discloses the invention as discussed above.
Locke further discloses wherein the first plurality of perforations comprise a different shape than the second plurality of perforations (235 may have a combination of shapes (see [0059]) thereby disclosing 235 of 230 and 225 respectively may comprise different shapes).
In regards to claim 14, Locke discloses the invention as discussed above.
Locke further discloses wherein the second plurality of perforations are larger than the first plurality of perforations in at least one dimension (see [0061]).
In regards to claim 15, Locke discloses the invention as discussed above.
Locke further discloses wherein the first plurality of perforations are configured to increase in size when the tissue site is exposed to a pressure (235 of 230 may be slits (see [0059]); slits when subject to negative pressure expand (see [0053] in reference to the slits 220 expanding); thus, 235 of 230 when formed as slits expand when exposed to the negative pressure), wherein the second plurality of perforations do not change in size when exposed to the pressure (the circular openings of 235 of 225 do not expand when subject to negative pressure), and wherein the second plurality of perforations are larger in size than the first plurality of perforations when the tissue site is exposed to the pressure and when the tissue site is not exposed to the pressure (see figure 7).
In regards to claim 18, Locke discloses the invention as discussed above.
Locke further discloses a system (100; see [0023]; see figure 1) for treating a tissue site with negative-pressure therapy (see [abstract]), comprising: the dressing according to claim 1 (see discussion above); and a negative-pressure source (102; see [0025]; see figure 1) configured to be fluidly coupled to the tissue site through the cover layer (see [0066]; see figure 2).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke in view of Merckel et al. (US 2022/0062059 A1) (hereinafter Merckel).
In regards to claim 2, Locke discloses the invention as discussed above.
Locke further discloses the first film layer (215) can be formed from multiple different materials (see [0056-0057]). However, Locke does not disclose wherein the first film layer comprises a polyurethane film having a thickness of between about 20 microns and about 35 microns.
However, Merckel teaches an analogous wound dressing (10; see [0074]; see figure 1) comprising an analogous first film layer (13; see [0075]; see figure 2) comprising a treatment region (region under 15; see figure 2) and sealing region (region outside of 15; see figure 2) around the treatment region (see figure 1); wherein the first film layer (13) comprises a polyurethane film (13a; see [0075]; see figure 2; “The perforated sheet material (13a) of the wound contact layer (13) is made from a polyurethane film (see [0075])) having a thickness of between about 20 microns and about 35 microns (the perforated material has a preferred thickness of 5-50 microns; see [0054]) for the purpose of forming the first film layer from a medically acceptable material (see [0054]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first film layer as disclosed by Locke and to have formed the first film layer from the polyurethane film as taught by Merckel in order to have provided an improved wound dressing that would add the benefit of forming the first film layer from a medically acceptable material (see [0054]).
The combination of Locke as now modified by Merckel discloses the range of the thickness of the first film layer is 5-50 microns which fully encompasses applicant’s claimed range of 20-35 microns. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thickness of the first film layer as disclosed by Locke as now modified by Merckel from 5-50 microns to 20-35 microns as applicant appears to have placed no criticality on the claimed range (“In some example embodiments, the first film layer can include a polyurethane film having a thickness of between about 20 microns and about 35 microns” see Specification [0007]) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 3, Locke discloses the invention as discussed above.
Locke does not disclose wherein the sealing adhesive comprises a silicone adhesive having a coating weight of between about 100 grams per square meter and about 250 grams per square meter.
However, Merckel teaches an analogous wound dressing (10; see [0074]; see figure 1) comprising an analogous first film layer (13; see [0075]; see figure 2) comprising a treatment region (region under 15; see figure 2) and sealing region (region outside of 15; see figure 2) around the treatment region (see figure 1); wherein the sealing adhesive (13b; see [0075]; see figure 2) comprises a silicone adhesive (see [0075]) having a coating weight of between about 100 grams per square meter and about 250 grams per square meter (the total coating weight of the silicone is preferably 100 g/m2 to 200 g/m2; see [0051]) for the purpose of providing an adhesive layer which adheres to a user’s skin without losing adhesiveness, while also allow for removal of the adhesive layer without causing pain or irritation to the wound or surrounding skin (see [0052]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first film layer as disclosed by Locke and to have used the silicone adhesive layer of the first film layer as taught by Merckel in order to have provided an improved first film layer that would add the benefit of providing an adhesive layer which adheres to a user’s skin without losing adhesiveness, while also allow for removal of the adhesive layer without causing pain or irritation to the wound or surrounding skin (see [0052]).
Claim(s) 16-17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke in view of Hu et al. (US 2010/0137775 A1) (hereinafter Hu).
In regards to claim 16, Locke discloses the invention as discussed above.
Locke does not disclose further comprising a carrier layer releasably coupled to a side of the cover layer opposite the cover adhesive.
However, Hu teaches an analogous wound dressing (1800; see [0104]; see figure 20) to be utilized during negative pressure treatments (see [abstract]) comprising an analogous cover layer (1803; see [0104]; see figure 18c); further comprising a carrier layer (1802; see [0104]; see figure 20) releasably coupled (see [0106]) to a side of the cover layer opposite the cover adhesive (see figure 18d) for the purpose of providing an increased stiffness and support to the dressing during application to a treatment site (see [0104]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover layer as disclosed by Locke and to have included the carrier layer as taught by Hu in order to have provided an improved wound dressing that would add the benefit of providing a carrier layer which provides an increased stiffness and support to the dressing during application to a treatment site (see [0104]).
In regards to claim 17, Locke as now modified by Hu discloses the invention as discussed above.
Locke as now modified by Hu further discloses wherein the carrier layer (1802 of Hu) comprises a coated paper or a polymeric film (see Hu [0098]).
In regards to claim 19, Locke discloses a system (100; see [0023]; see figure 1) for treating a tissue site with negative-pressure therapy (see [abstract]), comprising:
a dressing (104; see [0025]; see figure 2) configured to be positioned adjacent to a tissue site (see [0034]), comprising:
a first film layer (215; see [0043]; see figure 2) comprising a treatment region (230; see [0058]; see figure 7) and a sealing region (225; see [0058]; see figure 7) around the treatment region (see figure 7), a plurality of slits (235 of 230; see [0058]; see figure 7; 235 can be formed as slits (see [0059])) formed through the treatment region (see figure 7), a plurality of holes (235 of 225; see [0058]; see figure 7) and including a larger open area than the plurality of slits (the size and thus, the open area of 235 in 230 is smaller than the size/open area of 235 in 225; see [0061]), and a sealing adhesive covering the sealing region on a first side of the first film layer (patient facing side of 215) configured to face the tissue site (215 may be coated with a soft silicone (see [0056]); 215 must be tacky to hold 104 in position (see [0080]; thus, the silicone coating is a sealing adhesive positioned on the patient facing side as claimed),
a manifold (205; see [0043]; see figure 2), and
a second film layer (116; see [0025]; see figure 2) comprising an aperture (275; see [0066]; see figure 2), the second film layer coated with a pressure-sensitive adhesive (255; see [0064]; see figure 2) on a side of the second film layer configured to face the tissue site (see figure 2);
wherein the first film layer (215), the manifold (205), and the second film layer (116) are assembled in a stacked relationship with the first film layer and the second film layer enclosing the manifold (see figure 2), the manifold is aligned with the treatment region (see figure 2), the pressure-sensitive adhesive and the sealing adhesive are configured to face the tissue site (255 is disposed adjacent 235 of 225 and is exposed to the tissue site therethrough (see [0075]); the silicone coating is configured to face the tissue site to hold 104 in position as discussed in [0080]), at least some of the pressure-sensitive adhesive is exposed through the plurality of holes (see [0075]); and
wherein a negative-pressure source (102; see [0025]; see figure 1) is configured to be fluidly coupled to the tissue site through the aperture, the manifold, and the plurality of slits (see [0066]).
Locke does not disclose a carrier layer; wherein the carrier layer is part of the stacked relationship of the dressing, and the carrier layer is laminated to the second film layer on a side of the second film layer opposite the pressure- sensitive adhesive.
However, Hu teaches an analogous wound dressing (1800; see [0104]; see figure 20) to be utilized during negative pressure treatments (see [abstract]) comprising an analogous cover layer (1803; see [0104]; see figure 18c); further comprising a carrier layer (1802; see [0104]; see figure 20); wherein the carrier layer is part of the stacked relationship of the dressing, and the carrier layer is laminated to the second film layer on a side of the second film layer opposite the pressure- sensitive adhesive (see figures 18c-d) for the purpose of providing an increased stiffness and support to the dressing during application to a treatment site (see [0104]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover layer as disclosed by Locke and to have included the carrier layer as taught by Hu in order to have provided an improved wound dressing that would add the benefit of providing a carrier layer which provides an increased stiffness and support to the dressing during application to a treatment site (see [0104]).
In regards to claim 20, Locke as now modified by Hu discloses the invention as discussed above.
Locke further discloses wherein the sealing adhesive is not disposed on the treatment region (230 is free from adhesive to allow for the removal or repositioning of 104 without trauma to the tissue site; see [0080]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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