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 10/21/2024 in which claims 1 and 41-42 were amended, claims 1, 31, 41-54, 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instant application and in light of the reply to the restriction requirement filed 03/22/2024, claims 31 and 106 are withdrawn and claims 1, 41-54, 56, 60-62, 65, 67-68, 70, 72-73, 77, 83, 85-86, 91, 98, and 101 are examined on the merits herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/11/2025 has been entered.
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, 41-54, 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 03/11/2025 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 and Simmons do not disclose the newly amended limitation.
In response to the applicant’s arguments, the examiner acknowledges the applicant’s arguments and respectfully notes that Randolph and Simmons were not utilized in the previous rejection of record filed 01/13/2025 to read on the newly amended limitation.
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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Ex. Fig. 1 of Randolph Fig. 1
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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, 102 negative-pressure tissue interface; Fig. 8A, 202 negative-pressure tissue interface) 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 across the hindfoot section, the midfoot section, the forefoot section, and the forefoot extension (para. 0006; para. 0029-0032, 116 manifold material comprising 128 support layer and 134 pressure-transmitting layer as a single layer small-pore open cell-foam coated with 140 non-breathable material; Fig. 1, 116 manifold material spans entirety of dressing; Fig. 8A, 216 manifold material 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, 1 heel dressing) comprising: a hindfoot section comprising at least two heel flaps (Fig. 2, 32 and 34 heel flaps in 11 hindfoot section).
Östan is considered to be analogous to the instantly claimed invention in that Östan discloses a dressing for the foot. 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 fluid control layer having a plurality of fluid restrictions (Fig. 6A, 620 comfort/fluid control layer having 621 perforations/fluid restrictions); and a manifold directly adhered to the fluid control layer in a stacked relationship (para. 0041; para. 0066-0071; Fig. 6A, 610 manifold stacked on 620 fluid control layer; Fig. 6A-B showing 620 fluid control layer spanning entirety of 610 manifold and extending outwardly from 610 manifold to ensure that 620 fluid control layer is disposed between 610 manifold and epidermis).
Randolph ‘288 is considered to be analogous to the instantly claimed invention in that Simmons discloses a dressing for use with negative pressure. 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 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 (pg. 8 ln. 3-4; pg. 11 ln. 10-13; Fig. 2, 4 cover configured to envelope 12 tissue interface).
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 41-43, 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 claim 41, 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, 102 negative-pressure tissue interface; Fig. 8A, 202 negative-pressure tissue interface) comprising: a manifold (para. 0006; para. 0029-0032, 116 manifold material comprising 128 support layer and 134 pressure-transmitting layer as a single layer small-pore open cell-foam coated with 140 non-breathable material; Fig. 1, 116 manifold material spans entirety of dressing; Fig. 8A, 216 manifold material spans entirety of dressing); wherein the tissue interface is shaped anatomically for interaction with the foot (Fig. 1 showing 102 negative-pressure tissue interface 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 a fluid control layer having a plurality of fluid restrictions, and the manifold directly adhered in a stacked relationship to the fluid control layer.
Randolph ‘288 teaches a fluid control layer having a plurality of fluid restrictions (Fig. 6A, 620 comfort/fluid control layer having 621 perforations/fluid restrictions); and a manifold directly adhered to the fluid control layer in a stacked relationship (para. 0041; para. 0066-0071; Fig. 6A, 610 manifold stacked on 620 fluid control layer).
Randolph ‘288 is considered to be analogous to the instantly claimed invention in that Simmons discloses a dressing for use with negative pressure. 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).
Regarding claim 42, the combination of Randolph and Randolph ‘288 discloses the invention of claim 41, the combination further discloses: wherein the fluid control layer further comprises a film which is fluid impermeable (Randolph ‘288: para. 0041; para. 0069, 620 fluid control layer may be formed from an occlusive material).
Regarding claim 43, the combination of Randolph and Randolph ‘288 discloses the invention of claim 41, the combination further discloses: wherein the manifold comprises a porous material having a plurality of interconnected fluid pathways (Randolph: para. 0006; para. 0032, 116 manifold material comprising 128 support layer and 134 pressure-transmitting layer as a single layer small-pore open cell-foam coated with non-breathable material; Fig. 1, 116 manifold material spans entirety of dressing; Fig. 8A, 216 manifold material spans entirety of dressing).
Regarding claim 77, the combination of Randolph and Simmons discloses the invention of claim 41, the combination further discloses: wherein the fluid control layer comprises a polymer film (Randolph ‘288: para. 0041; para. 0069, 620 fluid control layer may be formed from an occlusive material).
Regarding claim 83, the combination of Randolph and Randolph ‘288 discloses the invention of claim 41, the combination further discloses: wherein the fluid restrictions comprise a plurality of slots (Randolph ‘288: para. 0069, 621 fluid restrictions include a plurality of perforations or holes); however, the combination of the prior art differs from the instantly claimed invention in that they fail to disclose that each of the slots has a length less than 4 millimeters and a width less than 2 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 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 combination of Randolph and Randolph ‘288 discloses the invention of claim 41, the combination further discloses: wherein the manifold comprises foam (Randolph: para. 0032 ln. 1-5).
Regarding claim 98, the combination of Randolph and Randolph ‘288 discloses the invention of claim 41, the combination further discloses: wherein the manifold has a thickness between 4-15 millimeters (Randolph: 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 claim 44, the combination of Randolph and Randolph ‘288 disclose the invention of claim 41, the combination further discloses: wherein the tissue interface (Randolph: Fig. 1, 102 negative-pressure tissue interface; Fig. 8A, 202 negative-pressure tissue interface) further comprises: a hindfoot section adapted for a heel of the foot (Randolph: 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 (Randolph: Ex. Fig. 1 showing underfoot section for remainder of foot; Ex. Fig. 2 extrapolated from Ex. Fig. 1); and a forefoot extension section configured to fold over at least a portion of the underfoot section (Randolph: Ex. Fig. 1 showing forefoot extension section 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 (Randolph: para. 0006; para. 0029-0032, 116 manifold material comprising 128 support layer and 134 pressure-transmitting layer as a single layer small-pore open cell-foam coated with 140 non-breathable material; Fig. 1, 116 manifold material spans entirety of dressing; Fig. 8A, 216 manifold material spans entirety of dressing; Randolph ‘288: para. 0069; Fig. 6A-B showing 620 fluid control layer spanning entirety of 610 manifold and extending outwardly from 610 manifold to ensure that 620 fluid control layer is disposed between 610 manifold and epidermis); however, the prior art differ from the instantly claimed invention in that they fail to disclose that the hindfoot section comprising at least two heel flaps.
Östan teaches a dressing (Fig. 2, 1 heel dressing) comprising: a hindfoot section comprising at least two heel flaps (Fig. 2, 32 and 34 heel flaps in 11 hindfoot section).
Östan is considered to be analogous to the instantly claimed invention in that Östan discloses a dressing for the foot. 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).
Regarding claim 45, the combination of Randolph, Randolph ‘288, and Östan discloses the invention of claim 44, the combination further discloses: wherein the underfoot section further comprises a midfoot section and a forefoot section (Randolph: Ex. Fig. 1 showing midfoot and forefoot sections of underfoot section; Ex. Fig. 2 extrapolated from Ex. Fig. 1).
Regarding claim 46, the combination of Randolph, Randolph ‘288, and Östan discloses the invention of claim 44, the combination further discloses: wherein the at least two heel flaps of the hindfoot section are separated from each other by a hindfoot notch (Östan: Fig. 2, 32 and 34 heel flaps separated by 46 hindfoot notch); and wherein the hindfoot section is separated from the underfoot section by two demarcation notches (Östan: Fig. 2, 11 hindfoot section comprising heel flaps separated from 12 underfoot section by two 74 notches).
Regarding claim 47, the combination of Randolph, Randolph ‘288, and Östan discloses the invention of claim 46, the combination further discloses: wherein the hindfoot notch is v-shaped (Östan: Fig. 2, 46 hindfoot notch generally v-shaped).
Regarding claim 48, the combination of Randolph, Randolph ‘288, and Östan discloses the invention of claim 46, the combination further discloses: wherein each of the demarcation notches is v-shaped (Östan: Fig. 2, 74 notches generally v-shaped).
Regarding claim 49, the combination of Randolph, Randolph ‘288, and Östan discloses the invention of claim 44, the combination further discloses: wherein the hindfoot section comprises a posterior portion which is curved (Randolph: Ex. Fig. 1 showing hindfoot section having a curved posterior portion; Östan: Fig. 2, 11 hindfoot section having a curved outer path).
Regarding claim 50, the combination of Randolph, Randolph ‘288, and Östan discloses the invention of claim 46, the combination further discloses: wherein the hindfoot notch is located on a longitudinal centerline axis (Östan: Fig. 2 showing 46 hindfoot notch located on P longitudinal centerline axis) of the tissue interface (Randolph: 102/202 negative pressure tissue interface).
Regarding claim 51, the combination of Randolph, Randolph ‘288, and Östan discloses 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. In re Dailey, 149 USPQ47 (CCPA 1976). 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 combination of Randolph, Randolph ‘288, and Östan discloses 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. In re Dailey, 149 USPQ47 (CCPA 1976). 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 combination of Randolph, Randolph ‘288, and Östan discloses the invention of claim 50, the combination further discloses: wherein the tissue interface is approximately symmetrical about the longitudinal centerline axis (Randolph: Ex. Fig. 1 showing 102 negative pressure tissue interface 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 202 negative pressure tissue interface).
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 claim 54, the current combination of Randolph and Randolph ‘288 discloses the invention of claim 41; however, the current combination of the prior art differs from the instantly claimed invention in that they fail to disclose a cover configured to envelope the tissue interface when applied to the foot, wherein the cover is water vapor permeable and liquid impermeable.
George teaches a cover configured to envelope a tissue interface when applied to the foot (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).
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.
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 cover (Fig. 1, 112 cover) that is water-vapor permeable (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 current combination of Randolph, Randolph ‘288, and George 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).
Regarding claim 56, the combination of Randolph, Randolph ‘288, and George discloses the invention of claim 54, the combination further discloses: wherein the cover is separate and apart from the tissue interface (George: pg. 11 ln. 10-13).
Regarding claim 60, the combination of Randolph, Randolph ‘288, and George discloses the invention of claim 54, the combination further discloses: wherein the cover comprises a bag-like configuration having an open end configured to receive the tissue interface (George: pg. 8 ln. 3-7; pg. 11 ln. 10-13; Fig. 2, 10 open end of 4 cover).
Regarding claim 61, the combination of Randolph, Randolph ‘288, and George discloses the invention of claim 54, the combination further discloses: wherein the cover is anatomically shaped to approximately match the foot (George: Fig. 2, 4 cover shown to be anatomically shaped to match the foot).
Regarding claim 62, the combination of Randolph, Randolph ‘288, and George discloses the invention of claim 60, the combination further discloses: an attachment device adapted to seal the open end of the cover (George: pg. 8 ln. 3-7; pg. 10 ln. 4-11).
Regarding claim 65, the combination of Randolph, Randolph ‘288, and George discloses the invention of claim 54, the combination further discloses: a fluid port configured to be fluidly coupled to the manifold through the cover (George: pg. 8 ln. 25-31; Fig. 2, 11 fluid port for fluidic connection to 12 tissue interface within 4 cover; Randolph: para. 0034 ln. 1-5; para. 0035 ln. 3-6; Fig. 1, 150 port fluidly coupled to 116 manifold material).
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 claim 67, the combination of Randolph, Randolph ‘288, and Östan discloses the invention of claim 44; however, the prior art differ from the instantly claimed invention in that they fail to disclose 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.
Locke teaches a gel layer (Fig. 1A, 112 adhesive layer; para. 0083 ln. 5-15) disposed adjacent to a polymeric layer comprising fenestrations (Fig. 1A, 112 adhesive layer disposed adjacent to 111 polymeric layer comprising 132 apertures), the gel layer having a plurality of apertures (Fig. 2, 112 adhesive layer comprising 116 apertures) at least partially aligned with the fenestrations of the polymeric layer (para. 0078 ln. 9-19; Fig. 3 showing alignment of 116 and 132 apertures).
Locke is considered to be analogous to the instantly claimed invention in that Locke discloses a negative pressure system. 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.
Regarding claim 68, the combination of Randolph, Randolph ‘288, Östan, and Locke discloses the invention of claim 67, the combination further discloses: wherein the gel layer is coextensive with the fluid control layer (Locke: Fig. 2, 112 adhesive layer coextensive with 111 polymeric layer comprising 132 apertures); however, the prior art differs from the instantly claimed invention in that they fail to disclose wherein the gel layer is coextensive with the manifold, spanning the entirety of the hindfoot section, the underfoot section, and 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 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. In re Dailey, 149 USPQ47 (CCPA 1976). 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.
Regarding claim 70, the combination of Randolph, Randolph ‘288, Östan, and Locke discloses the invention of claim 67, the combination further discloses: wherein the gel layer comprises an adhesive surface opposite the fluid control layer (Locke: para. 0074 ln. 1-4; para. 0079 ln. 11-15).
Regarding claim 73, the combination of Randolph, Randolph ‘288, Östan, and Locke discloses the invention of claim 67, the combination further discloses: wherein the gel layer comprises silicone (Locke: para. 0074 ln. 1-8; para. 0083 ln. 5-15).
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 combination of Randolph, Randolph ‘288, Östan, and Locke discloses 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 release liner in a stacked relationship with an adhesive layer (para. 0049 ln. 1-3; Fig. 2B, 220 release liner on an adhesive).
McNeil is considered to be analogous to the instantly claimed invention in that McNeil discloses a negative pressure dressing for a foot. 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 Randolph, Randolph ‘288, Östan, and Locke 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 combination of Randolph and Randolph ‘288 discloses the invention of claim 41; however, the combination of 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 a fluid-impermeable layer of a negative pressure system comprising fluid restrictions (para. 0008; Fig. 1, 21 fluid restrictions in 17 fluid-impermeable layer) (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 (para. 0011; para. 0015).
Vinton is considered to be analogous to the instantly claimed invention in that Vinton discloses a negative pressure wound dressing. 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 Randolph and Randolph ‘288 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 combination of Randolph and Randolph ‘288 discloses 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 tissue interface (Fig. 14-15, 1400 and 1500 tissue interface) comprising perforations spaced inward from an edge of the tissue interface and approximately tracking a contour of an exterior of the edge (Fig. 14-15, 1405 and 1505 perforations spaced inward from the edge of 1400 and 1500 tissue interfaces and somewhat tracking an exterior of the edge in at least some areas).
Jaeb is considered to be analogous to the instantly claimed invention in that Jaeb discloses a negative pressure dressing. 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 and Randolph ‘288 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
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
/NICHOLAS J. WEISS/Supervisory Patent Examiner, Art Unit 3781