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 .
Response to Amendment
The amendment filed 01/08/2026 has been entered. Claims 1, 8 and 12 have been amended. Claims 13-14 are cancelled. Claims 1-12, 15-20 remain pending in this application. Claims 15-20 are withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on the previously cited embodiment (fig. 3) of Hunt for any teaching or matter specifically challenged in the argument.
Amended claim 1 recites “a second layer coupled directly to the first layer and comprising an elastomeric film”. The embodiment of fig. 1 of Hunt comprises a second layer comprising an elastomeric film, as discussed in the rejection below. Further, Cotton is cited to teach direct coupling of the first layer to the second layer.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt et al. (Pub. No.: US 2004/0030304 A1) in view of Cotton (Pub. No.: US 2014/0309574 A1) and further in view of Locke et al. (Pub. No.: US 2014/0276490 A1).
Regarding claim 1, Hunt discloses (fig. 1) a dressing (10) for treating a tissue site with negative pressure (abstract), the dressing comprising: A first layer (lower foam layer 36) comprising a foam manifold (¶ 0030);
A second layer (lower wall 30) in direct contact with the first layer (fig. 1) and comprising an elastomeric film (¶ 0033) and a plurality of openings (holes 34) positioned in direct contact with the foam of the manifold (fig. 1, ¶ 0033);
A cover comprising a non-porous film (drape 14, ¶ 0014) and an adhesive (¶ 0039), the non-porous film coupled to the manifold (the adhesive is coated overall on one side of the drape, ¶ 0019, thus coupling the non-porous film to the manifold, fig. 3).
Hunt fails to disclose that the second layer is coupled directly to the first layer; and a third layer comprising a coating adjacent to the second layer, wherein a treatment aperture and a plurality of perforations around the treatment aperture are disposed through the coating, and wherein at least a portion of the plurality of openings and a portion of the second layer around the plurality of openings are exposed through the treatment aperture and configured to directly contact the tissue site.
Cotton teaches (fig. 13, annotated fig. 13) a dressing (90) for treating a tissue site with negative pressure (abstract), and thus in the same field of endeavor, the dressing comprising:
A first layer (textile material 65);
A second layer (sheet of melt-blown polyurethane) coupled directly to the first layer (¶ 0089) in order to affix the second layer to the first layer (¶ 0089).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dressing of Hunt such that the second layer is coupled directly to the first layer, as taught by Cotton, in order to affix the second layer to the first layer (Cotton, ¶ 0089) such that the layers do not shift during use.
Cotton further teaches a third layer (silicone gel layer 91) comprising a coating (fig. 13), wherein a treatment aperture (central opening, ¶ 0154, annotated fig. 13) and a plurality of perforations (92) around the treatment aperture are disposed through the coating (¶ 0154), wherein the third layer is configured to be soft, tactile and conformable and exhibit good adhesion to dry skin but low adherence to an underlying wound and can therefore allow the dressing to be applied and removed without causing trauma to the wound (¶ 0088).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dressing of Hunt such that it includes the third layer of Cotton disposed adjacent to the second layer of Hunt, as such third layer is soft, tactile and conformable and exhibits good adhesion to dry skin but low adherence to an underlying wound and can therefore allow the dressing to be applied and removed without causing trauma to the wound (Cotton, ¶ 0088).
The modification of the dressing of Hunt such that it includes the third layer of Cotton further results in: wherein at least a portion of each of the plurality of openings and a portion of the second layer around the plurality of openings are exposed through the treatment aperture and configured to directly contact the tissue site as the second layer of Hunt spans the width of the treatment aperture of the third layer of Cotton.
Hunt in view of Cotton fail to disclose wherein the adhesive is disposed adjacent to the plurality of perforations such that at least some of the adhesive is exposed through the perforations to contact the tissue site around the treatment aperture.
Locke teaches (fig. 1-3) a dressing (124) for treating a tissue site with negative pressure (¶ 0020) and thus in the same field of endeavor, comprising a third layer (base layer 132) comprising a plurality of perforations (apertures 160, ¶ 0024); and a cover comprising a non-porous film (sealing member 140, ¶ 0021) and an adhesive (136), wherein the adhesive is disposed adjacent to the plurality of perforations such that at least some of the adhesive is exposed through the perforations to contact the tissue stie around the treatment aperture (fig. 3, ¶ 0028).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dressing of Hunt in view of Cotton such that the adhesive is exposed through the perforations to contact the tissue site, as taught by Locke, in order to secure the dressing to the tissue site (Locke ¶ 0028).
Regarding claim 2, Hunt in view of Cotton and further in view of Locke disclose wherein the plurality of perforations are smaller than the treatment aperture (Cotton annotated fig. 13).
Regarding claim 3, Hunt in view of Cotton and further in view of Locke disclose wherein the coating comprises a hydrophobic material (Cotton, e.g., silicone ¶ 0089).
Regarding claim 4, Hunt in view of Cotton and further in view of Locke disclose wherein the coating comprises a gel (Cotton, ¶ 0089).
Regarding claim 5, Hunt in view of Cotton and further in view of Locke disclose wherein the coating comprises silicone (Cotton, ¶ 0089).
Regarding claim 6, Hunt in view of Cotton and further in view of Locke disclose wherein the perforations are circular (Cotton, fig. 14) and have a diameter in a range of 2-10 mm (Cotton, ¶ 0090) which encompasses the claimed range of about 7 mm to 9 mm.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 7, Hunt discloses wherein the second layer comprises a film of polyurethane (¶ 0030).
Regarding claim 8, Hunt discloses wherein the openings comprise slits in the film (¶ 0015).
Regarding claim 9, Hunt discloses wherein the slits each have a length of 3 to 6 mm (¶ 0033) which overlaps with the claimed range of about 2 to about 5 mm.
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
Regarding claim 10, Hunt discloses wherein the slits each have a length of about 3 mm (¶ 0033).
Regarding claim 11, Hunt in view of Cotton and further in view of Locke fail to disclose wherein the treatment aperture has a width in a range of about 90 millimeters to about 110 millimeters and a length in a range of about 150 millimeters to about 160 millimeters.
However, Cotton teaches sizing the treatment aperture such that it is slightly smaller in size than the manifold in order to expose the manifold to the wound (¶ 0154). Thus, Cotton discloses that the size of the treatment aperture is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment aperture of Hunt in view of Cotton and further in view of Locke such that the treatment aperture has a width in a range of about 90 millimeters to about 110 millimeters and a length in a range of about 150 millimeters to about 160 millimeters in order to size the treatment aperture such that the manifold is exposed to the wound.
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Regarding claim 12, Hunt in view of Cotton and further in view of Locke disclose wherein the cover, the manifold, the film and the coating are assembled in a stacked relationship with the coating and the portion of the plurality of openings exposed through the treatment aperture are being configured to face the tissue site (see rejection of claim 1 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Robinson et al. (Pub. No.: US 2012/0330253 A1) discloses a dressing for treating a tissue site with negative pressure comprising a second layer directly coupled to a first layer. Jaeb et al. (Pub. No.: US 2009/0227969 A1) discloses a third layer having a treatment aperture.
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 MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781