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 claims filed 06/12/2026, 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instant application and in light of the reply to the restriction requirement filed 03/22/2024, claims 31 and 106 are withdrawn and claims 1, 41-42, 44-54, 56, 60-62, 65, 67-68, 70, 72-73, 77, 83, 85-86, 91, 98, and 101 are examined on the merits herein.
Finality
The applicant’s arguments regarding the rejections of claims 1 and 41 in the Response After Final Action filed 06/12/2026 are persuasive; therefore, the finality of the previous Office Action filed 04/14/2026 is withdrawn.
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, see pg. 9-11, filed 06/12/2026, with respect to the rejection(s) of the independent claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a new interpretation of Randolph ‘264 and newly cited art to Hartwell as explained below.
Claim Objections
Claim 54 is objected to because of the following informalities: Claim 54 comprises the limitation “configured to envelope” in ln. 1-2. This should read “configured to envelop”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Primary Art: Randolph
Claims 41-42, 77, and 91 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US/2009/0234264 A1 to Randolph (hereinafter referred to as Randolph ‘264).
Regarding claim 41, Randolph ‘264 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 fluid control layer having a plurality of fluid restrictions (para. 0029, barrier layer as a fluid control layer 140 may be a non-breathable, fluid impermeable or fluid-resistant material; Fig. 1, barrier layer 140 having a plurality of fluid restrictive portions [each section of the tissue interface]), and
a manifold comprising a porous material including a plurality of interconnected fluid pathways, the porous material directly adhered in a stacked relationship to the fluid control layer (para. 0006; para. 0028-0032, pressure-transmitting layer 134 as an open-cell foam considered to be manifold as a layer which provides a means for collecting or distributing fluid across a tissue interface under pressure directly adhered to barrier layer 140; Fig. 1, manifold materials of 116 spans entirety of dressing; Fig. 8A, manifold materials of 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).
Regarding claim 42, the cited prior art discloses the invention of claim 41. Randolph ‘264 discloses: wherein the fluid control layer further comprises a film which is fluid impermeable, and
wherein the fluid control layer is directly adhered to the manifold by a heat-bond or an adhesive (para. 0006; para. 0028-0032, pressure-transmitting layer 134 as an open-cell foam considered to be manifold as a layer which provides a means for collecting or distributing fluid across a tissue interface under pressure directly adhered to barrier layer 140; Fig. 1, manifold materials of 116 spans entirety of dressing; Fig. 8A, manifold materials of 216 spans entirety of dressing).
Regarding claim 77, the cited prior art discloses the invention of claim 41. Randolph ‘264 further discloses: wherein the fluid control layer comprises a polymer film (para. 0006; para. 0028-0032, pressure-transmitting layer 134 as an open-cell foam considered to be manifold as a layer which provides a means for collecting or distributing fluid across a tissue interface under pressure directly adhered to barrier layer 140; Fig. 1, manifold materials of 116 spans entirety of dressing; Fig. 8A, manifold materials of 216 spans entirety of dressing).
Regarding claim 91, the cited prior art discloses the invention of claim 41. Randolph ‘264 further discloses: wherein the manifold comprises open cell foam (para. 0031).
Primary Art: Hartwell
Claims 41-42, 54, 56, 65, 77, 91, and 101 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US/2017/0181897 A1 to Hartwell.
Regarding claim 41, Hartwell discloses a dressing for use with negative-pressure treatment on a foot (Fig. 1, dressing 100; para. 0037), the dressing comprising:
a tissue interface (Fig. 4, tissue interface 102/105) comprising:
a fluid control layer having a plurality of fluid restrictions (Fig. 4, wound contact layer 102 as fluid control layer comprising perforations 104 as fluid restrictions; para. 0040; para. 0055), and
a manifold comprising a porous material including a plurality of interconnected fluid pathways, the porous material directly adhered in a stacked relationship to the fluid control layer (Fig. 1, manifold 105; para. 0040, fluid control layer 102 comprising pressure sensitive adhesive on upper surface 103 in contact with manifold 105; para. 0041);
wherein the tissue interface is shaped anatomically for interaction with the foot (para. 0054, dressing can comprise multiple shapes; interaction with human foot can occur on any portion of the foot such that the tissue interface can interact with the human foot).
Regarding claim 42, the cited prior art discloses the invention of claim 41. Hartwell further discloses: wherein the fluid control layer further comprises a film which is fluid impermeable, and
wherein the fluid control layer is directly adhered to the manifold by a heat-bond or an adhesive (para. 0040, fluid control layer 102 comprising pressure sensitive adhesive on upper surface 103 in contact with manifold 105, fluid control layer can be a polyurethane or polyethylene layer).
Regarding claim 54, the cited prior art discloses the invention of claim 41. Hartwell further discloses: a cover configured to envelop the tissue interface when applied to the foot, wherein the cover is moisture vapor permeable and liquid impermeable (Fig. 1, cover layer 160 enveloping tissue interface when in contact with tissue; para. 0052).
Regarding claim 56, the cited prior art discloses the invention of claim 54. Hartwell further discloses: wherein the cover is separate and apart from the tissue interface (Fig. 1, cover layer 160; para. 0052).
Regarding claim 65, the cited prior art discloses the invention of claim 54. Hartwell further discloses: a fluid port configured to be fluidly coupled to the manifold through the cover (Fig. 4, fluid port 165; para. 0053-0054).
Regarding claim 77, the cited prior art discloses the invention of claim 41. Hartwell further discloses: wherein the fluid control layer comprises a polymer film (para. 0040, fluid control layer 102 comprising pressure sensitive adhesive on upper surface 103 in contact with manifold 105, fluid control layer can be a polyurethane or polyethylene layer).
Regarding claim 91, the cited prior art discloses the invention of claim 41. Hartwell further discloses: wherein the manifold comprises open-cell foam (para. 0041, manifold is a reticulated foam; reticulated foam has open-cells).
Regarding claim 101, the cited prior art discloses the invention of claim 41. Hartwell further discloses: 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 (Fig. 4, perforations 104 on fluid control layer 102).
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.
Primary Art: Randolph
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Ex. Fig. 1-2 of Randolph Fig. 1 and 8A
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over US/2009/0234264 A1 to Randolph (hereinafter referred to as Randolph ‘264) in view of US/2017/0367898 A1 to Östan, and WO/2010/011148 A1 to George.
Regarding claim 1, Randolph ‘264 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),
a fluid control layer having a plurality of fluid restrictions (para. 0029, barrier layer 140 may be a non-breathable, fluid impermeable or fluid-resistant material; Fig. 1, barrier layer 140 having a plurality of fluid restrictive portions [each section of the tissue interface]), and
a manifold comprising open-cell foam directly adhered to the fluid control layer in a stacked relationship across the hindfoot section, the midfoot section, the forefoot section, and the forefoot extension (para. 0006; para. 0028-0032, pressure-transmitting layer 134 considered to be manifold as a layer which provides a means for collecting or distributing fluid across a tissue interface under pressure directly adhered to barrier layer 140; Fig. 1, manifold materials of 116 spans entirety of dressing; Fig. 8A, manifold materials of 216 spans entirety of dressing).
Randolph ‘264 differs from the instantly claimed invention in that Randolph ‘264 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 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, Randolph ‘264 differs from the instantly claimed invention in that Randolph ‘264 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).
It would be considered obvious to one of ordinary skill before the effective filing date of the instant application to modify the system of the cited prior art 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 44-53 are rejected under 35 U.S.C. 103 as being unpatentable over Randolph ‘264 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 ‘264 further discloses:
(Claim 44) 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. 0028-0032, pressure-transmitting layer 134 as an open-cell foam considered to be manifold as a layer which provides a means for collecting or distributing fluid across a tissue interface under pressure directly adhered to barrier layer 140; Fig. 1, manifold materials of 116 spans entirety of dressing; Fig. 8A, manifold materials of 216 spans entirety of dressing).
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 ‘264 is configured for dorsal and plantar wounds (para. 0026) and can be sized for any specific foot (para. 0042), 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 ‘264 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 ‘264 is configured for dorsal and plantar wounds (para. 0026) and can be sized for any specific foot (para. 0042), 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 ‘264 is configured for dorsal and plantar wounds (para. 0026) and can be sized for any specific foot (para. 0042), 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 ‘264 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 ‘264 as applied above, and further in view of WO/2010/011148 A1 to George and US/2014/0276288 A1 to Randolph (hereinafter referred to as Randolph ‘288).
Regarding claims 54, 56, 60-62, and 65, the cited prior art discloses the invention of claim 41.
Randolph ‘264 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 materials of 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 the cited prior art 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 ‘264, as currently modified by George, differs from the instantly claimed invention in that the prior art fails to disclose (Claim 54) 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).
Claim 98 is rejected under 35 U.S.C. 103 as being unpatentable over Randolph ‘264 as applied above.
Regarding claim 98, the cited prior art suggests the invention of claim 41. Randolph ‘264 further discloses: wherein the manifold has a thickness (Fig. 1).
Randolph ‘264 differs from the instantly claimed invention in that Randolph ‘264 fails to disclose wherein the manifold has a thickness less than 7 millimeters.
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 manifold of Randolph ‘264 to have a thickness less than 7 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 ‘264 would not operate differently with the claimed thickness and since the manifold of Randolph ‘264 is meant to distribute fluid, the manifold would function appropriately having the claimed thickness. 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.”).
Claim 101 is rejected under 35 U.S.C. 103 as being unpatentable over Randolph ‘264 as applied above, and further in view of AU/2014/277788 A1 to Jaeb.
Regarding claim 101, the cited prior art discloses the invention of claim 41; however, the prior art differs from the instantly claimed invention in that the prior art fails 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.
Primary Art: Hartwell
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over US/2017/0181897 A1 to Hartwell as applied above, and further in view of US/2009/0234264 A1 to Randolph (hereinafter referred to as Randolph ‘264), US/2017/0367898 A1 to Östan, and WO/2010/011148 A1 to George.
Regarding claim 1, Hartwell discloses a dressing for use with negative-pressure treatment on a foot (Fig. 1, dressing 100; para. 0037), the dressing comprising:
a tissue interface (Fig. 4, tissue interface 102/105) comprising:
a fluid control layer having a plurality of fluid restrictions (Fig. 4, wound contact layer 102 as fluid control layer comprising perforations 104 as fluid restrictions; para. 0040; para. 0055), and
a manifold comprising an open-cell foam directly adhered in a stacked relationship to the fluid control layer (Fig. 1, manifold 105; para. 0040, fluid control layer 102 comprising pressure sensitive adhesive on upper surface 103 in contact with manifold 105; para. 0041; reticulated foam is open-cell); and
a cover comprising a non-porous film (Fig. 1, cover layer 160 enveloping tissue interface when in contact with tissue; para. 0052).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose the tissue interface comprising:
a hindfoot section comprising at least two heel flaps,
a midfoot section,
a forefoot section, and
a forefoot extension configured to fold over the forefoot section.
Randolph ‘264 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), and
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
wherein the dressing is useful for providing reduced pressure for foot wounds and allows for a dressing to be placed in a cast shoe, sandal, or over size shoe (para. 0002-0003; para. 0008-0009; para. 0040; para. 0042).
Östan teaches a dressing (Fig. 2, heel dressing 1) comprising: 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).
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 the foot shaped pattern of Randolph ‘264 and two heel flaps as taught by Östan, because Randolph ‘264 discloses that the dressing of their invention is useful for providing reduced pressure for foot wounds and allows for a dressing to be placed in a cast shoe, sandal, or over size shoe (para. 0002-0003; para. 0008-0009; para. 0040; para. 0042) and 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 differs from the instantly claimed invention in that the prior art fails to disclose wherein the cover has an open end configured to receive the tissue interface applied to the foot.
George teaches a negative pressure dressing for a foot comprising a cover (pg. 9 ln. 27-34 and pg. 10 ln. 1-2; pg. 11 ln. 10-13; Fig. 2, cover 4), and wherein the cover comprises a bag-like configuration having an open end configured to receive the tissue interface so that the cover can be shaped as a sock for wounds on the foot (pg. 8 ln. 3-7; pg. 9 ln. 27-34 and pg. 10 ln. 1-11; pg. 11 ln. 10-13; Fig. 2, open end 10 of 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 the cited prior art 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, and that a bag-shaped cover can act as a sock for wounds on the foot (pg. 9 ln. 27-34 and pg. 10 ln. 1-11).
Claims 44-53, 67-68, 70, and 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell as applied above, and further in view of US/2009/0234264 A1 to Randolph ‘264 and US/2017/0367898 A1 to Östan.
Regarding claims 44-50 and 53, the cited prior art discloses the invention of claim 41.
The cited prior art differs from the instantly claimed invention in that Hartwell fails to disclose
(Claim 44) wherein the tissue interface further comprises:
a hindfoot section adapted for a heel of the foot and comprising at least two heel flaps; an underfoot section adapted to a remainder of the foot; and
a forefoot extension section extending along a longitudinal axis of the underfoot section and configured to fold over at least an anterior portion of toes of the foot;
wherein the fluid control layer and the manifold span the entirety of the hindfoot section, the underfoot section, and the forefoot extension section;
(Claim 45) wherein the underfoot section further comprises a midfoot section and a forefoot section;
(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; and
(Claim 53) wherein the tissue interface is approximately symmetrical about the longitudinal centerline axis.
Randolph ‘264 teaches a negative pressure wound therapy dressing (Fig. 1)
(Claim 44) 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. 0028-0032, pressure-transmitting layer 134 as an open-cell foam considered to be manifold as a layer which provides a means for collecting or distributing fluid across a tissue interface under pressure directly adhered to barrier layer 140; Fig. 1, manifold materials of 116 spans entirety of dressing; Fig. 8A, manifold materials of 216 spans entirety of dressing);
(Claim 45) 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);
(Claim 53) 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); and
wherein the dressing is useful for providing reduced pressure for foot wounds and allows for a dressing to be placed in a cast shoe, sandal, or over size shoe (para. 0002-0003; para. 0008-0009; para. 0040; para. 0042).
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);
(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); and
wherein the shape of the heel flap facilitates folding about the heel for the treatment of heel pressure ulcers (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 tissue interface of the cited prior art to comprise the foot shaped pattern of Randolph ‘264 and two heel flaps as taught by Östan, because Randolph ‘264 discloses that the dressing of their invention is useful for providing reduced pressure for foot wounds and allows for a dressing to be placed in a cast shoe, sandal, or over size shoe (para. 0002-0003; para. 0008-0009; para. 0040; para. 0042) and 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 ‘264 is configured for dorsal and plantar wounds (para. 0026) and can be sized for any specific foot (para. 0042), 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 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 ‘264 is configured for dorsal and plantar wounds (para. 0026) and can be sized for any specific foot (para. 0042), 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 ‘264 is configured for dorsal and plantar wounds (para. 0026) and can be sized for any specific foot (para. 0042), 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 67, the cited prior art suggests the invention of claim 44. Hartwell further discloses:
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 (para. 0040, lower pressure sensitive adhesive on side of fluid control layer 102 opposite manifold 105; for fluid to pass through fluid control layer 102, lower pressure sensitive adhesive must comprise apertures aligned with fluid restrictions 104).
Regarding claim 68, the cited prior art suggests the invention of claim 67; however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein the gel layer is coextensive with the fluid control layer and the manifold, spanning all areas of the wound dressing.
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 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).
Regarding claim 70, the cited prior art suggests the invention of claim 67. Hartwell further discloses: wherein the gel layer comprises an adhesive surface opposite the fluid control layer (para. 0040, lower pressure sensitive adhesive on side of fluid control layer 102 opposite manifold 105).
Regarding claim 72, the cited prior art suggests the invention of claim 67. Hartwell further discloses: a release liner in stacked relationship with the gel layer opposite the fluid control layer (para. 0060, lower protective layer).
Regarding claim 73, the cited prior art suggests the invention of claim 67. Hartwell further discloses: wherein the gel layer comprises silicone (para. 0040).
Claims 60-62 are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell as applied above, and further in view of WO/2010/011148 A1 to George.
Regarding claims 60-62, the cited prior art discloses the invention of claim 54. The cited prior art differs from the instantly claimed invention in that the prior art fails to disclose
(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; and (Claim 62) an attachment device adapted to seal the open end of 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);
(Claim 60) wherein the cover comprises a bag-like configuration having an open end configured to receive the tissue interface so that the cover can be shaped as a sock for wounds on the foot (pg. 8 ln. 3-7; pg. 9 ln. 27-34 and pg. 10 ln. 1-11; 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).
It would be considered obvious to one of ordinary skill before the effective filing date of the instant application to modify the system of the cited prior art 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, and that a bag-shaped cover can act as a sock for wounds on the foot (pg. 9 ln. 27-34 and pg. 10 ln. 1-11).
Claims 83 and 98 are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell as applied above.
Regarding claim 83, the cited prior art discloses the invention of claim 41. Hartwell further discloses: wherein the fluid restrictions comprise a plurality of slots (Fig. 1-4, fluid restrictions 104 as through holes; para. 0040).
The cited prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein the slots have a length less than 4 millimeters and a width less than 2 millimeters.
Hartwell discloses that the size of the fluid restrictions needs to be optimized such that the wound contact layer helps prevent tissue ingrowth while still allowing fluid through (para. 0040). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hartwell device to have fluid restriction dimensions within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, 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 device of Hartwell by making the slots have a length less than 4 mm and a width less than 2 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2144.05.
Regarding claim 98, the cited prior art discloses the invention of claim 41. Hartwell further discloses: wherein the manifold has a thickness (Fig. 1, manifold 105).
The cited prior art differs from the instantly claimed invention in that the cited prior art fails to disclose wherein the manifold has a thickness of less than 7 millimeters.
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 manifold of Hartwell to have a thickness less than 7 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 Hartwell would not operate differently with the claimed thickness and since the manifold of Hartwell is meant to distribute fluid, the manifold would function appropriately having the claimed thickness. 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 85-86 are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell as applied above, and further in view of US/2012/0046603 A1 to Vinton.
Regarding claims 85-86, the cited prior art discloses the invention of claim 41; however, the cited prior art differs from the instantly claimed invention in that the prior art fails 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 a 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. 001 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).
Conclusion
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 13 July 2026
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