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 .
Election/Restrictions
Claims 28-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 May 2026.
Applicant’s election without traverse of Group I, Claims 1-3, 6-10, 13-15, 17-22, and 27 in the reply filed on 27 May 2026 is acknowledged.
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) 1-3, 6, 8-10, 13-15, 17-21, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 20180353342 A1) in view of Locke et al. (US 20200121509 A1).
Regarding Claim 1, Locke ‘342 discloses A dressing ("dressing 110" [0030]; FIG. 2) for treating a tissue site with negative pressure ([0029-0030]) , the dressing comprising:
a cover ("cover 125" [0030]) comprising a first surface and a second surface ([0046]; FIG. 2);
a foam ("first layer 205" [0059]; FIG. 2) comprising a first surface, a second surface ([0063]), and
the first surface of the foam adjacent to the second surface of the cover (see FIG. 2); and
a film layer ("second layer 210" [0057]; FIG. 2) comprising a first surface, a second surface, and a plurality of fenestrations ("one or more fluid restrictions 220" [0069]; FIG. 2) through the first surface and the second surface,
the first surface of the film layer adjacent to the second surface of the foam (see FIG. 2).
Locke ‘342 fails to specify a plurality of slits, the plurality of slits comprising a first side wall and a second side wall extending between the first surface and the second surface of the foam that are deformable between a closed state and an open state, the first side wall in contact with the second side wall in the closed state, and the first side wall separated from the second side wall in the open state, and the plurality of fenestrations aligned with the plurality of slits of the foam.
However, Locke ‘509 teaches analogous “dressings for tissue treatment with negative pressure” ([0007]) comprising a plurality of slits ("fluid restrictions 225 may comprise or consist essentially of one or more slits" [0089]; FIG. 9), the plurality of slits comprising a first side wall and a second side wall extending between the first surface and the second surface of the foam that are deformable between a closed state and an open state ("fluid restrictions 225 generally may comprise or consist essentially of an elastic passage that is normally unstrained to substantially reduce liquid flow, and can expand in response to a pressure gradient" [0088]), the first side wall in contact with the second side wall in the closed state, and the first side wall separated from the second side wall in the open state ("normally closed when unstrained to substantially prevent liquid flow, and can open in response to a pressure gradient" [0088]); and a plurality of fenestrations (“apertures 220” [0094]; FIG. 2) that are aligned with the plurality of slits of the foam ("aligned or registered with the one or more apertures 220 in the second layer 210" [0088]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Locke ‘342 to incorporate the teachings of Locke ‘509 to suitably control the flow of fluids in response to a pressure gradient ([0088-0089]).
Regarding Claim 2, Locke ‘342 discloses the foam is positioned between the cover and the film layer ([0057]; FIG. 2).
Regarding Claims 3, 6 & 8-10, Locke ‘342 fails to specify the plurality of slits of the foam are configured to deform from the closed state to the open state when the dressing is exposed to the negative pressure, an axial force, or to a bending moment; the first side wall is positioned opposite from the second side wall across a slit opening of the plurality of slits; the plurality of fenestrations of the film layer are configured to deform in alignment with the plurality of slits of the foam when the dressing is exposed to the negative pressure; the plurality of fenestrations of the film layer and the plurality of slits in the foam are aligned in both the open state and the closed state and configured to deform in concert in response to the negative pressure; and the plurality of fenestrations each comprise opposing edges that are positioned flush with the first side wall and the second side wall of the plurality of slits.
However, Locke ‘509 teaches the plurality of slits of the foam are configured to deform from the closed state to the open state when the dressing is exposed to the negative pressure, an axial force, or to a bending moment ("fluid restrictions 225 may be an elastomeric valve that is normally closed when unstrained to substantially prevent liquid flow, and can open in response to a pressure gradient" [0088]); the first side wall is positioned opposite from the second side wall across a slit opening of the plurality of slits ([0088-0089]; FIG. 2); the plurality of fenestrations of the film layer are configured to deform in alignment with the plurality of slits of the foam when the dressing is exposed to the negative pressure ("fluid restrictions 225 can deform inward into the apertures 220 under negative pressure" [0131]); the plurality of fenestrations of the film layer and the plurality of slits in the foam are aligned in both the open state and the closed state and configured to deform in concert in response to the negative pressure ("fluid restrictions 225 can deform inward into the apertures 220 under negative pressure" [0131]); and the plurality of fenestrations each comprise opposing edges that are positioned flush with the first side wall and the second side wall of the plurality of slits ("third layer 215 may be cut flush with the edge of the second layer 210" [0117]).
Therefore, it would have been obvious to modify Locke ‘342 as taught by Locke ‘509 to suitably control and manage fluid flow and promote wound healing ([0007-00026]).
Regarding Claim 13, Locke ‘342 discloses the film layer is coupled to the foam ("first layer 205 may be disposed adjacent to the second layer 210" [0057]; FIG. 2).
Regarding Claim 14, Locke ‘342 discloses a base layer ("third layer 215" [0057]; FIG. 2) adjacent to the second surface of the film layer ("third layer 215 may also be disposed adjacent to the second layer 210" [0057]; FIG. 2), the base layer comprising a central portion including a base layer opening ("third layer 215 may have a periphery 225 surrounding or around a treatment aperture 230" [0073]) and a peripheral portion including a plurality of apertures ("apertures 235 in the periphery 225 disposed around the treatment aperture 230" [0073]; FIG. 2).
Regarding Claim 15, Locke ‘342 discloses the peripheral portion surrounds the central portion, and wherein the plurality of apertures in the peripheral portion are smaller than the base layer opening in the central portion ([0073]; FIG. 2).
Regarding Claim 17, Locke ‘342 discloses the base layer opening is a single opening ([0073]; FIG.2).
Regarding Claim 18, Locke ‘342 discloses the plurality of fenestrations and at least a portion of the film layer are exposed through the base layer opening ("substantial number of the fluid restrictions 220 may be aligned or otherwise exposed through the treatment aperture 230" [0084]; FIG. 2).
Regarding Claim 19, Locke ‘342 discloses the film layer is configured to contact the tissue site through the base layer opening ("at least some portion of the second layer 210, the fluid restrictions 220, or both may be exposed to a tissue site through the treatment aperture 230" [0094]), and wherein the peripheral portion of the base layer is configured to contact tissue surrounding the tissue site ("periphery 225 of the third layer 215 may be positioned adjacent to or proximate to tissue around or surrounding the tissue site" [0094]).
Regarding Claim 20, Locke ‘342 discloses the base layer does not contact the tissue site ("a filler may also be disposed between a tissue site and the third layer 215" [0104]).
Regarding Claim 21, Locke ‘342 discloses the base layer comprises a silicone gel ("silicone gel" [0071]) configured to be in contact with tissue around the tissue site ("periphery 225 of the third layer 215 may be positioned adjacent to or proximate to tissue around or surrounding the tissue site" [0094]).
Regarding Claim 27, Locke ‘342 discloses a system for treating a tissue site with negative pressure ("therapy system 100 that can provide negative-pressure therapy with instillation of topical treatment solutions to a tissue site" [0028]; FIG. 1), the system comprising: a dressing ("dressing 110" [0030]) according to claim 1 (see discussion for claim 1); and a negative-pressure source ("negative-pressure source 105" [0030]) configured to be fluidly coupled to the dressing ("negative-pressure source 105 may be directly coupled to the container 115 and may be indirectly coupled to the dressing 110 through the container 115" [0035]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke ‘342 in view of Locke ‘509, and further in view of Greener et al. (US 20180147091 A1).
Regarding Claim 7, Locke ‘342/Locke ‘509 fails to specify one or more of the plurality of slits is deformable between the closed state and the open state independently of another of the plurality of slits. However, Greener teaches “a wound dressing, suitable for use in negative pressure wound therapy, comprising a body of porous material, the body of porous material comprising a plurality of cuts” (Abstract) wherein one or more of the plurality of slits is deformable between the closed state and the open state independently of another of the plurality of slits ([0057-0059]; FIGs. 13 & 15). Therefore, it would have been obvious to modify Locke ‘342/Lock ‘509 as taught by Greener to suitably “achieve both increased visibility of the wound and increased extensibility of the material, without significant material waste” ([0016]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke ‘342 in view of Locke ‘509, and further in view of Locke (US 20180353337 A1).
Regarding Claim 22, Locke ‘342 discloses the film layer comprises a central portion including the plurality of fenestrations aligned with the foam ("first layer 205 and the second layer 210 may be substantially aligned with the treatment aperture 230" [0084]; FIG. 4) but Locke ‘342/Locke ‘509 fails to specify a peripheral portion extending beyond the foam and including a plurality of perforations surrounding the plurality of fenestrations, wherein the plurality of perforations are larger than the plurality of fenestrations and configured to align with the plurality of apertures of the base layer. However, Locke ‘337 teaches an analogous negative pressure multi-layered dressing comprising a plurality of apertures ([0010]) wherein a peripheral portion extending beyond the foam ("second layer 210 may be rectangular in shape and may include alignment areas 222 in each of its four corners" [0093]; FIG. 6) and including a plurality of perforations surrounding the plurality of fenestrations ("one or more registration apertures, such as alignment apertures 602" [0093]; FIG. 6), wherein the plurality of perforations are larger than the plurality of fenestrations ("each of the three alignment apertures 602 in each of the alignment areas 222 may be approximately 6 mm in diameter" [0095]; FIG. 6) and configured to align with the plurality of apertures of the base layer ("alignment apertures 602 may be configured so that when the second layer 210 is placed against the third layer 215, the alignment apertures 602 may be aligned with, or in some case be coextensive with one or more registration apertures, such as alignment holes 254, of the third layer 215" [0093]; FIG. 6). Therefore, it would have been obvious to modify Locke ‘342/Lock ‘509 as taught by Locke ‘337 to suitably align the layers with each other ([0093-0099]) and “allow for reel-to-reel volume manufacturing” ([0100]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights