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 .
Status of the Claims
Claims field 07/06/2026 has been entered. Claims 1, 5-46 and 73-75 are pending and under consideration. Claims 22-46 and 73-74 remain withdrawn.
Claims 1, 5-21 and 75 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/07/2026 was filed after the mailing date of the non-final office action on 04/06/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
In response to the applicant’s argument with respect to 35 USC 102(a)(1) and 103 rejections that the prior art fails to teach “the channels being shaped to direct fluids laterally across the wound surface between the first and second ends of the device” have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation as presented below. Accordingly, this action is second non-final rejection.
In response to applicant’s argument, page 13, that there is no motivation to combine the teaching of Blott with that of Locke, because Blott fails to teach or suggest a need to prevent collapse of any channel, and even if one or ordinary skill were to have considered the device of Blott lacking in structural stability on the application of negative pressure, they would not have looked to Locke as a means to resolving such a lack. This is not found persuasive.
The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Blott teaches that fluid path for negative pressure and instillation of fluid are defined by narrow slots between stacks of resilient layer ([0105] and figures 10a-c), the resilient layer deforms under negative pressure, and the deformation obstructs or blocks the slots. Accordingly, one of ordinary skill in the art seeking to improve Blott and prevent the blockage of the channel resulting from deformation of the resilient layers would have been motivated to look to the structure of Locke, i.e., manifold comprising projections, which are configured to withstand pressure and maintain the fluid path open, as taught by Locke.
In response to applicant’s argument, page 13, that there is no motivation provided by Blott to have combined its disclosure with that of Lockwood. In order to provide for a configuration of a device disclosed in Blott (comprising as it does inlet and outlet manifolds) that was trimmable, a wholesale redesign of the device would have been required, and one that would not have been arrived at simply by combining the teaching of Blott with that of Lockwood. This is not found persuasive.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642. In the instant case, the proposed modification does not require a wholesale incorporation of Lockwood into Blott. Instead, Lockwood’s teaching of a trimmable wound dressing is relied upon to modify Blott’s dressing. Lockwood explicitly provides the motivation for this modification, namely providing a trimmable dressing capable of accommodating various wound sizes. As set forth in MPEP, applying a known technique to a known device to yield predictable results is within the ordinary skill in the art. Trimming wound dressings to accommodate different wound sizes was well known in the art at the time of the invention. Accordingly, combining Lockwood’s trimmable feature with Blott’s device is a predictable application of a known technique with a reasonable expectation of success.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8, 10-13, 15-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blott et al (US 20110213319 A1)
Regarding claim 1, Blott teaches a wound interface device (figures 1 and 10-c and [0449, 0495-0508], dressing 2 incorporating manifold stack 120) for use in negative pressure wound therapy, the device comprising:
a flexible body (figures 10-c and [0105] manifold stack 120 made of flexible material) having a plurality of spacers (figure 10a-c, layers 121-125), the spacers configured to define a therapy space (figures 1 and 10a-c, the manifold stack 120 is configured to be positioned above wound surface 5 and defining a therapy space therebetween) between a wound surface and a wound facing surface of the device body;
an inlet (figure 1 and [0449] point 8 for inlet pipe 6 connection) for the instillation of fluids to a wound site; and
an outlet (figure 1 and [0449] point 11 for outlet pipe 9 connection) for the removal of fluids from the therapy space;
wherein the inlet is configured to deliver fluid to an area adjacent a first end of the device (figure 1 and annotated figure [0449, 0495-0508], the inlet is configured to supply fluid to the edge 126 adjacent to the first end of the device), and the outlet is configured to remove fluid from an area adjacent to a second, opposite, end of the device (figure 1, and annotated figure [0449, 0495-0508], the outlet is positioned and configured to remove fluid from the edge 132 adjacent to the second end of the manifold stack 120);
wherein the spacers define multiplicity of channels (annotated figure and [0449, 0495-0508], the manifold stack 120 comprising slot spreads into four adjacent branches 128 and 133 that defines plurality of fluid channels between the first and second ends) between the first and second ends of the device;
and wherein the channels are shaped to direct fluids laterally across the wound surface between the first and second ends of the device (annotated figure and [0449, 0495-0508], lateral flow, the fluid supplied from the inlet positioned at 127 is directed and distributed to the slot formed in inlet manifold slot 126, the fluid passes through apertures, 129, 130 and 134, and then flows laterally beneath layer 125 adjacent to the wound. The fluid subsequently flows back through apertures 135 and slots 133 and ultimately exits through the outlet pipe 9 positioned at edge 132).
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Regarding claim 8, Blott teaches a wound interface device as claimed in claim 1.
Blott further teaches wherein the body comprises a compliant, flexible member that flexes to conform to the contours of various wound surfaces ([0105] the dressing is made of flexible material configured to conform with wound surfaces).
Regarding claim 10, Blott teaches a wound interface device as claimed in claim 1.
Blott further teaches wherein the inlet comprises an inlet port (figures 1 and 10a, [0449] point 8 comprises inlet pipe 6 for coupling fluid reservoir 12a to the body) for coupling to a fluid source; and
an inlet channel (annotated figure and [0495-0508], a fluid channel defined in slot 126 is in fluid communication with the inlet port and configured to deliver fluid to the first end) in fluid communication with the inlet, configured to deliver fluid to the first end of the device.
Regarding claim 11, Blott teaches a wound interface device as claimed in claim 10.
Blott further teaches wherein the outlet comprises an outlet port (figures 1 and 10a [0162 and 0502] point 11 comprises outlet pipe 9 for coupling pump 18 to the body) for coupling to a negative pressure source; and
an outlet channel (annotated figure and [0495-0508] a fluid channel defined in slot 132 is in fluid communication with the outlet and configured to remove fluid to second end) in fluid communication with the outlet port, configured to remove fluid from the second end of the device.
Regarding claim 12, Blott teaches a wound interface device as claimed in claim 11.
Blott further teaches wherein the inlet channel extends in a first direction (annotated figure, portion of the inlet channel in layer 122 at least extends along the first direction), and the outlet channel extends in a second direction that is perpendicular to the first direction (annotated figure, portion of the outlet channel in layer 124, the portion extends along edge 132, extend along the second direction that is perpendicular to the first direction).
Regarding claim 13, Blott teaches a wound interface device as claimed in claim 12.
Blott further teaches wherein the outlet channel extends in a transverse direction of the device (annotated figure, at least a portion of the outlet channel in layer 124, the portion extends along edge 132, extends along the transverse direction).
Regarding claim 15, Blott teaches a wound interface device as claimed in claim 11.
Blott further teaches wherein the outlet channel comprises an elongate slot (annotated figure, the outlet channel formed of slot 131 allows the ingress of fluid from the therapy space into the outlet) positioned to allow the ingress of fluids from the therapy space into the outlet channel.
Regarding claim 16, Blott teaches a wound interface device as claimed in claim 15.
Blott further teaches wherein the slot extends in a transverse direction of the device (annotated figure, at least a portion of the slot 131 extends along transverse direction).
Regarding claim 17, Blott teaches a wound interface device as claimed in claim 11.
Blott further teaches wherein the outlet channel comprises a plurality of apertures (annotated figure [0504] apertures 135 allows the ingress of fluid from the therapy space into the slot 131) to allow the ingress of fluids from the therapy space into the outlet channel.
Regarding claim 19, Blott teaches a wound interface device as claimed in claim 11.
Blott further teaches wherein the body is formed from an elastomeric material ([0105] dressing is made of resiliently deformable material for example thermoplastic elastomers and elastomer blends).
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.
Claims 5-7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Blott et al (US 20110213319 A1) in view of Locke et al (US 20210045927 A1).
Regarding claim 5, Blott teaches a wound interface device as claimed in claim 1.
Blott does not teach wherein the spacers are shaped and distributed to prevent collapse of the spacers and/or of the therapy space under the application of negative pressure to the therapy space.
In the same field of endeavor, namely a dressing using differential surface features for use in compartment spaces, Locke teaches wherein the spacers are shaped and distributed to prevent collapse of the spacers and/or of the therapy space under the application of negative pressure to the therapy space (figures 24-25 and [0084], tissue interface 108 include layers 2402, 2404, 2406 and 2408, and each layers comprises bubbles 210 ).
Therefore, 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 Blott to incorporate the teachings of Locke and provides the spacers as claimed for the purpose of preventing the spacers from collapsing under therapeutic levels of negative pressure thereby maintaining the channel open and preventing obstruction of fluid, as taught by Locke ([0081 and 0084]).
Regarding claim 6, Blott teaches a wound interface device as claimed in claim 1.
Blott does not teach wherein the spacers comprise shaped projections.
In the same field of endeavor, namely a dressing using differential surface features for use in compartment spaces, Locke teaches wherein the spacers comprise shaped projections ([0103] bubbles 210 in form of open-celled blisters, spacers, protrusions, or closed cells)
Therefore, 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 Blott to incorporate the teachings of Locke and provides the spacers as claimed for the purpose of preventing the spacers from collapsing under therapeutic levels of negative pressure thereby maintaining the channel open and preventing obstruction of fluid, as taught by Locke ([0081 and 0084]).
Regarding claim 7, Blott, as modified by Locke, teaches a wound interface device as claimed in claim 6.
The combination further teaches wherein the spacers each comprise a convex wound contacting surface (Locke; figure 25, at least first layer 2502 comprises bubbles 210 that convex toward wound 2572).
Regarding claim 21, Blott teaches a wound interface device as claimed in claim 1.
Blott does not expressly teach wherein the body is liquid and air impermeable.
In the same field of endeavor, namely a dressing using differential surface feature for use in compartment spacers, Locke teaches wherein the body is liquid and air impermeable ([0079] manifold 202 formed of liquid impermeable material).
Therefore, 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 Blott to incorporate the teachings of Robinson and provides the body as claimed for the purpose of permitting the fluid within the body flow through the channels, as taught by Locke [0079], thereby facilitating fluid and negative pressure distribution across the body.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Blott et al (US 20110213319 A1) in view of Lockwood et al (US 20020161346 A1).
Regarding claim 9, Blott teaches a wound interface device as claimed in claim 1.
Blott does not teach the device is trimmable to fit within the perimeter of various wounds.
In the same field of endeavor, namely a vacuum therapy and cleansing dressing for wounds, Lockwood teaches the device is trimmable to fit within the perimeter of various wounds ([0013-0014]).
Therefore, 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 Blott to incorporate the teachings of Lockwood and provide the device as claimed for the purpose of accommodating different sized wounds as taught by Lockwood ([0103]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Blott et al (US 20110213319 A1) in an alternative view of Blott et al (US 20110213319 A1; figure 13a);
Regarding claim 14, Blott teaches a wound interface device as claimed in claim 12.
Blott does not expressly teach wherein the inlet and outlet ports are provided on a moulded member extending from an opposite side of the device body to the wound facing side.
However, Blott teaches, in an alternate embodiment of figure 13a, wherein the inlet and outlet ports are provided on a moulded member (figure 13a, inlet and outlet pipes 346 and 347 are provided on a moulded boss 351 extending from an upper surface of backing layer 342 to opposite wound facing side) extending from an opposite side of the device body to the wound facing side.
Therefore, 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 Blott to incorporate the teachings of Blott and provides the inlet and outlet ports on the moulded member as claimed for the purpose of reinforcing coupling between the inlet/outlet ports and the fluid source/negative pressure source as taught by Blott ([0166]).
Claim 18 and 20 rejected under 35 U.S.C. 103 as being unpatentable over Blott et al (US 20110213319 A1) in view of Locke et al (US 20180353339 A1, hereinafter Locke’339).
Regarding claim 18, Blott teaches a wound interface device as claimed in claim 17.
Blott does not teach wherein the outlet channel apertures comprise slits that are substantially perpendicular to a plane of the body of the device.
In the same field of endeavor, namely a composite dressing for negative pressure treatment, Locke’339 teaches wherein the outlet channel apertures comprise slits (figure 7, one or more slits 220 extend through the first layer 205 and perpendicular to a plane of the dressing 104) that are substantially perpendicular to a plane of the body of the device.
Therefore, 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 Blott to incorporate the teachings of Locke’339 and provides the outlet channel remain closed in an unstrained state to restrict flow and open under a pressure gradient as taught by Locke’339 ([0009, 0010 and 0055]), which prevent the backflow of wound exudate, thereby isolating the therapy space to maintain a desired wound healing environment.
Regarding claim 20, Blott teaches a wound interface device as claimed in claim 1.
Blott does not teach wherein the body is formed from silicone.
In the same field of endeavor, namely a composite dressing for negative pressure treatment, Locke’339 teaches wherein the body is formed from silicone ([0007, 0042 0048-0050] the dressing is made of silicone).
Therefore, 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 Blott to incorporate the teachings of Locke’339 and provides the body as claimed for the purpose of ensuring minimal interaction with biological tissues and fluid. This low-adhesion surface facilitates free liquid flow and reduce debris buildup which promotes wound healings as taught by Locke’399 ([0050]).
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Blott et al (US 20110213319 A1) in view of Mercer et al (US 20180214315 A1)
Regarding claim 75, Blott teaches the wound interface device according to claim 10.
Blott further teaches wherein the outlet comprises an outlet port (figure 1, the point 11 comprises outlet pipe 9 for connecting pump 18) for coupling to a negative pressure source, and an outlet channel (figure 1, annotated figure and [0449, 0495-0508] a fluid channel defined in slot 13 is in fluid communication with the outlet and outlet pipe) in fluid communication with the outlet port;
Blott does not expressly teach wherein the inlet port and outlet port co-reside at the same location on the body of the device at a connection point
In the same field of endeavor, namely a multi-layer abdominal closure dressing with instillation capabilities, Mercer teaches wherein the inlet port and outlet port co-reside at the same location on the body of the device at a connection point (figures 3-17 and [0085], specifically figures 3, distribution hub 160 co-reside with fluid removal hub 154 in treatment device 101 configured to be coupled to an interface 132 as shown figure 2).
Therefore, 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 Blot to incorporate the teachings of Mercer and provides the inlet and outlet ports as claimed for the purpose of providing a single integral port arrangement that facilitates both the supply of fluid to and removal of fluid from the body, as taught by Mercer ([0044]) . Such an arrangement allows the backing layer covering the body only requiring a single opening that accommodates both the fluid inlet and outlet ports, thereby improving sealing and aesthetics.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/SETH HAN/Examiner, Art Unit 3781
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