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 .
In light of the amendments to the claims filed 01/06/2026 in which claims 1, 41, 44, and 67 were amended and claim 43 was cancelled, claims 1, 31, 41-42, 44-54, 56, 60-62, 65, 67-68, 70, 72-73, 77, 83, 85-86, 91, 98, 101, and 106 are pending in the instant application and in light of the reply to the restriction requirement filed 03/22/2024, claims 31 and 106 are withdrawn and claims 1, 41-42, 44-54, 56, 60-62, 65, 67-68, 70, 72-73, 77, 83, 85-86, 91, 98, and 101 are examined on the merits herein.
Priority
The instant application is a 371 of PCT/IB2020/057150 filed 07/29/2020 which claims priority to U.S. Provisional Application no. 62/880,217 filed on 07/30/2019.
Claims 1, 31, 41-42, 44-54, 56, 60-62, 65, 67-68, 70, 72-73, 77, 83, 85-86, 91, 98, 101, and 106 receive priority to the prior-filed application, filed on 07/30/2019.
Response to Arguments
Rejections under 35 U.S.C. 103
Applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding amended claims 1 and 41, applicant asserts on pg. 9-11 that the prior art to Randolph ‘264 and Randolph ‘288 do not disclose the newly amended limitations and that Randolph ‘264 fails to illustrate the alternative embodiment of the manifold relied upon in the rejection or teach that the barrier layer (140) is the same feature as the non-breathable material described in the alternative embodiment.
In response to the applicant’s arguments, the examiner respectfully notes that Randolph ‘264 as used in the previous Office Action filed 10/10/2025 reads on the newly added limitation of the manifold comprising an open-cell foam or comprising a porous material including a plurality of interconnected fluid pathways. Further, as cited in the previous rejection, Randolph ‘264 discloses that the offloading manifold material includes a support layer, a pressure-transmitting layer, and a barrier layer and that the support layer and pressure-transmitting layer may be a single layer that is formed with a small-pore open-cell foam that is coated with a non-breathable material (para. 0006). Randolph ‘264 further discloses that the barrier layer may be formed from various materials, such as a flexible, non-breathable material formed from a polyurethane coated warp knitted fabric (para. 0029) that would be considered to provide some cushion; therefore, while it is not explicitly stated in the disclosure of Randolph ‘264, the barrier layer could be the non-breathable material that provides some offloading strength that is coated on the single layer support and pressure-transmitting layer. It seems clear from the disclosure of Randolph ‘264 that the manifold should comprise support, pressure-transmission, and non-breathability on an outside layer (para. 0027-0032). The alternative embodiment of Randolph ‘264 further does not need to be illustrated as it can be readily understood to be a simple modification of the illustrated manifold in Fig. 1.
Further, the newly amended limitation has necessitated a new grounds of rejection as explained below.
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.
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Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over US/2009/0234264 A1 to Randolph in view of US/2017/0367898 A1 to Östan, US/2014/0276288 A1 to Randolph (hereinafter referred to as Randolph ‘288), and WO/2010/011148 A1 to George.
Regarding claim 1, Randolph discloses a dressing for use with negative-pressure treatment on a foot (Fig. 1; Fig. 8A), the dressing comprising:
a tissue interface (Fig. 1, negative-pressure tissue interface 102; Fig. 8A, negative-pressure tissue interface 202) comprising:
a hindfoot section (Ex. Fig. 1 showing hindfoot section for heel of the foot; Ex. Fig. 2 extrapolated from Ex. Fig. 1),
a midfoot section,
a forefoot section (Ex. Fig. 1 showing midfoot and forefoot sections of underfoot section; Ex. Fig. 2 extrapolated from Ex. Fig. 1),
a forefoot extension section configured to fold over the forefoot section (Ex. Fig. 1 showing forefoot extension section configured to fold over forefoot section; Ex. Fig. 2 extrapolated from Ex. Fig. 1), and
a manifold comprising open-cell foam across the hindfoot section, the midfoot section, the forefoot section, and the forefoot extension (para. 0006; para. 0029-0032, manifold material 116 comprising support layer 128 and pressure-transmitting layer 134 as a single layer small-pore open cell-foam coated with non-breathable material 140; Fig. 1, manifold material 116 spans entirety of dressing; Fig. 8A, manifold material 216 spans entirety of dressing).
Randolph differs from the instantly claimed invention in that Randolph fails to disclose the hindfoot section comprising at least two heel flaps.
Östan teaches a dressing (Fig. 2, heel dressing 1) comprising: a hindfoot section comprising at least two heel flaps to facilitate folding and conforming of the dressing to the heel (Fig. 2, heel flaps 32/34 in hindfoot section 11; para. 0093 ln. 1-10).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the hindfoot section of the tissue interface of Randolph and Randolph ‘288 to comprise two heel flaps as taught by Östan, because Östan discloses that the shape and configuration of the heel flaps facilitates the folding and conforming of the dressing to the heel and that the heel flaps provide an additional advantage in cover the malleoli of the heel, which may be at risk of developing pressure ulcers when a person lies on their side (para. 0093 ln. 1-10).
Further, Randolph differs from the instantly claimed invention in that Randolph fails to disclose a fluid control layer having a plurality of fluid restrictions, and the manifold directly adhered to the fluid control layer in a stacked relationship.
Randolph ‘288 teaches a dressing for use with negative pressure treatment on a foot comprising a fluid control layer having a plurality of fluid restrictions (Fig. 6A, comfort/fluid control layer 620 having perforations/fluid restrictions 621); and a manifold directly adhered to the fluid control layer in a stacked relationship to provide additional comfort for a patient and prevent skin irritation without significantly impeding airflow (para. 0041; para. 0066-0071; Fig. 6A, manifold 610 stacked on fluid control layer 620; Fig. 6A-B showing fluid control layer 620 spanning entirety of manifold 610 and extending outwardly from manifold 610 to ensure that fluid control layer 620 is disposed between manifold 610 and epidermis).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the tissue interface of Randolph to comprise a fluid control layer and the manifold in a stacked relationship with the fluid control layer as taught by Randolph ‘288, because Randolph ‘288 teaches that the fluid control layer of their invention provides additional comfort for the patient and helps to prevent skin irritation without significantly impeding airflow (para. 0069).
Further still, Randolph differs from the instantly claimed invention in that Randolph fails to disclose a cover comprising a non-porous film having an open end configured to receive the tissue interface applied to the foot.
George teaches a negative pressure treatment system for a foot comprising a cover comprising a non-porous film (pg. 7 ln. 34 and pg. 8 ln. 1-3) having an open end configured to receive a tissue interface applied to the foot to provide a hermetically sealed environment (pg. 8 ln. 3-4; pg. 9 ln. 27-34 and pg. 10 ln. 1-2; pg. 11 ln. 10-13; Fig. 2, cover 4 configured to envelope tissue interface 12).
George is considered to be analogous to the instantly claimed invention in that George discloses a negative pressure dressing for a foot. It would be considered obvious to one of ordinary skill before the effective filing date of the instant application to modify the system of Randolph and Randolph ‘288 to further comprise a cover as taught by George, because George teaches that a cover provides a hermetically sealed environment (pg. 9 ln. 27-34 and pg. 10 ln. 1-2), such that the cover acts as a barrier to the egress of microorganisms and keeps in suction pressure.
Claims 41-42, 77, 83, 91, and 98 are rejected under 35 U.S.C. 103 as being unpatentable over US/2009/0234264 A1 to Randolph in view of US/2014/0276288 A1 to Randolph (hereinafter referred to as Randolph ‘288).
Regarding claims 41-42, 77, and 83, Randolph discloses
(Claim 41) a dressing for use with negative-pressure treatment on a foot (Fig. 1; Fig. 8A), the dressing comprising:
a tissue interface (Fig. 1, negative-pressure tissue interface 102; Fig. 8A, negative-pressure tissue interface 202) comprising:
a manifold (para. 0006; para. 0029-0032, manifold material 116 comprising support layer 128 and pressure-transmitting layer 134 as a single layer small-pore open cell-foam coated with non-breathable material 140; Fig. 1, manifold material 116 spans entirety of dressing; Fig. 8A, manifold material 216 spans entirety of dressing);
wherein the tissue interface is shaped anatomically for interaction with the foot (Fig. 1 showing negative-pressure tissue interface 102 shaped similarly to the foot; para. 0026 ln. 8-14; para. 0043 ln. 11-15).
Randolph differs from the instantly claimed invention in that Randolph fails to disclose
(Claim 41) a fluid control layer having a plurality of fluid restrictions, and the porous material of the manifold directly adhered in a stacked relationship to the fluid control layer;
(Claim 42) wherein the fluid control layer comprises a film which is fluid impermeable;
(Claim 77) wherein the fluid control layer comprises a polymer film; and
(Claim 83) wherein the fluid restrictions comprise a plurality of slots.
Randolph ‘288 teaches a dressing for use with negative pressure treatment on a foot comprising
(Claim 41) a fluid control layer having a plurality of fluid restrictions (Fig. 6A, comfort/fluid control layer 620 having perforations/fluid restrictions 621); and a manifold formed from an open-cell porous material directly adhered to the fluid control layer in a stacked relationship to provide additional comfort for a patient and prevent skin irritation without significantly impeding airflow (para. 0039-0041; para. 0066-0071; Fig. 6A-B showing fluid control layer 620 spanning entirety of manifold 610 and extending outwardly from manifold 610 to ensure that fluid control layer 620 is disposed between manifold 610 and epidermis);
(Claim 42) wherein the fluid control layer further comprises a film which is fluid impermeable (para. 0041; para. 0069, fluid control layer 620 may be formed from an occlusive material)
(Claim 77) wherein the fluid control layer comprises a polymer film (para. 0041; para. 0069, fluid control layer 620 may be formed from an occlusive material); and
(Claim 83) wherein the fluid restrictions comprise a plurality of slots (para. 0069, fluid restrictions 621 include a plurality of perforations or holes).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the tissue interface of Randolph to comprise a fluid control layer and the manifold in a stacked relationship with the fluid control layer as taught by Randolph ‘288, because Randolph ‘288 teaches that the fluid control layer of their invention provides additional comfort for the patient and helps to prevent skin irritation without significantly impeding airflow (para. 0069).
Further regarding claim 83, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid restrictions of Randolph, as modified by Randolph ‘288, to have a length less than 4 millimeters and a width less than 2 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Randolph, as modified by Randolph ‘288, would not operate differently with the claimed diameter and since the fluid restrictions of Randolph ‘288 are meant to allow airflow, the fluid restrictions would function appropriately having the claimed length and width. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length and width “may” be within the claimed ranges (specification pp. [0065]).
Regarding claim 91, the cited prior art suggests the invention of claim 41. Randolph further discloses: wherein the manifold comprises foam (para. 0032 ln. 1-5).
Regarding claim 98, the cited prior art suggests the invention of claim 41. Randolph further discloses: wherein the manifold has a thickness between 4-15 millimeters (para. 0028 ln. 9-13).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the manifold of Randolph, as modified by Randolph ‘288, from between 4-15 mm to less than 7 mm as applicant appears to have placed no criticality on the claimed range ([0057] In some embodiments, a thickness in a range of about 5 millimeters to 10 millimeters may be suitable.) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Randolph would not operate differently with the claimed range and since the manifold is configured provide support to the foot and Randolph discloses the use of thicknesses within the claimed range, the device would function appropriately using the claimed range. Further, applicant places no criticality on the range claimed, indicating simply that the thickness is about 5-10 mm ([0057] “In some embodiments, a thickness in a range of about 5 millimeters to 10 millimeters may be suitable.”)
Claims 44-53 are rejected under 35 U.S.C. 103 as being unpatentable over Randolph and Randolph ‘288 as applied above, and further in view of US/2017/0367898 A1 to Östan.
Regarding claims 44 and 46-50, the cited prior art suggests the invention of claim 41.
Randolph further discloses: wherein the tissue interface (Fig. 1, negative-pressure tissue interface 102; Fig. 8A, negative-pressure tissue interface 202) further comprises: a hindfoot section adapted for a heel of the foot (Ex. Fig. 1 showing hindfoot section for heel of the foot; Ex. Fig. 2 extrapolated from Ex. Fig. 1); an underfoot section adapted to a remainder of the foot (Ex. Fig. 1 showing underfoot section for remainder of foot; Ex. Fig. 2 extrapolated from Ex. Fig. 1); and a forefoot extension section extending along a longitudinal axis of the underfoot section and configured to fold over at least a portion of the underfoot section (Ex. Fig. 1 showing forefoot extension section extending along a longitudinal axis of the underfoot section in the folded configuration and configured to fold over underfoot section; Ex. Fig. 2 extrapolated from Ex. Fig. 1); wherein the fluid control layer and the manifold span the entirety of the hindfoot section, the underfoot section, and the forefoot extension section (para. 0006; para. 0029-0032, manifold material 116 comprising support layer 128 and pressure-transmitting layer 134 as a single layer small-pore open cell-foam coated with non-breathable material 140; Fig. 1, manifold material 116 spans entirety of dressing; Fig. 8A, manifold material spans entirety of dressing 216).
Randolph ‘288 (as explained in the rejection of claim 41 above) further teaches that the fluid control layer extends along the entire manifold (para. 0069; Fig. 6A-B showing fluid control layer 620 spanning entirety of manifold 610 and extending outwardly from manifold 610 to ensure that fluid control layer 620 is disposed between manifold 610 and epidermis).
The prior art differ from the instantly claimed invention in that they fail to disclose
(Claim 44) that the hindfoot section comprising at least two heel flaps to facilitate folding;
(Claim 46) wherein the at least two heel flaps of the hindfoot section are separated from each other by a hindfoot notch; and wherein the hindfoot section is separated from the underfoot section by two demarcation notches;
(Claim 47) wherein the hindfoot notch is v-shaped;
(Claim 48) wherein each of the demarcation notches is v-shaped;
(Claim 49) wherein the hindfoot section comprises a posterior portion which is curved;
(Claim 50) wherein the hindfoot notch is located on a longitudinal centerline axis of the tissue interface.
Östan teaches a dressing (Fig. 2, heel dressing 1) comprising:
(Claim 44) a hindfoot section comprising at least two heel flaps (Fig. 2, heel flaps 32/34 in hindfoot section 11) to facilitate folding and conforming of the dressing to the heel (para. 0093 ln. 1-10);
(Claim 46) wherein the at least two heel flaps of the hindfoot section are separated from each other by a hindfoot notch (Fig. 2, heel flaps 32/34 separated by hindfoot notch 46); and wherein the hindfoot section is separated from the underfoot section by two demarcation notches (Fig. 2, hindfoot section 11 comprising heel flaps separated from underfoot section 12 by two notches 74);
(Claim 47) wherein the hindfoot notch is v-shaped (Fig. 2, hindfoot notch 46 generally v-shaped);
(Claim 48) wherein each of the demarcation notches is v-shaped (Fig. 2, notches 74 generally v-shaped);
(Claim 49) wherein the hindfoot section comprises a posterior portion which is curved (Fig. 2, hindfoot section 11 having a curved outer path); and
(Claim 50) wherein the hindfoot notch is located on a longitudinal centerline axis of the tissue interface (Fig. 2 showing hindfoot notch 46 located on longitudinal centerline axis P).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the hindfoot section of the tissue interface of the cited prior art to comprise two heel flaps as taught by Östan, because Östan discloses that the shape and configuration of the heel flaps facilitates the folding and conforming of the dressing to the heel and that the heel flaps provide an additional advantage in cover the malleoli of the heel, which may be at risk of developing pressure ulcers when a person lies on their side (para. 0093 ln. 1-10).
Further, the prior art differ from the instantly claimed invention in that the prior art fails to disclose wherein the forefoot extension section is configured to fold over an anterior portion of toes of the foot.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the forefoot extension such that it is sized and shaped to fold over an anterior portion of toes of the foot, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04(IV)(B). As Randolph is configured for dorsal and plantar wounds (para. 0026), the modification would provide the additional benefit of providing a larger treatment surface for dorsal wounds on the toes. In the device as modified, the forefoot extension would be shaped to have an extension above the toes.
Regarding claim 45, the cited prior art suggests the invention of claim 44. Randolph further discloses: wherein the underfoot section further comprises a midfoot section and a forefoot section (Ex. Fig. 1 showing midfoot and forefoot sections of underfoot section; Ex. Fig. 2 extrapolated from Ex. Fig. 1).
Regarding claim 51, the cited prior art suggests the invention of claim 44; however, the prior art differs from the instantly claimed invention in that they fail to disclose wherein the forefoot extension section is approximately rectangular in shape.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the forefoot extension such that it is approximately rectangular in shape, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04(IV)(B). As Randolph is configured for dorsal and plantar wounds (para. 0026), the modification would provide the additional benefit of providing a larger treatment surface for dorsal wounds. In the device as modified, the forefoot extension would be shaped approximately rectangularly.
Regarding claim 52, the cited prior art suggests the invention of claim 44; however, the prior art differs from the instantly claimed invention in that they fail to disclose wherein the underfoot section necks down as it extends from the hindfoot section to the forefoot extension section.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the underfoot section such that it necks down as it extends from the hindfoot section to the forefoot extension section, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04(IV)(B). As Randolph is configured for dorsal and plantar wounds (para. 0026), the modification would provide the additional benefit of providing a tissue interface which is closer in shape to the natural anatomy of the foot. In the device as modified, the underfoot section would decrease in width from the hindfoot section up to the forefoot extension section.
Regarding claim 53, the cited prior art suggests the invention of claim 50. Randolph further discloses: wherein the tissue interface is approximately symmetrical about the longitudinal centerline axis (Ex. Fig. 1 showing negative pressure tissue interface 102 in a use condition; Ex. Fig. 2 would then be approximately symmetrical about a longitudinal centerline axis in said use condition such that the forefoot extension would be flipped above the rest of negative pressure tissue interface 202).
Claims 54, 56, 60-62, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Randolph and Randolph ‘288 as applied above, and further in view of WO/2010/011148 A1 to George.
Regarding claims 54, 56, 60-62, and 65, the cited prior art suggests the invention of claim 41.
Randolph further discloses (Claim 65) a fluid port configured to be fluidly coupled to the manifold (para. 0034 ln. 1-5; para. 0035 ln. 3-6; Fig. 1, port 150 fluidly coupled to manifold material 116).
The prior art differs from the instantly claimed invention in that they fail to disclose
(Claim 54) a cover configured to envelope the tissue interface when applied to the foot, wherein the cover is water vapor permeable and liquid impermeable
(Claim 56) wherein the cover is separate and apart from the tissue interface;
(Claim 60) wherein the cover comprises a bag-like configuration having an open end configured to receive the tissue interface;
(Claim 61) wherein the cover is anatomically shaped to approximately match the foot;
(Claim 62) an attachment device adapted to seal the open end of the cover; and
(Claim 65) a fluid port configured to be fluidly coupled to the manifold through the cover.
George teaches a negative pressure dressing for a foot comprising
(Claim 54) a cover configured to envelope a tissue interface when applied to the foot to provide a hermetically sealed environment (pg. 9 ln. 27-34 and pg. 10 ln. 1-2; pg. 11 ln. 10-13; Fig. 2, 4 cover configured to envelope 12 tissue interface), wherein the cover is liquid impermeable (pg. 7 ln. 34);
(Claim 56) wherein the cover is separate and apart from the tissue interface (pg. 11 ln. 10-13);
(Claim 60) wherein the cover comprises a bag-like configuration having an open end configured to receive the tissue interface (pg. 8 ln. 3-7; pg. 11 ln. 10-13; Fig. 2, open end 10 of cover 4);
(Claim 61) wherein the cover is anatomically shaped to approximately match the foot (Fig. 2, cover 4 shown to be anatomically shaped to match the foot);
(Claim 62) an attachment device adapted to seal the open end of the cover (pg. 8 ln. 3-7; pg. 10 ln. 4-11); and
(Claim 65) a fluid port configured to be fluidly coupled to the manifold through the cover (pg. 8 ln. 25-31; Fig. 2, fluid port 11 for fluidic connection to tissue interface 12 within cover 4).
It would be considered obvious to one of ordinary skill before the effective filing date of the instant application to modify the system of Randolph and Randolph ‘288 to further comprise a cover as taught by George, because George teaches that a cover provides a hermetically sealed environment (pg. 9 ln. 27-34 and pg. 10 ln. 1-2), such that the cover acts as a barrier to the egress of microorganisms and keeps in suction pressure.
Further, Randolph, as currently modified by Randolph ‘288 and George, differs from the instantly claimed invention in that the prior art fails to disclose the cover being water-vapor permeable.
Randolph ‘288 teaches a dressing for use with negative pressure treatment on a foot comprising a cover (Fig. 1, 112 cover) that is water-vapor permeable to allow the transmission of perspiration out of the cover (para. 0036; para. 0044).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to further modify the cover of the cited prior art to be water-vapor permeable as taught by Randolph ‘288, because Randolph ‘288 discloses a cover similar to that of George and Randolph ‘288’s cover performs the same function of that of George (para. 0042) with the additional advantage of allowing the transmission of perspiration out of the cover to mitigate the risk of infection caused by perspiration in the system (para. 0036 ln. 2-5; para. 0044 ln. 1-8).
Claims 67-68, 70, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Randolph, Randolph ‘288, and Östan as applied above, and further in view of US/2017/0079846 A1 to Locke.
Regarding claims 67-68, 70, and 73, the cited prior art suggests the invention of claim 44.
The prior art differ from the instantly claimed invention in that they fail to disclose
(Claim 67) a gel layer disposed adjacent to the fluid control layer opposite the manifold, the gel layer having a plurality of apertures at least partially aligned with the fluid restrictions of the fluid control layer such that the fluid restrictions and a portion of the fluid control layer around the fluid restrictions are exposed through at least one of the apertures in the gel layer;
(Claim 68) wherein the gel layer is coextensive with the fluid control layer and the manifold, spanning the entirety of the hindfoot section, the underfoot section, and the forefoot extension section;
(Claim 70) wherein the gel layer comprises an adhesive surface opposite the fluid control layer; and
(Claim 73) wherein the gel layer comprises silicone.
Locke teaches a dressing for use with negative pressure comprising:
(Claim 67) a gel layer (Fig. 1A, adhesive layer 112; para. 0083 ln. 5-15) disposed adjacent to a polymeric layer comprising fenestrations (Fig. 1A, adhesive layer 112 disposed adjacent to polymeric layer 111 comprising apertures 132), the gel layer having a plurality of apertures (Fig. 2, adhesive layer 112 comprising apertures 116) at least partially aligned with the fenestrations of the polymeric layer (para. 0078 ln. 9-19; Fig. 3 showing alignment of apertures 116/132) such that the fluid restrictions and a portion of the fluid control layer around the fluid restrictions are exposed through at least one of the apertures of the gel layer (Fig. 1A);
(Claim 68) wherein the gel layer is coextensive with the fluid control layer (Locke: Fig. 2, 112 adhesive layer coextensive with polymeric layer 111 comprising apertures 132);
(Claim 70) wherein the gel layer comprises an adhesive surface opposite the fluid control layer (para. 0074 ln. 1-4; para. 0079 ln. 11-15); and
(Claim 73) wherein the gel layer comprises silicone (para. 0074 ln. 1-8; para. 0083 ln. 5-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the hydrocolloid ring of Randolph that forms a seal between the tissue interface and the patient’s skin, for the silicone polymer adhesive of Locke since these mechanisms perform the same function of providing a sealed adhesive connection between the negative pressure device and the patient’s skin. Simply substituting one biocompatible adhesive means for another would yield the predicable result of allowing a sealed relationship between the negative pressure dressing and the user. See MPEP 2143.
Further regarding claim 68, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gel layer such that it is coextensive with both the fluid control layer and the manifold, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04(IV)(B). The modification would provide a larger sealing area, which would provide a stronger adhesive strength such that the device is less likely to come off in use. In the device as modified, the gel layer would be coextensive with both the fluid control layer and the manifold layer.
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over Randolph, Randolph ‘288, Östan, and Locke as applied above, and further in view of US/2010/0087767 A1 to McNeil.
Regarding claim 72, the cited prior art suggests the invention of claim 67; however, the prior art differs from the instantly claimed invention in that they fail to disclose a release liner in stacked relationship with the gel layer opposite the fluid control layer.
McNeil teaches a negative pressure dressing comprising a release liner in a stacked relationship with an adhesive layer to cover the adhesive until the dressing is ready for application (para. 0044 ln. 1-3; para. 0049 ln. 1-3; Fig. 2B, release liner 220 on an adhesive).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the adhesive surface of the gel layer opposite the fluid control layer of the cited prior art to further comprise a release liner as taught by McNeil, because McNeil teaches that a release liner may cover an adhesive layer until the dressing is ready for application (para. 0044 ln. 1-3), ensuring that the adhesive does not stick to anything other than the desired application area.
Claims 85-86 are rejected under 35 U.S.C. 103 as being unpatentable over Randolph and Randolph ‘288 as applied above, and further in view of US/2012/0046603 A1 to Vinton.
Regarding claim 85-86, the cited prior art suggests the invention of claim 41.
The prior art differ from the instantly claimed invention in that they fail to disclose
(Claim 85) wherein the fluid restrictions comprise elastomeric valves and the elastomeric valves are normally closed; and
(Claim 86) wherein the elastomeric valves are fenestrations.
Vinton teaches negative pressure dressing comprising a fluid-impermeable layer of a negative pressure system comprising fluid restrictions (para. 0008; Fig. 1, fluid restrictions 21 in fluid-impermeable layer 17)
(Claim 85) wherein the fluid restrictions comprise elastomeric valves and the elastomeric valves are normally closed (para. 0011; para. 0015); and
(Claim 86) wherein the elastomeric valves are fenestrations to seal the tissue from sources of external infection (para. 0011; para. 0015).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the fluid restrictions of the cited prior art to be elastomeric valves as taught by Vinton, because Vinton teaches that these allow for the dressing to provide optimal healing conditions for damaged tissue whilst allowing excessive fluid produced by the damaged tissue to be removed; therefore, the tissue may be sealed from sources of external infection and a beneficial amount of fluid may be maintained under the dressing (para. 0011; para. 0015).
Claim 101 is rejected under 35 U.S.C. 103 as being unpatentable over Randolph and Randolph ‘288 as applied above, and further in view of AU/2014/277788 A1 to Jaeb.
Regarding claim 101, the cited prior art suggests the invention of claim 41; however, the prior art differ from the instantly claimed invention in that they fail to disclose wherein the tissue interface comprises perforations spaced inward from an edge of the tissue interface and approximately tracking a contour of an exterior of the edge.
Jaeb teaches a negative pressure dressing comprising a tissue interface (Fig. 14-15, tissue interface 1400 and 1500) comprising perforations spaced inward from an edge of the tissue interface and approximately tracking a contour of an exterior of the edge to allow for tearing and sizing of the layers of the dressing (para. 0107 ln. 2-5; Fig. 14-15, perforations 1405 and 1505 spaced inward from the edge of tissue interfaces 1400 and 1500 and somewhat tracking an exterior of the edge in at least some areas).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the tissue interface of the cited prior art to comprise perforations as taught by Jaeb, because Jaeb teaches that these perforations allow for tearing and sizing of the layers for use in the dressing (para. 0107 ln. 2-5), allowing for some adaptability of the dressing.
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
10 April 2026
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