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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/13/2026 has been entered.
Response to Amendment
The amendment filed 05/13/2026 has been entered. Claims 1 has 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 Claims 15-20 are withdrawn.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 same combination and order of references as well as the same previously applied interpretation of Cotton for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made over Cotton in view of Hunt. Cotton discloses the feature of amended claim 1, namely, a cover comprising a non-porous film and an adhesive, at least a portion of the non-porous film positioned in direct contact with the manifold.
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 Cotton (Pub. No.: US 2014/0309574 A1) in view of Hunt et al. (Pub. No.: US 2004/0030304 A1).
Regarding claim 1, Cotton discloses (fig. 13-14, annotated fig. 13) a dressing (wound dressing 90) for treating a tissue site with negative pressure (abstract), comprising:
A first layer (foam pad 66) comprising a foam manifold (¶ 0091);
A second layer (textile material 65) coupled directly to the first layer (¶ 0143) and comprising an elastomeric material (¶ 0042) and a plurality of openings positioned in direct contact with the foam in the manifold (¶ 0069);
A third layer (silicone gel layer 91) comprising a coating adjacent to the second layer (fig. 13), wherein a treatment aperture and a plurality of perforations around the treatment aperture are disposed through the coating (¶ 0154, annotated fig. 13), 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 (fig. 13-14, ¶ 0154); and
A cover comprising a non-porous film (backing layer 61, ¶ 0099) and an adhesive (67), at least a portion of the non-porous film positioned in direct contact with the manifold (the adhesive maybe provided only at the border, ¶ 0090) and the adhesive disposed adjacent 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 (¶ 0144).
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Cotton annotated fig. 13
Cotton fails to disclose the second layer comprising an elastomeric film.
Hunt teaches (fig. 1) a dressing (10) for treating a tissue site with negative pressure (abstract) and thus in the same field of endeavor, comprising:
A second layer (lower wall 30 of elastomeric sheet 38) comprising an elastomeric film (¶ 0030), as such material resists wound adhesion and is appropriate for placement in direct contact with tissue surfaces (¶ 0030).
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 elastomeric material of the second layer of Cotton such that it comprises an elastomeric film, as taught by Hunt, as such material resists wound adhesion and is appropriate for placement in direct contact with tissue surfaces (Hunt ¶ 0030).
Regarding claim 2, Cotton discloses wherein the plurality of perforations are smaller than the treatment aperture (annotated fig. 13).
Regarding claim 3, Cotton discloses wherein the coating comprises a hydrophobic material (i.e., silicone gel layer, ¶ 0154).
Regarding claim 4, Cotton discloses wherein the coating comprises a gel (¶ 0154).
Regarding claim 5, Cotton discloses wherein the coating comprises silicone (¶ 0154).
Regarding claim 6, Cotton disclose wherein the perforations are circular (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, Cotton in view of Hunt fail to disclose wherein the second layer comprises a film of polyurethane.
Hunt further teaches wherein the second layer comprises a film of polyurethane (¶ 0030), as such material resists wound adhesion and is appropriate for placement in direct contact with tissue surfaces (¶ 0030).
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 elastomeric material of the second layer of Cotton such that it comprises a polyurethane film, as taught by Hunt, as such material resists wound adhesion and is appropriate for placement in direct contact with tissue surfaces (Hunt ¶ 0030).
Regarding claim 8, Cotton in view of Hunt fail to disclose wherein the openings comprise slits in the film.
Hunt further teaches (fig. 1) wherein the second layer comprises a plurality of openings (holes 34, ¶ 0033), wherein the openings comprise slits in the film (¶ 0033), such slits constituting a small proportion of the area of the film in contact with the wound so that there is limited ingrowth of fibrous tissue into the film (¶ 0015).
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 plurality of openings of Cotton in view of Hunt such that they comprise slits in the film, as taught by Hunt, as slits constitute a small proportion of the area of the film in contact with the wound so that there is limited ingrowth of fibrous tissue into the film (Hunt ¶ 0015).
Regarding claim 9, as discussed above in claim 8, 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 openings of Cotton in view of Hunts such that they comprise slits. Hunt further teaches 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, as discussed above in claim 8, 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 openings of Cotton in view of Hunts such that they comprise slits. Hunt further teaches wherein the slits each have a length of about 3 mm (¶ 0033).
Regarding claim 11, Cotton in view of Hunt 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 discloses 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 optimize the treatment aperture of Cotton in view of Hunt 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 (¶ 0154).
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, Cotton discloses wherein the cover, the manifold, the second layer 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 being configured to face the tissue site (fig. 13, ¶ 0069).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gundersen et al. (Pub. No.: US 2010/0292626 A1) discloses a dressing having a treatment aperture.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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