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 .
Response to Amendment
The amendment filed 2/10/2026 has been entered:
Applicant's submission filed on 8/21/2025 has been entered.
Claims 1-2, 5, 8, 11-12, 14-18, 20-21, 27-28, 31-33, 35, 40-48, and 54 remain pending in the present application. Claims 1, and 41 are currently amended. Claims 3, 4, 6, 7, 9, 10, 13, 19, 22-24-26, 29, 30, 34, 36-39, and 49-53 are canceled. Claims 1-2, 5, 8, 11-12, 14-18, 20-21, 27-28, 31-33, 35, 40-48, and 54 are examined in the merits.
Response to Arguments
Applicant’s amendments with respect to claims 1 and 41 have been considered and necessitated a new grounds of rejection with respect to the apertures being disposed through the third layer, and with respect to the pore sizes in the foam, as now recited in claims 11 and 41. As such, they are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Hunt remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention.
Randolph is now relied upon as a secondary reference in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claims 1 and 41 while Vinton is no longer relied upon.
Previously cited reference, Ingram, is also now relied upon to teach the amended limitations of claims 11 and 41.
Karami, Coulthard, Deibler, Sigurjonsson, Hartwell, Wilkes, Thomas, and Fabo, remain in the present rejection for disclosing and/or rendering obvious the limitations of the remaining claim limitations.
Claim Rejections - 35 USC § 103
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.
Claims 1, 14, 17, 28, 31, 33, and 40, 43 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt et al. (US 2004/0030304 A1), in view of Karami (US 5,308,313 A), Randolph et al. (US 2014/0276288 A1), and Coulthard et al. (US 2015/0119833 A1).
Regarding claim 1, Hunt teaches a dressing for treating a tissue site with negative pressure (dressing 10; Figs. 1 and 3; Abstract) comprising a first layer comprising a manifold (foam layer 12, Fig. 3) including foam (¶ 38); a second layer (sheet 38, Fig. 3) in contact with the first layer (Fig. 3 shows foam layer 12 directly above sheet 38), the second layer comprising an elastomeric film having a plurality of fluid passages (¶s 22-24 and 30 describe how the sheets are elastomeric; said sheets comprise holes 34, Fig. 3), and a cover adjacent to the first layer, the cover comprising a polymer drape (drape 14; ¶s 38 and 39), the second layer and the plurality of fluid passages positioned in contact with the first manifold layer (Fig. 3 shows sheet 38 adjacent manifold 12 and the fluid passages 34 within said sheet would implicitly contact manifold 12), and having a plurality of fluid passages, and a cover adjacent to the first layer, the cover comprising a polymer drape (drape 14, Fig. 3; ¶s 38 and 39). Hunt further teaches the cover comprising a margin that extends beyond the first layer and the second layer, and an adhesive disposed in the margin (see Hunt Fig. 3, drape 14; ¶ 39).
Hunt does not explicitly disclose a third layer disposed in contact with the second layer, the third layer comprising gel having a plurality of apertures disposed through the third layer, at least one of the plurality of apertures positioned such that more than one of the fluid passages is exposed through the at least one aperture, a portion of the second layer around the one or more fluid passages extends freely across, the at least one aperture, and wherein the cover further comprises a margin that extends beyond the first layer and an adhesive disposed in the margin that is exposed through at least one of the apertures in the third layer.
However, Karami teaches a vented wound dressing (wound dressing 10 in Fig. 1; Abstract) comprising a fenestrated polymer layer (sheet material 12 with slits 18) above a gel layer comprising apertures (adhesive layer 14; Col. 8, lines 19-21 describe hydrocolloid adhesive, which would comprise a gel), at least one of the plurality of apertures positioned such that one of the fluid passages is exposed through, and a portion of the layer around the fluid passages extends freely across, the at least one aperture of the plurality of apertures (Figs. 1-3 show how the slits are visible through the openings 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hunt to comprise the gel layer of Karami. Doing so would thus comprise a third layer in contact with the second layer comprising a gel layer including a plurality of apertures disposed through the third layer, at least one of the plurality of apertures positioned such that one or more of the fluid passages is exposed, and a portion of the second layer around the one or more fluid passages extends freely across, the at least one aperture of the plurality of apertures. Doing so would be advantageous in securing the dressing to the wound, preventing the wound from drying out (Col. 2, lines 27-33) and the adhesive free areas would ensure the fenestrations are not rendered nonfunctional by the adhesive.
The combination of Hunt and Karami still do not explicitly teach that more than one of the fluid passages are exposed through the at least one aperture or wherein the cover further comprises a margin that extends beyond the first layer and an adhesive disposed in the margin that is exposed through at least one of the apertures in the third layer.
However, Randolph teaches a negative pressure wound system (Fig. 1; Abstract) comprising a layer with large apertures (cutouts 615 in Fig. 6A) which expose a plurality of smaller fluid restrictions (perforations 621; best seen in Fig. 6B).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the layers of Robinson and Karami, including the sealing layer, to comprise the cutouts of Randolph. Doing so would be advantageous in enabling
layers to conform to contoured body shapes (¶ 68 of Randolph).
Further, doing so would be within ordinary skill in the art as a change in form or shape is
generally recognized as being within the level of ordinary skill in the art, absent any showing of
unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which
relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed
shape/size of the apertures (¶ 91 of Applicant’s specification only indicates the apertures “may”
be sized to expose more than one fluid restriction).
The combination of Hunt, Karami, and Randolph still do not explicitly teach that the cover further comprises a margin that extends beyond the first layer and an adhesive disposed in the margin that is exposed through at least one of the apertures in the third layer.
However, Coulthard teaches a dressing for treating a tissue site with negative pressure (Figs. 1 and 4A; Abstract), thus being in the same field of endeavor, wherein the cover further comprises a margin that extends beyond the first layer and an adhesive disposed in the margin that is exposed through at least one of apertures in a base, contact layer (¶s 36-37 describes adhesive 136 being exposed in periphery 152 of base layer 132).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover and base (third) layer of Hunt, Karami, and Randolph such that the cover comprises a margin that extends beyond the first layer and an adhesive disposed in the margin is exposed through at least one of the apertures in the third layer. Doing so would be advantageous in providing sufficient adhesive contact to secure the dressing to the skin, while also allowing for release and repositioning of the dressing (¶s 36 and 45 of Coulthard).
Regarding claim 14, Hunt further teaches the second elastomeric film layer being made from polyurethane (¶ 30).
As Applicant also discloses polyurethane being a suitable, hydrophobic material for the second layer (¶ 58), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As such, Hunt inherently discloses the second polymer layer is hydrophobic.
Regarding claim 17, Hunt further teaches said fluid passages comprising a plurality of slots having a length between 3 mm and 6 mm (¶ 33 of Hunt). The combination not explicitly disclose the slots having a length less than 5 mm.
However, 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 length of the slots from between 3 mm and 6 mm to between 3 mm and 5 mm (i.e. less than 5 mm) as applicant appears to have placed no criticality on the claimed range (¶ 7 of Applicant’s specification indicates the slots “may” be within the claimed range “in some examples”) 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”. See MPEP 2144.05(I).
Regarding claim 28, Karami further teaches the gel of the third layer is a hydrocolloid (Col. 8, lines 19-21). As stated above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hunt, Karami, Randolph, and Coulthard to further comprise the gel layer of Karami. Doing so would thus comprise a hydrocolloid third layer. Doing so would be advantageous in securing the dressing to the wound and preventing the wound from drying out (Col. 2, lines 27-33).
Regarding claim 31, Karami further teaches some of the plurality of apertures in the third layer have an effective diameter of about 2 millimeters to about 5 millimeters (Col. 7, lines 40-54 indicate a width of 1/8 inch, or 3.175 mm, which lies within, and thus anticipates the claimed range).
As stated above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hunt to comprise the gel layer of Karami. Doing so would thus comprise the third layer having apertures with an effective diameter of about 2 millimeters to about 5 millimeters. Doing so would be advantageous in securing the dressing to the wound and preventing the wound from drying out (Col. 2, lines 27-33).
Regarding claim 32, the combination of Hunt, Karami, Randolph, and Coulthard substantially discloses the invention of claim 1. The combination further teaches the third layer being the bottom-most layer (Karami teaches the gel layer being the bottom most layer and mounted on a polymer sheet, described in Col 7. Lines 3-14, which specifically indicates polyurethane; ¶ 20-21 and 30 of Hunt indicates the films can made of polyurethane, and thus one of ordinary skill in the art would undertint the gel layer of Karami being the lowest layer of the combination, while the cover is the highest layer of the combination, thus sandwiching the second layer therebetween), and thus the first layer and the second layer are enclosed between the third layer and the cover.
Regarding claim 33, Karami further teaches at least one of the plurality of apertures is registered with at least some of the fluid passages (as seen in Figs. 1-3).
As stated above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hunt to comprise the gel layer of Karami. Doing so would thus comprise at least some of the plurality of apertures being registered with at least some of the fluid passages. Doing so would be advantageous in securing the dressing to the wound and preventing the wound from drying out (Col. 2, lines 27-33).
Regarding claim 40, Hunt further teaches a fluid port coupled to the cover (Figs. 1 and 2, connectors 16 and 18) the fluid port configured to be coupled to a fluid conductor (¶ 40).
Regarding claim 43, the combination of Hunt, Karami, Randolph, and Coulthard substantially discloses the combination of Claim 1. The combination further teaches applying a wound dressing according to the invention as described in claim 1 with negative pressure (the Abstract and ¶s 1, 14, and 29-30 of Hunt describe use with wounds; ¶s 38 and 40 of Hunt specifically mention negative pressure).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(1), as such, Hunt, Karami, Randolph, and Coulthard teach a method for treating a wound with negative pressure, the method comprising applying a dressing according to claim 1 to the wound; fluidly coupling a negative pressure source to the dressing and delivering a therapeutic level of negative pressure from the negative pressure source (¶ 24 of Hunt).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Karami, Randolph, and Coulthard, as claim 1, and further in view of Deibler et al. (EP 3139877 B2, citations to the specification will be to the previously attached translation).
Regarding claim 2, the combination of Hunt, Karami, Randolph, and Coulthard do not explicitly teach the manifold includes a plurality of through-holes disposed through the foam, and wherein each of the plurality of through-holes has an effective diameter between 2 millimeters and 10 millimeters.
Deibler teaches a wound dressing (wound dressing 10, Fig. 2; Abstract), thus being in the
same field of endeavor, with a first layer (upper layer 2) comprising foam (lines 2069-2070 on page 50) with a plurality of through-holes through the foam (openings 3, described in lines 2150-2151 on Page 52) in contact with a drape layer (cover film 4), the through holes having a diameter between 1 mm and 15 mm (lines 384-386 on page 10).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the foam manifold of Hunt to comprise the
through-holes of Deibler. Doing so would thus comprise a manifold having a plurality of
through-holes disposed through the foam, wherein the cover comprising a polymer drape is
positioned in contact with the plurality of through-holes through the foam of the first layer (as
both Hunt and Deibler teach the cover contacting the uppermost foam manifold, the cover
would contact through-holes in said manifold). Doing so would be obvious to provide the
advantage of ensuring reliable exudate drainage and even distribution of negative pressure (recognized in lines 503-508, on Page 13 of Deibler).
Further, 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 combination of Hunt, Karami, Randolph, Coulthard, and Deibler to explicitly have the through hole have an effective diameter between 2 millimeters and 10 millimeters as Applicant appears to have placed no criticality on the claimed range (Applicant’s specification the diameter “may” be 1 millimeter to about 50 millimeters, but also having varying geometric properties; ¶s 85-86) 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 (lines 384-386 of page 10 of Deibler indicate more narrow ranges of 2 mm to 10 mm and 4 mm to 6 mm are “particularly preferable”), 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).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Karami, Randolph, Coulthard, and Deibler, as applied to claim 2, and further in view of Sigurjonsson et al. (US 2004/0138604 A1).
Regarding claim 5, the combination of Hunt, Karami, Randolph, Coulthard, and Deibler, substantially discloses the invention of claim 2. They do not explicitly disclose the plurality of through-holes being spaced about 2 mm on center and or are spaced about 10 mm on center.
In the same field of endeavor, Sigurjonsson teaches a perforated wound dressing (dressing 10, Figs. 1, and 10 - 12), thus being in the same field of endeavor. Sigurjonsson further teaches a series of cylindrical through-holes (i.e. receptacles) in a first layer (layers 16 and 18, Figs. 1 and 13; ¶ 42). Sigurjonsson further teaches that the spacing of these through holes affects fluid absorption (¶s 63 and 89).
Therefore, the spacing between through-holes is disclosed to be a result affective variable affecting fluid absorption through the perforated layer. Further, one of ordinary skill in the art would have a reasonable expectation of success in modifying the spacing of the through-holes in this manner as Hunt is directed to passing fluid through apertured layers for wound care in the same manner as Sigurjonsson, and thus would not disable this fundamental function of the through-holes. As such, it would have been obvious to a person of ordinary skill in the art before the effective filling date to modify the spacing of the through-holes of Hunt, Karami, Randolph, Coulthard, and Deibler to be spaced about 2 mm on the center and/or are spaced about 10 mm on the center 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 (II).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Karami, Randolph, Coulthard, and Deibler as applied to claim 2, and further in view of Hartwell et al. (US 2017/0143552 A1).
Regarding claim 8, the combination of Hunt, Karami, Randolph, Coulthard, and Deibler substantially discloses the invention of claim 2. Hunt further teaches the plurality of through-holes being formed into an array (¶s 16 and 33).
Karami also teaches at least some of the apertures are registered with the fluid passages (as seen in Figs. 1-3).
The combination does not explicitly teach through holes in the manifold explicitly being registered with both the fluid passages and at least one of the plurality of apertures.
Hartwell teaches a multilayer wound dressing (dressing 100 and 300, Figs. 1, 2, and 3A - 3C; Abstract), thus being in the same field of endeavor, comprising a film layer (layers 350 and 360, Fig. 3B), a gel layer in contact with said film layer (¶ 58 indicates a hydrocolloid or silicone adhesive carried by film layer 350) having openings (end of ¶ 58 indicates how the gel is also perforated), a film layer having apertures (transmission layer 320 and openings 325), and a manifold having through-holes (layer 310 and through-holes 315; ¶ 63 indicates foam) wherein the plurality of through-holes are registered with apertures and perforations (¶s 10, 67, and 68 all indicate how the through holes and fluid passages should be aligned to allow for viewing the wound site).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hunt, Karami, Randolph, Coulthard, and Deibler, to register the gel apertures with the fluid passages and through-holes. Doing so would thus result in at least some of the through-holes are registered with the fluid passages and at least one of the plurality of apertures. Doing so would provide the advantage of ensuring a medical professional can inspect the wound (¶ 67 of Hartwell indicates making viewing portals).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Karami, Randolph, and Coulthard as applied to claim 1, and further in view of Ingram et al. (US 2015/0320434 A1).
Regarding claim 11, Hunt further teaches the manifold comprising reticulated foam (¶s 30, 34, and 42 indicate the use of reticulated foam).
The combination does not explicitly teach the foam including a pore size from 400 microns to 600 microns.
Ingram teaches a wound dressing (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a porous foam with pore sizes in the range of 400 microns to 600 microns (¶ 46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the foam of Hunt, Karami, Randolph, and Coulthard to include a pore size from 400 microns to 600 microns. Doing so would be advantageous in meeting the needs of prescribed therapy, such as for instillation of topical treatment solutions (¶ 46 of Ingram).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Karami, Randolph, Coulthard, and Deibler as applied to claim 1, and further in view of Hartwell.
Regarding claim 35, the combination of Hunt, Karami, Randolph, and Coulthard do not explicitly teach the one or more fluid passages includes a length that extends across an edge of at least one of the plurality of apertures
Hartwell teaches a multilayer wound dressing (dressing 100 and 300, Figs. 1, 2, and 3A - 3C; Abstract), thus being in the same field of endeavor, comprising a film layer (layers 350 and 360, Fig. 3B), a gel layer in contact with said film layer (¶ 58 indicates a hydrocolloid or silicone adhesive carried by film layer 350) having openings (end of ¶ 58 indicates how the gel is also perforated), a film layer having apertures (transmission layer 320 and openings 325), and a manifold having through-holes (layer 310 and through-holes 315; ¶ 63 indicates foam) wherein the openings in higher levels are larger than lower levels (¶s 21, 70-72, and 77-78).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hunt, Karami, and Deibler, make higher level openings larger than lower level openings. Doing so would thus result I one or more fluid passages includes a length that extends across an edge of at least one of the plurality of apertures (as in order for the open fenestration to be larger than the apertures in the third layer below it, some dimension of the fenestration must extend beyond the edges of the apertures). Doing so would provide the advantage of ensuring a medical professional can inspect the wound (¶ 67 of Hartwell indicates making viewing portals).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable Hunt, Karami, Randolph, and Coulthard as applied to claim 14, and further in view of Sigurjonsson.
Regarding claim 15, the combination of Hunt, Karami, Randolph, and Coulthard substantially disclose the invention of claim 14. They do not explicitly disclose the elastomeric film on the second layer being polyethylene, rather Hunt teaches using a elastomeric film made of polyurethane.
In the same field of endeavor, Sigurjonsson teaches a perforated wound dressing (dressing 10, Figs. 1, and 10 - 12), thus being in the same field of endeavor, comprising a facing layer (second, bottom layer; Fig. 10 and 13; layer 12) made of polyurethane, polyethylene, or other suitable polymers (¶ 94).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made second layer out of polyethylene as taught by Sigurjonsson because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143. Here all elements of the claim are well known in the art of wound dressings. Modifying Hunt to have the second layer be polyethylene would not change the devise function of serving as a wound dressing, and drawing fluid out of the wound, and would also provide a soft, flexible, conformable, non-irritating base layer (Recognized in ¶ 94 of Sigurjonsson).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the second layer out of polyethylene, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Regarding claim 16, the combination of Hunt, Karami, Randolph, and Coulthard substantially discloses the invention of claim 14. The combination does not explicitly disclose the elastomeric film on the second layer being polyethylene having an area density of less than 30 grams per square meter.
In the same field of endeavor, Sigurjonsson teaches a perforated wound dressing (dressing 10, Figs. 1, and 10 - 12), thus being in the same field of endeavor, comprising a facing layer (second, bottom layer; Fig. 10 and 13; layer 12) made of polyurethane, polyethylene, or other suitable polymers (¶ 94).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made second layer out of polyethylene as taught by Sigurjonsson because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143. Here all elements of the claim are well known in the art of wound dressings. Modifying Hunt to have the second layer be polyethylene would not change the devise function of serving as a wound dressing, and drawing fluid out of the wound, and would also provide a soft, flexible, conformable, non-irritating base layer (Recognized in ¶ 94 of Sigurjonsson).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the second layer out of polyethylene, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Hunt, Karami, Randolph, Coulthard, and Sigurjonsson still do not teach said elastomeric film having an area density of less than 30 grams per square meter.
However, Applicant discloses the claimed invention may also be made of polyethylene and does not disclose any further modifications or properties pertaining to the area density as claimed. Thus, the polyethylene of Hunt, Karami, Randolph, Coulthard, and Sigurjonsson is presumed to be identical to the material as claimed. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. See MPEP 2112.01.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Karami, Randolph, and Coulthard, as applied to claim 1 above, and further in view of Wilkes et al. (US 2009/0293887 A1).
Regarding claim 12, the combination of Hunt, Karami, Randolph, and Coulthard substantially discloses the invention of claim 1. The do not explicitly teach said reticulated foam being compressed and/or felted.
In the same field of endeavor, Wilkes teaches a negative pressure therapy dressing (system 10, Fig. 3, 10 - 12; ¶ 80), thus being in the same field of endeavor. Wilkes also teaches the use of reticulated foam that is later felted (¶ 35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the reticulated foam of Hunt, Hunt, Karami, Randolph, and Coulthard with the specifically felted foam of Wilkes since these structures perform the same function of distributing fluid and negative pressure. Simply substituting these foams would achieve the predictable result of providing an equivalent distribution layer to distribute reduced pressure and fluids. See MPEP 2143. Doing so would thus comprise reticulated foam that is felted. Doing so would also provide the advantage of assisting in removing exudates (¶ 80 of Wilkes).
Claims 18, 20, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Karami, Randolph, and Coulthard, as applied to claim 1 above, and further in view of Thomas et al. (US 2009/0082746 A1).
Regarding claim 18, Hunt further teaches the fluid passages comprise a plurality of slots (¶s 15 and 16 of Hunt specifically indicate slots).
The combination of Hunt, Karami, Randolph, and Coulthard does not explicitly teach the fluid passages having a width less than 2 millimeters.
In addressing the same problem as Applicant, the problem being the forming of slit valves in elastomeric films, Thomas teaches a fenestrated elastomeric film (Fig. 3a; Abstract and ¶ 1) using slits made in a polymer film (¶ 16 indicates slits; ¶ 11 indicates various polyolefin polymers) which are formed as slots with a width less than 2 millimeters (Figs. 4a, 6b, 7a, and 7b of Thomas shows the fluid passages as slots; ¶ 35 indicates the width of the slot in Fig. 6b is 62.5 mils, which is approximately 1.6mm and anticipates the claimed range; ¶ 36 indicates the slots are 0.06” to 0.192” wide, which is about 1.6 - 4.9mm, which overlaps the claimed range).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid passages of Hunt, Karami, Randolph, and Coulthard to be formed as preferential valves as taught by Thomas. Doing so would thus comprise the fluid passages as slots having a width less than 2 millimeters. Doing so would provide the advantage of facilitating flow out of the wound and discouraging backflow (in the manner described in ¶s 7, 17, 27, 30, and 34 of Thomas).
Regarding claim 20, the combination Hunt, Karami, Randolph, and Coulthard substantially discloses the invention of claim 1.
The combination does not explicitly teach the fluid passages comprise or consist essentially of elastomeric passages disposed through the elastomeric film that are configured to expand in response to a pressure gradient across the elastomeric film.
In addressing the same problem as Applicant, the problem being the forming of slit valves in elastomeric films, Thomas teaches a fenestrated polymer film (Fig. 3a; Abstract and ¶ 1) using slits made in a polymer film (¶ 16 indicates slits; ¶ 11 indicates various polyolefin polymers) as elastomeric valves that are normally closed under atmospheric pressure when unstrained yet configured to expand in response to a pressure gradient across the polymer film (¶s 9, 17, 27, 30, and 34 describe how the slits are in a closed position, and may open to allow unidirectional flow through a pressure differential, which also indicated a degree of elasticity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid passages of Hunt, Karami, Randolph, and Coulthard to be formed as preferential valves as taught by Thomas. Doing so would thus comprise fluid passages as elastomeric passages in the elastomeric film that are configured to expand in response to a pressure gradient across the elastomeric film. Doing so would provide the advantage of facilitating flow out of the wound and discouraging backflow (in the manner described in ¶s 7, 17, 27, 30, and 34 of Thomas).
Regarding claim 54, the combination of Hunt, Karami, Randolph, and Coulthard substantially discloses the invention of claim 1.
In addressing the same problem as Applicant, the problem being the forming of slit valves in polymer films, Thomas teaches a fenestrated polymer film (Fig. 3a; Abstract and ¶ 1) using slits made in a polymer film (¶ 16 indicates slits; ¶ 11 indicates various polyolefin polymers) as elastomeric valves that are normally closed under atmospheric pressure when unstrained yet configured to expand in response to a pressure gradient across the polymer film (¶s 9, 17, 27, 30, and 34 describe how the slits are in a closed position, and may open to allow unidirectional flow through a pressure differential).
Thomas further describes the fluid passages as bi-directional (¶s 1 and 44 describe how the valves are preferential, and the degree to which fluid can pass through in one direction is restricted or allowed depends on the angle of the capillaries, thus while flow in one direction may be reduced, there would be some amount of flow in both directions).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid passages of Hunt to be formed as valves as taught by Thomas. Doing so would thus comprise fluid passages that are bi-directional. Doing so would be obvious to provide the advantage in facilitating flow out of the wound and discourage backflow (in the manner described in ¶s 7, 17, 27, 30, and 34 of Thomas).
Claims 27 is rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Karami, Randolph, and Coulthard as applied to claim 1, and further in view of Fabo (US 5,635,201).
Regarding claim 27, Karami further teaches said gel layer being a polymer gel Col. 8, lines 19-21 describe hydrocolloid adhesive).
The combination does not explicitly disclose the gel having a coat weight of 250 grams per square centimeter.
Fabo teaches a wound dressing comprising a perforated polymer carrier material (carrier 2, Fig. 1), thus being in the same field of endeavor, and a perforated gel layer (silicone 3, Figs. 1 - 2). Fabo also teaches the hardness of the gel (directly correlated to density) being relevant in the effectiveness of the dressing (Col. 5, lines 31 - 38). Thus, Fabo teaches the same slitted elastomeric film (Col. 3, lines 14 - 17) comprising the same silicone gel layer (Col. 4, lines 37 - 42) as Hunt.
Therefore, Fabo teaches the density (i.e. hardness) of the polymer gel is a result affective variable impacting its effectiveness in a wound dressing (e.g. durability, conformability, etc.; Col. 5, lines 31 - 38). Thus, it would have been obvious to a person of ordinary skill in the art before the effective filling date to modify the density of the gel layer to be 250 grams per square centimeter 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 (II).
Additionally, Applicant has placed no criticality on the claimed density, merely indicating said coat weight “may be suitable for some embodiments (¶ 9 of Applicant’s specification; ¶ 7 also indicates a coat weight of 450 grams would also be suitable).
Claims 41-42, 44, and 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Karami, Randolph, and Coulthard, as applied to claim 41 above, and further in view of Ingram.
Regarding claim 41, Hunt teaches a dressing for treating a tissue site with negative pressure (dressing 10, Fig. 1; Abstract) comprising a first layer comprising a manifold (foam layer 12, Fig. 3) including foam (¶ 38); a second layer(sheet 38, Fig. 3) in contact with the first layer (Fig. 3 shows foam layer 12 directly above sheet 38), the second layer comprising an elastomeric film (¶s 22-24 and 30 describe how the sheets are elastomeric; also see wall 28 and holes 34, Fig 3), the second layer and the plurality of fluid passages positioned in contact with the first manifold layer (Fig. 3 shows sheet 38 adjacent manifold 12 and the fluid restrictions 34 within said sheet would implicitly contact manifold 12), and having a plurality of fluid passages, and a cover adjacent to the first layer, the cover comprising a polymer drape (drape 14, Fig. 3; ¶s 38 and 39).
Hunt further teaches the cover comprising a margin that extends beyond the first layer and the second layer, and an adhesive disposed in the margin (see Hunt Fig. 3, drape 14; ¶ 39), and a negative pressure source fluidly coupled to the manifold through the cover layer (¶s 38 and 40).
Hunt does not explicitly teach the foam manifold including a pore size from 400 microns to 600 microns, a third layer comprising a gel including at least one aperture sized such that more than one of fluid passages are exposed through the at least one aperture and a portion of the second layer around the at least one fluid restriction extends freely across the at least one aperture in the third layer, or the cover further comprises a margin that extends beyond the first layer and an adhesive disposed in the margin that is exposed through at least one of the apertures in the third layer.
Karami teaches a vented wound dressing (wound dressing 10 in Fig. 1; Abstract) comprising a fenestrated polymer layer (sheet material 12 with slits 18) above a gel layer comprising apertures (adhesive layer 14; Col. 8, lines 19-21 describe hydrocolloid adhesive, which would comprise a gel), at least one of the plurality of apertures sized such that at least one fluid restriction is exposed through the at least one aperture and a portion of the second layer around the at least one fluid restriction extends freely across the at least one aperture (Figs. 1-3 show how the slits are visible through the openings 16, along with portions of layer 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hunt to comprise the gel layer of Karami. Doing so would thus comprise a third layer in contact with the second layer comprising a gel layer including a plurality of apertures, at least one of the plurality of apertures sized such that one or more of the fluid passages is exposed through the aperture and a portion of the second layer around the one or more fluid passages extends freely across the at least one aperture in the third layer. Doing so would be advantageous in securing the dressing to the wound, preventing the wound from drying out (Col. 2, lines 27-33) and the adhesive free areas would ensure the fenestrations are not rendered nonfunctional by the adhesive.
The combination of Hunt and Karami still do not explicitly teach the foam manifold including a pore size from 400 microns to 600 microns, the at least one aperture being sized such that more than one fluid passages are exposed therethrough, or the cover further comprises a margin that extends beyond the first layer and an adhesive disposed in the margin that is exposed through at least one of the apertures in the third layer.
Randolph teaches a negative pressure wound system (Fig. 1; Abstract) comprising a
layer with large apertures (cutouts 615 in Fig. 6A) which expose a plurality of smaller fluid
passages (perforations 621; best seen in Fig. 6B).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the layers of Robinson and Karami, including the sealing layer, to comprise the cutouts of Randolph. Doing so would be advantageous in enabling
layers to conform to contoured body shapes (¶ 68 of Randolph).
Further, doing so would be within ordinary skill in the art as a change in form or shape is
generally recognized as being within the level of ordinary skill in the art, absent any showing of
unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which
relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed
shape/size of the apertures (¶ 91 of Applicant’s specification only indicates the apertures “may”
be sized to expose more than one fluid restriction).
The combination of Hunt, Karami, and Randolph still do not explicitly teach the foam manifold including a pore size from 400 microns to 600 microns, or that the cover further comprises a margin that extends beyond the first layer and an adhesive disposed in the margin that is exposed through at least one of the apertures in the third layer.
Coulthard teaches a dressing for treating a tissue site with negative pressure (Figs. 1 and 4A; Abstract), thus being in the same field of endeavor, wherein the cover further comprises a margin that extends beyond the first layer and an adhesive disposed in the margin that is exposed through at least one of apertures in a base, contact layer (¶s 36-37 describes adhesive 136 being exposed in periphery 152 of base layer 132).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover and base (third) layer of Hunt, Karami, and Randolph such that the cover comprises a margin that extends beyond the first layer and an adhesive disposed in the margin is exposed through at least one of the apertures in the third layer. Doing so would be advantageous in providing sufficient adhesive contact to secure the dressing to the skin, while also allowing for release and repositioning of the dressing (¶s 36 and 45 of Coulthard).
The combination still does not explicitly teach the foam including a pore size from 400 microns to 600 microns.
Ingram teaches a wound dressing (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a porous foam with pore sizes in the range of 400 microns to 600 microns (¶ 46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the foam of Hunt, Karami, Randolph, and Coulthard to include a pore size from 400 microns to 600 microns. Doing so would be advantageous in meeting the needs of prescribed therapy, such as for instillation of topical treatment solutions (¶ 46 of Ingram).
Regarding claim 42, the combination of Hunt, Karami, Randolph, Coulthard, and Ingram substantially discloses the invention of claim 41.
They do not explicitly teach a source of instillation fluid coupled to the manifold.
In the same field of endeavor, the endeavor being wound dressings for negative pressure and irrigation, Ingram teaches a negative pressure wound dressing (Fig. 1; Abstract), having a manifold (layer 108 and interface 107, Fig. 1, and Fig. 1A) and a source of instillation fluid (Fig. 1, fluid source 120) fluidly coupled to the manifold (¶s 52 and 86-87).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combination of Hunt, Karami, Randolph, Coulthard, and Ingram to comprise the source of instillation fluid as taught by Ingram. Doing so would thus comprise a source of instillation solution fluidly coupled to the manifold. Doing so would be advantageous in removing debris to decrease healing times (¶s 5 and 61).
Further, the limitations of the fluid passages being bi0directioal such that a fluid path through the fluid passages is reversible is considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the fluid passages layer of Hunt, Karami, Randolph, Coulthard, and Ingram has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. if the device is configured to both remove and instill fluid, the fluid passages would be expected to be capable opening to both positive and negative fluid pressure).
Regarding claim 44, Ingram further teaches a source of instillation fluid (fluid source 120, Fig. 1) fluidly coupled to the manifold (¶s 52 and 86-87 describe how fluid is delivered to the manifold and dressing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combination of Hunt, Karami, Randolph, Coulthard, and Ingram to further comprise the source of instillation fluid as taught by Ingram. Doing so would thus comprise a source of instillation solution fluidly coupled to the manifold. Doing so would be advantageous in removing debris to decrease healing times (¶s 5 and 61).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2144.07. As such, Hunt, Karami, Randolph, Coulthard, and Ingram teaches the method of claim 43 further comprising fluidly coupling a source of instillation fluid to the dressing, the source of instillation solution being used for delivering solution from the source of instillation solution to the dressing.
Regarding claim 45, Hunt further teaches the cover comprising a margin that extends beyond the first layer and the second layer, and an adhesive disposed in the margin for sealing with the skin (see Hunt, Fig. 3, drape 14; ¶ 39).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(1), as such, Hunt, Karami, Randolph, Coulthard, and Ingram teaches the method of claim 43 wherein applying the dressing comprises sealing the dressing to the epidermis adjacent to the wound (i.e. by the margin adhesive).
Regarding claim 46, Hunt further teaches the cover may be trimmed such that it overlaps the wound edge (Hunt, ¶ 18).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(1), as such, Hunt, Karami, Randolph, Coulthard, and Ingram teaches the method of claim 43 wherein applying the dressing comprises disposing at least part of the dressing across an edge of the wound (¶ 18 of Hunt).
Regarding claim 47, Hunt further teaches the cover comprising a margin that extends beyond the first layer and the second layer, and an adhesive disposed in the margin for sealing with the skin (i.e. the wound is on the skin surface of the body; Fig. 3, drape 14; ¶ 39).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(1), as such, Hunt, Karami, Randolph, Coulthard, and Ingram teaches the method of claim 43 wherein the wound is a surface wound.
Regarding claim 48, the combination of Hunt, Karami, Randolph, Coulthard, and Ingram substantially discloses the invention of claim 43. Further, as the combination of references teaches all the structure of the claimed invention, and also discloses it is designed for “long term” wound care (Abstract), the device of Hunt would be capable of treating a wound for at least 7 days.
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(1), as such, Hunt, Karami, Randolph, Coulthard, and Ingram teaches the dressing remains on the wound for at least 7 days.
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 ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
Prosecution Insights