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 Arguments
Applicant’s arguments, filed 11/24/2025, with respect to claim(s) 1,2-8,10,12,14,18-21,23,26,28,32-33,35-37 have been considered but are not persuasive.
From the examiner’s understanding, applicant argues that the statement of rejection per the previous claim 2 and 35 that “it is interpreted that the manifold maintains 100% of an applied negative pressure throughout the length” is impossible due to pressure drop across materials. The examiner notes that per Locke para. 0044-0045 the negative pressure is configured to be distributed from a source through the tissue interface allowing fluid to be collected. There is no indication that pressure is lost throughout the device in Locke. The examiner further notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as the prior art applied previously and hereafter teaches a first polymer film layer with perforations, a second manifold layer, and is between 12 and 32cm in length and 7 to 9mm in thickness, where said device is used with negative pressure, it is interpreted that the structure of the prior art would reasonably provide the function of applying at least 80% of the negative pressure through the length. As such the prior art previously applied reads to the claimed limitation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3,6-8,10,12,14,18-21,23,26,28,32-33,35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. US 2018/0353338, hereafter Locke338 in view of Adie et al. US 2011/0282309, hereafter Adie.
Regarding claim 1, Locke338 discloses
A dressing for treating a tissue site with negative pressure(Abstract, Fig. 2-5), comprising: a first layer (Fig. 2-5, layer (210)) comprising a polymer film (Para. 0048,0050) having a plurality of perforations (Fig. 3 (220), Para. 0054) ; a second layer comprising a manifold (Fig. 2-5, layer (205)) disposed adjacent to the polymer film (Fig. 2,5, para. 0043), the manifold having a thickness of between 7 millimeters and about 9 millimeters (Para. 0047 where a suitable thickness is disclosed to be 5-10mm); and a cover adjacent to the second layer (Cover (116)), the cover comprising a polymer film (Para. 0038).
The examiner further notes that Locke338 discloses wherein the second layer has a perimeter that is exposed at an edge of the dressing (abstract, para. 0007, 0008). Per figure 2, it can be seen that a side edge, interpreted as an outermost periphery, of the second layer is exposed at an edge of the dressing, as said periphery extends the same length as the cover (116).
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The examiner notes that while Locke338 fails to specifically disclose that the manifold has a length of 12-32 centimeters, Locke338 does disclose that the dressing may be cut to a desired size, or may be different sizes base on the type of treatment being implemented (para. 0008, 0036).
Adie teaches a wound dressing device and is thus considered analogous to the claimed invention. Adie teaches that different dressing sizes are used based upon the type of wound being treated, where the size is taught to be varied ranging anywhere from 10-20 cm in width and 20-40cm in length (para. 0179). Per the same citation, “the absorbent layer…have a length and width that are both 3-10cm shorter than the overall dressing. The examiner notes that as the overall dressing lengths were taught to range from 20-40cm, the range (3-10cm shorter) for the length would equate to approximately 10-37cm. Adie also discloses examples of the absorbent layer sizes, ranging from 10-30cm. The range of the length of the absorbent is thus interpreted to be 10-30cm. This range overlaps with the claimed range of 12-32cm. Further, Adie teaches that said absorbent layer may be a foam layer (para. 0144) Therefore as Adie teaches that dressings may comprise foam absorbent layers 10-30cm in length depending on the type of wound being treated, and Locke338 teaches that the wound dressing is customizable as desired, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the foam manifold layer of Locke338 with a length of 10-30cm based on the size of wound being treated.
The examiner notes further that the same disclosure is presented for the transmission layer of Adie, where transmission layer length range from 9-34cm (para 0179), where the transmission layer is a foam layer (para. 0180).
The examiner notes that per the 11/24/25 amendments, claim 1 now requires wherein the manifold is configured to maintain at least 80% of an applied negative pressure through the length. As previously detailed under the rejection of claim 2 (see previous office action) and as detailed under the response to arguments section of this office action, Locke is interpreted to teach this limitation (Locke 338 Para. 0044, 0045). The examiner notes that per paragraph 0044, the layer (205), interpreted as the manifold as detailed under the rejection of claim 1, is configured to receive negative pressure from a source and distribute the pressure through multiple apertures. Further per paragraph 0045, the layer does so by being composed of an open cell foam comprising a plurality of apertures and fluid pathways. As the entire manifold therefore has apertures (open space) for distributing negative pressure and fluid flow, it is interpreted that the manifold maintains 100% of an applied negative pressure throughout the length.
Regarding claim 3, Locke338 and Adie teach
The dressing of claim 1, further comprising a dressing interface configured to be fluidly coupled to the manifold through the cover (Locke 338 Fig. 2,5, dressing interface (255), para. 0058).
Regarding claim 6, Locke338 and Adie teach
The dressing of claim 1, wherein the manifold comprises a foam having open cells (Locke338 Para. 0045, where manifold (205) is an open cell foam).
Regarding claim 7, Locke338 and Adie teach
The dressing of claim 6, wherein the foam has a free volume of at least 90% (Locke338 Para. 0046).
Regarding claim 8, Locke338 and Adie teach
The dressing of claim 6, wherein the open cells have an average width in a range of about 400 microns to about 600 microns (Locke338 Para. 0046).
Regarding claim 10, Locke338 and Adie teach
The dressing of claim 6, wherein the foam is polyurethane foam or polyurethane ether foam (Locke338 Para. 0046 where the foam may be polyurethane foam).
Regarding claim 12, Locke338 and Adie teach
The dressing of claim 1, wherein the second layer has a perimeter of the second layer is not sealed between the first layer and the cover. The examiner notes that as said perimeter (See rejection of claim 1) is disclosed to be exposed, it is interpreted as not being sealed between the first layer and cover. See also Locke338 paragraph 0060.
Regarding claim 14, Locke338 and Adie teach
The dressing of claim 1, wherein the perforations comprise a plurality of slots or slits (Locke338 Fig. 3, where defined first layer (210) has fluid restrictions (220) in the form of slits (Locke338 Fig. 3, para. 0055), each of the slots or slits having a length less than 5 millimeters (Locke338 Para. 0055, slits having a length of less than 4 mm) and a width less than 2 millimeters (Locke338 Para. 0055 slits having a width less than 1mm).
Regarding claim 18, Locke338 discloses
A dressing for use with negative-pressure treatment (Abstract, Figs. 2-5), the dressing comprising: a cover (Cover (116)) comprising a non-porous film (abstract, Para. 0038); a manifold adhered to the non-porous film (manifold 205, see abstract, para. 0008); and a fluid-control layer adhered to the manifold (fluid control layer 210, see abstract, para. 0008); wherein the manifold has a perimeter that is exposed between the cover and the fluid- control layer (abstract, para. 0008). The examiner notes, per figure 2, it can be seen that a side edge, interpreted as an outermost periphery, of the second layer is exposed at an edge of the dressing, as said periphery extends the same length as the cover (116).
Locke338 further discloses that the manifold is configured to maintain at least 80% of a negative pressure ((Locke 338 Para. 0044, 0045). The examiner notes that per paragraph 0044, the layer (205), interpreted as the manifold as detailed under the rejection of claim 1, is configured to receive negative pressure from a source and distribute the pressure through multiple apertures. Further per paragraph 0045, the layer does so by being composed of an open cell foam comprising a plurality of apertures and fluid pathways. As the entire manifold therefore has apertures for distributing negative pressure and fluid flow, it is interpreted that the manifold maintains 100% of an applied negative pressure throughout the length.
While it is interpreted that the pressure is maintained throughout the length of the manifold, Locke338 fails to disclose the specific length of the manifold. Locke338 does disclose that the dressing may be cut to a desired size, or may be different sizes base on the type of treatment being implemented (para. 0008, 0036).
Adie teaches a wound dressing device and is thus considered analogous to the claimed invention. Adie teaches that different dressing sizes are used based upon the type of wound being treated, where the size is taught to be varied ranging anywhere from 10-20 cm in width and 20-40cm in length (para. 0179). Per the same citation, “the absorbent layer…have a length and width that are both 3-10cm shorter than the overall dressing. The examiner notes that as the overall dressing lengths were taught to range from 20-40cm, the range (3-10cm shorter) for the length would equate to approximately 10-37cm. Adie also discloses examples of the absorbent layer sizes, ranging from 10-30cm. The range of the length of the absorbent is thus interpreted to be 10-30cm. This range overlaps with the claimed range of 12-32cm. Further, Adie teaches that said absorbent layer may be a foam layer (para. 0144) Therefore as Adie teaches that dressings may comprise foam absorbent layers 10-30cm in length depending on the type of wound being treated, and Locke338 teaches that the wound dressing is customizable as desired, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the foam manifold layer of Locke338 with a length of 10-30cm based on the size of wound being treated. As such negative pressure would be applied throughout the length of the manifold, where based on the size chosen, the length would be at least 6cm.
Regarding claim 19, Locke338 and Adie teach
The dressing of claim 18, where Locke338 further discloses the dressing comprising a fluid port coupled to the cover and fluidly coupled to the manifold through the cover. The examiner notes that per Locke338 figure 2,5 a dressing interface (255) may be used with the dressing where the dressing connects to distribution components (Locke338 para. 0030). Per paragraph 0031, one such distribution component may be a fluid port for coupling and decoupling of components.
Regarding claim 20, Locke338 and Adie teach
The dressing of claim 18, where Locke338 discloses that the dressing further comprising an attachment device configured to be positioned on top of an edge of the cover to seal the perimeter (Locke338 abstract, para. 0008, 0039). Per para. 0008, as the attachment device is configured to seal the exposed perimeter of the cover, it is interpreted as being positioned on top of an edge of the cover.
Regarding claim 21, Locke338 and Adie teach
The dressing of claim 18, wherein Locke338 further discloses that the fluid control layer (Locke Fig. 2, (210)) comprises a hydrophobic film and a plurality of fluid passages in the hydrophobic film (para. 0049 of Locke338 where the layer (210) is hydrophobic, and para. 0054 where the same layer may comprise fluid restrictions (See figure 3 of Locke 338)), wherein the fluid passages are elastic and configured to expand or open in response to a pressure gradient (Locke338 para. 0054). The examiner notes that per paragraph 0054, a pressure gradient across the fenestrations of the defined fluid control layer may strain the material allowing for the fenestration’s dimensions to increase and allow fluid to flow through, and thus it is interpreted that said fenestrations are elastic.
Regarding claim 23, Locke338 and Adie teach
The dressing of claim 21, wherein Locke338 further discloses the fluid passages comprise a plurality of fenestrations. Per paragraph 0054, the fluid control layer may consist fluid restrictions in the form of fenestrations, where said fenestrations allow liquid movement through them (Locke338 para. 00054).
Regarding claim 26, Locke338 and Adie teach
The dressing of claim 21, wherein Locke338 further discloses that the fluid passages comprise a plurality of slots or slits, each of the fluid passages having a length less than 4 millimeters and a width less than 2 millimeters (Locke338 Para. 0055, where the length is disclosed to be less than 4mm and the with is disclosed to be less than 2mm).
Regarding claim 28, Locke338 and Adie teach
The dressing of claim 26, wherein Locke338 further discloses that the length of the fluid passages is less than 3 millimeters and the width of the fluid passages is less than 1 millimeter (Locke338 Para. 0055, where the length is disclosed to be less than 4mm and the with is disclosed to be less than 2mm, where a further range is provided wherein the length is at least 2mm and the width is at least .4mm). Therefore Locke338 disclose a length range of 2-4mm, which overlaps with less than 3mm, and a width of .8-2mm, which overlaps with less than 1mm. Should applicant further disagree, Locke338 provides a suitable size of 3mm length and .8mm width, with a tolerance of .1mm (2.9mm length and .7mm) which is within the claimed range.
Regarding claim 32, Locke338 and Adie teach
The dressing of claim 18, wherein Locke338 further discloses that the cover and the fluid control layer are laminated to the manifold (Locke338 Para. 0007, 0063). The examiner notes that further, as seen in figures 2,5 of Locke, the manifold (205) is located between the cover (125) and fluid control layer (210).
Regarding claim 33, Locke338 and Adie teach
The dressing of claim 18, wherein Locke338 fails to disclose in the previously mentioned embodiments that the dressing further comprises a sealing layer having a plurality of perforations adjacent to the fluid control layer. However Locke338 discloses a second embodiment of the dress substantially the same as the embodiment of figure 2, still comprising cover (116), manifold (205), and fluid control layer (210). (Locke338 Fig. 5, layer (505) seen adjacent to fluid control layer (210) and with a plurality of perforations, further seen in figure 7). Per paragraph 0074 and para. 0075, layer (215) is disclosed to be a sealing layer. Therefore as Locke338 teaches that an extra sealing layer may be provided in the dressing previously disclosed (para. 0074), it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide said sealing layer.
Regarding claim 35, Locke338 discloses
A method for treating a tissue site with negative pressure (Para. 0011, see also claim 88), the method comprising: applying a dressing to the tissue site (Fig. 1 dressing (104) applied to tissue site (114), where Fig. 2 shows a detailed embodiment of the dressing), the dressing comprising a manifold (205) and a cover (116); applying one or more attachment devices on top of an edge of the to seal an exposed perimeter of the dressing (Locke338 abstract, para. 0008, 0039). Per para. 0008, as the attachment device is configured to seal the exposed perimeter of the cover, it is interpreted as being positioned on top of an edge of the cover.
Locke338 further discloses fluidly coupling a fluid conductor to the manifold (Fig. 2, fluid conductor (250), para. 0031); fluidly coupling the fluid conductor to a negative-pressure source (Fig. 1 (102), para. 0027)); applying negative pressure from the negative-pressure source to the manifold through fluid conductor (Para. 0067, 0096, Fig. 1, claim 88); and maintaining at least 80% of the negative pressure in the manifold (Locke 338 Para. 0044, 0045). The examiner notes that per paragraph 0044, the layer (205), interpreted as the manifold as detailed under the rejection of claim 1, is configured to receive negative pressure from a source and distribute the pressure through multiple apertures. Further per paragraph 0045, the layer does so by being composed of an open cell foam comprising a plurality of apertures and fluid pathways. As the entire manifold therefore has apertures for distributing negative pressure and fluid flow, it is interpreted that the manifold maintains 100% of an applied negative pressure throughout the length.
While it is interpreted that the pressure is maintained throughout the length of the manifold, Locke338 fails to disclose the specific length of the manifold. Locke338 does disclose that the dressing may be cut to a desired size, or may be different sizes base on the type of treatment being implemented (para. 0008, 0036).
Adie teaches a wound dressing device and is thus considered analogous to the claimed invention. Adie teaches that different dressing sizes are used based upon the type of wound being treated, where the size is taught to be varied ranging anywhere from 10-20 cm in width and 20-40cm in length (para. 0179). Per the same citation, “the absorbent layer…have a length and width that are both 3-10cm shorter than the overall dressing. The examiner notes that as the overall dressing lengths were taught to range from 20-40cm, the range (3-10cm shorter) for the length would equate to approximately 10-37cm. Adie also discloses examples of the absorbent layer sizes, ranging from 10-30cm. The range of the length of the absorbent is thus interpreted to be 10-30cm. This range overlaps with the claimed range of 12-32cm. Further, Adie teaches that said absorbent layer may be a foam layer (para. 0144) Therefore as Adie teaches that dressings may comprise foam absorbent layers 10-30cm in length depending on the type of wound being treated, and Locke338 teaches that the wound dressing is customizable as desired, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the foam manifold layer of Locke338 with a length of 10-30cm based on the size of wound being treated. As such negative pressure would be applied throughout the length of the manifold, where based on the size chosen, the length would be at least 6cm. through the length. As such the prior art previously applied reads to the claimed limitation.
Regarding claim 36, Locke338 and Adie teach
The method of claim 35, wherein Locke338 further discloses applying the dressing comprises: sizing the dressing (Locke388 para. 0011, claim 88).
Regarding claim 37, Locke338 and Adie teach
The method of claim 35, wherein Locke338 further discloses that the manifold has a thickness of about 7 millimeters to about 9 millimeters (Locke338 Para. 0047 where a suitable thickness is disclosed to be 5-10mm depending on the material used).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke338 in view of Adie, and further in view of Locke et al. US 2019/0117861, hereafter Locke861.
Regarding claim 4, Locke338 and Adie teach
The dressing of claim 3 wherein the dressing interface is disposed at least 6 centimeters from an edge of the manifold. The examiner notes that as detailed under the rejection of claim 1, the size of the dressing may be varied, where a suitable size may be 30cm. As seen in figure 2 of Locke338, the defined dressing interface is at approximately a center point of the dressing, and therefore is centered at about 15cm (halfway between the 30cm length). Therefore it is interpreted that the interface is at least 6cm from an edge of the manifold. However, should applicant disagree with this interpretation, Locke861 is provided to teach this limitation.
Locke861 teaches a dressing for negative pressure wound therapy and is thus considered analogous to the claimed invention. Locke861 further teaches the use of a dressing interface for coupling a dressing to a negative pressure source (Para. 0008), where said interface may comprise an applicator and bridge as seen in figure 2 (applicator (208) bridge (209)), where said components connect to the dressing and source of negative pressure. Further, per paragraph 0084, the dressing interface, including the applicator and bridge may be formed as a single device and has a variable length that ranges from 15cm to 30cm. Therefore as Locke338 teaches the use of a dressing interface for connecting a negative pressure source to a dressing, and Locke861 teaches dressing interfaces for connecting a negative pressure source to a dressing are known in the art to have variable structures and sizes ranging from 15-30cm, it would have been obvious to one of ordinary skill in the art to modify the dressing interface of Locke338 to include the applicator and bridge as taught by Locke861, where doing so would give the interface a length of 15-30cm. The examiner notes that as detailed under the rejection of claim 1, the manifold has a variable length of 1-30cm based on the wound type and therefore a dressing interface with a length of 15cm would in part be at least 6cm from any edge of a 30cm manifold.
Conclusion
THIS ACTION IS MADE FINAL. 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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781