DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 03/24/2026.
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 .
Status of Claims
Claims 48-63 and 68-69 are pending in the application.
Claims 48-63 and 68-69 are examined on the merits.
Information Disclosure Statement
The new information disclosure statements (IDS) submitted on 03/24/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the new information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments/remarks filed on 03/04/2026 have been fully considered.
Applicant argues that Karami does not teach “more than one of the fluid passages and a portion of the second layer are configured to be exposed through the at least one aperture of the plurality of apertures” because Karami discloses a one-to-one slit 18 to non-adhesive area 16. Applicant’s arguments are not found persuasive. Karami discloses providing a number of slits to a non-adhesive area (Col. 5, lines 3-12). In addition, in an incorporated reference Webster (US PAT 4541426), Webster discloses more than one slits 4 and a portion of layer 1 are configured to be exposed through a non-adhesive area (Col. 9, lines 15-20; and Fig. 2). Thus, Karami discloses the claimed limitation.
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 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.
Claim(s) 48-49, 51-56, 58, 60-63, and 68 is/are rejected under 35 U.S.C 103 as being unpatentable over Allen (US PGPUB 20150141941) in view of Karami (US PAT 5308313), Robinson (US PGPUB 20110178451), and, if necessary, Webster (US PAT 4541426).
Regarding claim 48, Allen discloses a dressing (a wound dressing 10: ¶0109-0111 and Figs. 1A-B) for treating a tissue site with negative pressure (Abstract), the dressing (10) comprising:
a first layer (220+222: ¶0111 and Fig. 1B) comprising a manifold (a porous transmission layer 222: ¶0111);
a second layer (a wound contact layer 203: ¶0111 and Fig. 1B) adjacent to the first layer (203 is adjacent to (220+222): Fig. 1B), the second layer (203) comprising a polymer film (203 is a polyurethane layer or polyethylene layer or other flexible layer: ¶0112; thus, the polyurethane layer or polyethylene layer or other flexible layer reads on polymer film) having a plurality of fluid passages (perforations 104 are through holes in 203: ¶0112) that are configured to expand in response to a pressure gradient across the polymer film (perforations 104 of layer 203 is capable of expanding in response to a pressure gradient due to the flexibility of layer 203: ¶0112);
a cover (a cover layer 218: ¶0118, 0133, and Fig. 1B) adjacent to the first layer (Fig. 1B), the cover comprising a polymer drape (¶0133).
Allen further discloses a third layer (a lower silicone pressure sensitive adhesive 200: ¶0112) disposed adjacent to the second layer (the lower silicone pressure sensitive adhesive 200 provided on the underside of the second layer 203: ¶0112 and Fig. 1B).
Allen does not disclose the third layer comprising a gel including a plurality of apertures sized such that more than one of the fluid passages and a portion of the second layer are configured to be exposed through the at least one aperture of the plurality of apertures to the tissue site and to extend freely across the at least one aperture of the plurality of apertures in the third layer.
In the same field of endeavor, wound dressing, Karami discloses a wound dressing 10 comprising a second layer (a thin conformable sheet/film 12: Figs. 1-5) and a third layer positioned closest to a tissue site (an adhesive layer 14 comprises hydrocolloid adhesive: Col. 4, lines 55-67 and Col. 7, lines 15-24; and Figs. 1-5; a person having ordinary skill in the art would have understood that the hydrocolloid adhesive would comprise a gel). Karami further discloses the second layer 12 comprising a plurality of fluid passages (slits 18: Col. 5, lines 3-7; and Figs. 1-5) and the third layer 14 comprising a plurality of apertures (non-adhesive areas 16: Col. 4, lines 63-68; and Figs. 1-5). In addition, Karami teaches to have/arrange more than one of the fluid passages 18 of the second layer 12 and a portion of the second layer 12 is exposed through and extends freely across at least one of the apertures of the third layer 14 (“providing slits in a portion of the non-adhesive areas”: Col. 5, lines 3-12; Claim 2; the Examiner regards the discussion of the Webster reference (US PAT 4541426) in the Karami reference as an implicit incorporation by reference. In any event, the Examiner includes Webster as the basis for the grounds of rejection herein. Webster discloses more than one slits 4 and a portion of layer 1 are configured to be exposed through a non-adhesive area of an adhesive 5: Col. 9, lines 15-20; and Fig. 2) for the benefit(s) of securing the wound dressing to the wound, preventing the wound from drying out, and permitting transfer of wound fluids (Abstract and Col. 2, lines 27-33). Furthermore, Karami discloses size and number of slits in the dressing are configured to provide a moist healing wound dressing.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Allen in view of Karami by replacing the third layer with a gel layer comprising a plurality of apertures, the plurality of apertures sized such that more than one of the fluid passages and a portion of the second layer are configured to be exposed through the at least one aperture of the plurality of apertures to the tissue site and to extend freely across the at least one aperture of the plurality of apertures in the third/gel layer, in order to secure the wound dressing to the wound, prevent the wound from drying out, and permitting transfer of wound fluids, as suggested in Abstract and Col. 2, lines 27-33 of Karami.
Allen/Karami does not disclose the manifold having variable density.
In the same field of endeavor, wound dressings, Robinson discloses a manifold (a wound insert 300: ¶0005, 0049 and Figs. 4-5) with high-density and low-density regions (Abstract and ¶0020). Robinson further teaches to have the combination of high-density regions and low-density regions on the manifold (Figs. 4-5) for the benefits of providing various characteristics of the manifold, improving wicking function, effectively transmitting fluid, and decreasing clogging (¶0061).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Allen/Karami in view of Robinson by providing high-density and low-density regions for the manifold, in order to provide various characteristics of the manifold, improve wicking function, effectively transmit fluid, and decrease clogging, as suggested in ¶0061 of Robinson.
Regarding claim 49, Allen/Karami does not disclose the manifold comprises a first area having a first density and a second area having a second density.
Robinson further teaches the manifold (300) comprises a first area (a thick region 304: ¶0049 and Fig. 4) having a first density (¶0050) and a second area (a thin region 308: ¶0049 and Fig. 4) having a second density (¶0050) for the benefits of wicking/drawing fluids away from a wound area with thick/high-density regions and permitting communication of negative pressure to a wound surface with thin/low-density regions (¶0050).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Allen/Karami/Robinson in view of Robinson by making the manifold with a first area having a first density and a second area having a second density, in order to wick/draw fluids away from a wound area with thick/high-density regions and permit communication of negative pressure to a wound surface with thin/low-density regions, as suggested in ¶0050 of Robinson.
Regarding claims 51-54, Allen/Karami does not disclose the manifold comprises a pattern of areas having different density; the pattern is an array; the areas are rectangular; and the pattern comprises concentric rings.
Robinson further teaches the manifold comprises a pattern of areas having different density (¶0018), the pattern is an array (¶0060), the pattern comprises concentric rings (¶0064), and the areas are rectangular (¶0064) for the benefits of providing various characteristics of the manifold and permitting the manifold to bend and conform to a wound (¶0061-0062).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Allen/Karami/Robinson in view of Robinson by having the manifold comprising a pattern of areas having different density such that the pattern is an array and the areas are rectangular or the pattern comprises concentric rings, in order to provide various characteristics of the manifold and permit the manifold to bend and conform to a wound, as suggested in ¶0061-0062 of Robinson and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. Further, one would have been motivated to select different configurations for the manifold for the purpose of providing various characteristics of the manifold and permitting the manifold to bend and conform to a wound. See MPEP § 2144.04 (IV) (B).
Regarding claim 55, Allen further discloses the manifold (222) comprises open-cell foam (¶0113).
Regarding claim 56, Allen further discloses a system for treating tissue with negative pressure (Fig. 1A),
the system comprising: a negative-pressure source (a pump or other source of negative pressure through a flexible tubing 14: ¶0109 and Fig. 1A); and
the dressing fluidly coupled to the negative-pressure source (¶0109 and Fig. 1A; wherein the dressing is modified in claim 48 by Allen in view of Karami and Robinson; see rejection of claim 48 above).
Regarding claim 58, Allen further discloses a method of treating a wound with negative pressure (Abstract, ¶0011, and 0032), the method comprising:
applying the dressing to the wound (¶0045; wherein the dressing is modified in claim 48 by Allen in view of Karami and Robinson; see rejection of claim 48 above);
fluidly coupling a negative-pressure source to the dressing (¶0046);
and delivering a therapeutic level of negative pressure from the negative-pressure source to the dressing (¶0254).
In addition, since the system of Allen in view of Karami and Robinson meets the structural limitations of the claimed system, it follows naturally that the combination suggested by the prior art would perform the method steps as claimed (See MPEP § 2112.02 (I)).
Regarding claims 60-61, Allen further discloses applying the dressing comprises sealing the dressing to epidermis adjacent to the wound (¶0007, 0022, 0112, and 0174: sealing the dressing to the skin around a wound site) and wherein applying the dressing comprises disposing at least part of the dressing across an edge of the wound (¶0045 and ¶0109).
In addition, since the dressing of Allen in view of Karami and Robinson meets the structural limitations of the claimed system, it follows naturally that the combination suggested by the prior art would perform the method steps as claimed (See MPEP § 2112.02 (I)).
Regarding claim 62, Allen/Karami/Robinson does not disclose the wound is a surface wound.
However, since the taught dressing and the claimed dressing are patentably indistinct in term of structures and both used for treating a tissue site with negative pressure, the taught dressing is considered/expected to be capable of being used in a surface wound. See MPEP §§ 2112.01 (I) and 2114 (I)-(II).
Regarding claim 63, Allen/Karami/Robinson does not disclose the dressing remains on the wound for at least 7 days.
However, since the taught dressing and the claimed dressing are patentably indistinct in term of structures and both used for treating a tissue site with negative pressure, the taught dressing is considered/expected to be capable of remaining on the wound for at least 7 days. See MPEP §§ 2112.01 (I) and 2114 (I)-(II).
Regarding claim 68, Allen further discloses the fluid passages comprising elastic passages disposed through the polymer film that are configured to expand in response to a pressure gradient across the polymer film (¶0112: since the polymer film 203 is flexible/stretchable and made of polyurethane/polyethylene and each perforation 104 is a through-hole disposed through the layer 203, each perforation inherently comprises an elastic passage disposed through the polymer film 203; thus, the fluid passages comprising elastic passages disposed through the polymer film of Allen is capable of expanding in response to a pressure gradient across the polymer film).
Claim(s) 50 is/are rejected under 35 U.S.C 103 as being unpatentable over Allen in view of Karami and Robinson, as applied to claim 49 above, and further in view of Dagger (US PGPUB 20150150729 – of record).
Regarding claim 50, Allen/Karami/Robinson does not disclose the first area comprises a first material and the second area comprises a second material.
In the same field of endeavor, wound dressing, Dagger discloses a wound filler for use in treating a wound with negative pressure (¶0007). Dagger further discloses the wound filler having a first area and a second area (¶0070). Dagger further discloses that the first area comprising a first material and the second area comprising a second material (¶0070) for the benefit of controlling collapsibility of the wound filler (¶0070).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Allen/Karami/Robinson in view of Dagger by providing the first area of the manifold with a first material and the second area of the manifold with a second material, in order to control collapsibility of the wound filler, as suggested in ¶0070 of Dagger.
Claim(s) 57 is/are rejected under 35 U.S.C 103 as being unpatentable over Allen in view of Karami and Robinson, as applied to claim 56 above, and further in view of Locke (US PGPUB 20150320603 – of record).
Regarding claim 57, Allen further implicitly discloses a source of instillation solution fluidly coupled to the dressing (¶0148: the wound site is irrigated with sterile saline solution; wherein sterile saline solution is a known solution used in instillation therapy; thus, Allen implicitly discloses this claimed limitation).
If Applicant believes that Allen does not teach a source of instillation solution fluidly coupled to the dressing, Locke also teaches a source of instillation solution fluidly coupled to a dressing. Furthermore, instillation therapy is generally well-known to those skilled in the art.
In the same field of endeavor, wound dressing, Locke discloses systems, methods, and apparatuses for debriding a tissue site (Abstract). Locke further teaches a source of instillation (a fluid source 120: ¶0049 and 0078) fluidly coupled to a dressing (120 is coupled to a sealed therapeutic environment 128 comprising a dressing 102 (¶0030, 0075, and Fig. 1) for the benefit of aiding in the removal of debrided tissue, cleaning a manifold and preventing blockage of the manifold (¶0078).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Allen/Karami/Robinson in view of Locke by providing/incorporating a source of instillation solution fluidly coupled to the dressing, in order to aid in the removal of debrided tissue, clean the manifold and prevent blockage of the manifold, as suggested in ¶0078 of Locke.
Claim(s) 59 is/are rejected under 35 U.S.C 103 as being unpatentable over Allen in view of Karami and Robinson, as applied to claim 58 above, and further in view of Locke (US PGPUB 20150320603 – of record).
Regarding claim 59, Allen further implicitly discloses a source of instillation solution fluidly coupled to the dressing (¶0148: the wound site is irrigated with sterile saline solution; wherein sterile saline solution is a known solution used in instillation therapy; thus, Allen implicitly discloses this claimed limitation). Thus, Allen further discloses methods of fluidly coupling a source of instillation solution to the dressing and delivering solution from the source of instillation solution to the dressing.
In addition, since the system of Allen in view of Karami and Robinson meets the structural limitations of the claimed system, it follows naturally that the combination suggested by the prior art would perform the method steps as claimed (See MPEP § 2112.02 (I)).
If Applicant believes that Allen does not teach a source of instillation solution fluidly coupled to the dressing, Locke also teaches a source of instillation solution fluidly coupled to a dressing. Furthermore, instillation therapy is generally well-known to those skilled in the art.
In the same field of endeavor, wound dressing, Locke discloses systems, methods, and apparatuses for debriding a tissue site (Abstract). Locke further teaches a source of instillation (a fluid source 120: ¶0049 and 0078) fluidly coupled to a dressing (120 is coupled to a sealed therapeutic environment 128 comprising a dressing 102 (¶0030, 0075, and Fig. 1) for the benefit of aiding in the removal of debrided tissue, cleaning a manifold and preventing blockage of the manifold (¶0078).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Allen/Karami/Robinson in view of Locke by providing/incorporating a source of instillation solution fluidly coupled to the dressing, in order to aid in the removal of debrided tissue, clean the manifold and prevent blockage of the manifold, as suggested in ¶0078 of Locke.
Claim(s) 69 is/are rejected under 35 U.S.C 103 as being unpatentable over Allen (US PGPUB 20150141941) in view of Karami (US PAT 5308313) and Robinson (US PGPUB 20110178451), as applied to claim 48 above, and further in view of Luckemeyer (US PGPUB 20150119830).
Regarding claim 69, Allen further discloses the cover comprising a margin that extends beyond the first layer and an adhesive disposed in the margin (¶0133: the cover layer 218 seals the layer 203 in a border region 200 around a circumference of the dressing via an adhesive).
Allen/Karami/Robinson does not disclose the adhesive exposed through at least one of the apertures in the third layer.
In the same field of endeavor, wound dressing, Luckemeyer discloses a wound dressing 124 comprising a cover layer 140 (Fig. 1), an adhesive 136 positioned in a periphery 164 of the cover layer 140 (¶0044 and Fig. 1), a fluid management assembly 144, and a base layer 132 comprising apertures 160 (¶0028-0029 and Fig. 4A). Luckemeyer further discloses the adhesive 136 exposed through at least one of the apertures in the base layer 132 (¶0034-0035) for the benefit of providing sufficient contact of the adhesive to secure the wound dressing to the tissue site (¶0035).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Allen/Karami/Robinson in view of Luckemeyer by having the adhesive exposed through at least one of the apertures in the third layer, in order to provide sufficient contact of the adhesive to secure the wound dressing to the tissue site, as suggested in ¶0035 of Luckemeyer.
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 NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781 /LESLIE R DEAK/Primary Examiner, Art Unit 3799
1 April 2026
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