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 Arguments
Applicant’s amendment filed 06/12/2026 is accepted and entered.
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive. Applicant alleges that Roos/Hartwell/Shuler does not teach that portions of the closed cells extend from opposite sides of the manifold layer. However, as set forth below, Roos can be interpreted as having a portion of closed cells that extend from the right side of the manifold layer and a second portion of closed cells that extend from the left side of the manifold, which is consistent with a broad but reasonable interpretation of the current claim limitation.
Applicant did not specifically argue the dependent claims.
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.
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) 35, 37, 38, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Roos (US 2019/0184075) in view of Shuler et al (US 2017/0028113).
Regarding Claim 35, Roos discloses a wound filler for use with negative-pressure treatment (¶ [0001]), the wound filler comprising:
a manifold layer comprising a first layer (organ contact layer 16, Figs. 4-5) having closed cells (sealed chambers 28, Figs. 4-5) and apertures (¶ [0061]; slits or holes can be provided in the sheet to make the sheet liquid permeable) configured to manifold fluid through the first layer (¶ [0061]), wherein the first layer comprises two films (top sheet 30 and bottom sheet 32, Figs. 4-5; ¶ [0063]) bonded together to define the closed cells (28, Figs. 4-5; ¶ [0063]), wherein portions of the closed cells (sealed chambers 28, Figs. 4-5) extend from opposite sides of the manifold layer (the closed cells can be separated into two areas, with each area considered a portion of the closed cells; one area can be interpreted as having closed cells that extend from the right side of the manifold and the other area can be interpreted as having closed cells that extend from the left side of the manifold, which is opposite to the right side; the claims as currently written do not require the closed cells to protrude above and below the “plane” of the manifold) and wherein the apertures (¶ [0061]) are positioned between the closed cells (28, Figs. 4-5; ¶ [0061] in order to have the layer be liquid permeable while still having the sealed chambers 28, the slits or holes must be placed between the sealed chambers) and extend through both of the films (¶ [0061]).
Roos is silent regarding a second layer and a third layer positioned on opposing sides of the manifold layer, the second layer and the third layer each comprising a film of a hydrophobic material and perforations or fenestrations configured to transfer fluid through the film.
Shuler teaches a wound dressing for use with negative pressure wound therapy, thus being in the same field of endeavor, with a second layer (perforated layer 142, Fig. 2) and a third layer (perforated layer 144, Fig. 2) positioned on opposing sides of the manifold layer (130, Fig. 2), the second layer (142, Fig. 2) and the third layer (144, Fig. 2) each comprising a film of a hydrophobic material and perforations or fenestrations configured to transfer fluid through the film (¶ [0037-0038, 0071]), where the second and third layers facilitate tissue irrigation and debridement, distribute negative pressure, and prevent tissue ingrowth (¶ [0038]).
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 wound dressing of Roos to include a second layer and a third layer positioned on opposing sides of the manifold layer, the second layer and the third layer each comprising a film of hydrophobic material and perforations or fenestrations configured to transfer fluid through the film, as taught by Shuler. These additional layers help to facilitate tissue irrigation and debridement, distribute negative pressure within the sealed space, and prevent tissue ingrowth (as motivated by Shuler ¶ [0038]).
Regarding Claim 37, Roos further discloses the closed cells (28, Figs. 4-5) contain fluid (¶ [0063]; air is a fluid) and are distributed in a pattern that extends across an entire surface of both of the films (as seen in Fig. 4, the closed cells extend in a pattern that covers the entire surface of both the top and bottom films; the closed cells on the bottom layer of film can be considered extending across the bottom surface of the top layer of film).
Regarding Claim 38, the combination of Roos/Shuler discloses the claimed invention substantially as claimed as set forth above for Claim 35.
Roos/Shuler further discloses the film of the second layer (Shuler 142, Fig. 2) and the third layer (Shuler 144, Fig. 2) is a polyethylene film (Shuler ¶ [0066]).
Regarding Claim 42, Roos further discloses the closed cells (28, Figs. 4-5) have a diameter of between 1.5 mm and 3 mm (¶ [0066]); 3 mm is fully within the claimed range).
Claims 36 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Roos (US 2019/0184075) in view of Shuler et al (US 2017/0028113) further in view of Riesinger (WO 2011/121127; paragraph numbers reference the translation attached to the Office Action dated 11/06/2024).
Regarding Claims 36 and 41, Roos/Shuler is silent whether the manifold layer further comprises a fourth layer having blisters and apertures configured to manifold fluid through the fourth layer, wherein the blisters comprise an open cavity; and wherein the manifold layer further comprises a fourth layer having blisters and apertures configured to manifold fluid through the manifold layer, wherein the blisters of the fourth layer comprise an empty cavity that is open on one side of the fourth layer; and a fifth layer having blisters and apertures configured to manifold fluid through the manifold layer, wherein the blisters of the fifth layer comprise an empty cavity that is open on one side of the fifth layer.
Riesinger teaches a wound dressing, thus being in the same field of endeavor, with a layer (bubble wrap 35, Figs. 13 and 14) having blisters (air bubbles 36, Figs. 13 and 14) and apertures (perforations 37, Figs. 13 and 14) configured to manifold fluid through the layer (¶ [0058]), wherein the blisters (36, Figs. 13 and 14) comprise an empty cavity that is open on one side of the layer (as seen in Figs. 13 and 14). These air bubbles assist in keeping the wound space warm (¶ [0059]).
Therefore, it would have been obvious to modify the dressing of Roos/Shuler to comprise a fourth layer having blisters and apertures configured to manifold fluid through the manifold layer, wherein the blisters of the fourth layer comprise an empty cavity that is open on one side of the fourth layer; and a fifth layer having blisters and apertures configured to manifold fluid through the manifold layer, wherein the blisters of the fifth layer comprise an empty cavity that is open on one side of the fifth layer, as taught by Riesinger to ensure the wound space is kept warm by the addition of two insulating layers above and below the primary wound manifold (¶ [0059]).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Roos (US 2019/0184075) in view of Shuler et al (US 2017/0028113) further in view of Vinton (US 2012/0046603).
Regarding Claim 39, Roos/Shuler is silent whether the perforations or fenestrations comprise linear fenestrations, each of the linear fenestrations having a length not greater than 4 millimeters.
Vinton teaches a dressing (41, Figs. 3-4) with fluid restrictions comprising linear fenestrations (slits 51, Figs. 3-4), each of the linear fenestrations (51, Figs. 3-4) having a length not greater than 4 millimeters (¶ [0016, 0067]; 2 millimeters is the preferred length and is used in the example embodiment, and 2 millimeters is not greater than 4 millimeters). A length of 2 millimeters has shown to be beneficial in the regulation of exudate removal (¶ [0016]).
Therefore, it would have been obvious to modify the perforations/fenestrations of Roos/Shuler to comprise linear fenestrations having a length not greater than 4 millimeters, as taught by Vinton, since a length of 2 millimeters has been shown to be beneficial in the regulation of exudate removal (as motivated by Vinton ¶ [0016]).
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
